What changed in this filing

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Item 1. Business

2025-02-25 compared with 2024-02-28 · 97 added, 93 removed, 480 unchanged (28% of the section changed)

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intensive care;

computed tomography;

and interventional gastroenterology.

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cardiovascular and endoscopy.

For information relating to our operating segments and product categories, see Note 13 to our consolidated financial statements set forth in Item 8 of this report and Management’s Discussion and Analysis set forth in Item 7 of this report.

For information relating to our operating segments and product categories, see Note 13 Segment Reporting and Foreign Operations to our consolidated financial statements set forth in Item 8 of this report and Management’s Discussion and Analysis set forth in Item 7 of this report.

The following sections describe our principal product offerings by reporting segment and product category.

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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;

● Merit Wrapsody ™ Endoprosthesis, a cell-impermeable endoprosthesis which is designed to maintain long-term vessel patency in patients with obstructions in the dialysis outflow circuit (this device is not currently available for use in the United States);

● Surfacer® Inside-Out® Access Catheter System that restores and preserves access in chronically occluded veins.

The products in our angiography portfolio are used to identify blockages and other disease states in the blood vessel.

The products in our angiography portfolio are used to identify blockages and other disease states in blood vessels.

The principal product offerings in our angiography portfolio include our:

● Newest offering of Merit SplashWire® hydrophilic Steerable Guide Wires, combining optimum lubricity, exceptional torque response and enhanced visibility;

● Merit SplashWire® hydrophilic Steerable Guide Wires, combining optimum lubricity, exceptional torque response and enhanced visibility;

● Performa® and Impress® Diagnostic Catheters, a catheter offering designed for traversing difficult to access peripheral blood vessels;

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● HepaSphere® Microspheres, soft embolics with a consistent cross-sectional diameter for predictable, flow-directed targeting;

● 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 products in our intervention (peripheral) portfolio are chiefly used to remove blood clots, retrieve foreign bodies in blood vessels and assist with placing balloons and stents to treat arterial disease.

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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;

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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.

The principal product offerings in our intervention (cardiac) portfolio include a full line of inflation devices and hemostasis valves, including the 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 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.

Custom Procedural Solutions

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● Trays and packs.

We provide coating services for medical tubes and wires under OEM brands in addition to many of the products identified above.

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.

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.

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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® Inflation Device, a 60-mL syringe and gauge designed to inflate and deflate non-vascular balloon dilators while monitoring and displaying inflation pressures up to 12 atmospheres;

● 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;

● Elation® Fixed Wire, Wire Guided and new 5-stage Balloon Dilators, intended for use in the alimentary tract.

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Target Market/Industry.

Our principal target markets are peripheral intervention, cardiac intervention, interventional oncology, critical care and endoscopy.

Our principal target markets are peripheral intervention (including, renal therapies), cardiac intervention, interventional oncology, critical care and endoscopy.

Within these markets our products are used in the following clinical areas:

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intensive care;

computed tomography;

and interventional gastroenterology.

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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 and 2023 in the form of decreased sales prices and purchase volumes.

We expect to continue to experience negative impacts from the VBP policy in 2024.

For further discussion of the risks and uncertainties associated with the VBP policy, please refer to disclosure under the heading “ Regulations and trade policies implemented by foreign governments to reduce the costs of healthcare or promote business in their countries have caused, and are likely to continue to cause our sales to decline in such countries” set forth in Item 1A “Risk Factors.”

We began experiencing the impact of the VBP policy in

2022 and 2023 in the form of decreased sales prices and revenue.

The negative impacts of the VBP policy persisted in 2024 and we expect to continue to experience these negative impacts in 2025.

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.

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In 2024, we completed projects that resulted in the newest additions to our product lineup:

BIG60 Alpha™ Inflation Device, Radial Length Merit Maestro® Microcatheters, Prelude Roadster® Guide Sheath Line Extensions, and the Micro ACE™ Advanced Micro-Access System, a novel addition to our Micro-Access lineup.

the Wrapsody Device, basixSky™ Inflation Device, MIGHTYwire® Guide Wire, Siege™ Vascular Plug, Bearing nsPVA Express™ Syringe, and 10FoRe™ hemostasis valve.

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, Texas, Utah, Ireland and France.

Manufacturing

We manufacture many of our products using our proprietary technology and our expertise in plastic injection and insert molding.

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.

We generally contract with third parties for the tooling of our molds, but we design and own most of our molds.

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(“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 nine global manufacturing facilities.

We have specialized manufacturing personnel at most of our ten global manufacturing facilities.

Consequently, we possess the capability to flexibly locate or shift the manufacture of products to the facilities providing the most strategic advantages.

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Manufacturing of our embolotherapy products includes the synthesis and processing of raw materials and third-party manufactured compounds.

We have packaging and manufacturing facilities located in Texas, Virginia, Utah, Mexico, Brazil, Ireland, France, The Netherlands, and Singapore.

We have packaging and manufacturing facilities located in Texas, Virginia, Utah, Minnesota, Mexico, Brazil, Ireland, France, The Netherlands, and Singapore.

“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 and Australia.

The medical products industry is highly competitive.

Merit operates in the complex, highly competitive and challenging global medical technology marketplace, specifically in the areas of cardiology, radiology, oncology, critical care and endoscopy.

This marketplace is characterized by rapid technological advancement, industry and customer consolidation, customer demands for price reductions, regulatory reform, and evolving patient needs.

We compete with companies of varying sizes.

Many of our competitors are much larger than we are and have access to greater resources.

We also compete with smaller companies that sell single or limited numbers of products in specific product lines or geographies.

We compete globally in several market areas, including radiology;

diagnostic and interventional cardiology;

interventional radiology;

neurointerventional radiology;

vascular, general and thoracic surgery;

electrophysiology;

cardiac rhythm management;

interventional pulmonology;

interventional nephrology;

orthopedic spine surgery;

interventional oncology;

pain management;

outpatient access centers;

intensive care;

computed tomography;

and interventional gastroenterology.

In certain countries, and particularly in China and Japan, we also face competition from domestic medical device companies that may benefit from their status as local suppliers.

We also face competition from non-medical device companies offering alternative therapies for disease states that could also be treated using our products.

The principal competitive factors in the markets in which our products are sold are quality, price, product features, customer service, breadth of line, and customer relationships.

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manufacturing integration to secure our supply chain;

and strong cadence of new products and product line extensions that enhance our portfolio.

commitment to innovation and strong cadence of new products and product line extensions that enhance our portfolio.

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”).

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for control syringes, radar localization, waste-disposal systems, embolic beads, tubing and manifolds.

Although we believe our recent and planned additions to these product lines will help us compete even more effectively in both the U.S.

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.

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however, fluctuations and uncertainties in supply chain, transportation logistics, and freight expenses that we have experienced during the past several years have challenged our operating capabilities and could result in disruptions in our operations and materially impact our financial results.

For further discussion of the risks and uncertainties associated with recent disruptions in supply chain and logistics, please refer to disclosure under the heading “ Termination or interruption of our supply relationships and increases in labor costs and the prices of our component parts, finished products, third-party services and raw materials, particularly petroleum-based products, is negatively impacting our business and could have a further adverse effect on our business, operations or financial condition.

For further discussion of the risks and uncertainties associated with recent disruptions in supply chain and logistics, please refer to disclosure under the heading “ Disruptions in the supply from third-party vendors of the materials and components used in manufacturing or sterilizing our products could adversely affect our business, operations or financial condition.

” set forth in Item 1A “Risk Factors.”

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and (viii) report or disclose certain events and physician payments.

We recently completed our third reporting period under the CIA and continue to implement compliance program enhancements.

We recently completed our fourth reporting period under the CIA and continue to implement compliance program enhancements.

Our failure to comply with our obligations under the CIA could result in monetary penalties and our exclusion from participation in federal health care programs.

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Our products and operations are global and are subject to regulations by the FDA and various other federal and state agencies, as well as by foreign governmental agencies.

These agencies enforce laws and regulations that control the design, development, testing, clinical trials, manufacturing, labeling, storage, advertising, marketing, distribution, and post-market surveillance of our medical products.

The time required to obtain approval by the FDA and foreign governmental agencies can be lengthy and the requirements may differ.

In particular, in May 2017, the European Union (E.U.) adopted Regulation (EU) 2017/745 (“MDR”), which replaced Council Directive 93/92/EEC (“MDD”) as of May 26, 2021.

These agencies enforce laws and regulations that control the design, development, testing, clinical trials, manufacturing, labeling, storage, advertising, marketing, distribution, import and export, and post-market surveillance of our medical products.

Further, approval by one governmental agency does not assure approval by another governmental agency, although sometimes test results from one country can be used in applications for regulatory approval in another country.

Finally, changes in government administrations may result in changed administrative or legislative priorities and could also prevent or delay approval of our current or future products, restrict or regulate post-approval activities and affect our ability to profitably sell our current or future products for which we obtain marketing approval.

The time required to obtain approval by the FDA and foreign governmental agencies can be lengthy and complicated given that the regulatory requirements may differ in each jurisdiction.

For example, in May 2017, the European Union (E.U.) adopted Regulation (EU) 2017/745 (“MDR”), which replaced Council Directive 93/92/EEC (“MDD”) as of May 26, 2021.

Under transitional provisions, medical devices with notified body certificates issued under the MDD prior to May 26, 2021, for which we intend to seek approval under the MDR and which meet certain other requirements, may continue to be placed on the E.U.

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After the expiry of the applicable transitional period, only devices that have been CE marked under the MDR may be placed on the market in the E.U.

For medical devices with notified body certificates issued under the MDD prior to May 26, 2021 for which we do not intend to seek approval under the MDR, these devices may continue to be placed on the E.U.

market only until May 26, 2024.

We are preparing to comply with these new regulations under the MDR before the transitional period expires.

However, there will be products that we will instead choose to discontinue or postpone introduction in the E.U.

This decision will depend on a number of factors, including changing business strategies, timing and cost of obtaining MDR certification, availability of necessary data and the capacity of notified bodies.

This decision will depend on a number of factors, including, without limitation, changing business strategies, timing and cost of obtaining MDR certification, availability of necessary data and the capacity of notified bodies.

The MDR includes increasingly stringent requirements in multiple areas, such as pre-market clinical evidence, review of high-risk devices, labeling, post-market surveillance and post-market clinical follow-up.

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and foreign counter-part regulatory approval processes for medical devices are expensive, uncertain and lengthy.

In certain circumstances, human clinical trials are required for regulatory clearance or approval for devices, which can be expensive, time-consuming and produce uncertain results.

There can be no assurance that we will be able to obtain necessary regulatory approvals for any product on a timely basis or at all.

Delays in, or failure to receive, such approvals, the loss of previously received approvals, or the failure to comply with existing or future regulatory requirements could have a material adverse effect on our business, financial condition, results of operations or prospects.

In May 2020, we received the CE mark for the Merit Wrapsody Cell-Impermeable Endoprosthesis, and we are pursuing regulatory approval in the U.S.

and elsewhere.

We are conducting a large, multinational pivotal human clinical trial of the Wrapsody Endoprosthesis, which is required for us to obtain approval from the FDA and some foreign regulatory agencies.

Further, even if a regulatory approval or clearance is issued by the FDA, the FDA may impose post-clearance or post-approval marketing restrictions or other regulatory requirements regarding a medical product that could have a material adverse effect on our business, financial conditions, operations or prospects.

Finally, even after regulatory approval or clearance, Merit is subject to several laws, rules and regulations, and the failure to comply with any applicable laws, rules or regulations at any time during the lifecycle of a product, including without limitation, after approval or clearance, may subject us to a variety of administrative or judicial proceedings, penalties or sanctions, including refusal by the applicable regulatory authority to approve pending applications, withdrawal of an approval, imposition of a clinical hold, issuance of warning letters and other types of letters, product recalls, product seizures, total or partial suspension of production or distribution, injunctions, fines, refusals of government contracts, restitution, disgorgement of profits, or civil or criminal investigations and penalties brought by the FDA and the Department of Justice or other governmental entities.

With respect to regulatory approvals for the Wrapsody Device, in May 2020, we received the CE mark and in December 2024, we received premarket approval from the FDA.

We continue to seek regulatory approvals for the Wrapsody Device in other jurisdictions.

We are conducting a large, multinational pivotal human clinical trial of the Wrapsody Device, which was required for us to obtain approval from the FDA and is required by some foreign regulatory agencies.

Human clinical trials of a medical device are often required for regulatory clearance or approval for devices and are expensive, time-consuming and uncertain.

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These requirements are complex, technical and require substantial resources to remain compliant.

Our failure or the failure of our suppliers to maintain compliance with these requirements could result in the shutdown of our manufacturing operations or the recall of our products, or could restrict our ability to obtain new product approvals or certificates from regulatory authorities, such as the FDA, that are necessary for import and export of our products.

Our failure or the failure of our distributors or suppliers to maintain compliance with these requirements could result in the shutdown of our manufacturing operations or the recall of our products, or could restrict our ability to obtain new product approvals or certificates from regulatory authorities, such as the FDA, that are necessary for import and export of our products.

Any of these results could have a material adverse effect on our business.

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Among other things, labeling violates the law if it is false or misleading in any respect or it fails to contain adequate directions for use.

Moreover, product claims that are outside the approved or cleared labeling violate the FDCA and other applicable laws.

Moreover, product claims that are outside the approved or cleared labeling (for example, an uncleared or unapproved use) violate the FDCA and other applicable laws.

If the FDA determines that our promotional materials constitute promotion of an uncleared or unapproved use, or otherwise violate the FDCA, it could request that we modify our promotional materials or subject us to regulatory or enforcement actions, including the issuance of an untitled letter, a notice of violation, a warning letter, injunction, seizure, civil fines or criminal penalties.

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The FDA also regularly inspects companies to determine compliance with the QSRs and other post-market requirements.

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 expensive, time-consuming and uncertain, 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.”

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.”

Reimbursement.

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Reports submitted under these requirements are placed in a public database.

Several other jurisdictions outside the U.S.

A number of other jurisdictions outside the U.S.

have also adopted or begun adopting similar transparency laws.

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We believe our policies and practices comply, in all material respects, with applicable environmental laws and regulations.

We strive to continuously improve our environmental metrics with a goal of reducing pollution, minimizing depletion of natural resources and reducing our overall environmental footprint.

We strive to continuously improve our environmental management system with a goal of reducing pollution, minimizing depletion of natural resources and reducing our overall environmental footprint.

Specifically, we are working to optimize energy and resource usage, ultimately reducing greenhouse gas emissions, water use and waste.

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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.

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.

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.

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.

California’s Consumer Protection Act (“CCPA”) went into effect on January 1, 2020, giving consumers the right to (i) prevent businesses from sharing their personal information, (ii) correct inaccurate personal information, and (iii) restrict companies from utilizing sensitive data and personal information.

The California Privacy Rights Act (“CPRA”), which went into effect on January 1, 2023, amended the CCPA to include job applicants, employees, owners, officers, directors, and medical staff members of a business (collectively “employees”), give consumers even more control over their data, and increase the maximum penalties for violations against consumers who are less than 16 years old.

The CPRA also prevents companies from keeping personal data longer than necessary.

The addition of employees to the protections afforded by the CCPA can cause business concerns because we also have legal requirements to retain certain employee data, such as confidential disciplinary files, as well as legal document retention requirements.

Virginia’s Consumer Data Protection Act, which also went into effect on January 1, 2023, sets forth regulations regarding how we can control and process data, giving consumers the right to access, delete, and correct their data, as well as opt-out of personal data processing for advertising purposes.

The Colorado Privacy Act and the Connecticut Personal Data Privacy and Online Monitoring law, both of which establish standards for how companies control and process consumer personal data, are both scheduled to take effect July 1, 2023.

The Utah Consumer Privacy Act, which is scheduled to take effect on December 31, 2023, gives consumers the right to know what type of data businesses collect about them, how their data is being used and whether or not businesses intend to sell their

data to third parties.

All five of these state laws let consumers access and delete their personal data that the business has collected on them and opt out of data collection.

Because privacy and data security laws and regulations continue to expand, differ from jurisdiction to jurisdiction, and are subject to evolving (and at times inconsistent) governmental interpretation, compliance with these laws and regulations may require significant additional cost expenditures or changes in products or business that increase competition or reduce revenue.

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Under the oversight of our Board of Directors and management team, we continue to make sustainability a key focus of our business.

We have a cross-functional Corporate Sustainability Council that is driving long-term Environment, Social and Governance (“ESG”) goals across our enterprise.

We have a cross-functional Corporate Sustainability Council that is driving long-term environment, social and governance goals across our enterprise.

These efforts have included proactive actions to address both risks and opportunities related to our sustainability program, as we strive for continued growth and profitability.

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Our sustainability values in action include:

• achievement of ISO 14001 certification at seven facilities including six manufacturing facilities (seven in scope) and one large distribution facility (one in scope), with the goal of achieving ISO 14001certification at our seventh in scope facility by the end of 2024.

● 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.

(ISO 14001 is the international standard that specifies requirements for an effective environmental management system);

• achievement of ISO 50001 certification at five manufacturing facilities (six in scope) with the goal of achieving of ISO 50001 certification at our sixth in scope manufacturing facility by the end of 2025 (ISO 50001 is the international standard that specifies requirements for an effective energy 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;

• transition to re-usable pallets and methods to move products in reusable bulk containers, reducing intra-company shipping materials;

● 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 per box, eliminate the usage of intermediate packaging, reducing film thickness and use original product packaging where possible;

● 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

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.

At full completion, this project will save millions of pieces of paper and thousands of plastic sleeves annually.

Currently, our eWorq program is in place at three of our largest manufacturing sites and in 2023 we eliminated 2,569,710 pages of paper.

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, our eWorq program is in place at three of our largest manufacturing sites and in 2024 we estimate that we eliminated 4,223,770 pages of paper.

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 our employees recycle materials, including food waste, paper, plastic, cardboard, beverage containers, scrap metal, and pallets, and re-use of our plastic scrap waste leftover from the manufacturing process of our molded parts;

● 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 manufacturing facilities;

● 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;

• engaged in a comprehensive materiality assessment to better align ESG expectations from our internal and external stakeholders.

● engaged in a comprehensive materiality assessment to better align environmental, social and governance expectations from our internal and external stakeholders.

To learn more about our sustainability programs and accomplishments, you may visit www.merit.com/about/corporate-sustainability/.

however, the information on this website is not, and will not be deemed, a part of this report or incorporated into any other filings we make with the SEC.

As of December 31, 2023, we had 6,950 employees located in approximately 40 different countries in a variety of different roles.

As of December 31, 2024, we had approximately 7,400 employees located in approximately 40 different countries in a variety of different roles.

In the highly competitive medical device industry, we consider attracting, developing, and retaining talented people in technical, operational, marketing, sales, research, management, and other positions to be critical to our overall long-term growth strategy.

Our ability to recruit and retain such talent depends on several factors, including compensation and benefits, talent development, career opportunities, and work environment.

We invest in our people and cultivate a company culture committed to supporting a diverse and inclusive workforce.

Diversity, Equity and Inclusion.

Our goal is to create a diverse and inclusive global culture that reflects the diversity of the customers we serve and encourages an environment where employees feel welcomed, respected, and valued.

With this goal in mind, our Chief Human Resources Officer has been charged with working with our leadership team to strengthen and enhance our diversity and inclusion efforts company wide.

Our ability to recruit and retain such talent depends on several factors, including our work environment, employee engagement, compensation and benefits, talent and career development, and employee wellness.

We invest in our people and cultivate a company culture committed to supporting an inclusive workforce.

Work Environment.

We strive to create a global work environment where employees feel welcomed, respected, and valued.

With this goal in mind, our Chief Human Resources Officer has been charged with working with our leadership team to strengthen and enhance our inclusion efforts company wide.

We are committed to providing equal opportunity in all aspects of employment.

In the U.S., we are an equal opportunity/affirmative action employer committed to making employment decisions without regard to race, religion, ethnicity or national origin, gender, sexual orientation, gender identity or expression, age, disability, protected veteran status or any other characteristics protected by law.

Over 50% of our U.S.

employee population identifies as non-white.

To further promote a culture of inclusion, during 2021 we started the Women’s Leadership Initiative (“WLI”), our first ever affinity group led by women and open to all Merit employees.

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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.

Since 2021, we have substantially strengthened our employee communications capabilities through the addition of dedicated internal resources and programs aimed at doing even more to communicate with and engage our workforce.

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.

This survey provided 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.

This survey provided 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.

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.

In selecting recipients of the award, the Top Employers Institute considers a variety of factors, including people strategy, work environment, talent acquisition, learning and development, employee well-being, and diversity and inclusion.

The Merit Way—Our Core Values.

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.

The Merit Way is further described with the acronym H.E.A.R.T.

● 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 program aims to reinforce our purpose and create a consistent global culture with common terminology and expectations for all employees.

The development of the Merit Way program was a cross-organizational effort which included interviews with employees and leaders, workshops across departments and survey feedback from over 5,000 employees.

Compensation and Benefits.

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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.

As a result of our focus on competitive health and wellness benefits, we have achieved our ninth consecutive year of zero health care plan cost increases for our U.S.

As a result of our focus on competitive health and wellness benefits, we have achieved our tenth consecutive year of zero health care plan cost increases for our U.S.

employees who participate in our group healthcare plans.

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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.

To improve employee performance, we have begun building out a global performance management program which will be officially launched in 2024 using our recently-launched human resources information system.

To improve employee performance, we have begun developing a global performance management program which we expect to officially implement in 2025 using our recently-launched human resources information system.

Employee development programs are also being executed at different regional and local levels with a focus on management and leadership development.

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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 2022, we continued our support of humanitarian missions through Merit product donations in Haiti, Kenya, Honduras, Nicaragua, and Tanzania.

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.

Merit also conducts and/or participates in medical education conferences around the globe.

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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.

In addition, we have a Chief Wellness Coordinator dedicated to designing programs and initiatives that support the physical, emotional, and mental health of our employees.

We have a monthly wellness committee meeting and create a “Get Healthy” wellness program available to all sites across the globe.

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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 in our Utah headquarters.

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.

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.

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.

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Occupational Safety and Health Administration requirements.

We have obtained ISO 45001 certification at six manufacturing facilities (seven in scope) and one distribution facility (one in scope).

We have obtained ISO 45001 certification at six manufacturing facilities (eight in scope) and one distribution facility (one in scope).

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 in scope facility by the end of 2024.

We plan to achieve this certification at our seventh and eighth in scope facilities by the end of 2025.

We also have formal plans in place to protect our employee’s safety in the event of an emergency and maintain emergency action plans that employees receive training on annually.

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Additionally, we provide electronic and paper copies of such filings free of charge upon request.

The information on www.merit.com is not, and will not be deemed, a part of this report or incorporated into any other filings we make with the SEC.

Financial Information About Foreign and Domestic Sales

For financial information relating to our foreign and domestic sales see Note 2 and Note 13 to our consolidated financial statements set forth in Item 8 of this report.

For financial information relating to our foreign and domestic sales see Note 2 Revenues and Note 13 Segment Reporting and Foreign Operations to our consolidated financial statements set forth in Item 8 of this report.

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

What changed 10-K

Item 1. Business