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Merit Medical Systems

mmsi · NASDAQ Healthcare
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FY2022 Annual Report · Merit Medical Systems
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MERIT MEDICAL SYSTEMS, INC.

1600 West Merit Parkway

+1 (801) 253–1600

www.merit.com

South Jordan, Utah 84095

20
22 ANNUAL REPORT

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™

 
 
A MESSAGE FROM THE CHAIRMAN & CEO

DEAR SHAREHOLDERS,

In 2022, Merit completed the second year of a three-
year Foundations for Growth (FFG) program. The FFG
program has helped us strengthen the foundational
capabilities of our business. This includes expanding
our ability to scale, improving profitability, delivering
top-line growth, and innovating in the marketplace.

Despite the macroeconomic headwinds facing our
industry, we delivered record-setting revenue, and
experienced operating margin and free cash flow
levels that yielded shareholder returns at the upper
end of the medical device industry.

The foundation for our success stems from
innovation. We launched multiple products,
including the PreludeSYNC EZ™ Radial Compression
Device, TEMNO Elite® Biopsy System, Prelude
Roadster ® Guide Sheath, SafeGuard Focus Cool™
Compression Device, Resolve® Thoracostomy Tray,
and the smallest and shortest configuration of the
Elation® Pulmonary Balloon Dilator.

In addition, we were granted FDA clearance for the
SCOUT Bx™ Delivery System, and we received FDA
“Breakthrough Device Designation” for Embosphere®
Microspheres for use in genicular artery embolization
for symptomatic knee osteoarthritis.

Our innovation continued with several patient
studies. The WRAPSODY™ Registry (WRAP) Study
is being conducted to evaluate the clinical benefits
associated with the WRAPSODY Cell-Impermeable
Endoprosthesis in hemodialysis patients with vessel
stenosis or occlusion. We enrolled the first patient in a
multicenter observational study to evaluate the use of
EmboCube® Embolization Gelatin to control bleeding
or hemorrhage. In Canada, we enrolled the first

patient in the Streamlined Localization (STREAMLoc)
registry study that assessed clinical utility of using the
SCOUT® Radar Localization System at biopsy.

We remain focused on creating a more sustainable
future. Merit was named one of “America’s Most
Responsible Companies” by Newsweek. In addition,
during 2022 our facilities in Salt Lake City, Galway,
Paris, Richmond, and Venlo received one or more new
ISO certifications for safety, environment, and/or energy.

At Merit, taking care of our people and the
community is a core value. This year, we launched our
first-ever global employee engagement survey and
put into place more than 500 specific action plans
based on employee feedback. We continued to make
additional investments in employee development,
compensation, and benefits. Through partnering with
several non-profit organizations, we also donated
lifesaving medical devices to those in need through
missions across the globe.

We believe the continued execution of FFG initiatives
will further position Merit for long-term success and
perpetuate its mission to be the most customer-
focused company in healthcare. We also believe this
focus will, in turn, enable us to continue to deliver
increased shareholder value well into the future.

Sincerely,

FRED P. LAMPROPOULOS | CHAIRMAN & CEO

MARKET INFORMATION

Merit’s common stock is traded on the NASDAQ Global Select Market System under the

symbol “MMSI.” As of February 22, 2023, the number of shares of common stock outstanding

was 57,318,032, held by approximately 96 shareholders of record, not including shareholders

whose shares are held in securities position listings.

COR P OR ATE INFOR M ATION

EXECUTIVE OFFICERS

FORM 10-K

Merit Medical Systems, Inc. filed an Annual Report on Form 10-K with the U.S. Securities and

Exchange Commission for the fiscal year ended December 31, 2022. A copy may be obtained

by written request from Brian G. Lloyd, Corporate Secretary, at Merit’s corporate office in

All shareholders are invited to attend Merit’s Annual Meeting of Shareholders to be held

virtually via live webcast on Thursday, May 18, 2023, at 2:00 p.m. Mountain Time.

Fred P. Lampropoulos

Chairman, Chief Executive Officer

Raul Parra

Chief Financial Officer, Treasurer

Neil W. Peterson

Chief Operating Officer

Joseph C. Wright

Chief Commercial Officer

Brian G. Lloyd

Chief Legal Officer, Corporate Secretary

Michel J. Voigt

Chief Human Resources Officer

BOARD OF DIRECTORS

Fred P. Lampropoulos

Chairman and Chief Executive Officer

Merit Medical Systems, Inc.

A. Scott Anderson

President and Chief Executive Officer

Zions First National Bank

Lonny J. Carpenter

Former President, Global Quality

and Business Operations

Stryker Corporation

Stephen C. Evans

Founder, Chairman & CEO

Flag Bridge Global Solutions, LLC

David K. Floyd

Former Group President

Stryker Corporation

Thomas J. Gunderson

Director and Former Chair

Minneapolis Heart Institute Foundation

James T. Hogan

Former President of Latin America,

Medtronic plc (formerly Medtronic Inc.)

Laura S. Kaiser

SSM Health

President and Cheif Executive Officer,

Michael R. McDonnell

Chief Financial Officer

Biogen Inc.

F. Ann Millner, Ed. D.

Regents Professor and Professor

of Health Administrative Services

Weber State University

Lynne N. Ward

Former Executive Director of My529

(formerly Utah Educational Savings Plan)

South Jordan, Utah.

ANNUAL MEETING

STOCK TRANSFER AGENT/REGISTRAR

Zions Bank, a division of ZB, N.A.

P. O. Box 30880

Salt Lake City, Utah 84130

PR/MEDIA INQUIRIES:

Teresa Johnson

Merit Medical Systems, Inc.

(801) 208-4295

INVESTOR INQUIRIES:

Mike Piccinino, CFA, IRC

Westwicke - ICR

(443) 213-0509

Brian G. Lloyd

Corporate Secretary

Merit Medical Systems, Inc.

(801) 253-1600

CORPORATE OFFICES

Merit Medical Systems, Inc.

1600 West Merit Parkway

South Jordan, Utah 84095

(801) 253-1600

FOR MORE INFORMATION, CONTACT

INDEPENDENT ACCOUNTANTS

Deloitte & Touche LLP

LEGAL COUNSEL

Parr Brown Gee & Loveless

Corporate and Securities Counsel

Dorsey & Whitney LLP

Intellectual Property Counsel

Paper | Supporting

responsible forestry

UNITED STATES SECURITIES AND EXCHANGE COMMISSION 
Washington, D.C. 20549 

FORM 10-K 

☒  Annual report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 

For the fiscal year ended December 31, 2022 
or 

☐  Transition report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934. 

For the transition period from                to                     . 

Commission File Number   0-18592 

(State or other jurisdiction of incorporation or organization)

Utah 

87-0447695 
(IRS Employer Identification No.)

MERIT MEDICAL SYSTEMS, INC. 
(Exact name of registrant as specified in its charter) 

 1600 West Merit Parkway, South Jordan, Utah 84095 
(Address of principal executive offices, including zip code) 

Registrant’s telephone number, including area code: (801) 253-1600 
Securities registered pursuant to Section 12(b) of the Act: 

Title of each class 
Common Stock, no par value 

Trading Symbol
MMSI

Name of exchange on which registered
NASDAQ Global Select Market

Securities registered pursuant to Section 12(g) of the Act: None 

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☒ No ☐ 

Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes ☐ No ☒ 

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange 
Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to 
such filing requirements for the past 90 days. Yes ☒  No ☐ 

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted and posted 
pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was 
required to submit such files). Yes ☒  No ☐ 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting 

company or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and 
"emerging growth company" in Rule 12b-2 of the Exchange Act. 

Large 

Accelerated 

Non-

Smaller 

Emerging Growth Company ☐

Accelerated Filer ☒ 

Filer ☐ 

Accelerated Filer  ☐ 

Reporting Company ☐ 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying 

with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐ 

Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its 
internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm 
that prepared or issued its audit report. ☒  

If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant 

included in the filing reflect the correction of an error to previously issued financial statements. ☐ 

Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based 

compensation received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b). ☐ 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐  No ☒  

The aggregate market value of the registrant’s common stock held by non-affiliates of the registrant on June 30, 2022, based upon the 

closing price of the common stock as reported by the NASDAQ Global Select Market on such date, was approximately $3.0 billion. As of February 22, 
2023, the registrant had 57,318,032 shares of common stock outstanding. 

Portions of the following document are incorporated by reference in Part III of this Report: the registrant’s definitive proxy statement relating 

to its 2023 Annual Meeting of Shareholders. 

DOCUMENTS INCORPORATED BY REFERENCE 

 
 
 
 
 
 
   
 
 
 
 
 
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TABLE OF CONTENTS 

PART I   

Item 1.  Business 

Item 1A. Risk Factors 

Item 1B.  Unresolved Staff Comments 

Item 2.  Properties 

Item 3.  Legal Proceedings 

Item 4.  Mine Safety Disclosures 

PART II   

Item 5.  Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity 

Securities 

Item 6.  Reserved 

Item 7.  Management’s Discussion and Analysis of Financial Condition and Results of Operations 

Item 7A. Quantitative and Qualitative Disclosures About Market Risk

Item 8.  Financial Statements and Supplementary Data

Item 9.  Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 

Item 9A. Controls and Procedures 

Item 9B.  Other Information 

PART III  

Item 10.  Directors, Executive Officers and Corporate Governance

Item 11.  Executive Compensation 

Item 12.  Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

Item 13.  Certain Relationships and Related Transactions and Director Independence

Item 14.  Principal Accountant Fees and Services

PART IV 

Item 15.  Exhibits and Financial Statement Schedules

Item 16.  Form 10-K Summary 

SIGNATURES 

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PART I 

Unless  otherwise  indicated  in  this  report,  “Merit,”  “we,”  “us,”  “our,”  and  similar  terms  refer  to  Merit  Medical 
Systems, Inc. and our consolidated subsidiaries. 

DISCLOSURE REGARDING FORWARD-LOOKING STATEMENTS 

This report includes “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as 
amended, and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). All statements in 
this report, other  than  statements of historical  fact,  are  “forward-looking statements” for purposes  of  these  provisions, 
including any projections of earnings, revenues or other financial items, any statements of the plans and objectives of our 
management for future operations, any statements concerning proposed new products or services, any statements regarding 
the integration, development or commercialization of the business or any assets acquired from other parties, any statements 
regarding future economic conditions or performance, and any statements of assumptions underlying any of the foregoing. 
In some cases, forward-looking statements can be identified by the use of terminology such as “may,” “will,” “expects,” 
“plans,” “anticipates,” “intends,” “seeks,” “believes,” “estimates,” “potential,” “forecasts,” “continue,” or other forms of 
these words or similar words or expressions, or the negative thereof or other comparable terminology. Although we believe 
that the expectations reflected in the forward-looking statements contained herein are reasonable, there can be no assurance 
that such expectations or any of the forward-looking statements will prove to be correct, and actual results will likely 
differ,  and  could  differ  materially,  from  those  projected  or  assumed  in  the  forward-looking  statements.  Investors  are 
cautioned not to unduly rely on any such forward-looking statements. 

All subsequent forward-looking statements attributable to us or persons acting on our behalf are expressly qualified in 
their  entirety  by  these  cautionary  statements.  Our  actual  results  will  likely  differ,  and  may  differ  materially,  from 
anticipated results. Financial estimates are subject to change and are not intended to be relied upon as predictions of future 
operating results. All forward-looking statements included in this report are made as of the date hereof and are based on 
information available to us as of such date. We assume no obligation to update any forward-looking statement. If we do 
update or correct one or more forward-looking statements, investors and others should not conclude that we will make 
additional updates or corrections.  

Our future financial condition and results of operations, as well as any forward-looking statements, are subject to inherent 
risks and uncertainties. Please see Item 1A “Risk Factors” for a discussion of these risks and uncertainties. 

DISCLOSURE REGARDING TRADEMARKS 

This  report  includes  trademarks,  tradenames  and  service  marks  that  are  our  property  or  the  property  of  other  third 
parties. Solely  for  convenience,  such  trademarks  and  tradenames  sometimes  appear  without  any  “™”  or  “®”  symbol. 
However, failure to include such symbols is not intended to suggest, in any way, that we will not assert our rights or the 
rights of any applicable licensor, to these trademarks and tradenames. 

Item 1.   

Business. 

Our Company 

Merit Medical Systems, Inc. is a leading manufacturer and marketer of proprietary medical devices used in interventional, 
diagnostic and therapeutic procedures, particularly in cardiology, radiology, oncology, critical care and endoscopy. We 
strive  to  be  the  most  customer-focused  company  in  healthcare.  Each  day  we  are  determined  to  make  a  difference  by 
understanding our customers’ needs and innovating and delivering a diverse range of products that improve the lives of 
people and communities throughout the world. We believe that long-term value is created for our customers, employees, 
shareholders, and communities when we focus outward and are determined to deliver an exceptional customer experience. 

Merit Medical Systems, Inc. was founded in 1987 by Fred P. Lampropoulos, Kent W. Stanger, Darla Gill and William 
Padilla. Initially we focused our operations on injection and insert molding of plastics. Our first product was a specialized 
control  syringe  used  to  inject  contrast  solution  into  a  patient’s  arteries  for  a  diagnostic  cardiac  procedure  called  an 

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angiogram. Since that time, our products and product lines have expanded substantially, both through internal research 
and development projects and through strategic acquisitions. 

Business Strategy 

Our business strategy focuses on five target areas as follows: 

• 

• 

• 

enhancing global growth and profitability through research and development, sales model optimization, cost 
discipline and operational focus; 
optimizing  our  operational  capability  through  lean  processes,  cost  effective  environments  and  asset 
utilization; 
targeting  high-growth,  high-return  opportunities  by  understanding,  innovating  and  delivering  in  our  core 
divisions; 

•  maintaining  a  highly  disciplined,  customer-focused  enterprise  guided  by  strong  core  values  to  globally 

address unmet or underserved healthcare needs; and 
creating sustainability of our business for our employees, shareholders and community. 

• 

We conduct our operations through a number of domestic and foreign subsidiaries and representative offices. Our principal 
offices are located at 1600 West Merit Parkway, South Jordan, Utah, 84095, and our telephone number is (801) 253-1600. 
We maintain an internet website at www.merit.com. 

COVID-19 

During the last three years, COVID-19 has had an unsteady but significant impact on our business, suppliers, customers, 
employees,  families  and  communities.  Measures  designed  to  contain  the  virus,  including  travel  bans  and  restrictions, 
border closures, quarantines, shelter-in-place orders, business limitations and shutdowns continued during portions of the 
year ended December 31, 2022.  

In efforts to contain the spread of the virus, many of our hospital customers prioritized their efforts on their COVID-19 
response, diverting their focus and resources away from their normal operations and restricting access to their sites. In 
2022, these restrictions were generally reduced, and we were able to achieve the highest annual revenue in the history of 
the  Company.  However,  lingering  effects  continue,  including  unpredictable  freight  and  other  logistical  expenses  and 
obstacles, and the responses of government authorities and our customers vary from region to region. Please refer to the 
discussion of the risks and uncertainties associated with COVID-19 under the heading “The COVID-19 pandemic and 
related ongoing implications have negatively impacted our business and operations around the world and may continue 
to materially  and  adversely  impact  our  business,  operations  and  financial  results.”  set  forth  below  in  Item  1A  “Risk 
Factors.” 

Products 

We design, develop, market and manufacture, through our own operations and contract manufacturers, medical products 
that offer a high level of quality, value and safety to our customers, as well as the patients they serve. Our products are 
used  in  the  following  clinical  areas:  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;  breast  cancer  surgery,  outpatient  access  centers;  intensive  care;  computed  tomography;  ultrasound;  and 
interventional gastroenterology.  

The success of our products is enhanced by the extensive experience of our management team in the healthcare industry, 
our experienced direct sales force and distributors, our ability to provide custom procedural solutions such as kits, trays  

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and procedural packs at the request of our customers, and our dedication to offering facility-unique solutions in the markets 
we serve worldwide. 

We conduct our business through two operating segments: cardiovascular (which includes peripheral intervention, cardiac 
intervention,  custom  procedural  solutions,  and  original  equipment  manufacturer  (“OEM”))  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. 

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

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.  Our  cardiovascular  segment  includes  the  following  product  categories:  peripheral  intervention, 
cardiac intervention, custom procedural solutions, and OEM.  

Peripheral Intervention 

Our  peripheral  intervention  products  support  the  minimally  invasive  diagnosis  and  treatment  of  diseases  in  peripheral 
vessels and organs throughout the body, excluding the heart. 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). The principal product offerings in 
our access (peripheral) portfolio include our:  

•  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;  
•  Broad offering of peritoneal dialysis catheters, accessories and implantation kits for home dialysis therapy; 

and 

•  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).  

The products in our angiography portfolio are used to identify blockages and other disease states in the blood vessel. The 
principal product offerings in our angiography portfolio include our:  

•  Extensive  line  of  Merit  Laureate®  Hydrophilic  Guide  Wires,  a  smooth-surface  guide  wire  designed  to 

minimize friction and promote rapid catheter exchanges;  

•  Our  newest  offering  of  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; and 

•  Performa Vessel Sizing Catheters for vessel measurement. 

We offer a broad line of drainage products. The principal product offerings in our drainage portfolio include our:  

•  Aspira® Pleural Effusion Drainage and Aspira® Peritoneal Drainage Systems, a compassionate treatment 
option for end-stage cancer, allowing patients to spend more time at home by reducing the need for frequent 
hospital visits to treat their drainage needs; 

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•  Family  of  ReSolve®  Drainage  Catheters,  including  our  ReSolve  ConvertX®  Stent  System  and  ReSolve 

Mini™ Locking Drainage Catheter, and our related tubing sets and drainage bag;  

•  One-Step® and Valved One-Step® Drainage Catheters, sold individually and in kits, for quickly removing 

unwanted fluid accumulation; and 

•  Revolution™  Catheter  Securement  Device  and  StayFIX®  Fixation  Device,  used  to  stop  migration, 

movement and accidental removal of percutaneous catheters.  

The principal product offerings in our delivery systems portfolio include our:  

•  SwiftNINJA® Steerable Microcatheter, an advanced microcatheter with a 180-degree articulating tip, sold 
through our exclusive worldwide distribution agreement (excluding Japan) with SB-Kawasumi Laboratories, 
Inc.;  

•  Merit  Maestro®  and  Merit  Pursue™  Microcatheters,  small  microcatheters  designed  for  pushability  and 

trackability through small and tortuous vessels; and 

•  True Form™ Reshapable Guide Wire, designed to be reshaped multiple times, reducing the need for multiple 

guide wires. 

Our  embolotherapy  products  treat  disease  by  blocking  or  slowing  the  flow  of  blood  into  the  arteries  or  delivering 
chemotherapy  drugs  in  the  treatment  of  primary  and  metastatic  liver  cancer.  The  principal  product  offerings  in  our 
embolotherapy portfolio include our:  

•  Embosphere® Microspheres, a highly studied, round embolic for consistent and predictable results; and  
•  HepaSphere® Microspheres, soft embolics with a consistent cross-sectional diameter for predictable, flow-

directed targeting. 

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. The principal product offerings in our 
intervention (peripheral) portfolio include our:  

•  ClariVein® Specialty Infusion Catheter which is designed for controlled 360-degree dispersion of physician 

specified agents to the peripheral vasculature;  

•  Dynamis AV™ PTA Dilatation Catheter, a line of balloon catheters that facilitates the opening of blockages 

located in the arteriovenous system of dialysis patients; 

•  Q50X™, Q50® and Q50® Plus Stent Graft Balloon Catheters, a line of catheters that treat abdominal and 

thoracic endovascular aortic repair procedures and reinterventions;  

•  Fountain®  Infusion  System  and  Mistique®  Infusion  Catheters,  a  line  of  catheters  that  treat  arterial  and 

hemodialysis graft occlusions and deep vein thrombosis; and 

•  EN Snare® and One Snare® Endovascular Snare Systems, a complete line of snares designed to manipulate, 

capture and retrieve foreign material in the body. 

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  primary  product  offerings  in  the  vertebral 
augmentation and radiofrequency ablation portfolios include our:  

•  STAR™  Tumor  Ablation  System,  designed  to  provide  palliative  treatment  of  painful  metastatic  spinal 

tumors in cancer patients by targeted radiofrequency ablation; 

•  Arcadia® Steerable and straight balloons, designed to achieve controlled, precise, targeted cavity creation in 

vertebral augmentation procedures; and 

•  StabiliT® MX Vertebral Augmentation System, which uses our inflation devices to deliver bone cement. 

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The bone biopsy systems portfolio contains a full offering of manual bone biopsy products, including our Madison™, 
Huntington™, Kensington™, Preston™ and Westbrook™ biopsy products. 

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. 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; and  
•  SAVI®  Brachytherapy,  a  precise,  targeted  approach  to  accelerated  partial  breast  irradiation  with  lower 

toxicities and reduced treatment duration.  

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).  

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. 

The principal product offerings in our angiography portfolio include our InQwire® Guide Wires and Performa Diagnostic 
and Ultimate™ catheters for femoral and radial procedures. 

Electrophysiology  is  the  study  of  diagnosing  and  treating  abnormal  electrical  activities  of  the  heart.  Cardiac  rhythm 
management  (“CRM”)  is  the  field  of  cardiac  disease  therapy  that  relates  to  the  diagnosis  and  treatment  of  cardiac 
arrhythmias  or  the  improper  beating  of  the  heart.  The  principal  product  offerings  in  our  electrophysiology  and  CRM 
portfolio include our:  

•  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; and  
•  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.  

The product offerings in our fluid management portfolio include manifolds, control syringes and tubing. 

The principal product offerings in our hemostasis portfolio include our Prelude SYNC EVO™ and PreludeSYNC Distal™ 
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. 

5 

 
 
 
 
 
 
 
 
 
 
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. Our kit and 
pack solutions can optimize efficiency and reduce cost and waste. 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 

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.  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. 

Our gastroenterology products include a complete range of innovative, gastrointestinal solutions. Our primary product 
offerings in our gastroenterology portfolio include our: 

•  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; and 

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

tract. 

Our  pulmonary  products  consist  of  laser-cut  tracheobronchial  stents,  advanced  over-the-wire  and  direct  visualization 
delivery systems and dilation balloons to endoscopically dilate strictures. 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. 

Marketing and Sales 

Target Market/Industry. Our principal target markets are peripheral intervention, cardiac intervention, interventional 
oncology,  critical  care  and  endoscopy.  Within  these  markets  our  products  are  used  in  the  following  clinical  areas: 
diagnostic and interventional cardiology; interventional radiology; neurointerventional radiology; vascular, general and 

6 

 
 
 
thoracic surgery; electrophysiology; cardiac rhythm management; interventional pulmonology; interventional nephrology; 
orthopedic  spine  surgery;  interventional  oncology;  pain  management;  breast  cancer  surgery;  outpatient  access  centers; 
intensive care; computed tomography; ultrasound; and interventional gastroenterology. 

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. 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. We derive a large percentage of our revenues from sales of products used during percutaneous diagnostic 
and interventional procedures such as angiography, angioplasty and stent placement, and we intend to pursue additional 
sales growth by building on our existing market position in both core technology and accessory products. 

Marketing  Strategy. Traditionally,  as  part  of  our  product  sales  and  marketing  efforts,  we  attend  major  medical 
conventions throughout the world pertaining to our target markets and invest in market development including physician 
training, peer-to-peer education, and patient outreach. Due to the various restrictions imposed in response to COVID-19, 
during 2020 and 2021 most medical conventions in which we participated were virtual meetings; however, many of the 
groups hosting those conventions resumed in-person meetings during 2022. Additionally, we are building out digital and 
direct-to-customer programs to increase awareness of our products, and we work closely with major healthcare facilities 
and physicians involving our primary target markets in the areas of training, therapy awareness programs, clinical studies 
and ongoing product research and development. In general, our target markets are characterized by rapid change resulting 
from technological advances and scientific discoveries. We plan to continue to develop and launch innovative products to 
support clinical trends and to address the increasing demands of these markets. 

Product Development Strategy. Our product development is focused on identifying and introducing a regular flow of 
profitable  products  that  meet  customer  needs. To  stay  abreast  of  customer  needs,  we  work  closely  with  health  care 
professionals working in the fields of medicine in which we offer or develop products. Suggestions for new products and 
product improvements may also come from engineers, marketing and sales personnel, physicians and technicians who 
perform clinical procedures. 

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. 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. Sales of our products in the U.S. accounted for 57% of our net sales for each of the years 
ended  December 31, 2022,  2021  and  2020,  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. 

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  2022,  our  international  sales  grew  7.4%  over  our  2021 
international sales and accounted for 43% of our net sales. Our largest non-U.S. market is China, which represented 13% 
of our net sales in 2022 and reported net sales of $149.3 million, $138.2 million, and $113.2 million for the years ended 
December 31, 2022, 2021 and 2020, respectively. We maintain a distribution center and administrative office in Beijing. 
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. 

7 

Beginning in 2020, we experienced a significant disruption of our business throughout the world as a result of COVID- 19, 
and this disruption continued through 2021 and 2022. We are unable to calculate the full impact of COVID-19 on our 
business, and we are unable to predict whether we will continue to be affected by it, but we experienced a material adverse 
impact on our global operations and financial condition during 2020. In 2021, we saw growth in global sales compared to 
2020 as the demand for our products increased when many of the medical procedures delayed from 2020 were performed 
and the restrictions put in place in response to the pandemic were generally reduced. That trend continued during 2022, 
and we were able to achieve the highest annual revenue in the history of the Company. For further discussion of the risks 
and uncertainties associated with COVID-19, please refer to disclosure under the heading “The COVID-19 pandemic and 
related ongoing implications have negatively impacted our business and operations around the world and may continue 
to materially and adversely impact our business, operations and financial results.” set forth in Item 1A “Risk Factors.” 

In Europe, the Middle East and Africa (“EMEA), we have both direct and modified direct sales operations. Such sales 
operations are active throughout the region, including the largest markets in Western, Southern, Central and Eastern Europe 
and the emerging markets within EMEA. 

Our direct sales personnel are principally engaged in each of our divisions. Marketing teams responsible for each division 
operate clinical education programs, often directed by leading subject matter personnel, who provide technical instruction 
on  techniques  and  therapies  to  physicians,  nurses  and  technologists.  We  are  currently  conducting  education  programs 
specific to radial access, spinal intervention, surgical grafts, wire-free tumor localization, electrophysiology, endoscopy, 
dialysis and embolism. 

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. Foreign Corrupt Practices Act, as well 
as all applicable laws and regulations in their respective countries. 

We consider training to be a critical factor in the success of our sales force. Members of our sales force are trained by our 
clinical marketers, our staff professionals, consulting physicians, and senior field trainers in their respective territories. 

OEM  Sales. Our  global  OEM  Division  sells  components  and  finished  devices,  including  molded  components,  sub-
assembled  goods,  custom  kits  and  bulk  non-sterile  goods,  to  medical  device  manufacturers.  These  products  may  be 
combined with other components and products from other companies and sold under a Merit or customer label. Products 
sold by our OEM Division can be customized and enhanced to customer specifications, including packaging, labeling and 
a variety of physical modifications. Our OEM Division serves customers with a staff of regional sales representatives 
based in the U.S., Europe and Asia, and a dedicated OEM Engineering and Customer Service Group. 

Customers 

We provide products to hospitals and alternate site-based physicians, technicians and nurses. Hospitals and acute care 
facilities in the U.S. purchase our products through our direct sales force, distributors, OEM partners, or custom procedure 
tray manufacturers who assemble and combine our products in custom kits and packs. Outside the U.S., hospitals and 
acute care facilities generally purchase our products through our direct sales force, or, in the absence of a sales force, 
through independent distributors or OEM partners. 

Research and Development 

Our research and development operations have been central to our historical growth, and we believe they will be critical 
to our continued growth. In recent years, our commitment to innovation 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 2022, our Chief Executive Officer and our Executive Vice President of Global Research & Development worked closely 

8 

with our sales and marketing teams to incorporate feedback from physicians and clinicians in the field, which contributed 
to innovative new products and improvements to our existing products. 

In 2022, we completed projects that resulted in the newest additions to our product lineup: Prelude Roadster®, Sync EZ™, 
Safeguard Focus Cool™, and Scout BX™. 

Currently, we have research and development facilities in California, Texas, Utah, Ireland, France, and Singapore. 

Manufacturing 

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

Given the specialization of our manufacturing personnel and processes in our Utah and Ireland facilities, we possess the 
capability to strategically shift the manufacture of more technologically advanced products to those facilities and use the 
manufacturing capacity of our other facilities for more commoditized products. The actual determination of manufacturing 
location  will  be  based  upon multiple  factors,  including  technological  capabilities,  market  demand,  acquisition  and 
integration activities and economic and competitive conditions. 

We  currently  produce  and  package  all  of  our  embolic  products.  Manufacturing  of  our  embolic  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. 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 and Australia. 

Competition 

The medical products industry is highly competitive. Many of our competitors are much larger than us 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; 
ultrasound; and interventional gastroenterology. 

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. We believe our products are attractive to customers due to 
their innovative design, the quality of materials and workmanship, clinical performance, and our strong focus on customer 
needs, and our prompt attention to customer requests. 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; 
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”). 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 

9 

 
 
 
 
primary competitors in our oncology market are BD, Hologic, Inc., Argon Medical Devices, Inc. and Cook Medical. 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. 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. 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. 

Sources and Availability of Raw Materials 

Raw  materials  essential  to  our  business  are  generally  purchased  worldwide  and  are  normally  available  in  quantities 
adequate to meet the needs of our business. Where there are exceptions, the temporary unavailability of those raw materials 
has not historically had a material adverse effect on our financial results; 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.” set forth in Item 1A “Risk Factors.”   

Proprietary Rights and Litigation 

We rely on a combination of patents, trade secrets, trademarks, copyrights and confidentiality agreements to protect our 
intellectual property. We have a number of U.S. and foreign-issued patents and pending patent applications, including 
rights to patents and patent applications acquired through strategic transactions, which relate to various aspects of our 
products and technology. 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, 2022,  we  owned 
approximately 1,600 U.S. and international patents and patent applications. 

Additionally, we hold exclusive and non-exclusive licenses to a variety of third-party technologies covered by patents and 
patent  applications.  In  the  aggregate,  our  intellectual  property  assets  are  critical  to  our  business,  but  no  single  patent, 
trademark or other intellectual property asset is of material importance to our business. 

The Merit® name and logo are trademarks in the U.S. and other countries. In addition to the Merit name and logo, we 
have used, registered or applied for registration of other specific trademarks and service marks to help distinguish our 
products, technologies and services from those of our competitors in the U.S. and foreign countries. See Item 1. “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, 2022, we owned approximately 650 U.S. and foreign trademark registrations and trademark applications. 

There is substantial litigation regarding patents and other intellectual property rights in the medical device industry. At 
any given time, we may be involved as either a plaintiff or a defendant, as well as a counter-claimant or counter-defendant, 
in patent, trademark, and other intellectual property infringement actions. 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. 

10 

 
 
 
Regulation  

Corporate Integrity Agreement. 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. The CIA requires, among other matters, that we (i) maintain a compliance officer, a compliance 
committee, board review and oversight of certain federal healthcare compliance matters and compliance and disclosure 
programs; (ii) establish compliance policies and procedures to meet the requirements of all federal health care programs 
and the U.S. Food and Drug Administration (“FDA”); (iii) provide management certifications and compliance training 
and education; (iv) engage an independent review organization to conduct a thorough review of our systems, policies, 
processes and procedures related to promotional materials, product evaluations, consulting agreements, trainings provided 
to healthcare professionals, sponsorships, grants and charitable contributions; (v) implement a risk assessment and internal 
review process; (vi) establish a disclosure program for whistleblowers; (vii) increase oversight of the interactions between 
our  sales  personnel  and  healthcare  providers;  and  (viii)  report  or  disclose  certain  events  and  physician  payments.  We 
recently  completed  our  second  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. 

The  foregoing  description  of  the  CIA  is  qualified  in  its  entirety  by  the  full  terms  of  the CIA,  which  is  attached 
as Exhibit 10.44 hereto and incorporated herein by reference. 

Regulatory Approvals. 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  other  foreign  governmental  agencies  can  be  lengthy  and  the 
requirements may differ. In particular, in May 2017, the EU 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 MDD prior to May 26, 2021 may continue to be placed on the market for the remaining 
validity of the certificate or until May 26, 2024, whichever is first. After the expiry of any applicable transitional period, 
only devices that have been CE marked under MDR may be placed on the market in the EU. On January 6, 2023, the EU 
Commission  proposed  a  draft  amendment  to  the  MDR  which  would  extend  the  transitional  period,  thus  allowing  for 
additional time to transition to the new requirements of the MDR. At time of publication, the amendment had not been 
through the entire legislative process, leaving some uncertainty as to whether or not it would be approved. 

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 EU. 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. MDR includes increasingly stringent requirements in 
multiple areas, such as pre-market clinical evidence, review of high-risk devices, labeling and post-market surveillance. 
Under MDR, pre-market clinical data will now be required to obtain CE Mark approval for high-risk, new and modified 
medical devices.  

U.S. and global counter-part regulatory approval processes for medical devices are expensive, uncertain and lengthy. 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 receiving of 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 or results of operations. 

11 

 
 
 
 
 
 
 
 
 
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 international 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.  

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  and 
manufacturing  processes,  including  requirements  for  packaging,  labeling,  record  keeping,  personnel  training,  supplier 
controls, design controls, complaint handling, corrective and preventive actions and internal quality system auditing. The 
FDA 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. 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 
the FDA that are necessary for export of our products to foreign countries. Any of these results could have a material 
adverse effect on our business. If one of our suppliers fails to maintain compliance with our quality requirements, we may 
have  to  qualify  a  new  supplier  and  could  experience  manufacturing  delays  as  a  result.  We  also  could  be  subject  to 
injunctions, product seizures, or civil or criminal penalties. 

Labeling and Promotion. Our labeling and promotional activities are also subject to scrutiny by the FDA and foreign 
regulators. Labeling includes not only the label on a device, but also includes any descriptive or informational literature 
that accompanies or is used to promote the device. 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.  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. Allegations of off-label promotion 
can also result in enforcement action by federal, state, or foreign enforcement authorities and trigger significant civil or 
criminal penalties, including exclusion from the Medicare and Medicaid programs and liability under the False Claims 
Act, discussed further below. 

Our product promotion is also subject to regulation by the Federal Trade Commission (the “FTC”), which has primary 
oversight of the advertising of unrestricted devices, including FDA-cleared devices. The Federal Trade Commission Act 
prohibits unfair methods of competition and unfair or deceptive acts or practices in or affecting commerce, as well as 
unfair or deceptive practices such as the dissemination of any  false or misleading advertisement pertaining to medical 
devices. FTC enforcement can result in orders requiring, among other things, limits on advertising, corrective advertising, 
consumer redress, rescission of contracts and such other relief as the FTC may deem necessary. 

In addition, under the federal Lanham Act and similar state laws, competitors and others can initiate litigation relating to 
advertising claims. 

Import Requirements. To import a medical device into the U.S., the importer must file an entry notice and bond with the 
U.S. Bureau of Customs and Border Protection (“CBP”). All devices are subject to FDA examination before release from 
the CBP. Any article that appears to be in violation of the FDCA may be refused admission and a notice of detention and 
hearing may be issued. If the FDA ultimately refuses admission, the CBP may issue a notice for redelivery and assess 
liquidated damages for up to three times the value of the lot. Additionally, the laws of the U.S. require imported articles 
to  have  their  labels  accurately  marked  with  the  appropriate  country  of  origin,  the  violation  of  which  may  result  in 
confiscation, fines and penalties. 

Export  Requirements.  Products  for  export  are  subject  to  foreign  countries’  import  requirements  and  the  exporting 
requirements  of  the  exporting  countries’  regulating  bodies,  as  applicable.  International  sales  of  medical  devices 
manufactured in the U.S. that are not approved or cleared by the FDA for use in the U.S., or are banned or deviate from 
lawful performance standards, are subject to FDA export requirements and we may not be able to export such products. 

12 

 
Foreign countries often require, among other things, an FDA certificate for products for export, also called a Certificate to 
Foreign Government. To obtain this certificate from the FDA, the device manufacturer must apply to the FDA. The FDA 
certifies that the product has been granted clearance or approval in the U.S. and that the manufacturing facilities were in 
compliance with the QSR at the time of the last FDA inspection. 

Additionally, the export of our products is subject to restrictions due to trade and economic sanctions imposed by the U.S., 
the EU and other governments and organizations. The U.S. Departments of Justice, Commerce, State and Treasury and 
other federal agencies and authorities have a broad range of civil and criminal penalties they may seek to impose against 
corporations and individuals for violations of economic sanctions laws, export control laws, and other federal statutes and 
regulations,  including  those  established  by  the  Office  of  Foreign  Assets  Control  (“OFAC”).  Under  these  laws  and 
regulations, as well as other export control laws, customs laws, sanctions laws and other laws governing our operations, 
various government agencies may require export licenses and may seek to impose modifications to business practices, 
including cessation of business activities in sanctioned countries or with sanctioned persons or entities. With the U.S. and 
other countries exploring export sanctions in response to military exercises and escalating tensions in certain parts of the 
world, any such export restrictions may affect the company’s business in certain regions of the world. 

Additional  Post-Market  Requirements.  As  a  medical  device  manufacturer,  we  are  subject  to  other  post-market 
requirements  in  multiple  jurisdictions,  including  (i)  product  listing,  (ii)  establishment  registration,  (iii)  Unique  Device 
Identification (“UDI”),  and  (iv)  reports  of  corrections  and  removals.  We  are  also  subject  to  regulations  that  require 
manufacturers to report to the FDA, or an equivalent foreign regulatory body, any incident in which their device may have 
caused or contributed to a death or serious injury, or has malfunctioned in a way that would likely cause or contribute to a 
death or serious injury if the malfunction of the device or a similar device were to recur. Our obligation to report a complaint 
is triggered on the date on which we become aware of an adverse event and the nature of the event. 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 “Our products 
may  cause  or  contribute  to  adverse  medical  events  that  we  are  required  to  report  to  the  FDA  or  other  governmental 
authorities, and if we fail to do so, we may be subject to sanctions that may materially harm our business.” set forth in 
Item 1A “Risk Factors.” 

Reimbursement. Our products are generally used in medical procedures that are covered and reimbursed by governmental 
payers, such as Medicare, and/or private health plans. In general, these third-party payers cover a medical device and/or 
related procedure in which the device is used only when the payer determines that healthcare outcomes are supported by 
medical evidence and the device and procedure is medically necessary for the diagnosis or treatment of the patient’s illness 
or injury. Even if a device has received clearance or approval for marketing by the FDA or, for uses outside of the U.S., a 
similar foreign regulatory agency, there is no certainty that third-party payers will cover and reimburse for the cost of the 
device and/or related procedures involving the use of the device. Because of increasing cost-containment pressures, some 
private payers in the U.S. and government payers in foreign countries may also condition payment on the cost-effectiveness 
of the device and/or procedure. Even if coverage is available, third-party payers may place restrictions on the circumstances 
in which they provide coverage or may offer reimbursement that is not sufficient to cover the cost of our products. If 
healthcare providers such as hospitals and physicians cannot obtain adequate coverage and reimbursement for our products 
or the procedures in which they are used, this may affect demand for our products and our business, financial condition, 
results of operations, or cash flows could suffer a material adverse impact. 

Anti-Corruption Laws. Our international operations are subject to the Foreign Corrupt Practices Act (the “FCPA”), the 
U.K.  Bribery  Act  and  other  foreign  anti-corruption  laws.  The  FCPA  prohibits  offering,  paying,  or  promising  to  pay 
anything of value to foreign officials for the purpose of obtaining or maintaining an improper business advantage. The 
FCPA also requires that we maintain fair and accurate books and records and devise and maintain an adequate system of 
internal accounting controls. In certain countries, the individuals and entities that we regularly interact with may meet the 
definition of a foreign government official for purposes of the FCPA. As part of our compliance program, we train our 
U.S.  and  international  employees,  and  we  also  train  and  monitor  foreign  third  parties  with  whom  we  contract 
(e.g., distributors), to comply with the FCPA and other anti-corruption laws. Failing to comply with the FCPA or any other 
anti-corruption law could result in fines, penalties or other adverse consequences.  

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As we expand our international operations, we continue to increase the scope of our compliance programs to match the 
risks relating to the potential for violations of the FCPA and other anti-corruption laws. Our compliance program includes 
(i) policies addressing not only the FCPA, but also the provisions of a variety of anti-corruption laws in multiple foreign 
jurisdictions, (ii) provisions relating to books and records that apply to us as a public company, and (iii) effective training 
for our personnel and relevant third parties. 

Transparency Laws. The U.S. Physician Payment Sunshine Act, and similar state laws, include annual reporting and 
disclosure requirements for device manufacturers aimed at increasing the transparency of the interactions between device 
manufacturers  and  healthcare  providers.  Reports  submitted  under  these  requirements  are  placed  in  a  public  database. 
Several other jurisdictions outside the U.S. have also adopted or begun adopting similar transparency laws. In addition to 
the burden of establishing processes for compliance, if we fail to provide these reports, or if the reports we provide are not 
accurate, we could be subject to significant penalties. 

Anti-Kickback  Statutes.  The  federal  Anti-Kickback  Statute  prohibits  persons  and  entities  from,  among  other  things, 
knowingly and willfully offering or paying remuneration, directly or indirectly, to induce the purchase, order, lease, or 
recommendation of a good or service for which payment may be made in whole or part under a federal healthcare program 
such as Medicare or Medicaid, unless the arrangement fits within one of several statutory exemptions or regulatory “safe 
harbors.” The definition of remuneration has been broadly interpreted to include anything of value, including, for example, 
gifts, discounts, the furnishing of supplies or equipment, credit arrangements, payments of cash and waivers of payments. 
Violations  can  result  in  significant  penalties,  imprisonment  and  exclusion  from  Medicare,  Medicaid  and  other  federal 
healthcare programs. Exclusion of a manufacturer would preclude any federal healthcare program from paying for the 
manufacturer’s  products.  Under  the  Affordable  Care  Act,  a  violation  of  the  Anti-Kickback  Statute  is  deemed  to  be  a 
violation of the False Claims Act, which is discussed in more detail below. A party’s failure to fully satisfy the obligations 
of a regulatory “safe harbor” provision may result in increased scrutiny by government enforcement authorities. 

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. 

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. 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 Civil False Claims Act can be violated without actual knowledge and only requires reckless disregard or 
deliberate ignorance, while the Criminal False Claims Act requires a higher knowledge standard of actual knowledge and 
intent to violate. Manufacturers can be held liable under the False Claims Acts, even if they do not submit claims to the 
government,  if  they  are  found  to  have  caused  the  submission  of  false  claims  (e.g.,  by  third  parties  such  as  healthcare 
providers). The Civil False Claims Act also includes whistleblower provisions that allow private citizens to bring suit 
against an entity or individual on behalf of the U.S. and to recover a portion of any monetary recovery. Many of the recent, 
highly publicized settlements in the healthcare industry relating to sales and marketing practices have been cases brought 
under the Civil False Claims Act. Most states also have adopted statutes or regulations similar to the federal laws, which 
apply to items and services reimbursed under Medicaid and other state programs. Sanctions under the federal False Claims 
Acts and similar state laws may include civil monetary penalties, treble damages, criminal fines and/or imprisonment. 

Labor Standards Laws. We are also subject to corporate social responsibility (“CSR”) laws and regulations which require 
us to monitor the labor standards in our supply chain, including the California Transparency in Supply Chains Act, the UK 
Modern Slavery Act, and U.S. Federal Acquisition Regulations regarding Combating Trafficking in Persons. These CSR 
laws  and  regulations  may  impose  additional  processes  and  supplier  management  systems  and  have  led  certain  key 
customers to impose additional requirements on medical device companies, including audits, as a prerequisite to selling 
products to such customers, which could result in increased costs for our products, the termination or suspension of certain 
suppliers, and reductions in our margins and profitability. 

14 

Privacy and Security. Due to Merit’s global presence, we are impacted by the privacy and data security requirements at 
the international, federal, state and regional level, as well as on an industry specific basis. More privacy and data security 
laws  and  regulations  are  being  adopted  and  enforced,  with  increasingly  significant  fines  and  financial  penalties  for 
violations in the jurisdictions in which we conduct our operations.  Compliance with these evolving and complex data 
privacy  and  cybersecurity  laws  and  regulations  has  resulted  in,  and  will  likely  continue  to  result  in  new  compliance 
challenges and increased costs. Our business relies on the secure electronic transmission, storage and hosting of personal 
and sensitive personal information, including protected health information, financial information, intellectual property and 
other sensitive information related to our customers and workforce. 

Internationally,  Merit  is  impacted  by  a  number  of  stringent  privacy  regimes,  such  as  the  General  Data  Protection 
Regulation (“GDPR”) in the EU and the Personal Information Protection Law (“PIPL”) in China,  GDPR applies uniformly 
across the EU and includes, among other things, a requirement for prompt notice of data breaches to the owner of the 
personal  data  and  to  supervisory  authorities  in  certain  circumstances,  and  the  imposition  of  significant  fines  for  non-
compliance. GDPR also requires companies based outside of the EU but processing personal data of individuals residing 
in  the  EU  to  comply  with  EU  privacy  and  data  protection  rules.  Non-compliance  could  result  in  the  imposition  of 
significant fines, penalties, and/or orders to stop non-compliant activities. 

GDPR provides for a harmonization of the data protection regulations throughout the EU. It imposes a strict data protection 
compliance regime with severe penalties and includes rights such as the “portability” of personal data and the right of 
erasure of personal data for the data subject. Although GDPR applies across the EU without a need for local implementing 
legislation, it contains a number of opener clauses enabling the EU member states to provide for additional legislation. In 
addition,  local  data  protection  authorities  still  have  the  ability  to  interpret  GDPR,  which  has  the  potential  to  create 
inconsistencies on a country-by-country basis.  

As a consequence of Brexit, GDPR no longer directly applies in the United Kingdom. However, the UK has adopted its 
own UK General Data Protection Regulation (“UKGDPR”).  This regulation came into effect on January 1, 2021 and is 
generally similar to GDPR, while at the same time accommodating applicable laws in the UK.  

The People’s Republic of China has introduced a comprehensive personal information protection regime by establishing 
a  unified,  cross-sector  legislation,  as  the  EU  does  with  GDPR.  This  legislation,  called  PIPL,  went  into  effect  on 
November 1,  2021,  and  has  many  aspects  that  are  similar  to  GDPR.  The  PIPL  sets  rules  for  personal  information 
processing  activities  such  as collection,  use,  sharing,  transfer,  and  disclosure  of personal  information  in  China.  It  also 
applies to personal information processing activities outside of China if relevant business operators (a) aim at providing 
products or services to individuals in China; or (b) engage in analyzing and evaluating the behavior of individuals in China. 
Among other provisions, the PIPL requires companies identified as personal information processors (which can be viewed 
as  equivalent  to  data  controllers  under  GDPR)  to  obtain  informed  consents  from  the  data  subjects  for  the  processing 
activities of their personal information, and separate consents under certain circumstances such as cross-border transfer of 
personal information. The PIPL also requires storage of personal information locally in China if the company is certified 
as a critical information infrastructure operator or processing personal information exceeding a certain volume threshold. 
Further, the PIPL grants statutory rights to data subjects, such as the right to information, the right to withdraw consents, 
the right of data portability, and the right to refuse automated decision-making. In addition, the PIPL also imposes a number 
of new administrative requirements on the personal information processors, including, among others, designating a data 
protection officer if certain conditions are met, signing data processing agreements with entrusted processors (which can 
be viewed as equivalent to data processors under GDPR), preparing data breach notices, conducting a personal information 
impact  assessment  as  required,  and  obtaining  regulatory  approval  for  certain  cross-border  data  transfer  activities. 
Violations  of  the  PIPL  may  incur  severe  penalties,  revocation  of  the  company’s  license  to  do  business  in  China,  and 
personal liabilities for company executives. As the PIPL is new and relevant implementation rules are to be finalized and 
released,  we  are  in  the  process  of  implementing  changes  to  our  business  practices  to  comply  with  the  PIPL  while 
monitoring further developments in the law. 

In  the  U.S.,  the  collection,  maintenance,  protection,  use,  transmission,  disclosure  and  disposal  of  certain  personal 
information and the security of medical devices are regulated at the U.S. federal and state, international and industry levels. 
U.S.  federal  and  state  laws  protect  the  confidentiality  of  certain  patient  health  information,  including  patient  medical 
records (“PHI”), and restrict the use and disclosure of patient health information by healthcare providers. “Privacy” and 

15 

“Security” Rules under the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), as amended, and the 
Health Information Technology for Economic and Clinical Health Act (the “HITECH Act”), govern the use, disclosure, 
and security of protected health information by  “Covered Entities” (which are healthcare providers,  health plans and 
healthcare clearinghouses), and by their “Business Associates” (which is anyone that performs a service on behalf of a 
Covered Entity involving the use or disclosure of PHI and is not a member of the Covered Entity’s workforce). Regulations 
under these laws establish standards, including standards regarding the privacy and security of PHI and breach notification 
requirements.  The  U.S.  Department  of  Health  and  Human  Services  (through  the  Office  of  Civil  Rights)  has  direct 
enforcement authority against Covered Entities and Business Associates with respect to both the Security and Privacy 
Rules, including both civil and criminal liability. Although Merit is a healthcare provider, Merit is not a Business Associate 
under the  HIPAA/HITECH Act. Our risk is therefore significantly reduced because we do not create, receive, maintain, 
have access to, use, disclose or transmit PHI.  Many state laws also regulate the use and protection of PHI by healthcare 
providers and may require notification in the event of a breach of such information.  Merit may be subject to these laws in 
certain instances. 

With the advent of digital technology, artificial intelligence, social media, and the speed at which information moves, the 
protection and security of data has become an increasingly important public, media and legislative concern. As a result, 
and in addition to the U.S. federal regulation of PHI, a number of states have also adopted laws and regulations that may 
affect our privacy and data security practices for other kinds of personally identifiable information, such as state laws that 
govern  the  use,  disclosure  and  protection  of  personal  information  and  sensitive  personal  information  (such  as  social 
security numbers). State consumer protection laws may also establish privacy and security standard for the storage, use 
and management of personally identifiable information, including information related to consumers or employees (which 
include job applicants, employees, owners, officers, directors, and medical staff members of Merit). 

As  of  December  31  2022,  five  U.S.  states  had  enacted  comprehensive  data  privacy  laws.  In  general,  these  state  laws 
(California, Colorado, Connecticut, Utah and Virginia) give residents the right to obtain their personal information from 
companies, request to have their personal information deleted, and opt out of having that information sold to third parties. 
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. 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. 

16 

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. Noncompliance with such laws or regulations could result in the imposition of fines, penalties, or orders to stop 
noncompliant activities, as well as harm to reputation, or other consequences. If our customers were to reduce their use of 
our products and services as a result of these concerns, our business could be materially harmed. As noted above, we are 
also subject to the possibility of security and privacy breaches, which themselves may result in a violation of these privacy 
laws. 

CARES Act. On March 27, 2020, the Coronavirus Aid, Relief, and Economic Security Act (“CARES Act”) was signed 
into  law.  The  $2.2  trillion  economic  stimulus  bill  contains  numerous  tax  law  changes.  The  CARES  Act  established  a 
program  with  provisions  to  allow  U.S.  companies  to  defer  the  employer’s  portion  of  social  security  taxes  between 
March 27, 2020 and December 31, 2020 and pay such taxes in two installments in 2021 and 2022. As permitted by the 
CARES Act we deferred payment of the employer’s portion of social security payroll tax payments and made a payment 
equal to one half of the deferred amount during each of the years ended December 31, 2021 and 2022. 

Seasonality 

Our worldwide sales have not historically reflected a significant degree of seasonality; however, customer purchases have 
historically  been  lower  during  the  third  quarter  of  the year,  as  compared  to  other  quarters.  This  reflects,  among  other 
factors, lower demand during summer months in countries in the northern hemisphere. 

Sustainability 

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. 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.  

The majority of our products are disposable medical devices and are generally disposed of after a single use due primarily 
to the risks of exposing patients to bloodborne pathogens capable of transmitting disease or other potentially infectious 
materials.  Additionally,  repeated  sterilization  to  address  such  risks  is  not  possible  because  it  may  adversely  affect  the 
quality of the materials used in many of our products and result in the failure of our product to function properly if used 
in multiple medical procedures. 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.  

We have identified our sustainability opportunities, and have developed areas of focus where we are positioned to make a 
positive impact. These include programs designed to reduce waste, improve efficiencies, reduce greenhouse gas emissions, 
and protect the environment. Our sustainability values in action include: 

• 

• 

• 

achievement of ISO 14001 certification at all of our largest manufacturing facilities (seven in scope) with 
the goal of continual improvement of our environmental management system (ISO 14001 is the international 
standard that specifies requirements for an effective environmental management system); 
achievement of ISO 45001 certification at all of our largest manufacturing facilities (seven in scope) with 
the goal of continual improvement to our occupational health and safety management system (ISO 45001 is 
the international standard that specifies requirements for an effective safety management system); 
achievement of ISO 50001 certification at five of our largest manufacturing facilities (seven in scope), and 
our goal is to achieve ISO 50001 certification at all our in scope manufacturing facilities by the end of 2024 
(ISO  50001  is  the  international  standard  that  specifies  requirements  for  an  effective  energy  management 
system);  

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• 

• 

• 

• 

• 

• 

• 
• 

• 

• 

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; 
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; 
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 we are working to implement this program at our largest manufacturing facilities 
in South Jordan, Utah and Tijuana, Mexico, with plans to continue the roll-out to other sites thereafter; 
recycling programs where our employees recycle materials, including food waste, paper, plastic, cardboard, 
food waste and beverage containers, scrap metal, and pallets, and re-use of our plastic scrap waste leftover 
from the manufacturing process of our molded parts; 
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; 
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 ESG 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.  

Human Capital Management 

As of December 31, 2022, we had 6,846 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  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. 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.  

18 

 
 
 
 
 
 
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 engagement of our workforce is critical to delivering on our competitive strategy, and we 
place high importance on informed and engaged employees. 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. 
In partnership with the Gallup organization, in 2022 we launched our first ever global employee engagement survey. 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.  

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. That 
is  why  we  provide  all  our  employees  with  competitive  benefit  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 eighth consecutive year of zero health care plan cost increases for our U.S. employees who participate in our 
group healthcare plans. Our benefits 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. 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 
and  engagement. To  improve  employee  performance,  we  have  begun  building  out  a  global  performance  management 
program which will be officially launched in 2023 alongside our new 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. 

Community. 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. 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. 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. In addition, we have a Chief Wellness Officer 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. 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. Some programs include suicide prevention awareness, on-site 
diabetes screenings, mental health awareness, lifestyle modification to prevent diseases, tobacco cessation, breast cancer 
awareness, and our Smart Choice meal program designed by our onsite nutritionist and chef to provide free heart healthy 
meals to employees in our Utah headquarters. 

COVID-19  Response;  Health  and  Safety.  During  the  COVID-19  pandemic,  the  majority  of  our  manufacturing 
employees continued to work from our facilities, where we adopted health screening, implemented social distancing and 
personal  protective  equipment  requirements,  enhanced  food  service,  cleaning  and  sanitation  procedures,  and  modified 
workspaces to reduce the potential for disease transmission, and implemented a COVID-19 vaccine mandate for our U.S. 

19 

  
 
 
 
 
 
employees. During 2022 most employees who do not require access to our facility to perform their work continued to work 
remotely, without a significant impact to productivity.  

Information Security 

We maintain strong cybersecurity systems to guard against unauthorized access, malicious software, corruption of data, 
disruption of our networks and systems and unauthorized release of confidential information. We employ an experienced 
and dedicated information security team, follow industry best practices, and work with our employees globally to create 
awareness and mitigate cyber risk. On an ongoing basis, we assess risks and implement procedures and practices designed 
to  improve  the  security,  confidentiality,  integrity  and  availability  of  our  systems.  We  voluntarily  engage  third-party 
security auditors to test our systems and controls at least annually against the most widely recognized security standards 
and regulations. We have developed and continue to implement a continuing cyber awareness training program which is 
designed to increase awareness of cybersecurity threats throughout our company and reduce the risk of human error. We 
conduct periodic phishing testing on all our employees with e-mail access and emphasize information security in training 
events and programs we host throughout the year.  

We have established controls and procedures to escalate enterprise-level issues, including cybersecurity matters, to the 
appropriate management levels within our organization and our Board of Directors, or members or committees thereof, as 
appropriate. Our Board of Directors is responsible for enterprise risk management, including our approach to managing 
cybersecurity risk, and has delegated oversight responsibility of information security risks to its Audit Committee. The 
Audit Committee regularly reviews information security risks and receives reports from our Chief Technology Officer and 
other  members  of  the  Company’s  management  regarding  those  risks.  Under  our  framework,  cybersecurity  issues  are 
analyzed  by  subject  matter  experts  for  potential  financial,  operational,  and  reputational  risks,  based  on,  among  other 
factors, the nature of the matter and breadth of impact. Matters determined to present potential material impacts to the 
Company’s  financial  results,  operations,  and/or  reputation  are  immediately  reported  by  management  to  our  Board  of 
Directors  or  its  Audit  Committee,  as  appropriate,  in  accordance  with  our  escalation  framework.  In  addition,  we  have 
established procedures to ensure that management responsible for overseeing the effectiveness of disclosure controls is 
informed in a timely manner of known cybersecurity risks and incidents that may materially impact our operations and 
that timely public disclosure is made as appropriate. We maintain cyber insurance coverage that may, subject to policy 
terms, conditions and limitations, cover certain aspects of cybersecurity risks; however, such insurance coverage may be 
unavailable or insufficient to cover all losses or all types of claims that may arise in the continually evolving area of cyber 
risk. During the last three years, we have not experienced a material security breach and, as a result, we have not incurred 
any material expenses from such a breach. Furthermore, during such time, we have not been penalized or paid any amount 
under any information security breach settlement. 

Recent Developments 

None. 

Available Information 

We file annual, quarterly and current reports and other information with the SEC. The SEC maintains an Internet site that 
contains reports, proxy and information statements, and other information regarding issuers that file electronically with 
the SEC. The address of the SEC’s internet website is www.sec.gov. 

Our internet address is www.merit.com. On our Investor Relations website, www.merit.com/investors, we make available, 
free of charge, a variety of information for investors. Our goal is to maintain the Investor Relations website as a portal 
through which investors can easily find or navigate to pertinent information about us, including:  

•  Our annual report on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K, and any 
amendments to those reports, as soon as reasonably practicable after we electronically file that material with 
or furnish it to the SEC.  

•  Press  releases  on  our  quarterly  earnings  and  other  pertinent  information,  including  product  launches, 

corporate initiatives, and participation in upcoming investor conferences. 

20 

 
•  Corporate governance information including our corporate governance guidelines, committee charters, and 

codes of business conduct and ethics. 

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. 

21 

 
 
 
 
Item 1A. 

Risk Factors. 

Our business, operations and financial condition are subject to certain risks and uncertainties. Should one or more of these 
risks or uncertainties materialize, or should any underlying assumptions prove incorrect, our actual results will vary, and 
may vary materially, from those anticipated, estimated, projected or expected. Among the key factors that may have a 
direct bearing on our business, operations or financial condition are the factors identified below: 

Business, Economic, Industry and Operational Risks 

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. 

We rely on raw materials, component parts, finished products and third-party services in connection with our business. 
For example, substantially all of our products are sterilized by only a few different entities. If any of these sterilizers goes 
out of business or fails to comply with quality or regulatory requirements, we may be unable to find a suitable supplier to 
replace them. This could significantly delay or stop production and cause sales of such products to materially decline. 
Additionally, many of our products have components that are manufactured using resins, plastics and other petroleum-
based  materials  which  are  available  from  a limited  number  of  suppliers. We  are  experiencing  a  growing  trend  among 
suppliers of polymer resins to refuse to supply resin to the medical device manufacturers or to require such manufacturers 
to assume additional risks due to the potential for product liability claims. Additionally, 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. The military conflict between Russia and Ukraine may increase the likelihood of supply interruptions and further 
hinder our ability to find the materials we need to make our products. Supply disruptions are making it harder for us to 
find favorable pricing and 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. 

The availability and price of these materials, parts, products and services are affected by a variety of factors beyond our 
control, including the willingness of suppliers to sell into the medical device industry, changes in supply and demand, 
general economic conditions, labor costs, fuel-related transportation costs, liability concerns, climate change (including 
new and existing laws and regulations to address climate change), competition, import duties, tariffs, currency exchange 
rates  and  political  uncertainty  around  the  world.  During  2022,  we  experienced  significantly  elevated  commodity  and 
supply chain costs, including the costs of labor, raw materials, energy, fuel, packaging materials and other inputs necessary 
for the production and distribution of our products, and we expect elevated levels of inflation to continue in 2023. Our 
suppliers often pass some of their cost increases on to us, and if such increased costs are sustained or increase further, our 
suppliers  may  pass  further  cost  increases  on  to  us.  In  addition  to  the  effect  on  resin  prices,  transportation  costs  have 
generally  increased  and  may  further  increase  if  crude  oil  prices  increase.  Our  transportation  and  service  providers  are 
typically able to pass any significant increases in oil prices on to us.  

Our ability to recover such increased costs may depend upon our ability to raise prices on our products. Due to the highly 
competitive nature of the healthcare industry and the cost-containment efforts of our customers and third-party payers, we 
may be unable to pass along cost increases through higher prices. If we are unable to fully recover these costs through 
price  increases  or  offset  these  increases  through  cost  reductions,  or  we  experience  terminations  or  interruption  of  our 
relationships  with  our  suppliers,  we  could  experience  lower  margins  and  profitability,  and  our  results  of  operations, 
financial condition and cash flows could be materially harmed. 

Changes in general economic conditions, geopolitical conditions, domestic and foreign trade policies, monetary policies 
and other factors beyond our control may adversely impact our business and operating results. 

Our operations and performance depend significantly on global, regional and U.S. economic and geopolitical conditions. 
The global macroeconomic environment continues to be challenging due to the effects of the COVID-19 pandemic and 
government responses, increases in inflation globally, instability in the global credit markets, the impact of uncertainty 
regarding global central bank monetary policy, the instability in the geopolitical environment in many parts of the world 
(including  as  a  result  of  the  on-going  Russia  and  Ukraine  war  and  China-Taiwan  relations),  the  current  economic 
challenges in China, and other disruptions. Periods of intense diplomatic or armed conflict, such as the ongoing conflict 

22 

in  Ukraine,  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.  Non-compliance  with  sanctions  as  well  as  general  ecosystem  disruptions  could  result  in  reputational  harm, 
operational  delays,  monetary  fines,  loss  of  revenues,  increased  costs,  loss  of  export  privileges,  or  criminal  sanctions. 
Furthermore, U.S. trade policy could trigger retaliatory actions by other countries, including China, resulting in a “trade 
war.” A trade war could result in increased costs for raw materials we use in our manufacturing and could result in foreign 
governments  imposing  tariffs  on  products  that  we  export  outside  the  U.S.  or  otherwise  limiting  our  ability  to  sell  our 
products  abroad.  These  increased  costs  would  have  a  negative  effect  on  our  financial  condition  and  profitability. 
Furthermore, if the conflict between Russia and Ukraine continues for a long period of time, or if other countries, including 
the U.S., become further involved in the conflict, we could face significant adverse effects to our business and financial 
condition. 

The occurrence of regional epidemics or a global pandemic, such as COVID-19, may adversely affect our operations, 
financial condition, and results of operations. The COVID-19 pandemic and governmental responses have had widespread, 
rapidly evolving, and unpredictable impacts on global society, economies, financial markets, and business practices. The 
extent to which global pandemics impact our business going forward will depend on factors such as the duration and scope 
of  the  pandemic;  governmental,  business,  and  individuals’  actions  in  response  to  the  pandemic;  and  the  impact  on 
economic activity, including the possibility of recession or financial market instability.  

The  above  factors,  including  a  number  of  other  economic  and  geopolitical  factors  both  in  the  U.S.  and  abroad,  could 
ultimately have material adverse effects on our business, financial condition, results of operations or cash flows, including 
the following: 

• 

• 
• 
• 
• 

• 

• 
• 
• 
• 
• 
• 

effects of significant changes in economic, monetary and fiscal policies in the U.S. and abroad including 
currency fluctuations, inflationary pressures and significant income tax changes; 
global increases in inflation; 
a global or regional economic slowdown in any of our market segments; 
changes in government policies and regulations affecting the Company or its significant customers; 
industrial  policies  in  various  countries  that  favor  domestic  industries  over  multinationals  or  that  restrict 
foreign companies altogether; 
new or stricter trade policies and tariffs enacted by countries, such as China, in response to changes in U.S. 
trade policies and tariffs; 
postponement of spending, in response to tighter credit, financial market volatility and other factors; 
rapid material escalation of the cost of regulatory compliance and litigation; 
difficulties protecting intellectual property; 
longer payment cycles; 
credit risks and other challenges in collecting accounts receivable; and 
the impact of each of the foregoing on outsourcing and procurement arrangements. 

Any  damage  or  interruption  to  our  operations,  facilities,  infrastructure,  manufacturing  processes  or  information 
technology systems, or those of our suppliers, including as a result of our facility consolidation initiatives, could result 
in lost revenues and our business could be seriously harmed. 

Damage or interruption to our facilities or systems relating to manufacturing, distribution, research and development, or 
information technology because of fire, extreme weather conditions, natural disaster, power loss, communications failure, 
geopolitical  disruption,  labor  strikes,  riots,  cyber-attack,  health  epidemics  and  pandemics,  unauthorized  entry  or  other 
events could significantly disrupt our operations, the operations of suppliers and critical infrastructure. These events may 
also  delay  or  prevent  product  manufacturing  and  shipment  during  the  time  required  to  repair,  rebuild  or  replace  the 
damaged facilities or systems. We have recently closed or reduced the operations of certain facilities and moved operations 
and  resources  to  other  facilities,  and  we  are  in  the  process  of  other  facility  consolidation  initiatives.  The  resulting 
concentration of resources and the potential disruption and logistical challenges resulting from those initiatives may further 
exacerbate the adverse effects of these events or make it more difficult for us to respond to the effects of these events.  
Those initiatives may also divert the attention of our management team or other personnel, result in unanticipated expense 
and  disrupt  our  operations.  Climate  change  may  increase  both  the  frequency  and  severity  of  natural  disasters  and, 

23 

consequently,  risks  to  our  operations  and  growth.  Although  we  maintain  property  damage  and  business  interruption 
insurance coverage on our facilities, our insurance might not cover all losses under such circumstances, and we may not 
be able to renew or obtain such insurance in the future on acceptable terms with adequate coverage or at reasonable costs. 

Consolidation in the healthcare industry, group purchasing organizations and public procurement policies have lead 
to demands for price concessions, which reduces our revenues and may harm our ability to sell our products at prices 
necessary to support our current business strategies. 

Healthcare  costs  have  risen  significantly  over  the  past  decade,  which  has  resulted  in  or  led  to  numerous  cost  reform 
initiatives 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.  Additionally,  many  of  our  customers  belong  to  group  purchasing  organizations  or  integrated 
delivery networks that use their market power to consolidate purchasing decisions for these hospitals and healthcare service 
providers. These customers are often able to obtain lower prices and more favorable terms because of the potential sales 
volume they represent, which has lead to lower revenues and required us to take on additional liability. We expect that 
market  demand,  government  regulation,  third-party  coverage  and  reimbursement  policies  and  societal  pressures  will 
continue to change the healthcare industry worldwide, resulting in further business consolidations and alliances among 
our customers, which may exert further downward pressure on the prices of our products. 

We  may  be  unable  to  compete  in  our  markets,  particularly  if  there  is  a  significant  change  in  relevant  practices  or 
technology. 

The markets in which our products compete are highly competitive. We face competition from many companies which are 
larger, better established, have greater financial, technical and other resources and possess a greater market presence than 
we do. Such resources and market presence may enable our competitors to more effectively market competing products 
or to market competing products at reduced prices in order to gain market share. 

In addition, 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. Competing companies with 
substantially  greater  resources  than  us  are  actively  engaged  in  research  and  development  of  new  methods,  treatments, 
drugs, and procedures to treat or prevent cardiovascular disease that could limit the market for our products and eventually 
make some of our products obsolete. A reduction in the demand for a significant number of our products, or a few key 
products, could have a material adverse effect on our business, operations or financial condition. 

COVID-19 Risks 

The  COVID-19 pandemic  and  related  ongoing  implications  have  negatively  impacted  our  business  and  operations 
around the world and may continue to materially and adversely impact our business, operations and financial results. 

The COVID-19 pandemic and the resulting containment measures created significant disruption and uncertainty in the 
global economy and negatively impacted our business, results of operations and financial condition during 2020, 2021 and 
2022. Although the impact of COVID-19 and the resulting containment measures decreased during 2022, they have the 
potential to continue to negatively impact our business, results of operations and financial condition in the future. 

Numerous national, international, state and local jurisdictions imposed a variety of government orders and restrictions for 
their residents to control the spread of COVID-19. In 2020, such orders and restrictions caused significant alterations of 
our operations, work stoppages, slowdowns and delays, travel restrictions and event cancellations, among other effects, 
thereby significantly and negatively impacting our financial condition. In 2021 and 2022, these conditions continued at 
varying levels. Other disruptions that we experienced include (i) restrictions on our personnel and personnel of business 
partners to travel and access customers for training and case support; (ii) supply chain delays and disruptions, logistical 
challenges and increased freight, transportation and other expenses; (iii) delays in regulatory approvals by governmental 
and regulatory bodies; (iv) reductions in spending by our customers; (v) diversion of or limitations on employee resources 
that would otherwise be focused on the operations of our business, including because of sickness of employees or their 
families or the desire of employees to avoid contact with large groups of people; (vi) fluctuations in the availability of 
employees and potential employees; (vii) additional government requirements or other incremental mitigation efforts that 

24 

may  further  impact  our  or  our  suppliers'  capacity  to  manufacture  our  products;  (viii)  disruption  of  our  research  and 
development  activities;  and  (ix)  delays  in  ongoing  studies  and  pre-clinical  trials.  Although  some  of  these  disruptions 
diminished in 2021 and the impact lessened further during 2022, they may again return or further intensify their effect on 
our operations, whether as a direct result of COVID-19 or other factors exacerbated by the effects of COVID-19. 

In addition, elective procedures that use our products significantly decreased in number during much of 2020 as health 
care organizations around the world prioritized the treatment of patients with COVID-19 and reduced spending in other 
areas.  For  example,  in  the  United  States,  governmental  authorities  recommended,  and  in  certain  cases  required,  that 
elective, deferrable, specialty and other procedures and appointments (many of which use our products), be suspended or 
canceled to avoid non-essential patient exposure to medical environments and potential infection with COVID-19 and to 
focus limited resources and personnel capacity toward the treatment of COVID-19 patients. In 2021, these procedures 
resumed in many locations, and overall, we saw significant improvement in our business during 2021. We saw further 
improvement  in  the  availability  of  elective  procedures  during  2022.  It  is  possible,  however,  that  a  resurgence  of 
COVID- 19,  or  increased  spread  of  its  variants,  could  again  cause  a  rise  in  severe  infections  and  force  authorities  and 
customers to impose restrictions that would negatively impact our operations.  

All of these factors have also caused or contributed to disruptions and delays in our logistics and supply chain, and we 
may continue to experience these disruptions and delays. The full extent to which COVID-19 and resulting containment 
measures impact our business, operations and financial results will depend on future developments that are uncertain and 
cannot be predicted, including new information that may emerge concerning the severity and spread of the virus and its 
variants. To the extent COVID-19 (including existing variants and any new variants) and resulting containment measures 
continue to adversely affect our business, operations and financial results, they may also have the effect of heightening 
other risks described herein, such as those relating to general economic conditions, demand for our products, relationships 
with suppliers and sales efforts. 

Strategic, Business Development and Employee Attraction and Retention Risks 

We may be unable to successfully manage growth and maintain operational efficiencies. 

Successful implementation and execution of our business strategy will require that we effectively manage our growth. As 
the Company grows, we are often faced with decisions to (i) expand certain product lines and discontinue others, (ii) open 
or expand new facilities and close others, (iii) allocate resources between new and established markets, or (iv) allocate 
resources between the expansion of organic business and the acquisition of new product lines. The outcome of each of 
these  decisions  is  uncertain,  and  even  with  the  exercise  of  excellent  business  judgment,  results  may  not  align  with 
expectations  because  of  the  many  factors  listed  in  this  section.  In  addition,  our  management  will  need  to  continue  to 
implement changes in certain aspects of our business, improve our information systems, infrastructure and operations to 
respond to increased demand, attract and retain qualified personnel, and develop, train, and manage an increasing number 
of employees. We may not have the resources available to implement certain necessary changes, and as a result, growth 
may be delayed or we may not be able to take advantage of certain business opportunities. Growth has placed, and will 
likely continue to place, an increasing strain on our management, sales and other personnel, and on our financial, product 
design, marketing, distribution, technology and other resources. Any failure to manage growth effectively could have a 
material adverse effect on our business, operations or financial condition. 

Substantial  costs  are  incurred  when  identifying,  evaluating,  negotiating  and  closing  acquisitions,  and  failure  to 
integrate acquired businesses may adversely impact our business and financial results.  

We have completed a series of significant acquisitions and, continue to evaluate other potential acquisitions and strategic 
transactions, certain of which may also be significant. We have incurred, and will likely continue to incur, significant 
expenses in connection with evaluating, negotiating and consummating various acquisition and other strategic transactions. 
As  we grow  through  acquisitions, we face the  additional challenges of  integrating  the operations,  culture,  information 
management systems and other characteristics of the acquired entity with our own, including sales models related to capital 
equipment. Our efforts to integrate acquisitions may be hampered by delays, the loss of certain employees, suppliers or 

25 

customers,  proceedings  resulting  from  employment  terminations,  culture  clashes,  unbudgeted  costs,  and  other  issues, 
which may occur at levels that are more severe or prolonged than anticipated.  

Additionally, past and future acquisitions may increase the risks of competition we face by, among other things, extending 
our operations into industry segments and product lines where we have few existing customers or qualified sales personnel 
and  limited  expertise.  Further,  as  a  result  of  certain  acquisitions,  we  are  selling  capital  equipment,  in  addition  to  our 
historical  sales  of disposable medical devices.  The  sale of capital  equipment  may  create  additional risks  and potential 
liability, which may negatively affect our business, operations or financial condition.  

In addition, we may not realize competitive advantages, synergies or other benefits anticipated in connection with any 
such acquisition or other transaction. If we do not adequately identify and value targets for, or manage issues related to, 
acquisitions and strategic transactions, such transactions may not produce the anticipated benefits and have an adverse 
effect on our business, operations or financial condition. We have incurred expenses in connection with the disposition of 
businesses and assets which we acquired but determined that they did not produce the benefits contemplated at the time of 
acquisition. We may incur similar expenses in the future. 

We  will  be  required  to  expend  significant  resources  for  research,  development,  testing  and  regulatory  approval  or 
clearance of our products under development, and these products may not be developed successfully or approved for 
commercial use. 

Most of our products under development will require significant additional research, development, engineering and, in 
some cases, preclinical and clinical testing, as well as regulatory approval or clearance and a commitment of significant 
additional resources prior to their commercialization. It is possible that our products may not: 

• 
be developed successfully; 
• 
be proven safe or effective in clinical trials; 
• 
offer therapeutic or other improvements over current treatments and products; 
•  meet applicable regulatory standards or receive regulatory approvals or clearances; 
• 

be  capable  of production  in commercial  quantities  at  acceptable  costs  and  in  compliance  with  regulatory 
requirements; 
be successfully marketed; or 
be covered by private or public insurers. 

• 
• 

We may be unable to accurately forecast customer demand for our products and manage our inventory. 

To ensure adequate supply, we must forecast our inventory needs and place orders with our suppliers based on estimates 
of future demand for particular products. Our ability to accurately forecast demand for our products could be negatively 
affected by many factors, including our failure to accurately manage our expansion strategy and customer acceptance of 
new products, 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, effects of COVID-19 or decreased consumer confidence in future economic conditions. Inventory 
levels in excess of customer demand may result in inventory write-downs or write-offs, which would impact our gross 
margin. Conversely, if we underestimate customer demand for our products, our manufacturing facilities may not be able 
to deliver products to meet our order requirements, which could damage our reputation and customer relationships. 

Our  forecasts  of  customer  demand  and  related  decisions  that  we  make  about  production  levels  may  take  into  account 
potential opportunities created by regulatory issues, supply disruptions or other challenges experienced by our competitors. 
We generally do not know the extent and cannot predict the duration of these challenges experienced by our competitors. 
As a result, our estimates about related increased demand for our products are inherently uncertain and subject to change. 
If our estimates incorrectly forecast the extent or duration of this increased demand, or the product types to which it relates, 
our revenues, margins and earnings could be adversely affected. 

26 

We  lack  direct  sales  and  marketing  capabilities  in  many  countries  and  are  dependent  on  our  distributors  for  the 
commercialization of our products in these countries. If we are unable to maintain or establish sales capabilities on 
our own or through third parties, we may not be able to commercialize any of our products in those countries. 

We have no or limited direct sales or marketing capabilities in some of the regions and countries in which our products 
are sold, including, among others, China, Japan, Russia and India. We have entered into distribution agreements with third 
parties to market and sell our products in those countries in which we do not have a direct sales force and in those countries 
in  which  we  utilize  a  “modified  direct”  sales  approach.  If  we  are  unable  to  maintain  or  enter  into  such  distribution 
arrangements on acceptable terms, or at all, we may not be able to successfully commercialize our products in certain 
countries. Moreover, to the extent that we enter into distribution arrangements with other companies, our revenues, if any, 
will depend on the terms of any such arrangements and the efforts of others. These efforts may turn out not to be sufficient 
and our third-party distributors may not effectively sell our products. In addition, although our contract terms require our 
distributors  to  comply  with  all  applicable  laws  regarding  the  sale  of  our  products,  including  anti-competition,  anti-
corruption, anti-money laundering and sanctions laws, we may not be able to ensure proper compliance. If our distributors 
fail  to  effectively  market  and  sell  our  products  in  full  compliance  with  applicable  laws,  our  results  of  operations  and 
business could be impacted. 

We are dependent upon key personnel. 

Our success is dependent on key management personnel, including Fred P. Lampropoulos, our Chairman of the Board, 
President and Chief Executive Officer. Mr. Lampropoulos is not subject to any agreement prohibiting his departure, and 
we do not maintain key man life insurance on his life. The loss of Mr. Lampropoulos, or of certain other key management 
personnel, could have a materially adverse effect on our business and operations. Our success also depends on, among 
other factors, the successful recruitment and retention of key operating, manufacturing, sales and other personnel. 

Regulatory, Litigation, Tax and Legal Compliance Risks 

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.  

These regulations and policies result in increased costs, lower margins and lower sales than we would otherwise expect, 
which  have  a  material  adverse  effect  on  our  business,  financial  condition,  results  of  operations,  or  cash  flows.  Our 
customers  and  suppliers  may  also  be  affected  by  these  events,  so  even  if  we  are  not  directly  impacted,  we  may  still 
experience lower demand for our products and increases in our manufacturing costs because of the effects these events 
may have on our customers and suppliers. For example, China has implemented a volume-based procurement process 
designed to decrease prices for medical devices and other products. This process has had a negative impact on our revenues 
in China and we expect it will continue to cause a decrease in the revenue we are able to generate in China.  

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. 

Before we can introduce a new device or a new use of or a claim for a cleared device in the U.S., we must generally obtain 
clearance from the FDA, unless an exemption from premarket review or an alternative procedure, such as a de novo risk-
based classification or a humanitarian device exemption, applies. The FDA clearance and approval processes for medical 
devices are expensive, uncertain and time-consuming.  

We may make changes to our cleared products without seeking additional clearances or approvals if we determine such 
clearances or approvals are not necessary and document the basis for that conclusion. However, the FDA may disagree 
with  our  determination  or  may  require  additional  information,  including  clinical  data,  to  be  submitted  before  a 
determination is made, in which case we may be required to delay the introduction and marketing of our modified products, 
redesign our products, conduct clinical trials to support any modifications and pay significant regulatory fines or penalties. 
In addition, the FDA may not approve or clear our products for the indications that are necessary or desirable for successful 
commercialization. 

In  particular,  we  are  currently  conducting  a  large,  multinational  pivotal  human  clinical  trial  of  the  Wrapsody 
Endoprosthesis. A successful outcome of this trial is required to obtain approval from the FDA and some international 

27 

regulatory agencies. However, there is no assurance that we will be able to obtain the necessary regulatory clearances or 
approvals for the Wrapsody Endoprosthesis or any other products on a timely basis or at all. Further, the FDA may change 
its clearance and approval policies, adopt additional regulations or revise existing regulations, or take other actions which 
may prevent or delay approval or clearance of our products under development or impact our ability to modify our currently 
cleared  products  on  a  timely  basis.  Delays  in  receipt  of,  or  failure  to  obtain,  regulatory  clearances  for  any  product 
enhancements  or  new  products  we  develop  would  result  in  delayed  or  no  realization  of  revenue  from  such  product 
enhancements or new products and in substantial additional costs, which could decrease our profitability. 

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.  We  cannot  provide  assurance  that  we  will  successfully  maintain  the 
clearances  or  approvals  we  have  received  or  may  receive  in  the  future.  The  loss  of  previously  received  clearances  or 
approvals, or the failure to comply with existing or future regulatory requirements, could also have a material adverse 
effect on our business. 

Our products are generally subject to regulatory requirements in foreign countries in which we sell them. We have 
experienced delays and expended significant resources in obtaining those approvals and clearances and we will likely 
continue  to  experience  delays  and  uncertainty,  and  incur  significant  expenses,  in  obtaining  those  approvals  or 
clearances. 

In order  to  sell  our products in foreign  countries,  generally we  must obtain regulatory approvals  and comply  with  the 
regulations  of  those  countries.  These  regulations,  including  the  requirements  for  approvals  or  clearances  and  the  time 
required  for  regulatory  review,  vary  from  country-to-country.  See  our  related  discussion  under  Item  1.  “Business  – 
Regulation - Regulatory Approvals.” 

In general, we intend to obtain MDR approvals for our principal products sold in the EU ahead of expiry dates; however 
for multiple reasons, including but not limited to changing business strategies, limited labor pool and contract resources, 
administrative delays, increased costs of obtaining MDR certification, availability of necessary data and notified body 
capacity,  there  will  be  some  products  that  will  not  be  fully  compliant  at  the  time  of  expiry.  The  additional  time  and 
resources required to obtain MDR certification has been a significant factor in, and will likely continue to influence, our 
decisions to discontinue sales and distribution of certain products in the EU. 

Complying  with  and  obtaining  regulatory  approval  in  foreign  countries,  including  our  efforts  to  comply  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 our net 
sales, market share and operating profits from our international operations. 

The medical device industry is subject to extensive scrutiny and regulation by governmental authorities and we are 
currently  operating  under  a  Corporate  Integrity  Agreement.  If  governmental  authorities  determine  that  we  have 
violated  laws,  regulations  or  our  Corporate  Integrity  Agreement,  our  company  or  our  employees  may  be  subject  to 
various penalties, including civil or criminal penalties. 

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.  Congress,  DOJ,  OIG,  SEC  and  the  Department  of  Defense,  as  well  as  foreign 
counterparts, have issued subpoenas and other requests for information to medical device manufacturers, primarily related 
to financial arrangements with healthcare providers, regulatory compliance and product promotional practices.  

In  October  2020,  we  entered  into  a  Settlement  Agreement  with  the  DOJ  to  resolve  their  investigation  into  our  past 
marketing  transactions  and  practices.  Under  the  Settlement  Agreement  and  related  agreements,  we  paid  $18.7  million 
(which includes interest and certain fees) in exchange for a release from liability for the alleged conduct. The settlement 
was also conditioned upon our entering into the CIA. Please refer to the discussion in Item 1. “Business - Regulation - 
Corporate Integrity Agreement.” Even if we fully comply with the CIA, we have incurred, and anticipate that we will 
continue to incur, substantial costs in connection with the settlement and compliance with the CIA. It is unclear what 
impact the settlement has had and may have on our reputation. This matter has consumed a significant amount of our 
resources and management’s attention.  

28 

We anticipate that government authorities will continue to scrutinize our industry closely, and that additional regulation 
by  government  authorities  may  increase  compliance  costs,  exposure  to  litigation  and  other  adverse  effects  on  our 
operations.  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 and enforcement actions, including warning letters that require corrective action, 
injunctions, product seizures or 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, financial condition and ability to obtain financing 
on reasonable terms. 

We are subject to laws targeting fraud and abuse in the healthcare industry, the violation of which could adversely 
affect our business or financial results. 

Our operations are subject to various state and federal laws targeting fraud and abuse in the healthcare industry, including 
the federal Anti-Kickback Statute and other anti-kickback laws, 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. Violations of these fraud and abuse-related laws are punishable 
by criminal or civil sanctions, including substantial fines, imprisonment and exclusion from participation in healthcare 
programs such as Medicare and Medicaid, any of which could harm our business or negatively impact our financial results. 
Allegations of such violations could lead to expensive and time-consuming investigations by government authorities and 
result in conviction of these violations or settlement costs and additional restrictions, like the CIA discussed above under 
Item 1. “Business - Regulation - Corporate Integrity Agreement.”  

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. 

Our international operations make us subject to the U.S. Foreign Corrupt Practices Act and similar anti-bribery laws 
in non-U.S. jurisdictions, and our failure, or the failure of our distributors and agents, to comply with these laws could 
subject us to civil and criminal penalties and adversely affect our business. 

We currently conduct our business in various foreign countries, and we expect to continue to expand our foreign operations. 
As a result, we are subject to the FCPA, the U.K. Bribery Act, and similar anti-corruption laws in non-U.S. jurisdictions. 
These laws generally prohibit companies and their intermediaries from illegally offering things of value to any individual 
for the purpose of obtaining or retaining business.  

Compliance  with  the  FCPA  and  other  anti-bribery  laws  presents  challenges  to  our  operations.  Our  policies  mandate 
compliance  with  the  FCPA  and  all  other  applicable  anti-bribery  laws.  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 reckless or criminal 
acts committed by our employees, distributors or agents. If our employees, distributors or agents violate the provisions of 
the FCPA or other anti-bribery laws, or even if there are allegations of such violations, we could be subject to investigations 
or civil and criminal penalties or other sanctions, which could have a material, adverse effect on our reputation, business, 
results of operations, financial condition or cash flows. 

Limits on reimbursement imposed by governmental and other programs may adversely affect our business and results 
of operation. 

We sell our products to hospitals and other healthcare providers around the world that typically receive reimbursement for 
the services provided to patients, which incorporate the use of our products, from third-party payers such as government 
programs (e.g., Medicare and Medicaid in the U.S.) and private insurance programs. The ability of our customers to obtain 
adequate reimbursement for the health care procedures that use our products, such that the cost of our products is covered, 
is  critical  to  our  business. Limits  on  reimbursement  imposed  by  such  third-party  payers  may  adversely  affect  our 

29 

customers, such as hospitals, physicians and other healthcare providers, to purchase our products, which could adversely 
affect our business and results of operations. 

Third-party  payers,  whether  foreign  or  domestic,  or  governmental  or  commercial,  are  developing  increasingly 
sophisticated methods of controlling healthcare costs. In general, a third-party payer covers a medical procedure only when 
the plan administrator is satisfied that the product or procedure is reasonable and necessary to the patient’s treatment; 
however, for certain payers (such as foreign governments and some commercial insurers) the cost-effectiveness of the 
treatment  may  also  be  a  condition.  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, 
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.  We 
cannot  provide  assurance  that  we  will  be  successful  in  any  efforts  we may  potentially undertake  to reverse  such  non-
coverage or unfavorable coverage decisions. If we are not successful in reversing non-coverage or unfavorable coverage 
policies, or if third-party payers that currently cover or reimburse certain procedures involving the use of our products 
reverse, change or limit their coverage of such procedures in the future, or if other third-party payers issue similar policies 
or adopt similar practices, our business could be adversely impacted. 

Further, we believe that future coverage and reimbursement may be subject to increased restrictions, such as additional 
prior authorization requirements, both in the U.S. and in international markets. Third-party coverage and reimbursement 
for procedures using our products or any of our products in development for which we may receive regulatory approval 
may not be available or adequate in either the U.S. or international markets, which could have an adverse impact on our 
business. 

Our business is subject to complex and evolving U.S., state and international laws and regulations regarding privacy 
and data protection. Many of these laws and regulations are subject to change and uncertain interpretation and could 
result in claims, changes to our business practices, penalties, increased cost of operations, or declines in user growth 
or engagement, or otherwise harm our business. 

The U.S. and many other countries in which we conduct our operations have adopted laws and regulations protecting 
certain data, including medical and personal data (including HIPAA, the HITECH Act and the rules issued thereunder), 
and requiring data holders and controllers to implement administrative, logical and technical controls and procedures in 
order to protect the privacy of such data. 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. Internationally, 
some countries have also passed laws and regulations that require individually identifiable data on their citizens to be 
maintained on local servers and that may restrict transfer or processing of that data. In addition, regulatory authorities 
around the world are considering additional proposals concerning data protection. These 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. 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. It is possible that these laws 
and regulations may be interpreted and applied in a manner that is inconsistent with our data practices, resulting in fines 
or orders requiring that we change our data practices, which could in turn (i) cause us to incur substantial costs or (ii) have 
an adverse effect on our business. 

Legal developments in foreign countries have created uncertainty regarding certain transfers of personal data from certain 
countries to the U.S. or other foreign countries. For example, GDPR applies to the processing of personal data related to: 
(i) the activities of an establishment in the EU or (ii) the processing of personal data of data subjects who are in the EU 
where this is related to products and services that we offer to EU users. GDPR includes compliance obligations, which 
could  cause  us  to  change  our  business  practices,  and  significantly  increases  financial  penalties  for  noncompliance.  In 
addition, the PIPL, similar to GDPR, applies to personal information processing activities outside of China if companies 
provide products or services to individuals in China or analyze and evaluate the behavior of individuals in China. If we 
fail to comply with the requirements of the PIPL, we could incur severe penalties. If we incur any of these penalties in the 
EU or China for violations of GDPR or the PIPL, our business and operations in those areas could be adversely affected 
and have a material adverse effect on our financial results.  

30 

Our failure to comply with applicable environmental, health and safety laws and regulations could affect our business, 
operations or financial condition. 

We  manufacture  and  assemble  certain  products  that  require  the  use  of  hazardous  materials  that  are  subject  to  various 
national,  federal,  state  and  local  laws  and  regulations  governing  the  protection  of  the  environment,  health  and  safety. 
Moreover,  climate  change  and  sustainability  efforts  and  potential  climate  change  regulations  could  lead  to  business 
interruption, significantly increased costs and other adverse consequences to our business. While the cost of compliance 
with such laws and regulations has not had a material adverse effect on our results of operations historically, compliance 
with  future  regulations  may  require  additional  capital  investments  or  other  expenses.  Additionally,  because  we  use  a 
limited amount of hazardous and other regulated materials in our manufacturing processes, we are subject to certain risks 
of  future  liabilities,  lawsuits  and  claims  resulting  from  any  substances  we  manufacture,  dispose  of  or  release.  Certain 
environmental laws and regulations may impose “strict liability” for the conduct of, or conditions caused by, others, or for 
acts that were in non-compliance with all applicable laws at the time the acts were performed, rendering us liable without 
regard to our negligence or fault. Because of these laws, any accidental release may have an adverse effect on our business, 
operations or financial condition.  

Our operations are also subject to various laws and regulations relating to occupational health and safety. We maintain 
safety, training and maintenance programs as part of our ongoing efforts to ensure compliance with applicable laws and 
regulations.  Compliance  with  applicable  health  and  safety  laws  and  regulations  has  required  and  continues  to  require 
significant expenditures.  

We are also subject to corporate social responsibility, or CSR, laws and regulations which require us to monitor the labor 
standards in our supply chain, including the California Transparency in Supply Chains Act, the UK Modern Slavery Act, 
and  U.S.  Federal  Acquisition  Regulations  regarding  Combating  Trafficking  in  Persons.  These  CSR  labor  laws  and 
regulations may impose additional processes and supplier management systems and have led certain key customers to 
impose additional requirements on medical device companies, including audits, as a prerequisite to selling products to 
such customers, which could result in increased costs for our products, the termination or suspension of certain suppliers, 
and reductions in our margins and profitability. 

Use of our products in unapproved circumstances could expose us to liabilities. 

The marketing clearances and approvals from the FDA and other regulators of certain of our products are, or are expected 
to be, limited to specific uses. We are prohibited from marketing or promoting any uncleared or unapproved use of our 
product. However, physicians may use these products in ways or circumstances other than those strictly within the scope 
of the regulatory approval or clearance. The use of our products for unauthorized purposes could arise from our sales 
personnel or distributors violating our policies by providing information or recommendations about such unauthorized 
uses. Consequently, claims may be asserted by the FDA or other enforcement agencies that we are not in compliance with 
applicable laws or regulations or have improperly promoted our products for uncleared or unapproved uses. The FDA or 
such other agencies 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 products are used in connection with invasive procedures and in other medical contexts that entail an inherent risk of 
product liability claims. If medical personnel or their patients suffer injury or death in connection with the use of our 
products,  whether  as  a  result  of  a  failure  of  our  products  to  function  as  designed,  an  inappropriate  design,  inadequate 
disclosure of product-related risks or information, improper use, or for any other reason, we could be subject to lawsuits 
seeking  significant  compensatory  and punitive damages. Product  liability  claims  may  be  brought by  individuals or by 
groups seeking to represent a class. We have previously faced, and currently face, claims by patients claiming injuries 
from our products. To date, these claims have not resulted in material harm to our operations or financial condition. The 
outcome of this type of personal injury litigation is difficult to assess or quantify. We maintain product liability insurance; 
however, there is no assurance that this coverage will be sufficient to satisfy any claim made against us. 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 

31 

coverage in the future. As a result, any lawsuit seeking significant monetary damages may have a material adverse effect 
on our business, operations or financial condition. 

We generally offer a limited warranty for the return of product due to defects in quality and workmanship. We attempt to 
estimate our potential liability for future product returns and establish reserves on our financial statements in amounts that 
we believe will be sufficient to address our warranty obligations; however, our actual liability for product returns may 
significantly exceed the amount of our reserves. If we underestimate our potential liability for future product returns, or if 
unanticipated events result in returns that exceed our historical experience, our financial condition and operating results 
could be materially harmed. 

In addition, the occurrence of such an event or claim could result in a recall of products from the market or a safety alert 
relating to such products. Such a recall could result in significant costs, reduce our revenue, divert management’s attention 
from our business, and harm our reputation. 

Our products may cause or contribute to adverse medical events that we are required to report to the FDA or other 
governmental authorities, and if we fail to do so, we may be subject to sanctions that may materially harm our business. 

Our products are subject to medical device reporting regulations, which require us to report to the FDA information that 
reasonably suggests one of our products may have caused or contributed to a death or serious injury, or one of our products 
malfunctioned and, if the malfunction were to recur, this device or a similar device that we market would be likely to cause 
or  contribute  to  a  death  or  serious  injury.  Our  obligation  to  report  under  the  medical  device  reporting  regulations  is 
triggered  on  the  date  on  which  we  become  aware  of  information  that  reasonably  suggests  a  reportable  adverse  event 
occurred. We may fail to report adverse events of which we become aware within the prescribed timeframe. We may also 
fail to recognize that we have become aware of a reportable adverse event, especially if it is not reported to us as an adverse 
event or if it is an adverse event that is unexpected or if the product characteristic that caused the adverse event is removed 
in time from our products. Inspections by the FDA or other regulators may reveal violations or instances of noncompliance 
under the QSRs and other post-market requirements. If we fail to comply with our medical device reporting obligations or 
commit  a  violation  of  these  requirements,  the  FDA  could  issue  warning  letters  or  untitled  letters,  take  administrative 
actions, commence criminal prosecution, impose civil monetary penalties, demand or initiate a product recall, seize our 
products, or delay the clearance of our future products. Other regulatory authorities could take similar actions within their 
jurisdictions. 

Our employees, independent contractors, consultants, manufacturers and distributors may engage in misconduct or 
other improper activities, including noncompliance with regulatory standards and requirements. 

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 healthcare laws and regulations of the FDA and other federal, 
state and international authorities, manufacturing standards, and laws that require the true, complete and accurate reporting 
of financial information or data. 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 stemming from a failure to be in compliance with such laws or 
regulations. If any such actions are instituted against us, and we are not successful in defending ourselves or asserting our 
rights, those actions could have a significant impact on our business, including the imposition of significant civil, criminal 
and administrative penalties. 

We may be a party to litigation in the course of our business or otherwise, which could affect our financial condition 
and results of operations. 

We are routinely a party to or otherwise involved in legal proceedings, claims or other legal matters, arising in the course 
of our business. Legal proceedings can be complex and take many months, or even years, to reach resolution, with the 
final  outcome  depending  on  a  number  of  variables,  some  of  which  are  not  within  our  control.  Litigation  is  subject  to 
significant  uncertainty  and  may  be  expensive,  time-consuming,  and  disruptive  to  our  operations.  Although  it  is  our 
intention to vigorously defend ourselves in such legal proceedings, their ultimate resolution and potential financial and 

32 

other impacts on us are uncertain. If a legal proceeding is resolved against us, it could result in significant compensatory 
damages or injunctive relief that could materially adversely affect our financial condition, results of operations and cash 
flows. 

Intellectual Property 

We  may  not  be  able  to  effectively  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 our intellectual property rights to produce competing products. We seek to protect 
our intellectual property rights through a combination of confidentiality and license agreements, maintaining certain trade 
secrets,  and  through  registrations  under  patent,  trademark,  and  copyright  laws.  However,  these  measures  afford  only 
limited protection and may be challenged, invalidated, or circumvented by third parties. Additionally, these measures may 
not prevent competitors from duplicating our products or gaining access to our proprietary information and technology. 
Third parties may copy all or portions of our products or otherwise use our intellectual property without authorization, and 
we may not be able to prevent the unauthorized disclosure or use of our intellectual property by consultants, vendors, 
former  employees  and  current  employees.  Despite  our  efforts  to  restrict  such  unauthorized  disclosure  or  use  through 
nondisclosure agreements and other contractual restrictions, we may not be able to enforce these contractual provisions or 
we may incur substantial costs enforcing our legal rights.  

Third  parties  may  also  develop  similar  or  superior  technology  independently  or  by  designing  around  our  patents.  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. Further, no assurances can be given that any patent application we have filed or will 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. 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. 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 lawsuits that we 
might initiate could be expensive, take significant time and divert management’s attention from our business. Litigation 
also puts our patents at risk of being invalidated or interpreted narrowly. Additionally, we may provoke third parties to 
assert claims against us. Moreover, the legal systems of certain countries, particularly certain developing countries, do not 
favor the aggressive enforcement of patents and other intellectual property protections, which makes it difficult to stop 
infringement. We may not prevail in any lawsuits that we initiate, and the damages or other remedies awarded, if any, may 
not be commercially valuable.  

Third parties claiming that we infringe their intellectual property rights could cause us to incur significant legal or 
licensing expenses and prevent us from selling our products. 

Our commercial success will depend in part on not infringing or violating the intellectual property rights of others. From 
time to time, third parties may claim that we have infringed their intellectual property rights, including claims regarding 
patents, copyrights, trademarks, trade secrets, and confidential information. We may not be aware of whether our products 
do or will infringe existing or future patents or the intellectual property rights of others. Because of constant technological 
change in the medical device industry in which we compete, the extensive patent coverage of existing technologies, and 
the rapid rate of issuance of new patents, it is possible that the number of these claims may grow. In addition, former 
employers of our former, current, or future employees may assert claims that such employees have improperly disclosed 
to us the confidential or proprietary information of such former employers. 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. If we are not successful in defending such claims, we could be required 
to (i) stop selling our products, (ii) redesign our products, (iii) discontinue the use of related trademarks, technologies or 
designs, (iv) pay damages or indemnification obligations, or (v) enter into royalty or licensing arrangements. Royalty or 
licensing arrangements that we may seek in such circumstances may not be available to us on commercially reasonable 
terms or at all and we may not be able to redesign applicable products in a way to avoid infringing the intellectual property 

33 

rights of others. We have made and expect to continue making significant expenditures to investigate, defend and settle 
claims related to the use of technology and intellectual property rights as part of our strategy to manage this risk. 

Information Technology and Cybersecurity Risks 

We rely on the proper function, availability and security of information technology systems to operate our business, 
and  a  material  disruption  of  critical  information  systems  or  a  material  breach  in  the  security  of  our  systems  may 
adversely affect our business and customer relationships. 

We rely on information technology systems (including technology from third-party providers) to process, transmit, and 
store  electronic  information  in  our  day-to-day  operations,  including  sensitive  personal  information  and  proprietary  or 
confidential information. We also rely on our technology infrastructure, among other functions, to interact with customers 
and  suppliers,  fulfill  orders  and  bill,  collect  and  make  payments,  ship  products,  provide  support  to  customers,  fulfill 
contractual obligations and otherwise conduct business. Our internal information technology systems, as well as those 
systems maintained by third-party providers, may be subjected to computer viruses or other malicious code, unauthorized 
access attempts, and cyber-attacks, any of which could result in data leaks or otherwise compromise our confidential or 
proprietary information and disrupt our operations. Cyber-attacks are becoming more sophisticated and frequent, and 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,  particularly  attacks  that  result  in  our 
intellectual property and other confidential information being accessed or stolen. 

We rely on third-party vendors to supply and support certain aspects of our information technology systems. These third-
party  systems  could  also  become  vulnerable  to  cyber-attacks,  malicious  intrusions,  breakdowns,  interference  or  other 
significant disruptions, and may contain defects in design or manufacture or other problems that could result in system 
disruption or compromise the information security of our own systems. In addition, we continue to grow in part through 
business and product acquisitions and, as a result, may face risks associated with defects and vulnerabilities in the systems 
operated by the other parties to those transactions, or difficulties or other breakdowns or disruptions in connection with 
the integration of the acquired businesses and products into our information technology systems. 

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 class action or other 
civil litigation. If we fail to monitor, maintain or protect our information technology systems and data integrity effectively 
or fail to anticipate, plan for or manage significant disruptions to these systems, we could (i) lose customers, (ii) be subject 
to  fraud,  (iii)  breach  our  agreements  with  or  duties  toward  customers,  physicians,  other  health  care  professionals  and 
employees, (iv) be subject to regulatory sanctions or penalties, (v) incur expenses or lose revenues, (vi) sustain damage to 
our reputation, or (vii) suffer other adverse consequences. Unauthorized tampering, adulteration or interference with our 
products may also create issues with product functionality that could result in a loss of data, risk to patient safety, and 
product recalls or field actions. Any of these events could have a material adverse effect on our business, operations or 
financial condition. 

Market, Liquidity and Credit Risks 

The agreements and instruments governing our debt contain restrictions and limitations that could significantly affect 
our ability to operate our business, as well as significantly affect our liquidity. 

On July 31, 2019 we entered into a Third Amended and Restated Credit Agreement (“Third Amended Credit Agreement”), 
with Wells Fargo Bank, National Association, as administrative  agent and a lender, and Wells Fargo Securities, LLC, 
BOFA  Securities,  Inc.,  HSBC  Bank  USA,  National  Association,  and  U.S.  Bank  National  Association  as  joint  lead 
arrangers and joint bookrunners, and Bank of America, N.A., HSBC Bank USA, National Association and U.S. Bank 
National  Association  as  co-syndication  agents.  In  addition,  Bank  of  America,  N.A.,  HSBC  Bank  USA,  National 
Association, U.S. Bank, National Association, BMO Harris Bank, N.A., and MUFG Union Bank, Ltd. are parties to the 
Third Amended Credit Agreement as lenders. The Third Amended Credit Agreement amends and restates in its entirety 
our previously outstanding Second Amended and Restated Credit Agreement and all amendments thereto (the “Second 
Amended Credit Agreement”). The Third Amended Credit Agreement contains a number of significant covenants that 

34 

could adversely affect our ability to operate our business, our liquidity or our results of operations. These covenants restrict, 
among  other  things,  our  incurrence  of  indebtedness,  creation  of  liens  or  pledges  on  our  assets,  mergers  or  similar 
combinations or liquidations, asset dispositions, repurchases or redemptions of equity interests or debt, issuances of equity, 
payment of dividends and certain distributions and entry into related party transactions. 

We have pledged substantially all of our assets as collateral for the Third Amended Credit Agreement. Our breach of any 
covenant in the Third Amended Credit Agreement, not otherwise cured, waived or amended, could result in a default under 
that agreement and could trigger acceleration of the underlying obligations. Any default under the Third Amended Credit 
Agreement could adversely affect our ability to service our debt and to fund our planned capital expenditures and ongoing 
operations. The administrative agent, joint lead arrangers, joint bookrunners and lenders under the Third Amended Credit 
Agreement have available to them the remedies typically available to lenders and secured parties, including the ability to 
foreclose on the collateral we have pledged. It could lead to an acceleration of indebtedness and foreclosure on our assets. 

As currently amended, the Third Amended Credit Agreement provides for potential borrowings of up to $750 million. 
Such increased borrowing limits may make it more difficult for us to comply with leverage ratios and other restrictive 
covenants in the Third Amended Credit Agreement. 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. 

We  depend  on  generating  sufficient  cash  flow  to  fund  our  debt  obligations,  capital  expenditures,  and  ongoing 
operations. 

We are dependent on our cash on hand and free cash flow to fund our debt obligations, capital expenditures and ongoing 
operations. Our ability to service our debt and to fund our planned capital expenditures and ongoing operations will depend 
on our ability to continue to generate cash flow. If we are unable to generate sufficient cash flow or we are unable to access 
additional liquidity sources, we may not be able to service or repay our debt, operate our business, respond to competitive 
challenges, or fund our other liquidity and capital needs. 

The market price of our common stock has been and may continue to be volatile. 

The market price of our common stock has at times, been, and may in the future be, volatile for various reasons, including 
those  discussed  in  these  risk  factors.  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 or any investigation of us 
by the SEC, DOJ, OIG, FDA, or another regulatory authority; actions taken by activist investors or other shareholders, 
significant litigation or a decline, or rise, of stock prices in capital markets generally. 

Fluctuations in foreign currency exchange rates may negatively impact our financial results. 

As our operations have grown outside the U.S., we have also become increasingly subject to market risk relating to foreign 
currency. Those fluctuations could have a negative impact on our margins and financial results. During 2022, 2021 and 
2020, the exchange rate between all applicable foreign currencies and the U.S. Dollar resulted in a decrease in net sales of 
$23.8 million, an increase in net sales of $10.3 million, and a decrease in net sales of $1.3 million, respectively. 

For the year ended December 31, 2022, $394.1 million, or 34.2%, of our net sales were denominated in foreign currencies, 
with our CNY- and Euro-denominated sales representing our largest currency risks to net sales. If the rate of exchange 
between foreign  currencies  declines  against  the U.S. Dollar, we may  not  be  able  to  increase  the  prices  we  charge our 
customers  for products  whose  prices  are denominated  in  those  respective  foreign  currencies. Furthermore, we may  be 
unable or elect not to enter into hedging transactions which could mitigate the effect of declining exchange rates. As a 
result, if the rate of exchange between foreign currencies declines against the U.S. Dollar, our financial results may be 
negatively impacted.  

35 

We are subject to changes in tax laws, fluctuations in tax rates, the adoption of new tax legislation or exposure to 
additional tax liabilities, which may adversely affect our effective tax rate, business, financial condition, or results of 
operations.  

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.  Our 
effective tax rate may, however, differ from the estimated amount due to numerous factors, including a change in the mix 
of our profitability from country to country and changes in tax laws. Any of these factors could cause us to experience an 
effective tax rate significantly different from previous periods or our current expectations, which could have an adverse 
effect on our business, financial condition or results of operation. 

In many countries, including the United States, we are subject to transfer pricing and other tax regulations designed to 
ensure that appropriate levels of income are reported as earned by our U.S. or local entities and are taxed accordingly. 
Although we believe we are in substantial compliance with applicable regulations and restrictions, we are subject to the 
risk that governmental authorities could assert that we owe additional taxes. In the event that audits, assessments, or other 
determinations  by  governmental  authorities  are  concluded  adversely  to  us,  they  could  have  an  adverse  effect  on  our 
business, financial condition or results of operation. 

Item 1B.    

Unresolved Staff Comments. 

None. 

Item 2.   

Properties. 

Our world headquarters is located in South Jordan, Utah, with our principal office for European operations located in 
Galway, Ireland and our principal office for Asian distribution located in Beijing, China. We also support our European 
operations from a distribution and customer service facility located in Maastricht, 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, Ireland, Brazil, France, 
Singapore, Mexico, and The Netherlands. Our research and development activities are conducted principally at facilities 
located in Utah, California, Texas, Ireland, France, and Singapore. 

Our total manufacturing, commercial, distribution, and research space is approximately 1.9 million square feet, of which 
approximately 1.0 million square feet is owned, and 0.9 million square feet is leased.  

The following is a summary of the approximate square footage of our key facilities as of December 31, 2022: 

Location 
Utah 
Mexico 
Virginia 
Ireland 
The Netherlands 
Texas 
Singapore 
China 

      Main Purpose 
   HQ, Manufacturing, Distribution, Research
  Manufacturing
  Manufacturing, Distribution
  Manufacturing, Research
   Manufacturing, Distribution
  Manufacturing, Research
  Manufacturing, Research
  Distribution

      Area (sq. ft.) 
 724,170
 196,690
 187,659
 139,680
 136,501
 94,000
 68,000
 50,290

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. 

36 

 
 
 
  
 
 
 
  
 
 
 
 
 
 
We believe our existing and proposed facilities will generally be adequate for our present and future anticipated levels of 
operations. 

Item 3.   

Legal Proceedings. 

See Note 10 “Commitments and Contingencies” to our consolidated financial statements set forth in Item 8 of this report 
and incorporated herein by reference.  

Item 4.   

Mine Safety Disclosures. 

The disclosure required by this item is not applicable. 

37 

 
 
 
 
 
PART II 

Item 5. 

Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of 
Equity Securities. 

Market Price for the Common Stock 

Our common stock is traded on the NASDAQ Global Select Market under the symbol “MMSI.” As of February 22, 2023, 
the number of shares of our common stock outstanding was 57,318,032 held by approximately 96 shareholders of record, 
not including shareholders whose shares are held in securities position listings. We did not repurchase any shares during 
the years ended December 31, 2022, 2021 and 2020.  

Performance 

The  following  graph  compares  the  performance  of  our  common  stock  with  the  performance  of  the  NASDAQ  US 
Benchmark TR Index and NASDAQ Stocks (SIC 3840-3849 U.S. Companies - Surgical, Medical and Dental Instruments 
and  Supplies)  for  a  five-year  period  by  measuring  the  changes  in  common  stock  prices  from  December 31,  2017  to 
December 31, 2022.  

Comparison of 5 Year Cumulative Total Return
Among Merit Medical Systems, Inc., NASDAQ US Benchmark (TR)
and NASDAQ Stocks (SIC 3840-3849)

250.00

200.00

150.00

l

e
u
a
V
r
a

l
l

o
D

100.00

50.00

0.00

Dec-17

Jun-18

Dec-18

Jun-19

Dec-19

Jun-20
Date

Dec-20

Jun-21

Dec-21

Jun-22

Dec-22

Merit Medical Systems, Inc.

NASDAQ US Benchmark  (TR)

NASDAQ Stocks (SIC 3840-3849 US Companies
Surgical, Medical, and Dental Instruments and Supplies)

Merit Medical Systems, Inc. 
NASDAQ US Benchmark (TR) 
NASDAQ Stocks (SIC 3840-3849 U.S. 
Companies) 

      12/2017 
  $ 100.00
100.00

12/2018 
$ 129.19
94.56

$

12/2019 
72.27
124.03

12/2020 

      12/2021 
$ 128.50    $   144.21
 189.36

150.41   

12/2022 
$ 163.45
152.00

100.00

112.98

138.90

202.84   

 228.47

165.59

38 

 
 
 
 
    
    
    
    
 
 
 
 
 
 
 
 
The stock performance graph assumes for comparison that the value of our common stock and of each index was $100 on 
December 31,  2017  and  that  all  dividends  were  reinvested. Past  performance  is  not  necessarily  an  indicator  of  future 
results. 

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. 
Used with permission. All rights reserved. 

Item 6.   

Reserved. 

Item 7.   

Management’s Discussion and Analysis of Financial Condition and Results of Operations. 

The following discussion and analysis of our financial condition and results of operations should be read in conjunction 
with the Consolidated Financial Statements and related Notes thereto set forth in Item 8 of this report. 

Overview 

We design, develop, manufacture and market medical products for interventional and diagnostic procedures. For financial 
reporting purposes, we report our operations in two operating segments: cardiovascular and endoscopy. Our cardiovascular 
segment consists of cardiology and radiology devices, which assist in diagnosing and treating coronary arterial disease, 
peripheral vascular disease and other non-vascular diseases and includes embolotherapeutic, cardiac rhythm management, 
electrophysiology, critical care, breast cancer localization and guidance, biopsy, interventional oncology and spine devices. 
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. Within those two operating 
segments, we offer products focused in five core product categories: peripheral intervention, cardiac intervention, custom 
procedural solutions, OEM and endoscopy. 

For the year ended December 31, 2022, we reported sales of $1.151 billion, up $76.2 million or 7.1%, compared to 2021 
sales of $1.075 billion. Our revenue results for the year ended December 31, 2022 were driven primarily by stronger-than-
anticipated demand in the U.S. and more favorable than anticipated international sales trends, particularly in the EMEA 
and “Rest of World” (“ROW”) regions. 

Gross profit as a percentage of sales was 45.1% for the year ended December 31, 2022 as compared to 45.2% for the year 
ended December 31, 2021. 

Net income for the year ended December 31, 2022 was $74.5 million, or $1.29 per share, as compared to $48.5 million, 
or $0.84 per share, for the year ended December 31, 2021. 

During 2022 we received “Breakthrough Device Designation” for Embosphere Microspheres for use in genicular artery 
embolization for symptomatic knee osteoarthritis. We also received FDA clearance for the SCOUT Bx Delivery System, 
the  first  wire-free  breast  localization  solution  that  can  be  deployed  at  the  time  of  stereotactic  or  MRI-guided  biopsy 
representing a notable addition to the Merit Oncology portfolio.  

We  have  launched  eight  new  products  during  2022  including  the  basixALPHA  inflation  device,  PreludeSYNC  EZ™ 
Radial Compression Device, TEMNO Elite™ Soft Tissue Biopsy System, Prelude Roadster™ Guide Sheath, SafeGuard 
Focus Cool™ Compression Device, SCOUT® Mini Reflector, ReSolve® Thoracostomy Tray and the commercial release 
of the smallest and shortest configuration in the Elation Pulmonary Balloon Dilator portfolio. 

On November 10, 2020, we introduced a corporate transformation initiative known as “Foundations for Growth” with 
multi-year financial targets for growth and improved profitability for the three-year period ending December 31, 2023. As 
part of this initiative, we continue to review the need to consolidate facilities, strategically reduce operating expenses and 
incentivize  our  sales  force  to  focus  on  products  that  will  improve  our  financial  performance.  Our  dedication  to  the 
Foundations  for  Growth  program  has  helped  offset  inflationary  cost  pressures  in  certain  raw  materials,  shipping,  and 
freight expenses. 

39 

Results of Operations 

The following table sets forth certain operational data as a percentage of sales for the years indicated: 

Net sales 
Gross profit 
Selling, general and administrative expenses 
Research and development expenses 
Legal settlement 
Impairment charges 
Contingent consideration expense (benefit) 
Acquired in-process research and development expense
Income (loss) from operations
Income (loss) before income taxes 
Net income (loss) 

Sales 

2022 

2021 

2020 

100 %  
45.1
29.8
6.6
—
0.2
0.4
0.6
7.6
7.2
6.5

 100  %  
 45.2    
 31.2    
 6.6    
 0.9   
 0.4    
 0.3    
 —    
 5.7    
 5.0    
 4.5    

100 %
41.6
30.9
6.0
1.9
3.8
(0.8)
0.0
(0.2)
(1.4)
(1.0)

Listed below are the sales by product category within each operating segment for the years ended December 31, 2022, 
2021 and 2020 (in thousands, other than percentage changes): 

Cardiovascular 

Peripheral Intervention 
Cardiac Intervention 
Custom Procedural Solutions 
OEM 

Total 

Endoscopy 

Endoscopy Devices 

     % Change     

2022 

    % Change     

2021 

     % Change     

2020 

439,810
8.6 %  $
343,186
7.0 %  
190,194
(1.9)%  
145,034
17.4 %  
7.2 %   1,118,224

405,116   
18.6 %  $
320,641   
14.6 %  
193,942   
(4.6)%  
123,528   
12.5 %  
11.7 %   1,043,227   

 (2.7)%  $ 341,568
 (8.2)%   279,671
 8.5 %   203,196
 (6.9)%   109,767
 (2.8)%   934,202

3.9 %  

32,757

6.2 %  

31,524   

 (12.4)%  

29,673

Total 

7.1 %  $ 1,150,981

11.5 %  $ 1,074,751   

 (3.1)%  $ 963,875

Cardiovascular Sales. Our cardiovascular sales for the year ended December 31, 2022 were $1.118 billion, up 7.2%, when 
compared  to  the  year  ended  December  31,  2021  of  $1.043  billion.  Sales  for  the year  ended  December 31, 2022  were 
favorably affected by increased sales of:  

(a)  Peripheral intervention products, which increased by $34.7 million, or 8.6%, from the corresponding period 
of 2021. This increase was driven primarily by sales of our access, embolotherapy, and radar localization 
products.  

(b)  Cardiac intervention products, which increased by $22.5 million, or 7.0%, from the corresponding period of 
rhythm 
2021.  This 
management/electrophysiology  (“CRM/EP”),  and  angiography  products,  partially  offset  by  a  decrease  in 
sales of our fluid management products. 

increase  was  driven  primarily  by  sales  of  our 

intervention,  cardiac 

(c)  OEM products, which increased by $21.5 million, or 17.4% from the corresponding period of 2021. This 
increase was driven primarily by sales of our access, angiography, fluid management, intervention, coating 
products and kits, partially offset by a decrease in sales of our CRM/EP products. 

The foregoing increase in sales for the year ended December 31, 2022 was partially offset by decreased sales of: 

40 

 
     
     
     
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
  
  
  
  
 
 
 
 
 
  
 
 
 
  
 
(d)  Custom procedural solutions products, which decreased by $(3.7) million, or (1.9)% from the corresponding 
period of 2021. This decrease was driven primarily by decreased sales of our critical care products, offset 
partially by increased sales of trays.  

Our cardiovascular sales for the year ended December 31, 2021 were $1.043 billion, up 11.7%, when compared to the year 
ended December 31, 2020 of $934.2 million. Sales for the year ended December 31, 2021 were favorably affected by 
increased sales of: 

(a)  Peripheral intervention products, which increased by $63.5 million, or 18.6%, from the corresponding period 
of  2020.  This  increase  was  driven  primarily  by  sales  of  our  radar  localization,  embolotherapy,  drainage, 
biopsy, angiography, access and intervention products.  

(b)  Cardiac intervention products, which increased by $41.0 million, or 14.6%, from the corresponding period 
of 2020. This increase was driven primarily by sales of our intervention, fluid management (including our 
Medallion Syringes, which saw increased demand due to COVID-19 vaccination efforts) and angiography 
products. 

(c)  OEM products, which increased by $13.8 million, or 12.5% from the corresponding period of 2020. This 

increase was driven primarily by sales of our CRM/EP, angiography products and kits. 

The foregoing increase in sales for the year ended December 31, 2021 was partially offset by decreased sales of: 

(d)  Custom procedural solutions products, which decreased by $(9.3) million, or (4.6)% from the corresponding 
period of 2020. This decrease was driven primarily by decreased sales of our critical care products (including 
a $(15.9) million decrease in Cultura® nasopharyngeal swab and test kit sales) and trays, offset partially by 
sales of kits. 

Endoscopy  Sales.  Our  endoscopy  sales  for  the year  ended  December 31, 2022  were  $32.8  million,  up  3.9%,  when 
compared to sales for the year ended December 31, 2021 of $31.5 million. Sales for the year ended December 31, 2022 
were favorably affected by increased sales of our Elation Balloon Dilator and other stents, partially offset by a decrease in 
sales of our EndoMAXX fully covered esophageal stent. Our endoscopy sales for the year ended December 31, 2021 were 
$31.5 million, up 6.2%, when compared to sales for the corresponding period in 2020 of $29.7 million. Sales for the year 
ended December 31, 2021 were favorably affected by increased sales of our Elation Balloon Dilator and our EndoMAXX 
fully covered esophageal stent. 

Geographic Sales 

Sales  trends  for  the  years  ended  December  31, 2022,  2021,  and 2020 were  influenced  by  the  incidence  and  timing of 
COVID-19 infections and the associated governmental and patient responses, which varied between countries and regions 
in both the current and prior-year periods. Listed below are sales by geography for the years ended December 31, 2022, 
2021, and 2020 (in thousands, other than percentage changes): 

United States 
International 
Total 

2022 
    % Change     
650,559
6.8 %  
7.4 %  
500,422
7.1 %  $ 1,150,981

2021 
    % Change     
608,878   
10.7 %  
12.6 %  
465,873   
11.5 %  $ 1,074,751    

    % Change     

2020 

 (4.5)%   550,061
 (1.3)%   413,814
 (3.1)%  $ 963,875

United States Sales: U.S. sales for the year ended December 31, 2022 were $650.6 million, or 56.5% of net sales, up 6.8% 
when compared to 2021. The increase in our domestic sales in 2022 was driven primarily by our U.S. direct, sensors and 
OEM businesses. U.S. sales for the year ended December 31, 2021 were $608.9 million, or 56.7% of net sales, up 10.7% 
when compared to 2020. The increase in our domestic sales in 2021 was driven primarily by our U.S. direct and OEM 
businesses.  

International Sales. International sales for the year ended December 31, 2022 were $500.4 million, or 43.5% of net sales, 
up 7.4% when compared to 2021. The increase in our international sales during 2022 was primarily a result of higher sales 

41 

 
 
 
 
  
 
in APAC, which increased $13.3 million or 5.9%, higher sales in EMEA, which increased $11.4 million or 5.5%, and 
higher  rest  of  world  sales  which  increased  $9.9  million  or  30.8%,  compared  to  the  corresponding  period  of  2021. 
International  sales  for  the year  ended December 31, 2021  were $465.9 million, or  43.3% of  net  sales, up  12.6% when 
compared to 2020. The increase in our international sales during 2021 was primarily a result of higher sales in APAC, 
which increased 12.8% or $25.9 million, higher sales in EMEA, which increased 11.8% or $21.7 million, and higher rest 
of world sales which increased 16.2% or $4.5 million, compared to the corresponding period of 2020. 

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 (2.2)% for the year ended December 31, 2022 compared to 2021 
and increased sales 1.1% for the year ended December 31, 2021 compared to 2020.  

Gross Profit 

Our gross profit as a percentage of sales was 45.1%, 45.2%, and 41.6% for the years ended December 31, 2022, 2021 and 
2020, respectively. The decrease in gross profit as a percentage of sales for 2022, as compared to 2021, was primarily due 
to  less  favorable  manufacturing  variances  and  higher  freight  costs  as  a  percentage  of  sales,  partially  offset  by  more 
favorable changes in standard cost and product mix, decreased intangible amortization expense as a percentage of sales, 
and lower obsolescence expense, among other factors. The increase in gross profit as a percentage of sales for 2021, as 
compared to 2020, was primarily due to decreased amortization expense associated with acquisitions ($42.5 million in 
2021  compared  to  $50.7  million  in  2020),  changes  in  product  mix,  improvements  in  manufacturing  variances,  and 
decreased obsolescence expense as a percentage of sales, partially offset by higher shipping and freight costs, among other 
factors. 

Operating Expenses 

Selling,  General  and  Administrative  Expenses.  Our  selling,  general  and  administrative  (“SG&A”)  expenses  increased 
$6.8 million, or 2.0%, for the year ended December 31, 2022 compared to 2021 and increased $38.0 million, or 12.8%, 
for the year ended December 31, 2021 compared to 2020. SG&A expenses as a percentage of sales were 29.8%, 31.2% 
and 30.9% for the years ended December 31, 2022, 2021 and 2020, respectively. 

The increase in SG&A expenses for the year ended December 31, 2022 compared to the year ended December 31, 2021 
was primarily related to an increase in labor-related costs, including a $6.6 million increase for severance associated with 
restructuring and site closures, and higher travel related expenses as restrictions from the pandemic continued to decline; 
partially offset by a decrease of approximately $6 million for contract termination costs incurred in 2021 to renegotiate 
certain  terms  of  our  September  1,  2017  share  purchase  agreement  with  IntelliMedical  Technologies  Pty.  Ltd. 
(“IntelliMedical”). In addition, for the year ended December 31, 2022, we recorded $1.0 million of expense in connection 
with the negotiated settlement of a shareholder derivative lawsuit filed in the United States District Court for the District 
of Utah against Merit, our Chief Executive Officer, our Chief Financial Officer and certain of our directors. 

The increase in SG&A expenses for the year ended December 31, 2021 compared to the year ended December 31, 2020 
was primarily related to labor-related costs, which increased due primarily to higher commissions and bonus expense in 
the current-year period, in contrast to temporary salary cuts and furloughs in 2020. During the year ended December 31, 
2021, we incurred approximately $6 million of contract termination costs in SG&A to renegotiate certain terms of our 
September  1,  2017  share  purchase  agreement  with  IntelliMedical  and  $18.6  million  of  corporate  transformation  and 
restructuring costs, including consulting charges, in connection with our Foundations for Growth program. 

Research and Development Expenses. Our research and development (“R&D”) expenses as a percentage of sales were 
6.6%, 6.6% and 6.0% for the years ended December 31 2022, 2021, and 2020, respectively. R&D expenses increased by 
$4.3 million or 6.0% to $75.5 million for the year ended December 31, 2022, compared to $71.2 million in 2021. The 
increase in R&D expenses for the year ended December 31, 2022 compared to the year ended December 31, 2021 was 
primarily related to labor-related costs consistent with an increase in headcount. We also incurred increased outside service 
and consulting costs due to higher costs from clinical trials and the implementation of the MDR in the European Union. 

42 

R&D expenses increased by $13.7 million or 23.8% to $71.2 million for the year ended December 31, 2021, compared to 
$57.5 million for the year ended December 31, 2020. The increase in R&D expenses for the year ended December 31, 
2021 compared to the year ended December 31, 2020 was primarily related to labor-related costs, which increased due to 
higher bonus expense in the current-year period, in contrast to temporary salary cuts and furloughs in the prior year. We 
also incurred increased clinical expenses for certain R&D projects (including our Wrapsody AV Access Efficacy Study) 
and higher expenses related to implementation of the MDR in the European Union.  

Legal  Settlement.  For  the  year  ended  December  31,  2021,  we  recorded  approximately  $10  million  of  net  expense  in 
connection with an agreement in principle to settle the securities class action lawsuit in December 2019 against Merit, our 
Chief Executive Officer and our Chief Financial Officer in the United States District Court for the Central District of 
California  (the  “Class  Action  Litigation”).  This  expense  includes  $18.25  million  of  settlement  related  costs,  net  of 
$8.2 million of insurance proceeds. 

For the year ended December 31, 2020, we recorded $18.7 million of expense in connection with a settlement agreement 
with  the  United  States  Department  of  Justice  (“DOJ”) to  resolve  the  DOJ’s  investigation  of  certain  marketing  and 
promotional practices. 

Impairment Charges. For the year ended December 31, 2022, we recorded impairment charges of $2.2 million. These 
impairments included $1.7 million of intangible assets for our divestiture of STD Pharmaceutical Products Limited (“STD 
Pharmaceutical”) business acquired in our August 2019 acquisition of Fibrovein Holdings and $0.5 million impairment of 
our equity investment in XableCath, Inc. as this business ceased operations. 

For the year ended December 31, 2021 we recorded impairment charges of $4.3 million. These impairments included 
$1.6 million  of  intangible  asset  and  $1.3  million  of  property  and  equipment  due  to  the  planned  discontinuance  of  the 
Advocate™  Peripheral  Angioplasty  Balloon  product  line,  sold  under  our  license  agreements  with  ArraVasc  Limited 
(“ArraVasc”)  and  $1.4  million  of  impairments  of  certain  right-of-use  (“ROU”)  operating  lease  assets  due  to  site 
consolidation decisions and changes in our projected cash flows for the underlying lease assets. 

For the year ended December 31, 2020 we recorded impairment charges of $36.5 million, which included $1.8 million 
related to certain ROU operating lease assets and property and equipment, $6.0 million related to equity investments and 
purchase  options,  and  $28.7  million  related  to  certain  acquired  intangible  assets,  which  included  a  partial  impairment 
charge of $8.2 million of intangible assets from our acquisition of STD Pharmaceutical, a partial impairment charge of 
$8.0 million of intangible assets from our acquisition of certain assets from Laurane Medical S.A.S, a partial impairment 
charge of $4.8 million related to our license agreements with ArraVasc, and other intangible asset impairments charges of 
$7.7 million related to intangible assets from our acquisition of certain assets from DirectACCESS Medical, LLC, in-
process  technology  intangible  assets  of  Sontina  Medical  LLC  acquired  in  connection  with  our  acquisition  of  certain 
divested assets from BD, and a customer list intangible asset from our acquisition of ITL Healthcare Pty Ltd (“ITL”). 

Contingent  Consideration  Expense  (Benefit).  For  the  years  ended  December  31,  2022,  2021  and  2020,  we  recorded 
$4.6 million, $3.2 million and $(8.0) million, respectively, of net contingent consideration expense (benefit) from changes 
in the estimated fair value of our contingent consideration obligations stemming from our previously disclosed business 
acquisitions. The expense (benefit) 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,  2022,  we  incurred  in-process 
research and development charges of $6.7 million primarily associated with our acquisition of Restore Endosystems, LLC 
(“Restore Endosystems”). We did not incur in-process research and development charges during the year ended December 
31, 2021. We incurred $0.3 million for in-process research and development associated with various asset acquisitions 
during the year ended December 31, 2020. 

43 

Operating Income (Loss) 

Our  operating  profit  by  operating  segment  for  the years  ended  December 31, 2022,  2021  and  2020  was  as  follows 
(in thousands):  

Operating Income (Loss) 

Cardiovascular 
Endoscopy 

Total operating income (loss) 

2022 

2021 

$ 80,946    $   53,415
 7,501
$ 87,563    $   60,916

6,617   

2020 
$ (7,042)
5,480
$ (1,562)

Cardiovascular Operating Income (Loss). Our cardiovascular operating income for the year ended December 31, 2022 
was $80.9 million, compared to cardiovascular operating income of $53.4 million for the year ended December 31, 2021. 
This increase in cardiovascular operating income was primarily related to higher sales, decreased legal settlement costs, 
including $10 million in 2021 in connection with an agreement in principle to settle a securities class action lawsuit, and 
decreased impairment charges within our cardiovascular operating segment ($2.2 million in 2022 compared to $4.3 million 
in  2021),  partially  offset  by  increased  labor-related  and  travel  costs,  and  increased  contingent  consideration  expense 
($4.6 million in 2022, compared to $3.2 million in 2021). 

Our  cardiovascular  operating  income  for  the year  ended  December 31, 2021  was  $53.4  million,  compared  to 
cardiovascular  operating  loss  of  $(7.0)  million  for  the year  ended  December 31, 2020.  This  increase  in  cardiovascular 
operating income was primarily related to higher sales and increased gross margin percentage, decreased legal settlement 
costs  ($10  million  in  2021,  compared  to  $18.7  million  in  2020)  and  decreased  impairment  charges  within  our 
cardiovascular operating segment ($4.3 million in 2021 compared to $36.5 million in 2020), partially offset by increased 
labor-related  costs,  approximately  $6  million  of  contract  termination  costs  to  renegotiate  certain  terms  of  our  share 
purchase  agreement  with  IntelliMedical,  increased  corporate  transformation  costs,  including  consulting  charges,  in 
connection with our Foundations for Growth program and increased contingent consideration ($3.2 million of expense in 
2021, compared to a benefit of $(8.0) million in 2020). 

Endoscopy Operating Income. Our endoscopy operating income for the year ended December 31, 2022 was $6.6 million, 
compared  to  operating  income  of  $7.5  million  for  the year  ended  December 31, 2021.  This  decrease  in  endoscopy 
operating income relative to 2021 was primarily due to decreased gross margin percentage as a result of changes in product 
mix and higher shipping costs and higher labor-related costs, partially offset by higher sales. 

Our endoscopy operating income for the year ended December 31, 2021 was $7.5 million, compared to operating income 
of $5.5 million for the year ended December 31, 2020. This increase in endoscopy operating income relative to 2020 was 
primarily due to higher sales and increased gross margin percentage, partially offset by increased labor-related costs. 

Other Income (Expense) 

Our  other  expense  for  the years  ended  December 31, 2022,  2021  and  2020  was  $4.9  million,  $7.0  million,  and 
$11.7 million, respectively. The decrease in other expense for 2022 compared to 2021 was principally the result of an 
increase in other income associated with realized and unrealized foreign currency gain (loss), partially offset by an increase 
in interest expense associated with rising interest rates and an increase in other expense related to the divestiture of the 
STD Pharmaceutical business.  

The decrease in other expense for 2021 compared to 2020 was principally the result of decreased interest expense due to 
lower average debt balances and a lower average interest rate during 2021 partially offset by a gain of $0.5 million on the 
sale of the assets associated with our Hypotube™ product line in 2020.  

Effective Tax Rate 

Our provision for income taxes for the years ended December 31, 2022, 2021 and 2020 was a tax expense (benefit) of 
$8.1 million, $5.5 million and $(3.4) million, respectively, which resulted in an effective income tax rate of 9.8%, 10.1%, and 
25.6%,  respectively.  The  decrease  in  the  effective  income  tax  rate  for  2022  compared  to  2021  was  primarily  the  result  of 

44 

   
     
    
  
 
a  benefit  from  the  change  in  foreign  withholding  taxes  on  unremitted  foreign  earnings  due  to  the  restructuring  of  our 
foreign entities, more foreign tax credits being utilized, as well as additional benefit from the foreign-derived intangible 
income (FDII) deduction. The decrease in the effective income tax rate for 2021 compared to 2020 was primarily the result 
of a change in the jurisdictional mix of earnings, additional benefit from stock-based compensation awards, as well as 
more foreign tax credits being utilized.  

Net Income (Loss) 

Our net income (loss) for the years ended December 31, 2022, 2021 and 2020 was $74.5 million, $48.5 million, and $(9.8) 
million, respectively. The increase in net income for 2022, when compared to 2021, was primarily related to higher sales, 
decreased legal settlement costs primarily due to the $10.0 million settlement in 2021 in connection with an agreement in 
principle to settle a securities class action lawsuit, and decreased impairment charges ($2.2 million in 2022 compared to 
$4.3 million in 2021); partially offset by higher SG&A expenses due to higher labor-related and travel costs, as well as 
increased contingent consideration expense of $4.6 million in 2022 compared to $3.2 million in 2021.  

The increase in net income for 2021, when compared to 2020, was primarily related to higher sales and increased gross 
margin percentage, as we observed an operating environment with fewer COVID-19 related restrictions throughout the 
year. Legal settlement costs decreased to $10 million in 2021, compared to $18.7 million in 2020, and impairment charges 
decreased to $4.3 million in 2021 compared to $36.5 million in 2020. This was partially offset by higher SG&A expenses 
due to higher labor-related costs, $6 million of contract termination costs to renegotiate certain terms of an acquisition 
agreement, increased corporate transformation costs, including consulting charges, in connection with our Foundations for 
Growth  program,  as  well  as  contingent  consideration  expense  of  $3.2  million  in  2021  compared  to  a  benefit  of 
$(8.0) million in 2020.  

Liquidity and Capital Resources 

Capital Commitments and Contractual Obligations 

Our most significant contractual obligations as of December 31, 2022 included long-term debt of $198.2 million, of which 
$11.3 million is recorded in current liabilities, interest payments on this debt, operating lease liabilities of $70.7 million, 
of which $11.0 million is recorded in current liabilities, and contingent consideration liabilities of $18.1 million, of which 
$15.8 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. 

Cash Flows 

At December 31, 2022 and 2021, we had cash, cash equivalents and restricted cash of $60.6 million and $67.8 million 
respectively, of which $49.6 million and $55.7 million, respectively, were held by foreign subsidiaries. We do not consider 
our foreign earnings to be permanently reinvested. As of December 31, 2022 and 2021, approximately $2.1 million and 
$1.9 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. 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, 2022 
and 2021, we had cash and cash equivalents, including restricted cash, of $26.1 million and $28.5 million, respectively, 
held by our subsidiary in China. 

Cash flows provided by operating activities. We generated cash from operating activities of $114.3 million, $147.2 million 
and  $165.3  million  during  the years  ended  December 31, 2022,  2021  and  2020,  respectively.  Net  cash  provided  by 
operating  activities  decreased  $32.9  million  for  the  year  ended  December 31, 2022  compared  to  the  year  ended 
December 31, 2021. Significant changes in operating assets and liabilities affecting cash flows during these years included: 

•  Net  income  was  $74.5  million  and  $48.5  million  for  the  years  ended  December  31,  2022  and  2021, 
respectively. This improvement in net income was partially offset by an increase in the non-cash adjustment 
for deferred income taxes within the statement of cash flows of $(14.9) million and $(4.6) million for the 
years ended December 31, 2022 and 2021, respectively. 

45 

•  Cash (used for) accounts receivable was $(15.1) million and $(8.6) million for the years ended December 31, 

2022 and 2021, respectively, due primarily to increases in sales volume, 

•  Cash  provided  by  (used  for)  other  receivables  was  $4.2  million  and  $(10.4)  million  for  the  years  ended 
December 31, 2022 and 2021, respectively, due primarily to the collection of approximately $8.2 million of 
insurance  proceeds  in  connection  with  the  consolidated  securities  class  action  lawsuit  we  settled  in 
April 2022, 

•  Cash (used for) inventories was $(47.9) million and $(25.2) million for the years ended December 31, 2022 
and 2021, respectively, due primarily to efforts to normalize inventory levels as well as build bridge inventory 
for production line transfers and increases in safety stock due to vendor supply delays, and 

•  Cash provided by (used for) accrued expenses was $(16.4) million and $36.5 million for the years ended 
December  31, 2022  and  2021, respectively,  primarily  related  to payment  of  a  legal  settlement  accrual  of 
$18.25 million in 2022 associated with the agreement in principle to settle the Class Action Litigation and 
increased labor-related cost accruals associated with higher commissions and bonus expense in the prior-
year period, among other items. 

Net cash provided by operating activities decreased $18.0 million for the year ended December 31, 2021 compared to the 
year ended December 31, 2020. Significant changes in operating assets and liabilities affecting cash flows during these 
years included: 

•  Net income (loss) was $48.5 million and $(9.8) million for the years ended December 31, 2021 and 2020, 
respectively. This improvement in net income was offset by a decrease in the non-cash adjustment for the 
write-off of certain intangible and other long-term assets within the statement of cash flows of $4.4 million 
and $36.6 million for the years ended December 31, 2021 and 2020, respectively. 

•  Cash provided by (used for) accounts receivable was $(8.6) million and $10.4 million for the years ended 

December 31, 2022 and 2021, respectively, due primarily to increases in sales volume, 

•  Cash  provided  by  (used  for)  other  receivables  was  $(10.4)  million  and  $1.7  million  for  the  years  ended 
December 31, 2021 and 2020, respectively, due primarily to an increase in an insurance receivable associated 
with the agreement in principle to settle the Class Action Litigation, 

•  Cash provided by (used for) inventories was $(25.2) million and $29.4 million for the years ended December 
31, 2021 and 2020, respectively, due primarily to efforts to manage inventory levels to support the growth 
in  sales  and  reduced  production  in  the  prior-year  period  during  the  economic  downturn  related  to  the 
COVID- 19 pandemic, and 

•  Cash provided by accrued expenses was $36.5 million and $4.6 million for the years ended December 31, 
2021  and  2020,  respectively,  related  to  increased  labor-related  cost  accruals  associated  with  higher 
commissions and bonus expense in the current-year period and a legal settlement accrual of $18.25 million 
in 2021 associated with the agreement in principle to settle the Class Action Litigation, among other items. 

Cash  flows  used  in  investing  activities.  We  used  cash  in  investing  activities  of  $57.4  million,  $37.2  million,  and 
$58.7 million for the years ended December 31, 2022, 2021 and 2020, respectively. We invested in capital expenditures 
for property and equipment of $45.0 million, $27.9 million, and $46.0 million for the years ended December 31, 2022, 
2021 and 2020, respectively. 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 2023 for property and equipment. 

46 

 
 
 
 
 
 
Cash outflows invested in acquisitions for the year ended December 31, 2022 were $8.3 million and were primarily related 
to our $3.0 million upfront payment in our purchase of Restore Endosystems, our $2.5 million payment in our purchase of 
BioTrace  Medical,  Inc.,  and  our  additional  equity  investment  in  FluidX  Medical  Technology,  Inc.  (“Fluidx”)  of  $1.4 
million. Cash outflows invested in acquisitions for the year ended December 31, 2021 were $7.2 million and were primarily 
related to $4.1 for the settlement of deferred payments and the working capital adjustment associated with our acquisition 
of KA Medical, LLC (“KA Medical”) completed in November 2020 and $2.7 million for an equity investment in FluidX. 
Cash  outflows  invested  in  acquisitions  for  the  year  ended  December  31,  2020  were  $11.0  million  and  were  primarily 
related to our acquisition of KA Medical. For further discussion, refer to Note 3 to our consolidated financial statements 
set forth in Item 8 of this report. 

Cash flows used in financing activities. Cash used in financing activities for the years ended December 31, 2022, 2021 and 
2020 was $60.3 million, $98.4 million, and $95.7 million, respectively. 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”). In 2021 we decreased our net borrowings under our Third Amended Credit 
Agreement by $108.5 million and paid contingent consideration of $10.7 million, which is classified as a financing activity, 
principally related to our acquisition of Vascular Insights. In 2020 we decreased our net borrowings by $88.4 million and 
paid  contingent  consideration  of  $13.1  million,  which  is  classified  as  a  financing  activity,  principally  related  to  our 
acquisition of Cianna Medical. 

As  of  December  31,  2022,  we  had  outstanding  borrowings  of  $198.2  million  and  issued  letter  of  credit  guarantees  of 
$3.2 million under the Third Amended Credit Agreement, with additional available borrowings of approximately $523 
million, based on the leverage ratio required pursuant to the Third Amended Credit Agreement. Our interest rate as of 
December 31, 2022 was a fixed rate of 2.71% on $75 million as a result of an interest rate swap and a variable floating 
rate of 5.38% on $123.2 million. Our interest rate as of December 31, 2021 was a fixed rate of 2.71% on $75 million as a 
result  of  an  interest  rate  swap  and  a  variable  floating  rate  of  1.10%  on  $168.1  million.  The  foregoing  fixed  rates  are 
exclusive  of  potential  future  changes  in  the  applicable  margin.  See  Note  8  and  Note  9  to  our  consolidated  financial 
statements set forth in Item 8 of this report for additional details regarding the Third Amended Credit Agreement, our 
long-term debt and our interest rate swaps. 

We currently believe that our existing cash balances, anticipated future cash flows from operations and borrowings under 
the Third Amended Credit Agreement will be adequate to fund our current and currently planned future operations for the 
next twelve months and the foreseeable future. In the event we pursue and complete significant transactions or acquisitions 
in the future, additional funds will likely be required to meet our strategic needs, which may require us to raise additional 
funds in the debt or equity markets. 

Critical Accounting Policies and Estimates 

Our significant accounting policies are summarized in Note 1 to our consolidated financial statements set forth in Item 8 
of this report. While these significant accounting policies affect the reporting of our financial condition and results of 
operations, the SEC has requested that all registrants address their most critical accounting policies. The SEC has indicated 
that a “critical accounting policy” is one which is both important to the representation of the registrant’s financial condition 
and results and requires management’s most difficult, subjective or complex judgments, often as a result of the need to 
make estimates about the effect of matters that are inherently uncertain. We base our estimates on past experience and on 
various other assumptions our management believes to be reasonable under the circumstances, the results of which form 
the basis for making  judgments  about  carrying values of  assets and  liabilities  that  are  not readily  apparent  from other 
sources. Actual results will differ and may differ materially from these estimates under different assumptions or conditions. 
Additionally, changes in accounting estimates could occur in the future from period to period. The following paragraphs 
identify our most critical accounting policies:  

Inventory  Obsolescence.  Our  management  reviews  inventory  quantities  on  hand  and  records  provisions  for  estimated 
excess, slow moving and obsolete inventory. Based on this review, we provide adjustments for any slow-moving finished 
good products or raw materials that we believe will expire prior to being sold or used to produce a finished good and any 

47 

 
 
 
products that are unmarketable. This review of inventory quantities for unmarketable and/or slow moving products is based 
on forecasted product demand derived from our historical experience of product sales and production raw material usage. 
If market conditions become less favorable than those projected by our management, additional inventory write-downs 
may  be  required.  During  the  years  ended  December  31,  2022,  2021  and  2020,  we  recorded  obsolescence  expense  of 
approximately $9.8 million, $10.9 million, and $14.1 million, respectively, and wrote off approximately $10.2 million, 
$11.6 million, and $8.9 million, respectively. Based on this historical trend, we believe that our inventory balances as of 
December 31, 2022 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. We allocate any excess purchase price over the fair value of the net tangible 
and identifiable intangible assets acquired in a business combination to goodwill. 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.  

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. 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. The quantitative assessment considers whether the carrying amount of a reporting unit 
exceeds its fair value, in which case an impairment charge is recorded to the extent the reporting unit’s carrying value 
exceeds its fair value. This analysis requires significant judgment, including estimation of the amount, timing and duration 
of future cash flows, which is based on internal forecasts, and a determination of a discount rate based on our weighted 
average cost of capital. During our annual test of goodwill balances in 2022, which was completed during the third quarter 
of  2022,  we  determined  that  the  fair  value  of  each  reporting  unit  with  goodwill  exceeded  the  carrying  amount  by  a 
significant amount. 

We  evaluate  long-lived  assets,  including  amortizing  intangible  assets,  for  impairment  whenever  events  or  changes  in 
circumstances indicate that their carrying amounts may not be recoverable. We perform the impairment analysis at the 
asset group for which the lowest level of identifiable cash flows is largely independent of the cash flows of other assets 
and  liabilities. We  first  compare  undiscounted  cash  flows  to  the  carrying  amount  of  the  asset  group  to  determine  if 
impairment  exists,  and  then  determine  the  fair  value  of  our  amortizing  assets  based  on  estimated  future  cash  flows 
discounted back to their present value using a discount rate that reflects the risk profiles of the underlying activities. This 
analysis  requires  similar  significant  judgments  as  those  discussed  above  regarding  goodwill.  In-process  technology 
intangible assets, which are not subject to amortization until projects reach commercialization, are assessed for impairment 
at least annually and more frequently if events occur that would indicate a potential reduction in the fair value of the assets 
below their carrying value. 

During the years ended December 31, 2022, 2021 and 2020, we identified indicators of impairment associated with certain 
acquired intangible assets within the asset groups based on our qualitative assessment. During the years ended December 
31, 2022, 2021 and 2020 we recorded total impairment charges associated with intangible assets in our cardiovascular 
segment of $1.7 million, $1.6 million, and $28.7 million, respectively. These expenses are reflected within impairment 
charges  in  our  consolidated  statements  of  income  (loss). 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, due in part to the economic impacts of the COVID-19 
pandemic.  See  Note 5  to  our  consolidated  financial  statements  set  forth  in  Item 8  of  this  report  for  additional  details 
regarding impairments of intangible assets. 

Contingent Consideration. Contingent consideration is an obligation by the buyer to transfer additional assets or equity 
interests to the former owner upon reaching certain performance targets. Certain of our business combinations involve the 
potential for the payment of future contingent consideration, generally based on a percentage of future product sales or 
upon  attaining  specified  future  revenue  or  other  relevant  milestones.  In  connection  with  a  business  combination,  any 
contingent  consideration  is  recorded  at  fair  value  on  the  acquisition  date  based  upon  the  consideration  expected  to  be 

48 

transferred in the future. We base the fair value of contingent consideration obligations acquired in a business combination 
on  valuations  that  use  information  and  assumptions  that  a  market  participant  would  use,  including  assumptions  for 
estimated revenue growth rates, discount rates, probabilities of achieving regulatory approval, performance, or revenue-
based milestones and other relevant factors.  

We  re-measure  the  estimated  liability  each  quarter  and  record  changes  in  the  estimated  fair  value  through  operating 
expense in our consolidated statements of income (loss). Significant increases or decreases in our estimates could result in 
changes to the estimated fair value of our contingent consideration liability, as well as the result of changes in the timing 
and amount of revenue estimates and changes in the discount rate or periods. Our revenue milestone contingent liability 
associated with the November 2018 acquisition of Cianna Medical includes a sales growth multiplier, and our revenue 
milestones for the acquisition of Brightwater Medical, Inc. includes payment thresholds. These and other similar contract 
features of our contingent consideration liabilities create sensitivity regarding the occurrence, timing, and amount of future 
payments.  

For  the  years ended December 31, 2022,  2021  and  2020,  we  recognized  contingent  consideration  expense  (benefit)  of 
$4.6 million,  $3.2  million  and  $(8.0)  million,  respectively,  from  changes  in  the  estimated  fair  value  of  our  contingent 
consideration obligations stemming from our previously disclosed business acquisitions. Changes in the fair value of our 
contingent  consideration  liabilities  were primarily  attributable  to  changes  in  anticipated  sales  growth  in  the  acquired 
products and the anticipated timing of milestone payments. See Note 15 to our consolidated financial statements set forth 
in Item 8 of this report for additional details regarding our contingent liabilities. 

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, 2022, a portion of our net sales ($394.1 million, representing 34.2% of our aggregate net sales), was 
attributable  to  sales  that  were  denominated  in  foreign  currencies.  All  other  international  sales  were  denominated  in 
U.S. Dollars. Our principal market risk relates to changes in the value of the Chinese Yuan Renminbi (CNY) and Euro 
(EUR)  relative  to  the  U.S.  Dollar  (USD),  with  limited  market  risk  relating  to  various  other  currencies.  In  general,  a 
strengthening  of  the  U.S.  Dollar  against  CNY  has  a  negative  effect  on  our  operating  income.  Our  Euro-denominated 
expenses associated with our European operations (manufacturing sites, a distribution facility and sales representatives) 
provide a natural hedge for Euro-denominated revenues. Accordingly, a strengthening of the U.S. Dollar against the Euro 
will generally have a positive effect on our operating income.  

We forecast our net exposure related to sales and expenses denominated in foreign currencies. As of December 31, 2022 
and 2021, we had entered into foreign currency forward contracts, which qualified as cash flow hedges, with aggregate 
notional  amounts  of  $87.8  million  and  $123.0  million,  respectively.  We  also  forecast  our  net  exposure  in  various 
receivables and payables to fluctuations in the value of various currencies, and we enter into foreign currency forward 
contracts to mitigate that exposure. As of December 31, 2022 and 2021, 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 $92.4 million and $86.0 million, respectively. 

A sensitivity analysis of changes in the fair value of all currency exchange rate derivative contracts at December 31, 2022 
and 2021 indicates that, if the U.S. Dollar strengthened or weakened by 10% against all currencies, it would have the 
following impact on the fair value of these contracts (in thousands): 

10% Strengthening 
10% Weakening 

2022 

$
$

4,660   $ 
(4,660)  $ 

2021 
 3,470
 (3,470)

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.  These  offsetting  gains  and  losses  are  not  reflected  above.  See  Note 9  to  our 
consolidated financial statements set forth in Item 8 of this report for additional discussion of our foreign currency forward 
contracts. 

49 

 
 
    
     
 
Interest Rate Risk 

As discussed in Note 8 to our consolidated financial statements set forth in Item 8 of this report, as of December 31, 2022, 
we had outstanding borrowings of $198.2 million under the Third Amended Credit Agreement. Accordingly, our earnings 
and  after-tax  cash  flow  are  affected by  changes  in  interest  rates.  On  December 23, 2019, we  entered  into  a  pay-fixed, 
receive-variable interest rate swap with Wells Fargo Bank, with a notional amount of $75 million, to fix the one-month 
LIBOR rate at 1.71% for the period from July 6, 2021 to July 31, 2024. This interest rate swap is intended to reduce our 
exposure  to  interest  rate  fluctuations  and  was  not  entered  into  for  speculative  purposes.  Excluding  the  amount  that  is 
subject to a fixed rate under the interest rate swap and assuming the current level of borrowings remained the same, it is 
estimated that our interest expense and income before income taxes would change by approximately $1.2 million annually 
for each one percentage point change in the average interest rate under these borrowings. 

Certain  of  the  interest  rates  applicable  to  our  Third  Amended  Credit  Agreement  and  to  hedging  instruments  we  have 
purchased  to  offset  interest  rate  risk  under  our  Third  Amended  Credit  Agreement,  are  LIBOR-based.  We  anticipate 
replacement  rates  will  be  identified,  as  provided  for  in  our  Third  Amended  Credit  Agreement,  as  LIBOR-based  rates 
become unavailable.  

50 

 
Item 8.   

Financial Statements and Supplementary Data. 

REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM 

To the stockholders and the Board of Directors of Merit Medical Systems, Inc. 

Opinion on the Financial Statements 

We  have  audited  the  accompanying  consolidated  balance  sheets  of  Merit  Medical  Systems,  Inc.  and  subsidiaries  (the 
"Company")  as  of  December  31, 2022  and 2021,  the  related  consolidated  statements of  income (loss),  comprehensive 
income (loss), stockholders’ equity, and cash flows for each of the three years in the period ended December 31, 2022, 
and the related notes and the schedule listed in the Index at Item 15 (collectively referred to as the "financial statements"). 
In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company as of 
December 31, 2022 and 2021, and the results of its operations and its cash flows for each of the three years in the period 
ended December 31, 2022, in conformity with accounting principles generally accepted in the United States of America. 

We  have  also  audited,  in  accordance  with  the  standards  of  the  Public  Company  Accounting  Oversight  Board  (United 
States)  (PCAOB),  the  Company's  internal  control over  financial  reporting  as  of December 31,  2022, based  on  criteria 
established in Internal Control — Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of 
the Treadway Commission and our report dated February 24, 2023, expressed an unqualified opinion on the Company's 
internal control over financial reporting. 

Basis for Opinion 

These financial statements are the responsibility of the Company's management. Our responsibility is to express an opinion 
on the Company's financial statements based on our audits. We are a public accounting firm registered with the PCAOB 
and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and 
the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB. 

We  conducted  our  audits  in  accordance  with  the  standards  of  the  PCAOB.  Those  standards  require  that  we  plan  and 
perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, 
whether due to error or fraud. Our audits included performing procedures to assess the risks of material misstatement of 
the  financial  statements,  whether  due  to  error  or  fraud,  and  performing  procedures  that  respond  to  those  risks.  Such 
procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. 
Our audits also included evaluating the accounting principles used and significant estimates made by management, as well 
as evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for 
our opinion. 

Critical Audit Matter 

The critical audit matter communicated below is a matter arising from the current-period audit of the financial statements 
that  were  communicated  or  required  to  be  communicated  to  the  audit  committee  and  that  (1)  relate  to  accounts  or 
disclosures that are material to the financial statements and (2) involved our especially challenging, subjective, or complex 
judgments. The communication of critical audit matters does not alter in any way our opinion on the financial statements, 
taken as a whole, and we are not, by communicating the critical audit matters below, providing separate opinions on the 
critical audit matters or on the accounts or disclosures to which they relate. 

51 

 
Inventories - Provision for estimated excess, slow moving and obsolete inventories – Refer to Note 1 to the financial 
statements 

Critical Audit Matter Description  

Inventories are valued at the lower of cost, at approximate costs determined on a first-in, first-out method, or net realizable 
value. The Company reviews inventories on hand and records provisions based on estimated excess, slow moving and 
obsolete inventories. The inventories valuation reviews include an assessment of future product demand based on historical 
sales  and  raw  material  usage  and  product  expiration.  As  of  December  31,  2022,  the  Company’s  inventories  were 
$266.0 million. During the year ended December 31, 2022, the Company recorded obsolescence expense of approximately 
$9.8 million. 

We identified the provision for estimated excess, slow moving and obsolete inventories as a critical audit matter because 
of management’s significant judgment and estimates in determining the provision for estimated excess, slow moving and 
obsolete  inventories primarily  around  future  product  demand  based  on historical  sales.  This  required  a  high degree  of 
auditor judgment and an increased extent of effort. 

How the Critical Audit Matter Was Addressed in the Audit 

Our audit procedures related to management’s estimates of the valuation of excess and obsolete inventories included the 
following, among others: 

•  We tested the effectiveness of controls over the provision for estimated excess, slow moving and obsolete 

inventories.  

•  We evaluated management’s ability to accurately estimate the provision for estimated excess, slow moving 
and  obsolete  inventories  by  comparing  actual  write-downs  of  inventories  to  management’s  historical 
estimates. 

•  We evaluated the reasonableness of the Company's provision for estimated excess, slow moving and obsolete 
inventories, considering future product demand based on historical sales and raw material usage and product 
expiration and the underlying assumptions. 

•  We tested the accuracy and completeness of the underlying data used in the Company’s calculations of the 
valuation of excess and obsolete inventories, including historical usage, quantities on hand, expiration dates, 
and pricing. 

•  We assessed the reasonableness of the assumptions used in the calculations of the provision for estimated 
excess, slow moving and obsolete inventories by developing an independent expectation and comparing our 
independent expectation to the results of the Company’s calculations. 

•  We tested the mathematical accuracy of the Company’s calculations of excess, slow moving and obsolete 

inventories. 

/s/ DELOITTE & TOUCHE LLP 

Salt Lake City, Utah 
February 24, 2023 
We have served as the Company’s auditor since 1988.

52 

 
 
 
  
 
MERIT MEDICAL SYSTEMS, INC. AND SUBSIDIARIES 
CONSOLIDATED BALANCE SHEETS 
(In thousands) 

ASSETS 
Current assets: 

Cash and cash equivalents 
Trade receivables — net of allowance for credit losses — 2022 — $8,423 and 2021 — 
$6,767 
Other receivables 
Inventories 
Prepaid expenses and other current assets 
Prepaid income taxes 
Income tax refund receivables 

Total current assets 

Property and equipment: 

Land and land improvements 
Buildings 
Manufacturing equipment 
Furniture and fixtures 
Leasehold improvements 
Construction-in-progress 

Total property and equipment 
Less accumulated depreciation 

Property and equipment — net 

Other assets: 

Intangible assets: 

Developed technology — net of accumulated amortization — 2022 — $274,570 and 
2021 — $234,016 
Other — net of accumulated amortization — 2022 — $69,780 and 2021 — $65,053

Goodwill 
Deferred income tax assets 
Right-of-use operating lease assets 
Other assets 

Total other assets 

Total assets 

See notes to consolidated financial statements.

      December 31,       December 31, 

2022 

2021 

$ 

 58,408   $

67,750

 164,677  
 12,992  
 265,991  
 22,324  
 3,913  
 779  
 529,084  

 25,940  
 189,148  
 299,089  
 61,128  
 49,673  
 61,269  
 686,247  
 (303,271) 
 382,976  

152,301
17,763
221,922
16,149
3,550
2,777
482,212

25,287
190,044
277,976
61,446
46,341
51,182
652,276
(280,618)
371,658

 237,522  
 38,350  
 359,821  
 6,599  
 65,262  
 44,352  
 751,906  

276,833
42,436
361,741
6,080
65,913
41,421
794,424

$  1,663,966   $ 1,648,294

(continued)

53 

 
 
 
 
     
    
 
 
 
 
 
 
    
 
  
  
  
  
  
  
  
 
   
 
  
   
 
  
  
  
  
  
  
  
  
  
 
   
 
  
   
 
  
   
 
  
  
  
  
 
  
  
 
   
 
 
 
 
 
MERIT MEDICAL SYSTEMS, INC. AND SUBSIDIARIES 
CONSOLIDATED BALANCE SHEETS 
(In thousands) 

LIABILITIES AND STOCKHOLDERS’ EQUITY 
Current liabilities: 
Trade payables 
Accrued expenses 
Current portion of long-term debt 
Short-term operating lease liabilities 
Income taxes payable 

Total current liabilities 

Long-term debt 
Deferred income tax liabilities 
Long-term income taxes payable 
Liabilities related to unrecognized tax benefits
Deferred compensation payable 
Deferred credits 
Long-term operating lease liabilities 
Other long-term obligations 

Total liabilities 

Commitments and contingencies 

Stockholders' equity: 

Preferred stock — 5,000 shares authorized as of December 31, 2022 and 
December 31, 2021; no shares issued 
Common stock, no par value; 100,000 shares authorized; issued and outstanding as of 
December 31, 2022 - 57,306 and December 31, 2021 - 56,570
Retained earnings 
Accumulated other comprehensive loss 

Total stockholders’ equity 

Total liabilities and stockholders’ equity 

See notes to consolidated financial statements.

      December 31,       December 31, 

2022 

2021 

$ 

 68,504   $
 123,189  
 11,250  
 11,005  
 6,697  
 220,645  

 186,759  
 18,462  
 347  
 1,912  
 15,264  
 1,708  
 59,736  
 14,736  
 519,569  

55,624
159,014
8,438
10,668
2,536
236,280

234,397
31,503
347
932
18,111
1,815
61,526
23,584
608,495

 —  

—

 675,174  
 480,773  
 (11,550) 
   1,144,397  

641,533
406,257
(7,991)
1,039,799

$  1,663,966   $ 1,648,294

(concluded)

54 

 
 
 
     
    
 
 
 
 
 
 
   
 
  
  
 
  
  
 
   
 
  
  
  
  
  
  
 
  
  
 
   
 
  
   
 
 
   
 
  
   
 
  
  
  
  
 
   
 
 
 
 
 
 
MERIT MEDICAL SYSTEMS, INC. AND SUBSIDIARIES 
CONSOLIDATED STATEMENTS OF INCOME (LOSS) 
(In thousands, except per share amounts) 

Net sales 
Cost of sales 
Gross profit 

Operating expenses: 

Selling, general and administrative 
Research and development 
Legal settlement 
Impairment charges 
Contingent consideration expense (benefit) 
Acquired in-process research and development

Total operating expenses 

Income (loss) from operations

Other income (expense): 

Interest income 
Interest expense 
Other income (expense) — net 
Total other expense — net 

2022 
$ 1,150,981
631,882
519,099

2021 

$  1,074,751    $
 589,418   
 485,333   

2020 
963,875
562,698
401,177

342,525
75,510

—  

2,219
4,611
6,671
431,536

 335,690   
 71,247   
 10,036   
 4,283   
 3,161   
 —   
 424,417   

297,724
57,537
18,684
36,504
(7,960)
250
402,739

87,563

 60,916   

(1,562)

439
(6,339)
966
(4,934)

 769   
 (5,261)  
 (2,507)  
 (6,999)  

604
(9,994)
(2,279)
(11,669)

Income (loss) before income taxes 

82,629

 53,917   

(13,231)

Income tax expense (benefit) 

Net income (loss) 

Earnings (loss) per common share 

Basic 
Diluted 

Weighted average shares outstanding 

Basic 
Diluted 

See notes to consolidated financial statements. 

8,113

 5,463   

(3,388)

74,516

$

 48,454    $

(9,843)

1.31
1.29

$
$

 0.86    $
 0.84    $

(0.18)
(0.18)

$

$
$

56,806
57,671

 56,145   
 57,359   

55,434
55,434

55 

 
 
    
     
    
  
  
 
   
 
 
  
    
 
  
  
  
  
  
  
 
   
 
  
 
   
 
 
  
    
 
  
  
  
  
 
   
 
  
 
   
 
  
 
   
 
 
   
 
 
  
    
 
 
   
 
 
  
    
 
  
  
 
 
 
 
MERIT MEDICAL SYSTEMS, INC. AND SUBSIDIARIES 
CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS) 
(In thousands) 

Net income (loss) 
Other comprehensive income (loss): 

Cash flow hedges 

Income tax benefit (expense) 

Foreign currency translation adjustment 

Income tax benefit (expense) 
Total other comprehensive loss 
Total comprehensive income (loss) 

See notes to consolidated financial statements. 

2022 
74,516

$

2021 
 48,454    $

2020 

(9,843)

$

9,007
(2,177)
(10,491)
102
(3,559)
70,957

$

 5,965   
 (1,489)  
 (7,704)  
 689   
 (2,539)  
 45,915    $

(9,523)
2,365
7,786
(786)
(158)
(10,001)

$

56 

 
    
     
    
 
  
    
 
  
  
  
  
  
 
 
 
 
MERIT MEDICAL SYSTEMS, INC. AND SUBSIDIARIES 
CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY 
(In thousands) 

BALANCE — January 1, 2020 

Net loss 
Cumulative effect adjustment upon adoption 
of ASU 2016-13, Credit Losses 
Other comprehensive loss 
Stock-based compensation expense 
Options exercised 
Issuance of common stock under Employee 
Stock Purchase Plans 
Shares surrendered in exchange for payment 
of payroll tax liabilities 
Shares surrendered in exchange for exercise 
of stock options 

BALANCE — December 31, 2020 

Net income 
Other comprehensive loss 
Stock-based compensation expense 
Options exercised 
Issuance of common stock under Employee 
Stock Purchase Plans 
Shares issued from time-vested restricted 
stock units 
Shares surrendered in exchange for payment 
of payroll tax liabilities 
Shares surrendered in exchange for exercise 
of stock options 

BALANCE — December 31, 2021 

Net income 
Other comprehensive loss 
Stock-based compensation expense 
Options exercised 
Issuance of common stock under Employee 
Stock Purchase Plans 
Shares issued from time-vested restricted 
stock units 
Shares surrendered in exchange for payment 
of payroll tax liabilities 
Shares surrendered in exchange for exercise 
of stock options 

BALANCE — December 31, 2022 

See notes to consolidated financial statements. 

Common Stock 

Shares 
55,213

     Amount 
$ 587,017

Retained 
     Earnings 
$ 368,221
(9,843)

(575)

Accumulated Other  
Comprehensive 
Income (Loss) 

$

 (5,294)  $

 (158) 

442

30

13,433
6,948

1,159

(23)

(866)

(39)
55,623

(1,467)
606,224

883

18

59

14,579
20,374

1,112

—

(10)

(576)

(3)
56,570

(180)
641,533

703

19

70

16,045
20,092

1,118

—

(38)

(2,474)

357,803
48,454

 (5,452) 

 (2,539) 

406,257
74,516

 (7,991) 

 (3,559) 

Total 
949,944
(9,843)

(575)
(158)
13,433
6,948

1,159

(866)

(1,467)
958,575
48,454
(2,539)
14,579
20,374

1,112

—

(576)

(180)
1,039,799
74,516
(3,559)
16,045
20,092

1,118

—

(2,474)

(18)
57,306

(1,140)
$ 675,174

$ 480,773

$

(1,140)
 (11,550)  $ 1,144,397

57 

 
 
 
 
 
 
 
 
 
 
 
 
    
    
    
 
 
   
 
 
 
 
 
 
   
 
   
 
   
 
 
   
 
 
   
 
 
 
 
 
   
 
   
 
   
 
 
 
 
 
 
 
 
 
 
 
 
 
MERIT MEDICAL SYSTEMS, INC. AND SUBSIDIARIES 
CONSOLIDATED STATEMENTS OF CASH FLOWS 
(In thousands) 

CASH FLOWS FROM OPERATING ACTIVITIES:

Net income (loss) 
Adjustments to reconcile net income (loss) to net cash provided by operating 
activities: 

Depreciation and amortization 
Loss (gain) on disposition of business 
Loss on sale or abandonment of property and equipment
Write-off of certain intangible assets and other long-term assets
Acquired in-process research and development
Amortization of right-of-use operating lease assets
Adjustments related to contingent consideration liabilities
Amortization of deferred credits 
Amortization of long-term debt issuance costs
Deferred income taxes 
Stock-based compensation expense 

Changes in operating assets and liabilities, net of acquisitions and divestitures:

Trade receivables 
Other receivables 
Inventories 
Prepaid expenses and other current assets 
Prepaid income taxes 
Income tax refund receivables 
Other assets 
Trade payables 
Accrued expenses 
Income taxes payable 
Liabilities related to unrecognized tax benefits
Deferred compensation payable 
Operating lease liabilities 
Other long-term obligations 

Total adjustments 

Net cash, cash equivalents, and restricted cash provided by operating activities

CASH FLOWS FROM INVESTING ACTIVITIES:

Capital expenditures for: 
Property and equipment 
Intangible assets 

Proceeds from the sale of property and equipment
Proceeds (payments) from disposition of business
Cash received for settlement of note receivable
Issuance of note receivable 
Cash paid in acquisitions, net of cash acquired

Net cash, cash equivalents, and restricted cash used in investing activities

2022 

2021 

2020 

$ 74,516   $   48,454

$ (9,843)

81,804  
1,417  
380  
2,281  
6,671  
10,394  
4,611  
(107) 
604  
(14,924) 
18,042  

(15,116) 
4,154  
(47,929) 
(1,798) 
(379) 
1,952  
657  
12,661  
(16,379) 
4,521  
(45) 
(2,848) 
(11,127) 
278  
39,775  
114,291  

 84,066
 —
 1,303
 4,412
 —
 11,718
 3,161
 (108)
 604
 (4,631)
 16,090

 (8,618)
 (10,418)
 (25,183)
 (3,555)
 125
 739
 (1,670)
 6,050
 36,462
 (119)
 314
 1,303
 (12,410)
 (858)
 98,777
   147,231

94,070
(517)
2,159
36,609
250
12,746
(7,960)
(130)
604
(11,295)
14,339

10,425
1,668
29,429
(446)
(162)
(339)
(3,511)
333
4,603
(86)
(576)
1,953
(12,659)
3,606
175,113
165,270

(45,029) 
(3,175) 
65  
(971) 
—  
—  
(8,287) 

(45,988)
(3,288)
42
1,285
250
—
(10,953)
$ (57,397)  $  (37,161) $ (58,652)

 (27,939)
 (2,834)
 1,037
 —
 2,000
 (2,254)
 (7,171)

See notes to consolidated financial statements.

(continued)

58 

 
 
    
     
 
 
 
 
 
 
   
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
   
   
 
  
 
   
 
  
 
 
 
 
 
 
 
 
 
 
 
 
MERIT MEDICAL SYSTEMS, INC. AND SUBSIDIARIES 
CONSOLIDATED STATEMENTS OF CASH FLOWS 
(In thousands) 

CASH FLOWS FROM FINANCING ACTIVITIES:

Proceeds from issuance of common stock 
Proceeds from issuance of long-term debt 
Payments on long-term debt 
Contingent payments related to acquisitions 
Payment of taxes related to an exchange of common stock

Net cash, cash equivalents, and restricted cash used in financing activities
Effect of exchange rates on cash, cash equivalents, and restricted cash
Net increase (decrease) in cash, cash equivalents and restricted cash

2022 

2021 

2020 

$

20,070   $ 
215,205  
(260,143) 
(32,918) 
(2,474) 
(60,260) 
(3,826) 
(7,192) 

 21,306  $
 98,421 
   (206,921)
 (10,665)
 (576)
 (98,435)
 (801)
 10,834 

6,635
68,625
(157,000)
(13,100)
(866)
(95,706)
1,684
12,596

CASH, CASH EQUIVALENTS AND RESTRICTED CASH:

Beginning of period 
End of period 

67,750  
60,558   $ 

 56,916 
 67,750  $

44,320
56,916

  $

RECONCILIATION OF CASH, CASH EQUIVALENTS AND 
RESTRICTED CASH TO THE CONSOLIDATED BALANCE SHEETS:

Cash and cash equivalents 
Restricted cash reported in prepaid expenses and other current assets

Total cash, cash equivalents and restricted cash 

SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION
Cash paid during the period for: 

Interest (net of capitalized interest of $858, $480 and $813, respectively)
Income taxes 

SUPPLEMENTAL DISCLOSURES OF NON-CASH INVESTING AND 
FINANCING ACTIVITIES 

Property and equipment purchases in accounts payable
Current note receivable converted to equity investment
Proceeds from sale of business in other receivables
Acquisition purchases in accrued expenses and other long-term obligations
Merit common stock surrendered (18, 3, and 39 shares, respectively) in 
exchange for exercise of stock options 
Right-of-use operating lease assets obtained in exchange for operating lease 
liabilities 

58,408  
2,150  
60,558   $ 

 67,750 
 — 
 67,750  $

56,916
—
56,916

  $

$

$

6,258   $ 
17,092  

 5,261  $
 8,828 

10,077
8,918

3,702   $ 
—  
—  
3,526  

 2,558  $
 — 
 — 
 — 

1,140  

 180 

2,180
899
321
4,358

1,467

11,130  

 1,524 

10,938

See notes to consolidated financial statements.

(concluded)

59 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
   
   
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
   
   
 
  
 
   
 
  
 
 
 
 
   
   
 
  
 
 
 
 
 
 
 
 
 
 
 
MERIT MEDICAL SYSTEMS, INC. AND SUBSIDIARIES 
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS 

1. 

ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES 

Organization. Merit Medical Systems, Inc. (“Merit,” “we,” or “us”) designs, develops, manufactures and markets single-
use  medical  products  for  interventional  and  diagnostic  procedures. For  financial  reporting  purposes,  we  report  our 
operations in two operating segments: cardiovascular and endoscopy. Our cardiovascular segment consists of cardiology 
and radiology medical device products which assist in diagnosing and treating coronary artery disease, peripheral vascular 
disease and other non-vascular diseases and includes embolotherapeutic, cardiac rhythm management, electrophysiology, 
critical  care,  and  interventional  oncology  and  spine  devices.  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. Within those two operating segments, we offer products focused in five product 
categories: peripheral intervention, cardiac intervention, custom procedural solutions, original equipment manufacturer 
(“OEM”) and endoscopy.  

We  manufacture  our  products  in  plants  located  in  the  U.S.,  Mexico,  The  Netherlands, Ireland,  France,  Brazil  and 
Singapore. We export sales to dealers and have direct or modified direct sales forces in the U.S., Canada, Western Europe, 
Australia, Brazil, Japan, China, Malaysia, South Korea, UAE, India, New Zealand and South Africa (see Note 13). Our 
consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the 
United States. The following is a summary of the more significant of such policies. 

Use  of  Estimates  in  Preparing  Financial  Statements. The  preparation  of  financial  statements  in  conformity  with 
accounting principles generally accepted in the United States ("U.S. GAAP") requires management to make estimates and 
assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at 
the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual 
results could differ from those estimates. 

Principles of Consolidation. The consolidated financial statements include our wholly owned subsidiaries. Intercompany 
balances  and  transactions  have  been  eliminated.  Amounts  presented  in  this  report  are  rounded,  while  percentages  and 
earnings per share amounts presented are calculated from the underlying amounts.  

Cash and Cash Equivalents. We consider interest-bearing deposits with an original maturity date of three months or less 
to  be  cash  equivalents.  As  of  December  31,  2021,  approximately  $1.9  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. 

Receivables. Trade accounts receivable are recorded at the net invoice value and are not interest-bearing. An allowance 
for credit losses on trade receivables is recorded based on our expectation of credit losses and is based upon our historical 
bad  debt  experience,  current  economic  conditions,  expectations  of  future  economic  conditions  and  management’s 
evaluation of our ability to collect individual outstanding balances. Once collection efforts have been exhausted and a 
receivable is deemed to be uncollectible, such balance is charged against the allowance for credit losses. 

Inventories. We value our inventories at the lower of cost, at approximate costs determined on a first-in, first-out method, 
or net realizable value. Net realizable value is the estimated selling price in the ordinary course of business, less reasonably 
predictable costs of completion, disposal, and transportation. Inventory costs include material, labor and manufacturing 
overhead. We review inventories on hand and record provisions based on estimated excess, slow moving and obsolete 
inventory, as well as inventories with a carrying value in excess of net realizable value. The regular and systematic review 
of the valuation of inventories includes an assessment of future product demand based on historical sales and raw material 
usage and product expiration. 

Goodwill and Intangible Assets. We test goodwill balances for impairment on an annual basis 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. During our annual impairment test, we utilize four reporting units in evaluating goodwill for impairment 

60 

using a quantitative assessment, which uses a combination of a guideline public company market-based approach and a 
discounted cash flow income-based approach. The quantitative assessment considers whether the carrying amount of a 
reporting unit exceeds its fair value, in which case an impairment charge is recorded to the extent the reporting unit’s 
carrying value exceeds its fair value.  

Finite-lived intangible assets including developed technology, customer lists, distribution agreements, license agreements, 
trademarks and patents are subject to amortization. Intangible assets are amortized over their estimated useful life on a 
straight-line basis, except for customer lists, which are generally amortized on an accelerated basis. Estimated useful lives 
are determined considering the period the assets are expected to contribute to future cash flows. We evaluate long-lived 
assets, including amortizing intangible assets, for impairment whenever events or changes in circumstances indicate that 
their carrying amounts may not be recoverable. We perform the impairment analysis at the asset group for which the lowest 
level of identifiable cash flows are largely independent of the cash flows of other assets and liabilities. We compare the 
carrying value of the asset group to the undiscounted cash flows expected to result from the asset group and determine 
whether the carrying amount is recoverable. We determine the fair value of each asset group based on estimated future 
cash flows discounted back to their present value using a discount rate that reflects the risk profiles of the underlying 
activities. 

In-process technology intangible assets, which are not subject to amortization until projects reach commercialization, are 
assessed for impairment at least annually and more frequently if events occur that would indicate a potential reduction in 
the fair value of the assets below their carrying value. An impairment charge would be recognized to the extent the carrying 
amount of the in-process technology exceeded its fair value. 

Long-Lived Assets. We periodically review the carrying amount of our depreciable long-lived assets for impairment. An 
asset  is  considered  impaired  when  undiscounted  estimated  future  cash  flows  are  less  than  the  carrying  amount  of  the 
asset. In the event the carrying amount of such asset is not considered recoverable, the asset is adjusted to its fair value. Fair 
value is generally determined based on discounted future cash flow. 

Property and Equipment. Property and equipment is stated at the historical cost of construction or purchase. Construction 
costs include interest costs capitalized during construction. Maintenance and repairs of property and equipment are charged 
to operations as incurred. Leasehold improvements are amortized over the lesser of the base term of the lease or estimated 
life of the leasehold improvements. Construction-in-process consists of new buildings and various production equipment 
being constructed internally and externally. Assets in construction-in-process will commence depreciating once the asset 
has been placed in service. Depreciation is computed using the straight-line method over estimated useful lives as follows: 

Buildings 
Manufacturing equipment 
Furniture and fixtures 
Land improvements 
Leasehold improvements 

     40 years 
4 - 20 years
3 - 20 years
  10 - 20 years
4 - 25 years

Depreciation  expense  related  to  property  and  equipment  for  the years  ended  December 31, 2022,  2021  and  2020  was 
$33.4 million, $34.5 million, and $35.4 million, respectively. 

Deferred Compensation. We have a deferred compensation plan that permits certain management employees to defer a 
portion of their salary until the future. We established a Rabbi trust to finance obligations under the plan with corporate-
owned  variable  life  insurance  contracts. The  cash  surrender  value  totaled  $15.8  million  and  $19.1  million  at 
December 31, 2022 and 2021, respectively, which is included in other assets in our consolidated balance sheets. We have 
recorded  a  deferred  compensation  payable  of  $15.3  million  and  $18.1  million  at  December 31, 2022  and  2021, 
respectively, to reflect the liability to our employees under this plan. 

61 

 
 
 
 
Other Assets. Other assets as of December 31, 2022 and 2021 consisted of the following (in thousands): 

Investments in privately held companies
Deferred compensation plan assets
Long-term notes receivable, net 
Other 
Total  

2022 
15,576   $
15,767  
2,397  
10,612  
44,352   $

2021 
 14,711
 19,126
 2,345
 5,239
 41,421

$

$

We analyze our investments in privately held companies to determine if they should be accounted for using the equity 
method based on our ability to exercise significant influence over operating and financial policies of the investment. Our 
share of earnings associated with equity method investments is reported within other income (expense) in our consolidated 
statements of income (loss). Investments not accounted for under the equity method of accounting are accounted for at 
cost  minus  impairment,  if  applicable,  plus  or  minus  changes  in  valuation  resulting  from  observable  transactions  for 
identical or similar investments. 

Other Long-term Obligations. Other long-term obligations as of December 31, 2022 and 2021 consisted of the following 
(in thousands): 

Contingent consideration liabilities
Other long-term obligations 
Total  

2022 

2,260   $ 
12,476  
14,736   $ 

2021 
 13,500
 10,084
 23,584

$

$

In connection with a business combination, any contingent consideration is recorded at fair value on the acquisition date 
based upon the consideration expected to be transferred in the future. We re-measure the estimated liability each quarter 
based upon changes in revenue estimates, changes in the probability of achieving relevant milestones and changes in the 
discount rate or expected period of payment. Changes in the estimated fair value are recorded through operating expense 
in our consolidated statements of income (loss). 

Revenue  Recognition. We  sell  our  medical  products  through  a  direct  sales  force  in  the  U.S.  and through  OEM 
relationships, custom procedure tray manufacturers and a combination of direct sales force and independent distributors 
in  international  markets. Revenue  is  recognized  when  a  customer  obtains  control  of  promised  goods  based  on  the 
consideration we expect to receive in exchange for these goods. This core principle is achieved through the following 
steps: 

Identify the contract with the customer. A contract with a customer exists when (i) we enter into an enforceable contract 
with a customer that defines each party’s rights regarding the goods to be transferred and identifies the payment terms 
related to these goods, (ii) the contract has commercial substance and (iii) we determine that collection of substantially all 
consideration for services that are transferred is probable based on the customer’s intent and ability to pay the promised 
consideration. We do not have significant costs to obtain contracts with customers. For commissions on product sales, we 
have elected the practical expedient to expense the costs as incurred if the amortization period would have been one year 
or less. 

Identify  the  performance  obligations  in  the  contract.  Generally,  our  contracts  with  customers  do  not  include  multiple 
performance obligations to be completed over a period of time. Our performance obligations generally relate to delivering 
single-use medical products to a customer, subject to the shipping terms of the contract. Limited warranties are provided, 
under  which  we  typically  accept  returns  and  provide  either  replacement  parts  or  refunds.  We  do  not  have  significant 
returns. We do not typically offer extended warranty or service plans, except in limited cases which are not material.  

Determine the transaction price. Payment by the customer is due under customary fixed payment terms, and we evaluate 
if collectability is reasonably assured. Our contracts do not typically contain a financing component. Revenue is recorded 
at the net sales price, which includes estimates of variable consideration such as product returns, rebates, discounts, and 
other  adjustments.  The  estimates  of  variable  consideration  are  based  on  historical  payment  experience,  historical  and 

62 

 
    
     
 
 
  
 
 
    
     
 
 
 
 
projected sales data, and current contract terms. Variable consideration is included in revenue only to the extent that it is 
probable  that  a  significant  reversal  of  the  revenue  recognized  will  not  occur  when  the  uncertainty  associated  with  the 
variable consideration is subsequently resolved. Taxes collected from customers relating to product sales and remitted to 
governmental authorities are excluded from revenues. 

Allocate the transaction price to performance obligations in the contract. We typically do not have multiple performance 
obligations in our contracts with customers. As such, we generally recognize revenue upon transfer of the product to the 
customer’s control at contractually stated pricing. 

Recognize revenue when or as we satisfy a performance obligation. We generally satisfy performance obligations at a 
point in time upon either shipment or delivery of goods, in accordance with the terms of each contract with the customer. 
We do not have significant service revenue. Contract assets are recognized for the future right to invoice customers, and 
contract  liabilities  are  recognized  for unearned revenue  if  payment  is received prior  to  our  fulfillment  of performance 
obligations. We do not have material contract assets or contract liabilities.  

Reserves are recorded as a reduction in net sales and are not considered material to our consolidated statements of income 
(loss) for the years ended December 31, 2022, 2021 and 2020. In addition, we invoice our customers for taxes assessed by 
governmental authorities, such as sales tax and value-added taxes. We present these taxes on a net basis. 

Shipping and Handling. When billed to our customers, shipping and handling charges are included in net sales for the 
applicable period, and the corresponding shipping and handling expense is reported in cost of sales. 

Cost of Sales. We include product costs (i.e. material, direct labor and overhead costs), shipping and handling expense, 
product  royalty  expense,  developed  technology  amortization  expense,  production-related  depreciation  expense  and 
product license agreement expense in cost of sales. 

Research and Development. Research and development costs, including new product development, clinical trials, and 
regulatory compliance, are expensed as incurred. 

Income Taxes. Under our accounting policies, we initially recognize a tax position in our financial statements when it 
becomes more likely than not that the position will be sustained upon examination by the tax authorities. Such tax positions 
are initially and subsequently measured as the largest amount of tax positions that has a greater than 50% likelihood of 
being realized upon ultimate settlement with the tax authorities assuming full knowledge of the position and all relevant 
facts. Although we believe our provisions for unrecognized tax positions are reasonable, we can make no assurance that 
the final tax outcome of these matters will not be different from that which we have reflected in our income tax provisions 
and accruals. Such differences could have a material impact on our income tax provisions and operating results in the 
periods in which we make such determination. 

Earnings per Common Share. Net income (loss) per common share is computed by both the basic method, which uses 
the  weighted  average number  of our  common shares outstanding,  and  the  diluted  method, which  includes  the dilutive 
common shares from stock options and restricted stock units as calculated using the treasury stock method. Performance 
stock  units  are  considered  contingently  issuable  awards  and  are  excluded  from  the  weighted  average  basic  share 
calculation. These awards are included in the weighted average dilutive share calculation, to the extent they are dilutive, 
based on the number of shares, if any, that would be issuable as of the end of the reporting period assuming the end of the 
reporting period is also the end of the performance period. 

Fair Value Measurements. The fair value of a financial instrument is the amount that could be received upon the sale of 
an  asset  or  paid  to  transfer  a  liability  in  an  orderly  transaction  between  market  participants  at  the  measurement 
date. Financial assets are marked to bid prices and financial liabilities are marked to offer prices. Fair value measurements 
do not include transaction costs. A fair value hierarchy is used to prioritize the quality and reliability of the information 

63 

used to determine fair values. Categorization within the fair value hierarchy is based on the lowest level of input that is 
significant to the fair value measurement. The fair value hierarchy is defined in the following three categories: 

Level 1: Quoted market prices in active markets for identical assets or liabilities. 
Level 2: Observable market-based inputs or inputs that are corroborated by market data. 
Level 3: Unobservable inputs that are not corroborated by market data. 

Stock-Based Compensation. We recognize the fair value compensation cost relating to stock-based payment transactions 
in accordance with Accounting Standards Codification (“ASC”) 718, Compensation — Stock Compensation. Under the 
provisions of ASC 718, stock-based compensation cost is measured at the grant date, based on the fair value of the award, 
and is recognized over the employee’s requisite service period, which is generally the vesting period. The fair value of our 
stock options is estimated using a Black-Scholes option valuation model. The fair value of our performance stock units 
linked  to  total shareholder return  is  estimated using Monte-Carlo  simulations.  Compensation  expense is  adjusted  each 
period  based  on  the  grant-date  fair  value  and  the  number  of  shares  that  are  probable  of  being  awarded  based  on  the 
performance conditions of the awards. Restricted stock units are valued based on the closing stock price on the date of 
grant. Cash-settled share-based awards, or liability awards, are remeasured at fair value each reporting period until the 
awards are settled. Total stock-based compensation expense for the years ended December 31, 2022, 2021 and 2020 was 
$18.0 million, $16.1 million, and $14.3 million, respectively (see Note 12). 

Concentration of Credit Risk. Financial instruments that potentially subject us to concentrations of credit risk consist 
primarily  of  cash  and  cash  equivalents  and  accounts  receivable. We  provide  credit,  in  the  normal  course  of  business, 
primarily  to  hospitals  and  independent  third-party  custom  procedure  tray  manufacturers  and  distributors. We  perform 
ongoing credit evaluations of our customers and maintain allowances for potential credit losses. Due to the diversified 
nature and number of our customers, concentrations of credit risk with respect to accounts receivable are limited. 

Foreign  Currency. The  financial  statements  of  our  foreign  subsidiaries  are  measured  using  local  currencies  as  the 
functional  currency,  with  the  exception  of  our  manufacturing  subsidiaries  in  Ireland  and  Mexico,  which  each  use  the 
U.S. Dollar as its functional currency. Assets and liabilities are translated into U.S. Dollars at year-end rates of exchange 
and results of operations are translated at average rates for the year. Gains and losses resulting from these translations are 
included 
income  (loss)  as  a  separate  component  of  stockholders’ 
equity. Transactional exchange gains or losses are included in other income (expense) in determining net income (loss) 
for the period. 

in  accumulated  other  comprehensive 

Derivatives. We use forward contracts to mitigate our exposure to volatility in foreign exchange rates, and we use interest 
rate swaps to hedge changes in the benchmark interest rate related to our Third Amended Credit Agreement described in 
Note 8. All  derivatives  are  recognized  in  the  consolidated  balance  sheets  at  fair  value. Classification  of  each  hedging 
instrument is based upon whether the maturity of the instrument is less than or greater than 12 months. We do not purchase 
or hold derivative financial instruments for speculative or trading purposes (see Note 9). 

New  Financial  Accounting  Standards.  In  March  2020,  the  Financial  Accounting  Standards  Board  (“FASB”)  issued 
Accounting  Standard  Update  (“ASU”)  2020-04,  Reference  Rate  Reform  (Topic  848):  Facilitation  of  the  Effects  of 
Reference  Rate  Reform  on  Financial  Reporting,  which  provides  temporary  optional  expedients  and  exceptions  in 
accounting for modifications of contracts that reference the London interbank offered rate (“LIBOR”) or another reference 
rate expected to be discontinued as a result of reference rate reform. In January 2021, the FASB issued ASU 2021-01, 
Reference  Rate  Reform (Topic  848):  Scope,  which  amends  the  scope of ASU 2020-04.  In December 2022,  the FASB 
issued ASU 2022-06, Deferral of the Sunset Date of Topic 848, which defers the sunset date of the guidance in ASC 848 
to December 31, 2024. ASU 2020-04 and ASU 2021-01 were effective as of March 12, 2020; ASU 2022-06 was effective 
upon its issuance in December 2022. The provisions of these updates may be applied prospectively to transactions through 
December 31, 2024, when reference rate reform activity is expected to be completed. As of December 31, 2022, we had 
not modified any contracts as a result of reference rate reform. We are currently assessing the anticipated impact of these 
standards on our consolidated financial statements. 

We currently believe that all other issued and not yet effective accounting standards are not materially relevant to our 
financial statements. 

64 

 
2. 

REVENUES 

Disaggregation of Revenue. Our revenue is disaggregated based on reporting segment, product category and geographical 
region.  

We design, develop, manufacture and market medical products for interventional and diagnostic procedures. For financial 
reporting purposes, we report our operations in two operating segments: cardiovascular and endoscopy. Our cardiovascular 
segment  consists  of four product  categories:  peripheral  intervention,  cardiac  intervention,  custom procedural  solutions, 
and  OEM.  Within  these  product  categories,  we  sell  a  variety  of  products,  including  cardiology  and  radiology  devices 
(which  assist  in  diagnosing  and  treating  coronary  arterial  disease,  peripheral  vascular  disease  and  other  non-vascular 
diseases),  as  well  as  embolotherapeutic,  cardiac  rhythm  management,  electrophysiology,  critical  care,  breast  cancer 
localization  and  guidance, biopsy,  and  interventional  oncology and  spine  devices.  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. 

The following table presents sales by operating segment disaggregated based on product category and geographic region 
for the years ended December 31, 2022, 2021 and 2020 (in thousands). 

Year Ended  
December 31, 2022 

Year Ended  
December 31, 2021 

Year Ended  
December 31, 2020 

  United States   International   

Total 

 United States  International  

Total 

 United States   International  

Total 

Cardiovascular     

Peripheral 
Intervention 
Cardiac 
Intervention 
Custom 
Procedural 
Solutions 
OEM 

Total 

Endoscopy 
Endoscopy 
Devices 

  $   263,602    $  176,208    $  439,810 $ 244,459 $ 160,657 $

405,116 $ 211,999    $  129,569 $ 341,568

      128,711     

 214,475      

 343,186

122,452

198,189

320,641

108,109        171,562

279,671

      108,778     
      118,869     
      619,960     

 190,194
 81,416      
 26,165      
 145,034
 498,264       1,118,224

108,068
104,436
579,415

85,874
19,092
463,812

193,942
123,528
1,043,227

 92,927
110,269      
91,826      
 17,941
522,203        411,999

203,196
109,767
934,202

 30,599      

 2,158      

 32,757

29,463

2,061

31,524

27,858      

 1,815

29,673

Total 

  $   650,559    $  500,422    $ 1,150,981 $ 608,878 $ 465,873 $ 1,074,751 $ 550,061    $  413,814 $ 963,875

65 

 
 
 
 
 
 
   
    
 
 
 
 
     
 
 
 
    
   
    
   
     
   
 
     
     
    
 
     
   
 
     
     
  
 
 
3. 

ACQUISITIONS AND OTHER STRATEGIC TRANSACTIONS 

2022 Acquisitions 

On October 3, 2022, we entered into an asset purchase agreement with BioTrace Medical, Inc., developer of the Tempo® 
Temporary Pacing Lead device, for a purchase price of $2.5 million. We are also required to pay a total of six annual 
royalty payments between 5% and 10% of net sales, dependent on net sales goal achievement, upon achievement of the 
first device sold in the United States. We accounted for this transaction as an asset purchase. We recorded the amount paid 
upon closing as a developed technology intangible asset, which we are amortizing over 10 years. 

On April 30, 2022, we acquired the Restore Endosystems Bifurcated Stent System pursuant to the terms of a unit purchase 
agreement we executed with all of the members of Restore Endosystems. Subject to the terms and conditions of the unit 
purchase agreement, we paid $3 million in cash at closing. We also accrued $3.5 million of other long-term obligations, 
which represents the fair value of two separate $2 million payments which are payable no later than two and four years 
following the closing of the acquisition, respectively, or earlier upon the achievement of specified milestones. We will 
impute interest on these liabilities with the passage of time. We have accounted for this transaction as an asset purchase 
and recorded $6.5 million of acquired in-process research and development expense because the technological feasibility 
of the underlying research and development project has not yet been reached and such technology has no identified future 
alternative use as of the date of acquisition. 

During April 2022, we paid $1.4 million to acquire shares of series A preferred stock of Fluidx Medical Technology, 
Inc.("Fluidx"), owner of certain technology proposed to be used in the development of embolic and adhesive agents for 
use in arterial, venous, vascular graft and cardiovascular applications inside and outside the heart and related appendages. 
We  had  previously  purchased,  and  continue  to  hold,  $4.7  million  of  participating  preferred  shares  of  Fluidx.  Our 
investments  have  been  recorded  as  equity  investments  accounted  for  at  cost  and  reflected  within  other  assets  in  the 
accompanying consolidated balance sheets because we are not able to exercise significant influence over the operations of 
Fluidx. Our total current investment in Fluidx represents an ownership of approximately 17% of its outstanding capital 
stock. 

2021 Acquisitions  

During September 2021, we paid $2.7 million to acquire series A preferred shares of Fluidx. We had previously purchased 
$2  million  of  participating  preferred  shares  during  2019.  Our  investment  has  been  recorded  as  an  equity  investment 
accounted for at cost and reflected within other assets in the accompanying consolidated balance sheets because we are 
not able to exercise significant influence over the operations of Fluidx. Our total current investment in Fluidx represents 
an ownership of 15.0% of the outstanding stock.  

2020 Acquisitions 

On November 6, 2020, we entered into a unit purchase agreement to acquire KA Medical, LLC (“KA Medical”). Subject 
to the terms and conditions of the unit purchase agreement, we paid $14.6 million in cash, net of cash acquired, including 
adjustments for working capital and deferred payments of $4 million. KA Medical developed the Micro Plug Set, a self-
expanding nitinol vascular occlusion device, which is FDA-cleared and CE marked. We accounted for this acquisition as 
a  business  combination.  The  sales  and  results  of  operations  related  to  the  acquisition  have  been  included  in  our 
cardiovascular segment since the acquisition date and were not material for the years ended December 31, 2022, 2021 and 
2020. Acquisition-related costs associated with the KA Medical acquisition, which were included in selling, general and 

66 

administrative expenses, were not material. During the fourth quarter of 2021, certain immaterial measurement period 
adjustments were recorded to our purchase price allocation. The purchase price was allocated as follows (in thousands): 

Assets Acquired 

Trade receivables 
Other receivables 
Inventories 
Property and equipment 
Other long-term assets 
Intangible assets

Developed technology 
Goodwill 

Total assets acquired 

Liabilities Assumed 

Trade payables 
Accrued expenses 

Total liabilities assumed 

Total net assets acquired 

$ 

 24
 13
 211
 298
 10

 6,000
 8,570
 15,126

 (31)
 (507)
 (538)

$ 

 14,588

We are amortizing the developed technology intangible asset acquired from KA Medical over 17 years. The goodwill 
consists largely  of  the  synergies  expected from  combining  operations  and  is  expected to be  deductible for  income  tax 
purposes. We do not deem the pro forma effects to our consolidated results of operations of the KA Medical acquisition 
to be material. 

4. 

INVENTORIES 

Inventories at December 31, 2022 and 2021, consisted of the following (in thousands): 

Finished goods 
Work-in-process 
Raw materials 
Total inventories 

2022 

2021 

$ 147,051    $  132,403
    22,160
    67,359
$ 265,991    $  221,922

29,534   
89,406   

5. 

GOODWILL AND INTANGIBLE ASSETS 

The  changes  in  the  carrying  amount  of  goodwill  for  the years  ended  December 31, 2022  and  2021,  are  as  follows  (in 
thousands): 

Goodwill balance at January 1 
Effect of foreign exchange 
Additions and adjustments as the result of acquisitions
Goodwill balance at December 31

2022 

2021 

$ 361,741    $  363,533
 (2,078)
 286
$ 359,821    $  361,741

(1,920) 
 —   

Total accumulated goodwill impairment losses aggregated to $8.3 million as of December 31, 2022 and 2021. We did not 
have any goodwill impairments for the years ended December 31, 2022, 2021 and 2020. The total goodwill balance as of 
December 31, 2022 and 2021 is related to our cardiovascular segment. 

67 

      
 
 
  
 
 
    
 
 
  
 
 
 
  
 
  
  
  
 
 
 
 
 
    
    
 
 
 
    
    
  
  
 
Other intangible assets at December 31, 2022 and 2021, consisted of the following (in thousands): 

Patents 
Distribution agreements 
License agreements 
Trademarks 
Customer lists 
Total 

Patents 
Distribution agreements 
License agreements 
Trademarks 
Customer lists 
Total 

Gross Carrying
Amount 

December 31, 2022 
Accumulated   
    Amortization      

Net Carrying 
Amount 

$

$

29,445
3,250
11,109
30,221
34,105
108,130

$ 

$ 

 (10,203)  $
 (2,715) 
 (7,250) 
 (17,863) 
 (31,749) 
 (69,780)  $

19,242
535
3,859
12,358
2,356
38,350

Gross Carrying
Amount 

December 31, 2021 
Accumulated   
    Amortization      

Net Carrying 
Amount 

$

$

26,349
3,250
12,663
30,242
34,985
107,489

$ 

$ 

 (8,315)  $
 (2,519) 
 (7,768) 
 (15,256) 
 (31,195) 
 (65,053)  $

18,034
731
4,895
14,986
3,790
42,436

Aggregate amortization expense for the years ended December 31, 2022, 2021 and 2020 was $48.4 million, $49.6 million, 
and $58.6 million, respectively. 

Estimated amortization expense for the developed technology and other intangible assets for the next five years consists 
of the following as of December 31, 2022 (in thousands): 

Year Ending December 31, 
2023 
2024 
2025 
2026 
2027 

$

    Estimated Amortization Expense
 47,496
 44,434
 42,610
 32,040
 28,966

During the years ended December 31, 2022, 2021 and 2020, we identified indicators of impairment associated with certain 
acquired  intangible  assets  based  on  our  qualitative  assessment  that  carrying  amounts  may  not  be  recoverable,  which 
required us to then complete a quantitative impairment assessment. The primary indicators of impairment were planned 
closure and restructuring activities and uncertainty about future product development and commercialization associated 
with certain acquired technologies, due in part to the economic impacts of the COVID-19 pandemic in 2021 and 2020. 

During  the  year  ended  December  31,  2022,  we  recorded  total  impairment  charges  related  to  our  intangible  assets  of 
$1.7 million for our divestiture on April 30, 2022 of the STD Pharmaceutical Products Limited (“STD Pharmaceutical”) 
business acquired in our August 2019 acquisition of Fibrovein Holdings Limited. 

During  the  year  ended  December  31,  2021,  we  recorded  total  impairment  charges  related  to  our  intangible  assets  of 
$1.6 million for the remaining carrying value of ArraVasc license agreements.  

During  the  year  ended  December  31,  2020,  we  recorded  total  impairment  charges  related  to  our  intangible  assets  of 
$28.7 million which included a partial impairment charge of $8.2 million of intangible assets from our acquisition of STD 
Pharmaceutical, a partial impairment charge of $8.0 million of intangible assets from our acquisition of certain assets from 
Laurane  Medical  S.A.S,  a  partial  impairment  charge  of  $4.8  million  related  to  our  license  agreements  with  ArraVasc 
Limited, and other intangible asset impairments charges of $7.7 million related to intangible assets from our acquisition 
of certain assets from DirectACCESS Medical, LLC, in-process technology intangible assets of Sontina Medical LLC 

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acquired  in  connection  with  our  acquisition  of  certain  divested  assets  from  Becton,  Dickinson  and  Company,  and  a 
customer list intangible asset from our acquisition of ITL Healthcare Pty Ltd (“ITL”). 

6. 

INCOME TAXES 

On March 27, 2020, the Coronavirus Aid, Relief, and Economic Security Act (“CARES Act”) was signed into law. The 
$2.2 trillion economic stimulus bill contains numerous tax law changes. We evaluated the tax changes to determine what 
provisions would apply to us. As permitted by the CARES Act, we have deferred payment of the employer’s portion of 
social security payroll tax payments and made a payment equal to one half of the deferred amount during the year ended 
December 31, 2021. The remaining half was paid during the year ended December 31, 2022. 

On August 16, 2022, the Inflation Reduction Act of 2022 was signed into law. We currently do not anticipate the recently 
enacted  law,  including  the  corporate  alternative  minimum  tax,  one  percent  excise  tax  on  stock  repurchases,  or  tax 
incentives to promote clean energy, to have a material impact on our consolidated financial statements. 

For the years ended December 31, 2022, 2021 and 2020, income (loss) before income taxes is broken out between U.S. 
and foreign-sourced operations and consisted of the following (in thousands): 

Domestic 
Foreign 
Total 

2022 

2021 

$ 77,562    $   21,328
    32,589
$ 82,629    $   53,917

5,067   

2020 
$ (32,216)
18,985
$ (13,231)

The components of the provision for income taxes for the years ended December 31, 2022, 2021 and 2020, consisted of 
the following (in thousands): 

Current expense (benefit): 

Federal 
State 
Foreign 

Total current expense 

Deferred expense (benefit): 

Federal 
State 
Foreign 

Total deferred benefit 

2022 

2021 

2020 

$

9,584   $ 
3,162  
10,291  
23,037  

 808
 806
 8,480
    10,094

$

(937)
437
8,407
7,907

(10,438) 
(3,615) 
(871) 
(14,924) 

 (468)
 (1,845)
 (2,318)
 (4,631)

(2,688)
(4,524)
(4,083)
(11,295)

Total income tax expense (benefit) 

$

8,113   $ 

 5,463

$ (3,388)

69 

 
    
     
    
 
 
    
     
    
      
  
 
  
  
 
 
   
   
  
  
 
  
  
  
  
 
 
   
 
The difference between the income tax expense (benefit) reported and amounts computed by applying the statutory federal 
rate of 21.0% to pretax income (loss) for the years ended December 31, 2022, 2021 and 2020, consisted of the following 
(in thousands): 

2022 

2021 

2020 

Computed federal income tax expense (benefit) at applicable statutory rate of 
21% 
State income tax benefit 
Tax credits 
Tax effect of international items 
Uncertain tax positions 
Deferred compensation insurance assets 
Stock-based compensation 
Valuation allowance 
DOJ settlement 
Remeasurement of state deferred taxes 
Non-deductible expenses 
Remeasurement of contingent consideration liabilities
Other — including the effect of graduated rates
Total income tax expense (benefit) 

$ 17,352    $   11,323
 (283)
 (2,507)
 (281)
 401
 (413)
 (5,571)
 —
 —
 (526)
 2,455
 733
 132
 5,463

 35   
(1,978) 
(10,698) 
(47) 
706   
(3,423) 
3,523   
 —   
(375) 
2,027   
1,061   
(70) 
8,113    $ 

$

$ (2,778)
(1,448)
(2,391)
4,705
(455)
(290)
(1,822)
1,257
1,890
(1,765)
1,077
(1,185)
(183)
$ (3,388)

Deferred income tax assets and liabilities at December 31, 2022 and 2021, consisted of the following temporary differences 
and carry-forward items (in thousands): 

Deferred income tax assets: 

Allowance for credit losses on trade receivables
Accrued compensation expense 
Inventory differences 
Net operating loss carryforwards
Stock-based compensation expense
Operating lease assets 
Federal R&D tax credit 
UT R&D Credit 
IRC section 174 capitalized R&D 
Other 

Total deferred income tax assets 

Deferred income tax liabilities: 

Prepaid expenses 
Property and equipment 
Intangible assets
Foreign withholding tax 
Operating lease liabilities 
Other 

Total deferred income tax liabilities
Valuation allowance 
Net deferred income tax liabilities 

Reported as: 
Deferred income tax assets 
Deferred income tax liabilities 
Net deferred income tax liabilities

70 

$

2022 

2021 

1,925    $ 
9,968   
5,712   
11,117   
7,167   
12,801   
634   
4,679   
15,012   
8,827   
77,842   

 1,494
 11,063
 4,887
 14,833
 6,388
 13,431
 5,003
 4,126
 —
 9,939
 71,164

(1,568) 
(20,925) 
(38,547) 
(1,571) 
(11,527) 
(2,040) 
(76,178) 
(13,527) 

 (1,047)
    (20,797)
    (42,888)
 (5,575)
 (11,938)
 (3,556)
    (85,801)
    (10,786)
$ (11,863)  $   (25,423)

$

6,599    $ 

 6,080
    (31,503)
$ (11,863)  $   (25,423)

(18,462) 

 
 
    
     
    
  
  
  
  
  
  
 
 
 
 
 
  
 
 
    
     
      
 
  
  
  
  
 
 
 
 
  
  
 
 
   
   
  
 
  
  
 
  
 
 
   
   
  
 
 
Deferred tax assets and liabilities are netted on the balance sheet by separate tax jurisdictions. Deferred income tax balances 
reflect the temporary differences between the carrying amounts of assets and liabilities and their tax basis and are stated 
at enacted tax rates expected to be in effect when taxes are actually paid or recovered. The valuation allowance is primarily 
related to state credit carryforwards, non-US net operating loss carryforwards, and capital loss carryforwards for which 
we believe it is more likely than not that the deferred tax assets will not be realized. The valuation allowance increased by 
$2.7 million during the year ended December 31, 2022, increased by $573,000 during the year ended December 31, 2021, 
and increased by $5.6 million during the year ended December 31, 2020. 

As of December 31, 2022, we had U.S federal net operating loss carryforwards of $29.7 million, which were generated by 
Cianna Medical, Vascular Access Technologies, Inc., DFINE Inc., and Biosphere Medical, Inc., prior to our acquisition 
of these companies. These net operating loss carryforwards are subject to annual limitations under Internal Revenue Code 
Section 382. If unused $29.6 million of the NOLs will expire between 2025 and 2037. Of the NOLs incurred post-2017, 
$97,000 can be carried forward indefinitely. We anticipate that we will utilize all current net operating loss carryforwards 
prior to their expiration dates over the next 13 years. We utilized a total of $15.9 million in U.S. federal net operating loss 
carryforwards during the year ended December 31, 2022. 

As of December 31, 2022, we had $22.2 million of non-U.S. net operating loss carryforwards, of which $21.1 million have 
no  expiration  date  and  $1.1  million  expire  at  various  dates  through  2034.  Non-U.S.  net  operating  loss  carryforwards 
utilized during the year ended December 31, 2022 were not material. 

We do not consider our foreign earnings to be permanently reinvested. Consequently, we have recorded tax expense of 
$320,000, $288,000 and $228,000 for foreign withholding taxes on unremitted foreign earnings during the years ended 
December 31, 2022, 2021 and 2020, respectively. Additionally, for the year ended December 31, 2022, a tax benefit of 
$4.3 million was recorded with respect to the restructuring of our foreign entities and the associated change in foreign 
withholding taxes on the unremitted foreign earnings. 

We  are  subject  to  income  taxes  in  the  U.S.  and  numerous  foreign  jurisdictions.  Significant  judgment  is  required  in 
determining  our  worldwide  provision  for  income  taxes  and  recording  the  related  assets  and  liabilities.  In  the  ordinary 
course of our business, there are many transactions and calculations where the ultimate tax determination is uncertain. In 
our opinion, we have made adequate provisions for income taxes for all years subject to audit. We are no longer subject 
to U.S. federal, state, and local income tax examinations by tax authorities for years before 2019. In foreign jurisdictions, 
we are no longer subject to income tax examinations for years before 2016. 

Although we believe our estimates are reasonable, the final outcomes of these matters may be different from those which 
we have reflected in our historical income tax provisions and accruals. Such differences could have a material effect on 
our income tax provision and operating results in the period in which we make such determination. 

The total liability for unrecognized tax benefits at December 31, 2022, including interest and penalties, was $1.9 million, 
of which $1.9 million would favorably impact our effective tax rate if recognized. At December 31, 2022, none of the total 
liability was presented as a reduction to non-current deferred income tax assets on our consolidated balance sheet. The 
total liability for unrecognized tax benefits at December 31, 2021, including interest and penalties, was $2.0 million, of 
which $2.0 million would favorably impact our effective tax rate if recognized. At December 31, 2021, $1.0 million of the 
total liability was presented as a reduction to non-current deferred income tax assets on our consolidated balance sheet. As 
of December 31, 2022 and 2021, we had accrued $336,000 and $322,000 respectively, in total interest and penalties related 
to unrecognized tax benefits. We account for interest and penalties for unrecognized tax benefits as part of our income tax 
provision.  During  the years  ended  December 31,  2022,  2021  and  2020,  our  liability  for  unrecognized  tax  benefit  was 
increased  (decreased)  for  interest  and  penalties  by  $14,000,  $46,000,  and  $(90,000),  respectively.  We  estimate  it  is 
reasonably possible that within the next 12 months the total liability for unrecognized tax benefits may decrease, including 
expirations related to statutes of limitation, up to $109,000. 

71 

A reconciliation of the beginning and ending amount of liabilities associated with uncertain tax benefits for the years ended 
December 31, 2022, 2021 and 2020, consisted of the following (in thousands): 

Unrecognized tax benefits, opening balance 
Gross increases (decreases) in tax positions taken in a prior year
Gross increases in tax positions taken in the current year
Lapse of applicable statute of limitations 
Unrecognized tax benefits, ending balance 

2022 
1,635   $ 
(10) 
294  
(343) 
1,576   $ 

2021 
 1,674
 82
 316
 (437)
 1,635

$

$

2020 
2,161
115
283
(885)
1,674

$

$

The tabular roll-forward ending balance does not include interest and penalties related to unrecognized tax benefits. 

7. 

ACCRUED EXPENSES 

Accrued expenses at December 31, 2022 and 2021, consisted of the following (in thousands): 

Payroll and related liabilities 
Current portion of contingent liabilities
Advances from employees 
Accrued rebates payable 
Accrued legal settlement 
Other accrued expenses 

Total 

$

2022 
58,620   $ 
15,813  
165  
10,925  
1,000  
36,666  

2021 
 59,435
 34,735
 201
 11,271
 18,250
 35,122

$ 123,189   $   159,014

8. 

REVOLVING CREDIT FACILITY AND LONG-TERM DEBT 

Principal balances outstanding under our long-term debt obligations as of December 31, 2022 and 2021, consisted of the 
following (in thousands): 

Term loans 
Revolving credit loans 
Less unamortized debt issuance costs
Total long-term debt 
Less current portion 
Long-term portion 

Third Amended and Restated Credit Agreement 

2022 

2021 

$ 124,688   $   133,125
 110,000
 (290)
 242,835
 8,438
$ 186,759   $   234,397

73,500  
(179) 
198,009  
11,250  

On  July  31,  2019,  we  entered  into  a  Third  Amended  and  Restated  Credit  Agreement  (the  "Third  Amended  Credit 
Agreement"). The Third Amended Credit Agreement is a syndicated loan agreement with Wells Fargo Bank, National 
Association and other parties. The Third Amended Credit Agreement amends and restates in its entirety our previously 
outstanding Second Amended and Restated Credit Agreement and all amendments thereto. The Third Amended Credit 
Agreement  provides  for  a  term  loan  of $150 million and  a  revolving  credit  commitment  up  to  an  aggregate  amount 
of $600 million, inclusive of sub-facilities for multicurrency borrowings, standby letters of credit and swingline loans. On 
July  31,  2024,  all  principal,  interest  and  other  amounts  outstanding  under  the  Third  Amended  Credit  Agreement  are 
payable in full. At any time prior to the maturity date, we may repay any amounts owing under all term loans and revolving 
credit loans in whole or in part, without premium or penalty, other than breakage fees (as defined in the Third Amended 
Credit Agreement). 

72 

 
    
     
    
  
  
  
 
 
 
    
     
  
  
 
 
  
 
 
   
 
 
 
 
    
     
  
  
  
  
 
 
 
 
Revolving credit loans denominated in dollars and term loans made under the Third Amended Credit Agreement bear 
interest, at our election, at either the Base Rate or the Eurocurrency Rate (as such terms are defined in the Third Amended 
Credit Agreement) plus the Applicable Margin (as defined in the Third Amended Credit Agreement). Revolving credit 
loans denominated in an Alternative Currency (as defined in the Third Amended Credit Agreement) bear interest at the 
Eurocurrency Rate plus the Applicable Margin. Swingline loans bear interest at the Base Rate plus the Applicable Margin 
(as defined in the Third Amended Credit Agreement). Interest on each loan featuring the Base Rate is due and payable on 
the last business day of each calendar quarter; interest on each loan featuring the Eurocurrency Rate is due and payable on 
the last day of each interest period applicable thereto, and if such interest period extends over three months, at the end of 
each three-month interval during such interest period. 

The  Third  Amended  Credit  Agreement  is  collateralized  by  substantially  all  of  our  assets.  The  Third  Amended  Credit 
Agreement contains affirmative and negative covenants, representations and warranties, events of default and other terms 
customary for loans of this nature. In particular, the Third Amended Credit Agreement requires that we maintain certain 
financial covenants, as follows: 

Consolidated Total Leverage Ratio (1)
Consolidated Interest Coverage Ratio (2)
Facility Capital Expenditures (3) 

Covenant Requirement 
4.0 to 1.0 
3.0 to 1.0 
$50 million 

(1)  Maximum Consolidated Total Net Leverage Ratio (as defined in the Third Amended Credit Agreement) as of any 

fiscal quarter end. 

(2)  Minimum ratio of Consolidated EBITDA (as defined in the Third Amended Credit Agreement and adjusted for certain 
expenditures) to Consolidated interest expense (as defined in the Third Amended Credit Agreement) for any period 
of four consecutive fiscal quarters. 

(3)  Maximum level of the aggregate amount of all Facility Capital Expenditures (as defined in the Third Amended Credit 

Agreement) in any fiscal year. 

As of December 31, 2022, we believe we were in compliance with all covenants set forth in the Third Amended Credit 
Agreement. 

As  of  December 31, 2022,  we  had  outstanding  borrowings  of  $198.2  million  and  issued  letter  of  credit  guarantees  of 
$3.2 million  under  the  Third  Amended  Credit  Agreement,  with  additional  available  borrowings  of  approximately 
$523 million, based on the leverage ratio required pursuant to the Third Amended Credit Agreement. Our interest rate as 
of December 31, 2022 was a fixed rate of 2.71% on $75 million as a result of an interest rate swap (see Note 9) and a 
variable floating rate of 5.38% on $123.2 million. Our interest rate as of December 31, 2021 was a fixed rate of 2.71% on 
$75 million as a result of an interest rate swap and a variable floating rate of 1.10% on $168.1 million. The foregoing fixed 
rates are exclusive of potential future changes in the applicable margin. 

Certain of the interest rates applicable to our Third Amended Credit Agreement, and applicable to hedging instruments we 
have purchased to offset interest rate risk under our Third Amended Credit Agreement, are LIBOR-based. We anticipate 
replacement  rates  will  be  identified,  as  provided  for  in  our  Third  Amended  Credit  Agreement,  as  LIBOR-based  rates 
become unavailable. 

Future Payments 

Future minimum principal payments on our long-term debt as of December 31, 2022, are as follows (in thousands): 

Years Ending 
December 31, 
2023 
2024 
Total future minimum principal payments

73 

$ 

  Future Minimum 
     Principal Payments
 11,250
 186,938
 198,188

$ 

 
 
 
 
   
 
 
 
 
 
 
9. 

DERIVATIVES 

General. Our earnings and cash flows are subject to fluctuations due to changes in interest rates and foreign currency 
exchange rates, and we seek to mitigate a portion of these risks by entering into derivative contracts. The derivatives we 
use are interest rate swaps and foreign currency forward contracts. We recognize derivatives as either assets or liabilities 
at  fair  value  in  the  accompanying  consolidated  balance  sheets,  regardless  of  whether  or  not  hedge  accounting  is 
applied. We report cash flows arising from our hedging instruments consistent with the classification of cash flows from 
the underlying hedged items. Accordingly, cash flows associated with our derivative programs are classified as operating 
activities in the accompanying consolidated statements of cash flows. 

We formally document, designate and assess the effectiveness of transactions that receive hedge accounting initially and 
on  an  ongoing  basis. For  qualifying  hedges,  the  change  in  fair  value  is  deferred  in  accumulated  other  comprehensive 
income  (loss)  (“AOCI”),  a  component  of  stockholders’  equity  in  the  accompanying  consolidated  balance  sheets,  and 
recognized in earnings at the same time the hedged item affects earnings. Changes in the fair value of derivatives not 
designated as hedging instruments are recorded in earnings throughout the term of the derivative.  

Interest Rate Risk. Our debt bears interest at variable interest rates and, therefore, we are subject to variability in the cash 
paid for interest expense. In order to mitigate a portion of this risk, we use a hedging strategy to reduce the variability of 
cash  flows  in  the  interest  payments  associated  with  a  portion  of  the  variable-rate  debt  outstanding  under  our  Third 
Amended Credit Agreement that is solely due to changes in the benchmark interest rate. 

Derivatives Designated as Cash Flow Hedges 

On  August 5,  2016,  we  entered  into  a  pay-fixed,  receive-variable  interest  rate  swap  with  a  current  notional  amount 
of $175 million with Wells Fargo Bank to fix the one-month LIBOR rate at 1.12%. The variable portion of the interest 
rate swap was tied to the one-month LIBOR rate (the benchmark interest rate). The interest rate swap expired on July 6, 
2021. 

On  December  23,  2019,  we  entered  into  a  pay-fixed,  receive-variable  interest  rate  swap  with  a  notional  amount  of 
$75 million with Wells Fargo Bank to fix the one-month LIBOR rate at 1.71% for the period from July 6, 2021 to July 31, 
2024. The variable portion of the interest rate swap is tied to the one-month LIBOR rate (the benchmark interest rate). On 
a monthly basis, the interest rates under both the interest rate swap and the underlying debt reset, the swap is settled with 
the counterparty, and interest is paid. 

At December 31, 2022 and 2021, our interest rate swaps qualified as cash flow hedges. The fair value of our interest rate 
swap at December 31, 2022 was an asset of $3.4 million, partially offset by $0.8 million in deferred taxes. The fair value 
of our interest rate swaps at December 31, 2021 was a liability of $1.4 million, partially offset by $0.4 million in deferred 
taxes. 

Foreign Currency Risk. We operate on a global basis and are exposed to the risk that our financial condition, results of 
operations,  and  cash  flows  could  be  adversely  affected  by  changes  in  foreign  currency  exchange  rates.  To  reduce  the 
potential  effects  of  foreign  currency  exchange  rate  movements  on  net  earnings,  we  enter  into  derivative  financial 
instruments in the form of foreign currency exchange forward contracts with major financial institutions. Our policy is to 
enter into foreign currency derivative contracts with maturities of up to two years. We are exposed to foreign currency 
exchange rate risk with respect to transactions and balances denominated in various currencies, with our most significant 
exposure related to transactions and balances denominated in Chinese Renminbi and Euros, among others. We do not use 
derivative  financial  instruments  for  trading  or  speculative  purposes.  We  are  not  subject  to  any  credit  risk  contingent 
features related to our derivative contracts, and counterparty risk is managed by allocating derivative contracts among 
several major financial institutions. 

74 

 
 
 
 
Derivatives Designated as Cash Flow Hedges 

For derivative instruments that are designated and qualify as cash flow hedges, the gain or loss on the derivative instrument 
is temporarily reported as a component of other comprehensive income (loss) and then reclassified into earnings in the 
same  line  item  associated  with  the  forecasted  transaction  and  in  the  same  period  or  periods  during  which  the  hedged 
transaction affects earnings. We entered into forward contracts on various foreign currencies to manage the risk associated 
with  forecasted  exchange  rates  which  impact  revenues,  cost  of  sales,  and  operating  expenses  in  various  international 
markets. The objective of the hedges is to reduce the variability of cash flows associated with the forecasted purchase or 
sale of foreign currencies. 

We enter into approximately 100 cash flow foreign currency hedges every month. As of December 31, 2022 and 2021, we 
had entered into foreign currency forward contracts, which qualified as cash flow hedges, with aggregate notional amounts 
of $87.8 million and $123.0 million, respectively. 

Derivatives Not Designated as Cash Flow Hedges 

We forecast our net exposure in various receivables and payables to fluctuations in the value of various currencies, and 
we  enter  into  foreign  currency  forward  contracts  to  mitigate  that  exposure.  We  enter  into  approximately  50  foreign 
currency fair value hedges every month. As of December 31, 2022 and 2021, we had entered into foreign currency forward 
contracts related to those balance sheet accounts with aggregate notional amounts of $92.4 million and $86.0 million, 
respectively. 

Balance Sheet Presentation of Derivatives. As of December 31, 2022 and 2021, all derivatives, both those designated as 
hedging instruments and those that were not designated as hedging instruments, were recorded gross at fair value on our 
consolidated balance sheets. We are not subject to any master netting agreements. The fair value of derivative instruments 
on a gross basis is as follows (in thousands): 

Fair Value of Derivative Instruments Designated as 
Hedging Instruments 
Assets 
Interest rate swaps 
Foreign currency forward contracts 
Foreign currency forward contracts 

(Liabilities) 
Interest rate swaps 
Foreign currency forward contracts 
Foreign currency forward contracts 

Fair Value of Derivative Instruments Not Designated as 
Hedging Instruments 
Assets 
Foreign currency forward contracts 

(Liabilities) 
Foreign currency forward contracts 

   Balance Sheet Location 

    December 31, 2022     December 31, 2021

Other assets (long-term)
Prepaid expenses and other assets
Other assets (long-term)

$

 3,444    $ 
 3,215   
 56   

Other long-term obligations
Accrued expenses
Other long-term obligations

 —   
 (1,509) 
 (531) 

—
1,326
179

(1,447)
(2,288)
(502)

Balance Sheet Location 

    December 31, 2022     December 31, 2021

Prepaid expenses and other assets $

 1,512    $ 

736

Accrued expenses

 (1,946) 

(856)

75 

 
      
 
 
  
 
 
   
 
   
  
 
 
  
  
 
 
   
 
   
  
 
 
 
 
 
   
  
 
  
 
Income Statement Presentation of Derivatives 

Derivatives Designated as Cash Flow Hedges 

Derivative  instruments  designated  as  cash  flow  hedges  had  the  following  effects,  before  income  taxes,  on  other 
comprehensive income ("OCI") in our consolidated statements of comprehensive income (loss) and consolidated balance 
sheets (in thousands): 

Derivative instrument 
Interest rate swaps 
Foreign currency forward contracts 

$

Amount of Gain/(Loss) 
Recognized in OCI 
Year Ended December 31,  
2021 
 1,402
 (1,521)

4,879   $
6,263  

$

2022 

2020 
(6,131)
(5,516)

Derivative instruments designated as cash flow hedges had the following effects, before income taxes, on AOCI and net 
earnings in our consolidated statements of income (loss), consolidated statements of comprehensive income (loss) and 
consolidated balance sheets (in thousands): 

Location in statements of income 
Interest expense 
Revenue 
Cost of sales 

$ 

Consolidated Statements 
of Income 
Year Ended December 31,  
2021 
(5,261) $

2022 
 (6,339) $

 1,150,981
 (631,882)

1,074,751
(589,418)

2020 

(9,994) $

963,875
(562,698)

2022 

Amount of Gain/(Loss) 
reclassified from AOCI 
Year ended December 31,  
2021 
 (1,509)
 (5,592)
 1,017 

$

(12)   $ 

3,583   
(1,436)  

2020 

(872)
36
(1,288)

As of December 31, 2022, $2.7 million or $2.1 million after taxes, was expected to be reclassified from AOCI to earnings 
in revenue and cost of sales over the succeeding twelve months. As of December 31, 2022, $2.3 million, or $1.8 million 
after taxes, was expected to be reclassified from AOCI to earnings in interest expense over the succeeding twelve months. 

Derivatives Not Designated as Hedging Instruments 

The following gains/(losses) from these derivative instruments were recognized in our consolidated statements of income 
(loss) for the years presented (in thousands): 

Derivative Instrument 
Foreign currency forward contracts 

   Location in statements of income 
   Other income (expense) — net

$

See Note 15 for additional information about our derivatives. 

10. 

COMMITMENTS AND CONTINGENCIES 

Year ended December 31,  
2021 

2022 
1,420    $   (1,598)

2020 
$ (2,190)

We are obligated under non-terminable operating leases for manufacturing facilities, finished good distribution centers, 
office space, equipment, vehicles, and land. See Note 17 for disclosures regarding these operating leases. 

Royalties. As of December 31, 2022, we had entered into a number of agreements to license or acquire rights to certain 
intellectual property which require us to make royalty payments during the term of the agreements generally based on 
a percentage of  sales. During  the years  ended December 31, 2022,  2021  and  2020,  total  royalty  expense  approximated 
$7.3 million, $7.6 million and $7.1 million, respectively, and is recorded in cost of sales on the consolidated statement of 
income  (loss).  Minimum  contractual  commitments  under  royalty  agreements  to  be  paid  within  twelve months  of 
December 31, 2022 were not significant. See Note 15 for discussion of future royalty commitments related to acquisitions. 

Litigation. In the ordinary course of business, we are involved in various claims and litigation matters. These proceedings, 
actions  and  claims  may  involve  product  liability,  intellectual  property,  contract  disputes,  employment,  governmental 

76 

 
 
 
 
 
 
    
    
    
  
 
 
 
 
 
 
 
 
 
 
     
  
 
 
   
     
    
  
 
  
 
 
 
     
 
    
     
    
 
 
inquiries or other matters, including those more fully described below. The outcomes of these matters will generally not 
be  known  for  prolonged  periods  of  time.  In  certain  proceedings,  the  claimants  may  seek  damages  as  well  as  other 
compensatory  and  equitable  relief  that  could  result  in  the  payment  of  significant  claims  and  settlements  and/or  the 
imposition of injunctions or other equitable relief. For legal matters for which our management had sufficient information 
to reasonably estimate our future obligations, a liability representing management’s best estimate of the probable loss, or 
the minimum of the range of probable losses when a best estimate within the range is not known, is recorded. The estimates 
are based on consultation with legal counsel, previous settlement experience and settlement strategies. If actual outcomes 
are less favorable than those estimated by management, additional expense may be incurred, which could unfavorably 
affect our financial position, results of operations and cash flows. The ultimate cost to us with respect to actions and claims 
could be materially different than the amount of the current estimates and accruals and could have a material adverse effect 
on our financial position, results of operations and cash flows. 

Shareholder Derivative Action 

On June 3, 2021, Steffen Maute filed a complaint, derivatively on behalf of Merit, against Merit (as a nominal defendant), 
our Chief Executive Officer, our Chief Financial Officer, our former President of EMEA and certain of our directors in 
the United States District Court for the District of Utah (Case No. 2:21-cv-00346-DBP). The derivative complaint alleged 
that the individual defendants violated their fiduciary duties owed to Merit and were unjustly enriched at the expense of 
and  to  the  detriment  of  Merit  between  February  2019  and  October  2019,  and  sought  unspecified  damages,  costs,  and 
professional  fees.  Following  mediation,  the  parties  negotiated  an  agreement  to  settle  the  dispute,  which,  among  other 
provisions, provides for the release of all claims against Merit and the other defendants in exchange for Merit’s undertaking 
to implement certain corporate governance revisions and pay attorneys fees and expenses in the amount of $1.0 million. 
On February 16, 2023, the court held a hearing and announced approval of the settlement, which has the effect of resolving 
all claims arising from the litigation. The expense associated with the settlement has been reflected in our financial results 
reported for the year ended December 31, 2022. 

SEC Inquiry  

We have received requests from the Division of Enforcement of the U.S. Securities and Exchange Commission (“SEC”) 
seeking the voluntary production of information relating to the business activities of Merit’s subsidiary in China, including 
interactions with hospitals and health care officials in China. We are cooperating with the requests and investigating the 
matter and, at this time, are unable to predict the scope, timing, significance or outcome of this matter. 

It is possible that the ultimate resolution of the foregoing matter, or similar matters, if resolved in a manner unfavorable to 
us, may be materially adverse to our business, financial condition, results of operations or liquidity. Legal costs for these 
matters, such as outside counsel fees and expenses, are charged to expense in the period incurred. 

77 

 
 
 
 
 
11. 

EARNINGS PER COMMON SHARE (EPS) 

The computation of weighted average shares outstanding and the basic and diluted earnings (loss) per common share for 
the following periods consisted of the following (in thousands, except per share amounts): 

Net income (loss) 
Average common shares outstanding 
Basic EPS 

Average common shares outstanding 
Effect of dilutive stock awards 
Total potential shares outstanding 
Diluted EPS 

Equity awards excluded as the impact was anti-dilutive (1)

  $

$

$

2022 

2021 

2020 

$

$

$

74,516
56,806
1.31

56,806
865
57,671
1.29

1,438

 48,454   
 56,145   
 0.86   

 56,145   
 1,214   
 57,359   
 0.84   

$ 

$ 

$ 

(9,843)
55,434
(0.18)

55,434
—
55,434
(0.18)

 799   

4,216

(1)  Does not reflect the impact of incremental repurchases under the treasury stock method.  

12. 

EMPLOYEE STOCK PURCHASE PLAN, STOCK OPTIONS AND WARRANTS 

Our stock-based compensation primarily consists of the following plans: 

2018 Long-Term Incentive Plan. In June 2018, our Board of Directors adopted and our shareholders approved, the Merit 
Medical Systems, Inc. 2018 Long-Term Incentive Plan, which was subsequently amended effective December 14, 2018 
(the “2018 Incentive Plan”) to supplement the Merit Medical Systems, Inc. 2006 Long-Term Incentive plan (the "2006 
Incentive Plan"). The 2018 Incentive Plan provides for the granting of stock options, stock appreciation rights, restricted 
stock, stock units (including restricted stock units) and performance awards (including performance stock units). Options 
may be granted to directors, officers, outside consultants and key employees and may be granted upon such terms and such 
conditions as the Compensation Committee of our Board of Directors determines. Options typically vest on an annual 
basis over a three to five-year life with a contractual life of seven years. As of December 31, 2022, a total of 2,817,861 
shares remained available to be issued under the 2018 Incentive Plan.  

2006 Long-Term Incentive Plan. In May 2006, our Board of Directors adopted, and our shareholders approved, the 2006 
Incentive Plan. As of December 31, 2022, the 2006 Incentive Plan was no longer being used for new equity award grants. 
However, as of December 31, 2022, options granted under this plan were still outstanding, vesting, and being exercised 
and will continue to be outstanding until the vesting periods end and the terms of the equity awards expire. 

Employee  Stock  Purchase  Plan.  We  have  a  non-qualified  Employee  Stock  Purchase  Plan  (“ESPP”),  which  has  an 
expiration date of June 30, 2026. As of December 31, 2022, the total number of shares of common stock that remained 
available to be issued under our non-qualified plan was 102,739 shares. ESPP participants purchase shares on a quarterly 
basis at a price equal to 95% of the market price of the common stock at the end of the applicable offering period. 

78 

 
 
    
     
     
  
 
 
 
 
 
 
 
 
 
 
 
 
 
Stock-Based Compensation Expense. The stock-based compensation expense before income tax expense for the years 
ended December 31, 2022, 2021 and 2020, consisted of the following (in thousands): 

Cost of sales 

Nonqualified stock options 

Research and development 

Nonqualified stock options 

Selling, general and administrative 

Nonqualified stock options 
Performance-based restricted stock units 
Restricted stock units 
Cash-settled performance-based share-based awards ("Liability Awards")

Total selling, general and administrative 

2022 

2021 

2020 

$

1,606    $ 

 1,476

$

1,357

1,789   

 1,343

1,157

7,305   
3,509   
1,836   
1,997   
14,647   

 6,678
 3,525
 1,557
 1,511
 13,271

7,332
2,829
758
906
11,825

Stock-based compensation expense before taxes

$ 18,042    $   16,090

$ 14,339

We recognize stock-based compensation expense (net of a forfeiture rate) for those awards which are expected to vest on 
a straight-line basis over the requisite service period. We estimate the forfeiture rate based on our historical experience 
and expectations about future forfeitures.  

Nonqualified Stock Options 

As of December 31, 2022, the total remaining unrecognized compensation cost related to non-vested stock options, net of 
expected forfeitures, was $20.4 million and is expected to be recognized over a weighted average period of 2.1 years. 

In applying the Black-Scholes methodology to the option grants, the fair value of our stock-based awards granted was 
estimated using the following assumptions for the years ended December 31, 2022, 2021 and 2020: 

Risk-free interest rate 
Expected option term 
Expected dividend yield 
Expected price volatility 

2022 
1.4% - 4.3%
4.0 years
—
46.2% - 47.5%

2021 
0.5% - 1.1% 
4.0 years
—
46.1% - 46.7% 

2020 
0.3% - 1.7%
4.0 - 5.0 years
—
38.7% - 45.1%

The average risk-free interest rate is determined using the U.S. Treasury rate in effect as of the date of grant, based on the 
expected  term  of  the  stock  option. We  determine  the  expected  term  of  the  stock  options  using  the  historical  exercise 
behavior of employees. The expected price volatility was determined based upon the historical volatility for our stock. We 
recognize compensation expense for options on a straight-line basis over the service period, which corresponds to the 
vesting period. During the years ended December 31, 2022, 2021 and 2020, approximately 251,000, 716,000 and 329,000 
nonqualified  stock  option  grants  were  made,  respectively,  for  a  total  fair  value  of  $6.3  million,  $17.5  million  and 
$4.5 million. 

The table below presents information related to stock option activity for the years ended December 31, 2022, 2021 and 
2020 (in thousands): 

Total intrinsic value of stock options exercised
Cash received from stock option exercises 
Excess tax benefit from the exercise of stock options

2022 

2021 

$ 27,110   $   36,086
    20,194
 5,571

18,952  
3,423  

2020 
$ 11,733
5,481
1,815

79 

 
   
     
    
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
   
     
   
 
 
 
 
 
 
    
     
    
  
 
Changes in stock options for the year ended December 31, 2022, consisted of the following (shares and intrinsic value in 
thousands): 

Beginning balance 
Granted 
Exercised 
Forfeited/expired 
Outstanding at December 31 
Exercisable 
Ending vested and expected to vest 

Term (in years) 

  Number   Weighted Average  Remaining Contractual 
     of Shares      Exercise Price 
44.70
$
63.69
28.58
53.16
49.62
43.50
49.37

3,640
251
(703)
(111)
3,077
1,792
3,013

 3.51
 2.61
 3.47

Intrinsic 

     Value 

$ 64,634
48,595
64,026

The weighted average grant-date fair value of options granted during the years ended December 31, 2022, 2021 and 2020 
was $24.98, $24.38 and $13.70, respectively. 

Stock-Settled Performance-Based Restricted Stock Units (“PSUs”) and Time-Vested Restricted Stock Units (“RSUs”) 

Since 2020, we have granted PSUs to certain of our executive officers. Conversion of PSUs occurs at the end of one, two 
and three-year performance periods, or one year after the agreement date, whichever is later. The conversion ratio is based 
upon attaining targeted levels of free cash flow (“FCF”) and relative shareholder return as compared to the Russell 2000 
Index (“rTSR”), as defined in the award agreements. In 2020, our Board of Directors amended PSUs granted in 2020 with 
a one-year performance period to adjust the performance targets and reduce the maximum FCF multiplier to 100% for the 
one-year awards, which lowered the potential shares of our common stock to be granted pursuant to the one-year awards 
by 25,415 shares. We accounted for this amendment in accordance with ASC 718 as a “Type I” modification. 

The payout for each PSU is equal to one share of common stock multiplied by a FCF multiplier (between 50% and 100% 
in the case of the 2020 one-year awards, as amended, or 50% and 200% in the case of all other PSU awards) and a rTSR 
multiplier (between 75% and 125%). PSUs convey no shareholder rights unless and until shares are issued in settlement 
of the award. We use Monte-Carlo simulations to estimate the grant-date fair value of the PSUs linked to total shareholder 
return. Compensation expense is recognized using the grant-date fair value for the number of shares that are probable of 
being awarded based on the performance conditions. Each reporting period, this probability assessment is updated, and 
cumulative catchups are recorded based on the level of FCF that is expected to be achieved. At the end of the performance 
period, cumulative expense is calculated based on the actual level of FCF achieved. 

We grant RSUs to our non-employee directors, which are subject to continued service through the vesting date, which is 
one year from the date of grant. The expense recognized for RSUs is equal to the closing stock price on the date of grant, 
which is recognized over the vesting period. 

80 

 
 
    
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Changes in PSUs and RSUs for the year ended December 31, 2022, consisted of the following: 

Beginning nonvested balance 

Granted 
rTSR adjustment 
Vested 
Forfeited 

Nonvested balance at December 31 

PSUs 
  Weighted Average 

RSUs 
  Weighted Average

Stock Units 
(In Thousands) (1) 

Grant Date 
Fair Value 

Stock Units 

(In Thousands)       

Grant Date 
Fair Value 

163   $
97
8 (2) 

(44) 
(45)
179  

53.71
64.54
65.03
65.03
60.81
65.20

 26    $ 
 31    
 —   
 (26)  
 —    
 31   

61.77
59.02
—
61.77
—
59.02

(1)  Based on the maximum payout, excluding the impact of the rTSR multiplier. The actual number of shares which vest 
is determined based on the satisfaction of performance conditions and the application of an rTSR multiplier between 
75% and 125%.  

(2)  Represents the application of an rTSR multiplier of 125% to awards vested in 2022 based on the performance of our 

common stock and the terms of the awards. 

The following table summarizes PSUs and RSUs granted during the years ended December 31, 2022, 2021, and 2020 
(units and shares in thousands): 

PSUs 

Target units granted 
Maximum units granted (1) 
Maximum potential shares (1)(2) 
Weighted average grant date fair value 

RSUs 

Units granted 
Weighted average grant date fair value 

2022 

2021 

2020 

48  
97  
121  

52  
103   
129   

61
102 (3)
127 (3)

$

64.54   $  61.39   $

43.63

31  

 26  

$

59.02   $  61.77   $

34
42.98

(1)  Based on the maximum payout, excluding the impact of the rTSR multiplier.  
(2) 
Includes the impact of the maximum potential rTSR multiplier of 125%. 
(3) 
Includes the impact of the 2020 amendment which reduced the maximum FCF multiplier for one-year awards from 200% to 100%. 

During the years ended December 31, 2022 and 2021, there were approximately 44,000 and 26,000 shares, respectively, 
that vested under PSUs, prior to the reduction of shares withheld to satisfy tax withholding obligations. Vested shares were 
calculated based upon achievement of the maximum performance multiplier, as amended, of 200% and 100% for 2022 
and 2021, respectively, and an rTSR multiplier of 125%. There were no shares that vested under PSUs during the year 
ended December 31, 2020. During the years ended December 31, 2022 and 2021, there were approximately 26,000 and 
34,000 shares, respectively, that vested under RSUs. There were no shares that vested under RSUs during the year ended 
December 31, 2020. 

The fair value of each PSU was estimated as of the grant date using the following assumptions for awards granted in the 
years ended December 31, 2022 and 2021: 

Risk-free interest rate 
Performance period 
Expected dividend yield 
Expected price volatility 

2022 

2021 

    1.6% - 2.7%      0.1% - 0.3%
2.6 - 2.8 years    1.8 - 2.8 years

—

— 

38.5% - 42.6%    43.7% - 49.3%

The risk-free interest rate of return was determined using the U.S. Treasury rate at the time of grant with a remaining term 
equal to the expected term of the award. The expected volatility was based on a weighted average volatility of our stock 

81 

 
 
 
 
 
 
 
 
 
 
 
 
    
    
  
 
  
  
  
 
 
 
 
     
    
    
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
price and the average volatility of our compensation peer group's volatilities. The expected dividend yield was assumed to 
be zero because, at the time of the grant, we had no plans to declare a dividend. 

As of December 31, 2022, the total remaining unrecognized compensation cost related to stock-settled performance stock 
units  and  restricted  stock  units,  net  of  expected  forfeitures,  was  $4.7  million  and  $0.7  million,  respectively,  which  is 
expected to be recognized over a weighted average period of 1.6 years and 0.4 years, respectively. 

Cash-Settled Performance-Based Share-Based Awards (“Liability Awards”) 

During  the  years  ended  December 31, 2022,  2021  and  2020,  we  granted  liability  awards  to  certain  executive  officers. 
These  awards  entitle  them  to  cash  payments  equal  to  a  total  target  cash  incentive  of  $1.0  million,  $1.0  million,  and 
$1.0 million,  respectively,  multiplied  by  rTSR  and  FCF  multipliers,  as  defined  in  the  award  agreements.  In  2020,  our 
Board of Directors amended the liability awards with a one-year performance period. The potential maximum payout of 
these liability awards is 125% of the target cash incentive for the 2020 one-year award, as amended, and 250% of the target 
cash incentive for all other liability awards, resulting in a total potential maximum payout of $2.5 million and $2.5 million 
for liability awards granted during the years ended December 31, 2022 and 2021, respectively. Settlement generally occurs 
at the end of one, two and three-year performance periods based upon the same performance metrics and vesting period 
as our performance stock units.  

These  awards  are  classified  as  liabilities  and  reported  in  accrued  expenses  and  other  long-term  liabilities  within  our 
consolidated balance sheet. The fair value of these awards is remeasured at each reporting period until the awards are 
settled.  As  of  December  31, 2022,  our  recorded  liabilities  associated  with  these  awards  was  $3.2  million,  and  we  had 
remaining unrecognized compensation cost related to cash-settled performance-based share-based awards of $1.9 million, 
which is expected to be recognized over a weighted average period of 1.7 years. During 2022 and 2021, we paid $833,000 
and $417,000, respectively, in connection with liability awards, and no awards were forfeited. There were no liability 
awards vested or forfeited in the year ended December 31, 2020.  

13. 

SEGMENT REPORTING AND FOREIGN OPERATIONS 

We report our operations in two operating segments: cardiovascular and endoscopy. Our cardiovascular segment consists 
of four product categories: peripheral intervention, cardiac intervention, custom procedural solutions, and OEM. Within 
these  product  categories,  we  sell  a  variety  of  products,  including  cardiology  and  radiology  devices  (which  assist  in 
diagnosing and treating coronary arterial disease, peripheral vascular disease and other non-vascular diseases), as well as 
embolotherapeutic, cardiac rhythm management, electrophysiology, critical care, breast cancer localization and guidance, 
biopsy,  and  interventional  oncology  and  spine  devices.  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. We evaluate the performance of our operating segments based on net sales and 
operating income (loss). See Note 2 to our consolidated financial statements set forth in Item 8 of this report for a detailed 
breakout of our sales by operating segment and product category, disaggregated between domestic and international sales. 

During the years ended December 31, 2022, 2021 and 2020, we had international sales of $500.4 million, $465.9 million 
and  $413.8  million,  respectively,  or  43%,  43%  and  43%,  respectively,  of  net  sales.  Our  largest  international  markets 
include  China,  Japan,  Germany,  France  and  the  United  Kingdom,  with China  representing  our  most  significant 
international  sales  market  with  sales  of  $149.3  million,  $138.2  million,  and  $113.2  million  for  the years  ended 
December 31, 2022,  2021  and  2020,  respectively.  International  sales  are  attributed  based  on  location  of  the  customer 
receiving the product. 

82 

 
 
 
 
 
Our long-lived assets (which are comprised of our net property and equipment) by geographic area at December 31, 2022, 
2021 and 2020, consisted of the following (in thousands): 

United States 
Ireland 
Other foreign countries 
Total 

2022 
281,290
40,749
60,937
382,976

$

$

2021 
 275,311   $ 
 39,863  
 56,484  

 371,658   $ 

2020 
277,643
42,951
62,134
382,728

$

$

Financial information relating to our reportable operating segments and reconciliations to the consolidated totals for 
the years ended December 31, 2022, 2021 and 2020, are as follows (in thousands): 

Net sales 

Cardiovascular 
Endoscopy 
Total net sales 

Income (loss) from operations 

Cardiovascular 
Endoscopy 
Total income (loss) from operations 

Total other expense — net 
Income tax expense (benefit) 

2022 

2021 

2020 

$

$

1,118,224
32,757
1,150,981

1,043,227   $ 
 31,524  
1,074,751  

934,202
29,673
963,875

80,946
6,617
87,563

(4,934)
8,113

 53,415  
 7,501  
 60,916  

 (6,999) 
 5,463  

(7,042)
5,480
(1,562)

(11,669)
(3,388)

Net income (loss) 

$

74,516

$

 48,454   $ 

(9,843)

Total assets by operating segment at December 31, 2022, 2021 and 2020, consisted of the following (in thousands): 

Cardiovascular 
Endoscopy 
Total 

2022 
1,652,145
11,821
1,663,966

$

$

2021 
1,635,676   $ 
 12,618  
1,648,294   $ 

2020 
1,654,866
9,530
1,664,396

$

$

Total  depreciation  and  amortization  by  operating  segment  for  the years  ended  December 31, 2022,  2021  and  2020, 
consisted of the following (in thousands): 

Cardiovascular 
Endoscopy 
Total 

2022 

2021 

2020 

80,777
1,027
81,804

$

$

 83,000    $ 
 1,066   
 84,066    $ 

93,160
910
94,070

$

$

Total capital expenditures for property and equipment by operating segment for the years ended December 31, 2022, 2021 
and 2020, consisted of the following (in thousands): 

Cardiovascular 
Endoscopy 
Total 

2022 

2021 

2020 

44,925
104
45,029

$

$

 27,557   $ 
 382  
 27,939   $ 

45,803
185
45,988

$

$

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14. 

EMPLOYEE BENEFIT PLANS 

We have defined contribution plans covering all U.S. full-time adult employees and certain of our foreign employees. Our 
contributions  to  these  plans  are  discretionary  in  certain  countries,  including  the  U.S.  In  September  2019,  we  ceased 
discretionary contributions to certain of our defined contribution plans and subsequently reinstated those contributions in 
May 2021. Total expense for contributions made to these plans for the years ended December 31, 2022, 2021 and 2020 
was $7.7 million, $6.5 million and $3.9 million, respectively. 

15. 

FAIR VALUE MEASUREMENTS 

Assets (Liabilities) Measured at Fair Value on a Recurring Basis 

Our financial assets and (liabilities) carried at fair value measured on a recurring basis as of December 31, 2022 and 2021, 
consisted of the following (in thousands): 

Total Fair 
Value at 
   December 31, 2022    

Quoted prices in
active markets
(Level 1) 

Significant other  
observable inputs   unobservable inputs

Significant 

(Level 2) 

(Level 3) 

Fair Value Measurements Using 

Marketable securities (1) 
Interest rate contract asset, long-term (2) 
Foreign currency contract assets, current and 
long-term (3) 
Foreign currency contract liabilities, current and 
long-term (4) 
Contingent consideration liabilities 

$
$
$

$

$

$
138
3,444
$
 4,783   $

138

$
— $
 —   $

 —   $ 
 3,444   $ 
 4,783   $ 

 (3,986)  $

 —   $

 (3,986)  $ 

—
—
 —

 —

(18,073) $

— $

 —   $ 

(18,073)

Fair Value Measurements Using 

Interest rate contract liability, long-term (2) 
Foreign currency contract assets, current and 
long-term (3) 
Foreign currency contract liabilities, current and 
long-term (4) 
Contingent consideration liabilities 

$

$

Total Fair 
Value at 
    December 31, 2021    
(1,447) $
 2,241   $

$
  $

Quoted prices in
active markets
(Level 1) 

Significant other  
observable inputs   unobservable inputs

Significant 

(Level 2) 

(Level 3) 

— $
 —   $

 (1,447)  $ 
 2,241   $ 

 (3,646)  $

 —   $

 (3,646)  $ 

(48,234) $

— $

 —   $ 

(48,234)

—
 —

 —

(1)  Our marketable securities, which consist entirely of available-for-sale equity securities, are valued using market prices 
in active markets. Level 1 instrument valuations are obtained from real-time quotes for transactions in active exchange 
markets involving identical assets. 

(2)  The fair value of the interest rate contracts is determined using Level 2 fair value inputs and is recorded as accrued 

expenses or other long-term obligations in the consolidated balance sheets. 

(3)  The fair value of the foreign currency contract assets (including those designated as hedging instruments and those 
not designated as hedging instruments) is determined using Level 2 fair value inputs and is recorded as prepaid and 
other assets or other long-term assets in the consolidated balance sheets. 

(4)  The fair value of the foreign currency contract liabilities (including those designated as hedging instruments and those 
not  designated  as  hedging  instruments)  is  determined  using  Level  2  fair  value  inputs  and  is  recorded  as  accrued 
expenses or other long-term obligations in the consolidated balance sheets. 

Certain of our business combinations involve the potential for the payment of future contingent consideration, generally 
based on a percentage of future product sales or upon attaining specified future revenue or other milestones. Contingent 
consideration liabilities are re-measured to fair value at each reporting period, with the change in fair value recognized 

84 

 
 
 
 
 
 
   
    
 
 
 
 
 
 
    
    
 
 
 
within operating expenses in the accompanying consolidated statements of income (loss). We measure the initial liability 
and re-measure the liability on a recurring basis using Level 3 inputs as defined under authoritative guidance for fair value 
measurements.  Changes  in  the  fair  value  of  our  contingent  consideration  liabilities  during  the years  ended 
December 31, 2022 and 2021, consisted of the following (in thousands): 

Beginning balance 
Contingent consideration expense
Contingent payments made 
Effect of foreign exchange 
Ending balance 

2022 

2021 

$ 48,234    $  55,750
 3,161
   (10,665)
 (12)
$ 18,073    $  48,234

4,610   
(34,762) 
 (9) 

As of December 31, 2022, $2.3 million in contingent consideration liability was included in other long-term obligations 
and $15.8 million in contingent consideration liability was included in accrued expenses in our consolidated balance sheet 
related to contingent liabilities. As of December 31, 2021, $13.5 million in contingent consideration liability was included 
in other long-term obligations and $34.7 in contingent consideration liability was included in accrued expenses in our 
consolidated balance sheet related to contingent liabilities.  

Cash payments related to the settlement of the contingent consideration liability recognized at fair value as of the applicable 
acquisition date been reflected as a cash outflow from financing activities in the accompanying consolidated statements of 
cash flows. Payments related to increases in the contingent consideration liability subsequent to the date of acquisition of 
$1.8 million for the year ended December 31, 2022 are reflected as operating cash flows.  

The  recurring  Level  3  measurement  of  our  contingent  consideration  liabilities  includes  the  following  significant 
unobservable inputs at December 31, 2022 and 2021 (amounts in thousands): 

  Fair value at  
  December 31,  

2022 
 2,097     Discounted cash flow 

Valuation 
technique 

Contingent 
consideration liability       
Revenue-based 
royalty payments 
contingent liability 

  $ 

Unobservable inputs 

   Discount rate 

  Weighted
  Average(1)
14% - 17%    15.7%

Range 

Projected year of payments

2023-2034

2026

Revenue 
milestones 
contingent liability 

  $ 

Regulatory 
approval 
contingent liability 

  $ 

 13,064     Monte Carlo simulation   Discount rate 

  5.1% - 14.0% 

5.2% 

 2,912    Scenario-based method   Discount rate 

5.7% 

Projected year of payments

2023-2033

2023

Probability of milestone payment 
Projected year of payment

90% 
2023-2030

2024

(1)  Unobservable inputs were weighted by the relative fair value of the instruments. No weighted average is reported for 

contingent consideration liabilities without a range of unobservable inputs. 

85 

 
    
     
  
 
 
 
 
 
 
 
 
    
 
 
 
 
 
     
    
     
 
 
 
  
      
 
 
 
   
 
 
 
 
 
 
  
      
 
 
 
   
 
 
 
 
 
 
 
 
 
   
 
 
 
 
   
 
 
 
 
  Fair value at  
  December 31,  

Contingent 
consideration liability       
Revenue-based 
royalty payments 
contingent liability 

  $ 

2021 
 2,870    Discounted cash flow 

Valuation 
technique 

Unobservable inputs 

   Discount rate 

  Weighted
  Average(1)
13% - 16%    14.7%

Range 

 41,671    Monte Carlo simulation   Discount rate 

  7.5% - 12.5% 

8.2% 

Projected year of payments

2022-2034

2026

 3,693   Scenario-based method   Discount rate 

2.6% 

Projected year of payments

2022-2031

2022

Revenue 
milestones 
contingent liability 

  $ 

Regulatory 
approval 
contingent liability 

  $ 

Probability of milestone payment 
Projected year of payment

80% 
2024-2025

2025

(1)  Unobservable inputs were weighted by the relative fair value of the instruments. No weighted average is reported for 

contingent consideration liabilities without a range of unobservable inputs. 

The  contingent  consideration  liabilities  are  re-measured  to  fair  value  each  reporting  period  using  projected  revenues, 
discount  rates,  probabilities  of  payment,  and  projected  payment  dates.  Projected  contingent  payment  amounts  are 
discounted back to the current period using a discounted cash flow model. Projected revenues are based on our most recent 
internal operational budgets and long-range strategic plans. An increase (decrease) in either the discount rate or the time 
to payment, in isolation, may result in a significantly lower (higher) fair value measurement. A decrease (increase) in the 
probability of any milestone payment may result in lower (higher) fair value measurements. Our determination of the fair 
value of contingent consideration liabilities could change in future periods based upon our ongoing evaluation of these 
significant  unobservable  inputs.  We  intend  to  record  any  such  change  in  fair  value  to  operating  expenses  in  our 
consolidated statements of income (loss). 

Contingent  Payments  to  Related  Parties.  During  the  years  ended  December  31,  2022  and  2020,  we  made  contingent 
payments of  approximately $1.6 million  and $800,000  to a  former  director of Merit  and  former  shareholder of  Cianna 
Medical which we acquired in 2018. We made no such payments in 2021. In 2023, the Company expects to make additional 
payments consistent with prior years. The terms of the acquisition, including contingent consideration payments, were 
determined  prior  to  the  appointment  of  the  former  Cianna  Medical  shareholder  as  a  director  of  Merit.  As  a  former 
shareholder of Cianna Medical, the former Merit director may be eligible for additional payments for the achievement of 
sales milestones specified in our merger agreement with Cianna Medical. 

Fair Value of Other Financial Instruments 

The carrying amount of cash and cash equivalents, receivables, and trade payables approximate fair value because of the 
immediate, short-term maturity of these financial instruments. Our long-term debt re-prices frequently due to variable rates 
and entails no significant changes in credit risk and, as a result, we believe the fair value of long-term debt approximates 
carrying value. The fair value of assets and liabilities whose carrying value approximates fair value is determined using 
Level 2 inputs, with the exception of cash and cash equivalents, which are Level 1 inputs. 

Impairment Charges 

We recognize or disclose the fair value of certain assets, such as non-financial assets, primarily property and equipment, 
intangible  assets  and  goodwill  in  connection  with  impairment  evaluations.  All  of  our  nonrecurring  valuations  use 
significant unobservable inputs and therefore fall under Level 3 of the fair value hierarchy.  

Intangible Assets. During the years ended December 31, 2022, 2021 and 2020, we had losses of $1.7 million, $1.6 million 
and $28.7 million, respectively, related to certain acquired intangible assets (see Note 5).  

86 

 
 
 
 
 
 
    
 
 
 
 
 
     
    
     
 
 
 
  
      
 
 
 
   
 
 
 
 
 
 
  
      
 
 
 
   
 
 
 
 
 
 
 
 
 
   
 
 
 
 
   
 
 
 
 
Right of Use Operating Lease Assets. We identified changes in events and circumstances relating to certain right-of-use 
(“ROU”) operating lease assets. We compared the anticipated undiscounted cash flows generated by a sublease to the 
carrying value of the ROU operating lease and related long-lived assets and determined that the carrying values were not 
recoverable. Consequently, we recorded impairment losses during the years ended December 31, 2021 and 2020 of $1.4 
million and $1.5 million, respectively, which is equal to the excess of the carrying value of the assets over their estimated 
fair value. The impairment losses were driven primarily by site consolidation decisions and changes in our projected cash 
flows for the ROU operating lease asset and related long-lived assets, due to changes in the real estate market as a result 
of the COVID-19 pandemic. These changes include an increase in the anticipated time to identify a lessee, an increase in 
anticipated lease concessions, and a decrease in the expected lease rates for the property. The ROU operating lease asset 
impairment losses pertained to our cardiovascular segment. We had no such losses during the year ended December 31, 
2022. 

Property  and  Equipment.  During  the  year  ended  December  31,  2021,  we  had  losses  of  $1.3 million  related  to  the 
measurement of property and equipment at fair value based on the planned discontinuance of the Advocate™ Peripheral 
Angioplasty Balloon product line, sold under our license agreements with ArraVasc, which pertained to our cardiovascular 
segment. During the year ended December 31, 2020, we had losses of $359,000 related to the measurement of certain 
property  and  equipment  measured  at  fair  value  based  on  restructuring  activities  associated  with  the  suspension  of  our 
distribution agreement with NinePoint, which pertained to our endoscopy segment. We had no such losses during the year 
ended December 31, 2022.  

Equity Investments, Purchase Options and Notes Receivable. During the year ended December 31, 2022, we recognized 
$0.5 million of impairment expense related to our equity method investment in XableCath, as business ceased operations. 
During the year ended December 31, 2020, we recognized $2.5 million of impairment expense related to our equity method 
investment in the 19.5 percent ownership in preferred shares of Fusion Medical, Inc. (“Fusion”) due to uncertainty about 
future product development and commercialization associated with the technologies and a charge of $3.5 million related 
to Bluegrass Vascular due to our decision not to exercise our option to purchase the company. We had no such losses 
during the year ended December 31, 2021. Our equity investments in privately held companies were $15.6 million and 
$14.7  million  at  December  21,  2022  and  2021,  respectively,  which  are  included  within  other  long-term  assets  in  our 
consolidated  balance  sheets.  We  analyze  our  investments  in  privately  held  companies  to  determine  if  they  should  be 
accounted for using the equity method based on our ability to exercise significant influence over operating and financial 
policies of the investment. Investments not accounted for under the equity method of accounting are accounted for at cost 
minus impairment, if applicable, plus or minus changes in valuation resulting from observable transactions for identical 
or similar investments.  

Current Expected Credit Losses 

Our  outstanding  long-term  notes  receivable,  including  accrued  interest  and  our  allowance  for  current  expected  credit 
losses, were $2.4 million and $2.3 million, as of December 31, 2022 and 2021, respectively. As of December 31, 2022 and 
2021, we had an allowance for current expected credit losses of $281,000 and $199,000, respectively, associated with 
these notes receivable. We assess the allowance for current expected credit losses on an individual security basis, due to 
the limited number of securities, using a probability of default model, which is based on relevant information about past 
events, including historical experience, current conditions and reasonable and supportable forecasts that affect the expected 
collectability of securities. During the year ended December 31, 2021, we collected $2.8 million from Bluegrass Vascular 
Technologies, Inc. pursuant to the terms of a note receivable, which represents the entire principal balance and all accrued 
interest payable pursuant to that note.  

The table below presents a rollforward of the allowance for current expected credit losses on our notes receivable for the 
years ended December 31, 2022 and 2021 (in thousands): 

Beginning balance 
Provision for credit loss expense 
Ending balance 

2022 

2021 

$

$

 199    $ 
 82   
 281    $ 

 730
 (531)
 199

87 

 
 
 
 
 
16. 

ACCUMULATED OTHER COMPREHENSIVE INCOME (LOSS) 

The  changes  in  each  component  of  Accumulated  Other  Comprehensive  Income  (Loss)  for  the  years  ended 
December 31, 2022, 2021 and 2020 were as follows (in thousands): 

January 1, 2020 

Other comprehensive income (loss) 
Income taxes 
Reclassifications to:  

Revenue 
Cost of sales 
Interest expense 

Net other comprehensive income (loss) 

December 31, 2020 

Other comprehensive income (loss) 
Income taxes 
Reclassifications to:  

Revenue 
Cost of sales 
Interest expense 

Net other comprehensive income (loss) 

December 31, 2021 

Other comprehensive income (loss) 
Income taxes 
Reclassifications to:  

Revenue 
Cost of sales 
Interest expense 

Net other comprehensive income (loss) 

      Cash Flow Hedges 
  $

 218  

(11,647)
2,365

(36)
1,288
872
(7,158)

 (6,940) 

(119)
(1,489)

5,592
(1,017)
1,509
4,476

 (2,464) 

11,142
(2,177)

(3,583)
1,436
12
6,830

Foreign Currency 
Translation 

Total 

 (5,512) 

 7,786  
 (786) 

 7,000  

 1,488  

(7,704) 
 689  

(7,015) 

 (5,527) 

(10,491) 
 102  

(10,389) 

 (5,294)

(3,861)
1,579

(36)
1,288
872
(158)

 (5,452)

(7,823)
(800)

5,592
(1,017)
1,509
(2,539)

 (7,991)

651
(2,075)

(3,583)
1,436
12
(3,559)

December 31, 2022 

  $

 4,366   $

 (15,916)  $ 

 (11,550)

88 

 
 
 
 
 
 
 
     
     
 
 
 
 
 
 
 
 
 
 
 
 
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
   
 
   
 
   
 
 
 
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
   
 
   
 
   
 
 
 
   
 
 
 
 
 
 
 
 
 
   
 
 
 
 
17. 

LEASES 

We have operating leases for facilities used for manufacturing, research and development, sales and distribution, and office 
space, as well  as  leases  for manufacturing  and office  equipment, vehicles,  and  land. Our  leases have  remaining  terms 
ranging from less than one year to approximately 27 years. A number of our lease agreements contain options to renew at 
our discretion for periods of up to 15 years and options to terminate the leases within one year. The lease term used to 
calculate ROU assets and lease liabilities includes renewal and termination options that are deemed reasonably certain to 
be  exercised.  Lease  agreements  with  lease  and  non-lease  components  are  generally  accounted  for  as  a  single  lease 
component. We do not have any bargain purchase options in our leases. For leases with an initial term of one year or less, 
we do not record a ROU asset or lease liability on our consolidated balance sheet. Substantially all of the ROU assets and 
lease  liabilities  as  of  December 31, 2022  recorded  on  our  consolidated  balance  sheet  are  related  to  our  cardiovascular 
segment. 

From time to time, we enter into agreements to sublease a portion of our facilities to third parties. Such sublease income 
is not material. We also lease certain hardware consoles to customers and record rental revenue as a component of net 
sales. Rental revenue under such console leasing arrangements for the years ended December 31, 2022, 2021 and 2020 
was not significant. 

The following was included in our consolidated balance sheet as of December 31, 2022 and 2021 (in thousands): 

Assets 
ROU operating lease assets 

Liabilities 
Short-term operating lease liabilities
Long-term operating lease liabilities
Total operating lease liabilities 

2022 

2021 

65,262   $ 

 65,913

11,005   $ 
59,736  
70,741   $ 

 10,668
 61,526
 72,194

$

$

$

We recognize lease expense for operating leases on a straight-line basis over the term of the lease. Net lease cost for the 
years ended December 31, 2022, 2021 and 2020 was $13.8 million, $15.9 million, and $16.7 million, respectively. The 
components of lease costs for the years ended December 31, 2022, 2021 and 2020 were as follows, in thousands: 

Classification 

2022 

2021 

2020 

Lease Cost 
Operating lease cost (a) 

   Selling, general and administrative 

expenses 

Sublease (income) (b) 

   Selling, general and administrative 

Net lease cost 

expenses 

$

$

14,219

(409)
13,810

$

$

 16,013   $ 

16,735

 (75) 
 15,938   $ 

(15)
16,720

(a)  Includes expense related to short-term leases and variable payments, which were not significant. 
(b)  Does not include rental revenue from leases of hardware consoles to customers, which was not significant. 

Supplemental cash flow information for the years ended December 31, 2022, 2021 and 2020 was as follows, in thousands: 

Cash paid for amounts included in the measurement of 
lease liabilities 
Right-of-use assets obtained in exchange for lease 
obligations 

2022 
$  13,710

2021 

2020 

$  14,970   $   15,059

$  11,130

$  1,524   $   10,938

Generally, our lease agreements do not specify an implicit rate. Therefore, we estimate our incremental borrowing rate, 
which is defined as the interest rate we would pay to borrow on a collateralized basis, considering such factors as length 

89 

 
    
     
      
 
 
 
   
   
  
 
  
 
 
 
 
 
  
  
 
 
 
 
   
    
    
 
of lease term and the risks of the economic environment in which the leased asset operates. As of December 31, 2022, 
2021 and 2020, our lease agreements had the following remaining lease term and discount rates: 

Weighted average remaining lease term
Weighted average discount rate 

2022 

2021 
10.4 years 11.4 years  11.5 years
3.4% 

3.3% 

3.4%

2020 

As of December 31, 2022, maturities of operating lease liabilities were as follows, in thousands: 

Year ended December 31,  
2023 
2024 
2025 
2026 
2027 
Thereafter 
Total lease payments 
Less: Imputed interest 
Total 

$

    Amounts due under operating leases
 12,638
 11,554
 8,941
 7,523
 5,944
 37,983
 84,583
 (13,842)
 70,741

$

As of December 31, 2022, we had additional operating leases for office space that had not yet commenced. These leases 
will commence during 2023 and are not deemed material. 

Item 9.   

Changes in and Disagreements with Accountants on Accounting and Financial Disclosure. 

None. 

Item 9A.  

Controls and Procedures. 

EVALUATION OF DISCLOSURE CONTROLS AND PROCEDURES 

Under the supervision and with the participation of our management, including our principal executive officer and principal 
financial officer, we conducted an evaluation of the design and operation of our disclosure controls and procedures, as 
such term is defined under Rule 13a-15(e) promulgated under the Securities Exchange Act of 1934 ("Exchange Act"), as 
of December 31, 2022. Based on this evaluation, our principal executive officer and principal financial officer concluded 
that as of December 31, 2022, our disclosure controls and procedures were effective, at a reasonable assurance level, to 
ensure that information we are required to disclose in the reports we file or submit under the Exchange Act is (a) recorded, 
processed, summarized and reported, within the time periods specified in the SEC’s rules and forms and is (b) accumulated 
and  communicated  to  our  management,  including  our  principal  executive  officer  and  principal  financial  officer,  as 
appropriate to allow timely decisions regarding required disclosure. 

MANAGEMENT’S REPORT ON INTERNAL CONTROL OVER FINANCIAL REPORTING 

Our  management  is  responsible  for  establishing  and  maintaining  adequate  internal  control  over  financial  reporting  as 
defined in Rules 13a-15(f) and 15d-15(f) under the Securities Exchange Act of 1934, as amended. Our internal control 
over  financial  reporting  is  a  process  designed  to  provide  reasonable  assurance  regarding  the  reliability  of  financial 
reporting  and  the  preparation  of  financial  statements  for  external  purposes  in  accordance  with  accounting  principles 
generally accepted in the U.S. of America. 

Our management assessed the effectiveness of our internal control over financial reporting as of December 31, 2022. In 
making this assessment, our management used the criteria set forth by the Committee of Sponsoring Organizations of the 
Treadway Commission ("COSO") in Internal Control-Integrated Framework (2013). Based on the criteria discussed  

90 

 
    
   
    
 
 
 
 
 
above and our management’s assessment, our management concluded that, as of December 31, 2022, our internal control 
over financial reporting was effective. 

CHANGES IN INTERNAL CONTROL OVER FINANCIAL REPORTING 

During the quarter ended December 31, 2022, there were no changes in our internal control over financial reporting that 
materially affected, or are reasonably likely to materially affect, our internal control over financial reporting (as defined 
in Exchange Act Rules 13a-15(f) and 15d-15(f) under the Securities Exchange Act of 1934). 

Our  independent  registered  public  accountants  have  also  issued  an  audit  report  on  our  internal  control  over  financial 
reporting. Their report appears below. 

91 

 
 
 
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM 

To the stockholders and the Board of Directors of Merit Medical Systems, Inc. 

Opinion on Internal Control over Financial Reporting 

We  have  audited  the  internal  control  over  financial  reporting  of  Merit  Medical  Systems,  Inc.  and  subsidiaries  (the 
“Company”) as of December 31, 2022, based on criteria established in Internal Control — Integrated Framework (2013) 
issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO). In our opinion, the Company 
maintained, in all material respects, effective internal control over financial reporting as of December 31, 2022, based on 
criteria established in Internal Control — Integrated Framework (2013) issued by COSO. 

We  have  also  audited,  in  accordance  with  the  standards  of  the  Public  Company  Accounting  Oversight  Board  (United 
States) (PCAOB), the consolidated financial statements as of and for the year ended December 31, 2022, of the Company 
and our report dated February 24, 2023, expressed an unqualified opinion on those financial statements. 

Basis for Opinion 

The Company’s management is responsible for maintaining effective internal control over financial reporting and for its 
assessment of the effectiveness of internal control over financial reporting, included in the accompanying Management’s 
Report on Internal Control over Financial Reporting. Our responsibility is to express an opinion on the Company’s internal 
control over financial reporting based on our audit. We are a public accounting firm registered with the PCAOB and are 
required  to  be  independent  with  respect  to  the  Company  in  accordance  with  the  U.S.  federal  securities  laws  and  the 
applicable rules and regulations of the Securities and Exchange Commission and the PCAOB. 

We conducted our audit in accordance with the standards of the PCAOB. Those standards require that we plan and perform 
the audit to obtain reasonable assurance about whether effective internal control over financial reporting was maintained 
in  all  material  respects.  Our  audit  included  obtaining  an  understanding  of  internal  control  over  financial  reporting, 
assessing the risk that a material weakness exists, testing and evaluating the design and operating effectiveness of internal 
control based on the assessed risk, and performing such other procedures as we considered necessary in the circumstances. 
We believe that our audit provides a reasonable basis for our opinion. 

Definition and Limitations of Internal Control over Financial Reporting 

A company’s internal control over financial reporting is a process designed to provide reasonable assurance regarding the 
reliability  of  financial  reporting  and  the  preparation  of  financial  statements  for  external  purposes  in  accordance  with 
generally accepted accounting principles. A company’s internal control over financial reporting includes those policies 
and procedures that (1) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the 
transactions and dispositions of the assets of the company; (2) provide reasonable assurance that transactions are recorded 
as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, 
and that receipts and expenditures of the company are being made only in accordance with authorizations of management 
and  directors  of  the  company;  and  (3)  provide  reasonable  assurance  regarding  prevention  or  timely  detection  of 
unauthorized acquisition, use, or disposition of the company’s assets that could have a material effect on the financial 
statements. 

Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, 
projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate 
because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate. 

/s/ DELOITTE & TOUCHE LLP 
Salt Lake City, Utah 
February 24, 2023 

92 

 
 
 
Item 9B. 

  Other Information. 

None. 

Item 9C. 

Disclosure Regarding Foreign Jurisdictions that Prevent Inspections. 

Not applicable. 

Items 10, 11, 12, 13 and 14. 

PART III 

The information required by these items is incorporated by reference to our definitive proxy statement relating to our 2023 
Annual Meeting of Shareholders. We currently anticipate that our definitive proxy statement will be filed with the SEC 
not later than 120 days after December 31, 2022, pursuant to Regulation 14A of the Securities Exchange Act of 1934, as 
amended. 

Item 15. 

Exhibits and Financial Statement Schedules. 

(a)  Documents filed as part of this Report: 

PART IV 

(1)  Financial Statements. The following consolidated financial statements and the notes thereto, and the Reports of 
Independent Registered Public Accounting Firm are incorporated by reference as provided in Item 8 and Item 9A 
of this report: 

Report of Independent Registered Public Accounting Firm (PCAOB ID 34) — Internal Control 

Report of Independent Registered Public Accounting Firm — Financial Statements

Consolidated Balance Sheets as of December 31, 2022 and 2021

Consolidated Statements of Income (Loss) for the Years Ended December 31, 2022, 2021 and 2020 

Consolidated Statements of Comprehensive Income (Loss) for the Years Ended December 31, 2022, 2021 and 2020

Consolidated Statements of Stockholders’ Equity for the Years Ended December 31, 2022, 2021 and 2020

Consolidated Statements of Cash Flows for the Years Ended December 31, 2022, 2021 and 2020 

Notes to Consolidated Financial Statements 

(2)  Financial Statement Schedules. 

—  Schedule II - Valuation and qualifying accounts 

Years Ended December 31, 2022, 2021 and 2020 
(In thousands) 

Allowance for Credit Losses:  
2020 
2021 
2022 

Balance at 

Additions Charged to 

Balance at 
     Beginning of Year      Costs and Expenses (a)       Deduction (b)       End of Year
(5,313)
(6,767)
(8,423)

 910    $
 1,224    $
 202    $

(3,115)
(2,678)
(1,858)

(3,108)
(5,313)
(6,767)

$ 
$ 
$ 

$
$
$

$
$
$

(a)  We record a bad debt provision based upon historical bad debt experience, current economic conditions, expectations 
of future economic conditions, and management’s evaluation of our ability to collect individual outstanding balances. 

93 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
   
 
 
 
(b)  When an individual customer balance becomes impaired and is deemed uncollectible, a deduction is made against the 

allowance for uncollectible accounts. 

Years Ended December 31, 2022, 2021 and 2020 
(In thousands) 

Tax Valuation Allowance: 
2020 
2021 
2022 

Balance at 
Beginning of Year 

Additions Charged to 
Costs and Expenses (a) 

       Deduction         

Balance at 
End of Year 

   $ 
   $ 
   $ 

(4,644)
(10,213)
(10,786)

$
$
$

(5,569)
(573)
(2,741)

$
$
$

 —    $ 
 —    $ 
 —    $ 

(10,213)
(10,786)
(13,527)

(a)  We record a valuation allowance against a deferred tax asset when it is determined that it is more likely than not that 

the deferred tax asset will not be realized. 

(b)  Exhibits: 

The following exhibits required by Item 601 of Regulation S-K are filed herewith or have been filed previously with the 
SEC as indicated below: 

Exhibit 
No. 

2.1 

2.2 

3.1 

3.2 

4.1 

4.2 

Index to Exhibits 

Agreement  and  Plan  of  Merger,  dated  October 1,  2018,  by  and  among  Merit  Medical  Systems, Inc.,  CMI 
Transaction Co., Cianna Medical, Inc. and Fortis Advisors LLC, as the Securityholder’s Representative *

Asset Purchase Agreement, dated December 14, 2018, by and among Merit Medical Systems, Inc., Vascular 
Insights, LLC and VI Management, Inc.*

  Amended and Restated Articles of Incorporation dated May 31, 2018*

  Third Amended and Restated Bylaws dated May 31, 2018*

  Specimen Certificate of the Common Stock*

Description of the Registrant's Securities Registered Pursuant to Section 12 of the Securities Exchange Act of
1934 

10.1 

  Merit Medical Systems, Inc. 2006 Long Term Incentive Plan, dated*†

10.2 

  First Amendment to the Merit Medical Systems 2006 Long-Term Incentive Plan, dated May 31, 2007*†

10.3 

  Lease Agreement dated as of June 8, 1993 for office and manufacturing facility* 

10.4 

  Amended and Restated Deferred Compensation Plan, dated January 1, 2004*†

10.5 

  Merit Medical Systems, Inc. Amended and Restated Deferred Compensation Plan, effective January 1, 2008*†

10.6 

10.7 

Second Amendment to the Merit Medical Systems, Inc. 2006 Long-Term Incentive Plan made and adopted 
effective May 31, 2009*† 

Second Restatement of the Merit Medical Systems, Inc. 401(k) Profit Sharing Plan made and adopted effective 
May 31, 2009*† 

94 

 
 
 
 
 
 
 
 
 
 
       
      
 
 
     
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
10.8 

10.9 

10.10 

10.11 

10.12 

10.13 

10.14 

10.15 

10.16 

First Amendment to the Second Restatement of the Merit Medical Systems, Inc. 401(k) Profit Sharing Plan, 
effective September 19, 2010*† 

Second Amendment to the Second Restatement of the Merit Medical Systems, Inc. 401(k) Profit Sharing Plan,
dated November 29, 2010 *† 

Third Amendment to the Second Restatement of the Merit Medical Systems, Inc. 401(k) Profit Sharing Plan, 
effective October 1, 2010*† 

Fourth Amendment to the Second Restatement of the Merit Medical Systems, Inc. 401(k) Profit Sharing Plan, 
dated December 31, 2011*† 

Fifth Amendment to the Second Restatement of the Merit Medical Systems, Inc. 401(k) Profit Sharing Plan, 
dated December 28, 2012*† 

Sixth Amendment to the Second Restatement of the Merit Medical Systems, Inc. 401(k) Profit Sharing Plan, 
dated December 31, 2013.*† 

Seventh Amendment to the Second Restatement of the Merit Medical Systems, Inc. 401(k) Profit Sharing Plan, 
dated June 10, 2014*† 

Eighth Amendment to the Second Restatement of the Merit Medical Systems, Inc. 401(k) Profit Sharing Plan, 
dated December 29, 2014*† 

Second  Amended  and  Restated  Credit  Agreement  dated  as  of  July 6,  2016  by  and  among  Merit  Medical 
Systems, Inc., Wells Fargo Bank, National Association, Well Fargo Securities, LLC and the lenders named 
therein* 

10.17 

Form of  Employment  Agreement,  dated  May 26,  2016  between  the  Company  and  each  of  the  following
individuals: Joseph C. Wright, and Brian G. Lloyd*†

10.18 

  Employment Agreement, dated May 26, 2016 between the Company and Fred P. Lampropoulos*†

10.19 

Third  Amendment  to  the  Merit  Medical  Systems, Inc.  2006  Long-Term  Incentive  Plan  dated  February 13, 
2015*† 

10.20 

  Merit Medical Systems, Inc., Restatement of the 1996 Employee Stock Purchase Plan dated July 1, 2000*†

10.21 

10.22 

10.23 

10.24 

10.25 

First  Amendment  to  the  Merit  Medical  Systems, Inc.,  1996  Employee  Stock  Purchase  Plan  dated  April 1, 
2001*† 

Second Amendment to the Merit Medical Systems, Inc., 1996 Employee Stock Purchase Plan dated January 1, 
2006*† 

Third  Amendment  to  the  Merit  Medical  Systems, Inc.,  1996  Employee  Stock  Purchase  Plan  dated  April 7, 
2006*† 

Fourth  Amendment  to  the  Merit  Medical  Systems, Inc.,  1996  Employee  Stock  Purchase  Plan  dated 
February 13, 2015*† 

Fifth Amendment to the Merit Medical Systems, Inc., 1996 Employee Stock Purchase Plan dated April 15,
2021*† 

95 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
10.26 

First  Amendment  to  Employment  Agreement  made  and  entered  into  by  and  between  Merit  Medical
Systems, Inc. and Fred P. Lampropoulos as of the 11th day of December, 2017*† 

10.27 

  Form of First Amendment to Employment Agreement for each of Joseph C. Wright, and Brian G. Lloyd*†

10.28 

  First Amendment to Lease Agreement dated May 22, 2017 for office and manufacturing facility*

10.29 

  Merit Medical Systems, Inc. 2018 Long-Term Incentive Plan effective May 24, 2018*† 

10.30 

10.31 

10.32 

First Amendment to the Merit Medical Systems, Inc. 2018 Long-Term Incentive Plan effective December 14, 
2018*† 

Second Amendment to the Merit Medical Systems, Inc. 2018 Long-Term Incentive Plan effective April 15, 
2021*† 

Employment Agreement made and entered into by and between Merit Medical Systems, Inc. and Raul Parra as 
of the 1st day of August, 2018.*† 

10.33 

  Merit Medical Systems, Inc. 2019 Executive Bonus Plan, dated January 1, 2019*† 

10.34 

10.35 

10.36 

10.37 

10.38 

10.39 

10.40 

10.41 

Ninth Amendment to the Second Restatement of the Merit Medical Systems, Inc. 401(k) Profit Sharing Plan,
dated August 1, 2016*† 

Tenth Amendment to the Second Restatement of the Merit Medical Systems, Inc. 401(k) Profit Sharing Plan,
dated January 1, 2017*† 

Eleventh Amendment  to  the Second  Restatement of  the Merit Medical  Systems,  Inc.  401(k)  Profit Sharing
Plan, dated January 1, 2019*† 

Twelfth Amendment to the Second Restatement of the Merit Medical Systems, Inc. 401(k) Profit Sharing Plan,
dated June 1, 2018*† 

Third Amended and Restated Credit Agreement entered into by and among Merit Medical Systems, Inc., Wells 
Fargo Bank National Association and the lenders and subsidiary guarantors named therein, dated July 9, 2019*

Thirteenth Amendment to the Second Restatement of the Merit Medical Systems, Inc. 401(k) Profit Sharing
Plan, effective January 1, 2019*† 

Performance Stock Unit Award Agreement (Three Year Performance Period), dated February 26, 2020, by and
between Merit Medical Systems, Inc. and Fred Lampropoulos.*†

Form  of  Performance  Stock  Unit  Award  Agreement  (Three  Year  Performance  Period),  dated  February  26,
2020, by and between Merit Medical Systems, Inc. and each of the following individuals: Raul Parra, Joseph 
C. Wright, and Brian G. Lloyd. *† 

10.42 

  First Amendment to the Merit Medical Systems, Inc. 2019 Executive Bonus Plan, effective June 22, 2020 *†

10.43 

Settlement Agreement, dated October 13, 2020, by and among the United States of America, acting through
the United States Department of Justice and on behalf of the Office of Inspector General (“OIG-HHS”) of the 
Department  of  Health  and  Human  Services  (“HHS”),  and  the  Defense  Health  Agency  (“DHA”),  acting  on
behalf of the TRICARE Program (collectively, the “United States”); the Company; and Charles J. Wolf, M.D.
(“Relator”), through their authorized representatives.*

96 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
10.44 

  Corporate Integrity Agreement, dated October 13, 2020, by and between the OIG-HHS and the Company.*

10.45 

10.46 

Form of Indemnification Agreement, dated October 24, 2020, between the Company and each of the following 
individuals: A. Scott Anderson, F. Ann Millner, Ed. D., Lynne N. Ward, and Thomas J. Gunderson *†

Form of Indemnification Agreement, dated October 24, 2020, between the Company and each of the following
individuals: Lonny J. Carpenter, David K. Floyd, and James T. Hogan *†

10.47 

  Form of Indemnification Agreement between the Company and each executive officer. *†   

10.48 

  Indemnification Agreement, dated as of June 17, 2021, between the Company and Stephen C. Evans.*†

10.49 

Form of Indemnification Agreement, dated as of May 19, 2022, between the Company and each of Laura Kaiser
and Michael McDonnell.*† 

10.50 

  Employment Agreement between the Company and Michel J. Voigt, dated December 11, 2020*†

10.51 

  Employment Agreement between the Company and Neil Peterson, dated May 19, 2022† 

10.52 

10.53 

10.54 

10.55 

10.56 

10.57 

10.58 

10.59 

10.60 

Performance Stock Unit Award Agreement (Two Year Performance Period), dated March 19, 2021, by and
between Merit Medical Systems, Inc. and Fred Lampropoulos.*†

Performance Stock Unit Award Agreement (Three Year Performance Period), dated March 19, 2021, by and
between Merit Medical Systems, Inc. and Fred Lampropoulos.*†

Form of Performance Stock Unit Award Agreement (Two Year Performance Period), dated March 19, 2021,
by and between Merit Medical Systems, Inc. and each of the following individuals: Raul Parra, Brian G. Lloyd, 
Michel J. Voigt, and Joseph C. Wright.*†

Form of Performance Stock Unit Award Agreement (Three Year Performance Period), dated March 19, 2021,
by and between Merit Medical Systems, Inc. and each of the following individuals: Raul Parra,  Brian G. Lloyd, 
Michel J. Voigt, and Joseph C. Wright.*†

Performance Stock Unit Award Agreement (Three Year Performance Period), dated February 26, 2022, by and 
between Merit Medical Systems, Inc. and Fred Lampropoulos.*†

Performance Stock Unit Award Agreement (Three Year Performance Period), dated February 26, 2022, by and
between Merit Medical Systems, Inc. and Raul Parra.*†

Form  of  Performance  Stock  Unit  Award  Agreement  (Three  Year  Performance  Period),  dated  February  26,
2022,  by  and between Merit  Medical  Systems, Inc.  and each of  the following  individuals:  Brian G. Lloyd, 
Michel J. Voigt, and Joseph C. Wright.*† 

Performance Stock Unit Award Agreement (Three Year Performance Period), dated May 19, 2022, by and
between Merit Medical Systems, Inc. and Neil Peterson.*† 

Form of Restricted Stock Unit Award Agreement, dated May 24, 2022, by and between Merit Medical Systems,
Inc. and each of the following individuals: A. Scott Anderson, Lonny J. Carpenter, Stephen C. Evans, David 
K. Floyd, James T. Hogan, Thomas J. Gunderson, Laura s. Kaiser, Michael R. McDonnell, F. Ann Millner, and
Lynne N. Ward.† 

10.61 

Second Amendment to Lease Agreement dated March 10, 2022 for office and manufacturing facility. 

97 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
10.62 

  Deferred Compensation Plan for Non-Employee Directors.*†

21 

  Subsidiaries of Merit Medical Systems, Inc.

23.1 

  Consent of Independent Registered Public Accounting Firm

31.1 

  Certification of Chief Executive Officer

31.2 

  Certification of Chief Financial Officer

32.1 

  Certification of Chief Executive Officer

32.2 

  Certification of Chief Financial Officer

101 

The following materials from the Merit Medical Systems, Inc. Annual Report on Form 10-K for the fiscal year 
ended  December 31,  2022,  formatted  in  iXBRL  (Inline  eXtensible  Business  Reporting  Language):  (i)
Consolidated Statements of Income (Loss), (ii) Consolidated Statements of Comprehensive Income (Loss), (iii)
Consolidated  Balance  Sheets,  (iv)  Consolidated  Statements  of  Cash  Flows,  (v)  Consolidated  Statements  of
Equity, and (vi) Notes to Consolidated Financial Statements

104 

  Cover Page Interactive Data File (the cover page XBRL tags are embedded within the Inline XBRL document).

*  These exhibits are incorporated herein by reference. 

† 

Indicates management contract or compensatory plan or arrangement. 

(c)  Schedules: 

None 

Item 16.  

Form 10-K Summary. 

None. 

98 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the Registrant has duly caused 
this Annual Report on Form 10-K to be signed on its behalf by the undersigned, thereunto duly authorized, on February 
24, 2023. 

SIGNATURES 

    MERIT MEDICAL SYSTEMS, INC. 

By:

/s/ FRED P. LAMPROPOULOS 
Fred P. Lampropoulos, President and 
Chief Executive Officer

99 

 
 
 
 
 
 
 
 
ADDITIONAL SIGNATURES 

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, this Annual Report on form 10-K has 
been signed below by the following persons in the capacities indicated on February 24, 2023. 

Signature 

Capacity in Which Signed 

/s/: FRED P. LAMPROPOULOS 
Fred P. Lampropoulos 

President, Chief Executive Officer and Director
(Principal executive officer)

/s/: RAUL PARRA 
Raul Parra 

/s/: A. SCOTT ANDERSON 
A. Scott Anderson 

/s/: LONNY J. CARPENTER 
Lonny J. Carpenter 

/s/: STEPHEN C. EVANS 
Stephen C. Evans 

/s/: DAVID K. FLOYD 
David K. Floyd 

/s/: THOMAS J. GUNDERSON 
Thomas J. Gunderson 

/s/: JAMES T. HOGAN 
James T. Hogan 

/s/: LAURA S. KAISER 
Laura S. Kaiser 

/s/: MICHAEL R. MCDONNELL 
Michael R. McDonnell 

/s/: F. ANN MILLNER 
F. Ann Millner 

/s/: LYNNE N. WARD 
Lynne N. Ward 

Chief Financial Officer and Treasurer 
(Principal financial and accounting officer) 

Director

Director

Director

Director

Director

Director

Director

Director

Director

Director

100 

    
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
A MESSAGE FROM THE CHAIRMAN & CEO

COR P OR ATE INFOR M ATION

EXECUTIVE OFFICERS

FORM 10-K

DEAR SHAREHOLDERS,

In 2022, Merit completed the second year of a three-

patient in the Streamlined Localization (STREAMLoc)

year Foundations for Growth (FFG) program. The FFG

registry study that assessed clinical utility of using the

program has helped us strengthen the foundational

SCOUT® Radar Localization System at biopsy.

capabilities of our business. This includes expanding

our ability to scale, improving profitability, delivering

top-line growth, and innovating in the marketplace.

We remain focused on creating a more sustainable

future. Merit was named one of “America’s Most

Responsible Companies” by Newsweek. In addition,

Despite the macroeconomic headwinds facing our

during 2022 our facilities in Salt Lake City, Galway,

industry, we delivered record-setting revenue, and

Paris, Richmond, and Venlo received one or more new

experienced operating margin and free cash flow

ISO certifications for safety, environment, and/or energy.

levels that yielded shareholder returns at the upper

end of the medical device industry.

The foundation for our success stems from

innovation. We launched multiple products,

At Merit, taking care of our people and the

community is a core value. This year, we launched our

first-ever global employee engagement survey and

put into place more than 500 specific action plans

including the PreludeSYNC EZ™ Radial Compression

based on employee feedback. We continued to make

Device, TEMNO Elite® Biopsy System, Prelude

additional investments in employee development,

Roadster ® Guide Sheath, SafeGuard Focus Cool™

compensation, and benefits. Through partnering with

Compression Device, Resolve® Thoracostomy Tray,

several non-profit organizations, we also donated

and the smallest and shortest configuration of the

lifesaving medical devices to those in need through

Elation® Pulmonary Balloon Dilator.

missions across the globe.

In addition, we were granted FDA clearance for the

We believe the continued execution of FFG initiatives

SCOUT Bx™ Delivery System, and we received FDA

will further position Merit for long-term success and

“Breakthrough Device Designation” for Embosphere®

perpetuate its mission to be the most customer-

Microspheres for use in genicular artery embolization

focused company in healthcare. We also believe this

for symptomatic knee osteoarthritis.

focus will, in turn, enable us to continue to deliver

increased shareholder value well into the future.

Our innovation continued with several patient

studies. The WRAPSODY™ Registry (WRAP) Study

Sincerely,

is being conducted to evaluate the clinical benefits

associated with the WRAPSODY Cell-Impermeable

Endoprosthesis in hemodialysis patients with vessel

stenosis or occlusion. We enrolled the first patient in a

multicenter observational study to evaluate the use of

EmboCube® Embolization Gelatin to control bleeding

or hemorrhage. In Canada, we enrolled the first

FRED P. LAMPROPOULOS | CHAIRMAN & CEO

Merit Medical Systems, Inc. filed an Annual Report on Form 10-K with the U.S. Securities and
Exchange Commission for the fiscal year ended December 31, 2022. A copy may be obtained
by written request from Brian G. Lloyd, Corporate Secretary, at Merit’s corporate office in
South Jordan, Utah.

ANNUAL MEETING

All shareholders are invited to attend Merit’s Annual Meeting of Shareholders to be held
virtually via live webcast on Thursday, May 18, 2023, at 2:00 p.m. Mountain Time.

STOCK TRANSFER AGENT/REGISTRAR

Zions Bank, a division of ZB, N.A.
P. O. Box 30880
Salt Lake City, Utah 84130

MARKET INFORMATION

Merit’s common stock is traded on the NASDAQ Global Select Market System under the
symbol “MMSI.” As of February 22, 2023, the number of shares of common stock outstanding
was 57,318,032, held by approximately 96 shareholders of record, not including shareholders
whose shares are held in securities position listings.

PR/MEDIA INQUIRIES:

Teresa Johnson
Merit Medical Systems, Inc.
(801) 208-4295

INVESTOR INQUIRIES:

Mike Piccinino, CFA, IRC
Westwicke - ICR
(443) 213-0509

FOR MORE INFORMATION, CONTACT

Brian G. Lloyd
Corporate Secretary
Merit Medical Systems, Inc.
(801) 253-1600

CORPORATE OFFICES
Merit Medical Systems, Inc.
1600 West Merit Parkway
South Jordan, Utah 84095
(801) 253-1600

INDEPENDENT ACCOUNTANTS
Deloitte & Touche LLP

LEGAL COUNSEL

Parr Brown Gee & Loveless
Corporate and Securities Counsel

Dorsey & Whitney LLP
Intellectual Property Counsel

Paper | Supporting
responsible forestry

Fred P. Lampropoulos
Chairman, Chief Executive Officer

Raul Parra
Chief Financial Officer, Treasurer

Neil W. Peterson
Chief Operating Officer

Joseph C. Wright
Chief Commercial Officer

Brian G. Lloyd
Chief Legal Officer, Corporate Secretary

Michel J. Voigt
Chief Human Resources Officer

BOARD OF DIRECTORS

Fred P. Lampropoulos
Chairman and Chief Executive Officer
Merit Medical Systems, Inc.

A. Scott Anderson
President and Chief Executive Officer
Zions First National Bank

Lonny J. Carpenter
Former President, Global Quality
and Business Operations
Stryker Corporation

Stephen C. Evans
Founder, Chairman & CEO
Flag Bridge Global Solutions, LLC

David K. Floyd
Former Group President
Stryker Corporation

Thomas J. Gunderson
Director and Former Chair
Minneapolis Heart Institute Foundation

James T. Hogan
Former President of Latin America,
Medtronic plc (formerly Medtronic Inc.)

Laura S. Kaiser
President and Cheif Executive Officer,
SSM Health

Michael R. McDonnell
Chief Financial Officer
Biogen Inc.

F. Ann Millner, Ed. D.
Regents Professor and Professor
of Health Administrative Services
Weber State University

Lynne N. Ward
Former Executive Director of My529
(formerly Utah Educational Savings Plan)

MERIT MEDICAL SYSTEMS, INC.

1600 West Merit Parkway

+1 (801) 253–1600

www.merit.com

South Jordan, Utah 84095

20

22 ANNUAL REPORT

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