QuidelOrtho Q3 2025 Earnings Report

QuidelOrtho EPS Results

• Actual EPS: $0.80
• Consensus EPS: $0.51
• Beat/Miss: Beat by +$0.29
• One Year Ago EPS: $0.85

QuidelOrtho Revenue Results

• Actual Revenue: $699.90 million
• Expected Revenue: $667.45 million
• Beat/Miss: Beat by +$32.45 million
• YoY Revenue Growth: -3.70%

QuidelOrtho Announcement Details

• Quarter: Q3 2025
• Date: 11/5/2025
• Time: After Market Closes
• Conference Call Date: Wednesday, November 5, 2025
• Conference Call Time: 5:00PM ET

QuidelOrtho (NASDAQ:QDEL) (NASDAQ:QDEL) develops, manufactures and distributes diagnostic products and solutions used to detect and monitor disease. The company serves hospitals, clinical laboratories, physician offices, retail clinics, blood banks and other healthcare providers worldwide.

Its portfolio includes point-of-care and molecular testing systems, immunoassays, clinical chemistry and immunodiagnostic platforms, and transfusion medicine products. Key product lines include the Sofia and QuickVue systems from Quidel and the VITROS, ORTHO Vision and ORTHO Workstation platforms from Ortho Clinical Diagnostics. These products support testing for infectious diseases, respiratory conditions, women’s health, cardiovascular health and other medical conditions, as well as blood screening and compatibility testing.

QuidelOrtho was formed through the combination of Quidel and Ortho Clinical Diagnostics, a transaction completed in 2022. The company is headquartered in San Diego, California, and operates across North America, Europe, Asia-Pacific and other international markets. Its products are designed to provide diagnostic information across a range of care settings, from decentralized point-of-care environments to centralized laboratories.

QuidelOrtho Q3 2025 Earnings Call Transcript

Key Takeaways

• Positive Sentiment: 5% organic revenue growth (ex-COVID and donor screening) with labs +4%, immunohematology +5% and point-of-care Triage +7%, and strong international performance led by Latin America +21%.
• Positive Sentiment: Adjusted EBITDA of $177 million (25% margin) and management says >$140 million of cost savings have been realized, putting the company on track to sustainable mid‑to‑high‑20s EBITDA margins.
• Negative Sentiment: Recorded a $701 million goodwill impairment (no goodwill remains), finished Q3 with net debt/adjusted EBITDA ~4.4x and reported an adjusted free cash flow of negative $50 million (ERP conversion timing cited).
• Neutral Sentiment: Narrowed full‑year 2025 guidance to $2.68–$2.74 billion revenue, adjusted EBITDA $585–$605 million and adjusted diluted EPS $2.00–$2.15; guidance reflects higher interest expense (~+$17M) and a ~25% effective tax rate.
• Positive Sentiment: FDA cleared the VITROS high‑sensitivity troponin assay, strengthening the cardiac menu for long‑term competitiveness; management also expects Lex Diagnostics' 510(k)/CLIA waiver review to conclude late‑2025/early‑2026 as a near‑term commercial milestone.

Presentation

[Operator]

Welcome to the QuidelOrtho Third Quarter 2025 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 prepared remarks. 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, VP of Investor Relations at QuidelOrtho]

Thank you. Good afternoon, everyone. Thanks for joining the QuidelOrtho 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, uncertainty, assumptions, and other factors. This includes the expected impact of tariffs and macroeconomic conditions and the proposed acquisition of LEX Diagnostics.

[Juliet Cunningham, VP of Investor Relations at QuidelOrtho]

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 factor section. Forward-looking statements are made as of today, November 5th, 2025, and we assume no obligation to update any forward-looking statement 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.

[Juliet Cunningham, VP of Investor Relations at QuidelOrtho]

Now I'd like to turn the call over to our CEO, Brian Blaser.

[Brian Blaser, President and CEO at QuidelOrtho]

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. 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. At the same time, we have made targeted investments in key strategic areas to position us for sustained long-term growth.

[Brian Blaser, President and CEO at QuidelOrtho]

None of this would have been possible without the dedication and focus of our exceptional team here at QuidelOrtho. 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. Let me further summarize our quarterly highlights before I turn things over to Joe for additional financial details. 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.

[Brian Blaser, President and CEO at QuidelOrtho]

We continue to benefit from under-penetration 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 support. Our Immunohematology business grew 5%, reflecting consistent strong demand from blood banks and hospitals as we expand automated testing solutions and strengthen our position in key geographies. Within our point-of-care business, our Triage product line posted 7% growth, supported by our strong value proposition, ongoing momentum in cardiac and BNP testing, and growing contribution from international markets. Other cardiac revenue increased by $8 million compared to the prior year period. Respiratory revenue declined versus the prior year quarter, primarily due to the 63% decline in COVID revenue. Flu revenue also decreased by 8% year-over-year due to timing versus the prior year period.

[Brian Blaser, President and CEO at QuidelOrtho]

As a result, our North America revenue was down 12% in total, but up 5% year-over-year, excluding the impact of respiratory revenue and the U.S. donor screening exit. Our Q3 performance outside the U.S., excluding COVID, was led by strength in Latin America, which grew 21% overall and 22% in labs. Japan, Asia-Pacific, and China each grew approximately 5%, and our Europe, Middle East, and Africa region grew 3%, while also increasing EBITDA margins by over 700 basis points year to date as a result of our cost discipline and focus on profitable growth. We continue to see significant growth opportunities outside the United States, reflecting our historical under-penetration in these markets. Moving now to our Q3 profitability, we are seeing consistent benefits in our results from the cost actions we have taken over the last year.

[Brian Blaser, President and CEO at QuidelOrtho]

Adjusted EBITDA in Q3 was $177 million, and adjusted EBITDA margin was 25%, which is a 180 basis point improvement from the prior year period. Adjusted diluted EPS was $0.80. These results reflect significant improvements in our underlying cost structure while also mitigating recent tariff headwinds. Our Q3 and year-to-date results continue to demonstrate considerable progress across our organization. Our global commercial team remains focused on profitable growth and expansion in key markets and strategic accounts. During the third quarter, we achieved several important competitive wins across both established and emerging geographies. In R&D, our team continues to focus on advancing a robust pipeline, including ongoing menu expansion and the development of next-generation systems. A great example of impactful menu expansion is the clearance of our new VITROS high-sensitivity troponin assay that we announced on Monday.

[Brian Blaser, President and CEO at QuidelOrtho]

This new test elevates our cardiac panel to world-class performance by providing clinicians with higher sensitivity and precision that allows for earlier detection of patients having a heart attack. It also leads to a reduction in unnecessary hospital admissions and ultimately lower costs for patient care. Getting this assay in the hands of our customers was a key focus for me as I joined the company, and I am especially proud of our R&D and regulatory affairs team for the work that they have done over the last several months to gain FDA clearance. Turning now to operations, our team is aggressively executing further cost improvements to reduce direct and indirect procurement costs, optimize our global supply chain, and consolidate our manufacturing footprint. The team has also done an outstanding job of managing the impact of tariffs, and we continue to expect to fully offset these impacts in 2025.

[Brian Blaser, President and CEO at QuidelOrtho]

We also continue to support Lex Diagnostics in their ongoing review of their 510(k) and CLIA waiver submission with the FDA. They continue to engage in a productive and collaborative dialogue with the agency, and based on the current review timeline, we continue to anticipate FDA clearance by late 2025 or early 2026. I will conclude by saying that we are encouraged by the progress we have made and confident in the path ahead. We remain focused on our execution to deliver sustainable, profitable growth. With that, I will turn the call over to Joe to take you through the details of our third quarter financial results.

[Joe Busky, CFO at QuidelOrtho]

Okay, thanks, Brian. Hello, everyone. I'll start by taking you through our third quarter results, which are detailed on slide three 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 2025 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.

[Joe Busky, CFO at QuidelOrtho]

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. 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.

[Joe Busky, CFO at QuidelOrtho]

Included in the other operating expenses 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 restructuring, integration, and other charges, which included approximately $11 million related to the discontinuation of the development of the Savannah platform. Integration costs were $28 million, which were primarily related to our ERP system conversion that went live in Q3. As expected, we saw our vendor-related system conversion costs decrease by $1.3 million from Q2. We continue to expect integration costs to decrease significantly in 2026. We also recorded a $10 million expense on the asset impairment line related to the expected value of the sale of our Raritan, New Jersey facility.

[Joe Busky, CFO at QuidelOrtho]

As we discussed last quarter, once we complete the Raritan facility consolidation, which is planned in 2027, we expect to save about $20 million in annual operating costs. As summarized on slide six, this is another example of the actions we are taking to move toward our adjusted EBITDA margin goal of mid to high 20s. Moving now to profitability metrics, as Brian discussed, adjusted EBITDA was $177 million, and adjusted EBITDA margin was 25%, a 180 basis point year-over-year improvement despite the lower respiratory revenue. On a year-to-date basis, adjusted EBITDA was $444 million, or a 13% increase compared to the prior year period, with a 22% margin, which represents an increase of 320 basis points. Adjusted diluted EPS was $0.80 in the third quarter, and year-to-date adjusted diluted EPS was $1.66, which was growth of 36%.

[Joe Busky, CFO at QuidelOrtho]

This growth demonstrates the success of our cost savings initiatives as we continue to drive toward our margin expansion targets. All right, turning now to the balance sheet on slide seven, we finished the quarter with $98 million in cash and $100 million in borrowings under our $700 million revolving credit facility. During the third quarter, one-time cash flows associated with systems integration decreased by $5 million or 23% compared to Q2. However, adjusted free cash flow was a negative $50 million, largely due to the timing of accounts receivable collections that moved into Q4. Accounts payable disbursements moved up into Q3 from Q4 as a direct result of our ERP system conversion. These temporary cash flow impacts from our system conversion were manageable due to the flexibility provided by our recent debt refinancing.

[Joe Busky, CFO at QuidelOrtho]

Because these impacts are purely timing-related, we continue to expect full-year adjusted recurring cash flow to represent 25-30% of adjusted EBITDA. We completed our debt refinancing in August, improving our debt covenant terms and reducing the required amortization over the life of the loan. A summary of our debt refinancing is on slide eight of our earnings presentation. As part of the refinancing, we booked a $5 million loss on extinguishment of debt within the quarter. At the end of Q3, our net debt to adjusted EBITDA ratio was 4.4x, and our goal continues to be net debt leverage of between 2.5 and 3.5. Note that the Q3 leverage ratio was slightly higher than anticipated due to the ERP system conversion impacts to our Q3 cash flow.

[Joe Busky, CFO at QuidelOrtho]

Our consolidated leverage ratio was 3.8x, including the pro forma EBITDA adjustments permitted and defined under our credit agreement. This compares to the credit agreement leverage ratio covenant of 4.5x. During the third quarter, the company's stock price and market cap, which remained below management's view of the company's intrinsic value, prompted an interim goodwill assessment. As a result, we booked a $701 million goodwill impairment charge in Q3. We have no goodwill remaining on the balance sheet as of the end of Q3. All right, now turning to slide nine, based on our current business outlook, we are providing our full year 2025 financial guidance as follows. Given that we only have two months left in the year, we are taking the opportunity to narrow our 2025 financial guidance.

[Joe Busky, CFO at QuidelOrtho]

Therefore, we now expect full year 2025 total reported revenue of between $2.68 billion and $2.74 billion, with neutral FX impact to the full year. While we're pleased with our revenue performance in Q3, we continue to expect a typical respiratory season with timing consistent with pre-pandemic patterns and similar to last year. That is occurring later in the fourth quarter and into the first quarter. Importantly, the midpoint of our narrowed guidance range remains the same as our prior guidance. Year-to-date COVID revenue was $60 million, and we continue to expect between $70 million and $100 million for the full year. We believe this range is reasonable and reflects pandemic levels. We are also narrowing our adjusted EBITDA range to $585 million-$605 million, which is, again, the same midpoint as our prior guidance.

[Joe Busky, CFO at QuidelOrtho]

This adjusted EBITDA guidance includes incremental cost savings in the range of $30 million-$40 million in 2025. Primarily related to indirect procurement efforts. These savings are in addition to any tariff-related offsets. Our outlook continues to reflect an adjusted EBITDA margin of 22% for the full year, which is a 250 basis point improvement versus the prior year. Following our debt refinancing in August, we expect interest expense for the full year to be up by approximately $17 million for a total of $177 million. This includes a roughly 100 basis point increase in the weighted average interest rate. The additional amortization of deferred financing fees is tied to the new term loans A and B. For the full year, we expect our effective tax rate to rise by roughly one percentage point from the previous guidance to 25%.

[Joe Busky, CFO at QuidelOrtho]

Reflecting the impact of tariff mitigation measures that have shifted income across different geographies. We are also updating our adjusted diluted EPS guidance solely to reflect the higher interest expense and the taxes just discussed. We now expect full year 2025 adjusted diluted EPS of $2-$2.15. Approximately 19 cents of the impact is attributable to higher interest expense and 5 cents in higher taxes at the midpoint of the guidance. To wrap up, we're encouraged by the progress we've made in the first nine months of the year, and we remain disciplined in our approach to margin expansion, cash generation, and balance sheet improvement. We're confident that our financial discipline, combined with our strategic priorities, positions us well to drive long-term value for our shareholders. With that, I'll ask the operator to please open up the line for questions.

[Operator]

Thank you. If you would like to ask a question, please press star followed by one on your telephone keypad. If your question has been answered or you wish to remove your question, please press star followed by two. Again, to ask a question, press star one. As a reminder, if you are using a speakerphone, please pick up your handset before asking your question. We will pause here briefly as questions are registered. Our first question comes from the line of Andrew Brackmann with William Blair. Andrew, your line is now open.

[Andrew Brackmann, Equity Research Analyst at William Blair]

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

[Brian Blaser, President and CEO at QuidelOrtho]

Yeah. 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. You see that, you certainly see those reflected in the underlying growth rates. We're excited about the traction that we're getting in those markets. Importantly, I would say we're very focused on wins now that are profitable as opposed to just winning at all costs. 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.

[Brian Blaser, President and CEO at QuidelOrtho]

The launch of high-sensitivity 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. It really strengthens our cardiac panel. More and more clinicians are requiring high sensitivity for troponin on their platforms. I would say by itself, 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. Getting that assay on the panel was really important. It was a huge priority for me when I joined the business.

[Brian Blaser, President and CEO at QuidelOrtho]

We're excited about that and expecting to be taking orders later this year and shipping product as quickly as we can.

[Andrew Brackmann, Equity Research Analyst at William Blair]

Okay. That's great color. I'll just ask China, so hopefully we can move on. I mean, it looks like you're not seeing any impact from BBP 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. 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? Thanks.

[Brian Blaser, President and CEO at QuidelOrtho]

Yeah. So there's not a whole lot that's changed from the last update that we did for Q2. We had adjusted our guidance on the Q2 call to mid-single-digit growth to reflect the sort of competitive dynamics and all of these different policies that were taking place. We have seen some impact from BBP 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.

[Brian Blaser, President and CEO at QuidelOrtho]

Our objective will be to continue to be in compliance with their regulations so that we can continue to manufacture and invest in China as long as the economics there remain favorable.

[Andrew Brackmann, Equity Research Analyst at William Blair]

Okay. Thanks, guys. Nice quarter.

[Brian Blaser, President and CEO at QuidelOrtho]

Thanks.

[Operator]

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

[Lu Li, Healthcare Equity Research at UBS]

Great. Thank you for taking my questions. I want to go back to the 2025 guidance. So you're 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. And then I have a follow-up.

[Joe Busky, CFO at QuidelOrtho]

Yeah. Hey, Lu, it's Joe. Yeah, we did take the opportunity, given that we only have two months left in the year, to narrow the guidance. We do want to stress the point that even though we've narrowed the guidance on revenue and adjusted EBITDA, the midpoint of that guidance is still precisely the same. The adjusted EPS guidance, again, was narrowed and also adjusted for the non-operational 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. 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, see slightly higher instrument revenue in Q4 as customers are attempting to use their budgets.

[Joe Busky, CFO at QuidelOrtho]

You see a lot more instrument revenue in Q4 versus other quarters. 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. You do get a sort of a negative mix impact by that instrument revenue. 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. That is going to have the impact of pulling down the margin slightly. Hopefully that answers your question.

[Lu Li, Healthcare Equity Research at UBS]

Yeah. I appreciate the color. Second question on instrument. What is the instrument performance in the quarter? Then, Brian, I think you mentioned there's a next-generation instrument in the pipeline. Do you have a timeline for that? Thank you.

[Brian Blaser, President and CEO at QuidelOrtho]

I could offer the last part of that. Yeah. 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. We hope to be talking a lot more about that in the future.

[Joe Busky, CFO at QuidelOrtho]

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

[Lu Li, Healthcare Equity Research at UBS]

Thank you.

[Brian Blaser, President and CEO at QuidelOrtho]

Sure.

[Operator]

Thank you. Our next question comes from the line of Jack Meehan with Nephron Research. Jack, your line is now open.

[Jack Meehan, Equity Research Analyst at Nephron Research]

Thank you. Sorry about earlier, had a phone issue. I wanted to start. Was just wondering if you could give us an update on the Sophia franchise, where you stand in terms of install base and pull through. 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. Thanks.

[Brian Blaser, President and CEO at QuidelOrtho]

Yeah. What I can say about the Sophia install base is it continues to be stable, expanding, very durable. It's a workhorse platform. 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 two years. We're looking forward to yet another solid season here in the upcoming respiratory season with Sophia.

[Jack Meehan, Equity Research Analyst at Nephron Research]

Great. You're further in where 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 Sophia?

[Brian Blaser, President and CEO at QuidelOrtho]

Yeah. As I mentioned in the prepared remarks, the dialogue with FDA continues to be constructive. We have not seen anything really out of the ordinary. Assuming an approval late this year or early 2026, we will 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. That is our current plan.

[Jack Meehan, Equity Research Analyst at Nephron Research]

Got it. Then last one, I saw on the slide still targeting the 100-200 basis points expansion for 2026, which is great. Can you just talk about how you're thinking about free cash flow conversion as a percentage of EBITDA? What we should be plugging in for that for 2026. Thanks.

[Joe Busky, CFO at QuidelOrtho]

Yeah. Hey, Jack. 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. Despite that timing issue due to the system conversions, we still feel that the full year 2025 recurring free cash flow would be in that range of 25-30%. We still are confident in getting to the target of 50% of adjusted EBITDA for recurring free cash flow. We will not hit that target next year. I would believe that hitting the cash flow target would be consistent with the timelines we have on hitting the EBITDA margin target. I would more target, I would say, mid-2027. For 2026, I would expect us to make progress towards that 50% target, but not fully get there. The levers.

[Joe Busky, CFO at QuidelOrtho]

That we have 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 one-time related cash cost that we have seen the last couple of years. Obviously, the EBITDA margin improvement is providing additional cash flow. Those are the levers.

[Jack Meehan, Equity Research Analyst at Nephron Research]

Okay. Thank you, Joe.

[Joe Busky, CFO at QuidelOrtho]

Sure.

[Operator]

Thank you. Our next question comes from the line of Tycho Peterson with Jefferies. Tycho, your line is now open.

[Jack Fabbri, MD of Equity Capital Markets at Jefferies]

Yeah. Hi. Good evening. This is Jack on for Tycho. Thanks for taking the question. Saw a nice step up in immunohematology 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?

[Brian Blaser, President and CEO at QuidelOrtho]

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

[Jack Fabbri, MD of Equity Capital Markets at Jefferies]

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 100-200 basis point margin improvement?

[Brian Blaser, President and CEO at QuidelOrtho]

Yeah. Jack, the Lex, we do expect, as Brian said, we're going to expect to get FDA clearance late this year, early next year. We'll have a very limited rollout in the first part of the year, the first part of the respiratory season. 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 diluted 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 diluted impact of Lex. 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. Okay.

[Operator]

Thank you. Our next question comes from the line of Patrick Donnelly with Citi. Patrick, your line is now open.

[Brendon Kon, Analyst at Citi]

Hi, this is Brendon on for Patrick. Thank you for taking our questions. 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? I think before you kind of mentioned that margin benefits should start to roll through. I'm just curious how we should be thinking about margins over the course of next year with focus on the U.S. donor screening business.

[Brian Blaser, President and CEO at QuidelOrtho]

Yeah. Hey, Brendon. Yeah, it's a good question. As a reminder, 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 then for the year to date, we're down $55 million or 57%. So it has been quite a headwind on that top line. We do expect that we'll be somewhere between $40-$50 million of revenue this year. And that residual revenue will completely wind down in the first half of 2026. That top line headwind that we've been seeing from the donor screening exit will dissipate as you get into second quarter. 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.

[Brian Blaser, President and CEO at QuidelOrtho]

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 2026 or into early 2027.

[Brendon Kon, Analyst at Citi]

Appreciate that. Thank you. Within the lab, I believe you talked about integrated analyzers being around 30% of the install 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. How should we think about kind of the long-term opportunity in terms of adding growth there? Thank you.

[Brian Blaser, President and CEO at QuidelOrtho]

Yeah. Thank you for the question, Brendon. Our integrated analyzer placements are almost completely inverse to our competitors' situation in the marketplace. 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 30-40% range. I think we have a tremendous opportunity there in terms of our runway for additional placement of integrated systems. That has been our strategy for the last several years, and will continue to be.

[Brendon Kon, Analyst at Citi]

Thank you.

[Operator]

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

[Andrew Cooper, Equity Research Analyst at Raymond James]

Hey, everybody. Thanks for the time. 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 Triage crew and bringing that high-sensitivity troponin to the point of care. Would love just the latest there, given that product's, 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?

[Brian Blaser, President and CEO at QuidelOrtho]

Yeah. 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. We are looking at that and seeing if we can press over those hurdles to get that assay into the market at some point. I do not have anything really concrete to share with you in the short term at this point.

[Andrew Cooper, Equity Research Analyst at Raymond James]

Okay. 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.

[Brian Blaser, President and CEO at QuidelOrtho]

Our initial focus was heavily around just staffing of the organization kind of at all levels across the board. We took out close to 12% of the organization as a result. 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. 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.

[Brian Blaser, President and CEO at QuidelOrtho]

We every day continue to come to work and challenge every corner of our P&L for cost savings. We'll continue to do that. It's just a matter of operating the business.

[Andrew Cooper, Equity Research Analyst at Raymond James]

Great. I'll stop there. Thank you.

[Operator]

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

[Brian Blaser, President and CEO at QuidelOrtho]

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 discipline, execution, operational focus, and commitment to innovation are delivering tangible results and positioning us well for the future. Thank you for your time today and your continued support and interest in the business. Take care.

[Operator]

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

Participants

Executives

• Joe Busky, CFO
• Juliet Cunningham, VP of Investor Relations
• Brian Blaser, President and CEO

Analysts

• Brendon Kon, Analyst at Citi
• Jack Fabbri, MD of Equity Capital Markets at Jefferies
• Lu Li, Healthcare Equity Research at UBS
• Andrew Brackmann, Equity Research Analyst at William Blair
• Andrew Cooper, Equity Research Analyst at Raymond James
• Jack Meehan, Equity Research Analyst at Nephron Research