07.20.22
Rank: #9 (Last year: #4)
€14.72 Billion ($16.67 Billion)
Prior Fiscal: €15.19 Billion
Percentage Change: -0.9%
R&D Expenditure: €1.8B
Best FY21 Quarter: Q4 €4.9B
Latest Quarter: Q1 €3.91B
No. of Employees: 78,189
Global Headquarters: Amsterdam, The Netherlands
KEY EXECUTIVES:
Frans van Houten, CEO, Chairman of the Board of Management and Executive Committee
Sophie Bechu, Exec. VP, Chief Operations Officer
Abhijit Bhattacharya, Exec. VP, CFO
Roy Jakobs, Exec. VP, Chief Business Leader Connected Care
Deeptha Khanna, Exec. VP, Chief Business Leader Personal Health
Bert van Meurs, Exec. VP, Chief Business Leader Image Guided Therapy
Kees Wesdorp, Exec. VP, Chief Business Leader Precision Diagnostics
Edwin Paalvast, Exec. VP, Chief of International Markets
Surely, this isn’t the kind of world Aladdin and Jasmine imagined.
It’s certainly not the one immortalized in song.
New? Definitely.
But that “fantastic” point of view is gone. So are the unbelievable sights and endless diamond sky to which the pair melodically refer—they’ve both been replaced by an endless white or light gray monotone.
And that “indescribable” feeling”? It actually could be any number of sentiments: boredom, confusion, disgust, anxiety, disappointment, or frustration.
Or it could be magnanimity.
It most likely is the latter emotion, as neither Aladdin nor Jasmine seem capable of such menial moods.
No, magnanimity would make the most sense since the pair would be traveling within an MRI machine for children’s sake. Aladdin and Jasmine are among a half-dozen beloved Disney characters chosen last year to help Royal Philips N.V. create a kid-friendly imaging environment.
“Undergoing an MRI exam can be quite challenging, especially for children,” Werner Satter, general manager, Philips Healthcare Experience, explained in an online video. “You need to lie still for quite a long period of time. Now, while being in the scanner, there’s also a lot of sound and noise, and this can be very intimidating.”
To reduce that intimidation, Disney developed custom-made animations and stories for the Philips’ Ambient Experience, a clinical setting design approach that combines dynamic lighting, video projections, and sound to create a friendlier, more relaxing environment for patients undergoing MRI scans.
Featuring Ariel, Aladdin and Jasmine, Marvel’s Avengers, Mickey Mouse, Spiderman, and Yoda, the stories aim to calm and support children during MRI scans. Philips tested the custom-made animations at six European hospitals last summer to determine their efficacy. A study conducted by the New Economics Foundation determined that well-known Disney characters can help build trust for children in anxious circumstances as well as inspire and create positive feelings, experiences, and memories.
“I think it’s great to be working with Philips on this one. Philips obviously is a technology company but I love the fact that Philips is actually thinking about the human journey in this one,” Jan Koeppen, president of The Walt Disney Company EMEA, said when the company’s partnership with Philips was announced in March 2021. “What a great thing to lean into. We as Disney obviously very often think about how can we make children’s experiences better? I love the idea, therefore, of marrying our stories up with Philips technology to improve a child’s hospital experience.”
Philips’ collaboration with Disney was one of the few bright spots amid a disappointing fiscal year. A still-broken supply chain, declining hospital ventilator demand, equipment installation postponements, and a Class I recall eroded sales 0.9% to €17.15 billion. Income from operations fell by more than half (to €533 million) and gross margin shrunk 8.3% to €7.16 billion (41.8% of sales) but net income jumped 64% to €3.32 billion, due mostly from the €3 billion sale of its Domestic Appliances business last spring.
Solid performances from two of Philips’ three reporting divisions saved the firm from further financial ruin in FY21. Diagnosis & Treatment sales swelled 8.1% to €8.63 billion, driven by double-digit growth in Image-Guided Therapy and mid-single-digit increases in both Diagnostic Imaging and Ultrasound.
Key to the Diagnosis & Treatment unit’s stellar showing was a bevy of product approvals and introductions. Among the innovations gaining U.S. Food and Drug Administration (FDA) 510(k) clearance were the Philips SmartCT application software and MR 5300 System, the latter of which uses artificial intelligence to improve workflow, efficiency, and image quality. The 1.5-tesla scanner with BlueSeal helium-free technology sports a 55-cm field of view, allowing for extended anatomical coverage, and supports Philips’ dStream Breeze radiofrequency coils.
SmartCT—cleared in April 2021—is part of Philips’ Image Guided Therapy System Azurion, which launched in September 2020. The image acquisition, visualization, and measurement software brings intuitive touchscreen control of the Azurion platform to the table-side, according to the company. The software provides interventionalists with CT-like 3D images (called Cone Beam CT) to support diagnosis, therapy planning, treatment, and follow-up for interventional radiology procedures. SmartCT is used for angiography, neurology, soft-tissue imaging, and guidewire or catheter navigation, and supports treatment for aneurysms, vascular diseases, and liver tumors.
Eight months after greenlighting SmartCT, the FDA granted Philips de novo clearance for its CavaClear inferior vena cava (IVC) filter removal laser sheath, a device designed to remove an IVC filter when previous methods have failed. CavaClear received FDA Breakthrough Device designation last July.
CavaClear uses circumferential tissue ablation to help capture an IVC filter within seconds of activation. The device has been clinically proven to provide a more than 99% success rate with low complication rates.
“Our strategy and portfolio continued to resonate very well with customers and consumers, generating solid demand for our products and solutions throughout the year,” Philips CEO Frans van Houten told analysts during a Q4/FY21 earnings call in late January. “Our Image-Guided Therapy business is really on a tear. We see strong demand, a lot of interest. We see hospitals wanting to buy more ambulatory surgical centers and expand capacity for elective procedures. We see minimally invasive therapy is being expanded beyond cardiovascular into neuro, stroke, spine, into minimally invasive oncology and so broader and broader application, more therapeutic areas, and Philips is very well-positioned in all of this. Also, our portfolio of devices very much reinforces our strengths in this business.”
That portfolio included the debuts of a patient monitoring system, echocardiography catheter, and intravascular imaging platform.
In July, the Mayo Clinic baptized the company’s VeriSight Pro ICE catheter in a minimally invasive heart surgery. The catheter provides 2D and 3D live image guidance for various procedures in structural heart disease and electrophysiology, allowing interventionalists to better navigate procedures. VeriSight Pro also offers a 90-by-90-degree 3D field of view, thereby enabling physicians to simultaneously look at two scan planes (i.e., long and short left atrial appendage axes).
Philips launched its IntraSight Mobile platform in North America last November at the Transcatheter Cardiovascular Therapeutics Annual Meeting in Orlando. IntraSight Mobile integrates imaging and physiology applications on a mobile system for coronary and peripheral artery disease therapy. The IntraSight platform allows interventionalists to perform intravascular ultrasound imaging and physiologic measurements of fractional flow reserve and instantaneous wave-free ratio to accurately locate ischemia-causing lesions.
“...we’re showing how we are continuously innovating and expanding our integrated ecosystem of interventional imaging systems and diagnostic and therapeutic devices to provide clinicians with a complete solution, from diagnosis to treatment and therapy monitoring, to optimize their workflow and the treatment of each individual patient,” Chris Landon, senior vice president and general manager, Image Guided Therapy at Philips, said amid the IntraSight launch.
Philips further expanded its interventional imaging systems portfolio last year by acquiring Vesper Medical, a Wayne, Pa.-based developer of MI peripheral vascular devices. The mid-December purchase provides Philips with a venous stenting solution that addresses the root cause of chronic deep venous disease and complements the company’s IVUS offering in venous imaging.
Acquired innovation was lacking in Philips’ Diagnostic Imaging and Ultrasound franchises last year, but the divisions still managed to complement their offerings through numerous product introductions. Portfolio additions included:
Personal Health debuted the Pregnancy+app and an electric breast pump that mimics a suckling baby’s wave-like tongue motion, while Connected Care launched two new HealthSuite informatics solutions—Patient Flow Capacity Suite and Acute Care Telehealth—as well as the Philips Medical Tablet, an end-to-end portable monitoring kit for remotely tracking larger patient populations.
Also unveiled by Connected Care in FY21 was the portable IntelliVue X3, MX750, and MX850 patient monitors. The IntelliVue X3, released in May, allows for monitoring during image-guided procedures on Philips’ Azurion platform, and helps improve workflow. The MX750 and MX850 monitors received FDA clearance in December and provide real-time vital sign data as well as support for remote hospital monitoring.
“Inspired by our purpose to improve people’s health and well-being, we innovate solutions that deliver meaningful impact,” van Houten wrote in the company’s 2021 annual report. “We have strengthened our portfolio through our R&D programs, partnerships, and acquisitions.”
Those acquisitions, however, only benefitted the Connected Care business dossier. The $635 million purchase of Capsule Technologies Inc. in January 2021 expanded Philips’ care delivery and integrated solutions offerings, while the November deal for French startup Cardiologs advanced the firm’s AI and cloud technology capabilities in both patient monitoring and cardiology. Additionally, the $2.8 billion deal for BioTelemetry (completed last February) expanded Philips’ remote monitoring prowess in patients’ homes.
Neither the acquisitions nor new product releases, though, could reverse the financial carnage wrought by a Class I recall of certain Philips Respironics continuous and non-continuous ventilators, including CPAP and BiPAP machines to treat sleep apnea. Initiated in June 2021, the recall contributed to a 22.6% decline in Connected Care revenue (to €4.59 billion). The loss more than offset the 9% spike in Personal Health sales (€3.41 billion) and 8.1% gain in Diagnosis & Treatment proceeds.
“We regret any concern or inconveniences caused by this field action and we are committed to supporting the community of patients who rely on our sleep and respiratory care solutions for their health and quality of life, and the physicians and customers who are dedicated to meeting patient needs,” David Ferguson, business leader of Philips Respironics, stated in May 2022. “We are replacing or repairing the devices related to the Respironics field action as fast as possible and are continuing to update patients and customers about the progress of the program. More than 1,000 of our colleagues are working around the clock on every aspect of the remediation.”
Philips recalled the ventilators upon discovering the built-in polyester-based polyurethane foam (PE-PUR) used for sound and vibration reduction could potentially harm patients. In its recall notice, the company said the foam could possibly “break down,” sending chemicals and black debris into the devices’ air pathway, where it might be inhaled or swallowed by patients, irritating their skin, eyes, or respiratory tract. The debris and chemicals also could conceivably damage internal organs or have other toxic carcinogenic effects.
The recall affects nearly two dozen models of Philips Respironics ventilators with product codes BZD and MNS, manufactured between 2007 and April 2021, and distributed beginning in July 2009.
Philips, of course, has offered to repair or replace the damaged models; the company has produced more than 1.5 million repair kits and replacement devices, of which more than half have reached customers.
To maximize the remediation program’s scope, the FDA ordered Philips to notify all device users, durable medical equipment suppliers, distributors, retailers, and Respironics product prescribers about the recall and possible health risks. Philips aims to complete the ventilator remediation program in Q4 this year.
“...we have a strong program management in place to ensure the corrective actions related to the recall are completed as fast as possible,” van Houten told analysts during a late January (2022) conference call. “We have submitted a detailed action plan to the FDA. Philips Respironics continues to engage with the FDA and we will work closely with the agency to clarify and follow up with the inspectional findings and its requests. As part of our focus on quality...we have reinforced the awareness and focus on patient safety across the company.”
Such a focus has been quite a challenge, though. More than 21,000 medical device reports—including 124 reports of deaths, have been linked to PE-PUR foam breakdown in Philips Respironics ventilators between April 2021, and April 30, 2022. In addition, the company is facing hundreds of CPAP-related lawsuits and a potential U.S. Department of Justice investigation.
€14.72 Billion ($16.67 Billion)
Prior Fiscal: €15.19 Billion
Percentage Change: -0.9%
R&D Expenditure: €1.8B
Best FY21 Quarter: Q4 €4.9B
Latest Quarter: Q1 €3.91B
No. of Employees: 78,189
Global Headquarters: Amsterdam, The Netherlands
KEY EXECUTIVES:
Frans van Houten, CEO, Chairman of the Board of Management and Executive Committee
Sophie Bechu, Exec. VP, Chief Operations Officer
Abhijit Bhattacharya, Exec. VP, CFO
Roy Jakobs, Exec. VP, Chief Business Leader Connected Care
Deeptha Khanna, Exec. VP, Chief Business Leader Personal Health
Bert van Meurs, Exec. VP, Chief Business Leader Image Guided Therapy
Kees Wesdorp, Exec. VP, Chief Business Leader Precision Diagnostics
Edwin Paalvast, Exec. VP, Chief of International Markets
Surely, this isn’t the kind of world Aladdin and Jasmine imagined.
It’s certainly not the one immortalized in song.
New? Definitely.
But that “fantastic” point of view is gone. So are the unbelievable sights and endless diamond sky to which the pair melodically refer—they’ve both been replaced by an endless white or light gray monotone.
And that “indescribable” feeling”? It actually could be any number of sentiments: boredom, confusion, disgust, anxiety, disappointment, or frustration.
Or it could be magnanimity.
It most likely is the latter emotion, as neither Aladdin nor Jasmine seem capable of such menial moods.
No, magnanimity would make the most sense since the pair would be traveling within an MRI machine for children’s sake. Aladdin and Jasmine are among a half-dozen beloved Disney characters chosen last year to help Royal Philips N.V. create a kid-friendly imaging environment.
“Undergoing an MRI exam can be quite challenging, especially for children,” Werner Satter, general manager, Philips Healthcare Experience, explained in an online video. “You need to lie still for quite a long period of time. Now, while being in the scanner, there’s also a lot of sound and noise, and this can be very intimidating.”
To reduce that intimidation, Disney developed custom-made animations and stories for the Philips’ Ambient Experience, a clinical setting design approach that combines dynamic lighting, video projections, and sound to create a friendlier, more relaxing environment for patients undergoing MRI scans.
Featuring Ariel, Aladdin and Jasmine, Marvel’s Avengers, Mickey Mouse, Spiderman, and Yoda, the stories aim to calm and support children during MRI scans. Philips tested the custom-made animations at six European hospitals last summer to determine their efficacy. A study conducted by the New Economics Foundation determined that well-known Disney characters can help build trust for children in anxious circumstances as well as inspire and create positive feelings, experiences, and memories.
“I think it’s great to be working with Philips on this one. Philips obviously is a technology company but I love the fact that Philips is actually thinking about the human journey in this one,” Jan Koeppen, president of The Walt Disney Company EMEA, said when the company’s partnership with Philips was announced in March 2021. “What a great thing to lean into. We as Disney obviously very often think about how can we make children’s experiences better? I love the idea, therefore, of marrying our stories up with Philips technology to improve a child’s hospital experience.”
Philips’ collaboration with Disney was one of the few bright spots amid a disappointing fiscal year. A still-broken supply chain, declining hospital ventilator demand, equipment installation postponements, and a Class I recall eroded sales 0.9% to €17.15 billion. Income from operations fell by more than half (to €533 million) and gross margin shrunk 8.3% to €7.16 billion (41.8% of sales) but net income jumped 64% to €3.32 billion, due mostly from the €3 billion sale of its Domestic Appliances business last spring.
Solid performances from two of Philips’ three reporting divisions saved the firm from further financial ruin in FY21. Diagnosis & Treatment sales swelled 8.1% to €8.63 billion, driven by double-digit growth in Image-Guided Therapy and mid-single-digit increases in both Diagnostic Imaging and Ultrasound.
Key to the Diagnosis & Treatment unit’s stellar showing was a bevy of product approvals and introductions. Among the innovations gaining U.S. Food and Drug Administration (FDA) 510(k) clearance were the Philips SmartCT application software and MR 5300 System, the latter of which uses artificial intelligence to improve workflow, efficiency, and image quality. The 1.5-tesla scanner with BlueSeal helium-free technology sports a 55-cm field of view, allowing for extended anatomical coverage, and supports Philips’ dStream Breeze radiofrequency coils.
SmartCT—cleared in April 2021—is part of Philips’ Image Guided Therapy System Azurion, which launched in September 2020. The image acquisition, visualization, and measurement software brings intuitive touchscreen control of the Azurion platform to the table-side, according to the company. The software provides interventionalists with CT-like 3D images (called Cone Beam CT) to support diagnosis, therapy planning, treatment, and follow-up for interventional radiology procedures. SmartCT is used for angiography, neurology, soft-tissue imaging, and guidewire or catheter navigation, and supports treatment for aneurysms, vascular diseases, and liver tumors.
Eight months after greenlighting SmartCT, the FDA granted Philips de novo clearance for its CavaClear inferior vena cava (IVC) filter removal laser sheath, a device designed to remove an IVC filter when previous methods have failed. CavaClear received FDA Breakthrough Device designation last July.
CavaClear uses circumferential tissue ablation to help capture an IVC filter within seconds of activation. The device has been clinically proven to provide a more than 99% success rate with low complication rates.
“Our strategy and portfolio continued to resonate very well with customers and consumers, generating solid demand for our products and solutions throughout the year,” Philips CEO Frans van Houten told analysts during a Q4/FY21 earnings call in late January. “Our Image-Guided Therapy business is really on a tear. We see strong demand, a lot of interest. We see hospitals wanting to buy more ambulatory surgical centers and expand capacity for elective procedures. We see minimally invasive therapy is being expanded beyond cardiovascular into neuro, stroke, spine, into minimally invasive oncology and so broader and broader application, more therapeutic areas, and Philips is very well-positioned in all of this. Also, our portfolio of devices very much reinforces our strengths in this business.”
That portfolio included the debuts of a patient monitoring system, echocardiography catheter, and intravascular imaging platform.
In July, the Mayo Clinic baptized the company’s VeriSight Pro ICE catheter in a minimally invasive heart surgery. The catheter provides 2D and 3D live image guidance for various procedures in structural heart disease and electrophysiology, allowing interventionalists to better navigate procedures. VeriSight Pro also offers a 90-by-90-degree 3D field of view, thereby enabling physicians to simultaneously look at two scan planes (i.e., long and short left atrial appendage axes).
Philips launched its IntraSight Mobile platform in North America last November at the Transcatheter Cardiovascular Therapeutics Annual Meeting in Orlando. IntraSight Mobile integrates imaging and physiology applications on a mobile system for coronary and peripheral artery disease therapy. The IntraSight platform allows interventionalists to perform intravascular ultrasound imaging and physiologic measurements of fractional flow reserve and instantaneous wave-free ratio to accurately locate ischemia-causing lesions.
“...we’re showing how we are continuously innovating and expanding our integrated ecosystem of interventional imaging systems and diagnostic and therapeutic devices to provide clinicians with a complete solution, from diagnosis to treatment and therapy monitoring, to optimize their workflow and the treatment of each individual patient,” Chris Landon, senior vice president and general manager, Image Guided Therapy at Philips, said amid the IntraSight launch.
Philips further expanded its interventional imaging systems portfolio last year by acquiring Vesper Medical, a Wayne, Pa.-based developer of MI peripheral vascular devices. The mid-December purchase provides Philips with a venous stenting solution that addresses the root cause of chronic deep venous disease and complements the company’s IVUS offering in venous imaging.
Acquired innovation was lacking in Philips’ Diagnostic Imaging and Ultrasound franchises last year, but the divisions still managed to complement their offerings through numerous product introductions. Portfolio additions included:
- The Philips Abdominal Aortic Aneurysm (AAA) Model, a patient-friendly solution for AAA treatment. Based on 3D ultrasound, the Philips AAA Model delivers accurate diagnostic information without exposing patients to high doses of radiation and nephrotoxic contrast agents.
- The AI-enabled Precise Suite solution for Philips’ Incisive CT platform. Precise Suite delivers smart workflows from image acquisition through reporting with AI-enabled image reconstruction, automated patient positioning, motion-free cardiac image capture, and real-time interventional guidance.
- The Spectral CT 7500, featuring intelligent software for delivering high-quality spectral images on every scan, every time without the need for special protocols. Spectral chest and head scans take less than one second, and a full upper body spectral scan takes less than two seconds. The CT 7500’s scanner uses two different scintillator materials that can detect two different X-ray energy levels.
- IntelliSite, an enterprise-wide digital pathology platform featuring scalable software tools designed to streamline workflows, enhance diagnostic confidence, facilitate collaboration, integrate AI, and increase pathology lab efficiency.
- Enhanced EPIQ and Affiniti ultrasound systems with tele-ultrasound capabilities and liver fat quantification tools that allow for non-invasive early-stage fatty liver disease diagnosis.
- The CT 5100 Incisive platform with CT Smart Workflow, which provides access to the company’s Technology Maximizer program and can potentially lower operating expenses by an estimated $420,000.
- The newly-designed Philips Scoring Balloon Catheter RX - AngioSculpt Evo, featuring a smaller tip for smoother lesion entry, a hydrophilic coating to reduce friction, and a laser-cut hypotube for enhanced flexibility.
- The Nexcimer laser system, with plug-and-play simplicity for coronary and peripheral artherectomy and lead extraction procedures. Smaller, lighter, and more maneuverable than the previous generation, the system starts up within 30 seconds, uses standard medical-grade 100-240 volt outlets, and has an intuitive touchscreen interface with guided workflow prompts.
Personal Health debuted the Pregnancy+app and an electric breast pump that mimics a suckling baby’s wave-like tongue motion, while Connected Care launched two new HealthSuite informatics solutions—Patient Flow Capacity Suite and Acute Care Telehealth—as well as the Philips Medical Tablet, an end-to-end portable monitoring kit for remotely tracking larger patient populations.
Also unveiled by Connected Care in FY21 was the portable IntelliVue X3, MX750, and MX850 patient monitors. The IntelliVue X3, released in May, allows for monitoring during image-guided procedures on Philips’ Azurion platform, and helps improve workflow. The MX750 and MX850 monitors received FDA clearance in December and provide real-time vital sign data as well as support for remote hospital monitoring.
“Inspired by our purpose to improve people’s health and well-being, we innovate solutions that deliver meaningful impact,” van Houten wrote in the company’s 2021 annual report. “We have strengthened our portfolio through our R&D programs, partnerships, and acquisitions.”
Those acquisitions, however, only benefitted the Connected Care business dossier. The $635 million purchase of Capsule Technologies Inc. in January 2021 expanded Philips’ care delivery and integrated solutions offerings, while the November deal for French startup Cardiologs advanced the firm’s AI and cloud technology capabilities in both patient monitoring and cardiology. Additionally, the $2.8 billion deal for BioTelemetry (completed last February) expanded Philips’ remote monitoring prowess in patients’ homes.
Neither the acquisitions nor new product releases, though, could reverse the financial carnage wrought by a Class I recall of certain Philips Respironics continuous and non-continuous ventilators, including CPAP and BiPAP machines to treat sleep apnea. Initiated in June 2021, the recall contributed to a 22.6% decline in Connected Care revenue (to €4.59 billion). The loss more than offset the 9% spike in Personal Health sales (€3.41 billion) and 8.1% gain in Diagnosis & Treatment proceeds.
“We regret any concern or inconveniences caused by this field action and we are committed to supporting the community of patients who rely on our sleep and respiratory care solutions for their health and quality of life, and the physicians and customers who are dedicated to meeting patient needs,” David Ferguson, business leader of Philips Respironics, stated in May 2022. “We are replacing or repairing the devices related to the Respironics field action as fast as possible and are continuing to update patients and customers about the progress of the program. More than 1,000 of our colleagues are working around the clock on every aspect of the remediation.”
Philips recalled the ventilators upon discovering the built-in polyester-based polyurethane foam (PE-PUR) used for sound and vibration reduction could potentially harm patients. In its recall notice, the company said the foam could possibly “break down,” sending chemicals and black debris into the devices’ air pathway, where it might be inhaled or swallowed by patients, irritating their skin, eyes, or respiratory tract. The debris and chemicals also could conceivably damage internal organs or have other toxic carcinogenic effects.
The recall affects nearly two dozen models of Philips Respironics ventilators with product codes BZD and MNS, manufactured between 2007 and April 2021, and distributed beginning in July 2009.
Philips, of course, has offered to repair or replace the damaged models; the company has produced more than 1.5 million repair kits and replacement devices, of which more than half have reached customers.
To maximize the remediation program’s scope, the FDA ordered Philips to notify all device users, durable medical equipment suppliers, distributors, retailers, and Respironics product prescribers about the recall and possible health risks. Philips aims to complete the ventilator remediation program in Q4 this year.
“...we have a strong program management in place to ensure the corrective actions related to the recall are completed as fast as possible,” van Houten told analysts during a late January (2022) conference call. “We have submitted a detailed action plan to the FDA. Philips Respironics continues to engage with the FDA and we will work closely with the agency to clarify and follow up with the inspectional findings and its requests. As part of our focus on quality...we have reinforced the awareness and focus on patient safety across the company.”
Such a focus has been quite a challenge, though. More than 21,000 medical device reports—including 124 reports of deaths, have been linked to PE-PUR foam breakdown in Philips Respironics ventilators between April 2021, and April 30, 2022. In addition, the company is facing hundreds of CPAP-related lawsuits and a potential U.S. Department of Justice investigation.