QDEL — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-05-06

• For the three months ended March 29, 2026, Total revenues decreased by 11% to $619.8 million as compared to the same period in the prior year. This decrease was primarily driven by (i) variability of our U.S. respiratory products, mainly due to decreases in flu and COVID-19 revenues, and (ii) the te…

• In February 2024, we initiated a wind-down plan to transition out of the U.S. donor screening portfolio. Specifically, we are winding-down the ORTHO VERSEIA Integrated Processor platform and microplate assays, which are only sold in the U.S. and have a lower growth and margin profile. This wind-down…

• In the second quarter of 2025, we launched the Optimization Plan that aims to (i) realign our costs with our long-term revenue expectations, (ii) drive operational efficiencies in manufacturing and distribution cost bases and (iii) support and align with our strategy to invest in key priorities. The…

• •Rationalization and consolidation of facilities to reduce operational costs, improve processes, and optimize resource allocation;

• •A structured approach to procurement to drive identified sourcing cost savings; and

Text removed vs the prior filing · source: 10-Q · 2025-11-06

• September 28, 2025, respectively, and $24.0 million and $75.0 million for the three and nine months ended September 29, 2024, respectively.

• For the nine months ended September 28, 2025, Total revenues decreased by 3% to $2,006.6 million as compared to the same period in the prior year. This decrease was primarily driven by variability of our U.S. respiratory products, mainly due to a decrease in COVID-19 revenues, partially offset by an…

• In February 2024, we initiated a wind-down plan to transition out of the U.S. donor screening portfolio. Specifically, we plan to wind-down only the ORTHO VERSEIA® Integrated Processor platform and microplate assays, which are only sold in the U.S. and have a lower growth and margin profile. This wi…

• In the second quarter of 2025, we launched multi-year, enterprise-wide cost-reduction, strategic productivity and margin improvement initiatives (the “Optimization Plan”) that aim to (i) realign our costs with our long-term revenue expectations, (ii) drive operational efficiencies in manufacturing a…

• •Rationalization and consolidation of facilities to reduce operational costs, improve processes, and optimize resource allocation.

Text added vs the prior filing · source: 10-Q · 2026-05-06

• Evaluation of disclosure controls and procedures: We have performed an evaluation under the supervision and with the participation of our management, including our CEO and CFO, of the effectiveness of our disclosure controls and procedures, as defined in Exchange Act Rules 13a-15(e) and 15d-15(e). B…

• Changes in internal control over financial reporting: There were no changes in our internal control over financial reporting during the fiscal quarter ended March 29, 2026 that materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

Text removed vs the prior filing · source: 10-Q · 2025-11-06

• Evaluation of disclosure controls and procedures: We have performed an evaluation under the supervision and with the participation of our management, including our CEO and CFO, of the effectiveness of our disclosure controls and procedures, as defined in Exchange Act Rules 13a-15(e) and 15d-15(e). B…

• Notwithstanding the material weakness, we have concluded that the Company’s unaudited Consolidated Financial Statements included in this report are fairly stated in all material respects in accordance with GAAP for each of the periods presented.

• Ongoing remediation efforts to address the previously identified material weaknesses: With respect to the material weaknesses in our internal control over financial reporting that was previously reported in the Company’s Annual Report, management, under the oversight of the Audit Committee, is in th…

• Implementation of ERP systems: In June 2025, we began migrating certain of our financial processing systems to a new instance of SAP. These system implementations are part of our ongoing global integration efforts and continued through the third quarter of 2025. We plan to continue implementing such…

• Changes in internal control over financial reporting: Except with respect to the continued implementation of ERP systems, there were no changes in our internal control over financial reporting during the fiscal quarter ended September 28, 2025 that materially affected, or are reasonably likely to ma…