Good day, and welcome to the Haemonetics Corporation Second Quarter Fiscal 2023 Earnings Call. At this time, all participants are in a listen-only mode. After the speakers' presentation there'll be a question-and-answer session, and instructions will be given at that time. As a reminder, this call may be recorded. I would now like to turn the call over to Olga Guyette, Senior Director of Investor Relations and Treasury. You may begin.

Good morning, everyone. Thank you for joining us for Haemonetics' second quarter fiscal '23 conference call and webcast. I'm joined today by Chris Simon, our CEO; Stewart Strong, President of our Global Hospital Business; and James D'Arecca, our CFO. This morning, we posted our second quarter and first-half fiscal '23 results to our Investor Relations Web site, along with updates to our fiscal '23 guidance and the analytical tables with the information that we'll refer to on this call. Unless otherwise noted, all revenue growth rates we'll discuss today are organic, and exclude the impact of currency fluctuation, strategic exits of product lines, acquisitions and divestitures. Additionally, to help investors understand Haemonetics' 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 period of fiscal '22, and reconciliations to our GAAP results, please refer to our second quarter and first-half fiscal '23 earnings release posted on our IR Web site. 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.

Thanks, Olga. Good morning and thank you all for joining. Today, we reported second quarter organic revenue growth of 27%, and adjusted earnings per diluted share of $0.83, an increase of 38% compared to the second quarter of the prior year. Our second quarter and year-to-date results are evidence of the accelerating momentum in our businesses. The macroeconomic environment is challenging, but we have taken actions and are well-positioned to navigate the headwinds. Demand for our products and services has never been stronger. We are helping fuel growth in the plasma industry by setting the standard for plasma collections, enabling our customers to collect record volumes to replenish depleted inventories. The essential value of our hospital solutions combined with our investments are expanding our presence and accelerating growth. Our operational excellence program is driving new efficiencies and enhanced processes to help counter inflationary pressures. Through our agile, flexible global manufacturing network and resilient supply chain, we are consistently producing and delivering the products and technology our customers depend on. We are pursuing the goals we set in our long-range plan for transformational growth, diversification, and sustainability. In October, we welcomed Roy Galvin to Haemonetics as President Global Plasma and Blood Center, his leadership and vast experience in medical technology will help drive continued strong results and long-term value creation. Turning now to the business unit results and guidance, plasma revenue increased 58% in the second quarter, and 52% year-to-date. North American disposables represent 85% of total plasma revenue, and increased 63% in the quarter, and 56% year-to-date, driven by strong growth in volume and price as a result of our technology upgrades. We completed our technology upgrade ahead of schedule, and the fully integrated bidirectional NexSys platform is now helping all of our long-term customers achieve effective and efficient plasma…

Thanks, Chris, and good, morning everyone. I am happy to be here today to discuss our hospital business unit result and the work we are doing to drive revenue growth and further strengthen our leadership position in the markets we serve. Hospital revenue grew 22% in the quarter and has grown 18% year-to-date. Despite continued macroeconomic challenges including staffing shortages, hospital capital budget constraints in the U.S. and Europe, and continued geopolitical risk, we meaningfully grew our revenue and our market share. Hemostasis Management revenue grew 11% in the quarter and has grown 8% year-to-date driven by strong adoption and utilization of our TEG disposable products. As a reminder, in the first-half of our fiscal '22, we won a large national European tender for ClotPro. The associated shipments of capital and stocking of disposables all took place in the first-half of fiscal '22, which created a difficult year-on-year comp for this part of our business in the first-half of fiscal '23. Vascular Closure revenue grew 42% in the quarter and has grown 39% year-to-date despite a more than typical adverse seasonality of this business during the summer months. Growth in the second quarter was disproportionately driven by new electrophysiology account within the top 600 hospitals further increasing our U.S. penetration. We are excited about the newly granted CE mark certification for both Vascade and Vascade MVP that helped unlock additional attractive market opportunities outside the U.S. While there is still more work to do, we plan to begin commercialization of our vascular closure device in Europe towards the end of this fiscal year. Our product development efforts also include inorganic investments in Vascular Closure, particularly in solutions for large-bore arterial closure necessary for procedures such as TAVR and EVAR. This is an attractive global market that we estimate to be…

Thank you, Stu, and good morning, everyone. Let's discuss our business results and some additional updates to our fiscal '23 guidance. Second quarter adjusted gross margin was 53.7%. An increase of 110 basis points compared to with the second quarter of the prior year. Adjusted gross margin year-to-date was 54.4%. An increase of 80 basis points compared with the first-half of the prior year. Adjusted gross margin both in the quarter and year-to-date benefited from volume and mix, particularly due to strong volume growth in plasma and hospital, plus an additional savings from our Operational Excellence Program. These adjusted gross margin benefits were partially offset by inflationary pressures, higher depreciation expense primarily related to finishing the conversion of all U.S. customers to our NexSys devices, and some of the recent investments in our manufacturing and supply chain network. Adjusted operating expenses in the second quarter were $99 million. An increase of $17 million or 20% compared with the second quarter of the prior year. As a percentage of revenue, adjusted operating expenses increased by 100% basis points and were at 33.3% when compared with the second quarter of fiscal '22. Adjusted operating expenses year-to-date were $198.5 million, an increase of $29 million or about 17% compared with the prior year. The increase in adjusted operating expenses in both periods was primarily driven by increased freight volumes and costs, continued growth investments including research and development, and sales and marketing, our return normal spending levels, and higher performance based compensation which was partially offset by savings from the Operational Excellence Program. Adjusted operating income was $60.6 million in the second quarter and $105.5 million in the first-half, representing increases of $70 million and $24 million respectively. As a percentage of revenue, adjusted operating margin was 20.4% in the second quarter and…

Thank you. [Operator Instructions] Our first question comes from Anthony Petrone with Mizuho. Your line is open.

Great, and congratulations on a very strong quarter here, and hope everyone is doing well. First couple would be either for Chris or Roy on Plasma, and just the numbers with the quarter, obviously North American volumes up substantially. But maybe just the optics of the overall number for this quarter, how much was contributed by price versus volume, that would be the first question? And when we think about the volume gains here, maybe a little bit on the recession and inflation tailwinds to the Plasma business, and when did the company start to see those come into the mix here? And what would be the expectation for how long those tailwinds could last? And I'll have one quick follow-up.

Hey, Anthony, it's Chris. Welcome back, great to have you in the mix. In terms of Plasma, yes, it was -- we have now collected more in the quarter than we did in the equivalent quarter prior to the pandemic. So, recovery is fully underway. The outperformance in the quarter was a mix of both volume and price, the price being associated with the completion ahead of schedule of our technology upgrades to NexSys and now fully half of our collections happening on our Persona technology. So, volume was by far the major driver but, clearly, our mix is helping as well. In terms of what's happening in the macro environment, as we said in our prepared remarks, all centers participated, mature and new alike. It's important to recognize that we have twice as many new centers as a percentage of our total supported centers than we had pre-pandemic, and they're growing at exactly the historic rate. So, it feels good. Southern border is back, not to its pre-pandemic levels, but the trajectory actually is more robust than we had anticipated at this point in the year. So, really feels like we're hitting on all cylinders. I do think this is a bit of a contrarian story; regardless of what happens in the macro environment, the combination of inflationary pressures, a potential recession, consumer sentiment being at all-times low has really motivated the donors to return. And our customers are doing everything in their power to take advantage of that, and to grow, not only to meet current patient need, but to replenish inventories for the ongoing growth that they see in Ig-based therapy. So, it's a robust time for sure, and we expect that tailwind to continue for the foreseeable future.

The follow-ups would be there, Chris, just on the notion on inventory build, fractionators clearly went through a period of record low levels of inventories out of the pandemic. And any way to sort of estimate where they are in replenishing inventories and safety stock? How long it may take for them to get back to a pre-pandemic level? And the last question for Stu, is just quickly on Cardiva, received the CE mark in September. And any color on the early launch days, across Europe for Cardiva, that would be helpful. Congratulations again. Thanks.

Thanks, Anthony. So, on inventory levels with our customers, they hold that close to the vest, as you can appreciate. So, we're going to respect and honor that as well. But I think in the current environment where the demand for Ig-based therapies is so strong, the end market demand for their products, I think inventory winds up taking on a real strategic role, it allows customers to bid for contracts and tenders that they might not otherwise be able to. And I think inventory matters a lot to all of our customers. They're at various stages of recovery. I think all of them have aspirations to grow their inventory levels from where we sit. And we'll watch closely number of new center openings and donor remuneration, but we don't see any abatement near-term, for sure. Stu?

Yes, hey, Anthony, thanks for the question. We're excited about the CE mark that we got. We plan to begin commercialization in Europe toward the end of this fiscal year. The CE mark, as you've heard from me before, represents a huge opportunity for us, particularly in EP. In Europe, it's about a $1.3 billion TAM globally. Europe is a significant part of that, so we're excited about that launch. Right now, we're going to target the markets that have a best conditions for launch, and that comes down to volume, comes down to clinical and economic value in the country, as well as pricing and reimbursement. So, those are the countries we're going to go after first. But just like we did in the U.S., we're going to take a very disciplined approach to the launch in Europe, and make sure we focus on the areas that are most opportune for us to launch in.

Thanks, again.

[Operator Instructions] Our next question comes from Drew Ranieri with Morgan Stanley. Your line is open.

Hi. Thanks for taking the questions. Chris, maybe for you, and I know you don't necessarily want to get on specifics for pricing. But as you're thinking about the guidance raise in Plasma, could you just help us maybe parse out a bit of what the expectation is for pricing now that NexSys has kind of fully rolled out earlier than expected? And I think you mentioned Persona was now 50% of collections. So, how should we maybe think about that being a benefit into the back-half of the year? And I have a couple follow-ups. Thank you.

Yes, thanks, Drew. Appreciate the questions. The technology upgrade is going exceptionally well. There's clearly value to our customers from the combination of NexSys and NexSys with Persona. And that's reflected in the contracts that we've entered into. There's an annualization, and some of that is occurring as we speak. But when you look at where we are year-to-date this fiscal year, halfway through, both volume and price have been meaningful contributors. And we think Persona is the answer across the board. It is -- we originally were targeting an enhanced safety profile by tailoring in more of a personalized medical way how we do the collections. In addition, you get a 10% to 12% gain in yield, which is significant as all strive to replenish, as we talked about already on this call. So, we'll continue to lean into that. There's a number of things that have to happen for our customers -- remaining customers to adopt that, but we feel quite good, as the year goes on, that the NexSys conversions will annualize. We're cautiously optimistic that we'll see additional opportunities for Persona over the next year-and-a-half, and as that comes to fruition we'll guide accordingly.

Got it. And then just with the expectations actually for 2024, are you still confident of delivering top line and bottom line growth? And just in Plasma, given all these tailwinds that you now have -- you're back, could you see another 30% year looking ahead at next year? And with vascular closure just with the CE mark, how should we kind of think about as supporting or enhancing the growth rate trajectory that you're currently on? Thanks for taking the questions.

Yes, thanks, Drew. I know there is a lot of interest in our ability to continue to grow. And I think, earlier this year, when our guidance was a little more modest, I think there was a question about '22 versus FY '23. I think, now with the revised guidance that James communicated this morning, with the midpoint which is just double-digit growth off of '22, within that we're guiding 30% to 35% revenue growth on Plasma. Our long-term customers are growing in excess of that, closer to 40%. So, it's coming together nicely. In short, while it's way too early to guide for FY '24, we don't have any confidence about our ability to continue to grow the trajectory that we're on, and we'll continue to watch this. Macro economic factors loom large, and in the main they're a positive for us, and I'm happy to break that down if it's helpful. But there's also a cost side of that where our teams are battling inflation and supply chain, and FX, as every company is. They're doing an outstanding job of mitigating those factors, but it's expensive, and that's reflected in our guidance as well.

Our next question comes from Andrew Cooper with Raymond James. Your line is open.

Great, thanks for the questions. Maybe first just starting with the investment in Vivasure, can you give us a little bit more of a sense of is that something that could be added, is it a technology when you think about bringing potentially VASCADE and that capability together? And maybe a little bit around the thinking of why not acquire outright earlier or what's the structure of your right to buy later is and just how sooner just that that could be to add large bore to what you already have as well?

Yes, so it is very synergistic to the VASCADE platform, Andrew. So, when we think about PerQseal, that will round out our closure portfolio, and really complement VASCADE and VASCADE MVP, it'll give us a closure option for large bore that we currently do not have in the VASCADE platform, okay. So, that's a key element to the purchase of this company potentially. It also adds to the TAM, that this large foreclosure is for TAVR and EVAR; it's about a $300 million global total addressable market. So, it opens up more of an addressable market for us for large foreclosure. And then I would say, as it relates to the option to purchase, we can exercise that option as early as we'd like to, however we're choosing to wait until we see the results of their IDE trial before we move forward with the potential to exercise the option.

Okay, great. And maybe just one more attempt at slicing this, just trying to get a sense for maybe when some of the Persona contracts went online, and how we should think about the impact on growth, moving forward, in terms of the step-up of getting everybody on NexSys, getting everybody on Persona. Can you -- when we think about the volume growth versus price, just is there any other flavor you can give us for timing and how we should expect that to roll on in the back-half of the fiscal year? And I'll stop there. Thanks.

Andrew, happy to do that. And I'm going to add a comment about the Vivasure question and M&A more broadly, if I might as well. In terms of Persona and NexSys, so we have completed the NexSys upgrade cycle, we got done in mid August, fully ahead of schedule, and feel great about that. So, the process will play forward as we upgrade the center, the pricing follows. So, we feel good about the trajectory we're on. As I said, it's included in our guidance. For Persona, we don't include anything in our guidance that's not already fully contracted. We're having discussions with all of our customers about the technology. Different customers are at different stages of assessment. And we'll play that forward and be as supportive as we can for customers as they do that assessment and ready their supply chains and their organizations for the changes that are associated with that increased 10% to 12% yield. So, stay tuned, additional guidance, we're not going to break down, as Olga said at the outset, for reasons of customer confidentiality, we're not going to talk specifically about price versus volume, but it will be included in our guidance and we'll try to give you a sense for that. You can certainly see it passing through in our gross margin. The point I would add to Stu's answer is we are really focused, first and foremost, about building out our presence and our relevance to the customers that we serve. We're committed to programmatic M&A. Vivasure is an example of that. Our general preference is real company with real revenues that's substantially de-risked. Unfortunately, that's everybody's priority. So, in this case we went earlier because we have a good sense for the potential of the technology. And as that potential becomes reality we have the option to act. We are strategic investors, we're not financial investors. So, this is about building out our portfolio, augmenting R&D with an organic growth through M&A.

Great, appreciate the time. Congrats on a nice quarter.

Thanks.

Our next question comes from David Turkaly with JMP Securities. Your line is open.

Hey, good morning. I'll give my shot here at this contribution. So, you said, I think, that your disposable North American volume was up 63%. And I think you called out 38% volume, and mathematically if we take the difference there as 25, I mean is that sort of a ballpark of what we are talking about as a price contribution in terms of how it impacted the number in the quarter?

Yes, I think the difference, Dave -- and I realized we threw a lot out there in the prepared remarks, we are separating long-term customers out and that's what the breakdown we gave you. So, it's not as straightforward as the math you are trying to do. And as I said, I just don't want to get into that much more detail around it. But, I know there is ongoing questions about robustness, sustainability given the steep trajectory that we are on. And that's why we want to give you the long-term number in addition to the overall market number.

Got it. And then just to clarify, I mean you made a comment about the new centers maybe that been twice as many from maybe pre-pandemic. I was wondering if you could give us any color on sort of the mix split there between the mature versus the new, how big are each of those in terms of the total business today?

Yes. So, historically, the mature centers reach a practical capacity and substantially all of the growth in the industry has been driven by new center openings. And there is a three to four-year ramp depending on the company as those centers to come up to speed. What we observed during the pandemic was the rate of new center openings was double what it was in the prior years as customers leaned in and did what they could to reach more donors and more geographies. In particular, we are seeing smaller centers in terms of the number of devices, number of beds but in slightly smaller metropolitan areas and surrounding metropolitan areas. Today, there are roughly 250 new centers somewhere on that three to four-year trajectory. And they are performing at least equivalent to what new centers have always performed at. In addition as I said in the prepared remarks, we are seeing growth from mature centers. They are not back to pre-pandemic levels. There is more opportunity there. But in totality, because of the significant up step in [technical difficulty] new centers we actually collected more plasma in the second quarter than we did in the second quarter of '22 which was our peak year prior to this.

Thank you.

[Operator Instructions] Our next question comes from Mike Matson of Needham & Company. Your line is open.

Yes, thanks. Just a few on gross margin, so, I know you gave guidance or reiterated the guidance for the operating margin. But looking at kind of where you at in the September quarter here for the second-half of the year, is it reasonable to assume the gross margin kind of being like up 53% to 54% sort of range?

Yes. Thanks, Mike. Yes, we typically haven't guided here on gross margin, but we are going to hit on our operating margin guidance, those gross margins that you see will have to be in that continued area. I mean gross margin for us has improved because of -- mostly because of mix, pricing gains that we've had. But the flipside of it has been, what I spoke about in my remarks, in that because the volume growth has been much greater than we initially planned this year. It's caused some inefficiencies for us in the supply chain so that it's less timely notice to vendors, more use of air freight, and overall less efficient utilization of resources like sterilization capacity and so forth. So, all those kind of take you back a little bit. But on balance, yes, you will see those gross margins I think hanging in there.

Okay. And then, at your Investor Day, you guided I think like a high 50% to low 60% range for fiscal '26. I know that that's ways off still. But, I would imagine that some of these pressures probably continue into your fiscal '24. So, do you still think you can reach those targets to '26?

Yes, we do. That will come from selling higher profitable products. That's going to continue no matter what as we go on here as we grow. But also on the macro level, we are assuming that once we get out to '25 and '26, that we do have some easing of those inflationary pressures that we experienced so significantly during the early part of the pandemic here.

Okay, thanks. And then, I know you said you are not going to comment on specific customers, but I will ask one just so anyway because you had quantified that in the past. So, is that still -- are you still expecting them to do $88 million with you of sales this year, or I mean just given the tremendous demand in plasma volumes, is that going to end up being higher than that? Or, they walked in at that amount?

Yes. Mike, I appreciate the interest here. And getting to the core of the sustainability of our outperformance, the $88 million is a minimum contractual agreement. That hasn't changed. CSL and all of our customers are experiencing robust growth, as we've said, across centers mature and new alike. Certainly, CSL is doing their part and driving accordingly. And we are benefiting from that as well.

Okay, thanks. Sorry, I didn't realize that was the minimum. All right, all right, thank you.

Thank you.

There are no further questions at this time. This concludes our question [technical difficulty] participation in today's conference. You may now disconnect. Everyone have a great day.