Form 8-K
8-K — QuidelOrtho Corp
Accession: 0001906324-26-000023
Filed: 2026-05-05
Period: 2026-05-05
CIK: 0001906324
SIC: 2835 (IN VITRO & IN VIVO DIAGNOSTIC SUBSTANCES)
Item: Results of Operations and Financial Condition
Item: Financial Statements and Exhibits
Documents
8-K — qdel-20260505.htm (Primary)
EX-99.1 (qdel3292026ex991earningsre.htm)
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8-K
8-K (Primary)
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qdel-20260505
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported): May 5, 2026
QUIDELORTHO CORPORATION
(Exact name of Registrant as specified in its Charter)
Delaware
001-41409
87-4496285
(State or other jurisdiction of incorporation)
(Commission File Number)
(IRS Employer Identification No.)
9975 Summers Ridge Road, San Diego, California 92121
(Address of principal executive offices, including zip code)
(858) 552-1100
(Registrant’s telephone number, including area code)
N/A
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the Registrant under any of the following provisions (see General Instruction A.2. below):
☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
Title of each class Trading symbol(s) Name of each exchange on which registered
Common Stock, $0.001 Par Value QDEL The Nasdaq Stock Market
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
☐
Item 2.02 Results of Operations and Financial Condition.
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. A copy of the press release is furnished with this Current Report on Form 8-K (“Form 8-K”) as Exhibit 99.1.
The information in this Form 8-K, including Exhibit 99.1, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, regardless of any general incorporation language in such filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
The following exhibit is furnished with this Form 8-K:
Exhibit Number Description of Exhibit
99.1
Press release, dated May 5, 2026, reporting QuidelOrtho Corporation's financial results for its first quarter ended March 29, 2026.
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Date: May 5, 2026
QUIDELORTHO CORPORATION
By: /s/ Joseph M. Busky
Name: Joseph M. Busky
Its: Chief Financial Officer
EX-99.1
EX-99.1
Filename: qdel3292026ex991earningsre.htm · Sequence: 2
Document
Exhibit 99.1
QuidelOrtho Reports First Quarter 2026 Financial Results
― LEX Diagnostics Acquisition Expected to Accelerate Growth in Point-of-Care Molecular Diagnostics ―
― Key Product Launches in U.S. and International Markets Expected to Drive Future Growth ―
― Company Updates Full-Year 2026 Financial Guidance ―
May 5, 2026
SAN DIEGO, CA May 5, 2026 — QuidelOrtho Corporation (Nasdaq: QDEL) (the “Company” or “QuidelOrtho”), a global leader of innovative in vitro diagnostics, today announced financial results for the first quarter ended March 29, 2026.
Key First Quarter 2026 Results:
(all comparisons are to the prior year period)
•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.
“Our first quarter results were in line with our preliminary revenue announcement and reflected a significantly weaker respiratory season and business disruption in China and the Middle East,” said Brian J. Blaser, President and Chief Executive Officer of QuidelOrtho. “Importantly, we believe the underlying business remains strong and we are well positioned to deliver on our objectives to expand our adjusted EBITDA margin and improve cash flow in 2026.”
“We completed our acquisition of LEX Diagnostics in April, adding an ultra-fast molecular diagnostics platform for point-of-care testing. We also advanced our key strategic priorities, including the U.S. launch of our High-Sensitivity Troponin assay and the rollout of the VITROS 450 platform in select international markets. We believe these innovations enhance our portfolio and position us to drive sustainable, long-term growth,” Blaser continued.
Full-year 2026 Financial Guidance
The Company provided its initial financial guidance for full-year 2026 on February 11, 2026. On April 15, 2026, the Company announced preliminary revenue for the first quarter 2026 and indicated that the low end of its full-year 2026 financial guidance ranges remained achievable. 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. In addition, this guidance does not assume a significant, prolonged impact related to the Middle East conflict.
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
Please see page 6 of the First Quarter 2026 Financial Results presentation on the “Investor Relations” page of the Company’s website for the full list of assumptions on which the Company’s current 2026 financial guidance is based.
A reconciliation of forward-looking non-GAAP measures, including adjusted EBITDA, adjusted EBITDA margin, adjusted diluted earnings per share and free cash flow, to the most directly comparable GAAP measures is not provided because comparable GAAP measures for such measures are not reasonably accessible or reliable due to the inherent difficulty in forecasting and quantifying measures that would be necessary for such reconciliation. We are not, without unreasonable effort, able to reliably predict the impact of impairment charges and related tax benefits and other non-recurring adjustments. These items are uncertain, depend on various factors and may have a material impact on our future GAAP results. In addition, the Company believes any such reconciliation would imply a degree of precision and certainty that could be confusing to investors. See "Forward-Looking Statements" and "Non-GAAP Financial Measures."
Conference Call Information
Following the release of financial results, QuidelOrtho will hold a conference call today beginning at 2:00 p.m. PT / 5:00 p.m. ET to discuss its financial results. Interested parties can access the call from the “Events & Presentations” section of the “Investor Relations” page of the Company’s website at https://ir.quidelortho.com. Presentation materials will also be posted to the “Events & Presentations” section of the “Investor Relations” page of the Company’s website at the time of the call.
A replay of the conference call will be available shortly after the event on the “Investor Relations” page of the Company’s website under the “Events & Presentations” section.
QuidelOrtho is dedicated to advancing diagnostics to power a healthier future. For more information, please visit quidelortho.com and follow QuidelOrtho on LinkedIn, Facebook and X.
About QuidelOrtho Corporation
With expertise spanning clinical chemistry, immunoassay, immunohematology and molecular testing, QuidelOrtho Corporation (Nasdaq: QDEL) is a leading global provider of diagnostic solutions, dedicated to advancing fast, accurate and reliable results that help improve patient outcomes – from the point of care to hospital, lab to clinic. Building on a legacy of innovation, QuidelOrtho works with healthcare providers to advance diagnostics that connect insights with solutions, defining a clearer path for informed decisions and better care.
Forward-Looking Statements
This press release 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 for 2026 and related assumptions and other future financial condition and operating results, including growth expectations and expected results of operations, financial position or cost-savings and operational improvement initiatives, and other future plans, objectives, strategies, expectations and intentions. Without limiting the foregoing, the words “may,” “will,” “could,” “would,” “should,” “might,” “expect,” “anticipate,” “believe,” “estimate,” “plan,” “intend,” “goal,” “project,” “strategy,” “future,” “continue,” “aim,” “strive,” “seek” or similar words, expressions or the negative of such terms or other comparable terminology are intended to identify forward-looking statements. Such statements are based on the beliefs and expectations of QuidelOrtho’s management as of the date of this press release and are subject to significant known and unknown risks and uncertainties. Actual results or outcomes may differ significantly from those set forth or implied in the forward-looking statements.
The following factors, among others, could cause actual results or outcomes to differ from those set forth or implied in the forward-looking statements: fluctuations in demand for QuidelOrtho’s non-respiratory and respiratory products; supply chain, production, logistics, distribution and labor disruptions and challenges; inability to successfully identify, consummate or realize the anticipated benefits of strategic transactions, strategic restructurings, divestitures, spin-offs or discontinuances of certain business operations, or debt financings, on the anticipated timelines, or at all; delays in the development of or failures or delays in the receipt of approvals for new or enhanced products; failure of new products and services to be commercially viable or accepted; changes in reimbursement rates for our products, including reimbursement rate reductions proposed by the China NHSA; disruptions and challenges related to the ongoing conflicts in the Middle East; and other macroeconomic, geopolitical, market, business, competitive and/or regulatory factors affecting the business of QuidelOrtho generally, including those arising from the effects of announced or future or amended tariffs, trade policies, investigations, global trade relations and other tariff-related developments, as well as those discussed in QuidelOrtho’s Annual Report on Form 10-K for the fiscal year ended December 28, 2025 and subsequent reports filed with the Securities and Exchange Commission (the “Commission”), including under Part I, Item 1A, “Risk Factors” of the Form 10-K. You should not rely on forward-looking statements as predictions of future events because these statements are based on assumptions that may not come true and are speculative by their nature. All forward-looking statements are based on information currently available to QuidelOrtho and speak only as of the date of this press release. QuidelOrtho undertakes no obligation to update any of the forward-looking information or time-sensitive information included in this press release, whether as a result of new information, future events, changed expectations or otherwise, except as required by law.
Non-GAAP Financial Measures
This press release contains financial measures that are considered non-GAAP financial measures under applicable rules and regulations of the Commission, including but not limited to “constant currency Point of Care revenue changes,” “constant currency Labs revenue changes,” “constant currency Immunohematology revenue changes,” “adjusted EBITDA,” “adjusted EBITDA margin,” “adjusted diluted loss per share,” “free cash flow” and other non-GAAP financial measures included in the reconciliation tables accompanying this press release. These non-GAAP financial measures should be considered supplemental to, and not a substitute for, financial information prepared in accordance with U.S. generally accepted accounting principles (“GAAP”). These non-GAAP financial measures eliminate impacts of certain non-cash, unusual or other items that the Company does not consider indicative of its ongoing operating performance, and the Company generally uses these non-GAAP financial measures to facilitate management’s financial and operational decision-making, including evaluation of the Company’s historical operating results and comparison to competitors’ operating results. The Company’s definitions of these non-GAAP measures may differ from similarly titled measures used by others. These non-GAAP financial measures reflect an additional way of viewing aspects of the Company’s operations that, when viewed with GAAP results and the reconciliations to corresponding GAAP financial measures, may provide a more complete understanding of factors and trends affecting the Company’s business. Because non-GAAP financial measures exclude the effect of items that will increase or decrease the Company’s reported results of operations, management strongly encourages investors to review the Company’s consolidated financial statements and reports filed with the Commission in their entirety. Reconciliations of the historical non-GAAP financial measures to the most directly comparable GAAP financial measures are included in the tables accompanying this press release.
Investor Contact:
Juliet Cunningham
Vice President, Investor Relations
IR@QuidelOrtho.com
Media Contact:
Stephanie Kleewein
Senior Corporate Communications and PR Manager
media@QuidelOrtho.com
QuidelOrtho
Consolidated Statements of Loss
(Unaudited)
(In millions, except per share data)
Three Months Ended
March 29, 2026 March 30, 2025
Total revenues $ 619.8 $ 692.8
Cost of sales, excluding amortization of intangibles 356.0 349.5
Selling, marketing and administrative 199.3 187.0
Research and development 44.9 53.2
Amortization of intangible assets 46.8 48.0
Restructuring, integration and other charges 4.4 16.1
Other operating expenses 0.2 6.4
Operating (loss) income (31.8) 32.6
Interest expense, net 51.1 40.0
Other (income) expense, net (3.4) 1.4
Loss before income taxes (79.5) (8.8)
Provision for income taxes 12.3 3.9
Net loss $ (91.8) $ (12.7)
Basic loss per share $ (1.35) $ (0.19)
Diluted loss per share $ (1.35) $ (0.19)
Weighted-average shares outstanding - basic 68.2 67.5
Weighted-average shares outstanding - diluted 68.2 67.5
QuidelOrtho
Condensed Consolidated Balance Sheets
(Unaudited)
(In millions)
March 29, 2026 December 28, 2025
ASSETS
Current assets:
Cash and cash equivalents $ 140.4 $ 169.8
Accounts receivable, net 359.9 417.0
Inventories 611.5 577.6
Prepaid expenses and other current assets 232.8 250.5
Assets held for sale 32.4 32.4
Total current assets 1,377.0 1,447.3
Property, plant and equipment, net 1,339.3 1,358.3
Right-of-use assets 158.0 155.5
Intangible assets, net 2,520.2 2,563.8
Other assets 234.2 244.4
Total assets $ 5,628.7 $ 5,769.3
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable $ 243.5 $ 279.4
Accrued payroll and related expenses 135.4 120.3
Income tax payable 12.7 11.5
Current portion of borrowings 228.2 178.3
Other current liabilities 342.6 376.6
Total current liabilities 962.4 966.1
Operating lease liabilities 155.4 154.4
Long-term borrowings 2,459.8 2,471.9
Deferred tax liabilities 87.3 90.0
Other liabilities 112.4 166.4
Total liabilities 3,777.3 3,848.8
Total stockholders’ equity 1,851.4 1,920.5
Total liabilities and stockholders’ equity $ 5,628.7 $ 5,769.3
QuidelOrtho
Condensed Consolidated Statements of Cash Flows
(Unaudited)
(In millions)
Three Months Ended
March 29, 2026 March 30, 2025
Cash (used for) provided by operating activities $ (33.0) $ 65.6
Cash used for investing activities (34.0) (56.2)
Cash provided by financing activities 37.6 17.6
Effect of exchange rates on cash — 1.7
Net (decrease) increase in cash, cash equivalents and restricted cash (29.4) 28.7
Cash, cash equivalents and restricted cash at beginning of period 169.8 98.5
Cash, cash equivalents and restricted cash at end of period $ 140.4 $ 127.2
Reconciliation to amounts within the consolidated balance sheets:
Cash and cash equivalents $ 140.4 $ 127.1
Restricted cash in Other assets — 0.1
Cash, cash equivalents and restricted cash $ 140.4 $ 127.2
QuidelOrtho
Reconciliation of Non-GAAP Financial Information - Adjusted Net (Loss) Income
(In millions, except per share data; unaudited)
Three Months Ended
March 29, 2026 Diluted EPS March 30, 2025 Diluted EPS
Net loss $ (91.8) $ (1.35) $ (12.7) $ (0.19)
Adjustments:
Amortization of intangibles 46.8 48.0
Restructuring, integration and other charges 4.4 16.1
Amortization of deferred cloud computing implementation costs 8.0 4.3
Employee compensation charges 5.5 —
Incremental depreciation on PP&E fair value adjustment 3.3 5.2
Accelerated depreciation 2.0 —
Loss (gain) on investments 0.9 (0.3)
EU medical device regulation transition costs 0.7 0.2
Other adjustments 4.7 1.2
Income tax impact of adjustments 13.1 (11.8)
Adjusted net (loss) income $ (2.4) $ (0.04) $ 50.2 $ 0.74
Weighted-average shares outstanding - diluted 68.2 67.9
QuidelOrtho
Reconciliation of Non-GAAP Financial Information - Adjusted EBITDA
(In millions, unaudited)
Three Months Ended
March 29, 2026 March 30, 2025
Net loss $ (91.8) $ (12.7)
Depreciation and amortization 112.9 107.1
Interest expense, net 51.1 40.0
Provision for income taxes 12.3 3.9
Restructuring, integration and other charges 4.4 16.1
Amortization of deferred cloud computing implementation costs 8.0 4.3
Employee compensation charges 5.5 —
Loss (gain) on investments 0.9 (0.3)
EU medical device regulation transition costs 0.7 0.2
Other adjustments 4.7 1.2
Adjusted EBITDA $ 108.7 $ 159.8
Total revenues $ 619.8 $ 692.8
Adjusted EBITDA margin 17.5 % 23.1 %
QuidelOrtho
Reconciliation of Non-GAAP Financial Information - Revenues by Business Unit
(In millions, unaudited)
Three Months Ended
March 29, 2026 March 30, 2025 % Change Currency Impact
Constant Currency (a)
Labs $ 353.1 $ 373.0 (5.3) % 2.3 % (7.6) %
Immunohematology 138.3 128.5 7.6 % 4.2 % 3.4 %
Donor Screening 7.8 12.8 (39.1) % 0.4 % (39.5) %
Point of Care 112.8 170.9 (34.0) % 0.6 % (34.6) %
Molecular Diagnostics 7.8 7.6 2.6 % 4.4 % (1.8) %
Total revenues $ 619.8 $ 692.8 (10.5) % 2.1 % (12.6) %
(a) The term “constant currency” means we have translated local currency revenues for all reporting periods to U.S. dollars using currency exchange rates held constant for each period. This additional non-GAAP financial information is not meant to be considered in isolation from or as a substitute for financial information prepared in accordance with GAAP.
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Reference 1: http://www.xbrl.org/2003/role/presentationRef
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-Name Exchange Act
-Number 240
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- Definition
Name of the Exchange on which a security is registered.
+ References
Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Number 240
-Section 12
-Subsection d1-1
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Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as soliciting material pursuant to Rule 14a-12 under the Exchange Act.
+ References
Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Number 240
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- Definition
Trading symbol of an instrument as listed on an exchange.
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No definition available.
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Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as written communications pursuant to Rule 425 under the Securities Act.
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Reference 1: http://www.xbrl.org/2003/role/presentationRef
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-Name Securities Act
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