QuidelOrtho Corporation

Welcome to the Quidel Ortho 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.

Thank you. Good afternoon, everyone. Thanks for joining the Quidel Third Quarter 2025 Financial Results Conference Call. Joining me today are Brian Blazer, President and Chief Executive Officer, and Joe Buskey, 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. 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 5, 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 it's 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 Blazer.

Thanks, Juliette. 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've 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 FIDEL Ortho. 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 last business, revenue grew 4%. Demand for our vitros, immunoassay, and clinical chemistry platforms remain 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 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. And 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 order, 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. And 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. 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 80 cents. And 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 of 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 BTROS high sensitivity proponent 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 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. We also continue to support Lex Diagnostics in their ongoing review of their 510K 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. So I'll 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. And with that, I'll turn the call over to Joe to take you through the details of our third quarter financial results.