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What changed in GLOBUS MEDICAL INC's 10-K — 2023 vs 2024

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Paragraph-level year-over-year comparison of GLOBUS MEDICAL INC's 2023 and 2024 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 2024 report.

+301 added−274 removedSource: 10-K (2025-02-20) vs 10-K (2024-02-21)

Top changes in GLOBUS MEDICAL INC's 2024 10-K

301 paragraphs added · 274 removed · 246 edited across 9 sections

Item 1. Business

Business — how the company describes what it does

74 edited+20 added−16 removed146 unchanged
Biggest changeThis includes encouraging a culture of health by providing benefits programs to best serve our employees and their family members. Our comprehensive benefits package may include competitive pay, annual incentive awards and bonus opportunities, health and wellness programs, healthcare and retirement benefits, and paid time off and sick leave.
Biggest changeOur 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.
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 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 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.
We offer educational and training courses globally through in-person formats and via virtual content, including virtual conferences and video and social channels, to demonstrate the benefits of our innovative products and procedures. Competition We believe that our significant competitors are Medtronic, DePuy Synthes, Stryker, Zimmer Biomet, and Smith and Nephew.
We offer educational and training courses globally through in-person formats and via virtual content, including virtual conferences and video and social channels, to demonstrate the benefits of our innovative products and procedures. Competition We believe that our significant competitors are Medtronic, DePuy Synthes, Stryker, Zimmer Biomet, and Smith + Nephew.
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, nurse midwives, and 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, 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 procedural portfolio includes surgical access instruments, spinal implants, fixation systems, biologics, software for surgical planning, navigation and imaging solutions, magnetically adjustable implant systems for spine and orthopedics, and intraoperative neuromonitoring (“IONM”) technology and service offerings. The Merger expanded our global commercial reach, increased operational capabilities and enhanced our comprehensive offerings of Musculoskeletal Solutions and Enabling Technologies.
The procedural portfolio includes surgical access instruments, spinal implants, fixation systems, biologics, software for surgical planning, navigation and imaging solutions, magnetically adjustable implant systems for spine and orthopedics, and intraoperative neuromonitoring (“IONM”) technology and service offerings. The NuVasive Merger expanded our global commercial reach, increased operational capabilities and enhanced our comprehensive offerings of Musculoskeletal Solutions and Enabling Technologies.
However, it is possible that governmental entities or other third parties, including Relators (whistleblowers) who can file complaints on behalf of the government and on their own behalf under the federal False Claims Act (“FCA”), could interpret these laws and our efforts to comply with them differently and assert otherwise.
However, it is possible that governmental entities or other third parties, including Relators (whistleblowers) who can file complaints on behalf of the government and on their own behalf under the federal civil False Claims Act (“FCA”), could interpret these laws and our efforts to comply with them differently and assert otherwise.
Our outsourcing strategy is targeted at companies that meet U.S. Food and Drug Administration (“FDA”), ISO, and quality standards supported by internal policies and procedures. We currently rely on several tissue banks as suppliers of allograft tissue implants, including for our Osteocel Plus and Osteocel Pro product lines.
Our outsourcing strategy is targeted at companies that meet U.S. Food and Drug Administration (the “FDA”), ISO, and quality standards supported by internal policies and procedures. We currently rely on several tissue banks as suppliers of allograft tissue implants, including for our Osteocel Plus and Osteocel Pro product lines.
Specialty societies such as the North American Spine Society (“NASS”), the American Association of Neurological Surgeons, and the American Academy of Orthopedic Surgeons provide advice to the AMA CPT ® Editorial Panel for developing codes. The availability of existing codes to bill for services and procedures may impact the adoption of technology.
Specialty societies such as the North American Spine Society, the American Association of Neurological Surgeons, and the American Academy of Orthopedic Surgeons provide advice to the AMA CPT ® Editorial Panel for developing codes. The availability of existing codes to bill for services and procedures may impact the adoption of technology.
Over 13 different implants have been marketed to date, including modular hip stems and acetabular cups for total hip arthroplasty as well as posterior stabilizing and cruciate retaining knee arthroplasty implants. Our neuromonitoring services utilize proprietary software that employs hunting algorithms and graphical user interfaces to provide surgeons with an enhanced and intuitive nerve avoidance system.
Over 16 different implants have been marketed to date, including modular hip stems and acetabular cups for total hip arthroplasty as well as posterior stabilizing and cruciate retaining knee arthroplasty implants. Our neuromonitoring services utilize proprietary software that employs hunting algorithms and graphical user interfaces to provide surgeons with an enhanced and intuitive nerve avoidance system.
The Centers for Medicare and Medicaid Services (“CMS”) and the National Center for Health Statistics are jointly responsible for overseeing changes and modifications to International Classification of Diseases, Clinical Modification/Procedure Coding System (“ICD-10-CM/PCS”) procedure codes used by all providers including physicians and facilities for reporting patient diagnosis(es) (“ICD-10-CM codes”) and hospitals for reporting inpatient procedures (“ICD-10-PCS codes”).
The Centers for Medicare and Medicaid Services (“CMS”) and the National Center for Health Statistics are jointly responsible for overseeing changes and modifications to International Classification of Diseases, Clinical Modification/Procedure Coding System (“ICD-10-CM/PCS”) procedure codes used by all providers including physicians and facilities for reporting patient diagnosis(es) and hospitals for reporting inpatient procedures.
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; 13 Table of Contents 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; 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.
Ownership and investment interests by physicians and their immediate family members also must be reported. The Sunshine Act also provides penalties for non-compliance. The Sunshine Act requires that we file an annual report on March 31 of a calendar year for the transfers of value incurred for the prior calendar year.
Ownership and investment interests by physicians and their immediate family members also must be reported. The Sunshine Act also provides penalties for non-compliance. The Sunshine Act requires that we file an annual report on March 31 of a calendar year for the payments and other transfers of value incurred for the prior calendar year.
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 Merger with NuVasive, we have significantly grown our global 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 Merger, we have significantly grown our U.S. sales force.
Violations of the federal Anti-Kickback Statute and off-label promotion have been pursued by the Department of Justice (“DOJ”) and the Department of Health and Human Services (“HHS”) as violations of the federal civil False Claims Act (“FCA”). Intent to deceive is not required to establish liability under the civil False Claims Act.
Violations of the federal Anti-Kickback Statute and off-label promotion have been pursued by the Department of Justice (the “DOJ”) and the Department of Health and Human Services (“HHS”) as violations of the FCA. Intent to deceive is not required to establish liability under the civil False Claims Act.
The EU has also adopted the EU Medical Device Regulation (“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.
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.
There are numerous increased burdens associated with the PMA process, which typically requires conduct and submission of human clinical trials with high costs and uncertain outcomes. 12 Table of Contents FDA Postmarket Requirements Pursuant to FDA regulations, we can only market our medical devices for cleared, approved, or granted uses.
There are numerous increased burdens associated with the PMA process, which typically requires conduct and submission of human clinical trials with high costs and uncertain outcomes. FDA Postmarket Requirements Pursuant to FDA regulations, we can only market our medical devices for cleared, approved, or granted uses.
This hybrid strategy is designed to improve customer service, minimize backlogs, increase asset turns, optimize freight costs, and maximize cash flow. Our pool of surgical equipment we make available to hospitals continues to increase as we increase our product offering, expand our distribution 9 Table of Contents channels and increase the market penetration of our products.
This hybrid strategy is designed to improve customer service, minimize backlogs, increase asset turns, optimize freight costs, and maximize cash flow. Our pool of surgical equipment we make available to hospitals continues to increase as we increase our product offering, expand our distribution channels and increase the market penetration of our products.
As the portion of the U.S. population over the age of 65 and eligible for Medicare continues to grow, we may be more vulnerable to coverage 10 Table of Contents and reimbursement limitations imposed by CMS. National and local coverage policy decisions are subject to unforeseeable change and have the potential to impact physician behavior.
As the portion of the U.S. population over the age of 65 and eligible for Medicare continues to grow, we may be more vulnerable to coverage and reimbursement limitations imposed by CMS. National and local coverage policy decisions are subject to unforeseeable change and have the potential to impact physician behavior.
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.
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.
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. National and regional coverage policy decisions are subject to unforeseeable change and have the potential to impact physician behavior and reimbursement for physician services.
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. National and regional coverage policy decisions are subject to unforeseeable change and have the potential to impact physician behavior and reimbursement for physician services.
Further, the advertising and promotion of our products in the EEA is subject to limited provisions under Regulation 2017/745 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 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.
We will also continue to provide our sales representatives with specialized development programs designed to improve their productivity. 5 Table of Contents Continue to expand into international markets . As of December 31, 2023, we had an existing direct or distributor sales presence in 64 countries outside the U.S.
We will also continue to provide our sales representatives with specialized development programs designed to improve their productivity. 5 Table of Contents Continue to expand into international markets . As of December 31, 2024, we had an existing direct or distributor sales presence in 65 countries outside the U.S.
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, 2023, we had a direct or distributor sales presence in the U.S. and in 64 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, 2024, we had a direct or distributor sales presence in the U.S. and in 65 other countries.
In addition to the presiding MDD (93/42/EEC; MDD) and MDR (2017/745; 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, including environmental compliance, product stewardship, technical considerations, material of manufacture, and labeling availability.
Following the expiration of the transitional provisions of the MDD relating to the CE mark (extended to December 2027), 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 EU 2017/745, which increased technical documentation requirements, imparted more labeling obligations of higher risk devices, and altered the classification of some of our products.
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.
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 are critical to our success as an organization.
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.
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, 2023, international sales accounted for approximately 18.4% 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, 2024, international sales accounted for approximately 20.6% of our total sales.
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 devices; 2028 for Class II and class I devices which require involvement of a Notified Body in the conformity assessment, at which time these products must comply with the new regulation.
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.
Globus is an engineering-driven company with a history of rapidly developing and commercializing advanced products and procedures to address treatment challenges. With over 10 product launches in 2023 and operations across 64 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 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.
(“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 “Merger”).
(“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”).
UK-approved Notified Bodies designated by the MHRA will conduct conformity assessments against applicable requirements of the UKCA mark. Obtaining the UKCA conformity mark is optional from January 2021 and will have rolling requirements for MDD/MDR certified devices through 2027.
UK-approved Notified Bodies designated by the MHRA will conduct conformity assessments against applicable requirements of the UKCA mark. Obtaining the UKCA conformity mark is optional from January 2021 and will have rolling requirements for MDD/MDR certified devices until June 30, 2030.
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 a 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. 16 Table of Contents Also under HIPAA, a Covered Entity is required to adhere to certain requirements regarding the use, disclosure and security of protected health information (“PHI”).
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.
These organizations support life-changing spine surgery for individuals around the world with limited access to high quality medical treatment by working with surgeons to advance the quality of spine care in disadvantaged communities. In addition, through our grants program, we support 18 Table of Contents medical research and education, charitable and philanthropic endeavors.
This organization supports life-changing spine surgery for individuals around the world with limited access to high quality medical treatment by working with surgeons to advance the quality of spine care in disadvantaged communities. In addition, through our grants program, we support medical research and education, charitable and philanthropic endeavors.
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). Other countries, such as Brazil, Canada, Switzerland and Japan, require separate region-specific regulatory filings.
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).
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.
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.
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 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.
Diversity and Inclusion We recognize the value associated with fostering a work environment that is culturally diverse an d 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 .
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.
Although CE conformity marking and certificates issued by Notified Bodies will continue to be recognized in the UK through 2027, all medical devices were required to be registered with the MHRA as of January 1, 2021 in accordance with the provided grace period depending on the product risk classification.
Although CE conformity marking and certificates issued by Notified Bodies will continue to be recognized in the UK until June 30, 2028 for medical devices that have undergone the conformity procedure under the EU MDD and until June 30, 2030 for medical devices that have undergone the conformity procedure under the EU MDR, all medical devices are required to be registered with the MHRA as of January 1, 2021 in accordance with the provided grace period depending on the product risk classification.
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.
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.
In addition, we strive to support our teams in the areas of professional development, mentoring, engagement, and health and wellness, enabling them to do their best work as they grow their careers.
In addition, we strive to support our teams in the areas of professional development, mentoring, engagement, and health and wellness, enabling them to do their best work as they grow their careers. To support long-term growth, we encourage employees to partner with their managers to create Individual Development Plans tailored to their career aspirations.
We have focused on developing a strong supplier base as part of our manufacturing strategy. Our relationship with our suppliers enables significant interaction between our design engineers and project managers and the suppliers’ engineers and schedulers to work through issues arising during the entire product development cycle.
Our relationship with our suppliers enables significant interaction between our design engineers and project managers and the suppliers’ engineers and schedulers to work through issues arising during the entire product development cycle.
Devices marketed in Japan must comply with the PMD Act, MO169, 2021 and are assessed by both government entities and third-party organizations using all three procedures in place for manufacturers.
Based on the risk-based classification, manufacturers are provided three procedures for satisfying the PMD Act requirements prior to placing products on the market: Premarket Submission, Premarket Certification, and Premarket Approval. Devices marketed in Japan must comply with the PMD Act, MO169, 2021 and are assessed by both government entities and third-party organizations using all three procedures in place for manufacturers.
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.
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.
Through our IONM platforms, we give surgeons the option to connect their instruments to a computer system that provides discrete, real-time, surgeon-directed and surgeon-controlled feedback about the directionality and relative proximity of nerves during surgery.
Through our IONM platforms, we give surgeons the option to connect certain instruments to a computer system that provides discrete, real-time, surgeon-directed and surgeon-controlled feedback about the directionality and relative proximity of nerves during surgery. Our systems analyze and then translate complex neurophysiologic data into simple, useful information to assist the surgeon’s clinical decision-making process.
The term “remuneration” has been interpreted broadly to include anything of value. State anti-kickback laws have similar prohibitions.
The term “remuneration” has been interpreted broadly to include anything of value.
In the EEA, our devices are required to comply with the essential requirements of the EU Medical Device Directive (Council Directive 93/42/EEC) (“MDD”). Compliance with these requirements entitles us to affix the CE conformity mark to our medical devices, without which medical devices cannot be commercialized in the EEA.
Compliance with these requirements entitles us to affix the CE conformity mark to our medical devices, without which medical devices cannot be commercialized in the EEA.
We responded to the FDA’s warning letter on November 20, 2018, provided periodic updates to the FDA on our progress, and notified the FDA of actions completed to resolve the observations. As of December 31, 2023, this warning letter has been resolved.
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.
The SEC maintains a website (www.sec.gov) that contains reports, proxy and information statements, and other information regarding issuers that file electronically.
We are subject to the filing requirements of the Exchange Act. Therefore, we file annual reports, periodic reports, proxy statements and other information with the SEC. The SEC maintains a website (www.sec.gov) that contains reports, proxy and information statements, and other information regarding issuers that file electronically.
We believe our team-oriented and highly integrated development approach, active surgeon input, and demonstrated performance position us to maintain a rapid rate of new product launches. We launched 10 new products in 2023, in addition to assuming NuVasive’s portfolio of products, which include the X360 portfolio, the C360 portfolio featuring the Simplify Cervical Disc, and the P360 portfolio.
We believe our team-oriented and highly integrated development approach, active surgeon input, and demonstrated performance position us to maintain a rapid rate of new product launches. We launched 18 new products in 2024, including the ExcelsiusHub™ and the ExcelsiusFlex™ surgical navigation system.
In addition to compliance with EU & EEA statutes, we must also comply with national laws of individual sovereign nations (i.e. Member States). These laws vary and can include additional registration efforts to be completed before CE -marked product can be distributed within respective Member States.
In addition to compliance with EU & EEA statutes, we must also comply with national laws of individual sovereign nations (i.e. Member States).
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. We value open and direct communication with our employees about their experiences.
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.
The ExcelsiusGPS ® robotic guidance and navigation system and Excelsius3D™ imaging system are assembled in our facility in Methuen, Massachusetts. Of our implant and instrument products that are not manufactured in-house, a majority are generally manufactured through a network of third-party suppliers. Our suppliers use high precision, computer-aided manufacturing equipment to manufacture our products.
Of our implant and instrument products that are not manufactured in-house, a majority are generally manufactured through a network of third-party suppliers. Our suppliers use high precision, computer-aided manufacturing equipment to manufacture our products. We have focused on developing a strong supplier base as part of our manufacturing strategy.
Payors may deem the clinical efficacy of a device or procedure to be experimental or investigational, not the most cost-effective treatment available, or used for an unapproved indication. Additionally, many private payors use coverage decisions and payment amounts established by CMS for the Medicare program as guidelines in setting their coverage and reimbursement policies.
Payors may deem the clinical efficacy of a device or procedure to be experimental or investigational, not the most cost-effective treatment available, or used for an unapproved indication.
We discuss below the statutes and regulations that are most relevant to our business. 11 Table of Contents U.S.
We discuss below the statutes and regulations that are most relevant to our business. 11 Table of Contents There may be future changes in legal and regulatory requirements that may materially impact our results of operations.
Since 2009, we have leveraged our expertise in spine care to give back to local and global communities through Globus Cares and NuVasive Spine Foundation, both 501(c)(3) nonprofit organizations.
Community Our employees and sales representatives have a long history of providing support and care to our communities, donating time, resources and funds to local causes. Since 2009, we have leveraged our expertise in spine care to give back to local and global communities through Globus Cares, our 501(c)(3) nonprofit organization.
Complying with this new regulatory framework will require us to invest in additional resources and could be expensive, time-consuming and disruptive to our existing operations in the UK. In 2014, the Japanese government revised the Pharmaceutical Affairs Law, now the Pharmaceutical and Medical Device Act (“PMD Act”), which made significant changes to the pre-approval regulatory systems.
In 2014, the Japanese government revised the Pharmaceutical Affairs Law, now the Pharmaceutical and Medical Device Act (“PMD Act”), which made significant changes to the pre-approval regulatory systems.
Additionally, we must comply with a variety of other laws that protect the privacy of individually identifiable healthcare information and impose extensive tracking and reporting related to transfers of value provided to certain healthcare professionals.
Violations of these laws may be punishable by criminal or civil sanctions, including substantial fines, imprisonment of current or former employees, and exclusion from participation in governmental healthcare programs. 17 Table of Contents Additionally, we must comply with a variety of other laws that protect the privacy of individually identifiable healthcare information and impose extensive tracking and reporting related to transfers of value provided to certain healthcare professionals.
Manufacturing and Supply We have greatly expanded our dedicated in-house manufacturing capabilities. Our implant products are manufactured in our facilities in Eagleville, Pennsylvania, Limerick, Pennsylvania and West Carrollton, Ohio. Most of our regenerative biologic products 8 Table of Contents are processed in our facilities in San Antonio, Texas, and in Audubon, Pennsylvania.
Our implant products are manufactured in our facilities in Eagleville, Pennsylvania, Limerick, Pennsylvania and West Carrollton, Ohio. Most of our regenerative biologic products are processed in our facilities in San Antonio, Texas, and in Audubon, Pennsylvania. The Excelsius ® robotic systems are assembled in our facility in Methuen, Massachusetts.
Our talent-related initiatives, including employee recruitment and development, compensation and benefit programs, are focused on building and retaining the world-class and talented staff that is needed to meet our goals. As of December 31, 2023, we had over 5,000 employees worldwide , including sales and marketing, product development, 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, 2024, we had over 5,300 employees worldwide, including sales and marketing, product development, operations, general administrative and accounting, both domestically and internationally.
Despite measures taken to protect our intellectual property, unauthorized parties may attempt to copy aspects of our products or to obtain and use information that we regard as proprietary.
Despite measures taken to protect our intellectual property, unauthorized parties may attempt to copy aspects of our products or to obtain and use information that we regard as proprietary As of December 31, 2024, we owned 2,859 issued U.S. patents (2,823 utility patents; 36 design patents) and had applications pending for 822 U.S. patents (all utility patents), and we owned 1,854 issued foreign patents and had applications pending for 464 foreign patents.
MDD compliant products intended to be placed on the market after May 2024 must meet certain conditions and be under contract with an MDR accredited Notified Body and in compliance with Transitional Provisions. 14 Table of Contents Additionally, in the EEA the procurement, testing, processing, preservation, storage and distribution of human tissues and cells is subject to the requirements of the laws of individual EEA Member States implementing Directive 2004/23/EC, Directive 2006/17/EC and Directive 2006/86/EC.
Additionally, in the EEA the procurement, testing, processing, preservation, storage and distribution of human tissues and cells is subject to the requirements of the laws of individual EEA Member States implementing Directive 2004/23/EC, Directive 2006/17/EC and Directive 2006/86/EC.
Our trademark portfolio contains 732 registered trademarks and 196 pending trademarks. Our portfolio includes domestic and foreign trademarks with associated logos and tag lines.
Our issued patents expired or will expire between March 2015 and December 2044. Our trademark portfolio contains 746 registered trademarks and 194 pending trademarks. Our portfolio includes domestic and foreign trademarks with associated logos and tag lines.
These inspections may include our manufacturing, suppliers’ and sub-contractors’ facilities. On October 31, 2018, we received a warning letter from the FDA resulting from an inspection of the facilities of our subsidiary Human Biologics of Texas, located in San Antonio, Texas, in April 2018.
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.
Following a national referendum and enactment of legislation by the government of the United Kingdom (“UK”), the UK formally withdrew from the EU and ratified a trade and cooperation agreement governing its future relationship with the EU. The agreement addresses trade, economic arrangements, law enforcement, judicial cooperation, and a governance framework, including procedures for dispute resolution, among other things.
The agreement addresses trade, economic arrangements, law enforcement, judicial cooperation, and a governance framework, including procedures for dispute resolution, among other things.
Our corporate website address is http://www.globusmedical.com . The information contained in or accessible through our website or contained on other websites is not deemed to be part of this Annual Report on Form 10-K. We are subject to the filing requirements of the Exchange Act. Therefore, we file annual reports, periodic reports, proxy statements and other information with the SEC.
Our principal executive offices are located at 2560 General Armistead Avenue, Audubon, Pennsylvania 19403, and our telephone number at that location is (610) 930-1800. Our corporate website address is http://www.globusmedical.com . The information contained in or accessible through our website or contained on other websites is not deemed to be part of this Annual Report on Form 10-K.
They may also develop and patent processes or products earlier than we can, or obtain regulatory clearance or approvals for competing products more rapidly than we can. We compete in the marketplace to recruit and retain qualified scientific, management, and sales personnel, as well as in acquiring technologies and technology licenses complementary to our products or advantageous to our business.
They may also develop and patent processes or products earlier than we can, or obtain regulatory clearance or approvals for competing products more rapidly than we can.
The Globus Solution We believe that our focus on actively listening and responding to the needs of our customers with high quality solutions separates us from our industry peers. Since 2003 we have introduced many products, including 10 products in 2023, designed for the treatment of musculoskeletal disorders.
We regularly evaluate possible acquisitions and strategic relationships and believe that our resources and experience make us an attractive acquirer or partner. The Globus Solution We believe that our focus on actively listening and responding to the needs of our customers with high quality solutions separates us from our industry peers.
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, 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 intend to selectively pursue acquisitions and alliances that complement our strategic plan and provide innovative technologies, personnel with significant relevant experience, or increased market penetration. We regularly evaluate possible acquisitions and strategic relationships and believe that our resources and experience make us an attractive acquirer or partner.
During the first quarter of 2024, the Company completed a share acquisition of a biotechnology company focused on research and development for hemostasis solutions. We intend to selectively pursue acquisitions and alliances that complement our strategic plan and provide innovative technologies, personnel with significant relevant experience, or increased market penetration.
Medicare may establish National Coverage Determinations or Medicare Administrative Contractors may establish Local Coverage Determinations that provide coverage information and determine whether services are reasonable and necessary.
Additionally, many private payors use coverage decisions and payment amounts established by CMS for the Medicare program as guidelines in setting their coverage and reimbursement policies. 10 Table of Contents Medicare may establish National Coverage Determinations or Medicare Administrative Contractors may establish Local Coverage Determinations that provide coverage information and determine whether services are reasonable and necessary.
We also review performance data and promotion and compensation information to ensure fair and objective decision-making. We believe that building diverse teams and leveraging broad perspectives will empower our employees and strengthen our ability to meet the needs of our customers, patients, and communities we serve.
Our HR and talent teams actively support professional development opportunities for employees across all demographics. We monitor voluntarily disclosed diversity data to track progress in hiring, promotion, and attrition and ensure fairness in performance evaluations, promotions, and compensation. By building diverse teams and leveraging broad perspectives, we strengthen our ability to meet the needs of our customers, patients, and communities.
This grace period has been extended, and the UK Parliament intends to bring forward an additional statutory instrument to legislate for further measures in Spring 2024. Additionally, for manufacturers based outside of the UK, a single UK Responsible Person with a place of business in the UK must be established.
Additionally, for manufacturers based outside of the UK, a single UK Responsible Person with a place of business in the UK must be established. Complying with this new regulatory framework will require us to invest in additional resources and could be expensive, time-consuming and disruptive to our existing operations in the UK.
Surgeons can connect certain instruments to our IONM systems, thus creating an interactive set of instruments that better enable the safe navigation through the body’s nerve anatomy during surgery. We provide onsite and remote monitoring of the neurological systems of patients undergoing spinal and brain-related surgeries.
We provide onsite and remote monitoring of the neurological systems of patients undergoing spinal and brain-related surgeries.
This highly maneuverable and intuitive imaging platform offers 3 imaging modalities, position memory, and a large field of view. Our innovative Enabling Technologies products offer surgeons more information about patient anatomy and surgical options to help them to make well-informed preoperative and intraoperative surgical decisions.
The ExcelsiusFlex® is a total knee arthroplasty robotic solution with imageless and computed tomography-based registration workflows. It was designed to give ergonomic control to the surgeon with enhanced feedback and visibility. Our innovative Enabling Technologies products offer surgeons more information about patient anatomy and surgical options to help them to make well-informed preoperative and intraoperative surgical decisions.
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We believe our proprietary IONM platforms are a differentiator in the market and are unique in their ability to provide information about the directionality and proximity of nerves. Our systems analyze and then translate complex neurophysiologic data into simple, useful information to assist the surgeon’s clinical decision-making process.
Added
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.
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Monitoring the health of the nervous system during spinal surgery has been a key component of our strategy of product differentiation since early in our development.
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We compete in the marketplace to recruit and retain qualified scientific, management, and sales personnel, as well as in acquiring technologies and technology licenses complementary to our products or advantageous to our business. 8 Table of Contents Manufacturing and Supply We have greatly expanded our dedicated in-house manufacturing capabilities.
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As of December 31, 2023, we owned 2,583 issued U.S. patents (2,547 utility patents; 36 design patents) and had applications pending for 867 U.S. patents (866 utility patents; 1 design patents), and we owned 1,744 issued foreign patents and had applications pending for 502 foreign patents. Our issued patents expired or will expire between March 2015 and November 2043.
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We do not generally receive separate economic value specific to the surgical instrument sets from the surgeons or hospitals that utilize them.

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Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

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Biggest changePotential 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. 26 Table of Contents 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.
Biggest changePotential 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.
Risks Relating to the Integration of NuVasive Integrating the NuVasive business into Globus may be more difficult, costly or time-consuming than expected and the Company may fail to realize the anticipated benefits of the Merger, which may adversely affect the Company’s business results and negatively affect the value of the Company’s common stock. The Company expects to incur substantial expenses related to the integration of NuVasive and may be unable to realize the anticipated synergies, which could adversely affect the Company’s business, financial condition and results of operations. 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.
Risks Relating to the Integration of NuVasive Integrating the NuVasive business into Globus may be more difficult, costly or time-consuming than expected and the Company may fail to realize the anticipated benefits of the NuVasive Merger, which may adversely affect the Company’s business results and negatively affect the value of the Company’s common stock. The Company expects to incur substantial expenses related to the integration of NuVasive and may be unable to realize the anticipated synergies, which could adversely affect the Company’s business, financial condition and results of operations. 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 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 and 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, and Smith + Nephew.
It is also possible that other federal, state or foreign enforcement authorities, such as DOJ or HHS, might take action if they consider our promotional or training materials to constitute promotion of an unapproved/off-label use, which could result in significant criminal and/or civil sanctions under other statutory authorities, such as laws prohibiting false claims for reimbursement (e.g., the FCA).
It is also possible that other federal, state or foreign enforcement authorities, such as the DOJ or HHS, might take action if they consider our promotional or training materials to constitute promotion of an unapproved/off-label use, which could result in significant criminal and/or civil sanctions under other statutory authorities, such as laws prohibiting false claims for reimbursement (e.g., the FCA).
The success of the 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 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 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 Merger, the failure of which would result in the anticipated benefits of the 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; 44 Table of Contents 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, 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.
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 34 Table of Contents 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 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.
Regulatory changes could result in restrictions on our ability to carry on or expand our operations, higher than anticipated costs or lower than anticipated sales. The processes by which 510(k) clearance, grant of a de novo classification request, or PMA approval is obtained can be expensive and lengthy and require the payment of significant fees.
Regulatory changes and uncertainty could result in restrictions on our ability to carry on or expand our operations, higher than anticipated costs or lower than anticipated sales. The processes by which 510(k) clearance, grant of a de novo classification request, or PMA approval is obtained can be expensive and lengthy and require the payment of significant fees.
Private litigation, including class actions, related to privacy and cybersecurity issues is also on the rise in the U.S. and other countries. If we experience significant disruptions in our information technology systems, our business, results of operations and financial condition could be adversely affected. The efficient operation of our business depends on our information technology systems.
Private litigation, including class actions, related to privacy and cybersecurity issues is also on the rise in the U.S. and other countries. If we experience significant disruptions in our information technology systems, our business, results of operations and financial condition could be adversely affected. The efficient operation of our business depends on our IT Systems.
An inability to realize the full extent of the anticipated benefits of the 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 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.
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-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 Merger integration process that takes longer than originally anticipated.
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 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 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.
The Company may be exposed to increased litigation, which could have an adverse effect on the Company’s business and operations . The Company may be exposed to increased litigation from stockholders, customers, partners, suppliers, contractors and other third parties due to the Merger of Globus’s and NuVasive’s businesses.
The Company may be exposed to increased litigation, which could have an adverse effect on the Company’s business and operations . The Company may be exposed to increased litigation from stockholders, customers, partners, suppliers, contractors and other third parties due to the NuVasive Merger of Globus’s and NuVasive’s businesses.
Our information systems, and those of third-parties with whom we contract, also require an ongoing commitment of significant resources to maintain, protect and enhance existing systems and develop new systems to keep pace with continuing changes in information technology.
Our IT Systems, and those of third-parties with whom we contract, also require an ongoing commitment of significant resources to maintain, protect and enhance existing systems and develop new systems to keep pace with continuing changes in information technology.
These events could lead to the unauthorized access to information systems maintained by us or our service providers or customers and result in the misappropriation or unauthorized disclosure of confidential information belonging to us, our employees, patients, partners, customers, or our suppliers.
These events could lead to the unauthorized access to IT Systems maintained by us or our service providers or customers and result in the misappropriation or unauthorized disclosure of confidential information belonging to us, our employees, patients, partners, customers, or our suppliers.
There can be no guarantee that Globus’s or NuVasive’s contractual counterparties will remain with or continue to have a relationship with the Company or do so on the same or similar contractual terms following the Merger.
There can be no guarantee that Globus’s or NuVasive’s contractual counterparties will remain with or continue to have a relationship with the Company or do so on the same or similar contractual terms following the NuVasive Merger.
Modifications to our products may require new 510(k) or de novo clearances, PMAs or PMA supplements, or may require us to cease marketing or recall the modified products until clearances or approvals are obtained.
Modifications to our products may require new 510(k) or de novo clearances, HDEs, PMAs or PMA supplements, or may require us to cease marketing or recall the modified products until clearances or approvals are obtained.
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 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; 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.
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. As of December 31, 2023, we had outstanding $450.0 million aggregate principal amount of our 0.375% Convertible Senior Notes due March 15, 2025, (the “2025 Notes”).
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. As of December 31, 2024, we had outstanding $450.0 million aggregate principal amount of our 0.375% Convertible Senior Notes due March 15, 2025, (the “2025 Notes”).
Certain counterparties may seek to terminate or modify contractual obligations following the Merger whether or not contractual rights are triggered as a result of the Merger.
Certain counterparties may seek to terminate or modify contractual obligations following the NuVasive Merger whether or not contractual rights are triggered as a result of the NuVasive Merger.
However, if the FDA determines that our promotional efforts constitutes promotion of an off-label use, it could request that we modify our training or promotional efforts or subject us to regulatory or enforcement actions, including the issuance of an untitled letter, a warning letter, injunction, seizure, civil penalties and criminal fines.
However, if the FDA determines that our promotional efforts constitute promotion of an off-label use, it could request that we modify our training or promotional efforts or subject us to regulatory or enforcement actions, including the issuance of an untitled letter, a warning letter, injunction, seizure, civil penalties and criminal fines.
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 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; 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.
Most jurisdictions have relaxed restrictions and resumed business operations, but a resurgence in infections or mutations of the coronavirus that causes COVID-19 could cause governments, hospitals, public institutions, or other authorities to reinstate such restrictions or impose additional restrictions.
Most jurisdictions have relaxed restrictions and resumed business operations, but a resurgence in infections or mutations of the coronavirus that causes COVID-19 or another disease could cause governments, hospitals, public institutions, or other authorities to reinstate such restrictions or impose additional restrictions.
This significant amount of debt has important risks to us and our investors, including: requiring a portion of our cash flow from operations to make interest payments on this debt; increasing our vulnerability to general adverse economic and industry conditions; reducing the cash flow available to fund capital expenditures and other corporate purposes and to grow our business; limiting our flexibility in planning for, or reacting to, changes in our business and the industry; and limiting our ability to borrow additional funds as needed or take advantage of business opportunities as they arise.
This significant amount of debt has important risks to us and our investors, including: requiring a portion of our cash flow from operations to make principal and interest payments on this debt; increasing our vulnerability to general adverse economic and industry conditions; reducing the cash flow available to fund capital expenditures and other corporate purposes and to grow our business; 38 Table of Contents limiting our flexibility in planning for, or reacting to, changes in our business and the industry; and limiting our ability to borrow additional funds as needed or take advantage of business opportunities as they arise.
Risks 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 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. 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. 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.
Risks 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.
If we are unable to do so, our sales or margins could decrease, thereby harming our business. 24 Table of Contents 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.
If we are unable to do so, our sales or margins could decrease, thereby harming our business. 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.
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.
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.
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.
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.
The cost of, or lack of, available credit or equity financing could 38 Table of Contents 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 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.
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.
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.
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.
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.
We have entered into 39 Table of Contents confidentiality agreements and intellectual property assignment agreements with our officers, employees, consultants and advisors regarding our intellectual property and proprietary technology. In the event of unauthorized use or disclosure or other breaches of such agreements, we may not be provided with meaningful protection for our trade secrets or other proprietary information.
We have entered into confidentiality agreements and intellectual property assignment agreements with our officers, employees, consultants and advisors regarding our intellectual property and proprietary technology. In the event of unauthorized use or disclosure or other breaches of such agreements, we may not be provided with meaningful protection for our trade secrets or other proprietary information.
The sale and shipment of our products across international borders, as well as the purchase of components and products from international sources, subject us to extensive U.S. and foreign governmental trade, import and export and customs regulations and laws. Compliance with these regulations 36 Table of Contents and laws is costly and exposes us to penalties for non-compliance.
The sale and shipment of our products across international borders, as well as the purchase of components and products from international sources, subject us to extensive U.S. and foreign governmental trade, import and export and customs regulations and laws. Compliance with these regulations and laws is costly and exposes us to penalties for non-compliance.
Given the nature of our business, we also may maintain personally identifiable information (“PII”) or access to PHI. Specifically, we rely on our information technology systems to effectively manage sales and marketing, accounting and financial functions, inventory management, engineering and product development tasks, and our research and development data.
Given the nature of our business, we also may maintain personally identifiable information (“PII”) or access to PHI. We rely on our IT Systems to effectively manage sales and marketing, accounting and financial functions, inventory management, engineering and product development tasks, and our research and development data.
Risks Relating to the Integration of NuVasive Integrating the NuVasive business into Globus may be more difficult, costly or time-consuming than expected and the Company may fail to realize the anticipated benefits of the Merger, which may adversely affect the Company’s business results and negatively affect the value of the Company’s common stock.
Risks Relating to the Integration of NuVasive 44 Table of Contents Integrating the NuVasive business into Globus may be more difficult, costly or time-consuming than expected and the Company may fail to realize the anticipated benefits of the NuVasive Merger, which may adversely affect the Company’s business results and negatively affect the value of the Company’s common stock.
Foreign regulatory bodies may evaluate our products or the testing that our products undergo against these standards. The specific standards, types of evaluation and scope of review differ among foreign regulatory bodies. We intend to comply with the standards enforced by such foreign regulatory bodies as needed to commercialize our products.
Foreign regulatory bodies may evaluate our products or the testing that our products undergo against these standards. The specific standards, types of evaluation and scope of review differ among foreign regulatory bodies. We intend to comply 32 Table of Contents with the standards enforced by such foreign regulatory bodies as needed to commercialize our products.
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.
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.
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.
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.
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.
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.
Risks Related to the Ownership of our Class A Common Stock Because of their significant stock ownership, our executive officers, and our directors and principal stockholders will be able to exert control over us and our significant corporate decisions. We are a “controlled company” within the meaning of the New York Stock Exchange Rules. Our Board is authorized to issue and designate shares of our preferred stock in additional series without stockholder approval. Anti-takeover provisions in our organizational documents and Delaware law may discourage or prevent a change of control. 21 Table of Contents General Risk Factors If we do not successfully implement our business strategy, our business and results of operations will be adversely affected If we fail to properly manage our anticipated growth, our business could suffer. Fluctuations in insurance cost and availability could adversely affect our profitability or our risk management profile. We are exposed to the credit risk of some of our customers, which could result in material losses. The widespread outbreak of a communicable disease, or any other public health crisis, could adversely affect our financial condition and results of operations.
Risks Related to the Ownership of our Class A Common Stock Because of their significant stock ownership, our executive officers, and our directors and principal stockholders will be able to exert control over us and our significant corporate decisions. We are a “controlled company” within the meaning of the New York Stock Exchange Rules. Our Board is authorized to issue and designate shares of our preferred stock in additional series without stockholder approval. Anti-takeover provisions in our organizational documents and Delaware law may discourage or prevent a change of control. 21 Table of Contents General Risk Factors If we do not successfully implement our business strategy, our business and results of operations will be adversely affected If we fail to properly manage our anticipated growth, our business could suffer. Fluctuations in insurance cost and availability could adversely affect our profitability or our risk management profile. We are exposed to the credit risk of some of our customers, which could result in material losses. 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 widespread outbreak of a communicable disease, or any other public health crisis, could adversely affect our financial condition and results of operations.
It is also possible that, if we obtain new FDA regulatory clearances 30 Table of Contents or approvals, the clearances or approvals may contain limitations on the indicated uses or may prohibit certain uses which may impact the marketability of the product.
It is also possible that, if we obtain new FDA regulatory clearances or approvals, the clearances or approvals may contain limitations on the indicated uses or may prohibit certain uses which may impact the marketability of the product.
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. 32 Table of Contents 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 EU Medical Device Vigilance System.
Furthermore, as of December 31, 2023, we had 192,602,552 shares of Class B common stock available for issuance.
Furthermore, as of December 31, 2024, we had 192,602,552 shares of Class B common stock available for issuance.
Furthermore, there is no guarantee that future working capital, borrowings or equity financing will be available to repay or refinance any such debt. Risks Related to our Intellectual Property and Potential Litigation Our ability to protect our intellectual property and proprietary technology is uncertain.
Furthermore, there is no guarantee that future working capital, borrowings or equity financing will be available to repay or refinance any such debt. 39 Table of Contents Risks Related to our Intellectual Property and Potential Litigation Our ability to protect our intellectual property and proprietary technology is uncertain.
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.
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.
Such litigation may have an adverse impact on the Company’s business and results of operations or may cause disruptions to the Company’s operations. 45 Table of Contents Item 1B. Unresolved Staff Comments None.
Such litigation may have an adverse impact on the Company’s business and results of operations or may cause disruptions to the Company’s operations. Item 1B. Unresolved Staff Comments None.
International operations account for approximately 18.4% 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.
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.
Paul, our Executive Chairman, and his family members, controlled approximately 16.3% of our Class A and Class B common stock, representing approximately 65.8% 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 16.2% 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.
If certain of our direct sales representatives were to leave us, or if certain of our independent 23 Table of Contents distributors were to cease to do business with us, our sales could be adversely affected.
If certain of our direct sales representatives were to leave us, or if certain of our independent distributors were to cease to do business with us, our sales could be adversely affected.
We rely on our information technology systems to effectively manage: sales and marketing, accounting and financial functions; inventory management; engineering and product development tasks; and our research and development data.
We rely on our IT Systems to effectively manage: sales and marketing, accounting and financial functions; inventory management; engineering and product development tasks; and our research and development data.
In the U.S., all of our currently commercialized medical device products, other than SECURE ® -C 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, have either received premarket clearance under Section 510(k) of the FDCA or are exempt from PMA review.
In addition, we may have more difficulty maintaining our historical or prior rate of growth of revenues, profitability or cash 37 Table of Contents flows.
In addition, we may have more difficulty maintaining our historical or prior rate of growth of revenues, profitability or cash flows.
Although our computer and communications hardware is protected by reasonable physical, technical, and administrative safeguards, it is still vulnerable to system malfunction, computer viruses, and cybersecurity breaches – including ransomware, phishing DDoS, malware, brute force, insider threats, and other cyber attacks and security incidents.
Although our IT Systems are protected by reasonable physical, technical, and administrative safeguards, they are still vulnerable to system malfunction, computer viruses, and cybersecurity breaches – including ransomware, phishing DDoS, malware, brute force, insider threats, and other cyber attacks and security incidents.
We are increasingly dependent on sophisticated information technology systems to operate our business, including to process, transmit and store sensitive data, and many of our products and services include or use integrated software and information technology that may collect data regarding customers, patients, suppliers and third parties, or connects to our systems.
We use the IT Systems to operate our business, including to process, transmit and store sensitive data, and many of our products and services include or use integrated software and information technology that may collect data regarding customers, patients, suppliers and third parties, or connects to our systems.
Within the U.S., a number of states have enacted more onerous privacy laws, such as the California Consumer Privacy Act (the “CCPA”), which also impose stricter privacy requirements and are enforced by state attorneys general and other state agencies.
Within the U.S., a number of states have enacted more onerous privacy laws, such as the California Consumer Privacy Act (the “CCPA”), which also impose stricter privacy requirements and are enforced by state attorneys general and other state agencies and may allow for private litigation in some circumstances.
We have experienced rapid growth since our inception and increased our net sales to $1,568.5 million in 2023. 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 $2,519.4 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.
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 and imposes significant fines for non-compliance.
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; 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; power losses; and computer systems, or Internet, telecommunications or data network failures.
In addition to the regulation of personal health information, a number of states have also adopted laws and regulations that may affect our privacy and data security practices for other kinds of PII, such as state laws that govern the use, disclosure and protection of sensitive personal information, such as social security numbers, or that are designed to protect credit card account data. 27 Table of Contents State consumer protection laws may also establish privacy and security standards for use and management of PII, including information related to customers, suppliers, and care providers.
In addition to the regulation of personal health information, a number of states have also adopted laws and regulations that may affect our privacy and data security practices for other kinds of PII, such as state laws that govern the use, disclosure and protection of sensitive personal information, such as social security numbers, health-related data beyond HIPAA, biometrics, or that are designed to protect credit card account data.
If the FDA disagrees with our determination and requires us to submit new 510(k) notifications, de novo petitions, PMAs or PMA supplements for modifications to our previously cleared products for which we have concluded that new clearances or approvals are unnecessary, we may be required to cease marketing or to recall the modified product until we obtain clearance or approval, and we may be subject to significant regulatory fines or penalties. 31 Table of Contents Our HCT/P products are subject to extensive government regulation and our failure to comply with these requirements could cause our business to suffer.
If the FDA disagrees with our determination and requires us to submit new 510(k) notifications, de novo petitions, PMAs or PMA supplements for modifications to our previously cleared products for which we have concluded that new clearances or approvals are unnecessary, we may be required to cease marketing or to recall the modified product until we obtain clearance or approval, and we may be subject to significant regulatory fines or penalties.
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.
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.
We continue to introduce new products and services related to our the ExcelsiusGPS ® platform and orthopedic trauma products. We recently launched the Excelsius3D™ imaging system. Prior to launching these platforms, we had no prior experience marketing these new products and we may launch new products in the future that we have no prior experience marketing.
We continue to introduce new products and services related to the ExcelsiusGPS ® platform and orthopedic trauma products. Additionally, in 2024 we launched the ExcelsiusHub® and the ExcelsiusFlex® systems. Prior to launching these platforms, we had no prior experience marketing these new products and we may launch new products in the future that we have no prior experience marketing.
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. 35 Table of Contents Risks Related to our International Operations We may fail to obtain or maintain foreign regulatory approvals to market our products in other countries.
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.
Based on an aggregate of 136,335,662 shares of our Class A and Class B common stock outstanding as of December 31, 2023, our executive officers and directors and their affiliates beneficially owned, in the aggregate, approximately 66.1% of the voting power of our outstanding capital stock. In particular, as of December 31, 2023, David C.
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.
The failure of our information technology 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 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.
As a result of the Merger, the Company may experience impacts on relationships with contractual counterparties (such as business partners, surgeons, vendors, sales representatives, contractors, distributors or other third-party service providers) that may harm the Company’s business and results of operations.
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. 45 Table of Contents As a result of the NuVasive Merger, the Company may experience impacts on relationships with contractual counterparties (such as business partners, surgeons, vendors, sales representatives, contractors, distributors or other third-party service providers) that may harm the Company’s business and results of operations.
Additionally, the regulatory environment governing information, security and privacy laws is increasingly demanding and continues to evolve. If our information technology systems are compromised, we could be subject to fines, damages, litigation and enforcement actions and we could lose trade secrets or other confidential information, the occurrence of which could harm our reputation, business, results of operations and financial condition.
If our information technology systems are compromised, we could be subject to fines, damages, litigation and enforcement actions and we could lose PII, PHI, trade secrets or other confidential information, the occurrence of which could harm our reputation, business, results of operations and financial condition.
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. 42 Table of Contents In addition, we are subject to the provisions of Section 203 of the Delaware General Corporation Law regulating corporate takeovers, which may restrict or prohibit certain business combination transactions with stockholders owning 15% or more of our outstanding voting stock, including discouraging takeover attempts that might result in a premium over the market price for shares of our Class A common stock.
In addition, we are subject to the provisions of Section 203 of the Delaware General Corporation Law regulating corporate takeovers, which may restrict or prohibit certain business combination transactions with stockholders owning 15% or more of our outstanding voting stock, including discouraging takeover attempts that might result in a premium over the market price for shares of our Class A common stock.
We expect that market demand, government regulation, third-party coverage and reimbursement policies and societal pressures will continue to change the worldwide healthcare industry, resulting in further business consolidations and alliances among our customers, which may reduce competition, exert further downward pressure on the prices of our products and may adversely impact our business, results of operations or financial condition. 28 Table of Contents 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 and our financial results may be adversely affected.
We expect that market demand, government regulation, third-party coverage and reimbursement policies and societal pressures will continue to change the worldwide healthcare industry, resulting in further business consolidations and alliances among our customers, which may reduce competition, exert further downward pressure on the prices of our products and may adversely impact our business, results of operations or 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.
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.
In addition, given the reliance on technology, any disruption to our IONM equipment or the Internet could harm our service operations and our reputation among our customers. Further, any disruption to our information technology systems could adversely impact the performance of our neurophysiologists and oversight physicians.
In addition, given the reliance on technology, any disruption to our IONM equipment or the Internet could harm our service operations and our reputation among our customers.
If we are unable to convince surgeons and hospitals to use our products, or long-term data does not show the benefits of using our products, we will not achieve expected sales or sustain our growth, and our financial condition and results of operation may be adversely affected.
If we are unable to convince surgeons and hospitals to use our products, or long-term data does not show the benefits of using our products, we will not achieve expected sales or sustain our growth, and our financial condition and results of operation may be adversely affected. 22 Table of Contents Pricing pressure from our competitors and our customers may impact our ability to sell our products at prices necessary to support our current business strategies.
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 are marketing our human tissue products as Section 361 HCT/Ps, which are not subject to FDA premarket clearance or approval requirements.
If the level of credit losses we experience in the future exceed our expectations, such losses could have a material adverse effect on our financial condition or results of operations. The widespread outbreak of a communicable disease, or any other public health crisis, could adversely affect our financial condition and results of operations.
Such changes in tariffs and trade regulations could have a material adverse effect on our financial condition, results of operations and cash flows. The widespread outbreak of a communicable disease, or any other public health crisis, could adversely affect our financial condition and results of operations.
The preventative and precautionary measures that hospitals and federal, state, local, and international governments took to mitigate the spread of the disease led to restrictions on, disruptions in, and other related impacts on elective procedure rates. On May 5, 2023 the World Health Organization declared the end of the COVID-19 pandemic as a public health emergency .
The preventative and precautionary measures that hospitals and federal, state, local, and international governments took to mitigate the spread of the disease led to restrictions on, disruptions in, and other related impacts on elective procedure rates .
Likewise, if any of our current insurance coverage should become unavailable to us or become economically impractical, we would be required to operate our business without indemnity from commercial insurance providers.
If the costs of maintaining adequate insurance coverage increase significantly in the future, our operating results could be materially adversely affected. Likewise, if any of our current insurance coverage should become unavailable to us or become economically impractical, we would be required to operate our business without indemnity from commercial insurance providers.
Our business is subject to the risk of nonpayment by our customers. We sell our Enabling Technologies products through various credit and installment payment arrangements.
Our business is subject to the risk of nonpayment by our customers. We sell our Enabling Technologies products through various credit and installment payment arrangements. We may experience loss from a customer’s failure to make payments according to the contractual terms.
In addition, IONM services are directly billed to Medicare and commercial payors, which brings with it additional risks associated with proper billing practice regulations, HIPAA compliance, corporate practice of medicine laws, and collections risk associated with third-party payors.
Further, any disruption to our information technology systems could adversely impact the performance of our neurophysiologists and oversight physicians. 29 Table of Contents In addition, IONM services are directly billed to Medicare and commercial payors, which brings with it additional risks associated with proper billing practice regulations, HIPAA compliance, corporate practice of medicine laws, and collections risk associated with third-party payors.
Though members of our sales force generally enter into non-compete agreements that restrict their ability to compete with us, most of the members of our executive management team are not subject to such agreements. Accordingly, the adverse effect resulting from the loss of certain executives could be compounded by our inability to prevent them from competing with us.
Though members of our sales force generally enter into non-compete agreements that restrict their ability to compete with us, most of the members of our executive management team are not subject to such agreements.
Any failure by us to manage our growth effectively could have an adverse effect on our ability to achieve our development and commercialization goals. Fluctuations in insurance cost and availability could adversely affect our profitability or our risk management profile.
Any failure by us to manage our growth effectively could have an adverse effect on our ability to achieve our development and commercialization goals.

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Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

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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 of Directors.
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.
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.
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 Senior Vice President of Corporate Quality 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.
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.
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 Senior Vice President of Corporate Quality and IT.
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.
They also oversee the response to any significant cybersecurity incidents. Our Senior Vice President of Corporate Quality and IT, who has extensive cybersecurity knowledge and skills gained from over 20 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 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.
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Reporting to our Senior Vice president of Corporate Quality and IT are a number of trained information security professionals. In 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.

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

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. ‎ 46 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. 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 46 PART II Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 47 Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations 49 Item 7A. Quantitative and Qualitative Disclosure About Market Risk 59 Item 8. Financial Statements and Supplementary Data 61
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

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

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Biggest change( 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, 2023 - October 31, 2023 2,829 $ 53.31 2,829 $ 350,001 November 1, 2023 - November 30, 2023 — — — 350,001 December 1, 2023 - December 31, 2023 1,500 49.85 1,500 275,239 Total 4,329 4,329 (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 stock.
Biggest change( 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.
Issuer Purchases of Equity Securities We repurchase shares of the Company’s Class A common stock 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 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.
We believe that the number of beneficial owners is substantially greater than the number of record holders because a large portion of our Class A common stock is held of record through brokerage firms in “street name.” Recent Sales of Unregistered Securities None.
We believe that the number of beneficial owners is substantially greater than the number of record holders because a large portion of our Class A Common is held of record through brokerage firms in “street name.” Recent Sales of Unregistered Securities None.
On March 4, 2022, our Board of Directors authorized the expansion of the share repurchase program of the Company’s Class A common stock 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 stock .
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 .
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 stock. The following table provides the activity related to share repurchases for the fourth quarter of 2023.
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.
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. ‎ 47 Table of Contents Comparative Stock Performance Graph The following graph illustrates a comparison of the total cumulative stockholder return on our Class A common stock from December 31, 2018 through December 31, 2023 to two indices: the S&P 500 Index and the S&P 500 Health Care Equipment Index.
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.
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 trades on The New York Stock Exchange, under the symbol “GMED.” We had approximately 65 stockholders of record as of February 16, 2024.
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.
The graph assumes an initial investment of $100 on December 31, 2018, in each of our Class A common stock, 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.
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.
December 31, Company/Index 2018 2019 2020 2021 2022 2023 Globus Medical, Inc. $100 $136 $151 $167 $172 $123 S&P 500 Index $100 $131 $156 $200 $164 $207 S&P 500 Health Care Equipment $100 $129 $152 $182 $147 $161 ‎ 48 Table of Contents
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
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Historical stockholder return is not necessarily indicative of the performance to be expected for any future periods.

Item 7. Management's Discussion & Analysis

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

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Biggest changeCost of Sales Year Ended December 31, Change (In thousands, except percentages) 2023 2022 $ % Cost of sales $ 548,174 $ 263,725 $ 284,449 107.9% Percentage of net sales 34.9% 25.8% The increase of $284.4 million in cost of sales was primarily due to the addition of NuVasive, amortization of the inventory fair value step up, increased volume and product mix, higher write-downs of excess and obsolete inventory, and higher depreciation.
Biggest changeRegionally, 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.
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 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 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.
We assumed equity-classified awards for certain NuVasive RSUs, and performance restricted stock units (“PRSUs”), as part of the Merger. These RSUs and PRSUs are measured at the grant date based on the estimated fair value of the award. The fair value of equity instruments that are expected to vest is recognized and amortized over the requisite service period.
We assumed equity-classified awards for certain NuVasive RSUs, and performance restricted stock units (“PRSUs”), as part of the NuVasive Merger. These RSUs and PRSUs are measured at the grant date based on the estimated fair value of the award. The fair value of equity instruments that are expected to vest is recognized and amortized over the requisite service period.
The market for our Enabling Technologies in spine and orthopedic surgery is still in the 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 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.
However, sales of our Musculoskeletal Solutions products and services may be influenced by summer vacation and winter holiday periods during which we have experienced fewer surgeries taking place, as well as more surgeries taking place later in the year when patients have met the deductibles under insurance plans.
However, sales of our Musculoskeletal Solutions products and neuromonitoring services may be influenced by summer vacation and winter holiday periods during which we have experienced fewer surgeries taking place, as well as more surgeries taking place later in the year when patients have met the deductibles under insurance plans.
Revolving Loans under the September 2023 Credit Agreement bear interest at either a base rate or the Term SOFR Rate (as defined in the Revolving Credit Facility) plus, in each case, an applicable margin, as determined in accordance with the provisions of the September 2023 Credit Agreement.
Revolving Loans under the September 2023 Credit Agreement bear interest at either a base rate or the Term SOFR Rate (as defined in the September 2023 Credit Agreement) plus, in each case, an applicable margin, as determined in accordance with the provisions of the September 2023 Credit Agreement.
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, however, require additional liquidity as we continue to execute our business strategy.
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.
These costs will increase in absolute terms as we continue to expand our product pipeline and add personnel. 50 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.
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.
Financial 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 17 to the consolidated financial statements in “ Part II; Item 8.
Financial 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.
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, 2023, 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 twelve months ended December 31, 2024, there were no impairments in goodwill, finite-lived intangible assets, or IPR&D. Long-Lived Assets .
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. 52 Table of Contents Goodwill and Intangible Assets.
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.
(2) In connection with certain acquisitions completed in 2011 through 2023, 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.
(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 purposes of disclosure, we disaggregate our revenue into two categories, Musculoskeletal Solutions and Enabling Technologies. 51 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. 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.
Neuromonitoring services use proprietary software-driven nerve detection and avoidance technology and include IONM to aid spine surgery.
Our neuromonitoring services use proprietary software-driven nerve detection and avoidance technology and include IONM to aid spine surgery.
The fair value of contingent restricted stock unit grants (“RSUs”) are 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 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.
During the years ended December 31, 2023, 2022, and 2021 , we did not record any impairment charges related to long-lived assets. Stock-Based Compensation Expense.
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.
A discussion of our Results of Operations for the year ended December 31, 2022 can be found in “ Part II, Item 7.
A discussion of our Results of Operations for the year ended December 31, 2023 can be found in “ Part II, Item 7.
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.
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.
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, service our 2025 Notes, and potential future business or intellectual property acquisitions.
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.
Product & Service Categories While we group our products and services into two categories, Musculoskeletal Solutions and Enabling Technologies, they are not limited to a particular technology, platform or surgical approach.
Product & Service Categories While we group our revenue into two categories, Musculoskeletal Solutions and Enabling Technologies, they are not limited to a particular technology, platform or surgical approach.
We have sold our products in approximately 64 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 65 countries other than the U.S. through a combination of sales representatives employed by us and exclusive international distributors.
Enabling Technologies Our Enabling Technologies are comprised of 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.
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.
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 16). The following table summarizes our outstanding contractual obligations as of December 31, 2023.
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.
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. 49 Table of Contents Geographic Information To date, the primary market for our products has been the U.S. , where we sell our products 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.
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.
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, 2023, international net sales accounted for approximately 18.4% 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, 2024, international net sales accounted for approximately 20.6% of our total net sales.
Management’s Discussion and Analysis of Financial Condition and Results of Operations: Results of Operations; Year Ended December 31, 2022 Compared to the Year Ended December 31, 2021. ” on our Form 10-K filed on February 21, 2023 .
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 .
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.
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.
With numerous products launched since the founding of the Company, including 10 products launched on the market in 2023, 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.
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.
As of December 31, 2023, we have not borrowed under the September 2023 Credit Agreement and we are in compliance with all covenants. 56 Table of Contents Contractual Obligations and Commitments In connection with the 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.
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.
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.
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.
If a loss is reasonably possible but not known or probable, and can be reasonably estimated, the estimated loss or range of loss is disclosed. In most cases, significant judgment is required to estimate the amount and timing of a loss to be recorded. We expense legal costs related to loss contingencies as incurred.
In most cases, significant judgment is required to estimate the amount and timing of a loss to be recorded. We expense legal costs related to loss contingencies as incurred.
Financial Statements and Supplementary Data; Notes to Consolidated Financial Statements; Note 2. Summary of Significant Accounting Policies; (v) Recently Issued Accounting Pronouncements.” ‎ 58 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; (v) Recently Issued Accounting Pronouncements.” ‎ 59 Table of Contents
Cash Provided by Financing Activities The higher net cash used in financing activities for the year ended December 31, 2023 was primarily the result of higher repurchases of Class A common stock and lower proceeds from exercise of stock options.
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.
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 2023-2022 2022-2021 December 31, Change Change (In thousands) 2023 2022 2021 $ $ Net cash provided by/(used in) operating activities $ 243,499 $ 178,468 $ 276,274 $ 65,031 $ (97,806) Net cash provided by/(used in) investing activities 302,968 (110,362) (375,939) 413,330 265,577 Net cash provided by/(used in) financing activities (231,821) (109,962) 54,147 (121,859) (164,109) Effect of foreign exchange rate changes on cash 2,180 (747) (810) 2,927 63 Increase (decrease) in cash and cash equivalents $ 316,826 $ (42,603) $ (46,328) $ 359,429 $ 3,725 Cash Provided by Operating Activities The higher net cash provided by operating activities for the year ended December 31, 2023 was primarily the result of higher net income after adjusting out non-cash add-backs and non-cash expenses, such as amortization of purchase accounting related fair value step up, amortization, and stock based compensation, partially offset by unfavorable change in deferred income taxes.
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.
In some actions, the claimants seek damages, as well as other relief, including injunctions prohibiting us from engaging in certain activities, 53 Table of Contents which, if granted, could require significant expenditures and/or result in lost revenues.
In some actions, the claimants seek damages, as well as other relief, including injunctions prohibiting us from engaging in certain activities, which, if granted, could require significant expenditures and/or result in lost revenues. We record a liability in the consolidated financial statements for these actions when a loss is considered probable and the amount can be reasonably estimated.
We record a liability in the consolidated financial statements for these actions when a loss is considered probable and the amount can be reasonably estimated. If the reasonable estimate of a probable loss is a range, and no amount within the range is a better estimate than any other, the minimum amount of the range is accrued.
If the reasonable estimate of a probable loss is a range, and no amount within the range is a better estimate than any other, the minimum amount of the range is accrued. If a loss is reasonably possible but not known or probable, and can be reasonably estimated, the estimated loss or range of loss is disclosed.
A discussion of our cash flows for the year ended December 31, 2022 can be found in “ Part II, Item 7.
A discussion of our cash flows for the year ended December 31, 2023 can be found in “ Part II, Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations: Results of Operations; Cash Flows. ” On our Form 10-K filed on February 20, 2024 .
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.
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.
NuVasive Merger On September 1, 2023, pursuant to that certain Merger Agreement with NuVasive and 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.
(“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”).
Income Tax Provision Year Ended December 31, Change (In thousands, except percentages) 2023 2022 $ % Income tax provision $ 42,520 $ 52,850 $ (10,330) -19.5% Effective income tax rate 25.7% 21.7% The increase in the effective tax rate is primarily due to non-deductible compensation expenses and other non-deductible Merger-related transaction costs as a percentage of pretax earnings.
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.
Amortization of Intangibles Year Ended December 31, Change (In thousands, except percentages) 2023 2022 $ % Amortization of intangibles $ 51,032 $ 17,735 $ 33,297 187.7% Percentage of net sales 3.3% 1.7% The increase of $33.3 million in the amortization of intangibles is primarily due to the impact of the recognized intangibles in connection with the Merger.
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.
Cash Used in Investing Activities The higher cash provided by investing activities for the year ended December 31, 2023 was primarily from net inflows of purchases, maturities, and sales of marketable securities, partially offset by acquisition of businesses net of cash acquired and higher purchases of property and equipment.
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.
Results of Operations Year Ended December 31, 2023 Compared to the Year Ended December 31, 2022 Net Sales The following table sets forth, for the periods indicated, our net sales by geography expressed as dollar amounts and the changes in sales between the specified periods expressed in dollar amounts and as percentages: Year Ended December 31, Change (In thousands, except percentages) 2023 2022 $ % United States $ 1,279,765 $ 871,939 $ 407,826 46.8% International 288,711 150,904 137,807 91.3% Total net sales $ 1,568,476 $ 1,022,843 $ 545,633 53.3% In the U.S., the increase in net sales of $407.8 million was due primarily to the addition of NuVasive, as well as increased spine product sales, including robotic spine instruments, resulting from penetration in existing territories and an increase in sales volume of Enabling Technologies.
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.
Payments Due by Period (In thousands) Total Less than 1 Year 1-3 Years 3-5 Years More than 5 Years Convertible Notes $ 452,531 $ 1,687 $ 450,844 $ — $ — Operating leases 144,350 18,336 28,362 23,634 74,018 Financing Leases 850 498 352 — — Contingent consideration 46,137 43,137 1,000 1,000 1,000 Purchase obligations 6,429 4,629 1,700 100 — Total (2) * $ 650,297 $ 68,287 $ 482,258 $ 24,734 $ 75,018 (1) Reflects minimum annual volume commitments to purchase inventory under certain of our supplier contracts .
Payments Due by Period (In thousands) Total Less than 1 Year 1-3 Years 3-5 Years More than 5 Years Convertible Notes $ 450,844 $ 450,844 $ — $ — $ — Operating leases 129,932 16,297 28,063 22,987 62,585 Financing Leases 573 257 285 31 — Contingent consideration 16,544 14,044 1,000 1,000 500 Purchase obligations (1) 31,194 28,906 1,932 356 — Total (2) * $ 629,087 $ 510,348 $ 31,280 $ 24,374 $ 63,085 (1) Reflects minimum annual volume commitments to purchase inventory under certain of our supplier contracts .
Selling, General and Administrative Expenses Year Ended December 31, Change (In thousands, except percentages) 2023 2022 $ % Selling, general and administrative $ 643,410 $ 432,117 $ 211,293 48.9% Percentage of net sales 41.0% 42.2% The $211.3 million increase in selling, general and administrative expenses was due to the addition of NuVasive, and an increase in personnel-related expenses resulting primarily from higher product sales, and an increase in bad debt and meeting expenses.
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.
These increases were partially offset by lower production variances. 54 Table of Contents Research and Development Expenses Year Ended December 31, Change (In thousands, except percentages) 2023 2022 $ % Research and development $ 124,010 $ 73,015 $ 50,995 69.8% Percentage of net sales 7.9% 7.1% The increase of $51.0 million in research and development expenses was due primarily to the addition of NuVasive and an increase in personnel-related expenses due to our continued investment in product development.
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.
It also includes an unfavorable change in fair value of business acquisition liabilities, driven by changes in market conditions and the achievement of certain performance conditions.
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.
Provision for Litigation Year Ended December 31, Change (In thousands, except percentages) 2023 2022 $ % Provision for litigation, net $ 434 $ 2,341 $ (1,907) -81.5% Percentage of net sales 0.0% 0.2% The $1.9 million decrease in provision for litigation is due to a settlement receipt, partially offset by a settlement payment for the year ended December 31, 2023 compared to 2022.
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.
Other Income/(expense), Net Year Ended December 31, Change (In thousands, except percentages) 2023 2022 $ % Other income, net $ 32,251 $ 15,068 $ 17,183 114.0% Percentage of net sales 2.1% 1.5% 55 Table of Contents The increase of $17.2 million in othe r income, was primarily due to foreign currency exchange gains of $14.3 million in the current year compared to $1.0 million of foreign currency losses in the prior year and an increase of $5.9 million related to higher interest income yields on marketable securities from external market factors.
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.
Acquisition-Related Costs Year Ended December 31, Change (In thousands, except percentages) 2023 2022 $ % Acquisition-related costs $ 68,274 $ 5,959 $ 62,315 1045.7% Percentage of net sales 4.4% 0.6% The increase of $62.3 million in acquisition-related costs is due to costs incurred relating to the closing of the Merger, including investment banking, employee benefit and legal costs.
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.
Removed
International net sales increased by $137.8 million, which was due primarily due to the addition of NuVasive and increased spine product sales resulting from penetration in existing territories.
Added
Results of Operations We manage our business globally within two operating segments, which is consistent with how our management reviews our business, makes investment and resource allocation decisions and assesses operating performance. We have concluded that these operating segments are aggregated into one reportable segment, based on the aggregation criteria.
Removed
Additionally, we have varying needs for cash in connection with our Senior Convertible Notes, of which $450 million of Senior Convertible Notes are due March 2025, as well as for certain acquisition-related obligations and contingent consideration achievements.
Added
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.
Removed
Management’s Discussion and Analysis of Financial Condition and Results of Operations: Results of Operations; Cash Flows. ” On our Form 10-K filed on February 21, 2023 . 57 Table of Contents Recently Issued Accounting Pronouncements For further details on recently issued accounting pronouncements, please refer to “Part II; Item 8.
Added
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.
Added
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
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
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
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
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.
Added
Bank National Association, as administrative agent, Citizens Bank, N.A., as syndication agent, Royal Bank of Canada, as documentation agent, U.S.
Added
These include increased amortization of purchase accounting related fair value step-up of inventory of $143.7 million, increased depreciation and amortization of $109.3 million, a favorable change in inventory of $40.5 million, and increased amortization of the fair value step-up with respect to our 2025 Notes of $18.5 million, partially offset by unfavorable changes in deferred income taxes of $80.7 million and in accounts receivable of $28.1 million.
Added
These were partially offset by decreased outflows for the acquisition of businesses, net of cash acquired of $278.4 million, with individually immaterial acquisitions occurring in the current period as compared to the prior period that was primarily driven by the NuVasive Merger.

Item 7A. Quantitative and Qualitative Disclosures About Market Risk

Market Risk — interest-rate, FX, commodity exposure

11 edited+0 added−1 removed14 unchanged
Biggest changeWe 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.
Biggest changeIn 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.
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 Hedge”) 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 common stock.
Interest Rate Risk Our exposure to interest rate risk at December 31, 2023 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.
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.
Exchange rate fluctuations resulting from the translation of all other intercompany balances between domestic 59 Table of Contents 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.
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.
The financial exposures by exchange rate fluctuations are monitored and managed by us as an integral part of our overall risk management program, which recognizes the unpredictability of financial markets and seeks to reduce potentially adverse effects on our results. ‎ 60 Table of Contents
The financial exposures by exchange rate fluctuations are monitored and managed by us as an integral part of our overall risk management program, which recognizes the unpredictability of financial markets and seeks to reduce potentially adverse effects on our results. ‎ 61 Table of Contents
Based upon our overall interest rate exposure as of December 31, 2023, 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, 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.
Our policy also limits the amount of credit exposure to any one issue, issuer and type of instrument. As of December 31, 2023, we only held investments in securities classified as cash equivalents and marketable equity securities.
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.
Upon conversion of our convertible notes, the 2025 Hedge is 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 Hedge entitling them to acquire shares of our common stock.
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.
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 $10.0 million as of December 31, 2023, which were settled in January 2024.
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.
In addition, loss of financial stability within these markets could lead to delays in reimbursement or inability to remit payment due to currency controls. Specifically, we have operations in Puerto Rico, Brazil, and Argentina that have financial instability or currency controls.
In addition, loss of financial stability within these markets could lead to delays in reimbursement or inability to remit payment due to currency controls. Specifically, we have operations in Puerto Rico, Brazil, and Argentina, each of which have markets subject to financial instability or currency controls.
During the year ended December 31, 2023, a loss of $0.1 million was recognized in other expense, net due to the change in the fair value of the derivative instruments, and the fair value of the hedge contracts we held was de minimis on our Consolidated Balance Sheets as of December 31, 2023.
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.
Removed
In particular, as a result of NuVasive’s acquisition of Simplify Medical, we have additional exposure to fluctuations in the Australian dollar. We established intercompany receivables and payables in Australian dollars as a result of the acquisition of Simplify Medical.

Other GMED 10-K year-over-year comparisons