QuidelOrtho Corporation (QDEL) recently announced the FDA 510(k) clearance for its VITROS syphilis assay as part of its menu, which is likely to strengthen its position as a leader in infectious disease testing. The expansion into the U.S. market aims to provide timely and accurate diagnosis, crucial for effective treatment and control of the disease. With this latest development, QDEL's shares are likely to witness a northward movement. More on QDEL's VITROS Syphilis Assay The VITROS syphilis assay is desi ...

QuidelOrtho Corporation (QDEL) reported an adjusted loss per share of 7 cents in the second quarter of 2024 against earnings per share (EPS) of 26 cents in the year-ago period. However, the figure beat the Zacks Consensus Estimate by 66.7%. The adjustments include expenses related to the amortization of intangibles, and acquisition and integration costs, among others. GAAP loss per share in the quarter was $2.20 compared with 80 cents in the year-ago quarter. Revenues in Detail QuidelOrtho registered revenu ...

QuidelOrtho (QDEL) came out with a quarterly loss of $0.07 per share versus the Zacks Consensus Estimate of a loss of $0.21. This compares to earnings of $0.26 per share a year ago. These figures are adjusted for nonrecurring items. This quarterly report represents an earnings surprise of 66.67%. A quarter ago, it was expected that this medical diagnostics company would post earnings of $0.43 per share when it actually produced earnings of $0.44, delivering a surprise of 2.33%. Over the last four quarters, ...

Core Viewpoint - QuidelOrtho Corporation is positioned for growth due to its strong product portfolio and solid first-quarter 2024 performance, although it faces challenges from data security threats and reimbursement policies [1][2]. Company Performance - Over the past year, QuidelOrtho's stock has declined by 60%, while the industry saw a 2.2% decline and the S&P 500 grew by 23% [2]. - The company has a market capitalization of $2.32 billion and an earnings yield of 5.45%, significantly higher than the industry's 0.95% [2]. - QuidelOrtho's earnings have exceeded the Zacks Consensus Estimate in three of the last four quarters, with an average surprise of 16.1% [2]. Product Portfolio - QuidelOrtho offers a diverse range of diagnostic testing solutions, including Sofia and Sofia 2 Analyzers, QuickVue, InflammaDry, and AdenoPlus products [3]. - The recent addition of the ARK Fentanyl II Assay is expected to enhance the company's Labs business by meeting the demand for opioid testing [4]. - The FDA 510(k) clearance for the QuickVue COVID-19 test allows for its use in home and medical settings, expanding its market reach [5]. - Health Canada's approval for the Triage PLGF test is anticipated to boost the Point of Care business by addressing maternal and fetal complications [6]. Financial Results - In Q1 2024, QuidelOrtho's earnings and revenues surpassed the Zacks Consensus Estimate, with growth in total revenues excluding COVID-19 impacts [7]. - The company experienced revenue growth in its Labs segment and positive trends in regions like China and EMEA, excluding COVID-19 revenues [7]. Research and Development - QuidelOrtho plans to continue investing in R&D to develop new products and services, which is crucial for long-term growth and customer retention [10]. Challenges - The reliance on third-party reimbursement policies poses a risk, as inadequate reimbursement could affect the adoption of QuidelOrtho's products by healthcare providers [8]. - Data security threats remain a concern, as the company's complex IT systems may face challenges in meeting business needs [11]. Estimate Trends - The Zacks Consensus Estimate for QuidelOrtho's second-quarter 2023 revenues is projected at $617.3 million, reflecting a 7.2% decline from the previous year [9]. - The earnings estimate for 2024 has remained stable at $1.89 per share over the past 60 days [12].

Core Viewpoint - QuidelOrtho has faced significant challenges in its respiratory business, particularly related to COVID-19 test sales, leading to a decline in stock value and a class action lawsuit from investors [4][10]. Group 1: Business Overview - QuidelOrtho specializes in tests for respiratory diseases and other medical conditions, with a strong focus on seasonal flu and COVID-19 detection tests [1]. - The company has historically generated substantial revenue from high-margin COVID-19 tests sold to government entities, healthcare providers, and retail pharmacy chains [1]. Group 2: Recent Developments - On April 2, 2024, QuidelOrtho withdrew its FDA 510(k) submission for the Savanna RVP4 Test due to disappointing data [2]. - The company reported underwhelming fourth-quarter results for the period ending December 31, 2023, with Adjusted Earnings Per Share falling 46% below Wall Street expectations, primarily due to lower COVID-19 revenues from distributor destocking [6]. Group 3: Legal Issues - A class action complaint was filed against QuidelOrtho on April 12, 2024, alleging that the company misled investors about its business operations and prospects during the Class Period from February 18, 2022, to April 1, 2024 [4][10]. - The complaint highlighted that QuidelOrtho sold more COVID-19 tests than could be resold, leading to excess inventory and reduced orders from distributors and pharmacy chains [4]. Group 4: Stock Performance - Following the announcement of the FDA submission withdrawal, QuidelOrtho's stock price dropped by $4.85, or over 10%, closing at $42.15 on April 2, 2024 [8]. - On February 14, 2024, the stock price fell by $21.50, or more than 32%, closing at $45.27 after the company reported disappointing earnings [11].

Group 1 - The complaint against QuidelOrtho Corporation alleges that the company made materially false and misleading statements regarding its COVID-19 test sales and inventory levels [1] - It is claimed that QuidelOrtho sold more COVID-19 tests than its distributors and pharmacy chain customers could resell, leading to excess inventory throughout the supply chain [1] - The complaint suggests that these issues resulted in distributors and pharmacy chain customers significantly reducing their COVID-19 test orders, impacting the company's financial outlook [1] Group 2 - The class period for the allegations is defined as February 18, 2022, to April 1, 2024, during which shareholders are encouraged to register for the class action [5] - Shareholders who purchased shares of QuidelOrtho during the class period are invited to contact the Gross Law Firm regarding potential lead plaintiff appointment [4][5] - The deadline for shareholders to seek lead plaintiff status is June 11, 2024, and there is no cost or obligation to participate in the case [5]

NEW YORK, June 08, 2024 (GLOBE NEWSWIRE) -- WHY: Rosen Law Firm, a global investor rights law firm, reminds purchasers of common stock of QuidelOrtho Corporation (NASDAQ: QDEL) between February 18, 2022 and April 1, 2024, both dates inclusive (the "Class Period") of the important June 11, 2024 lead plaintiff deadline. SO WHAT: If you purchased QuidelOrtho common stock during the Class Period you may be entitled to compensation without payment of any out of pocket fees or costs through a contingency fee arra ...

CLASS DEFINITION: The lawsuit seeks to recover losses on behalf of QuidelOrtho investors who were adversely affected by alleged securities fraud between February 18, 2022 and April 1, 2024. Follow the link below to get more information and be contacted by a member of our team: WHAT'S NEXT? If you suffered a loss in QuidelOrtho during the relevant time frame, you have until June 11, 2024 to request that the Court appoint you as lead plaintiff. Your ability to share in any recovery doesn't require that you se ...

Core Viewpoint - QuidelOrtho's recent earnings report shows a significant decline in earnings and revenues, raising concerns about its future performance and leading to a downward revision of estimates by analysts [2][3][13]. Financial Performance - Adjusted EPS for Q1 2024 was 44 cents, down 75.6% year over year, but slightly above the Zacks Consensus Estimate by 1 cent [2]. - GAAP loss per share was $25.50 compared to an EPS of 73 cents in the same quarter last year [2]. - Total revenues for Q1 were $711 million, a decrease of 16% year over year, but beat the Zacks Consensus Estimate by 1.96% [3]. Revenue Breakdown - Excluding COVID-19-related revenues, total revenues were $660.8 million, reflecting a 4.9% increase year over year [3]. - Respiratory revenues fell to $137.3 million, down 48.3%, while non-respiratory revenues were $573.7 million, down 1.2% [4]. - Labs revenues were $356.9 million, down 3.7%, while Transfusion Medicine revenues increased to $160.3 million, up 2.8% [5][6]. Geographical Performance - North America revenues were $433.9 million, down 25.5%, while EMEA revenues increased to $84.8 million, up 4.3% [9]. - Revenues from China were $76.1 million, reflecting a 7.8% increase, and Other regions generated $116.2 million, also up 4.3% [9]. Margin Analysis - Adjusted gross profit declined 25.8% to $337.9 million, with adjusted gross margin contracting 630 basis points to 47.5% [10]. - Adjusted operating income fell 59% to $79.1 million, with adjusted operating margin contracting 1170 basis points to 11.1% [11]. Financial Position - Cash and cash equivalents at the end of Q1 2024 were $78.5 million, down from $118.9 million at the end of Q4 2023 [12]. - Total debt was $2.40 billion, slightly down from $2.41 billion in the previous quarter [12]. Guidance and Market Sentiment - QuidelOrtho has suspended its 2024 financial guidance while assessing the business under new leadership [13]. - Estimates have trended downward, leading to a Zacks Rank of 5 (Strong Sell) for the stock [15]. Industry Comparison - QuidelOrtho operates in the Zacks Medical - Products industry, where competitor Stryker reported revenues of $5.24 billion, a year-over-year increase of 9.7% [16].

NEW YORK, June 06, 2024 (GLOBE NEWSWIRE) -- The Gross Law Firm issues the following notice to shareholders of QuidelOrtho Corporation f/k/a Quidel Corporation (NASDAQ: QDEL). Shareholders who purchased shares of QDEL during the class period listed are encouraged to contact the firm regarding possible lead plaintiff appointment. Appointment as lead plaintiff is not required to partake in any recovery. CONTACT US HERE: https://securitiesclasslaw.com/securities/quidelortho-loss-submission-form/?id=82880&from=3 ...