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

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

+319 added−331 removedSource: 10-K (2026-02-24) vs 10-K (2025-02-25)

Top changes in MERIT MEDICAL SYSTEMS INC's 2025 10-K

319 paragraphs added · 331 removed · 275 edited across 7 sections

Item 1. Business

Business — how the company describes what it does

82 edited+11 added−17 removed131 unchanged
Biggest changeCustom Procedural Solutions Our custom procedural solutions product category is comprised of standard and custom kit and pack solutions that include items needed for peripheral procedures, safety and waste management products, and hemostasis accessories. Our kit and pack solutions can optimize efficiency and reduce cost and waste.
Biggest changeThe principal product offerings in our intervention (cardiac) portfolio include a full line of inflation devices and hemostasis valves, including the BasixSKY®, BasixCompak®, basixTOUCH®, Blue Diamond® and DiamondTouch™ inflation devices, the PhD™ Hemostasis Valve, and the 10Fore™ Hemostasis Valve, the latest addition to our hemostasis valve portfolio. 6 Table of Contents Custom Procedural Solutions Our custom procedural solutions product category is comprised of standard and custom kit and pack solutions that include items needed for peripheral procedures, safety and waste management products, and hemostasis accessories.
The following sections describe our principal product offerings by reporting segment and product category. 3 Table of Contents Cardiovascular We offer a broad line of medical devices used to gain and maintain vascular access. These products include our micropuncture kits, angiographic needles, our family of Prelude® Introducer Sheaths and a wide range of guide wires and safety products.
The following sections describe our principal product offerings by reporting segment and product category. 3 Table of Contents Cardiovascular We offer a broad line of medical devices used to gain and maintain vascular access. These products include our micropuncture kits, angiographic needles, family of Prelude® Introducer Sheaths and wide range of guide wires and safety products.
Please refer to our discussion of 13 Table of Contents the risks and uncertainties associated with these post-market requirements under the heading “ The FDA regulatory clearance process is extensive and dynamic, and the failure to obtain and maintain required regulatory clearances and approvals could prevent us from commercializing our products.” set forth in Item 1A “Risk Factors.” Reimbursement.
Please refer to our discussion of the risks and uncertainties associated with these post-market requirements under the heading “ The FDA regulatory clearance process is extensive and dynamic, and the failure to obtain and maintain required regulatory clearances and approvals could prevent us from commercializing our products.” set forth in Item 1A “Risk Factors.” 13 Table of Contents Reimbursement.
The Federal Food, Drug and Cosmetic Act (“FDCA”) and its counterpart non-U.S. laws require us to comply with quality system regulations (“QSR”) pertaining to all aspects of our product design, purchasing and supplier controls, manufacturing, distribution, servicing, complaint handling, corrective and preventive action and internal quality system audits.
Quality System Requirements. The Federal Food, Drug and Cosmetic Act (“FDCA”) and its counterpart non-U.S. laws require us to comply with quality system regulations (“QSR”) pertaining to all aspects of our product design, purchasing and supplier controls, manufacturing, distribution, servicing, complaint handling, corrective and preventive action and internal quality system audits.
When we believe that a product suggestion demonstrates a sustainable competitive advantage, meets customer needs, fits strategically and technologically with our business and has a good potential financial return, we generally assemble a “project team” comprised of individuals from our sales, marketing, engineering, manufacturing, legal and quality assurance departments.
When we believe that a product suggestion demonstrates a sustainable competitive advantage, meets customer needs, fits strategically and technologically with our business and has a good potential financial return, we generally assemble a “project team” comprised of individuals from our sales, marketing, engineering, manufacturing, legal, regulatory and quality assurance departments.
The principal product offerings in our electrophysiology and CRM portfolio include our: ● Recently-acquired Evolution® system for lead removal procedures relating to pacemakers and implantable cardioverter defibrillators; ● Worley™ Advanced LV Delivery System, used to aid in the insertion and implantation of left ventricular pacing leads; ● HeartSpan® Transseptal Needle, for left-heart access procedures; ● HeartSpan® Steerable and Fixed Curve Sheath Introducer, featuring a neutral position indicator and tactile click to help physicians identify curve orientation with an expanded product line that includes fixed curve shapes; and ● SafeGuard Focus TM and Focus Cool TM compression devices, used to protect closed surgical sites in the immediate postoperative period.
The principal product offerings in our electrophysiology and CRM portfolio include our: ● Evolution® system for lead removal procedures relating to pacemakers and implantable cardioverter defibrillators; ● Worley™ Advanced LV Delivery System, used to aid in the insertion and implantation of left ventricular pacing leads; ● HeartSpan® Transseptal Needle, for left-heart access procedures; ● HeartSpan® Steerable and Fixed Curve Sheath Introducer, featuring a neutral position indicator and tactile click to help physicians identify curve orientation with an expanded product line that includes fixed curve shapes; and ● SafeGuard Focus® and Focus Cool TM compression devices, used to protect closed surgical sites in the immediate postoperative period.
Our programs and policies are in compliance with applicable local, regional, and federal laws, including U.S. Occupational Safety and Health Administration requirements. We have obtained ISO 45001 certification at six manufacturing facilities (eight in scope) and one distribution facility (one in scope).
Our programs and policies are in compliance with applicable local, regional, and federal laws, including U.S. Occupational Safety and Health Administration requirements. We have obtained ISO 45001 certification at eight manufacturing facilities (eight in scope) and one distribution facility (one in scope).
The product offerings in our fluid management portfolio include manifolds, control syringes and tubing. The principal products we offer in our hemodynamic monitoring portfolio include the Meritrans DTXPLUS® disposable transducer, SAFEDRAW® closed arterial sampling system and related accessories.
The product offerings in our fluid management portfolio include manifolds, control syringes and tubing. The principal products we offer in our hemodynamic monitoring portfolio include the Meritrans DTXPLUS® disposable transducer, SAFEDRAW® closed arterial blood sampling system and related accessories.
Merit Spine Our spine products are used in the treatment of vertebral compression fractures and metastatic spinal tumors and in musculoskeletal biopsy procedures. Our spine product line includes the following product portfolios: vertebral augmentation, radiofrequency ablation, and bone biopsy systems.
Our spine products are used in the treatment of vertebral compression fractures and metastatic spinal tumors and in musculoskeletal biopsy procedures. Our spine product line includes the following product portfolios: vertebral augmentation, radiofrequency ablation, and bone biopsy systems.
Products in our peripheral intervention product category are organized into the following product groups: peripheral intervention, spine, and oncology. Merit Vascular – Peripheral Our peripheral intervention products include product offerings in the following product portfolios: access (peripheral), angiography, drainage, delivery systems, embolotherapy, and intervention (peripheral).
Products in our peripheral intervention product category are organized into the following product groups: peripheral intervention, and oncology. Merit Vascular – Peripheral Our peripheral intervention products include product offerings in the following product portfolios: access (peripheral), angiography, drainage, delivery systems, embolotherapy, and intervention (peripheral).
The principal product offerings in our embolotherapy portfolio include our: ● Embosphere® Microspheres, a highly-studied, round embolic for consistent and predictable results; ● HepaSphere® Microspheres, soft embolics with a consistent cross-sectional diameter for predictable, flow-directed targeting; and ● Recently-launched Siege™ Vascular Plug, a self-expanding vascular implant designed for peripheral arterial embolization in vessels measuring 1.5mm to 6.0mm in diameter.
The principal product offerings in our embolotherapy portfolio include our: ● Embosphere® Microspheres, a highly-studied, round embolic for consistent and predictable results; ● HepaSphere® Microspheres, soft embolics with a consistent cross-sectional diameter for predictable, flow-directed targeting; and ● Siege® Vascular Plug, a self-expanding vascular implant designed for peripheral arterial embolization in vessels measuring 1.5mm to 6.0mm in diameter.
We require our international dealers to store products and sell directly to customers within defined sales territories. Each of our products must be approved for sale under the laws of the country in which it is sold. International dealers are responsible for compliance with applicable anti-corruption laws, such as the U.S.
We require our international distributors to store products and sell directly to customers within defined sales territories. Each of our products must be approved for sale under the laws of the country in which it is sold. International distributors are responsible for compliance with applicable anti-corruption laws, such as the U.S.
Our total rewards package include competitive pay, annual incentive awards and bonus opportunities, healthcare and retirement benefits, an Employee Stock Purchase Plan, paid time off and sick leave, paid parental leave, flexible work schedules, remote working opportunities, and a wellness program. Talent Development.
Our total rewards package includes competitive pay, annual incentive awards and bonus opportunities, healthcare and retirement benefits, an Employee Stock Purchase Plan, paid time off and sick leave, paid parental leave, flexible work schedules, remote working opportunities, and a wellness program. Talent Development.
For further discussion of the risks and uncertainties associated with the VBP policy, please refer to disclosure under the heading “ Consolidation in the healthcare industry, group purchasing organizations and public cost-containment measures have led to demands for price concessions, which may reduce our revenues and harm our ability to sell our products at prices necessary to support our current business strategies.” set forth in Item 1A “Risk Factors.” In Europe, the Middle East and Africa (“EMEA), we have both direct and modified direct sales operations.
For further discussion of the risks and uncertainties associated with the VBP policy, please refer to disclosure under the heading “ Consolidation in the healthcare industry, group purchasing organizations and public cost-containment measures have led to demands for price concessions, which may reduce our revenues and harm our ability to sell our products at prices necessary to support our current business strategies.” set forth in Item 1A “Risk Factors.” In Europe, the Middle East and Africa (“EMEA”), we have direct, modified direct and distributor sales operations.
(“Merit Sensors”) develops and markets silicon pressure sensors to a range of enterprises and presently supplies the sensors we use in our digital inflation devices and blood pressure sensors. We have specialized manufacturing personnel at most of our ten global manufacturing facilities.
(“Merit Sensors”) develops and markets silicon pressure sensors to a range of enterprises and presently supplies the sensors we use in our digital inflation devices and blood pressure sensors. We have specialized manufacturing personnel at most of our eleven global manufacturing facilities.
Any failure, or perceived failure, by us to comply with our posted privacy notices or policies or with any applicable regulatory requirements or orders, or privacy, data protection, information security or consumer protection-related privacy laws and regulations in one or more jurisdictions could result in proceedings or actions against us by governmental entities or others, including class action privacy litigation in certain jurisdictions, subject us to significant fines, penalties, judgments and negative publicity, require us to change our business practices, increase the costs and complexity of compliance, and adversely affect our business.
Any failure, or perceived failure, by us to comply with our posted privacy notices or policies or with any applicable regulatory requirements or orders, or privacy, data protection, information security or consumer protection-related privacy laws and regulations in one or more jurisdictions could result in proceedings or actions against us by governmental entities or, in some jurisdictions, individuals, including class action privacy litigation, subject us to significant fines, penalties, judgments and negative publicity, require us to change our business practices, increase the costs and complexity of compliance, and adversely affect our business.
Additionally, for four consecutive years, our subsidiary in China has been recognized as a “China Top Employer” by the Top Employers Institute. This award reflects our unwavering commitment to excellence in human resources practices.
Additionally, for five consecutive years, our subsidiary in China has been recognized as a “China Top Employer” by the Top Employers Institute. This award reflects our unwavering commitment to excellence in human resources practices.
If a court rules against us in any intellectual property litigation we could be subject to significant liabilities, be forced to seek licenses from third parties, or be prevented from marketing certain products. In addition, intellectual property litigation is costly and may consume significant time of employees and management. Regulation Corporate Integrity Agreement .
If a court rules against us in any intellectual property litigation we could be subject to significant liabilities, be forced to seek licenses from third parties, or be prevented from marketing certain products. In addition, intellectual property litigation is costly and may consume significant time of employees and management. 11 Table of Contents Regulation Corporate Integrity Agreement .
We recently expanded the renal therapies portion of our access (peripheral) portfolio, which now includes the following key products: ● Merit Wrapsody® Cell-Impermeable Endoprosthesis (the “Wrapsody Device”), a cell-impermeable endoprosthesis which is designed to maintain long-term vessel patency in patients with obstructions in the dialysis outflow circuit; ● HeRO® (Hemodialysis Reliable Outflow) Graft, a fully subcutaneous vascular access system, which is intended for use in maintaining long-term vascular access for chronic hemodialysis patients; ● CentrosFLO® Long-Term Hemodialysis Catheter and ProGuide® Chronic Dialysis Catheter; ● BioFlo DuraMax® Catheter, which provides optimal ease of insertion and high flow rates at modest arterial pressure; ● Broad offering of peritoneal dialysis catheters, accessories and implantation kits for home dialysis therapy; and ● Surfacer® Inside-Out® Access Catheter System that restores and preserves access in chronically occluded veins.
The renal therapies portion of our access (peripheral) portfolio includes the following key products: ● Merit Wrapsody® Cell-Impermeable Endoprosthesis (the “Wrapsody Device”), a cell-impermeable endoprosthesis which is designed to maintain long-term vessel patency in patients with obstructions in the dialysis outflow circuit; ● HeRO® (Hemodialysis Reliable Outflow) Graft, a fully subcutaneous vascular access system, which is intended for use in maintaining long-term vascular access for chronic hemodialysis patients; ● CentrosFLO® Long-Term Hemodialysis Catheter and ProGuide® Chronic Dialysis Catheter, which are designed to maintain optimal blood flow; ● BioFlo DuraMax® Catheter, which provides optimal ease of insertion and high flow rates at modest arterial pressure; ● Broad offering of peritoneal dialysis catheters, accessories and implantation kits for home dialysis therapy; and ● Surfacer® Inside-Out® Access Catheter System that restores and preserves access in chronically occluded veins.
This team works to identify the customer requirements, develop the design, compile necessary documentation and testing, and prepare the product for market introduction. We believe that one of our competitive strengths is our capacity to rapidly conceive, design, develop and introduce new products that meet customer needs. U.S. and International Sales.
This team works to identify the customer requirements, develop the design, compile necessary documentation and testing, and prepare the product for market introduction. We believe that one of our competitive strengths is our capacity to rapidly conceive, design, develop and introduce new products that meet customer needs. 8 Table of Contents U.S. and International Sales.
Sales of our products in the U.S. accounted for 59%, 58% and 57% of our net sales for the years ended December 31, 2024, 2023 and 2022, respectively. In the U.S., we have dedicated, direct sales organizations primarily focused on selling to end-user physicians, hospitals and alternate site facilities (e.g., office-based labs), major buying groups and integrated healthcare networks.
Sales of our products in the U.S. accounted for 60%, 59% and 58% of our net sales for the years ended December 31, 2025, 2024 and 2023, respectively. In the U.S., we have dedicated, direct sales organizations primarily focused on selling to end-user physicians, hospitals and alternate site facilities (e.g., office-based labs), major buying groups and integrated healthcare networks.
We communicate frequently with our employees through a variety of communication methods, including video and written communications, town hall meetings, and our company intranet, and we acknowledge individual contributions to Merit by celebrating milestones of service in five-year increments.
We communicate frequently with our employees through a variety of communication methods, including video and written communications, town hall meetings, and our company intranet, and we acknowledge individual contributions to Merit by celebrating milestones of service in five-year 17 Table of Contents increments.
The Merit Way is further described with the acronym H.E.A.R.T. as follows: ● H ealth – Committed to employee and patient well-being ● E xcellence – Deliver your best with the highest of standards ● A gility – Decide, act, and adapt to change ● R esponsibility – Own your decisions, actions and results ● T eamwork – Collaborate and communicate to achieve a common goal.
The Merit Way values are described with the acronym H.E.A.R.T. as follows: ● H ealth – Committed to employee and patient well-being ● E xcellence – Deliver your best with the highest of standards ● A gility – Decide, act, and adapt to change ● R esponsibility – Own your decisions, actions and results ● T eamwork – Collaborate and communicate to achieve a common goal.
The WLI contributes to our long-term strategies by promoting a culture of diversity, equity and inclusion through (i) sponsoring professional development activities focused on overcoming barriers and restraints to the advancement of women’s careers, (ii) facilitating external interactions with organizations and thought leaders, and (iii) providing resources focused on improving diversity, equity, and inclusion. Employee Engagement.
The WLI contributes to our long-term strategies by promoting a culture of inclusion through (i) sponsoring professional development activities focused on overcoming barriers and restraints to the advancement of women’s careers, (ii) facilitating external interactions with organizations and thought leaders, and (iii) providing resources focused on improving inclusion.
We have a monthly wellness committee meeting and create a “Get Healthy” wellness program available to all sites across the globe. Programs include providing health information from medical and nutrition experts, newsletters with wellness and dietary tips, and activities promoting health and wellbeing such as walking groups and fitness challenges.
We have a monthly wellness committee meeting and create a “Get Healthy” 18 Table of Contents wellness program available to all sites across the globe. Programs include providing health information from medical and nutrition experts, newsletters with wellness and dietary tips, and activities promoting health and wellbeing such as walking groups and fitness challenges.
Although we believe our recent and planned additions to these product 10 Table of Contents lines will help us compete even more effectively in both the U.S. and international markets, we cannot give any assurance that we will be able to maintain our existing competitive advantages or compete successfully in the future.
Although we believe our recent and planned additions to these product lines will help us compete even more effectively in both the U.S. and international markets, we cannot give any assurance that we will be able to maintain our existing competitive advantages or compete successfully in the future.
Consequently, many of our used products will likely end up in a medical waste disposal facility at the end of their usefulness. We continually look for opportunities to deliver sustainable, long-term growth of our business. Our sustainability practices are an integral component of our business strategy.
Consequently, many of our used products will likely end up in regulated medical waste disposal facilities at the end of their usefulness. We continually look for opportunities to deliver sustainable, long-term growth of our business. Our sustainability practices are an integral component of our business strategy.
In 2019, China announced a volume-based procurement (“VBP”) policy applicable to medical device manufacturers that is designed to reduce the price of medical devices sold in China. We began experiencing the impact of the VBP policy in 8 Table of Contents 2022 and 2023 in the form of decreased sales prices and revenue.
In 2019, China announced a volume-based procurement (“VBP”) policy applicable to medical device manufacturers that is designed to reduce the price of medical devices sold in China. We began experiencing the impact of the VBP policy in 2022 in the form of decreased sales prices and revenue.
“Business - Products” above. The duration of our trademark registrations varies from country to country; in the U.S. we can generally maintain our trademark rights and renew any trademark registrations for as long as the trademarks are in use. As of December 31, 2024, we owned approximately 800 U.S. and foreign trademark registrations and trademark applications.
“Business - Products” above. The duration of our trademark registrations varies from country to country; in the U.S. we can generally maintain our trademark rights and renew any trademark registrations for as long as the trademarks are in use. As of December 31, 2025, we owned approximately 840 U.S. and foreign trademark registrations and trademark applications.
In recent years, our commitment to innovation has led to the introduction of several new products, improvements to our existing products and expansion of our product lines, as well as enhancements and new equipment in our research and development facilities. We continue to develop new products and make improvements to our existing products utilizing many different sources.
In recent years, our commitment to innovation has led to the introduction of several new products, 9 Table of Contents improvements to our existing products and expansion of our product lines, as well as enhancements in our research and development facilities. We continue to develop new products and make improvements to our existing products utilizing many different sources.
The FDA, Notified Bodies, and foreign regulators enforce these requirements through periodic inspections of medical device manufacturers. These requirements are complex, technical and require substantial resources to remain compliant.
The FDA, Notified Bodies, and foreign regulators enforce these requirements through 12 Table of Contents periodic inspections of medical device manufacturers. These requirements are complex, technical and require substantial resources to remain compliant.
In October 2020, we entered into a Corporate Integrity Agreement (“CIA”) with the Office of Inspector General (“OIG”), a five-year agreement that was a condition of our settlement with the United States Department of Justice (“DOJ”). The CIA subjects us to certain compliance, monitoring, reporting, certification, oversight and training obligations.
In October 2020, we entered into a Corporate Integrity Agreement (“CIA”) with the Office of Inspector General (“OIG”), a five-year agreement that was a condition of our settlement with the United States Department of Justice (“DOJ”). The CIA, which expired in October 2025, subjected us to certain compliance, monitoring, reporting, certification, oversight and training obligations.
Our employees are actively involved in their communities and supporting causes. At our headquarters, we provide an onsite garden where employees take part in growing and distributing produce to employees and to the local community. Employees also actively support causes by raising awareness and funds for non-profit organizations.
At our headquarters, we provide an onsite garden where employees take part in growing and distributing produce to employees and to the local community. Employees also actively support causes by raising awareness and funds for non-profit organizations.
Merit Vascular – Cardiac The principal product offerings in our access portfolio (cardiac) include our family of Prelude Introducer Sheaths, for both radial and femoral access, featuring our Prelude IDeal™ Hydrophilic Sheath Introducer, an ultra-thin wall introducer sheath that provides more room for the insertion of catheters and other devices in the radial artery.
Merit Vascular – Cardiac The principal product offerings in our access portfolio (cardiac) include our family of Prelude Introducer Sheaths, for both radial and femoral access, featuring our recently-launched Prelude Wave™ Hydrophilic Sheath Introducer with SnapFix™ technology and our Prelude IDeal™ Hydrophilic Sheath Introducer, an ultra-thin wall introducer sheath that provides more room for the insertion of catheters and other devices in the radial artery.
Consequently, we possess the capability to flexibly locate or shift the manufacture of products to the facilities providing the most strategic advantages. The determination of manufacturing location is based upon multiple factors, including facility technological capabilities, market demand, acquisition and integration activities and economic and competitive conditions. We currently produce and package all of our embolotherapy products.
Consequently, we possess the capability to flexibly locate or shift the manufacture of products to the facilities providing the most strategic advantages. The determination of manufacturing location is based upon multiple factors, including facility technological capabilities, market demand, acquisition and integration activities and economic and competitive conditions.
(ISO 14001 is the international standard that specifies requirements for an effective environmental management system); ● establishment and support of employee gardens that promote pollination and provide farm-to-table nutrition for our employees at our headquarters in South Jordan, Utah; ● use of re-usable pallets where possible and methods to move products in reusable bulk containers, reducing intra-company shipping materials; ● reduction in water consumption at our water-stressed location in South Jordan, Utah by investing in campus-wide xeriscaping and water recirculation systems within our most water intensive operations; ● reduction in packaging materials by implementing product family packaging reviews to consolidate shipments by better understanding our customers' purchasing practices-these reviews often allow us to increase quantities 16 Table of Contents per box, eliminate the usage of intermediate packaging, reduce film thickness and re-use original product packaging where possible; ● transition from paper work orders to electronic work orders through our internally designed eWorq program.
A key part of our ISO 14001 program is energy management which includes yearly energy reviews and procurement controls for energy efficient purchasing; ● establishment and support of employee gardens that promote pollination and provide farm-to-table nutrition for our employees at our headquarters in South Jordan, Utah; ● use of re-usable pallets where possible and methods to move products in reusable bulk containers, reducing intra-company shipping materials; ● reduction in water consumption at our water-stressed location in South Jordan, Utah by investing in campus-wide xeriscaping and water recirculation systems within our most water intensive operations; ● reduction in packaging materials by implementing product family packaging reviews to consolidate shipments by better understanding our customers' purchasing practices-these reviews often allow us to increase quantities 16 Table of Contents per box, eliminate the usage of intermediate packaging, reduce film thickness and re-use original product packaging where possible; ● transition from paper work orders to electronic work orders through our internally designed eWorq program.
The duration of our patents is determined by the laws of the country of issuance and, for the U.S., is typically 20 years from the date of filing of the patent application. As of December 31, 2024, we owned approximately 1,900 U.S. and international patents and patent applications.
The duration of our patents is determined by the laws of the country of issuance and, for the U.S., is typically 20 years from the date of filing of the patent application. As of December 31, 2025, we owned approximately 2,200 U.S. and international patents and patent applications.
We plan to continue implementing this program at our manufacturing facilities globally to eliminate as much paper as we can within our operations; ● recycling programs where we recycle materials, including food waste, paper, plastic, cardboard, beverage containers, scrap metal, and pallets; ● placement of free car charging stations for employees who have transitioned to electric vehicles; ● installation of efficient heating and cooling systems that operate on variable efficiency drives, increasing our energy efficiency at our headquarters in South Jordan, Utah and our transition to Light Emitting Diode ("LED") lighting in our global facilities; ● operation of an environmental tracking system at our world-wide facilities to facilitate monthly reporting and accountability for energy, water, waste, recycling, and scope 1 and 2 greenhouse gas emissions metrics—this system supports our 2030 operational sustainability goals; and ● engaged in a comprehensive materiality assessment to better align environmental, social and governance expectations from our internal and external stakeholders.
We plan to continue implementing this program at our manufacturing facilities globally to eliminate as much paper as we can within our operations; ● recycling programs where we recycle materials, including food waste, paper, plastic, cardboard, beverage containers, scrap metal, and pallets; ● Waste to energy (WtE) programs where we divert hard-to-recycle items from the landfill to certified WtE plants that utilize advanced pollution controls to burn the waste and create steam to drive turbines, resulting in the production of electricity and heat for homes and businesses; ● placement of free car charging stations for employees who have transitioned to electric vehicles; ● installation of efficient heating and cooling systems that operate on variable efficiency drives, increasing our energy efficiency at our headquarters in South Jordan, Utah and our transition to Light Emitting Diode ("LED") lighting in our global facilities; ● operation of an environmental tracking system at our world-wide facilities to facilitate monthly reporting and accountability for energy, water, waste, recycling, and scope 1 and 2 greenhouse gas emissions metrics—this system supports our 2030 operational sustainability goals; and ● engaged in a comprehensive materiality assessment to better align environmental, social and governance expectations from our internal and external stakeholders.
Internationally, we employ sales representatives and contract with independent dealer organizations and custom procedure tray manufacturers to distribute our products worldwide, including territories in Europe, the Middle East, Africa, Asia, Oceania, Central and South America, Mexico and Canada. In 2024, our international sales grew 4.8% over our 2023 international sales and accounted for 41% of our net sales.
Internationally, we employ sales representatives and contract with independent distributor organizations and custom procedure tray manufacturers to distribute our products worldwide, including territories in Europe, the Middle East, Africa, Asia, Oceania, Central and South America, Mexico and Canada. In 2025, our international sales grew 9.1% over our 2024 international sales and accounted for 40% of our net sales.
To learn more about our sustainability programs and accomplishments, you may visit www.merit.com/about/corporate-sustainability/. Our People As of December 31, 2024, we had approximately 7,400 employees located in approximately 40 different countries in a variety of different roles.
To learn more about our sustainability programs and accomplishments, you may visit www.merit.com/about/corporate-sustainability/. Our People As of December 31, 2025, we had approximately 7,500 employees located in approximately 43 countries performing a variety of roles.
According to statistics published by the National Center for Health Statistics, cardiovascular disease continues to be a leading cause of death and a significant health problem in the U.S. Treatment options range from dietary changes to surgery, depending on the nature of the specific disease or disorder.
According to statistics published by the World Health Organization, cardiovascular disease continues to be a leading cause of death and a significant global health problem. Treatment options range from dietary changes to surgery, depending on the nature of the specific disease or disorder.
We believe we are a market leader in the U.S. for control syringes, radar localization, waste-disposal systems, embolic beads, tubing and manifolds.
In addition, we believe we are one of the market leaders in the U.S. for analog inflation devices. We believe we are a market leader in the U.S. for control syringes, radar localization, waste-disposal systems, embolic beads, tubing and manifolds.
Our primary product offerings in our oncology portfolio include our: ● SCOUT® Radar Localization System, a nonradioactive, wire-free tumor localization system that facilitates successful surgical removal of marked lesions and lymph nodes, improving workflow and the patient experience; ● CorVocet® Biopsy System, one of our innovative soft tissue core needle biopsy and accessory products, designed to cut a full core of tissue and provide large specimens for pathological examination; ● Achieve®, Temno® and Tru-Cut® Soft Tissue Biopsy Devices; ● BioSentry® biopsy tract sealant system; and ● SAVI® Brachytherapy, a precise, targeted approach to accelerated partial breast irradiation with lower toxicities and reduced treatment duration.
Our primary product offerings in our oncology portfolio include our: ● SCOUT® Radar Localization System, a nonradioactive, wire-free tumor localization system that facilitates successful surgical removal of marked lesions and lymph nodes, improving workflow and the patient experience; ● CorVocet® Biopsy System, one of our innovative soft tissue core needle biopsy and accessory products, designed to cut a full core of tissue and provide large specimens for pathological examination; ● Achieve®, Temno® and Tru-Cut® Soft Tissue Biopsy Devices which are designed to produce superior soft tisuue biopsy samples; ● BioSentry® biopsy tract sealant system designed to address the issues of biopsy-related pneumothorax; and ● SAVI® Brachytherapy, a precise, targeted approach to accelerated partial breast irradiation with lower toxicities and reduced treatment duration. 5 Table of Contents Cardiac Intervention We manufacture and sell a variety of products designed to treat various heart conditions.
Our primary product offerings in our pulmonary portfolio include our: ● AERO®, AEROmini® and AERO DV® Fully Covered Tracheobronchial Stents, for the treatment of tracheobronchial strictures produced by malignant neoplasms; and ● Elation® Pulmonary™ Balloon Dilator, for the dilation of strictures of the trachea and bronchi.
Our primary product offerings in our pulmonary portfolio include our: ● AERO®, AEROmini® and AERO DV® Fully Covered Tracheobronchial Stents, for the treatment of tracheobronchial strictures produced by malignant neoplasms; and ● Elation® Pulmonary™ Balloon Dilator, for the dilation of strictures of the trachea and bronchi. We also offer a variety of kits and accessories for endoscopy and bronchoscopy procedures.
Our primary product offerings in our gastroenterology portfolio include our: ● Recently-acquired EsophyX® Z+ system for minimally invasive non-pharmacological treatment of gastroesophageal reflux disease; ● Alimaxx-ES™ and EndoMAXX® Fully Covered Esophageal Stents, for maintaining esophageal luminal patency in certain esophageal strictures; ● BIG60® and BIG60 ALPHA™ Inflation Devices, 60-mL syringes and gauges designed to inflate and deflate non-vascular balloon dilators while monitoring and displaying inflation pressures up to 12 atmospheres; and ● Elation® Fixed Wire, Wire Guided and new 5-stage Balloon Dilators, intended for use in the alimentary tract.
Our primary product offerings in our gastroenterology portfolio include our: ● Recently-launched Resilience Through-the-Scope Esophageal Stent which provides luminal patency in the esophagus; ● Recently-acquired C2 CryoBalloon® device and related technology intended to treat patients suffering from Barretts esophagus and other gastrointestinal disorders; ● EsophyX® Z+ system for minimally invasive non-pharmacological treatment of gastroesophageal reflux disease; 7 Table of Contents ● Alimaxx-ES™ and EndoMAXX® Fully Covered Esophageal Stents for maintaining esophageal luminal patency in certain esophageal strictures; ● BIG60® and BIG60 ALPHA® Inflation Devices, 60-mL syringes and gauges designed to inflate and deflate non-vascular balloon dilators while monitoring and displaying inflation pressures up to 12 atmospheres; and ● Elation® Fixed Wire, Wire Guided and new 5-stage Balloon Dilators, intended for use in the alimentary tract.
In addition to the federal Anti-Kickback Statute, many states have their own anti-kickback laws. Often, these laws closely follow the language of the federal law, although they do not always have the same exceptions or safe harbors.
In addition to the federal Anti-Kickback Statute, many states have their own anti-kickback laws. Often, these laws closely follow the language of the federal law, although they do not always have the same exceptions or safe harbors. In some states, these anti-kickback laws apply with respect to all payers, including commercial health insurance companies.
We sell our products through more than 500 distributors in mainland China, who are responsible for reselling our products, primarily to hospitals. We use the “modified direct” sales approach in China, employing sales personnel throughout China who work with our distributors to promote the clinical advantages of our products to clinicians and other decision makers at hospitals.
We use the “modified direct” sales approach in China, employing sales personnel throughout China who work with our distributors to promote the clinical advantages of our products to clinicians and other decision makers at hospitals.
“Properties.” We ship our products through distribution centers located in Virginia, Utah, Canada, Brazil, The Netherlands, United Kingdom (“UK”), South Africa, South Korea, India, New Zealand, Japan, China, Hong Kong, Thailand, Mexico, Colombia and Australia.
We have packaging and manufacturing facilities located in Texas, Florida, Virginia, Utah, Minnesota, Mexico, Brazil, Ireland, France, The Netherlands, and Singapore. See Item 2. “Properties.” We ship our products through distribution centers located in Virginia, Utah, Canada, Brazil, The Netherlands, United Kingdom (“UK”), South Africa, South Korea, India, New Zealand, Japan, China, Hong Kong, Thailand, Mexico, Colombia and Australia.
This survey provided us with many insights into the engagement of 17 Table of Contents our employees from which we have been able to develop action plans at the team and company level in order to further strengthen employee engagement.
This survey provides us with many insights into the engagement of our employees from which we have been able to develop action plans at the team and company level in order to further strengthen employee engagement. The employee participation rate in the engagement survey reached a high of 93% in 2025.
The negative impacts of the VBP policy persisted in 2024 and we expect to continue to experience these negative impacts in 2025.
The negative impacts of the VBP policy have persisted since 2022 and we expect to continue to experience these negative impacts in 2026.
Areas that our employees have supported in recent years include Breast Cancer Awareness Month, Heart Health Month, children’s charities and supporting those in need. In 2024, we continued our support of humanitarian missions through Merit product donations in Belize, Cape Verde, Ethiopia, Haiti, Honduras, Kenya, Mauritius, Nicaragua, Peru and Tanzania.
Areas that our employees have supported in recent years include Breast Cancer Awareness Month, Heart Health Month, children’s charities and supporting those in need. In 2025, we continued our support of humanitarian missions through Merit product donations in Belize, Honduras, Ethiopia, Peru, Tanzania, Haiti, Mauritius, Nicaragua, and Syria. Merit also conducts and/or participates in medical education conferences around the globe.
This is a globally recognized standard for employee occupational health and safety, established by the International Standards Organization, which provides a voluntary framework to identify key occupational health and safety aspects associated with our business helping to deliver continuous improvement. We plan to achieve this certification at our seventh and eighth in scope facilities by the end of 2025.
This is a globally recognized standard for employee occupational health and safety, established by the International Organization for Standardization, which provides a voluntary framework to identify key occupational health and safety aspects associated with our business helping to deliver continuous improvement.
In some states, these anti-kickback laws apply with respect to all payers, including commercial health insurance companies. 14 Table of Contents Government officials continue their vigorous enforcement efforts on the sales and marketing activities of pharmaceutical, medical device and other healthcare companies, including the pursuit of cases against individuals or entities that allegedly offered unlawful inducements to potential or existing customers to procure their business.
Government officials continue their vigorous enforcement efforts on the sales and marketing activities of pharmaceutical, medical device and other healthcare companies, including the pursuit of cases against individuals or entities that allegedly offered unlawful inducements to potential or existing customers to procure their business.
Currently, 69% of our global work orders are managed by eWorq, with a goal to be at 89% by the end of 2025. This project saves millions of pieces of paper and thousands of plastic sleeves annually.
Currently, 84% of our global work orders are managed by eWorq, with a goal to be at 93% by the end of 2026. This project saves millions of pieces of paper and thousands of plastic sleeves annually. Currently, our eWorq program is in place at five of our largest manufacturing sites.
Since 2021, we have substantially strengthened our employee communication capabilities through the addition of dedicated internal resources and programs aimed at doing even more to communicate with and engage our workforce. In partnership with the Gallup organization, in 2022 we launched our first ever global employee engagement survey. We repeated this employee engagement survey in 2024.
Since 2021, we have substantially strengthened our employee communication capabilities through the addition of dedicated internal resources and programs aimed at doing even more to communicate with and engage our workforce.
Cardiac Intervention We manufacture and sell a variety of products designed to treat various heart conditions. Products in our cardiac intervention product category are organized into the following product portfolios: access (cardiac), angiography, electrophysiology and CRM, fluid management, hemodynamic monitoring, hemostasis, and intervention (cardiac).
Products in our cardiac intervention product category are organized into the following product portfolios: access (cardiac), angiography, electrophysiology and CRM, fluid management, hemodynamic monitoring, hemostasis, and intervention (cardiac).
We generally contract with third parties for the tooling of our molds, but we design and own most of our molds. We have also received various International Standards Organization (“ISO”) certifications for many of our facilities; for further details, please refer to Item 1. “Business - Sustainability” below. Merit Sensor Systems, Inc.
We have also received various International Organization of Standardization (“ISO”) certifications for many of our facilities; for further details, please refer to Item 1. “Business - Sustainability” below. Merit Sensor Systems, Inc.
Other products added to our new product portfolio include simplified connections to our Centesis and Aspira® drainage systems to facilitate compatibility with a broader range of drainage tools.
Other products added to our new product portfolio include simplified connections to our Centesis and Aspira® drainage systems to facilitate compatibility with a broader range of drainage tools. Currently, we have research and development facilities in California, Minnesota, Texas, Utah, Ireland and France.
Additionally, we provide coating services for medical tubes and wires under OEM brands in addition to many of the products identified above. We offer coated tubes and wires to customers on a spool or as further manufactured components including guide wire components, coated mandrels/stylets and coated needles. We also manufacture and sell sensor components for microelectromechanical systems.
We offer coated tubes and wires to customers on a spool or as further manufactured components, including guide wire components, coated mandrels/stylets and coated needles. We also manufacture and sell sensor components for microelectromechanical systems.
We post on our websites our privacy 15 Table of Contents notices, policies and practices regarding the collection, use and disclosure of user data, as well as providing our privacy policies to our employees (including job applicants) by linking to the Merit privacy policy (posted on the Merit website) from our Employee Handbook and our job application board.
The state laws also compel companies to post clear privacy policies that detail the types of personal information they collect about consumers, with whom they share this data, and how consumers can control their personal data. 15 Table of Contents We post on our websites our privacy notices, policies and practices regarding the collection, use and disclosure of user data, as well as providing our privacy policies to our employees (including job applicants) by linking to the Merit privacy policy (posted on the Merit website) from our Employee Handbook and our job application board.
The principal product offerings in our hemostasis portfolio include our Prelude SYNC EVO™, PreludeSYNC Distal™, PreludeSYNC EZ TM Radial Compression devices (designed to reduce and stop blood flow after radial access procedures), and the SafeGuard® Pressure Assisted Device which provides hemostasis after femoral procedures. 6 Table of Contents The principal product offerings in our intervention (cardiac) portfolio include a full line of inflation devices and hemostasis valves, including the BasixSKY™, BasixCompak™, basixTOUCH™, Blue Diamond™ and DiamondTouch™ inflation devices and the PhD™ Hemostasis Valve, the latest addition to our hemostasis valve portfolio.
The principal product offerings in our hemostasis portfolio include our Prelude SYNC EVO®, PreludeSYNC Distal™, PreludeSYNC EZ TM Radial Compression devices (designed to reduce and stop blood flow after radial access procedures), and the SafeGuard® Pressure Assisted Device which provides hemostasis after femoral procedures.
Settlements of these government cases have involved significant fines and penalties and, in some instances, criminal proceedings. False Claims Laws. The False Claims Acts prohibit any person from knowingly presenting, or causing to be presented, a false claim for payment to the federal government or knowingly making, or causing to be made, a false statement to get a claim paid.
The False Claims Acts prohibit any person from knowingly presenting, or causing to be presented, a false claim for payment to the federal government or knowingly making, or causing to be made, a false statement to get a claim paid.
Endovascular techniques, including angioplasty, stenting and endoluminal stent grafts, continue to represent important therapeutic options for the treatment of vascular disease. Breast cancer is the most commonly diagnosed cancer in women and is the second leading cause of cancer death among women.
Endovascular techniques, including angioplasty, stenting and endoluminal stent grafts, continue to represent important therapeutic options for the treatment of vascular disease.
Our primary competitors in our spine market are Medtronic, Stryker Corporation, and Johnson & Johnson. Our primary competitors in our oncology market are BD, Hologic, Inc., Endomagnetics Ltd., Argon Medical Devices, Inc. and Cook Medical. Our primary competitors in our endoscopy market are Getinge AB, Boston Scientific, Cook Medical, and Olympus Corporation.
Our primary competitors in our cardiac intervention market are BD, Teleflex, Medtronic, Abbott Laboratories, Terumo Corporation, Edwards Lifesciences Corporation, Cook Medical, and Boston Scientific. Our primary competitors in our spine market are Medtronic, Stryker Corporation, and Johnson & Johnson. Our primary competitors in our oncology market are BD, Hologic, Inc., Argon Medical Devices, Inc. and Cook Medical.
We also offer a variety of kits and accessories for endoscopy and bronchoscopy procedures. 7 Table of Contents Marketing and Sales Target Market/Industry. Our principal target markets are peripheral intervention (including, renal therapies), cardiac intervention, interventional oncology, critical care and endoscopy.
Marketing and Sales Target Market/Industry. Our principal target markets are peripheral intervention (including, renal therapies), cardiac intervention, interventional oncology, critical care and endoscopy.
As a company, some of our primary competitive strengths are our relative stability in the marketplace; comprehensive, broad line of ancillary products; manufacturing integration to secure our supply chain; commitment to innovation and strong cadence of new products and product line extensions that enhance our portfolio.
As a company, some of our primary competitive strengths are our relative stability in the marketplace; comprehensive, broad line of ancillary products; manufacturing integration to secure our supply chain; commitment to innovation and strong cadence of new products and product line extensions that enhance our portfolio. 10 Table of Contents Our primary competitors in our peripheral intervention market are Teleflex Incorporated (“Teleflex”), Cook Medical Incorporated (“Cook Medical”), Medtronic plc (“Medtronic”), Boston Scientific Corporation (“Boston Scientific”), and Becton, Dickinson and Company (“BD”).
These components consist of piezoresistive pressure sensors in various forms, including bare silicon die, die mounted on ceramic substrates, and fully calibrated components for numerous applications both inside and outside the healthcare industry. Endoscopy The products in our endoscopy operating segment, Merit Medical Endotek ™® , are organized in two product portfolios: gastroenterology and pulmonary.
These components consist of piezoresistive pressure sensors in various forms, including bare silicon die, die mounted on ceramic substrates, and fully calibrated components for numerous applications both inside and outside the healthcare industry. Merit Spine In 2025, we reorganized our sales teams and product categories to include our spine products under our OEM product category.
Ensuring our employees’ safety is a top priority. We strive to foster a safety-oriented culture, and we maintain an occupational health and safety management system that covers all our employees and contractors.
Retaining the KeepWell Mark™ demonstrates our ongoing dedication to workplace health, safety, and wellbeing, with senior management playing an active role in promoting these values. Health and Safety. Ensuring our employees’ safety is a top priority. We strive to foster a safety-oriented culture, and we maintain an occupational health and safety management system that covers all our employees and contractors.
Based on available industry data, with respect to the number of procedures performed, we believe we are a leading provider of digital inflation technology in the world. In addition, we believe we are one of the market leaders in the U.S. for analog inflation devices.
Our primary competitors in our endoscopy market are Getinge AB, Boston Scientific, Cook Medical, and Olympus Corporation. Based on available industry data, with respect to the number of procedures performed, we believe we are a leading provider of digital inflation technology in the world.
Because our mission is to create innovative medical devices that improve lives, we aim to hire and develop employees who want to build something special through hard work, team effort, and commitment. That is why we provide all our employees with competitive total rewards packages and strive to provide the most cost-effective medical benefits and wellness programs.
In 2025, the Merit Way values were embedded in performance management recognition programs in addition to global and local communications. Compensation and Benefits. Because our mission is to create innovative medical devices that improve lives, we aim to hire and develop employees who want to build something special through hard work, team effort, and commitment.
Our sustainability values in action include: ● achievement of the International Organization for Standardization (“ISO”) 14001 certification at nine facilities including eight manufacturing facilities (eight in scope) and one large distribution facility (one in scope). A key part of our ISO 14001 program is energy management which includes yearly energy reviews and procurement controls for energy efficient purchasing.
Our sustainability values in action include: ● achievement of the ISO 14001 certification (international standard that specifies requirements for an effective environmental management system) at nine facilities including eight manufacturing facilities (eight in scope) and one large distribution facility (one in scope).
This year, our Ireland subsidiary was honored with the “Best in Class - Mental Health” award, reflecting our strong focus on mental health and wellness culture. Retaining the KeepWell Mark™ demonstrates our ongoing dedication to workplace health, safety, and wellbeing, with senior management playing an active role in promoting these values. Health and Safety.
Additionally, Merit Medical Ireland has held the KeepWell Mark™ accreditation since 2021, recognizing our commitment to employee wellbeing. This year, our Ireland subsidiary was honored with the “Best in Class - Mental Health” award, reflecting our strong focus on mental health and wellness culture.
The engagement of our workforce is critical to delivering on our competitive strategy, and we place high importance on informed and engaged employees.
Through the WLI, the first global Strategic Leadership Program was launched in 2025 in partnership with the University of Utah and an external leadership development partner. Employee Engagement. The engagement of our workforce is critical to delivering on our competitive strategy, and we place high importance on informed and engaged employees.
The bone biopsy systems portfolio comprises a full offering of manual bone biopsy products, including our Madison™, Huntington™, Kensington™, Preston™ and Westbrook™ biopsy products. 5 Table of Contents Merit Oncology Our oncology products are dedicated to the accurate diagnosis and localization of breast and soft tissue tumors and the innovative treatment of early-stage breast cancer.
Merit Oncology Our oncology products are dedicated to the accurate diagnosis and localization of breast and soft tissue tumors and the innovative treatment of early-stage breast cancer. We also offer an extensive line of soft tissue biopsy products and accessories.
Merit also conducts and/or participates in medical education conferences around the globe. Wellness. Wellness is at the foundation of creating a positive employee experience. At our company headquarters in Utah, we have an onsite medical clinic available for our employees and their families where we provide preventative and general medical care.
At both our company headquarters in Utah and at our largest manufacturing location in Tijuana, Mexico, we have an onsite medical clinic available for our employees and their families where we provide preventative and general medical care.
Some programs include suicide prevention awareness, on-site diabetes screenings, mental health awareness, lifestyle modification to prevent diseases, tobacco cessation and breast cancer awareness.
Some programs include suicide prevention awareness, on-site diabetes screenings, mental health awareness, lifestyle modification to prevent diseases, tobacco cessation and breast cancer awareness. Additionally, we continue to offer our Smart Choice meal program designed by our onsite dietician and culinary team to provide a free healthy meal option to employees at our Utah headquarters.
Currently, we have research and development facilities in California, Texas, Utah, Ireland and France. 9 Table of Contents Manufacturing We manufacture many of our products using our proprietary technology and our expertise in plastic injection molding, insert molding and extrusion, along with many other technologically advanced manufacturing processes.
Manufacturing We manufacture many of our products using our proprietary technology and our expertise in plastic injection molding, insert molding and extrusion and in embolotherapy products production, along with many other technologically advanced manufacturing processes. We generally contract with third parties for the tooling of our molds, but we design and own most of our molds.
The principal product offerings in this product category include: ● Critical care products; ● Dual Cap® Disinfection Protection System and Medallion ® syringes; ● Manifold kits; and ● Trays and packs. OEM Our global OEM Division sells components and finished devices, including molded components, sub-assembled goods, custom kits and bulk non-sterile goods, to other medical device manufacturers.
OEM Our global OEM Division sells components and finished devices, including molded components, sub-assembled goods, custom kits and bulk non-sterile goods, to other medical device manufacturers. Additionally, we provide coating services for medical tubes and wires under OEM brands in addition to many of the products identified above.
In 2021, we hired our first ever Director of Global Talent Management who continues to be focused on building and strengthening global programs around strategic talent management, employee performance, development, succession planning and engagement.
Since 2021, we have been building and strengthening global programs around strategic talent management, employee performance, development, succession planning and engagement. In 2025, we launched an automated global performance management program with a focus on The Merit Way values using our global HR information system.
In 2024, Merit launched a new core values program known as “The Merit Way,” which is an employee culture initiative to preserve the workplace attributes that have contributed to Merit’s success while preparing the organization for the future.
In July 2025, Merit celebrated the one-year anniversary of the launch of our values program known as “The Merit Way,” which is an employee initiative designed to create a single global culture united by common values that honors Merit’s past and future.

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Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

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Biggest changeAdditionally, potential tariffs or other U.S. trade policy measures could trigger retaliatory actions by other countries, including by countries that are significant markets for our products, resulting in a “trade war.” A trade war could cause increased manufacturing costs, including with respect to our products manufactured in Mexico, foreign governments imposing tariffs on products that we export outside of the U.S., or limitations on our ability to sell our products domestically or abroad, any of which would negatively affect our business, operations and financial condition.
Biggest changeAdditionally, potential tariffs or other U.S. trade policy measures could trigger retaliatory actions by other countries, including by countries that are significant markets for our products, such as China.
Our ability to compete successfully is dependent, in part, upon our response to changes in technology and upon our efforts to develop and market new products which achieve significant market acceptance.
Our ability to compete successfully is dependent, in part, upon our response to changes in technology and our efforts to develop and market new products which achieve significant market acceptance.
If we do not adequately identify and value targets for, or manage issues related to, acquisitions and other transactions, such transactions may not produce the anticipated benefits and could have an adverse effect on our business, operations or financial condition. Failure to realize the benefits expected from recent acquisitions could adversely affect our business, operating results and financial condition.
If we do not adequately identify and value targets for, or manage issues related to, acquisitions and other transactions, such transactions may not produce the anticipated benefits and could have an adverse effect on our business, operations or financial condition. Failure to realize the benefits expected from recent acquisitions could adversely affect our business, operating results or financial condition.
Additionally, the development or enhancement of certain products or groups of products, for example the Wrapsody Device, may have a disproportionate impact on our business, financial condition and results of operations. We have devoted and currently devote significant research and development resources to certain products and groups of products.
Additionally, the development or enhancement of certain products or groups of products, for example the Wrapsody Device, may have a disproportionate impact on our business, financial condition or results of operations. We have devoted and currently devote significant research and development resources to certain products and groups of products.
In addition, the laws of some foreign countries do not offer the same level of protection for our intellectual property as the laws of the U.S.
In addition, the laws of some foreign countries do not offer the same level of protection for our intellectual property as U.S. laws.
There can be no assurance that our protective measures have prevented or will prevent security breaches, any of which could have a significant impact on our business, reputation and financial condition. We rely on third-party vendors to supply and support certain aspects of our information technology systems.
There can be no assurance that our protective measures have prevented or will prevent security breaches, any of which could have a significant impact on our business, reputation or financial condition. We rely on third-party vendors to supply and support certain aspects of our information technology systems.
We have incurred, and will likely continue to incur, significant expenses in connection with evaluating, negotiating and consummating various acquisition and other transactions. Our integration of acquired businesses requires considerable efforts, which may include corporate restructuring and the coordination of information technologies, research and development, sales and marketing, operations, regulatory, supply chain, manufacturing, quality systems and finance.
We have incurred, and will likely continue to incur, significant expenses in connection with evaluating, negotiating and consummating acquisition and other transactions. Our integration of acquired businesses requires considerable efforts, which may include corporate restructuring and the coordination of information technologies, research and development, sales and marketing, operations, regulatory, supply chain, manufacturing, quality systems and finance.
If we fail to monitor, maintain or protect our information technology systems and data integrity or fail to anticipate, plan for or manage significant disruptions to these systems, we could lose customers, be subject to fraud, breach our agreements with or duties toward customers, physicians, other parties, be subjected to regulatory sanctions or penalties, incur expenses or lose revenues, sustain damage to our reputation, or suffer other adverse consequences.
If we fail to maintain or protect our information technology systems and data integrity or fail to anticipate, plan for or manage significant disruptions to these systems, we could lose customers, be subject to fraud, breach our agreements with or duties toward customers, physicians or other parties, be subjected to regulatory sanctions or penalties, incur expenses or lose revenues, sustain damage to our reputation, or suffer other adverse consequences.
Furthermore, our existing competitors and new market entrants may respond more quickly to or integrate new or emerging technologies such as artificial intelligence and machine learning in their product offerings, which could also limit the market for our products. A reduction in demand for our products could have a material adverse effect on our business, operations or financial condition.
Furthermore, our existing competitors and new market entrants may respond more quickly to or integrate new or emerging technologies such as artificial intelligence (“AI”) and machine learning in their product offerings, which could also limit the market for our products. A reduction in demand for our products could have a material adverse effect on our business, operations or financial condition.
Healthcare costs have risen significantly over the past decade, which has led to numerous cost containment measures and other healthcare reforms by legislators, regulators and third-party payers. Cost reform has triggered a consolidation trend in the healthcare industry to aggregate purchasing power, which has created more requests for pricing concessions and is expected to continue in the future.
Healthcare costs have risen significantly over the past decade, which has led to numerous cost containment measures and other healthcare reforms by legislators, regulators and third-party payers. Cost reform has triggered a consolidation trend in the healthcare industry to aggregate purchasing power, which has created more requests for pricing concessions and is expected to continue.
There is no assurance that crude oil supplies will be uninterrupted or that petroleum-based manufacturing materials will be available for purchase in the future. Tensions in the Middle East and the military conflict in Ukraine may increase the likelihood of supply interruptions and hinder our ability to obtain the materials we need to make our products.
There is no assurance that crude oil supplies will be uninterrupted or that petroleum-based manufacturing materials will be available for purchase in the future. Tensions in the Middle East and Venezuela and the military conflict in Ukraine may increase the likelihood of supply interruptions and hinder our ability to obtain the materials we need to make our products.
We are exposed to the risk that our employees, independent contractors, consultants, manufacturers and distributors may engage in fraudulent conduct or other illegal activity. Misconduct by these parties could include intentional, reckless or negligent conduct, or unauthorized activities that violate the laws and regulations of the FDA and other federal, state and international authorities.
We are exposed to the risk that our employees, independent contractors, consultants, manufacturers and distributors may engage in misconduct or illegal activity. Misconduct by these parties could include intentional, reckless or negligent conduct, or unauthorized activities that violate the laws and regulations of the FDA and other federal, state and international authorities.
We may also have less cash available for operations and investments in our business, as we will be required to use additional cash to satisfy the minimum payment obligations associated with this increased indebtedness. Our management has broad discretion regarding the use of proceeds of the Convertible Notes and other borrowed funds.
We may also have less cash available for operations and investments in our business, as we will be required to use additional cash to satisfy the minimum payment obligations associated with the increased indebtedness. Our management has broad discretion regarding the use of proceeds of the Convertible Notes and other borrowed funds.
We have previously faced, and currently face, claims by patients claiming injuries from our products. To date, these claims have not had a material adverse effect on our business, operations or financial condition. The outcome of this type of personal injury litigation is difficult to assess or quantify.
We have faced, and currently face, claims by patients claiming injuries from our products. To date, these claims have not had a material adverse effect on our business, operations or financial condition. The outcome of this type of personal injury litigation is difficult to assess or quantify.
We may acquire businesses or assets which do not produce the benefits projected at the time of acquisition or we may identify legacy operations and products that are underperforming, do not fit with our longer-term business strategy or that become subject to unforeseen operating difficulties. We may seek to divest these underperforming businesses, operations or products.
We may acquire businesses or assets which do not produce the benefits projected at the time of acquisition or we may identify legacy operations and products that are underperforming, do not fit with our longer-term business strategy or become subject to unforeseen operating difficulties. We may divest these underperforming businesses, operations or products.
The process of obtaining and maintaining FDA clearances and approvals for our medical devices could require a significant period of time, require the expenditure of substantial resources, involve rigorous clinical testing and post-market surveillance, require changes to our products or result in limitations on the indicated uses of our products.
The process of obtaining and maintaining FDA clearances and approvals for our devices could require a significant period of time, require the expenditure of substantial resources, involve rigorous clinical testing and post-market surveillance, require changes to our products or result in limitations on the indicated uses of our products.
The U.S. and many other countries in which we operate have adopted laws and regulations protecting certain data, including medical and personal data (including HIPAA and the HITECH Act), and requiring data holders and controllers to implement administrative, logical and technical controls and procedures in order to protect the privacy of such data.
The U.S. and other countries in which we operate have adopted laws and regulations protecting certain data, including medical and personal data (including HIPAA and the HITECH Act), and requiring data holders and controllers to implement administrative, logical and technical controls and procedures in order to protect the privacy of such data.
Cyber-attacks could also result in unauthorized access to our systems and products, including personal information of individuals, which could trigger notification requirements, encourage actions by regulatory bodies, result in adverse publicity, prompt us to offer credit support products or services to affected individuals and lead to litigation.
Cyber-attacks could also result in unauthorized access to our systems and products, including personal information of individuals, which could trigger notification requirements, encourage actions by regulatory bodies, result in adverse publicity, prompt us to offer credit support products or services and lead to litigation.
Nontraditional entrants, such as technology companies, are also entering into the healthcare industry and some may have greater financial or other resources than we do. Additionally, the medical device industry is also subject to rapid technological change and frequent product introductions.
Nontraditional entrants, such as technology companies, are also entering into the healthcare industry and some may have greater financial or other resources than we do. The medical device industry is also subject to rapid technological change and frequent product introductions.
Our breach of any covenant in the Amended Fourth A&R Credit Agreement could result in a default under that agreement and could trigger acceleration of the underlying obligations. Any default under the Amended Fourth A&R Credit Agreement could adversely affect our ability to service our debt and to fund our planned capital expenditures and ongoing operations.
Our breach of any covenant in the Amended Fourth A&R Credit Agreement could result in a default under that agreement and could trigger acceleration of the underlying obligations. Any default under the Amended Fourth A&R Credit Agreement could adversely affect our ability to service our debt and to fund capital expenditures and ongoing operations.
All of our patents and copyrights will eventually expire and some of our patents, including patents protecting significant elements of our technology, will expire within the next several years. Filing, prosecuting and defending our intellectual property in countries throughout the world may be impractical and prohibitively expensive.
All of our patents and copyrights will eventually expire and some of our patents, including patents protecting significant elements of our technology, will expire within the next several years. Filing, prosecuting and defending our intellectual property in countries throughout the world may be impractical and expensive.
Changes in economic and geopolitical conditions, domestic and foreign trade policies, monetary policies and other factors beyond our control may adversely impact our business, operations and financial condition. Our operations and performance are significantly impacted by global, regional and U.S. economic and geopolitical conditions.
Changes in economic and geopolitical conditions, domestic and foreign trade policies, monetary policies and other factors beyond our control may adversely impact our business, operations or financial condition. Our operations and performance are significantly impacted by global, regional and U.S. economic and geopolitical conditions.
Further, no assurances can be given that any patent application we have filed or may file will result in a patent being issued, or that any existing or future patents will afford adequate or meaningful protection against competitors or against similar technologies.
No assurances can be given that any patent application we have filed or may file will result in a patent being issued, or that any existing or future patents will afford adequate or meaningful protection against competitors or against similar technologies.
Our products and business activities are subject to rigorous regulation by the FDA and other federal, state and foreign authorities. These authorities and domestic and foreign legislators continue to scrutinize the medical device industry. In recent years, the U.S.
Our products and business activities are subject to rigorous regulation by the FDA and other federal, state and foreign governmental authorities. These authorities and domestic and foreign legislators continue to scrutinize the medical device industry. In recent years, the U.S.
Before we can introduce a new device or a new claim for an existing device in the U.S., we must generally obtain clearance or approval from the FDA, unless an exemption from premarket review or an alternative clearance or approval procedure applies.
Before we can introduce a new device or a new claim for an existing medical device in the U.S., we must generally obtain clearance or approval from the FDA, unless an exemption from premarket review or an alternative clearance or approval procedure applies.
If we are unable to develop and launch new products and enhanced products, our ability to maintain or expand our market position in the markets in which we participate may be materially adversely impacted.
If we are unable to develop and launch new and enhanced products, our ability to maintain or expand our market position in the markets in which we participate may be adversely impacted.
Any such claim, with or without merit, could result in costly litigation, distract management from day-to-day operations and harm our brand or reputation, which in turn could harm our business or results of operations.
Any such claim, with or without merit, could result in costly litigation, distract management from day-to-day operations and harm our reputation, which in turn could harm our business or results of operations.
We have adopted a code of business conduct and ethics, and a global anti-corruption policy, but it is not always possible to identify and deter misconduct, and the precautions we take to detect and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits.
We have adopted a code of business conduct and ethics, and a global anti-corruption policy, but it is not possible to identify and deter all misconduct, and the precautions we take to detect and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits.
Other events that could cause volatility in our stock include, without limitation, variances in our financial results; analysts’ and other projections or recommendations regarding our common stock specifically or medical technology stocks generally; any restatement of our financial statements; governmental or regulatory investigations; actions taken by activist investors or other shareholders; significant litigation or a decline, or rise, of stock prices in capital markets generally.
Other events that could cause volatility in our stock include variances in our financial results; analysts’ and other projections or recommendations regarding our common stock specifically or medical technology stocks generally; any restatement of our financial statements; governmental or regulatory investigations; actions taken by activist investors or other shareholders; significant litigation or a decline, or rise, of stock prices in capital markets generally.
Litigation may be necessary in the future to enforce our intellectual property rights, protect our trade secrets or to determine the validity and scope of proprietary rights claimed by others. Any such litigation could be expensive, time consuming and divert management’s attention from our business. Litigation also puts our patents at risk of being invalidated or interpreted narrowly.
Litigation may be necessary to enforce our intellectual property rights, protect our trade secrets or to determine the validity and scope of proprietary rights claimed by others. Any such litigation could be expensive, time-consuming and divert management’s attention from our business. Litigation also puts our patents at risk of being invalidated or interpreted narrowly.
Further, we have incurred, and will likely continue to incur, significant expense in connection with our efforts to comply with those applicable laws and regulations.
Further, we have incurred, and will likely continue to incur, significant expense in connection with our efforts to comply with those laws and regulations.
If we fail to comply with applicable regulatory requirements, including the terms of the CIA, we may be subjected to a wide variety of sanctions, including warning letters that require corrective action, injunctions, product recalls, suspension of product manufacturing, revocation of approvals, import or export prohibitions, exclusion from participation in government healthcare programs, civil fines and/or criminal penalties, which in turn may have a negative impact on our business, results of operations or financial condition.
If we fail to comply with applicable regulatory requirements, we may be subjected to a wide variety of sanctions, including warning letters that require corrective action, injunctions, product recalls, suspension of product manufacturing, revocation of approvals, import or export prohibitions, exclusion from participation in government healthcare programs, civil fines and/or criminal penalties, which in turn may have a negative impact on our business, results of operations or financial condition.
Consolidation in the healthcare industry, group purchasing organizations and public cost-containment measures have led to demands for price concessions, which may reduce our revenues and harm our ability to sell our products at prices necessary to support our current business strategies.
Consolidation in the healthcare industry, group purchasing organizations and public cost-containment measures have led to demands for price concessions with respect to our products, which may reduce our revenues and harm our ability to sell our products at prices necessary to support our current business strategies.
In addition, we may not realize competitive advantages, synergies or other benefits anticipated in connection with any such acquisition or other transaction.
In addition, we may not realize competitive advantages, synergies or other benefits anticipated in connection with any acquisition or other transaction.
Volatile geopolitical turmoil, including popular uprisings, regional conflicts, terrorism and war could result in market instability, which could negatively impact our business results. We are a global company with international operations, and we sell our products in countries throughout the world.
Volatile geopolitical turmoil, including popular uprisings, regional conflicts, terrorism and war could result in market instability, which could negatively impact our financial results. We are a global company with international operations, and we sell our products in countries throughout the world.
In light of the significant investment of financial and personnel resources to the development of these products, failure to meet development timelines or growth projections, poor clinical outcomes, increasing regulatory requirements, launch delays and inability to effectively scale manufacturing and achieve targeted margins with respect to any of these products or groups of products in particular may adversely impact our business, operations and financial condition.
In light of the significant investment of financial and personnel resources to the development of these products, failure to meet development timelines or growth projections, poor clinical outcomes, increasing regulatory requirements, failure to obtain reimbursement approvals, launch delays and inability to effectively scale manufacturing and achieve targeted margins with respect to any of these products or groups of products in particular may adversely impact our business, operations or financial condition.
Moreover, any product liability claim brought against us could result in significant costs, divert our management’s attention from other business matters or operations, increase our product liability insurance rates, or prevent us from securing insurance coverage in the future. 28 Table of Contents We generally offer a limited warranty for the return of products due to defects in quality and workmanship.
Moreover, any product liability claim brought against us could result in significant costs, divert our management’s attention from other business matters or operations, increase our product liability insurance rates, or prevent us from securing insurance coverage in the future. We generally offer a limited warranty for the return of products due to defects in quality and workmanship.
We may not be able to service all of our indebtedness. As of December 31, 2024, our total outstanding indebtedness under the Convertible Notes and the Amended Fourth A&R Credit Agreement was $747.5 million.
We may not be able to service all of our indebtedness. As of December 31, 2025, our total outstanding indebtedness under the Convertible Notes and the Amended Fourth A&R Credit Agreement was $747.5 million.
We rely on third-party vendors to supply raw materials, component parts, finished products and services in connection with our business. Our reliance on these third-party vendors exposes us to product or service shortages and unanticipated price increases, whether due to inflationary pressure, regulatory changes, geopolitical tensions, the discretion of such vendors or otherwise.
We rely on third-party vendors to supply raw materials, component parts, finished products and services in connection with our business. Our reliance on these third-party vendors exposes us to product or service shortages and unanticipated price increases, whether due to inflationary pressure, regulatory changes, tariffs and related measures, geopolitical tensions, the discretion of such vendors or otherwise.
In addition, in the U.S., no uniform policy of coverage and reimbursement for procedures using our products exists among third-party payers. Therefore, coverage and reimbursement for procedures using our products can differ significantly from payer to payer and, in some cases, jurisdiction to jurisdiction.
In addition, in the U.S., no uniform policy of coverage and reimbursement for procedures using our products exists among payers. Therefore, coverage and reimbursement for procedures using our products can differ significantly from payer to payer and, in some cases, jurisdiction to jurisdiction.
Our operations are subject to various state and federal laws targeting fraud and abuse in the healthcare industry, including the U.S. federal Anti-Kickback Statute, which prohibit any person from knowingly and willfully offering, paying, soliciting or receiving remuneration, directly or indirectly, to induce or reward either the referral of an individual, or the furnishing or arranging for an item or service, for which payment may be made under federal healthcare programs, such as the Medicare and Medicaid programs.
Our operations are subject to state and federal laws targeting fraud and abuse in the healthcare industry, including the U.S. federal Anti-Kickback Statute, which prohibit knowingly and willfully offering, paying, soliciting or receiving remuneration, directly or indirectly, to induce or reward either the referral of an individual, or the furnishing or arranging for an item or service, for which payment may be made under federal healthcare programs, such as the Medicare and Medicaid programs.
The FDA or such other authorities could require a recall of products or allege that our promotional activities misbrand or adulterate our products or violate other legal requirements, which could result in investigations, prosecutions, fines or other civil or criminal actions. Our products may be subject to product liability claims and warranty claims .
The FDA 28 Table of Contents or such other authorities could require a recall of products or allege that our promotional activities misbrand or adulterate our products or violate other legal requirements, which could result in investigations, prosecutions, fines or other civil or criminal actions. Our products may be subject to product liability claims and warranty claims .
Our ability to accurately forecast demand for our products could be negatively affected by many factors, including product introductions by our competitors, an increase or decrease in customer demand for our products or for products of our competitors, unanticipated changes in general market conditions or regulatory matters and weakening of economic conditions, or decreased consumer confidence.
Our ability to accurately forecast demand for our products could be negatively affected by many factors, including product introductions by our competitors, an increase or decrease in customer demand 24 Table of Contents for our products or for products of our competitors, unanticipated changes in general market conditions or regulatory matters and weakening of economic conditions, or decreased consumer confidence.
In addition, payers continually review new and existing technologies for possible coverage and can, without notice, deny, change or reverse coverage decisions or alter prior authorization requirements for new or existing products and procedures.
In addition, payers regularly review new and existing technologies for possible coverage and can, without notice, deny, change or reverse coverage decisions or alter prior authorization requirements for new or existing products and procedures.
A significant number of countries where we operate have enacted privacy or data protection laws, rules and regulations, many of which restrict outbound data transfers and have extraterritorial scope, creating significant compliance challenges as we seek to maintain our global reach, with significant penalties for non-compliance.
A significant number of countries where we operate have enacted privacy or data protection laws and regulations, many of which restrict outbound data transfers, creating significant compliance challenges as we seek to maintain our global reach, with significant penalties for non-compliance.
Further, we expect our employees, distributors, agents and others who work for us or on our behalf to comply with these anti-bribery laws. Despite our training and compliance programs, our internal control policies and procedures may not always protect us from negligent, reckless or criminal acts or other violations committed by our employees, distributors or agents.
Further, we expect our employees, distributors, 27 Table of Contents agents and others who work for us or on our behalf to comply with these anti-bribery laws. Despite our training and compliance programs, our internal control policies and procedures may not always protect us from negligent, reckless or criminal acts or other violations committed by our employees, distributors or agents.
On December 5, 2023, we 32 Table of Contents executed an amendment to the Fourth A&R Credit Agreement (as amended, the "Amended Fourth A&R Credit Agreement”) to facilitate the issuance of our Convertible Notes described below. We have pledged substantially all of our assets as collateral for the Amended Fourth A&R Credit Agreement.
On December 5, 2023, we executed an amendment to the Fourth A&R Credit Agreement (as amended, the "Amended Fourth A&R Credit Agreement”) to facilitate the issuance of our Convertible Notes described below. We have pledged substantially all of our assets as collateral for the Amended Fourth A&R Credit Agreement.
Under the terms of the Amended Fourth A&R Credit Agreement, we are potentially able to borrow up to $697 million in additional funds, which could result in total indebtedness under the Convertible Notes and Amended Fourth A&R Credit Agreement of up to $1,444.5 million.
Under the terms of the Amended Fourth A&R Credit Agreement, we are potentially 33 Table of Contents able to borrow up to $697 million in additional funds, which could result in total indebtedness under the Convertible Notes and Amended Fourth A&R Credit Agreement of up to $1,444.5 million.
Our internal information technology systems, as well as those systems maintained by third-party providers, may be subjected to inadvertent leaks, computer viruses or other malicious code, unauthorized access attempts, and ransom or other cyber-attacks (including through phishing emails, attempts to induce employees to disclose information, and the exploitation of software and operating vulnerabilities), any of which could result in data leaks or otherwise compromise our confidential or proprietary information and disrupt our operations.
Our internal information technology systems, as well as those systems maintained by third-party providers, may be subjected to leaks, computer viruses or other malicious code, unauthorized access attempts, and ransom or other cyber-attacks (including through phishing emails, attempts to induce employees to disclose information, and the exploitation of software and operating vulnerabilities), any of which could compromise our confidential or proprietary information and disrupt our operations.
Some of the factors that could affect the success of our acquisitions include the effectiveness of our due diligence process, our ability to execute our business plan for the acquired companies, the strength of the acquired technology, results of clinical trials, regulatory approvals and reimbursement levels of the acquired products and related procedures, the performance of critical transition services, our ability to adequately fund acquired research and 22 Table of Contents development projects and retain key employees and our ability to achieve synergies with the acquired businesses.
Some of the factors that could affect the success of our acquisitions include the effectiveness of our due diligence process, our ability to execute our business plan for the acquired operations, the strength of the acquired technology, results of clinical trials, regulatory approvals and reimbursement levels of the acquired products and related procedures, the performance of critical transition services, our ability to adequately fund acquired research and development projects and retain key employees and our ability to achieve synergies with the acquired businesses.
We do not maintain key man life insurance on Mr. Lampropoulos. The loss of Mr. Lampropoulos, or of certain other key management personnel, could have a materially adverse effect on our business, operations and financial condition. Our ability to compete effectively depends on our ability to attract, develop and retain executives and key employees.
We do not maintain key man life insurance on Ms. Aronson. The loss of Ms. Aronson or of certain other key management personnel could have a materially adverse effect on our business, operations and financial condition. Our ability to compete effectively depends on our ability to attract, develop and retain executives and key employees.
Additionally, the continuing evolution of technology we use, including cloud-based computing, data hosting and artificial intelligence, create additional exposure to security breaches and loss of access to our confidential or proprietary information.
Additionally, the continuing evolution of technology we use, including cloud-based computing, data hosting and AI, create additional exposure to security breaches and loss of access to our confidential or proprietary information.
In addition, international conflicts could further result in global or regional market instability; increased energy costs; and increased risk of cybersecurity attacks, any of which could adversely impact our financial results.
In addition, international conflicts could further result in global or regional market instability, insurrections and civil unrest, increased energy costs, and increased risk of cybersecurity attacks, any of which could adversely impact our financial results.
The results of our product development efforts may be affected by a number of factors, including our ability to anticipate customer needs, innovate and develop new products, efficiently conduct and complete clinical trials, obtain regulatory approvals and reimbursement approvals in the U.S. and abroad, manufacture products in a cost-effective manner, obtain and enforce intellectual property rights and gain and maintain market approval of our products.
Our product development efforts may be affected by a number of factors, including our ability to anticipate customer needs, innovate and develop new products, efficiently complete clinical trials, obtain regulatory approvals and reimbursement approvals in the U.S. and abroad, efficiently manufacture products, obtain and enforce intellectual property rights and gain and maintain market approval of our products.
Unfavorable, unexpected or inconsistent clinical data from existing or future clinical trials conducted by us, by our competitors or by third parties, or the FDA's, foreign regulatory authorities’ or the market's perception of this clinical data, may adversely impact our ability to obtain and maintain product clearances and approvals, our position in, and share of, the markets in which we participate and our business, financial condition, results of operations or future prospects.
Unfavorable, unexpected or inconsistent clinical data from existing or future clinical trials conducted by us, by our competitors or by third parties, or the FDA's, foreign regulatory authorities’ or the market's perception of this clinical data, may adversely impact our ability to obtain and maintain product clearances and approvals, our position in, and share of, the markets in which we participate and our prospects.
Periods of diplomatic or armed conflict, such as the ongoing conflict in Ukraine, tensions in the Middle East and China-Taiwan relations, may result in (i) new and rapidly evolving sanctions and trade restrictions, which may impair trade with sanctioned individuals and countries, and (ii) negative impacts to regional trade ecosystems among our customers, partners, and us.
Periods of diplomatic or armed conflict, such as the ongoing conflict in Ukraine, tensions in the Middle East and in Venezuela and China-Taiwan relations, may result in (i) new or evolving sanctions and trade restrictions, which may impair trade with sanctioned individuals and countries, and (ii) negative impacts to regional 20 Table of Contents trade ecosystems among our customers, partners, and us.
The challenges involved in these integrations include the following: ● integrating operations and production lines; ● limiting business disruptions, preserving customer and other important relationships of the acquired businesses, and attracting new business and operational relationships; ● coordinating and integrating research and development and engineering teams across technologies and product lines to enhance product development while reducing costs; ● consolidating and integrating corporate, IT, cybersecurity, finance and administrative infrastructures; ● coordinating branding, sales and marketing efforts to effectively position the products acquired in the Recent Acquisitions; and ● integrating employees and related HR systems and benefits, maintaining employee productivity and retaining key employees.
The challenges involved in these integrations include: ● integrating operations and production lines; ● limiting business disruptions, preserving customer and other important relationships of the acquired businesses, and attracting new business and operational relationships; ● coordinating and integrating research and development and engineering teams across technologies and product lines to enhance product development while reducing costs; ● consolidating and integrating corporate, IT, cybersecurity, finance and administrative infrastructures; ● coordinating branding, sales and marketing efforts to effectively position acquired products; and ● integrating employees and human resource systems and benefits, maintaining employee productivity and retaining key employees.
Shifts in weather patterns caused by climate change are projected to increase the frequency, severity or duration of certain adverse weather conditions and natural disasters, such as hurricanes, tornadoes, earthquakes, wildfires, droughts, extreme temperatures or flooding, which could cause significant business and supply chain interruptions, damage to our products and facilities as well as the infrastructure of hospitals, medical care facilities and other customers, reduced workforce availability, increased costs of raw materials and components and increased liabilities, compared to our historical experience with such events.
Shifts in weather patterns caused by climate change are projected to increase the frequency, severity or duration of certain adverse weather conditions and natural disasters, such as hurricanes, tornadoes, earthquakes, wildfires, droughts or flooding, which could cause significant business and supply chain interruptions, damage to our products and facilities as well as the infrastructure of hospitals, medical care facilities and other customers, reduced workforce availability, increased costs of raw materials and components and increased liabilities.
Achieving the benefits of the Recent Acquisitions will depend, in part, on our ability to integrate the acquired businesses and operations successfully and efficiently with our business.
Achieving the benefits of the Recent Acquisitions will depend, in part, on our ability to integrate the acquired 23 Table of Contents businesses and operations successfully and efficiently with our business.
We may incur substantial costs when evaluating, negotiating and closing acquisitions, and our failure to integrate acquired businesses may adversely impact our business and financial results. We seek to supplement our internal growth through strategic acquisitions and transactions. We regularly evaluate potential acquisitions and transactions, certain of which may be significant.
Strategic, Business Development and Employee Attraction and Retention Risks We may incur substantial costs when evaluating, negotiating and closing acquisitions, and our failure to integrate acquired businesses may adversely impact our business and financial results. We seek to supplement our internal growth through strategic acquisitions and transactions. We regularly evaluate potential acquisitions and transactions, certain of which may be significant.
Individual states have also begun to enact data privacy laws giving consumers the right to demand certain information and actions from companies who collect personal information.
Individual states have also enacted data privacy laws giving consumers the right to demand certain information and actions from companies who collect personal information.
These domestic and international laws and regulations have been, and may continue to be, inconsistent with each other, requiring different approaches in different jurisdictions. In addition, the interpretation and application of medical and personal data protection laws and regulations in the U.S., Europe, China and elsewhere are often uncertain and in flux.
These domestic and international laws and regulations have been, and may continue to be, inconsistent with each other, requiring different approaches in different jurisdictions. In addition, the interpretation and application of privacy and data protection laws and regulations in the U.S., Europe, Asia and elsewhere are often uncertain and in flux.
For the year ended December 31, 2024, $464.9 million, or 34.3%, of our net sales, were denominated in foreign currencies, with our Chinese Yuan- and Euro-denominated sales representing our largest currency risks. If the rate of exchange between foreign currencies declines against the U.S.
For the year ended December 31, 2025, $510.3 million, or 34%, of our net sales, were denominated in foreign currencies, with our Chinese Yuan- and Euro-denominated sales representing our largest currency risks. If the rate of exchange between foreign currencies declines against the U.S.
The design, manufacture and marketing of medical devices involves various risks. Frequently, our products are used in connection with invasive procedures, surgical and intensive care settings with seriously ill patients and in other medical contexts that entail an inherent risk of product liability claims.
The design, manufacture and marketing of medical devices involve various risks. Frequently, our products are used in connection with invasive procedures, surgical and intensive care settings and in other contexts that entail an inherent risk of product liability claims.
Our effective tax rate is derived from a combination of applicable tax rates in the various countries, states and other jurisdictions in which we operate. In preparing our financial statements, we estimate the amount of tax that will become payable in each of these jurisdictions.
We are subject to taxation in numerous countries, states and other jurisdictions. Our effective tax rate is derived from a combination of applicable tax rates in the various countries, states and other jurisdictions in which we operate. In preparing our financial statements, we estimate the amount of tax that will become payable in each of these jurisdictions.
Damage or interruption to our facilities or systems, or those of our suppliers, because of extreme weather conditions, natural disaster, power loss, communications failure, geopolitical disruption, labor strikes, riots, cyber-attack, public health crises, unauthorized entry or other events could significantly disrupt our operations, the operations of suppliers or critical infrastructure.
Damage or interruption to our facilities or systems, or those of our suppliers, because of extreme weather conditions, natural disaster, power loss, communications failure, geopolitical disruption, labor strikes, civil unrest, cyber-attack, public health crises, unauthorized entry or other events could significantly disrupt our operations, the operations of suppliers or 21 Table of Contents critical infrastructure.
In addition, we are required to continue to comply with applicable FDA and other regulatory requirements once we have obtained clearance or approval for a product, including good manufacturing practices, timely adverse event reporting, completion of required post-market studies, timely annual and other periodic reports, submission of significant changes 25 Table of Contents and other post-market requirements.
In addition, we are required to continue to comply with applicable FDA and other regulatory requirements once we have obtained clearance or approval for a product, including good manufacturing practices, timely adverse event reporting, completion of required post-market studies, timely annual and other periodic reports and other requirements.
In addition, increased public concern over climate change could result in new legal or regulatory requirements designed to mitigate the effects of climate change. Such developments could result in increased 30 Table of Contents compliance costs and adverse impacts on raw material sourcing, manufacturing operations and the distribution of our products, which could adversely affect our operations and operating results.
In addition, increased public concern over climate change could result in new legal or regulatory requirements designed to mitigate the effects of climate change. Such developments could result in increased compliance costs and adverse impacts on raw material sourcing, manufacturing operations and the distribution of our products, which could adversely affect our business and operations.
Compliance with applicable health and safety laws and regulations has required and continues to require significant expenditures. We could be negatively impacted by corporate social responsibility laws, regulations, practices and expectations.
Compliance with applicable health and safety laws and regulations has required and continues to require significant expenditures. 30 Table of Contents We could be negatively impacted by corporate social responsibility laws, regulations, practices and expectations.
Those fluctuations could have a negative impact on our margins and financial results. During 2024, 2023 and 2022, the exchange rate between all applicable foreign currencies and the U.S. Dollar resulted in decreases in our net sales of $7.2 million, $6.4 million and $23.8 million, respectively.
Those fluctuations could have a negative impact on our margins and financial results. During 2025, 2024 and 2023, the exchange rate between all applicable foreign currencies and the U.S. Dollar resulted in increases/(decreases) in our net sales of $5.2 million, $(7.2) million and $(6.4) million, respectively.
For example, we rely on a relatively small number of service providers to sterilize our products prior to sale. If any of these service providers goes out of business, ceases to provide services to us or fails to comply with quality or regulatory requirements, we may be unable to find a suitable service provider to replace them.
For example, we rely on a relatively small number of service providers to sterilize our products. If any of these service providers ceases operations, ceases to provide services to us or fails to comply with quality or regulatory requirements, we may be unable to find a suitable service provider to replace them.
Failure to comply with applicable rules or regulations or with contractual or other requirements may result in monetary damages and criminal or civil penalties, as well as termination of our government contracts or our suspension or debarment from government contract work. We are subject to the U.S.
Furthermore, our contracts with government-sponsored healthcare entities are subject to specific procurement requirements. Failure to comply with applicable rules or regulations or with contractual or other requirements may result in monetary damages and criminal or civil penalties, as well as termination of our government contracts or our suspension or debarment from government contract work. We are subject to the U.S.
Supply disruptions are making it harder for us to find reliable sources for the materials we need, putting upward pressure on our costs and increasing the risk that we may be unable to acquire the materials and services we need to continue to manufacture certain products.
Supply disruptions are making it harder for us to obtain the materials we need, putting upward pressure on our costs and increasing the risk that we may be unable to acquire the materials we need to continue to manufacture certain products.
Due to uncertainties with the application of the VBP tender process, we are unable to reliably predict the impact of the VBP policy on our China revenues in 2025.
Due to uncertainties with the application of the VBP tender process, we are unable to reliably forecast the impact of the VBP policy on our China revenues in 2026.
If we are unable to recover these costs through price increases or offset these increases through cost reductions, or we experience terminations or interruptions of our relationships with our suppliers, we could experience lower margins and profitability, and our business, operations or financial condition could be materially harmed.
If we are unable to recover these costs through price increases or offset these increases through cost reductions, we could experience lower margins and profitability, and our business, operations or financial condition could be materially harmed.
Complying with and obtaining regulatory approval in foreign countries, including our efforts to comply with changing requirements and with the requirements of the MDR, have caused and will likely continue to cause us to experience more uncertainty, risk, expense and delay in commercializing products in certain foreign jurisdictions, which could have a material adverse impact on our net sales, market share and financial results from our international operations.
Complying with and obtaining regulatory approval in foreign countries, including our efforts to comply with changing requirements and with the requirements of the MDR, have caused and will likely continue to cause us to experience more uncertainty, risk, expense and delay in commercializing products in certain foreign jurisdictions, which could have a material adverse impact on our net sales, market share and financial results from our international operations. 26 Table of Contents Unsuccessful pre- and post-market clinical trials relating to our products could have a material adverse effect on our prospects.
The benefits we expect from the Recent Acquisitions are based on projections and assumptions about the performance of the acquired assets under our ownership and control, which may not materialize as expected or which may prove to be inaccurate.
The benefits we expect from the Recent Acquisitions are based on projections and assumptions about the performance of the acquired assets under our ownership, which may not materialize as expected.
The ultimate impact of any announced or future tariffs will depend on various factors, including whether such tariffs are ultimately implemented, the timing of implementation and the amount, scope and nature of such tariffs and potential exclusions from the application of those tariffs.
However, the ultimate impact of any announced or future tariffs will depend on various factors, including (i) whether such tariffs are ultimately implemented or suspended, (ii) the timing and duration of implementation or suspension and the amount, scope and nature of such tariffs and (iii) potential exclusions from the application of those tariffs.
However, we expect that the VBP tender process in China will continue to have a negative impact on the revenue we are able to generate in China in 2025, and there can be no assurance that the VBP policy will not have a materially adverse effect on our business, operations or financial condition.
However, we expect that the VBP tender process in China will continue to negatively impact our revenue from China in 2026, and there can be no assurance that the VBP policy will not have a materially adverse effect on our business, operations or financial condition.
Intellectual Property We may not be able to protect our intellectual property, which could harm our business and financial condition . Our ability to remain competitive is dependent, in part, upon our ability to protect our intellectual property rights and prevent other companies from infringing those rights.
Intellectual Property We may not be able to protect our intellectual property, which could harm our business and financial condition . Our ability to remain competitive is dependent, in part, upon our ability to protect our intellectual property rights.

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Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

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Biggest changeOn an ongoing basis, we assess risks (including our exposure from significant information technology suppliers, significant software as a service providers and major vendors with access to our information technology systems) and implement procedures and practices designed to improve the security, confidentiality, integrity and availability of our systems.
Biggest changeOn an ongoing basis, we assess risks (including our exposure from significant information technology suppliers, significant software as a service providers and major vendors with access to our data and information technology systems) and implement procedures and practices designed to improve the security, confidentiality, integrity and availability of our systems.
Our Vice President, Information Security, functions as our senior information security officer and has over 18 years of relevant industry experience. Further, team members who support our cybersecurity program have relevant educational and industry experience through various roles involving information technology, security, auditing, compliance, systems and programming, as well as cybersecurity certifications such as Certified Information Systems Security Professional.
Our Vice President, Information Security, functions as our senior information security officer and has over 19 years of relevant industry experience. Further, team members who support our cybersecurity program have relevant educational and industry experience through various roles involving information technology, security, auditing, compliance, systems and programming, as well as cybersecurity certifications such as Certified Information Systems Security Professional.
Our cybersecurity program is managed by a dedicated Chief Information Officer whose global team, including the Vice President, Information Security, is responsible for leading enterprise-wide cybersecurity strategy, policy, standards, architecture and processes. Our Chief Information Officer has over 29 years of relevant industry experience, including 18 years with Merit.
Our cybersecurity program is managed by a dedicated Chief Information Officer whose global team, including the Vice President, Information Security, is responsible for leading enterprise-wide cybersecurity strategy, policy, standards, architecture and processes. Our Chief Information Officer has over 30 years of relevant industry experience, including 19 years with Merit.

Item 2. Properties

Properties — owned and leased real estate

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Biggest changeThe following is a summary of the approximate square footage of our key facilities as of December 31, 2024: ​ ​ ​ ​ ​ Location Main Purpose Area (sq. ft.) Utah HQ, Manufacturing, Distribution, Research 724,170 Mexico ​ Manufacturing ​ 262,020 Virginia ​ Manufacturing, Distribution ​ 187,659 The Netherlands Manufacturing, Distribution 162,646 Ireland ​ Manufacturing, Research ​ 139,680 Texas ​ Manufacturing, Research ​ 94,000 Singapore ​ Manufacturing ​ 68,000 China ​ Distribution ​ 57,520 ​ Operations associated with our cardiovascular segment utilize all of our facilities, while operations associated with our endoscopy segment are conducted primarily from our facilities located in Utah and Texas.
Biggest changeThe following is a summary of the approximate square footage of our key facilities: ​ ​ ​ ​ ​ Location ​ ​ ​ Main Purpose ​ ​ ​ Area (sq. ft.) Utah HQ, Manufacturing, Distribution, Research 932,735 Mexico ​ Manufacturing ​ 262,020 Virginia ​ Manufacturing, Distribution ​ 187,659 The Netherlands Manufacturing, Distribution 162,646 Ireland ​ Manufacturing, Research ​ 139,680 Texas ​ Manufacturing, Research ​ 98,995 Singapore ​ Manufacturing ​ 68,000 China ​ Distribution ​ 58,521 ​ Operations associated with our cardiovascular segment utilize all of our facilities, while operations associated with our endoscopy segment are conducted primarily from our facilities located in Utah and Texas.
Our research and development activities are conducted principally at facilities located in Utah, California, Texas, Ireland and France. Our total manufacturing, commercial, distribution, and research space is approximately 2.0 million square feet, of which approximately 1.0 million square feet is owned, and 1.0 million square feet is leased.
Our research and development activities are conducted principally at facilities located in Utah, California, Texas, Ireland and France. Our total manufacturing, commercial, distribution, and research space is approximately 2.2 million square feet, of which approximately 1.2 million square feet is owned, and 1.0 million square feet is leased.
In addition, we lease commercial space in India, Hong Kong, Italy, Dubai, Australia, Canada, Brazil, Malaysia, South Korea, Japan, South Africa, Singapore, Great Britain, Vietnam, Taiwan, New Zealand, Indonesia, and France, as well as in California and Texas. Our principal manufacturing and packaging facilities are located in Utah, Virginia, Texas, Ireland, Brazil, Singapore, Mexico, France and The Netherlands.
In addition, we lease commercial space in India, Hong Kong, Italy, Dubai, Australia, Canada, Brazil, Malaysia, South Korea, Japan, South Africa, Singapore, Great Britain, Vietnam, Taiwan, New Zealand, Indonesia, and France, as well as in California and Texas. Our principal manufacturing and packaging facilities are located in Utah, Virginia, Texas, Florida, Ireland, Brazil, Singapore, Mexico, France and The Netherlands.

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

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Biggest changeCompanies - Surgical, Medical and Dental Instruments and Supplies) f or a five-year period by measuring the changes in common stock prices from December 31, 2019 to December 31, 2024. ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ 12/2019 12/2020 12/2021 12/2022 12/2023 12/2024 Merit Medical Systems, Inc. ​ $ 100.00 ​ $ 177.80 ​ $ 199.55 ​ $ 226.17 ​ $ 243.24 ​ $ 309.68 NASDAQ US Benchmark (TR) ​ ​ 100.00 ​ ​ 121.27 ​ ​ 152.67 ​ ​ 122.55 ​ ​ 154.93 ​ ​ 192.86 NASDAQ Stocks (SIC 3840-3849 U.S.
Biggest changeCompanies - Surgical, Medical and Dental Instruments and Supplies) f or a five-year period by measuring the changes in common stock prices from December 31, 2020 to December 31, 2025. ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ 12/2020 ​ ​ ​ 12/2021 ​ ​ ​ 12/2022 ​ ​ ​ 12/2023 ​ ​ ​ 12/2024 ​ ​ ​ 12/2025 Merit Medical Systems, Inc. ​ $ 100.00 ​ $ 112.23 ​ $ 127.20 ​ $ 136.81 ​ $ 174.17 ​ $ 158.70 NASDAQ US Benchmark (TR) ​ ​ 100.00 ​ ​ 125.89 ​ ​ 101.05 ​ ​ 127.76 ​ ​ 159.03 ​ ​ 186.96 NASDAQ Stocks (SIC 3840-3849 U.S.
NOTE: Performance graph data is complete through last fiscal year. Corporate Performance Graph with peer group uses peer group only performance (excludes only Merit). Peer group indices use beginning of period market capitalization weighting. Prepared by Zacks Investment Research, Inc. Used with permission. All rights reserved. Copyright 1980-2023. Used with permission. All rights reserved. Index Data: Copyright NASDAQ OMX, Inc.
NOTE: Performance graph data is complete through last fiscal year. Corporate Performance Graph with peer group uses peer group only performance (excludes only Merit). Peer group indices use beginning of period market capitalization weighting. Prepared by Zacks Investment Research, Inc. Used with permission. All rights reserved. Copyright 1980-2026. Index Data: Copyright NASDAQ OMX, Inc. Used with permission.
We did not repurchase any shares during the years ended December 31, 2024, 2023 and 2022. Dividends We have never declared or paid cash dividends on shares of our common stock.
We did not repurchase any shares during the years ended December 31, 2025, 2024 and 2023. Dividends We have never declared or paid cash dividends on shares of our common stock.
Market Information Our common stock is traded on the NASDAQ Global Select Market under the symbol “MMSI.” As of February 21, 2025, the number of shares of our common stock outstanding was 58,834,568 held by approximately 90 shareholders of record, not including shareholders whose shares are held in securities position listings.
Market Information Our common stock is traded on the NASDAQ Global Select Market under the symbol “MMSI.” As of February 20, 2026, the number of shares of our common stock outstanding was 59,431,931 held by approximately 87 shareholders of record, not including shareholders whose shares are held in securities position listings.
Used with permission. All rights reserved. ​ Item 6. Reserved. ​ 38 Table of Contents
All rights reserved. ​ Item 6. Reserved. ​ 38 Table of Contents
Companies) ​ 100.00 ​ ​ 133.88 ​ ​ 153.19 ​ ​ 107.20 ​ ​ 114.09 ​ ​ 130.41 The stock performance graph assumes for comparison that the value of our common stock and of each index was $100 on December 31, 2019 and that all dividends were reinvested. Past performance is not necessarily an indicator of future results.
Companies) ​ 100.00 ​ ​ 114.90 ​ ​ 80.42 ​ ​ 85.77 ​ ​ 98.74 ​ ​ 100.10 The stock performance graph assumes for comparison that the value of our common stock and of each index was $100 on December 31, 2020 and that all dividends were reinvested. Past performance is not necessarily an indicator of future results.

Item 7. Management's Discussion & Analysis

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

49 edited+13 added−14 removed19 unchanged
Biggest changeWith this approval, Merit can begin commercialization of the device in the U.S. in 2025. 39 Table of Contents Results of Operations The following table sets forth certain operational data as a percentage of sales for the years indicated: ​ ​ ​ ​ ​ ​ ​ ​ ​ 2024 2023 2022 Net sales 100 % 100 % 100 % Gross profit 47.4 46.4 45.1 ​ Selling, general and administrative expenses 29.5 29.7 29.8 ​ Research and development expenses 6.4 6.6 6.6 ​ Impairment charges — — 0.2 ​ Contingent consideration expense 0.0 0.1 0.4 ​ Acquired in-process research and development expense — 0.1 0.6 ​ Income from operations 11.5 9.9 7.6 ​ Other expense — net (0.4) (0.9) (0.4) ​ Income before income taxes 11.1 8.9 7.2 ​ Net income 8.9 7.5 6.5 ​ ​ Sales Listed below are the sales by product category within each operating segment for the years ended December 31, 2024, 2023 and 2022 (in thousands, other than percentage changes): ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ % Change 2024 % Change 2023 % Change 2022 Cardiovascular ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Peripheral Intervention 9.9 % $ 552,168 14.2 % $ 502,220 8.6 % $ 439,810 Cardiac Intervention 3.5 % 370,993 4.4 % 358,451 7.0 % 343,186 Custom Procedural Solutions 3.0 % 201,201 2.7 % 195,333 (1.9) % 190,194 OEM 7.8 % 177,382 13.5 % 164,556 17.4 % 145,034 Total 6.7 % 1,301,744 9.2 % 1,220,560 7.2 % 1,118,224 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Endoscopy ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Endoscopy Devices 48.8 % 54,770 12.4 % 36,806 3.9 % 32,757 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Total 7.9 % $ 1,356,514 9.2 % $ 1,257,366 7.1 % $ 1,150,981 ​ Cardiovascular Sales.
Biggest changeResults of Operations The following table sets forth certain operational data as a percentage of sales for the years indicated: ​ ​ ​ ​ ​ ​ ​ ​ 2025 ​ ​ ​ 2024 ​ ​ ​ 2023 Net sales 100 % 100 % 100 % Gross profit 48.7 47.4 46.4 ​ Selling, general and administrative expenses 30.0 29.5 29.7 ​ Research and development expenses 6.4 6.4 6.6 ​ Contingent consideration expense 0.1 0.0 0.1 ​ Acquired in-process research and development expense — — 0.1 ​ Income from operations 12.2 11.5 9.9 ​ Other expense — net (0.9) (0.4) (0.9) ​ Income before income taxes 11.3 11.1 8.9 ​ Net income 8.5 8.9 7.5 ​ ​ 39 Table of Contents Sales Listed below are the sales by product category within each operating segment for the years ended December 31, 2025, 2024 and 2023 (in thousands, other than percentage changes): ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ % Change ​ ​ ​ 2025 ​ ​ ​ % Change ​ ​ ​ 2024* ​ ​ ​ 2023* Cardiovascular ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Peripheral Intervention 8.8 % $ 579,840 10.2 % $ 532,770 $ 483,265 Cardiac Intervention 21.7 % 448,914 3.4 % 368,951 356,650 Custom Procedural Solutions 4.6 % 209,333 3.3 % 200,033 193,717 OEM 2.5 % 204,955 7.0 % 199,990 186,928 Total 10.9 % 1,443,042 6.7 % 1,301,744 1,220,560 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Endoscopy ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Endoscopy Devices 33.0 % 72,864 48.8 % 54,770 36,806 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Total 11.8 % $ 1,515,906 7.9 % $ 1,356,514 $ 1,257,366 *Commencing January 1, 2025, we reorganized our sales teams and product categories to include revenues from the sale of our spine devices under our OEM product category.
Discussion of the year ended December 31, 2023, compared to the year ended December 31, 2022 is included in Part II, Item 7 “Management’s Discussion and Analysis of Financial Condition and Results of Operations” of our Annual Report on Form 10-K for the year ended December 31, 2023, and is incorporated by reference into this Form 10-K.
Discussion of the year ended December 31, 2024, compared to the year ended December 31, 2023 is included in Part II, Item 7 “Management’s Discussion and Analysis of Financial Condition and Results of Operations” of our Annual Report on Form 10-K for the year ended December 31, 2024, and is incorporated by reference into this Form 10-K.
Based on this historical trend, we believe that our inventory balances as of December 31, 2024 have been accurately adjusted for any unmarketable and/or slow moving products that may expire prior to being sold. Valuation of Goodwill and Intangible Assets.
Based on this historical trend, we believe that our inventory balances as of December 31, 2025 have been accurately adjusted for any unmarketable and/or slow moving products that may expire prior to being sold. Valuation of Goodwill and Intangible Assets.
For the years ended December 31, 2024, 2023 and 2022, we recorded $0.4 million, $1.7 million and $4.6 million, respectively, of net contingent consideration expense from changes in the estimated fair value of our contingent consideration obligations stemming from our previously disclosed business acquisitions.
For the years ended December 31, 2025, 2024 and 2023, we recorded $1.0 million, $0.4 million and $1.7 million, respectively, of net contingent consideration expense from changes in the estimated fair value of our contingent consideration obligations stemming from our previously disclosed business acquisitions.
As of December 31, 2024, we had outstanding borrowings of $747.5 million and issued letter of credit guarantees of $2.9 million, with additional available borrowings of approximately $697 million under the Amended Fourth A&R Credit Agreement, based on the leverage ratio required pursuant to the Amended Fourth A&R Credit Agreement.
As of December 31, 2025, we had outstanding borrowings of $747.5 million and issued letter of credit guarantees of $2.8 million, with additional available borrowings of approximately $697 million under the Amended Fourth A&R Credit Agreement, based on the leverage ratio required pursuant to the Amended Fourth A&R Credit Agreement.
During the years ended December 31, 2024, 2023 and 2022, we recorded obsolescence expense of approximately $10.6 million, $11.5 million, and $9.8 million, respectively, and wrote off approximately $12.0 million, $11.9 million, and $10.2 million, respectively.
During the years ended December 31, 2025, 2024 and 2023, we recorded obsolescence expense of approximately $11.2 million, $10.6 million, and $11.5 million, respectively, and wrote off approximately $9.0 million, $12.0 million, and $11.9 million, respectively.
Cash outflows invested in acquisitions and other equity investments for the year ended December 31, 2024 were $320.2 million and were primarily related to payments required by our asset purchase agreements with Cook Medical Holdings LLC ($210.0 million), Endogastric Solutions, Inc. ($105.0 million) and Scholten Surgical Instruments, Inc. ($3.0 million).
Cash outlfows invested in acquisitions for the year ended December 31, 2024 were $320.2 million and were primarily related to payments required by our asset purchase agreements with Cook Medical Holdings LLC ($210.0 million), Endogastric Solutions, Inc. ($105.0 million) and Scholten Surgical Instruments, Inc. ($3.0 million).
Our international sales are subject to foreign currency exchange rate fluctuations between the natural currency of a foreign country and the U.S. Dollar. Foreign currency exchange rate fluctuations, calculated by using the applicable average foreign exchange rates for the prior year decreased sales (0.6)% for the year ended December 31, 2024 compared to 2023.
Our international sales are subject to foreign currency exchange rate fluctuations between the natural currency of a foreign country and the U.S. Dollar. Foreign currency exchange rate fluctuations, calculated by using the applicable average foreign exchange rates for the prior year increased sales 0.3% for the year ended December 31, 2025 compared to 2024.
Effective Tax Rate Our provision for income taxes for the years ended December 31, 2024, 2023 and 2022 was a tax expense of $29.6 million, $17.7 million and $8.1 million, respectively, which resulted in an effective income tax rate of 19.8%, 15.8%, and 9.8%, respectively.
Effective Tax Rate Our provision for income taxes for the years ended December 31, 2025, 2024 and 2023 was a tax expense of $42.4 million, $29.6 million and $17.7 million, respectively, which resulted in an effective income tax rate of 24.8%, 19.8%, and 15.8%, respectively.
Cash held by our subsidiary in China is subject to local laws and regulations that require government approval for the transfer of such funds to entities located outside of China. As of December 31, 2024 and 2023, we had cash and cash equivalents, including restricted cash, of $18.1 million and $17.6 million, respectively, held by our subsidiary in China.
Cash held by our subsidiary in China is subject to local laws and regulations that require government approval for the transfer of such funds to entities located outside of China. As of December 31, 2025 and 2024, cash and cash equivalents, including restricted cash, held by our subsidiary in China was $20.0 million and $18.1 million, respectively.
Cash outflows invested in acquisitions for the year ended December 31, 2023 were $134.5 million and were primarily related to payments required by our asset purchase agreements with AngioDynamics, Inc. ($100 million), Bluegrass Vascular Technologies, Inc. ($32.7 million) and ART ($1.5 million).
Cash outflows invested in acquisitions for the year ended December 31, 2023 were $134.5 million and were primarily related to payments required by our asset purchase agreements with AngioDynamics, Inc. ($100 million), Bluegrass Vascular Technologies, Inc. ($32.7 million) and ART ($1.5 million). 43 Table of Contents Cash flows provided by (used in) financing activities.
Other Income (Expense) Our other expense for the years ended December 31, 2024, 2023 and 2022 was $5.7 million, $11.9 million, and $4.9 million, respectively.
Other Income (Expense) Our other expense for the years ended December 31, 2025, 2024 and 2023 was $13.8 million, $5.7 million, and $11.9 million, respectively.
Cash flows provided by operating activities. We generated cash from operating activities of $220.8 million, $145.2 million and $114.3 million during the years ended December 31, 2024, 2023 and 2022, respectively. Net cash provided by operating activities increased $75.6 million for the year ended December 31, 2024 compared to the year ended December 31, 2023.
Cash flows provided by operating activities. We generated cash from operating activities of $297.4 million, $220.8 million and $145.2 million during the years ended December 31, 2025, 2024 and 2023, respectively. Net cash provided by operating activities increased $76.6 million for the year ended December 31, 2025 compared to the year ended December 31, 2024.
Cash flows used in investing activities. We used cash in investing activities of $368.7 million, $175.3 million, and $57.4 million for the years ended December 31, 2024, 2023 and 2022, respectively. We invested in capital expenditures for property and equipment of $35.1 million, $34.3 million, and $45.0 million for the years ended December 31, 2024, 2023 and 2022, respectively.
We used cash in investing activities of $247.4 million, $368.7 million, and $175.3 million for the years ended December 31, 2025, 2024 and 2023, respectively. We invested in capital expenditures for property and equipment of $81.7 million, $35.1 million, and $34.3 million for the years ended December 31, 2025, 2024 and 2023, respectively.
Our selling, general and administrative (“SG&A”) expenses as a percentage of sales were 29.5%, 29.7% and 29.8% for the years ended December 31, 2024, 2023 and 2022, respectively. SG&A expenses increased $26.1 million, or 7.0%, for the year ended December 31, 2024 compared to 2023.
Our selling, general and administrative (“SG&A”) expenses as a percentage of sales were 30.0%, 29.5% and 29.7% for the years ended December 31, 2025, 2024 and 2023, respectively. SG&A expenses increased $55.5 million, or 13.9%, for the year ended December 31, 2025 compared to 2024.
Our endoscopy segment consists of gastroenterology and pulmonology devices which assist in the palliative treatment of expanding esophageal, tracheobronchial and biliary strictures caused by malignant tumors. For the year ended December 31, 2024, we reported sales of $1.357 billion, up $99.1 million or 7.9%, compared to 2023 sales of $1.257 billion.
Our endoscopy segment consists of gastroenterology and pulmonology devices which assist in the palliative treatment of expanding esophageal, tracheobronchial and biliary strictures caused by malignant tumors. For the year ended December 31, 2025, we reported sales of $1.516 billion, up $159.4 million or 11.8%, compared to 2024 sales of $1.357 billion.
The increase in gross profit as a percentage of sales for 2024, as compared to 2023, was primarily due to increased sales combined with favorable changes in standard costs and product mix, partially offset by higher intangible amortization expense as a percentage of sales associated with acquisitions. Operating Expenses Selling, General and Administrative Expenses .
The increase in gross profit as a percentage of sales for 2025, as compared to 2024, was primarily due to favorable changes in pricing and product mix, partially offset by higher intangible amortization expense as a percentage of sales associated with acquisitions and unfavorable manufacturing variances. Operating Expenses Selling, General and Administrative Expenses .
Gross Profit Our gross profit as a percentage of sales was 47.4%, 46.4%, and 45.1% for the years ended December 31, 2024, 2023 and 2022, respectively.
Gross Profit Our gross profit as a percentage of sales was 48.7%, 47.4%, and 46.4% for the years ended December 31, 2025, 2024 and 2023, respectively.
The increase in our domestic sales in 2024 was driven primarily by our U.S. direct, OEM and endoscopy businesses. International Sales . International sales for the year ended December 31, 2024 were $555.7 million, or 41.0% of net sales, up 4.8% when compared to 2023.
The increase in our domestic sales in 2025 was driven primarily by our U.S. direct, endoscopy, and OEM businesses. International Sales . International sales for the year ended December 31, 2025 were $606.4 million, or 40.0% of net sales, up 9.1% when compared to 2024.
We test our goodwill balances for impairment annually as of July 1, or whenever impairment indicators arise. When impairment indicators are identified, we may elect to perform an optional qualitative assessment to determine whether it is more likely than not that the fair value of our reporting units has fallen below their carrying value.
When impairment indicators are identified, we may elect to perform an optional qualitative assessment to determine whether it is more likely than not that the fair value of our reporting units has fallen below their carrying value.
We base the fair value of identifiable intangible assets acquired in a business combination on valuations that use information and assumptions that a market 44 Table of Contents participant would use, including assumptions for estimated revenue projections, growth rates, cash flows, discount rates, useful life, and other relevant assumptions.
We base the fair value of identifiable intangible assets acquired in a business combination on valuations that use information and assumptions that a market participant would use, including assumptions for estimated revenue projections, growth rates, cash flows, discount rates, useful life, and other relevant assumptions. 44 Table of Contents We test our goodwill balances for impairment annually as of July 1, or whenever impairment indicators arise.
The decrease in other expense for 2024 compared to 2023 was principally the result of an increase in interest income associated with and increased cash and cash equivalents and reduced borrowings under the Amended Fourth A&R Credit Agreement, partially offset by interest expense associated with outstanding convertible debt.
The increase in other expense for 2025 compared to 2024 was principally the result of a decrease in interest income associated with decreased average cash and cash equivalents during the period, partially offset by reduced interest expense associated with borrowings under the Amended Fourth A&R Credit Agreement.
Geographic Sales Listed below are sales by geography for the years ended December 31, 2024, 2023 and 2022 (in thousands, other than percentage changes): ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ % Change 2024 % Change 2023 % Change 2022 United States ​ 10.2 % ​ 800,780 ​ 11.7 % ​ 726,989 ​ 6.8 % ​ 650,559 International ​ 4.8 % ​ 555,734 ​ 6.0 % ​ 530,377 ​ 7.4 % ​ 500,422 Total 7.9 % $ 1,356,514 9.2 % $ 1,257,366 7.1 % $ 1,150,981 ​ United States Sales: U.S. sales for the year ended December 31, 2024 were $800.8 million, or 59.0% of net sales, up 10.2% when compared to 2023.
Geographic Sales Listed below are sales by geography for the years ended December 31, 2025, 2024 and 2023 (in thousands, other than percentage changes): ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ % Change ​ ​ ​ 2025 ​ ​ ​ % Change ​ ​ ​ 2024 ​ ​ ​ 2023 United States 13.6 % $ 909,466 ​ 10.2 % $ 800,780 ​ $ 726,989 International 9.1 % ​ 606,440 ​ 4.8 % ​ 555,734 ​ ​ 530,377 Total 11.8 % $ 1,515,906 7.9 % $ 1,356,514 $ 1,257,366 ​ 40 Table of Contents United States Sales: U.S. sales for the year ended December 31, 2025 were $909.5 million, or 60.0% of net sales, up 13.6% when compared to 2024.
Our cardiovascular sales for the year ended December 31, 2024 were $1.302 billion, up 6.7%, when compared to the year ended December 31, 2023 of $1.221 billion. Sales for the year ended December 31, 2024 were favorably affected by increased sales of: (a) Peripheral intervention products, which increased by $49.9 million, or 9.9%, from the corresponding period of 2023.
Our cardiovascular sales for the year ended December 31, 2025 were $1.443 billion, up 10.9%, when compared to the year ended December 31, 2024 of $1.302 billion. Sales for the year ended December 31, 2025 were favorably affected by increased sales of: (a) Cardiac intervention products, which increased by $80.0 million, or 21.7%, from the corresponding period of 2024.
See Note 8 Debt and Note 9 Derivatives to our consolidated financial statements set forth in Item 8 of this report for additional details regarding the Amended Fourth A&R Credit Agreement, Convertible Notes, and our interest rate swap.
Our interest rate as of December 31, 2025 and 2024 was a fixed rate of 3.0% on our Convertible Notes. See Note 8 Debt to our consolidated financial statements set forth in Item 8 of this report for additional details regarding the Amended Fourth A&R Credit Agreement and our Convertible Notes.
Capital expenditures in each period were primarily related to investment in property and equipment to support development and production of our products. Historically, we have incurred significant expenses in connection with facility construction, production automation, product development and the introduction of new products. We anticipate that we will spend approximately $55 to $60 million in 2025 for property and equipment.
Capital expenditures in each period were primarily related to investment in property and equipment to support development and production of our products and in 2025 includes costs for the construction of a new distribution facility in South Jordan, Utah. Historically, we have incurred significant expenses in connection with facility construction, production automation, product development and the introduction of new products.
This increase was driven primarily by increased sales of our kits and critical care products , offset partially by decreased sales of trays. (d) OEM products, which increased by $12.8 million, or 7.8% from the corresponding period of 2023.
This increase was driven primarily by increased sales of our kits, trays and critical care products . (d) OEM products, which increased by $5.0 million, or 2.5% from the corresponding period of 2024.
As of December 31, 2024 and 2023, approximately $2.1 million and $2.1 million respectively, of our cash and cash equivalents represents restricted cash for the payment of certain import and other taxes for our subsidiary in China.
We do not consider our foreign earnings to be permanently reinvested. As of December 31, 2025 and 2024, approximately $2.1 million and $2.1 million respectively, of our cash and cash equivalents represents restricted cash for the payment of certain import and other taxes for our subsidiary in China.
The increase in our international sales during 2024 was primarily a result of higher sales in EMEA, which increased $11.2 million or 4.8%, higher ROW sales which increased $8.9 million or 18.1%, and higher sales in our Asia Pacific region, which increased $5.3 million or 2.1%, compared to the corresponding period of 2023.
The increase in our international sales during 2025 was primarily a result of higher sales in EMEA, which increased $37.9 million or 15.3%, higher Rest of World (“ROW”) sales which increased $7.0 million or 12.2%, and higher sales in our Asia Pacific region, which increased $5.8 million or 2.3%, compared to the corresponding period of 2024.
Cash (used in) provided by financing activities for the years ended December 31, 2024, 2023 and 2022 was $(60.0) million, $559.3 million, and $(60.3) million, respectively. In 2024 we decreased our net borrowings under our Amended Fourth A&R Credit Agreement by $99.1 million and had cash proceeds from the issuance of common stock of $40.9 million.
In 2024 we decreased our net borrowings under our Amended Fourth A&R Credit Agreement by $99.1 million and had cash proceeds from the issuance of common stock of $40.9 million.
On February 28, 2024, we introduced our “Continued Growth initiatives” Program with muti-year financial targets for the three-year period ending December 31, 2026, which reflects our commitment to better-position Merit for long-term, sustainable growth and enhanced profitability. On December 20, 2024, we announced that the WRAPSODY® Cell-Impermeable Endoprosthesis has received premarket approval from the US Food and Drug Administration (FDA).
In February 2024, we introduced our “Continued Growth initiatives” Program with muti-year financial targets for the three-year period ending December 31, 2026, which reflects our commitment to better-position Merit for long-term, sustainable growth and enhanced profitability.
See Note 5 Goodwill and Intangible Assets to our consolidated financial statements set forth in Item 8 of this report for additional details regarding impairments of intangible assets. ​ 45 Table of Contents
We did not have any goodwill or intangible asset impairments for the years ended December 31, 2025, 2024 and 2023. See Note 5 Goodwill and Intangible Assets to our consolidated financial statements set forth in Item 8 of this report for additional details regarding goodwill and intangible asset balances. ​ 45 Table of Contents
Our revenue results for the year ended December 31, 2024 were driven primarily by demand in the U.S. and favorable international sales trends, particularly in Europe, the Middle East and Africa (“EMEA”) and in the “Rest of World” (“ROW”) regions.
Our revenue results for the year ended December 31, 2025 were driven primarily by demand in the U.S. and favorable international sales trends, particularly in Europe, the Middle East and Africa (“EMEA”) region. Gross profit as a percentage of sales was 48.7% for the year ended December 31, 2025 as compared to 47.4% for the year ended December 31, 2024.
This increase was driven primarily by sales of our access, radar localization, delivery systems, and drainage products. (b) Cardiac intervention products, which increased by $12.5 million, or 3.5%, from the corresponding period of 2023.
(b) Peripheral intervention products, which increased by $47.1 million, or 8.8%, from the corresponding period of 2024. This increase was driven primarily by increased sales of our embolotherapy, radar localization, access, delivery systems and drainage products . (c) Custom procedural solutions products, which increased by $9.3 million, or 4.6% from the corresponding period of 2024.
Our endoscopy sales for the year ended December 31, 2024 were $54.8 million, up 48.8%, when compared to sales for the year ended December 31, 2023 of $36.8 million. Sales for the year ended December 31, 2024 were favorably affected by sales of our recently-acquired EsophyX® Z+ Device.
Our endoscopy sales for the year ended December 31, 2025 were $72.9 million, up 33.0%, when compared to sales for the year ended December 31, 2024 of $54.8 million. Sales for the year ended December 31, 2025 were favorably affected by increased sales of our EsophyX® Z+ device acquired from Endogastric Solutions, Inc. in July 2024 .
Research and Development Expenses . Our research and development (“R&D”) expenses as a percentage of sales were 6.4%, 6.6% and 6.6% for the years ended December 31 2024, 2023, and 2022, respectively. R&D expenses increased by $4.7 million or 5.7% to $87.5 million for the year ended December 31, 2024, compared to $82.7 million in 2023.
In addition, higher marketing, advertising, and travel expenditures contributed to the year‑over‑year increase in 2025. Research and Development Expenses . Our research and development (“R&D”) expenses as a percentage of sales were 6.4%, 6.4% and 6.6% for the years ended December 31 2025, 2024, and 2023, respectively.
Our endoscopy operating income for the year ended December 31, 2024 was $5.5 million, compared to operating income of $9.5 million for the year ended December 31, 2023.
Our endoscopy operating income for the year ended December 31, 2025 was $18.6 million, compared to operating income of $5.5 million for the year ended December 31, 2024. This increase in endoscopy operating income relative to 2024 was primarily due to increased sales and gross profit.
This increase in cardiovascular operating income was primarily related to higher sales and gross profit, decreased acquired in-process research and development charges, and decreased contingent consideration expense ($0.4 million in 2024 compared to $1.7 million in 2023), partially offset by higher SG&A and R&D expenses. Endoscopy Operating Income.
Our cardiovascular operating income for the year ended December 31, 2025 was $166.1 million, compared to cardiovascular operating income of $150.2 million for the year ended December 31, 2024. This increase in cardiovascular operating income was primarily related to increased sales and gross profit, partially offset by increased SG&A and R&D expenses. Endoscopy Operating Income.
Operating Income Our operating profit by operating segment for the years ended December 31, 2024, 2023 and 2022 was as follows (in thousands): ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Operating Income ​ 2024 2023 2022 Cardiovascular ​ $ 150,150 ​ $ 114,440 ​ $ 80,946 Endoscopy ​ 5,543 ​ 9,504 ​ 6,617 Total operating income ​ $ 155,693 ​ $ 123,944 ​ $ 87,563 ​ Cardiovascular Operating Income.
The expense in each fiscal year relates to changes in the probability and timing of achieving certain revenue and operational milestones, as well as expense for the passage of time. 41 Table of Contents Operating Income Our operating profit by operating segment for the years ended December 31, 2025, 2024 and 2023 was as follows (in thousands): ​ ​ ​ ​ ​ ​ ​ ​ ​ Operating Income 2025 ​ ​ ​ 2024 ​ ​ ​ 2023 Cardiovascular $ 166,133 ​ $ 150,150 ​ $ 114,440 Endoscopy 18,587 ​ 5,543 ​ 9,504 Total operating income $ 184,720 ​ $ 155,693 ​ $ 123,944 ​ Cardiovascular Operating Income.
This increase was driven primarily by sales of our access, vertebral compression fracture, and fluid management products as well as our kits, partially offset by a decrease in sales of our CRM/EP products. 40 Table of Contents Endoscopy Sales.
This increase was driven primarily by increased sales of our intervention, CRM/EP, kits and peripheral intervention products, offset partially by decreased sales of our access and coated tube and wire products. Endoscopy Sales.
The increase in net income for 2024, when compared to 2023, was primarily related to higher sales, higher gross margin as a percentage of sales, decreased contingent consideration expense ($0.4 million in 2024 compared to $1.7 million in 2023), decreased acquired in-process research and development expense ($0 in 2024 compared to $1.6 million in 2023) and decreased other expenses; partially offset by higher SG&A, R&D, and income tax expense . 42 Table of Contents Liquidity and Capital Resources Capital Commitments and Contractual Obligations Our most significant contractual obligations as of December 31, 2024 included total long-term debt obligations of $747.5 million, interest payments on this debt, contingent consideration liabilities of $3.5 million, of which $0.4 million is recorded in current liabilities, and operating lease liabilities of $65.1 million, of which $10.3 million is recorded in current liabilities.
Liquidity and Capital Resources Capital Commitments and Contractual Obligations Our most significant contractual obligations as of December 31, 2025 included total long-term debt obligations of $747.5 million, interest payments on this debt, contingent consideration liabilities of $4.5 million, of which $3.2 million is recorded in current liabilities, and operating lease liabilities of $87.5 million, of which $10.9 million is recorded in current liabilities.
Additional information about these obligations is contained in Notes 8, 15 and 17 to our consolidated financial statements set forth in Item 8 of this report.
Additional information about these obligations is contained in Notes 8, 15 and 17 to our consolidated financial statements set forth in Item 8 of this report. 42 Table of Contents Cash Flows At December 31, 2025 and 2024, we had cash, cash equivalents and restricted cash of $448.5 million and $378.8 million respectively, of which $66.0 million and $50.6 million, respectively, were held by foreign subsidiaries.
This increase was driven primarily by sales of our cardiac rhythm management/electrophysiology (“CRM/EP”), fluid management, and access products, partially offset by a decrease in sales of our hemostasis products. (c) Custom procedural solutions products, which increased by $5.9 million, or 3.0% from the corresponding period of 2023.
This increase was driven primarily by $35.3 million in incremental sales associated with products acquired from Cook in November 2024, $11.9 million in sales associated with products acquired in connection with the Biolife Merger in May 2025 and increased sales of our intervention, cardiac rhythm management/electrophysiology (“CRM/EP”), angiography, access and fluid management products.
Significant changes in operating assets and liabilities affecting cash flows during these years included: ● Net income was $120.4 million and $94.4 million for the years ended December 31, 2024 and 2023, respectively. ● Cash used for inventories was $2.3 million and $32.1 million for the years ended December 31, 2024 and 2023, respectively due primarily to efforts to normalize inventory levels following prior year investments to build bridge inventory for production line transfers and increases in safety stock due to vendor supply delays. ● Cash provided by (used for) accrued expenses was $9.7 million and $(2.5) million for the years ended December 31, 2024 and 2023, respectively, primarily due to an increase in accrued interest and the associated expense related to our convertible debt. ● Cash paid for income taxes was $45.0 million and $31.5 million for the years ended December 31, 2024 and 2023, respectively, primarily due to increases in income before tax.
Significant changes in operating assets and liabilities affecting cash flows during these years included: ● Net income was $128.5 million and $120.4 million for the years ended December 31, 2025 and 2024, respectively. ● Depreciation and amortization was $123.2 million and $102.7 million for the years ended December 31, 2025 and 2024, respectively, primarily due to an increase in intangible assets as a result of acquisitions. ● Cash paid for income taxes was $31.4 million and $45.0 million for the years ended December 31, 2025 and 2024, respectively, primarily as the result of increased taxes payable and an increased portion of our total tax expense relating to deferred tax expense. ● Stock-based compensation expense was $43.5 million and $28.5 million for the years ended December 31, 2025 and 2024, respectively.
The increase in the effective income tax rate for 2024 compared to 2023 was primarily the result of decreased benefit from items such as stock-based compensation and foreign tax credit utilization. Net Income Our net income for the years ended December 31, 2024, 2023 and 2022 was $120.4 million, $94.4 million, and $74.5 million, respectively.
Net Income Our net income for the years ended December 31, 2025, 2024 and 2023 was $128.5 million, $120.4 million, and $94.4 million, respectively.
The increase in SG&A expenses for the year ended December 31, 2024 compared to the year ended December 31, 2023 was primarily related to increased labor-related costs associated with an increase in headcount and higher variable compensation linked to company performance, an increase of stock-based compensation expense associated with new equity grants and variability in our stock price, and an increase in travel related costs associated with our sales and marketing activities, partially offset by a decrease in consulting costs primarily associated with our Foundations for Growth Program which ended in 2023.
The increase in SG&A expenses for the year ended December 31, 2025 compared to the year ended December 31, 2024 was primarily due to an increase in labor-related costs including (i) variable compensation associated with performance-based bonus programs, commissions associated with sales growth, as well as an increase in expense associated with both performance and non-performance based equity awards; and (ii) headcount additions to support investment in the business and growth from acquisitions, including those in connection with the Cook Transaction and the Biolife Merger.
Gross profit as a percentage of sales was 47.4% for the year ended December 31, 2024 as compared to 46.4% for the year ended December 31, 2023. Net income for the year ended December 31, 2024 was $120.4 million, or $2.03 per share, as compared to $94.4 million, or $1.62 per share, for the year ended December 31, 2023.
Net income for the year ended December 31, 2025 was $128.5 million, or $2.13 per share, as compared to $120.4 million, or $2.03 per share, for the year ended December 31, 2024. In May 2025, we completed a merger transaction with Biolife Delaware, L.L.C. (“Biolife”), a manufacturer of unique patented hemostatic devices under the brand names StatSeal® and WoundSeal®.
This decrease in endoscopy operating income relative to 2023 was primarily due to higher SG&A expense associated with the acquisition and integration of operations acquired from EGS and higher R&D expenses, partially offset by higher sales.
The increase in net income for 2025, when compared to 2024, was primarily related to higher sales and higher gross margin as a percentage of sales; partially offset by higher SG&A, R&D, other expense and income tax expense .
The increase in R&D expenses for the year ended December 31, 2024 compared to the year ended December 31, 2023 was primarily related to labor-related costs consistent with an increase in headcount and an increase materials and scrap utilized in R&D, partially offset by lower regulatory costs related to Medical Device Rgulation in the E.U. Impairment Charges .
The increase in R&D expenses for the year ended December 31, 2025 compared to the year ended December 31, 2024 was primarily related to increased labor-related costs including variable compensation associated with bonus and equity award programs and increased consulting services and clinical trials. Contingent Consideration Expense .
Removed
In July 2024, we executed an asset purchase agreement with EndoGastric Solutions, Inc. (“EGS”), acquiring the EsophyX® Z+ device which delivers a durable, minimally invasive non-pharmacological treatment option for patients suffering from GERD. In November 2024, we completed the acquisition of a portfolio of Lead Management products from Cook Medical.
Added
In November 2025, pursuant to the terms of an asset purchase agreement between Merit and Pentax of America, Inc., we acquired the C2 CryoBalloon® device and related technology.
Removed
During the year ended December 31, 2024, we recognized no impairment costs. 41 Table of Contents Contingent Consideration Expense .
Added
Revenue figures for 2024 and 2023 have been recast to reflect this realignment of our portfolio of spine products, representing approximately $22.6 million and $22.4 million in revenue, respectively, within the OEM product category to provide comparability between the reported periods. ​ Cardiovascular Sales.
Removed
The expense in each fiscal year relates to changes in the probability and timing of achieving certain revenue and operational milestones, as well as expense for the passage of time. Acquired In-process Research and Development . During the year ended December 31, 2024, we recognized no acquired in-process research and development costs.
Added
R&D expenses increased by $9.9 million or 11.3% to $97.4 million for the year ended December 31, 2025, compared to $87.5 million in 2024.
Removed
Our cardiovascular operating income for the year ended December 31, 2024 was $150.2 million, compared to cardiovascular operating income of $114.4 million for the year ended December 31, 2023.
Added
The increase in the effective income tax rate for 2025 compared to 2024 was primarily the result of decreased benefit from discrete items such as share-based compensation and contingent liabilities and increased permanent tax differences in various jurisdictions and items related to the budget reconciliation package enacted during the period and retroactive to the beginning of the year.
Removed
Cash Flows At December 31, 2024 and 2023, we had cash, cash equivalents and restricted cash of $378.8 million and $589.1 million respectively, of which $50.6 million and $48.7 million, respectively, were held by foreign subsidiaries. We do not consider our foreign earnings to be permanently reinvested.
Added
The increase in stock-based compensation expense during 2025 is primarily associated with the increase in the Company’s stock price and grants of restricted stock units. ● Cash used for inventories was $21.6 million and $2.3 million for the years ended December 31, 2025 and 2024, respectively.
Removed
Cash outflows invested in acquisitions for the year ended December 31, 2022 were $6.9 million and were primarily related to our $3.0 million upfront payment in our purchase of Restore Endosystems LLC and our $2.5 million payment in our purchase of BioTrace Medical, Inc. 43 Table of Contents Cash flows provided by (used in) financing activities.
Added
The increase in inventories during 2025 was principally associated with our strategy to proactively invest in our inventory balances to encourage high customer service levels, as well as to build bridge inventory for production line transfers and increases in safety stock due to vendor supply delays. Cash flows used in investing activities.
Removed
In 2022 we decreased our net borrowings under our Third Amended Credit Agreement by $44.9 million and paid contingent consideration of $32.9 million, which is classified as a financing activity, principally related to our acquisitions of Cianna Medical Inc. (“Cianna Medical”) and Vascular Insights LLC (“Vascular Insights”).
Added
We anticipate that we will spend approximately $80 to $100 million in 2026 for property and equipment. Cash outflows invested in acquisitions for the year ended December 31, 2025 were $144.8 million and were primarily related to payments required by our merger agreement with Biolife LLC ($120.0 million) and our asset purchase agreement with Pentax of America, Inc. ($19 million).
Removed
Our interest rate as of December 31, 2024 was a fixed rate of 3.0% on our Convertible Notes.
Added
Cash provided by (used in) financing activities for the years ended December 31, 2025, 2024 and 2023 was $16.0 million, $(60.0) million, and $559.3 million, respectively. In 2025 we had cash proceeds from the issuance of common stock of $28.2 million.
Removed
Our interest rate as of December 31, 2023 was a fixed rate of 3.0% on our Convertible Notes, a fixed rate of 3.39% on $75 million as a result of an interest rate swap, and a variable floating rate of 7.21%% on $24.1 million.
Added
Our election to perform a qualitative impairment assessment for an individual reporting unit in a given year is influenced by a number of factors, including, but not limited to, the size of the reporting unit's goodwill, the significance of the excess of the reporting unit's estimated fair value over carrying value at the last quantitative assessment date, the amount of time since the last quantitative analysis was performed, and other performance and market indicators.
Removed
The foregoing fixed rates are exclusive of potential future changes in the applicable margin associated with our variable rate debt under the Amended Fourth A&R Credit Agreement.
Added
During a qualitative assessment, if we determine that it is not more likely than not that the implied fair value of the goodwill is less than its carrying amount, no further testing is necessary.
Removed
During our annual impairment test performed as of July 1, we utilized four reporting units in evaluating goodwill for impairment using a quantitative assessment, which uses a combination of a guideline public company market-based approach and a discounted cash flow income-based approach.
Added
If we do not perform a qualitative assesment, or we determine that it is more likely than not that the implied fair value of the goodwill is less than its carrying amount, we perform a quantitative assessment, which uses a combination of a guideline public company market-based approach and a discounted cash flow income-based approach.
Removed
During our annual test of goodwill balances in 2024, which was completed during the third quarter of 2024, we determined that the fair value of each reporting unit with goodwill exceeded the carrying amount by a significant amount.
Added
During our annual impairment test performed during the third quarter of 2025, we evaluated each of our four reporting units using a qualitative assessment.
Removed
During the year ended December 31, 2022, we identified indicators of impairment associated with certain acquired intangible assets within the asset groups based on our qualitative assessment. During the year ended December 31, 2022, we recorded total impairment charges associated with intangible assets in our cardiovascular segment of $1.7 million.
Added
As a result of the assessment, we determined that it was not more likely than not that the implied fair value was less than its carrying amount for each of our four reporting units, and no detailed quantitative assessment was necessary.
Removed
We did not have any goodwill or intangible asset impairments for the years ended December 31, 2024 and 2023. These expenses are reflected within impairment charges in our consolidated statements of income. The primary factors driving impairment of certain intangible assets were planned closure and restructuring activities and uncertainty about future product development and commercialization associated with certain acquired technologies.

Item 7A. Quantitative and Qualitative Disclosures About Market Risk

Market Risk — interest-rate, FX, commodity exposure

7 edited+0 added−0 removed5 unchanged
Biggest changeDollar strengthened or weakened by 10% against all currencies, it would have the following impact on the fair value of these contracts (in thousands): ​ ​ ​ ​ ​ ​ ​ ​ 2024 2023 10% Strengthening ​ $ 5,545 ​ $ 7,264 10% Weakening ​ $ (5,545) ​ $ (7,264) ​ Gains or losses on the fair value of derivative contracts would generally be offset by gains and losses on the underlying hedged transaction or net exposure.
Biggest changeDollar strengthened or weakened by 10% against all currencies, it would have the following impact on the fair value of these contracts (in thousands): ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ 2025 ​ ​ ​ 2024 10% Strengthening ​ $ 13,569 ​ $ 5,545 10% Weakening ​ $ (13,569) ​ $ (5,545) ​ Gains or losses on the fair value of derivative contracts would generally be offset by gains and losses on the underlying hedged transaction or net exposure.
Interest Rate Risk As discussed in Note 8 Debt to our consolidated financial statements set forth in Item 8 of this report, as of December 31, 2024, we had no outstanding borrowings under the Amended Fourth A&R Credit Agreement. Our exposure to market risk for changes in interest rates relates primarily to variable interest earned on cash balances.
Interest Rate Risk As discussed in Note 8 Debt to our consolidated financial statements set forth in Item 8 of this report, as of December 31, 2025, we had no outstanding borrowings under the Amended Fourth A&R Credit Agreement. Our exposure to market risk for changes in interest rates relates primarily to variable interest earned on cash balances.
A sensitivity analysis of changes in the fair value of all currency exchange rate derivative contracts at December 31, 2024 and 2023 indicates that, if the U.S.
A sensitivity analysis of changes in the fair value of all currency exchange rate derivative contracts at December 31, 2025 and 2024 indicates that, if the U.S.
Assuming the current level of cash balances remained the same and no additional borrowings are withdrawn, it is estimated that our interest income before income taxes would change by approximately $3.8 million annually for each one percentage point change in the average interest rate associated with these cash holdings. ​ 46 Table of Contents
Assuming the current level of cash balances remained the same and no additional borrowings are withdrawn, it is estimated that our interest income before income taxes would change by approximately $4.5 million annually for each one percentage point change in the average interest rate associated with these cash holdings. ​ 46 Table of Contents
We forecast our net exposure related to sales and expenses denominated in foreign currencies. As of December 31, 2024 and 2023, we had entered into foreign currency forward contracts, which qualified as cash flow hedges, with aggregate notional amounts of $117.5 million and $141.1 million, respectively.
We forecast our net exposure related to sales and expenses denominated in foreign currencies. As of December 31, 2025 and 2024, we had entered into foreign currency forward contracts, which qualified as cash flow hedges, with aggregate notional amounts of $138.6 million and $117.5 million, respectively.
Item 7A. Quantitative and Qualitative Disclosures About Market Risk. Currency Exchange Rate Risk Our consolidated financial statements are denominated in, and our principal currency is, the U.S. Dollar. For the year ended December 31, 2024, a portion of our net sales ($464.9 million, representing 34.3% of our aggregate net sales), was attributable to sales that were denominated in foreign currencies.
Item 7A. Quantitative and Qualitative Disclosures About Market Risk. Currency Exchange Rate Risk Our consolidated financial statements are denominated in, and our principal currency is, the U.S. Dollar. For the year ended December 31, 2025, a portion of our net sales ($510.3 million, representing 33.7% of our aggregate net sales), was attributable to sales that were denominated in foreign currencies.
As of December 31, 2024 and 2023, we had entered into foreign currency forward contracts, which were not designated as hedging instruments, related to those balance sheet accounts with aggregate notional amounts of $95.7 million and $108.4 million, respectively.
As of December 31, 2025 and 2024, we had entered into foreign currency forward contracts, which were not designated as hedging instruments, related to those balance sheet accounts with aggregate notional amounts of $107.6 million and $95.7 million, respectively.

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