QuidelOrtho Q1 2026 Earnings Call - Respiratory Weakness and China Pricing Headwinds Offset by Strategic Product Launches and Margin Expansion

Operator: Welcome to the first quarter twenty twenty-six financial results conference call and webcast. At this time, all participant lines are in a listen-only mode. For those of you participating in the conference call, there will be an opportunity for your questions at the end of today’s call and prepared remarks. If you would like to ask a question, please press star one on your telephone keypad. To withdraw your question, press star one again. 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.

Juliet Cunningham, Vice President of Investor Relations, QuidelOrtho: Good afternoon, everyone, and thanks for joining us today. With me are Brian Blaser, President and Chief Executive Officer, and Joseph 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 our investor relations page that will be referenced in this call. This conference call and supplemental information may contain forward-looking statements which are made as of today, May 5, 2026. We assume no obligation to update any forward-looking statement except as required by law. Statements that are not strictly historical, including the company’s expectations, plans, financial guidance, future performance and prospects are forward-looking statements that are subject to certain risks, uncertainty, assumptions, and other factors. Actual results may vary materially from those expressed or implied in these forward-looking statements.

Please refer to our SEC filings for a description of potential risks. 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 supplemental information on the investor relations page of our website. 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.

Brian Blaser, President and Chief Executive Officer, QuidelOrtho: Thanks, Juliet, good afternoon, everyone. I’ll start today with a brief perspective on the first quarter and then discuss details of our business performance more broadly. Our first quarter results were impacted by a significantly softer respiratory season compared to Q1 of last year, with influenza-like illness or ILI visits down approximately 30% as reported by the CDC in April. While ILI visits are one indicator, the season was also notably weaker across other key measures, including severity of illness, hospitalizations, and duration. Overall, the respiratory season was both significantly milder and shorter than in Q1 2025. We also experienced broader macroeconomic and geopolitical headwinds during the first quarter. In China, sales slowed in March ahead of the anticipated national IVD pricing guidelines as distributors exercised caution on inventory purchases in light of potential future pricing declines.

While final guidelines have not yet been issued following the comment period, our updated full year 2026 guidance reflects the estimated impact based on the current draft. As is expected, this estimate may change once the final guidelines and implementation timeline are announced. Accordingly, we are preparing mitigation actions to help offset these headwinds. Moving into 2027, the proposed pricing changes would impact only about half our sales in China. Even with the new guidelines, that business certainly isn’t going away and will continue to be a meaningful component of our revenues. Notably, even after these pricing changes are implemented, we believe our China business will continue to be accretive to the company margin profile. We don’t think the changes will be fully implemented until the middle of next year, which gives us time to work on mitigating actions.

Shifting back to Q1 results, we also saw delays in some orders and tenders due to the ongoing disruption in the Middle East. Assuming conditions stabilize, we expect these orders and tenders to resume during the remainder of the year. Importantly, our underlying business remains strong and durable. Our core labs and immunohematology franchises are performing well, and we are executing against our priorities. As a result, we believe we are well-positioned to deliver on our objectives to expand our adjusted EBITDA margin and improve cash flow in 2026. We are also making solid progress in advancing our strategy.

We completed the acquisition of LEX Diagnostics in April, adding a highly differentiated, ultra-fast molecular platform that strengthens our position in point of care, an area we believe will be a meaningful driver of future growth and reinforces our ability to deliver integrated diagnostic solutions across the continuum of care. We are already seeing strong customer interest and have secured our first orders. Customer insights reinforce this opportunity. Approximately 90% of Sofia customers currently use both antigen and molecular testing systems, and many have indicated a willingness to switch to our more competitive molecular platform. Their priorities are clear. Better ease of use, faster time to result, and lower costs. LEX is designed to deliver all three.

To support launch readiness, we are expanding manufacturing capacity at our site in the U.K. We expect to begin placing instruments this quarter with measurable assay pull-through and associated revenue beginning in early 2027. Turning to our labs business, we launched our high-sensitivity troponin assay in the U.S., strengthening our cardiac portfolio and enhancing our clinical value proposition. We are seeing strong demand. We are now shipping to more than 300 U.S. customers. We also began rolling out the VITROS 450 platform in select international markets, expanding access to our diagnostic solutions. As a successor to the VITROS 350, this platform is designed to meet the needs of emerging markets requiring low volume, cost-effective solutions. Initial shipments are targeted for JPAC, followed by LATAM and EMEA, where we recently received the CE mark.

Importantly, the combination of VITROS 450 and VITROS ECiQ enables us to deliver a comprehensive solution across clinical chemistry and immunoassays in attractive international markets. We expect these product launches to support our mid-single-digit revenue growth expectations for the labs business, which represents over half of our revenue. In summary, we are navigating near-term headwinds, but our strategy is sound, our innovation pipeline is strong, and we remain focused on executing with discipline to deliver sustainable, profitable growth. Now I’ll turn the call over to Joe.

Joseph Busky, Chief Financial Officer, QuidelOrtho: Okay. Thanks, Brian. I’ll walk through the key financials for the 1st quarter of 2026. Unless otherwise noted, all comparisons are to the prior year period on a constant currency basis. Total reported revenue was $620 million. Of that, non-respiratory revenue was $552 million, or $544 million, excluding the Donor Screening business. Labs revenue declined 8% primarily to the factors Brian just discussed. In addition, the termination of our joint business agreement with Grifols reduced Q1 Labs revenue and created a difficult year-over-year comp. Immunohematology grew 3% driven by North America, China, and JPAC. Triage declined by $3 million, primarily due to slower distributor sales in China. Looking at our respiratory revenue, as was widely reported, the North America respiratory market showed an atypical decline versus the prior year period.

This was an industry-wide trend, not unique to QuidelOrtho, and is supported by KOLs and competitor reports. As a result, our respiratory revenue was $68 million, down significantly, as noted in our pre-announcement, due to the approximately 30% lower ILI visits compared to Q1 2025. Keep in mind, though, that our large global installed base of the Sofia platform and QuickVue has demonstrated growth over time. Importantly, during the first quarter of 2026, we saw no change in testing protocols and our market share remained stable. Lastly, on revenue, foreign currency exchange was favorable by 210 basis points during the quarter. Now moving down the P&L, non-GAAP OpEx decreased by 2%, primarily due to R&D efficiencies. Adjusted gross profit margin was 44%, a decrease of 630 basis points due to product mix with lower respiratory revenue contribution.

Our adjusted EBITDA was $109 million, representing an 18% adjusted EBITDA margin and adjusted diluted loss per share was $0.04. We expect to continue to drive adjusted EBITDA margin expansion for the full year with targeted staffing reductions, procurement, and facility consolidation cost savings initiatives. Now turning to the balance sheet. At the end of March, we had cash of $140 million and borrowings of $130 million under our revolving credit facility. From a cash flow standpoint, operating cash flow was negative $33 million, and free cash flow was negative $67 million.

While we expected cash flow to be negative in the first half, which is consistent with our historical seasonality, first quarter 2026 cash flow declined year-over-year, primarily due to lower EBITDA related to the weaker respiratory season and the timing of accounts payable and accrued interest. Inventory also increased due to the weaker respiratory season as well as in preparation for multiple upcoming product launches. On the positive side, we delivered strong accounts receivable cash collections of $54 million and reduced our CapEx by $22 million compared to the prior year period, which was the result of lower systems and manufacturing capacity spend.

We remain focused on improving cash flow generation still expect positive cash flow for the full year, now expected to be in the range of $100 million-$120 million, with positive cash flow driven by higher revenue in the second half of the year. Lastly, net debt to adjusted EBITDA leverage was 4.1 times, including pro forma adjustments allowable under our credit agreement. We continue to expect pro forma leverage under the terms of our credit agreement to be at 3.25-3.5 times by the end of this year. To wrap up, first quarter results reflected the impact of lower respiratory volumes, macro and geopolitical pressure, and continued investment in our strategic initiatives, including molecular diagnostics. Now I’d like to cover our full year 2026 outlook at a high level.

For a full list of assumptions, please refer to page 6 of our first quarter 2026 earnings presentation. Importantly, we are providing a new guidance range. As noted in our Q1 pre-announcement, we are tethered to the low end of our previously provided range, which was purposely wide to account for respiratory season variability. We now expect total reported revenue of $2.7 billion-$2.75 billion, which is driven by 2 changes: our first quarter performance and the expected lower full year revenue in China, which takes into consideration distributor reactions to the pending China National IVD pricing guidelines as currently drafted. In North America, first quarter respiratory revenue reflecting a weaker ILI trend.

Looking back over the past 10 years and excluding pandemic years, of course, in periods where ILI declined in Q1 versus the prior year, trends rebounded over the remainder of the year, resulting in higher ILI on a full year basis. Despite this empirical data, to be prudent, we are continuing to plan for an average respiratory season and forecasting a flat second half without a bump up and an 8% decline in respiratory revenue for the full year 2026. These two revenue impacts flow from the top line to the bottom line. Therefore, we now expect full year 2026 adjusted EBITDA of $615 million-$630 million, still representing an adjusted EBITDA margin of 23%, which reflects a 100 basis point improvement over full year 2025.

We expect adjusted diluted earnings per share of $1.80-$2.00, and we expect to deliver free cash flow of $100 million-$120 million. Note that the second quarter has historically been our seasonally lowest quarter. Consistent with this pattern, we expect sequential revenue, adjusted EBITDA, and adjusted EPS to be roughly in line with Q1 2026, but still reflecting year-over-year growth across all three metrics. Our updated outlook reflects improving operating performance in the second half of the year, as well as continued disciplined execution and the ramping up of the LEX Diagnostics business. With that, we’ll now open up the line for questions.

Operator: Your first question comes from Tycho Peterson of Jefferies. Your line is open. Please go ahead.

Jack, Analyst, Jefferies: Yeah, hi, this is Jack on for Tycho. Thanks for the question. Could you just walk us through the guide for second quarter growth by segment and then also, you know, down to P&L, what margins are going to look like?

Joseph Busky, Chief Financial Officer, QuidelOrtho: Yeah, as, hey Jack, as noted in the prepared remarks, we do expect that sequentially Q2 will be relatively flat with Q1, but will provide growth year-over-year. The growth is gonna come from the core business, as you think about the labs business and the IH business and the Triage business, that growth versus prior year.

Jack, Analyst, Jefferies: Okay, that’s helpful. Now in China NHSA, can you tell us exactly how big of a headwind that is in 2026? What you’re assuming in the guidance and just a little bit more detail on how you arrived at that number.

Joseph Busky, Chief Financial Officer, QuidelOrtho: Yeah, sure. As you think about the updated, the updated revenue guide, which again, is tethered to the low end of the previous revenue guide, there’s really only two changes that we made to the revenue guide. I wanna be really clear with that. One is the respiratory season weakness we saw in Q1. Then the impacts that we’re seeing in China from our distributors pausing on their purchases due to the pending new national pricing guidelines, which we expect to come out in the next couple of months. I would say if you look at the new revenue guide, Jack, it’s down roughly $75 million at the midpoint, and it’s probably, you know, split almost 50/50 between the respiratory and the China.

Maybe a little bit less on China, a little bit more on respiratory. Maybe, you know, maybe 45, 30 respiratory and 30 China kind of thing. That’s where we’re seeing it. We have pretty good visibility, as you would imagine, from our local team and the good relationships we have with our customer base. We feel pretty good about this new guide for 2026.

Operator: Your next question comes from the line of Andrew Brackmann of William Blair. Your line is open. Please go ahead.

Andrew Brackmann, Analyst, William Blair: Hey guys, good afternoon. Thanks for taking the questions. I wanted to pick up off of Jack’s first question there with respect to Q2. If you’re sequentially sort of flattish to Q1, I think that implies a pretty significant ramp in adjusted EBITDA margin in Q3 and Q4. Can you maybe just talk to us about some of the levers that you see there, not just on the revenue side, but also on the cost side as well? Thanks.

Brian Blaser, President and Chief Executive Officer, QuidelOrtho: Hey, Andrew. I do think that what we’re looking at in the guide as you think about first half, second half, is that we are expecting the revenue growth to pick up quite a bit in the second half versus the first half. That’s really a function of, you know, we expect that the China impacts that we’ve talked about in the prepared remarks generally are going to happen in the first half of the year and not so much in the second half of the year. In addition, as I said, you know, we are expecting continued growth with labs, IH, and Triage, and we are planning for an average respiratory season in the second half of the year.

Joseph Busky, Chief Financial Officer, QuidelOrtho: Not, again, we’re not expecting growth in the second half for respiratory year-over-year, we are expecting it to be flat. I don’t expect it to be a headwind. The, you know, all those, all those factors, including, you know, what Brian mentioned with the new products coming out, the VITROS 450, the high-sensitivity troponin, and you’re gonna have some less revenue in the second half. You know, all those things contribute to the higher revenue in the second half versus the first half of the year, which will drop down and drive higher EBITDA, EPS, and cash flow.

Andrew Brackmann, Analyst, William Blair: Okay. Thanks. Thanks for all that. Brian, with respect to LEX here, it sounds like, you know, some folks in your customer base are pretty interested in this. Can you maybe just sort of remind us about the switching costs that might exist for this platform for customers? How big of that is a hurdle here? I guess, what are some of the things that you can do to maybe be a little bit more aggressive to get these share wins, be that on pricing strategies, bundling or anything like that? Thanks.

Brian Blaser, President and Chief Executive Officer, QuidelOrtho: Yeah. Thanks, Andrew. We are excited about LEX and, you know, working actively, as I mentioned, to build additional capacity in our site in the U.K. to support the ramp up. You know, at this point, we’re expecting to place a few hundred instruments this year, then, you know, followed by a more significant ramp up in 2027 that I think is really gonna begin to create meaningful assay pull-through. We’re doing everything we can to bring on additional capacity as quickly as possible, because I think more than anything, we’ll probably be capacity constrained versus demand constrained given what we’re seeing with the product. Most of these instruments will be placed in customers, meaning there’s no real capital outlay, you know, from a switching cost standpoint.

The ease of use profile, this is truly a plug-and-play instrument that requires, you know, sample in, answer out in 6 to 10 minutes. You know, your question about the switching costs really have very low barriers to, you know, customer objection to placing new instruments. We don’t think that’s gonna be an issue, and we think the value proposition across speed, turnaround time, and cost are really gonna position this platform well.

Andrew Brackmann, Analyst, William Blair: Great. Thanks for all the color.

Operator: Your next question comes from the line of Patrick Donnelly of Citi. Your line is open. Please go ahead.

Patrick Donnelly, Analyst, Citi: Hey, guys. Thank you for taking the question. Maybe one on the China side. You know, I’m sure you guys saw this morning a competitor of sorts kind of walked away from their China diagnostics business and sold it, which was rewarded, you know, just given that it’s been an overhang on a lot of the companies. I guess, what’s your commitment there on the China side and visibility, you know, given some of these recent changes? It just feels like a slippery slope over there. How are you framing up that risk and the comfort level going forward on that business?

Brian Blaser, President and Chief Executive Officer, QuidelOrtho: Yeah. Thanks, Patrick. You know, clearly the reimbursement changes are a headwind there, but, you know, the way we’re looking at it, you know, the reimbursement changes themselves will only impact about half our sales there. You know, we have no plans to walk away from China. Even after these changes are implemented, we believe the business continues to be accretive to our company margin profile. In time to address this, we think that the changes won’t be fully implemented until probably mid-next year. We’re gonna be taking actions to offset that. You know, clearly, we will continue to monitor the environment in China, you know, after these changes are made.

As long as the economics continue to be favorable of, you know, we intend to remain in that market, I think over the very long term, it continues to be an attractive growth market for healthcare and diagnostic testing in particular.

Patrick Donnelly, Analyst, Citi: Okay. That’s helpful. Then, maybe just on the margin side, the EBITDA build, can you just talk about, you know, some of the actions you’re taking on the cost side, you know, not only this year, but just the base heading forward? Obviously, you guys in the past have given some longer term targets. Just how you’re thinking about the key levers there as we work our way through the year and into next year. Thank you, guys.

Brian Blaser, President and Chief Executive Officer, QuidelOrtho: Yeah. You know, we continue to do a lot of heavy lifting on the margin side of the business. That’s, you know, I think I’ve referenced that we’ve taken out, you know, close to 1,000 positions in the organization. A lot of that work pushed us into the low 20s adjusted EBITDA margin. We’re going to start to see a 50 to 100 basis point improvement starting in the second half of 2026 from our Donor Screening exit. We’ve got a really a rich portfolio of projects across our indirect and direct procurement efforts. We’ve got the shutdown of our Raritan facility in progress, and we’ve got, you know, a lot of opportunity outside the U.S. to optimize our profitability in our OUS regions.

You know, I’d say additionally, we continue to benefit from this dynamic of placing more immunoassay volume that’s at higher margin. You know, we see the benefit of that. I think, you know, what you’re gonna see moving forward is the benefit of LEX and the molecular margins being, you know, typically much higher than immunoassay margins as well. You know, I think we get into that mid-twenties range solidly with our procurement initiatives and the Raritan footprint optimization and, you know, maybe some targeted staff reductions. I think we push into the higher twenties as LEX becomes a bigger component of the business, you know, over the next few years.

Operator: Your next question comes from the line of Yi-Dan Lu of UBS. Your line is open. Please go ahead.

Yi-Dan Lu, Analyst, UBS: Great. Thank you for taking my questions. Why don’t you go back to China a little bit? I think you mentioned that, in the guide, you’re assuming the China impact are basically happening in first half and not the second half. I’m wondering if you can provide a little bit more color on that, whether you’re still seeing like distributors pausing sales maybe in April, May. Just a little bit more color in terms of like what they’re saying as well. That’s my first question.

Brian Blaser, President and Chief Executive Officer, QuidelOrtho: Yeah, you know, it’s still early days. You know, I think our distributors got a bit spooked with this, you know, change in the reimbursement coming. They got very conscious of their inventories. You know, we’ve been working with them on some rebates and discounts and other things to offset some of that pressure. I think over the next 2 months here, we’re gonna see that that sort of behavior in the 1st quarter, you know, starts to mitigate and that will stabilize over time.

Yi-Dan Lu, Analyst, UBS: Got it. My second question, why don’t you double confirm your margin target? Are you still hoping to get to like mid-to-high 20s% by mid-2027, or that margin target maybe get a little bit delayed just given the potential changes in China and then maybe other macro factors?

Joseph Busky, Chief Financial Officer, QuidelOrtho: Yeah. Hey, Lu, it’s Joe. I think Brian touched on this a minute in his previous answer. Just to reiterate, you know, we are confident in our margin, EBITDA margin goals and the timeline for them. There’s no change to that. That’s because we still have, as Brian said, all these initiatives around procurement and site consolidation in flight that we expect to complete as we move through this year and into early next year. On China, you know, we do have some time. You know, we don’t think that these potential reimbursement changes will be enacted until you get more into mid-2027. We’ve got about a year, really, to implement cost mitigation actions to offset any potential price declines that we may see in 2027.

Because of all that, we still feel really good about the margin goals and the timing that we’ve communicated already in the past.

Yi-Dan Lu, Analyst, UBS: Thank you.

Joseph Busky, Chief Financial Officer, QuidelOrtho: Sure.

Operator: If you would like to ask a question, please press star one to raise your hand. To withdraw your question, press star one again. We ask that you pick up your handset when asking a question to allow for optimum sound quality. If you are muted locally, please remember to unmute your device. There are no further questions at this time. I will now turn the call back to Brian Blaser, President and Chief Executive Officer, for closing remarks.

Brian Blaser, President and Chief Executive Officer, QuidelOrtho: Thank you, operator. In closing and stepping back from the first quarter, you know, the headwinds that we saw in the respiratory season and China, this really doesn’t change our direction. We are executing well, our strategy’s working, and we are strengthening the business in the right areas. We do expect a stronger second half and remain focused on delivering consistent profitable growth. Thank you for your interest in the company, and we look forward to updating you in the quarters ahead.

Operator: This concludes today’s call. Thank you for attending. You may now disconnect.