Back

QuidelOrtho Corporation f/k/a Quidel Corporation

Case Details

Class Period: February 18, 2022 - April 1, 2024
Date Filed: April 12, 2024
Case Number: 1:24-cv-02804
Jurisdiction: Southern District of New York
icon-casetype Case Type: Securities Case
Days Left to
Seek Plaintiff:
19

Case Summary

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.

Documents
Complaint