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Five-year ILLUMENATE EU RCT and Pivotal study results confirm safety profile of Philips Stellarex .035” low-dose drug-coated balloon

January 25, 2021

Two major randomized controlled trials (RCTs) show no difference in mortality between patients treated with the Philips Stellarex drug-coated balloon (DCB) and those treated with percutaneous angioplasty (PTA), the current standard of care

Amsterdam, the Netherlands Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, today announced the final, five-year results of two major randomized controlled trials (RCTs) that show no difference in all-cause mortality between patients treated with the Stellarex drug-coated balloon (DCB) and those treated with percutaneous angioplasty (PTA), the current standard of care. Moreover, the studies showed no difference in mortality between the Stellarex DCB and PTA at every 12-month endpoint over the course of the study. Results from the two RCTs were presented at the virtual 2021 Leipzig Interventional Course (LINC).

The ILLUMENATE EU RCT and ILLUMENATE Pivotal RCT together comprised approximately 600 patients in Europe and the U.S. After five years, the ILLUMENATE EU RCT showed 19.3% mortality among patients treated with the Stellarex DCB compared to 19.4% mortality for those treated with PTA. The five-year results for the ILLUMENATE Pivotal study also show no statistically significant difference among patients treated with the Stellarex DCB (21.2%) compared to those treated with PTA (20.2%). Both studies had a high vital status follow-up compliance, with the status of over 90% of patients known.

“The five-year final results show favourable overall safety of the Stellarex low-dose paclitaxel DCB, and are applicable within an extensive patient cohort,” said Marianne Brodmann, MD, Professor, vascular specialist at the Medical University of Graz, Austria, primary investigator for both trials and a paid consultant to Philips. “Every year, the Stellarex program has demonstrated low mortality rates with no difference in rates between the two patient cohorts.”

“These study results build on the robust, consistent long-term data of the Stellarex program and confirm the safety and performance of our unique DCB,” said Chris Landon, Senior Vice President and General Manager Image Guided Therapy Devices at Philips. “The Stellarex DCB, with its low drug dose and unique drug coating composition, continues to be an important treatment choice for healthcare providers treating patients with peripheral arterial disease.”

Featuring Philips EnduraCoat technology, a unique coating consisting of a polyethylene glycol excipient with amorphous and crystalline paclitaxel particles dispersed in it, Stellarex .035” DCB is unlike any other drug-coated balloon for the treatment of peripheral artery disease. EnduraCoat technology provides efficient drug transfer and effective drug residency coupled with high coating durability and minimal particulate loss, thereby enabling a low therapeutic drug dose.

Philips’ Image Guided Therapy business provides complete procedural solutions of systems, smart devices, disease-specific software and services for minimally invasive procedures, helping caregivers decide, guide, treat and confirm the right therapy for each patient during their procedure.

For further information, please contact:

Mark Groves
Philips Global Press Office
Tel.: +31 631 639 916
E-mail: mark.groves@philips.com

Fabienne van der Feer
Philips Image Guided Therapy
Tel: + 31 622 698 001
E-mail : fabienne.van.der.feer@philips.com

About Royal Philips

Royal Philips (NYSE: PHG, AEX: PHIA) is a leading health technology company focused on improving people’s health and well-being, and enabling better outcomes across the health continuum – from healthy living and prevention, to diagnosis, treatment and home care. Philips leverages advanced technology and deep clinical and consumer insights to deliver integrated solutions. Headquartered in the Netherlands, the company is a leader in diagnostic imaging, image-guided therapy, patient monitoring and health informatics, as well as in consumer health and home care. Philips generated 2020 sales of EUR 19.5 billion and employs approximately 82,000 employees with sales and services in more than 100 countries. News about Philips can be found at www.philips.com/newscenter.

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Samsung Bioepis Opens the New State-of-the-Art Headquarters to Accommodate Next Stage of Growth and Innovation

Samsung Bioepis New Headquarters

Samsung Bioepis

  • Located in Korea’s ‘Bio Cluster’ of Songdo in the Incheon Free Economic Zone (IFEZ)
  • The 52,000-square-foot campus to become the hub of Samsung Bioepis’ drive for accelerated development of next-generation biologic medicines
  • Includes ‘Welfare Center’ with cafeteria, in-house fitness center, and a daycare center

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/370961b4-344f-49bf-86e4-e882f7265b1c

INCHEON, Korea, Jan. 25, 2021 (GLOBE NEWSWIRE) — Samsung Bioepis Co., Ltd. today announced the opening of its new headquarters in Korea’s ‘Bio Cluster’ of Songdo, located in the Incheon Free Economic Zone (IFEZ), a specially-designated economic zone in the city of Incheon. The new site is approximately 52,000 square feet, and will be the hub of Samsung Bioepis’ drive for development of next-generation biologic medicines. Construction of the new building was completed in December 2020.

“We are very excited to be opening our new headquarters which will serve as the foundation for the company’s next stage of growth. Our colleagues who were previously stationed in two campuses in Korea will be working together at the new headquarters to accelerate our passion for health,” said Christopher Hansung Ko, President and Chief Executive Officer, Samsung Bioepis. “With the new office equipped with the state-of-the-art laboratories, we look forward to providing our high-quality biologic medicines with more agility and with stringent quality control so that patients around the world can have access to our proven medicines more quickly and more widely available.”

The newly established 12-story building will house approximately 1,000 employees, who will be working at the 17,300-square-foot laboratory space and 15,200-square-foot office space. Attached to the main building is a three-story ‘Welfare Center’ which includes 4,750-square-foot cafeteria, a gymnasium and a fitness center for employees to enjoy. Furthermore, the company has an onsite childcare center to support employees with young children.

Established in 2012, Samsung Bioepis has rapidly grown to have five biologic products in immunology and oncology with more than 215,000 patients treated with the company’s immunology products in Europe alone. The company is continuing its work to improve access to medicines through its unique ‘process innovation’ development platform and currently has five biologic candidates in its pipeline ranging from hematology and ophthalmology.

About Samsung Bioepis Co., Ltd.

Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world’s leading biopharmaceutical company. Samsung Bioepis continues to advance a broad pipeline of biosimilar candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology and hematology. Samsung Bioepis is a joint venture between Samsung Biologics and Biogen. For more information, please visit: www.samsungbioepis.com and follow us on social media – TwitterLinkedIn.

MEDIA CONTACT
Yoon Kim: yoon1.kim@samsung.com

Philips and Spanish healthcare group Vithas sign strategic agreement to incorporate Philips’ most advanced technologies into Vithas hospitals and clinics

January 25, 2021

  • 5-year alliance will provide Vithas Group with state-of-the-art diagnostic imaging, image viewing solutions, and minimally-invasive intervention technology to deliver faster and more accurate diagnosis and treatment to patients
  • Vithas will become a ‘reference technology partner’ for Philips in Spain, giving it fast access to advances and innovations that Philips develops prior to their commercialization
  • New enterprise-wide network for diagnostic imaging will support unified working between more than 100 radiologists to facilitate workflow efficiency and research, as well as allowing patients to securely view their diagnostic reports and images on PCs and mobile devices

Amsterdam, the Netherlands and Madrid, Spain  Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, and Vithas Group, Spain’s second largest private healthcare group, today signed a 5-year innovation and collaboration agreement in the areas of precision diagnosis and image-guided intervention. The agreement will allow Vithas Group hospitals and medical centers to benefit from the latest innovations in diagnostic imaging technology, healthcare informatics, and equipment for minimally-invasive interventional procedures. Vithas Group hospitals and clinics offer healthcare and advanced medical care in thirteen provinces in seven autonomous regions of Spain.

Under the terms of the agreement, Philips will deliver a technology management model that ensures Vithas Group’s current and future health technology needs in the relevant areas are met, together with the associated maintenance, updating, and equipment and system renewal needs. This management model will enable Vithas Group to achieve better results, provide optimal care at lower cost, and deliver a better experience for its patients and healthcare professionals.

In addition, Vithas will become a ‘reference technology partner’ for Philips in Spain, which means that its hospitals and medical centers will be able to implement new advances and innovations developed by Philips, before standard commercialization of these solutions in Spain.

“This new alliance with Philips integrates cutting-edge technology, healthcare excellence, innovation, and research, which are the fundamental pillars on which we support our commitment to always seek the best experience for our patients,” said Dr. Pedro Rico, CEO of Vithas Group. “Furthermore, our professionals will have the most advanced technological solutions at all times, which will reinforce the quality of care and facilitate their research work.”

“We are very excited about the trust placed in Philips and convinced that, through this collaboration agreement, Vithas will have all the technology and innovation necessary to continue achieving the best health results and the best experience for its patients and its healthcare professionals,” said Juan Sanabria, President of Philips Ibérica. “We are proud to become the technological partner and strategic ally of a group as important as Vithas.”

The most advanced diagnostic imaging technology
The agreement includes the replacement of Vithas Group’s existing MR imaging equipment with Philips’ latest innovative MR systems, which stand out for their image quality and patient comfort, and because they do not consume helium, also stand out for their sustainability. Philips will also install hybrid operating room solutions, including its latest ceiling mounted live-image guidance system for minimally-invasive interventional therapy, allowing Vithas hospitals to perform many types of procedure with maximum precision and safety. Four new hybrid operating rooms will be installed across four of the group’s hospitals.

Next to this, Philips will replace the Vithas hospitals’ CT (Computed Tomography) equipment by high-end equipment, allowing them to perform more precise cardiac diagnoses thanks to the Philips equipment’s speed, coverage, and high image quality, while also minimizing radiation dose. The agreement also includes X-ray equipment, solutions for dose management, and a Corporate Network for Diagnostic Imaging.

Benefits of the Corporate Network for Diagnostic Imaging
Through this network, and thanks to a solution for reviewing, post-processing and sharing information from advanced medical imaging studies, more than 100 radiologists will be able to work in a unified way with access to tools that speed up and improve the quality of results. Likewise, more than 5,000 referring physicians will have higher quality radiological reports directly available to them via a clinical viewer. The solution will also improve the patient experience, because they will be able to view their reports and images from any PC or mobile device via a secure web portal.

Joint scientific research
The innovation and collaboration agreement between Philips and Vithas Group will make it possible for the two organizations to collaborate in technological innovation projects in Vithas Group reference centers. These projects will involve joint scientific research in key healthcare areas, as well as the training of Vithas Group professionals in new technologies and clinical procedures.

For further information, please contact:

Joost Maltha
Philips Global Press Office
Tel.: +31 6 10 55 81 16
E-mail: joost.maltha@philips.com

César García Requena
Brand & Communications Manager
Philips Ibérica
Tel : +34 670 264 471
E-mail: cesar.garcia.requena@philips.com

About Royal Philips

Royal Philips (NYSE: PHG, AEX: PHIA) is a leading health technology company focused on improving people’s health and well-being, and enabling better outcomes across the health continuum – from healthy living and prevention, to diagnosis, treatment and home care. Philips leverages advanced technology and deep clinical and consumer insights to deliver integrated solutions. Headquartered in the Netherlands, the company is a leader in diagnostic imaging, image-guided therapy, patient monitoring and health informatics, as well as in consumer health and home care. Philips generated 2020 sales of EUR 19.5 billion and employs approximately 82,000 employees with sales and services in more than 100 countries. News about Philips can be found at www.philips.com/newscenter.

About Vithas Group
Vithas’ commitment: accredited healthcare quality, personal service and long-term vision.

Vithas’ strategic commitment is that all healthcare is endorsed by the standards of the most prestigious international quality accreditation, the Joint Commission International. Only 15 prestigious hospitals in Spain have such accreditation and recognition, and three of them are part of Vithas, in Madrid, Malaga and Granada. Every year Vithas treats more than 5,200,000 patients in its 19 hospitals and 21 Vithas Salud medical centers. The 40 centers are located throughout Spain and include hospitals in Alicante, Almería, Benalmádena, Castellón, Granada, Las Palmas de Gran Canaria, Lleida, Madrid, Málaga, Seville, Tenerife, Vigo, Valencia and Vitoria-Gasteiz. The 26 Vithas Salud centers are located in Alicante, Elche, El Ejido, Fuengirola, Granada, Las Palmas de Gran Canaria, Lleida, Madrid, Malaga, Nerja, Pontevedra, Rincón de la Victoria, Sanxenxo, Seville, Torre del Mar, Torremolinos, Vilagarcía de Arousa, and Vitoria-Gasteiz. Additionally, Vithas has more than 300 locations throughout Spain as part of the Vithas Lab laboratories network. Its PlazaSalud24 purchasing center, a benchmark in the sector, serves 39 hospitals, 35 medical centers and 20 dental clinics.

Vithas has a stake in the leading hospital project in the Balearic Islands, the Juaneda Healthcare Network, which has 5 hospitals and a wide network of medical centers throughout the region.

Vithas’ commitment to proven quality healthcare and personalized service goes hand in hand with the strong support and long-term vision of Vithas’ shareholders: Goodgrower, which controls 80% of the capital, and CriteriaCaixa, with the remaining 20%.

With a growth model based on geographic diversification and sustainability, Vithas plans to continue consolidating its national presence both by opening new centers and through acquisitions and strategic agreements. www.vithas.es

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Philips and Rennes University Hospital sign 5-year technology, research and innovation partnership to advance patient care

January 25, 2021

  • Hospital will have access to Philips’ latest technologies and informatics solutions to enhance the diagnosis, treatment, monitoring and management of patients
  • Multi-year strategic partnership will accelerate clinical research focused on image-guided minimally-invasive therapy, neurology, intensive care units and digital pathology

Amsterdam, the Netherlands – Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, and Rennes University Hospital, one of France’s leading hospitals in image-guided interventions, robotics and clinical research, today announced the signing of a 5-year technology and innovation partnership to support diagnostic, interventional imaging and patient monitoring and management, undertake clinical research, and leverage Philips’ and Rennes University Hospital’s ecosystems of open innovation to foster French start-up companies.

Philips will deliver new medical technologies and provide management and maintenance services for the hospital’s diagnostic and interventional imaging modalities (MRI, CT, and image-guided therapy) as well as patient monitoring. Informatics solutions will offer central, high-resolution data capture and storage (data warehouses) to drive quality and efficiency improvements, and comprehensive visualization and analysis tools to enhance diagnostic  confidence for complex medical cases. Philips Healthcare Transformation Services experts will help to optimize the hospital’s clinical pathways and patient experience, especially for intensive care units (ICUs) and neuro-radiology departments.

“Philips and Rennes University Hospital are entering into a ground-breaking partnership aimed at significantly improving the stroke pathway and co-developing AI algorithms to improve care for the most acute patients, particularly those in the ICU,” said David Corcos, General Manager Philips France. “Leveraging the hospital’s clinical expertise and our respective innovation ecosystems, we believe we can jointly innovate to help the hospital’s healthcare professionals improve care and outcomes for their patients, while contributing to a more sustainable healthcare system. We are thrilled by this unique opportunity.”

Research and innovation
Key elements of the partnership are collaborative research and innovation activities focused on areas that combine Philips’ technological expertise with Rennes University Hospital’s clinical expertise. Co-development projects will focus on several key areas of joint strategic interest – optimized stroke management, robotics for neurological interventions, big data analytics and artificial intelligence (AI) for monitoring patients in ICUs, and AI algorithms to support digital pathology. In addition, the hospital will have access to Philips’ in-house expertise and open-innovation ecosystem to foster the creation of French tech start-ups that can translate research into clinical solutions.  

“The University Hospital of Rennes is particularly glad to join its forces with Philips in the framework of an original and ambitious partnership, unique in France, offering tremendous opportunities for innovation and co-development of new solutions to shape the future of medicine and patient care,” said Véronique Anatole-Touzet, CEO at Rennes University Hospital. “This collaboration is the result of several years of fruitful collaboration. Thanks to its rich and integrated character, this partnership will be an amazing catalyst for innovation and research for the University Hospital of Rennes.”

Rennes University Hospital, with more than 1,800 beds shared among 4 different sites, is one of the top 10 hospitals in France and a reference center in cardiac and vascular surgery, transplantation, next to other specialisms such as neurosurgery, neuroradiology and robotics. In terms of research and innovation, it has around 200 professionals involved in more than 1,700 research projects shared among 14 research units. Philips and Rennes University Hospital already have multiple collaborations in the field of medical imaging, plus an innovation partnership in digital pathology – the first of its kind in France. Today’s strategic partnership also includes two associate partners of the University Hospital – the University of Rennes 1 and the Saint-Laurent polyclinic.

For further information, please contact:

Joost Maltha
Philips Global Press Office
Tel.: +31 6 10 55 81 16
E-mail: joost.maltha@philips.com

Elise Decenciere
Philips France media relations manager
Tel : +33 6 49 20 18 50
E-mail: elise.decenciere@philips.com

About Royal Philips

Royal Philips (NYSE: PHG, AEX: PHIA) is a leading health technology company focused on improving people’s health and well-being, and enabling better outcomes across the health continuum – from healthy living and prevention, to diagnosis, treatment and home care. Philips leverages advanced technology and deep clinical and consumer insights to deliver integrated solutions. Headquartered in the Netherlands, the company is a leader in diagnostic imaging, image-guided therapy, patient monitoring and health informatics, as well as in consumer health and home care. Philips generated 2020 sales of EUR 19.5 billion and employs approximately 82,000 employees with sales and services in more than 100 countries. News about Philips can be found at www.philips.com/newscenter.

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Philips delivers Q4 sales of EUR 6.0 billion, with 7% comp. sales growth; income from cont. operations increases to EUR 608 million, Adjusted EBITA margin improves 110 bps to 19.0%, and operating cash flow increases to EUR 1,305 million

January 25, 2021

Fourth-quarter highlights
•        Sales amounted to EUR 6.0 billion, with 7% comparable sales growth
•        Comparable order intake increased 7%
•        Income from continuing operations increased to EUR 608 million, compared to EUR 550 million in Q4 2019
•        Adjusted EBITA margin increased to 19.0% of sales, compared to 17.9% of sales in Q4 2019
•        Income from operations improved to EUR 795 million, compared to EUR 730 million in Q4 2019
•        EPS from continuing operations (diluted) amounted to EUR 0.66; Adjusted EPS increased to EUR 0.94, compared to EUR 0.83 in Q4 2019
•        Operating cash flow improved to EUR 1,305 million, compared to EUR 1,271 million in Q4 2019
•        Free cash flow improved to EUR 1,055 million, compared to EUR 959 million in Q4 2019

Full-year highlights
•        Sales amounted to EUR 19.5 billion, with 3% comparable sales growth
•        Comparable order intake increased 9%
•        Income from continuing operations increased to EUR 1,205 million, compared to EUR 1,192 million in 2019
•        Adjusted EBITA margin was 13.2% of sales, in line with 2019
•        Income from operations amounted to EUR 1,542 million, compared to EUR 1,644 million in 2019
•        EPS from continuing operations (diluted) amounted to EUR 1.31; Adjusted EPS amounted to EUR 1.98, in line with 2019
•        Operating cash flow improved to EUR 2,777 million, compared to EUR 2,031 million in 2019
•        Free cash flow improved to EUR 1,852 million, compared to EUR 1,053 million in 2019
•        Proposed dividend of EUR 0.85 per share, in cash or shares at the option of the shareholder

Frans van Houten, CEO of Royal Philips:

“Against the backdrop of the ongoing COVID-19 pandemic, we continued to support healthcare providers and medical staff with the provision of both acute COVID-19 care and regular healthcare. In the quarter, Philips entered into 25 new long-term strategic partnerships with hospitals in the US, Europe and Asia, to help them achieve their clinical and operational goals with our integrated solutions. We also supported consumers in their homes with telehealth solutions such as tele-dentistry services and remote monitoring.

I am pleased that, as a result of these efforts, in the quarter we recorded 7% comparable sales growth for the Group and 7% comparable order intake growth. The Adjusted EBITA margin improved by 110 basis points, and we delivered a strong free cash flow of EUR 1,055 million.

We launched several new products and solutions in the quarter, including the Philips Shaver Series 1000 that specifically addresses the personal care needs of young men in China. We also introduced our next-generation IntelliSpace Portal advanced visualization workspace with AI capabilities to support a precision diagnosis. To expand our Connected Care solutions, we signed agreements to acquire BioTelemetry and Capsule Technologies. These acquisitions will further broaden and scale Philips’ patient care management solutions for the hospital and the home to enhance patient outcomes, streamline clinical workflows and increase productivity. We target significant revenue synergies, and these businesses will be accretive to Philips’ sales growth and Adjusted EBITA margin in 2021. This is another important step in our strategy to become a leading solutions provider.

As a result of our stronger performance in the second half of the year, following a challenging first half due to the impact of COVID-19, our performance was resilient. For the full year 2020 we delivered 3% comparable sales growth, an Adjusted EBITA margin of 13.2% and a strong free cash flow of EUR 1.9 billion. Moreover, driven by 9% comparable order intake growth, we continued to gain market share in our healthcare businesses, and ended the year with a strong order book.

I am very grateful and proud of the commitment, resourcefulness and hard work of our more than 80,000 employees in 2020. Through our efforts, we were able to deliver against our triple duty of care – meeting critical customer needs, safeguarding the health and safety of our employees, and ensuring business continuity.

Looking ahead, we continue to see uncertainty related to the impact of COVID-19 across the world. For 2021, Philips plans to deliver low-single-digit comparable sales growth, driven by solid growth in Diagnosis & Treatment and Personal Health, partly offset by lower Connected Care sales, and an Adjusted EBITA margin improvement of 60-80 basis points.”

Business segment performance

The Diagnosis & Treatment businesses returned to growth, with 1% comparable sales growth in the quarter, driven by high-single-digit growth in Diagnostic Imaging. Comparable order intake showed a 3% increase, compared to a 5% decrease in the previous quarter. The Adjusted EBITA margin decreased to 14.0%, mainly due to mix changes. For the full year, the Diagnosis & Treatment businesses recorded a 2% comparable sales decrease and an Adjusted EBITA margin of 10.0%.

Comparable sales in the Connected Care businesses increased 24% in the quarter, with double-digit growth in Monitoring & Analytics and Sleep & Respiratory Care. Comparable order intake showed a 17% increase, with strong growth across all businesses. The Adjusted EBITA margin increased to 27.2%, due to operating leverage and productivity programs. For the full year, the Connected Care businesses delivered 22% comparable sales growth and an Adjusted EBITA margin of 21.5%.

The Personal Health businesses delivered a comparable sales increase of 5% in the quarter, with double-digit growth in Domestic Appliances and mid-single-digit growth in Personal Care. The Adjusted EBITA margin was 20.0%, in line with Q4 2019. For the full year, the Personal Health businesses recorded a 4% comparable sales decline and an Adjusted EBITA margin of 13.0%.

Philips’ ongoing focus on innovation and partnerships resulted in the following key developments in the quarter and the year:

•      In 2020, Philips’ products and solutions improved the lives of 1.75 billion people, compared to 1.64 billion in 2019. This figure includes 207 million people in underserved communities, compared to 194 million in 2019. In addition, Philips was once again recognized in 2020 for its sustainability performance in the 2020 Dow Jones Sustainability Indices and CDP’s Climate Change A-list.

•      Philips signed 25 new long-term strategic partnerships in the quarter, including a 5-year technology and innovation partnership with Rennes University Hospital, one of the top 10 hospitals in France, with four sites and more than 1,800 beds. Philips will deliver integrated solutions to support a precision diagnosis, image-guided therapies, and patient monitoring and management. This includes consultancy services to help optimize the hospital’s clinical pathways.

•      Expanding its range of patient-centric solutions for the home, Philips launched the BiPAP A40 EFL non-invasive ventilator. With this introduction, Philips is extending its respiratory care solutions with a new ventilation therapy feature to treat COPD patients with expiratory flow limitation (EFL) with targeted therapy to reduce symptoms and increase their comfort while sleeping.

•      Highlighting the company’s strength in enterprise imaging solutions, Philips created a single system for all 12 hospitals in the Region of Southern Denmark to store, retrieve, and view radiology and nuclear medicine images and data. This unified imaging ecosystem, which comprises Philips’ Vendor-Neutral Archive and Universal Viewer, will serve all of the region’s radiologists and nuclear medicine specialists, improving collaboration and enhancing patient care.

•      Leveraging Philips’ remote patient monitoring capabilities, Philips and BioIntelliSense have been selected by the U.S. Department of Defense to validate BioIntelliSense’s BioSticker sensor for the early detection of COVID-19 symptoms. The validation study aims to accelerate the use of wearable diagnostics for the early identification and containment of pre-symptomatic COVID-19 cases.

•      Highlighting its leadership in image-guided therapy, there was strong demand for Philips’ mobile surgery solutions, including the Philips Zenition mobile C-arm platform, resulting in double-digit growth for this category during the quarter. Earlier in the year, Philips introduced several new innovations on its Zenition platform to improve the workflow of complex surgical procedures.

•      Philips launched a vendor-neutral, multimodality Radiology Operations Command Center to enable real-time, remote collaboration between technologists, radiologists and imaging operations teams across multiple sites, with the aim of increasing productivity, minimizing issues with image quality, and expanding access to MR- and CT-based diagnosis.

Cost savings

In the fourth quarter of 2020, cost savings totaled EUR 123 million, with procurement savings of EUR 67 million and savings from overhead and other productivity programs of EUR 56 million, resulting in annual savings of EUR 447 million in 2020. As a result, Philips has delivered EUR 1.9 billion productivity savings for the Group over the 2017-2020 period, exceeding the target of EUR 1.8 billion.

Click here to view the release online

For further information, please contact:

Ben Zwirs
Philips Global Press Office
Tel: +31 6 1521 3446
Email: ben.zwirs@philips.com

Martijn van der Starre
Philips Global Press Office
Tel.: +31 6 2847 4617
E-mail: martijn.van.der.starre@philips.com


About Royal Philips

Royal Philips (NYSE: PHG, AEX: PHIA) is a leading health technology company focused on improving people’s health and well-being, and enabling better outcomes across the health continuum – from healthy living and prevention, to diagnosis, treatment and home care. Philips leverages advanced technology and deep clinical and consumer insights to deliver integrated solutions. Headquartered in the Netherlands, the company is a leader in diagnostic imaging, image-guided therapy, patient monitoring and health informatics, as well as in consumer health and home care. Philips generated 2020 sales of EUR 19.5 billion and employs approximately 82,000 employees with sales and services in more than 100 countries. News about Philips can be found at www.philips.com/newscenter.

Forward-looking statements and other important information

Forward-looking statements
This document and the related oral presentation, including responses to questions following the presentation, contain 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 Adjusted EBITA; future restructuring, acquisition-related and other costs; 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.

These factors include but are not limited to: changes in industry or market circumstances; economic, political and societal changes; Philips’ increasing focus on health technology and solutions; the successful completion of divestments such as the disentanglement and divestment of our Domestic Appliances businesses; the realization of Philips’ objectives in growth geographies; business plans and integration of acquisitions; securing and maintaining Philips’ intellectual property rights and unauthorized use of third-party intellectual property rights; COVID-19 and other pandemics; breaches of cybersecurity; IT system changes or failures; the effectiveness of our supply chain; challenges to drive operational excellence, productivity and speed in bringing innovations to market; attracting and retaining personnel; future trade arrangements following Brexit; compliance with regulations and standards including quality, product safety and data privacy; compliance with business conduct rules and regulations; treasury risks and other financial risks; tax risks; costs of defined-benefit pension plans and other post- retirement plans; reliability of internal controls, financial reporting and management process. As a result, Philips’ actual future results may differ materially from the plans, goals and expectations set forth in such forward-looking statements. For a discussion of factors that could cause future results to differ from such forward-looking statements, see also the Risk management chapter included in the Annual Report 2019.

Third-party market share data
Statements regarding market share, including those regarding Philips’ competitive position, contained in this document are based on outside sources such as research institutes, industry and dealer panels in combination with management estimates. Where information is not yet available to Philips, those statements may also be based on estimates and projections prepared by outside sources or management. Rankings are based on sales unless otherwise stated.

Use of non-IFRS information
In presenting and discussing the Philips Group’s financial position, operating results and cash flows, management uses certain non-IFRS financial measures. These non-IFRS financial measures should not be viewed in isolation as alternatives to the equivalent IFRS measure and should be used in conjunction with the most directly comparable IFRS measures. Non-IFRS financial measures do not have standardized meaning under IFRS and therefore may not be comparable to similar measures presented by other issuers. A reconciliation of these non-IFRS measures to the most directly comparable IFRS measures is contained in this document. Further information on non-IFRS measures can be found in Annual Report 2019.

Use of fair value information
In presenting the Philips Group’s financial position, fair values are used for the measurement of various items in accordance with the applicable accounting standards. These fair values are based on market prices, where available, and are obtained from sources that are deemed to be reliable. Readers are cautioned that these values are subject to changes over time and are only valid at the balance sheet date. When quoted prices or observable market data are not readily available, fair values are estimated using appropriate valuation models and unobservable inputs. Such fair value estimates require management to make significant assumptions with respect to future developments, which are inherently uncertain and may therefore deviate from actual developments. Critical assumptions used are disclosed in the Annual Report 2019. In certain cases independent valuations are obtained to support management’s determination of fair values.

Presentation
All amounts are in millions of euros unless otherwise stated. Due to rounding, amounts may not add up precisely to totals provided. All reported data is unaudited. Financial reporting is in accordance with the significant accounting policies as stated in the Annual Report 2019.

Effective Q1 2020, Philips has simplified its order intake policy by aligning horizons for all modalities to 18 months to revenue, compared to previously used delivery horizons of 6 months for Ultrasound, 12 months for Connected Care and 15 months for Diagnosis & Treatment. At the same time, Philips has aligned order intake for software contracts to the same 18 months to revenue horizon, meaning that only the next 18 months conversion to revenue under the contract is recognized, compared to the full contract values recognized previously. This change eliminates major variances in order intake growth and better reflects expected revenue in the short term from order intake booked in the reporting period. This realignment has not resulted in any material additional order intake recognition.

In 2020, Philips revised the definition of net finance expenses used in the calculation of Adjusted income from continuing operations attributable to shareholders, to exclude fair value movements of limited life fund investments recognized at fair value through profit and loss. This change leads to more relevant information as the fair value movements are not indicative of Philips’ performance. The fair value movements do not represent cash items. Philips believes making this change is helpful for investors to evaluate Philips’ performance.

Per share and weighted average share calculations have been adjusted for all periods presented to reflect the issuance of shares for the share dividend in respect of 2019.

Prior-period amounts have been reclassified to conform to the current-period presentation.

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FDA Grants Toripalimab Fast Track Designation for Mucosal Melanoma

SHANGHAI, China, Jan. 25, 2021 (GLOBE NEWSWIRE) — Junshi Biosciences (HKEX: 1877; SSE: 688180), an innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies, announced today that U.S. Food and Drug Administration (FDA) has granted toripalimab Fast Track designation for the first-line treatment of mucosal melanoma. Meanwhile, the FDA has also approved the Investigational New Drug (IND) application for a global Phase III trial of Toripalimab in combination with Axitinib versus Pembrolizumab for the first-line treatment of patients with advanced mucosal melanoma (Combination Clinical Trial).

About Toripalimab
Toripalimab was the first domestic anti-PD-1 monoclonal antibody approved for marketing in China. More than thirty company-sponsored clinical studies covering more than fifteen indications have been conducted globally, including in China and the United States. On December 17, 2018, Toripalimab obtained a conditional approval from the National Medical Products Administration (the “NMPA”) for the second-line treatment of unresectable or metastatic melanoma. Toripalimab was included in the 2019 and 2020 Guidelines of Chinese Society of Clinical Oncology (CSCO) for the Diagnosis and Treatment of Melanoma. Two supplemental New Drug Applications (NDAs) of Toripalimab for the third-line treatment of recurrent/metastatic nasopharyngeal carcinoma and the second-line treatment of metastatic urothelial carcinoma were accepted by the NMPA in April and May 2020, respectively. Both supplemental NDAs received priority review designations from the NMPA in July 2020. In addition, Toripalimab for the treatment of recurrent/metastatic nasopharyngeal carcinoma was granted the Breakthrough Therapy Designation (BTD) by the FDA in September 2020. In December 2020, Toripalimab was included in the updated National Reimbursement Drug List (NRDL) (2020 Edition).

About Combination Clinical Trial
The Combination Clinical Trial is an international, multi-center, randomized Phase III study designed to evaluate the efficacy and safety of Toripalimab in combination with Axitinib versus Pembrolizumab as a first-line treatment in patients with unresectable, locally advanced or metastatic mucosal melanoma. The trial intends to enroll 220 patients who will be randomized at 1:1 ratio into two study arms. The primary endpoint of the Combination Clinical Trial is progression-free survival (PFS). The secondary endpoints include objective response rate (ORR), duration of response (DOR), overall survival (OS), and safety.

Mucosal melanoma is a subtype of melanoma with mucosal origin. Compared with cutaneous melanoma, mucosal melanoma is less responsive to traditional chemotherapy and immunotherapy, and thus remains an unmet medical need. Toripalimab and Axitinib combination was the world’s first clinical application of PD-1 checkpoint blockade with a VEGFR inhibitor for the treatment of mucosal melanoma in a Phase Ib study (NCT03086174). The results of the study were published in the Journal of Clinical Oncology in August 2019. The study showed that the combination of Toripalimab with Axitinib in the first-line setting achieved an ORR of 48.3% and a disease control rate (DCR) of 86.2% for advanced mucosal melanoma with a manageable safety profile. The median progression-free survival (mPFS) was 7.5 months. In March 2020, Toripalimab in combination with Axitinib for the treatment of mucosal melanoma was granted the Orphan-Drug Designation (ODD) by the FDA.

About Fast Track Designation (FTD)
The FTD aims to facilitate the development and accelerate the review process of treatments for serious or life-threatening diseases or conditions that remain unmet clinical needs. The FTD is designed to make important new drugs accessible to patients faster. According to FDA regulations, drugs that receive FTDs will be granted an accelerated review process through various forms, including but not limited to (1) more frequent interactions and meetings with the FDA to discuss drug development and clinical trial design; (2) eligibility for priority review and accelerated approval after meeting relevant criteria; (3) rolling review, which means instead of waiting until all sections of the NDA are completed, a company can submit completed sections of its biologic license application (BLA) or new drug application (NDA) for review on a rolling basis.

The FTD will significantly accelerate the research, development, and marketing of Toripalimab in the United States. This marks another important milestone, after Toripalimab was granted the ODD and the BTD by the FDA.

About Junshi Biosciences
Founded in December 2012, Junshi Biosciences (HK: 1877; SH: 688180) is an innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapeutics. The company has established a diversified R & D pipeline comprising 27 innovative drug candidates and 2 biosimilars, with five therapeutic focus areas covering cancer, autoimmune, metabolic, neurological, and infectious diseases. Junshi Biosciences was the first Chinese pharmaceutical company that obtained marketing approval for anti-PD-1 monoclonal antibody in China. Its first-in-human anti-BTLA antibody for solid tumors was the first in the world to be approved for clinical trials by the FDA and NMPA and its anti-PCSK9 monoclonal antibody was the first in China to be approved for clinical trials by the NMPA. In early 2020, Junshi Biosciences joined forces with the Institute of Microbiology Chinese Academy of Science and Eli Lilly to co-develop JS016, China’s first neutralizing fully human monoclonal antibody against SARS-CoV-2, which has entered clinical trials and is now a part of our continuous innovation for disease control and prevention of the global pandemic. Junshi Biosciences has over 2,000 employees in the United States (San Francisco and Maryland) and China (Shanghai, Suzhou, Beijing and Guangzhou). For more information, please visit: http://junshipharma.com.

Contact Information

IR Team:
Junshi Biosciences
info@junshipharma.com
+ 86 021-2250 0300

Solebury Trout
Bob Ai
bai@soleburytrout.com
+ 1 646.378-2926

PR Team:
Junshi Biosciences
Zhi Li
zhi_li@junshipharma.com
+ 86 021-6105 8800