Form 8-K - Current report

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): October 12, 2023

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 October 12, 2023, QuidelOrtho Corporation (“QuidelOrtho”) issued a press release announcing its preliminary revenue results for its fiscal third quarter ended October 1, 2023. 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 issued by QuidelOrtho Corporation dated October 12 , 2023.

104

Cover Page Interactive Data File - the cover page XBRL tags are embedded within the Inline XBRL Document.

CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS

The financial information set forth in this Form 8-K reflects QuidelOrtho’s current preliminary revenue estimates, and is subject to adjustments based on QuidelOrtho’s completion of its quarter-end financial close process. QuidelOrtho’s actual third quarter results may differ significantly from the preliminary estimates provided in this Form 8-K. You should not rely on these preliminary estimates as predictions of actual results because these estimates are based on assumptions that may not come true and are speculative by their nature. QuidelOrtho has no obligation to update any of the forward-looking information included in this Form 8-K, whether as a result of new information, future events, changed expectations or otherwise, except as required by law. All forward-looking statements are based on information currently available to QuidelOrtho and speak only as of the date hereof.

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: October 12, 2023





QUIDELORTHO CORPORATION

By:			/s/ Joseph M. Busky
Name:			Joseph M. Busky
Its:			Chief Financial Officer

Exhibit 99.1

October 12, 2023

QUIDELORTHO REPORTS PRELIMINARY REVENUE RESULTS FOR THE THIRD QUARTER 2023

Earlier-than-expected demand for respiratory products in core markets drives strong preliminary performance

Company to report third quarter 2023 financial results on November 1, 2023

SAN DIEGO, CA — QuidelOrtho Corporation (Nasdaq: QDEL) (the “Company” or “QuidelOrtho”), a global provider of innovative in vitro diagnostics technologies designed for point-of-care settings, clinical labs and transfusion medicine, today announced strong preliminary unaudited revenue results for the fiscal third quarter ended October 1, 2023, primarily driven by higher respiratory product sales, particularly SARS and flu.

Third Quarter 2023 Preliminary Unaudited Revenue Results

•Total revenues of $738 million to $744 million;

•Non-respiratory product revenue of $557 million to $560 million; and

•Respiratory product revenue of $181 million to $184 million.

“Our strong performance in the third quarter reflects the critical role our technologies play in healthcare settings and the trust medical professionals place in us,” said Douglas Bryant, President and Chief Executive Officer, QuidelOrtho. “Influenza and new variants of COVID-19 across the Northern Hemisphere generated significant demand for both our retail and point of care offerings. We also continued to see strength in our non-respiratory businesses, and all of our regions, including China, met or exceeded our expectations.”

Preliminary unaudited revenue results described herein are based on management’s initial analysis for the fiscal third quarter ended October 1, 2023, and are subject to adjustments based on the Company’s completion of its quarter-end financial close process.

Fiscal Year 2023 Financial Guidance

The Company is maintaining its 2023 financial guidance, provided on August 8, 2023, as follows:


Total revenues (reported)			$2.88 - $3.08 billion
Non-respiratory revenue			$2.27 - $2.31 billion
Respiratory revenue			$610 - $775 million
Adjusted EBITDA			$800 - $830 million
Adjusted EBITDA %			26.9% - 27.7%
Adjusted diluted earnings per share			$4.85 - $5.30

“The earlier-than-expected arrival of respiratory illnesses is driving greater demand for our diagnostics. As a result, we now expect third quarter performance to be higher than originally expected,” said Joseph Busky, Chief Financial Officer, QuidelOrtho. “With the pull-forward of the typical respiratory seasonality into the third quarter from the fourth quarter, we are reiterating our 2023 financial guidance. We remain confident in our strategic plan and our ability to achieve our 2023 financial guidance.”

Quarterly Conference Call Information

QuidelOrtho will report financial results for its third quarter 2023 after the market close on Wednesday, November 1, 2023. Following the release of the financial results, QuidelOrtho will hold a conference call beginning at 2:00 p.m. PT/5:00 p.m. ET to discuss the financial results. Interested parties can access the conference call on the “Events & Presentations” section of the “Investor Relations” page of QuidelOrtho’s website at https://ir.quidelortho.com/. Those unable to access the webcast may join the call via phone by dialing 404-975-4839 (domestic) or 929-526-1599 (international) and entering Conference ID 697176.

A replay of the conference call will be available shortly after the event on the “Investor Relations” page of QuidelOrtho’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

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include any statements contained herein that are not strictly historical, including, but not limited to, QuidelOrtho's preliminary unaudited revenue results for the quarter ended October 1, 2023, commercial, integration, transformation and other strategic goals, future financial and operating results, and future plans, objectives, strategies, expectations and intentions. These statements in this press release may be identified by words such as “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. 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: the challenges and costs of integrating, restructuring and achieving anticipated synergies as a result of the business combination; the ability to retain key employees; and other economic, business, competitive and/or regulatory factors affecting the business of QuidelOrtho generally. Additional risks and factors are identified under “Risk Factors” in QuidelOrtho’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (the “Commission”) on February 23, 2023, and subsequent reports filed with the Commission. 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. 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. All forward-looking statements are based on information currently available to QuidelOrtho and speak only as of the date hereof.

Investor Contact:

Juliet Cunningham

Vice President, Investor Relations

IR@quidelortho.com

Media Contact:

Stephanie Kleewein

Communications Manager

media@quidelortho.com

Document and Entity Information Document	Oct. 12, 2023
Entity Information [Line Items]
Document Type	8-K
Document Period End Date	Oct. 12, 2023
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