Revvity, Inc. (RVTY) 2021年年度報告「NYSE」.pdf

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1、2021 AnnualReportTRANSFORMINGTOGETHERFor both PerkinElmer and the world,2021 was ayear marked by significant transformation.Withinthe company,last year was the culminationof immense internal work that has takenplace over the past three years.Following theorganizational changes we made and programswe

2、 implemented in 2019 around refocusing ourcommercial and operating teams,we saw theoutput from those changes shine through in2020 as we quickly responded to the challengesand opportunities presented by the pandemic.Now,as I look back on 2021,it was clearly theyear of portfolio transformation and our

3、 evolutioninto the“new PerkinElmer.”Moving ahead,2022is expected to be the beginning of an excitingacceleration in our growth driven by the progresswe have made over the last several years.Reflecting on our portfolio transformation,we have significantly expanded our scale in the faster growingareas

4、of Life Sciences and Diagnostics through nine acquisitions over the past 14 months.Theseadditions have already delivered strong performance,with substantial revenue growth in 2021.WithinDiagnostics,Immunodiagnostic Systems joined PerkinElmer bringing its endocrinology,autoimmune andinfectious diseas

5、e focused testing menu which seamlessly fits with our EUROIMMUN immunodiagnosticsportfolio.In addition,the acquisition of Oxford Immunotec provided entry into the sizable testing marketfor latent tuberculosis,the deadliest infectious disease in the world behind COVID-19.Now,asIlookbackon2021,itwascl

6、earlytheyearofportfoliotransformationandourevolutionintothenewPerkinElmer.Dear Fellow Shareholders,Colleaguesfromaroundtheworld,includingourEUROIMMUN,OxfordImmunotecandIDSteams,attendedthe2021AACCAnnualScientificMeeting&ClinicalLabExpoeventinAtlanta,GA.Dr.Prahlad SinghPresident&CEOOn the Life Scienc

7、e front,we welcomed the additions of BioLegend,Nexcelom,Sirion and Horizon Discovery into thePerkinElmer family which have not only bolstered our offerings in the pre-clinical space,but also allow us to now providea differentiated offering within the exciting cell and gene therapy market.We see trem

8、endous potential and opportunitiesfor new innovations through collaborations among all our businesses,and I am excited about what we are alreadylearning from each other.In November,we held a company-wide Innovation Summit at the headquarters of BioLegend,aleading developer and manufacturer of high-q

9、uality antibodies and reagents.This was a terrific way to start building thefoundation for and share ideas around the many product and technology collaborations in front of us.Closeto90employeesfromacrossthePerkinElmerfamilycametogetheratthe2021InnovationSummitheldatBioLegendsheadquartersinSanDiego,

10、CAtoshareideas,buildconnections,andexplorecross-companysynergies.Outside of Diagnostics and Life Science,our other market segments are focused on delivering exciting new productlaunches over the coming months that will meaningfully impact our business moving ahead.In both our Food andApplied Markets

11、 businesses,we have stepped up R&D investments to ensure that we can continue to deliver theproducts our customers need to help solve their most specific challenges.In addition to significantly strengthening our portfolio,our team has been hard at work executing on several key strategicpriorities th

12、at we outlined last year.Within Operational Excellence for example,our Integration Transformation Office hascreated opportunities for collaboration and helped ensure that we remain committed to our acquisition-specific approachto successful integration.Specific to innovation,our R&D teams have conti

13、nuedto push the boundaries of what is possible,deliveringeven more advanced products to the market fasterand more efficiently,with new product introductionsup 15%in 2021.And looking at how we engage withand serve our customers,we have seen tremendousprogress with our Global Commercial Office and its

14、initiatives to further digitize the customer experience,which have already changed the way we work withand strengthen our connections with customers.Andlast but certainly not least,the thing I am most proudof is how we have significantly enhanced our focus onculture and our people.AcolleagueatourLig

15、hthouseLabinNewport,UKprocessesCOVID-19samplesonourJANUSG3BloodiQWorkstation.Im extremely proud of and grateful for our now more than 16,000 colleagues for leading with science,their deep-seatedcommitment to our mission,and the support that they give to one another,our customers and communities.Fund

16、amentalto the heart and soul of PerkinElmer has always been our dedication to innovation and passionate people who want totransform the future of health and science.Today,I could not be more excited about where we are and where PerkinElmeris headed.I look forward to seeing how we can continue to hel

17、p our customers advance their science like never before,tocontribute to a better and healthier world.Regards,PrahladOur reinvigorated culture is one centered around entrepreneurial spirit,agility,teamwork and inclusivity.I am especiallypleased with the initial momentum weve built around our ESG goal

18、s,specifically around talent development,employeeengagement as well as diversity,equity and inclusion,and look forward to sharing more progress in the months ahead.Even with all of the exciting changes and meaningful progress that has taken place across PerkinElmer,at the end of theday,the most impo

19、rtant measure of our success comes down to the impact that we make across science and healthcare.And today,that impact is much more profound than ever before.In 2021,140 million PerkinElmer tests were used to screen babies in over 100 countries for various disorders-saving thelives of an average of

20、70 babies each day,and to date,more than 735 million babies have been tested for life-threateningdiseases using PerkinElmers newborn screening tools.Within food testing,90%of the worlds commercially traded wheat crop is tested for quality or safety using PerkinElmersolutions,which can detect food fr

21、aud in as little as 30 seconds.PerkinElmer is providing environmental scientists andresearchers with technologies to better understand the prevalence and sources of the over 14 million tons of microplasticsthat are churning through our oceans,posing a threat to both the marine ecosystem and humans.P

22、erkinElmers discovery solutions and services are used by 47 of the worlds top 50 leading pharmaceutical companies,tohelp them work towards finding novel therapeutics to combat the worlds toughest diseases and viruses.And leveragingour OneSource strategic consulting and laboratory support services,sc

23、ientists have been able to focus on their researchinstead of lab management activities,returning more than 100,000 hours back to science.Specific to COVID-19,to-dateour workflow solutions have helped test more than 75 million individuals around the world during this pandemic.SAVINGTHELIVESOFNEWBORNS

24、SCREENEDACROSSCOUNTRIES70+BABIESEACHDAY735+M14,000,00075,000,000100,000TONSOFMICROPLASTICS100+QUALITY&SAFETYTESTINGFOROF COMMERCIALWHEATCROPSCOVID-19 SOLUTIONSTHATHELPEDPEOPLE ACROSSTHE GLOBETECHNOLOGIESTOANALYZETHEENVIRONMENTALIMPACTOFDISCOVERYSOLUTIONS&SERVICESUSEDBY47OFTHE50WORLDSTOPPHARMACOMPANI

25、ESLABSERVICESTHATSAVESCIENTISTSHOURSOFNON-SCIENTIFICTASKSCORPORATE GOVERNANCEBOARD OF DIRECTORSCORPORATE OFFICERSPrahlad Singh,PhDPresident and Chief Executive OfficerPerkinElmer,Inc.Peter Barrett,PhDPartner,Atlas VentureSamuel R.ChapinRetired Executive Vice ChairmanBank of America Merrill LynchSylv

26、ie Grgoire,PharmDCo-founder and Executive ChairEIP Pharma,Inc.Alexis P.MichasManaging PartnerJuniper Investment Company,LLCMichel VounatsosChief Executive OfficerBiogen Inc.Frank Witney,PhDFormer Chief Executive OfficerAffymetrix,Inc.Pascale WitzFounder and PresidentPWH AdvisorsPrahlad Singh,PhDPres

27、ident and Chief Executive OfficerJoel S.GoldbergSenior Vice President,Administration,GeneralCounsel and SecretaryJames M.MockSenior Vice President and Chief Financial OfficerDaniel R.TereauSenior Vice President,Strategy and BusinessDevelopmentMiriame VictorSenior Vice President,Chief Commercial Offi

28、cerTajinder VohraSenior Vice President,Global OperationsAndrew OkunVice President,Chief Accounting Officer andTreasurerUNITED STATES SECURITIESAND EXCHANGE COMMISSIONWashington,DC 20549_Form 10-K(Mark One)ANNUALREPORT PURSUANT TO SECTION 13 OR 15(d)OFTHE SECURITIESEXCHANGEACT OF 1934For the fiscal y

29、ear ended January 2,2022orTRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d)OFTHE SECURITIESEXCHANGEACT OF 1934For the transition period from _ to _Commission file number 001-5075_PerkinElmer,Inc.(Exact name of registrant as specified in its charter)Massachusetts04-2052042(State or other jurisdiction

30、 ofincorporation or organization)(I.R.S.EmployerIdentification No.)940 Winter Street,Waltham,Massachusetts02451(Address of Principal Executive Offices)(Zip Code)(781)663-6900(Registrants telephone number,including area code)_Securities registered pursuant to Section 12(b)of theAct:Title of Each Clas

31、sTrading Symbol(s)Name of Each Exchange on Which RegisteredCommon Stock,$1 Par ValuePKIThe New York Stock Exchange1.875%Notes due 2026PKI 21AThe New York Stock ExchangeSecurities registered pursuant to Section 12(g)of theAct:NoneIndicate by check mark if the registrant is a well-known seasoned issue

32、r,as defined in Rule 405 of the SecuritiesAct.Yes No Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d)of theAct.Yes No Indicate by check mark whether the registrant:(1)has filed all reports required to be filed by Section 13 or Section 1

33、5(d)of theSecurities ExchangeAct of 1934 during the preceding 12 months(or for such shorter period that the registrant was required to file suchreports),and(2)has been subject to such filing requirements for the past 90 days.Yes No Indicate by check mark whether the registrant has submitted electron

34、ically every Interactive Data File required to be submitted pursuantto Rule 405 of Regulation S-T(232.405 of this chapter)during the preceding 12 months(or for such shorter period that the registrant wasrequired to submit and post such files).Yes No Indicate by check mark whether the registrant is a

35、 large accelerated filer,an accelerated filer,a non-accelerated filer,a smaller reportingcompany,or emerging growth company.See the definitions of“large accelerated filer,”“accelerated filer,”“smaller reporting company,”andemerging growth company in Rule 12b-2 of the ExchangeAct.Large accelerated fi

36、lerAccelerated filerNon-accelerated filerSmaller reporting companyEmerging growth companyIf an emerging growth company,indicate by check mark whether the registrant has elected not to use the extended transition period forcomplying with any new or revised financial accounting standards provided purs

37、uant to Section 13(a)of the ExchangeAct.Indicate by check mark whether the registrant has filed a report on and attestation to its managements assessment of the effectiveness ofits internal control over financial reporting under Section 404(b)of the Sarbanes-Oxley Act(15 U.S.C.7262(b)by the register

38、ed publicaccounting firm that prepared or issued its audit report.Indicate by check mark whether the registrant is a shell company(as defined in Rule 12b-2 of the ExchangeAct).Yes No The aggregate market value of the common stock,$1 par value per share,held by non-affiliates of the registrant on Jul

39、y 2,2021,was$17,332,583,779 based upon the last reported sale of$155.57 per share of common stock on July 2,2021.As of February 25,2022,there were outstanding 126,183,492 shares of common stock,$1 par value per share.DOCUMENTS INCORPORATED BY REFERENCEPortions of PerkinElmer,Inc.s Definitive Proxy S

40、tatement for itsAnnual Meeting of Shareholders to be held onApril 26,2022 areincorporated by reference into Part III of this Form 10-K.TABLE OF CONTENTSPagePART IItem 1.Business3Item 1A.Risk Factors14Item 1B.Unresolved Staff Comments23Item 2.Properties23Item 3.Legal Proceedings23Item 4.Mine Safety D

41、isclosures23PART IIItem 5.Market for Registrants Common Equity,Related Stockholder Matters and Issuer Purchases of EquitySecurities26Item 6.Reserved27Item 7.Managements Discussion andAnalysis of Financial Condition and Results of Operations28Item 7A.Quantitative and Qualitative DisclosuresAbout Mark

42、et Risk38Item 8.Financial Statements and Supplemental Data41Item 9.Changes in and Disagreements withAccountants onAccounting and Financial Disclosure94Item 9A.Controls and Procedures94Item 9B.Other Information97Item 9C.Disclosure Regarding Foreign Jurisdictions that Prevent Inspections97PART IIIItem

43、 10.Directors,Executive Officers and Corporate Governance98Item 11.Executive Compensation98Item 12.Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters98Item 13.Certain Relationships and Related Transactions,and Director Independence98Item 14.PrincipalAccoun

44、tant Fees and Services98PART IVItem 15.Exhibits and Financial Statement Schedules99Item 16.Form 10-K Summary103Signatures1033PART IItem 1.BusinessOverviewWe are a leading provider of products,services and solutions for the diagnostics,life sciences and applied markets.Through our advanced technologi

45、es and differentiated solutions,we address critical issues that help to improve lives and theworld around us.Our headquarters are in Waltham,Massachusetts,and we market our products and services in more than 190 countries.As of January 2,2022,we employed approximately 16,700 employees.Our common sto

46、ck is listed on the New York StockExchange under the symbol“PKI”and we are a component of the S&P 500 Index.We maintain a website with the address http:/.We are not including the information contained inour website as part of,or incorporating it by reference into,this annual report on Form 10-K.We m

47、ake available free of chargethrough our website our annual reports on Form 10-K,quarterly reports on Form 10-Q,current reports on Form 8-K andamendments to these reports,as soon as reasonably practicable after we electronically file these materials with,or otherwisefurnish them to,the Securities and

48、 Exchange Commission.Our StrategyOur strategy is to develop and deliver innovative products,services and solutions in high-growth markets that utilize ourknowledge and expertise to address customerscritical needs and drive scientific breakthroughs.To execute on our strategy andaccelerate revenue gro

49、wth,we focus on broadening our offerings through both the investment in research and development andthe acquisition of innovative technology.Our strategy includes:Strengthening our position within key markets by expanding our global product and service offerings,maintainingsuperior product quality a

50、nd driving an enhanced customer experience;Attracting,retaining and developing talented and engaged employees;Accelerating transformational innovation through both internal research and development and third-partycollaborations and alliances;Augmenting growth in both of our core business segments,Di

51、scovery&Analytical Solutions and Diagnostics,through strategic acquisitions and licensing;Engraining focused operational excellence to improve organizational efficiency and agility;andOpportunistically utilizing our share repurchase programs to help drive shareholder value.Recent DevelopmentsAs part

52、 of our strategy to grow our core businesses,we have recently taken the following actions:Acquisitions in Fiscal Year 2021:In fiscal year 2021,we completed the acquisition of BioLegend,Inc.(BioLegend)and paid an aggregate purchase priceof$5.7 billion,net of cash acquired of$292.4 million,reflecting

53、working capital and other adjustments(the AggregateConsideration).TheAggregate Consideration was paid in a combination of$3.3 billion in cash and shares of our commonstock having a value of approximately$2.6 billion based on the$187.56 per share closing price of our common stock on theNew York Stock

54、 Exchange on September 17,2021(the Stock Consideration).The Stock Consideration consisted of14,066,799 shares of our common stock and was issued on September 17,2021 in a private placement pursuant to an exemptionfrom registration under the SecuritiesAct of 1933,as amended(the SecuritiesAct),provide

55、d by Section 4(a)(2)of theSecuritiesAct.BioLegend is recognized as a leading,global provider of life science antibodies and reagents headquartered inSan Diego,California,with approximately 700 employees.In fiscal year 2021,we also completed the acquisition of seven other businesses for aggregate con

56、sideration of$1.2billion.The acquired businesses include Oxford Immunotec Global PLC(Oxford),a company based inAbingdon,UK withapproximately 275 employees,for total consideration of$590.9 million,Nexcelom Bioscience Holdings,LLC(Nexcelom),acompany based in Lawrence,Massachusetts with approximately 1

57、30 employees,for total consideration of$267.3 million,andfive other businesses,which were acquired for total consideration of$331.0 million.4Business Segments and ProductsWe report our business in two segments:Discovery&Analytical Solutions and Diagnostics.Discovery&Analytical Solutions SegmentOur c

58、omprehensive portfolio of technologies helps life sciences researchers better understand diseases and developtreatments.In addition,we enable scientists to detect,monitor and manage contaminants and toxic chemicals that impact ourenvironment and food supply.Our Discovery&Analytical Solutions segment

59、 serves the life sciences and applied markets.Life Sciences:Life Sciences consists of the life sciences research market and laboratory services market.In the life sciences researchmarket,we provide a broad suite of solutions including reagents,informatics,contract research services,and detection and

60、imaging technologies that enable scientists to work smarter,make research breakthroughs and transform those breakthroughs toreal-world outcomes.These products,solutions and services support pharmaceutical,biotech,and contract researchorganizations,as well as academic institutions globally in discove

61、ring and developing better treatments and therapeutics to fightdisease,faster and more efficiently.BioLegends acquisition provides us with access to new markets as well,notably the flowcytometry and multiomic cell analysis markets.We also provide services designed to help customers in the laboratory

62、 services market increase efficiencies andproduction time while reducing laboratory maintenance costs.Our OneSource laboratory service business is aligned withcustomers needs,enabling them to accelerate scientific progress and commercial opportunities.Applied Markets:The applied markets consist of e

63、nvironmental,food and industrial markets.For the environmental market,we developand provide analytical technologies,solutions and services that enable our customers to understand and characterize the healthand quality of our environment,including air,water and soil.Our solutions are used to detect a

64、nd help reduce the impactcommercial products and industrial processes have on our environment.For example,our solutions help ensure compliancewith regulatory standards that protect the purity of the worlds water supply by detecting harmful substances,including tracemetals such as lead,and organic po

65、llutants such as pesticides and benzene.We provide the tools needed to meet rigorousregulatory requirements for environmental testing,meet quality specifications and safety standards,and innovate for nextgeneration analytical products.We also offer a variety of solutions that help farmers and food p

66、roducers provide a growing population with food that issafe,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 el

67、ements,as well as detect the presence of potentially dangerous contaminants,such as veterinary drug residues in milk.Our workflowscan also be used to identify the origin of food products such as olive oil,which helps prevent counterfeiting.Our methods andanalyses are transferable throughout the supp

68、ly chain to enable customers to keep pace with industry standards as well asgovernmental regulations and certifications.We also provide analytical instrumentation for the industrial market which includes the chemical,semiconductor andelectronics,energy,lubricant,petrochemical and polymer industries.

69、Our technologies for this market are primarily used bycustomers focusing on quality assurance standards.They are also used to drive advancement or innovation of new products,with a recent focus on increasing the recyclability and biodegradability of materials and improving electric vehicle batterype

70、rformance.Principal Products:Our principal products and services for Discovery&Analytical Solutions applications include the following:Life Sciences Market:Radiometric detection solutions,including over 1,100 radiochemicals and instrumentation such as the Tri-CarbandQuantulusGCT families of liquid s

71、cintillation analyzers,Wizard2Gamma counters and MicroBeta2plate basedLSA,which are used for beta,gamma and luminescence counting in microplate and vial formats utilized in research,environmental and drug discovery applications.5The Opera PhenixPlus high-content screening system,which is used for se

72、nsitive and high-speed phenotypic drugscreening of complex cellular models.The OperettaCLShigh-content analysis system,which enables scientists to reveal fine sub-cellular details fromeveryday assays as well as more complex studies,for example using live cells,3D and stem cells.Reagents and solution

73、s for microscopy and imaging applications.These include fluorophore-conjugated andenzyme-conjugated antibodies,as well as buffers and solutions such as our Ce3D collection of buffers for 3Dtissue imaging.The MuviCyte live-cell imaging system,designed to operate inside a cell-culture incubator,enabli

74、ng researchersto study cellular behaviors and pathways in living cells to gain a deeper understanding of functions,diseasemechanisms and responses to treatments.The VICTOR Nivomultimode plate reader benchtop system,which is designed for assay development andacademic labs including those using HTRFan

75、dAlphaLISAtechnologies.The EnSightmultimode plate reader benchtop system,which offers well plate imaging alongside labeled detectiontechnologies for target-based and phenotypic assays.The EnVisionmultimode plate reader,which is designed for high-throughput screening laboratories,includingthose using

76、 HTRF,AlphaScreenandAlphaLISAtechnologies.Awide range of homogeneous biochemical and cell-based reagents using HTRF,LANCE Ultra,DELFIA,AlphaLISA,AlphaLISASureFireUltra,AlphaScreen,AlphaPlexand luminescence assay technologies.Abroad portfolio of recombinant GPCR and ion channel cell lines,including o

77、ver 300 products and 120 ready-to-use frozen cell lines for a wide range of disease areas.ELISAMAX Standard Sets,ELISAMAX Deluxe Sets,LEGEND MAX ELISAKits and RAPID MAXELISAKits,as well as complementary solutions and buffers for immunoassays to cover more than 200 targets forhuman,mouse,and rat samp

78、les,many of which are designed to assess the immune environment and itsinflammatory state for vaccine,infectious disease and autoimmune disease research.LEGENDplex bead-based reagents,which,in contrast to single analyte assays such as ELISAs,can quantitate upto 14 targets,from one small sample volum

79、e in a flow cytometry assay.In vivo imaging technologies and reagents for preclinical research,comprised of the IVISSpectrumseries for 2Dand 3D optical imaging and optionally integrated low-dose CT imaging and the IVISLuminaseries for benchtop2D imaging,along with IVISbrite bioluminescent and IVISen

80、se fluorescent imaging agents,cell lines and dyes.GoInVivo as well as Ultra-LEAF and LEAF functional antibodies,which provide an affordable solution forresearchers performing in vivo and ex vivo studies.The QuantumTMGX2 system,which enables low-dose in vivo CT imaging of multiple species and areas o

81、fanatomical interest across multiple disease areas by way of high resolution,tomographic imaging.Nexcelom BioScience automated cell counters,image cytometers,reagents and consumables for cell analysis usedin life science research,drug discovery and drug development.Horizon Discovery offerings that e

82、nable critical elements of the drug development and therapeutic value chain,particularly in the area of precision medicine with a portfolio of cell engineering tools and services,featuring geneediting technologies such as CRISPR,and base editing and gene modulation technologies such as RNAi.Sirion B

83、iotech consultancy services and technologies to design and manufacture viral vectors for cell and genetherapy research and preclinical development.BioLegend best-in-class antibodies and reagents,which are used by life science researchers across biologics,celland gene therapy,proteogenomics,and recom

84、binant proteins.Fluorophore-conjugated antibodies,which are used in flow cytometers to characterize protein expression on thesurface and in internal compartments of cells.The large collection of dyes and antibodies allows for an increasingnumber of conjugate options,facilitating the use of bigger an

85、d better flow cytometry panels.Notable products areBrilliant Violet and Spark dyes,among others.TotalSeq reagents,which are oligonucleotide-barcoded antibodies that enable protein detection by sequencing andcombining traditional RNAor DNAsequencing experiments with high-parameter protein detection.C

86、ell culture and biofunctional assay reagents,including bioactive recombinant proteins,as well as other specializedreagents such as Cell-Vive T-NK Xeno-Free Serum Substitute(GMP),and other GMP-produced recombinantproteins and reagents.These products serve several markets,notably cell and gene therapy

87、 applications.MojoSort and Lymphopure reagents that cover the main spectrum of cell separation technologies,whichtogether with our fluorophore-antibody conjugates,can be used for FACS(Fluorescence-activated Cell Sorting).Flex-T reagents that utilize major histocompatibility complex tetramers to pres

88、ent peptides for the identificationof antigen-specific T cells.Our Flex-T products can be used to screen the efficacy of antigen peptides for vaccineand drug trials,as well as characterizing the dominance of cancer-specific self-peptides,and more recently,SARS-CoV2 peptides for COVID-19 research.6An

89、tibodies and solutions for Western blotting.Alarge collection of validated antibodies,as well as supportingbuffers and substrates,which provide a convenient set of tools to characterize protein size and relative expressionlevels in cell or tissue lysates.OneSourcelaboratory services,a comprehensive

90、portfolio of multivendor instrument management,QA/QC,labrelocation,scientific,laboratory IT and regulatory compliance services.OneSourceservices programs are tailoredto the specific needs and goals of individual customers and offer a series of informatics-based consulting,planningand management offe

91、rings to assist in laboratory productivity and the optimization of complex InformationTechnology platforms.OneSourceDashboard software,a TIBCOSpotfiretechnology-driven interactive graphical platform,whichprovides visibility to a customers global asset population,service event and downtime distributi

92、on,as well as keyperformance indicators to assist in asset operation.OneSourceInsights as a ServiceTMofferings,which leverages comprehensive OneSourceanalytics and industrydata to develop and deliver customer-need driven recommendations to optimize,integrate and accelerate laboperations.PerkinElmer

93、Signals Medical ReviewTMsoftware,which empowers medical monitors to detect safety signals fasterand reduce overall time to submission by combining innovative medical review workflow with advanced analytics.PerkinElmer Signals Lead DiscoveryTMsoftware,which enables researchers to quickly gain new ins

94、ights intochemical and biomolecular research data,featuring guided search and analysis workflows and dynamic datavisualizations for on-the-fly exploration.PerkinElmer SignalsTMelectronic notebook,a scientific research data management solution,which allowsresearchers to record research data and exper

95、iments in digital notebooks,drag and drop,store,organize,share,findand filter data easily.PerkinElmer Signals TranslationalTMdata management,aggregation and analysis platform,which offers out-of-the-box support for the complete precision medicine workflow from data acquisition to biomarker discovery

96、 andvalidation.ChemDraw18 platform,a chemical structure drawing and visualization application for scientists and researchers.Lead DiscoveryTMPremium software,which allows scientists to import,filter by,analyze and interpret chemicalstructures and biosequences alongside other related data in a highly

97、 visual and interactive environment for fasterinsights and better decisions.OneSourceAsset Genius monitoring solution,part of theAsset Genius family,which offers a 360oview oflaboratory instruments regardless of the manufacturer,correlating instrument usage,age and service data,allowingcustomers to

98、visually pinpoint under-performing,ideally-performing and over-burdened assets,and to makeinformed decisions.Applied Markets:The series of Clarusgas chromatographs and gas chromatographs/mass spectrometers,and the family ofTurboMatrix sample-handling equipment,which are used to identify and quantify

99、 compounds in theenvironmental,forensics,food and beverage,hydrocarbon processing/biofuels,materials testing,pharmaceutical andsemiconductor industries.The LC 300 ultra-high performance liquid chromatography(UHPLC)and LC 300 high performance liquidchromatography(HPLC)systems,which provide high throu

100、ghput along with superior performance and sensitivity.The SimplicityChrom CDS software which offers liquid chromatography workflows and intuitive functions forfull 21CFR 11 compliance for laboratories working in regulated environments.Acomprehensive Liquid Chromatography(LC)Column portfolio of innov

101、ative and highly efficient HPLC/UHPLCand supercritical fluid chromatography(SFC)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 mostch

102、allenging speciation applications in food,water or consumer products such as childrens toys.The Flexar ultra-high performance liquid chromatography(UHPLC)and Flexar advanced liquid chromatographysystems,which provide high throughput and resolution chromatographic separations.The QSightTriple Quad LC

103、/MS/MS,a flow-based mass spectrometry system that provides high sensitivity andenables high levels of efficiency and productivity to meet both standard and regulatory requirements for food,cannabis and environmental testing laboratories.The TorionT-9 portable GC/MS,a fast person-portable GC/MS syste

104、m,enabling rapid detection and actionableresults to potentially hazardous and emergency environmental conditions.Atomic spectroscopy families of instruments,including the families of PinAAcleatomic absorption spectrometers,AvioMax inductively coupled plasma(“ICP”)optical emission spectrometers and N

105、exIONICP massspectrometers,all of which are used in the environmental,food,pharmaceutical,and chemical industries,amongothers,to determine the elemental content of a sample.7The LPC 500 liquid particle counter featuring single particle optical sizing technology.Coupled with theAvio550 Max ICP-OES oi

106、ls system,particle counting and sizing as well as wear metals analysis of in-service oils andlubricants are performed in one run with results delivered in less than a minute.Our infrared spectroscopy(IR)family of instruments,the Spectrum Two IR&NIR spectrometers,which arecompact and portable and use

107、d for advanced infrared analysis for unknown substance identification,materialqualification or concentration determination in fuel and lubricant analysis,polymer analysis and pharmaceutical andenvironmental applications.The Polymer ID analyzer,which provides accurate verification of identity,quality

108、,and composition of polymers andtheir blends used in industries such as food packaging,construction and automotive.The series of LAMBDAUV/Vis spectrophotometers that provide sampling flexibility to enable measurement of awide range of sample types,including liquids,powders and solid materials,both i

109、n regulated industries as well asQC/QAand research applications.The FL 6500TMand FL 8500TMfluorescence spectrophotometers,which address the challenges of bioscience,industrial,chemical,environmental,pharmaceutical,agricultural and academic application.The 2400 Series II CHNS/O elemental analyzer,one

110、 of the leading organic elemental analyzers,which is ideal forthe rapid determination of carbon,hydrogen,nitrogen,sulfur and oxygen content in organic and other types ofmaterials.Our thermal analysis family,which includes our series of Differential Scanning Calorimetry(DSC)instruments thatoffer excl

111、usive HyperDSC capability for unparalleled sensitivity and new insights into material processes,ourThermogravimetric(TGA)and Simultaneous ThermalAnalysis(STA)instruments that can be coupled with FourierTransform Infrared(FT-IR),Mass Spectrometry(MS),or Gas Chromatography/Mass Spectrometry(GC/MS)tech

112、nologies to provide a complete and advanced line of Evolved GasAnalysis(EGA)platforms for greater analysispower 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 measu

113、ring sprout damage.This is an importantfactor 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.The Bioo Scientifictest kits for detection of toxins,veterina

114、ry drug residues and contaminants,which enable rapidand easy testing at different steps in the food value chain.The PerkinElmer FT 9700 compact,high-performance and full-wavelength-range Fourier Transform NearInfrared(FT-NIR)spectrometer,which helps food and feed laboratories perform quick analyses

115、for qualityassurance of food and feed materials and reduces variations in production.The DA7250 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,o

116、il,and more in less than 40 seconds.TheAM 5200 grain moisture meter,which is based on the latest moisture meter technology,including the use of theUnified Grain MoistureAlgorithm(UGMA)and 149MHz.The QSightSP50 online solid phase extraction(SPE)system,which facilitates sample clean-up,enrichment andc

117、oncentration,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 mostcommonly tested mycotoxins.PerkinElmer Solus One Listeria monocytogenes ELISAAssay.This new offering is de

118、signed to help highthroughput food processors and contract labs focus on L.mono testing for food and environmental surface samples.DA7350 and DA7440 in-line and on-line NIR instruments combined with Process Plus cloud-basedsoftware provide continuous quality control of food and food ingredient manuf

119、acturing processes.Perten Glutomatic 2000 system for gluten quantity and quality testing of wheat,durum,semolina and flour.LactoScope FT-Ainstrument,which delivers quick and accurate full spectrum component testing and adulterantscreening for liquid dairy products such as whey,raw and skim milk,shel

120、f stable milk and cream with under 40%fatcontent.MaxSignalHTS Nitrofurans and Chloramphenicol ELISAkits,which will help food safety,quality andaquaculture labs simultaneously and accurately perform same-day testing for targeted antibiotic residues.8New Products:New products introduced or acquired fo

121、r Discovery&Analytical Solutions applications in fiscal year 2021 include thefollowing:Life Sciences Market:PhenoVue cellular imaging reagents,including cell painting kits,fluorescent probes and dyes and fluorescentsecondary antibodies,which are part of an expanded suite of high-content imaging cons

122、umables that includesPhenoPlate(formerly CellCarrier Ultra)cellular imaging microplates and GrowDex hydrogels.Arange of newAlphaLISAand HTRFreagents and assay kits serving key research and therapeutic areas,including GPCRs,targeted protein degradation,inflammation,oncology and neuroscience.The Signa

123、ls ImageArtist next-generation image analysis and management platform for drug discovery research,to help scientists process and analyze their high-content screening(HCS)and cellular imaging data in a matter ofhours vs.days or weeks,so they can make more informed decisions faster.Horizon CHOSOURCE p

124、latform expanded to include CHO-K1ADCC+expression cell line for development oftherapeutic antibodies in oncology,infectious disease and autoimmune conditions.Acatalog of more than 20,000 SKUs from the recent acquisition of BioLegend,incorporating antibodies as well as alarge collection of antibody c

125、onjugates and modifications.Other products include recombinant proteins,immunoassays and other supportive reagents and solutions for cell and molecular analysis.The T-SPOTDiscovery SARS-CoV-2 research use only assay to investigate cell-mediated immunity related toCOVID-19.AuroFlowAQ Mycotoxin platfo

126、rm that includes strip test versions for totalAflatoxin,Deoxynivalenol(DON),Fumonisin,OchratoxinA,Zearalenone and T-2/HT-2.Applied Markets:MappIR accessory for Spectrum 3 FT-IR,which helps ensure quality of incoming raw materials and finalproduct quality for better outcomes in semiconductor wafer ma

127、nufacturing.The TabletAnalyzer and portable SilicaAnalyzer platform,which are dedicated analyzers launched to addresscustomer needs for quick and accurate characterization of pharmaceutical tablet testing and respirable crystallinesilica in mining environments,respectively.PureView Certified and Pur

128、eView MS Certified vials,manufactured from Type 1 borosilicate glass which meetsall USP,JP and EP requirements.The low-expansion,coefficient glass exhibits excellent thermal conductivity andprovides an inert surface with a low free ion content,giving accurate and repeatable results every time.Brand

129、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,Chem

130、Office,CHOSOURCE,Dharmacon,DharmaFECT,Edit-R,ELISAMAX,EnSight,EnVision,Flex-T,FMT,FolateRSense,GoInVivo,HTRF,IVIS,IVISbrite,IVISense,LANCE,LANCEUltra,LEAF,LEGEND MAX,LEGENDplex,LentiBOOST,Lincode,Living Image,Lumina,Lymphopure,MicroBeta2,Mini ELISAPlate Reader,miRIDIAN,MojoSort,MuviCyte,OneSource,ON

131、-TARGET,ON-TARGETplus,Opera PhenixPlus,OperettaCLS,PerkinElmer Signalsfor Translational,PhenoPlate,PhenoVue,PIN-POINT,QuantulusGCT,RAPID MAX,RediJect,RNAiONE,Signals ImageArtist,SMARTpools,SMARTvector,Spark,Spectrum,Tri-Carb,T-SPOT,Ultra-LEAF,ViaStain,VICTOR Nivoand Wizard2.Applied Markets:Aquamatic

132、,Avio,Clarity,Clarus,DairyGuard,DoughLab,Falling Number,FL 6500TM,FL 8500TM,FlexarTM,Frontier,Glutomatic,Honigs Regression,HyperDSC,Inframatic,LAMBDA,LPC 500,NexION,NexSAR,OilExpress,OilPrep,Optima,Perten,Perten Instruments,PinAAcle,PureViewTM,QSight,SimplicityChrom,Spectrum,Spectrum Two,Spotlight,S

133、upra-clean,Supra-d,Supra-poly,Syngistix,Torion,TruQ,TurboMatrixand Ultraspray.9Diagnostics SegmentWe offer instruments,reagents,assay platforms,and software to hospitals,medical labs,clinicians and medical researchprofessionals to help improve the health of families.Our Diagnostics segment is especi

134、ally 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 thediagnostics market.Our screening products are designed to provide early and

135、accurate insights into the health of expectantmothers during pregnancy and into the health of their babies.Diagnostic labs use our instruments,reagents and software fortesting and screening genetic abnormalities and certain disorders and diseases,including Down syndrome,hypothyroidism,muscular dystr

136、ophy,infertility and various metabolic conditions.We also develop technologies that enable and support genomicworkflows using PCR and next-generation DNAsequencing for applications in oncology,immunodiagnostics and drugdiscovery.With the acquisition of BioLegend,we added a collection ofAnalyte Speci

137、fic Reagents(ASR)used in flow cytometry todevelop diagnostic assays.We also provide a limited set of Immunohistochemistry in vitro diagnostic(IVD)products used fordiagnostics in pathology labs,contract research organizations and other qualified institutions.Aselection of our flow cytometryconjugates

138、 are registered in China as Class I diagnostic products.We also developed a number of products and services in response to the COVID-19 pandemic,with a special emphasison supporting public health authorities both in the United States and abroad,including through the operation of COVID-19testing faci

139、lities.Further information is provided below under New Products.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,whichincludes a fast continuou

140、s loading system.It is supported by kits for first,second and third trimester analyses forprenatal screening and clinically validated LifeCycle software.The NeoBasenon-derivatized MS/MSAAAC kits,which are used to support detection of metabolic disorders innewborns through tandem mass spectrometry.Th

141、e kits analyze newborn dry blood spot samples for measurement ofamino acids and other metabolic analytes for specific diseases.The GSPNeonatal hTSH,T4 17-OHP,GALT IRT,BTD,PKU,Total Galactose,CK-MM and G6PD kits,used forscreening congenital neonatal conditions from a drop of blood.The Specimen Gatein

142、formatics data management solution,designed specifically for newborn screeninglaboratories.ViaCordumbilical cord blood banking services for the banking of stem cells harvested from umbilical cord bloodand cord tissue,for potential therapeutic application in transplant and regenerative medicine.An ex

143、panded portfolio of molecular-based infectious disease screening technologies for blood bank and clinicallaboratory settings in China.The tools include a qualitative 3-in-1 assay for the detection of hepatitis B,hepatitis Cand HIV,as well as assays for other communicable diseases.The EnLiteNeonatal

144、TRECsystem,a screening test for Severe Combined Immunodeficiency(SCID),consistingof EnLiteNeonatal TRECreagent kits,the Victor EnLiteinstrument and EnLiteworkstation software.NeoLSDTMMSMS kit,the first commercial IVD kit for screening of Pompe,MPS-I,Fabry,Gaucher,Niemann-PickA/B and Krabbe disorders

145、 from a single dried blood spot sample.QSightTriple Quad MSMS instrument,which is used for newborn screening.TRF-basedAnti HBs/HCV/TP kits for infectious disease testing.Chitasinstrument and HBV/HCV/HIV 3-in-1 PCR reagents for blood screening,and Hi Sensitivity HBV DNAandHCV RNAassays for clinical i

146、nfectious disease testing.The chemagic Prime instrument,a fully automated,LIMS-compatible solution for primary sample transfer,DNAand RNAisolation,optional normalization and the setup of PCR and NGS applications.Immune fluorescence testing(IFT),enzyme-linked immunosorbent assay(ELISA),chemiluminesce

147、nce-basedimmunotesting,immunoblots,molecular microarrays,PCR,liquid handlers and software solutions.Autoimmune testing covering rheumatology,hepatology,gastroenterology,endocrinology,neurology,nephrology,dermatology and infertility.Infectious disease testing covering bacteria,viruses and parasites.I

148、FT,ELISAand EUROLINETMassays for veterinary medical diagnostics.Automated liquid handling platforms(JANUS,Scicloneand Zephyr)that offer a choice of robotic solutions ingenomics,biotherapeutics,high throughput screening and high content analysis to assist life science research frombench to clinic.10J

149、ANUSBioTxand PreNAT IITMworkstations for automated small-scale purification,offering column,tip andplate-based chromatography on a single platform.The LabChip GXIITouchTMplatform,which provides a means of characterizing multiple protein product attributesfor research labs through QC.The explorerauto

150、mated workstation,which allows integration of multiple laboratory instrumentation using acentralized robotic interface,allowing high throughput and turnkey-application focused solutions.Allergy testing covering allergen-specific immunoglobin e(IgE),measuring the level of different IgE antibodies inb

151、lood using ELISAand EUROLINETMassays.VanadisNIPT,a breakthrough cfDNAtechnology for use in genetic and biochemistry laboratories for screeningcommon trisomies in the pregnant population as a leading NIPT solution.PG-Seq Rapid Non-Invasive Preimplantation Genetic Testing kit,an alternative to IVF emb

152、ryo biopsies.PerkinElmer Genomics is a global laboratory network offering services for testing in cytogenetics,biochemicalgenetics(prenatal and postnatal),molecular genetics and immunodiagnostics.The laboratory network includestesting laboratories in the United States,Sweden,India,Malaysia and China

153、.The EONISTMassay,a CE marked system utilizing real-time PCR technology,which allows for simultaneousscreening of SMA,SCID and XLAin newborns from a single DBS punch.EUROIMMUN SARS-CoV-2 Antigen ELISAfor specific determination of the SARS-CoV-2 protein.EURORealTime SARS-CoV-2/InfluenzaA/B real-time

154、PCR test for direct detection of SARS-CoV-2,influenzavirus typeAand influenza virus type B.Anti-SARS-CoV-2 QuantiVacTMELISA(IgG)to quantify IgG antibodies against the SARS-CoV-2 S1 antigen liquidchromatography(UHPLC)capabilities with intuitive instrument control and data analysis.PKamp Respiratory S

155、ARS-CoV-2 RT-PCR assay panel designed to conserve resources by testing a singlenasopharyngeal,oropharyngeal or nasal swab sample collected from an individual suspected of respiratory viralinfection consistent with COVID-19,the flu and RSV.explorer workstations for SARS-CoV-2 testing capable of prepa

156、ring and running up to 10,000 COVID-19 testsper day.These modular and scalable workstations enable laboratories to ramp up SARS-CoV-2 testing capacityquickly to generate results.The DELFIAXpress sFlt-1 kit,which enables short term prediction of pre-eclampsia and aids in diagnosis in thesecond and th

157、ird trimesters of pregnancy together with the previously launched DELFIAXpress PlGF 1-2-3assay.Laboratory facilities for COVID-19 testing developed with public health authorities in the State of California andthe United Kingdom.New Products:New products or services introduced or acquired for Diagnos

158、tics applications in fiscal year 2021 include the following:Prenatal testing utilizing PerkinElmer Genomics Next Generation Sequencing products.PerkinElmer Genomics Whole Genome Sequencing products,including sequencing for Spinal MuscularAtrophyand Repeat disorders.PerkinElmer Genomics Digital Genom

159、e sequencing test for Facioscapularhumeral dystrophy(FSHD).Oxford Immunotec T-SPOTTechnology platform,a modified ELISPOT used to detect a T cell immune responseto infection.Tests available using the platform include:The T-SPOT.TB test,an FDA approved and CE marked test to aid the diagnosis of Tuberc

160、ulosis infection.The T-SPOT.COVID test,a CE marked test to detect a T cell immune response to SARS-CoV-2 infectionand vaccination.The T-SPOT.CMV test,a CE marked test to assess anti-CMV T cell mediated immunity.Brand Names:Our Diagnostics segment offers additional products under various brand names,

161、includingAutoDELFIA,BACS-on-Beads,BIOCHIPs,Bioo Scientific,BoBs,chemagic,Chitas,Datalytix,DELFIA,DELFIAXpress,DOPlify,EONISTM,EUROArrayTM,EUROIMMUN,EUROLabWorkstationTM,EUROlineTM,EUROPatternTM,Evolution,Evoya,explorer,FragilEase,Genoglyphix,GSP,HaoyuanTM,iLab,JANUS,LabChip,LifeCycle,LimsLink,MultiP

162、ROBE,NEXTFLEX,NextPrep,Pannoramic,PG-SeqTM,PG-FindTM,PKampTM,PreNAT,Protein ClearTM,ProteinEXactTM,QSight,QuantiVacTM,Sciclone,SimplicityChrom,Specimen Gate,SuperflexTM,SymbioTM,T-SPOT,Twister,Vanadis,VariSpec,ViaCordand Zephyr.11MarketingAll of our businesses market their products and services prim

163、arily through their own specialized sales forces.As ofJanuary 2,2022,we employed approximately 6,500 sales and service representatives operating in approximately 40 countriesand marketing products and services in more than 190 countries.In geographic regions where we do not have a sales andservice p

164、resence,we utilize distributors to sell our products.Raw Materials,Key Components and SuppliesEach of our businesses uses a wide variety of raw materials,key components and supplies that are generally availablefrom alternate sources of supply and in adequate quantities from domestic and foreign sour

165、ces.We generally have multi-yearcontracts,with no minimum purchase requirements,with our suppliers.For certain critical raw materials,key components andsupplies required for the production of some of our principal products,we have qualified only a limited or a single source ofsupply.We periodically

166、purchase quantities of some of these critical raw materials in excess of current requirements,inanticipation of future manufacturing needs.With sufficient lead times,we believe we would be able to qualify alternativesuppliers for each of these raw materials and key components.See the applicable risk

167、 factor in“Item 1A.Risk Factors”for anadditional description of this risk.Intellectual PropertyWe own numerous United States and foreign patents and have patent applications pending in the United States andabroad.We also license intellectual property rights to and from third parties,some of which be

168、ar royalties and are terminable inspecified circumstances.In addition to our patent portfolio,we possess a wide array of unpatented proprietary technology andknow-how.We also own numerous United States and foreign trademarks and trade names for a variety of our product names,and have applications fo

169、r the registration of trademarks and trade names pending in the United States and abroad.We believethat patents and other proprietary rights are important to the development of both of our reporting segments,but we also relyupon trade secrets,know-how,continuing technological innovations and licensi

170、ng opportunities to develop and maintain thecompetitive position of both of our reporting segments.We do not believe that the loss of any one patent or other proprietaryright would have a material adverse effect on our overall business or on any of our reporting segments.In some cases,we may partici

171、pate in litigation or other proceedings to defend against or assert claims of infringement,toenforce our patents or our licensorspatents,to protect our trade secrets,know-how or other intellectual property rights,or todetermine the scope and validity of our or third partiesintellectual property righ

172、ts.Litigation of this type could result insubstantial cost to us and diversion of our resources.An adverse outcome in any litigation or proceeding could subject us tosignificant liabilities or expenses,require us to cease using disputed intellectual property or cease the sale of a product,orrequire

173、us to license the disputed intellectual property from third parties.CompetitionDue to the range and diversity of our products and services,we face many different types of competition andcompetitors.Our competitors range from foreign and domestic organizations,which produce a comprehensive array of g

174、oodsand services and that may have greater financial and other resources than we do,to more narrowly focused firms producing alimited number of goods or services for specialized market segments.We compete on the basis of service level,price,technological innovation,operational efficiency,product dif

175、ferentiation,product availability,quality and reliability.Competitors range from multinational organizations with a wide range of products tospecialized firms that in some cases have well-established market positions.We expect the proportion of large competitors toincrease through the continued cons

176、olidation of competitors.Regulatory AffairsOur operations are subject to regulation by different state and federal government agencies in the United States and othercountries,as well as to the standards established by international standards bodies.Some of our products are subject toregulation by th

177、e United States Food and DrugAdministration and similar foreign agencies.These regulations govern a widevariety 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-com

178、pliance,fines,injunctions,and civil penalties;import orexport restrictions;partial suspensions or total shutdown of production facilities or the imposition of operating restrictions;12increased difficulty in obtaining required FDAclearances or approvals or foreign equivalents;seizures or recalls of

179、our productsor 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 aresubject to various statutes and regulations that apply to companies doing business with the government.We are

180、also subject toinvestigation for compliance with the regulations governing government contracts.Afailure to comply with these regulationscould 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

181、 things,the importation andexportation of products,and our business practices in the United States and abroad such as anti-bribery,anti-corruption andcompetition laws.In addition,changes in governmental regulations may reduce demand for our products or increase ourexpenses.The healthcare industry,in

182、cluding the genetic screening market,is subject to extensive and frequently changinginternational and United States federal,state and local laws and regulations.This requires that we devote substantial resourcesto maintaining our compliance with those laws,regulations and standards.If we fail to com

183、ply with applicable laws and regulations,we could suffer civil and criminal damages,fines andpenalties,exclusion from participation in governmental healthcare programs,and the loss of various licenses,certificates andauthorizations necessary to operate our business,as well as incur liabilities from

184、third-party claims,all of which could have asignificant adverse effect on our business.Environmental MattersOur operations are subject to various foreign,federal,state and local environmental and safety laws and regulations.These requirements include the handling,transportation,manufacture and dispo

185、sal of toxic or hazardous substances,theremediation of contaminated soil and groundwater,the regulation of radioactive materials,and the health and safety of ouremployees.We may have liability under the Comprehensive Environmental Response Compensation and LiabilityAct andcomparable state statutes t

186、hat impose liability for investigation and remediation of contamination without regard to fault,inconnection with materials that we or our former businesses sent to various third-party sites.We have incurred,and expect toincur,costs pursuant to these statutes.We are conducting a number of environmen

187、tal investigations and remedial actions at our current and former locationsand,along with other companies,have been named a potentially responsible party(“PRP”)for certain waste disposal sites.Weaccrue for environmental issues in the accounting period that our responsibility is established and when

188、the cost can bereasonably estimated.We have accrued$11.9 million and$12.9 million as of January 2,2022 and January 3,2021,respectively,which represents our managements estimate of the cost of the remediation of known environmental matters,and does notinclude any potential liability for related perso

189、nal injury or property damage claims.Our environmental accrual is notdiscounted and does not reflect the recovery of any material amounts through insurance or indemnification arrangements.Thecost estimates are subject to a number of variables,including the stage of the environmental investigations,t

190、he magnitude of thepossible contamination,the nature of the potential remedies,possible joint and several liability,the time period over whichremediation 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 ant

191、icipate any additional liability to result from the inability of other significant namedparties to contribute.We expect that the majority of such accrued amounts could be paid out over a period of up to ten years.Asassessment and remediation activities progress at each individual site,these liabilit

192、ies are reviewed and adjusted to reflectadditional information as it becomes available.There have been no environmental problems to date that have had,or areexpected to have,a material adverse effect on our consolidated financial statements.While it is possible that a loss exceedingthe amounts recor

193、ded in the consolidated financial statements may be incurred,the potential exposure is not expected to bematerially different from those amounts recorded.We may become subject to new or unforeseen environmental costs or liabilities.Compliance with new or more stringentlaws or regulations,stricter in

194、terpretations of existing laws,or the discovery of new contamination could cause us to incuradditional costs.Human Capital ManagementAs of January 2,2022,we employed approximately 16,700 employees on a worldwide basis.Roughly 75%of ourworkforce is based outside of the United States.Employees at seve

195、ral of our subsidiaries outside the United States belong tolabor unions and/or workers councils in those jurisdictions.During fiscal year 2021,our voluntary turnover rate was roughly10%.We believe that management of our human capital resources is vital to the continued growth and success of the Comp

196、any,13and we endeavor to create an environment that encourages productivity,rewards performance and values diversity.There areseveral 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,re

197、cruiting,developing,retaining,incentivizing,andintegrating our existing and new employees.We strive to meet this objective by offering competitive compensation andbenefits,in a diverse,inclusive and safe workplace,with opportunities for our employees to grow and develop in their careers.We hold our

198、employees to high performance standards and our compensation plans are designed to deliver competitive base payand attractive incentive opportunities.Our benefits programs are specifically tailored to the various countries in which weoperate and maintain a significant workforce.We benchmark for mark

199、et practices and adjust our compensation and benefitsprograms to ensure they remain both equitable and competitive.Diversity and InclusionWe believe in an inclusive workforce,where employees from a number of cultures and countries are engaged andencouraged to leverage their collective talents.We hav

200、e employees in more than 40 countries around the world.As of the dateof filing of this annual report on Form 10-K,women comprised roughly 30%of our leadership positions on a global basis,which we define as director level and above.We provided further information regarding our diversity demographics

201、in ourCorporate Social Responsibility(CSR)Report and elsewhere on our website at ,including from ourconsolidated EEO-1 report.An EEO-1 report is filed with the United States Equal Employment Opportunity Commission anddescribes the racial,ethnic and gender composition of our U.S.-based workforce.Info

202、rmation on our website,including theCSR Report and the consolidated EEO-1 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.Bymaintaining a culture of diversity a

203、nd inclusion,we believe we can innovate more effectively.To that end,we seek to promotediverse perspectives throughout our organization and are an equal opportunity employer committed to making employmentdecisions without regard to race,religion,national or ethnic origin,sex,sexual orientation,gende

204、r identity or expression,age,disability,protected veteran status or other characteristics protected by law.Our commitment to diversity is evidenced by the establishment in 2020 of our internal Inclusion and DiversityCommittee,which is comprised of a wide cross-section of leaders from all regions and

205、 backgrounds.The Committee focuses ondriving increased diversity within our workforce,as well as creating a safe and engaging platform for dialogue on these issuesfor all our employees.Our commitment to creating a diverse and inclusive work environment is further validated by ouremployees,as reflect

206、ed in the results of our recent employee engagement survey,where we received high scores in the areas ofDiversity&Inclusion,Inclusiveness,and Non-Discrimination.Among other comments,employees shared that they are proudof the emphasis PerkinElmer places on diversity and inclusion,and on making Perkin

207、Elmer a place where everyone is valuedand respected.Training and DevelopmentWe are committed to the continued development and training of our employees.We seek to provide our employees withmeaningful learning opportunities to help grow their capabilities and careers.We provide learning through a var

208、iety of channelsand formats,including formal(classroom-based,blended learning solutions,digital learning)and informal,on-the-job learning.We are also dedicated to our employeesprofessional development,with a pivotal component of our annual performance reviewand goal-setting process focused on provid

209、ing employees with constructive and actionable feedback,as well as managementsupport and engagement in the creation and completion of development goals.Our training opportunities are designed topromote learning across all levels of our organization.We seek to provide opportunities for our employees

210、to grow their careersand regularly fill open vacancies with internal candidates.In addition,management periodically assesses succession planningfor certain key positions and reviews our workforce to identify high potential employees for future growth and development.We also provide formal and inform

211、al training opportunities for our employees covering a variety of professional,technical andleadership topics.Health and SafetyOur success depends on the well-being of our employees,and one of our top priorities is to protect the health and safetyof our employees.We maintain a culture focused on saf

212、ety and strive to identify,eliminate,and control risk in the workplace toprevent injury and illness.Our employees have access to a global safety management system and are encouraged to reportincidents,near misses,or other observations in the system.The system has been widely adopted in our manufactu

213、ring locationsacross the globe,and management uses the information generated by it to set safety-related policies and establish goals forfuture performance.Further,we provide our employees with a comprehensive benefits package that includes health insuranceand other resources that support their phys

214、ical and mental well-being.In response to the COVID-19 pandemic,we have taken,and we continue to take,proactive,aggressive actions to protect the health and safety of our employees,customers,partners,14and suppliers.We enacted rigorous safety measures,including social distancing protocols,encouragin

215、g employees who do notneed to be physically present on the manufacturing floor or in a lab to perform their work from home,suspending non-essentialtravel,implementing temperature checks and other access controls at the entrances to our facilities,extensively and frequentlydisinfecting our workspaces

216、,and providing appropriate personal protective equipment to employees who are physically presentat our facilities.We expect to continue to implement these measures until the COVID-19 pandemic is adequately contained,andwe may take further actions as government authorities require or recommend,or as

217、we determine to be in the best interests ofour employees,customers,partners,and suppliers.CommunityAt PerkinElmer,we have long held the view that responsible global citizenship along with good governance principlesand ethical business practices,are essential tenets for sustainability and success.We

218、encourage our employees to support thecommunities in which they live and where we operate,and to assist in that effort,we fund a long-term charitable matchingprogram for our employees.In addition,we have established a group comprised of management and subject matter experts atour company,to focus on

219、 developing and delivering on measurable advancements in the areas of reducing waste,reducingcarbon emissions,and improving employee engagement and diversity.Item 1A.Risk FactorsThe following important factors affect our business and operations generally or affect multiple segments of our businessan

220、d operations:Risks Related to our Business Operations and IndustryIf the markets into which we sell our products decline or do not grow as anticipated due to a decline in general economicconditions,or there are uncertainties surrounding the approval of government or industrial funding proposals,or t

221、here areunfavorable changes in government regulations,we may see an adverse effect on the results of our business operations.Our customers include pharmaceutical and biotechnology companies,laboratories,academic and research institutions,public health authorities,private healthcare organizations,doc

222、tors and government agencies.Our quarterly revenue and resultsof operations are highly dependent on the volume and timing of orders received during the quarter.In addition,our revenuesand earnings forecasts for future quarters are often based on the expected trends in our markets.However,the markets

223、 we servedo not always experience the trends that we may expect.Negative fluctuations in our customersmarkets,the inability of ourcustomers to secure credit or funding,restrictions in capital expenditures,general economic conditions,cuts in governmentfunding or unfavorable changes in government regu

224、lations would likely result in a reduction in demand for our products andservices.In addition,government funding is subject to economic conditions and the political process,which is inherently fluidand unpredictable.Our revenues may be adversely affected if our customers delay or reduce purchases as

225、 a result ofuncertainties surrounding the approval of government or industrial funding proposals.Such declines could harm ourconsolidated financial position,results of operations,cash flows and trading price of our common stock,and could limit ourability to sustain profitability.The pandemic caused

226、by coronavirus disease 2019(“COVID-19”)is having,and may continue to have,a negative effecton the demand for certain of our products and our global operations including our manufacturing capabilities,logistics andsupply chain that may materially and adversely impact our business,financial conditions

227、,results of operations and cashflows.We face risks related to public health crises and pandemics,including the COVID-19 pandemic.The global impact ofCOVID-19 has resulted in an adverse impact on our operations,supply chains and distribution systems,as significant globalmitigation measures,including

228、government-directed quarantines,social distancing and shelter-in-place mandates,travelrestrictions and/or bans,have been implemented,and in some areas relaxed,and then implemented again.Continueduncertainty with respect to the severity and duration of the COVID-19 pandemic has contributed to the vol

229、atility of financialmarkets.The COVID-19 pandemic has caused extended global economic disruption,and a global recession is possible.We have experienced significant reductions in demand for certain of our products due to the COVID-19 pandemic andalthough the severity and duration of the COVID-19 pand

230、emic cannot be reasonably estimated at this time,additional impactsthat we may experience include,but are not limited to:fluctuations in our stock price due to market volatility;further decreasesin demand for certain of our products;reduced profitability;large-scale supply chain disruptions impeding

231、 our ability to shipand/or receive product;potential interruptions of,or limitations on manufacturing operations imposed by local,state or federalgovernments;shortages of key raw materials or components;workforce absenteeism and distraction;labor shortages includingthose resulting from unwillingness

232、 to comply with vaccination or other requirements;customer credit concerns;cybersecurity15risks and data accessibility disruptions due to remote working arrangements;reduced sources of liquidity;increased borrowingcosts;fluctuations in foreign currency markets;potential impairment in the carrying va

233、lue of goodwill;other asset impairmentcharges;increased obligations related to our pension and other postretirement benefit plans;and deferred tax valuationallowances.The rapid and continually evolving development of the COVID-19 pandemic,and the extent to which mitigationmeasures will be effective,

234、preclude any prediction as to its ultimate impact.However,we currently anticipate that businessdisruptions and market volatility resulting from the COVID-19 pandemic will continue to have a material adverse impact on thegrowth rate of certain of our businesses,and may also have a material adverse im

235、pact on our overall financial condition,resultsof operations and cash flows.Our Diagnostics segment has experienced an increase in revenue resulting from increased demand for ourimmunodiagnostics and applied genomics COVID-19 product offerings as well as from the COVID-19 testing laboratoryfacilitie

236、s we have developed with the State of California and the United Kingdom.We expect demand for these products andservices to decline during 2022,with revenue and valuation of our inventory largely contingent upon consumer demand forCOVID-19 testing as well as our ability to develop and produce COVID-1

237、9 products and successfully staff and manage thelaboratories.Our growth is subject to global economic and political conditions,and operational disruptions at our facilities.Our business is affected by global economic and political conditions as well as the state of the financial markets,particularly

238、 as the United States and other countries balance concerns around debt,inflation,growth and budget allocations intheir policy initiatives.There can be no assurance that global economic conditions and financial markets will not worsen andthat we will not experience any adverse effects that may be mat

239、erial to our consolidated cash flows,results of operations,financial position or our ability to access capital,such as the adverse effects resulting from a prolonged shutdown ingovernment operations both in the United States and internationally.Our business is also affected by local economicenvironm

240、ents,including inflation,recession,financial liquidity and currency volatility or devaluation.Political changes,including war or other conflicts,some of which may be disruptive,could interfere with our supply chain,our customers and allof our activities in a particular location.While we take precaut

241、ions to prevent production or service interruptions at our global facilities,a major earthquake,fire,flood,power loss or other catastrophic event that results in the destruction or delay of any of our critical business operationscould result in our incurring significant liability to customers or oth

242、er third parties,cause significant reputational damage orhave a material adverse effect on our business,operating results or financial condition.Certain of these risks can be hedged to a limited degree using financial instruments,or other measures,and some of theserisks are insurable,but any such mi

243、tigation efforts are costly and may not always be fully successful.Our ability to engage insuch mitigation efforts has decreased or become even more costly as a result of recent market developments.If we do not introduce new products in a timely manner,we may lose market share and be unable to achie

244、ve revenuegrowth targets.We sell many of our products in industries characterized by rapid technological change,frequent new product and serviceintroductions,and evolving customer needs and industry standards.Many of the businesses competing with us in theseindustries have significant financial and

245、other resources to invest in new technologies,substantial intellectual propertyportfolios,substantial experience in new product development,regulatory expertise,manufacturing capabilities,and establisheddistribution channels to deliver products to customers.Our products could become technologically

246、obsolete over time,or wemay invest in technology that does not lead to revenue growth or continue to sell products for which the demand from ourcustomers is declining,in which case we may lose market share or not achieve our revenue growth targets.The success of ournew product offerings will depend

247、upon several factors,including our ability to:accurately anticipate customer needs,innovate and develop new reliable technologies and applications,receive regulatory approvals in a timely manner,successfully commercialize new technologies in a timely manner,price our products competitively,and manuf

248、acture and deliver our products in sufficient volumes and on time,anddifferentiate our offerings from our competitorsofferings.16Many of our products are used by our customers to develop,test and manufacture their products.We must anticipateindustry trends and consistently develop new products to me

249、et our customersexpectations.In developing new products,wemay be required to make significant investments before we can determine the commercial viability of the new product.If wefail to accurately foresee our customersneeds and future activities,we may invest heavily in research and development ofp

250、roducts that do not lead to significant revenue.We may also suffer a loss in market share and potential revenue if we areunable to commercialize our technology in a timely and efficient manner.In addition,some of our licensed technology is subject to contractual restrictions,which may limit our abil

251、ity to developor commercialize products for some applications.We may not be able to successfully execute acquisitions or divestitures,license technologies,integrate acquired businessesor licensed technologies into our existing businesses,or make acquired businesses or licensed technologies profitabl

252、e.We have in the past supplemented,and may in the future supplement,our internal growth by acquiring businesses andlicensing technologies that complement or augment our existing product lines,such as our recent acquisition of BioLegend,Inc.However,we may be unable to identify or complete promising a

253、cquisitions or license transactions for many reasons,such as:competition among buyers and licensees,the high valuations of businesses and technologies,the need for regulatory and other approval,andour inability to raise capital to fund these acquisitions.Some of the businesses we acquire may be unpr

254、ofitable or marginally profitable,or may increase the variability of ourrevenue recognition.If,for example,we are unable to successfully commercialize products and services related to significantin-process research and development that we have capitalized,we may have to impair the value of such asse

255、ts.Accordingly,theearnings or losses of acquired businesses may dilute our earnings.For these acquired businesses to achieve acceptable levels ofprofitability,we would have to improve their management,operations,products and market penetration.We may not besuccessful in this regard and may encounter

256、 other difficulties in integrating acquired businesses into our existing operations,such as incompatible management,information or other systems,cultural differences,loss of key personnel,unforeseenregulatory requirements,previously undisclosed liabilities or difficulties in predicting financial res

257、ults.Additionally,if we arenot successful in selling businesses we seek to divest,the activity of such businesses may dilute our earnings and we may not beable to achieve the expected benefits of such divestitures.As a result,our financial results may differ from our forecasts or theexpectations of

258、the investment community in a given quarter or over the long term.To finance our acquisitions,we may have to raise additional funds,either through public or private financings.We maybe unable to obtain such funds or may be able to do so only on terms unacceptable to us.We may also incur expenses rel

259、ated tocompleting acquisitions or licensing technologies,or in evaluating potential acquisitions or technologies,which may adverselyimpact our profitability.If we do not compete effectively,our business will be harmed.We encounter aggressive competition from numerous competitors in many areas of our

260、 business.We may not be able tocompete effectively with all of these competitors.To remain competitive,we must develop new products and periodicallyenhance our existing products.We anticipate that we may also have to adjust the prices of many of our products to staycompetitive.In addition,new compet

261、itors,technologies or market trends may emerge to threaten or reduce the value of entireproduct lines.Our quarterly operating results could be subject to significant fluctuation,and we may not be able to adjust ouroperations to effectively address changes we do not anticipate,which could increase th

262、e volatility of our stock price andpotentially cause losses to our shareholders.Given the nature of the markets in which we participate,we cannot reliably predict future revenue and profitability.Changes in competitive,market and economic conditions may require us to adjust our operations,and we may

263、 not be able tomake those adjustments or make them quickly enough to adapt to changing conditions.Ahigh proportion of our costs are fixedin the short term,due in part to our research and development and manufacturing costs.As a result,small declines in sales coulddisproportionately affect our operat

264、ing results in a quarter.Factors that may affect our quarterly operating results include:demand for and market acceptance of our products,competitive pressures resulting in lower selling prices,17changes in the level of economic activity in regions in which we do business,including as a result of CO

265、VID-19and other global health crises or pandemics,changes in general economic conditions or government funding,settlements of income tax audits,expenses incurred in connection with claims related to environmental conditions at locations where we conduct orformerly conducted operations,contract termi

266、nation and litigation costs,differing tax laws and changes in those laws,or changes in the countries in which we are subject to taxation,changes in our effective tax rate,changes in industries,such as pharmaceutical and biomedical,changes in the portions of our revenue represented by our various pro

267、ducts and customers,our ability to introduce new products,our competitorsannouncement or introduction of new products,services or technological innovations,costs of raw materials,labor,energy or supplies,changes in healthcare or other reimbursement rates paid by government agencies and other third p

268、arties for certainof our products and services,our ability to realize the benefit of ongoing productivity initiatives,changes in the volume or timing of product orders,fluctuation in the expense related to the mark-to-market adjustment on postretirement benefit plans,changes in our assumptions under

269、lying future funding of pension obligations,changes in assumptions used to determine contingent consideration in acquisitions,andchanges in foreign currency exchange rates.Asignificant disruption in third-party package delivery and import/export services,or significant increases in prices forthose s

270、ervices,could interfere with our ability to ship products,increase our costs and lower our profitability.We ship a significant portion of our products to our customers through independent package delivery and import/exportcompanies,including UPS and Federal Express in the United States;TNT,UPS and D

271、HL in Europe;and UPS inAsia.We alsoship our products through other carriers,including commercial airlines,freight carriers,national trucking firms,overnightcarrier services and the United States Postal Service.If one or more of the package delivery or import/export providersexperiences a significant

272、 disruption in services or institutes a significant price increase,including a service disruption as a resultof the COVID-19 pandemic,we may have to seek alternative providers and the delivery of our products could be prevented ordelayed.Such events could cause us to incur increased shipping costs t

273、hat could not be passed on to our customers,negativelyimpacting our profitability and our relationships with certain of our customers.Disruptions in the supply of raw materials,certain key components and other goods from our limited or single sourcesuppliers could have an adverse effect on the resul

274、ts of our business operations,and could damage our relationships withcustomers.The production of our products requires a wide variety of raw materials,key components and other goods that aregenerally available from alternate sources of supply.However,certain critical raw materials,key components and

275、 other goodsrequired for the production and sale of some of our principal products are available from limited or single sources of supply.Wegenerally have multi-year contracts with no minimum purchase requirements with these suppliers,but those contracts may notfully protect us from a failure by cer

276、tain suppliers to supply critical materials or from the delays inherent in being required tochange suppliers and,in some cases,validate new raw materials.Such raw materials,key components and other goods canusually be obtained from alternative sources with the potential for an increase in price,decl

277、ine in quality or delay in delivery.Aprolonged inability to obtain certain raw materials,key components or other goods is possible and could have an adverse effecton our business operations,and could damage our relationships with customers.In addition,a global health crisis or pandemicsuch as the CO

278、VID-19 pandemic could have a significant adverse effect on our supply chain.18We are subject to the rules of the Securities and Exchange Commission requiring disclosure as to whether certainmaterials known as conflict minerals(tantalum,tin,gold,tungsten and their derivatives)that may be contained in

279、 our productsare mined from the Democratic Republic of the Congo and adjoining countries.As a result of these rules,we may incuradditional costs in complying with the disclosure requirements and in satisfying those customers who require that thecomponents used in our products be certified as conflic

280、t-free,and the potential lack of availability of these materials atcompetitive prices could increase our production costs.If we do not retain our key personnel,our ability to execute our business strategy will be limited.Our success depends to a significant extent upon the continued service of our e

281、xecutive officers and key management andtechnical personnel,particularly our experienced engineers and scientists,and on our ability to continue to attract,retain,andmotivate qualified personnel.The competition for these employees is intense.The loss of the services of key personnel couldhave a mate

282、rial adverse effect on our operating results.In addition,there could be a material adverse effect on us should theturnover rates for key personnel increase significantly or if we are unable to continue to attract qualified personnel.We do notmaintain any key person life insurance policies on any of

283、our officers or employees.Our success also depends on our ability to execute leadership succession plans.The inability to successfully transitionkey management roles could have a material adverse effect on our operating results.If we experience a significant disruption in,or breach in security of,ou

284、r information technology systems or those of ourcustomers,suppliers or other third parties,or cybercrime,resulting in inappropriate access to or inadvertent transfer ofinformation or assets,or if we fail to implement new systems,software and technologies successfully,our business could beadversely a

285、ffected.We rely on several centralized information technology systems throughout our company to develop,manufacture andprovide products and services,keep financial records,process orders,manage inventory,process shipments to customers andoperate other critical functions.Our and our third-party servi

286、ce providers information technology systems may be susceptibleto damage,disruptions or shutdowns due to power outages,hardware failures,computer viruses,attacks by computer hackers,telecommunication failures,user errors,catastrophes or other unforeseen events.If we were to experience a prolonged sys

287、temdisruption in the information technology systems that involve our interactions with customers,suppliers or other third parties,itcould result in the loss of sales and customers and significant incremental costs,which could adversely affect our business.Inaddition,security breaches of our informat

288、ion technology systems or cybercrime,resulting in inappropriate access to orinadvertent transfer of information or assets,could result in losses or misappropriation of assets or unauthorized disclosure ofconfidential information belonging to us or to our employees,partners,customers or suppliers,whi

289、ch could result in oursuffering significant financial or reputational damage.Our results of operations will be adversely affected if we fail to realize the full value of our intangible assets.As of January 2,2022,our total assets included$11.5 billion of net intangible assets.Net intangible assets c

290、onsistprincipally of goodwill associated with acquisitions and costs associated with securing patent rights,trademark rights,customerrelationships,core technology and technology licenses and in-process research and development,net of accumulatedamortization.We test certain of these itemsspecifically

291、 all of those that are considered“indefinite-lived”at least annuallyfor potential impairment by comparing the carrying value to the fair market value of the reporting unit to which they areassigned.All of our amortizing intangible assets are also evaluated for impairment should events occur that cal

292、l into questionthe value of the intangible assets.Adverse changes in our business,adverse changes in the assumptions used to determine the fair value of our reportingunits,or the failure to grow our Discovery&Analytical Solutions and Diagnostics segments may result in impairment of ourintangible ass

293、ets,which could adversely affect our results of operations.Risks Related to our Intellectual PropertyWe may not be successful in adequately protecting our intellectual property.Patent and trade secret protection is important to us because developing new products,processes and technologies givesus a

294、competitive advantage,although it is time-consuming and expensive.We own many United States and foreign patents andintend to apply for additional patents.Patent applications we file,however,may not result in issued patents or,if they do,theclaims allowed in the patents may be narrower than what is n

295、eeded to protect fully our products,processes and technologies.The expiration of our previously issued patents may cause us to lose a competitive advantage in certain of the products andservices we provide.Similarly,applications to register our trademarks may not be granted in all countries in which

296、 they are19filed.For our intellectual property that is protected by keeping it secret,such as trade secrets and know-how,we may not useadequate measures to protect this intellectual property.Third parties have in the past and may in the future also challenge the validity of our issued patents,may ci

297、rcumvent or“design around”our patents and patent applications,or claim that our products,processes or technologies infringe their patents.In addition,third parties may assert that our product names infringe their trademarks.We may incur significant expense in legalproceedings to protect our intellec

298、tual property against infringement by third parties or to defend against claims of infringementby third parties.Claims by third parties in pending or future lawsuits could result in awards of substantial damages against us orcourt orders that could effectively prevent us from manufacturing,using,imp

299、orting or selling our products in the United Statesor other countries.If we are unable to renew our licenses or otherwise lose our licensed rights,we may have to stop selling products or wemay lose competitive advantage.We may not be able to renew our existing licenses,or licenses we may obtain in t

300、he future,on terms acceptable to us,orat all.If we lose the rights to a patented or other proprietary technology,we may need to stop selling products incorporating thattechnology and possibly other products,redesign our products or lose a competitive advantage.Potential competitors could in-license

301、technologies that we fail to license and potentially erode our market share.Our licenses typically subject us to various economic and commercialization obligations.If we fail to comply with theseobligations,we could lose important rights under a license,such as the right to exclusivity in a market,o

302、r incur losses forfailing to comply with our contractual obligations.In some cases,we could lose all rights under the license.In addition,rightsgranted under the license could be lost for reasons out of our control.For example,the licensor could lose patent protection fora number of reasons,includin

303、g invalidity of the licensed patent,or a third-party could obtain a patent that curtails our freedomto operate under one or more licenses.Risks Related to Legal,Government and Regulatory MattersThe manufacture and sale of products and services may expose us to product and other liability claims for

304、which wecould have substantial liability.We face an inherent business risk of exposure to product and other liability claims if our products,services or productcandidates are alleged or found to have caused injury,damage or loss.We may be unable to obtain insurance with adequatelevels of coverage fo

305、r potential liability on acceptable terms or claims of this nature may be excluded from coverage under theterms of any insurance policy that we obtain.If we are unable to obtain such insurance or the amounts of any claimssuccessfully brought against us substantially exceed our coverage,then our busi

306、ness could be adversely impacted.If we fail to maintain satisfactory compliance with the regulations of the United States Food and Drug Administrationand other governmental agencies in the United States and abroad,we may be forced to recall products and cease theirmanufacture and distribution,and we

307、 could be subject to civil,criminal or monetary penalties.Our operations are subject to regulation by different state and federal government agencies in the United States and othercountries,as well as to the standards established by international standards bodies.If we fail to comply with those regu

308、lationsor standards,we could be subject to fines,penalties,criminal prosecution or other sanctions.Some of our products are subjectto regulation by the United States Food and DrugAdministration and similar foreign and domestic agencies.These regulationsgovern a wide variety of product activities,fro

309、m design and development to labeling,manufacturing,promotion,sales anddistribution.If we fail to comply with those regulations or standards,we may have to recall products,cease their manufactureand distribution,and may be subject to fines or criminal prosecution.We are also subject to a variety of l

310、aws,regulations and standards that govern,among other things,the importation andexportation of products,the handling,transportation and manufacture of toxic or hazardous substances,the collection,storage,transfer,use,disclosure,retention and other processing of personal data,and our business practic

311、es in the United States andabroad such as anti-bribery,anti-corruption and competition laws.This requires that we devote substantial resources tomaintaining our compliance with those laws,regulations and standards.Afailure to do so could result in the imposition of civil,criminal or monetary penalti

312、es having a material adverse effect on our operations.Changes in governmental regulations may reduce demand for our products or increase our expenses.We compete in markets in which we or our customers must comply with federal,state,local and foreign regulations,suchas environmental,health and safety

313、,data privacy and food and drug regulations.We develop,configure and market our products20to meet customer needs created by these regulations.Any significant change in these regulations could reduce demand for ourproducts or increase our costs of producing these products.The healthcare industry is h

314、ighly regulated and if we fail to comply with its extensive system of laws and regulations,wecould suffer fines and penalties or be required to make significant changes to our operations which could have a significantadverse effect on the results of our business operations.The healthcare industry,in

315、cluding the genetic screening market,is subject to extensive and frequently changinginternational and United States federal,state and local laws and regulations.In addition,legislative provisions relating tohealthcare fraud and abuse,patient privacy violations and misconduct involving government ins

316、urance programs providefederal enforcement personnel with substantial powers and remedies to pursue suspected violations.We believe that ourbusiness will continue to be subject to increasing regulation as the federal government continues to strengthen its position onhealthcare matters,the scope and

317、effect of which we cannot predict.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 healthcareprograms,and the loss of various licenses,certificates and authorizations necessary to ope

318、rate our business,as well as incurliabilities from third-party claims,all of which could have a significant adverse effect on our business.Risks Related to our Foreign OperationsEconomic,political and other risks associated with foreign operations could adversely affect our international sales andpr

319、ofitability.Because we sell our products worldwide,our businesses are subject to risks associated with doing businessinternationally.Our sales originating outside the United States represented the majority of our total revenue in fiscal year 2021.We anticipate that sales from international operation

320、s will continue to represent a substantial portion of our total revenue.Inaddition,many of our manufacturing facilities,employees and suppliers are located outside the United States.Accordingly,ourfuture results of operations could be harmed by a variety of factors,including:changes in actual,or fro

321、m projected,foreign currency exchange rates,a global health crisis of unknown duration,such as the COVID-19 pandemic,wars,conflicts,or other changes in a countrys or regions political or economic conditions,particularly indeveloping or emerging markets,longer payment cycles of foreign customers and

322、timing of collections in foreign jurisdictions,trade protection measures including embargoes,sanctions and tariffs,such as the sanctions recently implementedby the U.S.and other governments on the Russian Federation and related parties,the extent and impact of whichhave yet to be fully determined,im

323、port or export licensing requirements and the associated potential for delays or restrictions in the shipment ofour products or the receipt of products from our suppliers,policies in foreign countries benefiting domestic manufacturers or other policies detrimental to companiesheadquartered in the Un

324、ited States,differing tax laws and changes in those laws,or changes in the countries in which we are subject to tax,adverse income tax audit settlements or loss of previously negotiated tax incentives,differing business practices associated with foreign operations,difficulty in transferring cash bet

325、ween international operations and the United States,difficulty in staffing and managing widespread operations,differing labor laws and changes in those laws,differing protection of intellectual property and changes in that protection,expanded enforcement of laws related to data protection and person

326、al privacy,increasing global enforcement of anti-bribery and anti-corruption laws,anddiffering regulatory requirements and changes in those requirements.21The United Kingdoms withdrawal from the European Union could adversely impact our results of operations.Nearly 10%of our net sales from continuin

327、g operations in fiscal year 2021 came from the United Kingdom.Following thereferendum vote in the United Kingdom in June 2016 in favor of leaving the European Union,on January 31,2020,the countryformally withdrew from the European Union(commonly referred to as“Brexit”)and,on December 24,2020,the Uni

328、tedKingdom and the European Union entered into a Trade and CooperationAgreement to govern the relationship between theUnited Kingdom and the European Union following Brexit.The potential effects of Brexit remain uncertain.Brexit has caused,and may continue to create,volatility in global stock market

329、s and regional and global economic uncertainty particularly in theUnited Kingdom financial and banking markets.Weakening of economic conditions or economic uncertainties tend to harm ourbusiness,and if such conditions worsen in the United Kingdom or in the rest of Europe,it may have a material adver

330、se effect onour operations and sales.Any significant weakening of the Great Britain Pound to the U.S.dollar will have an adverse impact on our Europeanrevenues due to the importance of our sales in the United Kingdom.Currency exchange rates in the pound sterling and the eurowith respect to each othe

331、r and the U.S.dollar have already been adversely affected by Brexit and that may continue to be thecase.Risks Related to our DebtWe have a substantial amount of outstanding debt,which could impact our ability to obtain future financing and limitour ability to make other expenditures in the conduct o

332、f our business.We have a substantial amount of debt and other financial obligations.Our debt level and related debt service obligationscould have negative consequences,including:requiring us to dedicate significant cash flow from operations to the payment of principal and interest on our debt,which

333、reduces the funds we have available for other purposes,such as acquisitions and stock repurchases;reducing our flexibility in planning for or reacting to changes in our business and market conditions;exposing us to interest rate risk as a portion of our debt obligations are at variable rates;increasing our foreign currency risk as a portion of our debt obligations are in denominations other than t