Prepared remarks
Welcome to the QuidelOrtho Third Quarter 2025 Financial Results Conference Call and webcast. 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. 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.
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. 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 and 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 BMP 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. 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 underpenetration 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. 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. 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 into 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. 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. 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've made and confident in the path ahead. We remain focused on our execution to deliver sustainable, profitable growth. With that, I'll turn the call over to Joe to take you through the details of our third quarter financial results.
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. 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 restructuring, integration, and other charges, which included approximately $11 million related to the discontinuation of the development of the Savanna 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, and 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. 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. 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%. This growth demonstrates the success of our cost savings initiatives as we continue to drive toward our margin expansion targets. Turning now to the balance sheet on Slide 7, 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 and accounts payable disbursements that 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. Because these impacts are purely timing-related, we continue to expect full year adjusted recurring cash flow to represent 25% to 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 8 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 3.5x. Note that the Q3 leverage ratio was slightly higher than anticipated due to the ERP system conversion impacts on our Q3 cash flow. 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. Note that we have no goodwill remaining on the balance sheet as of the end of Q3. Now turning to Slide 9. Based on our current business outlook, we are providing our full year 2025 financial guidance as follows. Given that we only have 2 months left in the year, we are taking the opportunity to narrow our 2025 financial guidance. 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. 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 endemic levels. We are also narrowing our adjusted EBITDA range to $585 million to $605 million, which is again, the same midpoint as our prior guidance. This adjusted EBITDA guidance includes incremental cost savings in the range of $30 million to $40 million in '25, primarily related to indirect procurement efforts, and 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 and the additional amortization of deferred financing fees tied to the new term loans A and B. For the full year, we expect our effective tax rate to rise by roughly 1 percentage point from the previous guidance to 25%, 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 higher interest expense and the taxes just discussed. We now expect full year 2025 adjusted diluted EPS of $2 to $2.15. Approximately $0.19 of the impact is attributable to higher interest expense and $0.05 in higher taxes at the midpoint of the guidance. To wrap up, we're encouraged by the progress we made in the first 9 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.
Questions and answers
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. 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 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. Regarding the troponin launch, I'm just so proud of the work that the team did there in conjunction with the 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, and more and more clinicians are requiring high-sensitivity troponin on their platforms. 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. This was a priority when I joined the business, and we are excited about that and expecting to be taking orders later this year and shipping products as quickly as we can.
Okay. That's great color. And then I'll just ask about China. 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 quarter. I just want to make sure that's right, and that's the expectation moving forward. Also, 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 not a whole lot has changed from our last update for Q2. We adjusted our guidance to mid-single-digit growth reflecting competitive dynamics and policies happening. 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 high proportion of our instruments are used in stat labs where they're less likely to debundle panels. There’s not much change since our last update. Regarding the new policy on localization, we already have manufacturing in China, and our objective will be to remain in compliance with regulations to continue to invest there as long as the economics remain favorable.
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. Secondly, I saw on the guidance slide that you expect over half of the flu test to be combo. Just curious your thoughts around the durability of the ABC test and physician preference around that.
Regarding the Sofia installed base, it continues to be stable, expanding, and very durable. The durability of our flu combo test is also solid, with steady performance in terms of sales over the last two years. We're looking forward to another solid season in the upcoming respiratory season with Sofia.
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 in Europe, not yet in the U.S. How important or how much of an opportunity do you view that point of care today relative to how it was thought about a few years ago?
Yes. Triage is an assay that we would love to have on Triage. We do have it outside the U.S. It's a very successful test. Currently, there are some technical challenges to overcome to meet performance requirements for the U.S. market. We're looking at that to see if we can address those hurdles, but there’s nothing concrete I can share in the short term.
Our next question comes from the line of Tycho Peterson with Jefferies.
Sorry about earlier, I 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. 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. We're looking forward to yet another solid season here in the upcoming respiratory season with Sofia. 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.