Labaton Keller Sucharow LLP (“Labaton”) announces that, on April 12, 2024, it filed a securities class action lawsuit (the “Complaint”) on behalf of its client Bristol County Retirement System (“Bristol County”) against QuidelOrtho Corporation, formerly known as Quidel Corporation (“QuidelOrtho” or the “Company”) (NASDAQ: QDEL), and certain QuidelOrtho officers (collectively, “Defendants”). The action, which is captioned Bristol County Retirement System v. QuidelOrtho Corporation, No. 24-cv-02804 (S.D.N.Y. Apr. 12, 2024), asserts claims under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934, and U.S. Securities and Exchange Commission Rule 10b-5 promulgated thereunder, on behalf of all persons or entities who purchased or otherwise acquired QuidelOrtho common stock between February 18, 2022 and April 1, 2024, inclusive (the “Class Period”).

QuidelOrtho provides tests for the detection and diagnosis of various respiratory diseases and other medical conditions. The Company’s respiratory business has historically been tied to the sale of seasonal flu tests and more recently to COVID-19 detection tests. Since the onset of the COVID-19 pandemic, the Company has generated a significant portion of its revenue through the sale of high-margin COVID-19 tests to government customers, healthcare providers (through its authorized distributors), and large retail pharmacy chains. QuidelOrtho manufactures respiratory tests under various brands, including QuickVue, Sofia, and Savanna.

In December 2022, the Company announced that it had agreed to merge with Ortho Clinical Diagnostics Holdings plc (“Ortho”). The merger closed in May 2022, shortly after the start of the Class Period. Meanwhile, COVID-19 was transitioning from pandemic to “endemic” status (i.e., COVID-19 infections no longer growing exponentially). Despite COVID-19 transitioning into an endemic, Defendants assured investors that it was well positioned to maintain a stable high margin revenue stream from its respiratory business. Among other strategies, the Company aimed to launch its “next flagship product,” a new test called the Savanna Respiratory Viral Panel-4 (the “Savanna RVP4 Test,” which tests for COVID-19 along with other respiratory conditions) by utilizing Ortho’s commercial distribution network. During the Class Period, the Savanna RVP4 Test was not approved by the U.S. Food and Drug Administration (the “FDA”) to be marketed or sold in the United States. Therefore, investors closely monitored the Company’s progress in getting the Savanna RVP4 Test approved.

Throughout the Class Period, Defendants misled investors by making statements that were false and misleading when made because they knew or deliberately disregarded and failed to disclose the following adverse facts about QuidelOrtho’s business, operations, and prospects: (a) that QuidelOrtho sold more COVID-19 tests to its distributors and pharmacy chain customers than they could resell to healthcare providers and end customers; (b) that excess inventories of COVID-19 tests existed throughout the supply chain; (c) that, as a result of (a)-(b), QuidelOrtho’s distributors and pharmacy chain customers were poised to significantly reduce their COVID-19 test orders; (d) that undisclosed problems created a heightened risk that the Savanna RVP4 Test would experience a delayed commercial launch in the United States; and (e) that, as a result of (a)-(d), Defendants lacked a reasonable basis for their positive statements about QuidelOrtho’s business, financials, and growth trajectory.

The truth began to emerge on February 13, 2024, when QuidelOrtho reported underwhelming results for its fourth quarter ended December 31, 2023. Among other things, the Company’s Adjusted Earnings Per Share was 46% below the midpoint of Wall Street analysts’ expectations. This miss was largely attributed to lower COVID-19 revenues during the quarter due to distributor destocking. QuidelOrtho also lowered its annual endemic COVID-19 revenue forecast from the range of $200-$400 million to $200 million. On this news, the price of QuidelOrtho stock dropped $21.50, or more than 32 percent, to close at $45.27 on February 14, 2024. Then, on April 2, 2024, QuidelOrtho announced that it had withdrawn its FDA 510(k) submission for approval to sell the Savanna RVP4 Test in the United States after recent data did not meet expectations. On this news, the price of QuidelOrtho stock dropped $4.85, or more than 10 percent, to close at $42.15 on April 2, 2024.

If you purchased or acquired QuidelOrtho common stock during the Class Period and were damaged thereby, you are a member of the “Class” and may be able to seek appointment as Lead Plaintiff. Lead Plaintiff motion papers must be filed no later than June 11, 2024. The Lead Plaintiff is a court-appointed representative for absent members of the Class. You do not need to seek appointment as Lead Plaintiff to share in any Class recovery in this action. If you are a Class member and there is a recovery for the Class, you can share in that recovery as an absent Class member. You may retain counsel of your choice to represent you in this action.

If you would like to consider serving as Lead Plaintiff or have any questions about this lawsuit, you may contact Francis P. McConville, Esq. of Labaton, at (212) 907-0650, or via email at fmcconville@labaton.com. You can view a copy of the Complaint here.

Plaintiff Bristol County Retirement System is represented by Labaton, which represents many of the largest pension funds in the United States and internationally with combined assets under management of more than $3.5 trillion. Labaton’s litigation reputation is built on its half-century of securities litigation experience, more than sixty full-time attorneys, and in-house team of investigators, financial analysts, and forensic accountants. Labaton has been recognized for its excellence by the courts and peers, and it is consistently ranked in leading industry publications. Offices are located in New York, NY, Wilmington, DE, and Washington, D.C. More information about Labaton is available at www.labaton.com.

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