Financial Data and Key Metrics Changes - Total reported revenue for Q1 2025 was $693 million, down from $711 million in the prior year, primarily due to lower COVID and donor screening revenue [18] - Excluding COVID and donor screening, the company achieved a mid single-digit revenue growth of 6% [18] - Adjusted EBITDA margin improved by 450 basis points year over year to 23%, with adjusted diluted EPS increasing by 68% to $0.74 [24][25] Business Line Data and Key Metrics Changes - Labs business, accounting for 54% of total revenue, grew by 7%, driven by clinical chemistry and immunoassay testing [10] - Immunohematology business grew by 4%, maintaining its global leadership position [10] - Point of Care business represented 25% of Q1 revenue and grew by 8% excluding COVID, with strong flu sales leading to an 18% year-over-year growth [10] - Molecular Diagnostics business grew by 11% excluding COVID, with ongoing clinical trials for the Savanna respiratory panel [11] Market Data and Key Metrics Changes - Revenue from the "Other" region (Japan, Asia Pacific, Latin America) grew by 12%, driven by a 17% increase in Labs revenue [19] - North America revenue declined by 6% due to lower COVID revenue and donor screening wind down, but grew by 5% when excluding these factors [19] - Europe, Middle East, and Africa grew by 9%, while China revenue remained flat, primarily due to order timing and decreased Triage revenue [20] Company Strategy and Development Direction - The company is focused on a narrow set of strategic initiatives, including increasing platform content and utility, expanding margins, and enhancing commercial execution [11] - Plans to realize $100 million in annualized cost savings, with $50 million expected in the first half of 2025 [12] - The company aims to maintain its manufacturing footprint and continue investing in U.S.-based manufacturing and R&D [14] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's strategy and operational discipline, highlighting strong Q1 results and ongoing initiatives [9] - The company anticipates potential tariff impacts of $30 million to $40 million in 2025 but believes mitigation plans will offset these impacts [15] - Full-year 2025 financial guidance remains unchanged, with expectations for total reported revenue between $2.6 billion and $2.81 billion [27] Other Important Information - The company has invested nearly $1 billion in U.S.-based manufacturing and R&D over the past three years [13] - Adjusted free cash flow for Q1 2025 was $47 million, representing 29% of adjusted EBITDA [26] - The company plans to refinance its debt in the second half of 2025 or early 2026, depending on market conditions [31] Q&A Session Summary Question: Can you elaborate on the tariff impact and pricing actions? - Management indicated that selective pricing actions are being considered to offset tariff impacts, but competitive market conditions must be taken into account [36][37] Question: Will tariff impacts affect long-term manufacturing plans? - Management does not expect changes to the overall manufacturing footprint, emphasizing the importance of their global manufacturing network [38] Question: How confident is the company in mitigating tariff impacts? - Management expressed confidence in fully mitigating tariff impacts through various actions, including cost reductions and realigning inventories [43] Question: What underpins the confidence in China's growth rate? - Confidence in mid to high single-digit growth in China is based on strong performance in labs and immunohematology, despite some softness in Triage sales [49] Question: What is the status of the Savanna program? - The company is focused on completing the RBP4x submission to the FDA and is not speculating on outcomes beyond that [45][61] Question: How is the respiratory sales performance impacting guidance? - Management expects to maintain the guidance range for COVID revenue despite a decline, as flu sales have been strong [56][58]

Financial Data and Key Metrics Changes - Total reported revenue for Q1 2025 was $693 million, down from $711 million in the prior year, primarily due to lower COVID and donor screening revenue [19][20] - Excluding COVID and donor screening, revenue growth was 6%, driven by the labs business and a strong flu season [7][19] - Adjusted EBITDA was $160 million, compared to $132 million in the prior year, with an adjusted EBITDA margin of 23%, reflecting a 450 basis point improvement [25][28] - Adjusted diluted EPS increased by 68% year over year to $0.74 [25] Business Line Data and Key Metrics Changes - Labs business, accounting for 54% of total revenue, achieved 7% growth, with strong performance in clinical chemistry and immunoassay testing [8][20] - Immunohematology business grew by 4%, maintaining its global leadership position [8][22] - Point of Care business represented 25% of Q1 revenue and grew 8% excluding COVID [8] - Molecular Diagnostics business grew 11% excluding COVID, with ongoing clinical trials for the Savanna respiratory panel [10] Market Data and Key Metrics Changes - Revenue from the "Other" region (Japan, Asia Pacific, Latin America) grew by 12%, driven by a 17% increase in Labs revenue [20] - North America revenue declined by 6% due to lower COVID revenue and the wind down of donor screening, but grew by 5% excluding these factors [20] - Europe, Middle East, and Africa grew by 9%, supported by labs and immunohematology contributions [20] - China revenue was flat year over year, with labs revenue growing by 2% [21] Company Strategy and Development Direction - The company is focused on a narrow set of strategic initiatives, including increasing platform utility, expanding margins, and enhancing commercial execution [10][11] - Plans to realize $100 million in annualized cost savings, with $50 million expected in the first half of 2025 [11][28] - The company aims to maintain a recurring revenue model, with over 90% of sales from consumables [12] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strategy and operational discipline, highlighting strong Q1 results and ongoing initiatives [6][7] - The company is navigating a dynamic macro environment, with expected tariff impacts of $30 million to $40 million in 2025, which they believe can be fully mitigated [14][28] - Full year 2025 financial guidance remains unchanged, with expectations for total reported revenue between $2.6 billion and $2.81 billion [28][30] Other Important Information - The company has invested nearly $1 billion in U.S.-based manufacturing and R&D over the past three years [12] - Adjusted free cash flow for Q1 was $47 million, representing 29% of adjusted EBITDA [26] Q&A Session Summary Question: Can you elaborate on the tariff impact and pricing actions? - Management indicated that selective pricing actions are being considered to offset tariffs, but competitive market conditions must be taken into account [37][38] Question: Will tariff impacts affect long-term manufacturing plans? - Management does not expect changes to the overall manufacturing footprint, emphasizing the importance of their global manufacturing network [39] Question: Can you quantify tariff exposures and confidence in offsets? - Most products are manufactured in the U.S., with the largest tariff impacts on immunoassay products from the U.K. Management is confident in their mitigation strategies [43][45] Question: What underpins confidence in China's growth rate? - Despite some softness in Triage sales, strong growth in labs and immunohematology supports the mid to high single-digit growth target for China [49][51] Question: What is the status of the Savanna program? - The company is focused on completing the RBP4x submission to the FDA and remains committed to the molecular diagnostics segment [46][62] Question: Are there timing impacts from mitigation efforts? - Management does not anticipate significant timing impacts from mitigation actions, although some softness in China revenue is expected in Q2 due to shipment delays [70][71]

Revenue Performance - Total revenues for the three months ended March 30, 2025, decreased by 3% to $692.8 million compared to $711.0 million for the same period in the prior year[90]. - Revenue from respiratory products accounted for 17% of total revenues for the three months ended March 30, 2025, down from 19% in the prior year, with COVID-19 related revenue decreasing from $50.2 million to $23.4 million[81]. - Labs revenue increased by 5% to $373.1 million, driven by growth in reagents, consumables, and services, while Point of Care revenue decreased by 8% to $170.8 million[89]. - Total revenues for North America decreased by 6% to $406.7 million for the three months ended March 30, 2025, compared to $433.9 million for the same period in 2024[104]. - EMEA segment reported a 5% increase in total revenues to $88.9 million, with Adjusted EBITDA rising 42% to $16.5 million[106]. - China total revenues decreased by 1% to $75.0 million, while Adjusted EBITDA increased by 12% to $29.3 million[108]. - Total revenues for the "Other" segment increased by 5% to $122.2 million, but Adjusted EBITDA decreased by 6% to $29.6 million[111]. Expenses and Cost Management - Cost of sales decreased to $349.5 million, or 50.4% of total revenues, down from $378.9 million, or 53.3% of total revenues, for the same period last year[91]. - Selling, marketing, and administrative expenses decreased by 8.6% to $187.0 million, primarily due to cost-savings initiatives[93]. - Research and development expenses decreased by 10.1% to $53.2 million, also attributed to cost-savings initiatives[94]. - Integration-related costs decreased to $16.1 million from $22.6 million in the prior year, reflecting lower consulting and compensation-related charges[96]. Tax and Financial Position - The effective tax rate for the three months ended March 30, 2025, was negative 44.3%, compared to an effective tax rate of 5.2% in the prior year, primarily due to operating losses in certain subsidiaries[101]. - Cash and cash equivalents increased by $28.8 million to $127.1 million as of March 30, 2025[113]. - Net cash provided by operating activities was $65.6 million for the three months ended March 30, 2025, compared to a cash outflow of $0.7 million in the same period of 2024[117]. - Capital expenditures for the three months ended March 30, 2025, were $56.2 million, primarily for manufacturing capacity expansion[116]. - The company anticipates that current cash and cash equivalents, along with cash from operations, will be sufficient to fund near-term capital and operating needs for at least the next 12 months[122]. Strategic Initiatives - The company initiated a wind-down plan for the U.S. donor screening portfolio, expected to be substantially complete by the end of 2025, contributing to revenue decline[82]. - The company expects overall demand for its products to continue to fluctuate, influenced by seasonal respiratory demands and competitive pressures[85]. - The company is focused on expanding the number of instruments placed in the field through a reagent rental model to enhance recurring revenue and cash flows[126].

Revenue Performance - Total revenue for Q1 2025 was $693 million, a decrease of 2.5% from $711 million in the prior year period, primarily due to lower COVID-19 and Donor Screening revenue[3] - Non-respiratory revenue was $573 million, flat compared to the prior year, while Labs revenue grew by 5% as reported and 7% in constant currency[5] - Total revenues for the three months ended March 30, 2025, were $692.8 million, a decrease of 2.6% compared to $711.0 million for the same period in 2024[32] - Respiratory revenues decreased by 12.7% to $119.8 million for the three months ended March 30, 2025, compared to $137.3 million for the same period in 2024[32] - Non-respiratory revenues remained relatively stable at $573.0 million, a slight decrease of 0.1% compared to $573.7 million in the prior year[32] Profitability Metrics - GAAP diluted loss per share for Q1 2025 was $0.19, significantly improved from a loss of $25.50 in the prior year period[4] - GAAP operating income for Q1 2025 was $33 million, compared to an operating loss of $1.76 billion in the prior year, with an operating margin of 5%[4] - Adjusted EBITDA for Q1 2025 was $160 million, up from $132 million in the prior year, with an adjusted EBITDA margin of 23%[6] - Adjusted net income for the three months ended March 30, 2025, was $50.2 million, or $0.74 per diluted share, compared to $29.8 million, or $0.44 per diluted share, for the same period in 2024[25] - The company reported a net loss of $12.7 million for the three months ended March 30, 2025, compared to a net loss of $1,706.0 million for the same period in 2024[30] Cash Flow and Assets - Cash provided by operating activities was $65.6 million for the three months ended March 30, 2025, compared to cash used of $0.7 million for the same period in 2024[22] - Cash, cash equivalents, and restricted cash at the end of the period increased to $127.2 million from $79.0 million at the end of the same period in 2024[22] - Total current assets increased to $1,258.2 million as of March 30, 2025, from $1,218.9 million as of December 29, 2024[20] - Total liabilities increased to $3,464.4 million as of March 30, 2025, compared to $3,439.1 million as of December 29, 2024[20] Guidance and Future Outlook - The company maintains its full-year 2025 financial guidance, expecting total revenues between $2.60 billion and $2.81 billion[7] - Adjusted diluted EPS for 2025 is projected to be between $2.07 and $2.57[7] Operational Initiatives - Integration-related charges for Q1 2025 amounted to $16 million, contributing to the overall operating expenses of $240 million, which decreased by 9%[5] - The company is focused on operational improvement initiatives to address macroenvironment challenges and enhance profitability[2]

Looking for a stock that has been consistently beating earnings estimates and might be well positioned to keep the streak alive in its next quarterly report? QuidelOrtho (QDEL) , which belongs to the Zacks Medical - Products industry, could be a great candidate to consider.This medical diagnostics company has seen a nice streak of beating earnings estimates, especially when looking at the previous two reports. The average surprise for the last two quarters was 94.37%.For the most recent quarter, QuidelOrtho ...

QuidelOrtho (QDEL) shares ended the last trading session 10.1% higher at $28.85. The jump came on an impressive volume with a higher-than-average number of shares changing hands in the session. This compares to the stock's 29.7% loss over the past four weeks.The upside can be attributed to relief-rally across global markets following the announcement of a 90-day pause on tariff hike by the United States.This medical diagnostics company is expected to post quarterly earnings of $0.61 per share in its upcomin ...

Company Overview - QuidelOrtho (QDEL) has launched the Results Manager System, aimed at streamlining diagnostic data management and improving laboratory workflow efficiency [1][2] - The system enhances connectivity by integrating test results from multiple sources, facilitating faster and more accurate decision-making [1][3] Product Features - The Results Manager System centralizes diagnostic data management, providing a unified view of patient diagnostics and reducing manual data entry, which minimizes errors [3][4] - It supports real-time quality monitoring and automates workflows with features like auto-verification, thus reducing manual effort [4] - The system is scalable and cost-effective, designed to optimize efficiency and reliability for laboratories of all sizes [4] Industry Prospects - The global in vitro diagnostics market was valued at $108.30 billion in 2024 and is projected to grow at a CAGR of 5.62% from 2025 to 2030, driven by the demand for accurate and rapid diagnostic solutions [5][6] - Key growth drivers include the rising prevalence of chronic and infectious diseases, advancements in diagnostics, and a shift towards value-based healthcare [6] Competitive Landscape - Hologic (HOLX) is expanding its diagnostic portfolio with a focus on women's health and has received CE-marking for its Affirm Contrast Biopsy Software [7] - Abbott (ABT) is innovating in infectious disease diagnostics, with recent WHO approval for its Alinity m MPXV assay for emergency use [8] - Grail (GRAL) is advancing early cancer detection through collaborations aimed at improving access to its multi-cancer early detection test [9]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ________________________________ FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 29, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _____ to _____ Commission file number: 001-41409 QUIDELORTHO CORPORATION (Exact name of registrant as specified in its charter) De ...

Healthcare in vitro diagnostics company QuidelOrtho (QDEL 4.28%) attracted the right kind of attention from investors after posting its latest quarterly earnings report on Thursday. A rather encouraged market traded the company's shares up by more than 4% in response. That was more than good enough to top the S&P 500 index's slightly over 1% increase.Narrower-than-expected declinesQuidelOrtho's fourth-quarter and full-year results, unveiled after market close on Wednesday, showed that the company earned $70 ...

QuidelOrtho Corporation (QDEL) delivered adjusted earnings per share (EPS) of 63 cents in the fourth quarter of 2024, down 46.2% year over year. The figure, however, topped the Zacks Consensus Estimate by 14.6%.Find the latest EPS estimates and surprises on Zacks Earnings Calendar.The adjustments include expenses related to the amortization of intangibles, and acquisition and integration costs, among others.GAAP loss per share for the quarter was $2.28 against the year-earlier EPS of 10 cents.Full-year 2024 ...