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What changed in GLOBUS MEDICAL INC's 10-K — 2024 vs 2025

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Paragraph-level year-over-year comparison of GLOBUS MEDICAL INC's 2024 and 2025 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2025 report.

+425 added−405 removedSource: 10-K (2026-02-24) vs 10-K (2025-02-20)

Top changes in GLOBUS MEDICAL INC's 2025 10-K

425 paragraphs added · 405 removed · 332 edited across 9 sections

Item 1. Business

Business — how the company describes what it does

118 edited+39 added−25 removed97 unchanged
Biggest changeWe will continue to provide resources to patients, surgeons, hospitals, and insurers in order to ensure optimum patient care and clarity regarding reimbursement and work to remove any and all non-coverage policies by third-party payors. National and regional coverage policy decisions are subject to unforeseeable change and have the potential to impact physician behavior and reimbursement for physician services.
Biggest changeNational and local coverage policy decisions are subject to unforeseeable change and have the potential to impact physician behavior. We will continue to provide the appropriate and compliant resources to patients, physicians, hospitals, and insurers in order to promote the best patient care, provide clarity regarding coverage and reimbursement policies, and work to reverse any non-coverage policies.
Under the Merger Agreement, each share of common stock, par value $0.001 per share, of NuVasive issued and outstanding immediately prior to the effective time of the NuVasive Merger (other than certain excluded shares as described in the Merger Agreement) was cancelled and converted into the right to receive 0.75 fully paid and non-assessable shares of Class A common stock of Globus, $0.001 par value per share, and the right to receive cash in lieu of fractional shares.
Under the NuVasive Merger Agreement, each share of common stock, par value $0.001 per share, of NuVasive issued and outstanding immediately prior to the effective time of the NuVasive Merger (other than certain excluded shares as described in the NuVasive Merger Agreement) was cancelled and converted into the right to receive 0.75 fully paid and non-assessable shares of Class A common stock of Globus, $0.001 par value per share, and the right to receive cash in lieu of fractional shares.
In the U.S., as a result of healthcare reform, third-party payors are increasingly required to demonstrate they can improve quality and reduce costs; we accordingly see an increase in pre-approval/prior authorizations and non-coverage policies citing higher levels of evidence required for medical therapies and technologies.
In the U.S., as a result of healthcare reform, third-party payors are increasingly required to demonstrate they can improve quality and reduce costs; accordingly, we see an increase in pre-approval/prior authorizations and non-coverage policies citing higher levels of evidence required for medical therapies and technologies.
Our INR solutions include the ExcelsiusGPS ® platform which is a robotic guidance and navigation system that supports minimally invasive and open procedures with screw and interbody spacer placement applications. The ExcelsiusGPS ® platform has a modular design that we expect will serve as a foundation for future clinical applications using artificial intelligence and augmented reality.
Our INR solutions include the ExcelsiusGPS ® platform, which is a robotic guidance and navigation system that supports minimally invasive and open procedures with screw and interbody spacer placement applications. The ExcelsiusGPS ® platform has a modular design that we expect will serve as a foundation for future clinical applications using artificial intelligence (“AI”) and augmented reality.
Further, the advertising and promotion of our products in the EEA is subject to limited provisions under MDR and the laws of individual EEA Member States implementing Directive 2006/114/EC concerning misleading and comparative advertising, and Directive 2005/29/EC on unfair commercial practices, as well as other EEA Member State laws and industry codes governing the advertising and promotion of medical devices.
Further, the advertising and promotion of our products in the EEA is subject to limited provisions under the MDD, MDR, and the laws of individual EEA Member States implementing Directive 2006/114/EC concerning misleading and comparative advertising, and Directive 2005/29/EC on unfair commercial practices, as well as other EEA Member State laws and industry codes governing the advertising and promotion of medical devices.
Our comprehensive benefits package includes: Competitive pay and annual incentive awards Bonus opportunities tied to individual and Company performance Comprehensive health and wellness programs Retirement benefits Paid time off and sick leave These offerings are tailored to promote a culture of health, well-being, and work-life balance for employees and their families.
Our comprehensive benefits package for eligible employees includes: • Competitive pay and annual incentive awards; • Bonus opportunities tied to individual and Company performance; • Comprehensive health and wellness programs; • Retirement benefits; and • Paid time off and sick leave. These offerings are tailored to promote a culture of health, well-being, and work-life balance for employees and their families.
We have developed a robust onboarding program for our newly hired associates that provides a comprehensive overview of our product portfolio and company history. We put an emphasis on training our employees and sales representatives to understand our business, including the underlying medical conditions that our products treat.
We have developed a robust onboarding program for our newly-hired employees that provides a comprehensive overview of our product portfolio and Company history. We put an emphasis on training our employees and sales representatives to understand our business, including the underlying medical conditions that our products treat.
Except for one market outside the U.S. where employees are subject to a collective bargaining agreement, our workforce is not unionized. We value our positive relationship with employees and strive to maintain a collaborative and supportive environment.
Except for one market outside of the U.S. where employees are subject to a collective bargaining agreement, our workforce is not unionized. We value our positive relationship with employees and strive to maintain a collaborative and supportive environment.
We, and our third-party manufacturers, are subject to the quality system regulations of the FDA, state regulations (such as the regulations promulgated by the California Department of Health Services), and regulations promulgated by foreign regulatory bodies (such as in the European Union).
We, and our third-party manufacturers, are subject to the quality system regulations of the FDA, state regulations (such as the regulations promulgated by the California Department of Health Services), and regulations promulgated by foreign regulatory bodies (such as in the European Union (the “EU”)).
We make our annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K and all amendments to such reports filed or furnished pursuant to Section 13(a) or 15(d) of the Exchange Act available free of charge through a link on the Investors section of our website located at http://www.globusmedical.com (under “SEC Filings”) as soon as reasonably practicable after they are filed with or furnished to the SEC. ‎ 19 Table of Contents
We make our Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and all amendments to such reports filed or furnished pursuant to Section 13(a) or 15(d) of the Exchange Act available free of charge through a link on the Investors section of our website located at http://www.globusmedical.com (under “SEC Filings”) as soon as reasonably practicable after they are filed with or furnished to the SEC. 20 Table of Contents
FDA Premarket Clearance and Approval Requirements for Medical Devices Unless an exemption applies (as is usually the case with instruments not intended for implantation), each medical device we wish to introduce within interstate commerce in the U.S. requires pre-authorization by the FDA either via 510(k) clearance, premarket approval (“PMA”), grant of a de novo classification request grant or, in less frequent occasions, via Humanitarian Device Exemption (“HDE”) approval.
FDA Premarket Clearance and Approval Requirements for Medical Devices Unless an exemption applies (as is usually the case with instruments not intended for implantation), each medical device we wish to introduce within interstate commerce in the U.S. requires pre-authorization by the FDA either via 510(k) clearance, premarket approval (“PMA”), de novo classification request grant or, in less frequent occasions, via Humanitarian Device Exemption (“HDE”) approval.
Our facilities and the facilities of our third-party manufacturers are subject to periodic announced and unannounced inspections by regulatory authorities, and may undergo compliance inspections conducted by the FDA, state, and/or international regulatory agencies for, among other things, conformance to Quality System Regulations and Current Good Manufacturing Practice requirements as well as separate foreign or international standards.
Our facilities and the facilities of our third-party manufacturers are subject to periodic announced and unannounced inspections by regulatory authorities and may undergo compliance inspections conducted by the FDA, state, and/or international regulatory agencies or equivalent bodies for, among other things, conformance to Quality System Regulations and Current Good Manufacturing Practice requirements as well as separate foreign or international standards.
Surgical Instrument, Implant Sets and Equipment Sales For many of our customers, we provide surgical instrumentation sets, including both implants and instruments, as well as our IONM systems in a manner tailored to fulfill our customer’s obligations to meet surgery schedules.
Surgical Instrument, Implant Sets and Equipment Sales For many of our customers, we provide surgical instrumentation sets, including both implants and instruments, as well as our IONM systems in a manner tailored to fulfill our customers' obligations to meet surgery schedules.
In addition to the presiding MDD and MDR outlined above, we must also comply with EU / EEA laws, directives, regulations and recognized standards as applicable to the devices we produce. These requirements can include all facets of healthcare, including environmental compliance, product stewardship, technical considerations, material of manufacture, and labeling availability.
In addition to the presiding MDD and MDR outlined above, we must also comply with EU / EEA laws, directives, regulations and recognized standards as applicable to the devices we produce. These requirements can include all facets of healthcare, 15 Table of Contents including environmental compliance, product stewardship, technical considerations, material of manufacture, and labeling availability.
While this does not constitute a material component of our business, as customer penetration and volume increases, these sales of sets allow our customers to increase the amount of surgical volume performed locally. Additionally, we offer flexibility to customers for our capital equipment by offering capital sales and leasing arrangements.
While this does not constitute a material component of our business, as customer penetration and volume increases, these sales of sets allow our customers to increase the amount of surgical volume performed locally. Additionally, we offer flexibility to customers for our capital equipment within our Excelsius ® ecosystem by offering capital sales and leasing arrangements.
Employee Engagement and Communication Our success depends on our employees understanding our strategy as well as our annual goals and priorities. This is accomplished through a number of channels, including a global intranet and sales enablement platform, regional and functional meetings, and quarterly 18 Table of Contents updates in global Town Halls with leadership.
Employee Engagement and Communication Our success depends on our employees understanding our strategy, as well as our annual goals and priorities. This is accomplished through a number of channels, including a global intranet and sales enablement platform, regional and functional meetings, and quarterly updates in global Town Halls with leadership.
Failure to comply with applicable regulatory requirements can result in enforcement action by the FDA, which may include any of the following sanctions: untitled letters or formal warning letters; fines, injunctions and civil penalties; recall or seizure of our products; operating restrictions, partial suspension or total shutdown of production; refusing our request for review of 510(k), de novo, or PMA of new products; withdrawal of 510(k) clearance(s), de novo grant(s), or PMA approval(s) that are already issued; refusal to grant export approval of our products; and criminal prosecution.
Failure to comply with applicable regulatory requirements can result in enforcement action by the FDA, which may include any of the following sanctions: • untitled letters or formal warning letters; • import alerts; • fines, injunctions and civil penalties; • recall or seizure of our products; • operating restrictions, partial suspension or total shutdown of production; • refusing our request for review of 510(k), de novo , PMA or HDE applications for new or modified products; • withdrawal of 510(k) clearance(s), de novo grant(s), PMA or HDE approval(s) that are already issued; • refusal to grant export approval of our products; and • criminal prosecution.
Research resources available in-house include a mechanical testing laboratory, spinal kinematics laboratory, tribology laboratory, cadaveric laboratory, materials characterization laboratory, computational laboratory, and clinical and biomechanical research experts. The markets in which we operate are subject to rapid technological advancements. We must constantly improve existing products and introduce new products in order to continue to succeed.
Research resources available in-house include a mechanical testing laboratory, spinal kinematics laboratory, tribology laboratory, cadaveric laboratory, materials characterization laboratory, computational laboratory, and clinical and biomechanical research experts. The markets in which we operate are subject to rapid technological advancements. We must constantly improve existing products and introduce new products.
Below is a non-exhaustive list of requirements to apply to devices within our portfolio and to which we must demonstrate some degree of compliance: Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorization and Restriction of Chemicals; Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment (recast); Directive 2012/19/EU of the European Parliament and of the Council of 4 July 2012 on waste electrical and electronic equipment; Commission Implementing Regulation (EU) 2021/2226 of 14 December 2021 laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards electronic instructions for use of medical devices; Directive (EU) 2023/2413 of the European Parliament and of the Council of 18 October 2023 amending Directive (EU) 2018/2001, Regulation (EU) 2018/1999 and Directive 98/70/EC as regards the promotion of energy from renewable sources, and repealing Council Directive (EU) 2015/652; Directive 2014/30/EU of the European Parliament and the Council of 26 February 2014 on the harmonization of the laws of the Member States relating to electromagnetic compatibility; Directive 2006/66/EC of the European Parliament and of the Council of 6 September 2006 on batteries and accumulators and waste batteries and accumulators and repealing Directive 91/157/EEC; and Directive 94/62/EC of 20 December 1994 on packaging and packaging waste.
Below is a non-exhaustive list of requirements that apply to devices within our portfolio and to which we must demonstrate some degree of compliance (each as may be amended by the relevant authorities from time to time): • Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorization and Restriction of Chemicals; • Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment (recast); • Directive 2012/19/EU of the European Parliament and of the Council of 4 July 2012 on waste electrical and electronic equipment; • Commission Implementing Regulation (EU) 2021/2226 of 14 December 2021 laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards electronic instructions for use of medical devices; • Directive (EU) 2023/2413 of the European Parliament and of the Council of 18 October 2023 amending Directive (EU) 2018/2001, Regulation (EU) 2018/1999 and Directive 98/70/EC as regards the promotion of energy from renewable sources, and repealing Council Directive (EU) 2015/652; • Directive 2014/30/EU of the European Parliament and the Council of 26 February 2014 on the harmonization of the laws of the Member States relating to electromagnetic compatibility; • Directive 2006/66/EC of the European Parliament and of the Council of 6 September 2006 on batteries and accumulators and waste batteries and accumulators and repealing Directive 91/157/EEC; and • Directive 94/62/EC of 20 December 1994 on packaging and packaging waste.
We value open and direct communication with our employees about their experiences. We use a variety of channels to obtain employee feedback, including open forums with leadership, and an employee resource group. Each year, the input received through these mechanisms is used to help strengthen our culture and improve employee engagement.
We value open and direct communication with our employees about their experiences. We use a variety of channels to obtain employee feedback, including open forums with leadership. Each year, the input received through these mechanisms is used to help strengthen our culture and improve employee engagement.
With the exception of removal and implantation, we provide services in all of these areas. 13 Table of Contents The procurement of human tissue is also subject to state anatomical gift acts and some states have statutes similar to NOTA. In addition, some states require that tissue processors be licensed by that state.
With the exception of removal and implantation, we provide services in all of these areas. The procurement of human tissue is also subject to state anatomical gift acts and some states have statutes similar to NOTA. In addition, some states require that tissue processors be licensed by that state.
Other federal statutes pertaining to healthcare fraud and abuse include the civil monetary penalties statute, which prohibits, among other things, the offer or payment of remuneration to a Medicaid or Medicare beneficiary that the offeror or payor knows or should know is likely to influence the beneficiary to order or receive a reimbursable item or service from a particular supplier, and the additional federal criminal statutes created by the Health Insurance Portability and Accountability Act of 1996, as amended (“HIPAA”), which prohibits, among other things, knowingly and willfully executing or attempting to execute a scheme to defraud any healthcare benefit program or obtain by means of false or fraudulent pretenses, representations or promises any money or property owned by or under the control of any healthcare benefit program in connection with the delivery of or payment for healthcare benefits, items or services.
Other federal statutes pertaining to healthcare fraud and abuse include the civil monetary penalties statute, which prohibits, among other things, the offer or payment of remuneration to a Medicaid or Medicare beneficiary that the offeror or payor knows or should know is likely to influence the beneficiary to order or receive a reimbursable item or service from a particular supplier, and the additional federal criminal statutes created by the Health Insurance Portability and Accountability Act of 1996, as amended (“HIPAA”), which prohibits, among other things, knowingly and willfully executing or attempting to execute a scheme to defraud or 17 Table of Contents to obtain by means of false or fraudulent pretenses, representations or promises any money or property owned by or under the control of any healthcare benefit program, regardless of whether the payor is public or private, in connection with the delivery of or payment for healthcare benefits, items or services.
We also work with a limited number of suppliers for certain components of our Enabling Technologies and IONM platforms and continue to develop redundancies for critical components within those supply chains. Our quality assurance group conducts periodic audits to ensure continued compliance with our standards.
We also work with a limited number of suppliers for certain 9 Table of Contents components of our Enabling Technologies and IONM platforms and continue to develop redundancies for critical components within those supply chains. Our quality assurance group conducts periodic audits to ensure continued compliance with our standards.
We believe there is significant opportunity for us to further penetrate existing markets, and to enter new markets, by increasing the size and geographic scope of our exclusive U.S. sales force for Musculoskeletal Solutions. Through the NuVasive Merger, we have significantly grown our U.S. sales force.
We believe there is significant opportunity for us to further penetrate existing markets, and to enter new markets, by increasing the size and geographic scope of our exclusive U.S. sales force for Musculoskeletal Solutions. Through the NuVasive and Nevro Mergers, we have significantly grown our U.S. sales force.
However, it is possible that material environmental costs or liabilities may arise in the future. Human Capital Workforce Overview We believe our employees are our most valuable asset and the cornerstone of our success as an organization.
However, it is possible that material environmental costs or liabilities may arise in the future. 18 Table of Contents Human Capital Workforce Overview We believe our employees are our most valuable asset and the cornerstone of our success as an organization.
These inspections may include our manufacturing, suppliers’ and sub-contractors’ facilities. On July 16, 2024, Globus Medical, Inc. received a warning letter from the FDA following an inspection of our facilities in Audubon, Pennsylvania.
These inspections may include our manufacturing, suppliers’ and sub-contractors’ facilities. 14 Table of Contents On July 16, 2024, Globus Medical, Inc. received a warning letter from the FDA following an inspection of our facilities in Audubon, Pennsylvania.
Musculoskeletal Solutions Our Musculoskeletal Solutions consist primarily of implantable devices, biologics, accessories, unique surgical instruments, and neuromonitoring services, used in an expansive range of spinal, orthopedic and neurosurgical procedures. Musculoskeletal disorders are a leading driver of healthcare costs worldwide. Disorders range in severity from mild pain and loss of feeling to extreme pain and paralysis.
Musculoskeletal Solutions Our Musculoskeletal Solutions consist primarily of implantable devices, biologics, accessories, unique surgical instruments, spinal cord stimulation treatment therapy, and neuromonitoring services, used in an expansive range of spinal, orthopedic and neurosurgical procedures. Musculoskeletal disorders are a leading driver of healthcare costs worldwide. Disorders range in severity from mild pain and loss of feeling to extreme pain and paralysis.
Alphatec Holdings, Orthofix, Integra LifeSciences , ZimVie and other smaller public and private companies are also competitors of ours. At any time, these or other market participants may develop alternative treatments, products or procedures for the treatment of musculoskeletal disorders that compete directly or indirectly with our products.
Alphatec Holdings, Orthofix, Integra LifeSciences , ZimVie, VB Spine, Boston Scientific and other smaller public and private companies are also competitors of ours. At any time, these or other market participants may develop alternative treatments, products or procedures for the treatment of musculoskeletal disorders that compete directly or indirectly with our products.
We expect to continue to increase the number of our direct and distributor sales representatives in each of these areas, both in the U.S. and internationally, to expand into new geographic territories and to deepen our penetration in existing territories.
We expect to continue to increase the number of our direct and distributor sales representatives in each of these areas, both in the U.S. and 8 Table of Contents internationally, to expand into new geographic territories and to deepen our penetration in existing territories.
Accordingly, we have made significant investments in our product development and research capabilities. Sales and Marketing We market and sell our products primarily through our exclusive global sales force. As of December 31, 2024, we had a direct or distributor sales presence in the U.S. and in 65 other countries.
Accordingly, we have made significant investments in our product development and research capabilities. Sales and Marketing We market and sell our products primarily through our exclusive global sales force. As of December 31, 2025, we had a direct or distributor sales presence in the U.S. and in 64 other countries.
To demonstrate compliance with the essential requirements and obtain the right to affix the CE conformity mark we must undergo a conformity assessment procedure, which varies according to the type of medical device and its classification.
To demonstrate compliance with the relevant requirements and obtain the right to affix the CE conformity mark we must undergo a conformity assessment procedure, which varies according to the type of medical device and its risk classification.
Since 2003 we have introduced many products, including 18 products in 2024, designed for the treatment of musculoskeletal disorders. Given our robust product portfolio of unique and differentiated products, as well as the numerous disruptive products in various stages of development, we believe we are well positioned for growth in the musculoskeletal markets we operate in.
Since 2003, we have introduced many products, including 9 products in 2025, designed for the treatment of musculoskeletal disorders. Given our robust product portfolio of unique and differentiated products, as well as the numerous disruptive products in various stages of development, we believe we are well positioned for growth in the musculoskeletal markets we operate in.
Sales and Marketing Commercial Compliance Federal anti-kickback laws and regulations prohibit, among other things, persons from knowingly and willfully soliciting, receiving, offering or paying remuneration, directly or indirectly, in exchange for, to induce or to reward either the referral of an individual, or the purchase, order or recommendation of, any good or service paid for under federal healthcare programs such as the Medicare and Medicaid programs.
Sales and Marketing Commercial Compliance The U.S. federal Anti-Kickback Statute and its implementing regulations prohibit, among other things, persons from knowingly and willfully soliciting, receiving, offering or paying remuneration, directly or indirectly, in exchange for, to induce or to reward either the referral of an individual, or the purchase, order or recommendation of, any good or service paid for under federal healthcare programs such as the Medicare and Medicaid programs.
These laws and codes may limit or restrict the advertising and promotion of our products to the general public and may impose limitations on our promotional activities with healthcare professionals.
These laws and codes may limit or restrict the advertising and promotion of our products to the general public in certain countries and may impose limitations on our promotional activities with healthcare professionals.
There can be no assurance that our products will be accepted by third-party payors, that coverage and reimbursement will be available or, if available, that the third-party payors’ coverage and reimbursement policies will not adversely affect our ability to sell our products profitably.
There can be no assurance that our products will be accepted by third-party payors, that coverage and reimbursement 11 Table of Contents will be available or, if available, that the third-party payors’ coverage and reimbursement policies will not adversely affect our ability to sell our products profitably.
Our talent-related initiatives, including recruitment, development, compensation and benefits, are designed to build and retain a world-class team capable of driving innovation and achieving our strategic goals. As of December 31, 2024, we had over 5,300 employees worldwide, including sales and marketing, product development, operations, general administrative and accounting, both domestically and internationally.
Our talent-related initiatives, including recruitment, development, compensation and benefits, are designed to build and retain a world-class team capable of driving innovation and achieving our strategic goals. As of December 31, 2025, we had over 6,000 employees worldwide, including sales and marketing, product development, operations, general administrative and accounting, both domestically and internationally.
We responded to the FDA’s warning letter on August 2, 2024, provided periodic updates to the FDA on our progress, and notified the FDA of actions completed to resolve the observations. As of February 20, 2025, this warning letter remains open.
We responded to the FDA’s warning letter on August 2, 2024, provided periodic updates to the FDA on our progress, and notified the FDA of actions completed to resolve the observations. As of February 24, 2026, this warning letter remains open.
Globus is an engineering-driven company with a history of rapidly developing and commercializing advanced products and procedures to address treatment challenges. With 18 product launches in 2024 and operations across 66 countries worldwide, we offer a comprehensive portfolio of innovative and differentiated technologies that are used to treat a variety of musculoskeletal conditions.
Globus is an engineering-driven company with a history of rapidly developing and commercializing advanced products and procedures to address treatment challenges. With 9 product launches in 2025 and operations across 65 countries worldwide, we offer a comprehensive portfolio of innovative and differentiated technologies that are used to treat a variety of musculoskeletal conditions.
We believe there is significant opportunity to strengthen our position in the U.S. market by increasing the size of our sales force and continuing to add direct and distributor sales representatives in the future. During the year ended December 31, 2024, international sales accounted for approximately 20.6% of our total sales.
We believe there is significant opportunity to strengthen our position in the U.S. market by increasing the size of our sales force and continuing to add direct and distributor sales representatives in the future. During the year ended December 31, 2025, international sales accounted for approximately 19.4% of our total sales.
This highly maneuverable and intuitive imaging platform offers 3 imaging modalities, position memory, and a large field of view. In 2024, we launched the ExcelsiusHub® and the ExcelsiusFlex® to further expand our Excelsius® ecosystem. The ExcelsiusHub® provides real-time patient array monitoring, tissue sparing drills, and registration flexibility to elevate the safety of spine navigation.
This highly maneuverable and intuitive imaging platform offers three imaging modalities, position memory, and a large field of view. In 2024, we launched the ExcelsiusHub ® and the ExcelsiusFlex ® . The ExcelsiusHub ® provides real-time patient array monitoring, tissue sparing drills, and registration flexibility to elevate the safety of spine navigation.
Although surgeons are permitted to use medical devices for indications other than those cleared or approved by the FDA based on their medical judgment, we are prohibited from promoting products for such off-label uses.
Pursuant to FDA regulations, we can only market our products for cleared or approved uses. Although surgeons are permitted to use medical devices for indications other than those cleared or approved by the FDA based on their medical judgment, we are prohibited from promoting products for such off-label uses.
Diversity and Inclusion We recognize the value associated with fostering a work environment that is diverse and inclusive and believe that diverse teams stimulate innovation, enhance our understanding of the needs of our customers, and ultimately deliver better results for our stakeholders. Our goal is to cultivate a respectful and professional environment where all voices are heard and valued.
Culture We recognize the value associated with fostering a work environment that is inclusive and believe that varied backgrounds and experiences stimulate innovation, enhance our understanding of the needs of our customers, and ultimately deliver better results for our stakeholders. Our goal is to cultivate a respectful and professional environment where all voices are heard and valued.
It is our policy to implement safeguards to educate our employees and agents on these legal requirements and prohibit improper practices. The government may seek to hold us liable for FCPA violations committed by companies that we acquire.
It is our policy to implement safeguards to educate our employees and agents on these legal requirements and prohibit improper practices. The government may seek to hold us liable for FCPA violations committed by companies that we acquire and by certain of our vendors, contractors, and agents, including our independent distributors.
The Physician Payments Sunshine Act of 2009 (the "Sunshine Act”) was enacted into law in 2010 and requires public disclosure to the U.S. government of certain payments and other transfers of value to U.S.-licensed physicians, physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists and anesthesiologist assistants, and nurse midwives, and to U.S. teaching hospitals, including in-kind transfers of value such as educational items or meals.
The Physician Payments Sunshine Act of 2009 (the “Sunshine Act”) was enacted into law in 2010 and requires public disclosure to the U.S. government of certain payments and other transfers of value to U.S.-licensed physicians (defined to include doctors of medicine and osteopathy, dentists, optometrists, podiatrists, and chiropractors), physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists, anesthesiologist assistants, certified nurse-midwives, and to U.S. teaching hospitals, including in-kind transfers of value such as educational items or meals.
Our Environmental, Health & Safety team spearheads global initiatives to: Develop safety practices and procedures Conduct training programs and annual safety campaigns Monitor compliance to reduce and ultimately eliminate serious injuries Our programs also emphasize corporate compliance, recycling, hazardous waste management, and emergency preparedness.
Our Environmental, Health & Safety team spearheads global initiatives to: • Develop safety practices and procedures; 19 Table of Contents • Conduct training programs and annual safety campaigns; and • Monitor compliance to reduce and ultimately eliminate serious in juries. Our programs also emphasize corporate compliance, recycling, hazardous waste management, and emergency preparedness.
Although we manage our business globally within one reportable segment, we separate our products and services into two major categories: Musculoskeletal Solutions and Enabling Technologies. NuVasive Merger On September 1, 2023, pursuant to that certain merger agreement (the “Merger Agreement”) with NuVasive, Inc. (“NuVasive”) and Zebra Merger Sub Inc.
Although we manage our business globally within one reportable segment, we separate our products and services into two major categories: Musculoskeletal Solutions and Enabling Technologies. NuVasive Merger As previously disclosed, on September 1, 2023, pursuant to that certain merger agreement (the “NuVasive Merger Agreement”) with NuVasive, Inc.
This law, along with various international and individual state reporting, compliance program, gift ban and marketing program requirements, such as in Massachusetts and Vermont, increases the possibility that a healthcare company may run afoul of one or more of the requirements. The U.S.
This law, along with applicable individual state reporting, compliance programs, gift ban and marketing program requirements, such as in Massachusetts and Vermont, increases the possibility that a company may run afoul of one or more of the requirements.
Most devices that are CE-marked under the MDD may continue to be marketed in the EU under certain conditions until December 2027 for Class III and IIb implantable devices; 2028 for other Class IIb, IIa and Class I devices which require involvement of a Notified Body in the conformity assessment, at which time these products must comply with the MDR.
However, given the increase in the requirements and transition provisions that have been put in place, most devices that are CE-marked under the previous MDD may continue to be marketed in the EU under certain conditions until December 2027 for Class III and IIb implantable devices; 2028 for other Class IIb, IIa and Class I devices which require involvement of a Notified Body in the conformity assessment, at which time these products must comply with the MDR.
Relators are incentivized to pursue claims against manufacturers and providers by the potential to share in any monetary recoveries by the government in litigation or as part of a settlement, which can be significant.
Lawsuits under the FCA often are initiated by Relators on behalf of the government. Relators are incentivized to pursue claims against manufacturers and providers by the potential to share in any monetary recoveries by the government in litigation or as part of a settlement, which can be significant.
In addition, state-level workers’ compensation coverage and reimbursement vary from state to state. Payment by Medicare and other third-party payors may not be adequate to cover the cost of medical devices used in musculoskeletal procedures. Additionally, more musculoskeletal procedures are being performed in the hospital outpatient and ambulatory surgery center settings, in part due to innovation.
Payment by Medicare and other third-party payors may not be adequate to cover the cost of medical devices used in musculoskeletal procedures. Additionally, more musculoskeletal procedures are being performed in the hospital outpatient and ambulatory surgery center settings, in part due to innovation.
Our employee resource group, Globus Women’s Network, contributes to charitable causes, including shelters, food banks, and breast cancer research. We are proud to operate responsibly and prioritize community engagement as part of our broader mission. Information We were incorporated in Delaware in March 2003.
We contribute to charitable causes, including shelters, food banks, and breast cancer research. We are proud to operate responsibly and prioritize community engagement as part of our broader mission. Information We were incorporated in Delaware in March 2003.
Third-Party Coverage and Reimbursement We expect that sales volumes and prices of our Musculoskeletal Solutions products including spinal implant, orthopedic trauma, hip and knee arthroplasty, regenerative biologics, advanced technology products and IONM services may grow to be more dependent on the availability of coverage and reimbursement from third-party payors, such as state and federal programs including Medicare, Medicaid and workers’ compensation as well as private insurance plans including Blue Cross Blue Shield plans and commercial insurers.
Our portfolio includes domestic and foreign trademarks with associated logos and tag lines. 10 Table of Contents Third-Party Coverage and Reimbursement We expect that sales volumes and prices of our Musculoskeletal Solutions products, including spinal implant, orthopedic trauma, hip and knee arthroplasty, regenerative biologics, advanced technology products, IONM services and spinal cord stimulation services, may grow to be more dependent on the availability of coverage and reimbursement from third-party payors, such as state and federal programs including Medicare, Medicaid and workers’ compensation, as well as private insurance plans including Blue Cross Blue Shield plans and commercial insurers.
Global enforcement of anti-corruption laws has increased considerably in recent years, with more frequent voluntary self-disclosures by companies, aggressive investigations and enforcement proceedings by U.S. and non-U.S. governmental agencies, and assessment of significant fines and penalties against companies and individuals.
Notwithstanding initial announcements by the current U.S. administration regarding FCPA enforcement priorities global enforcement of anti-corruption laws has increased considerably in recent years, with more frequent voluntary self-disclosures by companies, aggressive investigations and enforcement proceedings by U.S. and non-U.S. governmental agencies, and assessment of significant fines and penalties against companies and individuals.
(“Merger Sub”), Merger Sub, a wholly owned subsidiary of the Company, merged with and into NuVasive, with NuVasive surviving as a wholly owned subsidiary of the Company (the “NuVasive Merger”).
(“NuVasive”) and Zebra Merger Sub Inc., a wholly owned subsidiary of the Company (“Zebra Merger Sub”), Zebra Merger Sub, merged with and into NuVasive, with NuVasive surviving as a wholly owned subsidiary of the Company (the “NuVasive Merger”).
Devices deemed by the FDA to pose the greatest risk to patients, such as life-sustaining, life-supporting or implantable devices, and devices deemed not substantially equivalent to a previously cleared 510(k) devices are designated as Class III, which typically requires approval of a PMA application.
Devices deemed by the FDA to pose the greatest risk to patients, such as life-sustaining, life-supporting or implantable devices are designated as Class III, which typically requires approval of a PMA application.
These regulatory requirements could include, but are not limited to: device listing and establishment registration; adherence to the Quality System Regulation (per 21 CFR Part 820) (“QSR”) and the newly published Quality Management System Regulation (effective February 2, 2026) which requires stringent design, testing, control, documentation and other quality assurance procedures; labeling requirements and FDA prohibitions against the promotion of off-label uses or indications; adverse event reporting (Manufacturer and User Facility Device Experience); post-approval restrictions or conditions, which could include post-approval clinical trials or other required testing and periodic reporting; post-market surveillance requirements; the FDA’s recall authority, whereby it can ask for, or require, the recall of products from the market (see FDA Enforcement section below); and requirements relating to voluntary corrections or removals.
These regulatory requirements could include, but are not limited to: • device listing and establishment registration; • adherence to the Quality Management System Regulation (per 21 CFR Part 820) (“QMSR”), which requires stringent design, testing, control, documentation and other quality assurance procedures; • labeling requirements and FDA prohibitions against the promotion of off-label uses or indications; • unique device identification (UDI) requirements; • adverse event reporting (Medical Device Reporting, or “MDR”); 13 Table of Contents • post-approval restrictions or conditions, which could include post-approval clinical trials or other required testing and periodic reporting; • post-market surveillance requirements; • the FDA’s recall authority, whereby it can ask for, or require, the recall of products from the market (see FDA Enforcement section below); and • requirements relating to voluntary corrections or removals, including reporting to the FDA for such corrections and removals.
State anti-kickback laws have similar prohibitions. 16 Table of Contents Federal false claims laws prohibit any person from knowingly presenting, or causing to be presented, a false or fraudulent claim for payment to the federal government; knowingly making, or causing to be made, a false statement to get a false claim paid; or knowingly avoiding, decreasing or concealing an obligation to pay money to the federal government.
Federal false claims laws prohibit any person from knowingly presenting, or causing to be presented, a false or fraudulent claim for payment to the federal government; knowingly making, or causing to be made, a false statement to get a false claim paid; or knowingly avoiding, decreasing or concealing an obligation to pay money to the federal government.
The FDA regulates human tissue products as Human Cells and Cellular and Tissue-Based Products (“HCT/Ps”). Certain HCT/Ps are regulated solely under Section 361 of the Public Health Service Act and are referred to as “Section 361 HCT/Ps,” while other HCT/Ps are subject to the FDA’s regulatory requirements for medical devices or biologics under 21 CFR Parts 1270 and 1271.
Certain HCT/Ps are regulated solely under Section 361 of the Public Health Service Act and are referred to as “Section 361 HCT/Ps,” while other HCT/Ps are subject to the FDA’s regulatory requirements for medical devices or biologics in addition to the regulatory requirements under 21 CFR Parts 1270 and 1271.
We will continue to provide the appropriate and compliant resources to patients, physicians, hospitals, and insurers in order to promote the best patient care, provide clarity regarding coverage and reimbursement policies, and work to reverse any non-coverage policies. However, certain third-party payors, large and small, may have policies significantly limiting coverage of, products or services that we offer.
However, certain third-party payors, large and small, may have policies significantly limiting coverage of, products or services that we offer. We will continue to provide resources to patients, surgeons, hospitals, and insurers in order to ensure optimum patient care and clarity regarding reimbursement and work to remove any and all non-coverage policies by third-party payors.
The FDA and other state and regional agencies periodically inspect tissue processors to determine compliance with these requirements. Entities that provide us with allograft bone tissue are responsible for performing donor recovery, donor screening and donor testing and our compliance with those aspects of the CGTP regulations that regulate those functions are dependent upon the actions of these independent entities.
Entities that provide us with allograft bone tissue are responsible for performing donor recovery, donor screening and donor testing and our compliance with those aspects of the CGTP regulations that regulate those functions are dependent upon the actions of these independent entities.
Enabling Technologies Our Enabling Technologies are comprised of imaging, navigation and robotics (“INR”) solutions for assisted surgery which are advanced computer-assisted intelligent systems designed to enhance a surgeon’s capabilities, and ultimately improve patient care and reduce radiation exposure for all involved, by streamlining surgical procedures to be safer, less invasive, and more accurate.
We provide onsite and remote monitoring of the neurological systems of patients undergoing spinal and brain-related surgeries. 7 Table of Contents Enabling Technologies Our Enabling Technologies are comprised of imaging, navigation and robotics (“INR”) solutions for assisted surgery which are advanced computer-assisted intelligent systems designed to enhance a surgeon’s capabilities, and ultimately improve patient care and reduce radiation exposure for all involved, by streamlining surgical procedures to be safer, less invasive, and more accurate.
Further, pursuant to guidance issued by the UK Government, the Medicines and Healthcare products Regulatory Agency (“MHRA”) became the standalone medicines and medical devices regulator for the UK as of January 1, 2021. A new mark, UK Conformity Assessed (“UKCA”), has also been introduced and will replace the CE conformity mark in the UK.
Further, the Medicines and Healthcare products Regulatory Agency (“MHRA”) became the standalone medicines and medical devices regulator for the UK as of January 1, 2021. A new mark, UK Conformity Assessed (“UKCA”), has been introduced.
Legislation periodically is introduced in the United States Congress that would broaden the applicability of the FCA and implement other changes that would not be favorable to defendants in FCA cases. If enacted, such legislation could apply to any case filed under the FCA on or after the date of enactment.
Legislation periodically is introduced in the United States Congress that would broaden the applicability of the FCA and implement other changes that would not be favorable to defendants in FCA cases. If enacted, the government and Relators could assert that such legislation applies to any pending FCA cases, even those filed under prior to the date of enactment.
The EU/European Economic Area (“EEA”) requires a CE mark in order to place medical devices “in market”. Many other countries, such as Australia, India, New Zealand, Pakistan and Sri Lanka, accept CE or FDA authorizations (clearance, approval or grant).
The EU/European Economic Area (“EEA”) requires a CE mark in order to place medical devices “on the market”. Many other countries, such as Australia, India, New Zealand, Pakistan and Sri Lanka, accept, or recognize CE or FDA authorizations (clearance, approval or grant) in certain circumstances. Other countries, such as Brazil, Canada, Switzerland and Japan, require separate region-specific regulatory filings.
We believe we pioneered innovative expandable solutions for interbody fusion, corpectomy and interspinous fixation that allow intraoperative customization of our devices to the patient’s anatomy, eliminating sequential trialing and potentially saving surgical time.
This includes traditional fusion implants such as pedicle screw and rod systems, plating systems, intervertebral spacers and corpectomy devices. We believe we pioneered innovative expandable solutions for interbody fusion, corpectomy and interspinous fixation that allow intraoperative customization of our devices to the patient’s anatomy, eliminating sequential trialing and potentially saving surgical time.
Tissue banks that handle HCT/Ps must register their establishments with the FDA, list their HCT/P products with the FDA, and comply with FDA donor eligibility and screening requirements, current Good Tissue Practice (“CGTP”), Cellular- and Tissue-Based Product Establishments , product labeling, and postmarket reporting requirements for HCT/Ps.
Tissue banks that handle HCT/Ps must register their establishments with the FDA, list their HCT/P products with the FDA, and comply with FDA donor eligibility and screening requirements, current Good Tissue Practice (“CGTP”), product labeling requirements, and postmarket reporting requirements for HCT/Ps. The FDA and other state and regional agencies periodically inspect tissue processors to determine compliance with these requirements.
We believe our approach to product development is unique and highly efficient. We employ an integrated team approach to product development involving collaboration among surgeons, our engineers, our dedicated researchers, our highly-skilled machinists, and our regulatory personnel.
Product Development and Research We believe in bringing products to market quickly by reducing the time from product conception to launch. We believe our approach to product development is unique and highly efficient. We employ an integrated team approach to product development involving collaboration among surgeons, our engineers, our dedicated researchers, our highly-skilled machinists, and our regulatory personnel.
IDEs, PMAs and HDEs most often have post-approval obligations to the FDA and to participating clinical sites, including but not limited to: continued follow-up of enrolled / implanted investigational patients, periodic annual clinical reporting, site monitoring and oversight of on-going Institutional Review Board compliance. 12 Table of Contents Since the Institute of Medicine published their review of the predicated 510(k) review process in 2010, the FDA has continually worked to strengthen and modernize the 510(k) Program.
IDEs, PMAs and HDEs most often have post-approval obligations to the FDA and to participating clinical sites, including but not limited to: continued follow-up of enrolled / implanted investigational patients, periodic annual clinical reporting, site monitoring and oversight of on-going Institutional Review Board compliance.
If a manufacturer cannot establish that a new or modified product is substantially equivalent to a predicate device, it may be required to seek premarket approval through the PMA or de novo process (the latter only for new products).
If a manufacturer cannot establish that a new or modified product is substantially equivalent to a predicate device, the 510(k) notification will be rejected, and the manufacturer may be required to seek premarket approval through the PMA or de novo process (as discussed below).
In 2024, we launched two training platforms designed to enhance skills for individual contributors and to develop current and emerging leaders. These programs reinforce our commitment to talent development and to providing opportunities for employees to achieve their career goals.
We continue to offer training programs for current leaders and to develop emerging talent, both in leadership roles and as individual contributors. These programs reinforce our commitment to talent development and to providing opportunities for employees to achieve their career goals.
We expect to continue to increase the number of our direct and distributor sales representatives in the U.S., to expand into new geographic territories and to deepen our penetration in existing territories.
We expect to continue to increase the number of our direct and distributor sales representatives in the U.S., to expand into new geographic territories and to deepen our penetration in existing territories. We will also continue to provide our sales representatives with specialized development programs designed to improve their productivity. • Continue to expand into international markets.
CE, an acronym for “Conformité Européenne” or European Conformity, is the registration marking designating that a device can be commercially distributed throughout the European Union (“EU”).
CE, an acronym for “Conformité Européenne” or European Conformity, is the conformity marking demonstrating that a device meets the necessary regulatory requirement and can be commercially distributed throughout the EU.
For novel/unclassified devices not previously formally classified by the FDA with no legally marketed predicate which present low to moderate risk, a risk-based classification determination can be requested in accordance with the de novo classification request process, under which the FDA may determine that the product can be appropriately regulated as a Class I or II device and “granted” authorization for commercialization within the U.S.
If such a novel device presents low to moderate risk, a risk-based classification determination can be requested through the de novo classification request process, under which the FDA may determine that the product can be appropriately reclassified as a Class I or II device and “granted” authorization for commercialization within the U.S.
Following the expiration of the transitional provisions of the MDD relating to the CE mark (extended to December 2027 or December 2028 depending on product classification), all medical device companies intending to manufacture and/or market products in the EEA after May 2024, including Globus Medical, NuVasive and NuVasive Specialized Orthopedics), will be required to comply with requirements of the MDR, which increased technical documentation requirements, imparted more labeling obligations of higher risk devices, and altered the classification of some of our products.
All medical device companies intending to manufacture and/or market products in the EEA (including Globus), will be required to comply with requirements of the MDR, which increased technical documentation requirements, imparted more labeling obligations of higher risk devices, and altered the classification of some of our products.
We expect to continue to increase our international presence through the commercialization of additional Musculoskeletal Solutions products in current markets and through the expansion of our international sales force in current and new markets. Pursue strategic acquisitions .
As of December 31, 2025, we had an existing direct or distributor sales presence in 64 countries outside of the U.S. We expect to continue to increase our international presence through the commercialization of additional Musculoskeletal Solutions products in current markets and through the expansion of our international sales force in current and new markets. • Pursue strategic acquisitions.
Device and tissue pre-market approval, registration. and facility licensing requirements also exist in other markets where international facilities are established and where we may conduct business, including, but not limited to, Southeast Asia, Australia, and Latin America. Such requirements vary by country and Globus Medical & all its subsidiaries have established procedures to drive its compliance with these requirements.
Device and tissue pre-market approval, registration. and facility licensing requirements also exist in other markets where international facilities are established and where we may conduct business, including, but not limited to, Southeast Asia, Australia, and 16 Table of Contents Latin America.
In many cases, once the surgery is finished, the surgical instrument sets are returned to us, and we prepare them for shipment to meet future surgeries. 9 Table of Contents We complement this implant and instrument shipment model with field-based instrument assets.
We do not generally receive separate economic value specific to the surgical instrument sets from the surgeons or hospitals that utilize them. In many cases, once the surgery is finished, the surgical instrument sets are returned to us, and we prepare them for shipment to meet future surgeries. We complement this implant and instrument shipment model with field-based instrument assets.
Our orthopedic trauma solutions are designed to treat a wide variety of orthopedic fracture patterns and patient anatomies in the upper and lower extremities as well as the hip. Our orthopedic trauma and extremity products, covering four major segments of the orthopedic trauma market: fracture plates, compression screws, intramedullary nails, and external fixation.
Our orthopedic trauma solutions are designed to treat a wide variety of orthopedic fracture patterns and patient anatomies in the upper and lower extremities as well as the pelvis and hip.
Third-party payors are increasingly challenging the prices charged for a wide range of medical products and services. For federal/state programs, such as Medicaid, coverage and reimbursement differ from state to state. Some state Medicaid programs may not reimburse an adequate amount for the procedures performed with our products, if any payment is made at all.
For federal/state programs, such as Medicaid, coverage and reimbursement differ from state to state. Some state Medicaid programs may not reimburse an adequate amount for the procedures performed with our products, if any payment is made at all. In addition, state-level workers’ compensation coverage and reimbursement vary from state to state.
The EU has also adopted the EU Medical Device Regulation 2017/745 (“MDR”), which replaced existing directives and imposes stricter requirements for the marketing and sale of medical devices, including new clinical evaluation, quality system, and post-market surveillance requirements.
In the EEA, the EU has adopted the EU Medical Device Regulation 2017/745 (“MDR”), which replaces the previous EU Medical Device Directive (Council Directive 93/42/EEC) (“MDD”), and imposes stricter requirements for marketing and sale of our medical devices, including new clinical evaluation, quality systems, and post-market surveillance requirements.

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Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

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Biggest changeRisks Related to Our Business and Our Industry To be commercially successful, we must convince surgeons and hospitals that our products are an attractive alternative to our competitors’ products and to existing surgical treatments of musculoskeletal disorders. Pricing pressure from our competitors and our customers may impact our ability to sell our products profitably. If our customers are unable to obtain adequate coverage and reimbursement for their purchases of our products, we may not be able to sell them profitably. If we are unable to maintain and expand our network of direct sales representatives and independent distributors, we may not be able to generate anticipated sales. Our sales and operating results may be negatively affected and we may not grow if we are unable to compete successfully. We are dependent on a limited number of third-party suppliers, and the loss of any of these suppliers, or their inability to provide us with an adequate supply of products or materials in a timely manner could harm our business. The proliferation of physician-owned distributorships (“PODs”) could result in increased pricing pressure on our products or harm our ability to sell our products to physicians. Our business could suffer if we lose the services of key members of our senior management, advisors or personnel. The safety and efficacy of our products is not yet supported by long-term clinical data. If we do not enhance our product offerings and introduce new products, we may be unable to effectively compete. We are subject to risks arising from our acquisitions of or investments in new or complementary businesses, products or technologies. We are required to maintain high levels of inventory, which may be costly. We rely on internal and third-party information technology systems and network infrastructure to operate and manage our business, which may be subject to a breach, cyber-attack or other disruption. We are subject to data privacy laws and our failure to comply with them could subject us to substantial liabilities. If we experience significant disruptions in our information technology systems, our business, results of operations and financial condition could be adversely affected. The increasing utilization of artificial intelligence (“AI”) in the medical device and healthcare industries presents novel obstacles and risks to our business. Consolidation in the healthcare industry could lead to demands for price concessions or to the exclusion of some suppliers from certain of our markets, which could have an adverse effect on our business. If our Enabling Technologies products require significant amounts of service after sale or we receive a significant number of warranty claims, our costs may increase. We experience long and variable capital sales cycles for our Enabling Technologies products. Certain contractual counterparties may seek to modify contractual relationships with the Company, which could have an adverse effect on the Company’s business and operations. The Company may be exposed to increased litigation, which could have an adverse effect on the Company’s business and operations . Our IONM business exposes us to risks inherent with the sale of services. 20 Table of Contents Risks Related to our Legal and Regulatory Environment Our medical device products and operations are subject to extensive governmental regulation both in the U.S. and abroad. There may be future changes in legal and regulatory requirements, and changes impacting the federal workforce and agency policies, that may impact our operations and product development. Modifications to our products may require new 510(k) or de novo clearances, PMAs or PMA supplements. Our HCT/P products are subject to extensive government regulation. We and our suppliers are subject to the FDA’s good manufacturing practice regulations and similar international regulations. We may be subject to a recall of our products or the discovery of serious safety issues with our products. We may be subject to enforcement action if we engage in the off-label promotion of our products. Governmental regulation and limited sources and suppliers could restrict our procurement and use of tissue. Negative publicity concerning methods of tissue recovery and screening of donor tissue could reduce demand for our regenerative biologics products and impact the supply of available donor tissue. We are subject to environmental laws and regulations that can impose significant costs and expose us to potential financial liabilities. We or our suppliers may be the subject of claims for non-compliance with FDA regulations in connection with the processing, manufacturing or distribution of regenerative biologics implants and products. We and our distributor sales representatives might be subject to claims for failing to comply with U.S. federal, state, local and foreign fraud and abuse laws.
Biggest changeRisks Related to Our Business and Our Industry • To be commercially successful, we must convince surgeons and hospitals that our products are an attractive alternative to our competitors’ products and to existing surgical treatments of musculoskeletal disorders. • Pricing pressure from our competitors and our customers may impact our ability to sell our products profitably. • If our customers are unable to obtain adequate coverage and reimbursement for their purchases of our products, we may not be able to sell them profitably. • If we are unable to maintain and expand our network of direct sales representatives and independent distributors, we may not be able to generate anticipated sales. • Our sales and operating results may be negatively affected, and we may not grow if we are unable to compete successfully. • We are dependent on a limited number of third-party suppliers, and the loss of any of these suppliers, or their inability to provide us with an adequate supply of products or materials in a timely manner could harm our business. • The proliferation of physician-owned distributorships (“PODs”) could result in increased pricing pressure on our products or harm our ability to sell our products to physicians. • Our business could suffer if we lose the services of key members of our senior management, advisors or personnel. • The safety and efficacy of our products is not yet supported by long-term clinical data. • If we do not enhance our product offerings and introduce new products, we may be unable to effectively compete. • We are required to maintain high levels of inventory, which may be costly. • We rely on internal and third-party information technology systems and network infrastructure to operate and manage our business, which may be subject to a breach, cyber-attack or other disruption. • We are subject to data privacy laws and our failure to comply with them could subject us to substantial liabilities. • If we experience significant disruptions in our information technology systems, our business, results of operations and financial condition could be adversely affected. • The increasing utilization of AI in the medical device and healthcare industries presents novel obstacles and risks to our business. • Consolidation in the healthcare industry could lead to demands for price concessions or to the exclusion of some suppliers from certain of our markets, which could have an adverse effect on our business. • If our Enabling Technologies products require significant amounts of service after sale or we receive a significant number of warranty claims, our costs may increase. • We experience long and variable capital sales cycles for our Enabling Technologies products. • Certain contractual counterparties may seek to modify contractual relationships with the Company, which could have an adverse effect on the Company’s business and operations. • The Company may be exposed to increased litigation, which could have an adverse effect on the Company’s business and operations. • Our IONM business exposes us to risks inherent with the sale of services.
This process is shorter and typically requires the submission of less supporting documentation than other FDA approval processes and does not always require long-term clinical studies. Additionally, for most products launched to date, we have not been required to complete long-term clinical studies in connection with the sale of our products outside the U.S. market.
This process is shorter and typically requires the submission of less supporting documentation than other FDA approval processes and does not always require long-term clinical studies. Additionally, for most products launched to date, we have not been required to complete long-term clinical studies in connection with the sale of our products outside of the U.S. market.
State consumer protection laws may also establish privacy and security standards for use and management of PII and PHI, including information related to customers, suppliers, and care providers. Outside the U.S., we are impacted by the privacy and data security requirements at the international, national and regional level, and on an industry specific basis.
State consumer protection laws may also establish privacy and security standards for use and management of PII and PHI, including information related to customers, suppliers, and care providers. Outside of the U.S., we are impacted by the privacy and data security requirements at the international, national and regional level, and on an industry specific basis.
In addition, if the FDA disagrees with our determination that a product we currently market is subject to an exemption from premarket review, the FDA may require us to submit a 510(k), de novo , or PMA and may require us to cease distribution of the product and/or recall the product unless and until we obtain 510(k) or de novo clearance or PMA.
In addition, if the FDA disagrees with our determination that a product that we currently market is subject to an exemption from premarket review, the FDA may require us to submit a 510(k), de novo , or PMA and may require us to cease distribution of the product and/or recall the product unless and until we obtain 510(k) or de novo clearance or PMA.
The cost of, or lack of, available credit or equity financing could impact our ability to develop sufficient liquidity to maintain or grow our company, which in turn may adversely affect our business, results of operations or financial condition. We also manage cash and cash equivalents and short-term investments through various institutions.
The cost of, or lack of, available credit or equity financing could impact our ability to develop sufficient liquidity to maintain or grow the Company, which in turn may adversely affect our business, results of operations or financial condition. We also manage cash and cash equivalents and short-term investments through various institutions.
Due to differences between foreign and U.S. patent laws, our patented intellectual property rights may not receive the same degree of protection in foreign countries as they would in the U.S. Even if patents are granted outside the U.S. , effective enforcement in those countries may not be available.
Due to differences between foreign and U.S. patent laws, our patented intellectual property rights may not receive the same degree of protection in foreign countries as they would in the U.S. Even if patents are granted outside of the U.S., effective enforcement in those countries may not be available.
Any potential intellectual property litigation also could force us to do one or more of the following: stop selling products or using technology that contains the allegedly infringing intellectual property; lose the opportunity to license our technology to others or to collect royalty payments based upon successful protection and assertion of our intellectual property rights against others; incur significant legal expenses; pay substantial damages to the party whose intellectual property rights we may be found to be infringing; redesign those products that contain the allegedly infringing intellectual property, which could be costly and disruptive; or 40 Table of Contents attempt to obtain a license to the relevant intellectual property from third parties, which may not be available on reasonable terms or at all.
Any potential intellectual property litigation also could force us to do one or more of the following: • stop selling products or using technology that contains the allegedly infringing intellectual property; 40 Table of Contents • lose the opportunity to license our technology to others or to collect royalty payments based upon successful protection and assertion of our intellectual property rights against others; • incur significant legal expenses; • pay substantial damages to the party whose intellectual property rights we may be found to be infringing; • redesign those products that contain the allegedly infringing intellectual property, which could be costly and disruptive; or • attempt to obtain a license to the relevant intellectual property from third parties, which may not be available on reasonable terms or at all.
Further, in the course of our regular review of pending legal matters, we determine whether it is probable that a potential loss relating to a legal proceeding may have a material impact on our business, financial performance or cash position.
Further, in the course of our regular review of pending legal matters, whether we determine it is probable that a potential loss relating to a legal proceeding may have a material impact on our business, financial performance or cash position.
This concentration of ownership may harm the value of our Class A common stock by, among other things: delaying, deferring or preventing a change in control of our company; impeding a merger, consolidation, takeover or other business combination involving our company; or causing us to enter into transactions or agreements that are not in the best interests of all stockholders.
This concentration of ownership may harm the value of our Class A common stock by, among other things: • delaying, deferring or preventing a change in control of the Company; • impeding a merger, consolidation, takeover or other business combination involving the Company; or • causing us to enter into transactions or agreements that are not in the best interests of all stockholders.
Section 203 and other provisions in our amended and restated certificate of incorporation, amended and restated bylaws and Delaware law could make it more difficult for stockholders or potential acquirers to obtain control of our Board or initiate actions that are opposed by our then-current Board, including delay or impede a merger, tender offer, or proxy contest involving our company.
Section 203 and other provisions in our amended and restated certificate of incorporation, amended and restated bylaws and Delaware law could make it more difficult for stockholders or potential acquirers to obtain control of our Board or initiate actions that are opposed by our then-current Board, including delay or impede a merger, tender offer, or proxy contest involving the Company.
We do not know if we will be able to identify acquisitions we deem suitable, whether we will be able to successfully complete any such acquisitions on favorable terms or at all, or whether we will be able to successfully integrate any acquired business, product or technology into our business or retain any key personnel, suppliers or distributors.
We do not know if we will be able to identify acquisitions that we deem suitable, whether we will be able to successfully complete any such acquisitions on favorable terms or at all, or whether we will be able to successfully integrate any acquired business, product or technology into our business or retain any key personnel, suppliers or distributors.
A failure to utilize AI as efficiently or effectively as our competitors or a failure to adopt cost-effective and compliant AI systems as quickly as our competitors could have a material adverse effect on our business, results of operations or financial condition.
A failure to utilize AI as efficiently or effectively as our competitors or a failure to adopt cost-effective and compliant AI systems as quickly as our competitors could have a material adverse effect on our reputation, business, results of operations or financial condition.
A government-mandated or voluntary recall by us or one of our distributors could occur as a result of risk to health, component failures, manufacturing errors, design or labeling defects or other deficiencies and issues.
A government-mandated or voluntary recall or correction by us or one of our distributors could occur as a result of risk to health, component failures, manufacturing errors, design or labeling defects or other deficiencies and issues.
The challenges involved in this integration, which will be complex and time-consuming, include the following: combining the businesses of Globus and NuVasive, including respective operations and corporate functions, and meeting the capital requirements of the Company in a manner that permits the Company to achieve any revenue synergies or efficiencies anticipated to result from the NuVasive Merger, the failure of which would result in the anticipated benefits of the NuVasive Merger not being realized in the timeframe currently anticipated or at all; integrating and retaining personnel from the two companies while continuing to provide consistent, high-quality products and services to customers; integrating each company’s technologies and technologies licensed by them from third parties; identifying and eliminating redundant and underperforming functions and assets; harmonizing each company’s operating practices, employee development and compensation programs, financial reporting, internal controls and other policies, procedures and processes; maintaining existing agreements with each company’s business partners, surgeons, suppliers and vendors, avoiding delays in entering into new agreements with prospective business partners, surgeons, suppliers and vendors, and leveraging relationships with such third parties for the benefit of the Company; addressing possible differences in business backgrounds, corporate cultures and management philosophies; consolidating each company’s administrative and information technology infrastructure; combining the companies’ research and development functions; integrating and unifying the products and services available to historical Globus and NuVasive customers; coordinating sales activities and go-to-market efforts; managing the movement of certain positions to different locations; coordinating geographically dispersed organizations; managing the operations of a significantly larger and more complex company; and effecting actions that may be required in connection with obtaining regulatory or other governmental approvals.
The challenges involved in this integration, which will be complex and time-consuming, include the following: • combining the businesses of Globus and NuVasive and Nevro, including respective operations and corporate functions, and meeting the capital requirements of the Company in a manner that permits the Company to achieve any revenue synergies or efficiencies anticipated to result from the NuVasive and Nevro Mergers, the failure of which would result in the anticipated benefits of the NuVasive and Nevro Mergers not being realized in the timeframe currently anticipated or at all; • integrating and retaining personnel from the two companies while continuing to provide consistent, high-quality products and services to customers; • integrating each company’s technologies and technologies licensed by them from third parties; • identifying and eliminating redundant and underperforming functions and assets; • harmonizing each company’s operating practices, employee development and compensation programs, financial reporting, internal controls and other policies, procedures and processes; 45 Table of Contents • maintaining existing agreements with each company’s business partners, surgeons, suppliers and vendors, avoiding delays in entering into new agreements with prospective business partners, surgeons, suppliers and vendors, and leveraging relationships with such third parties for the benefit of the Company; • addressing possible differences in business backgrounds, corporate cultures and management philosophies; • consolidating each company’s administrative and information technology infrastructure; • combining the companies’ research and development functions; • integrating and unifying the products and services available to historical Globus and NuVasive and Nevro customers; • coordinating sales activities and go-to-market efforts; • managing the movement of certain positions to different locations; • coordinating geographically dispersed organizations; • managing the operations of a significantly larger and more complex company; and • effecting actions that may be required in connection with obtaining regulatory or other governmental approvals.
For example, we intend to continue to seek regulatory clearance to market our primary products in the EEA, Japan, Brazil, the UK, Canada and other key markets.
For example, we intend to continue to seek regulatory clearance to market our primary products in the EEA, Japan, Brazil, the UK, Canada, Australia and other key markets.
This amount exceeds 5% of our outstanding common stock, meaning our Board of Directors (“Board”) could issue Class B common stock without necessarily triggering the automatic conversion of that Class B common stock to Class A common stock that, pursuant to our charter, will occur when any holder’s shares of Class B common stock represents less than 5% of the aggregate number of all outstanding shares of our common stock, thereby further concentrating the voting power of our capital stock in a limited number of stockholders.
This amount exceeds 5% of our outstanding common stock, meaning our Board could issue Class B common stock without necessarily triggering the automatic conversion of that Class B common stock to Class A common stock that, pursuant to our charter, will occur when any holder’s shares of Class B common stock represents less than 5% of the aggregate number of all outstanding shares of our common stock, thereby further concentrating the voting power of our capital stock in a limited number of stockholders.
Examples of laws that may affect our ability to operate include: the Federal Anti-Kickback Statute, which prohibits, among other things, persons from knowingly and willfully soliciting, receiving, offering or paying remuneration, directly or indirectly, in exchange for, to induce or to reward either the referral of an individual for, or the purchase, order or recommendation of, any good or service for which payment may be made under federal healthcare programs such as the Medicare and Medicaid programs; federal false claims laws which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, claims for payment to Medicare, Medicaid, or other government payors that are false or fraudulent; HIPAA, which created federal criminal laws that prohibit executing a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters; the Federal Trade Commission Act and similar laws regulating advertisement and consumer protections; the FCPA, which prohibits corrupt payments, gifts or transfers of value to foreign officials; the Physician Payment Sunshine Act, which requires medical device companies to report ownership and investment interests by physicians and members of their immediate family as well as certain payments and other transfers of value, including gifts and other benefits, provided to physicians and certain other healthcare professionals licensed in the U.S. and to teaching hospitals; and foreign and U.S. state law and code equivalents of each of the above federal laws, such as anti-kickback and false claims laws and disclosure of transfers of value and gift bans with respect to healthcare professionals, some of which may apply to items or services reimbursed by any third-party payor, including commercial insurers.
Examples of laws that may affect our ability to operate include: • the Federal Anti-Kickback Statute, which prohibits, among other things, persons from knowingly and willfully soliciting, receiving, offering or paying remuneration, directly or indirectly, in exchange for, to induce or to reward either the referral of an individual for, or the purchase, order or recommendation of, any good or service for which payment may be made, in whole or in part, under federal healthcare programs such as the Medicare and Medicaid programs; • federal false claims laws which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, claims for payment to Medicare, Medicaid, or other government payors that are false or fraudulent; • HIPAA, which created federal criminal laws that prohibit executing a scheme to defraud any healthcare benefit program, regardless of whether the payor is public or private or making false statements relating to healthcare matters; • the Federal Trade Commission Act and similar laws regulating advertisement and consumer protections; • the FCPA, which prohibits corrupt payments, gifts or transfers of value to foreign officials; • the Physician Payment Sunshine Act, which requires medical device companies to report ownership and investment interests by physicians and members of their immediate family as well as certain payments and other transfers of value, including gifts and other benefits, provided to physicians and certain other healthcare professionals licensed in the U.S. and to teaching hospitals; and • foreign and U.S. state law and code equivalents of each of the above federal laws, such as anti-kickback and false claims laws and disclosure of transfers of value and gift bans with respect to healthcare professionals, some of which may apply to items or services reimbursed by any third-party payor, including commercial insurers.
Potential and completed acquisitions and strategic investments involve numerous risks, including: problems assimilating the purchased technologies, products or business operations; 26 Table of Contents issues maintaining uniform standards, procedures, controls and policies; unanticipated costs associated with acquisitions; diversion of management’s attention from our core business; adverse effects on existing business relationships with suppliers and customers; risks associated with entering new markets in which we have limited or no experience; potential loss of key employees of acquired businesses; and increased legal and accounting compliance costs.
Potential and completed acquisitions and strategic investments involve numerous risks, including: • problems assimilating the purchased technologies, products or business operations; • issues maintaining uniform standards, procedures, controls and policies; • unanticipated costs associated with acquisitions; • diversion of management’s attention from our core business; • adverse effects on existing business relationships with suppliers and customers; • risks associated with entering new markets in which we have limited or no experience; • potential loss of key employees of acquired businesses; and • increased legal and accounting compliance costs.
Alphatec Holdings, Orthofix, Integra LifeSciences , ZimVie and other smaller public and private companies are also competitors of ours. At any time, these or other industry participants may develop alternative treatments, products or procedures for the treatment of musculoskeletal disorders that compete directly or indirectly with our products.
Alphatec Holdings, Orthofix, Integra LifeSciences , ZimVie, Boston Scientific and other smaller public and private companies are also competitors of ours. At any time, these or other industry participants may develop alternative treatments, products or procedures for the treatment of musculoskeletal disorders that compete directly or indirectly with our products.
Our HCT/P products are subject to extensive government regulation and our failure to comply with these requirements could cause our business to suffer. In the U.S., we are marketing our human tissue products as Section 361 HCT/Ps, which are not subject to FDA premarket clearance or approval requirements.
Our HCT/P products are subject to extensive government regulation, and our failure to comply with these requirements could cause our business to suffer. In the U.S., we market our human tissue products as Section 361 HCT/Ps, which are not subject to FDA premarket clearance or approval requirements.
Additionally, in the EEA, we must inform the Notified Body that carried out the conformity assessment of the medical devices we market or sell in the EEA of any planned substantial changes to our quality system or changes to our devices which could affect compliance with the essential requirements or the devices’ intended use.
Additionally, in the EEA, we must inform the Notified Body that carried out the conformity assessment of the medical devices we market or sell in the EEA of any planned substantial changes to our quality system or changes to our devices which could affect compliance with the relevant requirements or the devices’ intended use.
Our industry is intensely competitive, subject to rapid change and highly sensitive to the introduction of new products or other market activities of industry participants. We believe that our significant competitors are Medtronic, DePuy Synthes, Stryker, Zimmer Biomet, and Smith + Nephew.
Our industry is intensely competitive, subject to rapid change and highly sensitive to the introduction of new products or other market activities of industry participants. We believe that our significant competitors are Medtronic, DePuy Synthes, Stryker, Zimmer Biomet, Smith + Nephew and VB Spine.
We may also be required to bear other costs or take other actions that may have a negative impact on our future sales and our ability to generate profits. In the EEA, we must comply with the EU Medical Device Vigilance System.
We may also be required to bear other costs or take other actions that may have a negative impact on our future sales and our ability to generate profits. In the EEA, we must comply with the requirements in the MDR and the EU Medical Device Vigilance System.
Risks Related to the Ownership of our Class A Common Stock Because of their significant stock ownership, our Executive Chairman, our chief executive officer, our other executive officers, and our directors and principal stockholders will be able to exert control over us and our significant corporate decisions.
Risks Related to the Ownership of our Class A Common Stock Because of their significant stock ownership, our Executive Chairman, our other executive officers, and our directors and principal stockholders will be able to exert control over us and our significant corporate decisions.
We and our third-party suppliers are required to comply with the FDA’s QSR, which covers the methods and documentation of the design, testing, production, control, quality assurance, labeling, packaging, sterilization, storage and shipping of our products.
We and our third-party suppliers are required to comply with the FDA’s QMSR, which covers the methods and documentation of the design, testing, production, control, quality assurance, labeling, packaging, sterilization, storage and shipping of our products.
We depend on a limited number of sources of human tissue for use in some of our regenerative biologics products and a limited number of entities to process the human tissue for use in those regenerative biologics products, and any failure to obtain tissue from 33 Table of Contents these sources or to have the tissue processed by these entities for us in a timely manner will interfere with our ability to effectively meet demand for our regenerative biologics products incorporating human tissue.
We depend on a limited number of sources of human tissue for use in some of our regenerative biologics products and a limited number of entities to process the human tissue for use in those regenerative biologics products, and any failure to obtain tissue from these sources or to have the tissue processed by these entities for us in a timely manner will interfere with our ability to effectively meet demand for our regenerative biologics products incorporating human tissue.
Because of the broad and far-reaching nature of these laws, we may be required to alter or discontinue one or more of our business practices. 34 Table of Contents Healthcare fraud and abuse regulations are complex, and even minor irregularities can potentially give rise to claims that a statute or prohibition has been violated.
Because of the broad and far-reaching nature of these laws, we may be required to alter or discontinue one or more of our business practices. Healthcare fraud and abuse regulations are complex, and even minor irregularities can potentially give rise to claims that a statute or prohibition has been violated.
A determination that we have failed to comply, whether knowingly or inadvertently, may result in substantial penalties, including fines and enforcement actions and civil and/or criminal sanctions, the disgorgement of profits and the imposition of a court-appointed monitor, as well as the denial of export privileges, and may have an adverse effect on our reputation.
A determination that we have failed to comply, whether knowingly or inadvertently, may result in substantial penalties, including fines and enforcement actions and civil and/or criminal sanctions, the disgorgement of 36 Table of Contents profits and the imposition of a court-appointed monitor, as well as the denial of export privileges, and may have an adverse effect on our reputation.
Our information technology systems are vulnerable to damage or interruption from: earthquakes, fires, floods and other natural disasters; terrorist attacks and attacks by computer viruses or hackers or other cybersecurity attacks or breaches; human errors in configuration, management, hosting, and maintenance of the IT Systems; power losses; and computer systems, or Internet, telecommunications or data network failures.
Our information technology systems are vulnerable to damage or interruption from: • earthquakes, fires, floods and other natural disasters; • terrorist attacks and attacks by computer viruses or hackers or other cybersecurity attacks or breaches; • human errors in configuration, management, hosting, and maintenance of the IT Systems; 28 Table of Contents • power losses; and • computer systems, or Internet, telecommunications or data network failures.
The process of obtaining regulatory clearances through the 510(k) process, de novo classification, or approvals through the PMA process to market a medical device in the U.S. or internationally can be costly and time-consuming, and we may not be able to obtain these clearances, grants of de novo classification, or approvals on a timely basis, if at all.
The process of obtaining regulatory clearances through the 510(k) process, de 30 Table of Contents novo classification, or approvals through the PMA process to market a medical device in the U.S. or internationally can be costly and time-consuming, and we may not be able to obtain these clearances, grants of de novo classification, or approvals on a timely basis, if at all.
Our amended and restated certificate of incorporation and amended and restated bylaws contain other provisions that could delay or prevent a change of control of our company or changes in our Board that our stockholders might consider favorable.
Our amended and restated certificate of incorporation and amended and restated bylaws (the “Bylaws”) contain other provisions that could delay or prevent a change of control of the Company or changes in our Board that our stockholders might consider favorable.
Our relationships with surgeons, hospitals and our independent distributors are subject to scrutiny under these laws. Violations of these laws are punishable by criminal and civil sanctions, including, in some instances, imprisonment and exclusion from participation in federal and state healthcare programs, including the Medicare, Medicaid and Veterans Administration health programs.
Our relationships with surgeons, hospitals and our independent distributors are subject to 34 Table of Contents scrutiny under these laws. Violations of these laws are punishable by criminal and civil sanctions, including, in some instances, imprisonment and exclusion from participation in federal and state healthcare programs, including the Medicare, Medicaid and Veterans Administration health programs.
These and other factors may have a material adverse effect on our international operations or on our business, results of operations and financial condition generally. 36 Table of Contents Our results of operations could suffer if we are unable to manage our planned international expansion effectively. Expansion into international markets is an element of our business strategy and involves risk.
These and other factors may have a material adverse effect on our international operations or on our business, results of operations and financial condition generally. Our results of operations could suffer if we are unable to manage our planned international expansion effectively. Expansion into international markets is an element of our business strategy and involves risk.
If our sales grow more slowly than 37 Table of Contents we anticipate or if our operating expenses exceed our expectations, our business, financial condition and results of operations will likely be adversely affected. We may be unable to grow our revenue or earnings as anticipated, which may have a material adverse effect on our results of operations.
If our sales grow more slowly than we anticipate or if our operating expenses exceed our expectations, our business, financial condition and results of operations will likely be adversely affected. We may be unable to grow our revenue or earnings as anticipated, which may have a material adverse effect on our results of operations.
The failure of our business partners or suppliers to ensure that AI systems are used in a safe and secure manner may expose us to novel cybersecurity risks, which could have a material adverse effect on our reputation, business, results of operations and financial condition.
The failure of the Company, our business partners or suppliers to ensure that AI systems are used in a safe and secure manner may expose us to novel cybersecurity and data privacy risks, which could have a material adverse effect on our reputation, business, results of operations and financial condition.
It is possible that the integration process could result in the loss of key employees, the loss of customers, the disruption of the Company’s business, inconsistencies in standards, controls, procedures and policies, unexpected integration issues, higher than expected integration costs and an overall post-NuVasive Merger integration process that takes longer than originally anticipated.
It is possible that the integration process could result in the loss of key employees, the loss of customers, the disruption of the Company’s business, inconsistencies in standards, controls, procedures and policies, unexpected integration issues, higher than expected integration costs and an overall post-NuVasive and Nevro Mergers integration process that takes longer than originally anticipated.
In the U.S., all of our currently commercialized medical device products, other than SECURE-C ® and Simplify ® Cervical Artificial Disc, have either received premarket clearance under Section 510(k) of the FDCA or are exempt from PMA review.
In the U.S., all of our currently commercialized medical device products, other than SECURE-C ® and Simplify ® Cervical Artificial Disc and the Senza ® SCS system, have either received premarket clearance under Section 510(k) of the FDCA or are exempt from PMA review.
In addition to the sanctions described above, any state or federal regulatory review 35 Table of Contents or FCA lawsuit, regardless of the outcome, would be costly and time-consuming and could have a material adverse effect on our business, financial condition and results of operations.
In addition to the sanctions described above, any state or federal regulatory review or FCA lawsuit, regardless of the outcome, would be costly and time-consuming and could have a material adverse effect on our business, financial condition and results of operations.
Because of their significant stock ownership, our Executive Chairman, our chief executive officer, our other executive officers, and our directors will be able to exert substantial control over us and our significant corporate decisions.
Because of their significant stock ownership, our Executive Chairman, our other executive officers, and our directors will be able to exert substantial control over us and our significant corporate decisions.
The FDA audits compliance with the QSR and CGTP requirements through periodic announced and unannounced inspections of manufacturing and other facilities. The FDA may conduct inspections or audits at any time.
The FDA audits compliance with the QMSR and CGTP requirements through periodic announced and unannounced inspections of manufacturing and other facilities. The FDA may conduct inspections or audits at any time.
As a result, we currently lack the breadth of published long-term clinical data supporting the safety and efficacy of virtually all of our products and the benefits they offer that might have been generated in connection with other approval processes.
As a result, we currently lack the breadth of published long-term clinical data supporting the safety and efficacy of many of our products and the benefits they offer that might have been generated in connection with other approval processes.
If NOTA is interpreted or enforced in a manner that prevents us from receiving payment for services we render or that prevents us from paying tissue banks or certain of our clients for the services they render for us, our business could be materially adversely affected.
If NOTA is interpreted or enforced in a manner that prevents us from receiving payment for services we render or that prevents us from paying tissue banks or certain of our clients for the services they 33 Table of Contents render for us, our business could be materially adversely affected.
Our operating results are directly dependent upon the sales and marketing efforts of not only our employees, but also our independent distributors. We expect our direct sales representatives and independent distributors to develop long-lasting relationships 23 Table of Contents with the surgeons they serve.
Our operating results are directly dependent upon the sales and marketing efforts of not only our employees, but also our independent distributors. We expect our direct sales representatives and independent distributors to develop long-lasting relationships with the surgeons they serve.
As a result, our ability to compete successfully will depend on our ability to develop proprietary products that reach the market in a timely manner, receive adequate coverage and reimbursement from third-party payors, and are safer, less invasive and more effective 24 Table of Contents than alternatives available for similar purposes.
As a result, our ability to compete successfully will depend on our ability to develop proprietary products that reach the market in a timely manner, receive adequate coverage and reimbursement from third-party payors, and are safer, less invasive and more effective than alternatives available for similar purposes.
We could become the subject of product liability lawsuits alleging that component failures, manufacturing flaws, design defects or inadequate disclosure of product-related risks or product-related information resulted in an unsafe condition or injury to patients.
We could become the subject of product liability lawsuits alleging that component failures, manufacturing flaws, design defects or inadequate disclosure of product-related risks or product-related information resulted in an 41 Table of Contents unsafe condition or injury to patients.
If the FDA requires us to go through a lengthier, more 30 Table of Contents rigorous examination for future products or modifications to existing products than we had expected, our product introductions or modifications could be delayed or canceled, which could cause our sales to decline and potentially harm our ability to compete.
If the FDA requires us to go through a lengthier, more rigorous examination for future products or modifications to existing products than we had expected, our product introductions or modifications could be delayed or canceled, which could cause our sales to decline and potentially harm our ability to compete.
We may also have difficulty obtaining similar components from other suppliers that are acceptable to the FDA or other foreign regulatory authorities. We could incur delays while we locate and engage qualified alternative suppliers, and we may be unable to engage alternative suppliers on favorable terms or at all.
We may also have difficulty obtaining 25 Table of Contents similar components from other suppliers that are acceptable to the FDA or other foreign regulatory authorities. We could incur delays while we locate and engage qualified alternative suppliers, and we may be unable to engage alternative suppliers on favorable terms or at all.
Furthermore, as of December 31, 2024, we had 192,602,552 shares of Class B common stock available for issuance.
Furthermore, as of December 31, 2025, we had 192,602,552 shares of Class B common stock available for issuance.
The medical device industry is characterized by patent litigation and we could become subject to litigation that could be costly, result in the diversion of management’s time and efforts, require us to pay damages, and/or prevent us from marketing our existing or future products.
Patent litigation is highly prevalent in the medical device industry, and we could become subject to litigation that could be costly, result in the diversion of management’s time and efforts, require us to pay damages, and/or prevent us from marketing our existing or future products.
If our product liability insurance is inadequate to pay a damages award, we may have to pay the excess out of our cash reserves, which may 41 Table of Contents harm our financial condition.
If our product liability insurance is inadequate to pay a damages award, we may have to pay the excess out of our cash reserves, which may harm our financial condition.
As legal and regulatory requirements governing the utilization of AI are further developed, we may face increased costs associated with operating in a competitive manner while maintaining compliance with U.S. and foreign regulations governing the utilization of AI and AI systems.
As legal and regulatory requirements governing the utilization of AI are further developed, we may face increased costs or potential liability associated with operating in a competitive manner while maintaining compliance with evolving U.S. and foreign regulations governing the utilization of AI and AI systems.
In the EU, stringent data protection and privacy rules impact the use of patient data across the healthcare industry. The GDPR applies across the EU, with similar requirements applying to the UK and European Economic Area countries, and includes, among other things, a requirement for prompt notice of data breaches in certain circumstances and imposes significant fines for non-compliance.
In the EU, stringent data protection and privacy rules impact the use of patient data across the healthcare industry. The GDPR applies across the EU, with similar requirements applying to the UK and European Economic Area countries, and includes, among other things, a requirement for prompt notice of data breaches in certain circumstances.
International operations account for approximately 20.6% of our total net sales, and we intend to continue to expand our international presence. A significant portion of our foreign revenues and expenses are generated in Japan, the Euro zone, UK and Australia.
International operations account for approximately 19.4% of our total net sales, and we intend to continue to expand our international presence. A significant portion of our foreign revenues and expenses are generated in Japan, the Euro zone, UK and Australia.
An inability to realize the full extent of the anticipated benefits of the NuVasive Merger, as well as any delays encountered in the integration process, could have an adverse effect upon the revenues, level of expenses and operating results of the Company, which may adversely affect the value of the common stock of the Company.
An inability to realize the full extent of the anticipated benefits of the NuVasive and Nevro Mergers, as well as any delays encountered in the integration process, could have an adverse effect upon the revenues, level of expenses and operating results of the Company, which may adversely affect the value of the Class A common stock of the Company.
While we are committed to the responsible and beneficial use of AI, the use or misuse of AI by our suppliers, business partners or competitors may result in new threats and challenges to our business, the nature of which is unable to be determined at this time.
While we are committed to the responsible and beneficial use of AI and machine learning, the use or misuse of these technologies by ourselves, our suppliers, business partners or competitors may result in new threats and challenges to our business, the nature of which is unable to be determined at this time.
In addition, at times the attention of certain members of the Company’s management and resources may be focused on the integration of the businesses of the two companies and diverted from day-to-day business operations or other opportunities that may have been beneficial to such company, which may disrupt each company’s ongoing business and the business of the Company.
In addition, at times the attention of certain members of the Company’s management and resources may be focused on the integration of the businesses of NuVasive and Nevro and diverted from day-to-day business operations or other opportunities that may have been beneficial to such company, which may disrupt each company’s ongoing business and the business of the Company. Item 1B.
Risks Related to our Financial Results and Need for Financing We will need to generate significant sales to remain profitable We may be unable to grow our revenue or earnings as anticipated, which may have a material adverse effect on our results of operations. Our quarterly and annual operating results may fluctuate significantly. We have a significant amount of outstanding indebtedness, and our financial condition and results of operations could be adversely affected if we do not effectively manage our liabilities. The availability of funding under existing credit arrangements may be limited, and our cash and cash equivalents are subject to volatility. Our future capital needs are uncertain and we may need to raise funds in the future, and such funds may not be available on acceptable terms or at all. Our existing revolving credit facility contains restrictive covenants that may limit our operating flexibility.
Risks Related to our Financial Results and Need for Financing • We will need to generate significant sales to remain profitable. • We may be unable to grow our revenue or earnings as anticipated, which may have a material adverse effect on our results of operations. • Our quarterly and annual operating results may fluctuate significantly. • The availability of funding under existing credit arrangements may be limited, and our cash and cash equivalents are subject to volatility. • Our future capital needs are uncertain, and we may need to raise funds in the future, and such funds may not be available on acceptable terms or at all. • Our existing revolving credit facility contains restrictive covenants that may limit our operating flexibility.
Possible sanctions for violation of these laws include monetary penalties and other civil and criminal sanctions, exclusion from Medicare and Medicaid programs and forfeiture of amounts collected in violation of such prohibitions.
Possible sanctions for violation of these laws include monetary penalties and other civil and criminal sanctions, exclusion from participation in federal healthcare programs such as Medicare and Medicaid and forfeiture of amounts collected in violation of such prohibitions.
The success of the NuVasive Merger will depend on, among other things, our ability to realize the anticipated synergies, efficiencies and other benefits from combining the businesses of Globus and NuVasive. This success will depend on, among other factors, our ability to successfully integrate the Company’s business with the business of NuVasive.
The success of the NuVasive and Nevro Mergers will depend on, among other things, our ability to realize the anticipated synergies, efficiencies and other benefits from combining the businesses of Globus and NuVasive and Nevro, respectively. This success will depend on, among other factors, our ability to successfully integrate the Company’s business with the respective businesses of NuVasive and Nevro.
Failure to comply with applicable regulations could jeopardize our ability to sell our products and result in enforcement actions such as: untitled letters or warning letters; fines; injunctions; civil penalties; termination of distribution; recalls or seizures of products; delays in the introduction of products into the market; total or partial suspension of production; refusal of the FDA or other regulator to grant future clearances or approvals; withdrawals or suspensions of current clearances or approvals, resulting in prohibitions on sales of our products; refusal to grant export approvals; and/or 31 Table of Contents in the most serious cases, criminal penalties.
Failure to comply with applicable regulations could jeopardize our ability to sell our products and result in enforcement actions such as: • untitled letters or warning letters; • fines; • import alerts; • injunctions; • civil penalties; 31 Table of Contents • termination of distribution; • recalls or seizures of products or limits on our ability to sell our products in certain territories; • increased inspections and scrutiny by regulatory authorities; • delays in the introduction of products into the market; • total or partial suspension of production; • refusal of the FDA or other regulator to grant future clearances or approvals; • withdrawals or suspensions of current clearances or approvals, resulting in prohibitions on sales of our products; • refusal to grant export approvals; and/or • in the most serious cases, criminal penalties.
We have experienced rapid growth since our inception and increased our net sales to $2,519.4 million in 2024. Our ability to achieve future growth will depend upon, among other things, the success of our growth strategies, which we cannot assure will be successful.
We have experienced rapid growth since our inception and increased our net sales to $2,938.9 million in 2025. Our ability to achieve future growth will depend upon, among other things, the success of our growth strategies, which we cannot assure will be successful.
EU CE markings for medical devices will continue to be recognized in Great Britain until June 30, 2028, and certificates issued for medical devices by EU-recognized Notified Bodies will continue to be valid for the Great Britain market until June 30, 2028 and the EU no longer recognizes UK Notified Bodies.
EU CE markings for medical devices will continue to be recognized in Great Britain until June 30, 2028, and certificates issued for medical devices by EU-designated Notified Bodies will continue to be valid for the Great Britain market until June 30, 2028; however the EU no longer recognizes UK Notified Bodies, now known as Approved Bodies.
If we or our suppliers have significant non-compliance issues or if any corrective action plan that we or our suppliers propose in response to observed deficiencies is not sufficient, the FDA could take enforcement action, including any of the following sanctions: untitled letters, warning letters, fines, injunctions, consent decrees and civil penalties; customer notifications or repair, replacement, refunds, recall, detention or seizure of our products; operating restrictions or partial suspension or total shutdown of production; refusing or delaying our requests for 510(k) or de novo clearance or PMA of new products or modified products; withdrawing 510(k) or de novo clearances or PMAs that have already been granted; refusal to grant export approval for our products; or criminal prosecution.
If we or our suppliers have significant non-compliance issues or if any corrective action plan that we or our suppliers propose in response to observed deficiencies is not sufficient, the FDA could take enforcement action, including any of the following sanctions: • untitled letters, warning letters, fines, import alerts, injunctions, consent decrees and civil penalties; • customer notifications or repair, replacement, refunds, recall, detention or seizure of our products; • operating restrictions or partial suspension or total shutdown of production; • refusing or delaying our requests for 510(k) or de novo clearance or PMA of new products or modified products; • withdrawing 510(k) or de novo clearances or PMAs that have already been granted; • refusal to grant export approval for our products; or • criminal prosecution. 32 Table of Contents Any of these sanctions could have a material adverse effect on our reputation, business, results of operations and financial condition.
Paul, our Executive Chairman, and his family members, controlled approximately 16.2% of our Class A and Class B common stock, representing approximately 65.6% of the voting power of our outstanding capital stock as of that date. As a result, David C.
Paul, our Executive Chairman, and his family members, controlled approximately 16.5% of our Class A common stock and Class B common stock, representing approximately 66.1% of the voting power of our outstanding capital stock as of that date. As a result, David C.
Our sales and results of operations will be affected by numerous factors, including: our ability to drive increased sales of our products; our ability to establish and maintain an effective and dedicated sales force; pricing pressure applicable to our products, including adverse third-party coverage and reimbursement outcomes; results of clinical research and trials on our existing products and products in development; the mix of our products sold because profit margins differ amongst our products; timing of new product offerings, acquisitions, licenses or other significant events by us or our competitors; the ability of our suppliers to timely provide us with an adequate supply of materials and components; the evolving product offerings of our competitors; regulatory approvals and legislative changes affecting the products we may offer or those of our competitors; interruption in the manufacturing or distribution of our products; the effect of competing technological, industry and market developments; changes in our ability to obtain regulatory clearance or approval for our products; and our ability to expand the geographic reach of our sales and marketing efforts.
Our sales and results of operations will be affected by numerous factors, including: • our ability to drive increased sales of our products; • our ability to establish and maintain an effective and dedicated sales force; • pricing pressure applicable to our products, including adverse third-party coverage and reimbursement outcomes; • results of clinical research and trials on our existing products and products in development; • the mix of our products sold because profit margins differ amongst our products; • timing of new product offerings, acquisitions, licenses or other significant events by us or our competitors; • the ability of our suppliers to timely provide us with an adequate supply of materials and components; • the evolving product offerings of our competitors; • regulatory approvals and legislative changes affecting the products we may offer or those of our competitors; • interruption in the manufacturing or distribution of our products; • the effect of competing technological, industry and market developments; • changes in our ability to obtain regulatory clearance or approval for our products; and • our ability to expand the geographic reach of our sales and marketing efforts. 38 Table of Contents Many of the products we may seek to develop and introduce in the future will require FDA approval or clearance before commercialization in the U.S., and commercialization of such products outside of the U.S. would likely require additional regulatory approvals and import licenses.
Shifts in governmental policies including tariffs, trade policies or regulations in various jurisdictions could increase the cost of raw materials and components necessary for our operations, disrupt supply chains and negatively impact profitability. Tariffs may increase product costs for our customers, ultimately lowering consumer demand.
As discussed in greater detail below, shifts in governmental policies including tariffs, trade policies or regulations in various jurisdictions have and could continue to increase the cost of raw materials and components necessary for our operations, disrupt supply chains and negatively impact profitability. Tariffs may increase product costs for our customers, ultimately lowering consumer demand.
While we generally apply for patents in those countries where we intend to make, have made, use or sell patented products, we may not accurately predict all of the countries where patent protection will ultimately be desirable.
We have applied for patent protection relating to certain existing and proposed products and processes. While we generally apply for patents in those countries where we intend to make, have made, use or sell patented products, we may not accurately predict all of the countries where patent protection will ultimately be desirable.
If we are not able to successfully integrate NuVasive’s business into the Company within the anticipated timeframe, or at all, the anticipated synergies, efficiencies and other benefits of the NuVasive Merger may not be realized fully, or at all, or may take longer to realize than expected.
If we are not able to successfully integrate these businesses into the Company within the anticipated timeframe, or at all, the anticipated synergies, efficiencies and other benefits of the NuVasive and Nevro Mergers may not be realized fully, or at all, or may take longer to realize than expected.
From time to time we expect to consider opportunities to acquire or make investments in other technologies, products and businesses that may enhance our capabilities, complement our current products or expand the breadth of our markets or customer base.
We have acquired, and expect to consider opportunities in the future to acquire or make investments in, technologies, products and businesses that may enhance our capabilities, complement our current products or expand the breadth of our markets or customer base.
Risks Related to our International Operations We may fail to obtain or maintain foreign regulatory approvals to market our products in other countries. We are subject to risks associated with our non-U.S. operations. Our results of operations could suffer if we are unable to manage our planned international expansion effectively. We are subject to risks arising from currency exchange rate fluctuations on our international transactions and translation of local currency results into U.S. dollars, which could adversely affect our profitability.
Risks Related to our International Operations • We may fail to obtain or maintain foreign regulatory approvals to market our products in other countries. • We are subject to risks associated with our non-U.S. operations. • Our results of operations could suffer if we are unable to manage our planned international expansion effectively. • We are subject to risks arising from currency exchange rate fluctuations on our international transactions and translation of local currency results into U.S. dollars, which could adversely affect our profitability. • Tariff policies and potential countermeasures could increase our costs and disrupt our global supply chain, which could negatively impact the results of our operations.
The above factors may contribute to fluctuations in our quarterly operating results. Because of these fluctuations, it is possible that in future periods our operating results will fall below the expectations of securities analysts or investors. If that happens, the market price of our stock would likely decrease.
The above factors may contribute to fluctuations in our quarterly operating results. Because of these fluctuations, it is possible that in future periods our operating results will fall below the expectations of securities analysts or investors.
Private payors may adopt coverage decisions and payment amounts determined by CMS as guidelines in setting their coverage and reimbursement policies. Private payors that do not follow the Medicare guidelines may adopt different coverage and reimbursement policies for procedures performed with our products. In addition, for governmental programs, such as Medicaid, coverage and reimbursement differs from state to state.
Private payors may adopt coverage decisions and payment amounts determined by CMS as guidelines in setting their coverage and reimbursement policies. Private payors that do not follow the Medicare guidelines may adopt different coverage and reimbursement policies for procedures performed with our products.
If implemented, these tariffs and countermeasures could increase the cost of raw materials and components necessary for our operations, disrupt our global supply chain and create additional operational challenges. Further, it is possible that government policy changes and related uncertainty about policy changes could increase market volatility and currency exchange rate fluctuations.
Specifically, changes to tariffs and trade policies have and could continue to impact the cost of raw materials and components necessary for our operations, disrupt our global supply chain and create additional operational challenges. Further, it is possible that government policy changes and related uncertainty about policy changes could increase market volatility and currency exchange rate fluctuations.
The failure of our IT Systems to perform as we anticipate or our failure to effectively implement new systems could disrupt our entire operation and could result in decreased sales, increased overhead costs, excess inventory and product shortages, all of which could have a material adverse effect on our reputation, business, results of operations and financial condition. 28 Table of Contents The increasing utilization of AI in the medical device and healthcare industries presents novel obstacles and risks to our business.
The failure of our IT Systems to perform as we anticipate or our failure to effectively implement new systems could disrupt our entire operation and could result in decreased sales, increased overhead costs, excess inventory and product shortages, all of which could have a material adverse effect on our reputation, business, results of operations and financial condition.
The failure of our information technology systems to perform as we anticipate or our failure to effectively implement new systems could disrupt our operations and could result in decreased sales, increased overhead costs, excess inventory and product shortages, all of which could have a material adverse effect on our reputation, business, results of operations and financial condition. 27 Table of Contents We are subject to data privacy laws and our failure to comply with them could subject us to substantial liabilities.
The failure of our information technology systems to perform as we anticipate or our failure to effectively implement new systems could disrupt our operations and could result in decreased sales, increased overhead costs, excess inventory and product shortages, all of which could have a material adverse effect on our reputation, business, results of operations and financial condition.
Accordingly, while we remain a controlled company and during any transition period following a time when we are no longer a controlled company, you will not have the same protections afforded to stockholders of companies that are subject to all of the New York Stock Exchange’s corporate governance requirements. 42 Table of Contents Our Board is authorized to issue and designate shares of our preferred stock in additional series without stockholder approval.
Accordingly, while we remain a controlled company and during any transition period following a time when we 42 Table of Contents are no longer a controlled company, you will not have the same protections afforded to stockholders of companies that are subject to all of the New York Stock Exchange’s corporate governance requirements.
Reimbursement and healthcare payment systems in international markets vary significantly by country, and include both government-sponsored healthcare and private insurance. Our Musculoskeletal Solutions products may not obtain international coverage and reimbursement approvals in a timely manner, if at all.
Reimbursement and healthcare payment systems in international markets vary significantly by country, and include both government-sponsored healthcare and private insurance and generally have lower prices and more restrictive reimbursement conditions than in the U.S. Our Musculoskeletal Solutions products may not obtain international coverage and reimbursement approvals in a timely manner, if at all.
Medicaid payments to physicians and facilities are often lower than payments by other third-party payors and some state Medicaid programs may not pay an adequate amount for the procedures performed with our products, if any payment is made at all.
In 23 Table of Contents addition, for governmental programs, such as Medicaid, coverage and reimbursement differs from state to state. Medicaid payments to physicians and facilities are often lower than payments by other third-party payors and some state Medicaid programs may not pay an adequate amount for the procedures performed with our products, if any payment is made at all.
Additionally, our future success will depend on, among other things, our ability to continue to hire and retain the necessary qualified scientific, technical and managerial personnel, for whom we compete with numerous other companies, academic institutions and organizations.
The loss of any one of these individuals could disrupt our operations or our strategic plans. Additionally, our future success will depend on, among other things, our ability to continue to hire and retain the necessary qualified scientific, technical and managerial personnel, for whom we compete with numerous other companies, academic institutions and organizations.
Based on an aggregate of 137,420,316 shares of our Class A and Class B common stock outstanding as of December 31, 2024, our executive officers and directors and their affiliates beneficially owned, in the aggregate, approximately 65.8% of the voting power of our outstanding capital stock. In particular, as of December 31, 2024, David C.
Based on an aggregate of 135,055,223 shares of our Class A common stock and Class B common stock outstanding as of December 31, 2025, our executive officers and directors and their affiliates beneficially owned, in the aggregate, approximately 66.3% of the voting power of our outstanding capital stock. In particular, as of December 31, 2025, David C.

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Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

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Biggest changeIn addition to our extensive in-house cybersecurity capabilities, at times we also engage assessors, consultants, auditors, or other third parties to assist with assessing, identifying and managing cybersecurity risks. Our cybersecurity risks and associated mitigations are evaluated by senior leadership, including as part of our risk assessments that are reviewed by the Audit Committee and our Board of Directors.
Biggest changeOur cybersecurity risks and associated mitigations are evaluated by senior leadership, including as part of our risk assessments that are reviewed by the Audit Committee and our Board.
Cybersecurity Risk Management , Strategy, Governance, and Incident Disclosure We have processes in place for assessing, identifying, and managing material risks from cybersecurity threats, including potential unauthorized occurrences on or through both, our physical systems and electronic information systems, that could adversely affect the confidentiality, integrity, or availability of our information systems or the information residing on those systems.
Item 1C. Cybersecurity Risk Management, Strategy, Governance, and Incident Disclosure We have processes in place for assessing, identifying, and managing material risks from cybersecurity threats, including potential unauthorized occurrences on or through both, our physical systems and electronic information systems, that could adversely affect the confidentiality, integrity, or availability of our information systems or the information residing on those systems.
We have a unified and centrally-coordinated team, led by our Vice President of IT, that is responsible for implementing and maintaining centralized cybersecurity and data protection practices at Globus in close coordination with senior leadership and other teams across Globus. Reporting to our Vice president of IT are a number of trained information security professionals.
We have a unified and centrally-coordinated team, led by our Senior Vice President of Global Quality, Regulatory, and IT, that is responsible for implementing and maintaining centralized cybersecurity and data protection practices at Globus in close coordination with senior leadership and other teams across Globus.
The Board of Directors, which is comprised of independent directors, oversees our policies and procedures for protecting our cybersecurity infrastructure and for compliance with applicable data protection and security regulations, and related risks. They receive reports regarding such risks from management, including our Vice President of IT. They also oversee the response to any significant cybersecurity incidents.
The Board, the majority of which is comprised of independent directors, oversees our policies and procedures for protecting our cybersecurity infrastructure and for compliance with applicable data protection and security regulations, and related risks. The Board receives reports regarding such risks from management, including our Senior Vice President of Global Quality, Regulation, and IT.
Our Vice President of IT, who has extensive cybersecurity knowledge and skills gained from over 25 years of work experience, heads the team responsible for implementing and maintaining cybersecurity and data protection practices at Globus and reports directly to the Chief Operating Officer.
Our Senior Vice President of Global Quality, Regulatory, and IT, who has extensive cybersecurity knowledge and skills gained from 20 years of work experience, leads a team of individuals who have extensive cybersecurity knowledge and skills gained from years of work experience, heads the team responsible for implementing and maintaining cybersecurity and data protection practices at Globus and reports directly to the Chief Executive Officer. 46 Table of Contents
Added
Reporting to our Senior Vice President of Global Quality, Regulation, and IT are a number of trained information security professionals. In addition to our in-house cybersecurity capabilities, at times we also engage assessors, consultants, auditors, or other third parties to assist with assessing, identifying and managing cybersecurity risks.
Added
The Board also oversees the response to any significant cybersecurity incidents.

Item 2. Properties

Properties — owned and leased real estate

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Biggest changeWe maintain leased distribution warehouses and administrative offices in seventeen additional countries. 46 Table of Contents
Biggest changeWe maintain leased distribution warehouses and administrative offices in fourteen additional countries.

Item 3. Legal Proceedings

Legal Proceedings — active lawsuits and investigations

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Biggest changeFinancial Statements and Supplementary Data; Notes to Consolidated Financial Statements; Note 15. Commitments and Contingencies” below. In addition, we are subject to legal proceedings arising in the ordinary course of business. Item 4. Mine Safety Disclosures Not applicable. ‎ 47 Table of Contents PART II
Biggest changeFinancial Statements and Supplementary Data; Notes to Consolidated Financial Statements; Note 15. Commitments and Contingencies” below. In addition, we are subject to legal proceedings arising in the ordinary course of business.
Added
Consistent with Item 103 of Regulation S-K, we have elected to disclose those environmental proceedings with a governmental entity as a party where the Company reasonably believes that such proceeding would result in monetary sanctions, exclusive of interest and costs, of $1.0 million or more.
Added
Applying this threshold, there are no environmental matters to disclose for the fiscal year ended December 31, 2025. Item 4. Mine Safety Disclosures Not applicable. 47 Table of Contents PART II

Item 4. Mine Safety Disclosures

Mine Safety Disclosures — required of mining issuers

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Biggest changeItem 4. Mine Safety Disclosures 47 PART II Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 48 Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations 50 Item 7A. Quantitative and Qualitative Disclosure About Market Risk 60 Item 8. Financial Statements and Supplementary Data 62
Biggest changeItem 4. Mine Safety Disclosures 47 PART II Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 48 I tem 6. [ Reserved] 49 Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations 50 Item 7A. Quantitative and Qualitative Disclosure About Market Risk 60 Item 8.

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

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Biggest changeThe shares may be purchased through privately negotiated or open market transactions. This program has no time limit and may be suspended for periods or discontinued at any time. (b) Inclusive of an immaterial amount of commission fees. Dividend Policy We have never declared or paid any cash dividends on our capital stock.
Biggest change(b) Inclusive of an immaterial amount of commission fees. Dividend Policy We have never declared or paid any cash dividends on our capital stock. We currently intend to retain future earnings, if any, for development of our business and do not anticipate that we will declare or pay cash dividends on our capital stock in the foreseeable future.
The graph assumes an initial investment of $100 on December 31, 2019, in each of our Class A Common, the stocks comprising the S&P 500 Index, and the stocks comprising the S&P 500 Health Care Equipment Index, including reinvestment of dividends, if any. Historical stockholder return is not necessarily indicative of the performance to be expected for any future periods.
The graph assumes an initial investment of $100 on December 31, 2020, in each of our Class A Common, the stocks comprising the S&P 500 Index, and the stocks comprising the S&P 500 Health Care Equipment Index, including reinvestment of dividends, if any. Historical stockholder return is not necessarily indicative of the performance to be expected for any future periods.
Item 5. Market for the Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities Class A Common Stock Our Class A common stock (“Class A Common”) trades on The New York Stock Exchange, under the symbol “GMED.” We had approximately 60 stockholders of record as of February 18, 2025.
Item 5. Market for the Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities Class A Common Stock Our Class A common stock (“Class A Common”) trades on The New York Stock Exchange, under the symbol “GMED.” We had approximately 61 stockholders of record as of February 20, 2026.
( In thousands except for per share prices ) Period Total number of shares purchased (a) Average price paid per share (b) Total number of shares purchased as part of publicly announced plans or programs (a) Approximate dollar value of shares that may yet be purchased under the plans or programs (a) October 1, 2024 - October 31, 2024 — — — 190,261 November 1, 2024 - November 30, 2024 — — — 190,261 December 1, 2024 - December 31, 2024 — — — 190,261 Total — — (a) On March 11, 2020, our Board of Directors authorized a share repurchase program that allows for the repurchase up to $200 million of the Company’s Class A Common.
(In thousands except for per share prices) Period Total number of shares purchased (a) Average price paid per share (b) Total number of shares purchased as part of publicly announced plans or programs (a) Approximate dollar value of shares that may yet be purchased under the plans or programs (a) October 1, 2025 - October 31, 2025 767 58.65 767 390,000 November 1, 2025 - November 30, 2025 — — — 390,000 December 1, 2025 - December 31, 2025 — — — 390,000 Total 767 767 (a) On May 15, 2025, the Board approved a new share repurchase program that authorizes the Company to repurchase $500.0 million of the Company’s Class A Common.
Issuer Purchases of Equity Securities We repurchase shares of the Company’s Class A Common pursuant to the publicly announced share repurchase program authorized by the Board of Directors in March 2020 and the expansion of the stock repurchase plan authorized by the Board of Directors in March 2022.
Issuer Purchases of Equity Securities We previously repurchased shares of our Class A Common pursuant to the publicly announced $200 million share repurchase program that was authorized by the Board in March 2020 and subsequently increased by authorization of the Board by $200 million and $350 million in March 2022 and September 2023, respectively.
We currently intend to retain future earnings, if any, for development of our business and do not anticipate that we will declare or pay cash dividends on our capital stock in the foreseeable future. ‎ 48 Table of Contents Comparative Stock Performance Graph The following graph illustrates a comparison of the total cumulative stockholder return on our Class A Common from December 31, 2019 through December 31, 2024 to two indices: the S&P 500 Index and the S&P 500 Health Care Equipment Index.
Comparative Stock Performance Graph The following graph illustrates a comparison of the total cumulative stockholder return on our Class A Common from December 31, 2020 through December 31, 2025 to two indices: the S&P 500 Index and the S&P 500 Health Care Equipment Index.
The following graph and related information shall not be deemed “soliciting material” or to be “filed” with the SEC, nor shall such information be incorporated by reference into any future filing, except to the extent that we specifically incorporate it by reference into such filing.
The following graph and related information shall not be deemed “soliciting material” or to be “filed” with the SEC, nor shall such information be incorporated by reference into any future filing, except to the extent that we specifically incorporate it by reference into such filing. 48 Table of Contents Company/Index 2020 2021 2022 2023 2024 2025 Globus Medical, Inc. $100 $111 $114 $82 $127 $134 S&P 500 Index $100 $129 $105 $133 $166 $196 S&P 500 Health Care Equipment $100 $119 $97 $106 $117 $127
Removed
On September 27, 2023, the share repurchase program was expanded by authorizing the Company to repurchase an additional $350.0 million of the Company’s Class A Common. The following table provides the activity related to share repurchases for the fourth quarter of 2024.
Added
On May 15, 2025, the Board approved a new share repurchase program that authorizes the Company to repurchase $500.0 million of the Company's Class A Common. Repurchases may be made through privately negotiated transactions or open market transactions, including pursuant to a trading plan in accordance with Rule 10b5-1 and/or Rule 10b-18 under the Exchange Act.
Removed
On March 4, 2022, our Board of Directors authorized the expansion of the share repurchase program of the Company’s Class A Common by an additional $200 million. On September 27, 2023, the share repurchase program was expanded by authorizing the Company to repurchase an additional $350.0 million of the Company’s Class A Common .
Added
The repurchase program has no time limit and may be suspended for periods or discontinued at any time. The following table provides the activity relat ed to share repurchases for the fourth quarter of 2025.
Removed
Company/Index 2019 2020 2021 2022 2023 2024 Globus Medical, Inc. $100 $111 $123 $126 $90 $140 S&P 500 Index $100 $118 $152 $125 $158 $197 S&P 500 Health Care Equipment $100 $118 $140 $114 $124 $138 ‎ 49 Table of Contents

Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

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Biggest changeFinancial Statements and Supplementary Data. ” * Excludes contributions to pension and other post-employment benefit plans, uncertain tax positions, non-current tax liabilities and royalty obligations for which we cannot make a reliable estimate of the period of cash settlement. For further information, see Notes 14 , and 18 to the consolidated financial statements in “ Part II; Item 8.
Biggest changePayments Due by Period (In thousands) Total Less than 1 Year 1-3 Years 3-5 Years More than 5 Years Purchase obligations (1) $ 36,147 $ 34,756 $ 1,035 $ 356 $ — Total * $ 36,147 $ 34,756 $ 1,035 $ 356 $ — 58 Table of Contents (1) Reflects minimum annual volume commitments to purchase inventory under certain of our supplier contracts. * Excludes contributions to pension and other post-employment benefit plans, uncertain tax positions, non-current tax liabilities, lease liabilities, business acquisition liabilities and royalty obligations for which we cannot make a reliable estimate of the period of cash settlement.
Under the Merger Agreement, each share of common stock, par value $0.001 per share, of NuVasive issued and outstanding immediately prior to the effective time (other than certain excluded shares as described in the Merger Agreement) was cancelled and converted into the right to receive 0.75 fully paid and non-assessable shares of Class A Common of Globus, $0.001 par value per share, and the right to receive cash in lieu of fractional shares.
Under the NuVasive Merger Agreement, each share of common stock, par value $0.001 per share, of NuVasive issued and outstanding immediately prior to the effective time of the NuVasive Merger (other than certain excluded shares as described in the NuVasive Merger Agreement) was cancelled and converted into the right to receive 0.75 fully paid and non-assessable shares of Class A common stock of Globus, $0.001 par value per share, and the right to receive cash in lieu of fractional shares.
Contingent consideration represents contingent milestone, performance or revenue-sharing payment obligations related to acquisitions and is measured at fair value, based on significant inputs that are not observable in the market, which represents a Level 3 measurement within the fair value hierarchy. The valuation of contingent consideration uses assumptions we believe would be made by a market participant.
Contingent consideration represents contingent milestone, performance or revenue-sharing payment obligations related to acquisitions and is measured at fair value, based on significant inputs that are not observable in the market, which represents a Level 3 measurement within the fair value hierarchy. The valuation of contingent consideration uses assumptions that we believe would be made by a market participant.
The fair value of contingent restricted stock unit grants (“RSUs”) is recorded as additional paid-in capital in the consolidated balance sheet on the day of the grant due to the remote likelihood of forfeiture.
The fair value of contingent restricted stock unit (“RSUs”) grants is recorded as additional paid-in capital in the consolidated balance sheet on the day of the grant due to the remote likelihood of forfeiture.
We may request an increase in the revolving commitments in an aggregate amount not to exceed (i) $200 million or (ii) so long as the Leverage Ratio (as defined in the September 2023 Credit Agreement) is at least 0.25 to 1.00 less than the applicable Leverage Ratio then required under the September 2023 Credit Agreement, an unlimited amount.
We may request an increase in the revolving commitments in an aggregate amount not to exceed (i) $200 million or (ii) an unlimited amount, so long as the Leverage Ratio (as defined in the September 2023 Credit Agreement) is at least 0.25 to 1.00 less than the applicable Leverage Ratio then required under the September 2023 Credit Agreement.
Many of our Musculoskeletal Solutions products come in sets which feature components in a variety of sizes so that the implant or device may be customized to the patient’s needs. In order to market our Musculoskeletal Solutions products effectively, we must often maintain and provide surgeons and hospitals with surgical sets, back-up products and products of different sizes.
Many of our Musculoskeletal Solutions products come in sets that feature components in a variety of sizes so that the implant or device may be customized to the patient’s needs. In order to market our Musculoskeletal Solutions products effectively, we must often maintain and provide surgeons and hospitals with surgical sets, back-up products and products of different sizes.
Intangible assets are tested for impairment annually or whenever events or circumstances indicate that a carrying amount of an asset (asset group) may not be recoverable. If an impairment is indicated, we measure the amount of the impairment loss as the amount by which the carrying amount exceeds the fair value of the asset.
Intangible assets are tested for impairment whenever events or circumstances indicate that a carrying amount of an asset (asset group) may not be recoverable. If an impairment is indicated, we measure the amount of the impairment loss as the amount by which the carrying amount exceeds the fair value of the asset.
The Applicable Margin ranges from 0.125% to 0.625% for the Base Rate and 1.125% to 1.625% for the Term SOFR Rate. We may also request Swingline Loans (as defined in the September 2023 Credit Agreement) at either the Base Rate or the Daily Term SOFR Rate.
The Applicable Margin ranges from 0.125% to 0.625% for the Base Rate (as defined in the September 2023 Credit Agreement) and 1.125% to 1.625% for the Term SOFR Rate. We may also request Swingline Loans at either the Base Rate or the Daily Term SOFR Rate (each as defined in the September 2023 Credit Agreement).
Critical Accounting Policies and Estimates The preparation of the consolidated financial statements requires us to make assumptions, estimates and judgments that affect the reported amounts of assets and liabilities, the disclosures of contingent assets and liabilities as of the date of the consolidated financial statements, and the reported amounts of sales and expenses during the reporting periods.
Critical Accounting Estimates The preparation of the consolidated financial statements requires us to make assumptions, estimates and judgments that affect the reported amounts of assets and liabilities, the disclosures of contingent assets and liabilities as of the date of the consolidated financial statements, and the reported amounts of sales and expenses during the reporting periods.
The critical accounting policies addressed below reflect our most significant judgments and estimates used in the preparation of our consolidated financial statements. We have reviewed these critical accounting policies with the audit committee of our Board. Revenue Recognition .
The critical accounting policies addressed below reflect our most significant judgments and estimates used in the preparation of our consolidated financial statements. We have reviewed these critical accounting policies with the audit committee of our Board of Directors. Revenue Recognition .
On an ongoing basis, we evaluate our judgments, including but not limited to those related to inventories, recoverability of long-lived assets and the fair value of our common stock. We use historical experience and other assumptions as the basis for our judgments and making these estimates.
On an ongoing basis, we evaluate our judgments, including but not limited to those related to inventories, recoverability of long-lived assets and the fair value of our Class A common stock. We use historical experience and other assumptions as the basis for our judgments and making these estimates.
Our assets and liabilities measured at fair value on a recurring basis are classified and disclosed in one of the following three categories: Level 1—quoted prices (unadjusted) in active markets for identical assets and liabilities; Level 2—observable inputs other than quoted prices in active markets for identical assets and liabilities; and Level 3—unobservable inputs in which there is little or no market data available, which require the reporting entity to use significant unobservable inputs or valuation techniques.
Our assets and liabilities measured at fair value on a recurring basis are classified and disclosed in one of the following three categories: Level 1—quoted prices (unadjusted) in active markets for identical assets and liabilities; Level 2—observable inputs other than quoted prices in active markets for identical assets and liabilities; and 53 Table of Contents Level 3—unobservable inputs for which there is little or no market data available, which require the reporting entity to use significant unobservable inputs or valuation techniques.
The composite income tax rate, tax provisions, deferred tax assets and deferred tax liabilities will vary according to the jurisdiction in which profits arise.
The composite income tax rate, tax provisions, deferred tax assets and deferred tax liabilities vary according to the jurisdiction in which profits arise.
Expected volatility is based on the historical volatility of the Company’s common stock over the most recent period commensurate with the estimated expected term of the Company’s stock options offering period which is derived from historical experience. The risk-free interest rate assumption is based on observed interest rates of U.S.
Expected volatility is based on the historical volatility of the Company’s Class A common stock over the most recent period commensurate with the estimated expected term of the Company’s stock options offering period which is derived from historical experience. The risk-free interest rate assumption is based on observed interest rates of U.S.
Recently Issued Accounting Pronouncements For further details on recently issued accounting pronouncements, please refer to “Part II; Item 8. Financial Statements and Supplementary Data; Notes to Consolidated Financial Statements; Note 2. Summary of Significant Accounting Policies; (v) Recently Issued Accounting Pronouncements.” ‎ 59 Table of Contents
Recently Issued Accounting Pronouncements For further details on recently issued accounting pronouncements, please refer to “Part II; Item 8. Financial Statements and Supplementary Data; Notes to Consolidated Financial Statements; Note 2. Summary of Significant Accounting Policies; (w) Recently Issued Accounting Pronouncements.” 59 Table of Contents
Goodwill represents the excess of purchase price over the fair values of the identifiable assets acquired less the liabilities assumed in the acquisition of a business. Goodwill is tested for impairment at least annually or whenever events or circumstances indicate that a carrying amount may be impaired. We perform our goodwill impairment analysis at the reporting unit level.
Goodwill represents the excess of purchase price over the fair values of the identifiable assets acquired less the liabilities assumed in the acquisition of a business. Goodwill is tested for impairment at least annually or whenever events or circumstances indicate that a carrying amount may not be recoverable. We perform our goodwill impairment analysis at the reporting unit level.
We have sold our products and services in approximately 65 countries other than the U.S. through a combination of sales representatives employed by us and exclusive international distributors.
We have sold our products and services in approximately 64 countries other than the U.S. through a combination of sales representatives employed by us and exclusive international distributors.
For purposes of disclosure, we disaggregate our revenue into two categories, Musculoskeletal Solutions and Enabling Technologies. 52 Table of Contents Our Musculoskeletal Solutions products consist primarily of the implantable devices, disposables, unique instruments, and neuromonitoring services used in an expansive range of spine, orthopedic trauma, hip, knee and extremity procedures.
For purposes of disclosure, we disaggregate our revenue into two categories, Musculoskeletal Solutions and Enabling Technologies. Our Musculoskeletal Solutions products consist primarily of the implantable devices, disposables, unique instruments, and neuromonitoring services used in an expansive range of spine, orthopedic trauma, hip, knee and extremity procedures.
During the years ended December 31, 2024, 2023, and 2022 , we did not record any impairment charges related to long-lived assets. Stock-Based Compensation Expense.
During the years ended December 31, 2025, 2024, and 2023, we did not record any impairment charges related to long-lived assets. Stock-Based Compensation Expense.
Our principal liquidity requirements are to fund working capital, research and development, including clinical trials, capital expenditures primarily related to investment in surgical sets required to maintain and expand our business, contingent consideration achievement obligations, potential future business or intellectual property acquisitions, and to service our 2025 Notes.
Our principal liquidity requirements are to fund working capital, research and development, including clinical trials, capital expenditures primarily related to investment in surgical sets required to maintain and expand our business, contingent consideration achievement obligations, potential future business or intellectual property acquisitions.
Certain of our more critical accounting policies require the application of significant judgment by management in selecting the appropriate assumptions for calculating financial estimates. By their nature, these judgments are subject to an inherent degree of uncertainty.
Certain of our more critical accounting policies require the application of significant judgment by management in selecting the appropriate assumptions for 52 Table of Contents calculating financial estimates. By their nature, these judgments are subject to an inherent degree of uncertainty.
Musculoskeletal Solutions Our Musculoskeletal Solutions consist primarily of implantable devices, biologics, accessories, unique surgical instruments, and neuromonitoring services, used in an expansive range of spinal, orthopedic and neurosurgical procedures. Musculoskeletal disorders are a leading driver of healthcare costs worldwide. Disorders range in severity from mild pain and loss of feeling to extreme pain and paralysis.
Musculoskeletal Solutions Our Musculoskeletal Solutions consist primarily of implantable devices, biologics, accessories, unique surgical instruments, spinal cord stimulation treatment therapy, and neuromonitoring services, used in an expansive range of spinal, orthopedic and neurosurgical procedures. Musculoskeletal disorders are a leading driver of healthcare costs worldwide. Disorders range in severity from mild pain and loss of feeling to extreme pain and paralysis.
We expect to continue to grant stock-based awards in the future, and to the extent that we do, our actual stock-based compensation expense recognized may increase. 54 Table of Contents Legal Proceedings. We are involved in a number of proceedings, legal actions, and claims.
We expect to continue to grant stock-based awards in the future, and to the extent that we do, our actual stock-based compensation expense recognized may increase. Legal Proceedings. We are involved in a number of proceedings, legal actions, and claims.
If the related project is not completed in a timely manner, we may have an impairment related to the IPR&D, calculated as the excess of the asset’s carrying value over its fair value. During the twelve months ended December 31, 2024, there were no impairments in goodwill, finite-lived intangible assets, or IPR&D. Long-Lived Assets .
If the related project is not completed in a timely manner, we may have an impairment related to the IPR&D, calculated as the excess of the asset’s carrying value over its fair value. During the year ended December 31, 2025, there were no impairments in goodwill, finite-lived intangible assets, or IPR&D. Long-Lived Assets .
The market for our Enabling Technologies in spine and orthopedic surgery is still in its infancy stage and consists primarily of imaging, navigation and robotic systems. In spine, a majority of these technologies are limited to surgical planning and assistance in implant placement for increased accuracy and time savings with less intraoperative radiation exposure to the patient and surgical staff.
The market for our Enabling Technologies in spine, cranial and orthopedic surgery is still in its infancy stage and consists primarily of INR systems. In spine, a majority of these technologies are limited to surgical planning and assistance in implant placement for increased accuracy and time savings with less intraoperative radiation exposure to the patient and surgical staff.
To the extent that we require new sources of liquidity, we may consider incurring debt, including borrowing against our existing credit facility, convertible debt instruments, and/or raising additional funds through an equity offering. The sale of additional equity may result in dilution to our stockholders.
We may, require additional liquidity as we continue to execute our business strategy. To the extent that we require new sources of liquidity, we may consider incurring debt, including borrowing against our existing credit facility, convertible debt instruments, and/or raising additional funds through an equity offering. The sale of additional equity may result in dilution to our stockholders.
We believe there is significant opportunity to strengthen our position in the U.S. market by increasing the size of our U.S. sales force and we intend to add additional direct and distributor sales representatives in the future. During the year ended December 31, 2024, international net sales accounted for approximately 20.6% of our total net sales.
We believe there is significant opportunity to strengthen our position in the U.S. market by increasing the size of our U.S. sales force and we intend to add additional direct and distributor sales representatives in the future. During the year ended December 31, 2025, international net sales accounted for approximately 19.4% of our total net sales.
Amortization of Intangibles We amortize finite lived intangible assets over the period of estimated benefit using the straight-line method. Indefinite lived intangible assets are tested for impairment annually or whenever events or circumstances indicate that the carrying amount of the asset (asset group) may not be recoverable.
We plan to hire more personnel to support the growth of our business. Amortization of Intangibles We amortize finite lived intangible assets over the period of estimated benefit using the straight-line method. Indefinite lived intangible assets are tested for impairment annually or whenever events or circumstances indicate that the carrying amount of the asset (asset group) may not be recoverable.
Substantially all of our suppliers manufacture our products in the U.S. Our cost of sales consists primarily of costs from our in-house manufacturing, costs of products purchased from third-party suppliers, excess and obsolete inventory charges, depreciation of surgical instruments and cases, royalties, shipping, inspection and related costs incurred in making our products available for sale or use.
Our cost of sales consists primarily of costs from our in-house manufacturing, costs of products purchased from third-party suppliers, 51 Table of Contents excess and obsolete inventory charges, depreciation of surgical instruments and cases, royalties, shipping, inspection and related costs incurred in making our products available for sale or use.
Intangible assets consist of purchased in-process research and development (“IPR&D”), developed technology, supplier network, patents, customer relationships, re-acquired rights, and non-compete agreements. Intangible assets with finite useful lives are amortized over the period of estimated benefit using the straight-line method and estimated useful lives ranging from one to twenty-one years.
Intangible assets consist of purchased developed technology, customer relationships, in-process research and development (“IPR&D”), trade names and patents. Intangible assets with finite useful lives are amortized over the period of estimated benefit using the straight-line method and estimated useful lives ranging from one to twenty-one years.
Treasury securities appropriate for the expected terms of the stock options. The dividend yield assumption is based on the history and expectation of no dividend payouts. The fair value of restricted stock units is estimated on the day of grant based on the closing price of the Company’s common stock.
Treasury securities appropriate for the expected terms of the stock 54 Table of Contents options. The dividend yield assumption is based on the history and expectation of no dividend payouts. The fair value of RSUs is estimated on the day of grant based on the closing price of the Company’s Class A common stock.
The September 2023 Credit Agreement is guaranteed by certain direct or indirect wholly owned subsidiaries of the Company. The September 2023 Credit Agreement contains financial and other customary covenants, including a funded net indebtedness to adjusted EBITDA ratio. As of December 31, 2024, we have not borrowed under the September 2023 Credit Agreement and are in compliance with all covenants.
The September 2023 Credit Agreement is guaranteed by certain direct or indirect wholly owned subsidiaries of the Company. The September 2023 Credit Agreement contains financial and other customary covenants, including a funded net indebtedness to adjusted EBITDA ratio.
There is no assurance that we will be able to secure such additional funding on terms acceptable to us, or at all . 57 Table of Contents Line of Credit In September 2023, we entered into an unsecured credit agreement with U.S.
There is no assurance that we will be able to secure such additional funding on terms acceptable to us, or at all. Line of Credit In September 2023, we entered into an unsecured credit agreement with U.S. Bank National Association, as administrative agent, Citizens Bank, N.A., as syndication agent, Royal Bank of Canada, as documentation agent, U.S.
Acquisition-Related Costs Acquisition-related costs represent the change in fair value of business acquisition-related contingent consideration and specific costs related to the consummation of the acquisition process such as banker fees, legal fees and other acquisition-related professional fees. Income Tax Provision We are taxed at the rates applicable within each jurisdiction.
Acquisition-Related Costs Acquisition-related costs represent the change in fair value of business acquisition-related contingent consideration and specific costs related to the consummation of the acquisition process, such as banker fees, legal fees and other acquisition-related professional fees.
These costs will increase in absolute terms as we continue to expand our product pipeline and add personnel. 51 Table of Contents Selling, General and Administrative Expenses Selling, general and administrative expenses primarily consist of salaries, benefits and other related costs, including stock-based compensation, for personnel employed in sales, marketing, finance, legal, compliance, administrative, information technology, medical education and training, quality and human resource departments.
Selling, General and Administrative Expenses Selling, general and administrative expenses primarily consist of salaries, benefits and other related costs, including stock-based compensation, for personnel employed in sales, marketing, finance, legal, compliance, administrative, information technology, medical education and training, quality and human resource departments.
Cash Used in by Financing Activities The lower net cash used in financing activities for the year ended December 31, 2024 was primarily the result of decreased repurchases of Class A Common of $139.8 million, and higher proceeds from the exercise of stock options of $98.0 million partially offset by increased payments of business acquisition-related liabilities of $37.6 million.
Cash Used in by Financing Activities The lower net cash used in financing activities for the year ended December 31, 2025 was primarily the result of the repayment of the 2025 Notes for $450.0 million and increased repurchases of Class A common stock of $214.7 million, partially offset by decreased payments of business acquisition-related liabilities of $30.0 million.
(“NuVasive”) and Zebra Merger Sub Inc. (“Merger Sub”), Merger Sub, a wholly owned subsidiary of the Company, merged with and into NuVasive, with NuVasive surviving as a wholly owned subsidiary of the Company (the “NuVasive Merger”).
NuVasive Merger On September 1, 2023, pursuant to that certain merger agreement (the “NuVasive Merger Agreement”) with NuVasive, Inc. (“NuVasive”) and Zebra Merger Sub Inc. a wholly owned subsidiary of the Company (“Zebra Merger Sub”), Zebra Merger Sub merged with and into NuVasive, with NuVasive surviving as a wholly owned subsidiary of the Company (the “NuVasive Merger”).
Management’s Discussion and Analysis of Financial Condition and Results of Operations: Results of Operations; Year Ended December 31, 2023 Compared to the Year Ended December 31, 2022. ” on our Form 10-K filed on February 20, 2024 .
Management’s Discussion and Analysis of Financial Condition and Results of Operations” of our Annual Report on Form 10-K for the fiscal year ended December 31, 2024 filed on February 20, 2025 .
The purchase price of business acquisitions is primarily allocated to the tangible and identifiable intangible assets acquired and liabilities assumed based on their estimated fair values on the acquisition date, with the excess recorded as goodwill. We utilize Level 3 inputs in the determination of the initial fair value. 53 Table of Contents Goodwill and Intangible Assets.
The purchase prices of business acquisitions are primarily allocated to the tangible and identifiable intangible assets acquired and liabilities assumed based on their estimated fair values on the applicable acquisition date, with the excess recorded as goodwill.
With numerous products launched since the founding of the Company, we offer a comprehensive portfolio of innovative and differentiated technologies that treat a variety of musculoskeletal conditions. We separate our products and services into two major categories: Musculoskeletal Solutions and Enabling Technologies. NuVasive Merger On September 1, 2023, pursuant to that certain merger agreement (the “Merger Agreement”) with NuVasive, Inc.
With numerous products launched since the founding of the Company, we offer a comprehensive portfolio of innovative and differentiated technologies that address a variety of musculoskeletal pathologies, anatomies, and surgical approaches. We separate our products and services into two major categories: Musculoskeletal Solutions and Enabling Technologies.
Furthermore, we believe as new technologies such as augmented reality and artificial intelligence are introduced, Enabling Technologies have the potential to transform the way surgery is performed and most importantly, continue to improve patient outcomes. 50 Table of Contents Geographic Information To date, the primary market for our products and services has been within the United States (“U.S.”) , where we sell our products and services through a combination of direct sales representatives employed by us and distributor sales representatives employed by exclusive independent distributors, who distribute our products for a commission that is generally based on a percentage of sales.
Geographic Information To date, the primary market for our products and services has been within the U.S., where we sell our products and services through a combination of direct sales representatives employed by us and distributor sales representatives employed by exclusive independent distributors, who distribute our products for a commission that is generally based on a percentage of sales.
Financial Statements and Supplementary Data. ” Cash Flows The following table summarizes, for the periods indicated, cash flows from operating, investing and financing activities: Year Ended 2024-2023 2023-2022 December 31, Change Change (In thousands) 2024 2023 2022 $ $ Net cash provided by/(used in) operating activities $ 520,638 $ 243,499 $ 178,468 $ 277,139 $ 65,031 Net cash provided by/(used in) investing activities (176,051) 302,968 (110,362) (479,019) 413,330 Net cash provided by/(used in) financing activities (27,696) (231,821) (109,962) 204,125 (121,859) Effect of foreign exchange rate changes on cash 255 2,180 (747) (1,925) 2,927 Increase (decrease) in cash and cash equivalents $ 317,146 $ 316,826 $ (42,603) $ 320 $ 359,429 58 Table of Contents Cash Provided by Operating Activities The higher net cash provided by operating activities for the year ended December 31, 2024 was primarily the result of higher net income after adjusting out non-cash add-backs and non-cash expenses, primarily due to the NuVasive Merger.
Financial Statements and Supplementary Data. ” Cash Flows The following table summarizes, for the periods indicated, cash flows from operating, investing and financing activities: Year Ended December 31, 2025-2024 Change 2024-2023 Change (In thousands) 2025 2024 2023 $ $ Net cash provided by/(used in) operating activities $ 753,447 $ 520,638 $ 243,499 $ 232,809 $ 277,139 Net cash provided by/(used in) investing activities (355,014) (176,051) 302,968 (178,963) (479,019) Net cash provided by/(used in) financing activities (679,160) (27,696) (231,821) (651,464) 204,125 Effect of foreign exchange rate changes on cash 22,445 255 2,180 22,190 (1,925) Increase (decrease) in cash and cash equivalents $ (258,282) $ 317,146 $ 316,826 $ (575,428) $ 320 Cash Provided by Operating Activities The higher net cash provided by operating activities for the year ended December 31, 2025 was primarily the result of higher net income of $434.9 million, favorable changes in deferred income taxes of $144.5 million and favorable changes in accounts receivable of $25.9 million.
We plan to hire more personnel to support the growth of our business. Provision for Litigation We record a provision for litigation settlements when a loss is known or considered probable and the amount can be reasonably estimated and in the case of a favorable settlement, income when realized.
Additionally, provision for litigation is included within selling, general and administrative expenses and is recorded when a loss is known or considered probable and the amount can be reasonably estimated and in the case of a favorable settlement, income when realized.
Certain amounts and percentages in this discussion and analysis have been rounded for convenience of presentation. Overview We are an engineering-driven company with a history of rapidly developing and commercializing advanced products and procedures to address treatment challenges.
Overview We are an engineering-driven company with a history of rapidly developing and commercializing advanced products and procedures to assist surgeons in effectively treating their patients and to address new treatment options.
Future litigation or requirements to escrow funds could also materially impact our liquidity and our ability to invest in and operate our business on an ongoing basis. We may, require additional liquidity as we continue to execute our business strategy.
We expect to continue to make investments in surgical sets as we launch new products, increase the size of our U.S. sales force, and expand into international markets. Future litigation or requirements to escrow funds could also materially impact our liquidity and our ability to invest in and operate our business on an ongoing basis.
Year Ended December 31, 2024 Compared to the Year Ended December 31, 2023 Net Sales The following table sets forth, for the periods indicated, our net sales by geography expressed as dollar amounts and the changes in net sales between the specified periods expressed in dollar amounts and as percentages: Year Ended December 31, Change (In thousands, except percentages) 2024 2023 $ % United States $ 2,000,067 $ 1,279,765 $ 720,302 56.3% International 519,288 288,711 230,577 79.9% Total net sales $ 2,519,355 $ 1,568,476 $ 950,879 60.6% U.S. net sales increased by $720.3 million, or 56.3%, for the year ended December 31, 2024 and were significantly driven by the NuVasive Merger.
Year Ended December 31, 2025 Compared to the Year Ended December 31, 2024 Net Sales The following table sets forth, for the periods indicated, our net sales by geography expressed as dollar amounts and the changes in net sales between the specified periods expressed in dollar amounts and as percentages: Year Ended December 31, Change (In thousands, except percentages) 2025 2024 $ % U.S. $ 2,367,596 $ 2,000,067 $ 367,529 18.4 % International 571,335 519,288 52,047 10.0 % Total net sales $ 2,938,931 $ 2,519,355 $ 419,576 16.7 % 55 Table of Contents In the U.S., net sales increased by $367.5 million, or 18.4%, for the year ended December 31, 2025.
Other Income/(expense), Net Year Ended December 31, Change (In thousands, except percentages) 2024 2023 $ % Other income, net $ (45,269) $ 32,251 $ (77,520) -240.4% Percentage of net sales -1.8% 2.1% The decrease of $77.5 million in other income/(expense), was primarily due to $43.3 million of foreign currency loss and increases in interest expense of $29.4 million from amortization of the fair value adjustment on the 2025 Notes from acquisition accounting and other contractual interest incurred.
Other Income/(Expense), Net Year Ended December 31, Change (In thousands, except percentages) 2025 2024 $ % Other income/(expense), net $ 7,548 $ (45,269) $ 52,817 (116.7 %) Percentage of net sales 0.3 % (1.8 %) The increase of $52.8 million, or 116.7%, in other income/(expense), was primarily due to a $3.0 million of foreign currency loss in the current period compared to a $43.2 million loss in the prior period.
From a product standpoint, domestic musculoskeletal solutions sales increased by $685.8 million, mainly driven by sales increases in spine products by $564.6 million, and neuromonitoring solution product and services of $73.7 million. Domestic enabling technology sales increased by $36.2 million compared to the prior year, driven by higher unit placement.
From a product standpoint, the increase was primarily driven by Nevro sales of $254.2 million, increased Musculoskeletal Solutions sales of $125.7 million. Further, there was a decrease in domestic Enabling Technology sales of $17.3 million compared to the same period in the prior year, primarily driven by lower unit placement.
As our Enabling Technologies become more fully integrated with our Musculoskeletal Solutions, a continued rise in adoption is expected.
As our Enabling Technologies become more fully integrated with our Musculoskeletal Solutions, a continued rise in adoption is expected. Furthermore, we believe as new technologies are introduced, Enabling Technologies have the potential to transform the way surgery is performed and most importantly, continue to improve patient outcomes.
During the current period, the expense was primarily driven by the change to the fair value of business acquisition liabilities recorded as a net charge of $26.5 million resulting from changes in contract terms, market conditions and the achievement of certain performance conditions.
For the year ended December 31, 2025, acquisition-related costs also included $13.5 million of charges recorded from changes in the fair value of business acquisition liabilities driven by changes in market conditions and the achievement of certain performance conditions, compared to the $26.5 million recorded for the year ended December 31, 2024.
Cash Used in Investing Activities The higher cash used in investing activities for the year ended December 31, 2024 was due primarily to decreases in marketable securities net inflows of $720.3 million as we manage our liquidity, as well as increased purchases of property and equipment of $37.2 million primarily driven by increased production resulting from the NuVasive Merger.
Cash Used in Investing Activities The higher cash used in investing activities for the year ended December 31, 2025 was primarily due to an increased outflow of $234.9 million in acquisition of businesses and an increase in purchases of property and equipment of $49.3 million, partially offset by increased sales of marketable securities of $103.8 million.
International net sales increased by $230.6 million, or 79.9% for the year ended December 31, 2024 and were significantly driven by the NuVasive Merger. From a product standpoint, the increase was mainly due to musculoskeletal solutions sales increases of $231.3 million, primarily due to spine products.
International net sales increased by $52.0 million, or 10.0%, for the year ended December 31, 2025. From a product standpoint, the increase was primarily driven by Nevro sales of $39.4 million. From a geographic standpoint, sales in the Europe and Middle East region increased by $49.9 million, and sales in the Asia Pacific region increased by $4.6 million.
Amortization of Intangibles Year Ended December 31, Change (In thousands, except percentages) 2024 2023 $ % Amortization of intangibles $ 119,373 $ 51,032 $ 68,341 133.9% Percentage of net sales 4.7% 3.3% Amortization of intangibles increased by $68.3 million or 133.9% for the year ended December 31, 2024 compared to the year ended December 31, 2023, due to the impact of the intangibles acquired from the NuVasive Merger.
Financial Statements and Supplementary Data” ) offset by $5.7 million of various net settlements received. 56 Table of Contents Amortization of Intangibles Year Ended December 31, Change (In thousands, except percentages) 2025 2024 $ % Amortization of intangibles $ 118,194 $ 119,373 $ (1,179) (1.0 %) Percentage of net sales 4.0 % 4.7 % Amortization of intangibles decreased by $1.2 million, or 1.0%, for the year ended December 31, 2025 compared to the year ended December 31, 2024.
They contributed $103.1 million in amortization expense in the current period as compared to $34.1 million in amortization expense for the year ended December 31, 2023. 56 Table of Contents Acquisition-Related Costs Year Ended December 31, Change (In thousands, except percentages) 2024 2023 $ % Acquisition-related costs $ 29,623 $ 68,274 $ (38,651) -56.6% Percentage of net sales 1.2% 4.4% The decrease of $38.7 million in acquisition-related costs compared to the prior year was due primarily to the closing of the merger with NuVasive during the period ended December 31, 2023.
Acquisition-Related Costs Year Ended December 31, Change (In thousands, except percentages) 2025 2024 $ % Acquisition-related costs $ 42,326 $ 29,623 $ 12,703 42.9 % Percentage of net sales 1.4 % 1.2 % The increase of $12.7 million, or 42.9%, in acquisition-related costs compared to the prior year was primarily driven by $28.9 million of costs associated with the Nevro Merger, partially offset by changes in the fair value of business acquisition liabilities.
Research and Development Expenses Year Ended December 31, Change (In thousands, except percentages) 2024 2023 $ % Research and development $ 163,754 $ 124,010 $ 39,744 32.0% Percentage of net sales 6.5% 7.9% The $39.7 million or 32.0% increase in research and development expenses shows our continued investment in product development.
Research and Development Expenses Year Ended December 31, Change (In thousands, except percentages) 2025 2024 $ % Research and development $ 147,246 $ 163,754 $ (16,508) (10.1 %) Percentage of net sales 5.0 % 6.5 % The $16.5 million, or 10.1%, decrease in research and development expenses for the year ended December 31, 2025 was primarily driven by a decrease of $21.9 million in employee-related expenses, excluding Nevro employee-related expenses, and a decrease o f $12.6 million in acquired intellectual property research and development.
Additionally, interest income decreased by $8.2 million which was driven by a lower average marketable securities portfolio size and lower market-related yields in the current period.
This was partially offset by a decrease in interest income of $8.2 million due to a lower average balance across the Company’s marketable securities, cash and cash equivalents in the current period as compared to the prior period.
Provision for Litigation Year Ended December 31, Change (In thousands, except percentages) 2024 2023 $ % Provision for litigation, net $ 314 $ 434 $ (120) -27.6% Percentage of net sales 0.0% 0.0% The provision for litigation was consistent for the year ended December 31, 2024, as compared to the provision expense recorded during the year ended December 31, 2023.
Bargain Purchase Gain Year Ended December 31, Change (In thousands, except percentages) 2025 2024 $ % Bargain purchase gain $ 117,704 $ — $ 117,704 100.0 % Percentage of net sales 4.0 % — % The increase of $117.7 million was due to the bargain purchase gain related to the Nevro Merger as of December 31, 2025.
Our neuromonitoring services use proprietary software-driven nerve detection and avoidance technology and include IONM to aid spine surgery.
Our spinal cord stimulation treatment therapy uses neuromodulation technology delivered by an implantable device that delivers electrical impulses to 50 Table of Contents treat chronic pain. Our neuromonitoring services use proprietary software-driven nerve detection and avoidance technology and include intraoperative neuromonitoring (“IONM”) services to aid spine surgery.
(2) In connection with certain acquisitions completed in 2011 through 2024, we have certain contingent consideration obligations payable to the sellers in these transactions upon the achievement of certain regulatory and sales milestones. For further information, see Notes 3 , and 6 to the consolidated financial statements in “ Part II; Item 8.
For further information, see Notes 6, 14, 17 and 18 to the consolidated financial statements in “ Part II; Item 8.
Selling, General and Administrative Expenses Year Ended December 31, Change (In thousands, except percentages) 2024 2023 $ % Selling, general and administrative $ 981,048 $ 643,410 $ 337,638 52.5% Percentage of net sales 38.9% 41.0% The increase of $337.6 million or 52.5% in selling, general and administrative expenses was primarily driven by increases to personnel-related expenses of $251.1 million due to increased headcount primarily from the NuVasive Merger, as well as increases to professional fees of $23.8 million, consulting and outside service expenses of $13.6 million, and rent expenses of $14.3 million.
Selling, General and Administrative Expenses Year Ended December 31, Change (In thousands, except percentages) 2025 2024 $ % Selling, general and administrative $ 1,178,498 $ 981,362 $ 197,136 20.1 % Percentage of net sales 40.1 % 39.0 % The increase of $197.1 million, or 20.1%, in selling, general and administrative expenses for the year ended December 31, 2025 was primarily driven by an increase of $160.2 million for Nevro expenses.
A discussion of our Results of Operations for the year ended December 31, 2023 can be found in “ Part II, Item 7.
Discussions of the fiscal year ended December 31, 2024 and year-to-year comparisons between the fiscal years ended December 31, 2024 and 2023 that are not included in this Annual Report can be found in “Part II. Item 7.
Removed
Regionally, the increase was driven by sales growth in the Europe and Middle East region by $116.9 million, the Latin America region by $26.8 million and the Asia Pacific region by $87.2 million. 55 Table of Contents Cost of Sales Year Ended December 31, Change (In thousands, except percentages) 2024 2023 $ % Cost of sales (exclusive of amortization of intangibles) $ 1,035,479 $ 548,174 $ 487,305 88.9% Percentage of net sales 41.1% 34.9% The $487.3 million or 88.9% increase in cost of sales was primarily driven by increases to inventory product costs of $221.0 million from increased volume, significantly due to the NuVasive Merger.
Added
Certain amounts and percentages in this discussion and analysis have been rounded for convenience of presentation. This “Management’s Discussion and Analysis of Financial Condition and Results of Operations” generally discusses the fiscal years ended December 31, 2025 and 2024 and provides year-to-year comparisons between the fiscal years ended December 31, 2025 and 2024.
Removed
Additionally, there was increased amortization of inventory fair value step-up of $143.8 million, due to a full year of post-acquisition amortization occurring in the current period as compared to four months in the prior period.
Added
Nevro Merger On April 3, 2025, pursuant to the terms of that certain merger agreement (the “Nevro Merger Agreement”) with Nevro Corp.
Removed
Further, increases in costs of sales were also impacted by depreciation of $29.2 million and increased changes in excess and obsolete inventory reserves by $12.4 million.
Added
(“Nevro”) and Palmer Merger Sub, Inc., a wholly owned subsidiary of the Company (“Palmer Merger Sub”), Palmer Merger Sub merged with and into Nevro (the “Nevro Merger” and, together with the NuVasive Merger, th e “NuVasive and Nevro Mergers”), wit h Nevro surviving as a wholly owned subsidiary of the Company.
Removed
This increase was primarily driven by increased personnel-related expenses of $24.0 million due to increased headcount and $12.6 of IPR&D expense recorded in the current period from an acquisition.
Added
Upon the consummation of the Nevro Merger, each issued and outstanding share of common stock of Nevro, $0.001 par value per share, was cancelled and converted into the right to receive cash in an amount equal to $5.85 per share of common stock of Nevro, without interest and subject to any applicable withholding taxes.
Removed
During the prior period, costs incurred were primarily related to the closing of the NuVasive Merger, including personnel-related charges for fees and severance of $34.7 million and banking and legal fees related to the NuVasive Merger of $12.1 million.
Added
Substantially all of our suppliers manufacture our products in the U.S.
Removed
Income Tax Provision Year Ended December 31, Change (In thousands, except percentages) 2024 2023 $ % Income tax provision $ 17,738 $ 42,520 $ (24,782) -58.3% Effective income tax rate 14.7% 25.7% The decrease in the effective tax rate is primarily due to windfall benefits, reserve releases, and internal reorganization, as a percentage of pretax earnings.
Added
These costs will increase in absolute terms as we continue to expand our product pipeline and add personnel.
Removed
We expect to continue to make investments in surgical sets as we launch new products, increase the size of our U.S. sales force, and expand into international markets. Our Senior Convertible Notes, with a principal balance of $450 million, are due March 2025. We anticipate being able to support this need through existing or new sources of liquidity.
Added
Restructuring Costs Restructuring costs represent costs associated with the Company’s plans to optimize the organizational structure, merge synergies and leverage the strength of both commercial organizations. Income Tax Provision We are taxed at the rates applicable within each jurisdiction.
Removed
Bank National Association, as administrative agent, Citizens Bank, N.A., as syndication agent, Royal Bank of Canada, as documentation agent, U.S.
Added
If the estimated fair values of the liabilities assumed on the acquisition date exceed the tangible and identifiable intangible assets acquired, the excess will be recorded to bargain purchase gain.We utilize Level 3 inputs in the determination of the initial fair value. Goodwill and Intangible Assets.
Removed
Contractual Obligations and Commitments In connection with the NuVasive Merger, the Company acquired additional obligations and commitments, including, but not limited to (i) the 2025 Notes, with a principal balance of $450.0 million, (ii) contingent consideration arrangements associated with certain historical NuVasive acquisitions, and (iii) operating lease and finance lease obligations.
Added
This increase was partially offset by a decrease in sales in the Latin America region of $2.4 million. Enabling Technology sales increased by $4.3 million compared to the same period in the prior year, primarily driven by increased unit placement.
Removed
Refer to the Notes to the consolidated financial statements for further description of our 2025 Notes (Note 11), contingent consideration arrangements (Notes 6 and 15), and lease obligations (Note 17). The following table summarizes our outstanding contractual obligations as of December 31, 2024.

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Item 7A. Quantitative and Qualitative Disclosures About Market Risk

Market Risk — interest-rate, FX, commodity exposure

12 edited+5 added−3 removed10 unchanged
Biggest changeDuring the periods presented, we did not hold any investments that were in a significant unrealized loss position and no impairment charges were recorded. Realized gains and losses and interest income related to cash equivalents were immaterial during all periods presented.
Biggest changeOur policy also limits the amount of credit exposure to any one issue, issuer and type of instrument. During the periods presented, we did not hold any investments that were in a significant unrealized loss position and no impairment charges were recorded.
Market Price Risk In order to reduce the potential equity dilution associated with our convertible notes, we entered into transactions for convertible notes hedge (the “2025 Hedges”) in connection with the issuance in March 2020 of $450.0 million principal amount of unsecured senior convertible notes with a stated interest rate of 0.375% and a maturity date of March 15, 2025 (the “2025 Notes”), entitling us to purchase our common stock.
Market Price Risk In order to reduce the potential equity dilution associated with our convertible notes, we entered into transactions for convertible notes hedge (the “2025 Hedges”) in connection with the issuance in March 2020 of $450.0 million principal amount of unsecured senior convertible notes with a stated interest rate of 0.375% and a maturity date of March 15, 2025 (the “2025 Notes”), entitling us to purchase our Class A common stock.
Based upon our overall interest rate exposure as of December 31, 2024, a change of 10 percent in interest rates, assuming the amount of our investment portfolio and overall economic environment remains constant, would not have a material effect on interest income.
Based upon our overall interest rate exposure as of December 31, 2025, a change of 10 percent in interest rates, assuming the amount of our investment portfolio and overall economic environment remains constant, would not have a material effect on interest income.
The warrant transactions could have a dilutive effect on our earnings per share to the extent that the price of our common stock during a given measurement period (the quarter or year to date period) exceeds the strike price of the warrants.
The warrant transactions could have had a dilutive effect on our earnings per share to the extent that the price of our Class A common stock during a given measurement period (the quarter or year to date period) exceeds the strike price of the warrants.
Net gains or losses resulting from the translation of foreign financial statements and the effect of exchange rate changes on intercompany receivables and payables of a long-term investment nature are recorded as a separate component of stockholders’ equity. These adjustments will affect net income only upon sale or liquidation of the underlying investment in foreign subsidiaries.
Net gains or losses resulting from the translation of foreign financial statements and the effect of exchange rate changes on intercompany receivables and payables of a long-term investment nature are recorded as a separate 60 Table of Contents component of stockholders’ equity. These adjustments will affect net income only upon sale or liquidation of the underlying investment in foreign subsidiaries.
Exchange rate fluctuations resulting from the translation of all other intercompany balances between domestic entities and our foreign subsidiaries are recorded as foreign currency transaction gains or losses and are included in other expense, net 60 Table of Contents in the Consolidated Statements of Operations.
Exchange rate fluctuations resulting from the translation of all other intercompany balances between domestic entities and our foreign subsidiaries are recorded as foreign currency transaction gains or losses and are included in other expense, net in the Consolidated Statements of Operations.
For certain intercompany balances, we may enter into foreign currency forward contracts to partially offset the impact from fluctuation of the foreign currency rates. The notional amount of the outstanding foreign currency forward contracts was $5.0 million as of December 31, 2024, which were settled in January 2025.
For certain intercompany balances, we may enter into foreign currency forward contracts to partially offset the impact from fluctuation of the foreign currency rates. The notional amount of the outstanding foreign currency forward contracts was $12.5 million as of December 31, 2025, which were settled in January 2026.
During the year ended December 31, 2024, a gain of $1.4 million was recognized in other income/(expense), net due to the changes in the fair value of the derivative instruments, and the fair value of the hedge contracts we held as of December 31, 2024 was de minimis.
During the year ended December 31, 2025, a gain of $0.6 million was recognized in other income/(expense), net due to the changes in the fair value of the derivative instruments, and the fair value of the hedge contracts we held as of December 31, 2025 was de minimis.
Item 7A. Quantitative and Qualitative Disclosure About Market Risk Market risk is the potential loss arising from adverse changes in the financial markets. We are exposed to various market risks, which may result in potential losses arising from adverse changes in market rates, such as interest rates and foreign exchange rates.
Market risk is the potential loss arising from adverse changes in the financial markets. We are exposed to various market risks, which may result in potential losses arising from adverse changes in market rates, such as interest rates and foreign exchange rates.
Interest Rate Risk Our exposure to interest rate risk at December 31, 2024 is related to our investment portfolio which consists of municipal bonds, corporate debt securities, commercial paper, asset-backed securities, and securities of government, federal agency, and other sovereign obligations of high quality financial institutions.
Financial Statements and Supplementary Data. ” Interest Rate Risk Our exposure to interest rate risk at December 31, 2025 is related to our cash equivalents and investment portfolio which consists of money market mutual funds, municipal bonds, corporate debt securities, commercial paper, asset-backed securities, and securities of government, federal agency, and other sovereign obligations of high-quality financial institutions.
We do not enter into derivatives or other financial instruments for trading or speculative purposes and do not believe we are exposed to material market risk with respect to our cash, cash equivalents and marketable debt securities.
We do not enter into derivatives or other financial instruments for trading or speculative purposes and do not believe we are exposed to material market risk with respect to our cash, cash equivalents and marketable debt securities. There were no changes in these risks from the previous fiscal year.
Upon conversion of our convertible notes, the 2025 Hedges are expected to reduce the equity dilution if the daily volume-weighted average price per share of our common stock exceeds the strike price of the applicable hedge. We also entered into warrant transactions with the counterparties of the 2025 Hedges entitling them to acquire shares of our common stock.
During the first quarter of 2025, we paid off the remaining balance of the 2025 Notes and the 2025 Hedges expired. We also entered into warrant transactions with the counterparties of the 2025 Hedges entitling them to acquire shares of our Class A common stock.
Removed
See Note 11, Debt, in the Notes to Consolidated Financial Statements included in this Annual Report for further discussion.
Added
Item 7A. Quantitative and Qualitative Disclosure About Market Risk The following quantitative and qualitative disclosure about market risk should be read together with our consolidated financial statements and related notes included elsewhere in this Annual Report on Form 10-K. This discussion and analysis contains forward-looking statements that involve risks, uncertainties and assumptions.
Removed
Our policy also limits the amount of credit exposure to any one issue, issuer and type of instrument. As of December 31, 2024, we only held investments in securities classified as cash equivalents and marketable equity securities.
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You should review the “Risk Factors” and “Cautionary Note Concerning Forward-Looking Statements” sections of this Annual Report on Form 10-K for a discussion of certain of the important factors that could cause actual results to differ materially from the results described in or implied by the forward-looking statements described in the following quantitative and qualitative disclosures about market risk.
Removed
In particular, as a result of NuVasive’s acquisition of Simplify Medical, we have additional exposure to fluctuations in the Australian dollar. We also have future contingent consideration liabilities denominated in U.S. dollars, in connection with the acquisition of Simplify Medical, which are the financial obligation of our subsidiary, NuVasive (AUST/NZ) Pty Limited , an Australian dollar denominated company.
Added
Those warrant transactions expired throughout 2025 with the final trance of warrants expiring in October 2025. For further discussion, see Note 11 to the consolidated financial statements in “Part II; Item 8.
Added
A sensitivity analysis of changes in the fair value of all currency rate derivative contracts at December 31, 2025 and 2024, indicates that if the U.S. dollar uniformly strengthened/weakened by 10 percent against all currencies, the fair value of these contracts would not increase/decrease by a material amount.
Added
Any gains and losses on the fair value of the derivative contracts would generally be offset by gains and losses on underlying transactions.

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