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Philips Respironics reaches agreement with US government on a consent decree creating a clear path forward

AGÊNCIA DE COMUNICAÇÃO Conteúdo de responsabilidade da empresa 10 de abril de 2024

Royal Philips

April 10, 2024

Philips confirms that further to communicating the main terms of the Philips Respironics consent decree on January 29, 2024, Philips subsidiaries Philips Holding USA and Philips Respironics have now reached final agreement on the consent decree with the DOJ and FDA. As previously stated:

Amsterdam, the Netherlands – Following the FDAs inspection of Philips Respironics facility in Murrysville in 2021 and the subsequent inspectional observations, the US Department of Justice (DOJ), representing the US Food and Drug Administration (FDA), began discussions with Royal Philips (NYSE: PHG, AEX: PHIA) in July 2022 regarding the terms of a proposed consent decree. On January 29, 2024, Philips announced that it agreed with the DOJ and FDA on the terms of the proposed consent decree.

Philips subsidiaries Philips Holding USA and Philips Respironics have now reached final agreement on the consent decree with the DOJ and FDA, that primarily focuses on Philips Respironics business operations in the US, including its manufacturing facilities in Murrysville and New Kensington, its service center in Mount Pleasant and its Respironics headquarters in Pittsburgh in Pennsylvania.

The consent decree provides Philips Respironics with a roadmap of defined actions, milestones, and deliverables to meet relevant regulatory requirements, as previously communicated by Philips on January 29, 2024, including:

Philips Respironics devices with the new silicone sound abatement foam have been subject to extensive testing in accordance with the applicable industry testing standards, and Philips Respironics has not identified any safety issues. These devices may continue to be used in accordance with the instructions for use.

Roy Jakobs, CEO at Philips said: Strengthening patient safety and quality remains Philips highest priority and the increased scrutiny will help us to improve even more. With the agreement on a consent decree for Philips Respironics in place, we now have a clear path forward to gradually restore the business, serving patients around the world. 

Philips Chief Patient Safety and Quality Officer Steve C de Baca said: Patient safety and quality is our number one priority. We know what we must do to meet the consent decree requirements. Philips Respironics has been working with the FDA, and is already making significant changes in its organization, quality management systems and operations. This includes strengthening the quality management processes and deepening the competencies of the relevant teams. We are fully committed to meeting the terms of the consent decree and continuing to serve the millions of patients who rely on our devices every day.

Financial impact
As previously stated on January 29, 2024, as a consequence of addressing this consent decree, which is a multi-year plan, Philips expects costs of around 100 basis points in 2024 that relate to remediation activities and profit disgorgement payments for Philips Respironics sales in the US.

The previously stated 2023-2025 Group financial outlook of mid-single-digit comparable sales growth, low-teens Adjusted EBITA margin, and EUR 1.4-1.6 billion free cash flow now takes the consent decree into account and remains unchanged. It excludes the investigation by the US DOJ related to the Respironics field action and the impact of the ongoing litigation.

General information about this consent decree can be found here. Further information about this consent decree for investors and financial analysts can be found here and here.

For further information, please contact:

Philips External Relations
Steve Klink
Tel.: +31 6 1088 8824
E-mail: steve.klink@philips.com

Philips Investor Relations
Leandro Mazzoni
Tel.: +31 20 5977055
E-mail: leandro.mazzoni@philips.com

About Royal Philips
Royal Philips (NYSE: PHG, AEX: PHIA) is a leading health technology company focused on improving peoples health and well-being through meaningful innovation. Philips patient- and people-centric innovation leverages advanced technology and deep clinical and consumer insights to deliver personal health solutions for consumers and professional health solutions for healthcare providers and their patients in the hospital and the home. Headquartered in the Netherlands, the company is a leader in diagnostic imaging, ultrasound, image-guided therapy, monitoring and enterprise informatics, as well as in personal health. Philips generated 2023 sales of EUR 18.2 billion and employs approximately 69,700 employees with sales and services in more than 100 countries. News about Philips can be found at www.philips.com/newscenter.

Forward-looking statements
This release contains certain forward-looking statements with respect to the financial condition, results of operations and business of Philips and certain of the plans and objectives of Philips with respect to these items. Examples of forward-looking statements include statements made about the strategy, estimates of sales growth, future EBITA, future developments in Philips organic business and the completion of acquisitions and divestments. By their nature, these statements involve risk and uncertainty because they relate to future events and circumstances and there are many factors that could cause actual results and developments to differ materially from those expressed or implied by these statements.



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