QuidelOrtho Reports Second Quarter 2024 Financial Results

— $100 million in annualized cost-savings initiatives will benefit second half 2024 and first half 2025 —

— Strong progress on business review and refocusing R&D investments on core growth areas —

Second quarter 2024 revenue was $637 million, as reported:

• Total recurring revenue¹ grew 3% as reported and 5% in constant currency compared to the prior year period, excluding COVID-19 revenue and U.S. Donor Screening revenue

YTD 2024 revenue was $1.35 billion, as reported:

• Total recurring revenue¹ grew 6% as reported and 7% in constant currency compared to the prior year period, excluding COVID-19 revenue, a one-time third-party collaboration settlement and U.S. Donor Screening revenue

SAN DIEGO, CA July 31, 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 second quarter ended June 30, 2024.

“During the second quarter we performed in line with our expectations across all segments and geographies while concurrently undertaking a significant review of our assets, operations, and opportunities for further company-wide savings,” said Brian J. Blaser, President and Chief Executive Officer, QuidelOrtho. “The findings of our internal review will serve as the foundation for our long-range plan to drive growth and improve margins, as well as focusing our R&D efforts and investments on the areas where we see the greatest opportunity and return.”

The Company reported total revenue for the second quarter of 2024 of $637 million, compared to $665 million in the prior year period. The decrease in total revenue was primarily due to lower COVID-19 revenue in the second quarter of 2024 compared to the prior year period. Foreign currency translation negatively impacted second quarter 2024 results by 100 basis points. GAAP diluted loss per share for the second quarter of 2024 was ($2.20), compared to diluted loss per share of ($0.80) in the prior year period.

GAAP operating loss for the second quarter of 2024 was ($118) million, compared to an operating loss of ($27) million in the prior year period, and GAAP operating margin was (18%) compared to (4%) in the prior year period. Second quarter 2024 results included $31 million in integration-related charges and a $57 million asset impairment charge related to long-term assets held for sale.

Adjusted diluted loss per share for the second quarter of 2024 was ($0.07), compared to adjusted diluted EPS of $0.26 in the prior year period. Adjusted EBITDA was $90 million, compared to $113 million in the prior year period. Adjusted EBITDA margin was 14%, compared to 17% 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.

_{1  Recurring revenue means revenues from sales of our assays, reagents, consumables and services, and excludes instruments.}

Blaser concluded, “During the second quarter, I had the opportunity to engage with many of our customers, employees, and investors, reinforcing my belief in QuidelOrtho’s long-term opportunity. We evaluated our business and made progress on aligning operating expenses with revenue expectations and focusing our R&D efforts on key priorities. As we enter the second half of the year, our strategic priorities remain clear: operate our business to provide exceptional customer satisfaction and patient care at the highest levels of quality and compliance; improve our cost structure, focus on the areas of our product portfolio with the highest growth potential and strengthen our position as a leading in vitro diagnostic company.”

QuidelOrtho will hold a conference call beginning at 2:00 p.m. PDT / 5:00 p.m. EDT to discuss its financial results. 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 533267.

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 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.

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 savings initiatives, 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. 

This press release contains financial measures, including but not limited to “constant currency” revenue and revenue changes, “constant currency” recurring revenue and revenue changes, “constant currency, ex-COVID-19” revenue and revenue changes, “adjusted net (loss) income,” “adjusted diluted (loss) earnings per share,” “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” recurring revenue and revenue changes, “constant currency, ex-COVID-19” revenue and revenue changes, “adjusted net (loss) income,” “adjusted diluted (loss) earnings per share,” “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.