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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 8, 2024

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 classTrading symbol(s)Name of each exchange on which registered
Common Stock, $0.001 Par ValueQDELThe 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 8, 2024, QuidelOrtho Corporation (“QuidelOrtho”) issued a press release announcing the financial results for its first quarter ended March 31, 2024 and will hold an earnings conference call at 2:00 p.m., Pacific Time, on May 8, 2024 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 NumberDescription of Exhibit
99.1
104Cover Page Interactive Data File - the cover page XBRL tags are embedded within the Inline XBRL Document.





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 8, 2024
   
QUIDELORTHO CORPORATION
  
By:/s/ Joseph M. Busky 
Name:Joseph M. Busky 
Its:Chief Financial Officer 


Exhibit 99.1

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May 8, 2024


QuidelOrtho Reports First Quarter 2024 Financial Results
- Global year-over-year revenue growth of 5% as reported and 6% in constant currency, excluding COVID-19 revenue -
- Cost reduction initiatives well underway, headcount reductions expected to deliver approximately $100 million in annualized savings -
- Company suspends 2024 financial guidance while it assesses business under new President and Chief Executive Officer -

First Quarter 2024 Results and Recent Highlights

•Revenue was $711 million, as reported:
◦Non-respiratory revenue was flat at $574 million compared to the prior year period, as reported and in constant currency
▪Excluding the one-time third-party settlement of $21 million in the prior year period, non-respiratory revenue grew 3% as reported and 4% on a constant currency basis
◦Respiratory revenue was $137 million, a 48% decrease as reported and in constant currency, primarily due to lower COVID-19 revenue in the first quarter of 2024 compared to the prior year period
▪Excluding COVID-19-related government orders of $143 million in Q1 2023 and $7 million in Q1 2024, which are not expected to recur, respiratory revenue grew 6% as reported and in constant currency
•Secured credit agreement amendment to provide additional flexibility through 2027
•Appointed Brian J. Blaser as President and Chief Executive Officer, effective May 6, 2024

SAN DIEGO, CA May 8, 2024 — 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, today announced financial results for the first quarter ended March 31, 2024.

“During the first quarter, we achieved solid business performance with 6% top-line constant currency revenue growth across our global regions, excluding COVID-19 revenue,” said Michael S. Iskra, EVP and Chief Commercial Officer, QuidelOrtho. “Additionally, we have been steadfast in implementing company-wide cost initiatives, including margin restoration, which includes headcount reductions that are expected to deliver approximately $100 million in annualized savings. While these actions are never easy, they are a necessary step in positioning the Company for durable long-term growth.”

First Quarter 2024

The Company reported total revenue for the first quarter of 2024 of $711 million, compared to $846 million in the prior year period. The decrease in total revenue was primarily due to lower COVID-19 revenue in the first quarter of 2024 compared to the prior year period. Foreign currency translation did not significantly impact first quarter 2024 results. GAAP diluted loss per share for the first quarter of 2024 was $25.50, compared to diluted earnings per share (“EPS”) of $0.73 in the prior year period. GAAP operating loss for the first quarter of 2024 was $1.76 billion, compared to operating income of $100 million in the prior year period. The first quarter of 2024 GAAP operating loss included a non-cash goodwill impairment charge of approximately $1.74 billion for the North America reporting unit due to the decrease in the estimated fair value, which was consistent with the decline in the Company’s market capitalization during the three months ended March 31, 2024. As a result of the goodwill impairment charge, GAAP operating margin was (247%) compared to 12% in the prior year period. First quarter 2024 results included $23 million in integration-related charges.


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Adjusted diluted EPS for the first quarter of 2024 was $0.44, compared to $1.80 in the prior year period. Adjusted EBITDA was $132 million, compared to $245 million in the prior year period. Adjusted EBITDA margin was 19%, compared to 29% in the prior year period. The year-over-year change in adjusted diluted EPS and adjusted EBITDA was primarily due to lower COVID-19 revenue.

Fiscal Year 2024 Financial Guidance

Following the appointment of Brian J. Blaser as President and Chief Executive Officer, QuidelOrtho is suspending its 2024 financial guidance while it assesses the business under its new President and Chief Executive Officer. The Company plans to provide an update in today’s earnings conference call.

Conference Call Information

QuidelOrtho will hold a conference call today at 2:00 p.m. PDT / 5:00 p.m. EDT to discuss its financial results for the first quarter ended March 31, 2024. Interested parties can access the call on 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. Those unable to access the webcast may join the call via phone by dialing 833-470-1428 (domestic) or +1 929-526-1599 (international) and entering Conference ID number 295379.

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.

About QuidelOrtho Corporation

QuidelOrtho Corporation (Nasdaq: QDEL) is a world leader in in-vitro diagnostics, developing and manufacturing intelligent solutions that transform data into understanding and action for more people in more places every day.

Offering industry-leading expertise in immunoassay and molecular testing, clinical chemistry, and transfusion medicine, bringing fast, accurate and reliable diagnostics when and where they are needed – from home to hospital, lab to clinic. So that patients, clinicians and health officials can spot trends sooner, respond quicker and chart the course ahead with accuracy and confidence.

Building upon its many years of groundbreaking innovation, QuidelOrtho continues to partner with customers across the healthcare continuum and around the globe to forge a new diagnostic frontier. One where insights and solutions know no bounds, expertise seamlessly connects and a more informed path is illuminated for each of us.

QuidelOrtho is advancing diagnostics to power a healthier future.

For more information, please visit www.quidelortho.com.
Source: QuidelOrtho Corporation


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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, integration, transformation and other strategic goals, future financial condition and operating results, including results of cost initiatives and operating flexibility achieved by the credit agreement amendment, and other future plans, objectives, strategies, expectations and intentions. Without limiting the foregoing, the words “may,” “will,” “would,” “should,” “might,” “expect,” “anticipate,” “believe,” “estimate,” “plan,” “intend,” “goal,” “project,” “strategy,” “future,” “continue” 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 today 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 to differ from those set forth or implied in the forward-looking statements: supply chain, production, logistics, distribution and labor disruptions and challenges; the challenges and costs of integrating, restructuring and achieving anticipated synergies as a result of the business combination of Quidel Corporation and Ortho Clinical Diagnostics Holdings plc; and other macroeconomic, geopolitical, market, business, competitive and/or regulatory factors affecting the business of QuidelOrtho generally, including those discussed in QuidelOrtho’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023 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 hereof. 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, including but not limited to “constant currency” revenue and revenue changes, “constant currency, ex-COVID-19” revenue and revenue changes, revenue ex-COVID-19, “adjusted net income,” “adjusted diluted EPS,” “adjusted EBITDA” and “adjusted EBITDA margin,” which are considered non-GAAP financial measures under applicable rules and regulations of the Commission. 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”). “Constant currency” revenue and revenue changes, “constant currency, ex-COVID-19” revenue and revenue changes, revenue ex-COVID-19, “adjusted net income,” “adjusted diluted EPS,” “adjusted EBITDA” and “adjusted EBITDA margin” 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 non-GAAP financial measures to the most directly comparable GAAP financial measures are included in the tables accompanying this press release.




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Investor Contact:
Juliet Cunningham
Vice President, Investor Relations
IR@quidelortho.com

Media Contact:
D. Nikki Wheeler
Senior Director, Corporate Communications
media@quidelortho.com

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QuidelOrtho
Consolidated Statements of Operations
(Unaudited)
(In millions except per share data)

 Three Months Ended
 March 31, 2024April 2, 2023
Total revenues$711.0 $846.1 
Cost of sales, excluding amortization of intangibles378.9 397.5 
Selling, marketing and administrative204.7 202.4 
Research and development59.2 62.3 
Amortization of intangible assets51.7 50.8 
Acquisition and integration costs22.6 29.7 
Goodwill impairment charge1,743.9 — 
Other operating expenses8.0 3.8 
Operating (loss) income(1,758.0)99.6 
Interest expense, net39.0 36.7 
Other expense, net1.9 2.9 
(Loss) income before income taxes(1,798.9)60.0 
(Benefit from) provision for income taxes(92.9)11.2 
Net (loss) income$(1,706.0)$48.8 
Basic (loss) earnings per share$(25.50)$0.73 
Diluted (loss) earnings per share$(25.50)$0.73 
Weighted-average shares outstanding - basic66.9 66.6 
Weighted-average shares outstanding - diluted66.9 67.1 

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QuidelOrtho
Condensed Consolidated Balance Sheets
(Unaudited)
(In millions)

March 31, 2024December 31, 2023
Cash and cash equivalents$78.5 $118.9 
Marketable securities— 48.4 
Accounts receivable, net271.7 303.3 
Inventories583.1 577.8 
Prepaid expenses and other current assets279.1 262.1 
Property, plant and equipment, net1,441.3 1,443.8 
Marketable securities— 7.4 
Right-of-use assets180.5 169.6 
Goodwill734.8 2,492.0 
Intangible assets, net2,887.3 2,934.3 
Deferred tax asset24.9 25.9 
Other assets222.1 179.6 
Total assets$6,703.3 $8,563.1 
Accounts payable$249.6 $294.8 
Accrued payroll and related expenses108.9 84.8 
Income tax payable9.5 11.1 
Current portion of borrowings161.1 139.8 
Other current liabilities250.7 303.3 
Operating lease liabilities181.8 172.8 
Long-term borrowings2,241.0 2,274.8 
Deferred tax liability125.6 192.2 
Other liabilities67.4 83.6 
Total liabilities3,395.6 3,557.2 
Total stockholders’ equity3,307.7 5,005.9 
Total liabilities and stockholders’ equity$6,703.3 $8,563.1 



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QuidelOrtho
Condensed Consolidated Statements of Cash Flows
(Unaudited)
(In millions)

Three Months Ended
March 31, 2024April 2, 2023
Cash (used for) provided by operating activities$(0.7)$188.9 
Cash used for investing activities(20.2)(68.9)
Cash used for financing activities(18.5)(59.6)
Effect of exchange rates on cash(1.1)0.6 
Net (decrease) increase in cash, cash equivalents and restricted cash(40.5)61.0 
Cash, cash equivalents and restricted cash at beginning of period119.5 293.9 
Cash, cash equivalents and restricted cash at end of period$79.0 $354.9 
Reconciliation to amounts within the consolidated balance sheets:
Cash and cash equivalents$78.5 $353.9 
Restricted cash in Other assets0.5 1.0 
Cash, cash equivalents and restricted cash$79.0 $354.9 

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QuidelOrtho
Reconciliation of Non-GAAP Financial Information - Adjusted Net Income
(In millions, except per share data; unaudited)

Three Months Ended
March 31, 2024Diluted EPSApril 2, 2023Diluted EPS
Net (loss) income$(1,706.0)$(25.50)$48.8 $0.73 
Adjustments:
Goodwill impairment charge1,743.9 — 
Amortization of intangibles51.7 50.8 
Acquisition and integration costs22.6 29.7 
Incremental depreciation on PP&E fair value adjustment9.1 8.6 
Employee compensation charges5.6 — 
Amortization of deferred cloud computing implementation costs2.9 1.6 
EU medical device regulation transition costs0.6 0.8 
Non-cash interest expense for deferred consideration— 0.6 
Impairment of long-lived assets— 0.5 
Other adjustments1.4 1.5 
Income tax impact of adjustments(101.4)(22.1)
Discrete tax items(0.6)0.2 
Adjusted net income$29.8 $0.44 $121.0 $1.80 
Weighted-average shares outstanding - diluted67.3 67.1 

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QuidelOrtho
Reconciliation of Non-GAAP Financial Information - Adjusted EBITDA
(In millions, unaudited)

Three Months Ended
March 31, 2024April 2, 2023
Net (loss) income$(1,706.0)$48.8 
Depreciation and amortization114.9 114.2 
Interest expense, net39.0 36.7 
(Benefit from) provision for income taxes(92.9)11.2 
Goodwill impairment charge1,743.9 — 
Acquisition and integration costs22.6 29.7 
Employee compensation charges5.6 — 
Amortization of deferred cloud computing implementation costs2.9 1.6 
EU medical device regulation transition costs0.6 0.8 
Impairment of long-lived assets— 0.5 
Tax indemnification expense— 0.3 
Other adjustments1.4 1.5 
Adjusted EBITDA$132.0 $245.3 

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QuidelOrtho
Revenues by Business Unit and Region
(In millions, unaudited)

Three Months Ended
March 31, 2024April 2, 2023% ChangeCurrency Impact
Constant Currency (a)
Respiratory revenues$137.3 $265.6 (48.3)%— %(48.3)%
Non-Respiratory revenues573.7 580.5 (1.2)%(1.0)%(0.2)%
Total revenues$711.0 $846.1 (16.0)%(0.5)%(15.5)%
COVID-19 revenue impact
(50.2)(216.1)(76.8)%— %(76.8)%
Total revenues ex COVID-19 revenue
$660.8 $630.0 4.9 %(1.0)%5.9 %


Three Months Ended
March 31, 2024April 2, 2023% ChangeCurrency Impact
Constant Currency (a)
COVID-19 revenue impact
Constant Currency (a)
ex COVID-19 Revenue
Labs$356.9 $370.7 (3.7)%(0.8)%(2.9)%(0.6)%(2.3)%
Transfusion Medicine160.3 155.9 2.8 %(1.3)%4.1 %— %4.1 %
Point of Care186.6 308.1 (39.4)%(0.1)%(39.3)%(76.8)%37.5 %
Molecular Diagnostics7.2 11.4 (36.8)%(0.1)%(36.7)%(52.0)%15.3 %
Total revenues$711.0 $846.1 (16.0)%(0.5)%(15.5)%(21.4)%5.9 %


Three Months Ended
March 31, 2024April 2, 2023% ChangeCurrency Impact
Constant Currency (a)
COVID-19 revenue impact
Constant Currency (a)
ex COVID-19 Revenue
North America$433.9 $582.8 (25.5)%(0.2)%(25.3)%(30.1)%4.8 %
EMEA84.8 81.3 4.3 %0.5 %3.8 %(2.0)%5.8 %
China76.1 70.6 7.8 %(4.3)%12.1 %— %12.1 %
Other116.2 111.4 4.3 %(1.6)%5.9 %0.4 %5.5 %
Total revenues$711.0 $846.1 (16.0)%(0.5)%(15.5)%(21.4)%5.9 %
(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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QuidelOrtho
Revenues reconciliation to non-GAAP measures
(In millions, unaudited)

Three Months Ended
March 31, 2024April 2, 2023% ChangeCurrency Impact
Constant Currency (a)
Respiratory revenues$137.3 $265.6 (48.3)%— %(48.3)%
COVID-19-related government orders(6.7)(142.6)(95.3)%— %(95.3)%
Respiratory Revenue ex COVID-19-related government orders$130.6 $123.0 6.2 %— %6.2 %


Three Months Ended
March 31, 2024April 2, 2023% ChangeCurrency Impact
Constant Currency (a)
Non-Respiratory revenues$573.7 $580.5 (1.2)%(1.0)%(0.2)%
One-time third party settlement— (20.7)(100.0)%— %(100.0)%
Non-Respiratory Revenue ex One-time third party settlement$573.7 $559.8 2.5 %(1.0)%3.5 %

(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.


v3.24.1.u1
Document and Entity Information Document
May 08, 2024
Entity Information [Line Items]  
Document Type 8-K
Document Period End Date May 08, 2024
Entity Incorporation, State or Country Code DE
Entity File Number 001-41409
Entity Tax Identification Number 87-4496285
Entity Address, Address Line One 9975 Summers Ridge Road
Entity Address, City or Town San Diego
Entity Address, State or Province CA
Entity Address, Postal Zip Code 92121
City Area Code 858
Local Phone Number 552-1100
Written Communications false
Soliciting Material false
Pre-commencement Tender Offer false
Pre-commencement Issuer Tender Offer false
Title of 12(b) Security Common Stock, $0.001 Par Value
Trading Symbol QDEL
Security Exchange Name NASDAQ
Entity Emerging Growth Company false
Entity Central Index Key 0001906324
Amendment Flag false
Entity Registrant Name QUIDELORTHO CORP
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