SAN DIEGO, March 24, 2026 /PRNewswire/ -- QuidelOrtho Corporation (Nasdaq: QDEL) (the "Company" or "QuidelOrtho"), a global leader of in vitro diagnostics, is pleased to announce the appointment of Nathaniel "Nate" Sisitsky as its new Chief Legal Officer, effective March 23, 2026. He will report to Brian Blaser, President and Chief Executive Officer, and will lead QuidelOrtho's global legal, compliance and corporate governance functions. Nathaniel Sisitsky Joins QuidelOrtho as Chief Legal Officer Accessibil ...

Company Overview - QuidelOrtho reported a total revenue of $2.7 billion and a net income of -$1.1 billion for the trailing twelve months (TTM) [4] - The company's market capitalization stands at $1.6 billion, with shares priced at $23.58 as of February 13, 2026 [4] - The stock has decreased by 43.4% over the past year, underperforming the S&P 500 by 55.2 percentage points [7] Business Model and Operations - QuidelOrtho is a global provider of diagnostic solutions, utilizing a diversified product suite across key healthcare testing segments [6] - The company combines proprietary technology, established distribution, and a broad customer base to enhance scale and recurring revenue [6] - It develops and manufactures diagnostic testing technologies across various areas, including labs, transfusion medicine, point-of-care, and molecular diagnostics [8] - Revenue is generated through direct sales and distributor channels, offering instruments, consumables, and diagnostic tests for both professional and over-the-counter use worldwide [8] Recent Developments - Rice Hall James & Associates, LLC acquired 574,877 shares of QuidelOrtho in the fourth quarter, increasing its stake to 1.3% of the fund's reportable assets under management [2][7] - The acquisition reflects a belief that the stock is undervalued despite QuidelOrtho's inconsistent revenue growth and profitability in recent years [9] - Changes in key leadership positions last year may lead to improving financial results, which could attract value investors [9]

QuidelOrtho Conference Call Summary Company Overview - **Company**: QuidelOrtho - **Industry**: Diagnostics and Life Science Tools Key Points and Arguments Market Position and Growth Strategy - QuidelOrtho holds differentiated positions in attractive segments of the diagnostics market, aiming for sustainable long-term growth through innovation, execution, and disciplined capital management [2] - The company services a broad range of testing environments, with over 145,000 instruments installed in 140 countries, generating 55% of revenue from North America [3] - Approximately 96% of revenue is recurring, providing visibility and a strong foundation for margin expansion and cash generation [4] Macro Environment and Demand Drivers - Growth in diagnostic testing is driven by an aging population, decentralization of healthcare, investment in emerging markets, and a focus on wellness and preventative care [4] - The company targets a $50 billion market within the broader IVD market, with its labs business contributing 55% of total revenue and showing mid-single-digit growth [5][6] Product Portfolio and Innovations - The VITROS product line is a key growth driver, with plans to launch the VITROS 450, a modernized system designed for international markets [9] - The immunohematology business leads globally, while the point-of-care segment is valued at $9 billion, with strong positions in respiratory and cardiac testing [6][10] - The molecular diagnostics market is expanding, with the company acquiring Lex Diagnostics to enhance its offerings in this area [7][11] Financial Performance and Guidance - For 2025, QuidelOrtho reported $2.73 billion in revenue, a 5% growth excluding COVID and donor screening revenue, with an adjusted EBITDA margin of 22% [15] - The company expects to generate significantly more cash in 2026, moving from -$77 million to +$140 million, reflecting a $217 million increase [17] - Guidance for 2026 includes expectations for continued growth and margin expansion of around 130 basis points [17] Leadership and Organizational Changes - The company has made significant changes to its leadership team, bringing in new expertise to strengthen its strategy and culture [14] Long-term Outlook - QuidelOrtho aims to achieve a 50% run rate for free cash flow conversion by the second half of 2027, with a target to reduce net debt leverage to 2.5x-3.5x by 2027 [18] - The company is positioned for mid-single-digit growth, supported by strong fundamentals and an expanding product portfolio [19] Additional Important Information - The company emphasizes the importance of customer satisfaction, with a high Net Promoter Score in its labs business [6] - The strategic focus includes organic growth, partnerships, and targeted M&A to drive sustainable long-term growth [14]

Forward-Looking Statements and Non-GAAP Financial Measures Forward-Looking Statements: This presentation of QuidelOrtho Corporation ("QuidelOrtho" or the "Company") contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are any statement contained herein that is not strictly historical, including, but not limited to, QuidelOrtho's commercial and other strategic goals, financial guidance and related assumptions and other future finan ...

Core Insights - Matthew Strobeck, a Board Director at QuidelOrtho Corp., purchased 10,000 common shares for approximately $240,000, indicating confidence in the company's future [1][2]. Transaction Summary - The transaction involved 10,000 shares traded at a value of $239,586, with a reported price of $23.96 per share [2]. - Post-transaction, Strobeck holds 27,775 shares directly, valued at approximately $655,000 based on the market close price of $23.58 on February 13, 2026 [2][4]. - This acquisition represents 13.78% of Strobeck's total reported holdings and 56.26% of his direct stake [4]. Company Overview - QuidelOrtho Corporation is a global diagnostics testing solutions company with a diverse portfolio that includes laboratory, transfusion medicine, point-of-care, and molecular testing platforms [6]. - The company serves a wide range of clients, including healthcare providers, laboratories, blood banks, donor centers, and retail channels globally [6]. Financial Performance - QuidelOrtho reported a revenue of $2.73 billion for the trailing twelve months (TTM) but experienced a net loss of $1.13 billion [5]. - The company has seen a 1.89% year-over-year decline in revenue for Q4 FY 2025, marking the third consecutive year of declining annual revenue [8]. - QuidelOrtho's stock has declined approximately 44.37% over the past year, with a 23% drop so far in 2026 [5][7]. Executive Changes - The company is undergoing significant structural changes, including the retirement of CFO Joseph M. Busky, which necessitates finding a replacement by June [7]. - This follows a period of instability marked by the firing of the previous President and CEO and substantial workforce layoffs [7].

Core Insights - QuidelOrtho Corporation has released a podcast episode discussing the impact of high-sensitivity troponin (hs troponin) on early cardiac diagnosis and emergency department efficiency [1] Group 1: Diagnostic Advancements - High-sensitivity troponin is transforming early cardiac diagnosis, enabling quicker detection of cardiac injury compared to traditional assays [1] - The use of hs troponin supports rapid rule-out of heart attacks through shortened serial testing intervals (0/1 or 0/2 hour protocols), which enhances patient flow in emergency departments [1] - The precision of hs troponin allows clinicians to distinguish true myocardial injury from analytical noise, providing reliable results at low troponin levels [1] Group 2: Broader Applications and Equity - Emerging research is exploring new applications of hs troponin in cardio-oncology, perioperative care, and long-term risk prediction, indicating broader potential for its use [1] - The implementation of sex-specific cutoffs and higher accuracy in hs troponin testing ensures more consistent diagnosis across diverse patient groups, promoting equitable care [1] Group 3: Clinical Context and Outcomes - Combining precision diagnostics with clinical context supports faster and more confident decision-making, ultimately leading to better outcomes for patients with suspected cardiac events [1]

Global Operations and Manufacturing - QuidelOrtho operates globally with manufacturing facilities in the U.S., U.K., and China, serving customers in over 140 countries[16] - The company has a strong commercial footprint with over 2,500 employees in sales, service, and marketing across more than 140 countries[36] - The company’s manufacturing operations are supported by a broad global footprint, with primary facilities located in the U.S. and China[53] - The Summers Ridge facility in San Diego is certified to ISO 13485:2016 and MDSAP medical device standards, focusing on immunoassay reagent manufacturing and producing finished devices[55] - The Athens facility supports the manufacturing of molecular nucleic acid amplification products and is also certified to ISO 13485:2016 and MDSAP medical device standards[56] - The Raritan facility is a CBER licensed biologics/510(k) facility, certified to ISO 13485 and MDSAP medical device standards, and recognized for environmental stewardship[57] - The Rochester facility manufactures slides and fluids for clinical diagnostic assays, certified to ISO 13485:2016 and MDSAP medical device standards[58] - The Pompano Beach facility manufactures immunohematology CAT products for the North American market, also certified to ISO 13485 and MDSAP medical device standards[59] - The Changsha facility manufactures VITROS analyzers for the China market and has obtained ISO 13485 certification[61] Revenue and Business Units - QuidelOrtho's revenue is generated from various business units, including Labs, Transfusion Medicine, Point of Care, and Molecular Diagnostics, with non-core revenue from contract manufacturing and collaborations[18] - The company initiated a wind-down plan for its U.S. donor screening portfolio in February 2024, which is expected to be substantially complete by the first half of 2026, contributing to a decline in revenue[19] - Revenues from respiratory products accounted for approximately 15% of total revenues for the fiscal year ended 2025[68] - A significant portion of revenues is generated from a limited number of customers, with potential adverse effects if key distributor relationships are lost[131] - The company's respiratory products accounted for approximately 15% of total revenues for the year ended December 28, 2025[130] Research and Development - R&D expenses were $186.2 million, $218.7 million, and $245.0 million for fiscal years ended 2025, 2024, and 2023, respectively, indicating a focus on product and technology development[41] - The company aims to increase market share in high-value profit pools and develop new and improved products, including assays and software[43][44] - The company plans to release multiple products within its digital solutions portfolio in 2026, including QuidelOrtho RESULTS MANAGER for Transfusion Medicine and QuidelOrtho AUTOMATION ROUTING Solution[32] Regulatory Compliance and Risks - The FDA may withdraw marketing authorization if compliance with regulatory requirements is not maintained, which could lead to product recalls or fines[81] - Manufacturers must submit a summary of every manufactured lot of product to the FDA for review prior to distribution, and changes to approved products require prior FDA approval[80] - The EU MDR and EU IVDR impose stricter requirements for medical devices, with compliance deadlines that have already passed, affecting market access[86] - Significant expenditures may be required to comply with regulatory requirements, impacting business operations in the EU and other regions[87] - The FDA requires post-market studies to assess product safety and effectiveness after commercialization, which may limit further marketing based on results[81] - The company must maintain compliance with cGMP and other regulatory standards to avoid penalties and ensure product safety[80] - The company is subject to various healthcare-related laws that regulate fraud and abuse, impacting sales and marketing practices[90] - The transition period for certain medical devices under EU regulations is set to end between December 31, 2026, and December 31, 2028, depending on device classification[86] - The company must navigate reimbursement policies from Medicare and Medicaid, which are subject to periodic adjustments due to legislative and budgetary pressures[97] Cybersecurity and IT Risks - The company is highly dependent on IT networks and systems for operations, and any disruptions could lead to significant costs and impact revenue[166] - Cybersecurity risks have increased due to sophisticated malware and hacking tools, necessitating additional resources for mitigation[171] - The company has implemented various security measures to mitigate cybersecurity risks, but complete elimination of such risks is impossible[170] - The company may need to make significant investments to protect its information systems and infrastructure in response to cybersecurity threats[167] Market and Competitive Environment - The company faces risks from a highly competitive industry, including the need to develop new technologies and products to maintain market position[118] - There is a trend toward industry consolidation, which may impact the company's ability to compete effectively in the market[124] - The company is experiencing pressure on pricing and sales due to consolidation among healthcare providers and the formation of group purchasing organizations[154] - The Chinese government's volume-based procurement program may lower prices for certain diagnostic products, affecting revenues and margins in China[154] Employee and Organizational Culture - As of December 28, 2025, the company had approximately 6,500 employees worldwide, with 3,600 in the U.S. and 2,900 outside the U.S.[107] - Approximately 16% of the company's global associates are covered by a union or collective bargaining agreement, with no work stoppages reported to date[107] - The company emphasizes a culture of inclusion and belonging, aiming to attract and retain a diverse workforce to drive innovation and operational execution[108] - Employee benefits include health insurance, retirement plans with employer match, and various voluntary benefits tailored to meet diverse employee needs[111] Environmental and Safety Compliance - The company is committed to environmental sustainability and compliance with health and safety regulations, with a focus on minimizing risks and improving safety across operations[112] - The company is subject to various environmental, health, and safety laws that govern its manufacturing and research activities[96] - Compliance with environmental, health, and safety laws requires significant effort and costs, impacting the company's R&D and manufacturing activities[212] - The company could incur liability for contamination or injury related to hazardous materials, which may negatively impact its financial condition and results of operations[213] Financial and Economic Risks - The company has experienced shortages and delays in raw materials and components, impacting financial results and customer relationships[134] - Incremental costs due to tariffs on imports have been incurred, with ongoing uncertainty about future tariff levels and their impact on financial performance[139] - Macroeconomic conditions, including inflation and unemployment rates, could adversely affect demand for products and services[128] - The implementation of the PAMA provisions has led to lower Medicare reimbursement rates for clinical diagnostic lab tests, impacting revenue potential[150] - The company is facing significant changes in the healthcare industry, including staffing constraints and cost reduction efforts, which could adversely affect its business and financial condition[150] Intellectual Property and Legal Risks - The company actively pursues patent protection for its technologies, with issued patents in the U.S. and internationally, although the outcome of patent applications can be unpredictable[101] - The company is aware of existing patents that may require licensing agreements, which could involve significant costs[104] - Recent changes in patent laws, particularly in Europe, may weaken the company's ability to secure and enforce patents, impacting its competitive position[178] - The company may face increased costs and liabilities due to potential infringement claims from third parties, which could divert management's attention and resources[181] Strategic Initiatives and Future Plans - The company initiated a plan to transition out of its U.S. donor screening portfolio, which is expected to impact growth and margins negatively[157] - An Optimization Plan was launched aiming for approximately $50 million in net cost savings by 2027, with pre-tax charges expected to be around $100 million[158] - The company is incorporating AI into its operations, which may enhance effectiveness but also poses legal and regulatory risks[159]

Core Viewpoint - QuidelOrtho Corporation will present at the 47th Annual Raymond James Institutional Investor Conference on March 3, 2026, highlighting its commitment to advancing diagnostics in healthcare [1]. Company Overview - QuidelOrtho Corporation is a global leader in innovative in vitro diagnostics, specializing in clinical chemistry, immunoassay, immunohematology, and molecular testing [1]. - The company aims to provide fast, accurate, and reliable diagnostic solutions that improve patient outcomes across various healthcare settings [1]. Event Details - The presentation is scheduled for 1:40 p.m. ET / 10:40 a.m. PT, and interested parties can access the live webcast and replay through the company's Investor Relations page [1].

Core Insights - QuidelOrtho (QDEL) has entered a long-term strategic supply agreement with Lifotronic Technology to enhance its global immunoassay portfolio, gaining access to over 70 assays and multiple analyzer platforms [1][6][8] Company Developments - The agreement addresses key menu gaps for QuidelOrtho, strengthening its position in full-service laboratory tenders across Europe, Asia-Pacific, and Latin America [2][4] - The partnership is expected to add more than 25 new assays not currently available on QuidelOrtho's VITROS systems, enhancing its competitive edge in various laboratory settings [6][8] - QuidelOrtho reported Q4 2025 revenues of $723.6 million, reflecting a 2.2% year-over-year increase, with adjusted earnings per share of 46 cents [8][12] Market Position and Trends - QuidelOrtho's market capitalization stands at $1.6 billion, and its stock has gained 3.4% over the last six months, outperforming the industry which declined by 6.9% [5][3] - The global immunoassay analyzers market is projected to grow from $7.2 billion in 2024 to $9.2 billion by 2030, with a CAGR of 4.1% driven by the rising prevalence of chronic diseases [10] - The collaboration with Lifotronic is expected to drive recurring reagent revenue and enhance international revenue diversification, supporting stable growth outside the U.S. market [7]

Core Insights - QuidelOrtho Corporation (QDEL) reported adjusted earnings per share (EPS) of 46 cents for Q4 2025, a decrease from 63 cents year-over-year, but exceeded the Zacks Consensus Estimate by 6.9% [1] - The company registered revenues of $723.6 million in Q4 2025, reflecting a 2.2% year-over-year increase and surpassing the Zacks Consensus Estimate by 3.6% [2] Financial Performance - The GAAP loss per share for Q4 was $1.92, an improvement from a loss of $2.65 in the same quarter last year [1] - Adjusted gross profit declined 1.8% year-over-year to $325.2 million, with an adjusted gross margin contracting by 190 basis points to 44.9% [9] - Adjusted operating profit totaled $89.3 million, down 8.7% from the prior-year quarter, with an adjusted operating margin of 12.3%, a contraction of 150 basis points [10] Revenue Breakdown - Respiratory revenues were $123.3 million, down 13.9% year-over-year, while Non-Respiratory revenues increased to $600.3 million, up 6.3% [2] - Labs revenues reached $389.2 million, an 8.1% increase, while Immunohematology revenues were $141 million, up 3.4% [3][4] - Donor Screening revenues fell significantly to $11.8 million, down 40.1%, and Point of Care revenues declined to $173.1 million, down 6.4% [4] Geographical Performance - North America revenues were $390.1 million, reflecting a decline of 2.4%, while EMEA revenues increased by 9.3% to $92.7 million [6] - Revenues from China amounted to $91.7 million, up 5.5%, and Latin America revenues increased by 22% to $73.2 million [8] Future Guidance - For 2026, QuidelOrtho expects total revenues to be in the range of $2.7 billion to $2.9 billion, with a consensus estimate of $2.71 billion [12] - The company anticipates steady growth in its core Labs business and low-single-digit growth in Immunohematology, while Point-of-Care revenues are expected to remain flat [13][14]