Core Insights - QuidelOrtho reported $2.73 billion in revenue for the full year, with non-respiratory revenue growing 5% and Labs business growing 6%, representing 55% of total revenue [1][6] - The company experienced a decline in respiratory revenue, totaling $402 million, primarily due to lower COVID testing [1][6] Financial Performance - For Q4, QuidelOrtho reported revenue of $724 million, a 2% year-over-year increase; excluding COVID and donor screening, revenue growth was 7% [2] - The company achieved $140 million in cost savings, expanded adjusted EBITDA margins to the low 20% range, and reported an adjusted EBITDA margin of 22% for 2025, a 240 basis point improvement year-over-year [3][6] - Adjusted diluted EPS was $0.46 in Q4 and $2.12 for the full year, representing a 15% growth year-over-year [6] Segment and Regional Performance - Labs revenue grew 7% in Q4 and 6% for the full year, driven by strength in clinical chemistry; respiratory revenue declined 14% in Q4 and 20% for the year [8][9] - North America revenue was up 4% in Q4 but down 2% for the year; Europe, Middle East, and Africa was flat in Q4 and up 4% for the year [9] Research and Development - Recent FDA clearances include a high-sensitivity Troponin I assay and a DAT direct anticoagulant test card; plans for the launch of the VITROS 450 platform are underway [5][10] - The Lex molecular platform is in the final stages of FDA review, designed for point-of-care applications [13] 2026 Outlook - Management guided for 2026 revenue of $2.7 billion to $2.9 billion, with expected growth in Labs and Immunohematology, and a decline in molecular diagnostics due to the discontinuation of the Savanna business [17][18] - Adjusted EBITDA is expected to be between $630 million and $670 million, implying an adjusted EBITDA margin of about 23.3% [19] Leadership Update - The CFO, Joe Busky, will retire in June, and the company has initiated a search for a successor [20]

Financial Data and Key Metrics Changes - Total revenue for Q2 2025 was $614 million, a decrease from $637 million in the prior year, primarily due to lower COVID and donor screening revenue [20][27] - Adjusted EBITDA increased by 19% year-over-year to $107 million, with an adjusted EBITDA margin improvement of 330 basis points to 17% [27] - Adjusted diluted EPS was $0.12, compared to a loss of $0.07 in the prior year, representing a growth of 271% [27] Business Line Data and Key Metrics Changes - The labs business grew by 5%, driven by strong performance in clinical chemistry and immunoassay testing [21] - Immunohematology revenue grew by 3%, with notable strength in Latin America and EMEA [22] - Respiratory business revenue decreased by $2 million, primarily due to a 52% decline in COVID sales [23] Market Data and Key Metrics Changes - North America revenue declined by 12% during the quarter, while international markets showed growth, particularly in Latin America (14% growth) and Japan/Asia Pacific (6% growth) [9][10] - China experienced 2% growth in Q2 despite tariff-related shipment holds, with expectations for mid-single-digit growth for the full year [11][12] Company Strategy and Development Direction - The company is focused on expanding its low OUS penetration as a significant growth opportunity [10] - Plans to acquire Lex Diagnostics to enhance its molecular diagnostics capabilities, with expected FDA clearance and market placements in 2026 [16][17] - Continued emphasis on cost structure optimization and operational improvements to drive profitability [12][27] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in mitigating tariff impacts, estimating potential headwinds of $20 million to $25 million for 2025, lower than previous estimates [15] - The company remains committed to delivering on its strategy to drive growth and expand profitability, with a focus on customer service and innovation [18][27] Other Important Information - The company completed its ERP conversion related to the business combination, which is expected to lower integration costs in the second half of the year [26] - The company anticipates annual operating cost savings of approximately $20 million from the consolidation of its New Jersey manufacturing site [26] Q&A Session Summary Question: Can you walk through your respiratory expectations for the remainder of the year? - The company is not changing flu assumptions, but COVID revenue guidance has been lowered due to lower emergency room visits and hospitalizations [35][36] Question: Can you provide insights on the visibility for China growth? - The company has good visibility for mid-single-digit growth in China, with minimal impact from recent pricing and volume actions [39][45] Question: What are the moving pieces affecting EBITDA? - The decrease in COVID revenue is offset by lower tariff impacts and the discontinuation of the Savannah platform, leading to no change in adjusted EBITDA guidance [48][51] Question: How is the company planning for the commercialization of the Lex platform? - No commercial efforts have started yet; the focus is on FDA approval before any marketing activities [92] Question: What is the outlook for free cash flow in the second half? - The company expects to generate more cash in the second half, targeting $140 million to $160 million of free cash flow [77][78]