SAN DIEGO, Aug. 28, 2025 /PRNewswire/ -- QuidelOrtho Corporation (Nasdaq: QDEL) (the "Company" or "QuidelOrtho"), a global provider of innovative in vitro diagnostic technologies designed for point-of-care settings, clinical labs and transfusion medicine, announced today that members of its management team will participate in the Baird 2025 Global Healthcare Conference on Wednesday, September 10, 2025. The Company's fireside chat will begin at 3:10 p.m. ET / 12:10 p.m. PT. Interested parties can access the ...

Core Viewpoint - QuidelOrtho Corporation has successfully completed a series of transactions to refinance its debt structure, extending debt maturities and reducing required amortization payments, which supports future growth [1][3]. Summary of New Transactions - The company has secured a $1.15 billion 5-year senior secured Term Loan A, replacing the previous Term Loan A from 2022 [8]. - A $100 million delayed draw Term Loan A has been established, which remains undrawn at the close [8]. - Additionally, a $1.45 billion 7-year senior secured Term Loan B has been arranged [8]. - The refinancing includes a $700 million revolving credit facility that replaces and pays in full the previous credit facility [8]. Financial Strategy - The Chief Financial Officer emphasized that the highest capital allocation priority is to reduce total debt and net debt leverage, improving financial flexibility and cash flow [3]. - The improved debt covenant terms and reduced amortization requirements will provide greater options for funding continued business growth [3].

Key points from Dr. Temte's discussion include: This episode reflects QuidelOrtho's commitment to equipping healthcare providers and the public with timely, actionable information. By highlighting expert insights and practical solutions, QuidelOrtho aims to reduce illness spread and safeguard community health. The QuidelOrtho Science Bytes podcast is available on major streaming platforms and at: https://www.quidelortho.com/global/en/resources/podcasts/quidelortho-science-bytes. About QuidelOrtho Corporatio ...

Core Insights - QuidelOrtho Corporation has appointed Erich Wolff as Executive Vice President, Strategy & Corporate Development, to lead enterprise strategy and business development [1][2] - Mr. Wolff has over 20 years of experience in strategy, M&A, and business development in the healthcare and diagnostics sectors [2][3] - The company aims to leverage Mr. Wolff's expertise to enhance its growth strategies and deliver long-term value [3][4] Company Overview - QuidelOrtho is a global leader in in vitro diagnostics, focusing on developing intelligent diagnostic solutions [6][7] - The company provides fast, accurate, and reliable diagnostics across various settings, including home, hospital, lab, and clinic [7] - QuidelOrtho emphasizes innovation and collaboration with global healthcare customers to advance diagnostic capabilities [7]

Core Insights - QuidelOrtho aims to enhance diagnostic excellence by repurposing and certifying high-performing analyzers to improve access to reliable diagnostic technology for healthcare facilities in underserved communities [1][3] - The certification process for analyzers includes over 140 system checks, functional adjustments, hardware cleaning or replacement, and extensive performance testing, ensuring alignment with QuidelOrtho's quality and performance criteria [1][2] - The program features certified VITROS XT 7600 and 5600 Integrated Systems and the VITROS 3600 Immunodiagnostic System, designed to support community labs with general chemistries, immunoassay tests, and drug screening [2] Company Overview - QuidelOrtho Corporation (Nasdaq: QDEL) is a leader in in vitro diagnostics, focusing on developing intelligent solutions that transform data into actionable insights for a broader audience [4] - The company specializes in immunoassay and molecular testing, clinical chemistry, and transfusion medicine, providing fast, accurate, and reliable diagnostics across various settings [4][5] - QuidelOrtho is committed to advancing diagnostics and improving healthcare outcomes through innovation and collaboration with global healthcare customers [5]

Core Insights - QuidelOrtho Corporation (QDEL) reported adjusted earnings per share (EPS) of $0.12 for Q2 2025, reversing a loss of $0.07 from the previous year and exceeding the Zacks Consensus Estimate of breakeven [1][6] - The company experienced a revenue decline of 3.6% year-over-year, totaling $613.9 million, but this figure surpassed the Zacks Consensus Estimate by 0.4% [2][6] - QDEL's shares rose nearly 12.8% in after-market trading, although they have decreased 46.8% year-to-date compared to a 4.9% increase in the industry [3] Revenue Breakdown - Respiratory revenues fell to $46.7 million, down 19.5% year-over-year, while Non-Respiratory revenues were $567.2 million, down 2% [2] - Revenue contributions from various business units included Labs at $369.7 million (up 4.4%), Immunohematology at $132.3 million (up 4.3%), and Donor Screening at $13.3 million (down 61.2%) [7][8] Geographical Performance - North America revenues were $310.7 million, reflecting an 11.3% decline, while EMEA revenues increased by 7.6% to $87.3 million [9][10] - Revenues from China were $83.4 million (up 2.2%), and Other regions contributed $132.5 million (up 6.7%) [10] Margin and Cost Management - Adjusted gross margin improved by 150 basis points to 45.7%, with adjusted operating margin increasing by 420 basis points to 9.8% [6][12] - Adjusted operating profit rose by 67.7% year-over-year to $60.2 million, while adjusted selling, marketing, and administrative expenses decreased by 5.9% [11][12] Financial Position - QuidelOrtho ended Q2 2025 with cash and cash equivalents of $151.7 million, up from $127.1 million at the end of Q1 [13] - Total debt increased to $2.61 billion from $2.49 billion in the previous quarter [13] Guidance and Future Outlook - The company reaffirmed its 2025 revenue guidance of $2.60 billion to $2.81 billion, with a consensus estimate of $2.72 billion [15][16] - QDEL anticipates stable growth across most business lines, particularly in Labs and Immunohematology, with expected COVID-19 revenues between $110 million and $140 million [17][21] - Management expects a gross tariff impact of $20–$25 million in 2025, reduced from previous estimates due to effective mitigation strategies [20]

QuidelOrtho (QDEL -1.78%), a global provider of diagnostic testing solutions, released its financial results for the quarter ended June 29, 2025, on August 5, 2025. The most notable headline was a return to positive adjusted earnings per share (non-GAAP) and improved adjusted profit margins (non-GAAP), even amid continued year- over-year revenue decline. Reported GAAP revenue of $614 million beat analyst consensus of $611.1 million, and Adjusted non-GAAP earnings per share came in at $0.12, far exceeding th ...

PART I—FINANCIAL INFORMATION [ITEM 1. Financial Statements](index=3&type=section&id=ITEM%201.%20Financial%20Statements) QuidelOrtho reported a widened net loss in Q2 2025, reflecting asset decrease and significant restructuring charges [Consolidated Financial Statements](index=3&type=section&id=Consolidated%20Financial%20Statements) This section presents key financial performance, balance sheet, and cash flow summaries Key Financial Performance (Q2 & YTD 2025 vs 2024) | Metric | Three Months Ended June 29, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 29, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | **Total Revenues** | $613.9M | $637.0M | $1,306.7M | $1,348.0M | | **Operating Loss** | $(180.7)M | $(117.5)M | $(148.1)M | $(1,875.5)M | | **Net Loss** | $(255.4)M | $(147.7)M | $(268.1)M | $(1,853.7)M | | **Diluted Loss Per Share** | $(3.77) | $(2.20) | $(3.97) | $(27.67) | Consolidated Balance Sheet Summary | Account | June 29, 2025 | December 29, 2024 | | :--- | :--- | :--- | | **Total Current Assets** | $1,281.5M | $1,218.9M | | **Total Assets** | $6,379.1M | $6,423.6M | | **Total Current Liabilities** | $1,142.1M | $998.8M | | **Total Liabilities** | $3,586.4M | $3,439.1M | | **Total Stockholders' Equity** | $2,792.7M | $2,984.5M | Consolidated Cash Flow Summary (Six Months Ended) | Cash Flow Activity | June 29, 2025 | June 30, 2024 | | :--- | :--- | :--- | | **Net cash from operating activities** | $18.8M | $(98.6)M | | **Net cash used for investing activities** | $(89.2)M | $(55.5)M | | **Net cash from financing activities** | $120.9M | $144.0M | | **Net increase (decrease) in cash** | $53.2M | $(12.0)M | [Note 3. Revenue](index=9&type=section&id=Note%203.%20Revenue) This note details revenue breakdown by business unit and highlights significant customer concentration Revenue by Business Unit (Three Months Ended) | Business Unit | Q2 2025 Revenue | Q2 2024 Revenue | % Change | | :--- | :--- | :--- | :--- | | Labs | $369.7M | $354.2M | +4.4% | | Immunohematology | $132.3M | $126.9M | +4.3% | | Donor Screening | $13.3M | $34.3M | -61.2% | | Point of Care | $93.0M | $117.2M | -20.6% | | Molecular Diagnostics | $5.6M | $4.4M | +27.3% | | **Total Revenues** | **$613.9M** | **$637.0M** | **-3.6%** | - For the six months ended June 29, 2025, one customer represented **11% of total revenues**[38](index=38&type=chunk) [Note 4. Segment and Geographic Information](index=10&type=section&id=Note%204.%20Segment%20and%20Geographic%20Information) This note provides a breakdown of revenue and Adjusted EBITDA by geographic segment Segment Revenue (Three Months Ended) | Segment | Q2 2025 Revenue | Q2 2024 Revenue | % Change | | :--- | :--- | :--- | :--- | | North America | $310.7M | $350.1M | -11.3% | | EMEA | $87.3M | $81.1M | +7.6% | | China | $83.4M | $81.6M | +2.2% | | Other | $132.5M | $124.2M | +6.7% | Segment Adjusted EBITDA (Three Months Ended) | Segment | Q2 2025 Adj. EBITDA | Q2 2024 Adj. EBITDA | % Change | | :--- | :--- | :--- | :--- | | North America | $159.7M | $185.6M | -14.0% | | EMEA | $18.3M | $12.1M | +51.2% | | China | $42.1M | $35.7M | +17.9% | | Other | $37.9M | $34.0M | +11.5% | [Note 7. Borrowings](index=15&type=section&id=Note%207.%20Borrowings) This note details the company's borrowing components and compliance with financial covenants Components of Borrowings | Component | June 29, 2025 | December 29, 2024 | | :--- | :--- | :--- | | Term Loan | $2,213.9M | $2,282.7M | | Revolving Credit Facility | $390.0M | $198.0M | | **Total Borrowings** | **$2,606.3M** | **$2,483.1M** | - As of June 29, 2025, availability under the Revolving Credit Facility was **$397.3 million**[57](index=57&type=chunk) - The company was in compliance with all financial covenants[58](index=58&type=chunk) [Note 9. Commitments and Contingencies](index=16&type=section&id=Note%209.%20Commitments%20and%20Contingencies) This note outlines ongoing legal proceedings, including class action and derivative lawsuits, with no estimable loss - The company is defending a putative class action lawsuit filed in April 2024, alleging violations of federal securities laws related to statements about COVID-19 diagnostic test sales and the Savanna RVP4 assay[60](index=60&type=chunk) - Two related stockholder derivative complaints were also filed and have been consolidated and stayed[61](index=61&type=chunk) - The company disputes all allegations and cannot estimate a possible range of loss[62](index=62&type=chunk) [Note 13. Restructuring, Integration and Other Charges](index=21&type=section&id=Note%2013.%20Restructuring,%20Integration%20and%20Other%20Charges) This note details significant Q2 2025 restructuring charges from the Optimization Plan and Savanna platform discontinuation - The company recorded **$178.9 million** in restructuring charges in Q2 2025, primarily related to a new 'Optimization Plan' and the discontinuation of the Savanna platform development ('Savanna Exit')[81](index=81&type=chunk)[83](index=83&type=chunk) Q2 2025 Restructuring Charges Breakdown | Charge Category | Amount (in millions) | | :--- | :--- | | Provision for restructuring (Optimization Plan) | $6.6 | | Savanna exit charges | $149.6 | | Integration expenses & other | $23.7 | | **Total Charges** | **$179.9** | - The Optimization Plan is expected to incur cumulative pretax charges of approximately **$100 million** through 2027[82](index=82&type=chunk) [ITEM 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=23&type=section&id=ITEM%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses revenue decline, strategic initiatives, improved operating loss, and liquidity position [Overview](index=23&type=section&id=Overview) This section summarizes financial performance, strategic initiatives, and key operational changes - Six-month 2025 revenues decreased **3%** to **$1.31 billion**, primarily due to lower COVID-19 revenues and the planned wind-down of the U.S. donor screening portfolio[91](index=91&type=chunk)[92](index=92&type=chunk) - In Q2 2025, the company launched a multi-year 'Optimization Plan' to realign costs, expecting to incur ~**$100 million** in charges through 2027 to achieve ~**$50 million** in net savings[93](index=93&type=chunk) - The company announced a strategic refocus of its Molecular Diagnostics business, which includes discontinuing the development of the Savanna platform[94](index=94&type=chunk) [Results of Operations](index=25&type=section&id=Results%20of%20Operations) This section analyzes revenue, cost of sales, and significant charges impacting operating results - Q2 2025 total revenues decreased **4%** YoY to **$613.9 million**, driven by a **61%** decline in Donor Screening and a **21%** decline in Point of Care revenue[102](index=102&type=chunk)[103](index=103&type=chunk) - Cost of sales as a percentage of revenue improved to **55.2%** in Q2 2025 from **56.7%** in Q2 2024, driven by procurement-related cost savings[106](index=106&type=chunk) - Restructuring, integration and other charges increased significantly to **$178.9 million** in Q2 2025 from **$30.9 million** in Q2 2024, due to the Optimization Plan and Savanna Exit[114](index=114&type=chunk) - The company recognized a non-cash goodwill impairment charge of **$1.7 billion** in the first six months of 2024, which did not recur in 2025[115](index=115&type=chunk) [Segment Results](index=28&type=section&id=Segment%20Results) This section details revenue and Adjusted EBITDA performance across geographic segments Q2 2025 vs Q2 2024 Segment Performance | Segment | Revenue Change | Adjusted EBITDA Change | | :--- | :--- | :--- | | **North America** | -11% | -14% | | **EMEA** | +8% | +51% | | **China** | +2% | +18% | | **Other** | +7% | +11% | - The decrease in North America was primarily driven by the wind-down of the U.S. donor screening business and lower sales of QuickVue and Sofia SARS Antigen assays[124](index=124&type=chunk) [Liquidity and Capital Resources](index=29&type=section&id=Liquidity%20and%20Capital%20Resources) This section assesses cash position, operating cash flow, and available credit for future funding needs Liquidity Position | Source | June 29, 2025 | December 29, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $151.7M | $98.3M | | Available Revolving Credit | $397.3M | $589.0M | - For the first six months of 2025, net cash provided by operating activities was **$18.8 million**, a significant improvement from the **$98.6 million** used in the same period of 2024[144](index=144&type=chunk)[145](index=145&type=chunk) - The company believes current cash, cash from operations, and available credit will be sufficient to fund needs for at least the next 12 months[150](index=150&type=chunk) [ITEM 3. Quantitative and Qualitative Disclosures About Market Risk](index=32&type=section&id=ITEM%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) No material change in market risk exposure from the 2024 Annual Report was reported - There has been no material change in the company's exposure to market risk from that described in its Annual Report[159](index=159&type=chunk) [ITEM 4. Controls and Procedures](index=32&type=section&id=ITEM%204.%20Controls%20and%20Procedures) Disclosure controls were ineffective due to material weaknesses, with remediation and SAP ERP implementation ongoing - The CEO and CFO concluded that disclosure controls and procedures were not effective as of June 29, 2025, due to previously reported material weaknesses in internal control over financial reporting[160](index=160&type=chunk) - Remediation efforts to address the material weaknesses are ongoing[162](index=162&type=chunk) - In June 2025, the company began migrating certain financial processing systems to a new SAP ERP system as part of its global integration efforts[163](index=163&type=chunk) PART II—OTHER INFORMATION [ITEM 1. Legal Proceedings](index=33&type=section&id=ITEM%201.%20Legal%20Proceedings) This section incorporates Note 9, detailing ongoing legal proceedings including class action and derivative lawsuits - Information regarding legal proceedings is incorporated by reference from Part I, Item 1, 'Financial Statements—Note 9. Commitments and Contingencies'[165](index=165&type=chunk) [ITEM 1A. Risk Factors](index=33&type=section&id=ITEM%201A.%20Risk%20Factors) No material changes to risk factors previously disclosed in the Annual Report on Form 10-K - There has been no material change in the company's risk factors as previously disclosed in its Annual Report[166](index=166&type=chunk) [Other Items (2, 3, 4, 5, 6)](index=33&type=section&id=Other%20Items%20(2,%203,%204,%205,%206)) No unregistered sales, issuer repurchases, or defaults on senior securities were reported, with exhibits provided - The company reported no unregistered sales of equity securities, issuer purchases of equity securities, or defaults upon senior securities[167](index=167&type=chunk)[168](index=168&type=chunk)[169](index=169&type=chunk) - Item 6 provides a list of exhibits filed with the Form 10-Q, including certifications and financial statements in Inline XBRL format[173](index=173&type=chunk)

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]

August 5, 2025 QuidelOrtho Second Quarter 2025 Financial Results QuidelOrtho – Proprietary & Confidential. | © 2025. All Rights Reserved. 2 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, includin ...