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The Gross Law Firm Reminds Shareholders of a Lead Plaintiff Deadline of June 11, 2024 in QuidelOrtho Corporation f/k/a Quidel Corporation Lawsuit - QDEL
prnewswire.com· 2024-05-21 09:45
CONTACT US HERE: NEW YORK, May 21, 2024 /PRNewswire/ -- 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. NEXT STEPS FOR SHAREHOLDERS: Once you register as a shareholder who purchased shares of QDEL dur ...
QuidelOrtho Corporation f/k/a Quidel Corporation Securities Fraud Class Action Lawsuit Pending: Contact Levi & Korsinsky Before June 11, 2024 to Discuss Your Rights - QDEL
prnewswire.com· 2024-05-20 09:45
NEW YORK, May 20, 2024 /PRNewswire/ -- Levi & Korsinsky, LLP notifies investors in QuidelOrtho Corporation f/k/a Quidel Corporation ("QuidelOrtho" or the "Company") (NASDAQ: QDEL) of a class action securities lawsuit. 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: https://zlk.com/ ...
ROSEN, TRUSTED INVESTOR COUNSEL, Encourages QuidelOrtho Corporation Investors to Secure Counsel Before Important Deadline in Securities Class Action - QDEL
prnewswire.com· 2024-05-17 23:30
NEW YORK, May 17, 2024 /PRNewswire/ -- Follow us for updates on LinkedIn: https://www.linkedin.com/company/the-rosen-law-firm, on Twitter: https://twitter.com/rosen_firm or on Facebook: https://www.facebook.com/rosenlawfirm/. WHY ROSEN LAW: We encourage investors to select qualified counsel with a track record of success in leadership roles. Often, firms issuing notices do not have comparable experience, resources or any meaningful peer recognition. Many of these firms do not actually litigate securities cl ...
Shareholders of QuidelOrtho Corporation f/k/a Quidel Corporation Should Contact Levi & Korsinsky Before June 11, 2024 to Discuss Your Rights – QDEL
Newsfilter· 2024-05-17 17:03
NEW YORK, May 17, 2024 (GLOBE NEWSWIRE) -- Levi & Korsinsky, LLP notifies investors in QuidelOrtho Corporation f/k/a Quidel Corporation ("QuidelOrtho" or the "Company") (NASDAQ:QDEL) of a class action securities lawsuit. WHY LEVI & KORSINSKY: Over the past 20 years, the team at Levi & Korsinsky has secured hundreds of millions of dollars for aggrieved shareholders and built a track record of winning high-stakes cases. Our firm has extensive expertise representing investors in complex securities litigation a ...
QuidelOrtho Corporation f/k/a Quidel Corporation Sued for Securities Law Violations - Contact The Gross Law Firm Before June 11, 2024 to Discuss Your Rights - QDEL
prnewswire.com· 2024-05-17 09:45
NEW YORK, May 17, 2024 /PRNewswire/ -- 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: ALLEGATIONS: The complaint alleges that during the class period, Defendants issued materially fa ...
QuidelOrtho (QDEL) - 2024 Q1 - Earnings Call Transcript
2024-05-09 00:08
Financial Data and Key Metrics Changes - First quarter 2024 revenue was $711 million, down from $846 million in the prior year, primarily due to COVID-19 related declines [117] - Excluding COVID-19 revenue, total revenue grew by 6% in constant currency, with a 10% growth when excluding a one-time $21 million third-party collaboration settlement from the previous year [117] - Adjusted EBITDA was $132 million compared to $245 million in the prior year, with an adjusted EBITDA margin of 19% versus 29% [51] - The company recorded a noncash goodwill impairment charge of $1.7 billion for the North America reporting unit due to a decrease in estimated fair value [19] Business Line Data and Key Metrics Changes - First quarter 2024 respiratory revenue was $137 million, including approximately $50 million in COVID-19 revenue, with a 48% year-over-year decrease primarily due to lower COVID-19 revenue [18][106] - Non-respiratory revenue was flat at $574 million, but grew 4% when excluding the one-time collaboration settlement [18] - Point-of-Care business grew approximately 38% year-over-year, driven by strong sales of Sofia tests [31] - Molecular Diagnostics revenue grew approximately 15%, albeit from a low base [31] Market Data and Key Metrics Changes - Revenue growth in North America was 5%, EMEA grew 6%, China grew 12%, and the Rest of the World grew 6% in constant currency, excluding COVID-19 revenue [50] - The company expects COVID-19 revenue for the full year 2024 to be approximately $150 million, down from a prior expectation of $225 million [52] Company Strategy and Development Direction - The company is focused on improving profitability and cash flow while reducing debt levels, with a target of $100 million in annualized savings from headcount reductions [112][117] - The new CEO emphasized the importance of customer satisfaction and patient care, as well as the need for a competitive product offering in the market [116][34] - The company is working on producing a competitive respiratory panel for the U.S. market and expanding its test menu [32] Management's Comments on Operating Environment and Future Outlook - Management acknowledged challenges in forecasting respiratory and flu sales, implementing a new methodology to improve accuracy [2][43] - The company plans to resume guidance later in 2024 after assessing the business under new leadership [108][56] - Management expects Q2 to be seasonally low for revenue and margins, with improvements anticipated in the second half of 2024 [10][65] Other Important Information - The company amended its credit agreement to increase the maximum consolidated leverage ratio, providing a cushion for financial flexibility [37][119] - The effective tax rate for Q1 2024 was 23.5%, consistent with the prior year [19] Q&A Session All Questions and Answers Question: How involved were you in the forecasting of respiratory and flu sales? - Management acknowledged that they overcalled COVID and flu revenue in Q4 2023 and have implemented a new forecasting methodology [2] Question: What is the trajectory on the leverage piece as we work through the year? - The leverage ratio is expected to creep up slightly in Q2 but will start to come down in Q3 and Q4, with an expected year-end ratio of around 3.5 times [10] Question: What are your views on the competitive landscape for Savanna? - The new CEO expressed confidence in the competitive product offering and emphasized the need to get the menu of tests to market quickly [34][81] Question: Can you discuss customer conversations around Sofia ahead of the next respiratory season? - Management indicated that they are actively engaging with customers regarding contract renewals and leveraging the installed base of Sofia tests [95] Question: What are the expectations for gross margins throughout the year? - Management expects Q2 to be the lowest quarter for gross margins, with improvements anticipated in Q3 and Q4 due to seasonally higher revenues [65][69]
QuidelOrtho (QDEL) - 2024 Q1 - Earnings Call Presentation
2024-05-08 22:18
© 2024. All Rights Reserved. 3 (76%) y/y3 Q1 2024 Highlights1Total Revenue $711M (16 %) y/y1 Global year-over-year revenue growth 2 3 across regions of 5% as reported and 6% in constant currency ("CC"), excluding COVID-19 revenue Adjusted EBITDA $132M 19% Margin2 Adjusted Diluted EPS $0.44 • Excluding the one-time thirdparty collaboration settlement in Q1'23, non-respiratory revenue grew 3% as reported and 4% in CC • Excluding government COVID19 orders, respiratory revenue grew 6% as reported and in CC © 20 ...
QuidelOrtho (QDEL) - 2025 Q1 - Quarterly Report
2024-05-08 22:04
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ____________________________________________________________________________ FORM 10-Q ____________________________________________________________________________ (Mark One) QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 or TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commi ...
QuidelOrtho (QDEL) - 2025 Q1 - Quarterly Results
2024-05-08 20:07
Exhibit 99.1 May 8, 2024 QuidelOrtho Reports First Quarter 2024 Financial Results - Global year-over-year revenue growth of 5% as reported and 6% in constant currency, excluding COVID-19 revenue - - Cost reduction initiatives well underway, headcount reductions expected to deliver approximately $100 million in annualized savings - - Company suspends 2024 financial guidance while it assesses business under new President and Chief Executive Officer - First Quarter 2024 Results and Recent Highlights SAN DIEGO, ...
QuidelOrtho (QDEL) - 2023 Q4 - Annual Report
2024-02-29 20:29
Global Operations - QuidelOrtho operates globally with manufacturing facilities in the U.S. and U.K., serving customers in over 130 countries[17]. - The company operates in over 130 countries with approximately 2,900 commercial sales, service, and regional marketing teammates, supporting a broad global footprint[34]. - The company manages its business geographically, with reportable segments including North America, EMEA, and China[18]. Product Offerings and Innovation - The company generated revenue primarily from Labs, Transfusion Medicine, Point of Care, and Molecular Diagnostics business units[21]. - The QuickVue At-Home OTC COVID-19 test was introduced to new markets, including school districts and health departments[18]. - The Vitros XT 7600 integrated system offers 40% greater test throughput and a 98% up-time guarantee for e-connected U.S. customers[23]. - The Savanna platform can run up to 12 unique analytes from a single patient sample in less than 25 minutes[25]. - The Triage platform aids in diagnosing critical conditions, potentially reducing hospital admissions and improving clinical outcomes[26]. - QuidelOrtho's molecular diagnostics include the Lyra and Solana platforms, which provide high-quality testing for infectious diseases[25]. - The company completed a business combination with Ortho Clinical Diagnostics, enhancing its diagnostic capabilities[18]. - QuidelOrtho's product portfolio includes over 60 immunoassay tests, utilizing enhanced chemiluminescent technology for precision[23]. - The strategic focus includes expanding into the at-home testing market, with plans for additional tests such as for flu and RSV, reflecting a response to evolving healthcare needs[37]. Research and Development - R&D expenses increased to $246.8 million for fiscal year 2023, up from $190.5 million in 2022 and $95.7 million in 2021, indicating a strong commitment to innovation and product development[41]. - The company aims to leverage third-party partnerships and acquisitions to enhance R&D capabilities and accelerate time to market for innovative offerings[39]. Supply Chain and Manufacturing - The company operates multiple manufacturing facilities in the U.S. and internationally, all certified to ISO 13485:2016 and MDSAP medical device standards, ensuring compliance with quality management systems[52][53][54][55][56][57][58]. - The company is diversifying its supply base and creating redundancy in its global supply chain to mitigate supply chain challenges[61]. - In fiscal years 2023 and 2022, the company faced increasing pressures on raw material pricing, although the pressures were less severe in 2023 compared to 2022[61]. Regulatory Compliance - The company’s diagnostic products are primarily marketed in the U.S. under 510(k) clearances and PMA approvals, which are subject to rigorous FDA regulations[70][73]. - The FDA can authorize emergency use of unapproved medical products during public health emergencies, which has applied to some of the company's respiratory products[71]. - The company must adhere to various healthcare-related laws regulating fraud, abuse, and marketing practices[87]. - The company is subject to various privacy, data security, and data protection laws, including HIPAA and GDPR, which impose significant compliance obligations and potential fines of up to €20 million or 4% of total worldwide annual turnover[90]. - The company is subject to routine inspections by the FDA and other regulatory agencies to ensure compliance with applicable requirements, including the FDA's Quality System Regulation[189]. Financial Performance and Market Risks - Sales of respiratory products accounted for approximately 24% of total revenues for the year ended December 31, 2023[127]. - A significant portion of revenues is generated from a limited number of product families, particularly respiratory products, which have higher gross margins compared to other core products[128]. - The company faces risks from global market conditions, including economic downturns, inflation, and geopolitical instability, which could adversely affect sales and profitability[125]. - The company relies on a small number of key distributors for sales, and the loss of any of these distributors could significantly disrupt business operations[129]. - The company may experience challenges in achieving market acceptance of new products, which could impact future sales levels[145]. Employee and Corporate Governance - As of December 31, 2023, the company had approximately 7,100 employees worldwide, with 4,200 in the U.S. and 2,900 outside the U.S.[101]. - Approximately 15% of global associates are covered by a union or collective bargaining agreement, with no work stoppages reported to date[101]. - The executive management team consists of 8 members, with 25% identifying as female, and the board of directors has 27% female representation[107]. - The company plans to conduct periodic pulse surveys throughout 2024 to measure employee engagement and satisfaction[103]. - Employee benefits include health insurance, retirement plans with employer match, and various voluntary benefits tailored to individual needs[108]. Environmental and Social Responsibility - The company is committed to maintaining compliance with environmental regulations, with no expected material impact on financial position from current compliance costs[110]. - The company aims to align corporate actions with environmental sustainability and social responsibility to positively impact communities and stakeholders[113]. - The company has established a charitable giving program that includes matching employee contributions up to $200 annually and donations for volunteer work[115]. Cybersecurity and Intellectual Property - Cybersecurity risks pose a threat to the company's information systems, which are critical for business operations and may lead to costly disruptions[164]. - The company employs various measures to mitigate cybersecurity risks, including technical, physical, and organizational security measures, but vulnerabilities remain due to evolving threats[166]. - The company holds significant intellectual property, including patents and trade secrets, which are crucial for maintaining competitive advantage in the diagnostic market[171]. - Failure to protect intellectual property rights could lead to loss of market share or the need to reduce prices due to competition from lower-priced products[172].