Item 1. Business
Item 1. Business
Overview
We are a leading provider of products, services and solutions for the diagnostics, life sciences and applied markets. Through our advanced technologies and differentiated solutions, we address critical issues that help to improve lives and the world around us.
Our headquarters are in Waltham, Massachusetts, and we market our products and services in more than 190 countries. As of January 1, 2023, we employed approximately 16,700 employees. Our common stock is listed on the New York Stock Exchange under the symbol “PKI” and we are a component of the S&P 500 Index.
We maintain a website with the address http://www.perkinelmer.com . We are not including the information contained in our website as part of, or incorporating it by reference into, this annual report on Form 10-K. We make available free of charge through our website our annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K and amendments to these reports, as soon as reasonably practicable after we electronically file these materials with, or otherwise furnish them to, the Securities and Exchange Commission.
Our Strategy
Our strategy is to develop and deliver innovative products, services and solutions in high-growth markets that utilize our knowledge and expertise to address customers’ critical needs and drive scientific breakthroughs. To execute on our strategy and accelerate revenue growth, we focus on broadening our offerings through both the investment in research and development and the acquisition of innovative technology. Our strategy includes:
• Strengthening our position within key markets by expanding our global product and service offerings, maintaining superior product quality and driving an enhanced customer experience;
• Attracting, retaining and developing talented and engaged employees;
• Accelerating transformational innovation through both internal research and development and third-party collaborations and alliances;
• Augmenting growth in both of our core business segments, Discovery & Analytical Solutions and Diagnostics, through strategic acquisitions and licensing;
• Engraining focused operational excellence to improve organizational efficiency and agility; and
• Opportunistically utilizing our share repurchase programs to help drive shareholder value.
Recent Developments
As part of our strategy to grow our core businesses and transform our portfolio, we have recently taken the following actions:
Discontinued Operations in Fiscal Year 2022:
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In August 2022, we entered into a Master Purchase and Sale Agreement (the “Purchase Agreement”) with Polaris Purchaser, L.P. (the “Purchaser”), a Delaware limited partnership owned by funds managed by affiliates of New Mountain Capital L.L.C. (the “Sponsor”), under which we agreed to sell to the Purchaser certain assets and the equity interests of certain entities constituting our Analytical, Food and Enterprise Services businesses (the “Business”) (as further defined in the Purchase Agreement), for cash consideration of up to approximately $2.45 billion and the Purchaser’s assumption of certain liabilities relating to the Business (collectively, the “Transaction”). Approximately $2.30 billion of the purchase price will be payable at closing, subject to certain customary adjustments, which includes $75.0 million in deferred payments tied to the transfer of the PerkinElmer brand and related trademarks to the Purchaser (which may be completed within 24 months following the date of the closing at our election). The Purchase Agreement also provides for potential post-closing payments totaling up to $150.0 million, which are contingent on the exit valuation the Sponsor and its affiliated funds receive on a sale or other capital events related to the Business. The Transaction is expected to close in the first quarter of fiscal year 2023, subject to regulatory approvals and other customary closing conditions.
Business Segments and Products
We report our business in two segments: Discovery & Analytical Solutions and Diagnostics.
Discovery & Analytical Solutions Segment
Our comprehensive portfolio of technologies helps life sciences researchers better understand diseases and develop treatments. In addition, we enable scientists to detect, monitor and manage contaminants and toxic chemicals that impact our environment and food supply as well as enable manufacturers to verify product quality and safety. Our Discovery & Analytical Solutions segment serves the life sciences and applied markets.
Life Sciences:
In the life sciences market, we provide a broad suite of products, solutions and services that facilitate optimized workflows, increase productivity, and accelerate every stage of the drug discovery and development pipeline. Our offerings span the areas of cell, gene, and protein research, enabling scientists to work smarter, make research breakthroughs, and transform those breakthroughs into real-world outcomes. We partner with global pharmaceutical, biotech and contract research organizations, as well as academic institutions, to enable them to discover and develop better treatments and therapeutics to fight disease faster and more efficiently.
Applied Markets:
The applied markets consist of environmental, food and industrial markets.
For the environmental market, we develop and provide analytical technologies, solutions and services that enable our customers to understand and characterize the health and quality of our environment, including air, water and soil. Our solutions are used to detect and help reduce the impact commercial products and industrial processes have on our environment. For example, our solutions help ensure compliance with regulatory standards that protect the purity of the world’s water supply by detecting harmful substances, including trace metals such as lead, organic pollutants such as pesticides and benzene, and emerging contaminants such as microplastics and polyfluoroalkyl substances (PFAS). We provide the tools needed to meet rigorous regulatory requirements for environmental testing, meet quality specifications and safety standards, and innovate for next generation analytical products.
We also offer a variety of solutions that help farmers and food producers provide a growing population with food that is safe, nutritious and appealing, and assist manufacturers with ensuring product consistency and maximizing production yield. Our solutions confirm food quality, including the level of moisture in grain or the level of fat in butter and nutritional elements, as well as detect the presence of potentially dangerous contaminants, such as veterinary drug residues in milk and harmful microbiological pathogens in foods. Our workflows can also be used to identify the origin of food products such as olive oil, which helps prevent counterfeiting. Our methods and analyses are transferable throughout the supply chain to enable customers to keep pace with industry standards as well as governmental regulations and certifications.
We also provide analytical instrumentation for industrial markets, which include the chemical, semiconductor, mining, energy, lubricant, petrochemical and polymer industries. Our solutions are used to meet the testing needs for quality assurance standards and in on-going product research and development. By providing material and chemical identification, characterization and quantification techniques, we help organizations drive the advancement and innovation of new products,
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with a focus on sustainability to increase the recyclability and biodegradability of materials as well as improving renewable energy solutions and energy storage.
We also provide services designed to help customers in the laboratory services market increase efficiencies and production time while reducing laboratory maintenance costs. Our OneSource ® laboratory service business is aligned with customers’ needs, enabling them to accelerate scientific progress and commercial opportunities.
Principal Products:
Our principal products and services for Discovery & Analytical Solutions applications include the following:
Life Sciences Market:
• Radiometric detection solutions, including over 750 radiochemicals and instrumentation such as the Tri-Carb ® and Quantulus ™ GCT families of liquid scintillation analyzers, Wizard 2® Gamma counters and MicroBeta 2® plate based LSA, which are used for beta, gamma and luminescence counting in microplate and vial formats utilized in research, environmental and drug discovery applications.
• The Opera Phenix ® Plus high-content screening system, which is used for sensitive and high-speed phenotypic drug screening of complex cellular models.
• The Operetta ® CLS ™ high-content analysis system, which enables scientists to reveal fine sub-cellular details from everyday assays as well as more complex studies, for example using live cells, 3D and stem cells.
• Reagents and solutions for microscopy and imaging applications. These include PhenoVue™ cellular imaging reagents and cell painting kits, PhenoPlate (formerly CellCarrier Ultra™) cellular imaging microplates and GrowDex ® hydrogels, fluorophore-conjugated and enzyme-conjugated antibodies, as well as buffers and solutions, such as our Ce3D™ collection of buffers for 3D tissue imaging.
• The MuviCyte™ live-cell imaging system, designed to operate inside a cell-culture incubator, enabling researchers to study cellular behaviors and pathways in living cells to gain a deeper understanding of functions, disease mechanisms and responses to treatments.
• The Signals Image Artist™ next-generation image analysis and management platform for drug discovery research, to help scientists process and analyze high-content screening (HCS) and cellular imaging data in a matter of hours versus days or weeks, so they can make more informed decisions faster.
• The VICTOR Nivo ® multimode plate reader benchtop system, which is designed for assay development and academic labs, including those using HTRF ® and AlphaLISA ® assay technologies.
• The EnSight ® multimode plate reader benchtop system, which offers well plate imaging alongside labeled detection technologies for target-based and phenotypic assays.
• The EnVision ® multimode plate reader, which is designed for high-throughput screening laboratories, including those using HTRF ® , AlphaScreen ® and AlphaLISA ® assay technologies.
• A wide range of homogeneous biochemical and cell-based reagents using HTRF ® , LANCE ® Ultra™, DELFIA ® , AlphaLISA ® , AlphaLISA ® SureFire ® Ultra, AlphaScreen ® , AlphaPlex ® and luminescence assay technologies.
• A broad portfolio of recombinant GPCR and ion channel cell lines, including over 300 products and 120 ready-to-use frozen cell lines for a wide range of disease areas.
• BioLegend ® ELISA MAX™ Standard Sets, ELISA MAX™ Deluxe Sets, LEGEND MAX™ ELISA Kits and RAPID MAX™ ELISA Kits as well as complementary solutions and buffers for immunoassays to cover more than 200 targets for human, mouse, and rat samples, many of which are designed to assess the immune environment and its inflammatory state for vaccine, infectious disease and autoimmune disease research.
• LEGENDplex™ bead-based reagents, which, in contrast to single analyte assays such as enzyme-linked immunosorbent assays (“ELISAs”), can quantitate up to 14 targets, from one small sample volume in a flow cytometry assay, and include both desktop and cloud-based analysis software.
• In vivo imaging technologies and reagents for preclinical research, comprised of the IVIS ® Spectrum ™ series for 2D and 3D optical imaging and optionally integrated low-dose CT imaging and the IVIS ® Lumina ™ series for benchtop 2D imaging, along with IVISbrite™ bioluminescent and IVISense™ fluorescent imaging agents, cell lines and dyes.
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• The Quantum TM GX2 system, which enables low-dose in vivo CT imaging of multiple species and areas of anatomical interest across multiple disease areas by way of high-resolution, tomographic imaging.
• GoInVivo™ as well as Ultra-LEAF™ and LEAF™ functional antibodies, which provide an affordable solution for researchers performing in vivo and ex vivo studies.
• Nexcelom BioScience high-throughput, microwell Celigo ® image cytometry system, Cellaca™ MX high-throughput cell counter, the new Cellaca™ PLX image cytometry system, and Cellometer ® automated cell counters, complemented by consumables and reagents, including reagents and kits for cell counting assays and cell viability, microplates, slides, and counting beads.
• Horizon Discovery tools and services that support drug discovery and development for greater understanding of gene function, identify genetic drivers behind human disease, develop and validate diagnostic workflows, and help deliver biotherapeutics, cellular and gene therapies for precision medicine with a portfolio of cell engineering tools, including Dharmacon™ Reagents, gene modulation technologies such as RNAi, and the Pin-point™ base editing technology.
• Sirion Biotech consultancy services and technologies to design and manufacture viral vectors for cell and gene therapy research and preclinical development.
• BioLegend best-in-class antibodies, recombinant proteins and related reagents, which are used across multiple applications and research areas, including proteogenomics, tissue, cell and protein analysis, cancer research, immunology, cell and gene therapy, stem cell therapy and neuroscience.
• Fluorophore-conjugated antibodies, which are used in flow cytometers to characterize protein expression on the surface and in internal compartments of cells. The large collection of dyes and antibodies allows for an increasing number of conjugate options, facilitating the use of bigger and better flow cytometry panels using conventional and spectral flow cytometers. Notable products are Brilliant Violet™ and the Spark™ and Fire dye series, among others.
• TotalSeq™ reagents, which are oligonucleotide-barcoded antibodies that enable protein detection by sequencing that can be combined with traditional RNA or DNA sequencing experiments with high-parameter protein detection, including comprehensive cloud-based analysis software.
• Cell culture and biofunctional assay reagents, including bioactive recombinant proteins, as well as other specialized reagents such as Cell-Vive™ T-NK Xeno-Free Serum Substitute (compliant with Good Manufacturing Practice requirements (“GMP”)), and other GMP-produced recombinant proteins and reagents. These products serve several markets, notably cell and gene therapy applications.
• MojoSort™ and Lymphopure™ reagents for cell separation that complement our fluorophore-antibody conjugates, used for FACS (Fluorescence-activated Cell Sorting), thus covering most cell separation and cell sorting technologies and applications.
• Flex-T™ reagents that utilize peptide-loaded major histocompatibility molecules assembled into tetramers for the identification of antigen-specific T cells. Our Flex-T products can be used to screen the efficacy of antigen peptides for vaccine and drug trials, as well as characterize the dominance of cancer-specific self-peptides, and more recently, SARS-CoV2 peptides for COVID-19 research.
• Antibodies and solutions for Western blotting. A large collection of validated antibodies, as well as supporting buffers and substrates, which provide a convenient set of tools to characterize protein size and relative expression levels in cell or tissue lysates.
• OneSource ® laboratory services, a comprehensive portfolio of multivendor instrument management, QA/QC, lab relocation, scientific, laboratory Information Technology and regulatory compliance services. OneSource ® services programs are tailored to the specific needs and goals of individual customers and offer a series of informatics-based consulting, planning and management offerings to assist in laboratory productivity and the optimization of complex Information Technology platforms.
• OneSource ® Dashboard software, a TIBCO ® Spotfire ® technology-driven interactive graphical platform, which provides visibility to a customer’s global asset population, service event and downtime distribution, as well as key performance indicators to assist in asset operation.
• OneSource ® Insights as a Service TM offerings which leverage comprehensive OneSource ® analytics and industry data to develop and deliver customer-need-driven recommendations to optimize, integrate and accelerate lab operations.
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• PerkinElmer Signals Medical Review TM software, which empowers medical monitors to detect safety signals faster and reduce overall time to submission by combining innovative medical review workflows with advanced analytics.
• PerkinElmer Signals Lead Discovery TM software, which enables researchers to quickly gain new insights into chemical and biomolecular research data, featuring guided search and analysis workflows and dynamic data visualizations for on-the-fly exploration.
• PerkinElmer Signals TM electronic notebook, a scientific research data management solution, which allows researchers to record research data and experiments in digital notebooks, drag and drop, store, organize, share, find and filter data easily.
• PerkinElmer Signals Translational TM data management, aggregation and analysis platform, which offers out-of-the-box support for the complete precision medicine workflow from data acquisition to biomarker discovery and validation.
• ChemDraw ® 18 platform, a chemical structure drawing and visualization application for scientists and researchers.
• Lead Discovery TM Premium software, which allows scientists to import, filter by, analyze and interpret chemical structures and biosequences alongside other related data in a highly visual and interactive environment for faster insights and better decisions.
• OneSource ® Asset Genius™ monitoring solution, part of the Asset Genius family, which offers a 360-degree view of laboratory instruments regardless of the manufacturer, correlating instrument usage, age and service data, allowing customers to visually pinpoint under-performing, ideally-performing and over-burdened assets, and to make informed decisions.
• Horizon CHOSOURCE™ platform, which was expanded to include CHO-K1 ADCC+ expression cell line for development of therapeutic antibodies in oncology, infectious disease and autoimmune conditions.
• A catalog of more than 20,000 SKUs from our recent acquisition of BioLegend, incorporating antibodies as well as a large collection of antibody conjugates and modifications. Other products include recombinant proteins, immunoassays and other supportive reagents and solutions for cell and molecular analysis.
• The T-SPOT ® Discovery SARS-CoV-2 research use only assay to investigate cell-mediated immunity related to COVID-19.
Applied Markets:
• The series of Clarus ® gas chromatographs and gas chromatographs/mass spectrometers, and the family of TurboMatrix™ sample-handling equipment, which are used to identify and quantify compounds in the environmental, forensics, food and beverage, hydrocarbon processing/biofuels, materials testing, pharmaceutical and semiconductor industries.
• A comprehensive gas chromatography (“GC”) column portfolio spanning many popular and application-specific phases that cover the vast majority of the GC market’s separation requirements.
• The LC 300™ ultra-high performance liquid chromatography (“UHPLC”) and LC 300 high performance liquid chromatography (“HPLC”) systems, which provide high throughput along with superior performance and sensitivity.
• The SimplicityChrom™ ™ Chromatography Data System (“CDS”) Software, an easy-to-learn, modern and intuitive CDS software platform that enables efficient control of PerkinElmer HPLC, UHPLC, GC and gas chromatography/mass spectrometry (“GC/MS”) solutions while integrating the overall chromatographic workflow. For labs requiring compliance, SimplicityChrom CDS Software supports 21 CFR Part 11.
• A comprehensive Liquid Chromatography (“LC”) Column portfolio of innovative and highly efficient HPLC/ UHPLC and supercritical fluid chromatography chemistries.
• The NexSAR™ HPLC, which is a speciation analysis ready system engineered with a completely inert and metal-free fluid path, enabling laboratories to meet low chromatographic background requirements on the most challenging speciation applications in food, water or consumer products such as children's toys.
• The Flexar™ UHPLC and Flexar advanced LC systems, which provide high throughput and resolution chromatographic separations.
• The QSight ® Triple Quadrupole LC/MS/MS, a flow-based mass spectrometry system that enables high levels of efficiency and productivity to meet both standard and regulatory requirements for food, cannabis and environmental testing laboratories.
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• The Torion ® T-9 portable GC/MS, a fast person-portable GC/MS system, enabling rapid detection and actionable results to potentially hazardous and emergency environmental conditions.
• Atomic spectroscopy portfolio of instruments, including the families of PinAAcle ® atomic absorption spectrometers, Avio ® Max inductively coupled plasma (“ICP”) optical emission spectrometers and NexION ® ICP mass spectrometers, all of which are used in the environmental, food, pharmaceutical and chemical industries, among others, to determine the elemental content of a sample.
• The LPC 500™ liquid particle counter featuring single particle optical sizing technology. Coupled with the Avio ® 550 Max ICP-OES oils system, particle counting and sizing as well as wear metals analysis of in-service oils and lubricants are performed in one run with results delivered in less than a minute.
• Our infrared (“IR”) spectroscopy family of instruments, the Spectrum Two™ IR & NIR spectrometers, which are compact and portable and used for advanced infrared analysis for unknown substance identification, material qualification or concentration determination in fuel and lubricant analysis, polymer analysis and pharmaceutical and environmental applications.
• The OilExpress™ 4 systems, which deliver highly automated, rapid, reliable oil condition monitoring results using recognized industry standard protocols such as ASTM ® , JOAP and Caterpillar ® S•O•S℠.
• The series of LAMBDA ® UV/Vis spectrophotometers that provide sampling flexibility to enable measurement of a wide range of sample types, including liquids, powders and solid materials, both in regulated industries as well as QC/QA and research applications.
• The FL 6500 TM and FL 8500 TM fluorescence spectrophotometers, which address the challenges of bioscience, industrial, chemical, environmental, pharmaceutical, agricultural and academic application.
• The 2400 Series II CHNS/O elemental analyzer, one of the leading organic elemental analyzers, which is ideal for the rapid determination of carbon, hydrogen, nitrogen, sulfur and oxygen content in organic and other types of materials.
• Our thermal analysis family, which includes our series of Differential Scanning Calorimetry (DSC) instruments that offer exclusive HyperDSC™ capability for unparalleled sensitivity and new insights into material processes, our Thermogravimetric and Simultaneous Thermal Analysis instruments that can be coupled with Fourier Transform Infrared (“FT-IR”), mass spectrometry (“MS”), or GC/MS technologies to provide a complete and advanced line of Evolved Gas Analysis (EGA) platforms for greater analysis power and knowledge with materials characterization in polymers, pharmaceuticals, chemicals, petroleum, rubber, food and other areas.
• Perten ® Falling Number ® , which is the world standard method for measuring sprout damage. This is an important factor affecting the price of wheat and, ultimately, bread, baked goods, and pasta/noodle quality.
• RVA™ performance analyzer, which provides a screening tool for both producers and users of food ingredients and can be used to test the viscous properties of starch, grain, dairy products and other foods.
• The Bioo Scientific ® and Meizheng Group test kits for detection of toxins, veterinary drug residues and contaminants, which enable rapid and easy testing at different steps in the food value chain.
• AuroFlow ® AQ Mycotoxin platform that includes strip test versions for total Aflatoxin, Deoxynivalenol (DON), Fumonisin, Ochratoxin A, Zearalenone and T-2/HT-2.
• The PerkinElmer FT 9700™ compact, high-performance and full-wavelength-range FT Near Infrared (“NIR”) spectrometer, which helps food and feed laboratories perform quick analyses for quality assurance of food and feed materials and reduces variations in production.
• The DA 7250 diode-array based NIR lab and at-line system, which simultaneously measures multiple constituents (moisture, protein, fat fiber, etc.) in 10 seconds.
• The IM 9500 Whole Grain NIR, which measures moisture, protein, oil, and more in less than 40 seconds.
• The AM 5200 grain moisture meter, which is based on the latest moisture meter technology, including the use of the Unified Grain Moisture Algorithm (UGMA) and 149MHz.
• The QSight ® SP50 online solid phase extraction (SPE) system, which facilitates sample clean-up, enrichment and concentration, obviating the need for elaborate and time-consuming sample preparation procedures.
• MaxSignal HTS™ mycotoxin kits featuring automated and easy-to-use testing workflows for the six most commonly tested mycotoxins.
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• PerkinElmer Solus One™ Listeria monocytogenes ELISA Assay. This offering is designed to help high throughput food processors and contract labs focus on L. mono testing for food and environmental surface samples.
• DA 7350™ and DA 7440™ in-line and on-line NIR instruments – combined with Process Plus™ cloud-based software – provide continuous quality control of food and food ingredient manufacturing processes.
• Perten® Glutomatic ® 2000 system for gluten quantity and quality testing of wheat, durum, semolina and flour.
• LactoScope™ FT- instruments, which deliver quick and accurate full spectrum in-lab component testing and adulterant screening for liquid dairy products such as whey, raw and skim milk, shelf stable milk and cream with under 40% fat content.
• Lactoscope Wine LQA 300 FT-IR, which is a fit-for-purpose wine analyzer for the analysis of finished wine, grape must, and must under fermentation for a number of key quality parameters, including acidity, brix, pH, glucose and fructose, in less than 45 seconds.
• The Indiscope, a simple FT-IR milk analyzer designed for analysis by novice users at animal milk collection stations that can provide results for fat, protein, and solids-non-fat, as well as targeted and untargeted adulterants screening in 30 seconds.
• MappIR™ accessory for Spectrum™ 3 FT-IR, which helps ensure quality of incoming raw materials and final product quality for better outcomes in semiconductor wafer manufacturing.
• The Polymer ID analyzer, which provides accurate verification of identity, quality and composition of polymers and their blends used in industries such as food packaging, construction and automotive.
• The Tablet Analyzer™ and portable Silica Analyzer™ platform, which are dedicated analyzers launched to address customer needs for quick and accurate characterization of pharmaceutical tablet testing and respirable crystalline silica in mining environments, respectively.
• PureView™ Certified and PureView MS Certified vials, manufactured from Type 1 borosilicate glass which meets all USP, JP and EP requirements. The low-expansion, coefficient glass exhibits excellent thermal conductivity and provides an inert surface with a low free ion content, giving accurate and repeatable results every time.
New Products:
New products introduced or acquired for Discovery & Analytical Solutions applications in fiscal year 2022 include the following:
Life Sciences Market:
• Vega ® ultrasound imaging system, which is a hands-free, automated, high-throughput preclinical ultrasound imaging system that delivers high-resolution 2D and 3D ultrasound images in just a few minutes and was originally developed by SonoVol Inc., which was acquired by PerkinElmer in early 2022. The system is complemented by VesselVue ® microbubble contrast agents which can be used to study tissue perfusion and blood flow characteristics.
• New assay kits for Adeno-associated Virus Vectors (AAVs) and gene therapy applications in our range of HTRF ® and AlphaLISA ® reagents, for detecting and quantifying CHO HCP impurities in biotherapeutics development, as well as kits across oncology, neuroscience, and targeted protein degradation applications.
• Cellaca PLX™ image cytometry system, which combines best-in-class image cytometer hardware, software, validated consumables and optimized reagent kits with validated antibodies from our BioLegend business, and trackable data reporting to enable the simultaneous detection of multiple markers and to streamline cell and gene therapy workflows.
• New fluorescent stains, reagents and secondary antibodies in our PhenoVue TM cellular imaging reagents portfolio for the detection and analysis of cellular components.
• The latest version of the Signals Image Artist™ next-generation image analysis and management platform, which provides improved 3D cell segmentation and analysis, an AWS S3 cloud deployment option and enhanced cloud security, and compatibility with a broader range of systems, including the Nexcelom from PerkinElmer Celigo ® image cytometer.
• An updated VICTOR ® Nivo™ multimode plate reader with a new software version for streamlined data analysis.
• OptiScint™ NPE-free scintillation cocktails and quench standards, providing a more environmentally friendly alternative without compromising performance.
• Expansion of our Western blotting reagents with the addition of the Western Lightning™ One range, which has a pre-mixed one component chemiluminescent HRP substrate for more consistent results.
• Additional Spark™ and Fire dye-conjugated antibodies, enabling higher-parameter flow cytometry. Notable products are the Spark UV™ 387 and Spark Red™ 718 conjugates.
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• For the TotalSeq reagent portfolio, more large panels of pre-titrated oligo-conjugated antibodies released in Universal Panels for the analysis of human and mouse samples.
• Software solutions for LEGENDplex™ assays, multiomics analysis with TotalSeq reagents, and flow cytometry-based cell analysis software (Ryvett) that are now part of BioLegend’s data integration offerings.
• OneSource Laboratory Services: Instrument Concierge™ Flow Cytometry, which helps labs streamline the entire flow cytometry workflow by providing a range of support-based services for each lab’s unique needs, including expert onsite flow cytometry specialists to help manage instruments and processes more efficiently and effectively, facilitating reduced downtime, increased productivity as well as better data integrity and reproducibility.
• OneSource Laboratory Services: Instrument Concierge™ Purification, which offloads the complex and time-consuming process of prepping, purifying and analyzing to provide high quality data output for scientific discovery.
• OneSource Laboratory Services: MES (Manufacturing Execution Systems) IT support, which drives production and minimizes downtime in pharmaceutical manufacturing environments by providing customized IT infrastructure support and maintenance, onsite or remotely.
• OneSource Laboratory Services: LabIT per PC Delivery Model, which eliminates the complexity of other pricing models for customers by providing a flat rate for each PC being serviced that includes maintenance and repair as well as a network of IT expertise in benchtop support and scientific applications.
• OneSource Laboratory Services: Food Service Offering, which provides support in various food quality and safety activities such as QA/QC lab testing, on-site troubleshooting and repair of instruments and coordinating vendor visits.
Applied Markets:
◦ The MPS 320™, a microwave digestion system for PerkinElmer’s AA, ICP-OES, and ICP-MS instruments, which accommodates a wide range of sample matrices and elemental analysis applications across environmental, food, cannabis, pharmaceutical or manufacturing QA/QC applications and more.
◦ GC 2400TM Gas Chromatography Platform with Detachable Touchscreen, featuring GC system, Liquid and Headspace Autosampler, FID and MS Detectors, offering innovative technology that enables access to real-time information on the go. With easy-to-learn SimplicityChrom Software, labs in all markets can take advantage of integrated workflows, and benefit from lab efficiency through the smart, simplified, and sustainable GC 2400 Platform.
◦ LAMBDA ® 365+ double-beam UV/V is a spectrometer, which delivers the performance researchers and analysts need to measure high absorbance liquids and unravel chemical kinetics. The large sample compartment and wide range of accessories fully integrated with software provide sampling flexibility and simplified workflows to meet all throughput needs without requiring extensive training.
Brand Names:
Our Discovery & Analytical Solutions segment offers additional products under various brand names:
Life Sciences Market:
Accell™, AdenoBOOST™, AlphaLISA ® , AlphaPlex ™ , AlphaScreen ® , Alpha™ SureFire ® , Brilliant Violet™, Ce3D™, CellCarrier ® , Cellaca™, Celigo ® ™, Cellometer ® ™, cell::explorer ™ , Cell-Vive™, Chalice ™ , Chem3D ® , ChemDraw ® , ChemOffice ® , CHOSOURCE™, Dharmacon™, DharmaFECT ™, Edit-R™, ELISA MAX™, EnSight ® , EnVision ® , Flex-T™, FMT ® , FolateRSense ™ , GoInVivo™, HTRF®, IVIS ® , IVISbrite™, IVISense™, LANCE ® , LANCE ® Ultra ™, LEAF™, LEGEND MAX™, LEGENDplex™, LentiBOOST™, L incode ™ , Living Image ® , Lumina™, Lymphopure™, MicroBeta 2® , Mini ELISA Plate Reader™, miRIDIAN ™ , MojoSort™, MuviCyte™, OneSource ® , ON-TARGET™, ON-TARGETplus™, Opera Phenix ® Plus, Operetta ® CLS™, OptiScint™, PerkinElmer Signals for Translational ™ , PhenoPlate™, PhenoVue™, Pin-point™, Quantulus ™ GCT, RAPID MAX™, RediJect™, RNAiONE™, Signals Image Artist™, SMARTpools ™ , SMARTvector ™ , Spark™, Spectrum™, TotalSeq™, Tri-Carb ® , T-SPOT ® , Ultra-LEAF™, Vega®, VesselVue ® , ViaStain™, VICTOR Nivo ™ Western Lightning ™ , and Wizard 2® .
Applied Markets:
Aquamatic ™ , AuroFlow ® , Clarus ® , DairyGuard ™ , DoughLab ™ , Falling Number ® , FL 6500 TM , FL 8500 TM , Flexar TM , Frontier ™ , GC 2400™ , Glutomatic ® , Honigs Regression ™ , HyperDSC ® , Inframatic ™, LAMBDA ® , LPC 500™, MaxSignal ™ , NexION ® , NexSAR™, OilExpress ™ , OilPrep ™ , Optima ® , Perten ® , Perten Instruments ® , PinAAcle ® , PureView TM , QSight ® , SimplicityChrom ™ , Spectrum ™ , Spectrum Two ™ , Spotlight ™ , Supra-clean ® , Supra-d ™ , Supra-poly ® , Syngistix™, Torion ® , TruQ™, TurboMatrix ™ and Ultraspray ® .
Diagnostics Segment
We offer instruments, reagents, assay platforms and software to hospitals, medical labs, clinicians and medical research professionals to help improve the health of families. Our Diagnostics segment is especially focused on reproductive health, immunodiagnostics, emerging market diagnostics and applied genomics.
We provide early detection for genetic disorders from pregnancy to early childhood, and infectious disease testing for the diagnostics market. Our screening products are designed to provide early and accurate insights into the health of expectant
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mothers during pregnancy and into the health of their babies. Diagnostic labs use our instruments, reagents and software for testing and screening genetic abnormalities and certain disorders and diseases, including Down syndrome, hypothyroidism, muscular dystrophy, infertility and various metabolic conditions. We also develop technologies that enable and support genomic workflows using PCR and next-generation DNA sequencing for applications in oncology, immunodiagnostics and drug discovery.
Principal Products:
Our principal products and services for Diagnostics applications include the following:
• The DELFIA ® Xpress screening platform, a complete solution for prenatal and maternal health screening, which includes a fast continuous loading system. It is supported by kits for first, second and third trimester analyses for prenatal screening and clinically validated LifeCycle™ software.
• The DELFIA ® Xpress sFlt-1 kit, which enables short term prediction of pre-eclampsia and aids in diagnosis in the second and third trimesters of pregnancy together with the previously launched DELFIA ® Xpress PlGF 1-2-3™ assay. The NeoBase™ non-derivatized MS/MS AAAC kits, which are used to support detection of metabolic disorders in newborns through tandem mass spectrometry. The kits analyze newborn dry blood spot samples for measurement of amino acids and other metabolic analytes for specific diseases.
• The GSP ® Neonatal hTSH, T4 17á-OHP, GALT IRT, BTD, PKU, Total Galactose, CK-MM and G6PD kits, used for screening congenital neonatal conditions from a drop of blood.
• The Specimen Gate ® informatics data management solution, designed specifically for newborn screening laboratories.
• The NeoLSD TM MS/MS kit, the first commercial IVD kit for screening of Pompe, MPS-I, Fabry, Gaucher, Niemann-Pick A/B and Krabbe disorders from a single dried blood spot sample.
• QSight ® 210MD and 225MD UHPLC MS/MS instruments, which are used for newborn screening.
• ViaCord ® umbilical cord blood banking services for the banking of stem cells harvested from umbilical cord blood and cord tissue, for potential therapeutic application in transplant and regenerative medicine.
• An expanded portfolio of molecular-based infectious disease screening technologies for blood bank and clinical laboratory settings in China. The tools include a qualitative 3-in-1 assay for the detection of hepatitis B, hepatitis C and HIV, as well as assays for other communicable diseases.
• TRF-based Anti HBs/HCV/TP kits for infectious disease testing.
• Chitas ® instrument and HBV/HCV/HIV 3-in-1 PCR reagents for blood screening, and Hi Sensitivity HBV DNA and HCV RNA assays for clinical infectious disease testing.
• The Bead Ruptor™ Elite Bead Mill Homogenizer, which enables grinding, lysing, and homogenizing of biological samples prior to molecular extraction delivering repeatable sample disassociation.
• The chemagic™ Prime™ instrument, a fully automated, LIMS-compatible solution for primary sample transfer, DNA and RNA isolation, optional normalization and the setup of PCR and Next Generation Sequencing (“NGS”) applications.
• Automated liquid handling platforms (JANUS ® , Sciclone ® , Zephyr ® and FlexDrop™) that offer a choice of robotic solutions in genomics, biotherapeutics, high throughput screening and high content analysis to assist life science research from bench to clinic.
• JANUS ® BioTx ™ and PreNAT II TM workstations for automated small-scale purification, offering column, tip and plate-based chromatography on a single platform.
• HIVE™ scRNAseq Solution, which integrates sample storage and single cell profiling into a complete workflow, solving the issues that limit single cell RNA analysis.The LabChip ® GXII Touch ™ protein characterization system, which provides a means of characterizing multiple protein product attributes for research labs through QC.
• The explorer ™ automated workstation, which allows integration of multiple laboratory instrumentation using a centralized robotic interface, allowing high throughput and turnkey-application focused solutions.
• Vanadis ® NIPT, a non-PCR non-sequencing fully automated cfDNA technology for use in any laboratory for screening common trisomies in the pregnant population.
• PerkinElmer Genomics, a global laboratory network offering services for testing in cytogenetics, biochemical genetics (prenatal and postnatal), molecular genetics and immunodiagnostics. The laboratory network includes testing laboratories in the United States, Sweden, India, China and the United Kingdom.
• The EONISTM assay, a CE marked and United States Food and Drug Administration (“FDA”) authorized system utilizing real-time PCR technology, which allows for simultaneous screening of SMA, SCID and XLA in newborns from a single DBS punch.
• Immune fluorescence testing (“IFT”), ELISAs, chemiluminescence-based immunotesting, immunoblots, molecular microarrays, PCR for infectious disease, autoimmune and allergy diagnostics as well as liquid handlers and software solutions for automated processing of those test systems.
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• Chemiluminescence immunoassays covering endocrinology, autoimmunity, infectious diseases, allergy and therapeutic drug monitoring.
• ELISAs covering endocrinology, autoimmunity, diabetes monitoring, steroids, thyroid monitoring, animal research and tumor markers.
• Radioactive immunoassays in calcium metabolism.
• Autoimmune testing covering rheumatology, hepatology, gastroenterology, endocrinology, neurology, nephrology, dermatology, and infertility.
• Allergy testing covering allergen-specific immunoglobin E (IgE), measuring the level of different IgE antibodies in blood using ELISA and EUROLINETM assays.
• Infectious disease testing covering bacteria, viruses, fungi and parasites.
• IFT, ELISA and EUROLINETM assays for veterinary diagnostics.
• EUROIMMUN SARS-CoV-2 Antigen ELISA for specific determination of the SARS-CoV-2 protein.
• EURORealTime SARS-CoV-2 Fast: real-time PCR test for direct detection of SARS-CoV-2.
• EURORealTime SARS-CoV-2/Influenza A/B real-time PCR test for direct detection of SARS-CoV-2, influenza virus type A and influenza virus type B.
• Immunoassays for detection of antibodies and T-cells against SARS-CoV-2.
• Anti-SARS-CoV-2 QuantiVacTM ELISA (IgG) to quantify IgG antibodies against the SARS-CoV-2 S1 antigen.
• SARS-CoV-2 NeutraLISA to identify neutralizing antibodies against SARS-CoV-2 (CE-marked).
• EUROLabPolaris, which provides the secure transfer of indirect immunofluorescence data to several locations enabling central evaluation within the software (CE-marked).
• MyFoodProfile immunoblots for the determination of IgG and IgE reactivity against more than 200 foods (CE-marked).
• Prenatal and Postnatal testing utilizing PerkinElmer Genomics Next Generation Sequencing products including gene panels, exomes and genomes.
• PerkinElmer Genomics Whole Genome Sequencing test, which detects single nucleotide and copy number variants and includes screening for Spinal Muscular Atrophy and more than 30 short tandem repeat disorders.
• PerkinElmer Genomics Digital Genome test for Facioscapularhumeral dystrophy (FSHD) Genome Optical Mapping technology.
• Oxford Immunotec T-SPOT ® Technology platform, a modified ELISPOT used to detect a T cell immune response to infection. Tests available using the platform include:
▪ The T-SPOT ® . TB test, an FDA-approved and CE-marked test to aid the diagnosis of Tuberculosis infection.
• The T-Cell Select ™ reagent kit, which is intended for use with the T-SPOT ® . TB test for the isolation of peripheral blood mononuclear cells from whole blood using positive selection via a magnetic bead-based cell separation system.
• The T-Cell Xtend ® reagent kit, which is intended for use with the T-SPOT ® . TB test for the pretreatment of whole blood prior to lymphocyte separation. The reagent aids in the removal of selected white blood cells from whole blood.
▪ The T-SPOT ® . COVID test, a CE marked test to detect a T cell immune response to SARS-CoV-2 infection and vaccination.
▪ The T-SPOT ® . CMV test, a CE marked test to assess anti-CMV T cell mediated immunity.
New Products:
New products or services introduced or acquired for Diagnostics applications in fiscal year 2022 include the following:
• EONIS™ Q for Research Use Only (RUO), which is a novel ‘dry-chemistry’ qPCR reader.
• GAMT RUO assay for Mass Spectrometry that detects the Guanidinoacetate methyltransferase molecule in dried blood spots.
• RONIA™ Platform for Research Use Only, which is a novel point of care device for quantitative determination of Placental Growth Factor.
• The BioQule™ NGS System combines automation, reagents, consumables, and scripts, enabling walkaway automation to simplify low throughput NGS library prep and quantitation.
• PKamp™ Monkeypox Virus Real-time PCR RUO Kit V1 which specifically targets the Monkeypox virus’ F3L gene and offers seamless integration with PerkinElmer’s sample prep workflow.
• HDPCR™ Tick-Borne Pathogen Research Use Only Panel and HDPCR™ Multi-Drug Resistance Panel for Research Use Only.
• NeoMDx™ cCMV Real-time PCR assay to amplify and detect cCMV DNA.
• OMNI Prep 96 Automated Homogenizer Workstation, which is a fully automated homogenization workstation, enabling true walk-away processing.
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• chemagic™ 360-D instrument (IVDR) and chemagic™ Prime™ Junior-D instrument (IVDR) for automated nucleic acid isolation, and related kits such as CE-IVD chemagic™ Nucleic Acid Purification Kits and chemagic™ miRNA 200 Kit.
• NEXTFLEX® Small RNA-Seq Kit v4 enables gel-free miRNA library prep while delivering exceptional miRNA discovery.
• NEXTFLEX® Rapid XP V2 DNA-Seq Kit incorporates normalization beads shortening the time needed for quantification and pooling preparation for sequencing and library prep costs.
• NEXTFLEX® Variant-Seq™ SARS-CoV-2 V2 Kit, which reduces the costs and time of SARS-CoV-2 variant detection by incorporating normalization beads into an NGS workflow.
• The PG-Seq™ Rapid Kit v2 analyzes picogram quantities of DNA from an embryo biopsy for preimplantation genetic research with enhanced whole genome coverage and accuracy.
• DOPlify® WGA V2 Kit performs fast whole genome amplification on single cells or limited template DNA samples, allowing cell chromosome copy number status to be determined.
• PerkinElmer® COVID-19 Antigen Self-Test is a CE marked in vitro diagnostic device for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigen in nasal swab specimen in a non-professional setting by non-professional users.
• PerkinElmer Genomics WholePanel test, which is an enhanced panel testing (WholeCancer, WholeAtaxia, WholeCardiology and WholeMuscularDystrophy panels) using genome sequencing as a backbone and provides full intrinsic coverage and short tandem repeat screening in on test.
• PerkinElmer Genomics UltraRapid Whole Genome Sequencing with StepOne, which provides the sickest babies in NICU multiomic testing results in five days or less.
• EURORealTime SARS-CoV-2 Fast, which is real-time PCR test for direct detection of SARS-CoV-2 (CE-marked)
• Microwell Imager (CE-marked).
• EUROMicroblot Anti-Borrelia (IgG, IgM) (CE-marked) Miniaturised immunoblots for borrelia diagnostics in microplate format where processing can be carried out on automated ELISA systems and evaluation is done fully automatically by the Microwell Imager device and the EUROLineScan software.
• EUROLINE Autoimmune Inflammatory Myopathies 20 Ag (IgG) (CE-marked), in which the immunoblot profile combines 20 target antigens – including the exclusive cN-1A – in one test strip, allowing parallel and monospecific detection of antibodies for the diagnostics of idiopahtic inflammatory myopathies, e.g. myositis.
• Neurology: Complete portfolio of chemiluminescence immunoassays (ChLIA) for precise Alzheimer’s disease diagnostics, which provides reliable analysis of the established CSF biomarkers beta-amyloid (1-40), beta-amyloid (1-42), total tau and pTau(181) and high degree of standardisation due to fully automated processing:
◦ Beta-Amyloid (1-40) ChLIA (CE-marked). Chemiluminescence immunoassay (ChLIA) for quantitative in vitro determination of beta-amyloid (1-40) in human cerebrospinal fluid. Supports the diagnosis of amyloid pathology (Alzheimer’s disease). Fully automated processing on the random-access devices IDS-iSYS Multi-Discipline Automated System and IDS-i10.
◦ Beta-Amyloid (1-42) ChLIA (CE-marked). Chemiluminescence immunoassay (ChLIA) for quantitative determination of beta-amyloid (1-40) in human cerebrospinal fluid. Supports the diagnosis of amyloid pathology (Alzheimer’s disease). Calibrated against certified reference material. Fully automated processing on the random-access devices IDS-iSYS Multi-Discipline Automated System and IDS-i10.
◦ Total-Tau ChLIA (CE-marked). Chemiluminescence immunoassay (ChLIA) for quantitative determination of total tau in human cerebrospinal fluid. Supports the diagnosis of Alzheimer’s disease. Fully automated processing on the random-access devices IDS-iSYS Multi-Discipline Automated System and IDS-i10.
◦ pTau(181) ChLIA (CE-marked). Chemiluminescence immunoassay (ChLIA) for quantitative determination of total tau in human cerebrospinal fluid. Supports the diagnosis Supports the diagnosis of Alzheimer’s disease. Fully automated processing on the random-access devices IDS-iSYS Multi-Discipline Automated System and IDS-i10.
• EUROArray PneuVir (CE-marked). PCR-based multiplex test (Microarray) to detect 17 respiratory viruses including SARS-CoV-2 in just one analysis. The differential diagnostic approach for quick virus identification may thus help to rule out a bacterial infection and avoid unnecessary antibiotic treatment.
• Anti-Herpes simplex Virus 1 ChLIA (IgG) (CE-marked). Chemiluminescence immunoassay (ChLIA) for the quantitative determination of human IgG antibodies against herpes simplex virus 1 (HSV-1) High reliability of the HSV type-specific IgG determination due to the use of glycoprotein G1 (gG1). ). Fully automated processing on the random-access devices IDS-iSYS Multi-Discipline Automated System and IDS-i10.
• Anti-Herpes simplex Virus 2 ChLIA (IgG) (CE-marked). Chemiluminescence immunoassay (ChLIA) for quantitative determination of human IgG antibodies against herpes simplex virus 2 (HSV-2). High reliability of the HSV type-specific IgG determination due to the use of glycoprotein G2 (gG2). Fully automated processing on the random-access devices IDS-iSYS Multi-Discipline Automated System and IDS-i10.
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• Anti-SARS-CoV-2 RBD ChLIA (IgG) (CE-marked). Chemiluminescence immunoassay (ChLIA) for quantitative determination of human IgG antibodies against the receptor binding domain (RBD) of SARS-CoV-2 with the possibility of conversion into standardised units (BAU/ml). Fully automated processing on the random-access devices IDS-iSYS Multi-Discipline Automated System and IDS-i10.
Brand Names:
Our Diagnostics segment offers additional products under various brand names, including AutoDELFIA ® , BACS-on-Beads ® , BIOCHIPs, Bioo Scientific ® , BoBs ® , chemagic™, Chitas ® , Datalytix ™ , DELFIA ® , DELFIA ® Xpress, DOPlify ® , EONIS TM , EUROArray TM , EUROIMMUN ® , EUROLabWorkstation TM , EUROLINE TM , EUROPattern TM , Evolution ™ , Evoya ® , explorer™, Genoglyphix ® , GSP ® , Haoyuan TM , IDS ® Immunodiagnosticsystems, IDS-i10 ®, IDS-i10T ® , IDS-iSYS ®, iLab ™ , JANUS ® , LabChip ® , LifeCycle ™ , LimsLink ™ , Migele™, MultiPROBE ® , NEXTFLEX ® , NextPrep™, Pannoramic ™ , Panthera Puncher™, PG-Seq TM , PG-Find TM , PKamp TM , PreNAT II TM , Protein Clear TM , ProteinEXact TM , QSight ® , QuantiVac TM , RONIA™, Sciclone ® , SimplicityChrom™, Specimen Gate ® , Superflex TM , Symbio TM , T-SPOT ® , Twister ® , Vanadis ® , VariSpec ™ , ViaCord ®, VICTOR 2™ D, and Zephyr ® .
Marketing
All of our businesses market their products and services primarily through their own specialized sales forces. As of January 1, 2023, we employed approximately 6,300 sales and service representatives operating in approximately 40 countries and marketing products and services in more than 190 countries. In geographic regions where we do not have a sales and service presence, we utilize distributors to sell our products.
Raw Materials, Key Components and Supplies
Each of our businesses uses a wide variety of raw materials, key components and supplies that are generally available from alternate sources of supply and in adequate quantities from domestic and foreign sources. We generally have multi-year contracts, with no minimum purchase requirements, with our suppliers. For certain critical raw materials, key components and supplies required for the production of some of our principal products, we have qualified only a limited or a single source of supply. We periodically purchase quantities of some of these critical raw materials in excess of current requirements, in anticipation of future manufacturing needs. With sufficient lead times, we believe we would be able to qualify alternative suppliers for each of these raw materials and key components. See the applicable risk factor in “Item 1A. Risk Factors” for an additional description of this risk.
Intellectual Property
We own numerous United States and foreign patents and have patent applications pending in the United States and abroad. We also license intellectual property rights to and from third parties, some of which bear royalties and are terminable in specified circumstances. In addition to our patent portfolio, we possess a wide array of unpatented proprietary technology and know-how. We also own numerous United States and foreign trademarks and trade names for a variety of our product names, and have applications for the registration of trademarks and trade names pending in the United States and abroad. We believe that patents and other proprietary rights are important to the development of both of our reporting segments, but we also rely upon trade secrets, know-how, continuing technological innovations and licensing opportunities to develop and maintain the competitive position of both of our reporting segments. We do not believe that the loss of any one patent or other proprietary right would have a material adverse effect on our overall business or on any of our reporting segments.
In some cases, we may participate in litigation or other proceedings to defend against or assert claims of infringement, to enforce our patents or our licensors’ patents, to protect our trade secrets, know-how or other intellectual property rights, or to determine the scope and validity of our or third parties’ intellectual property rights. Litigation of this type could result in substantial cost to us and diversion of our resources. An adverse outcome in any litigation or proceeding could subject us to significant liabilities or expenses, require us to cease using disputed intellectual property or cease the sale of a product, or require us to license the disputed intellectual property from third parties.
Competition
Due to the range and diversity of our products and services, we face many different types of competition and competitors. Our competitors range from foreign and domestic organizations, which produce a comprehensive array of goods
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and services and that may have greater financial and other resources than we do, to more narrowly focused firms producing a limited number of goods or services for specialized market segments.
We compete on the basis of service level, price, technological innovation, operational efficiency, product differentiation, product availability, quality and reliability. Competitors range from multinational organizations with a wide range of products to specialized firms that in some cases have well-established market positions. We expect the proportion of large competitors to increase through the continued consolidation of competitors.
Regulatory Affairs
Our operations are subject to regulation by different state and federal government agencies in the United States and other countries, as well as to the standards established by international standards bodies. Some of our products are subject to regulation by the FDA and similar foreign agencies. These regulations govern a wide variety of our product activities, and if we fail to comply with those regulations or standards, we may face, among other things, warning letters; adverse publicity; investigations or notices of non-compliance, fines, injunctions, and civil penalties; import or export restrictions; partial suspensions or total shutdown of production facilities or the imposition of operating restrictions; increased difficulty in obtaining required FDA clearances or approvals or foreign equivalents; seizures or recalls of our products or those of our customers; or the inability to sell our products.
We have agreements relating to the sale of our products and services to government entities and, as a result, we are subject to various statutes and regulations that apply to companies doing business with the government. We are also subject to investigation for compliance with the regulations governing government contracts. A failure to comply with these regulations could result in suspension of these contracts, as well as other penalties.
We are also subject to a variety of laws, regulations and standards that govern, among other things, the importation and exportation of products, and our business practices in the United States and abroad such as anti-bribery, anti-corruption and competition laws. In addition, changes in governmental regulations may reduce demand for our products or increase our expenses. The healthcare industry, including the genetic screening market, is subject to extensive and frequently changing international and United States federal, state and local laws and regulations. This requires that we devote substantial resources to maintaining our compliance with those laws, regulations and standards.
If we fail to comply with applicable laws and regulations, we could suffer civil and criminal damages, fines and penalties, exclusion from participation in governmental healthcare programs, and the loss of various licenses, certificates and authorizations necessary to operate our business, as well as incur liabilities from third-party claims, all of which could have a significant adverse effect on our business.
Environmental Matters
Our operations are subject to various foreign, federal, state and local environmental and safety laws and regulations. These requirements include the handling, transportation, manufacture and disposal of toxic or hazardous substances, the remediation of contaminated soil and groundwater, the regulation of radioactive materials, and the health and safety of our employees.
We may have liability under the Comprehensive Environmental Response Compensation and Liability Act and comparable state statutes that impose liability for investigation and remediation of contamination without regard to fault, in connection with materials that we or our former businesses sent to various third-party sites. We have incurred, and expect to incur, costs pursuant to these statutes.
We are conducting a number of environmental investigations and remedial actions at our current and former locations and, along with other companies, have been named a potentially responsible party (“PRP”) for certain waste disposal sites. We accrue for environmental issues in the accounting period that our responsibility is established and when the cost can be reasonably estimated. We have accrued $12.2 million and $11.9 million as of January 1, 2023 and January 2, 2022, respectively, which represents our management’s estimate of the cost of the remediation of known environmental matters, and does not include any potential liability for related personal injury or property damage claims. Our environmental accrual is not discounted and does not reflect the recovery of any material amounts through insurance or indemnification arrangements. The cost estimates are subject to a number of variables, including the stage of the environmental investigations, the magnitude of the possible contamination, the nature of the potential remedies, possible joint and several liability, the time period over which remediation may occur, and the possible effects of changing laws and regulations. For sites where we have been named a PRP, our management does not currently anticipate any additional liability to result from the inability of other significant named parties to contribute. We expect that the majority of such accrued amounts could be paid out over a period of up to ten years. As
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assessment and remediation activities progress at each individual site, these liabilities are reviewed and adjusted to reflect additional information as it becomes available. There have been no environmental problems to date that have had, or are expected to have, a material adverse effect on our consolidated financial statements. While it is possible that a loss exceeding the amounts recorded in the consolidated financial statements may be incurred, the potential exposure is not expected to be materially different from those amounts recorded.
We may become subject to new or unforeseen environmental costs or liabilities. Compliance with new or more stringent laws or regulations, stricter interpretations of existing laws, or the discovery of new contamination could cause us to incur additional costs.
Human Capital Management
As of January 1, 2023, we employed approximately 16,700 employees on a worldwide basis. Roughly 80% of our workforce is based outside of the United States. Several of our subsidiaries outside the United States have employment contracts with our employees where the terms and conditions are influenced by labor unions and workers’ councils’ agreements that involve approximately 5,000 of our employees. During fiscal year 2022, our voluntary turnover rate was 14%. We believe that management of our human capital resources is vital to the continued growth and success of our company, and we endeavor to create an environment that encourages productivity, rewards performance and values diversity. There are several ways in which we attempt to attract, develop and retain highly qualified employees, as set forth below.
Our human capital objectives include, as applicable, identifying, recruiting, developing, retaining, incentivizing, and integrating our existing and new employees. We strive to meet this objective by offering competitive compensation and benefits, in a diverse, inclusive and safe workplace, with opportunities for our employees to grow and develop in their careers. We hold our employees to high performance standards and our compensation plans are designed to deliver competitive base pay and attractive incentive opportunities. Our benefits programs are specifically tailored to the various countries in which we operate and maintain a significant workforce. We benchmark for market practices and adjust our compensation and benefits programs to ensure they remain both equitable and competitive.
Diversity and Inclusion
We believe in an inclusive workforce, where employees from a number of cultures and countries are engaged and encouraged to leverage their collective talents. We have employees in roughly 40 countries around the world. As of the date of filing of this annual report on Form 10-K, women comprised roughly 34% of our leadership positions on a global basis, which we define as director level and above. We have provided further information regarding our diversity demographics in our Environmental, Social, and Governance (ESG) Report and elsewhere on our website at esg.perkinelmer.com, including summarized data from our EEO-1 form.
esg.perkinelmer.com is a home for information related to ESG policies and initiatives at PerkinElmer. The site provides information for our employees, customers and investors on our environmental and social metrics and policies, our global efforts to preserve our environment and our global efforts to promote social equality. It helps our employees and stakeholders know and understand of our commitment to make positive impacts on our employees, customers, local communities and the environment, while engaging others in our efforts.
Our EEO-1 form is a report filed with the United States Equal Employment Opportunity Commission describing the racial, ethnic and gender composition of our U.S.-based workforce. Information on our website, including the ESG Report, shall not be deemed incorporated by reference into this annual report.
We understand that our ability to operate in a multicultural world is critical to our long-term value creation. By maintaining a culture of diversity and inclusion, we believe that we can innovate more effectively. To that end, we seek to promote diverse perspectives throughout our organization and are an equal opportunity employer committed to making employment decisions without regard to race, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
Our commitment to diversity is evidenced by the establishment of our internal Inclusion and Diversity Committee, formed in fiscal year 2020, which is comprised of a wide cross-section of leaders across all regions and backgrounds. The committee focuses on driving increased diversity within our workforce, as well as creating a safe and engaging platform for dialogue on these issues for all of our employees. Our commitment to creating a diverse and inclusive work environment is further validated by our employees, as reflected in the results of our 2021 PerkinElmer People Experience Engagement Survey, where we received high scores in the areas of Diversity & Inclusion, Inclusiveness, and Non-Discrimination. Among other comments, employees shared that they are proud of the emphasis we place on diversity and inclusion, and on making our company a place
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where everyone is valued and respected. We furthered our journey to maintain a diverse and inclusive workplace in 2022 through the launch of three additional employee resource groups offering our Hispanic and Veteran communities enhanced opportunities and visibility as well our Able group highlighting the power of individuals with disabilities. Focusing also on engagement and belonging, we launched four new Employees Networking Groups during fiscal year 2022 to allow our employees to regroup and connect over their passions or common areas of interest.
Training and Development
We are committed to the continued development and training of our employees and we seek to provide them with meaningful learning opportunities to help grow their capabilities and careers. We provide such opportunities across all levels of our organization, covering a variety of professional, technical and leadership topics. We do so through a variety of channels and formats, including formal (classroom-based, blended learning solutions, digital learning) and informal, on-the-job learning.
A pivotal component of our annual performance review and goal-setting process focuses on providing employees with constructive and actionable feedback, as well as management engagement in the creation and completion of development goals. In addition, employees have access to confidential, anonymous feedback through a process that is used as a development tool to help raise awareness on how they are perceived. Lastly, we recognize that professional development requires support of the whole person, and we therefore offer virtual coaching to help eligible employees meet their unique development goals, whether such goals are leadership or well-being focused.
With regards to career growth, we regularly fill open vacancies with internal candidates. Our internal mobility program empowers employees to explore many different career options available to them.
Lastly, management periodically assesses succession planning for certain key positions and reviews our workforce to identify high potential employees for future growth and development.
Health and Safety
Our success depends on the well-being of our employees, and one of our top priorities is to protect the health and safety of our employees. We maintain a culture focused on safety and strive to identify, eliminate and control risk in the workplace to prevent injury and illness. Our employees have access to a global safety management system and are encouraged to report incidents, near misses, or other observations in the system. The system has been widely adopted in our manufacturing locations across the globe, and management uses the information generated by it to set safety-related policies and to establish goals for future performance. Further, we provide our employees with a comprehensive benefits package that includes health insurance and other resources that support their physical and mental well-being. In relation to the COVID-19 pandemic, we have continued to take actions to protect the health and safety of our employees, customers, partners and suppliers. In particular, during fiscal year 2022, we have followed rigorous safety measures in China, during the country’s various lockdowns and subsequent re-openings, and provided well-being support activities for our employees and their families.
Community
At PerkinElmer, we have long held the view that responsible global citizenship along with good governance principles and ethical business practices are essential tenets for sustainability and success. We encourage our employees to support the communities in which they live and where we operate, and to assist in that effort, we fund a long-term charitable matching program for our employees. In addition, we have established a group comprised of management and subject matter experts at our company to focus on developing and delivering on measurable advancements in the areas of reducing waste, reducing carbon emissions and improving employee engagement and diversity.