CONFLICT MINERALS REPORT
For The Year Ended December 31, 2025
Introduction
All references to "the Company," "we," "our" and "us" in this Conflict Minerals Report (this "Report") refer to QuidelOrtho Corporation ("QuidelOrtho") and its subsidiaries.
This Report of the Company for the year ended December 31, 2025 ("calendar year 2025") is presented to comply with Rule 13p-1 (the "Rule") under the Securities Exchange Act of 1934, as amended (the "Exchange Act"). The Rule imposes certain reporting obligations on registrants who manufacture products, or contract to manufacture products, containing certain minerals which are necessary to the functionality or production of those products. These minerals are cassiterite, columbite-tantalite (coltan), gold, wolframite, and their derivatives, which are limited to tin, tantalum and tungsten ("3TG" or "Conflict Minerals"). The Rule focuses on 3TG emanating from the Democratic Republic of Congo ("DRC") region and nine adjoining countries (together, the "Covered Countries"). If, based on a Reasonable Country of Origin Inquiry ("RCOI"), an issuer has reason to believe that any of the Conflict Minerals in its supply chain may have originated in the Covered Countries and may not be from recycled or scrap sources, then the issuer must exercise due diligence on the Conflict Minerals' source and chain of custody and submit a report to the Securities and Exchange Commission ("SEC") that includes a description of those due diligence measures.
This Report relates to the process undertaken for our products that were manufactured, or contracted to be manufactured, during calendar year 2025 and that contain or may contain Conflict Minerals.
Company Overview
Our vision is to advance diagnostics to power a healthier future. With our expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine, we aim to provide clarity to clinicians and patients to help create better health outcomes. Our global infrastructure and commercial reach support our customers across more than 140 countries and territories with quality diagnostics, a broad test portfolio and market-leading service. We operate globally with manufacturing facilities in the U.S., U.K. and China and with sales centers, administrative offices and warehouses located throughout the world.
We currently sell our products directly to end users through a direct sales force and through a network of distributors, for professional use in physician offices, hospitals, clinical laboratories, reference laboratories, urgent care clinics, universities, retail clinics, pharmacies, wellness screening centers, other point-of-care settings, blood banks and donor centers, as well as for individual, non-professional, over-the-counter use.
Description of Our Products Covered by This Report
This Report relates to our products: (i) that contain or may contain 3TG; (ii) that were manufactured, or contracted to be manufactured, by us; and (iii) for which the manufacture was completed during calendar year 2025. During this reporting period, we identified the following products as meeting this standard: our ORTHO OPTIX™ Reader, ORTHO VISION™ Max Swift Analyzer, ORTHO VISION Swift Analyzer, ORTHO™ Workstation, SAVANNA™ Real-Time PCR Testing Platform, SOFIA™ Analyzer, SOFIA™ 2 Analyzer, QUIDEL™ TRIAGE™ System, VITROS™ 4600 Chemistry System, VITROS ECiQ Immunodiagnostic System, VITROS 3600 Immunodiagnostic System, VITROS 5600 Integrated System, VITROS XT 7600 Integrated System, and VITROS XT 3400 Chemistry System.
1
Supply Chain
Our supply chain is complex and there are many third parties in the supply chain between the ultimate manufacture of our products and the original sources of 3TG. In this regard, we do not purchase 3TG directly from mines, smelters or refiners. We must therefore rely on our suppliers to provide information regarding the origin of the 3TG that is contained in our products. Moreover, we believe that the smelters and refiners of the 3TG are best situated to identify the sources of 3TG, and therefore have taken steps to identify the applicable smelters and refiners of 3TG that may be in our supply chain.
Conflict Minerals Compliance Program
We performed a RCOI on suppliers we believe provided materials or components containing 3TG necessary to the manufacturing of our products during calendar year 2025. Since many of our suppliers in calendar year 2025 provided similar materials or components containing 3TG as in calendar year 2024, we omitted suppliers from the scope of our 2025 RCOI who did not provide materials or components containing 3TGs based on data from the 2024 RCOI and did not add new parts compared to calendar year 2024 or earlier. As a result, fewer suppliers were contacted as part of this year's process compared to the prior year - a total of 179 suppliers were contacted, and 159 suppliers, or 89%, responded to our RCOI. Our suppliers identified 336 valid smelters and refineries ("Smelters") that may be in our supply chain. Of these 336 Smelters, we identified 48 as either sourcing or potentially sourcing 3TG from the Covered Countries. Our due diligence review indicated that 33 of these Smelters have been audited and recognized as conformant to the Responsible Minerals Assurance Process ("RMAP"). The remaining 15 Smelters potentially sourcing from the Covered Countries were subject to our due diligence process, which we designed to conform, in all material respects, with the Organisation for Economic Co-operation and Development's Due Diligence Guidance for Responsible Supply Chain of Minerals from Conflict-Affected and High-Risk Areas (the "OECD Guidance"), including related supplements. Below is a summary of the design of our due diligence program as it relates to the five-step framework under the OECD Guidance.
(1) Step One: Establish Strong Management Systems
Step 1A - Conflict Minerals Policy. We have adopted a policy on conflict minerals in accordance with the OECD Guidance that is publicly available at www.quidelortho.com through the "Investor Relations" link under the heading "Governance." Our policy sets forth our commitment to sourcing components and materials from companies that share our values regarding respect for human rights, integrity, and environmental responsibility. Our policy is communicated directly to our suppliers as part of the RCOI process and upon customer request, is communicated to customers in our Conflict Minerals Reporting Template ("CMRT").
Step 1B - Conflict Minerals Internal Management Structure. We have established a team comprised of representatives from our operations and legal departments to support our supply chain due diligence efforts and report its findings to a senior member of the supply chain management organization. This cross-functional internal team is also responsible for maintaining compliance with applicable SEC guidance, including the Rule, the adopting release associated with the Rule, and the related FAQs published by the SEC staff. In calendar year 2025, we engaged Claigan Environmental Inc. ("Claigan"), a recognized third-party professional consultant, to assist the Company in our efforts to implement the due diligence process in accordance with the OECD Guidance.
Step 1C - System of Controls Transparency, Information Collection and Control Over Supply Chain. We implemented a detailed process to collect required supplier and Smelter RCOI and due diligence data. The lists of RMAP conformant Smelters and Smelters actively working towards conformance provide a method of identifying potential risks in our supply chain. Additional details on the supply chain data gathering are included in the "Supplier RCOI" and "Due Diligence" sections of this Report. In addition, we retain documentation with respect to our due diligence compliance process in accordance with our record retention requirements. Our policy is to retain supplier, RCOI and due diligence data that we collect for at least five years.
Step 1D - Supplier Engagement. In calendar year 2025, we engaged Claigan to assist us in engaging with suppliers during the RCOI process. Additionally, in calendar year 2025, QuidelOrtho's supplier terms and conditions required
2
suppliers to comply with the Rule and provide information upon request to verify compliance. If a supplier is not in compliance with the Rule, the supplier must develop, implement and document plans to remedy such non-compliance.
Step 1E - Grievance Mechanism. We provide an ethics hotline so that our employees and suppliers can anonymously report any concerns, including those related to Conflict Minerals. We also maintain an e-mail address (
[email protected]) for suppliers and employees to report violations, ask questions and voice concerns regarding Conflict Minerals.
(2) Step Two: Identify and Assess Risks in the Supply Chain
In calendar year 2025, we conducted our RCOI and due diligence process with the assistance of Claigan. When suppliers did not respond, there were up to 3 attempts to request their CMRT.
Supplier RCOI
We designed our supplier RCOI process to identify the Smelters in our supply chain. Our supplier RCOI process for calendar year 2025 included:
•developing a list of all suppliers providing 3TG-containing components necessary to the functionality of our products;
•contacting each supplier and requesting Conflict Minerals data using the industry standard CMRT;
•reviewing supplier responses for accuracy and completeness and following up with suppliers when there are apparent inaccuracies or omissions;
•aggregating supplier-provided Smelters into a single unique list of Smelters meeting the definition of a Smelter under one of three industry-recognized audit protocols; and
•reviewing and validating the final Smelter list (and comparing it to industry peers) to determine if we reasonably identified all the Smelters in our supply chain.
Through the supplier RCOI process we identified 336 Smelters in our supply chain.
Due Diligence
We endeavored to engage with each Smelter identified in our supply chain to determine whether they sourced from the Covered Countries. For Smelters for which we could confirm, either directly or through industry associations, that they did not source from the Covered Countries but who were not recognized as conformant to the RMAP, we reviewed publicly available information to determine whether there was any evidence that contradicted the Smelter's declaration. In doing so, we reviewed sources such as NGO publications and the most recent United Nations Group of Experts reports on the DRC, in addition to performing public internet searches.
If Smelters did not respond to our inquiry, we reviewed the same publicly available sources to determine whether there was reason to believe the Smelter may have sourced from the Covered Countries during calendar year 2025.
We categorized Smelters that are sourcing or potentially sourcing from the Covered Countries and not currently RMAP conformant as high-risk, in alignment with the OECD Guidance. We conducted the risk mitigation procedures described below on all high-risk Smelters.
Of the 336 unique Smelters identified, 48 Smelters source, or there was reason to believe they may source, from the Covered Countries. We determined that 33 of these 48 Smelters have been audited and recognized as conformant to the RMAP. We conducted risk mitigation on the remaining 15 Smelters. Since most suppliers provide company level responses, which may include Smelter information for materials or components not sold to the Company, we are unable to determine whether any 3TG in our products was actually supplied from these Smelters. A list of Smelters
3
identified by our suppliers as potentially in our supply chain and the known countries from which such Smelters may have sourced necessary 3TG is set forth in Annex I below.
(3) Step Three: Design and Implement a Strategy to Respond to Identified Risks
We conducted risk mitigation on 15 Smelters that were identified as non-conformant to the RMAP and were sourcing or potentially sourcing from the Covered Countries. Our risk mitigation was designed in accordance with the OECD Guidance and was reported to our Chief Operations Officer in accordance with the OECD Guidance.
As part of our risk mitigation process, we performed additional due diligence to determine if there was reason to believe the Smelters directly or indirectly financed or benefited armed groups in the DRC or Covered Countries. We also attempted to verify with internal stakeholders and relevant suppliers whether the 3TGs from the Smelter in question were actually in our supply chain during calendar year 2025. Finally, if necessary and where possible, we engaged directly with the Smelter to encourage them to become audited and recognized as conformant to the RMAP.
We did not require the removal of Smelters if there was no reason to believe they were directly or indirectly financing or benefitting armed groups in the Covered Countries. However, we plan to re-evaluate the appropriateness of these Smelters in our supply chain in 2026.
We are committed to continued improvement in our due diligence process to further mitigate the risk that the 3TG materials in our products could directly or indirectly benefit or finance armed groups in the Covered Countries. We continue to engage with our suppliers to increase supplier response rates and improve the timeliness, accuracy, and comprehensiveness of the supplier survey responses we receive. We also continue to work with our suppliers to encourage them to source from RMAP conformant Smelters when sourcing material from the Covered Countries. Finally, we are attempting to engage with Smelters sourcing from the Covered Countries to encourage them to become audited to a protocol recognized by the RMAP.
(4) Step Four: Third-Party Audit
As discussed above, we do not have a direct relationship with 3TG Smelters, nor do we perform direct audits of these entities that provide our supply chain with Conflict Minerals. However, we do rely upon the Responsible Minerals Initiative's efforts to influence Smelters to get audited and certified through RMAP, the London Bullion Market Association Good Delivery Program or the Responsible Jewellery Council Chain-of-Custody Certification.
(5) Step Five: Report on Supply Chain Due Diligence
As indicated in the Form SD, we have filed this Report with the SEC and have made this Report available on our website at www.quidelortho.com through the "Investor Relations" link under the heading "Governance."
Limitations
As a downstream purchaser of 3TG, our due diligence measures cannot provide absolute assurance regarding the source and chain of custody of the necessary Conflict Minerals. Our due diligence processes require us to seek data from our suppliers and those suppliers seeking similar information within their supply chains to identify the original sources of the necessary Conflict Minerals. We also rely on third-party audit programs and other industry efforts and information.
A number of factors could introduce errors or otherwise affect our determinations, including, but not limited to, gaps in supplier data, gaps in Smelter data, errors or omissions by suppliers, errors or omissions by Smelters, confusion over SEC requirements, gaps in supplier education and knowledge, timeliness of data, public information not discovered during a reasonable search, errors in public data, language barriers and translation, supplier and Smelter unfamiliarity with the reporting process, oversights or errors in conflict-free Smelter audits, Covered Country sourced materials being declared secondary materials, certification programs not being equally advanced for all industry segments and metals, and smuggling of Conflict Minerals to countries beyond the Covered Countries.
4