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Merit Medical Systems

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FY2017 Annual Report · Merit Medical Systems
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BUILDING  
THE NEXT GREAT  
HEALTHCARE COMPANY

2017 ANNUAL REPORT

A MESSAGE FROM THE CHAIRMAN & CEO

DEAR SHAREHOLDERS,

2017 was a very active year for our company. As I sat 
down and prepared my thoughts for this letter, I was 
amazed at the progress we made during the last year. 
We successfully completed the last year of our three-
year plan and presented two additional years, which 
forecast 8% core growth, gross margin improvement  
of 100-150 basis points, and profitability of 13-15%  
for 2018 and 2019.

In February 2017, we announced the acquisition of  
Argon Critical Care, as well as Catheter Connections.  
Both businesses have been integrated and are 
performing consistent with our expectations. In 
November 2017, we signed a purchase agreement 
with Becton, Dickinson and Company (BD) to acquire 
soft tissue biopsy assets, as well as certain drainage 
products, as part of a divestiture required by BD’s 
acquisition of C.R. Bard, Inc. We closed the transaction 
in February 2018 and are currently transitioning the 
business into our facilities over the next 6-12 months. 
During the year we also raised additional capital to 
provide resources for future growth and opportunity.

And finally, we celebrated our 30th year since the 
founding of our company, which was initially housed in 
some spare offices of another business.

As gratifying as it is to reflect upon our growth, job 
creation, development and assembly of products that 
enhance human lives, and the opportunity to provide 
for 5,000 employee families, while delivering value to 
our shareholders and stakeholders, most of my time is 
spent looking forward and planning both tactically and 
strategically for the future.  

To all who have had faith and offered support, and in 
many cases advice, I thank you and look forward to many 
more years of exciting growth.

Warmest regards,

FRED P. LAMPROPOULOS  |  CHAIRMAN & CEO

 
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, 2017 
or 

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

(State or other jurisdiction of incorporation or organization) 

(Commission File No.) 

(IRS Employer Identification No.) 

Utah 

0-18592 

87-0447695 

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: Common Stock, No Par Value, registered on the 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 and posted on its corporate web site, if any, every Interactive Data 
File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§ 229.405 of this chapter) during the preceding 12 months 
(or for such shorter period that the registrant was required to submit and post such files). Yes    No 

Indicate  by  check  mark  if  disclosure  of  delinquent  filers  pursuant  to  Item  405 of  Regulation  S-K  is  not  contained herein,  and  will  not  be 
contained, to the best of the registrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this 
Form 10-K or any amendment to this Form 10-K.    

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 
Filer   

Accelerated Filer 

Non-Accelerated Filer 
(Do not check if a smaller 
reporting company) 

Smaller Reporting 

Emerging Growth 

Company 

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 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, 2017, which is the last day of 
the  registrant’s  most  recently  completed  second  fiscal  quarter  (based  upon  the  closing  sale  price  of  the  registrant’s  common  stock  on  the 
NASDAQ National Market System on June 30, 2017), was approximately $1,843,214,217. Shares of common stock held by each officer and 
director of the registrant and by each person who may be deemed to be an affiliate have been excluded. 

As of February 23, 2018, the registrant had 50,266,889 shares of common stock outstanding. 

DOCUMENTS INCORPORATED BY REFERENCE 
Portions of the following document are incorporated by reference in Part III of this Report: the registrant’s definitive proxy statement relating 
to the Annual Meeting of Shareholders scheduled for May 24, 2018. 

 
 
 
 
  
  
  
  
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
PART I 
Item 1.  
Item 1A.  
Item 1B.  
Item 2.  
Item 3.  
Item 4.  
PART II 
Item 5.  

Item 6.  
Item 7.  

Item 7A.  
Item 8.  
Item 9.  
Item 9A.  
Item 9B.  
PART III 
Item 10.  
Item 11.  
Item 12.  

TABLE OF CONTENTS 

   Business . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 
   Risk Factors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 
   Unresolved Staff Comments .  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 
   Properties . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 
   Legal Proceedings .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 
   Mine Safety Disclosures  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 

. . . . . 
. . . . .  
. . . . .  
. . . . . 
. . . . . 
. . . . .  

   Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer 

Purchases of Equity Securities  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 
. . . . . . . . . . . . . 

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

. . . .  

   Quantitative and Qualitative Disclosures About Market Risk  . . . . . . . . . . . . . . . . . . . . . . . 
   Financial Statements and Supplementary Data   . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 
   Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 
   Controls and Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . 
   Other Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 

. . . . . 
.  

. .  
. 
. . 

   Directors, Executive Officers and Corporate Governance. . . . . . . . . . . . . . . . . . . . . . . . . . . 
   Executive Compensation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 
   Security Ownership of Certain Beneficial Owners and Management and Related 

. . . 
. . . . 
Stockholder Matters   . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 
. . . . . . . . . . . . .  
   Certain Relationships and Related Transactions and Director Independence . . . . . . . . . . . . 
. 
   Principal Accountant Fees and Services .  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 
. . . . . .    

Item 13.  
Item 14.  
PART IV  
   Exhibits and Financial Statement Schedules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 
Item 15.  
Item 16.  
   Form 10-K Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .   
SIGNATURES   . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 
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49 
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91 
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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. 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. 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. Prospective investors are cautioned not to unduly rely on any such forward-looking statements.  

Our  future  financial  condition  and  results  of  operations,  as  well  as  any  forward-looking  statements,  are  subject  to 

inherent risks and uncertainties, including the following:  

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risks relating to managing growth, particularly if accomplished through acquisitions, and the integration of acquired 
businesses;  

risks relating to protecting our intellectual property;  

claims by third parties that we infringe their intellectual property rights which could cause us to incur significant legal 
or licensing expenses and prevent us from selling our products;  

greater scrutiny and regulation by  governmental authorities, including risks relating to the subpoena  we received in 
October 2016 from the U.S. Department of Justice seeking information on our marketing and promotional practices;  

risks relating to physicians’ use of our products in unapproved circumstances;  

FDA regulatory clearance processes and any failure to obtain and maintain required regulatory clearances and approvals;  

disruption of our critical information systems or material breaches in the security of our systems;  

failure to comply with export control laws, customs laws, domestic procurement laws, sanctions laws and other laws 
governing our operations in the U.S. and other countries, which could subject us to civil or criminal penalties, other 
remedial measures and legal expenses; 

risks relating to significant adverse changes in, or our failure to comply, with governing regulations;  

restrictions and limitations in our debt agreements and instruments, which could affect our ability to operate our business 
and our liquidity;  

expending significant resources for research, development, testing and regulatory approval or clearance of our products 
under development and any failure to develop the products, any failure of the products to be effective or any failure to 
obtain approvals for commercial use;  

violations of laws targeting fraud and abuse in the healthcare industry: 

risks relating to healthcare reform legislation negatively affecting our financial results, business, operations or financial 
condition;  

1 

 
  
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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changes  in  the  regulatory  approval  process  and  requirements  in  foreign  countries,  which  could  force  us  to  incur 
additional expense or experience delays or uncertainties; 

loss of key personnel;  

product liability claims;  

failure to report adverse medical events to the FDA, which may subject us to sanctions that may materially harm our 
business; 

failure to maintain or establish sales capabilities on our own or through third parties, which may result in our inability 
to commercialize any of our products in countries where we lack direct sales and marketing capabilities;  

the addressable market for our product groups being smaller than our estimates; 

demands for price concessions resulting from consolidations in the healthcare industry, group purchasing organizations 
or public procurement policies;  

our inability to compete in markets, particularly if there is a significant change in relevant practices or technology;  

the effect of evolving U.S. and international laws and regulations regarding privacy and data protection; 

fluctuations in foreign currency exchange rates negatively impacting our financial results;  

termination or interruption of, or a failure to monitor, our supply relationships or increases in the price of our component 
parts, finished products, third-party services or raw materials, particularly petroleum-based products;  

our inability to accurately forecast customer demand for our products or manage our inventory; 

changes in international and national economic and industry conditions;  

inability to generate sufficient cash flow to fund our debt obligations, capital expenditures, and ongoing operations;  

risks relating to our revenues being derived from a few products and medical procedures;  

volatility of the market price of our common stock;  

risks relating to work stoppage, transportation interruptions, severe weather and natural disasters;  

fluctuations in our effective tax rate adversely affecting our business, financial condition or results of operation;  

limits on reimbursement imposed by governmental and other programs;  

failure to comply with applicable environmental laws and regulations; and  

other factors referenced in our press releases and in our reports filed with the Securities and Exchange Commission (the 
“SEC”).  

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, 
and we assume no obligation to update or disclose revisions to those estimates. 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. Additional 
factors that may have a direct bearing on our operating results are described under Item 1A “Risk Factors” beginning on page 
22. 

2 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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. 

The Company 

Merit Medical Systems, Inc. is a leading manufacturer and marketer of proprietary disposable 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  and  electronic  and  sensor-based 
technologies. 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 angiogram. Since that time, our sales and product lines have expanded substantially, both 
through internal research and development projects and through strategic acquisitions.  

Our business strategy focuses on four target areas as follows: 

• 

• 

• 

• 

enhancing 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  product 
groups; and 

maintaining a highly disciplined, customer-focused enterprise guided by strong core values to globally address unmet 
or underserved healthcare needs. 

We conduct our operations through a number of domestic and foreign subsidiaries. Our principal offices are located at 
1600 West Merit Parkway, South Jordan, Utah, 84095, and our telephone number is (801) 253-1600. See Item 2. “Properties.” 
We maintain an Internet website at www.merit.com. 

Products 

We design, develop, market, and manufacture, through our own operations and contract manufacturers, approximately 
190 innovative 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: diagnostic and interventional cardiology; interventional radiology; 
neurointerventional  radiology;  vascular,  general  and  thoracic  surgery;  electrophysiology;  cardiac  rhythm  management; 
interventional pulmonology; interventional nephrology; orthopaedic spine surgery; interventional oncology; pain management; 
outpatient access centers; intensive care; computed tomography; ultrasound; and interventional gastroenterology. During the year 
ended December 31, 2017, net sales generated by our top ten selling products accounted for approximately 37% of our total net 
sales. Sales of our inflation devices (including our Big60® device sold within our endoscopy segment and kits and packs which 
include inflation devices, but also include other products) accounted for approximately 11.4%, 12.7% and 14.0% of our net sales 
for the years ended December 31, 2017, 2016 and 2015, respectively.  

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

3 

 
 
 
  
 
 
 
 
 
 
 
 
 
 
      
 
 
We  offer  products  focused  in  five  core  product  groups:  peripheral  intervention,  cardiac  intervention,  interventional 
oncology and spine, cardiovascular and critical care, and endoscopy. A number of our products are marketed within multiple 
product groups; accordingly, we do not maintain separate measures of profitability by product group. Based on industry data and 
our internal market information, we estimate that the addressable market opportunities (in terms of annual net sales), that we are 
targeting with our current or newly released product portfolios, for each of our core product groups are as follows: 

• 

Peripheral Intervention: $2.3 billion (global) 

•  Cardiac Intervention: $1.8 billion (global)  

•  Cardiovascular and Critical Care: $3.4 billion (global) 

• 

Interventional Oncology and Spine: $1.4 billion (global)  

•  Endoscopy: $496 million (U.S. domestic) 

However,  we  operate  in  a  competitive  environment  with  many  companies  seeking  to  address  the  same  market 
opportunities. Additionally, these opportunities may evolve significantly as a result of changes in customer preferences or the 
macroeconomic and regulatory environments in which we operate. For these and other reasons, we cannot guarantee the degree 
to which we will be able to realize increased net sales as a result of these, or any other, opportunities.  

We  currently  conduct  our  business  through  two  financial  reporting  segments:  cardiovascular  (which  includes  our 
peripheral  intervention,  cardiac  intervention,  interventional  oncology  and  spine  and  cardiovascular  and  critical  care  product 
groups) and endoscopy. For information relating to our business segments, see Note 12 to our consolidated financial statements 
set forth in Item 8 of this report. 

Peripheral Intervention 

We  strive  to  provide  our  customers,  the  healthcare  providers,  with  superior  products  designed  to  alleviate  patient 
suffering from peripheral vascular and non-vascular diseases. These technologies support the minimally invasive diagnosis and 
treatment  of  diseases  in  peripheral  vessels  and  organs  throughout  the  body  excluding  the  heart.  Our  peripheral  intervention 
product line is organized into product portfolios as follows: Access, Angiography, Intervention and Drainage & Biopsy products. 

Peripheral Access Portfolio 

We offer a broad line of devices used to gain and maintain vascular access. These products include access systems such 
as the micropuncture family kits consisting of the MAK™ (mini access kit), the S-MAK™ (stiff MAK) and the PAK™ (pedal 
access kit). Additionally, our extensive line of Prelude® sheath introducers and related products provide clinicians with smooth, 
convenient, and less traumatic access to the patient's vasculature. The Prelude® Short Sheath provides vascular access to dialysis 
grafts, along with our extensive line of micro access devices as previously described. We also offer a wide range of guide wires, 
diagnostic catheters, therapeutic infusion systems and safety products that can be used during dialysis-related procedures. 

We  have  continued  our  strategic  partnership  with  Bluegrass  Vascular  Technologies,  and  have  continued  the  global 
distribution rights with respect to the Surfacer® Inside-Out® Access Catheter System. The Surfacer system, which received CE 
mark approval, is an innovative Inside-Out approach to restore access to the right internal jugular vein and to preserve treatment 
options  in  hemodialysis  patients  with  occluded  veins.  Additionally,  we  believe  the  Surfacer  system  aligns  with  our  existing 
peripheral access portfolio.  

In 2017, we continued our focus on the HeRO® (Hemodialysis Reliable Outflow) Graft, a fully subcutaneous vascular 
access system, intended for use in  maintaining long-term  vascular access for chronic hemodialysis patients  who have failing 
fistulas, grafts or are catheter dependent due to a central venous blockage. The Super HeRO® Adapter and its accompanying 
HeRO  Ally™  Revision Kit are the newest addition to our growing HeRO  family of dialysis devices.  This technology offers 
surgeons  the  safety  and  efficiency  of  the  original  HeRO  graft,  but  with  more  graft  options  to  choose  from,  including  early 
cannulation grafts, which can eliminate the need for a bridging catheter. 

The CentrosFLO® Long-Term Hemodialysis Catheters anchor our chronic dialysis line. With its self-centering distal 
tip  design,  the  CentrosFLO  is  designed  to  maintain  long-term  patency,  as  shown  by  retrospective  and  prospective  studies 
published in 2016. We also offer the ProGuide® Chronic Dialysis Catheter, a “workhorse” catheter for chronic dialysis. 

4 

 
 
 
 
 
 
 
 
 
 
 
 
We  offer  peritoneal  dialysis  catheters,  accessories  and  implantation  kits  as  part  of  our  dialysis  access  product  line, 
including  the  Flex-Neck®  and  ExxTended™  Peritoneal  Dialysis  Catheters.  Additionally,  we  have  expanded  our  peritoneal 
dialysis portfolio to include an implantation system for an over-the-wire catheter placement technique familiar to interventionists. 

Peripheral Angiography Portfolio 

The diagnosis and treatment of peripheral arterial disease ("PAD") is paramount to ensuring appropriate patient care 
and helping patients achieve an enduring productive lifestyle. We offer an extensive portfolio of diagnostic and interventional 
products for the diagnosis and treatment of PAD and work closely with the physicians to develop new products to aid in the 
treatment of this disease.  

We market a portfolio of hydrophilic and diagnostic guide wires for use in angiographic and interventional procedures 
in both the radiology and cardiology arena. Diagnostic guide wires are used to traverse the vascular anatomy and aid in placing 
catheters and other therapeutic devices to their target location. The Merit Laureate® Hydrophilic Guide Wire has a consistent, 
lubricious coating intended to promote advancement through the vasculature, provide support for crossing difficult lesions, and 
facilitate smooth catheter exchanges by minimizing friction. Our pre-coated InQwire® Diagnostic Guide Wires are lubricious 
and available in a wide range of configurations designed to assist physicians when navigating the peripheral vasculature and 
placement of devices.  

In 2017, we added the high performance InQwire® Amplatz guide wires to our product line, providing our customers 
with  a  more  supportive  guide  wire  portfolio  that  aids  in  stability  within  the  vasculature  for  enhanced  navigation  and  device 
delivery through the most difficult anatomy. 

Catheters play an important role in the diagnosis of peripheral disease. They carry contrast  media  which allows the 
blood vessels and any anomalies to be visualized in the imaging process. Our Performa® and Impress® Diagnostic Catheter 
products are designed to provide solutions for traversing difficult peripheral vasculature during diagnostic procedures. These 
catheters work in tandem with our guide wires to aid in the diagnosis of peripheral artery disease and can be used to facilitate 
transradial access, a procedure which uses the wrist artery as the access entry point for peripheral procedures rather than the more 
traditional femoral artery approach. 

Peripheral Intervention Portfolio 

We market an extensive line of products designed to treat blood clots that obstruct the flow of blood in arteries and 
veins.  Our  therapeutic  thrombolytic  infusion  systems  include  the  Fountain®  Infusion  System  and  the  Mistique®  Infusion 
Catheter. These catheters are used to treat thrombus, or blood clots, in the peripheral vessels of the body, as well as native dialysis 
fistula and synthetic grafts. We offer standard and low-profile ASAP® Aspiration Catheters, which offer clinicians two options 
for the safe and efficient removal of fresh, soft emboli and thrombi from vessels. 

For crossing tight, difficult lesions, we market our line of Merit SureCross® Support Catheters. Our SureCross catheters 
offer trackability, pushability and visibility utilized by physicians to cross partial and total chronic occlusions in the peripheral 
arteries. 

Our vascular retrieval devices are single-use products designed for foreign body manipulation and retrieval and can be 
used  to  retrieve  inferior  vena  cava  filters,  reposition  indwelling  venous  catheters,  strip  fibrin  sheath  formation,  and  assist  in 
recanalization of both arterial and venous chronic occlusions. We enhanced our EN Snare® Endovascular Snare System with a 
new robust delivery catheter and peel-away insertion tool, which simplifies the snare deployment process and increase reliability 
during use. 

For more than two decades, we have offered inflation devices designed to accurately measure pressures during balloon 
and  stent  deployment.  We  offer  the  basixTOUCH™  Inflation  Device  for  one-handed  preparation  and  priming  for  faster 
preparation time. Many procedures today require high pressures. For these procedures, we offer the basixTOUCH40™ Inflation 
Device.  Its  40  ATM  (standard  atmosphere)  pressure  capacity  allows  inflation  of  high  pressure  interventional  balloons. 
Additionally, the BasixCompak™ Inflation Device and the Blue Diamond™ Digital Inflation Device feature an angled gauge 
for better viewing. 

We  expanded  our  Advocate™  Peripheral  Angioplasty  Balloon  product  line  in  2017  with  the  launch  of  our  0.035” 
platform.  The  Advocate™  Peripheral  Angioplasty  Balloon  products  are  intended  for  balloon  dilation  or  percutaneous 
transluminal angioplasty of the iliac, femoral, popliteal, infra-popliteal and renal arteries.  

5 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Peripheral Drainage & Biopsy Portfolio 

We have a broad line of drainage access products. Our One-Step™ Drainage Catheter, Safety Paracentesis Procedure 
Tray and Thoracentesis and Paracentesis Set are designed to provide clinicians with safe, convenient and cost-effective methods 
for removing unwanted fluid accumulation. Our Valved One-Step™ Centesis Catheters are designed  with an integrated self-
sealing  valve  to  minimize  the  risk  of  air  entering  the  pleural  space  and  to  prevent  fluid  leakage  during  thoracentesis  and 
paracentesis procedures. 

The  ReSolve® Locking Drainage  Catheter offers a convenient locking  mechanism  that  we believe enhances patient 
comfort. A range of catheter fixation devices are also available including the StayFIX® Fixation Device and the Revolution™ 
Catheter Securement Device, which were designed to save time, enhance patient comfort and improve cost-effectiveness. We 
provide a wide selection of accessories that complement our drainage catheters, including tubing sets and drainage bags. For 
non-vascular applications, the mini access kit (MAK-NV™) is designed for easy visualization and quick access into the drainage 
area. For enhanced visibility, the kit features an echo-enhanced needle and radiopaque marker tip on the introducer. 

In  January  2017,  we  launched  the  CorVocet™  Biopsy  System  for  soft  tissue  biopsy  procedures.  This  exciting  new 
product is designed to cut a full-core  of tissue, providing large specimens  for pathological examination. Its sleek lines, light 
weight,  and  ergonomic  grip  help  facilitate  one-handed  priming,  positioning,  and  deployment,  which  is  especially  beneficial 
during image-guided procedures. Additionally, the CorVocet is the first full-core biopsy needle with a customizable throw length 
for precision clinician control.  

In August 2017, we acquired proprietary bone and spine biopsy products from Laurane Medical S.A.S. ("Laurane"), 
headquartered in Sonchamp, France. We are selling these  biopsy products exclusively to the existing customer base until we 
have transferred all of the manufacturing processes to our Irish manufacturing facility. We anticipate a full launch of the Laurane 
bone and spine biopsy products in the second quarter of 2018.  

Cardiac Intervention 

We manufacture and sell a variety of products designed to aid in the treatment of various cardiac conditions specific to 

interventional cardiology and electrophysiology including cardiac rhythm management and lead management. 

Two  key  program  drivers  in  cardiac  intervention  during  2017  were  the  Think  Radial™  Program  and  Think 

Interventional 
CRT™, which stands for cardiac resynchronization therapy. Think Radial is a global education program that provides clinicians 
with the training and tools to commence or further their practice of the transradial approach. The transradial approach uses  the 
artery in the wrist as the entry point for either cardiac catheterization or peripheral procedures, rather than the more traditional 
femoral  artery  in  the  groin.  In  2017,  we  hosted  several  Think  Radial  training  courses  at  our  facilities  for  interventional 
cardiologists and interventional radiologists from across the U.S., Europe and Canada. 

The Think Interventional CRT therapy training program showcases a new interventional approach to implanting left 
ventricle  leads.  This  approach  utilizes  new  products  and  offers  techniques  to  electrophysiologists  who  are  relatively  new  to 
telescoping support catheters, subclavian vein venoplasty, and using snares to provide guidewire support. In 2017, our Think 
Interventional CRT training programs globally assisted with the training and education of electrophysiologists from across the 
U.S., Europe and Canada. 

Our  cardiac  intervention  product  group  is  organized  under  product  portfolios  which  include:  Access,  Angiography, 

Hemostasis, Intervention, and Electrophysiology. 

Cardiac Access Portfolio 

We offer a broad line of devices used to gain and maintain vascular access for cardiology procedures, including needles, 
scalpels, arm boards and sheath introducers. Our line of Prelude® Sheath Introducers is designed to provide clinicians with quick 
and convenient access to the patient's vasculature. The PreludeEASE™ Hydrophilic Sheath Introducer is our anchor product for 
radial access, designed to provide access to the radial artery while minimizing the potential for spasm with a hydrophilic coating 
that extends to the tip of the sheath. 

To provide a more complete offering for radial access procedures, we offer the Rad Board® family of products. The 
Rad Board is designed to provide radiation protection to physicians, provide a larger work space for physicians and an area for 
patients to rest their arms during radial procedures. 

6 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
Cardiac Angiography Portfolio 

For angiography procedures, we market an array of diagnostic catheters including the Performa® line. We believe that 
these catheters offer physicians superior torque, high shaft strength for pushability and a large inner diameter for improved flow 
rates during a variety of angiographic procedures. Our MIV™ Radial Ventriculogram Pigtail Catheter addresses the difficulty in 
accessing the left ventricle from the radial artery, which occurs when using standard femoral approach catheters. 

Cardiac Hemostasis Portfolio 

Catheterization for diagnostic and interventional cardiology procedures generally takes one of two approaches, femoral 
or radial. We offer products to assist clinicians in obtaining and maintaining hemostasis following arterial catheterization by 
either approach. For hemostasis of the femoral artery, we offer the Safeguard® Pressure Assisted Device and for hemostasis of 
the radial artery, we now offer the PreludeSYNCTM hemostasis device, as well as our legacy Safeguard RadialTM device. These 
devices  compete  in  a  fast-growing  segment  within  the  interventional  cardiology  and  radial  compression  markets.  The 
PreludeSYNC was designed to address the market need for improved patient comfort and clinician use without compromising 
safety. To accomplish this, the device has a soft band with a secure hook and loop closure. To improve patient experience, the 
device comes packaged with creative, unique designs printed directly on the band, which is a first of its kind for our company. 
Additionally, we have recently provided the option to customize the bands for healthcare facilities. This can be with their logo 
or specific messaging, providing a personalized experience. 

We  have  developed  a  broad  line  of  clinically  acclaimed  hemostasis  valves,  MAP™  Merit  Angioplasty  Packs  and 
angioplasty accessories. Hemostasis valves connect to catheters and allow passage of additional guide wires, balloon catheters 
and other devices into the vasculature, while reducing the amount of blood loss during the procedures. Our hemostasis valve line 
includes the Honor®, PhD™, AccessPLUS™, Access-9™, DoublePlay™, MBA™ and the Passage®. 

Cardiac Intervention Portfolio 

For  more  than  two  decades,  we  have  offered  an  extensive  line  of  inflation  devices  designed  to  accurately  measure 
pressures  during  balloon  and  stent  deployment.  The  basixTOUCH™  Inflation  Syringe  reduces  preparation  time  through  its 
single-handed preparation and priming features. The Blue Diamond™ Digital Inflation Device features an angled gauge for better 
viewing. Additionally, our IntelliSystem® and Monarch® Inflation Devices, as well as the BasixCOMPAK™ Inflation Syringe, 
offer clinicians a wide range of features and prices. 

During  coronary  catheterization  procedures,  guiding  catheters  are  used  to  gain  access  to  the  heart.  Our  line  of 
Concierge® Guiding Catheters has an advanced braiding technology and proprietary polymer-blend shaft, which allow for an 
increased lumen size while maintaining exceptional support. 

Pericardiocentesis is a procedure through which fluid is aspirated from the pericardial sac (the sac enveloping the heart). 
Our  pericardiocentesis  kit  is  designed  as  an  organized,  ready-to-use,  convenient  tray  to  assist  the  clinician  in  draining  fluid 
quickly from the pericardial sac. 

For  angiography  and  angioplasty  procedures  we  offer  the  Ostial  PRO®  Stent  Positioning  System,  a  medical-grade 
disposable guide wire system designed to provide consistent and precise stent implantation in aorto-ostial lesions during coronary 
or peripheral interventional procedures. Additional angiographic accessories include the Flow Control Switch™, an integrated, 
one-handed, single-channel switch designed with clinician and patient safety in mind. 

Electrophysiology Portfolio 

We offer innovative solutions to address lead implantation and therapeutic delivery in the rapidly-expanding cardiac 

rhythm management and electrophysiology markets. 

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  with pacemakers and implantable cardioverter defibrillators. Our 
CRM  products  include  the  Classic  Sheath™,  Prelude  SNAP™,  and  Prelude  SNAP™  Hydrophilic  families  of  splittable 
hemostatic sheaths designed for the insertion of cardiac leads for pacemakers and implantable cardioverter defibrillators. We 
also offer the Worley™ Advanced LV Delivery System to aid in the insertion and implantation of left ventricular pacing leads, 
through the coronary sinus to the left lateral wall of the heart for heart failure patients. The Worley™ Advanced LV Delivery 
System has been shown to reduce lead implant failures, improve target lead location and reduce procedure times. 

7 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
Electrophysiology  is  the  study  of  diagnosing  and  treating  abnormal  electrical  activities  of  the  heart.  Common 
electrophysiology procedures include diagnostic electrophysiology studies and therapeutic ablation procedures designed to treat 
arrhythmias. We offer the HeartSpan® Transseptal Needle, which is designed with a larger ergonomic handle, unique unibody 
needle design and optimal needle sharpness; the HeartSpan® Transseptal Sheath, which features an improved hemostasis valve 
for  reduced  blood  loss  and  air  embolism,  smooth  sheath  to  dilator  transition  for  easier  transseptal  crossing,  and  reinforced 
stainless steel tubing for excellent torque response. In 2017 we updated this product line with new lengths and shapes to match 
market demands. Additionally, we launched a second generation HeartSpan® Steerable Sheath Introducer responding to user 
feedback with a variety of key features, most notably a neutral position indicator to help physicians with orientation.  

Cardiovascular and Critical Care  

Every year thousands of critical care patients experience Catheter Related Blood Stream Infections ("CRBSI"). CRBSI 
is one of the most frequent, costly, and mortal complications of central venous catheterization. In February 2017, we acquired 
the assets of Catheter Connections, Inc. to enhance our existing clinical safety product portfolio by providing a novel disinfectant 
cap,  the  DualCap®  Disinfection  and  Protection  System  to  minimize  the  potential  of  catheter  associated  infections.  To 
complement the acquisition of Catheter Connections, we also acquired critical care assets from Argon Medical Devices, Inc. 
("Argon") to create a broad business line of products and solutions for cardiac and critical care patients. Combined with a robust 
pipeline  of  product  development  projects,  we  believe  the  cardiovascular  and  critical  care  business  is  positioned  to  provide 
innovative solutions to meet the needs of critical care patients and clinicians for years to come.  

Infection Prevention & Safety  

Medical errors are cited as the third leading cause of death in the USA, with approximately 250,000 preventable deaths 
occurring  annually.  Color-coded  Medallion®  Syringes  along  with  the  Pen  and  Label  (PAL™)  Medication  Labeling  System 
comply with patient safety initiatives from the Joint Commission to reduce medication delivery errors. Contaminated fluids and 
needle stick injuries may spread infectious diseases to clinical workers and providers. Our ShortStop® Temporary Sharps Holders 
protect clinicians from accidental needlesticks while our family of BackStop® Disposable Basins meet the Occupational Safety 
& Health Administration (OSHA) guidelines for contaminated fluids and waste.  

The recent acquisition of the DualCap augments our foundation of safety products to further prevent contamination and 
infection of invasive vascular lines. Unlike other cleaning alternatives in the marketplace, the DualCap prevents alcohol from 
entering the blood stream of male luer connections while reducing the time required to disinfect needleless connectors.  

Hemodynamic Monitoring  

Blood  pressure  monitoring  assists  in  determining  proper  patient  treatment.  We  have  an  extensive  portfolio  of  fluid 
management and  monitoring  devices,  including the Meritrans® Disposable Pressure  Transducer and the TRAM®  Manifolds 
with Integral Transducers. The acquisition of certain critical care products from Argon expanded our patient monitoring portfolio 
by providing the Safedraw® Closed Arterial Blood Sampling Kits, thermodilution catheters, and DTXPlus® Disposable Pressure 
Transducers. The acquisition further bolstered our kits, packs, and procedure tray business by adding the Careflow® Central 
Venous Catheters, Arterial Catheters, and Introducer Sheaths. 

Interventional Oncology and Spine  

In June 2017, we received 513(f)(2) (de novo) classification from the U.S. Food and Drug Administration ("FDA") to 
expand indication for our Embosphere® Microspheres. The indication now includes prostatic artery embolization (“PAE”) for 
symptomatic benign prostatic hyperplasia. Embosphere is the first embolic agent to receive FDA clearance for prostatic artery 
embolization, providing a non-surgical treatment option for millions of men who suffer from benign prostatic hyperplasia. 

Benign prostatic hyperplasia is an enlarged prostatic gland and can cause lower urinary tract symptoms in men. The 
PAE procedure is performed through an incision in the patient’s upper thigh or wrist, and may use Embosphere Microspheres to 
occlude the prostatic arteries, reducing their blood supply and causing the prostate to shrink and improve symptoms. 

In July 2017, we acquired the assets of Osseon LLC ("Osseon"). The Osseon product line, Osseoflex®, compliments 
and rounds out our portfolio for the treatment of vertebral compression fractures ("VCF"). The Osseoflex products include access 
kits, steerable needles, steerable and straight balloons, bone cement, as well as cement mixing and delivery systems. Osseon’s 
steerable products fit well with our unique brand of directional devices that allow users to navigate and target specific spine 
anatomy.  

8 

 
 
 
 
 
 
 
 
 
 
     
 
 
 
 
Vertebral Compression Fractures Portfolio 

VCFs occur when a vertebra cracks, fractures or collapses due to osteoporosis or cancer. VCFs can be extremely painful 
and have debilitating effects on a patient’s quality of life. Using our StabiliT® System, physicians treat VCFs by inserting small 
instruments through the skin into the fractured vertebra. Bone cement is injected through a hollow needle into the fractured bone. 
Our  StabiliT®  System  is  a  comprehensive  treatment  system  and  includes  access  instruments,  osteotomes,  introducers,  bone 
cement and corresponding mixing and delivery systems. 

Ablation Portfolio 

We  offer  our  STAR™  Tumor  Ablation  System  to  cancer  patients  for  the  palliative  treatment  of  painful  metastatic 
tumors. Targeted radiofrequency ablation using the STAR System offers patients pain relief and improved quality of life in a 
minimally invasive treatment. This procedure requires an articulating radiofrequency, or RF, device to be placed through the skin 
into the vertebral body and inserted directly into the tumor to ablate the tumor. Thermocouples embedded in the RF device allow 
for constant monitoring of the temperature directly in the ablation zone, which is a key feature when performing ablations near 
vital  structures  like  the  spinal  cord.  The  STAR  system  includes  ablation  instruments,  introducers,  osteotomes  and  our 
MetaSTAR® RF Generator. 

Inflation Syringes 

Our digital inflation devices, the IntelliSystem®, Monarch and Blue Diamond™ are used in discography, a technique 

used to determine whether a disc is the source of pain in patients with back or neck pain. 

Oncology Portfolio 

In the United States,  we sell  QuadraSphere® Microspheres for the treatment of hypervascularized tumors, including 
hepatoma, and arteriovenous malformations. Malignant hepatoma, also known as hepatocellular carcinoma, is a common cancer 
and the third leading cause of cancer deaths worldwide. QuadraSphere Microspheres are precisely calibrated and designed to 
offer controlled, targeted embolization, treating hepatocellular carcinoma by reducing or stopping the blood flow to the tumors. 

In  Europe,  as  well  as  Brazil,  Russia,  and  in  many  other  markets,  excluding  the  U.S.,  we  offer  HepaSphere™ 

Microspheres for delivery of chemotherapy drugs in the treatment of primary and metastatic liver cancer. 

Embolotherapy Portfolio 

We  offer  Embosphere®  Microspheres  to  treat  hypervascularized  tumors,  including  symptomatic  uterine  fibroids, 
embolization  of  the  prostatic  arteries  for  the  treatment  of  symptomatic  benign  prostatic  hyperplasia,  and  arteriovenous 
malformations in the United States as well as Europe and other international markets. Additionally, in certain markets outside of 
the U.S., we offer Embosphere Microspheres for hemostatic embolization. 

We also offer polyvinyl alcohol particles, Bearing nsPVA®, globally for the treatment of hypervascularized tumors, 

including symptomatic uterine fibroids and vascular malformations. 

Delivery Systems Portfolio 

We  manufacture  a  variety  of  microcatheters  for  the  controlled  and  selective  infusion  of  diagnostic,  embolic,  or 
therapeutic agents into vessels. The SwiftNINJA® steerable microcatheter articulates up to 180 degrees in opposing directions. 
This  articulating  feature  allows  physicians  to  treat  diseases  that  in  the  past  would  have  been  too  difficult  to  access  due  to 
challenging patient anatomies. We continue to offer our Merit Maestro® Microcatheter, which has a swan neck design that allows 
physicians to "seat" the catheter in the vessel. The SwiftNINJA and Maestro can be used for the controlled and selective infusion 
of diagnostic, embolic, or therapeutic materials into vessels. They are compatible with many key configurations of Embosphere, 
Quadrasphere, HepaSphere, Bearing nsPVA, and other competitive embolic products. 

In 2017, we introduced the True Form™ Reshapable Guide Wire which was designed with the ability to be shaped and 
reshaped multiple times for vessel cannulation. True Form’s stainless steel core provides excellent support, its hydrophilic coating 
increases trackability through vessels, the flexible shaft easily navigates tortuous anatomy, and its shapeable tip retains shape 
during procedures. In August 2017, we began offering the Merit Maestro® Microcatheter and True Form Reshapable Guide Wire 
packaged together to make it more convenient for customers to order their microcatheters and guide wires. 

9 

 
 
 
 
 
 
 
 
     
 
 
 
 
 
 
 
 
 
Endoscopy 

Our  endoscopy  division,  Merit  Endotek,  integrates  advanced  non-vascular  stent  technology  with  balloon  dilators, 
inflation devices, guide wires, procedure kits, and other devices that are used by endoscopists in interventional gastroenterology, 
interventional pulmonology, and thoracic and general surgery. Merit Endotek has a dedicated marketing and sales organization 
serving these growing markets. 

Merit  Endotek  sells  a  variety  of  non-vascular  stents,  including  AERO®  and  AERO  DV®  Fully  Covered 
Tracheobronchial Stents. These covered, self-expanding nitinol stents are used by interventional pulmonologists and thoracic 
surgeons to treat strictures and fistulae in the airways, and to offer palliation to patients suffering from strictures caused by cancer. 
The AEROmini® fully covered bronchial stent was launched in 2015 and features a low-profile delivery system designed to 
provide additional flexibility, and aid in the accurate placement of stents in difficult airway anatomy. 

Merit Endotek's esophageal stents, the Alimaxx-ES™ and the EndoMAXX® fully covered esophageal stents, are used 
by interventional gastroenterologists, otolaryngologists and thoracic surgeons to palliate symptoms associated with malignant 
tumors and strictures affecting the esophagus, as well as to treat concomitant tracheoesophageal fistulae.  

Merit Endotek's biliary stent systems are marketed under the Alimaxx-B® brand name. Alimaxx-B stent systems are 

used by interventional gastroenterologists to palliate symptoms associated with malignant tumors affecting the bile duct.  

Merit Endotek's esophageal balloon dilator, the Elation® Fixed Wire Balloon Dilator, was introduced late in 2015, and 
is intended for use in adult and adolescent populations to endoscopically dilate strictures of the esophagus. In 2016, we added a 
wire-guided  balloon  dilator,  intended  for  use  in  the  alimentary  tract,  to  the  Elation  product  line,  and  in  2017,  the  Elation 
Pulmonary  Balloon  Dilator  was  introduced  to  the  market.  All  of  these  devices  can  be  paired  with  Merit  Endotek's  BIG60® 
inflation device. 

Merit Endotek's BIG60® Inflation Device is 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. Merit Endotek also offers Endotek-
labeled versions of the BasixCOMPAK™ and Monarch Inflation Device to customers in pulmonology, gastroenterology, and 
thoracic surgery. 

For non-vascular procedures, we  market  the MAXXWIRE® guide  wire, our line  of  specialty  guide  wires that have 

pulmonology and gastroenterology applications. 

For endoscopy and bronchoscopy procedures, we offer a variety of kits and accessories, including the AEROSIZER® 
tracheobronchial stent sizing device, the Brighton® Bipolar Probe, the BiliQUICK™ Cholangiography Rapid Refill Continuous 
Injection  Kit,  the  TIO™  Three-in-One  combination  oral  airway,  bite  block  and  oxygen  administration  device,  the  Vaclok® 
Negative Pressure Syringe, and the convenient BAL (bronchoalveolar lavage) Convenience Kit™. In 2017, Endotek introduced 
the TWISTER™ PLUS rotatable retrieval device for use in both gastroenterology and interventional pulmonology. 

Specialty Procedure Products 

We provide coating services for medical tubes and wires under original equipment manufacturer (“OEM”) brands. We 
offer  coated  tubes  and  wires  to  customers  on  a  spool  or  as  further  manufactured  components  like  hypotubes,  guide  wire 
components,  coated  mandrels/stylets  and  coated  needles.  We  operate  a  hypotube  manufacturing  facility  in  Galway,  Ireland, 
which  provides  advanced  laser  cutting  and  ablation,  passivation,  cleaning  and  other  hypotube  manufacturing  processes.  Our 
Merit HypotubeTM is used as the catheter shaft in percutaneous transluminal coronary angioplasty and percutaneous transluminal 
angioplasty balloon catheters, as well as functional guide wires. 

Customers  and  clinicians  often  have  unique  needs  when  performing  procedures.  We  have  a  long  history  of 
manufacturing and selling syringes, stopcocks, high pressure tubing, safety solutions, and many more products used across the 
clinical care continuum. We  work closely  with customers  to create standard and customized trays, packs, and kits  to enable 
clinicians to more effectively perform clinical procedures. In October 2017, we acquired ITL Healthcare Pty. Ltd. ("ITL"), a 
custom  procedure  pack  business  located  in  Melbourne,  Australia.  The  facility  we  acquired  from  ITL  includes  sterilization 
capabilities. 

Our  sensor  division  manufactures  and  sells  microelectromechanical  systems  sensor  components  consisting  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.  

10 

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

According to U.S. government statistics, cardiovascular disease continues to be a leading cause of death and a significant 
health problem in the United States. 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. 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  catheter 
technology and accessory products.  

In addition to products used in the treatment of coronary and peripheral vascular disease and in electrophysiology, we 
continue our efforts to develop and distribute other devices used in our target markets. For example, we have developed and are 
distributing products used for percutaneous drainage. Prior to the widespread use of computed tomography or ultrasound imaging, 
surgery  was  necessary  to  drain  internal  fluid  from  body  cavities  and  organs. Currently,  percutaneous  drainage  is  frequently 
prescribed as the treatment of choice for many types of fluid collections. Our family of drainage catheters and associated devices 
are used by physicians in interventional radiology, vascular surgery and cardiology catheter lab procedures. 

Marketing  Strategy. 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. We  work  closely  with  major  healthcare  facilities  and  key  opinion  leader  physicians 
involving our primary target markets in the areas of training, therapy awareness programs, clinical studies and ongoing research. 

We also offer products to service the dialysis access market. These products are used in renal replacement therapies, 
including the treatment of acute renal failure, chronic renal failure and end-stage renal disease. Our hemodialysis access products 
include  catheters  and  kits  for  interventional  radiologists  and  interventional  nephrologists.  Our  family  of  peritoneal  dialysis 
products is designed to support specific implantation techniques for interventional radiologists, interventional nephrologists and 
laparoscopic surgeons. We also offer a variety of products for dialysis access interventions for these customers. 

We  believe  the  development  of  Merit  Endotek  and  the  move  into  the  areas  of  interventional  gastroenterology, 
pulmonology and thoracic surgery will open new opportunities to sell our existing products, such as inflation devices, syringes, 
centesis  catheters  and  procedure  kits  to  those  markets,  but  will  also  provide  opportunities  to  market  additional  products 
incorporating our non-vascular stent, balloon dilator and guide wire technologies. 

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 frequently seek suggestions from health 
care professionals working in the fields of medicine in which we offer or are developing products. Suggestions for new products 
and product improvements  may also come from engineers, marketing, sales people, 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, integrate the design, compile necessary documentation and testing, and 
prepare the product for market introduction. We believe that one of our marketing strengths is our capacity to conceive, design, 
develop and introduce new products. 

U.S. and International Sales. Sales of our products in the U.S. accounted for approximately 58%, 61% and 61% of 
our net sales for the years ended December 31, 2017, 2016 and 2015, respectively. In the U.S., we have a dedicated, direct sales 

11 

 
 
 
 
 
 
 
 
 
 
 
organization  primarily  focused  on  selling  to  end-user  physicians,  hospitals  and  clinics,  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, Africa, the Middle East, Asia, 
South  and  Central  America,  Oceania,  and  Canada.  In  2017,  our  international  sales  grew  approximately  32%  over  our  2016 
international sales, and accounted for approximately 42% of our net sales. China represents our most significant international 
sales market with net sales of approximately $73.4 million, $59.9 million, and $50.7 million for the years ended December 31, 
2017, 2016 and 2015, respectively. With the recent and planned additions to our product lines, we believe our international sales 
will continue to increase.  

Our largest non-U.S. market is China, which represented approximately 10% of our net sales in 2017. We maintain a 
distribution center and administrative office in Beijing. We also have small sales offices in Shanghai, Guangzhou, and Hong 
Kong. We sell our products through more than 400 distributors in mainland China, who are responsible for reselling the products, 
primarily  to  hospitals.  We  employ  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. Under this “modified direct” sales approach, our 
salespeople are involved with promoting the advantages of our products to clinicians and other customers, while the distributors 
handle sales transactions and address issues related to fulfillment and inventory management. 

In Europe, the Middle East, and Africa, we have both corporate (i.e., direct) and modified corporate sales operations. 
Our corporate sales operations are active throughout Europe, including the largest markets of the UK, France, Germany, and 
Sweden.  

Our direct sales personnel are principally engaged in each of our product groups. Marketing teams responsible for each 
product group 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, and electrophysiology.  

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-bribery laws, such as the U.S. Foreign Corrupt Practices Act, as well as all applicable laws 
and regulations in their respective countries.  

In 2016, we began conversions from distributor-based sales models to direct sales models in Australia and Canada. We 
now supply hundreds of healthcare providers directly in Australia and Canada from Merit-operated distribution centers in those 
countries. In May 2017, we terminated our distribution agreement with Sheen Man Co., Ltd. and Sugan Co, Ltd., (collectively 
"Sugan"), a Japanese medical device distributor, and acquired the customer list Sugan used in the distribution of many of our 
products in Japan. In connection with our acquisition of the critical care division of Argon, we have implemented a modified 
direct sales approach (similar to the approach we are pursuing in China) to market and sell the majority of our products in Japan. 
Our goal with conversion is to obtain improved product pricing and more direct access to the end users of our products within 
these sales channels. 

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 third-party 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 clinic-based physicians, technicians and nurses. Hospitals and acute care facilities 
in  the  United  States  generally  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  United  States, 
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. 

12 

 
 
 
 
 
 
 
 
 
 
 
 
In 2017, our U.S. sales force made sales accounting for approximately 42% of our net sales directly to U.S. hospitals 
and sales accounting for approximately six percent of our net sales through other channels, such as U.S. custom procedure tray 
manufacturers and distributors. We also sell products to other  medical device  companies through our U.S. OEM  sales force, 
which accounted for approximately 10% of our 2017 net sales. The remaining 42% of our 2017 net sales was attributable to sales 
made to international markets by our direct sales force, international distributors, and our OEM sales force. Sales to our largest 
customer accounted for approximately two percent of net sales during the year ended December 31, 2017. 

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 2017, 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. 

Our research and development expenses were approximately $51.4 million, $45.2 million, and $40.8 million in 2017, 

2016, and 2015, respectively. 

We continue to develop new products and make improvements to our existing products utilizing many different sources. 
Our Chief Executive Officer and Executive Vice President of Global Research & Development, work closely with our sales and 
marketing teams to incorporate feedback from physicians and clinicians in the field, which can lead to innovative new products 
and improvements to our existing products. 

Currently we have research and development facilities in: 

Jackson Township, New Jersey 

•  Dallas, Texas 
•  Galway, Ireland 
• 
•  Malvern, Pennsylvania 
• 
• 
• 
• 
• 
•  Tijuana, Mexico  
•  Venlo, The Netherlands 
•  West Jordan, Utah  

Paris, France 
Pearland, Texas 
San Jose, California 
Singapore 
South Jordan, Utah 

Manufacturing 

We manufacture many of our products utilizing 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  utilize  our  experience  in  injection  and  insert  molding  technologies  in  the  manufacture  of  most  of  the  custom 
components used in our products. We have received International Standards Organization (“ISO”) 13485:2003 certification for 
our facilities in Utah, Texas, Virginia, Pennsylvania, The Netherlands, Ireland, France, Singapore and Mexico. We have also 
received ISO 9001:2008 certification for our coatings facility in Venlo, The Netherlands and our Merit Sensor Systems, Inc. 
(“Merit  Sensors”) facility in  South Jordan, Utah. Merit Sensors develops and  markets silicon pressure  sensors and presently 
supplies a substantial portion of the sensors we utilize 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 utilize  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  Chester,  Virginia;  Galway,  Ireland;  Joinville,  Brazil; 
Malvern, Pennsylvania; Melbourne, Australia; Paris, France; Pearland, Texas; Singapore; South Jordan and West Jordan, Utah; 
Tijuana, Mexico; and Venlo, The Netherlands. See Item 2. “Properties.” 

13 

 
 
 
 
 
 
 
 
 
 
 
 
We  have distribution centers  located in Auckland, New Zealand; Bangalore, India; Beijing and Hong Kong, China; 
Chester,  Virginia;  Joinville,  Brazil;  Maastricht,  The  Netherlands;  Malvern,  Pennsylvania;  Melbourne,  Australia;  Toronto, 
Canada; Podolsk, Russia; Seoul, South Korea; South Jordan, Utah; Tijuana, Mexico; and Tokyo, Japan.  

We believe that our variety of suppliers for raw materials and components necessary for the manufacture of our products, 
as well as our long-term relationships with such suppliers, promote stability in our manufacturing processes. Historically, we 
have  not  been  materially  affected  by  interruptions  with  such  suppliers;  however,  we  are  experiencing  a  growing  trend  from 
suppliers of polymer resins to refuse to supply resin to medical device manufacturers or require that we assume additional risks 
due to the potential for product liability claims. There can be no assurance that we will not experience supply disruptions in the 
future. We seek to develop and have relationships with potential back-up suppliers for materials and components in the event of 
supply interruptions. 

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  diagnostic  and  interventional  cardiology; 
interventional  radiology;  neurointerventional  radiology;  vascular,  general  and  thoracic  surgery;  electrophysiology;  cardiac 
rhythm  management;  interventional  pulmonology;  interventional  nephrology;  orthopaedic  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, value, device features, 
customer  service,  breadth  of  line,  and  customer  relationships.  We  believe  our  products  have  achieved  market  acceptance 
primarily  due  to  the  quality  of  materials  and  workmanship  of  our  products,  clinical  outcomes,  their  innovative  design,  our 
willingness to customize our products to fit customer needs, and our prompt attention to customer requests. Our products are 
priced competitively, but generally not below prices for competing products. Some of our primary competitive strengths are our 
relative stability in the marketplace; a comprehensive, broad line of ancillary products; and our history of introducing a variety 
of new products and product line extensions to the market on a regular basis. 

In the interventional cardiology and the radiology markets as well as the gastroenterology, endoscopy, general surgery, 
thoracic  surgery  and  pulmonology  markets,  we  compete  with  large  international,  multi-divisional  medical  supply  companies 
such as Cordis Corporation (Cardinal Health); Boston Scientific Corporation; Medtronic; Abbott; Teleflex; Becton, Dickinson 
and Company (including the operations previously conducted by C.R. Bard) ("BD"); Cook Incorporated; Stryker Corporation 
("Stryker"); 3M; ICU Medical and Terumo Corporation. Medium-size companies we compete with include B. Braun; Uresil; 
BTG; Olympus Medical; Edwards Lifesciences; Argon; CONMED; AngioDynamics; Medcomp and U.S. Endoscopy. 

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 United States 
for analog inflation devices. We believe we are a market leader in the United States for control syringes, waste-disposal systems, 
tubing  and  manifolds.  We  anticipate  the  recent  and  planned  additions  to  our  product  lines  will  help  us  compete  even  more 
effectively  in  both  the  U.S.  and  international  markets. There  is  no  assurance  that  we  will  be  able  to  maintain  our  existing 
competitive advantages or compete successfully in the future. 

We derive a substantial majority of our revenues from sales of products used in diagnostic angiography, interventional 
cardiology  and  radiology  procedures. We  believe  medical  professionals  are  starting  to  use  new  interventional  methods, 
procedures  and  devices,  as  well  as  drugs,  for  the  treatment  and  prevention  of  cardiovascular  disease. These  new  methods, 
procedures, devices and drugs may render some of our products obsolete or limit the markets for our products. However, with 
the advent of vascular stents and other procedures, we have experienced continued growth in sales of our products. 

In the vertebral augmentation market, our main competitors are Medtronic and Stryker. Both Medtronic and Stryker 
offer products to treat vertebral compression fractures (including the CareFusion products Stryker acquired from BD, but only 
Medtronic offers products to treat metastatic spine tumors. 

Within the field of uterine fibroid embolization ("UFE") and PAE, we believe we are a market share leader. Based on 
both research and clinical studies conducted on our product for UFE and PAE, we believe we offer physicians consistent and 
predictable product performance, ease of use, targeted delivery, and durable vessel occlusion, and therefore satisfactory short- 
and long-term clinical outcomes validated by peer-reviewed publications, when compared to our competitors. 

14 

 
 
 
 
 
 
 
 
 
 
 
Our primary embolotherapy product has been Embosphere Microspheres. Currently, the primary products with which 
our microspheres and embolic particles compete are Beadblock® and DC Bead®, sold by BTG plc; Embozene™ and Contour® 
sold  by  Boston  Scientific,  Inc;  PVA  Foam  Embolization  Particles,  sold  by  Cook  Medical;  HydroPearl®,  sold  by  Terumo 
International Systems ("Terumo"); and Gelfoam®, sold by Pfizer Inc. Our principal competitors in UFE are BTG plc, Boston 
Scientific and Terumo, as well as companies selling or developing non-embolotherapy solutions to treat uterine fibroids. 

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 patents 
and  rights  to  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. As of December 31, 2017, we owned or had a license to more than 1,000 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 “Products” above. The duration 
of our trademark registrations varies from country to country; in the U.S. we generally can maintain our trademark rights and 
renew any trademark registrations for as long as the trademarks are in use. As of December 31, 2017, we owned over 300 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. 

Regulation 

U.S. Regulation. The Food and Drug Administration (“FDA”) and other federal, state and local authorities regulate our 
products  and  product-related  activities.  Under  the  Federal  Food,  Drug,  and  Cosmetic  Act  (“FDCA”)  and  accompanying 
regulations,  the  FDA  regulates  the  design,  development,  clinical  trials,  testing,  manufacture,  packaging,  labeling,  storage, 
distribution  and  promotion  of  medical  devices.  We  believe  our  products  and  procedures  are  in  material  compliance  with  all 
applicable FDA regulations, but the regulations are subject to change. We cannot predict the effect, if any, that these changes 
may have on our business. In addition, if we experience regulatory problems with a product or manufacturer, we could become 
subject to fines, delays or suspensions of regulatory clearances, seizures or recalls of products, operating restrictions, and criminal 
prosecution. Such actions could have a material adverse effect on our business, financial condition or results of operations. 

In October 2016, we received a subpoena from the U.S. Department of Justice seeking information on certain of our 
marketing and promotional practices. We are in the process of responding to the subpoena, which we anticipate will continue 
during 2018. The investigation is ongoing and at this time we are unable to predict its scope, duration or outcome. Investigations 
such as this may result in the imposition of, among other things, significant damages, injunctions, fines or civil or criminal claims 
or penalties against our company or individuals.  

Overview of the FDA Regulation of Devices. The FDCA establishes a risk-based classification system for medical 

devices and applies regulatory controls commensurate with the risk posed by a device: 

• 

Class I devices are those for which safety and effectiveness can be reasonably assured by adherence to the FDA’s general 
regulatory controls, which include compliance with the applicable portions of the FDA’s Quality System Regulations 
(QSRs),  facility  registration  and  product  listing,  reporting  of  certain  adverse  medical  events  and  malfunctions,  and 
compliance with the FDA’s restrictions against misbranding and adulteration. While most Class I devices are exempt 
from the 510(k) premarket notification process (assuming they are within the limitations of the exemption), some Class 
I devices also require 510(k) clearance by the FDA. 

15 

 
  
 
 
 
 
 
 
 
 
 
 
 
• 

• 

Class II devices are subject to the FDA’s general controls, including the design control requirements of the QSRs, and 
any other special controls deemed necessary by the FDA to provide reasonable assurance of the safety and effectiveness 
of  the  device.  While  most  Class  II  devices  require  premarket  review  and  clearance  by  the  FDA  through  the  510(k) 
premarket  notification  procedure,  some  Class  II  devices  are  exempt  from  the  510(k)  premarket  notification  process 
(assuming they are within the limitations of the exemption). 

Class  III  devices  are  those  deemed  by  the  FDA  to  pose  the  greatest  risk,  such  as  life-sustaining,  life-supporting  or 
implantable devices, or those devices deemed not substantially equivalent to a legally marketed predicate device. Class 
III  devices  include  those  devices  for  which  the  FDA  has  determined  that  general  and  special  controls  alone  are 
insufficient to assure the safety and effectiveness of the device. 

FDA Premarket Review. In general, we cannot introduce a new medical device into the market until we obtain market 
clearance through a 510(k) premarket notification or approval through a premarket approval (“PMA”) application. Some devices, 
typically lower-risk devices, are subject to specific exemptions from premarket review. In addition, in limited cases, devices may 
come to the market through alternative procedures, such as a de novo classification request or humanitarian device exemption. 

To obtain 510(k) clearance, a device manufacturer must submit a premarket notification to the FDA demonstrating that 
the device is substantially equivalent to another legally marketed predicate device. A predicate device is a device that has been 
cleared through the 510(k) process; a device that was legally marketed prior to May 28, 1976; a device that has been down-
classified by the FDA to Class I or Class II; or a device that the FDA has previously determined to be exempt from the 510(k) 
process. To be substantially equivalent, the notification must show that the new device has the same intended use and the same 
technology as the predicate device, or, if the new device has different technology, that the device is as safe and effective as the 
predicate device and does not raise different questions of safety and effectiveness. Performance testing is generally required to 
demonstrate substantial equivalence, and, for some devices, clinical data may be required. The standards and data requirements 
necessary for the clearance of a new device may be unclear or may be subject to change. In addition, the FDA may publish or 
adopt special controls it deems necessary to provide a reasonable assurance of the safety and effectiveness of a device, which 
might include standards for the testing and clearance of a new device. The 510(k) clearance procedure usually takes between 
three  months and one  year from the date  a 510(k)  notification is submitted, but it  may  take longer. The FDA  may  find  that 
substantial equivalence has not been shown and, as a result, require additional clinical or non-clinical testing to support a 510(k) 
or require the submission of a de novo classification request or PMA application for the device. 

A de novo classification is an alternate pathway to classify novel devices that are low to moderate risk but for which no 
substantially equivalent predicate device exists. Clearance of a de novo request generally takes six months to one year from the 
time of submission of the de novo request, although it can take longer. 

A PMA application is required for Class III devices. The application must demonstrate that there is reasonable assurance 
that the device is safe and effective for its intended use based on valid scientific evidence. The PMA application process can be 
expensive,  generally  takes  several  years  to  complete  and  typically  includes,  among  other  things,  human  clinical  trials, 
manufacturing facility inspection, bench tests and laboratory and animal studies, which can be costly to conduct. There is also a 
substantial “user fee” that must be paid to the FDA in connection with the submission of each PMA application. The FDA may 
determine  that  additional  information,  including  clinical  data,  be  submitted  before  a  determination  is  made,  which  could 
significantly delay the introduction of new devices. If the FDA approves the PMA application, it may place restrictions on the 
device. If the FDA's evaluation of the PMA application is not favorable, the FDA may deny approval of the PMA application or 
issue a “not approvable” letter. The FDA may also require additional testing or clinical trials prior to approval or as a condition 
of approval. 

If  human  clinical  trials  of  a  medical  device  are  required  for  FDA  clearance  or  approval  and  the  device  presents  a 
significant risk, the sponsor of the trial must file an investigational device exemption (“IDE”) application with the FDA prior to 
commencing human clinical trials in the USA. Submission of an IDE application does not ensure that the FDA will issue the 
IDE. If the IDE application is approved, there can be no assurance the FDA will determine that the data derived from the trials 
support the  safety and effectiveness of the device  or  warrant the continuation of clinical trials.  An IDE  supplement  must be 
approved by the FDA before a sponsor or investigator may make a change to the investigational plan in such a way that may 
affect its scientific soundness, study indication or the rights, safety or welfare of human subjects. For clinical trials involving a 
device that does not present a significant risk, the sponsor is not required to obtain approval of an IDE, but the sponsor must 
obtain the review and approval of an institutional review board. Both significant risk and non-significant risk trials are subject to 
additional FDA regulations, including a requirement to obtain informed consent and reporting and recordkeeping requirements. 
We, the FDA, or the institutional review board, may suspend a clinical trial at any time for various reasons, including a belief 
that the risks to study subjects outweigh the anticipated benefits. 

16 

 
 
 
 
 
 
 
 
The FDA clearance and approval processes for medical devices are expensive, uncertain and lengthy. There can be no 
assurance that we will be able to obtain necessary regulatory clearances or approvals for any product on a timely basis or at all. 
Delays in receipt of or failure to receive such clearances or approvals, the loss of previously received clearances or 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. In addition, if the FDA discovers that an applicant has submitted false or misleading 
information, the FDA may refuse to review submissions until certain requirements are met pursuant to its Application Integrity 
Policy,  which  specifies  procedures  that  the  FDA  personnel  should  follow  to  ensure  the  integrity  of  data  and  information  in 
applications submitted for FDA review and approval.  

We are currently conducting a clinical trial to obtain PMA approval from the FDA to claim the use of the QuadraSphere 
Microspheres with doxorubicin for the treatment of liver cancer in the United States. In order for us to obtain FDA approval  to 
promote the use of QuadraSphere Microspheres for the purposes indicated in our clinical trial, we will need to complete the trial 
and submit positive clinical data to the FDA. If we cannot enroll study subjects in sufficient numbers to complete the necessary 
studies, if there is a disruption in the supply of materials for the trials or depending on other factors, we will likely not be able to 
complete the trial. Even if we complete the clinical trial, the FDA may require us to undertake additional testing, or the trial 
results may not be sufficient to obtain FDA approval for other reasons, including inconclusive or negative results of our trials or 
those conducted by our competitors or other third parties. If we do not obtain FDA approval of the product use claimed in a 
clinical trial, we will not be able to promote the subject product for the indicated treatment of the specific disease or condition in 
the United States. A clinical study involving the use of our EndoMAXX EVT Valved Esophageal Stent to relieve dysphagia in 
patients with malignant stricture of the esophagus was completed. As a result of the data obtained during the study, it was decided 
that we would not pursue a 510(k) clearance to promote the device. 

Changes  in  Cleared  or  Approved  Devices.  Certain  modifications  to  our  marketed  devices,  including  certain 
manufacturing changes, product enhancements and product line extensions, require new 510(k) clearance or approval of a PMA 
supplement.  For devices marketed under an approved PMA, we must submit a PMA supplement to the FDA for review and 
approval prior to making a change to the device that affects the safety or effectiveness of the device, including changes to the 
design, manufacturing or labeling of the device. Likewise, for 510(k)-cleared devices, we must obtain new FDA 510(k) clearance 
when there is a major change or modification in the intended use or indications for use or a change or modification of the device 
that could significantly affect the safety or effectiveness of the device. In some cases, clinical data may be required to support a 
PMA supplement or 510(k) premarket notification for a device modification. The FDA may determine that a modified device is 
not  substantially  equivalent  to  the  marketed  device  or  may  require  that  additional  information,  including  clinical  data,  be 
submitted before a determination is made, either of which could significantly delay the introduction of modified devices. 

Quality System Requirements. The FDCA requires us to comply with the Quality System Regulation (“QSR”) and 
various  foreign regulations require compliance  with ISO 13485 or national law requirements pertaining to all aspects of our 
product design and manufacturing processes, including requirements for packaging, labeling, record keeping, personnel training, 
supplier qualification, design controls, complaint handling, corrective and preventive actions and internal 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, 
which would 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 regulations. 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. 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 

17 

 
 
 
 
 
 
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 United States, the importer must file an entry notice and 
bond with the United States 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 United States 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 from Europe or the United States are subject to foreign countries' import 
requirements and the exporting requirements of the FDA or European regulating bodies, as applicable. In particular, international 
sales of medical devices manufactured in the United States that are not approved or cleared by the FDA for use in the United 
States, 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. 

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 United States 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 to certain countries is subject to restrictions due to trade and economic sanctions 
imposed by the United States, the European Union (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. 

Additional  Post-market  Requirements.  Medical  device  manufacturers  are  also  subject  to  other  post-market 
requirements, including product listing and establishment regulations, compliance with the FDA’s requirements for unique device 
identifiers, reports of corrections and removals and other requirements. Medical Device Reporting (“MDR”) requirements of the 
FDA, vigilance reporting requirements under the European Medical Devices Directive and similar regulations in other foreign 
markets, 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 under the 
MDR regulations is triggered on the date on which we become aware of an adverse event and the nature of the event. If we fail 
to comply with our MDR reporting obligations, the FDA could issue warning letters or untitled letters, take administrative actions, 
commence criminal prosecution, impose civil monetary penalties, revoke our device clearances, seize our products, or delay the 
clearance of our future products. 

The FDA regularly inspects companies to determine compliance with the QSRs and other post-market requirements. 
Failure to comply with statutory requirements and the FDA’s regulations can result in an FDA Form 483 (which is issued by the 
FDA at the conclusion of an inspection when an investigator has observed any conditions that may constitute violations), public 
warning letters, monetary penalties against a company or its officers and employees, suspension or withdrawal of regulatory 
approvals, operating restrictions, total or partial suspension of production, injunctions, product recalls, product detentions, refusal 
to provide export certificates, seizure of products and criminal prosecution. 

Foreign Regulations. Medical device laws and regulations are also in effect in many countries outside of the United 
States. These laws and regulations vary significantly from country to country and range from comprehensive device approval 
requirements for some or all of our medical device products to more basic requests for product data or certification. The number, 
scope, complexity, and cost of these requirements are increasing. 

Foreign  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 

18 

 
 
 
 
 
 
 
 
 
 
receipt 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. 

The regulatory framework for medical devices in the European Economic Area underwent a significant revision in 2017, 
which has introduced new regulatory requirements to obtain CE Mark approval. The new Medical Device Regulations (“MDR”) 
include a three-year transition period which is scheduled to end in 2020. The MDR includes increasingly stringent requirements 
in multiple areas, such as pre-market clinical evidence (some of which are now in effect), review of high-risk devices, labeling 
and post-market surveillance. Under the MDR, pre-market clinical data will now be required to obtain CE Mark approval for 
high-risk, new and modified medical devices. We believe these new requirements have the potential to be expensive and time-
consuming to implement and maintain and could have a material adverse effect on our business. 

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 only when the payer determines that healthcare outcomes are supported by medical evidence and the 
device or 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, there is no certainty that third-party payers will cover and reimburse 
for the cost of the device and related procedures. 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 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. 

Patient Protection and Affordable Care Act. The Patient Protection and Affordable Care Act (“Affordable Care Act”) 
has changed the way healthcare in the United States is financed by both governmental and private insurers and has significantly 
affected the medical device industry. This law contains a number of provisions, including provisions governing enrollment in 
federal  healthcare  programs,  reimbursement  changes,  the  increased  funding  of  comparative  effectiveness  research  for  use  in 
healthcare decision-making, and enhancements to fraud and abuse requirements and enforcement, that we believe affect existing 
government healthcare programs and result in the development of new programs. The Affordable Care Act imposed on medical 
device manufacturers a 2.3% excise tax on U.S. sales of certain medical devices, which adversely affected our gross profit and 
earnings for our marketed products in 2015. The U.S. Congress suspended the excise tax for the 2016 and 2017 tax years and 
recently extended the suspension until January 1, 2020. We cannot predict whether any new action will be taken and whether the 
suspension will continue past 2020. If the excise tax is not repealed or further suspended, it will likely adversely impact our 
future results of operations. 

Additionally, the long-term viability of the Affordable Care Act, and its impact on our business and results of operations, 
remains uncertain. For instance, in December 2017, the United States enacted the Tax Cuts and Jobs Act, which, among other 
things,  eliminated  the  tax  penalty  for  not  obtaining  health  coverage  (beginning  in  2019).  Additionally,  members  of  the  U.S. 
Congress  have  suggested  other  changes  that  may  impact  individual  insurance  marketplaces.  These  and  other  legislative  and 
executive initiatives may significantly change the scope and impact of the Affordable Care Act and, in turn, the medical device 
industry. See Note 5 of the notes to our consolidated financial statements for further information on the Tax Cuts and Jobs Act. 

The  U.S.  Physician  Payment  Sunshine  Act,  and  similar  state  laws,  also  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 new requirements are placed in a public database. Other jurisdictions 
outside the United States have also begun adopting similar physician 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-Corruption Laws. Anti-bribery and anti-corruption laws are in place in the United States and in many jurisdictions 
throughout the world. In the United States, the Foreign Corrupt Practices Act (the "FCPA") prohibits corruptly offering, paying, 
or promising to pay anything of value to foreign officials for the purpose of obtaining or maintaining business. Anti-bribery laws 
present particular challenges in the medical device industry because in many countries including China, hospitals are state-owned 
or operated by the government, and doctors and other hospital employees are considered foreign government officials. The FCPA 
also  requires  that  we  maintain  fair  and  accurate  books  and  records  and  devise  and  maintain  an  adequate  system  of  internal 
accounting controls. Among other requirements to implement compliance, we are required to train our U.S. and international 
employees, and to train and monitor foreign third parties with whom we contract, e.g., distributors, to ensure compliance with 
these anti-corruption laws. Failing to comply with the FCPA or any other anti-corruption law could result in fines, penalties or 
other adverse consequences. In addition, the Chinese government has also sponsored anti-corruption campaigns from time to 

19 

 
 
 
 
 
 
 
time, which could have a chilling effect on any future marketing efforts by us to new hospital customers. There have been recent 
occurrences in which certain hospitals have denied access to sales representatives from medical device companies because the 
hospitals wanted to avoid the perception of corruption. If this attitude becomes widespread among our potential customers, our 
ability to promote our products to hospitals may be adversely affected.  

As we expand our operations in China and other jurisdictions internationally, we will need to increase the scope of our 
compliance programs to address the risks relating to the potential for violations of the FCPA and other anti-bribery and anti-
corruption laws. Our compliance programs will need to include policies addressing not only the FCPA, but also the provisions 
of a  variety of anti-bribery and anti-corruption laws in  multiple  foreign jurisdictions,  including  China, provisions relating to 
books and records that apply to us as a public company, and include effective training for our personnel and relevant third-parties. 

Anti-Kickback Statutes. The federal healthcare Anti-Kickback Statute prohibits persons from, among other things, 
knowingly and willfully offering or paying remuneration, directly or indirectly, to a person 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. In 
addition, kickback arrangements can provide the basis for an action under the False Claims Act, which is discussed in more detail 
below. A party’s failure to fully satisfy a regulatory “safe harbor” provision may result in increased scrutiny by government 
enforcement authorities. 

Government  officials  have  recently  increased  enforcement  efforts  on  the  sales  and  marketing  activities  of 
pharmaceutical, medical device and other healthcare companies, and recently have brought 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 pleas. 

In  addition  to  the  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. 

False Claims Laws. The False Claims Act prohibits 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 false 
claim paid. Manufacturers can be held liable under false claims laws, even if they do not submit claims to the government, if 
they  are  found  to  have  caused  submission  of  false  claims.  Under  the  Affordable  Care Act,  a  violation  of  the  Anti-Kickback 
Statute is deemed to be a violation of the False Claims Act. The False Claims Act also includes whistleblower provisions that 
allow private citizens to bring suit against an entity or individual on behalf of the United States 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 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  Claims  Act  and  state  laws  may  include  civil  monetary  penalties,  exclusion  of  a  manufacturer's  products  from 
reimbursement under government programs, criminal fines and 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. 

Privacy  and  Security.  The  Health  Insurance  Portability  and  Accountability  Act  of  1996  (“HIPAA”),  the  Health 
Information Technology for Economic and Clinical Health Act (the “HITECH Act”), and accompanying rules, require certain 
entities,  referred  to  as  "covered  entities"  (including  most  healthcare  providers  and  health  plans),  to  comply  with  established 
standards,  including  standards  regarding  the  privacy  and  security  of  protected  health  information  (“PHI”).  HIPAA  further 
requires that covered entities enter into agreements meeting certain regulatory requirements with their “Business Associates,” as 
such term is defined by HIPAA, which, among other things, obligate the Business Associates to safeguard the covered entity's 
PHI against improper use and disclosure. In addition, a Business Associate may face significant statutory and contractual liability 

20 

 
 
 
 
 
 
 
 
if the Business Associate breaches the agreement or causes the covered entity to fail to comply with HIPAA. Additionally, many 
state laws regulate the use and disclosure of health information and require notification in the event of breach of such information.  

Although  we  do  not  believe  we  are  a  “covered  entity”  under  HIPAA  and  do  not  meet  the  definition  of  “Business 
Associate, we are committed to maintaining the security and privacy of patients’ health information and believe that we meet the 
expectations of the HIPAA rules in all material respects. However, to the extent we become subject to HIPAA, whether through 
a change in our business model or an enforcement action brought by the U.S. government, we would be directly subject to a 
broader  range  of  requirements  under  HIPAA,  HITECH,  the  rules  issued  thereunder  and  their  respective  civil  and  criminal 
penalties. 

The EU has recently adopted a comprehensive overhaul of its data protection regime from the current national legislative 
approach to a single EU privacy regulation, the General Data Protection Regulation (“GDPR”), which applies as of May 25, 
2018. The GDPR extends the scope of the EU data protection law to all companies processing personal data in the context of the 
activities of an establishment of a controller or a processor in the EU, regardless of whether the processing takes place in the EU 
or not. In addition, it applies to the processing of personal data of data subjects who are in the EU by a controller or processor 
not established in the EU, where the processing activities are related to: (a) the offering of goods or services, irrespective of 
whether a payment of the data subject is required, to such data subjects in the EU; or (b) the monitoring of their behavior as far 
as their behavior takes place within the EU. The GDPR provides for a harmonization of the data protection regulations throughout 
the EU. It imposes a strict data protection compliance regime  with severe penalties of up to the greater of 4% of worldwide 
turnover or €20 million and includes new rights such as the “portability” of personal data. Although the GDPR will apply 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 will still have the ability to interpret the GDPR, 
which has the potential to create inconsistencies on a country-by-country basis. We are evaluating the rule and its requirements 
and are implementing changes to our business practices to comply with the GDPR.  

We post on our websites our privacy policies and practices regarding the collection, use and disclosure of user data. 
Any failure, or perceived failure, by us to comply with our posted privacy 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.  Data 
protection, privacy and information security have become the subject of increasing public, media and legislative concern. 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. 

Environmental, Health and Safety Regulations. We are subject to various federal, state, local and foreign laws and 
regulations relating to the protection of the environment, as well as public and employee health and safety. In the course of our 
business, we are involved in the handling, storage and disposal of certain chemicals. The laws and regulations applicable to our 
operations include provisions that regulate the release or discharge of hazardous or other regulated materials into the environment. 
These environmental laws and regulations may impose “strict liability,” rendering a person liable without regard to negligence 
or fault on the part of such person. Such environmental laws and regulations may expose us to 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. 
Failure to comply with applicable environmental laws could have a material adverse effect on our business. 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 expenditures. Environmental, health 
and safety legislation and regulations change frequently. Changes in those regulations could have a material adverse effect on 
our business, operations or financial condition.  

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. 

Employees 

As of December 31, 2017, we employed 4,876 people. None of our U.S. employees are subject to collective bargaining 
agreements; however, certain of our European employees are subject to such agreements. We believe our employee relations are 

21 

 
 
 
  
 
 
 
 
 
generally good. Although our European employees will likely continue to be subject to collective organizing and bargaining 
activities, we do not expect such activities to materially affect our future operations.  

Recent Developments 

On February 14, 2018, we completed the acquisition of two product lines from BD pursuant to the terms of an asset 
purchase agreement, dated as of November 15, 2017 (the “BD Agreement”). The acquisition occurred in connection with BD’s 
acquisition of C.R. Bard, Inc. (“Bard”). The purchase price for the acquired product lines and related assets was $100.1 million, 
subject to adjustment for fluctuations in the value of transferred inventory. We financed the acquisition through borrowings under 
our existing credit facility. 

Under the BD  Agreement,  we  acquired soft tissue core  needle biopsy products  under the trade names of  Achieve® 
Programmable Automatic Biopsy System, Temno® Biopsy System, and Tru-Cut® Biopsy Needles (which were previously sold 
by  BD)  as  well  as  the  Aspira®  Pleural  Effusion  Drainage  Kits  and  the  Aspira®  Peritoneal  Drainage  System  (which  were 
previously sold by Bard). 

Available Information 

We file annual, quarterly and current reports and other information with the SEC. These materials can be inspected and 
copied at the SEC’s Public Reference Room at 100 F Street, NE, Washington, D.C. 20549. Copies of these materials may also 
be obtained by mail at prescribed rates from the SEC’s Public Reference Room at the above address. Information about the Public 
Reference Room can be obtained by calling the SEC at 1-800-SEC-0330. The SEC also 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. 

We make available, free of charge, on our Internet website, located at www.merit.com, our most recent Annual Report 
on Form 10-K, our most recent Quarterly Reports on Form 10-Q, any Current Reports on Form 8-K filed since our most recent 
Annual Report on Form 10-K, and any amendments to such reports as soon as reasonably practicable following the electronic 
filing of such report with the SEC. In addition, we provide electronic or paper copies of such filings free of charge upon request. 

Financial Information About Foreign and Domestic Sales 

For financial information relating to our foreign and domestic sales see Note 12 to our consolidated financial statements 

set forth in Item 8 of this report. 

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: 

We may be unable to successfully manage growth, particularly if accomplished through acquisitions, and the integration 
of acquired businesses may present significant challenges that could harm our operations. 

Successful implementation of our business strategy will require that we effectively manage any associated growth. To 
manage growth effectively, our management will need to continue to implement changes in certain aspects of our business, to 
improve our information systems, infrastructure and operations to respond to increased demand, to attract and retain qualified 
personnel, and to develop, train, and manage an increasing number of management-level and other employees. Growth could 
place an increasing strain on our management, financial, product design, marketing, distribution and other resources, and we 
could experience operating difficulties. Any failure to manage growth effectively could have a material adverse effect on our 
business, operations or financial condition.  

Over the past several years, we completed a series of significant acquisitions. 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. Efforts to integrate future acquisitions may be hampered by delays, the loss of certain employees, 
suppliers or 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.  

22 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
We  have  incurred,  and  will  likely  continue  to  incur,  significant  expenses  in  connection  with  negotiating  and 
consummating  various  acquisition  transactions,  and  we  may  inherit  significant  liabilities  in  connection  with  prospective 
acquisitions, including regulatory, infringement, product liability, discrimination or other legal claims or issues. In addition, we 
may not realize competitive advantages, synergies or other benefits anticipated in connection with any such acquisition. If we do 
not adequately identify targets for, or manage issues related to, our future acquisitions, such acquisitions may have an adverse 
effect on our business, operations or financial condition. 

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  using  our  intellectual  property.  We  seek  to  protect  our  intellectual  property  rights  through  a 
combination of confidentiality and license agreements, and through patent, trademark, copyright and trade secret laws. However, 
all  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 technical knowledge or trade 
secrets  by  consultants,  vendors,  former  employees  and  current  employees,  despite  the  existence  of  nondisclosure  and 
confidentiality  agreements  and  other  contractual  restrictions,  all  of  which  could  have  an  adverse  effect  on  our  business, 
operations, or financial condition. 

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 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 all countries throughout the world may be 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 patent 
and other intellectual property protection, 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, and trade secrets. 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 these 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  stop  selling,  delay  shipments  of,  or  redesign,  our  products, 
discontinue  the  use  of  related  trademarks,  technologies  or  designs,  pay  monetary  amounts  as  damages,  enter  into  royalty  or 
licensing arrangements or satisfy indemnification obligations that we have with some of our customers. 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 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.  

23 

 
 
 
 
 
 
 
 
 
 
The medical device industry is experiencing greater scrutiny and regulation by governmental authorities. Moreover, in 
October 2016, we received a subpoena from the U.S. Department of Justice seeking information on our marketing and 
promotional  practices.  If  governmental  authorities  determine  that  we  have  violated  laws  or  regulations,  including  in 
respect of our marketing or promotional practices, our company or our employees may be subject to various penalties, 
including civil or criminal penalties. 

Our medical devices and business activities are subject to rigorous regulation by the FDA and other federal, state and 
foreign governmental authorities. These authorities and members of Congress have been increasing their scrutiny of the medical 
device industry. In recent years, the U.S. Congress, Department of Justice, the Office of Inspector General of the Department of 
Health and Human Services and the Department of Defense 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. If we fail to comply with applicable regulatory requirements, 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, exclusion from participation in government healthcare 
programs, civil fines and criminal penalties. 

In October 2016, we received a subpoena from the U.S. Department of Justice seeking information on certain of our 
marketing and promotional practices.  Although  we  are  in the  process of responding to the subpoena,  we  may  not be able to 
resolve this matter, or similar matters that may arise in the future, without our company or employees incurring significant fines, 
penalties, or other adverse civil or criminal consequences. Even if we are successful in resolving the pending matter without such 
consequences, we have incurred, and anticipate that we will continue to incur, substantial costs in connection with the matter. 
The  pending  matter,  or  other  governmental  proceedings,  could  significantly  impact  our  reputation  and  divert  management’s 
attention  and  resources  from  growing  our  business,  which  in  turn  could  harm  our  business,  results  of  operations,  financial 
condition and ability to obtain financing on reasonable terms or at all. 

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. 

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

The marketing 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 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. 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. 

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 United States, we must 
generally obtain market clearance from the FDA through the 510(k) premarket notification process or through a PMA application, 
unless an exemption for lower-risk devices or an alternative procedure, such as a de novo classification request or a humanitarian 
device exemption, applies. The FDA clearance and approval processes for medical devices are expensive, uncertain and time-
consuming.  

If  human  clinical  trials  of  a  medical  device  are  required  for  FDA  clearance  or  approval  and  the  device  presents  a 
significant risk, the sponsor of the trial must file an IDE application with the FDA prior to commencing such trials in the U.S. 
Submission of an IDE application does not ensure that the FDA will issue the IDE. If the IDE application is approved, there can 
be no assurance the FDA will determine that the data derived from the trials support the safety and effectiveness of the device or 
warrant the continuation of clinical trials. For clinical trials involving a device that does not present a significant risk, the sponsor 
is not required to obtain approval of an IDE, but the sponsor must obtain the review and approval of an institutional review board. 
Both significant risk and non-significant risk trials are subject to additional FDA regulations, including a requirement to obtain 
informed consent and reporting and recordkeeping requirements. We, the FDA, or the institutional review board, may suspend a 
clinical trial at any time for various reasons, including a belief that the risks to study subjects outweigh the anticipated benefits. 

24 

 
 
 
 
 
 
 
 
 
 
We are also required to seek FDA clearance for certain manufacturing changes, product enhancements and product line 
extensions, which may require new 510(k) clearance or approval of a PMA supplement. For devices marketed under an approved 
PMA, we must submit a PMA supplement to the FDA for review and approval prior to making a change to the device that affects 
the safety or effectiveness of the device, including changes to the design, manufacturing or labeling of the device. Likewise, for 
510(k)-cleared devices, we must obtain new FDA 510(k) clearance when there is a major change or modification in the intended 
use or indications for use or a change or modification of the device that could significantly affect the safety or effectiveness of 
the device. In some cases, clinical data may be required to support a PMA supplement or 510(k) premarket notification for a 
device modification. 

The FDA requires every manufacturer to make the determination regarding the need for a new 510(k) submission or a 
PMA supplement in the first instance, but the FDA may review the manufacturer’s decisions not to seek a new 510(k) or PMA 
supplement. We may make changes to our cleared products without seeking additional clearances or approvals if we believe such 
clearances or approvals are not necessary. However, the FDA may disagree and determine that such a modified device is not 
substantially equivalent to the marketed device 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. 

There is no assurance that we will be able to obtain the necessary regulatory clearances or approvals for any product 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 for a product. We cannot assure you that we will successfully maintain the clearances we have received or 
may receive in the future. In addition,  our existing clearances can be revoked if any issues arise that bring into question our 
products’ safety or effectiveness. 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. 

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 codes, 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 will prevent security breaches that could have a significant impact on our business, reputation and financial results, 
particularly attacks that result in our intellectual property and other confidential information being accessed or stolen. Cyber-
attacks could also result in unauthorized access to our systems and products, including personal information of individuals, which 
could also result in actions by regulatory bodies or 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,  among  other  things,  lose  customers,  be  subject  to  fraud,  breach  our  agreements  with  or  duties  toward  customers, 
physicians, other health care professionals and employees, be subject to regulatory sanctions or penalties, incur expenses or lose 
revenues or 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. 

25 

 
 
 
 
 
 
 
 
 
We are subject to export control laws, customs laws, sanctions laws and other laws governing our operations in the U.S. 
and other countries. If we fail to comply with these laws, we could be subject to civil or criminal penalties, other remedial 
measures and legal expenses, which could adversely affect our business, results of operations and financial condition.  

Our global operations expose us to trade and economic sanctions and other restrictions imposed by the United States, 
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 Asset Control. 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, may seek to impose modifications to business practices, including cessation of business activities in sanctioned 
countries or with sanctioned persons or entities and modifications to compliance programs, which may increase compliance costs, 
and may subject us to fines, penalties and other sanctions. A violation of these laws or regulations could adversely impact our 
business, results of operations and financial condition. 

A significant  adverse change  in, or  failure to comply with, governing regulations could adversely affect our business, 
operations or financial condition. 

We have extensive global operations, which necessitate that we seek various regulatory approvals for our products in 
the jurisdictions where our products are sold. Different regulatory requirements for product approvals and our need to comply 
with different regulatory regimes could impact our business. 

Substantially  all  of  our  products  are  “devices,”  as  defined  in  the  FDCA,  and  the  manufacture,  distribution,  record 
keeping, labeling and advertisement of substantially all of our products are subject to regulation by the FDA in the United States 
and equivalent regulatory agencies in various foreign countries in which our products are manufactured, distributed, labeled, 
offered or sold. Further, we are subject to regular review and periodic inspections at our facilities with respect to compliance 
with  the  FDCA,  QSR,  ISO  standards  and  similar  requirements  of  foreign  countries,  which  may  cover,  among  others,  the 
procedures and documentation of the design, testing, production, control, quality assurance, labeling, packaging, sterilization, 
storage  and  shipment  of  medical  devices.  Costs  to  comply  with  regulations,  including,  for  instance,  regulations  for  medical 
devices  enacted  by  the  EU  in  May  2017  and  effective  in  2020,  and  costs  associated  with  remediation  can  be  significant. 
Additionally, failure to comply with such requirements, or later discovery of previously unknown problems with our products or 
our third-party manufacturers’ manufacturing processes, including any failure to take satisfactory corrective action in response 
to an adverse  QSR inspection, could result in total or partial suspension of production or distribution, a regulatory agency’s 
refusal to grant pending or future clearances or approvals for our products, withdrawal or suspension of regulatory clearances or 
approvals, clinical holds, warning letters or untitled letters or refusal to permit the import or export of our products. 

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. 

We have entered into a Second Amended and Restated Credit Agreement with Wells Fargo Bank, National Association, 
as administrative agent, swingline lender and a lender, Wells Fargo Securities, LLC, as sole lead arranger and sole bookrunner 
and the lenders who are or may become party thereto, which was amended on September 28, 2016, March 20, 2017 and December 
13, 2017 (as amended, the "Second Amended Credit Agreement"). The Second Amended Credit Agreement contains a number 
of  significant  covenants  that  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 Second Amended Credit Agreement. Our breach of 
any covenant in the Second 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  Second  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  and  lenders  under  the  Second  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. 
Any default under the Second Amended Credit Agreement would at a minimum harm our ability to service our debt and to fund 
our prospective capital expenditures and ongoing operations. It could lead to an acceleration of indebtedness and foreclosure on 
our assets. 

As  currently  amended,  the  Second  Amended  Credit  Agreement  provides  for  potential  borrowings  of  up  to  $525.0 
million. Such increased borrowing limits may make it more difficult for us to comply with leverage ratios and other restrictive 

26 

 
 
 
 
 
 
 
 
 
covenants in the Second 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  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 are currently conducting one clinical trial in an effort to obtain approval from the FDA that would enable us to 
expand our efforts to commercialize the QuadraSphere Microspheres. EU regulations do not currently require such applications 
for these classes of medical device. In order for us to obtain FDA approval to promote the use of QuadraSphere Microspheres 
for the purposes indicated in our clinical trial, we will need to complete the trial and submit positive clinical data to the FDA. If 
we cannot enroll study subjects in sufficient numbers to complete the necessary study, if there is a disruption in the supply of 
materials for the trial or if any other factors preclude us from completing the trial in a timely manner, we will likely not be able 
to complete the trial. Even if we complete the clinical trial, the FDA may require us to undertake additional testing, or the trial 
results may not be sufficient to obtain FDA approval for other reasons, including inconclusive or negative results of our trials or 
those conducted by our competitors or other third parties. Any clinical trials we undertake in the future will likely be subject to 
these and similar risks. If we do not obtain FDA approval or clearance of the product use claimed in a clinical trial, we will not 
be able to promote the subject product for the indicated treatment of the specific disease or condition in the United States. 

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 financial results. 

We are also subject to the FCPA, the U.K. Bribery Act, and similar anti-bribery 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. As we continue to expand our business activities internationally, compliance with the FCPA 
and other anti-bribery laws presents greater challenges to our operations. If our employees or agents violate the provisions of the 
FCPA or other anti-bribery laws, we may incur fines or penalties, which could have a material adverse effect on our operating 
results or financial condition. 

27 

 
 
 
 
 
 
 
 
     
 
 
 
 
 
 
 
 
Healthcare reform legislation has negatively affected our financial results and may have a material adverse effect on 
our business, operations or financial condition. 

The Affordable Care Act was enacted into law in March 2010, and most of the core pieces of the Affordable Care Act 
are now in effect. Certain other provisions of the legislation are not yet effective. There are many programs and requirements for 
which the details have not yet been fully established or consequences not fully understood, and it is unclear what the full impact 
of the legislation will be. The law imposes on medical device manufacturers a 2.3% excise tax on U.S. sales of certain medical 
devices. Although this tax has been suspended until January 1, 2020, during the year ended December 31, 2015 we incurred $4.3 
million related to this tax, which reduced our gross profit by 0.8%. We cannot predict whether the suspension will be continued 
beyond January 1, 2020. If the excise tax is not repealed or further suspended, it will likely adversely impact our future results 
of  operations.  In  addition,  the  costs  of  compliance  with  the  Affordable  Care  Act’s  reporting  and  disclosure  requirements, 
frequently identified as the Sunshine Act, with regard to payments or other transfers of value made to healthcare providers may 
have a material, negative impact on our results of operations and our cash flows. 

Additionally, the long-term viability of the Affordable Care Act, and its impact on our business and results of operations, 
remains uncertain. For instance, in December 2017, the United States enacted the Tax Cuts and Jobs Act, which, among other 
things,  eliminated  the  tax  penalty  for  not  obtaining  health  coverage  (beginning  in  2019).  Additionally,  members  of  the  U.S. 
Congress  have  suggested  other  changes  that  may  impact  individual  insurance  marketplaces.  These  and  other  legislative  and 
executive initiatives may significantly change the scope and impact of the Affordable Care Act and, in turn, the medical device 
industry. 

We are subject to the regulations of our medical devices in foreign countries in which we sell our products and we will be 
required to expend significant resources for obtaining regulatory approval or clearance of our products and there may 
be delays and uncertainty in obtaining regulatory approval.  

To be able to sell our products in foreign countries, we must obtain regulatory approvals and comply with the regulations 
of those countries. These regulations, including the requirements for approvals and the time required for regulatory review, vary 
from country-to-country.  

The EU requires that manufacturers of medical devices obtain the right to affix the CE mark, for compliance with the 
Medical Device Directive (93/42/EEC), as amended, to medical devices before selling them in member countries of the EU. The 
CE  mark  is  an  international  symbol  of  adherence  to  quality  assurance  standards  and  compliance  with  applicable  European 
medical device  directives. In  order to obtain the authorization to affix the CE  mark to products, a  manufacturer  must  obtain 
certification that its processes and products meet certain European quality standards.  

In April 2017, the EU adopted the Medical Device Regulation to replace the Medical Device Directive (93/42/EEC), as 
amended. The Medical Device Regulation will apply after a three-year transition period and imposes stricter requirements for 
the marketing and sale of medical devices and grants Notified Bodies increased post-market surveillance authority.  

Complying with and obtaining regulatory approval in foreign countries have caused or may cause us to experience more 
uncertainty, risk, expense and delay in commercializing products in certain foreign jurisdictions, which could affect our ability 
to obtain approvals for our products in those jurisdictions and adversely impact our net sales, market share and operating profits 
from our international operations. 

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. 

Our products may be subject to product liability 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 claims by patients claiming injuries from our products. To date, these claims have not resulted 

28 

 
 
 
 
 
 
 
 
 
 
 
 
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 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. 

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, 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 any incident in 
which our products may have caused or contributed to a death or serious injury, or in which our products malfunctioned and, if 
the malfunction were to recur, it could likely 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 an adverse event and the nature of 
the event. 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. If we fail to comply with our medical device reporting obligations, the FDA could issue warning letters or untitled 
letters,  take  administrative  actions,  commence  criminal  prosecution,  impose  civil  monetary  penalties,  revoke  our  device 
clearances, demand or initiate a product recall, seize our products, or delay the clearance of our future products. 

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. 

We lack direct sales and marketing capabilities in many countries, and are wholly 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. 

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 disclosure of unauthorized activities to us that violates 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. 

29 

 
 
 
 
 
 
 
 
 
The size of the market for our product groups has not been established with precision and may be smaller than we 
estimate. 

Our estimates of the annual total addressable market for our cardiac intervention, peripheral intervention, interventional 
oncology and spine, and cardiovascular and critical care and endoscopy product groups are based on a number of internal and 
third-party  estimates,  including  published  industry  data. While  we  believe  these  factors  have  historically  provided  and  may 
continue to provide us with effective tools in estimating the total market for our products, these estimates may not be correct and 
the  conditions  supporting  our  estimates  may  change  at  any  time,  thereby  reducing  the  predictive  accuracy  of  the  underlying 
factors we consider in our analysis. As a result, our estimates of the annual total addressable market for our products may prove 
to be incorrect. If the actual number of patients who would benefit from our products and the annual total addressable market for 
our products is smaller than we have estimated, our sales growth may be impaired and our business adversely impacted. Even if 
the markets are as large as projected, there is no assurance that our market share or aggregate sales will increase as a result of the 
size of addressable markets.  

Consolidation in the healthcare industry, group purchasing organizations or public procurement policies could lead to 
demands for price concessions, which 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  may create more requests for pricing concessions in the future. Additionally, 
group  purchasing  organizations,  independent  delivery  networks,  public  procurement  policies  and  large  single  accounts  may 
continue to use their market power to consolidate purchasing decisions for hospitals and healthcare service providers. 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. 

Our business is subject to complex and evolving U.S. and international laws and regulation 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, and requiring data holders and controllers to implement administrative, logical 
and technical controls and procedures. In addition, regulatory authorities around the world are considering a number of 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 in the U.S., Europe, China and elsewhere are often uncertain and in flux. It is possible that these 
laws may be interpreted and applied in a manner that is inconsistent with our data practices. These legislative and regulatory 
proposals, if adopted, and such interpretations could, in addition to the possibility of fines, result in an order requiring that we 
change our data practices, which could have an adverse effect on our business and results of operations. Complying with these 
various laws could cause us to incur substantial costs or require us to change our business practices in a manner adverse to our 
business. 

30 

 
 
 
 
 
 
 
 
 
 
Recent legal developments in Europe have created compliance uncertainty regarding certain transfers of personal data 
from the European Union (“EU”) to the United States and other non-EU jurisdictions. For example, the GDPR, scheduled to 
come into application in the EU on May 25, 2018, will apply to all of our activities conducted from an establishment in the EU 
or related to products and services that we offer to EU users. The GDPR will create a range of new compliance obligations, which 
could cause us to change our business practices, and will significantly increase financial penalties for noncompliance (including 
possible fines of up to 4% of global annual turnover for the preceding financial year or €20 million (whichever is higher) for the 
most serious infringements). 

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

As our operations have grown outside the United States, 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 2017, 2016 
and 2015, the exchange rate between all applicable foreign currencies and the U.S. Dollar resulted in an increase in net sales of 
approximately  $0.6  million,  a  decrease  of  approximately  $4.9  million  and  a  decrease  of  approximately  $11.3  million, 
respectively.  

For the year ended December 31, 2017, approximately $215.8 million, or 29.7%, of our net sales were denominated in 
foreign currencies, with our Euro-denominated sales representing our largest single currency risk. 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. 

Termination  or  interruption  of,  or  a  failure  to  monitor,  our  supply  relationships  and  increases  in  the  price  of  our 
component parts, finished products, third-party services or raw materials, particularly petroleum-based products, could 
have an 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. 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. Any interruption to the supply of polymers or petroleum-
based resins could have an adverse effect on our ability to produce, or on the cost to produce, our products. 

The  availability  and  price  of  these  materials  is  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, competition, import duties, tariffs, currency exchange rates and political uncertainty 
around the  world. Our suppliers may 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 generally increase based on the effect of higher crude oil prices, and these increased transportation costs may be passed on 
to us. 

We are also subject to 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.  

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. 

31 

 
 
 
 
 
 
 
 
 
 
 
 
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 or 
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. 

International and national economic and industry conditions constantly change, and could harm our business and results 
of operations. 

Our business and our results of operation are affected by many changing economic, industry and other conditions beyond 
our control, including, for instance, potential changes to the economic relationship between the United States and Mexico, China, 
and other countries in which we operate as a result of the new U.S. administration, and other changes and developments that we 
cannot anticipate, each of which could harm our business and results of operations. Actual or potential changes in international, 
national,  regional  and  local  economic,  business  and  financial  conditions,  including  recession,  inflation  and  trade  protection 
measures, may negatively affect consumer preferences, perceptions, spending patterns or demographic trends, any of which could 
harm our business or results of operations. Our customers may experience financial difficulties or be unable to borrow money to 
fund their operations, which may harm their ability or decision to purchase or pay for our products. Disruptions in the credit 
markets have previously resulted, and could again result, in volatility, decreased liquidity, widening of credit spreads, and reduced 
availability of financing. There can be no assurance that future financing will be available to us on acceptable terms, if at all. An 
inability to obtain necessary additional financing on acceptable terms may have an adverse impact on us and on our ability to 
implement our business plan. 

In particular, the new U.S. Administration has called for and may introduce substantial changes to fiscal, healthcare, 
trade and tax policies and legislation, which may include comprehensive tax reform and changes to existing trade agreements, 
including,  but  not  limited  to, the  North  American  Free Trade  Agreement  (“NAFTA”).  Such  changes  may  have  a  significant 
impact on our operations and financial results. In particular, the potential enactment of tariffs on goods imported into the U.S., 
including  but  not  limited  to,  goods  imported  from  Mexico  where  we  manufacture  many  of  our  products  that  we  sell 
internationally, could adversely affect our gross profit margins. If enacted, any legislation by the U.S. federal government that 
restricts trade, such as tariffs, trade barriers, and other protectionist or retaliatory measures taken by governments in Europe, 
Asia, and other regions, could adversely impact our ability to sell products and services internationally. We cannot predict the 
impact, if any, of these changes to our business. If economic conditions worsen or fail to improve, changes in legislation impact 
the relationship between the U.S. and Mexico and other countries in which we operate or the continuity of NAFTA and other 
trade agreements, or new legislation is passed related to the healthcare system, fiscal or tax policies, customer demand may not 
materialize to the levels we require to achieve our anticipated financial results, which could have a material adverse effect on our 
business, financial condition, results of operations, or cash flows. 

On June 23, 2016, the United Kingdom held a referendum in which voters approved an exit from the EU, commonly 
referred to as “Brexit”. As a result of the referendum, negotiations are under way to determine the future terms of the United 
Kingdom’s relationship with the EU, including the terms of trade. As it stands, the United Kingdom will depart the EU on March 
30, 2019 but the terms of its withdrawal and the nature of its future relationship with the EU are still being decided. In December 
2017, EU leaders announced an agreement to begin the next phase of negotiations, with talks on a transition period after March 
2019 to begin in early 2018 and discussions on the future UK-EU relationship, including trade and security, to begin in March 
2018. It is possible that there will be greater restrictions on the movement of goods and people between the United Kingdom and 
the EU countries and increased regulatory complexities, which could affect our ability to sell products in certain EU countries 
and in the United Kingdom. Brexit could adversely affect European and worldwide economic and market conditions and could 
further contribute to instability in global financial and foreign exchange markets, including volatility in the value of the British 
pound and Euro, to which we have significant exposure. In addition, other European countries may seek to conduct referenda 
with respect to continuing membership with the EU. The uncertainties surrounding Brexit are such that we do not know to what 
extent such changes will impact our business.  

The  above  developments,  and  others  that  we  cannot  anticipate,  could  adversely  affect  our  business,  operations  and 

financial results. 

32 

 
 
 
 
 
 
 
 
 
 
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. 

A significant portion of our revenues is derived from a few products and medical procedures. 

A significant portion of our revenues is attributable to sales of our inflation devices. During the year ended December 31, 
2017, sales of our inflation devices (including our Big60® device sold within our endoscopy segment and kits and packs which 
include  inflation devices, but also include  other products) accounted for approximately 11.4% of our net sales.  Any  material 
decline in market demand, or change in OEM supplier preference, for our inflation devices could have an adverse effect on our 
business, operations or financial condition. 

In addition, the products that have accounted for a majority of our historical revenues are designed for use in connection 
with a few related medical procedures, including angioplasty, stent placement procedures, and spinal procedures. If subsequent 
developments in medical technology or drug therapy make such procedures obsolete, or alter the methodology of such procedures 
so  as  to  eliminate  the  usefulness  of  our  products,  we  may  experience  a  material  decrease  in  demand  for  our  products  and 
experience deteriorating financial performance. 

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  risks  factors,  which  could  have  a  material  adverse  effect  on  our  business,  operations  or  financial 
condition. 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, the FDA or another regulatory 
authority; or a decline, or rise, of stock prices in the capital markets generally. 

We are subject to work stoppage, transportation, severe weather, natural disasters and related risks. 

We  manufacture  products  at  various  locations  in  the  United  States  and  foreign  countries  and  sell  our  products 
worldwide. We depend on third-party transportation companies to deliver supplies necessary to manufacture our products from 
vendors  to  our  various  facilities  and  to  move  our  products  to  customers,  operating  divisions,  and  other  subsidiaries  located 
worldwide.  Our  manufacturing  operations,  and  the  operations  of  the  transportation  companies  on  which  we  depend, may  be 
harmed by natural disasters or significant human events, such as a war, civil unrest, terrorist attack, riot, strike, slowdown, or 
similar events. Any disruption in our manufacturing or transportation could materially harm our ability to meet customer demands 
or our operations. 

Furthermore, our manufacturing operations could be affected by many other factors beyond our control, including severe 
weather  conditions  and  natural  disasters,  including  hurricanes,  earthquakes  and  tornadoes.  These  conditions  could  cause 
substantial damage to our facilities, interrupt our production and disrupt our ability to deliver products to our customers. 

Fluctuations in our effective tax rate may adversely affect our business, financial condition or results of operation. 

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. Relevant authorities may also disagree with tax positions we have taken and assess 
further taxes. On December 22, 2017, the U.S. government enacted comprehensive federal tax legislation commonly referred to 
as the Tax Cuts and Jobs Act of 2017 (“TCJA”). The TCJA makes changes to the corporate tax rate, business-related deductions 
and taxation of foreign earnings, among others, that will generally be effective for taxable years beginning after December 31, 
2017. These changes could have a material impact on the value of our U.S. deferred tax assets, result in significant one-time 
charges in the current or future taxable years and increase our future U.S. tax expense. We continue to evaluate the TCJA and its 
requirements, as well as its application to our business and its impact on our effective tax rate. At this stage, it is unclear how 
many U.S. states will incorporate these federal law changes, or portions thereof, into their tax codes. The implementation by us 
of new practices and processes designed to comply with, and benefit from, the TCJA and its rules and regulations could require 

33 

 
 
 
 
 
 
 
 
 
 
 
 
us  to  make  substantial  changes  to  our  business  practices,  allocate  additional  resources,  and  increase  our  costs,  which  could 
negatively affect our business, results of operations and financial condition. In addition, further changes in the tax laws of foreign 
jurisdictions could arise, including as a result of recommendations issued by the Organisation for Economic Cooperation and 
Development, or the OECD, which could, if implemented, result in substantial changes to numerous long-standing tax positions 
and principles. These contemplated changes, to the extent adopted by OECD members or other countries, could increase tax 
uncertainty  and  may  adversely  affect  our  provision  for  income  taxes.  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. 

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 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  appropriate  reimbursement  for  the  cost  of  our 
products from governmental and private third-party payers is critical to our business. Limits on reimbursement imposed by such 
programs may adversely affect the ability of hospitals and others 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, the 
cost-effectiveness of the treatment may also be a condition. In addition, in the United States, 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.  In  addition,  payers  continually  review  new  and 
existing  technologies  for  possible  coverage  and  can,  without  notice,  deny  or  reverse  coverage  or  alter  pre-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 decisions. If we are not successful in reversing non-coverage policies, 
or if third-party payers that currently cover or reimburse certain procedures reverse or limit their coverage of such procedures in 
the future, or if other third-party payers issue similar policies, our business could be adversely impacted. 

Further, we believe that future coverage and reimbursement may be subject to increased restrictions, such as additional 
preauthorization requirements, both in the United States 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 United States or international markets, which could have an adverse impact on our business.  

Our  failure  to  comply  with  applicable  environmental  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. 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. Additionally, because we use 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. Any accidental release may have an adverse effect on our 
business, operations or financial condition. We cannot predict what additional environmental, health and safety legislation or 
regulations will be enacted or become effective in the future or how existing or future laws or regulations will be administered 
or interpreted with respect to our operations, capital expenditures, results of operations or competitive position. Compliance with 
more stringent laws or regulations or adverse changes in the interpretation of existing laws or regulations by government agencies 
could have a material adverse effect on our business, operations or financial condition, and could require substantial expenditures. 

Item 1B.   Unresolved Staff Comments. 

None. 

34 

 
 
 
 
 
 
 
 
 
 
 
 
Item 2.     Properties. 

Our world headquarters is located in South Jordan, Utah, with our principal office for European operations located in 
Galway, Ireland. We also support our European operations from a European distribution and customer service facility located in 
Maastricht,  The  Netherlands.  In  addition,  we  lease  office  space  in  Bangalore,  India;  Beijing,  Hong  Kong,  GuangZhou  and 
Shanghai,  China;  Buccinasco,  Italy;  Dubai,  UAE;  Melbourne,  Australia;  Moscow,  Russia;  Toronto,  Canada;  Rockland, 
Massachusetts; São Paulo, Brazil; Selangor, Malaysia; Seoul,  Republic of  Korea; Tokyo, Japan; and Versailles, France. Our 
principal manufacturing and packaging facilities are located in Chester, Virginia; Galway, Ireland; Joinville, Brazil; Malvern, 
Pennsylvania; Melbourne, Australia; Paris, France; Pearland, Texas; Singapore; South Jordan and West Jordan, Utah; Tijuana, 
Mexico; and Venlo, The Netherlands. Our research and development activities are conducted principally at facilities located in 
South Jordan and West Jordan, Utah; Pearland and Dallas, Texas; Malvern, Pennsylvania; Jackson Township, New Jersey; San 
Jose, California; Galway, Ireland; Paris, France; Singapore; and Venlo, The Netherlands. 

The following is a summary of the approximate square footage of our facilities as of December 31, 2017: 

U.S. 
International 

Total 

Owned 

Leased 

Total 

552,207     
344,181     
896,388     

492,473     
554,907     
1,047,380     

1,044,680  
899,088  
1,943,768  

Operations associated with our cardiology segments utilize all of our facilities, while our operations associated with our 

endoscopy segment are conducted primarily from our facilities located in South Jordan, Utah and Pearland and Dallas, Texas. 

In connection with our acquisition of the Argon critical care division in January 2017, we acquired a manufacturing and 
warehouse facility in Singapore and an office in Tokyo, Japan. The Singapore facility, which totals approximately 68,000 square 
feet, is located on property leased from a Singapore governmental agency. The Singapore land lease is scheduled to expire on 
August 30, 2019. The Argon Tokyo office is approximately 2,600 square feet and the lease expired on November 22, 2017 and 
was not renewed.  

In  connection  with  our  acquisition  of  ITL  Healthcare  Pty.  Ltd.  ("ITL")  in  October  2017,  we  acquired  a  lease  to  a 

packaging facility located in Melbourne, Australia totaling approximately 52,000 square feet. 

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

of operations. 

Item 3.   Legal Proceedings. 

In the ordinary course of business, we are involved in various claims and litigation matters. These claims and litigation 
matters may include actions involving product liability, intellectual property, contract disputes, and employment or other matters 
that are significant to our business. Based upon our review of currently available information, we do not believe that any such 
actions  are  likely  to  be,  individually  or  in  the  aggregate,  materially  adverse  to  our  business,  financial  condition,  results  of 
operations or liquidity. 

In October 2016, we received a subpoena from the U.S. Department of Justice seeking information on certain  of our 
marketing and promotional practices. We are in the process of responding to the subpoena, which we anticipate will continue 
during 2018. We have incurred, and anticipate that we will continue to incur, substantial costs in connection with the matter. The 
investigation is ongoing and at this stage we are unable to predict its scope, duration or outcome. Investigations such as this may 
result in the imposition of, among other things, significant damages, injunctions, fines or civil or criminal claims or penalties 
against our company or individuals. 

In  the  event  of  unexpected  further  developments,  it  is  possible  that  the  ultimate  resolution  of  any  of  the  foregoing 
matters, or other 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. 

Item 4.  Mine Safety Disclosures. 

The disclosure required by this item is not applicable. 

35 

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

PART II 

Securities. 

Market Price for the Common Stock 

Our Common Stock is traded on the NASDAQ Global Select Market under the symbol “MMSI.” The following table 

sets forth high and low sale prices for the Common Stock for the periods indicated. 

For the year ended December 31, 2017 

First Quarter 
Second Quarter 
Third Quarter 
Fourth Quarter 

For the year ended December 31, 2016 

First Quarter 
Second Quarter 
Third Quarter 
Fourth Quarter 

High 

31.70 
38.55 
42.60 
45.90 

High 

19.49 
20.59 
25.08 
26.85 

  $ 
  $ 
  $ 
  $ 

  $ 
  $ 
  $ 
  $ 

Low 

24.23 
28.00 
36.25 
36.21 

Low 

15.47 
17.94 
19.61 
20.70 

    $ 
    $ 
    $ 
    $ 

    $ 
    $ 
    $ 
    $ 

As of February 23, 2018, the number of shares of Common Stock outstanding was 50,266,889 held by approximately 

115 shareholders of record, not including shareholders whose shares are held in securities position listings. 

Dividends 

We have never declared or paid cash dividends on the Common Stock. We presently intend to retain any future earnings 
for use in our business and, therefore, do not anticipate paying any dividends on the Common Stock in the foreseeable future. In 
addition, (i) 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 (which may prevent such funds from being used to pay dividends), 
and (ii) our Second Amended Credit Agreement contains covenants prohibiting the declaration and distribution of a cash dividend 
at any time prior to the termination of the Second Amended Credit Agreement. 

36 

 
   
 
 
 
  
  
 
 
 
 
  
  
 
 
 
 
 
     
 
 
 
 
Performance 

The following graph compares the performance of the Common Stock with the performance of the NASDAQ Stock 
Market (U.S. Companies) 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, 2012 to December 31, 
2017. 

Comparison of 5 Year Cumulative Total Return
Among Merit Medical Systems, Inc., NASDAQ Stock Market (U.S.)
and NASDAQ Stocks (SIC 3840-3849)

l

e
u
a
V
r
a
l
l
o
D

350.00

300.00

250.00

200.00

150.00

100.00

50.00

0.00

310.79

226.31

203.15

Dec-12 Jun-13 Dec-13 Jun-14 Dec-14 Jun-15 Dec-15 Jun-16 Dec-16 Jun-17 Dec-17
Date

Merit Medical Systems, Inc.

NASDAQ Stock Market (US Companies)

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

Merit Medical Systems, Inc. 
NASDAQ Stock Market (U.S. Companies) 
NASDAQ Stocks (SIC 3840-3849 U.S. 
Companies) 

12/2012 

12/2013 

12/2014 

12/2015 

12/2016 

12/2017 

$ 

100 
 100 

    $ 

113 
  139 

    $ 

125 
  161 

    $ 

134 
  173 

    $ 

191 
  190 

    $ 

311 
  203 

 100 

  117 

  137 

  153 

  159 

  226 

The stock performance graph assumes for comparison that the value of the Common Stock and of each index was $100 
on December 31, 2012 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. Performance graph with peer group uses peer group only performance (excludes only 
Merit).  Peer  group  indices  use  beginning  of  period  market  capitalization  weighting.  Index  Data:  Calculated  (or  Derived)  based  from  CRSP 
NASDAQ  Stock  Market  (US  Companies),  Center  for  Research  in  Security  Prices  (CRSP®),  Graduate  School  of  Business,  The  University  of 
Chicago. Copyright 2018. Used with permission. All rights reserved. 

37 

 
 
 
 
  
  
  
  
  
  
 
   
   
   
   
   
 
   
   
   
   
   
 
 
 
 
 
 
Securities Authorized for Issuance Under Equity Compensation Plans 

The  following  table  contains  information  regarding  our  equity  compensation  plans  as  of  December 31,  2017  (in 

thousands, except weighted-average price): 

Number of 
securities to be 
issued upon 
exercise of 
outstanding 
options, warrants 
and rights 

Weighted-average 
exercise price of 
outstanding options, 
warrants and rights 

Number of securities 
remaining available for 
future issuance under 
equity compensation plans 
(excluding securities 
reflected in column (a)) 

Plan category 

(a) 

(b) 

(c) 

Equity compensation Plans approved by security 
holders 

3,623 (1),(3) 

  $ 

20.40 

619 (2),(3) 

(1)  Consists of 3,622,834 shares of Common Stock subject to the options granted under the Merit Medical Systems, Inc. 2006 Long-

Term Incentive Plan. 

(2)  Consists of 126,863 shares available to be issued under the Merit Medical Systems, Inc. Non-Qualified Employee Stock Purchase 

Plan and 492,292 shares available to be issued under the Merit Medical Systems, Inc. 2006 Long-Term Incentive Plan. 

(3)  See Note 11 to our consolidated financial statements set forth in Item 8 of this report for additional information regarding  these 

plans. 

38 

 
 
 
  
  
  
  
  
  
  
  
  
    
  
  
    
    
    
 
 
 
 
Item 6.  Selected Financial Data (in thousands, except per share amounts).  

OPERATING DATA: 
Net Sales 
Cost of Sales 

Gross Profit 

Operating Expenses: 

Selling, general, and administrative 
Research and development 
Intangible asset impairment charge 
Contingent consideration expense (benefit) 
Acquired in-process research and development 

2017 

2016 

2015 

2014 

2013 

$  727,852     $ 603,838     $  542,149     $  509,689     $  449,049  
401,599      338,813      306,368      284,467      254,682  
326,253      265,025      235,781      225,222      194,367  

229,134      184,398      156,348      147,894      128,642  
33,886  
51,403     
809     
8,089  
(4,094 ) 
(298 )   
—  
12,136     

40,810     
—     
80     
1,000     

45,229     
—     
61     
461     

36,632     
1,102     
(572 )   
—     

Total operating expenses 

293,184      230,149      198,238      185,056      166,523  

Income from Operations 

33,069     

34,876     

37,543     

40,166     

27,844  

Other Income (Expense): 

Interest income 
Interest expense 
Bargain purchase gain 
Other income (expense) 

Other income (expense)—net 

381     
(7,736 )   
11,039     
(872 )   
2,812     

81     
(8,798 )   
—     
(773 )   

272     
(6,229 )   
—     
(386 )   

(9,490 )   

(6,343 )   

217     
(8,829 )   
—     
18     
(8,594 )   

255  
(8,044 ) 
—  
(216 ) 

(8,005 ) 

Income Before Income Taxes 

35,881     

25,386     

31,200     

31,572     

19,839  

Income Tax Expense 

8,358     

5,265     

7,398     

8,598     

3,269  

Net Income 

$  27,523     $  20,121     $  23,802     $  22,974     $  16,570  

Earnings Per Common Share: 

Diluted 

Average Common Shares: 

Diluted 

BALANCE SHEET DATA: 
Working capital 
Total assets 
Long-term debt, less current portion 
Stockholders’ equity 

$ 

0.55     $ 

0.45     $ 

0.53     $ 

0.53     $ 

0.39  

50,101     

44,862     

44,511     

43,409     

42,884  

$  200,501     $ 155,092     $  116,093     $  116,910     $  110,321  
1,111,811      942,803      778,728      747,165      728,283  
259,013      314,373      197,593      214,490      238,854  
676,334      498,189      466,103      435,259      405,706  

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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, which are included in Item 8 of this report. 

Overview 

We design, develop, manufacture and market 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 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 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 core 
product groups: peripheral intervention, cardiac intervention, interventional oncology and spine, cardiovascular and critical care 
and endoscopy. 

For the year ended December 31, 2017, we reported sales of approximately $727.9 million, up approximately $124.0 

million or 20.5%, over 2016 sales of approximately $603.8 million.  

Gross profit as a percentage of sales increased to 44.8% for the year ended December 31, 2017 as compared to 43.9% 

for the year ended December 31, 2016. 

Net income for the year ended December 31, 2017 was approximately $27.5 million, or $0.55 per share, as compared 

to $20.1 million, or $0.45 per share, for the year ended December 31, 2016.  

We continue to focus our efforts on expanding our presence in foreign markets, particularly Europe, Middle East and 
Africa ("EMEA"), China, Southeast Asia, Japan, Australia and Brazil, in an effort to expand our market opportunities. These 
efforts have increased our selling, general and administrative expenses, but we believe over time they will help us improve our 
profitability. Our international sales growth was strong for the year ended December 31, 2017. In 2017, international sales were 
approximately $307.1 million, or 42% of our net sales, up 32% from 2016.  

We believe the following new products will help us continue our growth objectives in 2018: 

SwiftNINJA® Steerable Microcatheter 

•  Achieve® Automatic Biopsy System 
•  Temno® Soft Tissue Biopsy System 
•  Tru-Cut® Biopsy Device 
•  CorVocet™ Biopsy System 
•  Aspira® Pleural Effusion Drainage System 
•  Aspira® Peritoneal Drainage System  
• 
•  Elation® GI & Pulmonary Balloons 
•  TWISTER® PLUS Rotatable Retrieval Device 
Prelude IDeal™ Hydrophilic Sheath Introduer 
• 
Prelude SYNC™ Radial Compression Device 
• 
• 
Prelude Choice™ Hemostasis Valve Adapter 
•  HeRO® Graft 
• 
Super HeRO® 
•  True Form™ Guide Wires  
•  Heartspan® Transseptal Sheath 
•  Amplatz Guide Wires 
•  Critical care products acquired from Argon  
•  DualCap® disinfection and protection products acquired from Catheter Connections 
•  QuadraSphere® Q2 Microsphere 

We believe these new products will strengthen our product  portfolio and help us achieve greater market penetration, 

which, if successful, is expected to drive top-line growth. 

40 

 
 
 
 
 
  
 
 
 
 
 
 
 
 
We anticipate that our business will be impacted in 2018 by the following trends, each resulting from the development 

of our business model, as well as changes in the business and regulatory environment in which we operate: 

• 

• 

• 

• 

• 

• 

• 

• 

We  anticipate  continued  international  expansion  through  the  transition  from  a  distributor-based  sales  model  to  a 
modified  direct  sales  model,  which  is  already  in  place  in  a  number  of  markets,  including  China. We  believe  this 
transition will improve revenue growth opportunities by providing us with greater control over the sales channel and 
improving gross margins, as we move from a wholesale channel to a retail channel. On the other hand, the transition 
may  result  in  increased  costs,  primarily  as  a  result  of  increased  compensation  expenses  for  existing  and  new  sales 
personnel. 

We also anticipate we will continue to expand product registrations of existing products and introduce new products in 
new and emerging markets, in an effort to increase the breadth of our product portfolio offered in international markets, 
thereby  supporting  revenue  growth  and  margin  expansion.  Improvement  in  gross  margin  remains  a  key  priority  for 
management,  through  the  management  of  product  mix,  continued  improvement  of  operational  performance  and 
continued new product introductions. However, any reversal in the aforementioned trends could have a negative impact 
on our future revenue and gross margin.  

Our revenue growth has been driven by, and we expect our revenue to continue to increase in the future as a result of, 
the introduction of new products, continued international expansion, and increased physician awareness of our products, 
among other factors. Any reversal in these trends could have a negative impact on our future revenue. In addition, we 
have continuously expanded our sales and marketing infrastructure to help us drive and support revenue growth and we 
intend to continue this expansion. 

Our revenue may fluctuate, from quarter to quarter, as well as within each quarter, due to a variety of factors, including 
the seasonality of demand for our products, foreign exchange fluctuations, the timing of new product introductions, 
competitor product introductions, associated physician evaluations and competitor pricing changes. 

Our gross margin has been, and we expect it will continue to be, affected by a variety of factors, including product sales 
mix, geographic sales mix and prices, launch of new products, the impact of distributor relationships and our focus on 
expanding  to  a  modified  direct  sales  model,  production  volumes,  manufacturing  costs  and  product  yields,  and  the 
implementation of cost-reduction strategies. As we continue to expand through acquisitions, the acquisitions may be 
gross margin dilutive. Our gross margins could be negatively affected to the extent that the products acquired have gross 
margins that differ from ours. For example, the gross margin for the critical care products we acquired from Argon 
during 2017 is less than our current gross margin. However, improvement in gross margin remains a key priority for 
management, through the control of product mix, continued improvement of operational performance and continued 
introductions of new product. 

The integration of recently completed acquisitions may increase our operating expenses, and it may take time to realize 
expected revenue from acquisitions. While we expect to integrate our acquired businesses  successfully, the expected 
synergies may not materialize. 

We continue to experience a variety of financial risks including changes in foreign currency exchange rates, especially 
when our acquisitions increase the proportion of our revenue from international sales; risks associated with our variable 
floating rate borrowings, which could negatively affect us in an increasing interest rate environment; and the potentially 
substantial changes to fiscal, healthcare, trade and tax policies and legislation, which may include comprehensive tax 
reform and changes to existing trade agreements, including, but not limited to, NAFTA, as well as healthcare reform, 
including the potential repeal of certain provisions of the Affordable Care Act. 

On  December  22,  2017,  the  U.S.  government  enacted  the  TCJA,  which  makes  changes  to  the  corporate  tax  rate, 
business-related deductions and taxation of foreign earnings, among others, that will generally be effective for taxable 
years beginning after December 31, 2017. We continue to evaluate the TCJA requirements, as well as its applications 
to our business operations. 

Our management utilizes a range of financial and non-financial key performance indicators to manage our business. 
The financial indicators we use include ratio of revenue to market growth, product mix, gross margin improvement, operating 
expense leverage, net income growth, working capital and cash flow metrics, capital allocation and return on investment. The 
non-financial indicators we use include various quality system and operational utilization metrics.  

41 

 
 
 
 
 
 
 
 
 
 
 
 
 
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 
Intangible asset impairment charges 
Contingent consideration expense (benefit) 
Acquired in-process research and development expenses 
Income from operations 
Income before income taxes 
Net income 

2017 

100% 
44.8 
31.5 
7.1 
0.1 
— 
1.7 
4.5 
4.9 
3.8 

2016 

100% 
43.9 
30.5 
7.5 
— 
— 
0.1 
5.8 
4.2 
3.3 

2015 

100% 
43.5 
28.8 
7.5 
— 
— 
0.2 
6.9 
5.8 
4.4 

Listed below are the sales by product category within each business segment for the years ended December 31, 2017, 

2016 and 2015 (in thousands): 

Cardiovascular 

Stand-alone devices 
Custom kits and procedure trays 
Inflation devices 
Catheters 
Embolization devices 
CRM/EP 

Total 

Endoscopy 

Endoscopy devices 

Total 

% Change 

2017 

   % Change 

2016 

   % Change 

2015 

44% 
6% 
8% 
13% 
8% 
15% 

21% 

  $  275,431     
126,114     
79,875     
127,747     
49,532     
41,914     
700,613     

23% 
2% 
1% 
17% 
2% 
8% 

11% 

  $ 191,148     
   119,226     
73,916     
   113,367     
46,035     
36,459     
   580,151     

8% 
5% 
1% 
11% 
3% 
3% 

6% 

  $  155,414  
116,368  
73,373  
96,833  
45,025  
33,902  
520,915  

15% 

27,239     

12% 

23,687     

18% 

21,234  

21% 

  $  727,852     

11% 

  $ 603,838     

6% 

  $  542,149  

Note: Certain product categories for 2016 have been adjusted from prior disclosure to reflect changes in product classifications 
to be consistent with updates in the management of our product portfolios in 2017. 

Cardiovascular  Sales.  Our  cardiovascular  sales  for  the  year  ended  December 31,  2017  were  approximately  $700.6 
million, up 20.8%, when compared to the corresponding period for 2016 of approximately $580.2 million. Sales for the year 
ended December 31, 2017 were favorably affected by increased sales of (a) our stand-alone devices (particularly our Map™, 
Medallion,  wires, and HeRO® Graft products, as well as new  sales from our acquisitions of the DFINE,  Argon critical care 
division  and  Catheter  Connections  product  lines)  of  approximately  $84.3  million,  up  44.1%;  (b)  catheters  (particularly  our 
SwiftNINJA®  product  line,  Concierge®  Guiding  Catheters,  Prelude®  radial  sheath  product  line,  and  our  Maestro® 
microcatheters) of approximately $14.4 million, up 12.7%; and (c) our custom kits and procedure trays of approximately $6.9 
million, up 5.8%, which includes sales from our acquisition of ITL.  

Our cardiovascular sales for the year ended December 31, 2016 were approximately $580.2 million, up 11.4%, when 
compared to the corresponding period for 2015 of approximately $520.9 million. Sales for the year ended December 31, 2016 
were favorably affected by increased sales of (a) our stand-alone devices (particularly our infusion bag, Map™, and Ensnare® 
products, as well as new sales from our acquisitions of the Hero Graft device and the DFINE product line) of approximately 
$35.7  million,  up  23.0%;  (b)  catheters  (particularly  our  Impress®  product  line,  Performa®  vessel  sizing  catheters,  and  our 
Maestro®  microcatheters)  of  approximately  $16.5  million,  up  17.1%;  and  (c)  our  custom  kits  and  procedure  trays  of 
approximately $2.9 million, up 2.5%.  

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Sales by our European direct sales force 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 increased sales 0.1% in 2017 
compared to 2016 and decreased sales 0.8% in 2016 compared to 2015. New products and market share gains in our existing 
product lines were additional sources of revenue growth. 

Endoscopy Sales. Our endoscopy sales for the year ended December 31, 2017 were approximately $27.2 million, up 
15.0%, when compared to sales in 2016 of approximately $23.7 million. This increase was primarily related to an increase in 
sales of our EndoMAXX™ fully covered esophageal stent and our Elation® balloon dilator. Our endoscopy sales for the year 
ended December 31, 2016 were approximately $23.7 million, up 11.6%, when compared to sales in the corresponding period of 
2015 of approximately $21.2 million. This increase  was primarily related to an increase in sales of our EndoMAXX™ fully 
covered esophageal stent, as well as the introduction of our Elation® balloon dilator.  

International Sales. International sales for the year ended December 31, 2017 were approximately $307.1 million, or 
42%  of  net  sales,  up  32%  from  the  same  period  in  2016.  International  sales  for  the  year  ended  December  31,  2016  were 
approximately $233.5 million, or 39% of net sales, up 9% from the same period in 2015. The increase in our international sales 
during 2017 was primarily related to a year-over-year sales increase in China of approximately $13.4 million, or 22.4%, the 
acquisition of the critical care division of Argon and sales in new modified direct markets in South Korea, Japan and India, as 
well as continued growth in direct markets added in 2016, namely Canada, Australia and Russia. The increase in our international 
sales during 2016 was primarily related to a year-over-year sales increase in China of approximately $9.2 million, or 18.2%, as 
well as sales in the new direct markets in Canada, Australia, and Russia.  

Gross  Profit.  Our  gross  profit  as  a  percentage  of  sales  was  44.8%,  43.9%,  and  43.5%  in  2017,  2016  and  2015, 
respectively. The increase in gross margin for 2017, as compared to 2016, was primarily related to changes in product mix and 
increased efficiencies gained from our operations team. The increase in gross margin for 2016, as compared to 2015 was primarily 
related to our increased focus on higher margin products and the suspension of the medical device tax in the United States, which 
was partially offset by increased amortization as part of the DFINE acquisition.  

Selling,  General  and  Administrative  Expenses.  Our  selling,  general  and  administrative  expenses  increased 
approximately $44.7 million,  or 24.3%, in 2017 compared to 2016 and $28.1 million, or 17.9%, in 2016 compared to 2015. 
Selling, general and administrative expenses as a percentage of sales were 31.5%, 30.5%, and 28.8% in 2017, 2016 and 2015, 
respectively.  

The increase in selling, general, and administrative expenses for the year ended December 31, 2017 compared to the 
year ended December 31, 2016 was primarily related to legal expenses of approximately $12.6 million incurred in responding to 
the pending subpoena from the U.S. Department of Justice, $6.6 million of acquisition and integration-related costs, increased 
headcount, increased amortization, and foreign market expansion. 

The increase in selling, general, and administrative expenses for the year ended December 31, 2016 compared to the 
year ended December 31, 2015 was primarily related to headcount additions, $1.0 million of expenses incurred in responding to 
an inquiry from the U.S. Department of Justice, $4.5 million of acquisition and integration-related costs and $10.3 million of 
severance costs primarily related to the DFINE acquisition, which were partially offset by a decrease in our foreign-currency-
based expenses of approximately $1.6 million due to fluctuations in the exchange rates between the U.S. Dollar and various 
foreign currencies.  

Research and Development Expenses. Research and development ("R&D") expenses increased by $6.2 million or 13.7% 
to approximately $51.4 million in 2017, compared to approximately $45.2 million in 2016. The increase in R&D expenses for 
the year ended December 31, 2017 was largely due to hiring additional research and development personnel to support various 
new core and acquired product developments. Research and development expenses increased by 10.8% to approximately $45.2 
million in 2016, compared to approximately $40.8 million in 2015. The increase in R&D expenses for the year ended December 
31,  2016  was  largely  due  to  hiring  of  additional  research  and  development  personnel  to  support  various  new  product 
developments. Our research and development expenses as a percentage of sales were 7.1%, 7.5% and 7.5% for 2017, 2016, and 
2015,  respectively.  We  have  a  pipeline  of  new  products,  and  we  believe  that  we  have  an  effective  level  of  capabilities  and 
expertise to continue the flow of new, internally developed products into the foreseeable future with average gross margins that 
are higher than our historical gross margins.  

In  addition,  during  the  years  ended  December 31,  2017,  2016  and  2015  we  incurred  in-process  research  and 
development charges of approximately $12.1 million, $0.5 million and $1.0 million, respectively. The increase in our in-process 
research  and  development  charges  for  the  year  ended  December  31,  2017  was  primarily  driven  by  the  acquisition  of 
IntelliMedical and its intellectual property rights associated with a steerable guidewire system as discussed in Note 2 of the notes 
to our consolidated financial statements. 

43 

 
 
 
   
 
 
 
 
 
 
Our  operating profits by business segment  for the  years ended December 31, 2017, 2016 and 2015  were as follows 

(in thousands): 

Operating Income (1) 

Cardiovascular 
Endoscopy 

Total operating income 

2017 

2016 

2015 

$ 

$ 

24,819  
8,250  
33,069  

  $ 

  $ 

30,053  
4,823  
34,876  

  $  34,052  
3,491  
  $  37,543  

(1)  Operating income has been adjusted from earlier reported amounts in 2016 to reflect changes in product classifications between our 

operating segments, which were made to be consistent with updates in the management of our product portfolios in 2017. 

Cardiovascular Operating Income. Our cardiovascular operating income for the year ended December 31, 2017 was 
approximately $24.8 million, compared to operating income of approximately $30.1 million for the year ended December 31, 
2016. This decrease in cardiovascular operating income was primarily related to legal expenses of approximately $12.6 million 
incurred in responding to the pending subpoena from the U.S. Department of Justice, $6.6 million of acquisition and integration-
related costs, increased headcount, increased amortization, and foreign market expansion. Our cardiovascular operating income 
for the year ended December 31, 2016 was approximately $30.1 million, compared to operating income of approximately $34.1 
million  for  the  year  ended  December 31,  2015.  This  decrease  was  primarily  related  to  headcount  additions,  $1.0  million  of 
expenses incurred in responding to an inquiry from the U.S. Department of Justice, $4.5 million of acquisition and integration-
related costs and $10.3 million of severance costs primarily related to the DFINE acquisition, which were partially offset by a 
decrease in our foreign-currency-based expenses of approximately $1.6 million due to fluctuations in the exchange rates between 
the U.S. Dollar and various foreign currencies. 

Endoscopy  Operating  Income.  Our  endoscopy  operating  income  for  the  year  ended  December 31,  2017  was 
approximately $8.3 million, compared to approximately $4.8 million for the year ended December 31, 2016. This increase was 
primarily the result of higher sales, improved gross margins, and lower SG&A expenses as a percentage of sales. Our endoscopy 
operating  income  for  the  year  ended  December 31,  2016  was  approximately  $4.8  million,  compared  to  approximately  $3.5 
million for the year ended December 31, 2015. This increase was primarily the result of higher sales, improved gross margins, 
and lower SG&A expenses as a percentage of sales, partially offset by increased R&D expenses as a percentage of sales. 

Effective Tax Rate. Our effective income tax rate for 2017, 2016 and 2015 was 23.3%, 20.7%, and 23.7%, respectively. 
On December 22, 2017, the U.S. government enacted the TCJA, which significantly revises the U.S. corporate tax by, among 
other things, lowering the corporate tax rates and imposing a one-time repatriation tax on deemed repatriated earnings of foreign 
subsidiaries (“transition tax”). The increase in the effective income tax rate for 2017 compared to 2016 was primarily the result 
of increased tax expense due  to the transition tax, partially offset by the favorable impact of the reduced tax rate  on our net 
deferred tax liabilities. The decrease in the effective tax rate for 2016 compared to 2015 was due primarily to a higher mix  of 
earnings from our foreign operations, primarily Ireland where the statutory rate is 12.5% compared to the U.S. federal rate of 
35%. 

Other  Income  (Expense).  Our  other  income  (expense)  for  the  years  ended  December 31,  2017,  2016  and  2015  was 
approximately $2.8 million, $(9.5) million, and $(6.3) million, respectively. The change in other income (expense) for 2017 over 
2016 was principally the result of a gain on bargain purchase related to the acquisition of the Argon critical care division  of 
approximately $11.0 million. The increase in other expense for 2016 over 2015 was principally the result of increased interest 
expense  related  to  higher  debt  balances  as  a  result  of  our  acquisition  of  DFINE,  as  well  as  losses  on  fluctuations  in  foreign 
exchange rates.  

Net Income. Our net income for 2017, 2016 and 2015 was approximately $27.5 million, $20.1 million, and $23.8 million, 
respectively. The increase in net income for 2017, when compared to 2016, was primarily due to increased sales, gross margin 
improvement and the gain on bargain purchase of approximately $11.0 million related to the acquisition of the Argon critical 
care division, which was partially offset by the acquired in-process research and development expenses of approximately $12.1 
million attributable to the IntelliMedical acquisition, approximately $12.6 million of legal expenses incurred in responding to the 
pending subpoena from the U.S. Department of Justice, and approximately $6.6 million of acquisition and integration-related 
costs. The decrease in net income for 2016, when compared to 2015, was primarily due to acquisition and severance costs, as 
well as increased interest expense related to higher debt balances related to the DFINE acquisition, which were partially offset 
by a higher gross margin percentage and a lower effective tax rate.  

Total Assets. Total assets utilized in our cardiovascular segment were approximately $1.10 billion as of December 31, 
2017, compared to approximately $932.9 million as of December 31, 2016 and approximately $768.0 million as of December 

44 

 
 
  
  
  
  
  
   
  
   
  
  
 
 
 
 
 
 
31, 2015. Total assets utilized in our endoscopy segment were approximately $8.0 million as of December 31, 2017, compared 
to approximately $9.9 million as of December 31, 2016 and approximately $10.8 million as of December 31, 2015.  

Off-Balance Sheet Arrangements. We do not have any off-balance sheet arrangements that have had, or are reasonably 
likely in the future to have, an effect on our financial condition, results of operations, liquidity, capital expenditures or capital 
resources. 

Liquidity and Capital Resources 

Capital Commitments and Contractual Obligations 

The following table summarizes our capital commitments and contractual obligations as of December 31, 2017, as well 

as the future periods in which such payments are currently anticipated to become due: 

Payment due by period (in thousands) 

  $ 

Contractual Obligations 

Long-term debt 
Interest on long-term debt (1) 
Operating leases 
Royalty obligations 

   After 5 Years 
—  
—  
57,211  
2,065  
59,276  
(1)  Interest payments on our variable long-term debt were forecasted using the LIBOR forward curves plus a base of 1.25% based on 
the terms of our Second Amended Credit Agreement. Interest payments on a portion of our long-term debt were forecasted using 
a fixed rate of 2.365% as a result of our interest rate swap (see Note 8 to our consolidated financial statements set forth in Item 8 
of this report). 

   Less than 1 Year     1-3 Years 
19,459     $ 
10,783     
12,293     
284     
42,819     $ 

Total 
278,959     $ 
38,846     
104,043     
3,728     
425,576     $ 

227,000     $ 
6,020     
13,995     
605     
247,620     $ 

32,500     $ 
22,043     
20,544     
774     
75,861     $ 

Total contractual cash 

4-5 Years 

  $ 

As of December 31, 2017, we had approximately $11.0 million of contingent consideration liabilities, $2.7 million of 
unrecognized tax positions, and $11.2 million of deferred compensation payable that have been recognized as liabilities that have 
not been included in the contractual obligations table due to uncertainty as to when such amounts may be settled.  

Additional information regarding our capital commitments and contractual obligations, including royalty payments, is 

contained in Notes 7 and 9 to our consolidated financial statements set forth in Item 8 below. 

Cash Flows 

At December 31, 2017 and 2016, we had cash and cash equivalents of approximately $32.3 million and $19.2 million 
respectively, of which approximately $30.4 million and $18.4 million, respectively, were held by foreign subsidiaries. The TCJA 
one-time repatriation tax liability effectively taxes the undistributed earnings previously deferred from U.S. income taxes. The 
Company has not provided for foreign withholding tax on the undistributed earnings from our non-U.S. subsidiaries because 
such earnings are considered to be indefinitely reinvested. The cash held by our foreign subsidiaries for indefinite reinvestment 
is used to fund the operating activities of our foreign subsidiaries and for further investment in foreign operations. 

In  addition,  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, 2017 and 2016, we had cash and 
cash equivalents of approximately $13.1 million and $9.5 million, respectively, held by our subsidiary in China. 

Cash flows provided by operating activities. Cash provided by operating activities during the years ended December 
31, 2017 and 2016 was primarily the result of net income excluding non-cash items, offset by shifts in working capital. Our 
working capital as of December 31, 2017, 2016 and 2015 was approximately $200.5 million, $155.1 million and $116.1 million, 
respectively. The increase in working capital as of December 31, 2017 compared to December 31, 2016 was primarily the result 
of increases in cash, trade receivables and inventories, which were partially offset by an increase in accrued expenses and the 
current portion of long-term debt. The increase in working capital as of December 31, 2016 compared to December 31, 2015 was 
primarily the result of increases in cash, trade receivables and inventories, as well as a decrease in trade payables, which  were 
partially offset by an increase in accrued expenses. As of December 31, 2017 and 2016, we had a current ratio of 2.73 to 1 and 
2.76 to 1, respectively.  

During  the  year  ended  December  31,  2017,  our  inventory  balance  increased  approximately  $34.6  million,  from 
approximately $120.7 million as of December 31, 2016 to approximately $155.3 million as of December 31, 2017. The increase 

45 

 
 
 
 
 
 
  
  
  
  
  
  
  
 
 
 
 
 
 
 
 
in the inventory balance was due to several factors, including acquisitions, increased sales, and the opening of new modified 
direct sales markets in South Korea, India, and Japan. During the year ended December 31, 2016, our inventory balance increased 
approximately  $14.7  million,  from  approximately  $106.0  million  at  December  31,  2015  to  approximately  $120.7  million  at 
December 31, 2016. The increase in the inventory balance was due to several factors, including increased sales, the acquisition 
of DFINE and the opening of new direct-sales markets in Canada, Australia, and Russia. The trailing twelve month inventory 
turns for the period ended December 31, 2017 was 2.91, compared to 2.99 for the twelve-month period ended December 31, 
2016.  

Cash flows provided by (used in) financing activities. Cash provided by financing activities for the year ended December 
31, 2017 was approximately $96.5 million compared to approximately $121.1 million for the year ended December 31, 2016, a 
decrease of approximately $24.6 million. The decrease in net cash provided from financing activities was primarily the result 
of a decrease in the proceeds from the issuance of long-term debt, which was partially offset by our public equity offering of 
5,175,000  shares  of  common  stock  from  which  we  received  net  proceeds  of  approximately  $136.6  million,  which  is  net  of 
approximately $8.8 million in underwriting discounts and commissions and approximately $816,000 in other direct cost incurred 
and paid by us in connection with this equity offering. 

Cash  provided  by  financing  activities  for  the  year  ended  December  31,  2016  was  approximately $121.1  million, 
compared to cash used in financing actives of approximately $(10.2) million for the year ended December 31, 2015, a change of 
approximately $131.3 million. This change was primarily the result of increased debt financing related to acquisitions, principally 
our acquisitions of DFINE and the HeRO Graft device and other related assets, as well as reduced proceeds from the issuance of 
common stock, during the year ended December 31, 2016, compared to the year ended December 31, 2015. 

The Second Amended Credit Agreement provides for a term loan of $150 million and a revolving credit commitment 
up to an aggregate amount of $375 million, which includes a reserve of $25 million to make swingline loans from time to time. 
The term loan is payable in quarterly installments in the amounts provided in the Second Amended Credit Agreement until the 
maturity date of July 6, 2021, at which time the term and revolving credit loans, together with accrued interest thereon, will be 
due and payable. At any time prior to the maturity date, we may repay any amounts owing under all revolving credit loans, term 
loans, and all swingline loans in whole or in part, subject to certain minimum thresholds, without premium or penalty, other than 
breakage costs. 

Revolving credit loans denominated in dollars and term loans made under the Second Amended Credit Agreement bear 
interest, at our election, at either a Base Rate or Eurocurrency Base Rate (as such terms are defined in the Second Amended 
Credit  Agreement)  plus  the  applicable  margin,  which  increases  as  our  Consolidated  Total  Leverage  Ratio  (as  defined  in  the 
Second Amended Credit Agreement) increases. Revolving credit loans denominated in an Alternative Currency (as defined in 
the Second 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. Upon an event of default, the interest rate may be increased by 2.0%. The 
revolving credit commitment will also carry a commitment fee of 0.15% to 0.40% per annum on the unused portion. 

The Second Amended Credit Agreement is collateralized by substantially all our assets. The Second Amended Credit 
Agreement contains covenants, representations and warranties and other terms customary for loans of this nature. The Second 
Amended Credit Agreement requires that we maintain certain financial covenants, as follows: 

Covenant Requirement 

Consolidated Total Leverage Ratio (1) 

July 1, 2017 through December 31, 2017    
January 1, 2018 through March 31, 2018    
April 1, 2018 and thereafter 

Consolidated EBITDA (2) 
Consolidated Net Income (3) 
Facility Capital Expenditures (4) 
(1)  Maximum Consolidated Total Leverage Ratio (as defined in the Second Amended Credit Agreement) as of any fiscal quarter end. 
(2)  Minimum ratio of Consolidated EBITDA (as defined in the Second Amended Credit Agreement and adjusted for certain expenditures) 
to Consolidated Fixed Charges (as defined in the Second Amended Credit Agreement) for any period of four consecutive fiscal quarters. 
(3)  Minimum level of Consolidated Net Income (as defined in the Second Amended Credit Agreement) for certain periods, and subject to 

certain adjustments. 

(4)  Maximum level of the aggregate amount of all Facility Capital Expenditures (as defined in the Second Amended Credit Agreement) in 

any fiscal year. 

46 

3.75 to 1.0 
3.5 to 1.0 
3.25 to 1.0 
1.25 to 1.0 
$— 
$30 million 

 
 
 
 
 
 
 
  
  
  
  
  
  
  
  
  
  
  
  
Additionally, the Second Amended Credit Agreement contains customary events of default and affirmative and negative 
covenants for transactions of this type. As of December 31, 2017, we believe we were in compliance with all covenants set forth 
in the Second Amended Credit Agreement. 

As of December 31, 2017, we had outstanding borrowings of approximately $272.0 million under the Second Amended 
Credit Agreement, with available borrowings of approximately $188.0 million, based on the leverage ratio required pursuant to 
the Second Amended Credit Agreement. Our interest rate as of December 31, 2017 was a fixed rate of 2.68% on $175.0 million 
as a result of an interest rate swap (see Note 8) and a variable floating rate of 2.82% on $97.0 million. Our interest rate as of 
December 31, 2016 was a fixed rate of 3.12% on $45.0 million and 2.98% on $130.0 million as a result of interest rate swaps, 
and a variable floating rate of 2.77% on approximately $150.0 million. 

Cash flows used in investing activities. Our cash flow used in investing activities for the year ended December 31, 2017 
was approximately $146.8 million compared to approximately $159.1 million for the year ended December 31, 2016, a decrease 
of approximately $12.3 million. This decrease was primarily a result of a decrease of approximately $19.6 million in net cash 
paid for acquisitions during the year ended December 31, 2017, compared to the year ended December 31, 2016 (see Note 2), 
partially offset by a $5.8 million increase in capital expenditures for property and equipment.  

Our cash flow used in investing activities for the year ended December 31, 2016 was approximately $159.1 million, 
compared to approximately $62.0 million for the year ended December 31, 2015, an increase of approximately $97.1 million. 
This increase was primarily a result of more cash paid for acquisitions during the year ended December 31, 2016, compared to 
the year ended December 31, 2015, principally the cash paid in the acquisitions of DFINE and the HeRO Graft device (see Note 
2 of the notes to our consolidated financial statements). 

Capital expenditures for property and equipment were approximately $38.6 million, $32.8 million, and $51.0 million 
for the  years ended December 31, 2017, 2016 and 2015, respectively. 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 $50 to $55 million in 2018 for buildings, property and equipment.  

We  currently  believe  that  our  existing  cash  balances,  anticipated  future  cash  flows  from  operations  and  borrowings 
under the Second 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 

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. Our management has discussed the development and selection of our most critical 
financial  estimates  with  the  audit  committee  of  our  Board  of  Directors.  The  following  paragraphs  identify  our  most  critical 
accounting policies:  

Inventory Obsolescence. Our management reviews on a quarterly basis inventory quantities on hand for unmarketable 
and/or slow-moving products that may expire prior to being sold. This review includes quantities on hand for both raw materials 
and finished goods. 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 products that are unmarketable. This 
review of inventory quantities for unmarketable and/or slow moving products is based on forecasted product demand prior to 
expiration lives.  

Forecasted unit demand is 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, 2017, 2016 and 2015, we recorded obsolescence expense of approximately $6.1 
million, $3.9 million, and $2.8 million, respectively, and wrote off approximately $2.9 million, $2.8 million, and $2.5 million, 
respectively. Based on this historical trend, we believe that our inventory balances as of December 31, 2017 have been accurately 
adjusted for any unmarketable and/or slow moving products that may expire prior to being sold.  

47 

 
 
 
 
 
 
 
 
     
     
Allowance  for  Doubtful  Accounts.  A  majority  of  our  receivables  are  with  hospitals  which,  over  our  history,  have 
demonstrated favorable collection rates. Therefore, we have experienced relatively minimal bad debts from hospital customers. 
In limited circumstances, we have written off bad debts as the result of the termination of our business relationships with foreign 
distributors. The most significant write-offs over our history have come from U.S. and international distributors, as well as from 
U.S. custom procedure tray manufacturers who bundle our products in surgical trays.  

We maintain allowances for doubtful accounts relating to estimated losses resulting from the inability of our customers 
to make required payments. These allowances are based upon historical experience and a review of individual customer balances. 
If the financial condition of our customers were to deteriorate, resulting in an impairment of their ability to make payments, 
additional allowances may be required.  

Stock-Based Compensation. We measure stock-based compensation cost at the grant date based on the value of the 
award and recognize the cost as an expense over the term of the vesting period. Judgment is required in estimating the fair value 
of share-based awards granted and their expected forfeiture rate. If actual results differ significantly from these estimates, stock-
based compensation expense and our results of operations could be materially impacted.  

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. The tax law is 
subject to varied interpretations, and we have taken positions related to certain matters where the law is subject to interpretation. 
Such differences could have a material impact on our income tax provisions and operating results in the period(s) in which we 
make such determination. 

Valuation of Goodwill, Intangible Assets and Contingent Consideration.  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 test 
our goodwill balances for impairment as of July 1 of each year, or whenever impairment indicators arise. We utilize several 
reporting units in evaluating goodwill for impairment. We assess the estimated fair value of reporting units using a combination 
of a guideline public company market-based approach and a discounted cash flow income-based approach. If the carrying amount 
of a reporting unit exceeds the fair value of the reporting unit, an impairment charge is recognized in an amount equal to the 
excess of the carrying amount of the reporting unit goodwill over the implied fair value of that goodwill. This analysis requires 
significant judgment, including estimation of future cash flows and the length of time they will occur, 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 2017, which was completed during the third quarter of 2017, we determined that the fair value of each reporting unit 
with goodwill exceeded the carrying amount by a significant amount.  

We evaluate the recoverability of intangible assets subject to amortization whenever events or changes in circumstances 
indicate that an asset's carrying amount may not be recoverable. This analysis requires similar significant judgments as those 
discussed above regarding goodwill, except that undiscounted cash flows are  compared to the carrying amount of intangible 
assets  to  determine  if  impairment  exists.  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 fourth quarter of 2017, we 
compared the carrying value of the amortizing intangible assets acquired in our July 2015 acquisition of certain assets from Distal 
Access, LLC to the undiscounted cash flows expected to result from the asset group and determined that the carrying amount 
was not recoverable. We then determined the fair value of the amortizing assets related to the Distal Access acquisition 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. Some of the factors that influenced our estimated cash flows were slower than anticipated sales growth in 
the products acquired from our Distal Access acquisition and uncertainty about future sales growth. The excess of the carrying 
value compared to the fair value was recognized as an intangible asset impairment charge. We recorded an impairment charge 
for Distal Access of approximately $809,000. 

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 
milestones. In connection with a business combination, any contingent consideration is recorded on the acquisition date based 
upon the  consideration expected to be transferred in the  future. We utilize a discounted cash flow  method,  which includes a 
probability factor for milestone payments, in valuing the contingent consideration liability. 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. 

48 

 
     
     
     
     
     
 
Significant  increases  or  decreases  in  our  estimates  could  result  in  changes  to  the  estimated  fair  value  of  our  contingent 
consideration liability, as the result of changes in the timing and amount of revenue estimates, as well as changes in the discount 
rate or periods.  

Item 7A.  Quantitative and Qualitative Disclosures About Market Risk. 

Our principal market risk relates to changes in the value of the Euro (EUR), Chinese Yuan Renminbi (CNY), and British 
Pound (GBP) relative to the value of the U.S. Dollar (USD). We also have a limited market risk relating to the Hong Kong Dollar 
(HKD), Mexican Peso (MXN), Australian Dollar (AUD), Canadian Dollar (CAD), Brazilian Real (BRL), Swiss Franc (CHF), 
Swedish  Krona  (SEK),  Danish  Krone  (DKK),  South  Korean  Won  (KRW),  and  Japanese  Yen  (JPY),  among  others.  Our 
consolidated financial statements are denominated in, and our principal currency is, the U.S. Dollar. For the year ended December 
31, 2017, a portion of our net sales (approximately $215.8 million, representing approximately 29.7% 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 Euro-denominated revenue represents our largest single currency risk. However, our Euro-denominated expenses 
associated with our European operations (manufacturing sites, a distribution facility and sales representatives) provide a natural 
hedge. Accordingly, changes in the Euro, and in particular a strengthening of the U.S. Dollar against the Euro, will positively 
affect  our  operating  income.  A  strengthening  U.S.  dollar  against  the  Euro  of  10%  would  increase  operating  income  by 
approximately  $3.2  million  dollars.  Conversely,  a  weakening  U.S.  dollar  against  the  Euro  of 10%  would  decrease  operating 
income by approximately $3.9 million dollars. A strengthening U.S. dollar against the Chinese Renminbi of 10% would decrease 
operating income by approximately $5.2 million dollars. Conversely, a weakening U.S. dollar against the Chinese Renminbi of 
10%  would  increase  operating  income  by  approximately  $6.3  million  dollars.  During  the  year  ended  December  31,  2017, 
exchange  rate  fluctuations  of  foreign  currencies  against  the  U.S.  Dollar  resulted  in  an  increase  in  our  gross  revenues  of 
approximately $0.6  million, or 0.1%, primarily as a  result  of favorable impacts due to sales denominated in EUR and BRL, 
partially offset by unfavorable impacts due to sales denominated in CNY. During the year ended December 31, 2017, exchange 
rate fluctuations of foreign currencies against the U.S. Dollar also resulted in a decrease in gross margin of approximately $0.4 
million, or 0.1% (or approximately 10 basis points in gross margin percentage), primarily as a result of unfavorable impacts from 
EUR fluctuations related to manufacturing costs from our facilities in Europe denominated in EUR, partially offset by favorable 
impacts due to MXN fluctuations on our manufacturing costs from our facility in Tijuana, Mexico denominated in MXN. 

We forecast our net exposure in various receivables and payables to fluctuations in value of various currencies, and we 
enter  into  foreign  currency  forward  contracts  to  mitigate  that  exposure.  As  of  December 31,  2017,  we  had  entered  into  the 
following foreign currency forward contracts (which were not designated as hedging instruments) related to those balance sheet 
accounts (amounts in thousands and in local currencies): 

Currency  

Australian Dollar 
Brazilian Real 
Canadian Dollar 
Swiss Franc 
Chinese Renminbi 
Danish Krone 
Euro 
British Pound 
Hong Kong Dollar 
Japanese Yen 
Korean Won 
Mexican Peso 
Swedish Krona 
Singapore Dollar 

Symbol 

Forward Notional Amount 

5,600  
8,500  
2,076  
242  
22,990  
1,881  
23,333  
1,868  
11,000  
178,500  
1,800,000  
17,540  
4,775  
5,023  

AUD 
BRL 
CAD 
CHF 
CNY 
DKK 
EUR 
GBP 
HKD 
JPY 
KRW 
MXN 
SEK 
SGD 

49 

 
 
 
 
 
 
 
 
We also forecast our net exposure related to sales and expenses denominated in foreign currencies. As of December 31, 
2017, we had entered into foreign currency forward contracts, which qualified as cash flow hedges, with the following notional 
amounts (in thousands and in local currencies): 

Currency  

Canadian Dollar 
Swiss Franc 
Chinese Renminbi 
Danish Krone 
Euro 
British Pound 
Mexican Peso 
Swedish Krona 

Symbol 

CAD 
CHF 
CNY 
DKK 
EUR 
GBP 
MXN 
SEK 

Forward Notional Amount 

2,310  
1,375  
45,000  
14,470  
9,165  
3,625  
95,075  
16,330  

See Note 8 to our consolidated financial statements for a discussion of our foreign currency forward contracts. 

As discussed in Note 7 to our consolidated financial statements set forth in Item 8 of this report, as of December 31, 
the  Second  Amended  Credit 
2017,  we  had  outstanding  borrowings  of  approximately  $272  million  under 
Agreement. Accordingly, our earnings and after-tax cash flow are affected by changes in interest rates. On August 5, 2016, we 
entered into a pay-fixed, receive-variable interest rate swap with Wells Fargo, which as of December 31, 2017 had a notional 
amount of $175 million, to fix the one-month LIBOR rate at 1.12%. The interest rate swap is scheduled to expire on July 6, 2021. 
These instruments are intended to reduce our exposure  to interest rate  fluctuations and  were  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 $1.0 million annually for each one percentage point change in the average interest rate under these borrowings. 

In  the  event  of  an  adverse  change  in  interest  rates,  our  management  would  likely  take  actions  to  mitigate  our 
exposure. However, due to the uncertainty of the actions that would be taken and their possible effects, additional analysis is not 
possible at this time. Further, such analysis would not consider the effects of the change in the level of overall economic activity 
that could exist in such an environment. 

50 

 
 
 
 
 
 
 
 
Item 8.    Financial Statements and Supplementary Data. 

REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM 

To the Board of Directors and Stockholders 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, 2017 and 2016, the related consolidated statements of income, comprehensive income, 
stockholders’ equity, and cash flows for each of the three years in the period ended December 31, 2017, 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, 2017 and 2016, and 
the results of its operations and its cash flows for each of the three years in the period ended December 31, 2017, 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,  2017,  based  on  the  criteria 
established  in  Internal  Control-Integrated  Framework  (2013)  issued  by  the  Committee  of  Sponsoring  Organizations  of  the 
Treadway Commission and our report dated March 1, 2018, 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. 

/s/ DELOITTE & TOUCHE LLP 

Salt Lake City, Utah 
March 1, 2018 
We have served as the Company's auditor since 1988. 

51 

 
 
  
 
  
  
 
 
 
  
 
  
  
  
  
  
  
 
 
 
MERIT MEDICAL SYSTEMS, INC. AND SUBSIDIARIES 
CONSOLIDATED BALANCE SHEETS 
DECEMBER 31, 2017 AND 2016 
(In thousands) 

ASSETS 

CURRENT ASSETS: 

Cash and cash equivalents 
Trade receivables — net of allowance for uncollectible accounts — 2017 — $1,769 and 2016 — 
$1,587 
Other receivables 
Inventories 
Prepaid expenses and other assets 
Prepaid income taxes 
Deferred income tax assets 
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 — 2017 — $72,420 and 2016 — 
$52,843 
Other — net of accumulated amortization — 2017 — $38,127 and 2016 — $30,048 

Goodwill 
Deferred income tax assets 
Other assets 

Total other assets 

TOTAL 

2017 

2016 

$ 

32,336  

   $ 

19,171  

105,536  
9,429  
155,288  
9,096  
3,225  
—  
1,211  

316,121  

19,877  
147,356  
197,651  
49,528  
31,161  
32,896  

478,469  

80,521  
5,643  
120,695  
6,226  
2,525  
8,219  
423  

243,423  

19,379  
139,119  
178,110  
43,433  
30,413  
28,180  

438,634  

(185,649 )    

(162,061 ) 

292,820  

276,573  

167,771  
59,553  
238,147  
2,359  
35,040  

502,870  

135,358  
47,339  
211,927  
171  
28,012  

422,807  

$ 

1,111,811  

   $ 

942,803  

See notes to consolidated financial statements. 

(continued) 

52 

 
 
  
  
  
     
  
  
     
  
     
  
  
  
  
  
  
  
  
  
     
  
  
  
     
  
     
  
  
  
  
  
  
  
  
     
  
  
  
     
  
  
     
  
  
  
     
  
     
  
     
  
  
  
  
  
  
  
     
  
  
  
     
  
  
     
 
 
 
MERIT MEDICAL SYSTEMS, INC. AND SUBSIDIARIES 
CONSOLIDATED BALANCE SHEETS 
DECEMBER 31, 2017 AND 2016  
(In thousands) 

LIABILITIES AND STOCKHOLDERS’ EQUITY 

CURRENT LIABILITIES: 

Trade payables 
Accrued expenses 
Current portion of long-term debt 
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 

OTHER LONG-TERM OBLIGATIONS 

2017 

2016 

$ 

34,931      $ 
58,932     
19,459     
2,298     

30,619  
45,519  
10,000  
2,193  

115,620     

88,331  

259,013     

314,373  

23,289     

25,981  

4,846     

2,746     

11,181     

2,403     

16,379     

—  

438  

9,211  

2,550  

3,730  

Total liabilities 

435,477     

444,614  

COMMITMENTS AND CONTINGENCIES (Notes 2, 7, 8, and 9) 

STOCKHOLDERS’ EQUITY: 

Preferred stock — 5,000 shares authorized as of December 31, 2017 and 2016; no shares 
issued 
Common stock, no par value; shares authorized — 2017 and 2016 - 100,000; issued and 
outstanding as of December 31, 2017 - 50,248 and December 31, 2016 - 44,645 
Retained earnings 
Accumulated other comprehensive income (loss) 

Total stockholders’ equity 

TOTAL 

—     

—  

353,392     
321,408     
1,534     

206,186  
293,885  
(1,882 ) 

676,334     

498,189  

$ 

1,111,811      $ 

942,803  

See notes to consolidated financial statements. 

(concluded) 

53 

 
 
  
  
  
     
  
  
     
  
     
  
  
     
  
  
     
  
  
     
  
  
     
  
  
     
  
  
     
  
  
     
  
  
     
  
  
     
  
  
     
     
  
  
  
     
  
     
  
  
     
  
  
     
  
  
     
 
MERIT MEDICAL SYSTEMS, INC. AND SUBSIDIARIES 
CONSOLIDATED STATEMENTS OF INCOME 
YEARS ENDED DECEMBER 31, 2017, 2016 AND 2015 
(In thousands, except per share amounts) 

NET SALES 

COST OF SALES 

GROSS PROFIT 

OPERATING EXPENSES: 

Selling, general and administrative 
Research and development 
Intangible asset impairment charges 
Contingent consideration expense (benefit) 
Acquired in-process research and development 

Total operating expenses 

INCOME FROM OPERATIONS 

OTHER INCOME (EXPENSE): 

Interest income 
Interest expense 
Gain on bargain purchase 
Other income (expense) - net 

Other income (expense) — net 

INCOME BEFORE INCOME TAXES 

INCOME TAX EXPENSE 

NET INCOME 

EARNINGS PER COMMON SHARE: 

Basic 

Diluted 

AVERAGE COMMON SHARES: 

Basic 

Diluted 

See notes to consolidated financial statements. 

2017 

2016 

2015 

$ 

727,852  

   $ 

603,838  

   $ 

542,149  

401,599  

326,253  

229,134  
51,403  
809  
(298 )    

12,136  

338,813  

306,368  

265,025  

235,781  

184,398  
45,229  
—  
61  
461  

156,348  
40,810  
—  
80  
1,000  

293,184  

230,149  

198,238  

33,069  

34,876  

37,543  

381  
(7,736 )    
11,039  

(872 )    

2,812  

35,881  

8,358  

81  
(8,798 )    
—  
(773 )    

272  
(6,229 ) 
—  
(386 ) 

(9,490 )    

(6,343 ) 

25,386  

5,265  

31,200  

7,398  

$ 

$ 

$ 

27,523  

   $ 

20,121  

   $ 

23,802  

0.56  

   $ 

0.45  

   $ 

0.55  

   $ 

0.45  

   $ 

48,805  

50,101  

44,408  

44,862  

0.54  

0.53  

44,036  

44,511  

54 

 
 
  
  
  
  
  
     
     
  
  
  
  
     
     
  
  
  
  
     
     
  
     
  
   
  
  
  
  
  
  
  
  
  
  
  
     
     
  
  
  
  
     
     
  
  
  
  
     
     
  
     
  
   
  
  
  
  
  
  
     
     
  
  
  
     
     
  
  
  
  
     
     
  
  
  
  
     
     
  
  
     
     
  
     
  
   
  
  
     
     
  
  
     
     
  
     
     
  
  
  
  
     
     
  
  
  
 
 
 
MERIT MEDICAL SYSTEMS, INC. AND SUBSIDIARIES 
CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME 
YEARS ENDED DECEMBER 31, 2017, 2016 AND 2015 
(In thousands) 

Net income 
Other comprehensive income (loss): 

Cash flow hedges 

Less income tax benefit (expense) 

Foreign currency translation adjustment 

Less income tax benefit (expense) 

Total other comprehensive income (loss) 

Total comprehensive income 

See notes to consolidated financial statements. 

2017 
27,523      $ 

2016 
20,121      $ 

2015 
23,802  

$ 

901     
(350 )    
3,117     
(252 )    
3,416     
30,939      $ 

4,784     
(1,861 )   
878     
(196 )   
3,605     
23,726      $ 

(571 ) 
222  
(3,037 ) 
311  
(3,075 ) 
20,727  

$ 

55 

 
 
 
  
  
  
  
     
     
 
 
 
MERIT MEDICAL SYSTEMS, INC. AND SUBSIDIARIES 
CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY 
YEARS ENDED DECEMBER 31, 2017, 2016 AND 2015 
 (In thousands) 

BALANCE — January 1, 2015 

Net income 

Other comprehensive loss 

Excess tax benefits from stock-based compensation 

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, 2015 

Net income 

Other comprehensive income 

Excess tax benefits from stock-based compensation 

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, 2016 

Net income 

Other comprehensive income 

Stock-based compensation expense 

Options exercised 
Issuance of common stock under Employee Stock Purchase 
Plans 

Issuance of common stock, net of offering costs 

Common Stock 

   Retained 

   Accumulated Other 
   Comprehensive 

Total 

   Shares 

   Amount 

   Earnings 

Income (Loss) 

$  435,259      43,614     $  187,709     $  249,962     $ 

(2,412 ) 

23,802     

(3,075 ) 

273,764     

(5,487 ) 

20,121     

3,605  

293,885     

(1,882 ) 

27,523       

3,416  

23,802     
(3,075 )   
2,124     
2,243     
10,029     

2,124     
2,243     
10,029     

858     

441     

23     

441     

(43 )   
(918 )   
(185 )   
(3,802 )   
466,103      44,267     

(918 )     
(3,802 )     
197,826     

20,121     
3,605     
669     
2,506     
4,923     

669     
2,506     
4,923       

362     

694     

34     

694     

(86 )   
(346 )   

(4 )   
(14 )   
498,189      44,645     

(86 )     
(346 )   
206,186     

27,523       
3,416       
4,075       
5,689     

4,075       
5,689       

404     

836     
136,606     

24     
5,175     

836       
136,606       

BALANCE — December 31, 2017 

$  676,334      50,248     $  353,392     $  321,408     $ 

1,534  

See notes to consolidated financial statements. 

56 

 
 
 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
       
    
    
    
      
      
   
      
      
      
      
      
   
      
      
   
      
   
      
   
    
    
  
  
    
    
    
    
      
      
   
      
      
      
      
      
   
      
      
   
    
      
   
    
      
   
  
  
    
    
    
    
    
  
    
    
  
  
    
    
    
    
 
 
 
 
 
MERIT MEDICAL SYSTEMS, INC. AND SUBSIDIARIES 
CONSOLIDATED STATEMENTS OF CASH FLOWS 
YEARS ENDED DECEMBER 31, 2017, 2016 AND 2015 
(In thousands) 

CASH FLOWS FROM OPERATING ACTIVITIES: 

Net income 

2017 

2016 

2015 

$ 

27,523      $ 

20,121      $ 

23,802  

Adjustments to reconcile net income to net cash provided by operating 
activities: 

Depreciation and amortization 
Gain on bargain purchase 
Losses (gains) on sales and/or abandonment of property and equipment 
Write-off of patents and intangible assets 
Acquired in-process research and development 
Amortization of deferred credits 
Amortization of long-term debt issuance costs 
Deferred income taxes 
Excess tax benefits from stock-based compensation 
Stock-based compensation expense 
Changes in operating assets and liabilities, net of effects from acquisitions: 

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 
Long-term income taxes payable 
Liabilities related to unrecognized tax benefits 
Deferred compensation payable 
Other long-term obligations 

Total adjustments 

Net cash provided by operating activities 

CASH FLOWS FROM INVESTING ACTIVITIES: 

Capital expenditures for: 
Property and equipment 
Intangible assets 

Proceeds from sale-leaseback transactions 
Proceeds from sale of cost method investment 
Proceeds from the sale of property and equipment 
Cash paid in acquisitions, net of cash acquired 

53,582     
(11,039 )    
427     
988     
12,136     
(147 )    
685     
(1,304 )    
—     
4,075     

(12,844 )    
(3,557 )    
(17,834 )    
(1,236 )    
(611 )    
(588 )    
(3,735 )    
417     
6,461     
21     
4,846     
(19 )    
1,970     
2,510     

35,204     

62,727     

43,755     
—     
530     
101     
461     
(170 )    
952     
(962 )    
(669 )    
2,506     

(6,816 )    
1,161     
(3,656 )    
271     
404     
406     
(3,763 )    
(6,835 )    
3,242     
1,451     
—     
597     
712     
(200 )    

33,478     

53,599     

(38,623 )    
(2,577 )    
—     
—     
21     
(105,582 )    

(32,837 )    
(2,217 )    
—     
1,089     
19     
(125,161 )    

37,425  
—  
(23 ) 
141  
1,000  
(171 ) 
987  
3,450  
(2,124 ) 
2,243  

(5,872 ) 
335  
(13,113 ) 
(696 ) 
(1,788 ) 
(784 ) 
(362 ) 
14,766  
5,873  
2,199  
—  
536  
(135 ) 
1,769  

45,656  

69,458  

(50,959 ) 
(1,956 ) 
2,017  
—  
1,247  
(12,368 ) 

Net cash used in investing activities 

(146,761 )    

(159,107 )    

(62,019 ) 

See notes to consolidated financial statements.  

(continued) 

57 

 
 
  
  
  
  
  
  
  
   
  
  
  
  
  
  
  
  
  
  
   
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
   
  
  
  
  
   
  
  
  
  
  
  
  
  
  
  
  
  
MERIT MEDICAL SYSTEMS, INC. AND SUBSIDIARIES 
CONSOLIDATED STATEMENTS OF CASH FLOWS 
YEARS ENDED DECEMBER 31, 2017, 2016 AND 2015 
 (In thousands) 

CASH FLOWS FROM FINANCING ACTIVITIES: 

Proceeds from issuance of common stock 

$ 

Offering costs 

Proceeds from issuance of long-term debt 

Payments on long-term debt 

Excess tax benefits from stock-based compensation 

Long-term debt issuance costs 

Contingent payments related to acquisitions 

Payment of taxes related to an exchange of common stock 

2017 

2016 

2015 

143,810      $ 
(816 )    
197,214     
(243,214 )    
—     
(416 )    
(61 )    
—     

5,271      $ 
—     
219,505     
(102,098 )    
669     
(1,948 )    
(218 )    
(86 )    

6,668  
—  
152,375  
(169,272 ) 
2,124  
—  
(1,212 ) 

(918 ) 

Net cash provided by (used in) financing activities 

96,517     

121,095     

(10,235 ) 

EFFECT OF EXCHANGE RATES ON CASH 

682     

(593 )    

(382 ) 

NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS 

13,165     

14,994     

(3,178 ) 

CASH AND CASH EQUIVALENTS: 

Beginning of year 

End of year 

SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION 

Cash paid during the year for: 

Interest (net of capitalized interest of $513, $460 and $325, respectively) 

Income taxes 

SUPPLEMENTAL DISCLOSURES OF NON-CASH INVESTING AND 
FINANCING ACTIVITIES 

Property and equipment purchases in accounts payable 

Cost method investment converted to intangible asset in acquisition in lieu of 
additional cash payment 

Contingent receivable in exchange for sale of cost method investment 

Receivable for issuance of common stock associated with option exercises 

Acquisition purchases in accrued expenses and other long-term obligations 

Merit common stock surrendered (0, 14 and 185 shares, respectively) in 
exchange for exercise of stock options 

19,171     

4,177     

32,336      $ 

19,171      $ 

7,707      $ 

8,872      $ 

6,049      $ 

2,318      $ 

7,355  

4,177  

6,273  

3,409  

1,992      $ 

2,398      $ 

3,199  

—      $ 

—      $ 

137      $ 

10,488      $ 

—      $ 

1,010  

711      $ 

—      $ 

—      $ 

—  

—  

1,300  

—      $ 

346      $ 

3,802  

$ 

$ 

$ 

$ 

$ 

$ 

$ 

$ 

$ 

See notes to consolidated financial statements. 

(concluded) 

58 

 
 
  
  
  
  
     
  
   
  
  
     
     
  
  
     
     
  
  
     
     
  
  
     
     
  
     
  
   
  
  
     
     
  
  
     
     
  
     
     
  
     
     
  
  
     
     
  
  
     
     
  
     
  
   
  
  
     
     
  
  
     
     
  
  
     
     
 
  
  
     
     
  
  
     
     
  
  
     
     
 
MERIT MEDICAL SYSTEMS, INC. AND SUBSIDIARIES 
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS 
YEARS ENDED DECEMBER 31, 2017, 2016 and 2015 

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 core product groups: peripheral intervention, 
cardiac intervention, interventional oncology and spine, cardiovascular and critical care, and endoscopy.  

We manufacture our products in plants located in the United States, Mexico, The Netherlands, Ireland, France, Brazil, 
Australia, and Singapore. We export sales to dealers and have direct or modified direct sales forces in the United States, Canada, 
Western Europe, Australia, Brazil, Russia, Japan, China, Malaysia, South Korea, UAE and India (see Note 12). Our consolidated 
financial statements have been prepared in accordance  with accounting principles  generally accepted in the  United States of 
America. 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 of America ("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. 

Reclassifications. Certain prior period amounts were reclassified to conform to the current period presentation. The 
consolidated balance sheet previously presented employee receivables and advances from employees which are now presented 
as components of other receivables and accrued expenses, respectively. The reclassifications provide a more concise financial 
statement presentation and additional information is disclosed in the notes if material. 

Principles  of  Consolidation. The  consolidated  financial  statements  include  our  wholly  owned  subsidiaries. 

Intercompany balances and transactions have been eliminated. 

Cash and Cash Equivalents. For purposes of the statements of cash flows, we consider interest bearing deposits with 

an original maturity date of three months or less to be cash equivalents. 

Receivables. Trade accounts receivable are recorded at the net invoice value and are not interest bearing. An allowance 
for uncollectible accounts receivable is recorded based on our historical bad debt experience and on 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 uncollectible accounts. 

Inventories. We value our inventories at the lower of cost, 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 at least quarterly and record provisions for estimated excess, slow moving and obsolete inventory, as well 
as  inventory  with  a  carrying  value  in  excess  of  net  realizable  value. The  regular  and  systematic  inventory  valuation  reviews 
include a current assessment of future product demand, historical experience 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. We utilize several reporting units in evaluating goodwill for impairment. We assess the estimated 
fair value of reporting units using a combination of a guideline public company market-based approach and a discounted cash 
flow income-based approach. If the carrying amount of a reporting unit exceeds the fair value of the reporting unit, an impairment 
charge is recognized in an amount equal to the excess of the carrying amount of the reporting unit goodwill over the implied fair 
value of that goodwill. 

Finite-lived  intangible  assets  including  developed  technology,  customer  lists,  distribution  agreements,  license 
agreements, trademarks, covenants not to compete and patents are subject to amortization. Intangible assets are amortized over 

59 

 
  
 
 
 
 
 
 
 
 
 
 
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 the recoverability of our finite-lived intangible assets periodically and take into account events or circumstances that 
warrant revised estimates of useful lives or that indicate impairment exists. 

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 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, 2017, 2016 and 2015 was 

approximately $26.8 million, $24.5 million, and $22.6 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 approximately $11.7 million and $9.9 million at December 31, 
2017 and 2016, respectively, which is included in other assets in our consolidated balance sheets. We have recorded a deferred 
compensation payable of approximately $11.2 million and $9.2 million at December 31, 2017 and 2016, respectively, to reflect 
the liability to our employees under this plan. 

Other  Assets. Other  assets  consist  of  our  deferred  compensation  plan  cash  surrender  value  discussed  above, 
unamortized issuance costs on revolving debt, investments in privately-held companies accounted for at cost, a long-term income 
tax refund receivable, deposits related to various leases, and the long-term assets related to derivatives.  

Deferred Credits. Deferred credits consist of grant money received from the Irish government. Grant money is received 
for a percentage of expenditures on eligible property and equipment, specific research and development projects and costs of 
hiring and training employees. Amounts related to the acquisition of property and equipment are amortized as a reduction of 
depreciation expense over the lives of the corresponding property and equipment. 

Revenue Recognition. We sell our single-use disposable 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. Revenues from these customers are recognized when all of the following have occurred: 
(i) persuasive evidence of an arrangement exists, (ii) delivery has occurred or services have been rendered, (iii) the price is fixed 
or determinable and (iv) the ability to collect is reasonably assured. These criteria are generally satisfied at the time of shipment 
when risk of loss and title passes to the customer. We have certain written agreements with group purchasing organizations to 
sell  our  products  to  participating  hospitals. These  agreements  have  destination  shipping  terms  which  require  us  to  defer  the 
recognition of a sale until the product has arrived at the participating hospitals. We reserve for sales returns, including returns 
related  to  defective  products, as  a  reduction  in  net  sales,  based  on  our  historical  experience. We  also  offer  sales  rebates  and 
discounts to purchasing groups. These reserves are recorded as a reduction in net sales and are not considered material to our 

60 

 
  
 
 
 
 
 
 
 
 
consolidated statements of income for the years ended December 31, 2017, 2016 and 2015. 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. 

As noted further below, we do not expect our reported revenue to be affected materially in any period due to the adoption 
of Accounting Standards Codification ("ASC") Topic 606 because: (1) we expect to identify similar performance obligations 
under ASC Topic 606 as compared with deliverables and separate units of account previously identified; (2) we have determined 
the transaction price to be consistent; and (3) we record revenue at the same point in time, upon shipment or delivery under both 
ASC Topic 605 and ASC Topic 606, as applicable under the terms of the contract with the customer. Additionally, we do not 
expect the accounting for fulfillment costs or costs incurred to obtain a contract to be affected materially in any period due to the 
adoption of Topic 606. 

Shipping and Handling. We bill our customers for shipping and handling charges, which 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 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. The tax law is 
subject to varied interpretations, and we have taken positions related to certain matters where the law is subject to interpretation. 
Such differences could have a material impact on our income tax provisions and operating results in the period(s) in which we 
make such determination. 

Earnings per Common Share. Net income 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 warrants, as calculated using the treasury stock method. 

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 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  share-based  payment 
transactions in accordance with ASC 718, Compensation — Stock Compensation. Under the provisions of ASC 718, share-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. Stock-based compensation expense for the years ended December 31, 2017, 2016 and 2015 was 
approximately $4.1 million, $2.5 million and $2.2 million, respectively. 

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. Sales to our single largest customer accounted 
for approximately 2%, 3%, and 3% of net sales for the years ended December 31, 2017, 2016 and 2015, respectively. 

Foreign  Currency. The  financial  statements  of  our  foreign  subsidiaries  are  measured  using  local  currencies  as  the 
functional currency, with the exception of our subsidiaries in Ireland and Mexico, which each use the U.S. Dollar as its functional 

61 

 
 
 
 
 
 
 
 
 
 
 
 
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  in  accumulated  other 
comprehensive income (loss) as a separate component of stockholders’ equity. Foreign currency transactions denominated in a 
currency other than the entity’s functional currency are included in determining net income for the period. 

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 Second Amended Credit Agreement described 
in  Note  7. 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 8). 

Accumulated Other Comprehensive  Income (Loss). As of December 31, 2017, accumulated other comprehensive 
income included approximately $3.5 million (net of tax of $(2.2) million) related to cash flow hedges and $(1.9) million (net of 
tax of $0) related to foreign currency translation. As of December 31, 2016, accumulated other comprehensive loss included 
approximately $2.9 million (net of tax of $(1.9) million) related to cash flow hedges and $(4.8) million (net of tax of $318,000) 
related to foreign currency translation. 

New Financial Accounting Standards.  

Recently Adopted 

In  January  2017,  the  Financial  Accounting  Standards  Board  (the  “FASB”)  issued  Accounting  Standards  Update 
(“ASU”)  No.  2017-04,  Intangibles  -  Goodwill  and  Other  (Topic  350):  Simplifying  the  Test  for  Goodwill  Impairment,  which 
eliminates the requirement to determine the fair value of individual assets and liabilities of a reporting unit to measure goodwill 
impairment.  Under  these  amendments,  goodwill  impairment  testing  will  be  performed  by  comparing  the  fair  value  of  the 
reporting unit  with its carrying amount and  recognizing an impairment charge for the amount by which the carrying amount 
exceeds the reporting unit’s fair value. We adopted ASU 2017-04 effective January 1, 2017 on a prospective basis, and it did not 
have a material impact on our consolidated financial statements for the year ended December 31, 2017. 

In January 2017, the FASB issued ASU No. 2017-01, Business Combinations (Topic 805): Clarifying the Definition of 
a Business, which provides guidance to assist entities with evaluating when a set of transferred assets and activities is a business 
and provides a screen to determine when a set is not a business. Under the new guidance, when substantially all the fair value of 
gross assets acquired (or disposed of) is concentrated in a single identifiable asset, or group of similar assets, the assets acquired 
would not represent a business. Also, to be considered a business, an acquisition would have to include an input and a substantive 
process that together significantly contribute to the ability to produce outputs. We adopted ASU 2017-01 effective January 1, 
2017 on a prospective basis. The implementation of ASU 2017-01 did not have a material impact on our consolidated financial 
statements for the year ended December 31, 2017. 

In March 2016, the FASB issued ASU No. 2016-09, Compensation - Stock Compensation (Topic 718): Improvements 
to  Employee  Share-Based  Payment  Accounting,  which  requires  companies  to  record  excess  tax  benefits  and  deficiencies  in 
income rather than the current requirement to record them through equity. ASU 2016-09 also allows companies the option to 
recognize forfeitures of share-based awards when they occur rather than the previous requirement to make an estimate upon the 
grant of the awards. We adopted ASU 2016-09 effective January 1, 2017 on a prospective basis and, as such, no prior periods 
were  adjusted.  In  accordance  with  the  new  standard  and  prospectively  since  the  date  we  adopted  ASU  2016-09,  excess  tax 
benefits from stock-based compensation are reported as an income tax benefit in our consolidated statements of income (see Note 
5).  

In November 2015, the FASB issued ASU No. 2015-17, Income Taxes (Topic 740): Balance Sheet Classification of 
Deferred Taxes, which requires all deferred tax assets and deferred tax liabilities to be presented as noncurrent within a classified 
balance sheet. We adopted ASU 2015-17 effective January 1, 2017 on a prospective basis and did not reclassify presentation of 
prior year balances. The adoption of this standard did not have a material impact on our consolidated financial statements for the 
year ended December 31, 2017. 

In  July  2015,  the  FASB  issued  ASU  No.  2015-11,  Simplifying  the  Measurement  of  Inventory,  which  requires  that 
inventory  be  measured  at  the  lower  of  cost  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 measured 
using last-in, first-out or the retail inventory method are excluded from the scope of ASU 2015-11, which is effective for fiscal 
years beginning after December 15, 2016, and interim periods within those fiscal years. The implementation of ASU 2015-11 
did not have a material impact on our consolidated financial statements for the year ended December 31, 2017. 

62 

 
 
 
 
 
 
 
 
 
 
 
Not Yet Adopted 

In February 2018, the FASB issued ASU 2018-02, Income Statement-Reporting Comprehensive Income (Topic 220): 
Reclassification of Certain Tax Effects from Accumulated Other Comprehensive Income, which allows a reclassification from 
accumulated other comprehensive income to retained earnings for stranded tax effects resulting from the Tax Cuts and Jobs Act 
enacted in December 2017. ASU 2018-02 is effective for fiscal years beginning after December 15, 2018, and interim periods 
within those fiscal years. Early adoption is permitted. We do not believe that the adoption of ASU 2018-02 will have a material 
impact on our consolidated financial statements.     

In  August  2017,  the  FASB  issued  ASU  2017-12, Derivatives  and  Hedging  (Topic  815):  Targeted  Improvements  to 
Accounting  for  Hedging  Activities,  which  expands  and  refines  hedge  accounting  for  both  financial  and  non-financial  risk 
components,  aligns  the  recognition  and  presentation  of  the  effects  of  hedging  instruments  and  hedge  items  in  the  financial 
statements, and includes certain targeted improvements to ease the application of current guidance related to the assessment of 
hedge effectiveness. ASU 2017-12 is effective for fiscal years beginning after December 15, 2018, and interim periods within 
those fiscal years. Early adoption is permitted. We are currently evaluating the anticipated impact of adopting ASU 2017-12 on 
our consolidated financial statements. 

In October 2016, the FASB issued ASU No. 2016-16, Income Taxes (Topic 740): Intra-Entity Transfers of Assets Other 
than Inventory, which requires the recognition of the income tax consequences of an intra-entity transfer of an asset, other than 
inventory, when the transfer occurs. ASU 2016-16 became effective  for us as of January 1, 2018. We do not believe that the 
adoption of ASU 2016-16 will have a material impact on our consolidated financial statements. 

In August 2016, the FASB issued ASU No. 2016-15, Statement of Cash Flows (Topic 230): Classification of Certain 
Cash Receipts and Cash Payments, which addresses eight specific cash flow issues with the objective of reducing the existing 
diversity in practice in how certain cash receipts and cash payments are presented and classified in the statement of cash flows. 
ASU 2016-15 became effective for us on January 1, 2018. We do not believe that the adoption of ASU 2016-15 will have a 
material impact on our consolidated financial statements. 

In February 2016, the FASB issued ASU No. 2016-02, Leases, which eliminates the current tests for lease classification 
under U.S. GAAP and requires lessees to recognize the right-of-use assets and related lease liabilities on the balance sheet for all 
leases greater than one year in duration. ASU 2016-02 is effective for fiscal years beginning after December 15, 2018, including 
interim periods within those fiscal years. Early adoption of ASU 2016-02 is permitted. ASU 2016-02 provides that lessees (for 
capital  and  operating  leases)  and  lessors  (for  sales-type,  direct  financing,  and  operating  leases)  must  apply  a  modified 
retrospective transition approach for leases existing at, or entered into after, the beginning of the earliest comparative period 
presented in the financial statements. The modified retrospective approach would not require any transition accounting for leases 
that expired before the earliest comparative period presented. Lessees and lessors may not apply a full retrospective transition 
approach. We are assessing the impact that ASU 2016-02 is anticipated to have on our consolidated financial statements. We 
currently  expect  that  most  of  our  operating  lease  commitments  will  be  subject  to  the  new  standard  and  recognized  as  lease 
liabilities and right-of-use assets upon our adoption of ASU 2016-02. 

In January 2016, the FASB issued ASU No. 2016-01, Financial Instruments - Overall: Recognition and Measurement 
of  Financial  Assets  and  Financial  Liabilities,  which  amends  the  guidance  regarding  the  classification  and  measurement  of 
financial instruments. Changes to the current guidance primarily affect the accounting for equity investments, financial liabilities 
under the fair value option, and the presentation and disclosure requirements for financial instruments. In addition, ASU 2016-
01  clarifies  guidance  related  to  the  valuation  allowance  assessment  when  recognizing  deferred  tax  assets  resulting  from 
unrealized losses on available-for-sale debt securities. ASU 2016-01 became effective for us on January 1, 2018. Upon adoption 
of ASU 2016-01, an entity should apply the amendments by means of a cumulative-effect adjustment to the balance sheet at the 
beginning of the first reporting period in which the guidance is effective. We do not presently believe the application of ASU 
2016-01 will have a material impact on our financial statements. 

In May 2014, the FASB issued ASU No. 2014-09, Revenue from Contracts with Customers (Topic 606), to update the 
financial reporting requirements for revenue recognition. Topic 606 outlines a single comprehensive model for entities to use in 
accounting  for  revenue  arising  from  contracts  with  customers  and  supersedes  most  current  revenue  recognition  guidance, 
including industry-specific guidance. The guidance is based on the principle that an entity should recognize revenue to depict the 
transfer of goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled 
in exchange for those goods or services. The guidance also requires additional disclosure about the nature, amount, timing and 
uncertainty of revenue and cash flows arising from customer contracts, including significant judgments and changes in judgments 
and assets recognized from costs incurred to fulfill a contract. This guidance became effective for us beginning on January 1, 
2018, and entities have the option of using either a full retrospective or a modified retrospective approach for the adoption of the 
new standard. We adopted this standard using the modified retrospective approach on January 1, 2018. 

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In preparation for adoption of the standard, we have implemented internal controls and completed our impact assessment 
of implementing this guidance. We have evaluated each of the five steps in Topic 606, which are as follows: 1) Identify the 
contract with the customer; 2) Identify the performance obligations in the contract; 3) Determine the transaction price; 4) Allocate 
the transaction price to the performance obligations; and 5) Recognize revenue when (or as) performance obligations are satisfied.  

We do not expect reported revenue to be affected materially in any period due to the adoption of ASC Topic 606 because: 
(1) we expect to identify similar performance obligations under ASC Topic 606 as compared with deliverables and separate units 
of account previously identified; (2) we have determined the transaction price to be consistent; and (3) we record revenue at the 
same point in time, upon shipment or delivery under both ASC Topic 605 and ASC Topic 606, as applicable under the terms of 
the contract with the customer. Additionally, we do not expect the accounting for fulfillment costs or costs incurred to obtain a 
contract to be affected materially in any period due to the adoption of Topic 606. 

There  are  also  certain  considerations  related  to  accounting  policies,  business  processes  and  internal  control  over 
financial reporting that are associated  with implementing Topic 606. We have evaluated our policies, processes,  and control 
framework for revenue recognition, and identified and implemented the changes needed in response to the new guidance.  

Lastly, disclosure requirements under the new guidance in Topic 606 have been significantly expanded in comparison 
to  the  disclosure  requirements  under  the  current  guidance,  including  disclosures  related  to  disaggregation  of  revenue  into 
appropriate  categories,  performance  obligations,  the  judgments  made  in  revenue  recognition  determinations,  adjustments  to 
revenue which relate to activities from previous quarters or years, any significant reversals of revenue, and costs to obtain or 
fulfill contracts. We have designed and implemented the appropriate controls over gathering and reporting the information as 
required under Topic 606, in order to support the expanded disclosure requirements. 

All other issued and not yet effective accounting standards are not relevant to our financial statements. 

2.    ACQUISITIONS 

On October 2, 2017 we acquired a custom procedure pack business located in Melbourne, Australia from ITL Healthcare 
Pty Ltd. ("ITL"), for an aggregate purchase price of $11.3 million. We accounted for this acquisition as a business combination. 
The following table summarizes the aggregate purchase price allocated to the assets acquired from ITL (in thousands): 

   Assets Acquired 

$ 

Trade receivables 
Other receivables 
Inventories 
Prepaid expenses and other assets 
Property and equipment 
Intangibles 

Customer lists 
Goodwill 

   Total assets acquired 

   Liabilities Assumed 
Trade payables 
Accrued expenses 
Deferred tax liabilities 

   Total liabilities assumed 

1,287  
56  
1,808  
65  
1,053  

5,940  
3,740  
13,949  

(216 ) 
(542 ) 
(1,901 ) 

(2,659 ) 

   Total net assets acquired 

$ 

11,290  

We are amortizing the customer list on an accelerated basis over seven years. Acquisition-related costs associated with 
the  ITL  acquisition,  which  are  included  in  selling,  general  and  administrative  expenses  in  the  accompanying  consolidated 
statements  of  income,  were  not  material.  The  results  of  operations  related  to  this  acquisition  have  been  included  in  our 
cardiovascular segment since the acquisition date. During the year ended December 31, 2017, our net sales of ITL products were 
approximately $3.3 million. It is not practical to separately report the earnings related to the ITL acquisition, as we cannot split 

64 

 
 
 
 
 
 
 
 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
 
out sales costs related solely to the products we acquired from ITL, principally because our sales representatives sell multiple 
products (including the products we acquired from ITL) in our cardiovascular business segment. 

On  September  1,  2017,  we  acquired  intellectual  property  rights  associated  with  a  steerable  guidewire  system  from 
IntelliMedical  Technologies  Pty.  Ltd.  ("IntelliMedical").  We  made  an  initial  payment  of  approximately  $11.9  million  in 
September 2017, and we are obligated to pay up to an additional A$15.0 million (Australian dollars) if certain milestones set 
forth in the share purchase agreement with IntelliMedical are achieved. We are also required to pay royalties equal to 6% of net 
sales, commencing upon the first commercial sale of the product and throughout the term of the applicable patents. We accounted 
for this transaction as an asset purchase. The initial payment has been included in the accompanying consolidated statements of 
income  as  acquired  in-process  research  and  development  expense  for  the  year  ended  December 31,  2017,  because  both 
technological feasibility of the underlying research and development project had not yet been reached and such technology had 
no identified future alternative use as of the date of acquisition. 

On  August  4,  2017  we  acquired  from  Laurane  Medical  S.A.S.  ("Laurane")  and  its  shareholders  inventories  and  the 
intellectual property rights associated with certain manual bone biopsy devices, manual bone marrow needles and muscle biopsy 
kits for an aggregate purchase price of $16.5 million. We also recorded a contingent consideration liability of $5.5 million related 
to royalties potentially payable to Laurane's shareholders pursuant to the terms of an intellectual property purchase agreement. 
We  accounted  for  this  acquisition  as  a  business  combination.  The  following  table  summarizes  the  aggregate  purchase  price 
(including contingent royalty payment liabilities) allocated to the assets acquired from Laurane (in thousands): 

   Net Assets Acquired 
Inventories 
Intangibles 

$ 

Developed technology 
Customer list 
Goodwill 

   Total net assets acquired 

$ 

594  

14,920  
120  
6,366  

22,000  

We are amortizing the developed technology intangible asset over 12 years and the customer list on an accelerated basis 
over one year. The total weighted-average amortization period for these acquired intangible assets is 11.9 years. 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. Acquisition-related costs associated with the Laurane acquisition, which are included in selling, general and 
administrative expenses in the accompanying consolidated statements of income, were not material. 

On July 3, 2017, we acquired from Osseon LLC (“Osseon”) substantially all the assets related to Osseon’s vertebral 
augmentation  products.  We  accounted  for  this  acquisition  as  a  business  combination.  The  purchase  price  for  the  assets  was 
approximately  $6.8  million.  Acquisition-related  costs  associated  with  the  Osseon  acquisition,  which  are  included  in  selling, 
general and administrative expenses in the accompanying consolidated statements of income, were not material. The results of 
operations related to this acquisition have been included in our cardiovascular segment since the acquisition date. During the 
year ended December 31, 2017, our net sales of Osseon products were approximately $942,000. It is not practical to separately 
report the earnings related to the Osseon acquisition, as we cannot split out sales costs related solely to the products we acquired 
from  Osseon,  principally  because  our  sales  representatives  sell  multiple  products  (including  the  products  we  acquired  from 
Osseon) in our cardiovascular business segment. The following table summarizes the preliminary purchase price allocated to the 
net assets acquired (in thousands): 

$ 

   Net Assets Acquired 
Inventories 
Property and equipment 
Intangibles 

Developed technology 
Customer list 
Goodwill 

   Total net assets acquired 

$ 

979  
58  

5,400  
200  
203  

6,840  

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We are amortizing the developed technology intangible asset over nine years and customer lists on an accelerated basis 
over eight years. The total weighted-average amortization period for these acquired intangible assets is approximately 9.0 years. 

On July 1, 2017, we entered into an exclusive license  agreement  with Pleuratech  ApS ("Pleuratech") to acquire the 
rights to manufacture and sell the KatGuideTM chest tube insertion tool. As of December 31, 2017, we had paid $2.0 million in 
connection with this agreement. We are obligated to pay an additional $5.0 million if certain milestones set forth in the license 
agreement are met. We are also required to pay royalties equal to 6% of net sales throughout the term of the license agreement. 
We  accounted  for  this  transaction  as  an  asset  purchase.  We  recorded  the  amount  paid  upon  closing  as  a  license  agreement 
intangible asset, which we intend to amortize over 15 years.     

On  June  16,  2017,  we  acquired  from  Lazarus  Medical  Technologies,  LLC  the  patent  rights  and  other  intellectual 
property related to the Repositionable Chest TubeTM and related devices. As of December 31, 2017, we had paid $570,000 in 
connection with this agreement. We are also obligated to pay an additional $750,000 if certain milestones set forth in the purchase 
agreement are met. We are also required to pay royalties equal to 6% of net sales throughout the term of the purchase agreement. 
We  accounted  for  this  transaction  as  an  asset  purchase.  We  recorded  the  amount  paid  upon  closing  as  a  license  agreement 
intangible asset, which we intend to amortize over 15 years.  

On May 23, 2017, we paid $2.5 million to acquire 182,000 shares of preferred stock of Fusion Medical, Inc. ("Fusion"), 
a developer of medical devices designed primarily for clot removal. The shares of preferred stock we acquired, which represent 
an ownership interest of approximately 19.5%, have been accounted for as an equity method investment of $2.5 million reflected 
within other assets in the accompanying consolidated balance sheets because we may be deemed to exercise significant influence 
over the operations of Fusion. 

On May 19, 2017, we terminated our distribution agreement with Sheen Man Co., Ltd. and Sugan Co, Ltd., ("Sugan"), 
a  Japanese  medical  device  distributor  and  entered  into  a  business  purchase  agreement,  distribution  agreement  and  a  supply 
agreement with Sugan. Pursuant to these agreements, we acquired the customer list Sugan used in the distribution of our products 
in Japan. The purchase price is recorded as a customer list intangible asset of approximately $1.2 million. We intend to amortize 
the customer list intangible asset on an accelerated basis over five years. In addition, we granted to Sugan the right to continue 
to distribute a limited number of our products, related to fluid administration, through December 31, 2021 and to manufacture 
and sell to Sugan certain contrast injector products during a term of four years, subject to extensions. 

On May 1, 2017, we entered into an agreement and plan of merger with Vascular Access Technologies, Inc. ("VAT"), 
pursuant to which we acquired  the SAFECVAD™ device. We accounted for this acquisition as a business combination. The 
purchase price for the business was $5.0 million. We also recorded $4.9 million of contingent consideration related to royalties 
potentially payable to VAT pursuant to the merger agreement. The following table summarizes the preliminary purchase price 
allocated to the net assets acquired and liabilities assumed (in thousands): 

Preliminary Allocation 

Adjustments (1) 

Revised Allocation 

   Net Assets Acquired 

Intangibles 

Developed technology 
In-process technology 
Goodwill 

Deferred tax liabilities 

   $ 

$ 

7,800  
850  
4,323  
(3,073 ) 

—  
70  
(42 ) 
(28 ) 

   $ 

7,800  
920  
4,281  
(3,101 ) 

   Total net assets acquired 

$ 

9,900  

   $ 

—  

   $ 

9,900  

(1)  Under U.S. GAAP, measurement period adjustments are recognized on a prospective basis in the period of change, instead of restating 
prior  periods.  There  was  no  impact  to  reported  earnings  in  connection  with  these  measurement  period  adjustments  for  the  periods 
presented. Amounts represent adjustments to the preliminary purchase price allocation first presented in our Quarterly Report on Form 
10-Q for the quarter ended June 30, 2017 resulting from our ongoing activities, including reassessment of the assets acquired and liabilities 
assumed, with respect to finalizing our purchase price allocation for this acquisition. 

We are amortizing the developed technology intangible asset over 15 years. 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. Acquisition-
related  costs  associated  with  the  VAT  acquisition,  which  are  included  in  selling,  general  and  administrative  expenses  in  the 
accompanying consolidated statements of income, were not material. 

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On January 31, 2017, we acquired Argon’s critical care division, including a manufacturing facility in Singapore, the 
related commercial operations in Europe and Japan, and certain inventories and intellectual property rights within the United 
States. We made an initial payment of approximately $10.9 million and received a subsequent reduction to the purchase price of 
approximately $797,000 related to a working capital adjustment according to the terms of the purchase agreement. We accounted 
for the acquisition as a business combination. 

Acquisition-related  costs  associated  with  the  acquisition  of  the  Argon  critical  care  division  during  the  year  ended 
December 31,  2017,  which  are  included  in  selling,  general  and  administrative  expenses  in  the  accompanying  consolidated 
statements of income, were approximately $2.6 million. The results of operations related to this acquisition have been included 
in our cardiovascular segment since the acquisition date. During the year ended December 31, 2017, our net sales of the Argon 
critical care products were approximately $41.2 million. It is not practical to separately report the earnings related to the Argon 
critical care acquisition, as we cannot split out sales costs related solely to the products we acquired from Argon, principally 
because our sales representatives sell multiple products (including the products we acquired from Argon) in our cardiovascular 
business segment. 

The assets and liabilities in the purchase price allocation for the Argon critical care acquisition are stated at fair value 
based on estimates of fair value using available information and making assumptions our management believes are reasonable. 
The following table summarizes the preliminary purchase price allocated to the net tangible and intangible assets acquired and 
liabilities assumed (in thousands), adjusted as of December 31, 2017: 

Preliminary Allocation    

Adjustments (2) 

   Revised Allocation 

   Assets Acquired 

Cash and cash equivalents 

$ 

Trade receivables 

Inventories 

Prepaid expenses and other assets 

Income tax refund receivable 

Property and equipment 

Deferred tax assets 

Intangibles 

Developed technology 

Customer lists 

Trademarks 

   Total assets acquired 

   Liabilities Assumed 

Trade payables 

Accrued expenses 

Income taxes payable 

Deferred income tax liabilities 

   Total liabilities assumed 

   Total net assets acquired 

   Gain on bargain purchase (1) 

   $ 

1,436  
8,351  
12,217  
1,275  
—  
2,667  
184  

2,600  
1,300  
1,500  
31,530  

(2,306 ) 

(5,083 ) 

(2 ) 

(999 ) 

(8,390 ) 

23,140  
(12,243 ) 

—  
—  
(995 ) 

—  
165  
(348 ) 

18  

(400 ) 

200  
(600 ) 

(1,960 ) 

(108 ) 

—  
2  
65  
(41 ) 

(2,001 ) 

1,204  
(797 ) 

   $ 

1,436  
8,351  
11,222  
1,275  
165  
2,319  
202  

2,200  
1,500  
900  
29,570  

(2,414 ) 

(5,083 ) 
—  
(934 ) 

(8,431 ) 

21,139  
(11,039 ) 

   Total purchase price 
(1)  The total fair value of the net assets acquired from Argon exceeded the purchase price, resulting in a gain on bargain purchase which was recorded within 
other income (expense) in our consolidated statements of income, and includes a negative adjustment of $1.2 million since the bargain purchase gain was 
first presented in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2017. We believe the reason for the gain on bargain purchase was a 
result of the divestiture of a non-strategic, slow-growth critical care business for Argon. It is our understanding that the divestiture allows Argon to focus on 
its higher growth interventional portfolio. 

10,897  

10,100  

   $ 

   $ 

$ 

(2)  Under U.S. GAAP, measurement period adjustments are recognized on a prospective basis in the period of change, instead of restating prior periods. There 
was no impact to reported earnings in connection with these measurement period adjustments for the periods presented. Amounts represent adjustments to 
the preliminary purchase price allocation first presented in our March 31, 2017 Form 10-Q resulting from our ongoing activities, including reassessment of 
the assets acquired and liabilities assumed, with respect to finalizing our purchase price allocation for this acquisition. 

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With respect to the Argon critical care assets, we are amortizing developed technology over seven years and customer 
lists on an accelerated basis over five years. While U.S. trademarks can be renewed indefinitely, we currently estimate that we 
will generate cash flow from the acquired trademarks for a period of five years from the acquisition date. The total weighted-
average amortization period for these acquired intangible assets is 6.0 years. 

On January 31, 2017, we acquired substantially all the assets, including intellectual property covered by approximately 
40 patents and pending applications, and assumed certain liabilities, of Catheter Connections, Inc. (“Catheter Connections”), in 
exchange  for  payment  of  $38.0  million.  Catheter  Connections,  based  in  Salt  Lake  City,  Utah,  developed  and  marketed  the 
DualCap®  System,  an  innovative  family  of  disinfecting  products  designed  to  protect  patients  from  intravenous  infections 
resulting from infusion therapy. We accounted for this acquisition as a business combination.  

Acquisition-related  costs  associated  with  the  Catheter  Connections  acquisition  during  the  year  ended  December 31, 
2017, which are included in selling, general and administrative expenses in the accompanying consolidated statements of income, 
were  approximately  $482,000.  The  results  of  operations  related  to  this  acquisition  have  been  included  in  our  cardiovascular 
segment  since  the  acquisition  date.  During  the  year  ended  December 31,  2017,  our  net  sales  of  the  products  acquired  from 
Catheter Connections were approximately $10.0 million. It is not practical to separately report the earnings related to the products 
acquired from Catheter Connections, as we cannot split out sales costs related solely to those products, principally because our 
sales representatives sell multiple products (including the DualCap System) in the cardiovascular business segment. The purchase 
price was preliminarily allocated as follows (in thousands): 

Preliminary Allocation    

Adjustments (1) 

   Revised Allocation 

   Assets Acquired 

Trade receivables 
Inventories 
Prepaid expenses and other assets 
Property and equipment 
Intangibles 

$ 

Developed technology 
Customer lists 
Trademarks 
Goodwill 

Total assets acquired 

Liabilities Assumed 
Trade payables 
Accrued expenses 

Total liabilities assumed 

   $ 

952  
2,244  
181  
1,472  

22,900  
100  
2,900  
7,612  
38,361  

(338 ) 
(23 ) 

(361 ) 

   Net assets acquired 

$ 

38,000  

   $ 

6  
(87 ) 
(96 ) 
—  

(1,800 ) 
600  
—  
1,377  
—  

—  
—  
—  

—  

   $ 

958  
2,157  
85  
1,472  

21,100  
700  
2,900  
8,989  
38,361  

(338 ) 
(23 ) 

(361 ) 

   $ 

38,000  

(1)  Under U.S. GAAP, measurement period adjustments are recognized on a prospective basis in the period of change, instead of restating 
prior  periods.  There  was  no  impact  to  reported  earnings  in  connection  with  these  measurement  period  adjustments  for  the  periods 
presented. Amounts represent adjustments to the preliminary purchase price first presented in our Quarterly Report on Form 10-Q for the 
Quarter Ended March 31, 2017, resulting from activities with respect to finalizing our purchase price allocation for this acquisition. The 
larger adjustments primarily relate to the valuation of the acquired intangible assets.  

We are amortizing the Catheter Connections developed technology asset over 12 years, the related trademarks over 10 
years, and the associated customer list over eight years. We have estimated the weighted average life of the intangible Catheter 
Connections assets acquired to be approximately 11.7 years. 

On December 19, 2016, we paid $5.0 million for 1,251,878 shares of common stock and a distribution agreement with 
Bluegrass  Vascular  Technologies,  Inc.  ("Bluegrass").  The  common  stock,  which  represents  an  ownership  interest  of 
approximately 19.5%, has been accounted for as a cost method investment of $4.0 million reflected within other assets in  the 
accompanying  consolidated  balance  sheets  because  we  are  not  able  to  exercise  significant  influence  over  the  operations  of 

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Bluegrass. The distribution agreement intangible asset was valued at $1.0 million and will be amortized over a period of three 
years. 

On July 6, 2016, we acquired all of the issued and outstanding shares of DFINE Inc. ("DFINE"). The DFINE acquisition 
added a line of vertebral augmentation products for the treatment of vertebral compression fractures ("VCF") as well as medical 
devices used to treat metastatic spine tumors. We made an initial payment of $97.5 million to certain DFINE stockholders on 
July 6, 2016 and paid approximately $578,000 related to a net working capital adjustment subject to review by Merit and the 
preferred stockholders of DFINE. We accounted for the acquisition as a business combination. In the three-month period ended 
December 31, 2016,  we negotiated the  final  net  working capital adjustment resulting in a reduction to the purchase  price  of 
approximately $1.1 million. As a result, we recorded measurement period adjustments to reduce inventories by approximately 
$89,000, reduce property and equipment by approximately $109,000, reduce goodwill by approximately $1.2 million, reduce 
accrued expenses by approximately  $407,000 and increase the associated deferred tax liabilities by approximately $113,000. 
Under U.S. GAAP, measurement period adjustments are recognized on a prospective basis in the period of change, instead of 
restating prior periods. There was no impact to reported earnings in connection with these measurement period adjustments.  

Acquisition-related  costs  during  the  year  ended  December  31,  2016,  which  are  included  in  selling,  general,  and 
administrative expenses in the accompanying consolidated statements of income, were approximately $1.6 million. The results 
of operations related to this acquisition have been included in our cardiovascular segment since the acquisition date. During the 
years ended December 31, 2017 and 2016, our net sales of DFINE products were approximately $27.0 million and $13.5 million, 
respectively. It is not practical to separately report the earnings related to the DFINE acquisition, as we cannot split out  sales 
costs related to DFINE products, principally because our sales representatives are selling multiple products (including DFINE 
products) in the cardiovascular business segment. 

The purchase price was allocated to the net tangible and intangible assets acquired and liabilities assumed, based on 

estimated fair values, as follows (in thousands): 

$ 

Assets Acquired 

Trade receivables 
Other receivables 
Inventories 
Prepaid expenses 
Property and equipment 
Other long-term assets 
Intangibles 

Developed technology 
Customer lists 
Trademarks 
Goodwill 

Total assets acquired 

Liabilities Assumed 
Trade payables 
Accrued expenses 
Deferred income tax liabilities - current 
Deferred income tax liabilities - noncurrent 

Total liabilities assumed 

Net assets acquired, net of cash received of $1,327  $ 

4,054  
6  
8,585  
630  
1,630  
145  

67,600  
2,400  
4,400  
24,818  
114,268  

(1,790 ) 
(5,298 ) 
(701 ) 
(10,844 ) 

(18,633 ) 

95,635  

The  gross  amount  of  trade  receivables  we  acquired  in  the  acquisition  was  approximately  $4.3  million,  of  which 
approximately  $224,000  was  expected  to  be  uncollectible  or  returned.  With  respect  to  the  DFINE  assets,  we  are  amortizing 
developed technology over 15 years and customer lists on an accelerated basis over nine years. While U.S. trademarks can be 

69 

 
 
 
 
 
  
  
  
  
  
  
  
 
renewed indefinitely, we currently estimate that we will generate cash flow from the acquired trademarks for a period of 15 years 
from the acquisition date. The total weighted-average amortization period for these acquired intangible assets is 14.8 years. 

On February 4, 2016, we purchased the HeRO® Graft device and other related assets from CryoLife, Inc., a developer 
of medical devices based in Kennesaw, Georgia ("CryoLife"). The HeRO Graft is a fully subcutaneous vascular access system 
intended for use in maintaining long-term vascular access for chronic hemodialysis patients who have failing fistulas, grafts or 
are catheter dependent due to a central venous blockage. The purchase price was $18.5 million, which was paid in full during 
2016. We accounted for this acquisition as a business combination. The purchase price was allocated as follows (in thousands): 

$ 

Assets Acquired 
Inventories 
Property and equipment 
Intangibles 

Developed technology 
Trademarks 
Customers Lists 
Goodwill 

Total assets acquired 

$ 

2,455  
290  

12,100  
700  
400  
2,555  

18,500  

We are amortizing the developed HeRO Graft technology asset over 10 years, the related trademarks over 5.5 years, 
and the associated customer lists over 12 years. We have estimated the weighted average life of the intangible HeRO Graft assets 
acquired to be approximately 9.8 years. Acquisition-related costs related to the HeRO Graft device and other related assets during 
the  year ended December 31, 2016, which are included in selling, general and administrative expenses in the accompanying 
consolidated statements of income, were not material. The results of operations related to this acquisition have been included in 
our cardiovascular segment since the acquisition date. During the years ended December 31, 2017 and 2016, our net sales of the 
products acquired from CryoLife were approximately $8.6 million and $7.1 million, respectively. It is not practical to separately 
report the earnings related to the products acquired from CryoLife, as we cannot split out sales costs related to those products, 
principally  because  our  sales  representatives  are  selling  multiple  products  (including  the  HeRO  Graft  device)  in  the 
cardiovascular business segment.  

During 2016, we paid approximately $3.0 million for 3,000,000 preferred limited liability company units of Cagent 
Vascular, LLC, a medical device company ("Cagent"), which represents a current ownership interest of approximately 18.1% 
and has been accounted for as a cost method investment reflected within other assets in the accompanying consolidated balance 
sheets because we are not able to exercise significant influence over the operations of Cagent. 

On December 4, 2015, we entered into a license agreement with ArraVasc Limited, an Irish medical device company, 
for the right to manufacture and sell certain percutaneous transluminal angioplasty balloon catheter products. As of December 31, 
2016, we had paid $2 million in connection with the agreement. During the year ended December 31, 2017, we paid an additional 
$500,000. There are no additional payments due under this agreement. We accounted for the transaction as an asset purchase and 
are amortizing the license agreement intangible asset over a period of 12 years.  

On September 29, 2015, we entered into a license agreement with Blockade Medical, LLC, a Delaware limited liability 
company ("Blockade"), for rights to manufacture, market and sell a set of endovascular embolization products. As part of the 
agreement, we paid $1.7 million during the year ended December 31, 2015 and, in lieu of any additional payment, we converted 
the cost method investment in Blockade of $1.0 million we had previously recorded, toward the purchase price of the license. 
We recorded $2.7 million to a license agreement intangible asset, which we intend to amortize over 10 years.  

On  August  19,  2015,  we  purchased  116,279  shares  of  Series  A  Preferred  Stock  of  Xablecath,  Inc.,  a  Delaware 
corporation  ("Xablecath"),  for  an  aggregate  price  of  approximately  $300,000.  During  the  three  months  ended  December  31, 
2017, we paid $247,500 for 656,848 shares  of Series B Preferred Stock of Xablecath. Our ownership interest in Xablecath is 
approximately  15.9%  and  is  accounted  for  as  a  cost-method  investment  reflected  within  other  assets  in  the  accompanying 
consolidated balance sheets. Xablecath is developing an over-the-wire crossing catheter. 

On July 17, 2015, we entered into an asset purchase agreement with LeMaitre Vascular, Inc., a Delaware corporation 
("LeMaitre"),  for  rights  to  the  Unballoon®  non-occlusive  modeling  catheter.  We  accounted  for  the  transaction  as  an  asset 

70 

 
     
 
  
  
  
  
 
 
 
 
 
  
purchase. The full purchase price  of $400,000 was paid as of December 31, 2015, and the purchase price  was recorded as a 
developed technology intangible asset, which we are amortizing over a period of 10 years. 

On  July  14,  2015,  we  entered  into  an  asset  purchase  agreement  with  Quellent,  LLC,  a  California  limited  liability 
company ("Quellent"), for superabsorbent pad technology. The purchase price for the asset was $1.0 million, payable in two 
installments.  We  accounted  for  this  acquisition  as  a  business  combination.  The  first  payment  of  $500,000  was  paid  as  of 
December 31, 2015, and the second payment of $500,000 was recorded as an accrued liability as of December 31, 2015 and paid 
in  the  first  quarter  of  2016.  We  also  recorded  $270,000  of  contingent  consideration  related  to  royalties  payable  to  Quellent 
pursuant to the asset purchase agreement. The sales and results of operations related to this acquisition have been included in our 
cardiovascular segment since the  acquisition date  and  were  not material. The purchase price  was allocated as follows: $1.21 
million  to  a  developed  technology  intangible  asset  and  $60,000  to  goodwill.  We  are  amortizing  the  developed  technology 
intangible asset over 13 years. 

On July 1, 2015, we entered into an agreement with Catch Medical, LLC, a Utah limited liability company ("Catch 
Medical"), to purchase rights to a steerable snare. We expensed the full purchase price of $1.0 million to in-process research and 
development during the year ended December 31, 2015, because the initial costs of in-process research and development acquired 
in this asset purchase do not have an alternative future use. These costs include payments incurred prior to regulatory approval 
in  connection  with  acquired  research  and  development  projects  that  provide  rights  to  develop,  manufacture,  market  and  sell 
products. As of December 31, 2017, we have paid cash of $600,000, have a current liability recorded in accrued expenses of 
$200,000 for the payment that  will be due in less  than a  year and have a long-term obligation of $200,000 recorded for the 
payments that will be due in over a year. 

On  July  1,  2015,  we  entered  into  a  license  agreement  with  Distal  Access,  LLC,  a  Utah  limited  liability  company 
("Distal"), for guidewire controller technology. We made a payment of $3.5 million upon the closing of the agreement during 
the year ended December 31, 2015. We accounted for this acquisition as an asset purchase. We recorded the purchase price to a 
license agreement intangible asset of $3.5 million, which we are amortizing over a period of six years.  

On March 26, 2015, we entered into an asset purchase agreement with Teleflex Incorporated, a Delaware corporation 
("Teleflex"). We accounted for the transaction as an asset purchase. During the year ended December 31, 2015, we paid $400,000 
to acquire the asset, which we recorded as a customer list intangible asset. We paid an additional $400,000 in the year-ended 
December 31, 2016, which was recorded to the customer list intangible asset, because Teleflex met certain obligations under the 
agreement. There are no additional payments due under this agreement. We are amortizing the asset over a period of five years. 

The following table summarizes our consolidated results of operations for the years ended December 31, 2017, 2016 
and 2015, as well as unaudited pro forma consolidated results of operations as though the DFINE acquisition had occurred on 
January 1, 2015 and the acquisition of the Argon critical care division had occurred on January 1, 2016 (in thousands, except per 
common share amounts): 

2017 

2016 

2015 

As Reported     Pro Forma 
$ 

727,852      $ 
27,523     

   As Reported     Pro Forma 
603,838      $ 
20,121     

664,366      $ 
23,068     

   As Reported     Pro Forma 
575,541  
542,149      $ 
3,135  
23,802     

730,612      $ 
17,419     

Net sales 
Net income 
Earnings per common 
share: 

Basic 

Diluted 

$ 

$ 

0.56      $ 
0.55      $ 

0.36      $ 
0.35      $ 

0.45      $ 
0.45      $ 

0.52      $ 
0.51      $ 

0.54      $ 
0.53      $ 

0.07  
0.07  

The unaudited pro forma information set forth above is for informational purposes only and includes adjustments related 
to the step-up of acquired inventories, amortization expense of acquired intangible assets, interest expense on long-term debt and 
changes in the timing of the recognition of the gain on bargain purchase. The pro forma information should not be considered 
indicative of actual results that would have been achieved if the DFINE acquisition had occurred on January 1, 2015 and the 
acquisition of the Argon critical care division had occurred on January 1, 2016, or results that may be obtained in any future 
period. The proforma consolidated results of operations do not include the ITL, Laurane, Osseon, VAT, Catheter Connections, 
HeRO Graft or Quellent acquisitions as we do not deem the pro forma effect of these transactions to be material. 

The goodwill arising from the acquisitions discussed above consists largely of the synergies and economies of scale we 
hope to achieve from combining the acquired assets and operations with our historical operations (see Note 4). The goodwill 
recognized from certain acquisitions is expected to be deductible for income tax purposes. 

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3.    INVENTORIES 

Inventories at December 31, 2017 and 2016, consisted of the following (in thousands): 

Finished goods 
Work-in-process 
Raw materials 

Total 

$ 

2017 
86,555  
12,799  
55,934  

  $ 

2016 
63,852  
11,008  
45,835  

$ 

155,288  

  $  120,695  

4.    GOODWILL AND INTANGIBLE ASSETS 

The changes in the carrying amount of goodwill for the years ended December 31, 2017 and 2016, are as follows (in 

thousands): 

Goodwill balance at January 1 
Effect of foreign exchange 
Additions as the result of acquisitions 

Goodwill balance at December 31 

2017 
211,927  
2,641  
23,579  
238,147  

$ 

$ 

2016 
184,472  
82  
27,373  
211,927  

  $ 

  $ 

As  of  December 31,  2017,  we  had  recorded  $8.3  million  of  accumulated  goodwill  impairment  charges.  All  of  the 

goodwill balance as of December 31, 2017 and 2016, is related to our cardiovascular segment.  

Other intangible assets at December 31, 2017 and 2016, consisted of the following (in thousands): 

Patents 
Distribution agreements 
License agreements 
Trademarks 
Covenants not to compete 
Customer lists 
In-process technology 

Total 

Patents 
Distribution agreements 
License agreements 
Trademarks 
Covenants not to compete 
Customer lists 
Royalty agreements 

Total 

Gross Carrying 
Amount 

$ 

16,528  
7,262  
23,783  
16,224  
1,028  
31,935  
920  

  $ 

2017 

Accumulated 
Amortization 

(3,737 ) 
(4,686 ) 
(5,568 ) 
(4,686 ) 
(968 ) 
(18,482 ) 
—  

  $ 

Net Carrying 
Amount 
12,791  
2,576  
18,215  
11,538  
60  
13,453  
920  

$ 

97,680  

  $ 

(38,127 ) 

  $ 

59,553  

2016 

Gross Carrying 
Amount 

Accumulated 
Amortization 

$ 

14,130  
6,626  
20,695  
12,380  
1,028  
22,261  
267  

  $ 

(3,165 ) 
(3,527 ) 
(3,422 ) 
(3,330 ) 
(936 ) 
(15,401 ) 
(267 ) 

  $ 

Net Carrying 
Amount 
10,965  
3,099  
17,273  
9,050  
92  
6,860  
—  

$ 

77,387  

  $ 

(30,048 ) 

  $ 

47,339  

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Aggregate  amortization  expense  for  the  years  ended  December 31,  2017,  2016  and  2015  was  approximately  $26.8 

million, $19.3 million and $14.8 million, respectively. 

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. 
During the fourth quarter of 2017, we compared the carrying value of the amortizing intangible assets acquired in our July 2015 
acquisition of certain assets from Distal Access, LLC, all of which pertained to our cardiovascular segment, to the undiscounted 
cash  flows  expected  to  result  from  the  asset  group  and  determined  that  the  carrying  amount  was  not  recoverable.  We  then 
determined the fair value of the amortizing assets related to the Distal Access acquisition 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. Some of the 
factors that influenced our estimated cash flows were slower than anticipated sales growth  in the products acquired from our 
Distal Access acquisition and uncertainty about future sales growth. The excess of the carrying value compared to the fair value 
was recognized as an intangible asset impairment charge. We recorded an impairment charge for Distal Access of approximately 
$809,000. We did not record any impairment charges during the years ended December 31, 2016 and 2015.  

Estimated amortization expense for the developed technology and other intangible assets for the next five years consists 

of the following as of December 31, 2017 (in thousands): 

Year Ending December 31   
2018 
2019 
2020 
2021 
2022 

$  30,413  
29,787  
28,373  
21,001  
19,396  

5.    INCOME TAXES 

On December 22, 2017, U.S. federal tax legislation, commonly referred to as the Tax Cuts and Jobs Act (“TCJA”) was 
signed  into  law.  Significant  provisions  that  have  impacted  (and  will  in  the  future  impact)  our  effective  tax  rate  include  the 
reduction in the corporate tax rate from 35% to 21%, effective in 2018; a one-time deemed repatriation (“transition tax”) on 
earnings of certain foreign subsidiaries that were previously tax deferred; and new taxes on certain foreign sourced earnings. At 
December 31, 2017, we had not completed our accounting for the tax effects of the TCJA; however, in certain cases, as described 
below,  we  have  made  reasonable  estimates  of  the  effects  on  our  existing  deferred  tax  balances  and  impact  of  the  one-time 
transition tax. In accordance with SEC Staff Accounting Bulletin 118 (“SAB 118”), income tax  effects of the TCJA may be 
refined upon obtaining, preparing, and/or analyzing additional information during the  measurement period and such changes 
could  be  material.  During  the  measurement  period,  provisional  amounts  may  also  be  adjusted  for  the  effects,  if  any,  of 
interpretative guidance issued after December 31, 2017, by U.S. regulatory and standard-setting bodies. For the items for which 
we were able to determine a reasonable estimate, we recognized the following provisional impacts. 

• 

• 

The reduction in the U.S. corporate tax rate resulted in a net tax benefit of approximately $8.4 million related to the 
revaluation of our U.S. net deferred tax liability. We are still analyzing certain aspects of the TCJA and refining our 
calculations, which could potentially affect the measurement of these balances or potentially give rise to new deferred 
tax amounts.  

The transition tax resulted in a one-time tax expense of approximately $10.6 million. We have not yet completed our 
calculation of the total post-1986 foreign earnings and profits (“E&P”) for our foreign subsidiaries as E&P will not be 
finalized until the federal income tax return is filed. 

The tax expense recognized represents our best estimate of the impact of the TCJA. During 2018, we will continue to 
refine the calculations related to both provisional amounts as we gain a more thorough understanding of the tax law and certain 
aspects of the TCJA are clarified by U.S. tax, regulatory, and standard-setting authorities. 

For tax years beginning after December 31, 2017, the TCJA introduces new provisions of U.S. taxation of certain Global 
Intangible Low-Tax Income (“GILTI”). Due to its complexity and a current lack of guidance as to how to calculate the tax, we 
are not yet able to determine a reasonable estimate for the impact of the incremental tax liability. The FASB provided guidance 
that companies should  make an accounting policy election to either treat taxes on GILTI as period costs or use the deferred 

73 

 
 
 
 
 
 
 
 
 
 
method. When additional analysis is complete and further guidance is available, we will make a policy election for how GILTI 
will be recorded. 

Our non-U.S. earnings are currently considered as indefinitely reinvested overseas. Previously, any repatriation by way 
of a dividend may have been subject to both U.S. federal and state income taxes, as adjusted for any non-U.S. tax credits. Such 
dividends should not be subject to U.S. federal tax under the TCJA. We are still analyzing how the TCJA impacts our existing 
accounting  position  to  indefinitely  reinvest  foreign  earnings,  and  we  have  yet  to  determine  whether  we  plan  to  change  our 
position. We will record the tax effects of any change to our existing assertion in the period that we complete our analysis  and 
make such a change. If such earnings were to be distributed, any foreign withholding taxes could be material. 

For the years ended December 31, 2017, 2016 and 2015, income before income taxes is broken out between U.S. and 

foreign-sourced operations and consisted of the following (in thousands): 

Domestic 
Foreign 
Total 

2017 
14,531  
21,350  
35,881  

  $ 

  $ 

2016 
6,174  
19,212  
25,386  

2015 
9,470  
21,730  
31,200  

  $ 

  $ 

$ 

$ 

The components of the provision for income taxes for the years ended December 31, 2017, 2016 and 2015, consisted of 

the following (in thousands): 

Current expense (benefit): 

Federal 
State 
Foreign 

Total current expense 

Deferred expense (benefit): 

Federal 
State 
Foreign 

Total deferred (benefit) expense 

2017 

2016 

2015 

  $ 

$ 

3,849  
645  
5,168  
9,662  

(314 ) 
(216 ) 
(774 ) 
(1,304 ) 

1,933  
492  
3,802  
6,227  

(144 ) 
(195 ) 
(623 ) 
(962 ) 

  $ 

(17 ) 
747  
3,218  
3,948  

3,250  
294  
(94 ) 
3,450  

Total income tax expense 

$ 

8,358  

  $ 

5,265  

  $ 

7,398  

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The difference between the income tax expense reported and amounts computed by applying the statutory federal rate 

of 35.0% to pretax income for the years ended December 31, 2017, 2016 and 2015, consisted of the following (in thousands): 

Computed federal income tax expense at statutory rate of 35% 
State income taxes 
Tax credits 
Production activity deduction 
Foreign tax rate differential 
Uncertain tax positions 
Deferred compensation insurance assets 
Transaction-related expenses 
U.S. transition tax 
TCJA remeasurement of deferred taxes 
Share-based payments 
Bargain purchase gain 
In-process research and development 
Other — including the effect of graduated rates 
Total income tax expense 

2017 
12,559  
279  
(1,377 ) 
—  
(3,329 ) 
(19 ) 
(479 ) 
90  
10,612  
(8,383 ) 
(2,264 ) 
(1,570 ) 
1,486  
753  
8,358  

  $ 

  $ 

2016 
8,885  
193  
(1,164 ) 
(53 ) 
(3,717 ) 
597  
(307 ) 
274  
—  
—  
—  
—  
—  
557  
5,265  

2015 
10,920  
698  
(1,019 ) 
—  
(3,564 ) 
536  
182  
—  
—  
—  
—  
—  
—  
(355 ) 
7,398  

  $ 

  $ 

$ 

$ 

Deferred  income  tax  assets  and  liabilities  at  December 31,  2017  and  2016,  consisted  of  the  following  temporary 

differences and carry-forward items (in thousands): 

Deferred income tax assets: 

Allowance for uncollectible accounts receivable 
Accrued compensation expense 
Inventory differences 
Net operating loss carryforwards 
Deferred revenue 
Stock-based compensation expense 
Federal research and development credit carryforward 
Foreign tax credits 
Other 

Total deferred income tax assets 

Deferred income tax liabilities: 

Prepaid expenses 
Property and equipment 
Intangible assets 
Other 

Total deferred income tax liabilities 

Valuation allowance 

Net deferred income tax assets (liabilities) 

Reported as: 
Deferred income tax assets - Current 
Deferred income tax assets - Long-term 
Deferred income tax liabilities - Long-term 
Net deferred income tax liabilities 

75 

2017 

2016 

$ 

467  
5,154  
2,505  
15,741  
58  
2,281  
—  
—  
8,986  
35,192  

   $ 

645  
6,203  
1,065  
27,742  
73  
2,738  
3,524  
364  
6,984  
49,338  

(930 ) 
(20,352 ) 
(28,588 ) 
(1,830 ) 

(51,700 ) 

(4,422 ) 

(782 ) 
(25,108 ) 
(35,773 ) 
(1,480 ) 

(63,143 ) 

(3,786 ) 

$  (20,930 ) 

  $  (17,591 ) 

$ 

—  
2,359  
(23,289 ) 
$  (20,930 ) 

  $ 

8,219  
171  
(25,981 ) 
  $  (17,591 ) 

 
 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
 
 
  
  
  
  
    
  
  
  
  
  
  
  
  
  
  
  
     
    
  
    
  
  
  
  
  
  
  
  
  
  
  
    
  
  
 
The long-term deferred income tax balances are not netted as they represent deferred amounts applicable to different 
taxing 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 approximately $636,000, $1.8 million, and $378,000 during the years ended December 31, 2017, 2016 
and 2015, respectively. 

As of December 31, 2017 and 2016, we had U.S federal net operating loss carryforwards of approximately $67.9 million 
and  $76.4  million,  respectively,  which  were  generated  by  Vascular  Access  Technologies,  Inc.,  DFINE,  Inc.,  and  Biosphere 
Medical, Inc. prior to our acquisition of  these companies. Vascular Access Technologies, Inc. was acquired on May 1, 2017. 
These net operating loss carryforwards, which expire at various dates through 2035, are subject to an annual limitation under 
Internal Revenue Code Section 382. We anticipate that we will utilize the net operating loss carryforwards over the next 18 years. 
We utilized a total of approximately $9.1 million and $6.2 million in U.S. federal net operating loss carryforwards during the 
years ended December 31, 2017 and 2016, respectively. 

As of December 31, 2017, we had approximately $5.4 million of non-U.S. net operating loss carryforwards, of which 
approximately $4.9 million have no expiration date and approximately $526,000 expire at various dates through 2027. As of 
December 31, 2016, we had $3.0 million of non-U.S. net operating loss carryforwards, which have no expiration date. Non-U.S. 
net operating loss carryforwards utilized during the years ended December 31, 2017 and 2016 were not material.  

We are subject to income taxes in the United States 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 2014. In foreign jurisdictions, we are no longer subject to 
income tax examinations for years before 2011. 

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,  2017,  including  interest  and  penalties,  was 
approximately $3.1 million, of which approximately $2.7 million would favorably impact our effective tax rate if recognized. 
The total liability for uncertain tax benefits, as presented on our consolidated balance sheets, has been reduced by approximately 
$307,000 related to certain liabilities for unrecognized tax benefits, which, if realized, would reduce the transition tax under the 
TCJA by approximately $307,000. The total liability for unrecognized tax benefits at December 31, 2016, including interest and 
penalties, was approximately $2.8 million, of which approximately $2.8 million would favorably impact our effective tax rate if 
recognized. Approximately $2.3 million of the total liability at December 31, 2016 was presented as a reduction to non-current 
deferred income tax assets on our consolidated balance sheet. As of December 31, 2017 and 2016, we had accrued approximately 
$304,000 and $216,000 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, 2017, 2016 
and  2015  we  added  interest  and  penalties  of  approximately  $88,000,  $30,000  and  $6,000,  respectively,  to  our  liability  for 
unrecognized tax benefits. It is reasonably possible that within the next 12 months the total liability for unrecognized tax benefits 
may change, net of potential decreases due to the expiration of statutes of limitation, up to $500,000. 

A reconciliation of the beginning and ending amount of liabilities associated with uncertain tax benefits for the years 

ended December 31, 2017, 2016 and 2015, consisted of the following (in thousands): 

Tabular Roll-forward 

2017 

2016 

2015 

Unrecognized tax benefits, opening balance 
Gross increases 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 

   $ 

2,549  
80  
403  
(283 ) 
2,749  

   $ 

   $ 

1,982  
77  
856  
(366 ) 
2,549  

   $ 

   $ 

1,736  
187  
763  
(704 ) 
1,982  

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

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6.    ACCRUED EXPENSES 

Accrued expenses at December 31, 2017 and 2016, consisted of the following (in thousands): 

Payroll and related liabilities 
Advances from employees 
Other accrued expenses 

Total 

$ 

2017 
30,225  
796  
27,911  

  $ 

2016 
24,429  
572  
20,518  

$ 

58,932  

  $ 

45,519  

7.    REVOLVING CREDIT FACILITY AND LONG-TERM DEBT 

Principal balances outstanding under our long-term debt obligations as of December 31, 2017 and 2016, consisted of 

the following (in thousands): 

2016 Term loan 
2016 Revolving credit loans 
2017 Debt facility 
Less unamortized debt issuance costs 

Total long-term debt 
Less current portion 

Long-term portion 

2017 Debt Facility 

2017 
85,000      $ 
187,000     
6,959     
(487 )   
278,472     
19,459     
259,013      $ 

2016 
145,000  
180,000  
—  
(627 ) 
324,373  
10,000  
314,373  

$ 

$ 

On February 23, 2017, we entered into a loan agreement with HSBC Bank USA, National Association ("HSBC Bank") 
whereby HSBC Bank agreed to provide us with a loan in the amount of approximately $7.0 million. The loan matures on February 
1, 2018, with an extension available at our option, subject to certain conditions. The loan agreement bears interest at the three-
month London Inter-Bank Offered Rate (“LIBOR”) plus 1.0%, which resets quarterly. The loan is secured by assets equal to the 
currently outstanding loan balance. The loan contains covenants, representations and warranties and other terms customary for 
loans of this nature. As of December 31, 2017, our interest rate on the loan was a variable rate of 2.38%. 

2016 Term Loan and Revolving Credit Loans 

On July 6, 2016, we entered into a Second Amended and Restated Credit Agreement (as amended to date, the “Second 
Amended Credit Agreement”), with Wells Fargo Bank, National Association, as administrative agent, swingline lender and a 
lender, and Wells Fargo Securities, LLC, as sole lead arranger and sole bookrunner. In addition to Wells Fargo Bank, National 
Association, Bank of America, N.A., U.S. Bank, National Association, and HSBC Bank USA, National Association, are parties 
to the Second Amended Credit Agreement as lenders. The Second Amended Credit Agreement amends and restates in its entirety 
our previously outstanding Amended and Restated Credit Agreement and all amendments thereto. The Second Amended Credit 
Agreement was amended on September 28, 2016 to allow for a new revolving credit loan to our wholly-owned subsidiary, on 
March  20,  2017  to  allow  flexibility  in  how  we  apply  net  proceeds  received  from  equity  issuances  to  prepay  outstanding 
indebtedness, and on December 13, 2017 to increase the revolving credit commitment by $100 million up to $375 million. 

The Second Amended Credit Agreement provides for a term loan of $150 million and a revolving credit commitment 
up to an aggregate amount of $375 million, which includes a reserve of $25 million to make swingline loans from time to time. 
The term loan is payable in quarterly installments in the amounts provided in the Second Amended Credit Agreement until the 
maturity date of July 6, 2021, at which time the term and revolving credit loans, together with accrued interest thereon, will be 
due and payable. At any time prior to the maturity date, we may repay any amounts owing under all revolving credit loans, term 
loans, and all swingline loans in whole or in part, subject to certain minimum thresholds, without premium or penalty, other than 
breakage costs. 

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Revolving credit loans denominated in dollars and term loans made under the Second Amended Credit Agreement bear 
interest, at our election, at either a Base Rate or Eurocurrency Base Rate (as such terms are defined in the Second Amended 
Credit  Agreement)  plus  the  applicable  margin,  which  increases  as  our  Consolidated  Total  Leverage  Ratio  (as  defined  in  the 
Second Amended Credit Agreement) increases. Revolving credit loans denominated in an Alternative Currency (as defined in 
the Second 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. Upon an event of default, the interest rate may be increased by 2.0%. The 
revolving credit commitment will also carry a commitment fee of 0.15% to 0.40% per annum on the unused portion.  

The Second Amended Credit Agreement is collateralized by substantially all our assets. The Second Amended Credit 
Agreement contains covenants, representations and warranties and other terms customary for loans of this nature. The Second 
Amended Credit Agreement requires that we maintain certain financial covenants, as follows: 

Covenant Requirement 

Consolidated Total Leverage Ratio (1) 

July 1, 2017 through December 31, 2017    
January 1, 2018 through March 31, 2018 
April 1, 2018 and thereafter 

3.75 to 1.0 
3.5 to 1.0 
3.25 to 1.0 
1.25 to 1.0 
$— 
$30 million 

Consolidated EBITDA (2) 
Consolidated Net Income (3) 
Facility Capital Expenditures (4)   
(1)  Maximum Consolidated Total Leverage Ratio (as defined in the Second Amended Credit Agreement) as of any fiscal quarter end. 
(2)  Minimum ratio of Consolidated EBITDA (as defined in the Second Amended Credit Agreement and adjusted for certain 

expenditures) to Consolidated Fixed Charges (as defined in the Second Amended Credit Agreement) for any period of four 
consecutive fiscal quarters. 

(3)  Minimum level of Consolidated Net Income (as defined in the Second Amended Credit Agreement) for certain periods, and subject 

to certain adjustments. 

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

Agreement) in any fiscal year. 

Additionally, the Second Amended Credit Agreement contains customary events of default and affirmative and negative 
covenants for transactions of this type. As of December 31, 2017, we believe we were in compliance with all covenants set forth 
in the Second Amended Credit Agreement. 

Future Payments 

Future minimum principal payments on our long-term debt as of December 31, 2017, are as follows (in thousands): 

Years Ending  

December 31 

2018 
2019 
2020 
2021 

Total future minimum principal payments 

  $ 

   Future Minimum  
   Principal Payments 
19,459  
15,000  
17,500  
227,000  
278,959  

  $ 

As of December 31, 2017, we had outstanding borrowings of approximately $272.0 million under the Second Amended 
Credit Agreement, with available borrowings of approximately $188.0 million, based on the leverage ratio required pursuant to 
the Second Amended Credit Agreement. Our interest rate as of December 31, 2017 was a fixed rate of 2.68% on $175.0 million 
as  a  result  an  interest  rate  swap  (see  Note  8)  and  a  variable  floating  rate  of  2.82%  on  $97.0  million.  Our  interest  rate  as  of 
December 31, 2016 was a fixed rate of 2.98% on $130.0 million and 3.12% on $45.0 million as a result of an interest rate swaps, 
and a variable floating rate of 2.77% on approximately $150.0 million. 

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8.    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. Changes in the fair value of derivatives that qualify for hedge accounting treatment are recorded, net of 
applicable taxes, in accumulated other comprehensive income (loss), a component of stockholders’ equity in the accompanying 
consolidated  balance  sheets. For  the  ineffective  portions  of  qualifying  hedges,  the  change  in  fair  value  is  recorded  through 
earnings in the period of change. 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. A  portion  of  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 Second 
Amended Credit Agreement that is solely due to changes in the benchmark interest rate.  

Derivatives Designated as Cash Flow Hedges 

On December 19, 2012, we entered into a pay-fixed, receive-variable interest rate swap having an initial notional amount 
of $150 million with Wells Fargo to fix the one-month LIBOR rate at 0.98%. The interest rate swap expired on December 19, 
2017. The variable portion of the interest rate swap was tied to the one-month LIBOR rate (the benchmark interest rate). The 
interest rates under both the interest rate swap and the underlying debt reset, the swap was settled with the counterparty, and 
interest was paid, on a monthly basis. The notional amount of the interest rate swap was reduced quarterly by 50% of the minimum 
principal payment due under the terms of our Second Amended Credit Agreement.  

On August 5, 2016, we entered into a pay-fixed, receive-variable interest rate swap having an initial notional amount 
of $42.5 million with Wells Fargo to fix the one-month LIBOR rate at 1.12%. 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. The notional amount of the 
interest rate swap increased quarterly by an amount equal to the decrease of the hedge entered into on December 19, 2012, up to 
the amount of $175.0 million, which was reached upon expiration of the other swap on December 19, 2017. The interest rate 
swap is scheduled to expire on July 6, 2021. 

At December 31, 2017 and 2016, our interest rate swaps qualified as cash flow hedges. The fair value of our interest 
rate swap at December 31, 2017 was an asset of approximately $5.7 million, which was partially offset by approximately $1.5 
million in deferred taxes. The fair value of our interest rate swaps at December 31, 2016 was an asset of approximately $5.0 
million, which was offset by approximately $1.9 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 primarily exposed to foreign currency exchange rate risk with 
respect to transactions and balances denominated in Euros, British Pounds, Chinese Renminbi, Mexican Pesos, Brazilian Reals, 
Australian Dollars, Hong Kong Dollars, Swiss Francs, Swedish Krona, Canadian Dollars, Danish Krone, Japanese Yen, Korea 
Won, and Singapore Dollars. 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.  

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Derivatives Designated as Cash Flow Hedges 

For derivative instruments that are designated and qualify as cash flow hedges, the effective portion of the gain or loss 
on the derivative instrument is reported as a component of other comprehensive income (loss) and 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. The remaining gain or loss on the derivative instrument in excess of the cumulative change in the 
present value of future cash flows of the hedged item, if any (i.e., the ineffective portion) or hedge components excluded from 
the  assessment  of  effectiveness,  are  recognized  in  earnings  during  the  current  period.  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 the associated foreign currencies.  

We enter into approximately 100 cash flow foreign currency hedges every month. As of December 31, 2017, we had 
entered into foreign currency forward contracts, which qualified as cash flow hedges, with the following notional amounts (in 
thousands and in local currencies): 

Currency  

Canadian Dollar 
Swiss Franc 
Chinese Renminbi 
Danish Krone 
Euro 
British Pound 
Mexican Peso 
Swedish Krona 

Symbol 

CAD 
CHF 
CNY 
DKK 
EUR 
GBP 
MXN 
SEK 

Forward Notional Amount 
2,310  
1,375  
45,000  
14,470  
9,165  
3,625  
95,075  
16,330  

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 20 foreign currency fair 
value hedges every month. As of December 31, 2017, we had entered into foreign currency forward contracts related to those 
balance sheet accounts with the following notional amounts (in thousands and in local currencies): 

Currency  

Australian Dollar 
Brazilian Real 
Canadian Dollar 
Swiss Franc 
Chinese Renminbi 
Danish Krone 
Euro 
British Pound 
Hong Kong Dollar 
Japanese Yen 
Korean Won 
Mexican Peso 
Swedish Krona 
Singapore Dollar 

Forward Notional Amount 
5,600  
8,500  
2,076  
242  
22,990  
1,881  
23,333  
1,868  
11,000  
178,500  
1,800,000  
17,540  
4,775  
5,023  

Symbol 

AUD 
BRL 
CAD 
CHF 
CNY 
DKK 
EUR 
GBP 
HKD 
JPY 
KRW 
MXN 
SEK 
SGD 

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Balance Sheet Presentation of Derivatives. As of December 31, 2017 and 2016, 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): 

Balance Sheet Location 

   December 31, 2017     December 31, 2016 

Fair Value 

Derivatives designated as hedging instruments 

Assets 

Interest rates swaps 

Foreign currency forward contracts 

Foreign currency forward contracts 

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

   $ 

Liabilities 

Foreign currency forward contracts 

Foreign currency forward contracts 

   Accrued expenses 
   Other long-term obligations 

Derivatives not designated as hedging instruments 

Assets 

5,749  
363  
35  

(468 ) 

(82 ) 

   $ 

4,991  
116  
18  

(275 ) 

(18 ) 

Foreign currency forward contracts 

   Prepaid expenses and other assets     $ 

223  

   $ 

220  

Liabilities 

Foreign currency forward contracts 

   Accrued expenses 

(841 ) 

(171 ) 

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 and net earnings in our consolidated statements of earnings, consolidated statements of comprehensive 
income and consolidated balance sheets (in thousands): 

Amount of Gain/(Loss) recognized 
in OCI 

Year ended December 31, 

2017 

2016 

2015 

Amount of Gain/(Loss) reclassified 
from AOCI 

Year ended December 31, 

2017 

2016 

2015 

Derivative instrument 

Interest rate swaps 

Foreign currency forward contracts 

$ 

853 
 491 

$  4,989  
(205 ) 

$ 

(571 ) 
—  

   Location in statements of income 
   Interest Expense 
   Revenue 
   Cost of goods sold 

$      95 

(277 ) 
625  

(718 ) 
21  
(26 ) 

(1,103 ) 
—  
—  

The net amount recognized in earnings during the years ended December 31, 2017, 2016 and 2015 due to ineffectiveness 

and amounts excluded from the assessment of hedge effectiveness were not significant. 

As  of  December  31,  2017,  approximately  $44,000,  or  $33,000  after  taxes,  was  expected  to  be  reclassified  from 
accumulated other comprehensive income to earnings in revenue and cost of sales over the succeeding twelve  months. As of 
December 31, 2017, approximately $1.1 million, or $840,000 after taxes, was expected to be reclassified from accumulated other 
comprehensive income to earnings in interest expense over the succeeding twelve months. 

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Derivatives Not Designated as Hedging Instruments 

The  following  gains/(losses)  from  these  derivative  instruments  were  recognized  in  our  consolidated  statements  of 

income for the years presented (in thousands): 

Derivative Instrument 
Foreign currency forward contracts  Other expense 

Location in statements of income 

  $ 

(4,746 ) 

$ 

69  

$ 

(302 ) 

Year ended December 31, 

2017 

2016 

2015 

See Note 15 for more information about our derivatives.  

9.    COMMITMENTS AND CONTINGENCIES 

We are obligated under non-terminable operating leases for manufacturing facilities, finished good distribution, office 
space and equipment. Total rental expense on these operating leases and on our manufacturing and office building for the years 
ended December 31, 2017, 2016 and 2015, approximated $13.6 million, $11.4 million and $10.7 million, respectively. 

The  future  minimum  lease  payments  for  operating  leases  as  of  December 31,  2017,  consisted  of  the  following  (in 

thousands): 

Years Ending 
December 31 

Operating 
Leases 

2018 
2019 
2020 
2021 
2022 
Thereafter 

  $ 

12,293  
11,237  
9,307  
7,527  
6,468  
57,211  

Total minimum lease payments 

  $ 

104,043  

Sale-Leaseback. During the year ended December 31, 2015, we entered into sale and leaseback transactions to finance 
certain production equipment for $2.0 million. We did not enter into any new sale and leaseback transactions during the years 
ended December 31, 2017 and 2016. The lease agreements from the sale and leaseback transactions are accounted for as operating 
leases. Under the terms of the lease agreements, we have agreed to operate and maintain the equipment. The lease term of the 
agreements is seven years.  

Irish  Government  Development  Agency  Grants.  As  of  December 31,  2017,  we  had  entered  into  several  grant 
agreements  with  the  Irish  Government  Development  Agency. Grants  related  to  the  acquisition  of  property  and  equipment 
purchased in Ireland are amortized as a reduction to depreciation expense over lives corresponding to the depreciable lives of 
such property and equipment. The balance of deferred credits related to such grants as of December 31, 2017 and 2016, was 
approximately  $2.4  million  and  $2.5  million,  respectively.  During  the  years  ended December 31,  2017,  2016  and  2015, 
approximately $147,000, $170,000 and $171,000, respectively, of the deferred credit was amortized as a reduction of operating 
expenses. 

We have committed to repay the Irish government for grants received if we cease production in Ireland prior to the 
expiration of the grant liability period. The grant liability period is usually between five and eight years from the last claim made 
on a grant. As of December 31, 2017, the total amount of grants that could be subject to refund was approximately $3.0 million, 
and the remaining grant liability period was one year. Our management does not currently believe we will have to repay any of 
these grant monies, as we have no current intention of ceasing operations in Ireland. 

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Royalties. As of December 31, 2017, we  had entered into several 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. Total royalty expense during the years ended December 31, 2017, 2016 and 2015, approximated $4.4 million, 
$3.2 million and $2.7 million, respectively. See Note 2 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 claims 
and litigation matters may include actions involving product liability, intellectual property, contract disputes, and  employment 
or other matters that are significant to our business. Based upon our review of currently available information, we do not believe 
that any such actions are likely to be, individually or in the aggregate, materially adverse to our business, financial condition, 
results of operations or liquidity. 

In October 2016, we received a subpoena from the U.S. Department of Justice seeking information on certain of our 
marketing and promotional practices. We are in the process of responding to the subpoena, which we anticipate will continue 
during 2018. We have incurred, and anticipate that we will continue to incur, substantial costs in connection with the matter. The 
investigation is ongoing and at this stage we are unable to predict its scope, duration or outcome. Investigations such as this may 
result in the imposition of, among other things, significant damages, injunctions, fines or civil or criminal claims or penalties 
against our company or individuals. 

In  the  event  of  unexpected  further  developments,  it  is  possible  that  the  ultimate  resolution  of  any  of  the  foregoing 
matters, or other 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. 

10.    EARNINGS PER COMMON SHARE (EPS) 

The computation of weighted average shares outstanding and the basic and diluted earnings per common share for the 

following periods consisted of the following (in thousands, except per share amounts):  

Year ended December 31, 2017: 

Basic EPS 

Effect of dilutive stock options and warrants 

Net 
Income 

$ 

27,523  

Per Share 
Amount 

  $ 

0.56  

Shares 

48,805  
1,296  

Diluted EPS 

$ 

27,523  

50,101  

  $ 

0.55  

Year ended December 31, 2016: 

Basic EPS 

Effect of dilutive stock options and warrants 

$ 

20,121  

  $ 

0.45  

44,408  
454  

Diluted EPS 

$ 

20,121  

44,862  

  $ 

0.45  

Year ended December 31, 2015: 

Basic EPS 

Effect of dilutive stock options and warrants 

$ 

23,802  

  $ 

0.54  

44,036  
475  

Diluted EPS 

$ 

23,802  

44,511  

  $ 

0.53  

For the years ended December 31, 2017, 2016 and 2015, approximately 381,000, 727,000 and 423,000, respectively, of 
stock options  were not included in the computation of diluted earnings per share because their effect  would  have been anti-
dilutive. 

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11.    EMPLOYEE STOCK PURCHASE PLAN, STOCK OPTIONS AND WARRANTS. 

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

2006 Long-Term Incentive Plan. In May 2006, our Board of Directors adopted and our shareholders approved, the 
Merit Medical Systems, Inc. 2006 Long-Term Incentive Plan (the “2006 Incentive Plan”). The 2006 Incentive Plan provides for 
the  granting  of  stock  options,  stock  appreciation  rights,  restricted  stock,  stock  units  (including  restricted  stock  units)  and 
performance awards. 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  will 
typically vest on an annual basis over a three to five-year life (or one year if performance based) with a contractual life of seven 
years. As of December 31, 2017, a total of 492,292 shares remained available to be issued under the 2006 Incentive Plan. 

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, 2017, the total number of shares of Common Stock that remained available 
to be issued under our non-qualified plan was 126,863 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. 

Stock-Based Compensation Expense. The stock-based compensation expense before income tax expense for the years 

ended December 31, 2017, 2016 and 2015, consisted of the following (in thousands): 

Cost of goods sold 
Research and development 
Selling, general, and administrative 

Stock-based compensation expense before taxes 

2017 
632  
376  
3,067  
4,075  

$ 

$ 

2016 
472  
184  
1,850  
2,506  

  $ 

  $ 

2015 
398  
122  
1,723  
2,243  

  $ 

  $ 

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. As of December 31, 2017, the total remaining unrecognized compensation cost related to 
non-vested stock options, net of expected forfeitures, was approximately $15.1 million and is expected to be recognized over a 
weighted average period of 3.46 years. 

In applying the Black-Scholes methodology to the option grants, the fair value of our stock-based awards granted were 

estimated using the following assumptions for the periods indicated below: 

2017 

2016 

2015 

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

1.77% 

-  1.83% 

   1.15% 

-  1.40% 

5.0 years 
—% 

5.0 years 
—% 

   1.53% 

1.66% 

- 
5.0 years 
—% 
- 

33.81%  -  34.07%     34.28%  -  37.06%     33.72% 

35.11% 

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 using a weighted average of daily historical volatility of our stock 
price over the corresponding expected option life and implied volatility based on recent trends of the daily historical volatility. For 
options  with  a  vesting  period,  compensation  expense  is  recognized  on  a  straight-line  basis  over  the  service  period,  which 
corresponds to the vesting period. Compensation expense is recognized immediately for options that are fully vested on the date 
of grant. During the years ended December 31, 2017, 2016 and 2015, approximately 1.3 million, 880,000 and 618,000 stock-
based compensation grants were made, respectively, for a total fair value of approximately $12.4 million, $5.2 million and $3.7 
million, net of estimated forfeitures, respectively. 

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The table below presents information related to stock option activity for the years ended December 31, 2017, 2016 and 

2015 (in thousands): 

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

$ 

2017 
9,264  
5,552  
2,264  

  $ 

2016 
3,648  
4,577  
669  

  $ 

2015 
7,548  
6,227  
2,124  

Changes in stock options for the year ended December 31, 2017, 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 

Number 
of Shares 
2,817  
1,297  
(404 ) 
(87 ) 
3,623  
1,110  
3,484  

  $ 

Weighted Average 
Exercise Price 
15.32  
29.31  
14.02  
18.79  
20.40  
14.35  
20.23  

Remaining Contractual 
Term (in years) 

Intrinsic 
Value 

4.57 years 
2.55 years 
4.52 years 

  $ 

82,615  
32,019  
80,052  

The weighted average grant-date fair value of options granted during the years ended December 31, 2017, 2016 and 2015 

was $9.57, $5.94 and $5.98, respectively. 

The  following  table  summarizes  information  about  stock  options  outstanding  at  December 31,  2017  (shares  in 

thousands):  

Range of Exercise 

$9.95 
- 
$13.77  - 
$18.80  - 
$28.20  - 

$13.75 
$17.27 
$22.00 
$38.35 

$9.95 

- 

$38.35 

Options Outstanding 

Weighted Average 
Remaining Contractual 
Life (in years) 

Number 
Outstanding 

925   
991   
425   
1,282   

3,623   

2.17 years 
4.38 years 
5.00 years 
6.30 years 

Weighted Average 
Exercise Price 
12.65  
16.18  
20.14  
29.33  

  $ 
  $ 
  $ 
  $ 

Options Exercisable 

Number 
Exercisable 

713 
294 
103 
   0 

Weighted Average 
Exercise Price 
12.84  
15.96  
20.18  
—  

  $ 
  $ 
  $ 
  $ 

1,110   

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12.    SEGMENT REPORTING AND FOREIGN OPERATIONS 

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 
("CRM"), electrophysiology ("EP"), critical care and interventional oncology and spine devices. Our endoscopy segment consists 
of gastroenterology and pulmonology medical device products 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 operating income (loss). Listed below are the sales by business segment for the years ended December 31, 2017, 2016 
and 2015 (in thousands): 

% Change 

2017 

   % Change 

2016* 

   % Change 

2015 

Cardiovascular 

Stand-alone devices 
Custom kits and procedure trays 
Inflation devices 
Catheters 
Embolization devices 
CRM/EP 

Total 

Endoscopy 

Endoscopy devices 

44% 
6% 
8% 
13% 
8% 
15% 
21% 

  $  275,431     
126,114     
79,875     
127,747     
49,532     
41,914     
700,613     

23% 
2% 
1% 
17% 
2% 
8% 
11% 

  $  191,148     
119,226     
73,916     
113,367     
46,035     
36,459     
580,151     

8% 
5% 
1% 
11% 
3% 
3% 
6% 

  $  155,414  
116,368  
73,373  
96,833  
45,025  
33,902  
520,915  

15% 

27,239     

12% 

23,687     

18% 

21,234  

Total 

  $  542,149  
  $  727,852     
* Certain product categories for 2016 have been adjusted from prior disclosure to reflect changes in product classifications  to be consistent 
with updates in the management of our product portfolios in 2017. 

  $  603,838     

11% 

21% 

6% 

During the years ended December 31, 2017, 2016 and 2015, we had international sales of approximately $307.1 million, 
$233.5 million and $214.0 million, respectively, or approximately 42%, 39% and 39%, respectively, of net sales, primarily in 
China, Japan, Germany, France, the United Kingdom and Russia. China represents our most significant international sales market 
with sales of approximately $73.4 million, $59.9 million, and $50.7 million for the years ended December 31, 2017, 2016 and 
2015, respectively. International sales are attributed based on location of the customer receiving the product. 

Our  long-lived  assets  by  geographic  area  at  December 31,  2017,  2016  and  2015,  consisted  of  the  following  (in 

thousands): 

United States 
Ireland 
Other foreign countries 
Total 

2017 
202,504  
45,671  
44,645  
292,820  

$ 

$ 

  $ 

  $ 

2016 
194,715  
47,337  
34,521  
276,573  

2015 
186,389  
48,896  
32,493  
267,778  

  $ 

  $ 

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Financial information relating to our reportable operating segments and reconciliations to the consolidated totals for the 

years ended December 31, 2017, 2016 and 2015, are as follows (in thousands): 

Net Sales (1) 

Cardiovascular 
Endoscopy 
Total net sales 

Operating expenses 
Cardiovascular 
Endoscopy 

Total operating expenses 

Operating income (loss) (1) 

Cardiovascular 
Endoscopy 
Total operating income 

Total other expense - net 
Income tax expense 

2017 

2016 

2015 

$ 

700,613     $ 
27,239     
727,852     

580,151     $ 
23,687     
603,838     

520,915  
21,234  
542,149  

281,095     
12,089     
293,184     

218,659     
11,490     
230,149     

187,492  
10,746  
198,238  

24,819     
8,250     
33,069     

2,812     
8,358     

30,053     
4,823     
34,876     

(9,490 )   
5,265     

34,052  
3,491  
37,543  

(6,343 ) 
7,398  

Net income 

23,802  
(1) Sales and operating income have been adjusted from prior disclosure to reflect changes in product classifications between our operating 

20,121     $ 

27,523     $ 

$ 

segments, which were made to be consistent with updates in the management of our product portfolios in 2017. 

Total assets by business segment at December 31, 2017, 2016 and 2015, consisted of the following (in thousands): 

Cardiovascular 
Endoscopy 

Total 

2017 
1,103,806     $ 
8,005     
1,111,811     $ 

2016 

2015 

932,927     $ 
9,876     
942,803     $ 

767,952  
10,776  
778,728  

$ 

$ 

Total  depreciation  and  amortization  by  business  segment  for  the  years  ended  December 31,  2017,  2016,  and  2015 

consisted of the following (in thousands): 

Cardiovascular 
Endoscopy 

Total 

2017 

2016 

2015 

$ 

$ 

52,700     $ 
882     
53,582     $ 

42,806     $ 
949     
43,755     $ 

36,474  
951  
37,425  

Total capital expenditures for property and equipment by business segment for the years ended December 31, 2017, 

2016 and 2015 consisted of the following (in thousands): 

Cardiovascular 
Endoscopy 

Total 

2017 

2016 

2015 

$ 

$ 

38,437     $ 
186     
38,623     $ 

32,613     $ 
224     
32,837     $ 

50,927  
32  
50,959  

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13.    EMPLOYEE BENEFIT PLANS 

We have a contributory 401(k) savings and profit sharing plan (the “Plan”) covering all U.S. full-time employees who 
are at least 18 years of age. The Plan has a 90-day minimum service requirement. We may contribute, at our discretion, matching 
contributions based on the employees’ compensation. Contributions we made to the Plan for the years ended December 31, 2017, 
2016 and 2015, totaled approximately $2.4 million, $2.3 million and $2.0 million, respectively.  

We also have defined contribution plans covering some of our foreign employees. We contribute between 2% and 32% 
of the employee’s compensation for certain foreign non-management employees, and between 2% and 32% of the employee’s 
compensation for certain foreign management employees. Contributions made to these plans for the years ended December 31, 
2017, 2016 and 2015, totaled approximately $2.3 million, $1.1 million and $893,000, respectively. 

14.    QUARTERLY RESULTS OF OPERATIONS (UNAUDITED) 

Quarterly data for the years ended December 31, 2017 and 2016 consisted of the following (in thousands, except per 

share amounts): 

2017 
Net sales 
Gross profit 
Income from operations 
Income tax expense 
Net income (loss) 
Basic earnings per common share 
Diluted earnings per common share 

2016 
Net sales 
Gross profit 
Income from operations 
Income tax expense (benefit) 
Net income 
Basic earnings per common share 
Diluted earnings per common share 

March 31 

June 30 

September 30 

December 31 

Quarter Ended 

$ 

$ 

171,069     $ 
75,942     
5,609     
690     
14,803     
0.33     
0.32     

138,077     $ 
60,100     
7,706     
1,555     
4,351     
0.10     
0.10     

186,549     $ 
84,141     
13,362     
1,830     
9,483     
0.19     
0.19     

151,071     $ 
66,854     
11,581     
2,572     
7,290     
0.16     
0.16     

179,337     $ 
80,514     
879     
1,364     
(3,569 )   
(0.07 )   
(0.07 )   

156,975     $ 
67,815     
2,987     
(978 )   
973     
0.02     
0.02     

190,897  
85,656  
13,219  
4,474  
6,806  
0.14  
0.13  

157,715  
70,256  
12,602  
2,116  
7,507  
0.17  
0.17  

Basic and diluted earnings per share are computed independently for each of the quarters presented. Therefore, the sum 

of the quarterly amounts may not equal the total computed for the year.  

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15.    FAIR VALUE MEASUREMENTS 

Our financial assets and (liabilities) carried at fair value measured on a recurring basis as of December 31, 2017 and 

2016, consisted of the following (in thousands): 

Fair Value Measurements Using 

Total Fair 

   Quoted prices in 

Value at 

active markets 

   Significant other 
   observable inputs 

Significant 
   unobservable inputs 

Description 

   December 31, 2017 

(Level 1) 

(Level 2) 

(Level 3) 

Interest rate contracts (1) 
Foreign currency contract assets, current and 
long-term (2) 
Foreign currency contract liabilities, current 
and long-term (3) 

  $ 

  $ 

5,749  

621  

  $ 

  $ 

  $ 

(1,391 ) 

  $ 

—  

—  

—  

  $ 

  $ 

5,749  

621  

  $ 

  $ 

  $ 

(1,391 ) 

  $ 

—  

—  

—  

Fair Value Measurements Using 

Total Fair 

   Quoted prices in 

Value at 

active markets 

   Significant other 
   observable inputs 

Significant 
   unobservable inputs 

Description 

   December 31, 2016 

(Level 1) 

(Level 2) 

(Level 3) 

Interest rate contracts (1) 
Foreign currency contract assets, current and 
long-term (2) 
Foreign currency contract liabilities, current 
and long-term (3) 

  $ 

  $ 

  $ 

4,991  

354  

  $ 

  $ 

(464 ) 

  $ 

—  

—  

—  

  $ 

  $ 

  $ 

4,991  

354  

  $ 

  $ 

(464 ) 

  $ 

—  

—  

—  

(1)   The fair value of the interest rate contracts is determined using Level 2 fair value inputs and is recorded as other assets or other long-

term obligations in the consolidated balance sheets. 

(2)   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. 

(3)   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  milestones.  See  Note  2  for  further 
information regarding these acquisitions. The contingent consideration liability is re-measured at the estimated fair value at each 
reporting period with the change in fair value recognized within operating expenses in the accompanying consolidated statements 
of income. 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 liability during the 
years ended December 31, 2017 and 2016, consisted of the following (in thousands): 

Beginning balance 
Contingent consideration liability recorded as the result of acquisitions (see Note 2) 
Fair value adjustments recorded to income during the period 
Contingent payments made 

Ending balance 

2017 
683  
10,400  
(66 ) 
(61 ) 
10,956  

$ 

$ 

2016 
1,024  
—  
(123 ) 
(218 ) 
683  

  $ 

  $ 

As of December 31, 2017, approximately $10.7 million was included in other long-term obligations and approximately 
$289,000 was included in accrued expenses in our consolidated balance sheet. As of December 31, 2016, approximately $595,000 
was included in other long-term obligations and $88,000 was included in accrued expenses in our consolidated balance sheet. 
The  cash  paid  to  settle  the  contingent  consideration  liability  recognized  at  fair  value  as  of  the  acquisition  date  (including 

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measurement-period  adjustments)  has  been  reflected  as  a  cash  outflow  from  financing  activities  in  the  accompanying 
consolidated statements of cash flows. 

During  the  year  ended  December  31,  2016,  we  sold  a  cost  method  investment  for  cash  and  for  the  right  to  receive 
additional payments based on various contingent milestones. We determined the fair value of the contingent payments using 
Level 3 inputs defined under authoritative guidance for fair value measurements, and we recorded a contingent receivable asset, 
which as of December 31, 2017 and 2016 had a value of approximately $760,000 and $528,000, respectively. We record any 
changes  in  fair  value to operating expenses as part of our cardiovascular segment in our consolidated statements of  income. 
During the year ended December 31, 2017, we recorded a gain on the contingent receivable of approximately $232,000. During 
the  year  ended  December  31,  2016,  we  recorded  a  loss  on  the  contingent  receivable  of  approximately  $184,000.  As  of 
December 31, 2017, approximately $319,000 was included in other long-term assets and approximately $441,000 was included 
in other receivables as a current asset in our consolidated balance sheet. During the year ended December 31, 2016, approximately 
$367,000 was included in other long-term assets and approximately $161,000 was included in other receivables as a current asset 
in our consolidated balance sheet. 

The  recurring  Level  3  measurement  of  our  contingent  consideration  liability  and  contingent  receivable  includes  the 

following significant unobservable inputs at December 31, 2017 and 2016 (amounts in thousands): 

Contingent consideration 
asset or liability 

Revenue-based payments 

  $ 

Fair value at 
December 31, 
2017 
10,956  

Valuation 
technique 

  Discounted 
cash flow 

contingent liability 

Unobservable inputs 

  Discount rate 

  Probability of milestone payment 
  Projected year of payments 

Contingent receivable 

  $ 

760  

  Discounted 
cash flow 

  Discount rate 

Asset 

Contingent consideration 
asset or liability 

Revenue-based payments 

  $ 

Fair value at 
December 31, 
2016 
683  

Valuation 
technique 

  Discounted 
cash flow 

contingent liability 

  Probability of milestone payment 
  Projected year of payments 

Unobservable inputs 

  Discount rate 

  Probability of milestone payment 
  Projected year of payments 

Contingent receivable 

  $ 

528  

  Discounted 
cash flow 

  Discount rate 

Asset 

  Probability of milestone payment 
  Projected year of payments 

Range 

9.9% - 15% 

100% 
2018-2037 

10% 

75% 
2018-2019 

Range 

9.9% - 15% 

100% 
2017-2028 

10% 

57% 
2017-2019 

The  contingent  consideration  liability  and  contingent  receivable  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 in the probability of any 
milestone  payment  may  result  in  lower  fair  value  measurements.  Our  determination  of  the  fair  value  of  the  contingent 
consideration  liability  and  contingent  receivable  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.  

During the years ended December 31, 2017, 2016 and 2015, we had losses of approximately $988,000, $101,000, and 
$141,000, respectively, related to the measurement of non-financial assets at fair value on a nonrecurring basis subsequent to 
their initial recognition (see Note 4). 

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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. The  carrying  amount  of  long-term  debt  approximates  fair 
value, as determined by borrowing rates estimated to be available to us for debt with similar terms and conditions. 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. 

16.     ISSUANCE OF COMMON STOCK 

On  March  28,  2017,  we  closed  a  public  offering  of 5,175,000 shares  of  common  stock  and  received  proceeds  of 
approximately $136.6  million,  which  is  net  of  approximately $8.8  million in  underwriting  discounts  and  commissions  and 
approximately $816,000 in other direct cost incurred and paid by us in connection with this equity offering. The net proceeds 
from  the  offering  were  used  primarily  to  repay  outstanding  indebtedness  under  our  Second  Amended  Credit  Agreement 
(including our term loan and revolving credit loans). 

17.    SUBSEQUENT EVENTS 

We evaluate events occurring after the date of our accompanying consolidated balance sheets for potential recognition 
or  disclosure  in  our  financial  statements.  We  did  not  identify  any  material  subsequent  events  requiring  adjustment  to  our 
accompanying  consolidated  financial  statements  (recognized  subsequent  events).  We  have  also  evaluated  whether  any 
subsequent events have occurred after the date  of our accompanying consolidated balance sheets to the time of filing of this 
report that would require disclosure in the consolidated financial statements. We note the following event below. 

On February 14, 2018, we completed the acquisition of two product lines from BD. Pursuant to the terms of the BD 
Agreement, we paid BD the purchase consideration of approximately $100.1 million in cash. The purchased assets constitute the 
soft tissue core needle biopsy products under the trade names of Achieve™ Programmable Automatic Biopsy System, Temno™ 
Biopsy System, and Tru-Cut™ Biopsy Needles previously sold by BD as well as the Aspira® Pleural Effusion Drainage Kits 
and the  Aspira® Peritoneal Drainage  System previously sold by  C.R. Bard, Inc. We are currently evaluating the accounting 
treatment of this purchase, as well as performing the valuation of assets acquired and the related purchase price allocation.  

Supplementary Financial Data 

The  supplementary  financial  information  required  by  Item  302  of  Regulation  S-K  is  contained  in  Note  14  to  our 

consolidated financial statements set forth above. 

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, 2017. Based on this evaluation, our principal executive officer and principal financial officer concluded that as of 
December 31,  2017,  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 
United States of America.   

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Our management assessed the effectiveness of our internal control over financial reporting as of December 31, 2017. 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). However, as permitted by SEC guidance, 
we  have  excluded  the  critical  care  assets  acquired  from  Argon  and  the  operations  of  ITL  from  management's  assessment  of 
internal  control  over  financial  reporting  as  of  December  31,  2017.  ITL  and  the  assets  we  acquired  from  Argon  constituted 
approximately  1.9%  of  our  total  assets  as  of  December  31,  2017  (excluding  approximately  $11.3  million  of  goodwill  and 
intangible assets, which were integrated into our systems and control environment). Additionally, the operations of ITL and the 
assets we acquired from Argon contributed 2.6% of our 2017 net sales, and resulted in a net pre-tax loss in 2017 of approximately 
$304,000 (excluding approximately $599,000 of amortization of intangible assets, which was integrated into our systems and 
control environment). 

Based  on  the  criteria  discussed  above  and  our  management’s  assessment,  our  management  concluded  that,  as  of 

December 31, 2017, our internal control over financial reporting was effective. 

CHANGES IN INTERNAL CONTROL OVER FINANCIAL REPORTING 

Except as set forth below, during the quarter ended December 31, 2017, 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). 

On January 31, 2017, we completed our acquisition of the critical care business of Argon, and on October 2, 2017, we 
completed our acquisition of ITL. We are currently integrating the policies, processes, employees, technology and operations of 
ITL and the critical care division of Argon. Management does not currently expect a material change to our internal controls over 
financial reporting as we fully integrate ITL and the critical care division of Argon into our operations. 

Our independent registered public accountants have also issued an audit report on our internal control over financial 

reporting. Their report appears below. 

92 

 
 
  
  
 
 
 
 
 
 
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM 

To the Board of Directors and Shareholders 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, 2017, 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, 2017, based on criteria established in 
Internal Control-Integrated Frame Work (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, 2017 of the Company and our 
report dated March 1, 2018, expressed an unqualified opinion on those financial statements. 

As described in Management’s Report on Internal Control over Financial Reporting, management excluded ITL and the 
critical care division of Argon from its assessment of internal control over financial reporting, which were acquired on January 
31, 2017 and October 2, 2017, respectively, and whose financial statements constitute approximately 1.9% of total assets as of 
December  31,  2017  (excluding  approximately  $11.3  million  of  goodwill  and  intangible  assets),  2.6%  of  2017  net  sales,  and 
resulted in a net pre-tax loss in 2017 of approximately $304,000 (excluding approximately $599,000 of amortization of intangible 
assets) of the consolidated financial statement amounts as of and for the year ended December 31, 2017. Accordingly, our audit 
did not include the internal control over financial reporting at ITL and the critical care division of Argon. 

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  the  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 
March 1, 2018  

93 

 
  
  
 
 
 
 
 
 
 
 
 
 
 
Item 9B.  Other Information. 

None. 

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 
Annual Meeting of Shareholders scheduled for May 24, 2018. We anticipate that our definitive proxy statement will be filed with 
the SEC not later than 120 days after December 31, 2017, 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 — Internal Control  
Report of Independent Registered Public Accounting Firm — Financial Statements  
Consolidated Balance Sheets as of December 31, 2017 and 2016  
Consolidated Statements of Income for the Years Ended December 31, 2017, 2016 and 2015  
Consolidated Statements of Comprehensive Income for the Years Ended December 31, 2017, 2016 and 2015  
Consolidated Statements of Stockholders’ Equity for the Years Ended December 31, 2017, 2016 and 2015  
Consolidated Statements of Cash Flows for the Years Ended December 31, 2017, 2016 and 2015  
Notes to Consolidated Financial Statements  

(2)  Financial Statement Schedule. 

—     Schedule II - Valuation and qualifying accounts 

Years Ended December 31, 2017, 2016 and 2015  
(In thousands) 

Balance at 
Beginning of Year 

Additions Charged to 
Costs and Expenses (a)     Deduction (b) 

Balance at 
End of Year 

Description 
ALLOWANCE FOR UNCOLLECTIBLE ACCOUNTS: 
2015 
2016 
2017 
(a)  We record a bad debt provision based upon historical experience and a review of individual customer balances.  
(b)  When an individual customer balance becomes impaired and is deemed uncollectible, a deduction is made against the allowance 

(893 ) 
(1,297 ) 
(1,587 ) 

(1,297 ) 
(1,587 ) 
(1,769 ) 

(607 ) 
(612 ) 
(1,012 ) 

203  
322  
830  

for uncollectible accounts. 

94 

 
  
  
 
  
  
  
 
 
 
 
 
 
 
 
  
  
  
  
   
  
   
  
  
  
  
  
  
  
  
  
  
  
  
 
 
 
 
Years Ended December 31, 2017, 2016 and 2015  
(In thousands) 

Balance at 
Beginning of Year 

Additions Charged to 
Costs and Expenses (c)    

Deduction 

Balance at 
End of Year 

Description 
TAX VALUATION ALLOWANCE:    
(1,603 ) 
2015 
(1,981 ) 
2016 
2017 
(3,786 ) 
(c) We record a valuation allowance against a deferred tax asset when it is determined that it is more likely than not that the 

(378 ) 
(1,805 ) 

—  
— 
 — 

(636 — 

(1,981 ) 
(3,786 ) 
(4,422 ) 

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: 

Description 

1.1 

   Underwriting Agreement, dated March 22, 2017, by and among Merit Medical Systems, Inc., Merrill Lynch, 

Pierce, Fenner & Smith Incorporated, and Piper Jaffray & Co.* 

2.1 

   Agreement and Plan of Merger by and among Merit, MMS Transaction Co., a wholly-owned subsidiary of 

Merit, DFine Inc., certain preferred stockholders and Shareholder Representative Services LLC as a 
stockholder representative*  

2.2 

23 

3.1 

3.2 

4.1 

10.1 

10.2 

10.3 

10.4 

10.5 

10.6 

10.7 

10.8 

10.9 

   Additional Materials to Agreement and Plan of Merger by and among Merit, MMS Transaction Co., a wholly-
owned subsidiary of Merit, DFine Inc., certain preferred stockholders and Shareholder Representative Services 
LLC as a stockholder representative*  

   Additional Materials to Agreement and Plan of Merger by and among Merit, MMS Transaction Co., a wholly-
owned subsidiary of Merit, DFine Inc., certain preferred stockholders and Shareholder Representative Services 
LLC as a stockholder representative*  

   Amended and Restated Articles of Incorporation dated February 28, 2017*  

   Second Amended and Restated Bylaws*  

   Specimen Certificate of the Common Stock*  

   Merit Medical Systems, Inc. Long Term Incentive Plan (as amended and restated) dated March 25, 1996*†  

   Lease Agreement dated as of June 8, 1993 for office and manufacturing facility*  

   Amended and Restated Deferred Compensation Plan*†  

   Seventh Amendment to the First Restatement of the Merit Medical Systems, Inc. 401(k) Profit Sharing Plan*†  

   Stock Purchase Agreement by and between Merit Medical Systems, Inc. and Sheen Man Co. LTD, dated 

April 1, 2007* 

   Merit Medical Systems, Inc. Amended and Restated Deferred Compensation Plan, effective January 1, 2008*†  

   Second Amendment to the Merit Medical Systems, Inc. 2006 Long-Term Incentive Plan*†  

   Second Restatement of the Merit Medical Systems, Inc. 401(k) Profit Sharing Plan*†  

   Separation Agreement and Release of All Claims of Greg Barnett dated November 3, 2015*†  

10.10 

   Separation Agreement and Release of All Claims of Rashelle Perry dated December 1, 2015*†  

10.11 

   Separation Agreement and Release of All Claims of Kent W. Stanger dated January 4, 2016*†  

10.12 

   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*  

10.13 

   Form of Indemnification Agreement, dated June 13, 2016, between the Company and each of the following 
individuals: Fred P. Lampropoulos, Kent W. Stanger, Nolan E. Karras, A. Scott Anderson, Richard W. 
Edelman, Franklin J. Miller, M.D., Michael E. Stillabower, M.D., F. Ann Millner, Ed. D., Bernard J. Birkett, 
Ronald A. Frost, Joseph C. Wright, Justin J. Lampropoulos, and Brian G. Lloyd*†   

95 

 
 
  
  
  
 
   
  
   
  
   
  
   
  
  
  
  
  
  
  
  
 
  
  
  
  
 
  
 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
10.14 

   Form of Employment Agreement, dated May 26, 2016 between the Company and each of the following 
individuals: Bernard J. Birkett, Ronald A. Frost, Joseph C. Wright, Justin J. Lampropoulos, and Brian G. 
Lloyd*†   

10.15 

   Employment Agreement, dated May 26, 2016 between the Company and Fred P. Lampropoulos*†  

10.16 

   Third Amendment to the Merit Medical Systems, Inc. 2006 Long-Term Incentive Plan dated February 13, 

2015*†  

10.17 

   Merit Medical Systems, Inc., Restatement of the 1996 Employee Stock Purchase Plan dated July 1, 2000*†  

10.18 

   First Amendment to the Merit Medical Systems, Inc., 1996 Employee Stock Purchase Plan dated April 1, 

2001*†  

10.19 

   Second Amendment to the Merit Medical Systems, Inc., 1996 Employee Stock Purchase Plan dated January 1, 

2006*†  

10.20 

   Third Amendment to the Merit Medical Systems, Inc., 1996 Employee Stock Purchase Plan dated April 7, 

2006*†  

10.21 

   Fourth Amendment to the Merit Medical Systems, Inc., 1996 Employee Stock Purchase Plan dated February 

13, 2015*†  

10.22 

Indemnification Agreement, dated July 23, 2016, between the Company and David M. Liu*†  

10.23 

   First Amendment to Second Amended and Restated Credit Agreement, dated September 28, 2016*  

10.24 

   Second Amendment to Second Amended and Restated Credit Agreement, dated March 20, 2017, entered into 
by and among Merit Medical Systems, Wells Fargo Bank, National Association and the lenders and subsidiary 
guarantors named therein*  

10.25 

Indemnification Agreement with Thomas J. Gunderson*†  

10.26 

   Third Amendment to Second Amended and Restated Credit Agreement and Incremental Increase Agreement, 

dated December 13, 2017, entered into by and among Merit Medical Systems, Inc., Wells Fargo Bank National 
Association and the lenders and subsidiary guarantors named therein*  

10.27 

   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*†  

10.28 

   Form of First Amendment to Employment Agreement for each of Ronald A. Frost, Bernard J. Birkett, Justin J. 

Lampropoulos, Joseph C. Wright, and Brian G. Lloyd*†  

10.29 

   First Amendment to Lease Agreement dated May 22, 2017 for office and manufacturing facility  

10.30 

   Asset Purchase Agreement by and between Merit Medical Systems, Inc. and Becton, Dickinson and Company 

21 

23.1 

31.1 

31.2 

32.1 

32.2 

101 

dated November 15, 2017  

   Subsidiaries of Merit Medical Systems, Inc.   

   Consent of Independent Registered Public Accounting Firm  

   Certification of Chief Executive Officer  

   Certification of Chief Financial Officer  

   Certification of Chief Executive Officer  

   Certification of Chief Financial Officer  

   The following materials from the Merit Medical Systems, Inc. Annual Report on Form 10-K for the fiscal year 
ended December 31, 2017, formatted in Extensible Business Reporting Language (XBRL): (i) the Consolidated 
Statements of Operations, (ii) Consolidated Balance Sheets, (iii) Consolidated Statements of Comprehensive 
Income (iv) Consolidated Statements of Stockholders' Equity, (v) Consolidated Statements of Cash Flows, and 
(vi) related notes. 

* 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. 

96 

 
 
 
 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
 
 
 
 
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 March 1, 
2018. 

SIGNATURES 

MERIT MEDICAL SYSTEMS, INC. 

By: 

/s/ FRED P. LAMPROPOULOS 

Fred P. Lampropoulos, President and 
Chief Executive Officer 

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 March 1, 2018.  

Signature 

Capacity in Which Signed 

/s/: FRED P. LAMPROPOULOS 
Fred P. Lampropoulos 

/s/: BERNARD J. BIRKETT 
Bernard J. Birkett 

/s/: A. SCOTT ANDERSON 
A. Scott Anderson 

/s/: THOMAS J. GUNDERSON 

Thomas J. Gunderson 

/s/: NOLAN E. KARRAS 

Nolan E. Karras 

/s/: DAVID M. LIU 

David M. Liu 

/s/: FRANKLIN J. MILLER 
Franklin J. Miller 

/s/: F. ANN MILLNER 

F. Ann Millner 

/s/: KENT W. STANGER 

Kent W. Stanger 

  President, Chief Executive Officer and Director 
  (Principal executive officer) 

  Chief Financial Officer, Secretary and Treasurer 
  (Principal financial and accounting officer) 

  Director 

  Director 

  Director 

  Director 

  Director 

  Director 

  Director 

/s/: MICHAEL E. STILLABOWER 

  Director 

Michael E. Stillabower 

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CORPORATE  INFORMATION

EXECUTIVE OFFICERS

FORM 10-K

Fred P. Lampropoulos 
Chairman, Chief Executive Officer

Bernard J. Birkett 
Chief Financial Officer, Treasurer

Ronald A. Frost 
Chief Operating Officer

Joseph C. Wright 
President, International

Brian G. Lloyd 
Chief Legal Officer, Corporate Secretary

Justin J. Lampropoulos 
Executive Vice President Global Sales,  
Marketing and Strategy

BOARD OF DIRECTORS

Fred P. Lampropoulos 
Chairman, Chief Executive Officer 
Merit Medical Systems, Inc.

A. Scott Anderson 
President and Chief Executive Officer 
Zions First National Bank

Thomas J. Gunderson 
Chairman at Minneapolis Heart  
Institute Foundation, Inc.

Nolan E. Karras 
Chairman and Chief Executive Officer 
The Karras Company, Inc.

David M. Liu, M.D. 
Clinical Associate Professor,  
Faculty of Medicine, 
University of British Columbia

Franklin J. Miller, M.D. 
Emeritus Professor, Interventional Radiology 
University of Utah

F. Ann Millner, Ed. D.  
Regents Professor and Professor  
of Health Administrative Services 
Weber State University

Kent W. Stanger 
Former Chief Financial Officer 
Merit Medical Systems, Inc.

Michael E. Stillabower, M.D. 
Director, Cardiovascular Clinic Trials 
Christiana Care Health System 
Clinical Associate Professor of Medicine 
Jefferson Medical College

INDEPENDENT ACCOUNTANTS 
Deloitte & Touche LLP

LEGAL COUNSEL

Parr Brown Gee & Loveless 
Corporate and Securities Counsel

Stoel Rives LLP 
Intellectual Property Counsel

Workman Nydegger 
Intellectual Property Counsel

Merit Medical Systems, Inc. filed an Annual Report on Form 10-K with the Securities and Exchange 
Commission for the fiscal year ended December 31, 2017. A copy may be obtained by written 
request from Anne-Marie Wright, Vice President, Corporate Communications, at Merit’s corporate 
office in South Jordan, Utah.

ANNUAL MEETING

All shareholders are invited to attend Merit’s Annual Meeting of shareholders on Thursday, May 24, 
2018, at 3:00 p.m. at Merit’s corporate offices in South Jordan, Utah.

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 23, 2018, the number of shares of common stock outstanding was 
50,266,889, held by approximately 115 shareholders of record, not including shareholders whose 
shares are held in securities position listings. The following chart sets forth the high and low closing 
sale prices for Merit’s common stock for the last two years:

2017   
First Quarter  

HIGH  
$31.70  

LOW 
$24.23

2016 
First Quarter  

HIGH 
$19.49  

LOW 
$15.47

Second Quarter  

$38.55  

$28.00

Second Quarter  

$20.59  

$17.94

Third Quarter  

$42.60  

$36.25

Third Quarter  

$25.08  

$19.61

Fourth Quarter  

$45.90  

$36.21

Fourth Quarter  

$26.85  

$20.70

Merit has never declared or paid any cash dividends on its common stock. Merit intends to retain  
any earnings for use in its business and does not anticipate paying any cash dividends in the 
foreseeable future.

MARKET INFORMATION

Anne-Marie Wright 
Vice President, Corporate Communications 
(801) 253-1600

FOR MORE INFORMATION, CONTACT

Bernard J. Birkett 
Chief Financial Officer, Treasurer 
Merit Medical Systems, Inc. 
(801) 253-1600 

CORPORATE OFFICES 
Merit Medical Systems, Inc. 
1600 West Merit Parkway 
South Jordan, Utah 84095 
(801) 253-1600

This report includes “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 
and Section 21E of the Securities Exchange Act of 1934. All statements other than statements of historical fact are 
forward-looking statements for purposes of these provisions. Merit assumes no obligation to update any forward-
looking statement. Although Merit believes 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 may differ materially, from those projected or 
assumed in the forward-looking statements. Merit’s future financial condition and results of operations, as well 
as any forward-looking statements, are subject to inherent risks and uncertainties, including factors referenced 
in Merit’s press releases and filings with the Securities and Exchange Commission. A number of the factors that 
may have a direct bearing on Merit’s financial condition and operating results are described under “Risk Factors” 
beginning on page 22 of Merit’s Annual Report on Form 10-K, filed with the U.S. Securities and Exchange Commission 
on March 1, 2018.

MERIT MEDIC AL SYSTEMS, INC.

1600 West Merit Parkway

South Jordan, Utah 84095

+1 (801) 253-1600

www.merit.com