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spk02: Good day and welcome to the Hamanetics Third Quarter Fiscal 23 Conference Call and Webcast. At this time, all participants are in a listen-only mode. After the speaker's presentation, there'll be a question and answer session. Instructions will be given at that time. As a reminder, this call is being recorded. I would like to turn the call over to David Trink, Manager, Investor Relations. You may begin.
spk20: Good morning, everyone.
spk21: Thank you for joining us for Humanetics third quarter fiscal 23 conference call and webcast. I'm joined today by Chris Simon, our CEO, Roy Galvin, president of our Global Plasma and Blood Center businesses, and James Durecka, our CFO. This morning, we posted our third quarter and year-to-date fiscal 23 results to our investor relations website, along with updates to our fiscal 23 guidance and the analytical tables with the information that we will refer to on this call. Unless otherwise noted, all revenue growth rates we will discuss today are organic and exclude the impact of currency fluctuation, strategic exits of product lines, acquisitions, and divestitures. Additionally, to help investors understand Humanetics' ongoing business performance, we will refer to non-GAAP financial measures. These measures exclude certain charges and income items. For additional details about excluded items, comparisons with the same periods in fiscal 22, and reconciliations to our GAAP results, please refer to our third quarter and year-to-date fiscal 23 earnings release posted on our IR website. Our remarks today will also include forward-looking statements, and our actual results may differ materially from the anticipated results. Please refer to the Safe Harbor Statement in the earnings release and other filings with the SEC for a complete list of risk factors that may impact our results. Additionally, in order to protect customer confidentiality, we will not be able to discuss any customer-specific details except as disclosed previously. And now, I'd like to turn it over to Chris.
spk17: Thanks, David. Good morning, and thank you all for joining. Today, we reported third quarter organic revenue growth of 21%. and adjusted earnings per diluted share of 85 cents, 1% growth over a record third quarter last year. Our third quarter results show that our long-range plan is driving continued strong performance. With growth in revenue across all of our business units, despite the macroeconomic environment, we continue to build significant momentum. We're harnessing this momentum to invest further in our plan and create additional opportunities to accelerate transformational growth. In plasma, our value proposition is unrivaled, enabling us to support the industry's record recovery by helping customers win donors and increase productivity to grow collections. Recently, we amended our non-exclusive supply agreement with CSL for the use of PCS2 devices and disposable kits to extend the term from December 2023 to December 2025. We look forward to continuing to provide CSL and all of our plasma customers with the highest level of service and support. In hospital, we remain focused on growing our market share both in the U.S. and internationally by advancing our technology and seeking targeted acquisitions to improve standards of care. In blood center, we are capitalizing on opportunities created by our agility and resilience to win with customers and extend our leadership in the new markets. We are pleased with our performance and the steps we have taken to accelerate revenue and adjusted EPS growth. We are not immune to the macroeconomic challenges of foreign exchange, inflation, supply discontinuities, and geopolitical risk. However, heightened demand for our products continues unabated. The essential nature of our solutions and the durability of our businesses, even during uncertain times, have us well positioned for sustained growth and market leadership. We have demonstrated perseverance in the ability of our global manufacturing and supply chain to fulfill our customers' needs uninterrupted. With increasing capital capacity and a robust allocation strategy, we are confident we can continue to deliver best-in-class solutions to our customers and attractive returns to our shareholders. We look forward to a strong fiscal 23 finish and carrying that momentum into fiscal 24. Now onto our business results and guidance. I will begin with total revenue and hospital, and Roy will discuss global plasma and blood center. Corporate revenue grew 21% in the quarter and 22% year to date due to accelerating growth in both hospital and plasma. We now expect fiscal 23 organic revenue growth in the range of 18 to 20% compared with 15 to 18% previously. Hospital revenue grew 14% in the quarter and 17% year-to-date as we meaningfully grew revenue and market share despite hospital staffing shortages, budgetary constraints, and COVID-related challenges in China. Hemostasis management revenue grew 7% in the quarter and 8% year-to-date. Growth in North America, our largest market, was 16% in the quarter and 13% year-to-date, driven by strong adoption and utilization of TEG disposables. International growth was partially offset by a difficult year-on-year comp due to a large national European tender for clot pro in fiscal 22 and the effects of COVID in China. Vascular closure revenue grew 33% in the quarter and 37% year-to-date. The adverse seasonality and procedure volumes that we experienced in our second quarter persisted, but we saw encouraging improvement in December and into our fourth quarter. Our growth is disproportionately being driven by converting new electrophysiology accounts from the top 600 hospitals, further increasing our U.S. penetration and market share. We are excited about CE Mark certification for Vascaid. As we move forward with commercialization in Europe, we plan to use a direct sales model and leverage our existing back office infrastructure. This is one of many investments we are making to solidify our leadership position on vascular closure and accelerate revenue growth. Transfusion management revenue grew 13% in the quarter and 23% year-to-date. Growth was driven by new software implementations in the US and UK and our previous investments to expand the sales force. Lastly, self-salvage revenue grew 1% in the quarter and 2% year-to-date, benefiting from favorable order timing among EMEA distributors and strong capital sales partially offset by weakness in China. In November, we received FDA approval for our CellSaver Elite Plus, featuring new intelligent control software to enhance simplicity and efficiency. It is another example of the investments we are making to solidify our market leadership, and we anticipate full market release in the U.S. before fiscal year end. We are enthusiastic about opportunities in our hospital business and the strong value of our products. We've done a lot of work to transform this business into a growth engine and feel very confident about the continued momentum. We update our expectation for hospital organic revenue growth to be approximately 19% in fiscal 23. The lower end of our previously issued guidance range of 19 to 22% due primarily to COVID-related challenges in China.
spk24: Now, over to you, Roy. Thank you, Chris. Good morning, everyone. This is my first time speaking with you since I joined Hemanetics at the start of our third quarter, and I'm very pleased to be here to talk about our plasma and blood center results. It's been a great quarter for both businesses. In plasma, revenue increased 42% in the third quarter and 48% year-to-date. North America disposals represented 85% of our plasma revenue and increased 46% in the quarter and 52% year-to-date, driven by strong growth in collection volume and price. as a result of the technology upgrades. Volume growth was pronounced across all geographies. In the US, plasma collections grew 26% in the quarter and 34% year-to-date, excluding CSL. In Europe, collections grew in the mid-teens in the quarter and year-to-date. Both geographies have surpassed pre-pandemic collection levels and are growing to meet patient demand. We remain focused on providing our customers with the tools necessary to support continued recovery and attract and retain their donors. Our persona technology represents over half of the nexus collections in the U.S. today and is an enabler of plasma volume growth and improved central efficiency. Since the commercial launch of this technology, more than 12 million persona procedures have been completed. The real-world data collected has reinforced the safety profile established in the original IMPACTS plasmapheresis clinical trial when combined with our NexLink DMS software and other digital tools Plasma Center has also experienced shorter door-to-door times and an overall more favorable donation experience. The substantial cost-per-liter improvement available through our integrated Nexus platform is unrivaled within the industry, and we are just getting started. Encouraged by the strength of our business and the opportunity to continue to support CSL as a result of the newly amended agreement, we are raising our fiscal 23 organic plasma revenue guidance to 35% to 40% growth. Up from the 30 to 35% growth we communicated last quarter. In Blood Center, revenue grew 3% in the quarter and declined 1% year to date. The environment for this business continues to be challenging. However, we remain focused on providing top quality products and the highest level of customer support while utilizing the strength of our supply chain and our technology to increase our market share. A3C's revenue declined 3% in the quarter and 6% year to date. This business was affected by unfavorable order timing, lower revenue from convalescent plasma, staffing and donor shortages at blood centers across the globe, and COVID-related challenges in China. Partially offsetting these was an increase in capital sales from an Egyptian plasma effort undertaken in partnership with a global plasma customer. Old Blood revenue increased 20% in the quarter and 11% year-to-date. Growth in this product line, both in the quarter and year-to-date, was driven by our hardy supply chain that enabled us to serve customers in need and favorable order timing in EMEA and Asia Pacific. Before I discuss updates to Blood Center guidance, I would like to remind everyone that earlier in the pandemic, we benefited from increased levels of safety stock across many of our customers. What we observed in the third quarter is the beginning of an inventory rationalization which we believe will continue into the fourth quarter and potentially beyond. We are confident in the continued durability of our blood center business and update our expectations of revenue decline to negative 2% to 4% in fiscal 23 compared with a negative 2% to 5% previously. Our guidance reflects strong year-to-date results and the anticipated impact of inventory rationalization. Now over to James to discuss the rest of the financial results and guidance.
spk17: Thank you, Roy, and good morning, everyone. As you heard from Chris and Roy, all of our businesses are performing exceptionally well. The demand for our products is strong, and we are doing everything we can to ensure uninterrupted supply and best-in-class service to our customers. In order to ensure continued success in fiscal 24, we are proactively making changes to our manufacturing and supply network. This includes increasing our production capacity for plasma disposables and securing additional vendor contracts. Most initiatives are underway, resulting in an additional impact on operational efficiencies in the second half of our fiscal 23, which I will discuss in more detail momentarily.
spk13: Moving on to gross margins.
spk17: The third quarter adjusted gross margin was 52.5%, a decrease of 240 basis points compared to last year, when we reported one of our highest ever adjusted gross margins of 54.9%. We continue to experience strong volume growth and realize benefits from price and our operational excellence program. Offsetting these benefits was a 70 basis point one-time inventory charge. Due to the effects of COVID in China, additional inflationary pressures, including operational inefficiencies, as we work to increase our production capacity and higher depreciation expenses. Adjusted gross margin year-to-date was 53.7%, a decrease of 40 basis points compared with the first nine months of the prior year. The primary drivers include strong growth in volume, benefits from price, mix, and our operational excellence program offset by higher manufacturing and supply chain costs and depreciation expense. Adjusted operating expenses in the third quarter, $101.4 million, an increase of $17.6 million, or 21%, compared with the prior year. As a percentage of revenue, adjusted operating expenses increased by 90 basis points to 33.2%. Adjusted operating expenses year-to-date were $299.9 million, an increase of $46.7 million, or 18%, compared with the prior year. As a percentage of revenue, adjusted operating expenses year-to-date decreased by 10 basis points to 34.7%. Higher adjusted operating expenses in both periods were driven by higher performance-based compensation, continuous investments in sales and marketing, higher freight costs and normalized spending levels partially offset by additional savings from the Operational Excellence Program. In our third quarter, we also had higher research and development costs primarily driven by increased investments in product innovation. Adjusted operating income was $59 million in the third quarter and $164.5 million year-to-date, representing increases of $.2 million and $24 million, respectively. As a percentage of revenue, adjusted operating margin was 19.3% in the third quarter and 19% year to date, down 330 basis points and 30 basis points, respectively, when compared with the same periods in fiscal 22. We reaffirm our adjusted operating margin guidance in the range of 18 to 19%. Our adjusted operating margin guidance includes higher performance-based compensation, approximately 380 basis points of impact from macroeconomic headwinds, and increased operational inefficiencies partially offset by $26 million in target fiscal year 23 gross savings from the Operational Excellence Program. The adjusted income tax rate was 25% in the third quarter, and 24% year-to-date, compared with 21% and 22% in the same period in fiscal 22. The higher income tax rate in our third quarter was related to changes in jurisdictional earnings, as well as a one-time catch-up related to executive stock compensation. We expect our fiscal 23 adjusted income tax rate to be approximately 24%. Third quarter adjusted net income was $43.6 million, up approximately $1 million or 2%, and adjusted earnings per diluted share was 85 cents, up 2% when compared to the third quarter of fiscal 22. Year-to-date adjusted net income was $116.5 million, up $17 million or 18%, and adjusted earnings per diluted share was $2.26, up 17% when compared with the first nine months of fiscal 22. The combination of the adjusted income tax rate, interest expense, and FX had a negative $0.02 and $0.12 impact on adjusted earnings per diluted share in the third quarter and year to date, respectively, when compared with fiscal 22. We are updating our fiscal 23 adjusted earnings for diluted share guidance to be in the range of $2.90 to $3, compared with the previous guidance of $2.70 to $3.
spk13: The midpoint of our adjusted earnings for diluted share guidance includes an approximate $0.16 headwind from volatility in foreign exchange, adjusted income tax, and slightly higher interest expense.
spk17: Now let's discuss our balance sheet and cash flow. Cash on hand at the end of the third quarter was $224 million, down $36 million since the beginning of the fiscal year, primarily due to the $75 million accelerated share repurchase program, $35 million in earn-out payments related to previous acquisitions, and a 30 million euro investment in VivaSure Medical, partially offset by higher net income. Free cash flow before restructuring and restructuring-related costs was $119 million, compared with $75.8 million in the first nine months of the prior year. The higher free cash flow before restructuring and restructuring-related costs was mainly due to higher cash flow from operating activities. These include significantly higher net income, lower inventory, primarily due to the nexus conversions in the U.S., and higher accrued liabilities, including higher performance-based compensation, excluding capital placements, inventory increased year over year. We believe in our ability to generate strong cash flow and update our guidance for free cash flow before restructuring and restructuring-related costs for fiscal 23 to be in the range of $160 to $180 million, compared with $150 to $180 million previously.
spk16: The updated guidance reflects higher net income and additional benefits from networking capital in fiscal 23.
spk17: Before I turn the call back to the operator, I'd like to summarize a few key takeaways from today's call. In our plasma business, we are experiencing unprecedented growth in collection volume across all of our customers, disproportionately contributing to the anticipated 35% to 40% revenue growth in our fiscal 23. Our technology is enabling substantial cost per liter improvement, and we are making meaningful progress with our innovation agenda. Hospital growth is propelled by revenue growth in hemostasis management and vascular closure, strengthening our market leadership and improving our adjusted gross margins.
spk13: This business continues to prove itself as a growth engine, and we look forward to continued momentum in fiscal 24.
spk17: The margin expansion goals we presented in our long-range plan are on track despite the additional near-term operational inefficiencies. The Operational Excellence Program continues to provide meaningful benefits for our company, from mitigating the effects of macroeconomic headwinds to helping effectively meet customer demand for our products. And finally, the strength of our underlying business coupled with steps we've taken over the past few months, will enable consistent expansion of our capital capacity. With the capital allocation priorities being unchanged, we will be disciplined with allocating capital to high impact, high ROI projects that accelerate growth and value creation.
spk16: Thank you for your time today.
spk13: And operator, you may now begin the Q&A.
spk02: Thank you. If you'd like to ask a question, please press star 1-1. If your question has been answered and you'd like to remove yourself from the queue, please press star 1-1 again.
spk35: One moment while we compile the Q&A roster.
spk02: Our first question comes from Drew Ranieri with Morgan Stanley. Your line is open.
spk32: Hi, good morning. Thanks for taking the questions. Chris, maybe kind of a first multi-part question. But just kind of given the current environment right now and your recent commentary at a conference, you sounded very confident in growth in every year of your LRP and including next one. Just how should we think about that, especially in the context with the amended CSL agreement and how you're thinking about that influencing the near-term plan? And then just on CSL, I know you don't want to get into the specifics on revenue, but for whatever assumptions investors want to make on the revenue impact for 23, 24, or 25, can you just maybe talk about the potential flow through to EPS? I mean, at Analyst Day, you gave a slide that gave us some incremental detail there for fiscal 2022, but just maybe walk us through the puts and takes if anything has kind of changed on that end. Sorry for the multi-part there.
spk17: Thanks, Drew. Appreciate you dialing in. In terms of the macro environment and our degree of confidence, it remains quite high, right? There are external challenges for sure, but I think as an organization, we benefit as much in this environment as we are challenged. We look at the durability of our blood center business. We look at the essential nature of what we do in hospital, whether it's cardiovascular or interventional cardiology or trauma, transplant, right? These are all high demand issues. So if hospitals are staffed and functioning, we're going to continue to perform as we have. And then plasma has done very well in good markets and in bad alike. And there's clearly strong forces at work that are helping what our customers are leaning heavily into, which is to drive increased plasma collections. So There are challenges on the cost side. James highlighted a bunch of those, and we're happy to talk through those. But from a macro perspective, there's real uptick in demand, and we don't see that abating across any of our three businesses anytime soon. In terms of the CSL agreement, I know there's a ton of curiosity around that, and I appreciate that you can understand that the terms of the agreement are strictly confidential. What I would say at the macro level, again, is This is good for patients, it's good for donors, it's good for customers, and it's good for shareholders. Our view from this from the outset has been that we are playing the long game and we will continue to invest and deliver accordingly. Anything that gets pulled forward from the CSL agreement will be additive to our prior commitments around growth in each year of the LRP and the overall margin expansion that we've outlined.
spk32: Thanks. And then just maybe a near-term question, but with a biotech company's readout potentially in the second quarter, how are you kind of thinking about that as a potential structural impact for plasma over the longer term? Thanks for taking the questions.
spk17: Yeah, thanks, Drew. We look at that near and long term. We've done a bunch of modeling. We don't profess to have any proprietary insight beyond what we hear from key opinion leaders and what we know from other algorithms of competitive entries in the biologic space. Candidly, from a patient service perspective, we hope that anti-FCRN has a role to play going forward, particularly in therapeutic areas where IG may not be the most efficacious treatment. From what we have seen and the most recent communications, We stand firm around our original assumptions, which is we've always talked about the long-term growth in demand for IG somewhere in that six to 8% range. And, you know, you can shave a point off of that, I guess, in either direction, depending on the relative success of the FCRN players. But from our vantage point, we feel quite good about that base assumption. We're going to watch carefully to see the next milestone readouts and talk closely with all of our customers about their view on this. But 6% to 8% demand for IG converts nicely to 8% to 10% demand in collection volumes, probably closer to 10% to 12% organic growth just given changes in the nature. Subcutaneous, for example, requires more IG for the same dose equivalency. We'll see this revert eventually to that long-term mean of 8% to 10% with a bit higher in our business because of mix and some of the other things that we have going on. But there's nothing we've heard or seen that would back us off of that long-range forecast.
spk33: Great. Thanks for taking the questions.
spk02: Thank you. Our next question comes from Mike Mattson with Needham & Company. Your line is open.
spk15: Yeah, good morning. Thanks for taking my questions. So I want to ask one on the gross margins. We've seen some really strong growth from the overall company and from the plasma business here. But yeah, your gross margins have been down. And I understand there's some one-off factors, inflation and things like that. But I guess, is there just a mix effect happening with, you know, the plasma gross margins being lower and that's where you're seeing the strongest growth? Or, you know, I guess why isn't, you know, I would have guessed you would have seen more leverage just given how fast that plasma business is growing.
spk17: Yeah, hi, Mike. It's James. Thanks for the questions. Yeah, on gross margin, you know, it actually is – you know, the mix element has been favorable to us along with our OEP savings.
spk13: But what's taken us in the opposite direction and offset those benefits is really a few things which we've kind of highlighted. One is the additional depreciation from our nexus systems.
spk17: And then the other one, which is the bigger part, is the manufacturing headwinds on inflation that you just referenced.
spk13: But also, as I noted in my remarks, we've been experiencing, I would say, larger than usual operational inefficiencies due to the strong growth.
spk17: That's put us in a position to have to buy components and other manufacturing inputs at spot prices. So things like sterilization or hard to find parts, which in the past you used to have to order in advance. Now when you have to go into the spot market, it raises the prices and it's having an effect on our margin. Longer term, however, We see that part of it, I'll call it the temporary inefficiency part of it, abating as our production plans become more crystallized. We do see over the longer term the one effect that you just said, mix, really helping us, volume helping us, and then by removing those inefficiencies that I just spoke about, that's what will push us, you know, push our gross margins much higher as we get out into our LRP.
spk15: That's helpful. Thanks. And then I understand, you know, that you don't want to really comment on the specifics of the CSL agreement, but, you know, we do have to update our models for 24 and 25 and I think for the most part, based on what you said at the analyst day, we took our CSL out of our – we're assuming no CSL revenue beyond 23. So, I mean, is that kind of a message here just to be conservative and not put anything in there for now until you guys give your guidance, I guess, for 24 or –
spk17: So Mike, it's a challenge and we appreciate what you're trying to do on that. We just need to balance disclosure requirements on one hand and our desire for transparency with the need to protect customer confidentiality across the board. This is now effectively a three-year agreement, so we think differently about the duration. Sitting here where we are at this point with less than two months remaining in the fiscal year, yes, we can confirm there will be revenue from CSL in FY24. The process that we're about to go through with all of our customers is to get very clear about what the demands are. We are facing unprecedented demand. It's great. We've expanded our manufacturing capacity, our supply chain resilience, et cetera, to respond, and the response has been nothing short of extraordinary in the eyes of our customer. So we feel great about that and our ability to continue to deliver over the next two months We'll sit down and go through this in detail with each of our customers, and the additional volumes will be included when we guide in May for FY24.
spk18: Okay, got it. Thank you.
spk02: Thank you. Our next question comes from Joanne Wundt with Citi. Your line is open.
spk25: Hi. Good morning, and thank you for taking the question. I actually have two questions. If you previously gave us $88 million for CSL contribution in this fiscal year, and then you raised the guidance for the fiscal year for plasma, is that raise all attributed to the new extended agreements, or is there something else in there?
spk17: Hey, Joanne. What we'd say is the guidance that we've put forward for the year reflects strong volume momentum, favorable mix, and improved price across all of our customers. As I said, we increased production and improved both the agility and resilience of our supply chain to provide uninterrupted supply. We and our customers are benefiting from that, as are the patients that they care for.
spk25: Okay. My second question has to do with China. Could you just peel apart for us what is happening in that market for you, and then how do we think about it falling off over the next couple of quarters and becoming less of a headwind? Thank you.
spk17: Yep. So two of our businesses are well represented there, both our blood center business and our hospital business. I'll get us started, and if there's any further follow-on questions, I'll defer to Roy for the blood center piece. Blood collections in plasma are different. They are overseen by the central government, and fortunately for us, because of the government's approach there, we've had good volume and demand throughout. We're the share leader there, and we've benefited by that. So blood is largely unaffected. That's probably not fair to the folks on the ground who are working feverishly to actually be able to deliver, but from a results perspective, it's largely unaffected. Where we're getting challenges is in the hospital base in terms of procedure volumes and with the various waves and the change in policy towards COVID, both our cell salvage and our tag businesses have had meaningful challenge kind of delivering. We thought Going into this, we'd see abatement in the second half of the year. We don't expect meaningful abatement, certainly over the next two months, and we'll get our heads around this and what that means for next year's guidance. That's the primary driver of why we now see hospital coming in closer to 19% for the year.
spk02: Thank you. Thank you. As a reminder, to ask a question, please press star 1-1. And our next question comes from Anthony Patron with Mizuho. Your line is open.
spk19: Thanks. Congrats on another good quarter here. A couple on plasma and a follow-up on hospital. Maybe, Chris, the language in the queue on CSL, it mentions PCS2. Just wondering if there is a potential that they take a look at Nexus Persona, just considering the real-world experience out there with yields and how that plays into the extension. And then the follow-up on plasma would just be, again, how do we think about the additional volume flowing through the margins? Obviously, excess volume plays at the margins, so what is the potential movement in margins, both gross and operating, from the additional volumes? And I'll have one follow-up on hospital. Thanks.
spk17: Thanks, Anthony. The CSL agreement is essentially an extension off of the existing agreement, which is non-exclusive for PCS2 devices and the disposables through those devices. So that hasn't changed. As it pertains to, you know, how we think about plasma and volumes and margin, maybe I'll invite Roy to comment.
spk24: Thanks, Anthony. You know, the plasma business overall is going very well in the U.S. We're seeing a growth overall sitting around 46%. So it's going very well overall. We're pleased with how things are going. As far as the business is concerned, long term, we're really going to have to watch how the economy impacts that and how the growth of the sort of business continues as we see changes in the macroeconomics around the U.S., which are really helping drive some of the growth in the plasma business. As far as margin is concerned, obviously, that will be driven as we move forward with any kind of conversions around product. That's something we'll see in the future possibly. But at this point, we're just really focused on grabbing the volumes, continuing to drive our production upwards, and making sure we're as successful as we can be supplying our customers and staying ahead of their demand.
spk19: Great. Maybe the follow-up on hospital, just on Vascade, maybe just to recap on the penetration in the 600 target EP sites in the U.S., sort of where that sits and how we should think about how the European launch of Vascade MVP should play out. over the next few quarters. Thanks.
spk17: Yeah, thanks for the questions, Anthony. In terms of Vascaid, it continues to exceed even our own high expectations for that product mix. What we're seeing in the U.S., you know, clearly there's some seasonality and some challenges. We're not immune from those in terms of electrophysiology procedures. What's really impressive for that team is as we saw some slowdown in procedure volumes, they leaned even harder into new account openings. So we're well through the first half of the top 600 in the U.S. We're pushing hard into that second half, and they did even more of that as the quarter progressed. So you saw the momentum coming through, particularly in December, and now carrying over into our fourth quarter. So That's a team that is as resourceful as they are focused, and they've been able to get there on new account openings this quarter rather than utilization. Obviously, we need the utilization, and I think that will continue going forward. So we feel very good about it. In terms of the CE mark in Europe, that presents a real opportunity. We're fully a year or more now ahead of schedule in that process. The team has been very thoughtful. about how to use some of the benefits that we're seeing across our business to get the additional investment. We're talking about a $1.3 billion international TAM for that product family, and the European launch is the first opportunity to go against that. We're trying to take a page out of the playbook from the US team, so it is very targeted, very focused by country and by key account within the country. We expect to have our first set of cases supported later this quarter in Italy. And very quickly thereafter, we'll move to Germany and the other European markets. So the outperformance we're seeing across hospital and the other businesses is providing the opportunity to fund additional investment and making that European launch that much more robust. And I think we've got a really good playbook. We'll leverage our existing back office infrastructure, but we're putting dedicated teams on the ground in the major markets. to make sure that there's no negative effect on our other hospital-based businesses.
spk30: Thank you.
spk02: Thank you. Our next question comes from Andrew Cooper with Raymond James. Your line is open.
spk04: Hey, everybody. Thanks for the question. Maybe to start just on plasma, you know, I think you were up on an absolute dollar basis, about 6% quarter over quarter in fiscal 3Q. Normal, I think, from a volume perspective in North America, you said is three to five. So a little bit above, but not too much. And then when we think about the guide for 4Q, I think it's implying something maybe a little bit bigger of a step down than the normal kind of 7% or so in a fiscal fourth quarter. So just are we back to normal in this kind of catch up and bolus that's driving that faster growth on some of the easier comps is largely behind us? Or how do we think about where we stand relative to you know, a world without COVID or normal and getting back to the typical seasonality that we would see. Just help me think about the trajectory in plasma, please.
spk24: Thanks for the question. What we're actually finding is that we're seeing continued seasonality in the business. We're doing a little bit better than we were expected. It is slowing down a little bit as the growth comes through. Our customers are still impacted a lot by staffing problems and donor issues. So we're still seeing that affecting the business overall, but we are definitely seeing slightly above normal seasonality still continuing to occur, which is a good sign. This is our fifth quarter in a row where we've seen above seasonality in the business.
spk17: The only thing I would add to that, Andrew, is if we think about subsegments within plasma, we think about new centers versus mature centers. And, you know, what's very powerful and will be at the core of our focus as we get our plans together for, you know, FY24 is, you know, these new centers are, you know, represent twice the volume they did, you know, on a percentage basis pre-pandemic. And they continue, even in the most recent period, to track almost spot on into the historic growth uptake. So that's a really encouraging sign. You know, what's less clear is, you know, how fast the remaining gap on the mature centers will close. We see really good things happening on the southern border, for example. But that's one we're watching for. And we'll have the conversations I mentioned earlier with our customers to really dial in on that.
spk04: Great. And if I can sneak one more in. Just on VACGATE and everything you just sort of talked about in a prior question, you know, when we think back to the analyst day and the LRP period, Obviously, there was a little bit longer time before you expected to be in Europe. So when we think about getting into Italy, you know, really pretty soon and some countries to follow, should we view that as incremental to at least the interim growth trajectories in that LRP? And help me think about what the timing there can look like and the magnitude maybe of some of these early launches.
spk17: Yep. It's a bit too early to guide for 24, particularly on a market like that that is so nascent. What I would say is this is a great example of how outperformance against what we thought was a pretty ambitious LRP year to date in FY23 is allowing us to free up funds to invest in growth as it presents itself. So we didn't have any plans in FY23 when we started the year for a build out of a direct sales force in Europe this year. We've been doing that. You see that passing through. It's a little bit of a challenge in terms of our operating margins, but it's exactly the right thing to do in terms of creating momentum. I think this is yet another example of accelerating a planned investment and maybe expanding beyond the base of the planned investment to ensure that the upside is there for us. As James said, these are challenging times. Things are expensive. It's expensive to be doing the hiring, but we think we'll be better served for it. And we'll come back as part of the FY24 guidance in May and give you as much detail as we can about how VASC-A is going to contribute accordingly.
spk23: Great. I'll stop there. Thanks.
spk02: Thank you. Our next question comes from Dave Turkley with JMP. Your line is open.
spk28: Hey, good morning. Chris, you mentioned the investments, the capacity expansion, and I'm I'm just curious if you could give us some commentary when you look at Plasma and maybe Vascade as well with CSL back and the momentum you're seeing. Do you now have what you need to be able to supply that demand? I don't know that I've asked you about Vascade in the past, but I don't know what facility where you're making that, but I guess if you could give us some color on Yeah. How you, when you're looking at this LRP 23, 24, 25, do you have all the capacity you need right now?
spk17: Yeah, Dave, thanks for the question. When we look, if you ask me, like, what am I most proud of, right? I am most proud of this organization's ability to respond to unprecedented demand. And it's exactly as you highlighted, you know, it's across the board, but it's particularly on plasma disposables and on the cascade products. And so, Our teams have leaned in. We mentioned back in June that we had opened a new facility in Pittsburgh, PA. We've asked things of that facility that we never intended to ask at this point in the process, and they've responded wonderfully, as has the rest of the network. Thankfully, we did OEP. We're doing OEP. We're on track for those savings this year and cumulatively, but the big benefit of OEP is the agility of and the increased capacity, the resilience to be able to deliver. It is a challenge, and we are managing day to day, but I'm proud to say that as an organization, we haven't disrupted or stocked out any of our major customers, and that's a testament to the supply chain's efforts. So I feel quite good about our ability to meet, you know, the higher targets that we've put forward, and I think that's, you know, part of the strength and the goodwill that we're building with customers. I said earlier, you know, we're playing the long game and we're playing to win. And being able to supply them in this environment is a huge part of it. Vascade, as you know, we acquired that from Cardiva. It's actually manufactured in a separate standalone plant down in Wymas. We've got plans underway to essentially double the capacity. They've risen to the challenge as well. And We don't have any worries about being able to meet demand.
spk28: Great. And just maybe as a quick follow-up, I think I can interpret the CSL news correctly, but do you have any additional thoughts on the Terumo device? And I guess any update that you're seeing of installs or how it's being used, I think I think that the extension says something, but I'd just love to get your most recent thoughts.
spk17: Yeah, Dave, I appreciate the question. We're not going to comment on competitors' conversion or proprietary activity at any of our customers. We're really pleased, as I said, global manufacturing and supply, but also our own rollout, right? We completed our technology upgrades back in August and September, and Our focus is on helping those customers scale and deliver record volume. Persona is a big part of that. The yield enhancements, the emerging data that gives us increased confidence that this is a safer and better way to collect. We're leaning into that, and I think we'll continue to seek opportunities to further advance our competitiveness, whether it's yield or speed or connectivity. or overall donor engagement, we're hitting it hard and we're going to continue to lean into it.
spk00: Thank you.
spk02: Thank you. And this concludes our question and answer session. Thank you for your participation in today's conference. You may now disconnect.
spk35: Everyone, have a great day.
spk28: The conference will begin shortly. To raise and lower your hand during Q&A, you can dial star 1 1. you Thank you. Thank you.
spk02: Good day and welcome to the Hamanetics Third Quarter Fiscal 23 Conference Call and Webcast. At this time, all participants are in a listen-only mode. After the speaker's presentation, there'll be a question and answer session. Instructions will be given at that time. As a reminder, this call is being recorded. I would like to turn the call over to David Trink, Manager, Investor Relations. You may begin.
spk20: Good morning, everyone.
spk21: Thank you for joining us for Humanetics third quarter fiscal 23 conference call and webcast. I'm joined today by Chris Simon, our CEO, Roy Galvin, president of our Global Plasma and Blood Center businesses, and James Durecka, our CFO. This morning, we posted our third quarter and year-to-date fiscal 23 results to our investor relations website, along with updates to our fiscal 23 guidance and the analytical tables with the information that we will refer to on this call. Unless otherwise noted, all revenue growth rates we will discuss today are organic and exclude the impact of currency fluctuation, strategic exits of product lines, acquisitions, and divestitures. Additionally, to help investors understand Humanetics' ongoing business performance, we will refer to non-GAAP financial measures. These measures exclude certain charges and income items. For additional details about excluded items, comparisons with the same periods in fiscal 22, and reconciliations to our GAAP results, please refer to our third quarter and year-to-date fiscal 23 earnings release posted on our IR website. Our remarks today will also include forward-looking statements, and our actual results may differ materially from the anticipated results. Please refer to the safe harbor statement in the earnings release and other filings with the SEC for a complete list of risk factors that may impact our results. Additionally, in order to protect customer confidentiality, we will not be able to discuss any customer-specific details except as disclosed previously. And now, I'd like to turn it over to Chris.
spk17: Thanks, David. Good morning, and thank you all for joining. Today, we reported third quarter organic revenue growth of 21%. and adjusted earnings per diluted share of 85 cents, 1% growth over a record third quarter last year. Our third quarter results show that our long-range plan is driving continued strong performance. With growth in revenue across all of our business units, despite the macroeconomic environment, we continue to build significant momentum. We're harnessing this momentum to invest further in our plan and create additional opportunities to accelerate transformational growth. In plasma, our value proposition is unrivaled, enabling us to support the industry's record recovery by helping customers win donors and increase productivity to grow collections. Recently, we amended our non-exclusive supply agreement with CSL for the use of PCS2 devices and disposable kits to extend the term from December 2023 to December 2025. We look forward to continuing to provide CSL and all of our plasma customers with the highest level of service and support. In hospital, we remain focused on growing our market share both in the U.S. and internationally by advancing our technology and seeking targeted acquisitions to improve standards of care. In blood center, we are capitalizing on opportunities created by our agility and resilience to win with customers and extend our leadership in the new markets. We are pleased with our performance and the steps we have taken to accelerate revenue and adjusted EPS growth. We are not immune to the macroeconomic challenges of foreign exchange, inflation, supply discontinuities, and geopolitical risk. However, heightened demand for our products continues unabated. The essential nature of our solutions and the durability of our businesses, even during uncertain times, have us well positioned for sustained growth and market leadership. We have demonstrated perseverance in the ability of our global manufacturing and supply chain to fulfill our customers' needs uninterrupted. With increasing capital capacity and a robust allocation strategy, we are confident we can continue to deliver best-in-class solutions to our customers and attractive returns to our shareholders. We look forward to a strong fiscal 23 finish and carrying that momentum into fiscal 24. Now onto our business results and guidance. I will begin with total revenue and hospital, and Roy will discuss global plasma and blood center. Corporate revenue grew 21% in the quarter and 22% year to date due to accelerating growth in both hospital and plasma. We now expect fiscal 23 organic revenue growth in the range of 18 to 20% compared with 15 to 18% previously. Hospital revenue grew 14% in the quarter and 17% year-to-date as we meaningfully grew revenue and market share despite hospital staffing shortages, budgetary constraints, and COVID-related challenges in China. Hemostasis management revenue grew 7% in the quarter and 8% year-to-date. Growth in North America, our largest market, was 16% in the quarter and 13% year-to-date, driven by strong adoption and utilization of TEG disposables. International growth was partially offset by a difficult year-on-year comp due to a large national European tender for clot pro in fiscal 22 and the effects of COVID in China. Vascular closure revenue grew 33% in the quarter and 37% year-to-date. The adverse seasonality and procedure volumes that we experienced in our second quarter persisted, but we saw encouraging improvement in December and into our fourth quarter. Our growth is disproportionately being driven by converting new electrophysiology accounts from the top 600 hospitals, further increasing our U.S. penetration and market share. We are excited about CE Mark certification for Vascaid. As we move forward with commercialization in Europe, we plan to use a direct sales model and leverage our existing back office infrastructure. This is one of many investments we are making to solidify our leadership position in vascular closure and accelerate revenue growth. Transfusion management revenue grew 13% in the quarter and 23% year-to-date. Growth was driven by new software implementations in the US and UK and our previous investments to expand the sales force. Lastly, self-salvage revenue grew 1% in the quarter and 2% year-to-date, benefiting from favorable order timing among EMEA distributors and strong capital sales partially offset by weakness in China. In November, we received FDA approval for our CellSaver Elite Plus, featuring new intelligent control software to enhance simplicity and efficiency. It is another example of the investments we are making to solidify our market leadership, and we anticipate full market release in the U.S. before fiscal year end. We are enthusiastic about opportunities in our hospital business and the strong value of our products. We've done a lot of work to transform this business into a growth engine and feel very confident about the continued momentum. We update our expectation for hospital organic revenue growth to be approximately 19% in fiscal 23, the lower end of our previously issued guidance range of 19 to 22% due primarily to COVID-related challenges in China.
spk24: Now, over to you, Roy. Thank you, Chris. Good morning, everyone. This is my first time speaking with you since I joined Hemanetics at the start of our third quarter, and I'm very pleased to be here to talk about our plasma and blood center results. It's been a great quarter for both businesses. In plasma, revenue increased 42% in the third quarter and 48% year-to-date. North America disposals represented 85% of our plasma revenue and increased 46% in the quarter and 52% year-to-date, driven by strong growth in collection volume and price. as a result of the technology upgrades. Volume growth was pronounced across all geographies. In the US, plasma collections grew 26% in the quarter and 34% year-to-date, excluding CSL. In Europe, collections grew in the mid-teens in the quarter and year-to-date. Both geographies have surpassed pre-pandemic collection levels and are growing to meet patient demand. We remain focused on providing our customers with the tools necessary to support continued recovery and attract and retain their donors. Our persona technology represents over half of the Nexus collections in the U.S. today and is an enabler of plasma volume growth and improved central efficiency. Since the commercial launch of this technology, more than 12 million persona procedures have been completed. The real-world data collected has reinforced the safety profile established in the original IMPACT Plasma-Free Clinical Trial when combined with our NexLink DMS software and other digital tools Plasma Center has also experienced shorter door-to-door times and an overall more favorable donation experience. The substantial cost-per-liter improvement available through our integrated Nexus platform is unrivaled within the industry, and we are just getting started. Encouraged by the strength of our business and the opportunity to continue to support CSL as a result of the newly amended agreement, we are raising our fiscal 23 organic plasma revenue guidance to 35% to 40% growth. Up from the 30 to 35% growth we communicated last quarter. In Blood Center, revenue grew 3% in the quarter and declined 1% year to date. The environment for this business continues to be challenging. However, we remain focused on providing top quality products and the highest level of customer support while utilizing the strength of our supply chain and our technology to increase our market share. A3's revenue declined 3% in the quarter and 6% year to date. This business was affected by unfavorable order timing, lower revenue from convalescent plasma, staffing and donor shortages at blood centers across the globe, and COVID-related challenges in China. Partially offsetting these was an increase in capital sales from an Egyptian plasma effort undertaken in partnership with a global plasma customer. Old Blood revenue increased 20% in the quarter and 11% year-to-date. Growth in this product line, both in the quarter and year-to-date, was driven by our hardy supply chain that enabled us to serve customers in need and favorable order timing in EMEA and Asia Pacific. Before I discuss updates to Blood Center guidance, I would like to remind everyone that earlier in the pandemic, we benefited from increased levels of safety stock across many of our customers. What we observed in the third quarter is the beginning of an inventory rationalization which we believe will continue into the fourth quarter and potentially beyond. We are confident in the continued durability of our blood center business and update our expectations of revenue decline to negative 2% to 4% in fiscal 23 compared with a negative 2% to 5% previously. Our guidance reflects strong year-to-date results and the anticipated impact of inventory rationalization. Now over to James to discuss the rest of the financial results and guidance.
spk17: Thank you, Roy, and good morning, everyone. As you heard from Chris and Roy, all of our businesses are performing exceptionally well. The demand for our products is strong, and we are doing everything we can to ensure uninterrupted supply and best in class service to our customers. In order to ensure continued success in fiscal 24, we are proactively making changes to our manufacturing and supply network. This includes increasing our production capacity for plasma disposables, and securing additional vendor contracts. Most initiatives are underway, resulting in an additional impact on operational efficiencies in the second half of our fiscal 23, which I will discuss in more detail momentarily. Moving on to gross margins. The third quarter adjusted gross margin was 52.5%, a decrease of 240 basis points compared to last year, when we reported one of our highest ever adjusted gross margins of 54.9%. We continue to experience strong volume growth and realize benefits from price and our operational excellence program. Offsetting these benefits was a 70 basis point one-time inventory charge. Due to the effects of COVID in China, additional inflationary pressures including operational inefficiencies as we work to increase our production capacity and higher depreciation expense. Adjusted gross margin year to date was 53.7%, a decrease of 40 basis points compared with the first nine months of the prior year. The primary drivers include strong growth in volume, benefits from price, mix, and our operational excellence program offset by higher manufacturing and supply chain costs and depreciation expense. Adjusted operating expenses in the third quarter were $101.4 million, an increase of $17.6 million, or 21%, compared with the prior year. As a percentage of revenue, adjusted operating expenses increased by 90 basis points to 33.2%. Adjusted operating expenses year-to-date were $299.9 million, an increase of $46.7 million, or 18%, compared with the prior year. As a percentage of revenue, adjusted operating expenses year to date decreased by 10 basis points to 34.7%. Higher adjusted operating expenses in both periods were driven by higher performance-based compensation, continuous investments in sales and marketing, higher freight costs, and normalized spending levels partially offset by additional savings from the Operational Excellence Program. In our third quarter, we also had higher research and development costs primarily driven by increased investments in product innovation. Adjusted operating income was $59 million in the third quarter and $164.5 million year-to-date, representing increases of $.2 million and $24 million, respectively.
spk13: As a percentage of revenue, adjusted operating margin was 19.3% in the third quarter and 19% year to date, down 330 basis points and 30 basis points, respectively, when compared with the same periods in fiscal 22.
spk17: We reaffirm our adjusted operating margin guidance in the range of 18 to 19%. Our adjusted operating margin guidance includes higher performance-based compensation, approximately 380 basis points of impact from macroeconomic headwinds, and increased operational inefficiencies partially offset by $26 million in target fiscal year 23 gross savings from the Operational Excellence Program. The adjusted income tax rate was 25% in the third quarter, and 24% year-to-date, compared with 21% and 22% in the same period in fiscal 22. The higher income tax rate in our third quarter was related to changes in jurisdictional earnings as well as a one-time catch-up related to executive stock compensation. We expect our fiscal 23 adjusted income tax rate to be approximately 24%. Third quarter adjusted net income was $43.6 million, up approximately $1 million or 2%, and adjusted earnings per diluted share was 85 cents, up 2% when compared to the third quarter of fiscal 22. Year-to-date adjusted net income was $116.5 million, up $17 million or 18%, and adjusted earnings per diluted share was $2.26, up 17% when compared with the first nine months of fiscal 22. The combination of the adjusted income tax rate, interest expense, and FX had a negative 2 cents and 12 cents impact on adjusted earnings per diluted share in the third quarter and year-to-date, respectively, when compared with fiscal 22. We are updating our fiscal 23 adjusted earnings for diluted share guidance to be in the range of $2.90 to $3, compared with the previous guidance of $2.70 to $3.
spk13: The midpoint of our adjusted earnings for diluted share guidance includes an approximate $0.16 headwind from volatility in foreign exchange, adjusted income tax, and slightly higher interest expense.
spk17: Now let's discuss our balance sheet and cash flow. Cash on hand at the end of the third quarter was $224 million, down $36 million since the beginning of the fiscal year, primarily due to the $75 million accelerated share repurchase program, $35 million in earn-out payments related to previous acquisitions, and a 30 million euro investment in VivaSure Medical, partially offset by higher net income. Free cash flow before restructuring and restructuring-related costs was $119 million, compared with $75.8 million in the first nine months of the prior year. The higher free cash flow before restructuring and restructuring-related costs was mainly due to higher cash flow from operating activities. These include significantly higher net income, lower inventory, primarily due to the nexus conversions in the U.S., and higher accrued liabilities, including higher performance-based compensation, excluding capital placements, inventory increased year over year. We believe in our ability to generate strong cash flow and update our guidance for free cash flow before restructuring and restructuring-related costs for fiscal 23 to be in the range of $160 to $180 million, compared with $150 to $180 million previously.
spk16: The updated guidance reflects higher net income and additional benefits from networking capital in fiscal 23. Before I turn the call back to the operator, I'd like to summarize a few key takeaways from today's call.
spk17: In our plasma business, we are experiencing unprecedented growth in collection volume across all of our customers, disproportionately contributing to the anticipated 35% to 40% revenue growth in our fiscal 23. Our technology is enabling substantial cost per liter improvement, and we are making meaningful progress with our innovation agenda. Hospital growth is propelled by revenue growth in hemostasis management and vascular closure, strengthening our market leadership and improving our adjusted gross margins.
spk13: This business continues to prove itself as a growth engine, and we look forward to continued momentum in fiscal 24.
spk17: The margin expansion goals we presented in our long-range plan are on track despite the additional near-term operational inefficiencies. The Operational Excellence Program continues to provide meaningful benefits for our company, from mitigating the effects of macroeconomic headwinds to helping effectively meet customer demand for our products. And finally, the strength of our underlying business coupled with steps we've taken over the past few months, will enable consistent expansion of our capital capacity. With the capital allocation priorities being unchanged, we will be disciplined with allocating capital to high impact, high ROI projects that accelerate growth and value creation.
spk16: Thank you for your time today.
spk13: And operator, you may now begin the Q&A.
spk02: Thank you. If you'd like to ask a question, please press star one one. If your question has been answered and you'd like to remove yourself in the queue, please press star one one again.
spk35: One moment while we compile the Q&A roster.
spk02: Our first question comes from Drew Ranieri with Morgan Stanley. Your line is open.
spk32: Hi, good morning. Thanks for taking the questions. Chris, maybe kind of a first multi-part question, but just kind of given the current environment right now and your recent commentary at a conference, you sounded very confident in growth in every year of your LRP and including next one. Just how should we think about that, especially in the context with the amended CSL agreement and how you're thinking about that influencing the near-term plan? And then just on CSL, I know you don't want to get into the specifics on revenue, but for whatever assumptions investors want to make on the revenue impact for 23, 24, or 25, can you just maybe talk about the potential flow through to EPS? I mean, at Analyst Day, you gave a slide that gave us some incremental detail there for fiscal 2022, but just maybe walk us through the puts and takes if anything has kind of changed on that end. Sorry for the multi-part there.
spk17: Thanks, Drew. Appreciate you dialing in. In terms of the macro environment and our degree of confidence, it remains quite high, right? There are external challenges for sure, but I think as an organization, we benefit as much in this environment as we are challenged. We look at the durability of our blood center business. We look at the essential nature of what we do in hospital, whether it's cardiovascular or interventional cardiology or trauma, transplant, right? These are all high demand issues. So if hospitals are staffed and functioning, we're going to continue to perform as we have. And then plasma has done very well in good markets and in bad alike. And there's clearly strong forces at work that are helping what our customers are leaning heavily into, which is to drive increased plasma collections. So There are challenges on the cost side. James highlighted a bunch of those, and we're happy to talk through those. But from a macro perspective, there's real uptick in demand, and we don't see that abating across any of our three businesses anytime soon. In terms of the CSL agreement, I know there's a ton of curiosity around that, and I appreciate that you can understand that the terms of the agreement are strictly confidential. What I would say at the macro level, again, is This is good for patients, it's good for donors, it's good for customers, and it's good for shareholders. Our view from this from the outset has been that we are playing the long game and we will continue to invest and deliver accordingly. Anything that gets pulled forward from the CSL agreement will be additive to our prior commitments around growth in each year of the LRP and the overall margin expansion that we've outlined.
spk32: Thanks. And then just maybe a near-term question, but with a biotech company's readout potentially in the second quarter, how are you kind of thinking about that as a potential structural impact for plasma over the longer term? Thanks for taking the questions.
spk17: Yep. Thanks, Drew. We look at that near and long term. We've done a bunch of modeling. We don't profess to have any proprietary insight beyond what we hear from key opinion leaders and what we know from other algorithms of competitive entries in the biologic space. Candidly, from a patient service perspective, we hope that anti-FCRN has a role to play going forward, particularly in therapeutic areas where IG may not be the most efficacious treatment. From what we have seen and the most recent communications, We stand firm around our original assumptions, which is we've always talked about the long-term growth in demand for IG somewhere in that six to 8% range. And, you know, you can shave a point off of that, I guess, in either direction, depending on the relative success of the FCRN players. But from our vantage point, we feel quite good about that base assumption. We're going to watch carefully to see the next milestone readouts and talk closely with all of our customers about their view on this. But 6% to 8% demand for IG converts nicely to 8% to 10% demand in collection volumes, probably closer to 10% to 12% organic growth just given changes in the nature. Subcutaneous, for example, requires more IG for the same dose equivalency. We'll see this revert eventually to that long-term mean of 8% to 10% with a bit higher in our business because of mix and some of the other things that we have going on. But there's nothing we've heard or seen that would back us off of that long-range forecast.
spk33: Great. Thanks for taking the questions.
spk02: Thank you. Our next question comes from Mike Mattson with Needham & Company. Your line is open.
spk15: Yeah, good morning. Thanks for taking my questions. So I want to ask one on the gross margins. We've seen some really strong growth from the overall company and from the plasma business here. But yeah, your gross margins have been down. And I understand there's some one-off factors, inflation and things like that. But I guess, is there just a mix effect happening with, you know, the plasma gross margins being lower and that's where you're seeing the strongest growth? Or, you know, I guess why isn't, you know, I would have guessed you would have seen more leverage just given how fast that plasma business is growing.
spk17: Yeah. Hi, Mike. It's James. Thanks for the questions. Yeah. On gross margin, you know, it actually is – you know, the mix element has been favorable to us along with our OEP savings.
spk13: But what's taken us in the opposite direction and offset those benefits is really a few things which we've kind of highlighted. One is the additional depreciation from our nexus systems.
spk17: And then the other one, which is the bigger part, is the manufacturing headwinds on inflation that you just referenced.
spk13: But also, as I noted in my remarks, we've been experiencing, I would say, larger than usual operational inefficiencies due to the strong growth.
spk17: That's put us in a position to have to buy components and other manufacturing inputs at spot prices. So things like sterilization or hard to find parts, which in the past you used to have to order in advance. Now when you have to go into the spot market, it raises the prices and it's having an effect on our margin. Longer term, however, We see that part of it, I'll call it the temporary inefficiency part of it, abating as our production plans become more crystallized. So we do see over the longer term the one effect that you just said, mix, really helping us, volume helping us, and then by removing those inefficiencies that I just spoke about, that's what will push us, you know, push our gross margins much higher as we get out into our LRP. Okay.
spk15: That's helpful. Thanks. And then I understand, you know, that you don't want to really comment on the specifics of the CSL agreement, but, you know, we do have to update our models for 24 and 25. And, you know, I think for the most part, based on what you said at the analyst day, we took our, you know, CSL out of our we're assuming no CSL revenue beyond 23. So, I mean, is that kind of the message here, just to be conservative and not, you know, put anything in there for now until, you know, you guys give your guidance, I guess, for 24?
spk17: So, Mike, it's a challenge, and we appreciate, you know, what you're trying to do on that. We just need to balance, you know, disclosure requirements on one hand versus and our desire for transparency with the need to protect customer confidentiality across the board. This is now effectively a three-year agreement, so we think differently about the duration. Sitting here where we are at this point with less than two months remaining in the fiscal year, yes, we can confirm there will be revenue from CSL in FY24. The process that we're about to go through with all of our customers is to get very clear about what the demands are. We are facing unprecedented demand. It's great. We've expanded our manufacturing capacity, our supply chain resilience, et cetera, to respond, and the response has been nothing short of extraordinary in the eyes of our customer. So we feel great about that and our ability to continue to deliver. Over the next two months, we'll sit down and go through this in detail with each of our customers, and the additional volumes will be included when we guide in May for FY24.
spk18: Okay, got it. Thank you.
spk02: Thank you. Our next question comes from Joanne Wundt with Citi. Your line is open.
spk25: Hi. Good morning, and thank you for taking the question. I actually have two. If you previously gave us $88 million for CSL contribution in this fiscal year, and then you raised the guidance for the fiscal year for plasma, Is that raise all attributed to the new extended agreements, or is there something else in there?
spk17: Hey, Joanne. What we'd say is the guidance that we've put forward for the year reflects strong volume momentum, favorable mix, and improved price across all of our customers. As I said, we increased production and improved both the agility and resilience of our supply chain to provide uninterrupted supply. We and our customers are benefiting from that, as are the patients that they care for.
spk25: Okay. My second question has to do with China. Could you just peel apart for us what is happening in that market for you, and then how do we think about it falling off over the next couple of quarters and becoming less of a headwind? Thank you.
spk17: Yeah. So two of our businesses are well represented there, both our blood center business and our hospital business. I'll get us started, and if there's any further follow-on questions, I'll defer to Roy for the blood center piece. Blood collections in plasma are different. They are overseen by the central government, and fortunately for us, because of the government's approach there, we've had good volume and demand throughout. We're the share leader there, and we've benefited by that. So blood is largely unaffected. That's probably not fair to the folks on the ground who are working... feverishly to actually be able to deliver. But, you know, from a results perspective, it's largely unaffected. Where we're getting challenges is in the hospital base in terms of procedure volumes and with the various waves and the change in policy towards COVID, both our cell salvage and our tag businesses have had meaningful challenge kind of delivering. We thought, you know, going into this, that we'd see abatement in the second half of the year. We don't expect meaningful abatement, certainly over the next two months, and we'll get our heads around this and what that means for next year's guidance. That's the primary driver of why we now see hospital coming in closer to 19% for the year.
spk02: Thank you. Thank you. As a reminder, to ask a question, please press star 1-1. And our next question comes from Anthony Patron with Mizuho. Your line is open.
spk19: Thanks. Congrats on another good quarter here. A couple on plasma and a follow-up on hospital. Maybe, Chris, the language in the queue on CSL, it mentions PCS2. Just wondering if there is a potential that they take a look at Nexus Persona, just considering the real-world experience out there with yields and how that plays into the extension. And then the follow-up on plasma would just be again, you know, how do we think about the additional volume flowing through the margins? Obviously, excess volume plays at the margin, so what is the potential movement in margins both gross and operating from the additional volumes? And I'll have one follow-up on hospital. Thanks.
spk17: Thanks, Anthony. The CSL agreement is essentially an extension off of the existing agreement, which is non-exclusive for PCS2 devices and the disposables through those devices. So that hasn't changed. As it pertains to, you know, how we think about plasma and volumes and margin, maybe I'll invite Roy to comment.
spk24: Thanks, Anthony. You know, the plasma business overall is growing very well in the U.S. We're seeing a growth overall sitting around 46%. So it's grown very well overall. We're pleased with how things are going. As far as the business is concerned, long-term, we're really going to have to watch how the economy impacts that and how the growth of the business continues as we see changes in the macroeconomics around the U.S., which are really helping drive some of the growth in the plasma business. As far as margins are concerned, obviously, that will be driven as we move forward with any kind of conversions around product. That's something we'll see in the future, possibly. But at this point, we're just really focused on grabbing the volumes, continuing to drive our production upwards, and making sure we're as successful as we can be supplying our customers and staying ahead of their demand.
spk19: Great. Maybe the follow-up on hospital, just on Vascade, maybe just a recap on the penetration in the 600 target EP sites in the U.S., sort of where that sits, and how we should think about how the European launch of Vascade MVP should play out. over the next few quarters. Thanks.
spk17: Yeah, thanks for the questions, Anthony. In terms of Vascaid, it continues to exceed even our own high expectations for that product mix. What we're seeing in the U.S., you know, clearly there's some seasonality and some challenges. We're not immune from those in terms of electrophysiology procedures. What's really impressive for that team is as we saw some slowdown in procedure volumes, they leaned even harder into new account openings. So we're well through the first half of the top 600 in the U.S. We're pushing hard into that second half, and they did even more of that as the quarter progressed. So you saw the momentum coming through, particularly in December, and now carrying over into our fourth quarter. So That's a team that is as resourceful as they are focused, and they've been able to get there on new account openings this quarter rather than utilization. Obviously, we need the utilization, and I think that will continue going forward. So we feel very good about it. In terms of the CE mark in Europe, that presents a real opportunity. We're fully a year or more now ahead of schedule in that process. The team has been very thoughtful. about how to use some of the benefits that we're seeing across our business to get the additional investment. We're talking about a $1.3 billion international TAM for that product family, and the European launch is the first opportunity to go against that. We're trying to take a page out of the playbook from the US team, so it is very targeted, very focused by country and by key account within the country. We expect to have our first set of cases supported later this quarter in Italy. And very quickly thereafter, we'll move to Germany and the other European markets. So the outperformance we're seeing across hospital and the other businesses is providing the opportunity to fund additional investment and making that European launch that much more robust. And I think we've got a really good playbook. We'll leverage our existing back office infrastructure, but we're putting dedicated teams on the ground in the major markets. to make sure that there's no negative effect on our other hospital-based businesses.
spk30: Thank you.
spk02: Thank you. Our next question comes from Andrew Cooper with Raymond James. Your line is open.
spk04: Hey, everybody. Thanks for the question. Maybe to start just on plasma, you know, I think you were up on an absolute dollar basis, about 6% quarter over quarter in fiscal 3Q. Normal, I think, from a volume perspective in North America, you said is three to five. So a little bit above, but not too much. And then when we think about the guide for 4Q, I think it's implying something maybe a little bit bigger of a step down than the normal kind of 7% or so in a fiscal fourth quarter. So just are we back to normal in this kind of catch up and bolus that's driving that faster growth on some of the easier comps is largely behind us? Or how do we think about where we stand relative to you know, a world without COVID or normal and getting back to the typical seasonality that we would see. Just help me think about the trajectory in plasma, please.
spk24: Thanks for the question. What we're actually finding is that we're seeing continued seasonality in the business. We're doing a little bit better than we were expected. It is slowing down a little bit as the growth comes through. Our customers are still impacted a lot by staffing problems and donor issues. So we're still seeing that affecting the business overall, but we are definitely seeing slightly above normal seasonality still continuing to occur, which is a good sign. This is our fifth quarter in a row where we've seen above seasonality in the business.
spk17: The only thing I would add to that, Andrew, is if we think about subsegments within plasma, we think about new centers versus mature centers. And, you know, what's very powerful and will be at the core of our focus as we get our plans together for, you know, FY24 is, you know, these new centers are, you know, represent twice the volume they did, you know, on a percentage basis pre-pandemic. And they continue, even in the most recent period, to track almost spot on into the historic growth uptake. So that's a really encouraging sign. You know, what's less clear is, you know, how fast the remaining gap on the mature centers will close. We see really good things happening on the southern border, for example. But that's one we're watching for. And we'll have the conversations I mentioned earlier with our customers to really dial in on that.
spk04: Great. And if I can sneak one more in. Just on VACGATE and everything you just sort of talked about in a prior question, you know, when we think back to the analyst day and the LRP period, Obviously, there was a little bit longer time before you expected to be in Europe. So when we think about getting into Italy, you know, really pretty soon and some countries to follow, should we view that as incremental to at least the interim growth trajectories in that LRP? And help me think about what the timing there can look like and the magnitude maybe of some of these early launches.
spk17: Yep. It's a bit too early to guide for 24, particularly on a market like that that is so nascent. What I would say is this is a great example of how outperformance against what we thought was a pretty ambitious LRP year to date in FY23 is allowing us to free up funds to invest in growth as it presents itself. So we didn't have any plans in FY23 when we started the year for a build out of a direct sales force in Europe this year. We've been doing that. You see that passing through. It's a little bit of a challenge in terms of our operating margins, but it's exactly the right thing to do in terms of creating momentum. I think this is yet another example of accelerating a planned investment and maybe expanding beyond the base of the planned investment to ensure that the upside is there for us. As James said, these are challenging times. Things are expensive. It's expensive to be doing the hiring, but we think we'll be better served for it. And we'll come back as part of the FY24 guidance in May and give you as much detail as we can about how VASC-A is going to contribute accordingly.
spk23: Great. I'll stop there. Thanks.
spk02: Thank you. Our next question comes from Dave Turkley with JMP. Your line is open.
spk28: Hey, good morning. Chris, you mentioned the investments, the capacity expansion, and I'm I'm just curious if you could give us some commentary when you look at Plasma and maybe Vascade as well with CSL back and the momentum you're seeing. Do you now have what you need to be able to supply that demand? I don't know that I've asked you about Vascade in the past, but I don't know what facility where you're making that, but I guess if you could give us some color on Yeah. How you, when you're looking at this LRP 23, 24, 25, do you have all the capacity you need right now?
spk17: Yeah, Dave, thanks for the question. When we look, if you ask me, like, what am I most proud of, right? I am most proud of this organization's ability to respond to unprecedented demand. And it's exactly as you highlighted, you know, it's across the board, but it's particularly on plasma disposables and on the cascade products. And so, Our teams have leaned in. We mentioned back in June that we had opened a new facility in Pittsburgh, PA. We've asked things of that facility that we never intended to ask at this point in the process, and they've responded wonderfully, as has the rest of the network. Thankfully, we did OEP. We're doing OEP. We're on track for those savings this year and cumulatively, but the big benefit of OEP is the agility of and the increased capacity, the resilience to be able to deliver. It is a challenge, and we are managing day to day, but I'm proud to say that as an organization, we haven't disrupted or stocked out any of our major customers, and that's a testament to the supply chain's efforts. So I feel quite good about our ability to meet, you know, the higher targets that we've put forward, and I think that's, you know, part of the strength and the goodwill that we're building with customers. I said earlier, you know, we're playing the long game and we're playing to win. And being able to supply them in this environment is a huge part of it. Vascade, as you know, we acquired that from Cardiva. It's actually manufactured in a separate standalone plant down in Wymas. We've got plans underway to essentially double the capacity. They've risen to the challenge as well. And We don't have any worries about being able to meet demand.
spk28: Great. And just maybe as a quick follow-up, I think I can interpret the CSL news correctly, but do you have any additional thoughts on the Terumo device? And I guess any update that you're seeing of installs or how it's being used, I think I think that the extension says something, but I'd just love to get your most recent thoughts.
spk17: Yeah, Dave, I appreciate the question. We're not going to comment on competitors' conversion or proprietary activity at any of our customers. We're really pleased, as I said, global manufacturing and supply, but also our own rollout, right? We completed our technology upgrades back in August and September, and Our focus is on helping those customers scale and deliver record volume. Persona is a big part of that. The yield enhancements, the emerging data that gives us increased confidence that this is a safer and better way to collect. We're leaning into that, and I think we'll continue to seek opportunities to further advance our competitiveness, whether it's yield or speed or connectivity. or overall donor engagement, we're hitting it hard and we're going to continue to lean into it.
spk00: Thank you.
spk02: Thank you. And this concludes our question and answer session. Thank you for your participation in today's conference. You may now disconnect. Everyone, have a great day.
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