Core Insights - QuidelOrtho's shares fell 12.8% after disappointing Q3 financial results and a reduced full-year earnings forecast [1] - The company's Q3 revenue was $699.9 million, a 3.7% decrease year-over-year, despite adjusted earnings per share of $0.80 beating Wall Street expectations [1] - A significant GAAP net loss, including a non-cash goodwill impairment charge, raised investor concerns [1] - QuidelOrtho lowered its adjusted earnings per share guidance for the full year by 10.6% at the midpoint [1] Market Reaction - QuidelOrtho's shares have shown extreme volatility, with 35 moves greater than 5% in the past year, indicating significant market impact from recent news [3] - The previous notable stock movement occurred 17 days prior, when shares gained 5.5% following positive news regarding the company's commitment to transfusion medicine and FDA approval of a new product [4] Stock Performance - Since the beginning of the year, QuidelOrtho's stock has declined by 47.9%, currently trading at $23.47, which is 50.7% below its 52-week high of $47.61 [5] - An investment of $1,000 in QuidelOrtho shares five years ago would now be worth $82.80 [5]

Revenue Performance - Total revenues for the nine months ended September 28, 2025, decreased by 3% to $2,006.6 million compared to $2,075.1 million for the same period in the prior year [110]. - Revenue from respiratory products accounted for 14% of total revenues for the nine months ended September 28, 2025, down from 17% in the prior year [110]. - Labs revenue increased by 5% for the nine months ended September 28, 2025, primarily due to growth in reagents, consumables, and services [125]. - Donor Screening revenue decreased by 57% for the nine months ended September 28, 2025, primarily due to the wind-down of the U.S. donor screening business [125]. - Point of Care revenue decreased by 23% for the nine months ended September 28, 2025, driven by a decline in sales of QuickVue and Sofia SARS Antigen assays [125]. - Total revenues for North America were $1,098.8 million for the nine months ended September 28, 2025, down 10% from $1,220.2 million for the same period in 2024 [148]. - Total revenues for EMEA increased by 9% to $91.8 million for the three months ended September 28, 2025, compared to $84.0 million for the same period in 2024 [151]. - Total revenues for the nine months ended September 28, 2025, were $268.0 million, a 7.4% increase from $249.9 million for the same period in 2024, driven by growth in Immunohematology and Point of Care revenues [152]. - In China, total revenues for the three months ended September 28, 2025, were $84.6 million, a 5.2% increase from $80.4 million in the same period of 2024, driven by a 7% increase in Labs revenues [154]. - Total revenues for the nine months ended September 28, 2025, in China were $243.0 million, a 2% increase from $238.1 million in 2024, supported by a 6% increase in Labs revenues [156]. - Total revenues for Other segments for the three months ended September 28, 2025, were $142.1 million, a 12.3% increase from $126.5 million in the same period of 2024 [157]. Cost and Expenses - Cost of sales, excluding amortization of intangible assets, decreased to $364.3 million, or 52.1% of total revenues, for the three months ended September 28, 2025 [126]. - Cost of sales decreased to $1,052.8 million, or 52.5% of total revenues, for the nine months ended September 28, 2025, down from $1,114.7 million, or 53.7% of total revenues, for the same period in 2024 [127]. - Selling, marketing, and administrative expenses for the nine months ended September 28, 2025, decreased by $27.4 million, or 4.7%, to $551.9 million from $579.3 million for the same period in 2024 [130]. - Research and development expenses for the nine months ended September 28, 2025, decreased by $31.0 million, or 18.1%, to $140.4 million from $171.4 million for the same period in 2024 [132]. Impairment and Charges - Goodwill impairment charge recognized was $700.7 million for the three months ended September 28, 2025, compared to $1.7 billion for the nine months ended September 29, 2024 [135]. - In Q3 2025, the company recorded a non-cash goodwill impairment charge of $614.8 million for the EMEA unit, $68.1 million for China, and $17.8 million for Latin America, representing a full impairment of goodwill allocated to these units [182]. - The quantitative goodwill impairment assessment utilized a discounted cash flow method and market approach, incorporating significant assumptions such as future revenue growth rates and EBITDA margins [183]. - The projected future revenue growth rates and EBITDA margins are based on historical experience and internal annual operating plans, extrapolated over the forecast period [183]. - Discount rates for the impairment assessment were determined using a weighted average cost of capital adjusted for specific risk factors related to the reporting units [183]. - Market multiples were derived from comparable publicly traded companies using the guideline public company method [183]. - The company believes the assumptions used in the goodwill impairment assessment are reasonable and consistent with those used by other market participants [184]. Financial Position and Outlook - The Optimization Plan is expected to incur approximately $100 million in pre-tax charges through 2027, aiming for net cost savings of about $50 million [112]. - The planned wind-down of the U.S. donor screening portfolio is expected to be substantially complete by the first half of 2026 [111]. - The company expects overall demand for non-respiratory and respiratory products to continue to fluctuate due to various market factors [118]. - The company plans to continue evaluating strategic opportunities to expand product lines and improve operational efficiencies [119]. - Interest expense, net was $126.6 million for the nine months ended September 28, 2025, compared to $122.9 million for the same period in 2024, reflecting a 3% increase [139]. - Income tax benefit for the three months ended September 28, 2025, was $23.9 million, with an effective tax rate of 3.2%, compared to an income tax benefit of $8.9 million and an effective tax rate of 30.9% for the same period in 2024 [142]. - Adjusted EBITDA for North America was $604.8 million for the nine months ended September 28, 2025, a decrease of 10% from $670.2 million for the same period in 2024 [150]. - Adjusted EBITDA for EMEA increased by 89% to $24.4 million for the three months ended September 28, 2025, compared to $12.9 million for the same period in 2024 [151]. - Adjusted EBITDA for the nine months ended September 28, 2025, was $59.2 million, up 61.5% from $36.6 million in the prior year, primarily due to increased revenues and lower operating expenses [153]. - Adjusted EBITDA for China remained stable at $36.8 million for the three months ended September 28, 2025, compared to the same period in 2024 [155]. - Adjusted EBITDA for Other segments for the nine months ended September 28, 2025, was $111.7 million, a 14% increase from $97.9 million in the prior year [159]. - As of September 28, 2025, the company had $98.1 million in cash and cash equivalents, a slight decrease from $98.3 million as of December 29, 2024 [160]. - The company entered into a Credit Agreement on August 21, 2025, securing a total of $3.45 billion in loans, including a $1.15 billion Term Loan A and a $1.45 billion Term Loan B [161]. - Capital expenditures for the nine months ended September 28, 2025, were $136.4 million, focused on expanding manufacturing capabilities [166]. - There has been no material change in the company's exposure to market risk as described in the Annual Report [185].

Financial Data and Key Metrics Changes - Total reported revenue for Q3 2025 was $700 million, a 4% decrease from $727 million in the prior year, primarily due to lower COVID and donor screening revenue [13][14] - Adjusted EBITDA was $177 million, with an adjusted EBITDA margin of 25%, reflecting a 180 basis point improvement year-over-year [10][17] - Adjusted diluted EPS was $0.80 for Q3, representing a 36% growth year-to-date [17][24] Business Line Data and Key Metrics Changes - Labs business revenue grew by 4%, driven by solid demand for VITROS, ImmunoAssay, and clinical chemistry platforms [6][9] - Immunohematology business grew by 5%, supported by strong demand from blood banks and hospitals [7] - Point-of-care business, particularly the Triage product line, posted 7% growth, with significant contributions from international markets [8][9] Market Data and Key Metrics Changes - North America revenue decreased by 12% overall, but increased by 5% year-over-year when excluding respiratory revenue and the U.S. donor screening exit [9] - Latin America experienced a 21% overall growth, with labs growing by 22% [9] - Japan, Asia-Pacific, and China each grew approximately 5%, while Europe, Middle East, and Africa grew by 3% [9] Company Strategy and Development Direction - The company is focused on margin improvement initiatives, achieving over $140 million in cost savings, aiming for sustainable mid to high 20s EBITDA margins [5][10] - Continued investment in strategic areas to position for long-term growth, including R&D advancements and new product launches [10][11] - The company is preparing for the anticipated FDA clearance of Lex Diagnostics by late 2025 or early 2026, which is expected to impact future growth [12][46] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's progress and the path ahead, emphasizing a focus on sustainable, profitable growth [12][24] - The company anticipates a typical respiratory season, with revenue timing consistent with pre-pandemic patterns [21][24] - Management acknowledged challenges from tariff impacts but remains committed to offsetting these in 2025 [11][19] Other Important Information - The company recorded a $701 million goodwill impairment charge in Q3, resulting in no goodwill remaining on the balance sheet [20] - Adjusted recurring cash flow is expected to represent 25-30% of adjusted EBITDA for the full year [19][24] - The company expects full-year 2025 total reported revenue between $2.68 billion and $2.74 billion, with adjusted EBITDA guidance of $585 million to $605 million [21][24] Q&A Session Summary Question: Can you provide more details on competitive wins? - Competitive wins have been evenly distributed across geographies, with significant wins in North America, Latin America, and EMEA, focusing on profitable growth rather than just market share [26][27] Question: What is the growth outlook for China? - The company expects mid-single-digit growth in China, with some impact from BBP and debundling dynamics, but less than competitors due to a high proportion of instruments used in stat labs [30][31] Question: Can you elaborate on the 2025 guidance and margin expectations? - The company narrowed its guidance while maintaining the same midpoint, with expectations for slightly lower margins in Q4 due to higher instrument revenue and incentive compensation [34][35] Question: What is the performance of the Sophia franchise? - The Sophia install base remains stable and expanding, with solid performance expected for the flu combo test in the upcoming respiratory season [43][44] Question: How will Lex Diagnostics impact margins? - Lex is expected to have a diluted impact on margins initially, with a more significant rollout planned for the second half of 2026 [50][51]

Financial Highlights - Total revenue for Q3 2025 was $700 million, a decrease of 5% year-over-year on a constant currency basis[5] - Adjusted EBITDA for Q3 2025 was $177 million, representing a 25% margin[5] - Adjusted diluted EPS for Q3 2025 was $080, a decrease of 6% year-over-year[6] - Year-to-date 2025 total revenue was $201 billion, a decrease of 3% year-over-year on a constant currency basis[11] - Year-to-date 2025 adjusted EBITDA was $444 million, representing a 22% margin[11] - Year-to-date 2025 adjusted diluted EPS was $166, an increase of 36% year-over-year[11] Revenue Breakdown - Recurring revenue accounted for 82% of total revenue in Q3 2025[7] and 84% year-to-date[10] - North America accounted for 57% of revenue in Q3 2025[7] and 58% year-to-date[10] - Labs business unit contributed 51% of revenue in both Q3 2025 and year-to-date 2025[7, 10] Financial Guidance - The company projects full-year 2025 revenues to be between $268 billion and $274 billion[22] - The company anticipates an adjusted EBITDA margin of 22% for full-year 2025[22]

Revenue Performance - Total revenue for Q3 2025 was $700 million, a 4% decrease from $727 million in the prior year period, primarily due to lower COVID-19 and Donor Screening revenue[4]. - Non-respiratory revenue was $588 million, an increase of 5% as reported and 4% in constant currency; excluding Donor Screening, non-respiratory revenue grew 6% in constant currency[6]. - Total revenues for the three months ended September 28, 2025, were $699.9 million, down 3.7% from $727.1 million in the same period of 2024[33]. - Total revenues for the nine months ended September 28, 2025, were $2,006.6 million, a decrease of 3.3% from $2,075.1 million[39]. - Total revenue excluding COVID-19 and Donor Screening for the three months ended September 28, 2025, was $658.3 million, reflecting a growth of 5.0% from $626.9 million[43]. - Donor Screening revenue significantly declined by 57.2% to $40.8 million from $95.4 million[39]. - Molecular Diagnostics revenue increased by 4.7% to $18.0 million from $17.2 million[39]. Profitability and Loss - GAAP diluted loss per share for Q3 2025 was $10.78, compared to a diluted loss per share of $0.30 in the prior year period[5]. - GAAP net loss for Q3 2025 was $733 million, compared to a net loss of $20 million in the prior year period, including a non-cash goodwill impairment charge of $701 million[5]. - Adjusted net income for the three months ended September 28, 2025, was $54.7 million, with a diluted EPS of $0.80, compared to $57.4 million and $0.85 in the prior year[26]. - Adjusted EBITDA for Q3 2025 was $177 million, compared to $171 million in the prior year period, with an adjusted EBITDA margin of 25%[8]. - Adjusted EBITDA for the three months ended September 28, 2025, was $177.1 million, with an adjusted EBITDA margin of 25.3%[31]. Operational Changes - The company is winding down its U.S. Donor Screening portfolio, impacting overall revenue[5]. - GAAP operating expenses decreased by 6%, driven by cost-savings initiatives[6]. - Cash used for operating activities was $(26.7) million for the nine months ended September 28, 2025, compared to $19.3 million provided in the same period of 2024[23]. - Cash provided by financing activities increased to $166.9 million in the nine months ended September 28, 2025, from $117.7 million in the prior year[23]. Asset and Liability Management - Total assets decreased from $6,423.6 million in December 2024 to $5,675.1 million in September 2025, a decline of approximately 11.6%[21]. - Total current assets increased from $1,218.9 million to $1,366.7 million, representing a growth of about 12.1%[21]. - Long-term borrowings increased from $2,141.3 million in December 2024 to $2,496.5 million in September 2025, an increase of approximately 16.7%[21]. Revenue Breakdown by Region - North America revenues decreased by 12.6% to $381.4 million from $436.2 million, while EMEA revenues increased by 9.3% to $91.8 million[36]. - Respiratory revenues decreased by 32.1% to $112.3 million, while non-respiratory revenues increased by 4.6% to $587.6 million[33]. - Respiratory revenues for the nine months ended September 28, 2025, were $278.8 million, down 22.7% from $360.7 million[37]. - Non-Respiratory revenues for the same period were $1,727.8 million, showing a slight increase of 0.8% compared to $1,714.4 million[37]. Innovation and Growth - The company added high-sensitivity Troponin on its VITROS platform, indicating a focus on innovation and growth[3].

Group 1 - The article discusses the importance of enabling Javascript and cookies in browsers to avoid access issues [1] - It highlights that users with ad-blockers may face restrictions when trying to access content [1]

Core Insights - QuidelOrtho Corporation emphasizes the transformative role of informatics in laboratory operations, enhancing efficiency, data integrity, and patient care [1][2][3] Group 1: Informatics in Clinical Decision-Making - The latest episode of the Science Bytes podcast discusses how informatics platforms connect instruments, data systems, and clinical decisions, evolving from a helpful tool to a critical engine for laboratory efficiency [1] - Informatics is crucial for laboratories to remain agile, secure, and prepared for future demands, particularly as the need for speed and accuracy increases [2] Group 2: Company Overview - QuidelOrtho Corporation is a leading global provider of diagnostic solutions, specializing in clinical chemistry, immunoassay, immunohematology, and molecular testing [3] - The company focuses on delivering fast, accurate, and reliable diagnostic results that improve patient outcomes across various healthcare settings [3] Group 3: Key Features of Informatics - Informatics enables smarter workflows through automation, speeding up results and reducing errors [5] - The systems ensure quality in decentralized testing, providing point-of-care confidence [5] - Built-in security features maintain cyber safety without hindering performance, while trustworthy data tracking ensures full accountability [5]

Core Insights - QuidelOrtho Corporation will report its financial results for Q3 2025 on November 5, 2025, after market close [1] - A conference call to discuss the financial results will take place at 2:00 p.m. PT / 5:00 p.m. ET on the same day [2] - The company is recognized as a global leader in in vitro diagnostics, focusing on advancing diagnostic solutions to improve patient outcomes [4] Financial Reporting - The financial results for the third quarter ended September 28, 2025, will be released after market hours on November 5, 2025 [1] - A conference call will be held to discuss these results, accessible via the company's Investor Relations page [2] Company Overview - QuidelOrtho specializes in various diagnostic fields, including clinical chemistry, immunoassay, immunohematology, and molecular testing [4] - The company aims to deliver fast, accurate, and reliable diagnostic results to enhance patient care across different healthcare settings [4]

Core Insights - QuidelOrtho Corporation showcases its leadership in transfusion medicine with the FDA approval of the MTS DAT Card and the expansion of its immunohematology portfolio at the AABB 2025 Annual Meeting [1][2][3] Product Highlights - The MTS DAT Card completes the gel-based solution for direct antiglobulin testing, enhancing laboratory efficiency and reliability when paired with the ORTHO VISION Platform [2][3] - The ORTHO VISION Max Swift Analyzer is designed for high-throughput labs, offering speed, reliability, and automation with increased sample and reagent capacity [7] - The ORTHO CONNECT Lab Management Software streamlines operations and addresses staffing challenges in laboratory networks [7] Educational Contributions - QuidelOrtho's participation in the AABB Annual Meeting includes sessions on Rh(D) antigen identification, gel test typing for DARA patients, and advanced immunohematology techniques for complex serological cases [3][7]

Core Insights - QuidelOrtho Corporation has launched the QUICKVUE Influenza + SARS Test, a rapid immunoassay designed for professional use in various healthcare settings [1][2][3] - The test allows for rapid detection of influenza A, influenza B, and SARS-CoV-2 from a single sample, providing results within 10 minutes, which aids in differentiating between COVID-19 and seasonal flu [3][7] - The launch is expected to significantly enhance QuidelOrtho's Molecular Diagnostics and Point of Care business units, strengthening its market position [2][4] Company Developments - The QUICKVUE Influenza + SARS Test expands QuidelOrtho's respiratory solutions portfolio and is currently available in the U.S. through existing distribution channels [2][7] - In August, QuidelOrtho reported strong growth in Molecular Diagnostics revenues for Q2 2025, indicating robust performance in this segment [5][8] Industry Prospects - The global point-of-care diagnostics market is projected to grow from $47.8 billion in 2024 to $68.5 billion by 2030, at a CAGR of 5.8%, driven by the demand for immediate results and technological advancements [4] - The recent product launch is anticipated to provide a significant boost to QuidelOrtho's business, capitalizing on the growing market potential [4] Peer Comparison - Qiagen N.V. received CE-IVDR certification for its QIAstat-Dx testing systems, enhancing its diagnostic capabilities [6] - Hologic, Inc. reported strong growth in Diagnostics revenues, driven by increased sales of its assays [7][8] - Thermo Fisher Scientific Inc. also reported robust Specialty Diagnostics revenues and launched new solutions to support clinical laboratories [9]