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NASDAQ: QDEL QuidelOrtho Corp 8-K

QuidelOrtho cuts 2026 guidance on weak respiratory season, China pricing uncertainty

Filed May 5, 2026 · Period ending May 5, 2026 · ~1 min read

5 key changes 3 high relevance 2 sections

Key Changes

  • high

    Full-year 2026 revenue guidance narrowed to $2.70-$2.75B (from $2.7-$2.9B), adjusted EPS cut to $1.80-$2.00 (from $2.00-$2.42), and free cash flow reduced to $100-$120M (from $120-$160M) due to Q1 performance and China market disruption.

    Exhibit 99.1 view on EDGAR →
  • high

    Exhibit 99.1 view on EDGAR →
  • high

    GAAP net loss of $92M ($1.35 per diluted share) versus adjusted EBITDA of $109M; updated guidance includes expected impact from draft China NHSA IVD pricing guidelines, though final impact cannot be assessed until guidelines are confirmed.

    Exhibit 99.1 view on EDGAR →
  • medium

    Completed acquisition of LEX Diagnostics in April 2026, adding ultra-fast molecular diagnostics platform for point-of-care testing to accelerate growth in molecular diagnostics segment.

    Exhibit 99.1 view on EDGAR →
  • medium

    Launched High-Sensitivity Troponin assay in U.S. and rolled out VITROS 450 platform in select international markets to enhance portfolio and drive long-term growth.

    Exhibit 99.1 view on EDGAR →

Summary

QuidelOrtho reported a challenging first quarter and slashed full-year 2026 guidance across all key metrics. Revenue of $620 million fell 10.5% year-over-year, driven by a 34% collapse in Point of Care sales due to a significantly weaker respiratory season compared to Q1 2025.

The Labs segment declined 8% in constant currency, pressured by slower distributor sales in China tied to pending changes in NHSA IVD pricing guidelines—a regulatory overhang the company cannot fully quantify until final rules are published. Additional headwinds included Middle East conflict disruption and the terminated Grifols joint venture. The company posted a $92 million GAAP net loss.

Management cut the revenue midpoint by $100 million, adjusted EPS by 20 cents at the midpoint, and free cash flow by $30 million at the midpoint. The updated guidance explicitly incorporates expected impact from the draft China pricing guidelines, though the company acknowledges uncertainty until implementation details are confirmed. For retail holders, the combination of a weak respiratory season (which may not repeat) and unresolved China regulatory risk creates near-term earnings volatility. The LEX Diagnostics acquisition and new product launches (High-Sensitivity Troponin, VITROS 450) offer growth levers, but the China pricing outcome will materially shape 2026 results and likely remains the key variable to watch through the year.

Section-by-Section Diff

Event · Exhibit 99.1

QuidelOrtho reported Q1 2026 results with revenue of $620M, a GAAP net loss of $92M, and lowered full-year 2026 guidance due to weaker respiratory season and China market disruption.

3 Added
Added Q1 2026 earnings results high

Added in current filing · view on EDGAR →

Total revenue was $620 million, as reported

◦Point of Care revenue of $113 million declined by 34% as reported and 35% in constant currency, primarily due to a significantly weaker respiratory season compared to the first quarter of 2025.

◦Labs revenue of $353 million declined by 5% as reported and 8% in constant currency, primarily due to slower distributor sales in China that the Company believes is related to pending changes to the China National Health Security Administration (“NHSA”) In Vitro Diagnostics (“IVD”) pricing guidelines, business disruption related to the Middle East conflict, and a decrease in revenue related in part to the Company’s termination of its joint business arrangement with Grifols.

◦Immunohematology revenue of $138 million grew 8% as reported and 3% in constant currency, primarily driven by growth in North America, China and JPAC.

•GAAP net loss was $92 million; GAAP operating loss was $32 million; adjusted EBITDA was $109 million.

•GAAP diluted loss per share was $1.35; adjusted diluted loss per share was $0.04.

QuidelOrtho reported Q1 2026 total revenue of $620 million, down 10.5% year-over-year. Point of Care revenue fell 34% due to a weaker respiratory season. Labs revenue declined 5% (8% constant currency) driven by slower China distributor sales tied to pending NHSA pricing guideline changes, Middle East conflict disruption, and the Grifols joint venture termination. Immunohematology grew 8%. The company posted a GAAP net loss of $92 million ($1.35 per diluted share) and adjusted EBITDA of $109 million.

Added Full-year 2026 guidance reduction high

Added in current filing · view on EDGAR → · paraphrased

Full-year 2026 Financial Guidance Updated (as of 5/5/26) Previous (as of 2/11/26)

Total revenues (reported) $2.70 - $2.75 billion $2.7 - $2.9 billion

Adjusted EBITDA $615 - $630 million $630 - $670 million

Adjusted EBITDA margin 23% 23.3%

Adjusted diluted earnings per share $1.80 - $2.00 $2.00 - $2.42

Free cash flow $100 - $120 million $120 - $160 million

QuidelOrtho lowered its full-year 2026 guidance. Total revenue guidance narrowed to $2.70-$2.75 billion (from $2.7-$2.9 billion), adjusted EBITDA to $615-$630 million (from $630-$670 million), adjusted diluted EPS to $1.80-$2.00 (from $2.00-$2.42), and free cash flow to $100-$120 million (from $120-$160 million). The company cited first-quarter performance, current China market dynamics including expected impact from draft NHSA IVD pricing guidelines, and Middle East conflict disruption.

Added China NHSA pricing guideline impact medium

Added in current filing · view on EDGAR →

Considering first-quarter performance and current market dynamics in China, the Company has updated its previously provided financial guidance. This guidance includes expected 2026 impact from the current draft of the China NHSA IVD pricing guidelines. The Company cannot fully assess the impact until the final NHSA guidelines and implementation timelines are confirmed.

QuidelOrtho disclosed that its updated 2026 guidance includes expected impact from the current draft of China NHSA IVD pricing guidelines. The company stated it cannot fully assess the impact until final guidelines and implementation timelines are confirmed. This regulatory uncertainty in China contributed to slower distributor sales in the Labs segment during Q1 2026.

Event · Item 2.02 — Results of Operations and Financial Condition

~100 words

QuidelOrtho announced Q1 2026 financial results via press release and scheduled an earnings call for May 5, 2026.

1 Added
Added Q1 2026 earnings announcement high

Added in current filing · verify on EDGAR →

On May 5, 2026, QuidelOrtho Corporation (“QuidelOrtho”) issued a press release announcing the financial results for its first quarter ended March 29, 2026 and will hold an earnings conference call at 2:00 p.m., Pacific Time, on May 5, 2026 to discuss such results.

QuidelOrtho disclosed its financial results for the first quarter ended March 29, 2026 through a press release. The company scheduled an earnings conference call for the same day at 2:00 p.m. Pacific Time to discuss the quarterly performance. The actual financial metrics are contained in the press release exhibit, not in the 8-K body itself.

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Figures/quotes linked to EDGAR · Narrative written by AI · Jun 26, 2026 · How we verify