QuidelOrtho — Third Quarter 2026 Earnings Summary

Financial Performance:

• Total revenue was $619 million, a 12% decrease year-over-year (YoY) both as reported and in constant currency.
• Excluding respiratory, China, and the U.S. Donor Screening business, total revenue grew 2% as reported and 3% in constant currency.
• GAAP net loss was $54 million (GAAP net loss margin 8.7%); GAAP operating loss was $8 million (GAAP operating loss margin 1.2%).
• Adjusted EBITDA was $148 million (adjusted EBITDA margin 23.9%), compared to $177 million in the prior year period.
• GAAP diluted loss per share was $0.78; adjusted diluted EPS was $0.31.
• Operating cash flow was $20 million; free cash flow was $0.3 million.
• For the nine months ended September 27, 2026, total revenue was $1.87 billion, GAAP net loss was $238.5 million, and adjusted EBITDA was $386 million.

Guidance and Future Outlook:

• Full-year 2026 total revenue guidance narrowed to $2.52–$2.54 billion (previously $2.52–$2.60 billion).
• Full-year 2026 adjusted EBITDA guidance narrowed to $540–$545 million (previously $540–$560 million).
• Full-year 2026 adjusted EBITDA margin guidance narrowed to approximately 21% (previously 21–22%).
• Full-year 2026 adjusted diluted EPS guidance narrowed to $0.65–$0.70 (previously $0.65–$0.90).
• The company expects to record approximately $30–$35 million in one-time restructuring charges in the fourth quarter of 2026.

Business Segments and Product Lines:

• Labs revenue was $353 million, down 6% YoY; outside China, Labs revenue grew 3% as reported and 4% in constant currency.
• Immunohematology revenue was $142 million, flat as reported and up 1% in constant currency; outside China, it grew 2% as reported and 3% in constant currency.
• Point of Care revenue was $120 million, down 27% YoY, driven by a softer respiratory season.
• Respiratory revenue was $68.8 million, down 38.7% YoY.
• China revenue excluding respiratory was $48.4 million, down 42.7% YoY, impacted by changes to In Vitro Diagnostics pricing.
• U.S. Donor Screening revenue was $1.7 million, down 88.4% YoY.
• Molecular Diagnostics revenue was $2.4 million, down 50.0% YoY.

Market and Competitive Landscape:

• China pricing changes announced by the National Health Security Administration negatively impacted Labs revenue.
• A softer respiratory season negatively impacted Point of Care results.
• Management cited the strength and durability of customer relationships and a large global installed base as supporting factors for underlying business performance.

Risks and Challenges:

• Risks include fluctuations in demand for non-respiratory and respiratory products, supply chain disruptions, and delays in product development or regulatory approvals.
• Potential impacts from changes in reimbursement rates, including reductions by the China National Health Security Administration.
• Macroeconomic, geopolitical, and trade factors, including tariffs and trade policy changes.
• Uncertainty regarding the successful identification, consummation, or realization of benefits from strategic transactions or restructurings.
• Difficulty in forecasting GAAP measures due to the inherent uncertainty of impairment charges and non-recurring adjustments.

Management Commentary and Tone:

• Brian J. Blaser, President and CEO, stated that underlying performance in Labs and Immunohematology remained solid despite headwinds from China and the respiratory season.
• Management described taking "decisive action" through a new cost transformation and enterprise restructuring program to strengthen the company.
• The program aims to improve profitability and cash flow while evolving the operating model around the distinct needs of Core Diagnostics and Point of Care Diagnostics.
• Management expressed belief that these actions will mitigate near-term headwinds and position the company for sustainable long-term growth.

Other Key Points:

• A new cost transformation and enterprise restructuring program is designed to deliver over $80 million in annual savings in 2027.
• The new operating model focuses on increasing customer focus, creating clearer accountability for business performance, and aligning technology development with specific business needs.
• The company will hold a conference call and webcast at 2:00 p.m. PT / 5:00 p.m. ET on November 3, 2026.
• Reconciliation of non-GAAP measures to GAAP is not provided for forward-looking guidance due to the difficulty in reliably predicting impairment charges and tax benefits.