Welcome to the QuidelOrtho Third Quarter 2025 Financial Results Conference Call and webcast. [Operator Instructions] Please note, this conference call is being recorded. An audio replay of the conference call will be available on the company's website shortly after this call. I would now like to turn the call over to Juliet Cunningham, Vice President of Investor Relations.

Thank you. Good afternoon, everyone. Thanks for joining the Quidel Third Quarter 2025 Financial Results Conference Call. Joining me today are Brian Blaser, President and Chief Executive Officer; and Joe Busky, Chief Financial Officer. This conference call is being simultaneously webcast on the Investor Relations page of our website. To assist in the presentation, we also posted supplemental information on the Investor Relations page that will be referenced throughout this call. This conference call and supplemental information contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Statements that are not strictly historical, including the company's expectations, plans, financial guidance and future performance and prospects are forward-looking statements that are subject to certain risks, uncertainties, assumptions and other factors. This includes the expected impact of tariffs and macroeconomic conditions and the proposed acquisition of LEX Diagnostics. Actual results may vary materially from those expressed or implied in these forward-looking statements. Information about potential factors that could affect our actual results is available on our annual report on Form 10-K for the 2024 fiscal year and subsequent reports filed with the SEC, including the Risk Factors section. Forward-looking statements are made as of today, November 5, 2025, and we assume no obligation to update any forward-looking statements, except as required by law. In addition, today's call includes discussion of certain non-GAAP financial measures. Tables reconciling these non-GAAP measures to their most directly comparable GAAP measures are available in our earnings release and the supplemental information, which is on the Investor Relations page of our website at quidelortho.com. Lastly, unless stated otherwise, all year-over-year revenue growth rates given on today's call are on a constant currency basis. Now I'd like to turn the call over to our CEO, Brian Blaser.

Thanks, Juliet. Good afternoon, everyone, and thanks for joining us today. This quarter, we delivered another solid performance that reflects the strength of our diversified global diagnostics portfolio. We reported organic sales growth of 5%, excluding COVID sales and the U.S. donor screening business that we are in the process of exiting. This growth demonstrated the underlying strength and durability of our labs, immunohematology and point-of-care businesses across our global geographies. We also delivered significant improvements to adjusted EBITDA, expanding to 25% of sales in the quarter, primarily driven by our continued focus and execution against our margin improvement initiatives. And these initiatives have now delivered over $140 million in cost savings and put us well on our path to sustainable mid- to high 20s EBITDA margins. And at the same time, we have made targeted investments in key strategic areas to position us for sustained long-term growth. None of this would have been possible without the dedication and focus of our exceptional team here at QuidelOrtho. So I want to thank them for their hard work and commitment during what has been a transformative period. Together, we are building momentum and remain focused on the opportunities ahead. So let me further summarize our quarterly highlights before I turn things over to Joe for additional financial details. And as a reminder, unless otherwise noted, I'll be discussing growth rates on a constant currency basis. In our Labs business, revenue grew 4%. Demand for our VITROS immunoassay and clinical chemistry platforms remained solid, supported by stable customer renewal rates and new business wins across our regions. We continue to benefit from underpenetration in the immunoassay segment as well as our brand recognition for testing solutions that have the lowest total cost of ownership and as the leader in customer service and…

Okay. Thanks, Brian, and hello, everyone. I'll start by taking you through our third quarter results, which are detailed on Slide 3 of our earnings presentation, which is available on the Investor Relations section of our website. I'll also discuss our full year 2025 financial guidance, and then we'll open up the call for your questions. Total reported revenue for the third quarter of '25 was $700 million compared to $727 million in the prior year period. The 4% year-over-year decrease was primarily due to lower COVID and donor screening revenue, the latter of which is related to the continued wind down of the U.S. business. Excluding COVID and donor screening, reported revenue growth was 5%. Foreign currency translation had a favorable impact of approximately 90 basis points during the third quarter. And based on FX exchange rates as of the end of October, we would expect FX to have a neutral impact on revenue and adjusted EBITDA for the full year. We said that we were pleased to see strength in our core business with continued mid-single-digit growth, and Brian provided updates on our business unit and regional performance, so I'll focus more on our P&L and balance sheet. Third quarter adjusted gross profit margin was 48.7% versus 49.2% in the prior year period. The 50 basis point year-over-year decrease was primarily driven by tariff impacts offset by cost mitigations. Non-GAAP operating expenses of $217 million comprised of SG&A and R&D decreased by $16 million or 7% as a direct result of our ongoing cost savings actions. Included in the other operating expense line of the P&L, we recorded $9 million of legal expense in connection with the final resolution of a long-running dispute with a COVID supplier that dates back to 2021. Q3 results included $40 million in…

[Operator Instructions] Our first question comes from the line of Andrew Brackmann with William Blair.

Brian, I think in your prepared remarks, you mentioned some competitive wins. Can you maybe just give a little bit more color around that commentary? And I guess, in particular, on the labs front and on that segment, can you maybe just sort of talk about shared dynamics there and how things like this additional assay that you added, I think, on Monday on VITROS should help there.

Yes. Our competitive wins have been dispersed across our geographies pretty evenly. We've had some nice wins in North America. I would say we had some very significant wins in Latin America as well as EMEA. And you see that -- you certainly see those reflected in the underlying growth rates. So we're excited about the traction that we're getting in those markets. And importantly, I would say we're very focused on wins now that are profitable as opposed to just winning at all costs. So I give a lot of credit to our commercial team for the discipline that they've placed in their organizations to make that happen. As far as troponin, the launch of high-sense troponin goes, first, what I would say there is I'm just so proud of the work that the team did there in conjunction with FDA, by the way, to gain the clearance of that assay in exactly 90 days from the time we submitted it. It's an excellent assay. It performs very well compared to peers. And it really strengthens our cardiac panel, and more and more clinicians are requiring high-sensitivity troponin on their platforms. I would say, by itself, it's not going to have a huge impact on our short-term growth rates, but it was a long-term competitive factor for the competitiveness of our cardiac panel. So getting that assay on the panel was really important, and it was a huge priority for me when I joined the business. So we're excited about that and expecting to be taking orders later this year and shipping product as quickly as we can.

Okay. That's great color. And then I'll just ask China, so hopefully, we can move on. I mean it looks like you're not seeing any impact from VBP or DRG dynamics. I think it was 5% constant currency growth in the country, this region -- this quarter. I just want to make sure that's right, and that's the expectation moving forward. And then also on China, I think there was a new procurement policy that came out late in Q3. Any color on how we should think about that?

Yes. So there's not a whole lot that's changed from our -- the last update that we did for Q2. We had adjusted our guidance in the -- on the Q2 call to mid-single-digit growth to reflect the sort of competitive dynamics in all of these different policies that were taking place. We have seen some impact from VBP and the debundling on our business, and that is reflected in the mid-single-digit growth forecast for the rest of 2025. We probably have seen less impact than others because a pretty high proportion of our instruments are used in stat labs where they're less likely to debundle panels and that sort of thing. So really, not much has changed there since our last update. As it relates to the new policy that came out around localization, we already have manufacturing in China and our objective will be to continue to be in compliance with the regulations so that we can continue to manufacture and invest in China as long as the economics there remain favorable.

Our next question comes from the line of Jack Meehan with Nephron Research. Jack, can you confirm your line is not on mute? Our next question comes from the line of Lu Li with UBS.

Great. I want to go back to the 2025 guidance. It does -- so you are keeping the EBITDA margin at 22% unchanged. It does seem like the Q4 implied margin will be sequentially lower compared to Q3. I'm wondering any color that you can offer on that front, and then I have a follow-up.

Yes. Lu, it's Joe. Yes, we did take the opportunity given that we only have 2 months left in the year to narrow the guidance. And we do want to stress the point that even though we've narrowed the guidance on revenue and adjusted EBITDA, the midpoints of that guidance are still precisely the same. And the adjusted EPS guidance, again, was narrowed and also adjusted for the nonoperational areas of interest expense being higher due to the refinance and the tax rate being slightly higher due to some mix of income by jurisdiction because of tariff mitigation actions. But if you look at Q4 sequentially versus Q3, I would say that the margins might be slightly lower because we will probably likely, like every year, we see slightly higher instrument revenue in Q4 as customers are attempting to use their budgets and you see a lot more instrument revenue in Q4 versus other quarters. And just as a reminder, the instrument revenue for us and most of the folks in our space is much lower than the reagents and consumables margins. So you do get a sort of a negative mix impact by that instrument revenue. And then also, I would say, and this is fairly typical each year for us, we tend to see a little higher incentive compensation expense in Q4 versus previous quarters. And so that's going to have the impact of pulling down the margin slightly. So hopefully, that answers your question.

I appreciate the color. Second question on instrument. What is the instrument performance in the quarter? And then, Brian, I think you mentioned there was a next-generation instrument in the pipeline. Do you have a time line for that?

I can start with the last part of that. Yes, the nice thing about the work we've been doing on margin expansion and getting the organization focused is we're now in a position where we can start to think about these new systems. We're still in the very early stages of concept development. So not in a position where we can share schedules at this time, but we hope to be talking a lot more about that in the future.

Yes. And Lu, the Q3 instrument revenue was down slightly, about $5 million year-over-year versus Q3 prior year. And this is not largely unexpected. We are seeing a higher number of contract extensions with our existing customers, which is -- actually is a positive thing for us from a margin mix perspective. And so that's what's driving that. Yes.

Our next question comes from the line of Jack Meehan with Nephron Research.

Sorry about earlier, had a phone issue. I wanted to start, I was just wondering if you could give us an update on the Sofia franchise, where you stand in terms of installed base and pull-through. And kind of secondarily, I saw on the guidance slide, you expect over half of the flu test to be combo. Just curious your thoughts around kind of the durability of the ABC test and physician preference around that.

Yes. So what I can say about the Sofia installed base is it continues to be stable, expanding, very durable. It's a workhorse platform. And the durability of our flu combo test is also very solid. We've really seen very steady performance in terms of sales of that test over the last 2 years. So we're looking forward to yet another solid season here in the upcoming respiratory season with Sofia.

Great. And then you're further -- or LEX is further into their FDA submission. Can you give us just an update on how you're thinking around launch timing and positioning of that relative to Sofia?

Yes. As I mentioned in the prepared remarks, the dialogue with FDA continues to be constructive. There's -- we haven't seen anything really out of the ordinary. Assuming an approval late this year or early 2026, we'll be looking to ramp up placements of the platform so that we can participate as much as we possibly can in the following year respiratory season. So that's our current plan.

Got it. And then last one. I saw on the slide still targeting the 100 to 200 bps expansion for 2026, which is great. Can you just talk about how you're thinking about free cash flow conversion like as a percentage of EBITDA, like how -- what we should be plugged in for that for 2026?

Yes. Jack, so Q3 was certainly a disappointing quarter for us for cash flow, primarily driven by the impacts of the system conversions, which had the impact of delaying cash into Q4 for us. But despite that timing issue due to the system conversions, we still feel that the full year 2025 recurring free cash flow will be in that range of 25% to 30%. And we still are confident in getting to the target of 50% of adjusted EBITDA for recurring free cash flow. We won't hit that target next year. I would believe that hitting the cash flow target would be consistent with the time lines we have on hitting the EBITDA margin targets. So I would more target, I would say, mid-'27. So for 2026, I would expect us to make progress towards that 50% target, but not fully get there. And the levers that we've talked about already are mitigating CapEx, reducing the number of days on hand of inventory on the balance sheet and reducing the level of integration or onetime related cash costs that we've seen in the last couple of years. And then obviously, the EBITDA margin improvement as providing additional cash flow. Those are the levers.

Our next question comes from the line of Tycho Peterson with Jefferies.

This is Jack on for Tycho. Saw a nice step-up in imunoheme growth. Is that mid-single-digit growth something we could look at as more sustainable moving forward? Or is it more one-off outperformance in the quarter?

Jack, yes, we did have a really nice quarter for immunohematology at 5% growth. But I would say there's probably a little bit of timing between Q3 and Q4. And I would expect that the full year immunohematology growth will be right around where we'd expect it to be sort of in that 3% to 4% range.

Okay. And then how should we think about LEX as it receives approval and you start to commercialize that next year in terms of sequential sort of step-up in OpEx spend relative to that 100 to 200 basis point margin improvement?

Yes. Jack, the LEX, we do expect, as Brian said, we're going to expect to get FDA clearance late this year, early next year, and we'll have a very limited rollout in the first part of the year and the first part of the respiratory season, and we'll have a more fulsome rollout in the second half of 2026 as the respiratory season heats up in Q3, Q4. I would expect that LEX will likely have a dilutive impact on margins next year to some extent. I certainly wouldn't expect it to be accretive. We will work hard to keep or mitigate, I should say, any dilutive impact of LEX. But I wouldn't expect any accretive impact from LEX until we get more up to scale with revenue, which I would not expect to happen for sure until we get into 2027 or potentially 2028.

Our next question comes from the line of Patrick Donnelly with Citi.

This is Brendan on for Patrick. I want to touch on the U.S. donor screening business. As we kind of move into next year, how should we think about modeling that over the course of the year? And I think before, you've kind of mentioned that margin benefit should start to roll through. I'm just curious how we should be thinking about margins over the course of next year with a focus on the U.S. donor screening business.

Yes. Brendan, yes, just -- it's a good question. As a reminder, the donor screening -- the U.S. donor screening business, it has been quite a headwind on our top line this year. For the quarter, we're down $13 million or 48%. And for the year-to-date, we're down $55 million or 57%. It is -- so it has been quite a headwind on that top line. We do expect that we'll be somewhere between $40 million to $50 million of revenue this year, and that residual revenue will completely wind down in the first half of 2026. So that top line headwind that we've been seeing from the donor screening exit will dissipate as you get into second quarter and for sure, as we get into the second half of next year. We do have some stranded costs that we have to pull out of the business. But once we are complete with that, I would expect that we'll be somewhere in the range of 50 basis points of margin accretion that will likely happen as you get into later '26 or into early '27.

Appreciate that. And then within the lab business, I believe you talked about integrated analyzers being around like 30% of the installed base with more runway to go. I was wondering if you could update us kind of where you guys are at in terms of the analyzers in the installed base? And how should we think about kind of like the long-term opportunity in terms of adding growth there?

Yes. Thank you for the questions, Brendan. Our integrated analyzer placements are almost completely inverse to our competitors' situation in the marketplace. So where they might have more -- let's say, 60% of their placements are integrated with a lot of immunoassay volume. Our installed base is heavily clinical chemistry with less immunoassay, probably in the 30% to 40% range. So we have, I think, a tremendous opportunity there in terms of our runway for additional placement of integrated systems, and that's been our strategy for the last several years and will continue to be.

Our next question comes from the line of Andrew Cooper with Raymond James.

Maybe just a quick one for me first. Nice to see the high-sensitivity troponin launch on VITROS. If we go back a bit, we used to talk about TriageTrue and bringing that high-sensitivity troponin to the point of care. Would love just the latest there given that product is, I think, in Europe, not yet in the U.S. And how important or how much of an opportunity do you view that point of care today relative to maybe how it was thought about a few years ago, even if predating some of your time here?

Yes. So thanks, Andrew. I appreciate that question. That is an assay that ultimately we would love to have on Triage. We do have it outside the U.S. It's a very successful test. There are some technical challenges that we have to overcome in order to have it meet the sort of performance requirements for the U.S. market. So we're looking at that and seeing if we can press over those hurdles to get that assay into the market at some point. But don't have anything really concrete to share with you in the short term at this point.

Okay. And then on the cost save efforts and transformation efforts that are underway, I think when these plans were initially kind of laid out, you obviously had certain programs that you had an eye on and likely a little bit to kind of go find and capture. Maybe just give a little bit of what have you found as you continue to dig? Maybe what surprised you where there's more room to pull some costs out and maybe where there's a little bit less as well.

Well, our initial focus was heavily around just staffing of the organization kind of at all levels across the board. And we took out close to 12% of the organization as a result, and that was the focus of our initial efforts. Lately, we have been more focused on indirect and direct procurement, have made a lot of progress on indirect procurement. We're now starting to turn our attention to the direct side of things, which are mainly product cost-related things and a little harder for us to action on. But there's nothing that's really surprised me in terms of where the cost pools were located in the business that we needed to go after. It's just a lot of heavy lifting and hard work to activate it. I would say as we get further down the path, it gets harder and harder to find new things, but we every day continue to come to work and challenge every corner of our P&L for cost savings, and we'll continue to do that. It's just a matter of operating the business.

That will conclude today's question-and-answer session. I will now pass the call back over to Brian Blaser for closing remarks.

Thank you, operator. Thanks, everyone, for taking the time to be with us today. I'll just conclude by saying that we're proud of the very solid progress that we're making and confident in the direction that the company is heading. Our team and its disciplined execution, operational focus and commitment to innovation are delivering tangible results and positioning us well for the future. So thank you for your time today and your continued support and interest in the business. Take care.

That concludes today's call. Thank you for your participation. You may now disconnect your lines.