What changed in this filing

/stocks — the workspaceLOADING

Item 1. Business

2021-02-23 compared with 2020-02-21 · 185 added, 118 removed, 187 unchanged (62% of the section changed)

The terms “we,” “our,” “us,” “Company” and “Integra” refer to Integra LifeSciences Holdings Corporation, a Delaware corporation, and its subsidiaries, unless the context suggests otherwise.

Integra, headquartered in Princeton, New Jersey, is a world leader in medical technology.

The Company, headquartered in Princeton, New Jersey, is a world leader in medical technology.

The Company was founded in 1989 with the acquisition of an engineered collagen technology platform used to repair and regenerate tissue.

Since then, Integra has developed numerous product lines from this technology for applications ranging from burn and deep tissue wounds, to the repair of dura mater in the brain, as well as nerves and tendons.

The Company has expanded its base regenerative technology business to include surgical instruments, neurosurgical products, advanced wound care, and orthopedic hardware, through a combination of several global acquisitions and development of products internally to further meet the needs of its customers and impact patient care.

The Company has expanded its base regenerative technology business to include surgical instruments, neurosurgical devices, advanced wound care products, and orthopedic hardware through a combination of several global acquisitions and development of products internally to further meet the needs of its customers and impact patient care.

We manufacture and sell our products in two reportable business segments:

Codman Specialty Surgical and Orthopedics and Tissue Technologies.

Our Codman Specialty Surgical products comprise specialty surgical implants and instrumentation for a broad range of specialties.

This segment includes products and solutions for dural access and repair, precision tools and instruments, advanced energy, cerebral spinal fluid ("CSF") management and neuro monitoring including market-leading product portfolios used in neurosurgery operation suites and critical care units.

Our Orthopedics and Tissue Technologies product portfolios consist of differentiated regenerative technology products for soft tissue repair and tissue regeneration products, surgical reconstruction, and small bone fixation and joint replacement hardware products for both upper extremities and lower extremities.

This business also includes private label sales of a broad set of our regenerative and wound care medicine technologies.

We have key manufacturing and research facilities located in California, New Jersey, Ohio, Massachusetts, Tennessee, Texas, Canada, France, Germany, Ireland, Switzerland, and Puerto Rico.

We also source most of our handheld surgical instruments, specialty metal and pyrocarbon implants, and dural sealant products through specialized third-party vendors.

Our Codman Specialty Surgical products are comprised of specialty surgical implants and instrumentation for a broad range of specialties.

This segment includes products and solutions for dural access and repair, instruments, advanced energy, cerebral spinal fluid ("CSF") management and neuro monitoring including market-leading product portfolios used in neurosurgery operating suites and critical care units.

Codman Specialty Surgical products are sold through a combination of directly employed sales representatives, distributors and wholesalers, depending on the customer call point.

Orthopedics and Tissue Technologies products are sold through directly employed sales representatives, distributors focused on their respective surgical specialties, and strategic partners.

We aspire to be a worldwide leader in neurosurgery & reconstructive surgery, with a portfolio of leading businesses that delivers outstanding customer experience through innovation, execution and teamwork to positively impact the lives of millions of patients and families.

Our Orthopedics and Tissue Technologies product portfolio consists of differentiated regenerative technology products for soft tissue repair and tissue regeneration products and surgical reconstruction.

This business also includes private label sales of a broad set of our regenerative and wound care medicine technologies.

Orthopedics and Tissue Technologies products are sold through directly employed sales representatives and distributors focused on their respective surgical specialties, and by strategic partners.

In January 2021, we completed the sale of our Extremity Orthopedics business to Smith & Nephew USD Limited for approximately $240 million in cash.

This transaction enables us to increase our investments in our business which will strengthen our existing leadership positions in both 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, Germany, Ireland, Switzerland, and Puerto Rico.

We also source most of our handheld surgical instruments and dural sealant products through specialized third-party vendors.

We aspire to continue to be a worldwide leader in neurosurgery and reconstructive surgery, with a portfolio of leading businesses that delivers outstanding customer experiences through innovation, execution and teamwork to positively impact the lives of millions of patients and their families.

Integra is committed to delivering high quality products that positively impact the lives of millions of patients and their families.

We focus on four key pillars of our strategy:

1) building an execution-focused culture, 2) achieving relevant scale, 3) improving agility and innovation, and 4) leading in customer experience.

1) building an execution-focused culture, 2) optimizing relevant scale, 3) improving agility and innovation, and 4) leading in customer experience.

We believe that by sharpening our focus on these areas through improved planning and communication, optimization of our infrastructure, and strategically aligned tuck-in acquisitions, we can build scale, increase competitiveness and achieve our long-term goals.

1 unchanged sentence

Strategic Acquisitions .

An important part of our strategy is pursuing strategic transactions and licensing agreements that increase relevant scale in the clinical areas in which Integra competes.

In 2019, we closed out of 45 transition service agreements, covering 90 countries, marking the successful completion of the integration of the Codman Neurosurgery acquisition, the most significant acquisition in the Company’s history.

This acquisition expanded our portfolio of neurosurgery products and established us as the world leader in neurosurgery.

It has also enabled us to bring our entire product portfolio to a global market.

In 2019, Integra acquired Arkis Biosciences, Inc.

and Rebound Therapeutics Corporation, both of which align with Company’s strategy to acquire and develop innovative technologies that address unmet needs in patient care.

An important part of the Company's strategy is pursuing strategic transactions and licensing agreements that increase relevant scale in the clinical areas in which Integra competes.

In December 2020, Integra entered into a merger agreement to acquire ACell, Inc., an innovative regenerative medicine company.

This acquisition, which closed on January 20, 2021, expands our product offering of regenerative technology and is complementary to Integra’s existing tissue technologies portfolio.

The acquisition also supports our long-term growth and profitability strategy with a financial profile similar to Integra’s tissue products.

In 2020, we continued to invest in our two recent acquisitions from 2019, Arkis Biosciences, Inc.

and Rebound Therapeutics Corporation, both of which are developing innovative technologies for neurosurgery.

Portfolio Optimization and New Product Introductions.

We are investing in innovative product development to drive a multi-generational pipeline for our key product franchises.

Our product development efforts span across our key global franchises focused on potential for significant returns on investment.

In 2019, we launched ten new products across our key product franchises.

In addition to new product development, we are funding studies to gather clinical evidence to support launches, ensure market access and improve reimbursement for existing products.

In 2019, we discontinued

certain low-growth, low margin products.

Our product development efforts span across our key global franchises and are focused on the potential for significant returns on investment.

In February 2020, we launched the AmnioExcel® Plus Placental Allograft Membrane, the next generation wound care offering to support soft tissue repair.

Throughout 2020, we continued to reap the benefits of many of our 10 new product launches from 2019.

In addition to new product development, we are funding studies to gather clinical evidence to support launches, ensure market access and improve reimbursement for

existing products.

We continue to identify ways of optimizing our portfolio including identifying low-growth, low-margin products and product franchises for discontinuation.

In January 2021, we completed the sale of our Extremity Orthopedics business to Smith & Nephew USD Limited for approximately $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 broader portfolio of products, investing in our sales channels is a core part of our strategy to create specialization and greater focus on reaching new and existing customers and addressing their needs.

With acquisitions, new product introductions and a broad portfolio of products, investing in our sales channels is a core part of our strategy to create specialization and greater focus on reaching new and existing customers and addressing their needs.

Internationally, we have increased our commercial resources significantly in many markets and are making investments to support our sales organization and maximize our commercial opportunities.

We now have a strong international sales channel that will deliver our current portfolio as well as position us for expansion.

In addition, we continue to build upon our leadership brands across our product franchises to enable us to engage hospital systems through enterprise-wide contracts.

We now have a strong international sales channel that delivers our current portfolio as well as positions us for future expansion.

In addition, we continue to build upon our leadership brands across our product franchises, enabling us to engage customers through enterprise-wide contracts.

Customer Experience .

We aspire to be ranked as a best-in-class provider and are committed to strengthening our relationships with all customers.

We aspire to be ranked as a best-in-class provider and are committed to strengthen our relationships with all customers.

We strive to consistently deliver outstanding customer service and continue to invest in technologies, systems and processes to improve the way our customers do business with us.

Additionally, we expect to build on the success of our professional education programs to drive continued customer familiarity with our growing portfolio of medical technologies globally.

Additionally, we utilize professional education programs to drive customer familiarity with our growing portfolio of medical technologies globally.

BUSINESS SEGMENTS

We currently manufacture and sell our products in the following two global reportable business segments:

Integra currently manufactures and sells our products and technologies in the following two global reportable business segments:

Codman Specialty Surgical and Orthopedics and Tissue Technologies.

We include financial information regarding our reportable business segments and certain geographic information under "Item 7.

Management's Discussion and Analysis of Financial Condition and Results of Operations" and in Note 16, Segment and Geographic Information to our consolidated financial statements.

Management's Discussion and Analysis of Financial Condition and Results of Operations", Note 17, Segment and Geographic Information and Note 18, Subsequent Events to our consolidated financial statements.

Codman Specialty Surgical

1 unchanged sentence

The product portfolio represents a continuum of care from pre-operative, to the neurosurgery operating room, to the neuro-critical care unit and post care for both adult and pediatric patients suffering from brain tumors, brain injury, cerebrospinal fluid pressure complications and other neurological conditions.

The acquisition of Codman Neurosurgery from Johnson & Johnson increased our global direct sales representation and commercial presence.

This acquisition expanded the product portfolio of our well known, leading technologies in dural repair, ultrasonic tissue ablation, intracranial pressure ("ICP") monitoring, hydrocephalus management, and cranial stabilization systems, while providing a rich research and development pipeline for growth.

Rounding out the portfolio is a catalog of surgical headlamps, surgical instrumentation, as well as asset management software and support, and after-market service.

We offer leading technologies in dural repair, ultrasonic tissue ablation, intracranial pressure ("ICP") monitoring, hydrocephalus management, and cranial stabilization systems, while providing a 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 specialty surgical instruments, we call on the central sterile processing unit of hospitals and acute care surgical centers.

Additionally, through a strong U.S.

distribution model, we can serve the needs of hundreds of physician, dental and veterinary offices.

distribution model, we can serve the needs of hundreds of medical offices.

Our global commercial network includes clinical specialists, a large direct global sales force and strategic partnerships and distributors that serve hospitals, integrated health networks, group purchasing organizations, clinicians, surgery centers and health care providers.

Orthopedics and Tissue Technologies

Orthopedics and Tissue Technologies products serve some of the fastest growing markets in the medical technology industry and provide solutions that primarily address the needs of orthopedic, plastic, reconstructive and general surgeons.

These products focus on addressing soft tissue, nerve, and tendon repairs as well as reconstruction in the hand, wrist, elbow, shoulder, ankle and foot.

We provide regenerative technology solutions for the treatment of acute wounds, such as burns, chronic wounds, including diabetic foot ulcers, surgical tissue repair including hernia repair, peripheral nerve repair and protection, and tendon repair.

For extremity bone and joint reconstruction procedures, we sell hardware products, such as bone and joint fixation and joint replacement devices, implants and instruments, which provide for the reconstruction of bone in the hand, wrist, elbow and shoulder (Upper Extremity), and the foot, ankle and leg below the knee (Lower Extremity).

In addition, we created opportunities to further expand our presence in the plastic and reconstructive surgery segments with our advanced wound care products such as Medihoney ® , weight offloading, and amniotic tissue.

Orthopedics and Tissue Technologies products serves some of the fastest growing markets in the medical technology industry.

The broad range of regenerative tissue technologies primarily address the needs of plastic, reconstructive and general surgeons focused on the treatment of acute wounds, such as burns, chronic wounds, including diabetic foot ulcers, and surgical tissue repair, such as hernia, tendon, peripheral nerve repair and protection.

We made significant investments with our channel expansion in the U.S.

and created four dedicated sales channels to have more focus and specialization within our call points to drive sustainable growth.

and created dedicated sales channels to have more focus and specialization within our call points to drive sustainable growth.

We have a specialized sales organization composed of directly employed sales representatives, as well as specialty distributors, organized based upon their call point.

Our extremity orthopedics sales representatives call on surgeons who treat extremity orthopedic disorders, including osteoarthritis, rheumatoid arthritis, wrist, ankle and shoulder arthroplasty, and other conditions requiring foot or hand

reconstruction.

Additionally, we sell our shoulder products through a specialty distributor network of sales agents who call on shoulder surgeons.

Our wound reconstruction acute (inpatient) sales representatives call on surgeons doing procedures in limb salvage, trauma, wound reconstruction and burns, while our advanced wound care sales representatives call on physicians who treat chronic wounds in the outpatient wound care clinic setting.

Our wound reconstruction sales representatives call on surgeons doing procedures in limb salvage, trauma, wound reconstruction and burns, and on physicians who treat chronic wounds in the outpatient wound care clinic setting.

We also have a dedicated surgical reconstruction sales team focused on plastic and reconstructive surgery and hernia procedures with differentiated products.

Finally, we have a distributor network focused on biologics.

Outside the U.S., we have a small direct sales presence, primarily in certain European countries, Australia, New Zealand, and Canada, and use distributors in other international markets to sell certain product lines.

Outside the U.S., we have a combination of direct and indirect channels in our international markets to sell certain product lines.

This business segment also includes private-label sales of a broad set of our regenerative and wound care technologies.

Our customers are other medical technology companies that sell to end markets primarily in orthopedics, spine, surgical and wound care.

Our competitors for Codman Specialty Surgical are Medtronic, Inc., Stryker Corporation, Becton Dickinson and Company and Aesculap division of B.

Braun Medical, Inc.

In addition, we compete with many smaller specialized companies and larger companies that do not otherwise focus on the offerings of Codman Specialty Surgical technologies.

We rely on the depth and breadth of our sales and marketing organization, our innovative technology, and our procurement and manufacturing operations to maintain our competitive position.

Our competition in Orthopedics and Tissue Technologies includes the DePuy/Synthes business of Johnson & Johnson, Stryker Corporation, Smith & Nephew plc, MiMedx Group, Inc., LifeCell Corporation, a subsidiary of Allergan PLC, and Zimmer Biomet Holdings, Inc.

In addition, our products also compete against medical practices that treat a condition without using a medical device or any particular product, such as medical practices that utilize autograft tissue instead of our dermal regeneration products, duraplasty products and nerve repair products.

Depending on the product line, we compete based on our products' features, strength of our sales force or distributors, sophistication of our technology and cost effectiveness of our solution.

RESEARCH AND DEVELOPMENT STRATEGY

Our research and development activities focus on identifying unmet surgical needs and addressing those needs with innovative solutions and products.

We apply our core competency in regenerative technology to products for neurosurgical, orthopedic and wound applications, plastic surgery, reconstructive surgery and we have extensive programs for our core platforms of orthopedic hardware and electromechanical technologies.

We are focusing our research and development efforts on products and clinical studies to generate efficacy and health economic evidence.

We apply our core competency in regenerative technology to products for neurosurgical, orthopedic and wound applications, plastic surgery, and reconstructive surgery and we have extensive programs for our core platforms of orthopedic hardware and electromechanical technologies.

Additionally, we conduct products and clinical studies to generate efficacy and health economic evidence.

Regenerative Technologies.

5 unchanged sentences

Our collagen manufacturing capability, combined with our history of innovation, provides us with strong platform technologies for multiple indications.

In 2019, we launched DuraGen® in Japan.

DuraGen is the first and only non-autologous collagen xenograft approved for use as a dural substitute in Japan.

We also continued to benefit from our 2019 product launches, such as DuraGen® in Japan which is the first and only non-autologous collagen xenograft approved for use as a dural substitute in Japan.

In early 2020, we launched AmnioExcel® Plus Placental Allograft Membrane, a human placental tissue product for treatment of wounds.

Additionally, the Company announced positive clinical and economic data on Integra® Bilayer Wound Matrix ("IBWM") in complex lower extremity reconstruction based on two retrospective studies recently published in Plastic and Reconstructive Surgery, the official journal of the American Society of Plastic Surgeons.

As surgeons looks for ways to efficiently and effectively repair and close wounds during these challenging times, IBWM helps address the efficiency needed in operating rooms by reducing both the operating time and costs to hospitals and patients.

Orthopedic Reconstruction .

We develop fixation and small joint reconstruction implants and instruments for upper and lower extremities to both provide next generation solutions and expand our product portfolio.

We developed fixation and small joint reconstruction implants and instruments for upper and lower extremities to both provide next generation solutions and expand our product portfolio.

This portfolio focuses on joint replacement products.

2 unchanged sentences

We have a strong differentiated asset that resides in our patented pyrocarbon products, and we continue to invest to bring new products to market with this technology, which has shown significantly less wear on bone than traditional metals.

To expand our ankle offering, in 2018 we launched the Integra ® XT Ankle Revision System which may be used to revise most ankle prosthesis currently in the market.

In 2019, we launched the Panta® II TTC Arthrodesis Nail System in the U.S.

We also continued to benefit from the 2019 U.S.

product launches, such as the Panta® II TTC Arthrodesis Nail System.

The Panta II system is our new fusion nail used in ankle fixation.

We also added a small post baseplate in our Titan™ Reverse Shoulder System which allows us to accommodate smaller patients.

We also launched a small post baseplate in our reverse shoulder system that accommodates smaller patients.

In addition, we initiated the limited market release of enhancements to our Salto Talaris® Total Ankle System.

Electromechanical Technologies and Instrumentation .

2 unchanged sentences

Our product development efforts are focused on core clinical applications in cerebral spinal fluid ("CSF") management, neuro-critical care ("NCC") monitoring, minimally invasive instruments and electrosurgery and ultrasonic medical technologies.

In 2019, we launched an innovative customer-centric toolkit for our Certas™ Plus Programmable Valve along with additional shunt configurations.

In addition, we launched our next generation of LED technology with our DUO LED Surgical Headlight System.

Duo LED Surgical Headlight System™.

We also work with several instrument partners to bring new surgical instrument patterns to the market, enabling us to add new instruments with minimal expense.

Our lighting franchise is among the most dynamic in the industry.

Our competitors for Codman Specialty Surgical are the Aesculap division of B.

Braun Medical, Inc., Medtronic, Inc., Stryker Corporation and Becton Dickinson and Company.

In addition, we compete with many smaller specialized companies and larger companies that do not otherwise focus on the offerings of Codman Specialty Surgical technologies.

We rely on the depth and

breadth of our sales and marketing organization, our innovative technology, and our procurement and manufacturing operations to maintain our competitive position.

Our competition in Orthopedics and Tissue Technologies includes the DePuy/Synthes business of Johnson & Johnson, ACell, Inc., Stryker Corporation, Wright Medical Group, N.V., Smith & Nephew plc, MiMedx Group, Inc., LifeCell Corporation, a subsidiary of Allergan PLC, and Zimmer Biomet Holdings, Inc., as well as other major orthopedic companies that carry a full line of small bone and joint fixation and soft tissue products.

Finally, in certain cases our products compete primarily against medical practices that treat a condition without using a medical device or any particular product, such as medical practices that utilize autograft tissue instead of our dermal regeneration products, duraplasty products and nerve repair products.

Depending on the product line, we compete based on our products' features, strength of our sales force or distributors, sophistication of our technology and cost effectiveness of our solution.

GOVERNMENT REGULATION

In the Codman Specialty Surgical segment, our focus is also on the new electrosurgery generator and irrigator system, an innovative customer-centric toolkit for our Certas™ Plus Programmable Valve along with additional shunt configurations.

Our lighting franchise is among the most

dynamic in the industry.

We continue to work with several instrument partners to bring new surgical instrument platforms to the market.

This enables us to add new instruments with minimal expense and invest in ongoing development, such as our next generation of LED technology with our DUO LED Surgical Headlight System™.

We develop core clinical applications in our electromechanical technologies portfolio.

In 2020, we updated our CUSA Clarity platform to incorporate a new ultrasonic handpiece, surgical tips and integrated electrosurgical capabilities.

In addition, the CUSA® Clarity Ultrasonic Surgical Aspirator System was cleared to treat malignant and benign tumors, but not limited to meningiomas and gliomas.

It is the first and only ultrasonic tissue ablation system with this specific indication.

The FDA clearance is based on a wealth of peer-reviewed clinical publications and 40 years of surgical cases involving resection of brain and spinal 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, CerebroFlo® external ventricular drainage (EVD) catheter with Endexo® technology, a permanent additive designed to reduce the potential for catheter obstruction due to thrombus formation.

The CerebroFlo EVD Catheter has demonstrated an average of 99% less thrombus accumulation onto its surface, in vitro, compared to a market leading EVD catheter.

We also acquired a company, Rebound Therapeutics, developers of a single-use medical device known as the AURORA Surgiscope® System ("Aurora") that enables minimally invasive access with enhanced lighting and visualization to the neurosurgery suite.

Importantly, these new platforms provide us with the opportunity to expand into new, faster growth therapeutic areas, such as intracerebral hemorrhage and minimally invasive neurosurgery.

In general, raw materials essential to our businesses are readily available from multiple sources.

For reasons of quality assurance, availability, or cost effectiveness, certain components and raw materials are available only from a sole supplier.

Our practice is to maintain sufficient inventory of components so that our production will not 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, wound care products, bone void fillers, nerve and tendon repair products, contain material derived from bovine tissue.

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 deep flexor tendon of cattle less than 24 months old from New Zealand, a country that has never had a reported case of bovine spongiform encephalopathy (“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 cattle tissue for relative risk of BSE transmission.

Deep flexor tendon and fetal bovine skin are in the lowest-risk category for BSE transmission, and therefore considered to have a negligible risk of containing the agent that causes BSE.

INTELLECTUAL PROPERTY

We seek patent and trademark protection for our key technology, products and product improvements, both in the U.S.

and in selected foreign countries.

When determined appropriate, we have enforced and plan to continue to enforce and defend our patent and trademark rights.

In general, however, we do not rely solely on our patent and trademark estate to provide us with any significant competitive advantages as it relates to our existing product lines.

We also rely upon trade secrets and continuing technological innovations to develop and maintain our competitive position.

In an effort to protect our trade secrets, we have a policy of requiring our employees, consultants and advisors to execute proprietary information and invention assignment agreements upon commencement of employment or consulting relationships with us.

These agreements also provide that all confidential information developed or made known to the individual during the course of their relationship with us 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™, CerebroFlo® EVD Catheter with Endexo® Technology, Certas®, Codman®, Codman Accu-Flo®, Codman Bicol®, Codman Certas®, Codman Hakim®, Codman Holter®, Codman ICP Express®, Codman Microsensor®, Codman VersaTru®, Codman VPV®, Contour-Flex®, Cranioplastic®, CRW®, CRW Precision™, Cterm™, CUSA®, DigiFuse®, DirectLink®, DuraGen®, DuraSeal®, Endorelease™, First Choice®, HeliCote®, HeliPlug®, HeliTape®, HeliMend®, Helistat®, Helitene®, Hermetic™, Hy-Tape®, ICP Express®, Integra®, IntegraLink®, IPP-ON®, Isocool®, Jarit®, Katalyst™, Lead-Lok™, Licox®, LimiTorr™, Luxtec®, Mayfield®, MediHoney®, MemoFix®, MicroFrance®, Miltex®, Mischler™, MoniTorr ICP™, Movement®, Natus®, NeuraGen®, NeuraWrap™, Nicolet®, NuGrip®, Omnigraft®, Omni-Tract®, OSV II®, Padgett®, PriMatrix®, Pureflow™, 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 the Integra logo are some of the material trademarks of Integra LifeSciences Corporation and its subsidiaries.

MAYFIELD® is a registered trademark of SM USA, Inc., and is used by Integra under license.

Revenues during our fourth quarter tend to be stronger than other quarters because many hospitals increase their purchases of our products during the fourth quarter to coincide with the end of their budget cycles in the U.S.

In general, our first quarter usually has lower revenues than the preceding fourth quarter, the second and third quarters have higher revenues than the first quarter, and the fourth quarter revenues are the highest in the year.

The main exceptions to this pattern occur because of material acquisitions as well as impacts of the novel coronavirus ("COVID-19") in 2020.

Impact of COVID-19 Pandemic on our business

In March 2020, the World Health Organization recognized the novel strain of coronavirus, COVID-19, as a pandemic.

This coronavirus outbreak has significantly impacted both the world and U.S.

In response to this coronavirus outbreak, the governments of many cities, counties, states and other geographic regions have taken preventative or protective actions, such as imposing restrictions on travel and business operations and are advising or requiring individuals to limit or forego their time outside of their homes which has created significant uncertainties in the U.S.

In certain geographic regions in which the Company operates, temporary closures of businesses have been ordered or suggested and numerous other businesses have temporarily closed voluntarily.

Further, individuals' ability to travel has been curtailed through mandated travel restrictions and may be further limited through additional voluntary or mandated closures of travel-related businesses.

The Company's focus during this global crisis remains on supporting patients, providing customers with life-saving products, and protecting the well-being of our employees.

The rapid and evolving spread of the virus has resulted in an unprecedented challenge to the global healthcare industry, as medical resources are reallocated to fight COVID-19.

During 2020, we were able to sustain ongoing operations by implementing contingency plans such as enabling its manufacturing and distribution sites around the world to continue operating at levels required to meet demand and to provide for the safety of our employees.

During April of 2020, the Company implemented cost-savings measures, which included the following:

• Reduced executive management compensation through July 2020 and director compensation;

• Reduced cash compensation for all other employees through reduced commissions, reduction in hours through July 2020 and/or furloughs;

• Hiring freeze, elimination of overtime, reduction in certain employee benefit costs, cessation of third-party services and temporary contractor relationships;

• Significant reduction in capital expenditures and discretionary spending including travel, events and marketing programs.

The Company restored employee wages and other spending in the third quarter of 2020, as revenues sequentially increased approximately 43.1% as compared to the second quarter of 2020.

We also continue to implement programs and strategies to effectively manage the business during the pandemic, such as partnering with key opinion leaders to increase our customer engagement through educational webinars and to improve the clinical components of sales training.

We remain confident that the underlying markets in which the Company competes 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 surgical procedure volumes.

The Company's adaptability and resiliency in the face of this unprecedented crisis is made possible in part by prior investments in technology infrastructure and operations, as well as by our talented and committed global workforce.

Throughout this period, we continue to prioritize and 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 in Item 1A.

Risk Factors.

GOVERNMENT REGULATION AND COMPLIANCE

We are a manufacturer and marketer of medical devices, and therefore are subject to extensive regulation by the FDA, the Center for Medicare Services of the U.S.

3 unchanged sentences

The regulatory process for obtaining product approvals and clearances can be onerous and costly.

The FDA requires, as a condition to marketing a medical device in the U.S., that we secure a Premarket Notification clearance pursuant to Section 510(k) of the Federal Food, Drug and Cosmetic Act (the “FD&C Act”) or an approved PMA application (or supplemental PMA application).

Obtaining these approvals and clearances can take up to several years and may involve preclinical studies and clinical trials.

1 unchanged sentence

To perform clinical trials for significant risk devices in the U.S.

on an unapproved product, we are required to obtain an Investigational Device Exemption ("IDE") from the FDA.

on an unapproved product, we are required to obtain

an Investigational Device Exemption ("IDE") from the FDA.

The FDA may also require a filing for approval prior to marketing products that are modifications of existing products or new indications for existing products.

6 unchanged sentences

An HCT/P is a product containing, or consisting of, human cells or tissue intended for transplantation into a human patient.

Examples include bone, ligament, skin and cornea.

Examples of HCT/P include bone, ligament, skin and cornea.

Some HCT/Ps fall within the definition of a biological product, medical device or drug regulated under the FD&C Act.

1 unchanged sentence

Section 361 of the Public Health Service Act (“Section 361”), authorizes the FDA to issue regulations to prevent the introduction, transmission or spread of communicable disease.

HCT/Ps regulated as “361” HCT/Ps are subject to requirements relating to registering facilities and listing products with the FDA, screening and testing for tissue donor eligibility, and Good Tissue Practice when processing, storing, labeling, and distributing HCT/Ps, including required labeling information, stringent record keeping, and adverse event reporting.

HCT/Ps regulated as “361” HCT/Ps are subject to requirements relating to registering facilities and listing products with the FDA, screening and testing for tissue donor eligibility, and Good Tissue Practices when processing, storing, labeling, and distributing HCT/Ps, including required labeling information, stringent record keeping, and adverse event reporting.

The American Association of Tissue Banks (“AATB”) has issued operating standards for tissue banking.

4 unchanged sentences

National Organ Transplant Act

of certain human organs and tissue for transplantation is subject to the restrictions of the National Organ Transplant Act, which prohibits the transfer of certain human organs, including skin and related tissue for valuable consideration, but permits the reasonable payment associated with the removal, transportation, implantation, processing, preservation, quality control and storage of human

tissue and skin.

Procurement of certain human organs and tissue for transplantation is subject to the restrictions of the National Organ Transplant Act, which prohibits the transfer of certain human organs, including skin and related tissue for valuable consideration, but permits the reasonable payment associated with the removal, transportation, 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 donated human amniotic tissue.

Amniotic tissue is considered an HCT/P.

However, on June 22, 2015, the FDA issued an Untitled Letter alleging that BioD’s morselized amniotic membrane tissue-based products do not meet the criteria for regulation as HCT/Ps solely under Section 361 and that, as a result, BioD would need a biologics license to lawfully market those morselized products.

On June 22, 2015, the FDA issued an Untitled Letter (the "Untitled Letter") alleging that BioD's morselized amniotic membrane tissue based products do not meet the criteria for regulation as HCT/Ps solely under Section 361 of the Public Health Services Act ("Section 361") and that, as a result, BioD would need a biologics license to lawfully market those morselized products.

Since the issuance of the Untitled Letter, BioD and more recently the Company have been in discussions with the FDA to communicate their disagreement with the FDA’s assertion that certain products are more than minimally manipulated.

The FDA has not changed its position that certain of the BioD acquired products are not eligible for marketing solely under Section 361.

In November 2017, the FDA issued the final guidance document related to human tissue titled, “Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products:

Minimal Manipulation and Homologous Use” (the “HCT/P Final Guidance”).

In July, 2020, the FDA issued the final guidance document related to human tissue titled, “Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products:

Minimal Manipulation and Homologous Use” (the “HCT/PFinal Guidance”).

This Guidance document supersedes the November 2017 guidance.

The HCT/P Final Guidance maintains the FDA’s position that products such as the Company’s morselized amniotic membrane tissue-based products do not meet the criteria for regulation solely as HCT/Ps.

In addition, the FDA articulated 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 be subject to immediate enforcement action.

The revised final guidance extends the discretionary enforcement period to May 31, 2021.

The Company does not believe the uses for its amniotic membrane tissue-based products fall into the high-risk category.

1 unchanged sentence

Nonetheless, we can make no assurances that the FDA will continue to exercise its enforcement discretion with respect to the Company’s morselized amniotic membrane tissue-based products, and any potential action of the FDA could have a financial impact regarding the sales of such products.

The company has been considering and continues to consider regulatory approval pathways for its morselized amniotic membrane tissue-based products.

Revenues from BioD morselized amniotic membrane-based products for the year ended December 31, 2020 were less than 1.0% of consolidated revenues.

See “Item 1A.

Risk Factors — Certain of our products are derived from human tissue and are subject to additional regulations and requirements.

Medical Device Regulations

5 unchanged sentences

Department of Justice.

All Integra manufacturing facilities participate in the Medical Device Single Audit Program and are audited annually for compliance with the Quality System for US FDA, Canada, Australia, Brazil, and Japan.

Medical device regulations also are in effect in many of the countries in which we do business outside the U.S.

1 unchanged sentence

Under the European Union Medical Device Directive, medical devices must meet the Medical Device Directive standards and receive CE Mark Certification prior to marketing in the European Union (the “EU”).

In addition, the EU enacted the EU Medical Device Regulation, which imposes stricter requirements on the marketing and sales of medical devices which includes but is not limited to quality systems and labeling.

CE Mark Certification requires a comprehensive quality system program, technical documentation, clinical evaluation and data on the product, which are then reviewed by a Notified Body.

2 unchanged sentences

Other countries are also instituting regulations regarding medical devices or interpreting and enforcing existing regulations more strictly.

Compliance with these regulations requires extensive documentation and clinical reports for all of our products, revisions to labeling, and other requirements such as facility inspections to comply with the registration requirements.

Compliance with these regulations requires extensive documentation and clinical reports for our products, revisions to labeling, and other requirements such as facility inspections to comply with the registration requirements.

A recognized Notified Body audits our facilities annually to verify our compliance with the ISO 13485 Quality System standard.

2 unchanged sentences

These regulations affect our dermal regeneration products, duraplasty products, hernia repair products, biomaterial products for the spine, nerve and tendon repair products and certain other products, all of which contain material derived from bovine tissue.

Although we take great care to provide that our products are safe and free of agents that can cause disease, products that contain materials derived from animals, including our products, may become subject to additional regulation, or even be banned in certain countries, because of concern over the potential for prion

transmission.

Significant new regulations, a ban of our products, or a movement away from bovine-derived products because of an outbreak of BSE could have a material, adverse effect on our current business or our ability to expand our business.

7 unchanged sentences

and the Reports of Corrections and Removals regulation, which require manufacturers to report recalls and field corrective actions to 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.

These foreign jurisdictions have similar requirements to the FDA which include reporting requirements such as adverse events, recalls, etc.

Other regulations

5 unchanged sentences

healthcare laws apply when a customer submits a claim for a product that is reimbursed under a federally funded healthcare program.

These global laws require that we exercise care in designing our sales and marketing practices, including involving interactions with healthcare professionals, and customer discount arrangements.

These global laws require that we exercise care in

designing our sales and marketing practices, including involving interactions with healthcare professionals, and customer discount arrangements.

See “Item 1A.

Risk Factors - Oversight of the medical device industry might affect the manner in which we may sell medical devices and compete in the marketplace .”

Risk Factors for further details.

Import-export .

9 unchanged sentences

These risks are managed to minimize or eliminate associated business impacts.

In the event of this type of accident, we could be held liable for damages that may result, and any liability could exceed our resources.

In the event of this type of accident, we could be held liable for damages and face a liability that could exceed our resources.

We could be subject to a regulatory shutdown of a facility that could prevent the distribution and sale of products manufactured there for a significant period of time, and we could suffer a casualty loss that could require a shutdown of the facility in order to repair it, any of which could have a material, adverse effect on our business.

11 unchanged sentences

Possible reductions in, or eliminations of, coverage or reimbursement by third-party payors, or denial of, or provision of uneconomical reimbursement for new products may affect our customers' revenue and ability to purchase our products.

Any changes in the healthcare regulatory, payment or

enforcement landscape relative to our customers' healthcare services have the potential to significantly affect our operations and revenue.

Any changes in the healthcare regulatory, payment or enforcement landscape relative to our customers' healthcare services have the potential to significantly affect our operations and revenue.

Data Privacy and Cybersecurity Laws and Regulations .

8 unchanged sentences

Legal requirements in these countries relating to the collection, storage, handling and transfer of personal data and, potentially, intellectual property continue to evolve with increasingly strict enforcement regimes.

In Europe, for example, we are subject to the EU data protection regulations, including the current EU Directive on Data Protection, which requires member states to impose minimum restrictions on the collection, use and transfer of personal data.

A new EU General Data Protection Regulation ("GDPR") which became enforceable in May 2018 includes, among other things, a requirement for prompt notice of data breaches to data subjects and supervisory authorities in certain circumstances and significant fines for non-compliance.

Europe, for example, we are subject to EU General Data Protection Regulation ("GDPR") which requires member states to impose minimum restrictions on the collection, use and transfer of personal data and includes, among other things, a requirement for prompt notice of data breaches to data subjects and supervisory authorities in certain circumstances and significant fines for non-compliance.

The GDPR also requires companies processing personal data of individuals residing in the EU to comply with EU privacy and data protection rules.

Risk Factors - We are subject to requirements relating to information technology which could adversely affect our business.

These laws and regulations impact the ways in which we use and manage personal data, protected health information, and our information technology systems.

2 unchanged sentences

They also may complicate our clinical research activities, as well as product offerings that involve transmission or use of clinical data.

INTELLECTUAL PROPERTY

We seek patent and trademark protection for our key technology, products and product improvements, both in the U.S.

and in selected foreign countries.

When determined appropriate, we have enforced and plan to continue to enforce and defend our patent and trademark rights.

In general, however, we do not rely solely on our patent and trademark estate to provide us with any significant competitive advantages as it relates to our existing product lines.

We also rely upon trade secrets and continuing technological innovations to develop and maintain our competitive position.

AccuDrain ® , AmnioExcel ® , AmnioMatrix ® , BioDFactor ® , BioDFence ® , BioDOptix ® , BioDRestore™, Bioguard ® , BioMotion ® , Bold ® , Budde ® , Buzz™, Cadence ® , Capture™, Codman ® , Codman Certas ® , Codman VersaTru ® , CRW ® , CUSA ® , DigiFuse ® , DirectLink ® , DuraGen ® , DuraSeal ® , First Choice ® , Hallu ® , HeliCote ® , HeliPlug ® , HeliTape ® , HeliMend ® , Helistat ® , Helitene ® , Integra ® , IntegraLink ® , IPP-ON ® , Isocool ® , Jarit ® , Licox ® , LimiTorr™, Luxtec ® , MediHoney ® , MemoFix ® , MicroFrance ® , Miltex ® , Movement ® , NeuraGen ® , NeuraWrap™, NuGrip ® , Omnigraft ® , Omni-Tract ® , OSV II ® , Qwix ® , Padgett ® , Panta ® , PriMatrix ® , PyroSphere ® , Redmond™, Ruggles ® , SafeGuard ® , Salto Talaris ® , Subtalar MBA ® , SurgiMend ® , TCC-EZ ® , TenoGlide ® , Ti6 ® , Tibiaxys ® , TissueMend ® , Titan™ , TruArch ® , Uni-CP ® , Uni-Clip ® , Xtrasorb ® and the Integra logo are some of the material trademarks of Integra LifeSciences Corporation and its subsidiaries.

MAYFIELD ® is a registered trademark of SM USA, Inc., and is used by Integra under license.

At December 31, 2019 , we had approximately 4,000 employees engaged in production and production support for warehouse, engineering and facilities, quality assurance, quality control, research and development, regulatory and clinical affairs, sales, marketing, administration and finance.

Except for certain employees at our facilities in Austria, Belgium, Brazil, France, Germany, Italy and Mexico, none of our employees are subject to a collective bargaining agreement.

HUMAN CAPITAL

Workforce Demographics

As of December 31, 2020, we had approximately 3,700 full-time and part-time employees and 700 contingent, subcontracted and outsourced partners.

As of December 31, 2020, 64% of our workforce was located in the United States, 25% in Europe, 4% in Latin America and Canada and 7% in Asia Pacific which includes Australia and New Zealand.

Diversity and Inclusion

A diverse workforce and an inclusive culture and work environment is a business priority and a key to our long-term success.

Our commitment to diversity and inclusion ("D&I") begins with our Board of Directors and CEO, and extends to all levels of the Company as we focus on attracting, retaining, and developing our global talent.

Leadership Commitment and Accountability.

The executive leadership team members set the D&I goals for the company and for the past three years it has been a company-wide goal to advance diversity and inclusion initiatives to build stronger teams.

Leadership Councils, Employee Resource Groups and External Partnerships.

We are accountable to our diversity commitment through our leadership councils, employee resource groups, and external partnerships.

• Peter Arduini, President & Chief Executive Officer has chaired our Women’s Leadership Council since its inception in 2017.

The Women’s Leadership Council is an action and results-oriented advisory group comprised of fifteen of our senior women leaders.

The specific charter of the Council is to work together to identify ways to continue to attract and retain female talent, advance the development of our women into leadership roles, increase the cultural awareness of the value of inclusion and diversity in our company, and create specific development forums for high performing women.

• Our employee resources groups encourage a culture of awareness and inclusion, assist in the attraction and retention of diverse talent, and help colleagues develop leadership skills.

Members of the executive leadership team serve as sponsors for each of Integra’s employee resources groups.

Integra has four employee resources groups:

◦ Women of Integra Networks with 20+ chapters globally

◦ African American Affinity Group

◦ Veteran Employee Resource Group

◦ Indian American Professional Network

• We reinforce our commitment to diversity by partnering with other organizations focused on driving inclusion in the work place including the CEO Action for Diversity & Inclusion, which is the largest CEO-driven business commitment to advance D&I in the work place and the Healthcare Businesswomen’s Association, an association dedicated to furthering the advancement and impact of women in the business of healthcare.

Promoting an Inclusive Culture Through Learning Opportunities.

To help drive our culture of inclusion, our colleagues 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 in a half-day micro-inequities training.

The content includes understanding unconscious bias and subtle behaviors that devalue, discourage and impair workplace performance, identifying these in day-to-day interactions, and exploring ways to mitigate these micro-inequities on an individual and organizational level.

• In 2020, Integra colleagues globally participated in two programs to promote inclusion:

a course that creates awareness of unconscious biases in the workplaces and tools to build-bias breaking skills and a course which examines what practicing inclusion in the workplace looks like.

Gender Diversity.

We believe that our company is better and delivers strong operating results when we build diverse teams and leverage broad perspectives to meet the needs of our shareholders, customers, colleagues, and communities we serve.

Integra's overall employee population is 47% female and 53% is male.

We continue to strive to ensure that diversity in our leadership ranks is representative of our overall population.

Through mentorship, sponsorship, recruitment efforts, and development programs we look to continue to grow our population of females in leadership roles at Integra.

Currently, 33% of our executive leaders and 36% of senior leaders (non-executive vice presidents) are female.

In partnership with Leadership Edge, a company founded by women leaders and dedicated to growing and mentoring women, Integra sponsors the Excel Women’s Leadership Program.

The program is designed to accelerate the development and advancement of high potential, mid-career female leaders into senior leadership roles.

The program has assisted in further building our pipeline of women leaders with 60% of the program’s graduates being promoted into roles with increased responsibility.

FINANCIAL INFORMATION ABOUT GEOGRAPHIC AREAS

Financial information about our geographical areas is set forth under “Item 7.

Management's Discussion and Analysis of Financial Condition and Results of Operations - Geographic Product Revenues and Operations” and in our financial statements Note 16, Segment and Geographic Information , to our consolidated financial statements.

SOURCES OF RAW MATERIALS

In general, raw materials essential to our businesses are readily available from multiple sources.

For reasons of quality assurance, availability, or cost effectiveness, certain components and raw materials are available only from a sole supplier.

Our policy is to maintain sufficient inventory of components so that our production will not be significantly disrupted even if a particular component or material is not available for a period of time.

Certain of our products, including our dermal regeneration products, duraplasty products, wound care products, bone void fillers, nerve and tendon repair products and certain other products, contain material derived from bovine tissue.

We take great care to provide that our products are safe and free of agents that can cause disease.

In particular, the collagen used in the products that Integra manufactures is derived either from the deep flexor tendon of cattle less than 24 months old from New Zealand, a country that has never had a reported case of bovine spongiform encephalopathy, or from the U.S.

or from fetal bovine dermis.

The World Health Organization classifies different types of cattle tissue for relative risk of BSE transmission.

Deep flexor tendon and fetal bovine skin are in the lowest-risk category for BSE transmission, and is therefore considered to have a negligible risk of containing the agent that causes BSE.

The main exceptions to this pattern occur because of material intervening acquisitions.

Financial information about our geographical areas is set forth in our financial statements Note 17, Segment and Geographic Information , to our consolidated financial statements.

AVAILABLE INFORMATION

3 unchanged sentences

A copy may also be obtained for any of these reports, without charge, from our Investor Relations department, 1100 Campus Road, Princeton, NJ 08540.

Alternatively, reports filed may be viewed or obtained with the SEC at the SEC's website at www.sec.gov .

Alternatively, reports filed may be viewed or obtained through the SEC's website at www.sec.gov .

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

18 unchanged sentences

In light of these risks and uncertainties, the forward-looking events and circumstances discussed in this report may not occur and actual results could differ materially from those anticipated or implied in the forward-looking statements.

UNRESOLVED STAFF COMMENTS

As of the filing of this Annual Report on Form 10-K, we had no unresolved comments from the staff of the Securities and Exchange Commission that were received not less than 180 days before the end of our 2020 fiscal year.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business