SAN DIEGO, July 22, 2025 /PRNewswire/ -- QuidelOrtho Corporation (Nasdaq: QDEL) (the "Company" or "QuidelOrtho"), a global provider of innovative in vitro diagnostic technologies designed for point-of-care settings, clinical labs and transfusion medicine, announced today that it will report its financial results for its second quarter 2025 ended June 29, 2025, after the market close on Tuesday, August 5, 2025.Following the release of financial results, QuidelOrtho will hold a conference call beginning at 2: ...

Accessibility StatementSkip Navigation Session Title: Real Labs, Real Decisions with Actionable Six Sigma Metrics When: Tuesday, July 29, 2025 Where: McCormick Convention Center Chicago, IL Exhibit Hall, Theater 1 Time: 2:45 p.m. – 3:45 p.m. CT Registration: Space is limited. ADLM attendees can register for the session usingthis link: https://www2.na-ma.quidelortho.com/25-adlm-workshop-subscribeMedia registered for ADLM – please reach out to Nikki Wheeler toaccess the session at [email  ...

This collaboration addresses key healthcare trends, including the rise of non-invasive diagnostic tools, the demand for cost-effective healthcare solutions, and the growing focus on gastrointestinal and pancreatic health and its systemic impact. The fCAL and fPELA turbo assays exemplify innovation in diagnostics technology, supporting the shift toward tailored medicine and preventive healthcare. The fCAL and fPELA turbo assays are both now available for use on QuidelOrtho's VITROS Systems (fCAL turbo and fP ...

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Core Viewpoint - QuidelOrtho (QDEL) has been upgraded to a Zacks Rank 2 (Buy) due to an upward trend in earnings estimates, which is a significant factor influencing stock prices [1][3]. Earnings Estimates and Stock Price Impact - The Zacks rating system is based on changes in earnings estimates, which are closely correlated with near-term stock price movements [4][6]. - Institutional investors often rely on earnings estimates to determine the fair value of a company's shares, leading to significant stock price movements when estimates are revised [4]. Company Performance and Outlook - The upgrade indicates an improvement in QuidelOrtho's underlying business, suggesting that investors may respond positively by driving the stock price higher [5][10]. - For the fiscal year ending December 2025, QuidelOrtho is expected to earn $2.39 per share, with a 4.6% increase in the Zacks Consensus Estimate over the past three months [8]. Zacks Rank System - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with a strong historical performance, particularly for Zacks Rank 1 stocks, which have generated an average annual return of +25% since 1988 [7][9]. - QuidelOrtho's upgrade to Zacks Rank 2 places it in the top 20% of Zacks-covered stocks, indicating a strong potential for market-beating returns in the near term [10].

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Summary of Quidel Ortho Conference Call Company Overview - Quidel Ortho was formed by the merger of Quidel and Ortho Clinical Diagnostics in May 2022, focusing on four major business areas: labs, transfusion medicine, point of care, and molecular diagnostics [5][6] - The company reported approximately $2.8 billion in revenue for the full year 2024, with North America contributing 58% of total revenues [6][7] Market Position and Growth Opportunities - The in vitro diagnostics market is valued at $50 billion, growing in the mid-single digits, with Quidel Ortho targeting segments worth approximately $20 billion [9] - The labs business generated $1.4 billion in revenue in 2024, representing about 50% of total revenue, and is expected to grow consistently [10] - The transfusion medicine business, excluding donor screening, generated $523 million in revenue in 2024, with low single-digit growth expected [12] - Point of care contributed $694 million in revenue in 2024, with mid-single-digit growth anticipated [13] - Molecular diagnostics revenue was $24 million in 2024, identified as a significant near-term growth opportunity [13] Strategic Initiatives - The company announced plans to acquire full ownership of Lex Diagnostics for approximately $100 million, aiming to enhance its product portfolio [14][15] - Discontinuation of the Savanna platform was decided due to unsatisfactory clinical trial results, allowing a focus on more promising technologies [15] - The Lex platform is expected to provide rapid and accurate testing, integrating well into existing workflows [16][17] Financial Performance and Cost Management - In Q1, Quidel Ortho achieved a 6% revenue growth, excluding COVID and donor screening, with a 450 basis point improvement in adjusted EBITDA [23] - Cost savings of over $100 million were identified in 2024, with an additional $30 million to $50 million expected in 2025 [22] - The company aims to reduce its net leverage ratio to 2.5 to 3.5 times while expanding margins [24][25] Future Outlook - The company reaffirmed its 2025 financial guidance, targeting mid to high 20s adjusted EBITDA margin [25] - Capital allocation will prioritize business needs, including menu expansion and molecular strategy, while focusing on cash generation and debt reduction [26] - Quidel Ortho is positioned for profitable growth with a strong value proposition and stable underlying business [27]

Acquisition of LEX Diagnostics - QuidelOrtho intends to acquire LEX Diagnostics for approximately $100 million at closing, pending FDA clearance expected in late 2025 or early 2026 [5] - An additional earnout component of up to $40 million may be payable for up to 6 years following the acquisition's closing [5] - The acquisition aims to strengthen QuidelOrtho's participation in the approximately $9 billion molecular diagnostics market [10] - LEX Diagnostics' system can report positive results in approximately 6 minutes with a single multiplex test for the detection and differentiation of Flu A, Flu B and COVID-19, while negative results can be reported in approximately 10 minutes [9] Discontinuation of Savanna Platform - QuidelOrtho plans to discontinue its Savanna platform development due to factors including recent clinical trial results [5] - No contribution from U S Savanna respiratory products is expected in 2025 [19] Financial Guidance - QuidelOrtho reaffirms its full-year 2025 financial guidance, with total revenues expected to be between $260 billion and $281 billion [17] - Adjusted EBITDA is projected to be between $575 million and $615 million, with an adjusted EBITDA margin of 22% [17] - Adjusted diluted EPS is expected to be in the range of $207 to $257 [17]

QuidelOrtho (QDEL) Conference Call Summary Company Overview - **Company**: QuidelOrtho - **Date of Call**: June 03, 2025 - **Key Participants**: Brian Blazer (CEO), Joe Bueske (CFO), Jonathan Segrist (EVP of R&D and CTO), Tammy Rinali (SVP and Business Unit Leader for Point of Care and Molecular Diagnostics) Core Industry Insights - **Industry**: Molecular Diagnostics - **Market Size**: Approximately $9 billion, growing in low double digits annually [18] - **Market Segmentation**: - Centralized hospital-based testing (growing at mid to high single digits) - Decentralized testing (growing at double-digit rates) [19][20] Key Announcements - **Acquisition of Lex Diagnostics**: - QuidelOrtho intends to acquire full ownership of Lex Diagnostics for approximately $100 million, contingent upon FDA clearance [5][24]. - Lex Diagnostics specializes in rapid molecular diagnostics, providing results in about six minutes for respiratory panels [6][8]. - The acquisition is expected to enhance QuidelOrtho's product portfolio and drive growth in molecular diagnostics [10][22]. - **Discontinuation of Savanna Platform**: - QuidelOrtho will discontinue the development of the Savanna platform due to underperformance in clinical trials and high costs associated with further development [9][10]. - A one-time noncash write-off of approximately $130 million to $150 million will be recorded related to the Savanna platform [25]. Technology and Product Insights - **Lex Diagnostics Technology**: - Utilizes a proprietary thermal cycling technology that combines speed and sensitivity, making it suitable for point-of-care applications [15][16]. - The platform is designed for ease of use, requiring no liquid handling, and is fully automated [16]. - Initial product offerings will include a multiplex assay for Flu A, Flu B, and COVID, with future expansions planned for other respiratory and women's health assays [22][23]. - **Performance Advantages**: - Lex's technology is expected to deliver results faster than competing systems, with a turnaround time of under ten minutes [21]. - The platform is designed to meet the growing demand for decentralized testing, which emphasizes speed, ease of use, and cost [20]. Financial Implications - **Investment and Funding**: - The acquisition will be funded through a combination of cash and a revolving line of credit, with potential earn-out payments of up to $40 million over six years [25]. - QuidelOrtho expects to see an annualized incremental benefit of approximately $25 million from discontinuing the Savanna platform [26]. - **2025 Financial Guidance**: - The company reaffirms its financial guidance for 2025, despite the discontinuation of the Savanna platform, due to macroeconomic uncertainties [26][75]. - Anticipated top-line growth for Lex is projected to begin in the second half of 2026, with margins expected to be accretive as product volume scales [27][28]. Market Strategy - **Positioning**: - QuidelOrtho aims to establish a leadership position in the decentralized molecular testing market through the Lex platform [20]. - The company plans to launch the Lex platform initially with a focus on respiratory assays, followed by expansions into other areas [22][23]. Additional Considerations - **Competitive Landscape**: - QuidelOrtho has evaluated various competitive platforms and believes Lex offers a superior value proposition due to its speed, cost, and ease of use compared to isothermal technologies [60]. - **Regulatory Pathway**: - Lex is expected to file for FDA clearance soon, with approval anticipated in late 2025 or early 2026 [8][25]. This summary encapsulates the key points discussed during the QuidelOrtho conference call, highlighting the company's strategic direction, market opportunities, and financial outlook.

Core Viewpoint - QuidelOrtho Corporation is refocusing its molecular diagnostics strategy by planning to acquire full ownership of LEX Diagnostics for approximately $100 million after FDA clearance and discontinuing the development of its Savanna platform [1][4][6] Company Strategy - The intended acquisition of LEX Diagnostics aims to strengthen QuidelOrtho's position in the rapidly growing point-of-care molecular diagnostics market [4][5] - The decision to discontinue the Savanna platform development is based on recent clinical trial results and a strategic review of market opportunities [5][6] LEX Diagnostics Overview - LEX Diagnostics specializes in molecular diagnostics, offering ultra-fast testing capabilities that can deliver positive results in about six minutes for Flu A, Flu B, and COVID-19 [3] - The technology integrates into point-of-care workflows, providing high sensitivity comparable to PCR testing at competitive prices [3] Financial Guidance - QuidelOrtho is maintaining its fiscal 2025 financial guidance as previously provided, indicating stability in its financial outlook despite the strategic changes [7]