Financial Data and Key Metrics - Q3 2024 revenue was $727 million, with adjusted EBITDA of $171 million and adjusted diluted EPS of $0.85 [8] - Total year-to-date revenue was $2.1 billion, with recurring revenue of $1.74 billion, representing 5% growth compared to the prior year period [19] - Adjusted EBITDA margin improved by 80 basis points year-over-year to 23.5% in Q3 2024 [30] - The company expects full-year 2024 revenue between $2.75 billion and $2.80 billion, with adjusted EBITDA between $530 million and $550 million [34] Business Line Performance - Labs business grew 5% year-over-year in Q3 2024, driven by integrated and automated analyzers, which grew 7% and 17% respectively [24] - Transfusion Medicine revenue grew 3%, while donor screening declined by 20% as expected [25] - Respiratory revenue declined by 11% year-over-year in Q3 2024, primarily due to higher COVID-19 and flu revenue in the prior year period [26] Regional Performance - EMEA grew 12% in Q3 2024, while the Asia-Pacific and Latin America region grew 8% [20] - North America declined by mid-single digits due to higher respiratory revenue in the prior year period and the wind-down of the U.S. Donor Screening business [20] - China revenue declined by 1% year-over-year, with Labs business growing 5% but offset by softness in Transfusion Medicine and cardiac point-of-care products [21] Strategic Direction and Industry Competition - The company is focusing on cost and process improvement initiatives in procurement, supply chain, manufacturing, quality, and IT to improve profitability [14] - The Savanna molecular platform is a key driver of future revenue growth, with plans to enter clinical trials for the respiratory panel in 2025 [13] - The company is aligning its leadership structure to be flatter and more agile, with global regions fully aligned with business units [11] Management Commentary on Operating Environment and Future Outlook - The company expects to realize $100 million in annualized cost savings by the first half of 2025 [8] - Management is optimistic about the path ahead, with a focus on improving profitability and growth through cost savings and business efficiency initiatives [41] - The company is closely monitoring value-based pricing initiatives and China's anti-corruption policies, which could impact future sales [22][23] Other Important Information - The company finished Q3 2024 with $144 million in cash and $230 million in borrowings on its $800 million revolver [31] - Adjusted free cash flow in Q3 2024 was $120 million, representing 70% of adjusted EBITDA [32] - The company expects to exit the U.S. Donor Screening business by the end of 2025, which will provide a tailwind to margins [81] Q&A Session Summary Question: 2025 Adjusted EBITDA Margin Target - The company expects 100-200 basis points of margin improvement in 2025, driven by $50 million in cost savings and additional initiatives in procurement, IT, and organizational restructuring [44][45] Question: Labs Business Visibility - The Labs business has strong visibility due to long-term contracts and predictable ordering patterns, with mid-single-digit growth expected in 2025 [48] Question: Respiratory Season and COVID-19 Revenue - The company expects $160-$170 million in COVID-19 revenue for 2024, with $20-$30 million in Q4, and is being cautious about timing due to potential revenue shifts into Q1 2025 [51][52] Question: China Cardiac Reimbursement Impact - Proposed reimbursement changes for cardiac biomarkers in China could impact 1% or less of 2025 revenue, with no significant impact expected from value-based pricing initiatives [55][63] Question: Organizational Changes - The company is flattening its organizational structure to improve efficiency and customer focus, with no expected disruption to the sales team or customer interface [59][60] Question: Savanna Platform Update - The Savanna platform is on track for clinical trials in 2025, with significant revenue impact expected in 2026 and 2027 [66] Question: Cross-Selling Efforts - The company is focusing on increasing cross-selling of legacy Quidel products, particularly in international markets, with a shift toward direct sales channels [74] Question: China Stimulus Impact - The company is monitoring the potential impact of China's economic stimulus but sees it as a potential tailwind, though it is too early to quantify [77] Question: Equipment Replacement Cycle - The company has long contract cycles and high retention rates, supporting stable mid-single-digit growth in its Labs business [78] Question: Respiratory Competitive Landscape - The company is the leader in the respiratory space and expects to maintain similar market share to 2023, with efforts to increase share in the current season [84][85]

QuidelOrtho (QDEL) came out with quarterly earnings of $0.85 per share, beating the Zacks Consensus Estimate of $0.31 per share. This compares to earnings of $0.90 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 174.19%. A quarter ago, it was expected that this medical diagnostics company would post a loss of $0.21 per share when it actually produced a loss of $0.07, delivering a surprise of 66.67%.Over the last four quarters, ...

NEW YORK, Oct. 31, 2024 (GLOBE NEWSWIRE) -- Kuehn Law, PLLC, a shareholder litigation law firm, is investigating whether certain officers and directors of QuidelOrtho Corporation (NASDAQ: QDEL) breached their fiduciary duties to shareholders. According to a federal securities lawsuit, QuidelOrtho insiders caused the company to misrepresent or fail to disclose that (a) QuidelOrtho sold more COVID-19 tests to its distributors and pharmacy chain customers than they could resell to healthcare providers and end ...

Core Viewpoint - QuidelOrtho Corporation (QDEL) is positioned for growth due to its strong product portfolio and solid performance in the first half of 2024, despite facing challenges from data security threats and reimbursement policies [1][2]. Company Performance - QuidelOrtho has experienced a year-to-date loss of 42.6%, contrasting with a 12.4% growth in the industry and an 18.5% increase in the S&P 500 [2]. - The company has a market capitalization of $2.84 billion and an earnings yield of 4.3%, significantly higher than the industry's 0.7% [2]. - Earnings have surpassed the Zacks Consensus Estimate in three of the last four quarters, with an average surprise of 31.73% [2]. Product Portfolio - QuidelOrtho's product offerings include the Sofia and Sofia 2 Analyzers, QuickVue, InflammaDry, and AdenoPlus, catering to both professional and over-the-counter markets [4]. - The recent addition of the ARK Fentanyl II Assay is expected to enhance the Labs business unit, addressing the critical demand for opioid testing [5]. - The FDA 510(k) clearance for the QuickVue COVID-19 test allows for its use in home and medical settings, further expanding the product's market [6]. - Health Canada's approval for the Triage PLGF test is anticipated to boost the Point of Care business by detecting pregnancy-related complications [7]. Research and Development - The company emphasizes continued investment in R&D to foster long-term growth and innovation, focusing on next-generation platforms and assays [8]. Financial Results - QuidelOrtho's earnings and revenues exceeded the Zacks Consensus Estimate in the first two quarters of 2024, with growth observed in total revenues excluding COVID-19 impacts [9]. - Revenue growth was noted in the Labs segment and in regions outside of China, excluding COVID-19 revenues, with strong performance in the EMEA region [9]. Challenges - Data security threats pose a risk as the company relies on complex IT systems for information management, which may require costly upgrades [10]. - Third-party reimbursement policies could impact the usage of QuidelOrtho's products, as healthcare providers depend on adequate reimbursements from insurers [11]. Estimate Trends - The Zacks Consensus Estimate for QuidelOrtho's earnings for 2024 remains stable at $1.80 per share, while the estimate for third-quarter 2024 revenues is projected at $648.2 million, reflecting a 12.9% decline from the previous year [12].

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]