Good day and thank you for standing by. Welcome to the Second Quarter 2025 Haemonetics Corporation Earnings Conference Call. At this time, all participants are in a listen-only mode. After the speaker presentation, there will be a question-and-answer session. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your first speaker, Olga Guyette. Please go ahead.

Good morning, everyone. Thank you for joining us for Haemonetics second quarter fiscal year 2025 conference call and webcast. I’m joined today by Chris Simon, our CEO; and James D’Arecca, our CFO. This morning, we posted our second quarter fiscal year 2025 results to our Investor Relations website along with our fiscal 2025 guidance. Before we begin, just a quick reminder that all revenue growth rates discussed today are organic unless specified otherwise, and exclude the impact of currency fluctuation and acquisitions. Our organic revenue growth guidance for fiscal year 2025 incorporates 15 weeks of revenue from OpSens due to the acquisition closing date being in December 2023. We’ll also refer to other non-GAAP financial measures to help investors understand Haemonetics ongoing business performance. Please note that these measures exclude certain charges and income items. For a full list of excluded items, reconciliations to our GAAP results and comparisons with the prior year periods, please refer to our second quarter fiscal year 2025 earnings release available on our website. Our remarks today include forward-looking statements and our actual results may differ materially from anticipated results. Factors that may cause our results to differ include those referenced in the Safe Harbor statement in today’s earnings release, and in our usual SEC filings. We do not undertake any obligation to update these forward-looking statements. And now, I’d like to turn it over to Chris.

Thanks, Olga. Good morning and thank you all for joining. Today, we reported second quarter revenue of $346 million, growth of 9% on a reported basis and 4% organically, primarily driven by our hospital business. Year-to-date, revenue growth was 8% reported and 3% organic. Second quarter adjusted earnings per share were $1.12, an increase of 13% from the prior year. Our growth and record financial performance speak to our agility and our progress executing our long-range plan. We continue to set the standard in plasma collection, accelerating center conversions and gaining share with our newest technologies, while we rapidly expand our presence and successfully address emerging industry trends in attractive hospital markets. We have the tools and the resources necessary to achieve increasingly profitable growth in both the short and long-term and to deliver significant value for our customers and stakeholders. We have momentum and we anticipate an even better performance going forward. We reaffirm our total revenue growth expectation for the fiscal year in the range of 5% to 8% and are raising our organic growth guidance to 1% to 4%, up from flat to 3% previously. Turning now to our business unit results, Plasma revenue declined 3% in the second quarter and year-to-date after growing 11% and 22% respectively in the same periods last year. North America disposables revenue declined 3% in the quarter and 4% year-to-date, primarily due to CSL's planned transition. Excluding CSL, revenue grew as declines in volume were more than offset by premium pricing from technology upgrades. Software revenue was flat in the second quarter and grew 10% year-to-date, driven by additional NexLynk DMS upgrades, where as the only plasma collection platform provider offering an independent DMS, we have 80% share of the U.S. market. Europe continued to show strong collections momentum as well. We believe recent pressure on volumes is transitory as customers are readying to support additional fractionation capacity and fuel continued growth. Our enhanced NexSys platform equips them with the tools to safely optimize center operations through increased yield and more efficient throughput. We are also using this opportunity to accelerate technology upgrades across the remaining U.S. NexSys centers and expect to complete these upgrades this fiscal year. With more than 35 million Persona collections to date and a strong body of real-world evidence supporting the superiority of the enhanced NexSys platform, we are gaining market share and converting competitors' centers. We expect that share gains will continue through the remainder of this year and into next year. Based on customer forecast, we foresee a return to more rapid collections in the near to intermediate term. End market demand for Ig therapies remains strong and our large customers have plans to expand fractionation capacity over the next several years to meet this demand. We reaffirm our full year fiscal '25 plasma guidance of a 3% to 6% decline, inclusive of an approximately $100 million contribution from CSL. Blood Center revenue declined 1% in the second quarter and year-to-date. Apheresis revenue was flat in the second quarter and grew 1% in the first half of the year, primarily driven by continued plasma share gains globally and strength in U.S. red cell collections, partially offset by fewer capital sales in the second quarter versus the prior year. Self-sufficiency is driving international demand for source plasma and we are strengthening our global customer relationships to expand NexSys worldwide. Whole Blood declined 3% in the second quarter and 10% in the first half of the year as we rationalize this franchise to expand margins. Based on strong performance, we are updating our fiscal '25 Blood Center guidance range to a decline of 4% to 6%, up from a decline of 5% to 7% previously. Moving to Hospital, revenue grew 31% on a reported basis in both the second quarter and year-to-date, with organic growth of 16% and 15% respectively. Blood Management Technologies increased momentum, growing 14% in the second quarter and 12% year-to-date, driven by the U.S. and EMEA. In the quarter, TEG grew an impressive 35% in the U.S., driven by strong capital sales and a 20% improvement in device utilization. Much of this success is attributed to our new global hemostasis heparinase neutralization assay cartridge that aids clinicians in managing fully heparinized adult patients, particularly in CV surgery and liver transplant. We have initiated regulatory efforts to expand patient access to this product globally. Success in the U.S. was partially offset by continued market challenges in China. Transfusion management grew double-digits in the quarter and year-to-date, benefiting from new account openings for SafeTrace Tx and BloodTrack in North America and EMEA. Cell Salvage revenue declined as growth in disposables was more than offset by both capital order timing and a purposeful shift away from lower-margin accounts. Interventional Technologies grew 61% in the second quarter and 64% year-to-date on a reported basis, with 20% organic growth in both periods. Growth in Vascular Closure was largely driven by the successful launch of VASCADE MVP XL halfway through our second quarter. With a 58% larger collagen plug and workflow similar to our other VASCADE devices, MVP XL is a game changer, enabling us to participate in the rapidly growing pulsed field ablation market and increase adoption in procedures such as left atrial appendage closures. In less than three months, since full market release, this device has been introduced in nearly half of our existing accounts, strengthening our leadership in enabling the treatment of atrial fibrillation across ablation technologies while expanding our presence in left atrial appendage closures where we had minimal use prior to this launch. With work underway to expand the label for the current design of VASCADE MVP XL up to 14 French inner diameter and 17 French outer diameter, we plan to further accelerate the adoption in the U.S. and internationally. We are seeing strong momentum in this business and expect growth for this product line to be in the high 20s in the second half of this fiscal driven by our success with MVP XL, improving utilization rates and an overall uptick in procedure volumes. Our newly acquired products delivered a total of $16 million in revenue in our second quarter and $34 million in revenue year-to-date. We are making significant progress with the Enzo ETM esophageal cooling device, having opened 32 new centers in the second quarter. This device is now available across more than 200 accounts, in line with our original expectations. We are also making progress with advancing our sensor-guided technology. SavvyWire is distinctly differentiated with a high accuracy pressure sensor for in-situ hemodynamic measurements, providing crucial information to the physician in real time and improving overall workflow for the TAVR procedure. We remain confident in realizing the commercial and financial benefits of these acquisitions over time as we further expand our market share in electrophysiology and build a solid foundation in interventional cardiology and structural heart. We have meaningful market opportunities and expect growth to accelerate driven by the launches of MVP XL, the TEG 6 heparinase neutralization cartridge, Enzo ETM and our sensor-guided technologies. In light of the growing momentum in our Hospital business, we are raising our organic revenue growth guidance to a range of 14% to 17% up from the previous 13% to 16%, while adjusting expectations for the newly acquired products, resulting in a 100 basis points reduction at the midpoint of our reported revenue guidance of 26% to 31%. Before I hand over the call to James to discuss the rest of our financials and updates to our fiscal 2025 guidance, I want to reaffirm our commitment to our LRP and delivering value to our shareholders through sustainable, profitable growth. Our product portfolio is increasingly well positioned to deliver on significant unmet needs and our commercial investments are strengthening our competitiveness. We are confident we will thrive in this dynamic environment and achieve our short- and long-term goals. We are navigating complex market challenges and adapting to emerging trends and opportunities. We're resilient. We find ways to deliver and we have a lot to be excited about. James, over to you.

Thank you, Chris, and good morning, everyone. Chris has already discussed our revenue, so I'll continue with the rest of our financial results and updates to our fiscal '25 guidance. Our portfolio evolution is having an increased impact on our business, driving sustainable margin improvements. In the second quarter, adjusted gross margin reached 56.7%, up 270 basis points from second quarter fiscal 2024 with approximately 70% of this improvement driven by volume and mix, followed by additional contributions from price across all business units and manufacturing efficiencies. These improvements were partially offset by approximately 130 basis points of headwind from foreign exchange. Year-to-date trends reflect a similar story. Having delivered an additional 140 basis point margin expansion sequentially, we finished the first six months of the fiscal year with an adjusted gross margin of 56%, up 190 basis points when compared with the prior year. Looking ahead, we expect further margin expansion in fiscal '25, primarily driven by an increase in momentum throughout our Hospital business, technology upgrades and overall higher-margin business in Plasma and incremental savings from our operational excellence program. Adjusted operating expenses in the second quarter were $112.3 million, an increase of $8.7 million or 8% compared with the second quarter of the prior year. As a percentage of revenue, adjusted operating expenses were at 32.5%, flat when compared with the same period last year. Adjusted operating expenses year-to-date were $227.2 million, an increase of $25 million or 12% compared with the prior year at 33.3% of revenue. The dollar increase in adjusted operating expenses in the quarter and year-to-date was primarily driven by the acquisitions of OpSens and Attune Medical, along with additional investments to support our growth momentum. Adjusted operating income reached $83.5 million in the second quarter, up $15 million to 24.2% of revenue, reflecting a 310 basis point sequential expansion from the prior quarter and a 270 basis point increase year-over-year, inclusive of an approximately 100 basis point headwind from foreign exchange. Adjusted operating income in the first 6 months was $154.5 million, up $16 million at 22.7% of revenue. As we continue to move through fiscal 2025, the expansion in adjusted operating margin is becoming more pronounced, reflecting impacts from our shifting portfolio mix, improved operating efficiencies and disciplined capital allocation. We reaffirm our fiscal year '25 adjusted operating margin guidance in the range of 23% to 24%. This guidance reflects our expectation of additional margin improvement in the second half of this fiscal year, more than offsetting the anticipated increase in adjusted operating expenses due to the expansion of our clinical teams and investments into innovation. This will help set the groundwork needed for continued margin increases into fiscal 2026 as we work towards achieving expected adjusted operating margins in the high 20s. The adjusted income tax rate was 25% in the second quarter and 23% year-to-date compared with 23% and 22% in the same periods of the prior year respectively. We anticipate our third quarter tax rate to be similar to the second quarter and a full year tax rate at around 23.5%. Second quarter adjusted net income was $57.3 million, up $7 million or 13% and adjusted earnings per diluted share was $1.12, also up 13% when compared with the second quarter of fiscal 2024. First half adjusted net income was $109.6 million, up $5.3 million or 5% and adjusted earnings per diluted share was $2.13, also up 5% when compared with the first half of fiscal 2024. The combination of the adjusted income tax rate, interest expense, net of interest income, changes in the share count and FX had a $0.13 unfavorable impact in the second quarter and a $0.20 unfavorable impact year-to-date when compared with the prior year. We're enthusiastic about our performance in the first six months of fiscal 2025 despite modest changes in the revenue mix included with our updated guidance and reaffirm our fiscal 2025 adjusted earnings per diluted share guidance to be in the range of $4.45 to $4.75. Before we move on to discuss our balance sheet and cash flow, I have an additional update related to capital allocation. In our second quarter, we entered into an accelerated share repurchase agreement to buy back $75 million of common stock under our previously announced $300 million share repurchase authorization. This share buyback helped offset some dilution from existing share-based compensation programs and return some capital to shareholders at an opportune time given our growth expectations. We have $150 million remaining under the existing share repurchase authorization and we will continue to be opportunistic with additional buybacks. Moving on to balance sheet and cash flow. In the first 6 months of fiscal 2025, we recorded cash provided by operating activities of $21.4 million, down from the $118 million in the same period last year and free cash flow of $20.4 million compared with $84.8 million in fiscal 2024. While our cash flow has improved significantly since the first quarter, working capital has also continued to increase, offsetting an increase in net income. The increase in working capital can be attributed to higher inventory levels driven by several factors, including an overall improvement in the disposable inventory position in plasma compared to the previous year when we were operating under critically low inventory levels, the continued transition of our customers to the latest technology, which includes new bowls and bottles, additional NexSys devices and inventory from recent acquisitions. And finally, the timing of certain payments and receivables, including settlement of specific legal expenses and performance-based bonus payments for fiscal 2024, both of which were paid out in our first quarter of fiscal 2025, we expect our working capital to improve in the second half of the year and reaffirm our expectation for fiscal 2025 free cash flow to be in the range of $130 million to $180 million. Cash on hand at the end of the quarter was $299.3 million, up $120.5 million since the end of fiscal 2024, primarily due to our recently completed debt transactions and partially offset by our acquisition of Attune Medical and share buybacks. There were no further changes made to our debt capital structure following a series of refinancings we completed earlier this fiscal year. Our debt tower consisted of $1 billion in convertible bonds, a $248 million Term Loan A and no outstanding borrowings on the revolving credit facility, resulting in a net leverage ratio of approximately 2.7x EBITDA as defined by our credit facility. Before opening the call for Q&A, I'd like to provide some key takeaways from our remarks. First, our long-range plan financial targets remain intact and we expect growth in the second half of this year to set a solid foundation for our final installment of the LRP as leverage and mix benefits become increasingly more evident in our results. In Plasma, we are upgrading our remaining customers to the latest technology and continue to win share, allowing us to deliver meaningful growth in this business ex-CSL despite short-term impacts to collection volumes. As collections return to historical growth levels, we are well positioned to sustain our above-market growth through ongoing innovation and expanded market share. Our Hospital business is well positioned to sustain its outsized growth trajectory amid dynamic market trends. We are dedicated to accelerating the adoption of all our products and expanding our reach and relevance as we unlock new growth opportunities and achieve operating leverage through scale. And finally, we will actively pursue opportunities to enhance shareholder returns with nearly $1 billion in available capacity today projected to grow up to $1.6 billion by the end of fiscal 2026. We are well positioned to deploy additional capital for organic investments, M&A, opportunistic share buybacks and debt repayment, maximizing outcomes for both the company and its shareholders. Thank you. We are now ready to open the call for Q&A.

Thank you. Our first question comes from the line of Anthony Petrone from Mizuho Financial Group. Your line is now open.

Thanks and good morning. Congratulations on a good print here. Maybe, Chris, I'll start off with VASCADE and then I'll have a follow-up on Plasma. Maybe to just kick off on VASCADE, Chris, you mentioned in the second half of the year in your prepared remarks, high 20s growth rate trajectory. Can you maybe walk through how many of the target 600 electrophysiology sites in the United States have adopted XL at this point? What's the rollout plan in the second half for more deeply penetrating those sites? And is there anything you can share on the pricing dynamics of XL versus the predecessor MVP device? And again, I'll have that follow-up on Plasma.

Thank you, Anthony. The introduction of MVP XL has put us back on our front foot in vascular closure. Clearly, PFA, fantastic technology, disruptive influence in the market and you see that, unfortunately, in our first quarter results where it was a setback for us. We did the limited market release. We truncated that because the results were so overwhelmingly positive and we had a lot of confidence with the product's performance. So mid-August, exactly halfway through the quarter for us, we began the launch. We are now, at this point in time, fully through 200 of our top 600 accounts. Again, feedback has been very similar to what we experienced in the limited market release in terms of ease of use and the functionality for closure, both for AFib and PFA included and for left atrial appendage closure, which is a market we didn't really have penetration in previously. So we're moving ahead nicely. In fact, if we just look at it from the results through today, if that 13-week period, which is about how long we've been on the market had been in the quarter, we would have already been talking about mid-20s growth. We think it will be high 20s in the second half of the year because of the continued penetration. In terms of pricing, we tend to price all of our innovation based on the value proposition. There's a clear and definitive value proposition for MVP XL in the market. It's a 58% larger collagen plug and our pricing reflects that. As we scale the business, the gross margin from that will be accretive to our overall closure business. It's not there today just given where it is in the launch. But certainly, over the second half of this year, we'll realize that benefit as well.

Very helpful. And then the follow-up on Plasma, Chris, maybe just to parse through if we exclude CSL, maybe just the pricing and volume dynamics of that base business, excluding CSL. And really, what I'm getting at, there was weather and IV shortages. So how is volume versus price in the base plasma business ex-CSL trending? Again, congrats.

Yes. Thank you. Our non-CSL business, we saw a mild pullback in total volumes, not unexpected. The growth rate over the prior two years, clearly not sustainable. The market for collections is excellent and there's a lot of foot traffic into the centers. And our largest customers are using this as an opportunity to manage inventory and to manage cost per liter. And that's where our value proposition for the integrated platform on NexSys with Persona and Express Plus and the software support is really front and center. And it's enabled us now to have commitments such that we know we will complete the upgrade to our latest technology across all U.S. customers on the NexSys device by the end of this fiscal year, if not sooner. As we upgrade, customers are seeing the benefit faster throughputs, better plasma yields and that's driving share gains as well. So excluding the CSL business, we actually grew that business, but not on collections. We grew it on the pricing on the revenue, which, again, just reflects the superiority of the platform and the demand for the product. So we remain very bullish. The share gains are happening as we speak. They'll continue into our FY 2026, all of which is meaningfully margin accretive for that plasma business. So we feel quite good about our positioning and what we can get done here over the next 4 to 6 quarters.

Thank you.

Thank you. Our next question comes from the line of Marie Thibault from BTIG. Your line is now open.

Good morning. Thanks for taking the questions and congrats on a good fiscal second quarter. I wanted to start here to talk a little bit more about the adjusted operating margin, a really nice jump in that metric, certainly more than we had expected, yet you held the guide for the year. Can you help us think about some of the cost cutting you're doing? I know you're making some investments in clinical teams. Should we think about the increases you talked about rest of the year being more incremental? Certainly, if we did larger jumps, we'd be getting past the top end of your guidance. So help us think a little bit about cadence and what's actually happening behind the scenes.

Yes Marie, I'll start and I'll invite James to finish it out. We are pleased with the gross margin and operating margin improvement in the quarter. Fully 40% of our business in the second quarter is Hospital-based business. We tend to run that overall business at roughly a 70% gross margin. As our plans entail, that's really driving the expansion, so pretty much all of the improvement. And we really saw close to a 400 basis points improvement. There was about 130 basis points of FX headwind that James called out, which got us back just below 300 overall. That's what our plans called for and we're delighted to be able to deliver it, taking advantage of some opportunities that have presented themselves in the market. Within Plasma, as I just mentioned on the prior question, the migration to NexSys with Persona and Express Plus and the share gains is meaningfully moving the gross margin of that business as well. We do have investments planned and we tried to be explicit and fulsome when we gave our guidance at the beginning of the year, still the midpoint of our guidance range has us growing in the mid-teens earnings year-over-year in a year where we're transitioning one of our largest customers. So we felt the original guide for the year was appropriately ambitious and we're pleased to be delivering against it, but I'll let James fill in the detail.

Yes. Thanks, Chris. And thanks, Marie, for the question. So for the remainder of the year, as Chris mentioned, we see the mix really being the story with continued two full quarters of MVP XL, continued momentum across TEG, continued progress in esophageal cooling and sensor-guided technologies and a more profitable Plasma business. Those are all very positive mix signals for us, which will continue throughout the year. Phasing-wise, third quarter will likely be flattish operating margin-wise to second quarter. And the reason for that is some of the investments that Chris just spoke about as we continue to build out our IVT commercial team and our clinical team to set the foundation for future growth. And then by the time we get to the fourth quarter, then we see a bit more of a bump up to finish the year strong and right within our guidance range for operating margin.

Okay. That's really helpful and good to hear. Maybe my follow-up quickly here on some of the acquired products in hospital. I heard $16 million in revenue from that segment this quarter. I think it was $18 million last quarter and I noticed a little bit of a nudge down on the guidance. Can you tell us what's happening a bit with the Attune and OpSens products and the rollout there? Thank you.

Yes, thanks, Marie. We are still very positive about both of those acquisitions. However, progress has been slower than we would like, particularly in electrophysiology compared to structural heart. For EnsoETM related to Attune, the difficulty lies with PFA. We recognize the impact of PFA, and our modeling indicates that it is expected to take slightly more market share. Some leading companies forecast it approaching 60%, whereas we had anticipated around 65%, which would still be beneficial for our business. In the first half, the PFA companies have been rightly focusing on our most desirable EnsoETM customers. As they conduct more procedures using PFA instead of RF, Enzo's involvement has diminished. We have opened 32 new accounts and are now concentrating on identifying high-volume RFA users. This will continue to be a task for us. To put this into perspective, we currently hold about 9% of the closure market with EnsoETM. If we can increase that to the mid-teens, around 15%, over the next three years, we expect to achieve a mid-teens return on invested capital during that time frame. This is by far the most valuable acquisition we have made, and we believe our goals are realistic. It will take time, and our field team is working through this process. Having XL as an offering certainly enhances our position in discussions with both PFA and RF users, and we appreciate the direction we are heading. Regarding OpSens and the Sensor Guidewire business, we are taking a deliberate approach to gradually accelerate our progress over time. The structural heart space is quite different from closure. We have established a presence and are expanding on it, but there is a steep learning curve and executing it effectively will take time. Recent developments from TCT give us optimism about sensor-guided technology. We need to leverage those advancements, and we believe that we can do so over time. The investments James mentioned for the second half of the year, aimed at strengthening our clinical sales team, are essential elements of our strategy for the sensor guidewire business, and there is more to come. We are optimistic but are proceeding with careful planning and intention for the launch.

Very clear, thank you so much.

Thank you. Our next question comes from the line of Larry Solow of CJS Securities. Your line is now open.

Great thanks, and good morning, everybody. I guess, first question, which is just on the TEG market there. Chris, I know you mentioned really strong growth in the U.S., 35% and then obviously continued challenges in China. Perhaps you could just kind of give us a little more color on directionally where you see both those, the U.S. and the international markets going on TEG?

Yes, good morning, Larry. The TEG is a significant positive development for us. We often joke that it's the oldest launch product in med tech. The heparinases neutralization cartridge has greatly enhanced the value proposition of the TEG 6S, speeding up the transition from TEG 5000 to 6S as it levels the products for use in care settings, which is very impactful. This is reflected in our results, with growth in the U.S. in the mid-30s and in Europe in the 20s. We are optimistic about building on this momentum. However, China presents a different situation; it remains a challenge, as many of our peer companies have noted. China accounts for about 5% of our overall revenue, divided mostly evenly between Blood Center and Hospital. Within the Blood Center, revenue is also balanced between TEG, which is entirely TEG 5000, and our cell salvage business. Currently, the challenges we face are primarily related to pricing for the TEG 5000. We will navigate through this, but there are no simple solutions, and we don't anticipate significant changes in the second half of the year.

Got it. And switching gears just back to, just on VASCADE. You mentioned it sounds like somewhat a lot of the acceleration in growth perhaps in the back half of the year, driven by the performance of MVP-XL. How about just VASCADE and VASCADE MVP? Are those still considerable, obviously, still should be a lot of room for growth there. Are those still hanging in and doing how you thought they would after a little bit of a slowness in Q2, Q1, excuse me.

Yes, Larry, it's performing as planned. I do think PFA has been so disruptive. It sucked all the oxygen out of the room. And we did see pushback on MVP in that regard in electrophysiology. What we've targeted with the launch of XL is to go and regain the share we lost in the first quarter. And I can tell you sitting here at this point in the third quarter, we've largely regained everything we lost and then some. And that's coming where clinicians being very thoughtful. They're using XL where appropriate and then they're using MVP accordingly. And like any other kind of sales effort, there's some spring in the step and that's helping across the entire closure product line. So yes, I think we're seeing a lift across all three and we anticipate building that momentum as we move into the second half.

Got it, great. And then just last question, if I could squeeze in, James, just you gave us some good guidance on the cadence of operating margin. It looks like this quarter, the expansion was kind of half by gross and half by operating leverage. As we look at in the back half of the year, gross margin had a nice little sequential uptick. Do you think that also is sort of flattish in Q3? How do we, just kind of how do you feel about gross margin in the back half of the year?

Yes. So the gross margin, yes, will follow, I would say, a similar pattern to the operating margin. You'll see it come up a bit in Q3 and then a little bit more in Q4 as we move forward in the rest of the year.

Got it great. Thanks, thanks very much, I appreciate it.

Thank you. Our next question comes from the line of Craig Bijou of Bank of America Securities. Your line is now open.

Good morning guys, thanks for taking the question and congrats on a strong quarter. I wanted to start with some of your comments on the VASCADE label expansion. And with the XL launch or now full launch, just kind of wanted to get your sense for pushback for maybe not having that label expansion or when you think about what that label expansion can, how it can drive XL, like, do you think it's needed or is it something that you guys just want to have going forward and maybe gives you access to some other procedures?

Welcome, Craig and thanks for the question. From our vantage point, MVP is getting, XL is getting a lot of consideration appropriately. And that's, one thing I can highlight a bit more is that the breakdown is 60-plus percent PFA, the remaining 35% or 40% is left atrial appendage closure. And that's completely new for us because we really didn't have a product that was applicable for that previously. That's exactly what we saw in the limited market release, where we have a lot of physician testimonial. They'll use it where they see appropriate. We obviously can't detail it or position it in that way out of the gate. And so, we're being very mindful about that and building the usage. We are making the label expansion a corporate priority because it's the right thing to do. And it will further reinforce and the label will reflect the appropriate use of the product over time. In the near-term, I think we've got a good market opportunity ahead of us and we expect to see continued uptake and judgment on behalf of the clinicians. Obviously, we don't promote it off-label. So we'd be really thoughtful about that.

Got it. That's helpful. And maybe just taking a step back and big picture on the longer-term opportunity for VASCADE, obviously, you guys are expecting high 20%s growth in the second half, a return to that. You guys had high 20%s growth in 2024. So when we think about the growth profile of that business, I guess, more longer term, 2026, 2027 over the next couple of years, can you maintain that high 20%s growth profile? And what are some of the assumptions, penetration that we should be thinking about in terms of the opportunity for VASCADE?

Yes. It's something we're grappling with. We know what the TAMs are and they remain really robust and significantly underpenetrated. So we do think continued accelerated growth is achievable. There is the math here. At the end of the day, if you continue to grow at 30% per annum, you become the market and we don't want to be unrealistic about that. What we look at is two offsetting effects that are really powerful that we describe as the net positive, Craig. There's less holes to be closed, right? That is a function of how the market adopts to PFA. We're going to have some dual modality coming to the market. That will certainly reduce the number of holes. We model it going from just over 3, approximately 3.2 down to the mid- to high 2s, 2.7, 2.8 per procedure. That is completely offset by our initial growth experience when we were a year and 2 years ago, where we were printing 30% growth, we were looking at a market that was growing in the low-double digits. Now we're the mid-teens or better, right? I think there's current forecast have procedure volume in aggregate growing at 16%. That more than offsets the lack of closures per procedure. Now having XL, having MVP, having VASCADE working down market, are development plans call for smaller closure ability and pushing more into venous. It will help us with the interventional front, PCI. We think there's a lot of opportunity. Part of it, as I described, broadening the shoulders of this application. Part of it's the expansion internationally as we follow PFA and the other ablation modalities into other geographies. Japan, for an example, is a really hot market for us right now. So we think there's good room to run. We hold off on guiding exactly what's going to happen next year until the spring. But at this point, we feel really good we're back on our front foot and able to participate fully in a very interesting ablation market.

All right, great Chris. Thanks for all the color.

Our next question comes from the line of Joanne Wuensch from Citi. Your line is now open.

This is Anthony on for Joanne. I want to just switch gears to Blood Center. That margin has been a bit volatile over the last few quarters. It stepped up pretty nicely this quarter. Should we think about, is this quarter a good way to think about stable margin for the business going forward? Should we expect it to expand more as you continue to rationalize that whole blood business, just any thoughts on profitability in Blood Center going forward? Thanks.

Yes. Thanks, Anthony. Look, that business doesn't have the growth potential of our Plasma or our source plasma or our Hospital businesses. So we are in a mode of margin expansion play for the profit contribution, which has improved nicely, as you say. I would separate it out really into three component parts. There's the whole blood filters business. We've announced more than a year ago now the rationalization of that business. It's a nonstrategic asset for us going forward and we just are looking to optimize it exactly as you described. Within the remaining business, Apheresis splits in two parts. There is a plasma collections Apheresis business, which we are actively migrating to the NexSys platform. Many, many of our Blood Center customers are partnering with our source plasma customers to drive self-sufficiency. You see that in our operations throughout the Middle East, for example, but it's also happening in Canada and elsewhere in Europe. That's a powerful driver of the Plasma Apheresis Blood Center, but it's looking more and more and growing more and more like the source plasma business. On the other part of the business, the other remaining Apheresis, it's platelets and it's red cells. Folks use our technology very specifically. And we've had the courage to lean into that and price those technologies accordingly. And so this is all part of the broader rationalization. It's not an active contributor to the top line. But it is meaningfully contributing through price and mix to our bottom line, which is all part of the LRP that we outlined previously.

Helpful. And then on the hemostasis management business, I don't know if you touched on this, just any color you can give on how much of that growth this quarter was from volume? I heard utilization was up 20% versus how much of it was pricing of that new assay that you're rolling out.

Yes. So the heparinase neutralization cartridge has been a real catalyst for that business and we're driving it in the U.S. We will bring it to our global markets in due course. So that is really the single driver behind the 35% growth rate in the quarter. It is a mix of both capital as we swap out TEG 5000 for the TEG 6 success device moving from a lab-based application to something that is site of care, much more user-friendly. And it's also utilization because adding that cartridge makes the full suite of opportunities available. So we feel both of those things are combining and it is at a higher margin, just given that again, the value prop of the cartridge, we had the confidence to price accordingly and I think we're seeing the market response.

Thank you. Our next question comes from the line of Andrew Cooper from Raymond James. Your line is now open.

Hi everybody. Thanks for the questions. Maybe just first, I do want to touch on, you mentioned some more clinical investments. Can you give a bit of sense of kind of exactly what those look like? And should we think about that as being somewhat reactionary to what you've learned as you look at selling OpSens as an example and it being a little bit more complex of a sale than maybe appreciated initially? And just would love kind of thoughts around how that progresses and when we can start to see maybe a little bit of acceleration there.

Thank you for the question, Andrew. I would characterize our approach as reactive. When we acquired OpSens, we established clear boundaries for their commercial and research efforts. Over the past six months, we have dedicated time to understanding how best to expedite bringing certain products to market, thereby enhancing the profile and value proposition of the sensor guidewires. This planning was indeed part of our deal models and has influenced our guidance for this year. We see significant potential in expanding the use cases for the sensor guidewires. The EnsoETM is somewhat simpler and requires less effort. Earlier in the call, I discussed our initiatives regarding the VASCADE family of products, where we are expanding their application and ensuring we cater to all closure needs with unique offerings for each area. Turning to the Plasma business, as we’ve mentioned before, we have a leading market share, and we plan to strengthen that position. We are actively engaging in discussions with all our customers about hardware, disposables, and software, especially DMS, where we are the primary provider. Our goal is to enhance the value we provide and better integrate with their processes, which necessitates significant investments. In the near future, we expect to organize either an Investor Day or an R&D Day to highlight some of these innovations, as we believe we are positioned to create the next major growth phase in this sector.

Okay. Great. That's helpful. Maybe just one more quick one. Can you give us an update on where you are in that international launch for VASCADE and maybe interventional overall? Obviously, still the early days, but maybe any sense for what that contributed in 1Q and 2Q and how we think about the curve there as you continue to build up the operational presence?

Yes. It is one of along with the label expansion and strengthening our U.S. interventional technologies field force, both sales and clinicals. International expansion is an important lever for us. We feel like we're meaningfully ahead of schedule there. There is a different market set that we enter into depending on where we are geographically. I'd highlight Japan as an absolute hotspot for us. We were able to secure really favorable reimbursement at the time of market release and you see that plying forward in the market. So that's a meaningful contributor. We're well ahead of schedule there. Europe has been more build as we go. There's a different base modality. They use much more suturing than compression. We have clear value, but there's some challenges with regards to the benefit of same-day discharge and how that's reimbursed. And we continue to work through that country by country in Europe. We're confident that we will meet our plans longer term, but it's slower going. It doesn't have quite the same rapid uptake that we saw previously in the U.S. or currently in Japan. But it's one of the three drivers, the international expansion, Andrew, and we're going to continue to lean in there. It is also part of the investment in our commercial and clinical efforts that James talked about earlier.

Perfect and I'm going to sneak one more in, if I can, just shifting to Plasma. You talked about the share gains sort of ongoing. Can you give us sense for, it sounds like you have some visibility. So can you give a sense for the magnitude, whether it's number of centers or kind of where those are coming from and how we think about what that business can look like ex-CSL with this sort of share gain over the next, call it, handful of quarters?

Yes. We'll move as fast as humanly possible based on our customers' willingness to accelerate. And so I think they've all been very clear. They want Express Plus because it speeds up the device in tandem with our software, the DMS software, it makes the door-to-door time unrivaled. Then they add in the plasma yield enhancement in a way that's not even in any way imposing on the donor's time. That's kind of the sequence. And then as we do that we're picking up additional share. We talked some time ago with the large customer transition out. We don't need to go one for one given the decidedly different price points and margin profile of the businesses. In fact, it's closer to two to three type of thing, a 2/3 ratio. We're not there yet today and that's what's included in our guidance. We do expect we'll gain momentum moving into FY 2026, all of which is factored into our overall plan.

Perfect. I appreciate the time.

Thanks.

Thank you. Our next question comes from the line of Mike Matson from Needham. Your line is now open.

Yes, thanks for taking my questions. So just one more on MVP XL. So on the labeling to get the larger French sizing, do you need clinical data there? And then just the timing, can you give us any sense of the timing on when you expect to have that labeling from the FDA?

Yes, Mike, thanks for the question. So there's no change to the workflow. The workflow for XL is the same as it is for MVP as it is for base VASCADE. There's really no change to the engineering design. What we are doing, beginning actually with our limited market release where we saw substantial PFA use is working with active clinicians in some of the largest leading centers and helping put the clinical evidence together of how Xcel works in that setting. We're in dialogue with FDA about the appropriate timing and structure and kind of what that submission needs to look like. That's still work-in-progress and we clearly don't control that. But I think without going too far out on the branch, I think FDA has been highly supportive of the need to expand the label and give clinicians and patients access to what is truly the best available closure technology. So more to say as we go forward, but we are making it a top priority, Mike.

Okay. Got it. And then there was a pretty large headwind from currency to margins and EPS in the first half of the fiscal year. And I know no one can really predict currency movements. But with rates where they currently stand at least, what is your expectation for the second half? Is that going to be, continue to be a headwind? Does it neutralize? Does it become a tailwind?

Yes. I think if at current prevailing rates, it should continue to be somewhat of a headwind. But I think I've seen rates moving around all over given the elections and some of the volatility in the global markets. So I don't want to make too much of a call there.

Okay. And then finally, I thought I heard you guys say that CSL was going to contribute $100 million this year. Did I hear that right?

Yes, Mike, you did and that was included in our affirmed guidance. What we're seeing from CSL, the approximately $85 million that we talked about back at the beginning of the fiscal was their minimum purchase commitment. Through the first half of the year, they've needed more. And like all of our customers, we're going to do what we can do to respond. Roughly 70% of that approximately $100 million has already been realized in the first half. Their transition will continue. In fact, our model has it accelerating over the second half of the year. We still expect them to fully transition not later than December of 2025 per the existing agreements. But yes, it's going to be marginally higher total volume than it was from the original expectation.

Okay got it, thank you.

Thank you. And our next question comes from the line of Kristen Stewart from CL King. Your line is now open.

Hi thanks for taking the question and congrats on a good quarter. I was wondering if you could just provide some over-level thinking on M&A and the environment that's out there and the need to do acquisitions going forward and what kind of areas you'd be looking at?

Welcome, Kristen, and thank you for the question. Growth, both organic and inorganic remains our top priority to drive the margins, to drive our profitability and to make this all significantly more sustainable going forward. Right now the here and now and certainly in our second half of this fiscal year, our first, second and third priority is delivering on those recent acquisitions for some of our prepared remarks. We really want to deliver fully against what we're doing with EnsoETM. We want to deliver fully against the Guidewire business and the R&D expenditures that we've had, whether it's XL or HEP neutralization, they're our immediate priorities. That said, we will continue to look to be opportunistic with regards to M&A. I think tuck-ins. In fact, we've been very public about our relationship and the option play that we've put for baby shower, for example. They had an outstanding readout on their patch trial at TCT. That's moving forward and we're helping shape that submission to FDA. So that's something we will talk about in fiscal 2026, for example. But, and then you saw we did the buyback in the quarter. We'll be opportunistic about returning value to shareholders where we can and that would include debt pay down as appropriate. But M&A is part of the equation. For now it's tuck-ins. Maybe a year from now or longer, we'll talk about the next leg on the stool. But our top priority is validating our performance in Interventional Technologies and really driving home this thesis that we can be the enabling tech in a very rapid and attractive category.

Thanks for taking the question.

Thank you for your participation in today's conference. This does conclude the program. You may now disconnect.