1、Transforming For GrowthAnnual Report2 02 0TO OUR SHAREHOLDERSUndeniably,2020 was a year we will remember a year in which a novel coronavirus pandemic upended communities,businesses and families,and disrupted life as we knew it.As the world managed the impact of this unprecedented event,we quickly ad
2、apted to our new environment.We rapidly organized the way we worked to keep our colleagues safe and to stay connected with customers.We optimized our product portfolio and accelerated our investments to drive future growth.It was inspiring to see Integra colleagues come together and navigate through
3、 this period of uncertainty,emerging with a greater sense of community and absolute determination to succeed.More importantly,our unwavering commitment to serving customers and patients made our recovery possible and our company even stronger.A YEAR LIKE NO OTHERIntegra kicked off the year strong an
4、d on track against our operating plans when the COVID-19 pandemic quickly dis-rupted this growth trajectory and adversely impacted our performance.As COVID-19 reached a tipping point in Europe and the United States during the last two weeks of March,its far-reaching repercussions were felt across ou
5、r industry and our businesses,with hospitals cancelling or postponing elec-tive procedures and eventually deferring certain non-elective procedures.As a result of the pandemic,full-year revenues declined nearly 10 percent to$1.37 billion.Putting the year in perspective,revenues in the first half dec
6、lined 18 percent and adjusted earnings per share declined by over 40 percent com-pared to the same period a year ago.As surgical procedures resumed,we saw a steady improvement in our business in the second half of the year,revenues declined by only 2 percent and adjusted earnings per share rebounded
7、,increasing over 20 percent compared to the second half of 2019.Codman Specialty Surgical(CSS)reported revenue was$895million,representing 9 percent organic growth,which was lower versus year ago because of deferrals of procedures and capital equipment spending.Despite the challenges brought on by t
8、he pandemic,many of our new product introductions,such as CUSA consumables and Certas Plus programmable valves,returned to growth in the second half of 2020.Full-year reported revenue for the Orthopedics and Tissue Technologies(OTT)business was$477 million,representing an 8-percent organic growth de
9、cline versus the prior year.The OTT business was significantly impacted in the first half of the year because of deferrals of non-emergent chronic wound treatments,plastic and reconstructive surgeries,and a significant decline in orthopedic procedures.As these procedures resumed in the second half o
10、f the year,we saw a steady recovery,particularly in Integra Dermal Regeneration Template,nerve,and amniotic tissue products.Our international business experienced softness throughout the year as the impact from the pandemic varied around the world and was most severe in markets where we do not have
11、direct sales presence.Japan remained one of our top perform-ing markets and showed strong performance during 2020 de-spite the COVID-19 challenges.Our China business exhibited strong recovery in the back half of 2020.ADJUSTING TO OUR NEW REALITYIn the early days of the pandemic,Integra teams reacted
12、 swift-ly,prioritizing the safety and well-being of our colleagues while continuing to serve our customers and patients.We im-plemented safety measures and protocols based on guidance set by government authorities and continuously reevaluated them to minimize the risks to our people,our facilities,a
13、nd our business.Leadership at all levels of the organization came together and made the necessary and critical decisions to preserve full-time jobs and protect the business for the long term.Colleagues quickly adjusted to our new realities,while bal-ancing the needs of their families and delivering
14、to our cus-tomers and patients.Our commercial organizations adopted digital collaboration tools to stay connected with our customers.We launched new digital programs and resources to provide healthcare professionals with access to product training.Our programs featured clinical and economic evidence
15、 demonstrating fewer complications,reduced risk and more predictable outcomes associated with key products within our neurosurgery port-folio.We held national educational webinars and interactive roundtables to highlight and differentiate our proven wound Peter J.ArduiniPresident and CEOSincerely,re
16、construction product solutions.We also launched educa-tional portals and microsites to drive product awareness and promote our thought leadership in segments where we main-tain leadership positions.Our digital platforms,combined with our strong,existing relationships and support structure,enabled ou
17、r field sales teams to stay highly engaged with our customers throughout the year.Our swift and balanced response to the pandemic paid off,fast-tracking our recovery once surgical procedure volumes returned to more normal levels in the back half of 2020.TRANSFORMING FOR GROWTHAs we adapted to our ne
18、w environment,we also spent our time during 2020 wisely,optimizing our business and invest-ing in priorities critical to our long-term growth.We completed strategic investments and operational improve-ments to bolster our supply and order-fulfillment capabilities at several regenerative product manu
19、facturing facilities.We kept our key clinical programs on track,and as a result,achieved several milestones last year.In May,we announced positive clinical and economic data on Integra Bilayer Wound Matrix in complex lower extremity reconstruction,based on the results of two retrospective studies pu
20、blished recently in the Plastic and Reconstructive Surgery Journal.We received FDA clearance of a specific indication for neurosur-gery for CUSA Clarity Ultrasonic Surgical Aspirator System,making it the first and only ultrasonic tissue ablation system cleared to treat malignant and benign tumors.We
21、 transformed our portfolio with the announcement of two significant transactions last year.First,we divested the ortho-pedics business,which will enhance our focus,increase mar-gins,and enable growth.With this divestiture,we renamed our OTT division Tissue Technologies to reflect a sharper focus on
22、our regenerative tissue technologies portfolio.We acquired ACell,Inc.,a regenerative medical device company,to broaden our complex wound management solutions to address more clinical challenges.We are thrilled to welcome our new colleagues to Integra and look forward to the excit-ing possibilities o
23、ur combined knowledge and experience in regenerative medicine will bring.With the years challenges compounded by racial unrest in the United States,we remained more determined than ever to nurture a culture of inclusion to be an organization in which colleagues from diverse backgrounds can come toge
24、ther to share different views and feel valued and respected.We have always believed that a diverse workforce and an inclusive work environment are keys to our long-term success.For the past several years,we have made diversity and inclusion one of our key business priorities and established initiati
25、ves aimed at building stronger,diverse teams.Last year,we completed microinequities training across the company.We also increased the number of women in executive and senior leadership positions.We are proud of these accomplishments,but recognize there is more work to be done.We intend to accelerate
26、 our diversity and inclusion efforts in the years ahead.Last year,we announced key executive leadership appoint-ments.We appointed Mike McBreen to executive vice presi-dent and president of our CSS business.Mike joined Integra as part of the Codman Neurosurgery acquisition from Johnson&Johnson and p
27、reviously led our international business.Steve Leonard was appointed the new head of global operations and supply chain in August,following the announcement of John Mooradians intention to retire at the end of 2020.These leadership transitions are a testament to the depth of our leadership bench and
28、 the strong pipeline of talent we have developed over the years.While the impact of the COVID-19 pandemic may be far from over,we are confident the important steps we took in 2020 have set us up for long-term success.Our companys financial position and liquidity remain strong.We have a broad port-fo
29、lio of market-leading medical technologies recognized as the standard of care within many hospitals and healthcare facilities around the world.We have deep knowledge and extensive experience in neurosurgery and regenerative med-icine,which will enable us to continue to bring innovations to patients.
30、Most importantly,we have the teams who remain committed to doing well by doing good for our shareholders,customers,and patients,and to supporting each other during these unsettling times.On behalf of our board of directors,executive leadership team,and our colleagues around the world,I thank you,our
31、 shareholders,for your continued support.All of us at Integra LifeSciences wish you and your loved ones good health in the year ahead.Peter J.ArduiniPresident and Chief Executive OfficerPeter J.ArduiniPresident and Chief Executive Officer,Integra LifeSciencesSravan K.EmanyCorporate Vice President,Co
32、mmercial Excellence,and Chief Strategy OfficerRaymond G.Murphyformer Senior Vice President and Treasurer,Time Warner Inc.,and Chair,Audit CommitteeSteve LeonardCorporate Vice President,Global Operations and Supply ChainLisa EvoliExecutive Vice President and Chief Human Resources OfficerChristian S.S
33、chadePresident and Chief Executive Officer,Aprea Therapeutics,and Chair,Finance CommitteeCarrie AndersonExecutive Vice President and Chief Financial OfficerRhonda G.Ballintynformer Chief Strategy and Marketing Officer,Honeywell InternationalBarbara McAleerCorporate Vice President,Global QualityKenne
34、th BurhopCorporate Vice President,Chief Scientific OfficerKeith Bradley,Ph.D.former Professor of International Management and Management Strategy,Open University and Cass Business School,U.K.Andrea CarusoCorporate Vice President,Business DevelopmentShaundra ClayGlobal Vice President,Finance,Beam Sun
35、tory,Inc.Michael McBreenExecutive Vice President and President,Codman Specialty SurgicalGlenn G.ColemanExecutive Vice President and Chief Operating OfficerStuart M.Essig,Ph.D.Managing Director,Prettybrook Partners,LLC,and Chairman of the BoardJudith E.OGrady,RNCorporate Vice President,Global Regulat
36、ory AffairsEric SchwartzExecutive Vice President,Chief Legal Officer and SecretaryWilliam ComptonCorporate Vice President and Chief Information OfficerBarbara B.HillOperating Partner,NexPhase Capital,and Chair,Nominating and Corporate Governance CommitteeRobert T.Davis,Jr.Executive Vice President an
37、d President,Tissue TechnologiesDonald E.Morel,Jr.,Ph.D.former Chief Executive Officer,West Pharmaceutical Services,Inc.,and Chair,Compensation CommitteeMANAGEMENT TEAMBOARD OF DIRECTORSFINANCIAL HIGHLIGHTS0501001502002500500100015002000($in Millions)20182019$199.7$203.82020$231.4(Per Share Amounts)2
38、018$1.572019$0.722020$0.580.00.51.01.52.02.53.0-5005010015020025012/31/1501/31/1502/29/1603/31/1504/30/1605/31/1506/30/1607/31/1508/31/1609/30/1510/31/1611/30/1512/31/1601/31/1602/28/1703/31/1604/30/1705/31/1606/30/1707/31/1608/31/1709/30/1610/31/1711/30/1612/31/1701/31/1702/28/1803/31/1704/30/1805/
39、31/1706/30/1807/31/1708/31/1809/30/1710/31/1811/30/1712/31/1801/31/1802/28/1903/31/1804/30/1905/31/1806/30/1907/31/1808/31/1909/30/1810/31/1911/30/1812/31/1902/29/2001/31/1404/30/2003/31/1406/30/2005/31/1408/31/2007/31/1410/31/2009/30/1412/31/2011/30/14Peer AverageNASDAQS&P HC EquipmentR1000IART5-Ye
40、ar IART and Peer Performance2020 Revenues by Geographic AreaDiluted Earnings Per Share1Operating Cash FlowTotal Revenues2020 Revenues by Product CategoryCodman Specialty SurgicalUnited StatesEuropeOrthopedics and Tissue TechnologiesRest of World66%34%71%13%16%2018$1,371.92019$1,472.42020$1,517.6($in
41、 Millions)$2.45$2.42$2.741.A reconciliation of GAAP net income to adjusted earnings per share for the years ended December 31,2020,2019,and 2018 is available on our corporate website at:http:/ regenerative tissue technologies have gained a place of prominence in reconstructive surgery.In many ways,t
42、hese products have changed what we can offer as reconstructive surgeons,and they have improved the paradigm of care for chronically ill patients.”Stephen Kovach III,M.D.,FACSTISSUE TECHNOLOGIESThe Tissue Technologies business,formerly Orthopedics and Tissue Technologies,focuses on delivering broad a
43、nd deep solutions to plastic and reconstructive surgeons who perform complex wound surgery,surgical reconstruction,and peripheral nerve repair.Our tissue products are used for a wide range of indications that include:acute wound care in the operating room,such as trauma reconstruction;burn treatment
44、;chronic wound management such as diabetic foot ulcers;hernia repair,including minimally invasive and robotic procedures;peripheral nerve repair and protection;and tendon repair.Integra is a pioneer and global leader in regenerative technologies,tracing its legacy back to the introduction of Integra
45、 Dermal Regeneration Template in 1996,the first product approved by the U.S.Food and Drug Administration to regenerate dermal tissue.This business also includes broad,private-label sales of our regenerative and tissue technologies,serving other medical technology companies that sell to end markets,p
46、rimarily in spine,infection prevention,surgical and wound care.Last year,we announced two transformative deals that fur-ther optimized our product portfolio the divestiture of the orthopedics business to Smith+Nephew and the acquisition of ACell,Inc.,a regenerative medical device company special-izi
47、ng in the manufacture of porcine urinary bladder extracel-lular matrix technologies.Because wound treatment is quite complex and varies across a broad continuum of care,it often requires a number of advanced solutions.ACells MatriStem UBM(Urinary Bladder Matrix)technology,the foundation of ACells pr
48、oduct lines,is highly complementary to Integras existing product portfolio.The addition of this proprietary technological platform expands our regenerative capabilities and offers surgeons and patients more treatment options.In 2020,we continued to make investments to shore up our product supply and
49、 advance our key clinical programs.We ex-panded capacity at several of our regenerative plants,specif-ically involving our AmnioExcel,SurgiMend and PriMatrix product lines.We also achieved a significant product mile-stone with the announcement of positive clinical and econom-ic data on Integra Bilay
50、er Wound Matrix(IBWM)in complex lower extremity reconstruction.These findings were based on data from two retrospective studies published in Plastic and Reconstructive Surgery Journal,which showed how IBWM can address the efficiency needed in operating rooms by reducing both operating time and hospi
51、tal and patient costs.Finally,to further support our commercial efforts,we expand-ed our two-tier specialist model to increase the presence in our focused segments.We created an inside sales team,which is a virtual selling organization focused on driving growth and serving the changing needs of our
52、customers.“Integra neurosurgical products and instruments are essential to my daily practice.I am really grateful for these products that help my patients and allow me to do my job effectively every single day.”Adnan Siddiqui,M.D.,Ph.D.,FACS,FAHACODMAN SPECIALTY SURGICALThe Codman Specialty Surgical
53、 segment represents mar-ket-leading technologies and instrumentation that are used in a wide range of specialties,such as neurosurgery,neuro-critical care,and otolaryngology.In 2020,we continued to advance product development and made key investments in programs to position us for future growth.We r
54、eceived U.S.Food and Drug Administration clearance of a specific indication for neurosurgery for CUSA Clarity Ultrasonic Surgical Aspirator System,making it the first and only ultrasonic tissue ablation system approved to treat malignant and benign tumors.We stayed on track with our programs focused
55、 on Aurora Surgiscope and evacuator,which we acquired in 2019,giving Integra access to the high-growth area of minimally invasive neurosurgery.The acquisition positions us to transform care for intracerebral hemorrhage patients.In addition,we con-tinued to advance on new innovations using the anti-o
56、cclu-sion Endexo technology,which we also acquired in 2019,and combining it with our market-leading antimicrobial Bactiseal technology.This sets us up to address the biggest unmet needs of infection and occlusion prevention in the neurocriti-cal care and hydrocephalus segments.Our new product introd
57、uctions also contributed to our growth,including the Certas Plus portfolio of programmable valves,CUSA consumables,and the DuraGen launch in Japan,which is the first and only dural xenograft.Despite the impact from the COVID-19 pandemic,we strengthened our commercial presence across the CSS busi-nes
58、s.Our markets in Japan and China were bright spots of growth during 2020.In Japan,we established a new surgical sales team and transitioned our CUSA Excel business in the general surgery market to a direct sales model.This transi-tion aligns with our strategy to expand our market-leading position in
59、 hepatectomies.In China,we continued to invest in professional education and market access.Additionally,we expanded our commercial presence in China,where we entered licensing and distribution deal with a local manufacturer to add complementary products to our portfolio.This partnership represents o
60、ur ongoing plans to supplement our commercial channels with locally sourced,market-appropriate products.We moved our Service&Repair center of excellence in Ratingen,Germany,to a new,expanded space to strengthen our support for our customers in the EMEA region.Finally,we launched new digital programs
61、 and resources to provide healthcare professionals with access to product train-ing.These programs feature clinical and economic evidence that show fewer complications,reduced risk and more predict-able outcomes associated with our key neurosurgery products.UNITED STATESSECURITIES AND EXCHANGE COMMI
62、SSIONWASHINGTON,DC 20549FORM 10-K(Mark One)ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d)OF THE SECURITIESEXCHANGE ACT OF 1934For the fiscal year ended December 31,2020orTRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d)OF THE SECURITIESEXCHANGE ACT OF 1934For the transition period fromtoCOMMISSION FI
63、LE NO.0-26224INTEGRA LIFESCIENCES HOLDINGS CORPORATION(EXACT NAME OF REGISTRANT AS SPECIFIED IN ITS CHARTER)Delaware51-0317849(STATE OR OTHER JURISDICTION OFINCORPORATION OR ORGANIZATION)(I.R.S.EMPLOYERIDENTIFICATION NO.)1100 Campus RoadPrinceton,New Jersey08540(ZIP CODE)(ADDRESS OF PRINCIPAL EXECUT
64、IVE OFFICES)REGISTRANTS TELEPHONE NUMBER,INCLUDING AREA CODE:(609)275-0500SECURITIES REGISTERED PURSUANT TO SECTION 12(b)OF THE ACT:Title of Each ClassTrading SymbolName of Exchange on Which RegisteredCommon Stock,Par Value$.01 Per ShareIARTNasdaq Global Select MarketSECURITIES REGISTERED PURSUANT T
65、O SECTION 12(g)OF THE ACT:NONEIndicate by check mark if the registrant is a well-known seasoned issuer,as defined in Rule 405 of the Securities Act.Yes No Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d)of the Securities ExchangeAct.Yes No Indi
66、cate by check mark whether the registrant:(1)has filed all reports required to be filed by Section 13 or 15(d)of the SecuritiesExchange Act of 1934 during the preceding 12 months(or for such shorter period that the registrant was required to file such reports),and(2)has been subject to such filing r
67、equirements for the past 90 days.Yes No Indicate by check mark whether the registrant has submitted electronically 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 reg
68、istrant wasrequired to submit such files).Yes No Indicate by check mark whether the registrant is a large accelerated filer,an accelerated filer,a non-accelerated filer,a smaller reportingcompany,or an emerging growth company.See the definitions of“large accelerated filer,”“accelerated filer,”“small
69、er reporting company,”and“emerging growth company”in Rule 12b-2 of the Exchange Act.(Check one):Large accelerated filer Accelerated filer Non-accelerated filer Smaller reporting company Emerging growth company If an emerging growth company,indicate by check if the registrant has elected not to use t
70、he extended transition period for complyingwith any new revised financial accounting standards provided pursuant to Section 13(a)of the Exchange Act.Indicate by check mark whether the registrant has filed a report on and attestation to its managements assessment of the effectiveness ofits internal c
71、ontrol over financial reporting under Section 404(b)of the Sarbanes-Oxley Act(15 U.S.C.7262(b)by the registered 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 Exchange Act).Yes No As of J
72、une 30,2020,the aggregate market value of the registrants common stock held by non-affiliates was approximately$3,370.2 million based upon the closing sales price of the registrants common stock on The Nasdaq Global Select Market on such date.Thenumber of shares of the registrants Common Stock,$0.01
73、 par value,outstanding as of February 19,2021 was 84,369,946.DOCUMENTS INCORPORATED BY REFERENCE:Certain portions of the registrants definitive proxy statement relating to its scheduled May 14,2021 Annual Meeting of Stockholdersare incorporated by reference in Part III of this report.INTEGRA LIFESCI
74、ENCES HOLDINGS CORPORATIONTABLE OF CONTENTSPagePART IItem 1.Business.1Item 1A.Risk Factors.16Item 1B.Unresolved Staff Comments.15Item 2.Properties.33Item 3.Legal Proceedings.33Item 4.Mine Safety Disclosures.33PART IIItem 5.Market for Registrants Common Equity,Related Stockholder Matters and IssuerPu
75、rchases of Equity Securities.34Item 6.Selected Financial Data.35Item 7.Managements Discussion and Analysis of Financial Condition and Results ofOperations.36Item 7A.Quantitative and Qualitative Disclosures About Market Risk.57Item 8.Financial Statements and Supplementary Data.59Item 9.Changes in and
76、 Disagreements with Accountants on Accounting and FinancialDisclosures.59Item 9A.Controls and Procedures.60Item 9B.Other Information.60PART IIIItem 10.Directors,Executive Officers and Corporate Governance.61Item 11.Executive Compensation.61Item 12.Security Ownership of Certain Beneficial Owners and
77、Management and RelatedStockholder Matters.61Item 13.Certain Relationships,Related Transactions,and Director Independence.61Item 14.Principal Accountant Fees and Services.61PART IVItem 15.Exhibits and Financial Statements Schedule.62Item 16.Form 10-K Summary.73SIGNATURES.74PART IITEM 1.BUSINESSOVERVI
78、EWThe terms“we,”“our,”“us,”“Company”and“Integra”refer to Integra LifeSciences Holdings Corporation,a Delaware corporation,and its subsidiaries,unless the context suggests otherwise.The Company,headquartered in Princeton,New Jersey,is a world leader in medical technology.TheCompany was founded in 198
79、9 with the acquisition of an engineered collagen technology platform used to repairand regenerate tissue.Since then,Integra has developed numerous product lines from this technology forapplications ranging from burn and deep tissue wounds,to the repair of dura mater in the brain,as well as nervesand
80、 tendons.The Company has expanded its base regenerative technology business to include surgicalinstruments,neurosurgical devices,advanced wound care products,and orthopedic hardware through acombination of several global acquisitions and development of products internally to further meet the needs o
81、f itscustomers and impact patient care.We manufacture and sell our products in two reportable business segments:Codman Specialty Surgical andOrthopedics and Tissue Technologies.Our Codman Specialty Surgical products are comprised of specialtysurgical implants and instrumentation for a broad range of
82、 specialties.This segment includes products andsolutions for dural access and repair,instruments,advanced energy,cerebral spinal fluid(“CSF”)managementand neuro monitoring including market-leading product portfolios used in neurosurgery operating suites andcritical care units.Codman Specialty Surgic
83、al products are sold through a combination of directly employed salesrepresentatives,distributors and wholesalers,depending on the customer call point.Our Orthopedics and TissueTechnologies product portfolio consists of differentiated regenerative technology products for soft tissue repairand tissue
84、 regeneration products and surgical reconstruction.This business also includes private label sales of abroad set of our regenerative and wound care medicine technologies.Orthopedics and Tissue Technologiesproducts are sold through directly employed sales representatives and distributors focused on t
85、heir respectivesurgical specialties,and by strategic partners.In January 2021,we completed the sale of our ExtremityOrthopedics business to Smith&Nephew USD Limited for approximately$240 million in cash.This transactionenables us to increase our investments in our business which will strengthen our
86、existing leadership positions inboth areas,fund pipeline opportunities to drive future growth and expand our addressable markets.See Note 18,Subsequent Events,for details.We have key manufacturing and research facilities located in California,New Jersey,Ohio,Massachusetts,Tennessee,Canada,France,Ger
87、many,Ireland,Switzerland,and Puerto Rico.We also source most of ourhandheld surgical instruments and dural sealant products through specialized third-party vendors.VisionWe aspire to continue to be a worldwide leader in neurosurgery and reconstructive surgery,with a portfolioof leading businesses th
88、at delivers outstanding customer experiences through innovation,execution andteamwork to positively impact the lives of millions of patients and their families.StrategyIntegra is committed to delivering high quality products that positively impact the lives of millions ofpatients and their families.
89、We focus on four key pillars of our strategy:1)building an execution-focused culture,2)optimizing relevant scale,3)improving agility and innovation,and 4)leading in customer experience.Webelieve that by sharpening our focus on these areas through improved planning and communication,optimizationof ou
90、r infrastructure,and strategically aligned tuck-in acquisitions,we can build scale,increase competitivenessand achieve our long-term goals.1To this end,the executive leadership team has established the following key priorities aligned to thefollowing areas of focus:Strategic Acquisitions.An importan
91、t part of the Companys strategy is pursuing strategic transactions andlicensing agreements that increase relevant scale in the clinical areas in which Integra competes.In December2020,Integra entered into a merger agreement to acquire ACell,Inc.,an innovative regenerative medicinecompany.This acquis
92、ition,which closed on January 20,2021,expands our product offering of regenerativetechnology and is complementary to Integras existing tissue technologies portfolio.The acquisition alsosupports our long-term growth and profitability strategy with a financial profile similar to Integras tissueproduct
93、s.In 2020,we continued to invest in our two recent acquisitions from 2019,Arkis Biosciences,Inc.andRebound Therapeutics Corporation,both of which are developing innovative technologies for neurosurgery.Portfolio Optimization and New Product Introductions.We are investing in innovative product develo
94、pmentto drive a multi-generational pipeline for our key product franchises.Our product development efforts spanacross our key global franchises and are focused on the potential for significant returns on investment.InFebruary 2020,we launched the AmnioExcelPlus Placental Allograft Membrane,the next
95、generation woundcare offering to support soft tissue repair.Throughout 2020,we continued to reap the benefits of many of our 10new product launches from 2019.In addition to new product development,we are funding studies to gatherclinical evidence to support launches,ensure market access and improve
96、reimbursement for existing products.We continue to identify ways of optimizing our portfolio including identifying low-growth,low-margin productsand product franchises for discontinuation.In January 2021,we completed the sale of our Extremity Orthopedics business to Smith&Nephew USDLimited for appro
97、ximately$240 million in cash.See Note 3,Assets and Liabilities Held for Sale,for details.Commercial Channel Investments.With acquisitions,new product introductions and a broad portfolio ofproducts,investing in our sales channels is a core part of our strategy to create specialization and greater foc
98、us onreaching new and existing customers and addressing their needs.Internationally,we have increased ourcommercial resources significantly in many markets and are making investments to support our salesorganization and maximize our commercial opportunities.We now have a strong international sales c
99、hannel thatdelivers our current portfolio as well as positions us for future expansion.In addition,we continue to build uponour leadership brands across our product franchises,enabling us to engage customers through enterprise-widecontracts.Customer Experience.We aspire to be ranked as a best-in-cla
100、ss provider and are committed to strengthenour relationships with all customers.We strive to consistently deliver outstanding customer service and continueto invest in technologies,systems and processes to improve the way our customers do business with us.Additionally,we utilize professional educati
101、on programs to drive customer familiarity with our growing portfolioof medical technologies globally.BUSINESS SEGMENTSIntegra currently manufactures and sells our products and technologies in the following two globalreportable business segments:Codman Specialty Surgical and Orthopedics and Tissue Te
102、chnologies.We includefinancial information regarding our reportable business segments and certain geographic information under“Item7.Managements Discussion and Analysis of Financial Condition and Results of Operations”,Note 17,Segmentand Geographic Information and Note 18,Subsequent Events to our co
103、nsolidated financial statements.Codman Specialty SurgicalOur Codman Specialty Surgical business offers global,neurosurgery market-leading technologies,brands and instrumentation.The product portfolio represents a continuum of care from pre-operative,to the2neurosurgery operating room,to the neuro-cr
104、itical care unit and post care for both adult and pediatricpatients suffering from brain tumors,brain injury,cerebrospinal fluid pressure complications and otherneurological conditions.We offer leading technologies in dural repair,ultrasonic tissue ablation,intracranialpressure(“ICP”)monitoring,hydr
105、ocephalus management,and cranial stabilization systems,while providinga rich research and development pipeline for growth.Rounding out the portfolio is a catalog of surgical headlamps,surgical instrumentation,as well as after-market service.With thousands of surgical instrument products,including sp
106、ecialty surgical instruments,wecall on the central sterile processing unit of hospitals and acute care surgical centers.Additionally,through astrong U.S.distribution model,we can serve the needs of hundreds of medical offices.Our global commercial network includes clinical specialists,a large direct
107、 global sales force andstrategic partnerships and distributors that serve hospitals,integrated health networks,group purchasingorganizations,clinicians,surgery centers and health care providers.Orthopedics and Tissue TechnologiesOrthopedics and Tissue Technologies products serves some of the fastest
108、 growing markets in themedical technology industry.The broad range of regenerative tissue technologies primarily address theneeds of plastic,reconstructive and general surgeons focused on the treatment of acute wounds,such asburns,chronic wounds,including diabetic foot ulcers,and surgical tissue rep
109、air,such as hernia,tendon,peripheral nerve repair and protection.We made significant investments with our channel expansion in the U.S.and created dedicated saleschannels to have more focus and specialization within our call points to drive sustainable growth.We have aspecialized sales organization
110、composed of directly employed sales representatives,as well as specialtydistributors,organized based upon their call point.Our wound reconstruction sales representatives call onsurgeons doing procedures in limb salvage,trauma,wound reconstruction and burns,and on physicians whotreat chronic wounds i
111、n the outpatient wound care clinic setting.We also have a dedicated surgicalreconstruction sales team focused on plastic and reconstructive surgery and hernia procedures withdifferentiated products.Finally,we have a distributor network focused on biologics.Outside the U.S.,we have a combination of d
112、irect and indirect channels in our international markets tosell certain product lines.This business segment also includes private-label sales of a broad set of our regenerative and woundcare technologies.Our customers are other medical technology companies that sell to end markets primarilyin orthop
113、edics,spine,surgical and wound care.COMPETITIONOur competitors for Codman Specialty Surgical are Medtronic,Inc.,Stryker Corporation,Becton Dickinsonand Company and Aesculap division of B.Braun Medical,Inc.In addition,we compete with many smallerspecialized companies and larger companies that do not
114、otherwise focus on the offerings of Codman SpecialtySurgical technologies.We rely on the depth and breadth of our sales and marketing organization,our innovativetechnology,and our procurement and manufacturing operations to maintain our competitive position.Our competition in Orthopedics and Tissue
115、Technologies includes the DePuy/Synthes business ofJohnson&Johnson,Stryker Corporation,Smith&Nephew plc,MiMedx Group,Inc.,LifeCell Corporation,asubsidiary of Allergan PLC,and Zimmer Biomet Holdings,Inc.In addition,our products also compete against medical practices that treat a condition without usi
116、ng amedical device or any particular product,such as medical practices that utilize autograft tissue instead of ourdermal regeneration products,duraplasty products and nerve repair products.Depending on the product line,we3compete based on our products features,strength of our sales force or distrib
117、utors,sophistication of ourtechnology and cost effectiveness of our solution.RESEARCH AND DEVELOPMENT STRATEGYOur research and development activities focus on identifying unmet surgical needs and addressing thoseneeds with innovative solutions and products.We apply our core competency in regenerativ
118、e technology toproducts for neurosurgical,orthopedic and wound applications,plastic surgery,and reconstructive surgery andwe have extensive programs for our core platforms of orthopedic hardware and electromechanical technologies.Additionally,we conduct products and clinical studies to generate effi
119、cacy and health economic evidence.Regenerative Technologies.Integra was the first Company to receive a United States Food and DrugAdministration(“FDA”)claim for regeneration of dermal tissue and is a world leader in regenerative technology.Because regenerative technology products represent a fast-gr
120、owing,high-margin opportunity for us,we allocate alarge portion of our research and development budget to these projects.Our regenerative technologydevelopment program applies our expertise in bioengineering to a range of biomaterials including naturalcollagen and human tissues as well as synthetics
121、 such as polymers.These unique product designs are used forneurosurgical and orthopedic surgical applications,as well as dermal regeneration,including the healing ofchronic and acute wounds,tendon and nerve repair.Our regenerative technology platform includes our legacyIntegraDermal Regeneration Tem
122、plate(IDRT)products and complementary technologies that we haveacquired over the last few years.Our collagen manufacturing capability,combined with our history ofinnovation,provides us with strong platform technologies for multiple indications.We also continued to benefitfrom our 2019 product launch
123、es,such as DuraGenin Japan which is the first and only non-autologous collagenxenograft approved for use as a dural substitute in Japan.In early 2020,we launched AmnioExcelPlus Placental Allograft Membrane,a human placental tissueproduct for treatment of wounds.Additionally,the Company announced pos
124、itive clinical and economic data onIntegraBilayer Wound Matrix(“IBWM”)in complex lower extremity reconstruction based on tworetrospective studies recently published in Plastic and Reconstructive Surgery,the official journal of theAmerican Society of Plastic Surgeons.As surgeons looks for ways to eff
125、iciently and effectively repair and closewounds during these challenging times,IBWM helps address the efficiency needed in operating rooms byreducing both the operating time and costs to hospitals and patients.Orthopedic Reconstruction.We developed fixation and small joint reconstruction implants an
126、d instrumentsfor upper and lower extremities to both provide next generation solutions and expand our product portfolio.Thisportfolio focuses on joint replacement products.Integra has a strong shoulder portfolio,which includes a totalshoulder system and a reverse shoulder.We continue to work on adva
127、nced shoulder products and are developingnext generation anatomical designs,bone preserving products and techniques,and a pyrocarbon shoulderhemiarthroplasty product to add to that portfolio.We have a strong differentiated asset that resides in ourpatented pyrocarbon products,and we continue to inve
128、st to bring new products to market with this technology,which has shown significantly less wear on bone than traditional metals.We also continued to benefit from the2019 U.S.product launches,such as the PantaII TTC Arthrodesis Nail System.The Panta II system is our newfusion nail used in ankle fixat
129、ion.We also launched a small post baseplate in our reverse shoulder system thataccommodates smaller patients.In addition,we initiated the limited market release of enhancements to our SaltoTalarisTotal Ankle System.Electromechanical Technologies and Instrumentation.Because our electromechanical prod
130、ucts andinstruments address significant needs in surgical procedures and limit uncertainty for surgeons,we continue toinvest in approvals for new indications and next generation improvements to our market-leading products.Wehave several active programs focused on life cycle management and innovation
131、,for capital and disposableproducts in our portfolio.Our product development efforts are focused on core clinical applications in cerebral4spinal fluid(“CSF”)management,neuro-critical care(“NCC”)monitoring,minimally invasive instruments andelectrosurgery and ultrasonic medical technologies.In the Co
132、dman Specialty Surgical segment,our focus is alsoon the new electrosurgery generator and irrigator system,an innovative customer-centric toolkit for our CertasPlus Programmable Valve along with additional shunt configurations.Our lighting franchise is among the mostdynamic in the industry.We continu
133、e to work with several instrument partners to bring new surgical instrumentplatforms to the market.This enables us to add new instruments with minimal expense and invest in ongoingdevelopment,such as our next generation of LED technology with our DUO LED Surgical Headlight System.We develop core cli
134、nical applications in our electromechanical technologies portfolio.In 2020,we updatedour CUSA Clarity platform to incorporate a new ultrasonic handpiece,surgical tips and integrated electrosurgicalcapabilities.In addition,the CUSAClarity Ultrasonic Surgical Aspirator System was cleared to treat mali
135、gnantand benign tumors,but not limited to meningiomas and gliomas.It is the first and only ultrasonic tissue ablationsystem with this specific indication.The FDA clearance is based on a wealth of peer-reviewed clinicalpublications and 40 years of surgical cases involving resection of brain and spina
136、l tumors.Throughout the year,we continued to advance the early-stage technology platforms we acquired in 2019.Through the Arkis Biosciences acquisition,we added a platform technology,CerebroFloexternal ventriculardrainage(EVD)catheter with Endexotechnology,a permanent additive designed to reduce the
137、 potential forcatheter obstruction due to thrombus formation.The CerebroFlo EVD Catheter has demonstrated an average of99%less thrombus accumulation onto its surface,in vitro,compared to a market leading EVD catheter.We alsoacquired a company,Rebound Therapeutics,developers of a single-use medical d
138、evice known as the AURORASurgiscopeSystem(“Aurora”)that enables minimally invasive access with enhanced lighting and visualizationto the neurosurgery suite.Importantly,these new platforms provide us with the opportunity to expand into new,faster growth therapeutic areas,such as intracerebral hemorrh
139、age and minimally invasive neurosurgery.RESOURCESIn general,raw materials essential to our businesses are readily available from multiple sources.For reasonsof quality assurance,availability,or cost effectiveness,certain components and raw materials are available onlyfrom a sole supplier.Our practic
140、e is to maintain sufficient inventory of components so that our production willnot be significantly disrupted even if a particular component or material is not available for a period of time.Certain of our products,including but not limited to our dermal regeneration products,duraplasty products,wou
141、nd care products,bone void fillers,nerve and tendon repair products,contain material derived from bovinetissue.We take great care to provide products that are safe and free of agents that can cause disease.In particular,the collagen used in the products that we manufacture is derived either from the
142、 deep flexor tendon of cattle lessthan 24 months old from New Zealand,a country that has never had a reported case of bovine spongiformencephalopathy(“BSE”)(otherwise known as mad cow disease),or from the U.S.or from fetal bovine dermis.The World Health Organization classifies different types of cat
143、tle tissue for relative risk of BSE transmission.Deep flexor tendon and fetal bovine skin are in the lowest-risk category for BSE transmission,and thereforeconsidered to have a negligible risk of containing the agent that causes BSE.INTELLECTUAL PROPERTYWe seek patent and trademark protection for ou
144、r key technology,products and product improvements,bothin the U.S.and in selected foreign countries.When determined appropriate,we have enforced and plan tocontinue to enforce and defend our patent and trademark rights.In general,however,we do not rely solely on ourpatent and trademark estate to pro
145、vide us with any significant competitive advantages as it relates to our existingproduct lines.We also rely upon trade secrets and continuing technological innovations to develop and maintainour competitive position.In an effort to protect our trade secrets,we have a policy of requiring our employee
146、s,consultants and advisors to execute proprietary information and invention assignment agreements uponcommencement of employment or consulting relationships with us.These agreements also provide that all5confidential information developed or made known to the individual during the course of their re
147、lationship withus must be kept confidential,except in specified circumstances.AccuDrain,Algicell,AmnioExcel,AmnioMatrix,Aquasonic,Auragen,Bactiseal,BioBlock,BioDFactor,BioDFence,BioDOptix,BioDRestore,Bioguard,BioMotion,Bold,Brainet,Budde,Buzz,Capture,CereLink,CerebroFloEVD Catheter with EndexoTechno
148、logy,Certas,Codman,Codman Accu-Flo,Codman Bicol,Codman Certas,Codman Hakim,Codman Holter,Codman ICPExpress,Codman Microsensor,Codman VersaTru,Codman VPV,Contour-Flex,Cranioplastic,CRW,CRW Precision,Cterm,CUSA,DigiFuse,DirectLink,DuraGen,DuraSeal,Endorelease,FirstChoice,HeliCote,HeliPlug,HeliTape,Hel
149、iMend,Helistat,Helitene,Hermetic,Hy-Tape,ICPExpress,Integra,IntegraLink,IPP-ON,Isocool,Jarit,Katalyst,Lead-Lok,Licox,LimiTorr,Luxtec,Mayfield,MediHoney,MemoFix,MicroFrance,Miltex,Mischler,MoniTorrICP,Movement,Natus,NeuraGen,NeuraWrap,Nicolet,NuGrip,Omnigraft,Omni-Tract,OSV II,Padgett,PriMatrix,Puref
150、low,PyroSphere,Q-Snor,Qwix,Redmond,Revize,Ruggles,SafeGuard,Signacreme,Spider,Spin,Subtalar MBA,SurgiMend,TCC-EZ,TenoGlide,Ti6,Tibiaxys,TissueMend,TruArch,Ultra VS,Uni-CP,Uni-Clip,VersaTru,Xtrasorb,zRIP,and theIntegra logo are some of the material trademarks of Integra LifeSciences Corporation and i
151、ts subsidiaries.MAYFIELDis a registered trademark of SM USA,Inc.,and is used by Integra under license.SEASONALITYRevenues during our fourth quarter tend to be stronger than other quarters because many hospitals increasetheir purchases of our products during the fourth quarter to coincide with the en
152、d of their budget cycles in theU.S.In general,our first quarter usually has lower revenues than the preceding fourth quarter,the second andthird quarters have higher revenues than the first quarter,and the fourth quarter revenues are the highest in theyear.The main exceptions to this pattern occur b
153、ecause of material acquisitions as well as impacts of the novelcoronavirus(“COVID-19”)in 2020.Impact of COVID-19 Pandemic on our businessIn March 2020,the World Health Organization recognized the novel strain of coronavirus,COVID-19,as apandemic.This coronavirus outbreak has significantly impacted b
154、oth the world and U.S.economies.In responseto this coronavirus outbreak,the governments of many cities,counties,states and other geographic regions havetaken preventative or protective actions,such as imposing restrictions on travel and business operations and areadvising or requiring individuals to
155、 limit or forego their time outside of their homes which has created significantuncertainties in the U.S.economy.In certain geographic regions in which the Company operates,temporaryclosures of businesses have been ordered or suggested and numerous other businesses have temporarily closedvoluntarily
156、.Further,individualsability to travel has been curtailed through mandated travel restrictions and maybe further limited through additional voluntary or mandated closures of travel-related businesses.The Companys focus during this global crisis remains on supporting patients,providing customers withl
157、ife-saving products,and protecting the well-being of our employees.The rapid and evolving spread of the virushas resulted in an unprecedented challenge to the global healthcare industry,as medical resources are reallocatedto fight COVID-19.During 2020,we were able to sustain ongoing operations by im
158、plementing contingencyplans such as enabling its manufacturing and distribution sites around the world to continue operating at levelsrequired to meet demand and to provide for the safety of our employees.During April of 2020,the Companyimplemented cost-savings measures,which included the following:
159、Reduced executive management compensation through July 2020 and director compensation;Reduced cash compensation for all other employees through reduced commissions,reduction in hoursthrough July 2020 and/or furloughs;6Hiring freeze,elimination of overtime,reduction in certain employee benefit costs,
160、cessation of third-party services and temporary contractor relationships;andSignificant reduction in capital expenditures and discretionary spending including travel,events andmarketing programs.The Company restored employee wages and other spending in the third quarter of 2020,as revenuessequential
161、ly increased approximately 43.1%as compared to the second quarter of 2020.We also continue toimplement programs and strategies to effectively manage the business during the pandemic,such as partneringwith key opinion leaders to increase our customer engagement through educational webinars and to imp
162、rove theclinical components of sales training.We remain confident that the underlying markets in which the Companycompetes remain attractive over the long term.We also remain focused on managing the business for the long-term,including preserving full time jobs needed to support the rebound in surgi
163、cal procedure volumes.TheCompanys adaptability and resiliency in the face of this unprecedented crisis is made possible in part by priorinvestments in technology infrastructure and operations,as well as by our talented and committed globalworkforce.Throughout this period,we continue to prioritize an
164、d invest in critical R&D and clinical programs.Information pertaining to additional risk factors as it relates to the COVID-19 pandemic can be found inItem 1A.Risk Factors.GOVERNMENT REGULATION AND COMPLIANCEWe are a manufacturer and marketer of medical devices,and therefore are subject to extensive
165、 regulation bythe FDA,the Center for Medicare Services of the U.S.Department of Health and Human Services,other federalgovernmental agencies and,in some jurisdictions,by state and foreign governmental authorities.Theseregulations govern the introduction of new medical devices,the observance of certa
166、in standards with respect tothe design,manufacture,testing,labeling,promotion and sales of the devices,the maintenance of certain records,the ability to track devices,the reporting of potential product defects,the import and export of devices,and othermatters.United States Food and Drug Administrati
167、onThe regulatory process for obtaining product approvals and clearances can be onerous and costly.The FDArequires,as a condition to marketing a medical device in the U.S.,that we secure a Premarket Notificationclearance pursuant to Section 510(k)of the Federal Food,Drug and Cosmetic Act(the“FD&C Act
168、”)or anapproved premarket approval(“PMA”)application(or supplemental PMA application).Obtaining theseapprovals and clearances can take up to several years and may involve preclinical studies and clinical trials.TheFDA also may require a post-approval clinical study as a condition of approval.To perf
169、orm clinical trials forsignificant risk devices in the U.S.on an unapproved product,we are required to obtain an Investigational DeviceExemption(“IDE”)from the FDA.The FDA may also require a filing for approval prior to marketing productsthat are modifications of existing products or new indications
170、 for existing products.Moreover,after clearance/approval is given,if the product is shown to be hazardous or defective,the FDA and foreign regulatory agencieshave the power to withdraw the clearance or approval,as the case may be,or require us to change the device,itsmanufacturing process or its lab
171、eling,to supply additional proof of its safety and effectiveness or to recall,repair,replace or refund the cost of the medical device.Because we currently export medical devices manufactured inthe U.S.that have not been approved by the FDA for distribution in the U.S.,we are required to obtain appro
172、val/registration in the country to which we are exporting and maintain certain records relating to exports and makethese available to the FDA for inspection,if required.Human Cells,Tissues and Cellular and Tissue-Based ProductsIntegra,through the acquisition of Derma Sciences and BioD LLC(“BioD”)is
173、involved with the recovery,processing,storage,transportation and distribution of donated amniotic tissue.The FDA has specific regulations7governing human cells,tissues and cellular and tissue-based products,or HCT/Ps.An HCT/P is a productcontaining,or consisting of,human cells or tissue intended for
174、 transplantation into a human patient.Examples ofHCT/P include bone,ligament,skin and cornea.Some HCT/Ps fall within the definition of a biological product,medical device or drug regulated under theFD&C Act.These biologic,device or drug HCT/Ps must comply both with the requirements exclusivelyapplic
175、able to HCT/Ps and,in addition,with requirements applicable to biologics,devices or drugs,includingpremarket clearance or approval from the FDA.Section 361 of the Public Health Service Act(“Section 361”),authorizes the FDA to issue regulations toprevent the introduction,transmission or spread of com
176、municable disease.HCT/Ps regulated as“361”HCT/Psare subject to requirements relating to registering facilities and listing products with the FDA,screening andtesting for tissue donor eligibility,and Good Tissue Practices when processing,storing,labeling,and distributingHCT/Ps,including required labe
177、ling information,stringent record keeping,and adverse event reporting.The American Association of Tissue Banks(“AATB”)has issued operating standards for tissue banking.Compliance with these standards is a requirement in order to become an AATB-accredited tissue establishment.In addition,some states
178、have their own tissue banking regulations.We are licensed or have permits for tissuebanking in California,Delaware,Illinois,Maryland,New York,Oregon,and Tennessee.In Tennessee,we areregistered with the FDA Center for Biological Evaluations and Research.National Organ Transplant ActProcurement of cer
179、tain human organs and tissue for transplantation is subject to the restrictions of theNational Organ Transplant Act,which prohibits the transfer of certain human organs,including skin and relatedtissue for valuable consideration,but permits the reasonable payment associated with the removal,transpor
180、tation,implantation,processing,preservation,quality control and storage of human tissue and skin.Our subsidiary,BioD LLC is a registered Tissue Bank and is involved with the recovery,storage and transportation of donatedhuman amniotic tissue.On June 22,2015,the FDA issued an Untitled Letter(the“Unti
181、tled Letter”)alleging that BioDs morselizedamniotic membrane tissue based products do not meet the criteria for regulation as HCT/Ps solely underSection 361 of the Public Health Services Act(“Section 361”)and that,as a result,BioD would need a biologicslicense to lawfully market those morselized pro
182、ducts.Since the issuance of the Untitled Letter,BioD and morerecently the Company have been in discussions with the FDA to communicate their disagreement with the FDAsassertion that certain products are more than minimally manipulated.The FDA has not changed its position thatcertain of the BioD acqu
183、ired products are not eligible for marketing solely under Section 361.In July,2020,theFDA issued the final guidance document related to human tissue titled,“Regulatory Considerations for HumanCells,Tissues,and Cellular and Tissue-Based Products:Minimal Manipulation and Homologous Use”(the“HCT/PFinal
184、 Guidance”).This Guidance document supersedes the November 2017 guidance.The HCT/P Final Guidance maintains the FDAs position that products such as the Companys morselizedamniotic membrane tissue-based products do not meet the criteria for regulation solely as HCT/Ps.In addition,the FDA articulated
185、a risk-based approach to enforcement and,while some uses for amniotic membrane tissue-based products would have as much as thirty-six months of enforcement discretion,other high risk uses could besubject to immediate enforcement action.The revised final guidance extends the discretionary enforcement
186、period to May 31,2021.The Company does not believe the uses for its amniotic membrane tissue-based productsfall into the high-risk category.As of February 23,2021,the Company has not received any further notice of enforcement action from theFDA regarding its morselized amniotic tissue-based products
187、.Nonetheless,we can make no assurances that theFDA will continue to exercise its enforcement discretion with respect to the Companys morselized amniotic8membrane tissue-based products,and any potential action of the FDA could have a financial impact regarding thesales of such products.Revenues from
188、BioD morselized amniotic membrane-based products for the year ended December 31,2020were less than 1.0%of consolidated revenues.Medical Device RegulationsWe also are required to register with the FDA as a medical device manufacturer.As such,ourmanufacturing sites are subject to periodic inspection b
189、y the FDA for compliance with the FDAs Quality SystemRegulations.These regulations require that we manufacture our products and maintain our documents in aprescribed manner with respect to design,manufacturing,testing and control activities.Further,we are requiredto comply with various FDA requireme
190、nts and other legal requirements for labeling and promotion.If the FDAbelieves that a company is not in compliance with applicable regulations,it may issue a warning letter,instituteproceedings to detain or seize products,issue a recall order,impose operating restrictions,enjoin futureviolations and
191、 assess civil penalties against that company,its officers or its employees and may recommendcriminal prosecution to the U.S.Department of Justice.All Integra manufacturing facilities participate in theMedical Device Single Audit Program and are audited annually for compliance with the Quality System
192、 for USFDA,Canada,Australia,Brazil,and Japan.Medical device regulations also are in effect in many of the countries in which we do business outside theU.S.These laws range from comprehensive medical device approval and Quality System requirements for someor all of our medical device products to simp
193、ler requests for product data or certifications.Under the EuropeanUnion Medical Device Directive,medical devices must meet the Medical Device Directive standards and receiveCE Mark Certification prior to marketing in the European Union(the“EU”).In addition,the EU enacted the EUMedical Device Regulat
194、ion,which imposes stricter requirements on the marketing and sales of medical deviceswhich includes but is not limited to quality systems,labeling and clinical data.CE Mark Certification requires acomprehensive quality system program,technical documentation,clinical evaluation and data on the produc
195、t,which are then reviewed by a Notified Body.A Notified Body is an organization designated by the nationalgovernments of the EU member states to make independent judgments about whether a product complies withthe requirements established by each CE marking directive.The Medical Device Directive,Medi
196、cal DeviceRegulation,ISO 9000 series and ISO 13485 are recognized international quality standards that are designed toensure that we develop and manufacture quality medical devices.Other countries are also instituting regulationsregarding medical devices or interpreting and enforcing existing regula
197、tions more strictly.Compliance with theseregulations requires extensive documentation and clinical reports for our products,revisions to labeling,andother requirements such as facility inspections to comply with the registration requirements.A recognizedNotified Body audits our facilities annually t
198、o verify our compliance with the ISO 13485 Quality Systemstandard.Certain countries,as well as the EU,have issued regulations that govern products that contain materialsderived from animal sources.Regulatory authorities are particularly concerned with materials infected with theagent that causes bov
199、ine spongiform encephalopathy(“BSE”),otherwise known as mad cow disease.Theseregulations affect our dermal regeneration products,duraplasty products,hernia repair products,biomaterialproducts for the spine,nerve and tendon repair products and certain other products,all of which contain materialderiv
200、ed from bovine tissue.Although we take great care to provide that our products are safe and free of agentsthat can cause disease,products that contain materials derived from animals,including our products,may becomesubject to additional regulation,or even be banned in certain countries,because of co
201、ncern over the potential forprion transmission.Significant new regulations,a ban of our products,or a movement away from bovine-derivedproducts because of an outbreak of BSE could have a material,adverse effect on our current business or ourability to expand our business.See“Item 1A.Risk Factors Cer
202、tain of our products contain materials derivedfrom animal sources and may become subject to additional regulation.”9Postmarket Requirements.After a device is cleared or approved for commercial distribution,numerousregulatory requirements apply.These include the FDA Quality System Regulations which c
203、over the proceduresand documentation of the design,testing,production,control,quality assurance,labeling,packaging,sterilization,storage and shipping of medical devices;the FDAs general prohibition against promoting productsfor unapproved or off-labeluses;the Medical Device Reporting regulation,whic
204、h requires that manufacturersreport to the FDA if their device may have caused or contributed to a death or serious injury or malfunctioned ina way that would likely cause or contribute to a death or serious injury if it were to recur;and the Reports ofCorrections and Removals regulation,which requi
205、re manufacturers to report recalls and field corrective actionsto the FDA if initiated to reduce a risk to health posed by the device or to remedy a violation of the FD&C Act.Postmarket requirements are also followed globally where our products are registered and approved.Theseforeign jurisdictions
206、have similar requirements to the FDA which include reporting requirements such as adverseevents,recalls,etc.Other regulationsAnti-Bribery Laws.In the U.S.,we are subject to laws and regulations pertaining to healthcare fraud andabuse,including anti-kickback laws and physician self-referral laws that
207、 regulate the means by which companiesin the health care industry may market their products to hospitals and health care professionals and may competeby discounting the prices of their products.Similar anti-bribery laws exist in many of the countries in which wesell our products outside the U.S.,as
208、well as the United States Foreign Corrupt Practices Act(which addressesthe activities of U.S.companies in foreign markets).Our products also are subject to regulation regardingreimbursement,and U.S.healthcare laws apply when a customer submits a claim for a product that is reimbursedunder a federall
209、y funded healthcare program.These global laws require that we exercise care in designing oursales and marketing practices,including involving interactions with healthcare professionals,and customerdiscount arrangements.See“Item 1A.Risk Factors for further details.Import-export.Our international oper
210、ations subject us to laws regarding sanctioned countries,entities andpersons,customs,and import-export.Among other things,these laws restrict,and in some cases can prevent,U.S.companies from directly or indirectly selling goods,technology or services to people or entities in certaincountries.In addi
211、tion,these laws require that we exercise care in our business dealings with entities in and fromforeign countries.Hazardous materials.Our research,development and manufacturing processes involve the controlled use ofcertain hazardous materials.We are subject to country-specific,federal,state and loc
212、al laws and regulationsgoverning the use,manufacture,storage,handling and disposal of these materials and certain waste products.Webelieve that our environmental,health and safety procedures for handling and disposing of these materialscomply with the standards prescribed by the controlling laws and
213、 regulations.However,risk of accidentalreleases or injury from these materials is possible.These risks are managed to minimize or eliminate associatedbusiness impacts.In the event of this type of accident,we could be held liable for damages and face a liabilitythat could exceed our resources.We coul
214、d be subject to a regulatory shutdown of a facility that could prevent thedistribution and sale of products manufactured there for a significant period of time,and we could suffer acasualty loss that could require a shutdown of the facility in order to repair it,any of which could have a material,ad
215、verse effect on our business.Although we continuously strive to maintain full compliance with respect to allapplicable global environmental,health and safety laws and regulations,we could incur substantial costs to fullycomply with future laws and regulations,and our operations,business or assets ma
216、y be negatively affected.Furthermore,global environmental,health and safety compliance is an ongoing process.Integra has complianceprocedures in place for compliance with Employee Health&Safety laws,driven by a centrally led organizationalstructure that ensures proper implementation,which is essenti
217、al to our overall business objectives.In addition to the above regulations,we are,and may be,subject to regulation under country-specific federaland state laws,including,but not limited to,requirements regarding record keeping,and the maintenance ofpersonal information,including personal health info
218、rmation.As a public Company,we are subject to the10securities laws and regulations,including the Sarbanes-Oxley Act of 2002.We also are subject to other presentand could be subject to possible future,local,state,federal and foreign regulations.Third-Party Reimbursement.Healthcare providers that purc
219、hase medical devices generally rely on third-party payors,including,in the U.S.,the Medicare and Medicaid programs and private payors,such as indemnityinsurers,employer group health insurance programs and managed care plans,to reimburse all or part of the costof the products.As a result,demand for o
220、ur products is and will continue to be dependent in part on the coverageand reimbursement policies of these payors.The manner in which reimbursement is sought and obtained variesbased upon the type of payor involved and the setting in which the product is furnished and utilized.Reimbursement from Me
221、dicare,Medicaid and other third-party payors may be subject to periodic adjustments asa result of legislative,regulatory and policy changes,as well as budgetary pressures.Possible reductions in,oreliminations of,coverage or reimbursement by third-party payors,or denial of,or provision of uneconomica
222、lreimbursement for new products may affect our customersrevenue and ability to purchase our products.Anychanges in the healthcare regulatory,payment or enforcement landscape relative to our customers healthcareservices have the potential to significantly affect our operations and revenue.Data Privac
223、y and Cybersecurity Laws and Regulations.As a business with a significant global footprint,compliance with evolving regulations and standards in data privacy and cybersecurity(relating to theconfidentiality and security of our information technology systems,products such as medical devices,and other
224、services provided by us)may result in increased costs,lower revenue,new complexities in compliance,newchallenges for competition,and the threat of increased regulatory enforcement activity.Our business relies on thesecure electronic transmission,storage and hosting of sensitive information,including
225、 personal information,financial information,intellectual property,and other sensitive information related to our customers andworkforce.For example,in the U.S.,the collection,maintenance,protection,use,transmission,disclosure and disposalof certain personal information and the security of medical de
226、vices are regulated at the U.S.federal and state,andindustry levels.U.S.federal and state laws protect the confidentiality of certain patient health information,including patient medical records,and restrict the use and disclosure of patient health information by health careproviders.In addition,the
227、 FDA has issued guidance advising manufacturers to take cybersecurity risks intoaccount in product design for connected medical devices and systems,to assure that appropriate safeguards are inplace to reduce the risk of unauthorized access or modification to medical devices that contain software and
228、reduce the risk of introducing threats into hospital systems that are connected to such devices.The FDA alsoissued guidance on post market management of cyber security in medical devices.Outside the U.S.,we are impacted by the privacy and data security requirements at the international,national and
229、regional level,and on an industry specific basis.Legal requirements in these countries relating to thecollection,storage,handling and transfer of personal data and,potentially,intellectual property continue toevolve with increasingly strict enforcement regimes.In Europe,for example,we are subject to
230、 EU General DataProtection Regulation(“GDPR”)which requires member states to impose minimum restrictions on thecollection,use and transfer of personal data and includes,among other things,a requirement for prompt notice ofdata breaches to data subjects and supervisory authorities in certain circumst
231、ances and significant fines fornon-compliance.The GDPR also requires companies processing personal data of individuals residing in the EUto comply with EU privacy and data protection rules.“Item 1A.Risk FactorsWe are subject to requirements relating to information technology which couldadversely aff
232、ect our business.These laws and regulations impact the ways in which we use and manage personal data,protected healthinformation,and our information technology systems.They also impact our ability to move,store,and accessdata across geographic boundaries.Compliance with these requirements may requir
233、e changes in businesspractices,complicate our operations,and add complexity and additional management and oversight needs.They11also may complicate our clinical research activities,as well as product offerings that involve transmission or useof clinical data.HUMAN CAPITALWorkforce DemographicsAs of
234、December 31,2020,we had approximately 3,700 full-time and part-time employees and 700contingent,subcontracted and outsourced partners.As of December 31,2020,64%of our workforce was locatedin the United States,25%in Europe,4%in Latin America and Canada and 7%in Asia Pacific which includesAustralia an
235、d New Zealand.United StatesLatin America and CanadaEurope,Middle East,AfricaAsia Pacific7%4%25%64%Diversity and InclusionA diverse workforce and an inclusive culture and work environment is a business priority and a key to ourlong-term success.Our commitment to diversity and inclusion(“D&I”)begins w
236、ith our Board of Directors andCEO,and extends to all levels of the Company as we focus on attracting,retaining,and developing our globaltalent.Leadership Commitment and Accountability.The executive leadership team members set the D&I goals forthe company and for the past three years it has been a co
237、mpany-wide goal to advance diversity and inclusioninitiatives to build stronger teams.Leadership Councils,Employee Resource Groups and External Partnerships.We are accountable to ourdiversity commitment through our leadership councils,employee resource groups,and external partnerships.Peter Arduini,
238、President&Chief Executive Officer has chaired our Womens Leadership Council sinceits inception in 2017.The Womens Leadership Council is an action and results-oriented advisorygroup comprised of fifteen of our senior women leaders.The specific charter of the Council is to worktogether to identify way
239、s to continue to attract and retain female talent,advance the development of ourwomen into leadership roles,increase the cultural awareness of the value of inclusion and diversity inour company,and create specific development forums for high performing women.Our employee resources groups encourage a
240、 culture of awareness and inclusion,assist in the attractionand retention of diverse talent,and help colleagues develop leadership skills.Members of the executiveleadership team serve as sponsors for each of Integras employee resources groups.Integra has fouremployee resources groups:12Women of Inte
241、gra Networks with 20+chapters globallyAfrican American Affinity GroupVeteran Employee Resource GroupIndian American Professional NetworkWe reinforce our commitment to diversity by partnering with other organizations focused on drivinginclusion in the work place including the CEO Action for Diversity
242、&Inclusion,which is the largestCEO-driven business commitment to advance D&I in the work place and the HealthcareBusinesswomens Association,an association dedicated to furthering the advancement and impact ofwomen in the business of healthcare.Promoting an Inclusive Culture Through Learning Opportun
243、ities.To help drive our culture of inclusion,ourcolleagues participate in programs focused on how to manage bias and value differences.Members of our executive leadership,senior management team,and larger scope leaders participate ina half-day micro-inequities training.The content includes understan
244、ding unconscious bias and subtlebehaviors that devalue,discourage and impair workplace performance,identifying these in day-to-dayinteractions,and exploring ways to mitigate these micro-inequities on an individual and organizationallevel.In 2020,Integra colleagues globally participated in two progra
245、ms to promote inclusion:a course thatcreates awareness of unconscious biases in the workplaces and tools to build-bias breaking skills and acourse which examines what practicing inclusion in the workplace looks like.13Gender Diversity.We believe that our company is better and delivers strong operati
246、ng results when we builddiverse teams and leverage broad perspectives to meet the needs of our shareholders,customers,colleagues,andcommunities we serve.Integras overall employee population is 47%female and 53%is male.We continue tostrive to ensure that diversity in our leadership ranks is represent
247、ative of our overall population.Throughmentorship,sponsorship,recruitment efforts,and development programs we look to continue to grow ourpopulation of females in leadership roles at Integra.Currently,33%of our executive leaders and 36%of seniorleaders(non-executive vice presidents)are female.All Em
248、ployeesExecutive LeadershipSenior Leadership0%10%20%30%40%50%60%70%80%90%100%FemaleMale53%47%67%33%64%36%In partnership with Leadership Edge,a company founded by women leaders and dedicated to growing andmentoring women,Integra sponsors the Excel Womens Leadership Program.The program is designed toa
249、ccelerate the development and advancement of high potential,mid-career female leaders into senior leadershiproles.The program has assisted in further building our pipeline of women leaders with 60%of the programsgraduates being promoted into roles with increased responsibility.FINANCIAL INFORMATION
250、ABOUT GEOGRAPHIC AREASFinancial information about our geographical areas is set forth in our financial statements Note 17,Segmentand Geographic Information,to our consolidated financial statements.AVAILABLE INFORMATIONWe are subject to the informational requirements of the Securities Exchange Act of
251、 1934,as amended,(the“Exchange Act”).In accordance with the Exchange Act,we file annual,quarterly and special reports,proxystatements and other information with the Securities and Exchange Commission(the“SEC”).Our financialinformation may be viewed,including the information contained in this report,
252、and other reports we file with theSEC,on the Internet,without charge as soon as reasonably practicable after we file them with the SEC,in the“SEC Filings”page of the Investor Relations section of our website at .A copy may also beobtained for any of these reports,without charge,from our Investor Rel
253、ations department,1100 Campus Road,Princeton,NJ 08540.Alternatively,reports filed may be viewed or obtained through the SECs website atwww.sec.gov.14SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTSWe have made statements in this report,including statements under“Business”and“ManagementsDiscussion a
254、nd Analysis of Financial Condition and Results of Operations”that constitute forward-lookingstatements within the meaning of Section 27A of the Securities Act of 1933,as amended(the“Securities Act”),and Section 21E of the Exchange Act.These forward-looking statements are subject to a number of risks
255、,uncertainties and assumptions about us including,among other things:general economic and business conditions,both nationally and in our international markets;our expectations and estimates concerning future financial performance,financing plans and the impactof competition;anticipated trends in our
256、 business;anticipated demand for our products,particularly capital equipment;our ability to produce regenerative-based products in sufficient quantities to meet sales demands;our expectations concerning our ongoing restructuring,integration and manufacturing transfer andexpansion activities;existing
257、 and future regulations affecting our business,and enforcement of those regulations;our ability to obtain additional debt and equity financing to fund capital expenditures,working capitalrequirements and acquisitions;physicians willingness to adopt our recently launched and planned products,third-pa
258、rty payorswillingness to provide or continue reimbursement for any of our products and our ability to secureregulatory approval for products in development;initiatives launched by our competitors;our ability to protect our intellectual property,including trade secrets;our ability to complete acquisi
259、tions,integrate operations post-acquisition and maintain relationshipswith customers of acquired entities;our ability to remediate all matters identified in FDA observations and warning letters that we receivedor may receive;andother risk factors described in the section entitled“Risk Factors”in thi
260、s report.Forward-looking statements can be identified by forward-looking words such as“believe,”“may,”“could,”“might,”“will,”“estimate,”“continue,”“anticipate,”“intend,”“seek,”“plan,”“expect,”“should,”“would”andsimilar expressions in this report.We undertake no obligation to publicly update or revis
261、e any forward-lookingstatements,whether as a result of new information,future events or otherwise.In light of these risks anduncertainties,the forward-looking events and circumstances discussed in this report may not occur and actualresults could differ materially from those anticipated or implied i
262、n the forward-looking statements.ITEM 1B.UNRESOLVED STAFF COMMENTSAs of the filing of this Annual Report on Form 10-K,we had no unresolved comments from the staff of theSecurities and Exchange Commission that were received not less than 180 days before the end of our 2020 fiscalyear.15ITEM 1A.RISK F
263、ACTORSRISKS RELATED TO COVID-19The effects of the COVID-19 pandemic continue to significantly impact global economic conditions andhave affected,and may continue to affect,our operations,supply chain,distribution,sales force,as well asthe financial stability of hospitals and other customers,and have
264、 caused and could again cause a reductionin procedures,which could materially adversely affect our business,results of operations,financialcondition,and stock price.On March 11,2020,the World Health Organization(“WHO”)characterized the Novel Coronavirus Disease2019(“COVID-19”)as a pandemic.To date,a
265、nd in continuing efforts to control the spread of COVID-19,and ahighly contagious variant of COVID-19,governments around the world,including in the U.S.,have and continueto implement various preventative measures including quarantines,“shelter in place”orders,“stay at home”orders,travel restrictions
266、,business operation restrictions,school closures,and other similar types of measures.The impact of the pandemic,while still evolving,has caused and will likely continue to cause significanteconomic and financial uncertainty in the U.S.and around the world,generating concerns the effects will lead to
267、a global recession or depression.In response to the COVID-19 pandemic and related mitigation efforts,similar to many other employers inthe U.S.,the Company has and continues to require many employees to work remotely.The Company hascontinued to operate certain manufacturing facilities to date in com
268、pliance with federal,state and local ordersregarding COVID-19.The health of the Companys workforce is our top concern and the Company has procuredequipment and implemented safety protocols in an effort to maintain the health and safety of our employees.While demand for our products has improved sinc
269、e mid-April 2020 when healthcare institutions werealtering how they managed medical procedures in light of virus-related constraints,it is not possible to predictwith precision whether and when demand for our products will return fully to levels that existed prior to the onsetof the pandemic.The Com
270、pany has implemented extensive business contingency plans across its globalorganization and network of business partners which helps limit some of the impact of the COVID-19 pandemicbut does not completely prevent or avoid a negative impact on the business.The extent to which the COVID-19pandemic wi
271、ll negatively affect the Companys operations and financial position will depend on futuredevelopments that remain uncertain and cannot be predicted with precision.For example,including,withoutlimitation,the pandemic could cause:Continued fluctuations in our operational results,revenues,and cash flow
272、s which may negativelyimpact our stock price;Impact our operations and sales including but not limited to delays in orders,ability to market,sell,deliver and service our products;Reductions in demand for our products and services due to the impact of COVID-19 on hospitals andcustomers such as contin
273、ued or future postponement or cancellations of procedures,hospitalpostponement or cancellation of capital purchases,or elimination of services;Local and/or global recessions,which may result in hospitals and customers reducing capital spendingand could materially affect our business,including but no
274、t limited to our future access to capital,andnegatively impact the value of our stock.;Continued limitations on our operations due to restrictions associated with“shelter in place”orders andtravel restrictions;Distraction of management time and focus;Increased risk that insurance coverage will not p
275、rovide protection for all of the COVID-19-relateddisruption;16Disruption to manufacturing operations and distribution supply chains;Increased challenges or restraints in obtaining necessary products or components from our suppliersand vendors;Reduction or interruption to our manufacturing processes
276、which could have a material adverse effecton our business;Continued and/or increased risks related to the health and safety of our employees(and retentionissues),volatility of foreign currency exchange rates,and risk of cybersecurity attacks and breaches;Possible liquidity constraints and credit imp
277、act;Delays in obtaining regulatory clearances,approval to market products,quality inspections,or delaysto clinical trial activity;Delays in coverage decisions by private and public health insurers and foreign governmental healthsystems;Delays in the completion of supportive clinical studies for paye
278、r coverage decisions or clinical andeconomic decision makers due to slowed study enrollments;Delays to acquisition plans,increased risks to the operations and financial condition of newly acquiredbusinesses,and increased costs or delays to integration of newly acquired businesses;The impact of any r
279、eprioritization of capital allocations on our ability to achieve our strategicobjectives over the medium and long-term;and,Write downs or impairments of investments in third parties,goodwill or intangible assets from recentlyacquired businesses,accounts receivable,or other assets;As the situation su
280、rrounding the COVID-19 pandemic remains fluid,it is difficult to predict,with anycertainty,the duration and extent of its impact which depends on future developments that cannot be accuratelypredicted at this time,such as the severity and transmission rate of the virus,the extent and effectiveness o
281、fcontainment actions including the distribution of a vaccine locally and globally,and the impact of these and otherfactors on our employees,customers,suppliers,service providers and business partners.If COVID-19,or avariant strain,continues to spread and escalate domestically or internationally,or i
282、f governments imposeadditional measures intended to mitigate the spread and related effects of the pandemic,the risks described abovecould be elevated significantly.Should that occur,and the COVID-19 pandemic persist for a prolonged time,theabove factors and others that are currently unknown could h
283、ave a material adverse impact on our business,resultsof operations,financial conditions and prospects and could elevate known risks described in this Item 1A.RiskFactors.Information pertaining to the potential impact of the COVID-19 pandemic and associated economicdisruptions,and the actual operatio
284、nal and financial impacts that we have experienced to date can be found inManagements Discussion and Analysis of Financial Position and Results of Operations.RISKS RELATING TO OUR BUSINESSOur operating results may fluctuate.Our operating results,including components of operating results such as gros
285、s margin and cost of productsales,may fluctuate from time to time,and such fluctuations could affect our stock price.Our operating resultshave fluctuated in the past and can be expected to do so from time to time in the future.Some of the factors thatmay cause these fluctuations include:risks relate
286、d to COVID-19;economic conditions worldwide,which could affect the ability of hospitals and other customers topurchase our products and could result in a reduction in elective and non-reimbursed operativeprocedures;17the impact of acquisitions,our ability to integrate acquisitions,and our restructur
287、ing activitiesincluding portfolio rationalization,divestitures and product lifecycle management;expenditures for major initiatives,including acquired businesses and integrations thereof andrestructuring;the timing of significant customer orders,which tend to increase in the fourth quarter coinciding
288、 withthe end of budget cycles;increased competition for a wide range of customers across all our product lines in the markets ourproducts are sold;market acceptance of our existing products,as well as products in development;retention of current employees and recruiting of new employees in light of
289、market competition fortalent and relevant skills;the timing of regulatory approvals as well as changes in country-specific regulatory requirements;changes in the exchange rates between the U.S.dollar and foreign currencies of countries in which wedo business;changes in the variable interest rates of
290、 our debt instruments which could impact debt servicerequirements;potential backorders,lost sales and expenses incurred in connection with product recalls or fieldcorrective actions;disruption of our operations and sales resulting from extreme weather conditions or natural disastersthat damage our m
291、anufacturing,distribution,or infrastructure of those facilities,or the suppliers andservice providers for those facilities;our ability to manufacture and ship our products efficiently or in sufficient quantities to meet salesdemands;changes in the cost or decreases in the supply of raw materials and
292、 services,including sterilization,energy,steel and honey;the timing of our research and development expenditures;reimbursement for our products by third-party payors such as Medicare,Medicaid,private and publichealth insurers and foreign governmental health systems;the ability to maintain existing d
293、istribution rights to and from certain third parties;the ability to maintain business if or when we opt to convert such business from distributors to a directsales model;the ability of our commercial sales representatives to obtain sales targets in a reasonable time frame;the impact of changes to ou
294、r sales organization,continued channel expansion,including increasedspecialization;peer-reviewed publications discussing the clinical effectiveness of the products we sell;inspections of our manufacturing facilities for compliance with Quality System Regulations(GoodManufacturing Practices)which cou
295、ld result in Form 483 observations,warning letters,injunctions orother adverse findings from the FDA or from equivalent regulatory bodies,and corrective actions,procedural changes and other actions that we determine are necessary or appropriate to address theresults of those inspections,any of which
296、 may affect production and our ability to supply our customerswith our products;18changes in regulations or guidelines that impact the sales and marketing practices for products that wesell;the increased regulatory scrutiny of certain of our products,including products which we manufacturefor others
297、,could result in removal from the market or involve field corrective actions that could affectthe marketability of our products;enforcement or defense of intellectual property rights;changes in tax laws,or their interpretations;andthe impact of goodwill and intangible asset impairment charges if fut
298、ure operating results of theacquired businesses are significantly less than the results anticipated at the time of the acquisitions.The industry and market segments in which we operate are highly competitive,and we may be unable tocompete effectively with other companies.There is intense competition
299、 among medical device companies.We compete with established medicaltechnology companies in many of our product areas.Competition also comes from early-stage companies,universities,research institutions and other non-profit entities.In certain cases,our products compete primarilyagainst medical pract
300、ices that treat a condition without using a device or any particular product,such as themedical practices that use autograft tissue instead of our dermal regeneration products,duraplasty products andnerve repair products,or that use other technologies that cost less than our products.Many of our com
301、petitorshave access to greater financial,technical,research and development,marketing,manufacturing,sales,distribution,administrative,consulting and other resources than we do.Our competitors may be more effective atdeveloping commercial products.They may be able to gain market share by offering low
302、er-cost products orproducts that enjoy better reimbursement from third-party payors and foreign governmental health systems.Our competitive position depends on our ability to achieve market acceptance for our products,develop newproducts,implement production and marketing plans,secure regulatory app
303、roval for products underdevelopment,demonstrate clinical and economic effectiveness,obtain and maintain reimbursement coverage andfunding under third-party payors and foreign governmental health systems,obtain patent protection and produceproducts consistently in sufficient quantities to meet demand
304、.We may need to develop new applications for ourproducts to remain competitive.Technological advances by one or more of our current or future competitors ortheir achievement of superior reimbursement from third-party payors and foreign governmental health systemscould render our present or future pr
305、oducts obsolete or uneconomical.Our future success will depend upon ourability to compete effectively against current technology as well as to respond effectively to technologicaladvances,changes in customers requirements or in payor or regulatory evidence requirements.Additionally,purchasing decisi
306、ons of our customers may be based on clinical evidence or comparative effectiveness studiesand,because of our vast array of products,we might not be able to fund the studies necessary to gain entry ormaintain our position or provide the required information to compete effectively.Other companies may
307、 havemore resources available to fund such studies.For example,competitors have launched and are developingproducts to compete with our dural repair products,regenerative skin,neuro critical care monitors and ultrasonictissue ablation devices,among others.In the current environment of managed care,c
308、onsolidation among healthcare providers,increased competition,and declining reimbursement rates,we have been increasingly required tocompete on the basis of price.Competitive pressures could adversely affect our profitability.Given these factors,we cannot guarantee that we will be able to compete ef
309、fectively or continue our level of success in the areas inwhich we compete.Changes in the healthcare industry may require us to decrease the selling price for our products,mayreduce the size of the market for our products,or may eliminate a market,any of which could have anegative impact on our fina
310、ncial performance.Trends toward managed care,healthcare cost containment and other changes in government and privatesector initiatives in the U.S.and other countries in which we do business are placing increased emphasis on the19delivery of more cost-effective medical therapies that could adversely
311、affect the sale and/or the prices of ourproducts.For example:third-party payors of hospital services and hospital outpatient services,including Medicare,Medicaid,private and public health insurers and foreign governmental health systems,annually revise theirpayment methodologies,which can result in
312、stricter standards for reimbursement of hospital chargesfor certain medical procedures or the elimination of reimbursement;several foreign countries have implemented reforms of their respective healthcare sectors in an effort toreduce healthcare spending,including restricting funding to only those m
313、edical technologies andprocedures with proven effectiveness,and increasing patient co-payments.Governmental healthsystems have revised and continue to consider revisions of healthcare budgets,which could result instricter standards for implementing certain medical procedures,increased scrutiny of me
314、dical devices,and downward pricing pressure;Medicare,Medicaid,private and public health insurer and foreign governmental cutbacks could createdownward pricing pressure on our products;in the U.S.,Medicare and Medicaid coverage as well as commercial payor coverage determinationscould reduce or elimin
315、ate reimbursement or coverage for certain of our wound matrix,amniotic,surgical reconstruction and advanced wound dressing products as well as other products in mostregions,negatively affecting our market for these products,and future determinations could reduce oreliminate reimbursement or coverage
316、 for these products in other regions and could reduce or eliminatereimbursement or coverage for other products;there has been a consolidation among healthcare facilities and purchasers of medical devices in theU.S.,some of whom prefer to limit the number of suppliers from whom they purchase medicalp
317、roducts,and these entities may decide to stop purchasing our products or demand discounts on ourprices;in the U.S.,we are party to contracts with group purchasing organizations,which negotiate pricing formany member hospitals,require us to discount our prices for certain of our products and limit ou
318、rability to raise prices for certain of our products,particularly surgical instruments;there is economic pressure to contain healthcare costs in domestic and international markets,and,regardless of the consolidation discussed above,providers generally are exploring ways to cut costs byeliminating pu
319、rchases or driving reductions in the prices that they pay for medical devices,orincreasing clinical or economic evidence thresholds for product formularies;there are proposed and existing laws,regulations and industry policies in domestic and internationalmarkets regulating the sales and marketing p
320、ractices and the pricing and profitability of companies inthe healthcare industry;proposed laws or regulations may permit hospitals to provide financial incentives to doctors forreducing hospital costs,will award physician efficiency,and will encourage partnerships withhealthcare service and goods p
321、roviders to reduce prices;andthere have been initiatives by third-party payors and foreign governmental health systems to challengethe prices charged for medical products that could affect our ability to sell products on a competitivebasis.Any and all of the above factors could materially and advers
322、ely affect our levels of revenue and ourprofitability.20Our current strategy involves growth through acquisitions,which requires us to incur substantial costs andpotential liabilities for which we may never realize the anticipated benefits,and also requires us tosuccessfully integrate acquired busin
323、esses into our business operations in order to avoid our business beingmaterially and adversely affected.In addition to internally generated growth,our current strategy involves growth through acquisitions.Between January 1,2018 and December 31,2020,we have acquired 2 businesses at a total cost of a
324、pproximately$70.7 million.In addition,in January 2021,we acquired ACell,Inc.for$300 million,which added products toour complex wound management product portfolio and advanced growth of our Tissue Technologies segment.We may be unable to continue to implement our growth strategy and it may ultimately
325、 be unsuccessful.Asignificant portion of our growth in revenues has resulted from,and is expected to continue to result from,theacquisition of businesses or products complementary to our own.We engage in evaluations of potentialacquisitions and are in various stages of discussion regarding possible
326、acquisitions,certain of which,ifconsummated,could be significant to us.Any new acquisition could result in material transaction expenses,increased interest and amortization expense,increased depreciation expense,increased operating expense,andpossible in-process research and development charges for
327、acquisitions that do not meet the definition of a“business,”any of which could have a material,adverse effect on our operating results.Certain businesses thatwe acquire may not have adequate financial,disclosure,regulatory,quality or other compliance controls at thetime we acquire them and could req
328、uire significant expenditures to address those controls or subject us toincreased risk.As we grow by acquisition,we must manage and integrate the new businesses to bring them intoour systems for financial,disclosure,compliance,regulatory and quality control,realize economies of scale,andcontrol cost
329、s.If we cannot integrate acquired businesses and operations,manage the cost of providing ourproducts or price our products appropriately,our profitability could suffer.In addition,acquisitions involve otherrisks,including diversion of management resources otherwise available for the running of our b
330、usiness and thedevelopment of our business as well as risks associated with entering markets in which our marketing teams andsales force has limited experience or where experienced distribution alliances are not available.Someacquisitions may include the need for ongoing product development to occur
331、 consistent with time sensitivemilestones in order for the Company to achieve its commercial projections for the acquisition.Our futureprofitability will depend in part upon our ability to develop our resources to adapt to these new products orbusiness areas and to identify and enter into or maintai
332、n satisfactory distribution networks.As a result of ouracquisitions of other healthcare businesses,we may be subject to the risk of unanticipated business uncertainties,regulatory and other compliance matters or legal liabilities relating to those acquired businesses for which thesellers of the acqu
333、ired businesses may not indemnify us,for which we may not be able to obtain insurance(oradequate insurance),or for which the indemnification may not be sufficient to cover the ultimate liabilities.Wemay not be able to identify suitable acquisition candidates in the future,obtain acceptable financing orconsummate any future acquisitions.Certain potential acquisitions are subject to antitrust and co
0731-84720580
sgpjbg002
工作日 9:30 - 18:00
研報
新質生產力
DeepSeek?
低空經濟
大模型
AI Agent
AI Infra
具身智能
自動駕駛
寵物
銀發經濟
人形機器人
企業出海
算力
微短劇
薪酬
白皮書
創新藥
人工智能
AI產業
信息科技
互聯網
消費經濟
汽車交通
電商零售
傳媒娛樂
醫藥健康
投資金融
能源環境
地產建筑
傳統產業
英文報告
其它
最新報告
中英對照
全文搜索
報告精選
PDF上傳翻譯
多格式文檔互轉
入駐&報告售賣
會員權益
機構報告
券商研報
財報庫
專題合集
英文報告
數據圖表
會議報告
其他資源
行業聚焦
芯片產業
熱點概念
全球咨詢智庫
人工智能
500強
新質生產力
會議峰會
新能源汽車
企業年報
互聯網
公司研究
行業綜觀
消費教育
科技通信
醫藥健康
人力資源
投資金融
汽車產業
物流地產
電子商務
傳統產業
傳媒營銷
其它
2025低空經濟/低空產業報告合集（共50套打包）
2025年智算中心/AIDC/AI數據中心研究報告合集（共37套打包）
AI、科技與通信
廣告、傳媒與營銷
消費、零售與支付
HR、文化與旅游
金融、保險與投資
能源、環境與工業
醫療制藥與大健康
物流、地產與建筑
其他行業
AI ? 科技 ? 通信
數字化
金融財經
智能制造
電商傳媒
地產建筑
醫療醫學
能源化工
其他行業
收藏
下載
2025-05-20
AI查數
行業數據
政策法規
商業模式
產業鏈
競爭格局
市場規模
產業概述
其它
2025年
AI讀財報
年報
一季報
半年報
三季報
IPO招股書
社會責任報告
A股
IPO申報
港股
美股&全球
新三板
掃碼登錄
手機快捷登錄
賬號登錄
