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]

Core Viewpoint - The Meridian Contrarian Fund reported a strong performance in Q2 2025, with a return of 16.42%, outperforming the Russell 2500 Index and the Russell 2500 Value Index, amidst a significant recovery in the U.S. equity market, which rose 23% during the quarter [1] Group 1: Fund Performance - The U.S. large-cap stocks gained 11.1% in Q2 2025, with growth stocks outperforming value stocks [1] - The Meridian Contrarian Fund's return of 16.42% (net) exceeded the Russell 2500 Index's return of 8.59% and the Russell 2500 Value Index's return of 7.29% [1] Group 2: QuidelOrtho Corporation (NASDAQ:QDEL) - QuidelOrtho Corporation is a diagnostic testing solutions provider, with a one-month return of -7.51% and a 52-week loss of 41.75%, closing at $26.53 per share on September 25, 2025, with a market capitalization of $1.802 billion [2] - The Meridian Contrarian Fund invested in QuidelOrtho following its merger with Ortho Clinical Diagnostics, believing it positioned the company for improved growth and margins [3] - Despite the company's earnings being in line with expectations, broader macro concerns affected its stock performance, particularly in the respiratory business and potential funding cuts in government health programs [3] Group 3: Hedge Fund Interest - QuidelOrtho Corporation was held by 31 hedge fund portfolios at the end of Q2 2025, a decrease from 32 in the previous quarter [4] - The company reported Q2 revenue of $614 million, down from $637 million in the prior year [4]

Core Viewpoint - QuidelOrtho Corporation is expanding its QUICKVUE portfolio with the introduction of the QUICKVUE Influenza + SARS Test, aimed at enhancing point-of-care diagnostic testing capabilities for respiratory illnesses [1][3]. Product Features and Benefits - The QUICKVUE Influenza + SARS Test allows for rapid, simultaneous detection of influenza A, influenza B, and SARS-CoV-2 antigens from a single patient sample, providing results in as fast as 10 minutes [2][5]. - This test is designed for use in various healthcare settings, including physician office laboratories, urgent care centers, emergency departments, and pharmacies, facilitating timely treatment decisions and improved patient outcomes [2][3]. - The test is a CLIA-waived, 510(k)–cleared immunoassay, emphasizing its reliability and efficiency in differentiating between COVID-19 and seasonal flu infections [1][3]. Market Position and Strategy - The launch of the QUICKVUE Influenza + SARS Test reinforces QuidelOrtho's leadership in point-of-care respiratory testing and expands its portfolio of respiratory solutions [3][4]. - The company aims to provide healthcare professionals with cost-effective solutions that streamline clinical decisions and manage seasonal surges in respiratory infections [3][4]. - QuidelOrtho's commitment to innovation is evident in its continuous development of diagnostic solutions that improve patient outcomes across various healthcare settings [4].

QuidelOrtho Conference Call Summary Company Overview - **Company**: QuidelOrtho (NasdaqGS: QDEL) - **Date**: September 10, 2025 - **Key Speaker**: Joe Buske, CFO Key Industry Insights Financial Performance - **Q2 Highlights**: Achieved 400+ basis points margin improvement compared to the previous year, marking two consecutive strong quarters in 2025 [2][3] - **Revenue Growth**: Base business continues to grow at a mid-single digit rate, particularly in labs and immunohematology [4] Strategic Decisions - **Manufacturing Facility Closure**: Decision to close a large manufacturing facility in Raritan, New Jersey, aimed at enhancing operating margins in the coming years [3] - **Product Development Shift**: Transition from Savannah molecular product development to acquiring Lex, a UK-based business, pending FDA approval for a respiratory panel [3][11] Market Positioning - **Lab Strategy**: Focus on small to mid-sized hospitals and labs, utilizing integrated analyzers for routine chemistry and immunoassays, which has proven effective [5][7] - **Automation Growth**: Integrated analyzers have seen high single-digit to low double-digit growth, indicating successful implementation of automation strategies [7][8] Regional Growth Opportunities - **Emerging Markets**: High single-digit to low double-digit growth expected in less developed regions such as Latin America and Asia Pacific, compared to low to mid-single digit growth in developed markets [9] Product Development and Future Outlook Lex Acquisition - **Strategic Rationale**: Pivoting to Lex due to its competitive advantages in turnaround time, ease of use, and cost-effectiveness compared to Savannah [11] - **Expansion Plans**: Focus on adding RSV and strep to the respiratory panel, with further opportunities in women's health and STIs [13] COVID-19 Revenue Trends - **Revenue Decline**: COVID revenue has significantly decreased from $1.4 billion in 2021 to an expected $70-100 million in 2025, with a stable professional use space revenue [18][19] Flu Season Expectations - **Flu Revenue Guidance**: Anticipating a typical flu season with projected volumes of 50-55 million tests, maintaining steady market share [20][21] Challenges and Risks Transfusion Medicine Business - **Business Wind Down**: The donor screening business is being phased out, with expected revenue dropping from $120 million last year to $40-50 million this year [23][24] China Market Dynamics - **Resilience Against Headwinds**: QuidelOrtho's unique dry slide technology has insulated it from some of the volume-based procurement initiatives affecting competitors [28][29] - **Long-term Growth Potential**: Despite complexities, the company sees opportunities for growth in the immunoassay business in China [31] Margin Improvement and Financial Strategy EBITDA Margin Goals - **Targeted Growth**: Aiming for adjusted EBITDA margins in the mid to high 20% range by mid-2027, up from 22% this year [32][34] - **Cost Reduction Initiatives**: Significant staffing reductions and indirect procurement initiatives are expected to yield substantial savings [33][34] Debt Management - **Debt Refinancing Benefits**: Recent refinancing has improved maturity profiles and financial covenants, providing more flexibility [36][37] - **Leverage Ratio Goals**: Targeting a leverage ratio of 2.5 to 3.5 by 2026, aligning with margin improvement timelines [39][40] Conclusion - **Opportunities**: The Lex product is viewed as the most significant growth opportunity in the near term [46] - **Challenges**: Ongoing macroeconomic conditions pose challenges to margin improvement and debt reduction goals [48] - **Stable Base Business**: The labs and immunohematology segments represent a stable revenue foundation, contributing to predictable growth [50][51]