QuidelOrtho Cuts 2026 Guidance as China IVD Pricing Headwinds and Soft Respiratory Season Weigh on Diagnostics Business
核心洞察
QuidelOrtho reported second-quarter 2026 total revenue of $631 million, up 3% as reported and 2% in constant currency, with ex-China revenue growing 6%.
China revenue declined 23% year over year as customers reduced inventories ahead of proposed In Vitro Diagnostics (IVD) pricing guidelines, prompting a downward revision of full-year guidance.
The company lowered full-year 2026 revenue guidance to $2.52–$2.60 billion and adjusted EPS to $0.65–$0.90, while withdrawing free-cash-flow guidance amid uncertainty.
QuidelOrtho Corporation (搜索) (Nasdaq: QDEL), a global provider of diagnostic solutions, reported second-quarter 2026 financial results on August 6, 2026, revealing solid underlying growth across its core franchises that was tempered by significant headwinds in China and a softer respiratory testing environment. Total revenue for the quarter ended June 28, 2026 reached $631 million, an increase of 3% as reported and 2% in constant currency, while revenue excluding China grew 6% both as reported and in constant currency.
"While the headline growth rate was affected by continued weakness in China, the underlying second-quarter performance of the business was stronger than the consolidated result would suggest," said Micah Young, Chief Financial Officer. Revenue outside of China, which represents nearly 90% of total company revenue, increased 6% year over year in the second quarter.
Segment and Geographic Performance
The company's diversified portfolio demonstrated broad-based strength across its core franchises. Labs revenue of $383 million grew 4% as reported and 2% in constant currency, driven by continued strength across the core business and partially offset by slower sales in China. Outside of China, Labs revenue grew 9% both as reported and in constant currency.
Immunohematology revenue of $134 million grew 1% both as reported and in constant currency, with ex-China growth reaching 5%. Point of Care revenue of $108 million grew 16% both as reported and in constant currency, including Triage (搜索) revenue growth of 10% as reported and 9% in constant currency.
Geographically, North America — the company's largest region — grew 6% on a constant-currency basis, supported by strength in Labs and Triage (搜索) products. JPAC revenue increased 10% on a constant-currency basis, driven by demand in Japan and India, while Latin America grew 8% with strength in Brazil and Central America.
China Headwinds and IVD Pricing Guidelines
The notable performance exception was China, where revenue declined 23% year over year. Uncertainty related to proposed In Vitro Diagnostics (IVD) pricing guidelines has impacted buying behavior as customers reduce their inventories pending the issuance of final nationwide guidelines.
The second draft of the IVD pricing guidelines, released for comment in late June, differs meaningfully from the preliminary draft issued in March. According to management, the second draft eliminates methodology and use-case differentiation, includes a broader range of products, and increases the pilot implementation scope from three to six provinces.
"Uncertainty regarding the guidelines is already impacting customer behavior," said Brian J. Blaser, President and Chief Executive Officer. "When we reviewed market performance data that became available after quarter-end, we observed customers adjusting their purchasing and inventory levels more quickly and significantly than we had anticipated."
Profitability and Cash Flow
Adjusted EBITDA increased 21% year over year to $129 million, representing a 20.5% margin — an improvement of 310 basis points. Adjusted diluted earnings per share was $0.13, compared to $0.12 in the prior-year period. GAAP net loss was $93 million, with a GAAP operating loss of $22 million.
Adjusted gross margin was 44.4%, down 130 basis points year over year, which management attributed to unfavorable geographic mix associated with lower China volumes. Non-GAAP SG&A and R&D operating expenses combined increased 2% to $219 million.
Operating cash flow was negative $111 million for the quarter, and free cash flow was negative $136 million. The quarter included a $25 million payment to Grifols associated with the termination of a joint business arrangement, with remaining obligations of $25 million in 2027 and $15 million in 2028. The company also deployed $97 million in cash for the Lex acquisition. Net debt leverage stood at 4.3x adjusted EBITDA at quarter-end.
Revised Full-Year 2026 Guidance
Based on current market conditions, QuidelOrtho updated its full-year 2026 guidance. The company now expects revenue in the range of $2.52 billion to $2.60 billion, lowered from the previous range of $2.70 billion to $2.75 billion. Full-year adjusted EBITDA guidance was revised to $540 million to $560 million, representing an expected margin of 21% to 22%, while adjusted EPS guidance was lowered to $0.65 to $0.90 from the previous forecast of $1.80 to $2.00.
The company also withdrew its free-cash-flow guidance. "We are taking a disciplined approach to external cash-flow guidance while remaining intensely focused on execution and strengthening the balance sheet," Young said.
The downward revision reflects two primary factors: expectations that challenges in China will persist through the remainder of the year, and a more prudent approach to respiratory-season assumptions in the second half. Management noted that the adjustment was not driven by changes in expectations for its core laboratory and immunohematology businesses outside of China, for which it assumes approximately 3% to 5% aggregate growth in the second half of 2026.
Respiratory Market and Neulixa Platform
The respiratory market remained softer heading into the summer season, with test positivity rates down markedly compared with 2025. "Early indicators are pointing to a below-average season ahead," Blaser said, citing lower U.S. positivity rates and data from the Southern Hemisphere suggesting either a later start or a softer season.
Amid these challenges, the company highlighted progress on the commercialization of the Lex point-of-care molecular platform, now branded as Neulixa (搜索). Since completing the Lex acquisition in April, QuidelOrtho has advanced manufacturing scale-up, supply-chain readiness, and commercial launch capabilities.
"We believe Neulixa (搜索) addresses an important need in the market by combining molecular accuracy and rapid turnaround time with a simple, efficient workflow at the point of care," Blaser said. The company expects customer placements and test utilization to gain steady momentum as it progresses into the respiratory season later in 2026, with an objective of entering the 2027–2028 respiratory season with a growing installed base.
"Our second-quarter and first-half results outside of China demonstrate the underlying strength of our business, the durability of our customer relationships, and the benefits of our diversified portfolio," Blaser concluded. "Our focus remains on executing with discipline, responding appropriately to current conditions, and positioning QuidelOrtho for stronger, more sustainable performance over the long term."