RMDResMed

system requirements of ISO 13485:2016. Although the FDA has stated that the We are subject to substantial regulation related to quality standards contained in ISO 13485:2016 are substantially similar applicable to those set forth in the QSR, our manufacturing and although our quality system is currently designed processes. Our failure to comply with ISO these standards in connection with our device certifications, it is unclear the extent to which this final rule, once effective, could impose additional or different regulatory requirements on us that could increase the costs of compliance or otherwise negatively affect our business. If we are unable to comply with QMSR, once effective, or with any other new or existing laws or regulations enforced by FDA or comparable regulatory authorities, we may be subject to enforcement action, which could have an adverse effect on our business, financial condition condition, or results of operations. The FDA regulates the approval, manufacturing, and sales and marketing of many of our products in the U.S. Significant government regulation also exists in Canada, Japan, Europe, Australia, China, and other countries in which we conduct business. In February 2026, the FDA implemented the Quality Management System Regulation (QMSR), which replaces the prior FDA Quality System Regulation in setting forth the current good manufacturing practice (cGMP) requirements for medical devices, and incorporates ISO 13485 into U.S. law. The QMSR introduces changes to documentation, terminology, and inspection approaches, including expanded FDA visibility into internal audit, supplier oversight, and management review activities. As a device manufacturer, we are required to register with the FDA and are subject to periodic inspection by the FDA for compliance with the FDA’s QMSR, requirements, which require manufacturers of medical devices to adhere to certain regulations, including testing, quality control and documentation procedures. It remains unclear the extent to which the QMSR may impose additional or different regulatory requirements on us. Compliance may require ongoing updates to our processes, systems, and training, and failure to maintain compliance could result in regulatory actions, product recalls, or delays in approvals, which could adversely affect our business, financial condition, and results of operations. In addition, the federal Medical Device Reporting regulations require us to provide information to the FDA whenever there is evidence that reasonably suggests that a device may have caused or contributed to a death or serious injury or, if a malfunction were to occur, could cause or contribute to a death or serious injury. Compliance with applicable regulatory requirements is subject to continual review and is rigorously monitored through periodic inspections by the FDA. In the European Union, we are required to maintain certain ISO certifications and comply with the Medical Device Regulation (MDR) in order to sell our products and must undergo periodic inspections by notified bodies to obtain and maintain these certifications. Failure to comply with current governmental regulations and quality assurance guidelines could lead to temporary manufacturing shutdowns, product recalls or related field actions, product shortages or delays in product manufacturing. Efficacy or safety concerns, an increase in trends of adverse events in the marketplace, and/or manufacturing quality issues with respect to our products could lead to product recalls or related field actions, withdrawals, and/or declining sales.

Total other income (loss), net for the year ended June 30, 2025 2026 was a loss income of $7.8 $33 million, compared to a loss of $55.1 $8 million for the year ended June 30, 2024. 2025. We recorded interest income, net, of $4.1 $50 million for the year ended June 30, 2026 compared to interest income, net, of $4 million for the year ended June 30, 2025 compared to interest expense, net of $45.7 million for the year ended June 30, 2024 due to lower debt levels following the repayment of our revolving credit facility facility, gains recognized on cross-currency swaps associated with our fair value and net investment hedges, and interest earned on cash balances. Losses associated with our investments in marketable and non-marketable equity securities were $10.3 million for the year ended June 30, 2025 compared to a loss of $4.0 million or the year ended June 30, 2024. Losses associated with our investments in marketable and non-marketable equity securities were partially offset by We also recognized a gain attributable to equity method investments for the year ended June 30, 2025 2026 of $3.6 $7 million, compared to a loss gain of $1.8 $4 million for the year ended June 30, 2024. 2025. Interest income, net, and gains attributable to equity method investments were partially offset by losses associated with our investments in marketable and non-marketable equity securities of $15 million for the year ended June 30, 2026 compared to a loss of $10 million or the year ended June 30, 2025.