UNITED STATES

SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
 
FORM 10-K
 
ý ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
 
For the fiscal year ended December 31, 20182021 or
 
o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
 
For the transition period from             to            
 
Commission File No. 001-34634
 
ICU MEDICAL, INC.
(Exact name of Registrant as specified in its charter)
 
Delaware33-0022692
(State or other jurisdiction of(I.R.S. Employer
incorporation or organization)(I.R.S. Employer Identification No.)
 
951 Calle Amanecer
San Clemente California,California92673
(Address of principal executive offices)(Zip Code)
 
Registrant’s Telephone Number, Including Area Code: (949) 366-2183
 
Securities registered pursuant to Section 12(b) of the Act:
 
Title of each classTrading SymbolName of each exchange on which registered
The NASDAQ Stock Market LLC
Common stock, par value $0.10 per share

ICUI
The NASDAQ Stock Market LLC
(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.  ý Yes  o No
 
Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Exchange Act. o Yes  ý No
 
Indicate by check mark whether 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 registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.  ý Yes  o No
 
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).  Yes ý   No o
 
Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K (§229.405 of this chapter) is not contained herein, and will not be contained, to the best of 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. o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company, or an emerging growth company.  See definition of “large accelerated filer”,filer,” “accelerated filer” andfiler,” “smaller reporting company”company,” and "emerging growth company," in Rule 12b-2 of the Exchange Act (Check one):
Act:
Large Accelerated FilerxAccelerated filero
Non-accelerated fileroSmall reporting company
Large accelerated filer x
Accelerated filer o
Non-accelerated filer o
Small reporting company o
Emerging growth company o
 
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.    o


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

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).  o Yes  ý No
 
The aggregate market value of the voting stock held by non-affiliates of registrant as of June 30, 2018,2021, the last business day of registrant’s most recently completed second fiscal quarter, was $5,575,024,829*$4,104,813,741*.
 
The number of shares outstanding of registrant’s common stock, $.10 par value, as of January 31, 20192022 was 20,498,949.23,786,887.
 
DOCUMENTS INCORPORATED BY REFERENCE
 
Portions of the Proxy Statement for registrant’s 20192022 Annual Meeting of Stockholders filed or to be filed pursuant to Regulation 14A within 120 days following registrant’s fiscal year ended December 31, 2018,2021, are incorporated by reference into Part III of this Report.
 
____________________________
*  Without acknowledging that any person other than Dr. George A. Lopez is an affiliate, all directors and executive officers have been included as affiliates solely for purposes of this computation.





ICU Medical, Inc.
Form 10-K
For the Year Ended December 31, 20182021
TABLE OF CONTENTS

Page
PART I
PART III









PART I


ITEM 1. BUSINESS
 
First person pronouns used in this Report, such as “we,” “us,” and “our,” refer to ICU Medical, Inc. ("ICU") and its subsidiaries unless context requires otherwise.


Changes from Prior Periodic Reports

In this report we have complied with the disclosures required by the Securities and Exchange Commission ("SEC") release No. 33-10890 "Management's Discussion and Analysis, Selected Financial Data, Supplementary Financial Information."

Management’s Discussion and Analysis, Selected Financial Data, and Supplementary Financial Information

In November 2020, the SEC issued Release No. 33-10890, “Management’s Discussion and Analysis, Selected Financial Data, and Supplementary Financial Information” which became fully effective on August 9, 2021. This release was adopted to modernize, simplify, and enhance certain financial disclosure requirements in Regulation S-K. Specifically, the SEC eliminated the requirement for selected financial data, only requiring quarterly disclosure when there are retrospective changes affecting comprehensive income, and amending the matters required to be presented under Management’s Discussion and Analysis (“MD&A”) to, among other things, eliminate the requirement of the contractual obligations table.

We have eliminated from this document the items discussed above that are no longer required. Information on our contractual obligations is still disclosed in a narrative within the “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in Item 7 of Part II of this report.

Company Background and Overview of Business


ICU is one of the world's leading pure-play infusion therapy companies with global operations and a wide-ranging product portfolio that includes IV solutions, IV smart pumps with pain management and safety software technology, dedicated and non-dedicated IV sets and needlefree connectors designed to help meet clinical, safety and workflow goals. In addition, ICU manufactures automated pharmacy IV compounding systems with workflow technology, closed system transfer devices for preparing and administering hazardous IV drugs and cardiac monitoring systems for critically ill patients.

Headquartered in San Clemente, California, ICU was founded in 1984 and1984. In 1992, we had our initial public offering was in 1992.and reincorporated under Delaware law. Our headquartersprimary customers are in San Clemente, California. In 1993, we launched the Clave™, an innovative one-piece needlefree intravenous ("IV") connection device.acute care hospitals, wholesalers, ambulatory clinics and alternate site facilities, such as outpatient clinics, home health care providers, and long-term care facilities. Since the late 1990's,our inception we have expanded our product offerings by introducing internally developed productsgrown organically and systems. Key developments have includedthrough acquisition, and we currently serve customers in more than 90 countries throughout the MicroClave Clear™ connector as an update to the Clave, Tego™ needlefree connector for use in hemodialysis, products for handling hazardous drugs including the ChemoClave™ and ChemoLock™ CSTDs (“closed-system transfer devices”, the Diana™ hazardous drug compounding system, and the Neutron®, a catheter patency device.world.

In October 2015, we acquired Excelsior Medical Corporation’s SwabCap® disinfecting cap for needlefree IV connectors to enhance our direct and OEM infusion therapy product offerings and to open new customer opportunities globally.


In February 2017, we acquired Pfizer Inc.'s ("Pfizer") Hospira Infusion Systems ("HIS") business. The HIS acquisition complementscomplemented our legacy non-dedicated infusion sets and oncology business by expanding our product portfolio to include a complete intravenous infusion therapy product-line from IV solutions to IV pumps to non-dedicated infusion sets.


General OverviewIn November 2019, we acquired Pursuit Vascular, Inc. ("Pursuit"). Pursuit was a privately-held medical device company with a primary focus on innovative catheter disinfecting products and technologies to reduce costly bloodstream infections and lower healthcare costs. Pursuit’s primary product is the ClearGuard® HD cap, which is used for the maintenance of Businesshemodialysis catheters.


We develop, manufactureIn September 2021, we entered into a definitive agreement to acquire Smiths Medical 2020 Limited ("Smiths Medical"), the holding company of Smiths Group plc's global medical device business and, sell innovative medical products used in infusion therapyon January 6, 2022, the acquisition closed. The Smiths Medical acquisition complements and critical care applications. Ourbroadens our existing product portfolio includes IV smart pumps, sets, connectors, closed system transferto include syringe and ambulatory infusion devices, for hazardous drugs, sterile IV solutions, cardiac monitoring systems, along with pain managementvascular access, and safety software technology designed to help meet clinical, safetyvital care products, and workflow goals.significantly strengthens and expands our global market reach. The following business discussion is as of December 31, 2021 and as such does not incorporate the Smiths Medical acquisition.
Our primary customers are acute care hospitals, wholesalers, ambulatory clinics and alternate site facilities, such as clinics, home health care providers and long-term care facilities. We sell our products in more than 90 countries throughout the world.


Products


OurAs of December 31, 2021, our primary product offerings are listed below, which we present in four product lines as follows:

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Infusion Consumables


Infusion therapy sets, used in hospitals and ambulatory clinics, consist of a tube running from a bottle or plastic bag containing a solution to a catheter inserted in a patient’s vein, that may or may not be used with an IV pump. Our primary IVInfusion Consumable products are:

Clave™ needlefree products, including the MicroClave, MicroClave Clear, and NanoClave™ brand of connectors, accessories, extension and administration sets used for the administration of IV fluids and medications and the Neutron catheter patency device, used to help maintain patency of central venous catheters;

SwabCap disinfecting cap, used to protect and disinfect any needlefree connector, including competitive brands of connectors;

Tego hemodialysis connector used to cap and protect hemodialysis central venous catheter hubs; and

NovaCathand SuperCath™ peripheral IV catheters(PIV).


Clave™ needlefree products, including the MicroClave, MicroClave Clear, and NanoClave™ brand of connectors, accessories, extension and administration sets used for the administration of IV fluids and medications and the Neutron catheter patency device, used to help maintain patency of central venous catheters;

SwabCap and SwabTip disinfecting caps, used to protect and disinfect any needlefree connector, including competitive brands of connectors, and male luers;

ClearGuard HD antimicrobial barrier caps for hemodialysis catheters; and

TegoTM hemodialysis connector used to cap and protect hemodialysis central venous catheter hubs.

Closed System Transfer Devices (CSTD)("CSTD") and hazardous drug compounding systems are used to prepare and deliver hazardous IV medications such as those used in chemotherapy, which, if released, can have harmful effects to the healthcare worker and environment. Our products are:


ChemoLock, is a pharmacy-preferred CSTD used for the preparation and administration of hazardous drugs. ChemoLock limits the escape of hazardous drug or vapor concentrations, blocks the transfer of environmental contaminants into the system, and eliminates the risk of needlestick injury;

ChemoLockTM CSTD, which utilizes a proprietary needlefree connection method, is used for the preparation and administration of hazardous drugs. ChemoLock is used to limit the escape of hazardous drug or vapor concentrations, block the transfer of environmental contaminants into the system, and eliminates the risk of needlestick injury;
ChemoClave, is an ISO standard and universally compatible CSTD used for the preparation and administration of hazardous drugs. ChemoClave utilizes standard ISO luer locking connections, making it compatible with all brands of needlefree connectors and pump delivery systems. ChemoClave also limits the escape of hazardous drug or vapor concentrations, blocks the transfer of environmental contaminants into the system, and eliminates the risk of needlestick injury; and


Diana hazardous drug compounding system is an automated sterile compounding system that incorporates ChemoClave and ChemoLock CSTD consumables and IV workflow technology for the accurate, safe, and efficient preparation of hazardous drugs. It is a user-controlled automated system that provides repeatable accuracy of drug mixes and minimizes clinician exposure to hazardous drugs while helping to maintain the sterility of the drugs being mixed.

ChemoClaveTM, an ISO Connection standard and universally compatible CSTD used for the preparation and administration of hazardous drugs. ChemoClave utilizes standard ISO luer locking connections, making it compatible with all brands of needlefree connectors and pump delivery systems. ChemoClave also is used to limit the escape of hazardous drug or vapor concentrations, block the transfer of environmental contaminants into the system, and eliminate the risk of needlestick injury; and

DianaTM hazardous drug compounding system, an automated sterile compounding system that incorporates ChemoClave and ChemoLock CSTD consumables and IV workflow technology for the accurate, safe, and efficient preparation of hazardous drugs. It is a user-controlled automated system that provides repeatable accuracy of drug mixes and minimizes clinician exposure to hazardous drugs while helping to maintain the sterility of the drugs being mixed.

The preparation of hazardous drugs typically takes place in a pharmacy location where drugs are removed from vials and prepared for delivery to a patient. Those prepared drugs are then transferred to a nursing unit where the chemotherapy is administered via an infusion pump set to a patient. Components of the ChemoClave and ChemoLock product lines are used both in pharmacies and on the nursing floors for the preparation and administration of hazardous drugs.


Infusion Systems

We offer a wide range of infusion pumps, dedicated IV sets, software and professional services. Our primary Infusion System products are dedicated IV sets and the following:

Infusion Pump Hardware:

Plum 360™:The Plum 360™ infusion pump is an ICU Medical MedNet™ ready large volume infusion pump with an extensive drug library and wireless capability. Plum 360 was named the 2018, 2019 and 2020 Best in KLAS winner as top-performing IV smart pump and was the first medical device to be awarded UL Cybersecurity Assurance Program Certification. Also, in 2021 and 2022, the Plum 360 won the award as the top-performing Smart Pump EMR-Integrated; and

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LifeCare PCA™: The LifeCare PCA infusion pump is an ICU Medical MedNet™ ready patient-controlled analgesia pump ("PCA"), providing complete IV Electronic Health Records ("IV-EHR") interoperability since 2016.

IV Medication Safety Software:

ICU Medical MedNet™: ICU Medical MedNet is an enterprise-class medication management platform for any sized healthcare system that can help reduce medication errors, improve quality of care, streamline workflows and maximize revenue capture. ICU Medical MedNet connects our industry-leading smart pumps to a hospital’s EHR, asset tracking systems, and alarm notification platforms with the largest array of integration partners.

Professional Services:

In addition to the products above, our teams of clinical, information technology, and professional services experts work with customers to develop and deliver safe and efficient infusion systems, providing customized and personalized configuration, implementation, and data analytics services to complement our infusion hardware and software.

IV Solutions


We provide a broad portfolio of IV solutions to meet our customers’ clinical needs, providing a consistent supply of IV solutions, irrigation, and nutritionals to help provide safe and effective patient care. Our primary IV Solutions products are:
        
IV Therapy and Diluents:


Including Sodium Chloride, Dextrose, Balanced Electrolyte Solutions, Lactated Ringer's, Ringer's, Mannitol, Sodium Chloride/Dextrose and Sterile WaterWater.


Irrigation/Urologics:Irrigation:


Including Sodium Chloride Irrigation, Sterile Water Irrigation, Physiologic Solutions, Ringer's Irrigation, Ringer's Irrigation, Acetic Acid Irrigation, Glycine Irrigation, Sorbitol-Mannitol Irrigation, Flexible Containers and Pour Bottle Options, 250 mL

Infusion Systems

We offer a wide range of infusion pumps, dedicated IV sets and software. Our primary Infusion System products are dedicated IV sets and the following:

Infusion Pump Hardware:

Plum 360™:The Plum 360™ infusion pump is an ICU Medical MedNet™ ready large volume infusion pump with an extensive drug library and wireless capability. Plum 360 was named the 2018 Best in KLAS winner as top-performing IV smart pump and is the first medical device to be awarded UL Cybersecurity Assurance Program Certification; and

LifeCare PCA™: The LifeCare PCA infusion pump is an ICU Medical MedNet™ ready patient-controlled analgesia pump ("PCA"), providing complete IV-EHR interoperability since 2016.

IV Mediation Safety Software:

ICU Medical MedNet™: ICU Medical MedNet is an enterprise-class medication management platform for any sized healthcare system that can help reduce medication errors, improve quality of care, streamline workflows and maximize revenue capture. ICU Medical MedNet connects our industry-leading smart pumps

to a hospital’s Electronic Health Records (EHR), asset tracking systems, and alarm notification platforms with the largest array of integration partners.

Professional Services:

In addition to the products above, our teams of clinical, information technology, and professional services experts work with customers to develop and deliver safe and efficient infusion systems, providing customized and personalized configuration, implementation, and data analytics services to complement our infusion hardware and software.Options.
    
Critical Care


Our critical careCritical Care products help clinicians get accurate real-time access to patients’ hemodynamic and cardiac status with an extensive portfolio of monitoring systems and advanced sensors & catheters. Measurements provided by our systems help clinicians determine how well the heart is pumping blood and how efficiently oxygen from the blood is being used by the tissues. Our primary Critical Care products are:


Cogent™ 2-in-1 hemodynamic monitoring systemsystem;
CardioFlo™ hemodynamic monitoring systemsystem;
TDQ™ and OptiQ™ cardiac output monitoring catheterscatheters;
TriOxTMvenous oximetry catheters;
Transpac™ blood pressure transducerstransducers; and
SafeSet™ closed blood sampling and conservation systemsystem.


Financial information relating to our reporting segment and primary product lines is set forth in Part I, Item 6. "Selected Financial Data" andII, Item 7. "Management"Management's Discussion and Analysis of Financial Condition and Results of Operations" inof this Annual Report on Form 10-K, and is incorporated herein by reference.

Recent Significant Acquisitions

On February 3, 2017, we completed the acquisition of Pfizer's HIS business, a leading global provider of IV infusion therapy products to hospitals and alternate site providers, such as clinics, home health care providers and long-term care facilities. Our acquisition of the HIS business was strategic and provides us with an increase in scale and product portfolio that we believe will result in a stronger competitive position within the industry. We believe the HIS business acquisition was the natural evolution for us based on a long-term successful and productive partnership with HIS for over 20 years.    


Manufacturing
 
As of December 31, 2018,2021, we operate four primary manufacturing facilities globally, which are detaileddiscussed in Part I, Item 2 of this report. We operate four main service centers globally. We also rely on certain outside manufacturers for certain product lines in Infusion Systems and IV Solutions.


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Our four primary manufacturing sites are:


La Aurora de Heredia, Costa Rica, which manufactures most of our infusion pumps and dedicated disposables, as well as a portion of our non-dedicated infusion consumables products;

La Aurora de Heredia, Costa Rica, which manufactures most of our infusion pumps and dedicated disposables, as well as a portion of our non-dedicated infusion consumables products;
Ensenada, Mexico, which manufactures infusion consumables products;


Salt Lake City, Utah, which produces primarily our proprietary brands of connector and CSTD components, and sends those products to Costa Rica or Mexico for finished goods assembly; and

Ensenada, Mexico, which manufactures infusion consumables products;
Austin, Texas, which produces our IV Solutions products.


Salt Lake City, Utah, which produces primarily our proprietary brands of connector and CSTD components, and sends those products to Costa Rica or Mexico for finished goods assembly; and

Austin, Texas, which produces our IV Solutions products.

Additionally, we leverage a long-term supply agreement with Pfizer (described below) to provide additional IV Solution products to us.

We also assemble compounders in our leased facility in Ludenscheid, Germany and Salt Lake City, Utah. 

During 2017, we closed our manufacturing facility in San Cristobal, Dominican Republic, which was part of the HIS acquisition, and transferred the assets and the production of Infusion Consumables to our plants in Costa Rica and Mexico.    


We have four main regional device service centers in San Jose, California; Sligo, Ireland; San Laurent, Quebec, Canada; Taipei, Taiwan and Rydalmere, Australia.


As part of ourIn 2017, HIS business acquisition, we entered into two Manufacturing and Supply Agreements ("MSAs") with Pfizer under which, (i) Pfizer manufactures and supplies us with certain agreed upon products for an initial five-year term with a one-time two-year option to extend and (ii) we manufacture and supply Pfizer certain agreed upon products for a term of five or ten years depending on the product, with a one-time two-year option to extend. The initial supply price will be annually updated and is in full consideration for all costs associated with the manufacture, documentation, packaging and certification of the products. In January 2021, we amended our MSA with Pfizer, whereby we manufacture and supply certain agreed upon products to Pfizer. The amendments include a change to the term of the agreement to end on December 31, 2024 with Pfizer's unilateral election to extend through December 31, 2025. Other changes to the terms of the MSA include (i) amendments to our level of supply of products to Pfizer, (ii) certain changes to our manufacturing lines, (iii) updates to our supply price with added volume price tiers for annual periods and (iv) certain minimum purchase requirements for certain products. On February 1, 2022, effective as of January 1, 2022, upon our request, Pfizer executed a Product Addendum (the "Product Addendum") to our MSA agreement, whereby Pfizer manufactures and supplies to us certain agreed upon products. The Product Addendum includes the supply of additional product to us subject to certain time and pricing terms and conditions. The Product Addendum expires on November 30, 2022.


We purchase many of the components and raw materials used in manufacturing our products from numerous suppliers in various countries. Certain components and raw materials are available only from a sole supplier. We work closely with our suppliers to ensure continuity of supply while maintaining high quality and reliability. We have generally been able to obtain adequate supplies of such raw materials and components.


Sales, Marketing and Administration
 
We ship around the world with the majority of our sales denominated in United States ("U.S.") dollars, Euro and Canadian dollars. We are not dependent on any single customer and no single customer accounted for 10% or more of our net sales in 2018.customer.


Distribution


Our products are marketed to medical product manufacturers, independent distributors and directly to end users.


The U.S. distribution of solutions, IV sets and accessories is supported by a network of threetwo owned and one leased distribution centers, acquired in the HIS business acquisition, which include King of Prussia, Pennsylvania; Los Angeles, California; and Dallas, Texas. We also acquired the contracts toutilize a number of public warehouses as part of the HIS acquisition.our supply chain.


Internationally, we manage our operations through the Netherlands, which utilizesdistribution by utilizing international regional hubs and we also manage operations through independent distributors.


Government Regulation
 
Our products and operations are subject to extensive and rigorous regulation by the Food and Drug Administration ("FDA") and other federal, state and local authorities, as well as foreign regulatory authorities. The FDA regulates, among other things, the research, development, testing, manufacturing, approval, labeling, storage, recordkeeping, advertising, promotion and marketing, distribution, post approvalpost-approval monitoring and reporting and import and export of drug products, medical devices and combination drug/device products in the U.S. to assure the safety and effectiveness of such medical products for their
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intended use.uses and otherwise meet the applicable requirements of the Federal Food, Drug and Cosmetic Act (“FDC Act”). The Federal Trade Commission ("FTC") also regulates the advertising of our products. Further, we are subject to laws directed at preventing fraud and abuse, which subject our sales and marketing, training and other practices to government scrutiny.


Medical Device Regulation in the U.S.

The majority of our products are regulated by the FDA as medical devices in the U.S. Device Classification and Clearance

Unless an exemption applies, each new or significantly modified medical device we seek to commercially distribute in the U.S. will require either a premarketpre-market notification to the FDA requesting permission for commercial distribution under Section 510(k) of the Federal Food, Drug and CosmeticFDC Act, ("FDC Act") also referred to as a 510(k) clearance, or approval from the FDA of a pre-market approval ("PMA") application. Under the FDC Act, medical devices are classified into one of three classes—Class I, Class II or Class III—depending on the degree of risk associated with each medical device and the extent of manufacturer and regulatory control needed to ensure its safety and effectiveness. Class I devices are those that pose the lowest risk to the patient and are those for which safety and effectiveness can be assured by adherence to the FDA's General Controls for medical devices, which include compliance with the applicable portions of current good manufacturing practices ("cGMPs") for medical devices known as the Quality System Regulation ("QSR"), facility registration and product listing, reporting of adverse medical events, and truthful and non-misleading labeling, advertising, and promotional materials. Class II devices are subject to the FDA's General Controls, and special controls as deemed necessary by the FDA to ensure the safety and effectiveness of the device. Devices deemed by the FDA to pose the greatest risks, such as life sustaining, life supporting or some implantable devices, or devices that have a new intended use, or use advanced technology that is not substantially equivalent to that of a legally marketed device, are placed into Class III.


Manufacturers of most Class II devices are required to obtain from the FDA a 510(k) clearance for permission to commercially distribute the device. Class III devices require approval of a PMA application evidencing safety and effectiveness of the device.

Under the 510(k) process, applicants must demonstrate to the FDA that the device is as safe and effective as, or substantially equivalent to, a legally marketed device, the “predicate”"predicate" device. A predicate device is a legally marketed device that is not subject to pre-market approval, i.e., a device that was legally marketed prior to May 28, 1976 (pre-amendments device) and for which a PMA is not required, a device that has been reclassified from Class III to Class II or I, or a device that was found substantially equivalent through the 510(k) process. Applicants must submit performance data to establish substantial equivalence. In some instances, data from human clinical trials must also be submitted in support of a 510(k) premarketpre-market notification. If so, these data must be collected in a manner that conforms to the applicable Investigational Device Exemption ("IDE") regulations. If the FDA agrees that the device is substantially equivalent to a lawfully marketed predicate device, it will grant 510(k) clearance to authorize the device for commercialization. If the FDA determines that the device is "not substantially equivalent," the device is automatically designated as a Class III device. The FDAdevice sponsor must issuethen fulfill more rigorous PMA requirements, or can request a decision finding substantial equivalence before commercial distribution can occur. Changesrisk-based classification determination for the device in accordance with the de novo classification process, which is a route to clearedmarket for novel medical devices that are low to moderate risk and are not substantially equivalent to a predicate device.

After a device receives 510(k) clearance, any modification that could not significantly affect theits safety or effectiveness, of the device can generally be made without additional 510(k) premarket notifications; otherwise,or that would constitute a major change or modification in its intended use, will require a new 510(k) clearance or, depending on the modification, PMA approval or de novo classification. The FDA requires each manufacturer to determine whether the proposed change requires submission of a 510(k), de novo classification request or a PMA in the first instance, but the FDA can review any such decision and disagree with a manufacturer’s determination. If the FDA disagrees with a manufacturer’s determination not to seek a new 510(k) or other form of marketing authorization for the modification to the 510(k)-cleared product, the FDA can require the manufacturer to cease marketing and/or request the recall of the modified device until 510(k) clearance or PMA approval is required.obtained or a de novo classification is granted.


In the PMA application process, the applicant must demonstrate to the satisfaction of the FDA that the device is safe and effective for its intended use. This approval process applies to most Class III devices, and generally requires clinical data to support the safety and effectiveness of the device, obtained in adherence with IDE requirements. Following receipt of a PMA application, the FDA determines whether the application is sufficiently complete to permit a substantive review. If FDA accepts the application for review, it has 180 days under the FDC Act to complete its review of a PMA, although in practice, the FDA's review often takes significantly longer, and can take up to several years. An advisory panel of experts from outside the FDA may be convened to review and evaluate the application and provide recommendations to the FDA as to the approvability of the device. The FDA may or may not accept the panel's recommendation. In addition, the FDA will generally conduct a pre-approval inspection of the applicant or its third-party manufacturers' or suppliers' facilities to ensure compliance with the QSR. The FDA will approve the PMA applicationnew device for commercial distribution if it findsdetermines that the data and information in the PMA constitute valid scientific evidence and that there is a reasonable assurance that the device is safe and effective for its intended purpose,
7


use(s). The FDA may approve a PMA with post-approval conditions intended to ensure the safety and effectiveness of the device, including, among other things, restrictions on labeling, promotion, sale and distribution, and collection of long-term follow-up data from patients in the clinical study that supported PMA approval or requirements to conduct additional clinical studies post-approval. Certain changes to an approved device, such as changes in manufacturing facilities, methods, or quality control procedures, or changes in the proposeddesign performance specifications, which affect the safety or effectiveness of the device, require submission of a PMA supplement, or in some cases a new PMA.

After a device is cleared or approved or otherwise authorized for marketing, numerous pervasive regulatory requirements continue to apply unless explicitly exempt. These include:

establishment registration and device listing with the FDA;

QSR requirements, which require manufacturers, including third-party manufacturers, to follow stringent design, testing, control, documentation and other quality assurance procedures during all aspects of the design and manufacturing process;

clearance or approval of product modifications to 510(k)-cleared devices that could significantly affect safety or effectiveness or that would constitute a major change in intended use of cleared devices;

medical device reporting regulations, which require that a manufacturer report to the FDA if a device it markets may have caused or contributed to a death or serious injury, or has malfunctioned and the device or a similar device that it markets would be likely to cause or contribute to a death or serious injury, if the malfunction were to recur;

correction, removal and recall reporting regulations, which require that manufacturers report to the FDA field corrections and product recalls or removals if undertaken to reduce a risk to health posed by the device or to remedy a violation of the FDC Act that may present a risk to health;

complying with requirements governing Unique Device Identifiers on devices and also requiring the submission of certain information about each device to the FDA's Global Unique Device Identification Database;

the FDA's recall authority, whereby the agency can order device manufacturers to recall from the market a product that is in compliance with the Quality System Regulation ("QSR"). For novel technologies,violation of governing laws and regulations; and

post-market surveillance activities and regulations, which apply when deemed by the FDA will generally seek input from an advisory panel of medical expertsto be necessary to protect public health or to provide additional safety and seek their views oneffectiveness data for the safety, effectiveness and benefit-risk of the device. The PMA process is generally more detailed, lengthier and more expensive than the 510(k) process, though both the 510(k) clearance and PMA processes can be expensive, and lengthy, and require payment of significant user fees, unless an exemption is available.     


Drug Regulation in the U.S.


In the U.S.,Certain of our IV solutions products are considered pharmaceutical products and subject to the same extensive pre- and post-market regulationsregulated by the FDA as indicated above.drugs. In the U.S., the FDA regulates drugs under the FDC Act, and its implementing regulations, and biologics under the FDC Act and its implementing regulations. The process required by the FDA before a drug may be marketed in the U.S. generally involves the following:


The pre-market completion of preclinical laboratory tests and animal studies performed in accordance with the FDA's Good Laboratory Practice requirements;

submission to the FDA of an investigational new drug application ("IND"), which must become effective before clinical trials may begin;

approval processby an institutional review board ("IRB") or ethics committee at each clinical site before the trial is commenced;

performance of adequate and well-controlled human clinical trials to establish the safety and efficacy of the proposed product candidate for its intended purpose;

preparation of and submission to the FDA of a time-intensive multi-phased process. When successfully completedNew Drug Application ("NDA") or abbreviated new drug application ("ANDA") after completion of all required clinical trials;

satisfactory completion of an FDA Advisory Committee review, if applicable;

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a determination by the FDA within 60 days of its receipt of an NDA to file the application mayfor review;

satisfactory completion of an FDA pre-approval inspection of the manufacturing facility or facilities at which the proposed product is produced to assess compliance with cGMPs and to assure that the facilities, methods and controls are adequate to preserve the product's continued safety, purity and potency, and of selected clinical investigation sites to assess compliance with Good Clinical Practices ("GCPs"); and

FDA review and approval of the NDA to permit commercial marketing of the product for particular indications for use in the U.S.

Prior to beginning clinical trials of a drug product in the U.S., an IND must be submitted to the FDA. An IND is a request for authorization from the FDA that includesto administer an investigational new drug product to humans. An IND must become effective before human clinical trials may begin. Assuming successful completion of all required testing in accordance with all applicable regulatory requirements, the results of product development, nonclinical studies and clinical trials are submitted to the FDA as part of an NDA requesting approval to market the product for one or more indications. The NDA must include all relevant data available from preclinical and clinical studies, including negative or ambiguous results as well as positive findings, together with detailed information relating to the product’s chemistry, manufacture,manufacturing, controls, and proposed labeling, among other things. ThisThe submission of an NDA requires payment of a substantial application processuser fee to the FDA, unless a waiver or exemption applies.

After the FDA evaluates an NDA and conducts inspections of manufacturing facilities where the investigational product and/or its drug substance will be produced and of select clinical trial sites, the FDA may issue an approval letter or a Complete Response Letter ("CRL"). An approval letter authorizes commercial marketing of the product with specific prescribing information for specific indications. A CRL will generally describe all of the deficiencies that the FDA has identified in the NDA. In issuing the CRL, the FDA may recommend actions that the applicant might take to place the NDA in condition for approval, including requests for additional information or clarification. The FDA may delay or refuse approval of an NDA if applicable regulatory criteria are not satisfied, require additional testing or information and/or require post-marketing testing and surveillance to monitor safety or efficacy of a product.

If regulatory approval of a drug is granted, such approval will be granted for particular indications and may include limitations on the indicated uses for which such drug may be marketed. The FDA also may condition approval on, among other things, changes to proposed labeling or the development of adequate controls and specifications. Once approved, the FDA may withdraw the approval if compliance with pre- and post-marketing requirements is not maintained or if problems occur after the product reaches the marketplace. The FDA may require one or more post-market studies and surveillance to further assess and monitor the drug’s safety and effectiveness after commercialization, and may limit further marketing of the drug based on the results of these post-marketing studies.

Any drugs manufactured or distributed pursuant to FDA approvals are subject to pervasive and continuing regulation by the FDA, including, among other things, requirements relating to record-keeping, reporting of adverse experiences, periodic reporting, product sampling and distribution, and advertising and promotion of the product. After approval, most changes to the approved product, such as adding new indications or other labeling claims, are subject to prior FDA review and approval. There also are continuing, annual program fees for any marketed products. Drug manufacturers and their subcontractors are required to register their establishments with the FDA and certain state agencies, and are subject to periodic unannounced inspections by the FDA and certain state agencies for compliance with cGMP, which impose certain procedural and documentation requirements upon us and our third-party manufacturers. FDA regulations also require investigation and correction of any deviations from cGMP and impose reporting requirements upon us and any third-party manufacturers that we may decide to use. Accordingly, manufacturers must continue to expend time, money and effort in the area of production and quality control to maintain compliance with cGMP and other aspects of regulatory compliance.

Post-Market Enforcement

The FDA may withdraw marketing authorizations for drugs or medical devices if compliance with regulatory requirements and standards is not maintained or if problems occur after the product reaches the market. Later discovery of previously unknown problems with a product, including adverse events of unanticipated severity or frequency, or with manufacturing processes, or failure to comply with regulatory requirements, may result in revisions to the approved labeling to add new safety information, imposition of post-market studies or clinical studies to assess new safety risks, or imposition of distribution restrictions or other restrictions. Other potential consequences include, among other things: complete withdrawal of the product from the market, product recalls, fines, warning letters, untitled letters, clinical holds on clinical studies, refusal of the FDA to approve pending applications or supplements to approved applications, product seizures or detention, refusal to
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permit the import or export of products, consent decrees, corporate integrity agreements, debarment or exclusion from federal healthcare programs, the issuance of corrective information, injunctions, or the imposition of civil or criminal penalties.

In addition, the FDA closely regulates the marketing, labeling, advertising and promotion of drugs and medical devices. A company can make only those claims relating to safety and efficacy, purity and potency that are cleared or approved by the FDA and in accordance with the provisions of the authorized label. The FDA and other agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses. Failure to comply with these requirements can result in, among other things, adverse publicity, warning letters, corrective advertising and potential civil and criminal penalties.

Regulation of Medical Devices in the European Union

The European Union ("EU") has adopted specific directives and regulations regulating the design, manufacture, clinical investigation, conformity assessment, labeling and adverse event reporting for medical devices.

Until May 25, 2021, medical devices were regulated by Council Directive 93/42/EEC (the "EU Medical Devices Directive") which has been repealed and replaced by Regulation (EU) No 2017/745 (the "EU Medical Devices Regulation"). Our current certificates have been granted under the EU Medical Devices Directive whose regime is described below. However, as of May 26, 2021, some of the EU Medical Devices Regulation requirements apply in place of the corresponding requirements of the EU Medical Devices Directive with regard to registration of economic operators and of devices, post-market surveillance and vigilance requirements. Pursuing marketing of medical devices in the EU will notably require that our devices be certified under the new regime set forth in the EU Medical Devices Regulation when our current certificates expire.

Medical Devices Directive

Under the EU Medical Devices Directive, all medical devices placed on the market in the EU must meet the relevant essential requirements laid down in Annex I to the EU Medical Devices Directive, including the requirement that a medical device must be designed and manufactured in such a way that it will not compromise the clinical condition or safety of patients, or the safety and health of users and others. In addition, the device must achieve the performance intended by the manufacturer and be designed, manufactured, and packaged in a suitable manner. The European Commission has adopted various standards applicable to medical devices. These include standards governing common requirements, such as sterilization and safety of medical electrical equipment and product standards for certain types of medical devices. There are also harmonized standards relating to design and manufacture. While not mandatory, compliance with these standards is viewed as the easiest way to satisfy the essential requirements as a practical matter as it creates a rebuttable presumption that the device satisfies that essential requirement.

To demonstrate compliance with the essential requirements laid down in Annex I to the EU Medical Devices Directive, medical device manufacturers must undergo a conformity assessment procedure, which varies according to the type of medical device and its (risk) classification. As a general rule, demonstration of conformity of medical devices and their manufacturers with the essential requirements must be based, among other things, on the evaluation of clinical data supporting the safety and performance of the products during normal conditions of use. Specifically, a manufacturer must demonstrate that the device achieves its intended performance during normal conditions of use, that the known and foreseeable risks, and any adverse events, are minimized and acceptable when weighed against the benefits of its intended performance, and that any claims made about the performance and safety of the device are supported by suitable evidence. Except for low-risk medical devices (Class I non-sterile, non-measuring devices), where the manufacturer can self-declare the conformity of its products with the essential requirements (except for any parts which relate to sterility or metrology), a conformity assessment procedure requires the intervention of a notified body. Notified bodies are independent organizations designated by EU member states to assess the conformity of devices before being placed on the market. A notified body would typically audit and examine a product's technical dossiers and the manufacturers' quality system (the notified body must presume that quality systems which implement the relevant harmonized standards – which is ISO 13485:2016 for Medical Devices Quality Management Systems – conform to these requirements). If satisfied that the relevant product conforms to the relevant essential requirements, the notified body issues a certificate of conformity, which the manufacturer uses as a basis for its own declaration of conformity. The manufacturer may then apply the European Conformity ("CE") mark to the device, which allows the device to be placed on the market throughout the EU.

Throughout the term of the certificate of conformity, the manufacturer will be subject to substantial fees.periodic surveillance audits to verify continued compliance with the applicable requirements. In particular, there will be a new audit by the notified body before it will renew the relevant certificate(s).


FDA approval
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Medical Devices Regulation

The regulatory landscape related to medical devices in the EU recently evolved. On April 5, 2017, the EU Medical Devices Regulation was adopted with the aim of ensuring better protection of public health and patient safety. The EU Medical Devices Regulation establishes a uniform, transparent, predictable and sustainable regulatory framework across the EU for medical devices and ensure a high level of safety and health while supporting innovation. Unlike the EU Medical Devices Directive, the EU Medical Devices Regulation is typically requireddirectly applicable in EU member states without the need for member states to implement into national law. This aims to increase harmonization across the EU.

The EU Medical Devices Regulation became effective on May 26, 2021. The new Regulation among other things:

strengthens the rules on placing devices on the market (e.g. reclassification of certain devices and wider scope than the EU Medical Devices Directive) and reinforces surveillance once they are available;

establishes explicit provisions on manufacturers' responsibilities for the follow-up of the quality, performance and safety of devices placed on the market;

establishes explicit provisions on importers' and distributors' obligations and responsibilities;

imposes an obligation to identify a responsible person who is ultimately responsible for all aspects of compliance with the requirements of the new regulation;

improves the traceability of medical devices throughout the supply chain to the end-user or patient through the introduction of a unique identification number, to increase the ability of manufacturers and regulatory authorities to trace specific devices through the supply chain and to facilitate the prompt and efficient recall of medical devices that have been found to present a safety risk;

sets up a central database (Eudamed) to provide patients, healthcare professionals and the public with comprehensive information on products available in the EU; and

strengthens rules for the assessment of certain high-risk devices, such as implants, which may have to undergo a clinical evaluation consultation procedure by experts before anythey are placed on the market.

Devices lawfully placed on the market pursuant to the EU Medical Devices Directive prior to May 26, 2021 may generally continue to be made available on the market or put into service until May 26, 2025, provided that the requirements of the transitional provisions are fulfilled. In particular, the certificate in question must still be valid. However, even in this case, manufacturers must comply with a number of new drug can be marketed. A New Drug Application ("NDA")or reinforced requirements set forth in the EU Medical Devices Regulation, in particular the obligations described below.

The EU Medical Devices Regulation requires that before placing a device, other than a custom-made device, on the market, manufacturers (as well as other economic operators such as authorized representatives and importers) must register by submitting identification information to the electronic system (Eudamed), or an Abbreviated New Drug Application ("ANDA"), is typically requiredunless they have already registered. The information to be submitted by manufacturers (and authorized representatives) also includes the name, address and contact details of the person or persons responsible for regulatory compliance. The new Regulation also requires that before placing a device, other than a custom-made device, on the market, manufacturers must assign a unique identifier to the FDAdevice and provide it along with other core data to obtain approval of pharmaceutical products.

Before approval, the FDA typically will inspect the facility or facilities where the product is manufactured. The FDA will not approve an application unless it determines that the manufacturing processesunique device identifier ("UDI") database. These new requirements aim at ensuring better identification and facilities are in compliance with current Good Manufacturing Practices ("cGMP") requirements and are adequate to assure consistent productiontraceability of the product within required specifications. Additionally,devices. Each device – and as applicable, each package – will have a UDI composed of two parts: a device identifier ("UDI-DI") specific to a device, and a production identifier ("UDI-PI") to identify the FDA may inspect one or more clinical trial sitesunit producing the device. Manufacturers are also notably responsible for entering the necessary data on Eudamed, which includes the UDI database, and for keeping it up to assure compliancedate. The obligations for registration in Eudamed will become applicable at a later date (as Eudamed is not yet fully functional). Until Eudamed is fully functional, the corresponding provisions of the EU Medical Devices Directive continue to apply for the purpose of meeting the obligations laid down in the provisions regarding exchange of information, including, and in particular, information regarding registration of devices and economic operators.

All manufacturers placing medical devices on the market in the EU must comply with Good Clinical Practice, or GCP, requirements.     the EU medical device vigilance system which has been reinforced by the EU Medical Devices Regulation. Under this system, serious incidents and Field Safety Corrective Actions ("FSCAs") must be reported to the relevant authorities of the EU member states. These reports will have to be submitted through Eudamed – once functional – and aim to ensure that, in addition to reporting to the relevant authorities of the EU member states, other actors such as the economic operators in the supply chain will also be informed. Until Eudamed is

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Post-Approval Regulation

 Afterfully functional, the FDA permits a drug or device to enter commercial distribution, numerous regulatory requirementscorresponding provisions of the EU Medical Devices Directive continue to apply. The FDA actively monitors regulations through reviewA serious incident is defined as any malfunction or deterioration in the characteristics or performance of a device made available on the market, including use-error due to ergonomic features, as well as any inadequacy in the information supplied by the manufacturer and inspectionany undesirable side-effect, which, directly or indirectly, might have led or might lead to the death of design and manufacturing practices, recordkeeping, reportinga patient or user or of adverse events, labeling and promotional practices. The FDA can ban certain medical devices; detainother persons or seize adulteratedto a temporary or misbranded medical devices; order repair, replacementpermanent serious deterioration of a patient's, user's or refund of these devices; and require notificationother person's state of health or a serious public health threat. Manufacturers are required to take FSCAs defined as any corrective action for technical or medical reasons to prevent or reduce a risk of a serious incident associated with the use of a medical device that is made available on the market. An FSCA may include the recall, modification, exchange, destruction or retrofitting of the device. FSCAs must be communicated by the manufacturer or its legal representative to its customers and/or to the end users of the device through Field Safety Notices. For similar serious incidents that occur with the same device or device type and for which the root cause has been identified or a FSCA implemented or where the incidents are common and well documented, manufacturers may provide periodic summary reports instead of individual serious incident reports.

The advertising and promotion of medical devices is subject to some general principles set forth in EU legislation. According to the EU Medical Devices Regulation, only devices that are CE marked may be marketed and advertised in the EU in accordance with their intended purpose. Directive 2006/114/EC concerning misleading and comparative advertising and Directive 2005/29/EC on unfair commercial practices, while not specific to the advertising of medical devices, also apply to the advertising thereof and contain general rules, for example, requiring that advertisements are evidenced, balanced and not misleading. Specific requirements are defined at a national level. EU member states' laws related to the advertising and promotion of medical devices, which vary between jurisdictions, may limit or restrict the advertising and promotion of products to the general public and may impose limitations on promotional activities with healthcare professionals.

Many EU member states have adopted specific anti-gift statutes that further limit commercial practices for medical devices, in particular vis-à-vis healthcare professionals and others with regardorganizations. Additionally, there has been a recent trend of increased regulation of payments and transfers of value provided to healthcare professionals or entities and many EU member states have adopted national "Sunshine Acts" which impose reporting and transparency requirements (often on an annual basis), similar to the requirements in the U.S., on medical device manufacturers. Certain countries also mandate implementation of commercial compliance programs.

The aforementioned EU rules are generally applicable in the European Economic Area ("EEA") which consists of the 27 EU member states plus Norway, Liechtenstein and Iceland.

Brexit

Since January 1, 2021, the Medicines and Healthcare Products Regulatory Agency ("MHRA") has become the sovereign regulatory authority responsible for Great Britain (i.e. England, Wales and Scotland) medical device market according to the requirements provided in the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) that sought to give effect to the three pre-existing EU directives governing active implantable medical devices, that present unreasonable risks of substantial harmgeneral medical devices and in vitro diagnostic medical devices whereas Northern Ireland continues to be governed by EU rules according to the public health. The FDA can take action against a company that promotes "off-label" uses. The FDA may also enjoin and restrain a company for certain violationsNorthern Ireland Protocol. Following the end of the FDC Act andUnited Kingdom's ("UK's") withdrawal from the EU ("Brexit") transitional period on January 1, 2021, new regulations pertaining torequire medical devices or initiate action for criminal prosecutionto be registered with the MHRA (but manufacturers were given a grace period of such violations. Any adverse regulatory action,four to 12 months, depending on its magnitude,the classification of the device, to comply with the new registration process) before being placed on the Great Britain market. The MHRA only registers devices where the manufacturer or their UK responsible person has a registered place of business in the UK. Manufacturers based outside the UK need to appoint a UK responsible person that has a registered place of business in the UK to register devices with the MHRA in line with the grace periods. By July 1, 2023, in Great Britain, all medical devices will require a UK Conformity Assessed ("UKCA") mark but CE marks issued by EU notified bodies will remain valid until this time. Manufacturers may restrictchoose to use the UKCA mark on a companyvoluntary basis until June 30, 2023. However, UKCA marking will not be recognized in the EU. The rules for placing medical devices on the market in Northern Ireland, which is part of the UK, differ from effectively marketingthose in the rest of the UK. Compliance with this legislation is a prerequisite to be able to affix the UKCA mark to our products, without which they cannot be sold or marketed in Great Britain.

An MHRA public consultation was opened until end of November 2021 on the post-Brexit regulatory framework for medical devices and selling its products, may limitdiagnostics. MHRA seeks to amend the UK Medical Devices Regulations 2002 (which are based on EU legislation, primarily the EU Medical Devices Directive and the EU In Vitro Diagnostic Medical Devices Directive 98/79/EC), in particular to create a company's abilitynew access pathway to obtain future premarket clearances or approvals,support innovation, create an innovative framework for regulating software and could resultsartificial intelligence as medical devices, reform IVD regulation and foster sustainability through the reuse and remanufacture of medical devices. The regime is expected to come into force in a substantial modificationJuly 2023, coinciding with the end of the acceptance period for EU CE marks in Great Britain, subject to appropriate transitional arrangements. The consultation indicated that the MHRA
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will publish guidance in relation to the company's business practiceschanges to the regulatory framework and operations.           may rely more heavily on guidance to add flexibility to the regime.


In addition, the trade deal between the UK and the EU generally provides for cooperation and exchange of information between the parties in the areas of product safety and compliance, including market surveillance, enforcement activities and measures, standardization-related activities, exchanges of officials, and coordinated product recalls. As such, processes for compliance and reporting should reflect requirements from regulatory authorities.

Under the terms of the Northern Ireland Protocol, Northern Ireland follows EU rules on medical devices and devices marketed in Northern Ireland require assessment according to the EU regulatory regime. Such assessment may be conducted by an EU notified body, in which case a CE mark is required before placing the device on the market in the EU or Northern Ireland. Alternatively, if a UK notified body conducts such assessment, a 'UKNI' mark is applied and the device may only be placed on the market in Northern Ireland and not the EU.

Manufacturing Regulation


We must also comply with FDA and International Organization for Standardization (“ISO”("ISO") and European Council Directive 93/42/EEC (“Medical Device Directive”) regulations governing medical device manufacturing practices. The FDA, state, foreign agencies and ISO require manufacturers to register and subject manufacturers to periodic FDA, state, foreign agencies and notified bodies and ISO inspections and audits of their manufacturing facilities. We are a FDA and ISO registered medical device manufacturer, and must demonstrate that we and our contract manufacturers comply with the FDA’sFDA's QSR, cGMPs and cGMPs.similar foreign requirements. The FDA, andother regulatory agencies and notified bodies outside the U.S. monitor compliance with these requirements through inspections and audits of manufacturing facilities. If an inspector observes conditions that might be violative, the manufacturer must correct those conditions or explain them satisfactorily, or face potential regulatory action that might include physical removal of the product from the marketplace.
We believe that our products and procedures are in compliance with all applicable FDA and international regulations.  There is no assurance, however, that other products we are developing or products that we may develop in the future will be cleared by the FDA and classified as Class II products, or that additional regulations restricting the sale of our present or proposed products will not be promulgated by the FDA.  In addition, changes in FDA, ISO or other federal or state health, environmental or safety regulations or their applications could adversely affect our business.

To market our products in the European Community (“EC”), we must conform to additional requirements of the EC and demonstrate conformance to established quality standards and applicable directives.  As a manufacturer that designs, manufactures and markets its own devices, we must comply with the quality management standards of EN ISO 13485. Those quality standards are similar to the QSR regulations.
To market our products in the EC, manufacturers of medical devices must also conform to EC Directives such as Council Directive 93/42/EEC and their applicable annexes.  Those regulations assure that medical devices are both safe and effective and meet all applicable established standards prior to being marketed in the EC.  Once a manufacturer and its devices are in conformance with the Medical Device Directive, the “CE” Mark may be affixed to its devices.  The CE Mark gives devices unobstructed entry to all the member countries of the EC.
We have demonstrated conformity to the regulation of EN ISO 13485 and the Medical Device Directive and we affix the CE Mark to our device labeling for product sold in member countries of the EC.

We believe our products and systems are in compliance with all EC requirements.  There can be no assurance, however, that other products we are developing or products that we may develop in the future will conform or that additional regulations restricting the sale of our present or proposed products will not be promulgated by the EC.


Other Healthcare Laws


We are subject to additional healthcare regulation and enforcement by the federal government and by authorities in the states and foreign jurisdictions in which we conduct our business. These laws include:

the federal Anti-Kickback Statute, which prohibits, among other things, persons from knowingly and willfully soliciting, receiving, offering or paying remuneration, directly or indirectly, in exchange for or to induce either the referral of an individual for, or the purchase, order or recommendation of, any good or service for which payment may be made under federal healthcare programs, such as the Medicare and Medicaid programs. A person or entity does not need to have actual knowledge of the federal Anti-Kickback Statute or specific intent to violate it to have committed a violation. In addition, the government may assert that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the False Claims Act;

federal false claims laws which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, claims for payment from Medicare, Medicaid or other federal third-party payors that are false or fraudulent;

the federal Civil Monetary Penalties Law, which prohibits, among other things, offering or transferring remuneration to a federal healthcare beneficiary that a person knows or should know is likely to influence the beneficiary’s decision to order or receive items or services reimbursable by the government from a particular provider or supplier;

federal criminal laws that prohibit executing a scheme to defraud any federal healthcare benefit program or making false statements relating to healthcare matters;

the federal Health Insurance Portability and Accountability Act of 1996, as amended by the Health Information Technology for Economic and Clinical Health Act, which governs the conduct of certain electronic healthcare transactions and protects the security and privacy of protected health information;

the federal Physician Payment Sunshine Act, which requires manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program (with certain exceptions) to report annually to the Centers for Medicare & Medicaid Services (“CMS”) information related to payments or other “transfers of value” made to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors) and teaching hospitals and ownership and investment interests held by the physicians described above and their immediate family members, and payments or other “transfers of value” to such physician owners; and

analogous state and foreign law equivalents of each of the above federal laws, such as anti-kickback and false claims laws which may apply to items or services reimbursed by any third-party payor, including commercial insurers; state laws that require pharmaceutical and device companies to comply with the industry’s voluntary compliance guidelines


the federal Anti-Kickback Statute, which prohibits, among other things, persons from knowingly and willfully soliciting, receiving, offering or paying remuneration, directly or indirectly, in exchange for or to induce either the referral of an individual for, or the purchase, order or recommendation of, any good or service for which payment may be made under federal healthcare programs, such as the Medicare and Medicaid programs. A person or entity does not need to have actual knowledge of the federal Anti-Kickback Statute or specific intent to violate it to have committed a violation;

federal false claims laws which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, claims for payment from Medicare, Medicaid or other federal third-party payors that are false or fraudulent. In addition, the government may assert that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the False Claims Act;

the federal Civil Monetary Penalties Law, which prohibits, among other things, offering or transferring remuneration to a federal healthcare beneficiary that a person knows or should know is likely to influence the beneficiary’s decision to order or receive items or services reimbursable by the government from a particular provider or supplier;

federal criminal laws that prohibit executing a scheme to defraud any federal healthcare benefit program or making false statements relating to healthcare matters. Similar to the federal Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it to have committed a violation;

the federal Health Insurance Portability and Accountability Act of 1996, as amended by the Health Information Technology for Economic and Clinical Health Act, which governs the conduct of certain electronic healthcare transactions and protects the security and privacy of protected health information;

the federal Physician Payment Sunshine Act, which requires manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children's Health Insurance Program (with certain exceptions) to report annually to the Centers for Medicare & Medicaid Services ("CMS") information related to payments or other "transfers of value" made to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors), certain health care professionals (physician assistants, nurse practitioners, clinical nurse
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specialists, anesthesiologist assistants, certified registered nurse anesthetists, anesthesiology assistants and certified nurse midwives), and teaching hospitals and ownership and investment interests held by the physicians described above and their immediate family members; and

analogous state and foreign law equivalents of each of the above federal laws, such as anti-kickback and false claims laws which may apply to items or services reimbursed by any third-party payor, including commercial insurers; state laws that require pharmaceutical and device companies to comply with the industry's voluntary compliance guidelines and the applicable compliance guidance promulgated by the federal government or otherwise restrict payments that may be made to healthcare providers and other potential referral sources; state laws that require device manufacturers to track and report information related to payments and other “transfers"transfers of value”value" to physicians and other healthcare providers or pricing, marketing expenditures and information; and state laws governing the privacy and securityinformation.

Violations of health information in certain circumstances, many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts.

Due to the breadth of these laws, the absence of guidance in the form of regulations or court decisions, and the potential for additional legal or regulatory change in this area, it is possible that our sales and marketing practices and/or our relationships with physicians and other healthcare providers might be challenged under such laws. If our operations are found to violate any of the laws described above or any other laws and regulations that apply to us, we may be subject to penalties, includinginclude civil and criminal penalties, damages, fines, the curtailment or restructuring of ouran entity’s operations, the debarment, suspension or exclusion from our participation in federal and state healthcare programs and imprisonment, any of which could adversely affect our ability to market our products and materially adversely affect our business, results of operations and financial condition. Any action against us for violation of these laws, even if we successfully defend against it, could cause us to incur significant legal expenses and divert our management’s attention from the operation of our business.and/or imprisonment.


Coverage and Reimbursement; Cost ContainmentReimbursement


Our profitability and operations are subject to changes in legislative, regulatory and reimbursement policies and decisions as well as changes in private payer reimbursement coverage and payment decisions and policies. Our products are purchased by hospitals, physicians and other healthcare providers that typically bill various third-party payors, such as governmental programs, private insurance plans and managed care plans, for the healthcare services and products provided to their patients. The ability of our customers to obtain appropriate coverage and reimbursement for healthcare services and products from third-party payors is critical because it affects which products customer purchase and the prices they are willing to pay.pay since our products are not separately reimbursed by any third-party payor. Third-party payors are increasingly reducing coverage and reimbursement for certain healthcare services and products and challenging prices charged for healthcare services and products.


In addition, the U.S. government, state legislatures and foreign governments have continued implementing cost containment programs, including price controls, restrictions on reimbursement and coverage. Adoption of price controls and cost-containment measures, and adoption of more restrictive policies in jurisdictions with existing controls and measures, could further limit our net revenue and results. Health Care Reform

In the U.S., there hashave been, and we expect that there will continue to be, a number of federal and state proposals to limit payments by governmental payors for medical devices, and the procedures in which medical devices are used. For example, in March 2010, comprehensive healthcare reform legislation was enacted through the passage of the Patient Protection and Affordable Care Act, as amended by the Health Care and Education and Reconciliation Act (the "ACA"), which, among other things, provided incentives to programs that increase the federal government’s comparative effectiveness research, and implemented payment system reforms including a national pilot program on payment bundling to encourage hospitals, physicians and other providers to improve the coordination, quality and efficiency of certain healthcare services through bundled payment models.

Since its enactment, there have been judicial, executive and Congressional challenges to certain aspects of the ACA. On June 17, 2021, the U.S. Supreme Court dismissed the most recent judicial challenge to the ACA brought by several states without specifically ruling on the constitutionality of the ACA. Prior to the Supreme Court's decision, President Biden issued an increaseexecutive order to initiate a special enrollment period for purposes of obtaining health insurance coverage through the ACA marketplace from February 15, 2021 through August 15, 2021. The executive order also instructed certain governmental agencies to review and reconsider their existing policies and rules that limit access to healthcare, including among others, reexamining Medicaid demonstration projects and waiver programs that include work requirements, and policies that create unnecessary barriers to obtaining access to health insurance coverage through Medicaid or the ACA.

In addition, other legislative changes have been proposed and adopted since the Affordable Care Act was enacted. On August 2, 2011, the Budget Control Act of 2011 was signed into law, which, among other things, included reductions to Medicare payments to providers of 2% per fiscal year, which went into effect on April 1, 2013, and will stay in political supporteffect through 2030, with the exception of a temporary suspension from May 1, 2020 through March 31, 2021 unless additional Congressional action is taken. On January 2, 2013, the American Taxpayer Relief Act of 2012, was signed into law, which, among other things, further reduced Medicare payments to several providers, including hospitals. We cannot predict whether future healthcare initiatives will be implemented at the federal or state level or internationally, or the effect any future legislation or regulation will have on us. Such legislation and regulation of healthcare costs may, however, result in decreased lower reimbursements by governmental and private payors to our customers, which may adversely affect our business, financial condition and results of operations.

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Data Privacy and Security

Medical device companies may be subject to U.S. federal and state and foreign data privacy, security and data breach notification laws governing the collection, use, disclosure and protection of health-related and other personal information. In the U.S., numerous federal and state laws and regulations, including data breach notification laws, health information privacy and security laws and consumer protection laws and regulations govern the collection, use, disclosure, and protection of health-related and other personal information. In addition, certain foreign laws govern the privacy and security of personal data, including health-related data. For example, the General Data Protection Regulation ("GDPR") imposes strict requirements for controllingprocessing the personal data of individuals within the EEA. Further, from January 1, 2021, companies have had to comply with the GDPR and also the UK GDPR, which, together with the amended UK Data Protection Act 2018, retains the GDPR in UK national law. The UK GDPR mirrors the fines under the GDPR, i.e., fines up to the greater of €20 million (£17.5 million) or 4% of global turnover. Privacy and security laws, regulations, and other obligations are constantly evolving, may conflict with each other to complicate compliance efforts, and can result in investigations, proceedings, or actions that lead to significant price increasescivil and/or criminal penalties and restrictions on data processing.

In the EU, the GDPR went into effect in May 2018 and imposes stringent data protection requirements for controllers and processors of drug products,personal data of persons within the EEA. The GDPR applies to any company established in the EEA as well as to those outside the EEA if they collect and use personal data in connection with the offering of goods or services to individuals in the EEA or the monitoring of their behavior. Companies that must comply with the GDPR face increased compliance obligations and risk, including more robust regulatory enforcement of data protection requirements and potential fines for noncompliance of up to €20 million or 4% of the annual global revenues of the noncompliant company, whichever is greater. Data privacy laws in the EU and the EEA are developing rapidly and, in July 2020, the Court of Justice of the European Union ("CJEU") limited how organizations could lawfully transfer personal data from the EEA to the U.S. by invalidating the Privacy Shield for purposes of international transfers and imposing further restrictions on use of the standard contractual clauses ("SCCs"). While the CJEU upheld the adequacy of the SCCs, it made clear that reliance on them alone may not necessarily be sufficient in all circumstances. Use of the SCCs must now be assessed on a case-by-case basis taking into account the legal regime applicable in the destination country, in particular dueapplicable surveillance laws and rights of individuals and additional measures and/or contractual provisions may need to high-profile casesbe put in place, however, the nature of these additional measures is currently uncertain. The CJEU went on to state that have gained national attention and triggered Congressional inquiries. Implementation of further legislative or administrative reformsif a competent supervisory authority believes that the SCCs cannot be complied with in the reimbursement systemdestination country and the required level of protection cannot be secured by other means, such supervisory authority is under an obligation to suspend or prohibit that transfer. The European Commission issued revised SCCs on June 4, 2021 to account for the decision of the CJEU and recommendations made by the European Data Protection Board. The revised SCCs must be used for relevant new data transfers from September 27, 2021; existing standard contractual clauses arrangements must be migrated to the revised clauses by December 27, 2022. There is some uncertainty around whether the revised clauses can be used for all types of data transfers, particularly whether they can be relied on for data transfers to non-EEA entities subject to the GDPR. The revised SCCs apply only to the transfer of personal data outside of the EEA and not the UK; the UK’s Information Commissioner’s Office launched a public consultation on its draft revised data transfers mechanisms in August 2021.

Since January 2021, companies have to comply with the GDPR and also the UK GDPR. The relationship between the UK and the EU in relation to certain aspects of data protection law remains uncertain, and it is unclear how UK data protection laws and regulations will develop in the U.S.medium to longer term. The European Commission has adopted an adequacy decision in favor of the UK, enabling data transfers from EU member states to the UK without additional safeguards. However, the UK adequacy decision will automatically expire in June 2025 unless the European Commission re-assesses and abroad or adverse decisions relatingrenews/extends that decision, and remains under review by the Commission during this period. In September 2021, the UK government launched a consultation on its proposals for wide-ranging reform of UK data protection laws following Brexit. There is a risk that any material changes which are made to coverage or reimbursementthe UK data protection regime could have an impact on acceptance of and demand for our productsresult in the European Commission reviewing the UK adequacy decision, and the prices that our customers are willingUK losing its adequacy decision if the European Commission deems the UK to payno longer provide adequate protection for them.personal data.
 
Competition


Our industry is highly competitive. We believe our ability to effectively compete in this industry will be determined by our ability to provide a wide breadth of cost-effective, high quality products. We believe the added breadth of our HIS businessacquired product portfolio hasportfolios have increased our competitiveness as we can now provide a one-stop shop for customers and offer more flexible competitive pricing. We also believe theour acquired infusion pump product offering will also enable us to pull through a larger volume of higher margin infusion consumables.  In addition,consumables, and we nowbelieve we have a wider customer reach through our unified distribution channels after the HIS acquisition.channels.


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Infusion Consumables


We believe that our ability to effectively compete in the Infusion Consumables market depends upon our ability to differentiate our products based on continued innovation, safety, quality, convenience, reliability, patent protection, ease of use and the pricing of our products, in addition to access to distribution channels. We encounter significant competition in this market both from global, large, established medical device manufacturers and from smaller companies. We compete with products and systems marketed by Becton Dickinson ("BD"), Baxter International ("Baxter"), and B. Braun Medical, Inc. ("B. Braun"), and Fresenius Kabi a division of Fresenius Group ("Fresenius").   Although we believe that our needlefree infusion devices and custom set manufacturing capabilities have distinct advantages over competing systems, there is no assurance that they will be able to compete successfully with these products. Our CSTD used for the preparation and safe handling of oncology drugs, compete with similar products from BD, and B. Braun.EquaShield. We believe that our current CSTD product offering provides benefits over these competing systems in several areas related to safety, ease of use, quality, and cost; however, on-goingongoing innovation in this market space will be required, and there is no assurance that these innovations will be able to sustain continued growth.required.

IV Solutions

We participate in the IV solutions only in the United States and Canada.   Our primary competitors in the United States include Baxter, B. Braun and Fresenius.  Demand for IV solutions is typically high and raw materials required to produce IV solutions are readily available.  Our ability to compete will depend on our ability to maximize production, develop innovations in our product line, focus on cost-effectiveness and our ability to maintain the appropriate quality infrastructure.


Infusion Systems


We face strong global competitors includingin the Infusion Systems market. In the United States ("U.S.") our competitors include BD, Baxter, and to a lesser extent B. Braun. Outside of the U.S., our primary competitors are BD, B. Braun, Fresenius Kabi, a division of Fresenius Group and Fresenius.a large number of local market pump manufacturers. These competitors benefit from greater financial, research and development and marketing resources than we have. The smart pump market in recent years has been troubled with security concerns and product recalls. We believe our ability to effectively compete in this market segment will be determined by our ability to build our brand strength using the development of technological advancements aimed at increasing the quality, reliability, safety and safetysecurity of our pumps while at the same time focusing on manufacturing efficiency and cost-effectiveness, which are operationally challenging with evolving product lines.


IV Solutions

We participate in the IV solutions market only in the U.S. and Canada. Our primary competitors in the U.S. include Baxter and B. Braun. Demand for IV solutions is typically high and raw materials required to produce IV solutions are readily available. Our ability to compete will depend on our ability to maximize production, develop innovations in our product line, focus on cost-effectiveness and our ability to maintain the appropriate quality infrastructure.

Critical Care


Our primary competitor in Critical Care is Edwards Lifesciences.


Patents
     
We have U.S. and/or certain foreign patents and/or pending patent applications relating to the technologies found in the Clave / MicroClave Connector,connector, MicroClave Clear Connector,connector, Neutron Connector, CLC2000 Connector,connector, Tego Connector,connector, ChemoClave Technologies,system, ChemoLock Technologies, Click Lock Technology, SwabCaps, Custom Set Designconnector, SwabCap disinfecting cap, Diana hazardous drug compounding system, ClearGuard antimicrobial barrier cap, Cogent hemodynamic monitoring system, and Manufacturing Methods, and Diana Hazardous Drug Compounding System. We have applications pending for additional U.S. and/or foreign patents on MicroClave Connector, Neutron Connector, Tego Connector, Y-Clave Connector with Integral Check Valve, ChemoClave Technologies, ChemoLock Technologies, Swabcaps, and Diana Hazardous Drug Compounding System.other products.
 
With the acquisition of HIS, we acquired rights, title and interest to a substantial number of patents and patent applications and related provisionals, divisionals, continuations, continuations-in-part, reissues, reexaminations, extensions, and substitutions of any of the foregoing (“Patent Rights”), that were primarily used or held for use by Pfizer in the HIS business. There is however, no single patent or group of patents that we acquired that we believe is material in relation to our business as a whole. Since the acquisition, we have filed additional patent applications on technologies relating to infusion pumps, software for operating infusion pumps, and software for communicating information to and from infusion pumps.


Our success may depend in part on our ability to obtain patent protection for our products and to operate without infringing the proprietary rights of third parties. While we have obtained certain patents and applied for additional U.S. and foreign patents covering certain of our products, there is no assurance that any additional patents will be issued, that the scope of any patent protection will prevent competitors from introducing similar devices or that any of our patents will be held valid if subsequently challenged. Our patents are important in preventing others from introducing competing products that are as effective as our products. The loss of patent protection on Clave/the Clave / MicroClave connector, Neutron connector, Tego Connector,connector, Swabcap disinfecting cap, Clearguard antimicrobial barrier cap, ChemoClave system, and ChemoLock technologies,connector could adversely affect our ability to exclude other manufacturers from producing effective competitive products and could have an adverse impact on our financial results.


The fact that a patent is issued to us does not eliminate the possibility that patents owned by others may contain claims that are infringed by our products.
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There has been substantial litigation regarding patent and other intellectual property rights in the medical device industry. Litigation, which would result in substantial cost to us and in diversion of our resources, may be necessary to defend us against claimed infringement of the rights of others and to determine the scope and validity of the proprietary rights of others. Adverse determinations in such litigation could subject us to significant liabilities to third parties or could require us to seek licenses from third parties and could prevent us from manufacturing, selling or using our products, any of which could have a material adverse effect on our business. In addition, we have initiated litigation, and may continue to initiate litigation in the future, to enforce our intellectual property rights against those we believe to be infringing on our patents.  Such litigation could result in substantial cost and diversion of resources.
 

Seasonality/Quarterly Results
 
There are no significant seasonal aspects to our business. We can experience fluctuations in net sales as a result of variations in the ordering patterns of our largest customers, which may be driven more by COVID-19 pandemic surges and its impact on hospital admissions and procedure volumes along with production scheduling and theircustomer inventory levels, and less by seasonality. Our expenses often do not fluctuate in the same manner as net sales, which may cause fluctuations in operating income that are disproportionate to fluctuations in our revenue.


Research and Development


Our research and development costs include personnel costs and expenses related to the development of new products. Research and development costs were $52.9$47.5 million in 2018, $51.32021, $42.9 million in 20172020 and $13.0$48.6 million in 2016.2019.
 
EmployeesHuman Capital Management


We believe our employees are the foundation of our business and are key to executing our strategy globally. The knowledge, skills and abilities of our diverse workforce is paramount in upholding our mission of connecting patients and caregivers through safe, life-saving, life enhancing IV therapy products, systems, and services.

We believe the health and well-being of our employees are cornerstones for our successful operations. Whether you are a machine operator in one of our four manufacturing locations, a material handler in a distribution center, a service technician supporting our products in the field, or a clinician training the use of our products in a hospital, we strive to prioritize the safety of our team members. This includes designing our work environments with a safety first mindset, providing personal protective equipment and safety training beginning day one.

Our ability to attract and retain talented individuals globally begins with our commitment to offer a career that gives people a unique opportunity to work in an exhilarating, fast-paced, inspiring, and collaborative environment where what they do makes a difference. We offer competitive salaries and participation to all employees in incentive plans based on individual and company performance.

We believe the development of our workforce is critical for personal growth and the success of our company as well. We reinforce this with challenging, yet rewarding assignments, continued learning and training programs through our global iLearning platform, and support continued education globally through tuition reimbursement programs. Our team believes in diversity, collaboration, and removing barriers to communication—all to create an environment where innovation and creativity can flourish. This is principal for us in attracting, developing, retaining and rewarding talent on a global scale.

Finally, our leadership team, with its broad, and deep category knowledge and averaging approximately 17 years of experience in IV therapy has the necessary experience to effectively lead the execution of our strategy.

At December 31, 2018,2021, we had 8,100 employees.approximately 8,500 employees located in over 20 countries.


Geographic Data


Information regarding financial data by geography is set forth in Part II, Item 8. "Financial Statements and Supplementary Data" of this Annual Report on Form 10-K in NoteNotes 4 and 13 to the Consolidated Financial Statements, and is incorporated herein by reference.


COVID-19 Pandemic

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In March 2020, the World Health Organization characterized a novel strain of coronavirus ("COVID-19") as a global pandemic. The COVID-19 pandemic continues to have widespread and unpredictable impact on global economies, financial markets, and business practices, and continues to impact our business operations, including our employees, customers and suppliers. See “Part II. Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations” for discussion regarding the impact of the COVID-19 pandemic on our financial results. Also, see “Part I. Item 1A. Risk Factors” for discussion of the risks and uncertainties associated with the COVID-19 pandemic.

Available Information


Our website address is http://www.icumed.com. We make available our Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q and Current Reports on Form 8-K, and amendments to those reports free of charge on our website as soon as reasonably practicable after filing them with the Securities and Exchange Commission ("SEC"). We also have our code of ethics posted on our website (http://www.icumed.com). The information on our website is not incorporated into this Annual Report.
 
The public may read and copy any materials we file with the SEC at the SEC’s Public Reference Room at 100 F Street, NE, Washington, DC 20549. The public may obtain information on the operation of the Public Reference Room by calling the SEC at 1-800-SEC-0330.  The SEC maintains an Internet site that contains reports, proxy and information statements, and other information regarding issuers that file electronically with the SEC on its website (http://www.sec.gov).


ITEM 1A. RISK FACTORS
 
In evaluating an investment in our common stock, investors should consider carefully, among other things, the following risk factors, as well as the other information contained in this Annual Report and our other reports and registration statements filed with the SEC. Any of the following risks, as well as additional risks and uncertainties not currently known to us or that we currently deem immaterial, could materially and adversely affect our results of operations or financial condition.


Risks RelatedRisk Factors Summary

Our business is subject to our Strategic Transactionsa number of risks and uncertainties, detail below. These risks include, among others, the following:


Failure to integrate acquired businesses into our operations successfullyWe may not realize the anticipated benefits of the Smiths Medical Transaction, which could adversely impact our business and our operating results.

The COVID-19 pandemic has had a material impact on the global economy and has disrupted our operations and could continue to have an adverse impact on our employees, suppliers and customers, which could adversely and materially impact our business, financial condition and results of operations.

We operate in a highly competitive industry, our ability to compete effectively to maintain or gain market share depends upon numerous factors, such as product innovation, the quality, convenience and such acquisitionsreliability of our products, access to distribution channels and patent protection and pricing. We can give no assurance that we will be successful in implementing any of our competitive strategies.

We are dependent on certain key suppliers; any supply interruptions could resultmaterially harm our business, financial condition and results of operations.

Damage to our manufacturing facilities or any other supply chain restrictions could materially impact our business, financial condition and results of operations.

Changes in unforeseen operating difficultiesor failure to comply with certain federal, state, foreign, legal and expenditures, require significanthealth regulations may harm our business and financial condition.

We depend on the leadership of our executive management resources,team and require significant chargesother key personnel; the loss of one or write-downs.more of our key employees could disrupt our business.


Our stock price may be volatile and you may be unable to sell your shares at or above your purchase price.

Risks Related to our Strategic Transactions

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We may seek to supplementnot realize the anticipated benefits of the Smiths Medical Transaction, which could adversely impact our internal growth through acquisitions of complementary businesses, technologies, services, or products, as well as investmentsbusiness and strategic alliances. Such transactions are inherently risky, and the integration of any newly-acquired business requires significant effort and management attention that otherwise would be available for ongoing development of our other businesses. The success of any acquisition, investment or alliance may be affected by a number of factors, including our ability to properly assess and value the potential business opportunity or to successfully integrate any business we may acquire into our existing business. There can be no assurance that any past or future transactions will be successful.operating results.


The HISSmiths Medical acquisition that closed on February 3, 2017January 6, 2022 was a significant transaction for us and the HISSmiths Medical business was onesignificantly expands our global presence. The success of our business will depend, in which we did not operate directly priorpart, on our ability to realize our anticipated benefits, opportunities and synergies from combining the closingbusinesses of our company and the Smiths Medical business. We can provide no assurance that the anticipated benefits of the transaction.Smiths Medical transaction will be fully realized in the time frame anticipated or at all. Integrating the operations of the HISSmiths Medical business with that of our own is a complex, costly and time-consuming process and the nature of a carve out acquisition makes it inherently

more difficult to assume operations on closing day as well as to integrate activities, as certain systems, processes and people may not all have transferred with the acquired business to support such activities. The integration process may disrupt the businesses and, if implemented ineffectively, would restrict the realization of the full expected benefits. The failure to meet the challenges involved in integrating the two businesses could cause an interruption of, or a loss of momentum in, the activities of the combined businesses and could adversely affect the results of operations of the combined businesses. Potential difficulties that may be encountered in the integration of the HIS business or in the process of integrating other businesses we acquire include the following:


challenges in preserving important strategic customer and other third-party relationships of both businesses;
the diversion of management’s attention to integration matters;
challenges in maintaining employee morale and retaining or attracting key employees;
potential incompatibility of corporate cultures;
costs, delays and other difficulties (i) consolidating corporate and administrative infrastructures and information systems and (ii) implementing common systems and procedures including, in particular, our internal controls over financial reporting; and
coordinating and integrating a geographically dispersed organization, including operations in jurisdictions we did not operate in prior to the Smiths Medical transaction.


Any one or all of these factors may increase operating costs or lower anticipated financial performance. Achieving the anticipated benefits and the potential benefits underlying our reasons for the HISSmiths Medical business acquisition will depend on successful integration of the businesses. Because of the significance of the HISSmiths Medical business acquisition to us, our failure to successfully integrate the HISSmiths Medical business with that of our own could have a material adverse impact on our business, financial condition and results of operations.


The Smiths Medical business acquisition has resulted in organizational change and significant growth to our business. If we fail to effectively manage this growth and change to our business in a manner that preserves our reputation with customers and the key aspects of our corporate culture, our business, financial condition and results of operations could be harmed.

The Smiths Medical business has resulted in significant growth in our personnel and operations. We will continue to incur significant expenditures and the allocation of management time to assimilate the Smiths Medical business employees in a manner that preserves the key aspects of our corporate culture, including a focus on strong customer satisfaction, but there can be no assurance that we will be successful in our efforts. If we do not effectively integrate, train and manage our combined employee base and maintain strong customer relationships, our corporate culture could be undermined, the quality of our products and customer service could suffer, and our reputation could be harmed, each of which could adversely impact our business, financial condition and results of operations.

The actual impact of the Smiths Medical acquisition on our financial results may be worse than the assumptions we have used.

We have made certain assumptions relating to the impact on our financial results of the Smiths Medical acquisition. These assumptions relate to numerous matters, including the acquisition costs, transaction and integration costs, and other financial and strategic risks of the acquisition. If one or more of these assumptions are incorrect, it could have an adverse effect on our business and operating results, and the perceived benefits from the acquisition may not be realized.

If we are unable to effectively manage our internal growth or growth through acquisitions of companies, assets or products, our financial performance may be adversely affected.


We intend to continue to expand our marketing and distribution capability, which may include external expansion through acquisitions both in the U.S. and foreign markets. We may also consider expanding our product offerings through acquisitions of companies or product lines. We can provide no assurance that we will be able to identify, acquire, develop or profitably manage additional companies or operations or successfully integrate such companies or operations into our existing operations without substantial costs, delays or other problems. We recently acquired the HISSmiths Medical business, in February 2017, which
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includes IV pumps, solutions,syringe and ambulatory infusion devices, in order to create a leading pure-play infusion therapy company,vascular access, and vital care products, but we continue to makehave significant integration efforts in order to achieve the anticipated benefits. See “We may not realize the anticipated benefits of the transaction.Smiths Medical Transaction, which could adversely impact our business and our operating results.”


We have additional production facilities outside the U.S. to reduce labor costs. The expansion of our marketing, distribution and product offerings both internally and through acquisitions or by contract may place substantial burdens on our management resources and financial controls. Decentralization of assembly and manufacturing could place further burdens on management to manage those operations and maintain efficiencies and quality control.


The increasing burdens on our management resources and financial controls resulting from internal growth and acquisitions could adversely affect our operating results. In addition, acquisitions may involve a number of special risks in addition to the difficulty of integrating cultures and operations and the diversion of management’s attention, including adverse short-term effects on our reported operating results, dependence on retention, hiring and training of key personnel, risks associated with unanticipated problems or legal liabilities and amortization of acquired intangible assets, some or all of which could materially and adversely affect our operations and financial performance.


As a result of the Smiths Medical acquisition, we have used a significant portion of our cash on hand and incurred a substantial amount of debt to finance the cash consideration portion and certain other amounts paid in connection with the Smiths Medical transaction, which could adversely affect our business, including by restricting our ability to engage in additional transactions or incur additional indebtedness.

Following the financing of the Smiths Medical acquisition transaction, we have significantly less cash, cash equivalents and investment securities on hand than the approximately $571.9 million of cash, cash equivalents and investment securities we had as of December 31, 2021. Although our management believes that we continue to have sufficient access to cash to meet our business objectives and capital needs, we do have a decreased availability of cash, cash equivalents and investment securities and we expect to have such decreased availability of cash for a period of time following the consummation of the Smiths Medical transaction which could constrain our ability to grow our business. In connection with the Smiths Medical transaction and the payment of the cash consideration, we entered into Senior Secured Credit Facilities (the "Senior Secured Credit Facilities") of $2.2 billion consisting of a term loan A facility of $850.0 million, a term loan B facility of $850.0 million and a revolving credit facility of $500.0 million. As a result of the credit facilities, we incurred additional borrowing costs. Our more leveraged financial position following the Smiths Medical transaction could make us vulnerable to general economic downturns and industry conditions, and place us at a competitive disadvantage relative to our competitors. In the event that we do not have adequate capital to maintain or develop our business, additional capital may not be available to us on a timely basis, on favorable terms, or at all. Moreover, our senior secured credit facilities have certain restrictions that may limit how we operate our business, including limiting our ability to engage in certain transactions and to incur additional indebtedness, and our business may be materially and adversely affected if these restrictions prevent us from implementing our business plan.

We have and may continue to acquire businesses, form strategic alliances or make investments in businesses or technologies that could adversely impact our business and our operating results and such transactions could result in unforeseen operating difficulties, expenditures and require significant management resources, charges or write-downs.

We have and may continue to seek to supplement our internal growth through acquisitions of complementary businesses, technologies, services, or products, as well as investments and strategic alliances. We compete for those opportunities with others including our competitors, some of which have greater financial or operational resources than we do. We may not be able to identify suitable acquisition candidates or strategic partners, we may have inadequate access to information or insufficient time to complete due diligence, and we may not be able to complete such transactions on favorable terms, if at all. Such transactions are inherently risky, and the integration of any newly-acquired business requires significant effort and management attention that otherwise would be available for ongoing development of our other businesses.

The success of any acquisition, investment or alliance may be affected by a number of factors, including our ability to properly assess and value the potential business opportunity or to successfully integrate any business we may acquire into our existing business. Integration of an acquired business also may disrupt our ongoing operations and require management resources that we would otherwise focus on developing our existing business. For example, we acquired the HIS business in February 2017, which includes IV pumps, solutions, and devices in order to create a leading pure-play infusion therapy company and we acquired Smiths Medical in January 2022, which includes syringe and ambulatory infusion devices, vascular access, and vital care products. We invested significant time and resources into the HIS integration in order to achieve the anticipated benefits of the transaction and we intend to do the same with the Smiths Medical integration.
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In addition, any acquisition could result in the incurrence of debt, contingent liabilities or future write-offs of intangible assets or goodwill, any of which could have a material adverse effect on our financial condition, results of operations
and cash flows. We may also experience losses related to investments in other companies, which could have an adverse effect on our results of operations and financial condition. As such, there can be no assurance that any past or future transactions will be successful.

Business and Operating Risks


We are dependent on single and limited source third-party suppliers, which subjects our business and results of operations to risks of supplier business interruptions, and a loss or degradation in performance in our suppliers could have an adverse effect on our business and financial condition.


Although we have risk mitigation plans in place with key suppliers, we have materials (such as resins) that are critical to our ability to manufacture our products, the supply of which is currently from a sole supplier. We cannot be certain that our current suppliers will continue to provide us with the quantities of materials that we require or satisfy our anticipated specifications and quality requirements on a timely basis or at all. Any supply interruption in limited or sole sourced raw materials could materially harm our ability to manufacture our products until a new source of supply, if any, could be identified and qualified. Although we believe there are other suppliers of these raw materials, we may be unable to find a sufficient alternative supply channel in a reasonable time or on commercially reasonable terms. The price and supply of these materials may be impacted or disrupted for reasons beyond our control including supplier shutdowns, transportation delays, inflationary pricing pressures, work stoppages, labor shortages and governmental regulatory actions. We have experienced, and may continue to experience, significant challenges to our global transportation channels and other aspects of the global supply chain network, including to the cost and availability of raw materials and components due to shortages and resulting cost inflation.

Additionally, the COVID-19 pandemic continues to impact supply channels resulting in raw material shortages and supply chain disruptions generally. Furthermore, our contract manufacturers could require us to move to another one of their production facilities. An interruption in our commercial operations could occur

if we encounter delays or difficulties in securing these components, materials or services and if we cannot then obtain an acceptable substitute. Additionally, we are subject to FDA and foreign regulations, which could further delay our ability to obtain a qualified alternative supplier. Any performance failure on the part of our suppliers could delay the development and manufacture of our products, which could have a material adverse effect on our business. Due to the highly competitive nature of the healthcare industry and the cost controls of our customers and third party payors, we may be unable to pass along cost increases for any key components or raw materials increases through higher prices to our customers. If the cost of key components or raw materials increases and we are unable to fully to recover those increased costs through price increases or offset these increases through other cost reductions, we could experience an adverse effect on our financial condition.


Damage to any of our manufacturing facilities or disruption to our supply chain network could impair our ability to produce our products.


A severe weather event, other natural or man-made disaster, or any other significant disruption, such as outbreak of disease (including the COVID-19 pandemic), work stoppages, labor shortages and similar interruptions affecting one of our manufacturing facilities or our suppliers and logistics partners could materially and adversely impact our business, financial condition and results of operations. The COVID-19 pandemic has caused us to temporarily shut down some of our facilities, to date these shut downs have not had a material impact on our business. Additionally, in 2021, we have experienced supply chain disruptions and general supply constraints as a result of the continued economic uncertainty and in part due to COVID-19 infections and quarantine protocols.


We have a single manufacturing facility for our Clave products located in Salt Lake City, Utah. Our Salt Lake City facility also produces other components on which our manufacturing operations in Mexico and Costa Rica rely. Our IV Solutions are manufactured at our manufacturing facility in Austin, Texas and by a third party manufacturer, Pfizer, in Rocky Mount, North Carolina.Carolina or our suppliers’ facilities. If our facilities are inoperable, for even a short period of time, it could adversely affect our ability to manufacture and distribute our products in a timely or cost-effective manner, and our ability to make product sales. Furthermore, our facilities and the equipment we use to perform our manufacturing processes could be unavailable or costly and time-consuming to repair or replace.


Damage to any of our facilities, work stoppages or labor shortages could render us unable to manufacture our products or require us to reduce the output of products at the damaged facility.

Expansionour facilities. Two of our manufacturing facilities are located near known earthquake fault zones and are vulnerable to damage from earthquakes. We carry insurance for damage to our property and
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disruption of our business, but this insurance may resultnot cover all of the risks associated with damage or disruption to our facilities and business, may not provide coverage in inefficiencies thatamounts sufficient to cover our potential losses and may not continue to be available to us on acceptable terms, if at all.

Prolonged periods of inflation could have ana material adverse effect on our operations and financial results.results of operations.


In the fourth quarter of 2006, weWe have also experienced significant production inefficiencies following a largesignificant increase in production volumematerial component inflation in Mexico2021, as well as inflation in other costs, such as freight and labor prices. Continued supply chain disruptions and delays, as well as continued heightened inflation, could lead to continued inefficiencies and heightened costs that could negatively impact our performance and our results of operations. Additionally the transfer of San Clemente production to Salt Lake City.  In 2007, we expanded our Mexico facility and, anticipating further increases in volume at that facility, increased the workforce.  An additional expansionmajority of our Mexico facility was completed in January 2011. Turnover among new employees was unusually high in Mexico, and the additional time spent in classroom training and on the job training could create production inefficiencies in Mexico in the future.  The addition of new products will require additional molding in Salt Lake City and manual assembly work in Mexico. Expansions of our production capacity will require significant management attentionsales are conducted pursuant to avoid inefficiencies of the type experienced in 2006, andlong-term contracts. Although we have attempted to minimize the effect of any inefficiencies can be particularly expensiveinflation on our business through contractual protections, the presence of longer pricing periods within our contracts along with sustained or higher than anticipated inflation increases the likelihood that the contract protections do not adequately mitigate the financial impact of inflation. If our contractual protections do not adequately protect us in Salt Lake City becausethe context of substantial cost increases and inflationary pressures, it could have a material adverse effect on our results of operations.

The COVID-19 pandemic has disrupted how we, our suppliers and our customers operate and the duration and extent to which this will impact our business, future results of operations, liquidity and overall financial performance remains uncertain.

    The COVID-19 pandemic has created significant volatility, uncertainty, and economic disruption. We operate globally and the COVID-19 pandemic and its adverse effects have impacted most of the high fixedlocations where we, our customers and our suppliers conduct business and, as a result, we have experienced some disruption to our operations, most notably due to reduced demand for our disposable product portfolio.

    Many hospitals are limiting access to their facilities to essential personnel and prioritizing their time and attention to COVID patients, which may negatively affect demand for our products by limiting the ability of our sales personnel to negotiate new and maintain existing contracts with customers. We have also experienced significant reductions in demand for certain products as our health care customers re-prioritize the treatment of patients, delay elective procedures and shift resources and operations to fight COVID-19 and the complications it causes. For example, during 2020, we have experienced lower demand from hospital customers for our Infusion Consumables non-dedicated sets and lower demand for our Infusion Systems dedicated sets. Additionally, the COVID-19 pandemic could potentially adversely affect our distributors if they are not able to maintain their historical levels of sales.

    Our manufacturing, distribution and pump service facilities are operating under our business continuity plan due to the need for our critical healthcare products; however, we have taken certain precautionary measures including the following to maximize the safety of our employees and to mitigate disruption to our operations:

implemented physical distancing measures;
enhanced hygiene protocols and increased frequency of cleaning procedures;
acquired additional personal protective equipment;
developed contingency plans and protocols to assess employee illness;
helped employees with childcare issues due to school and daycare closures;
initiated a visitor pre-entry questionnaire to limit potential exposure in our facilities.

    While we anticipate that the foregoing measures are temporary, we cannot predict the specific duration for which these precautionary measures will stay in effect, and we may elect to take additional measures as the information available to us continues to develop. These actions, and any future actions we may take in response to the COVID-19 pandemic, could negatively impact our business, financial condition and results of operations.

    The duration and extent of the impact on our business from the COVID-19 pandemic depends on future developments that cannot be fully predicted at this time, as such, the impact of the COVID-19 pandemic on our future results of operations and overall financial performance remain uncertain and cannot as yet be quantified. Additional factors that have contributed or may contribute to the adverse impact of the COVID-19 pandemic on our business, results of operations, financial condition and liquidity include, without limitation, the following:

lost revenue or additional costs associated with either disruptions at our production and distribution facilities or interruptions in our supply chain, including shortages of raw materials or components for our product;
labor shortages as a result of COVID-19 infections and quarantine protocols;
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fluctuations in demand from customers as a result of an increase in COVID-19 patient admissions in hospitals offset by the decline in non-COVID-19 patient admissions;
healthcare customers that defer the more profitable elective procedures may experience financial difficulties and may be unable to pay within payment terms for the products they purchased;
potential lower demand in future periods due to over-purchasing of our products due to the COVID-19 pandemic and supply chain disruption;
reduced revenue due to delays in implementation of our infusion systems and oncology products at hospital locations due to restricted access;
higher operating costs related to additional compensation paid to our manufacturing and distribution facility workers;
volatility in cash flow, revenue and income due to foreign currency fluctuations and volatility;
lower income due to a delay in cost savings projects as a result of the travel and social distancing requirements of COVID-19.

To the extent the COVID-19 pandemic and related containment measures continue to adversely affect regional, national and global economic conditions and financial markets, as well as the business, results of operations, financial conditions and liquidity of us, our suppliers and our customers, it may also have the effect of heightening many of the risks described in this highly automated facility."Risk Factors" section and elsewhere in this Annual Report on Form 10-K for the year ended December 31, 2021, including the risks resulting from our dependency on key personnel; impairment of our supply chain or manufacturing facilities; and the impact of negative economic conditions. In addition, in light of the COVID-19 pandemic and the measures taken to limit its spread, our historical information regarding our business, results of operations, financial condition or liquidity may not be representative of the future results of operations, financial condition, liquidity or other financial or operating results of us or our business.


We may be unable to realize any benefit from our cost reduction and restructuring efforts and our profitability may be hurt or our business otherwise might be adversely affected.


We have engaged in restructuring activities in the past and may engage in other restructuring activities in the future. These types of cost reduction and restructuring activities are complex. If we do not successfully manage our current restructuring activities, or any other restructuring activities that we may take in the future, any expected efficiencies and benefits might be delayed or not realized, and our operations and business could be disrupted. In addition, the costs associated with implementing restructuring activities might exceed expectations, which could result in additional future charges.


We are subject to risks associated with debt financing.

The credit agreements governing our Credit Facility and Senior Secured Credit Facilities contain, among other things, certain customary restrictive covenants that limit our ability to incur additional indebtedness and liens, merge with other companies or consummate certain changes of control, acquire other companies, make certain investments, pay dividends, enter into certain transactions with affiliates, and transfer or dispose of assets as well as financial covenants. While we have not previously breached and are not currently in breach of these or any other covenants contained in our credit agreements, there can be no guarantee that we will not breach these covenants in the future.

Additionally, our ability to comply with these covenants may be affected by events beyond our control, including the COVID-19 pandemic, supply chain interruptions or general economic environment, including increases in inflation and interest rates. These covenants could also limit our ability to seek capital through the incurrence of new indebtedness or, if we are unable to meet our obligations, require us to repay any outstanding amounts with sources of capital we may otherwise use to fund our business. As such, these restrictive covenants contained in our Credit Facility and our Senior Secured Credit Facilities may restrict our ability to pursue our business strategies.

Market and Other External Risks


If we are unable to compete successfully on the basis of product innovation, quality, convenience, price and rapid delivery with larger companies that have substantially greater resources and larger distribution networks than us,our competitors, we may be unable to maintain market share, in which case our sales may not grow and our profitability may be adversely affected.


The consumable medical device segment of the health care industry and in particular the infusion products market is intensely competitive and is experiencing both horizontal and vertical consolidation. We believe that our ability to compete depends upon numerous factors including, among other things, continued product innovation, the quality, convenience and reliability of our products, access to distribution channels, patent protection and pricing. The ability to compete effectively depends on our ability to differentiate our products based on safety features, product quality, cost effectiveness, ease of use and convenience,these factors, as well as our ability to perceive and respond to
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changing customer needs. We encounter significant competition in our markets both from large established medical device manufacturers and from smaller companies. Many of these companies have introduced competitive products with features not provided by the conventional products and methods they are intended to replace. Most of our current and prospective competitors have economic and other resources substantially greater than ours and are well established in the

healthcare industry. Several large, established competitors offer broad product lines and have been successful in obtaining full-line contracts with a significant number of hospitals and group purchasing organizations to supply all of their infusion product requirements. Due to the highly competitive nature of the group purchasing organizations (“GPOs”("GPOs") or integrated delivery networks (“IDNs”("IDNs") contracting processes, we may not be able to obtain or maintain contract positions with major GPOs and IDNs across our products portfolio. Furthermore, the increasing leverage of organizing buy-inorganized buying groups may reduce market prices for our products thereby affecting our profitability. While having a contract with a GPO or IDN can facilitate sales to members of that GPO or IDN, it is no assurance that the sales volume of those products will be maintained. The members of such groups may choose to purchase from our competitors due to the price or quality offered by such competitors, which could result in a decline in our sales and profitability. In addition, distributors of our products may begin to negotiate terms of sale more aggressively in an effort to increase their profitability. Failure to negotiate distribution arrangements having advantageous pricing or other terms of sale could adversely affect our results of operations and financial condition. In addition, if we fail to implement distribution arrangements successfully, it could cause us to lose market share to our competitors. Moreover, there is no assurance that our competitors will not substantially increase resources devoted to the development, manufacture and marketing of products competitive with our products. The successful implementation of such a strategy by one or more of our competitors could materially and adversely affect us.


If we do not successfully develop and commercialize enhanced or new products that remain competitive with new products or alternative technologies developed by others, we could lose revenue opportunities and customers, and our ability to grow our business would be impaired.


The medical device industry is characterized by rapid product development and technological advances, which places our products at risk of obsolescence. Our long-term success and profit margins depend upon the development and successful commercialization of new products, new or improved technologies and additional applications of our technology. The research and development process is time-consuming and costly, and may not result in products or applications that we can successfully commercialize.  We can give no assurance that any such new products will be successful or that they will be accepted in the marketplace.


Product development requires substantial investment that may be difficult for us to fund and may be challenging to
recover through commercial product sales.


Innovations generally require a substantial investment in product development before we can determine their commercial viability, and we may not have the financial resources necessary to fund these innovations. Even if we succeed in creating new product candidates from these innovations, those innovations still may fail to result in commercially successful products. The success of new product offerings for device products depends on several factors, including our ability to anticipate and meet customers'/patients’ or patients' needs, obtain timely regulatory approvals, clearances or clearances,certifications, and manufacture quality products in an economic and timely manner. Even if we are able to develop successfullysuccessful new products or enhancements, we may not produce sales exceeding the costs of development, and we may not avoid infringing the proprietary rights of third parties. Further, those new or enhanced products may be quickly rendered obsolete by changing customer preferences or the introduction by competitors of products embodying new technologies or features. Moreover, innovations may not be successful due to difficulties encountered in achieving positive clinical outcomes, meeting safety, efficacy or other regulatory requirements of government agencies or notified bodies, or obtaining favorable pricing on those products. Finally, innovations may not be accepted quickly in the marketplace because of, among other things, entrenched patterns of clinical practice and uncertainty over third-party reimbursement.


If demand for our products were to decline significantly, we might not be able to recover the cost of our expensive automated molding and assembly equipment and tooling, which could have an adverse effect on our results of operations.


Our production tooling is relatively expensive, with each “module,”"module," which consists of an automated assembly machine and the molds and molding machines that mold the components, costing several million dollars. Most of the modules are for the Clave product family. If the demand for these products changes significantly, which could happen with the loss of a customer or a change in product mix, it may be necessary for us to recognize an impairment charge for the value of the production tooling because its cost may not be recovered through production of saleable product, which could adversely affect our financial condition.


We have been and will be ordering production molds and equipment for our new products. We expect to order semi-automated or fully automated assembly machines for other new Infusion Consumables products in 2019.2021. We also are adding additional IV Solutions capacity atas we transition certain product lines to our IV SolutionsAustin manufacturing facility. facility from Rocky Mount.
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If we do not achieve significant sales of these newnew/transitioned products, it might be necessary for us to recognize an impairment charge for the value of the production tooling because its costs may not be recovered through production of saleable product, which could adversely affect our financial condition.

Our operating results may be adversely affected by unfavorable economic conditions that affect our customers’ ability to buy our products and could affect our relationships with our suppliers.

Disruptions in financial markets worldwide and other worldwide macro-economic challenges may cause our customers and suppliers to experience cash flow concerns.  If job losses and the resulting loss of health insurance and personal savings cause individuals to forgo or postpone treatment, the resulting decreased hospital use could affect the demand for our products.  As a result, customers may modify, delay or cancel plans to purchase our products and suppliers may increase their prices, reduce their output or change terms of sales. Additionally, if customers’ or suppliers’ operating and financial performance deteriorates, or if they are unable to make scheduled payments or obtain credit, customers may not be able to pay, or may delay payment of, accounts receivable owed to us and suppliers may impose different payment terms. Any inability of current and/or potential customers to pay us for our products or any demands by suppliers for different payment terms may adversely affect our earnings and cash flow.


Continuing pressures to reduce healthcare costs and inadequate coverage and reimbursement may adversely affect our prices. If we cannot reduce manufacturing costs of existing and new products, our sales may not grow and our profitability may decline.


Increasing awareness of healthcare costs, public interest in healthcare reform and continuing pressure from Medicare, Medicaid, group purchasing organizationsGPOs and other payers,payors, both domestic and international, to reduce costs in the healthcare industry, as well as increasing competition from other protective products, could make it more difficult for us to sell our products at current prices. Our products are purchased by hospitals, physicians and other healthcare providers that typically bill various third-party payors, such as governmental programs, private insurance plans and managed care plans, for the healthcare services and products provided to their patients. The ability of our customers to obtain appropriate coverage and reimbursement for healthcare services and products from third-party payors is critical because it affects which products customers purchase and the prices they are willing to pay. Because there is often no separate reimbursement for supplies used in surgical procedures, the additional cost associated with the use of our products can affect the profit margin of the hospital or surgery center where the procedure is performed. Some of our target customers may be unwilling to adopt our products in light of the additional associated cost. Further, any decline in the amount payors are willing to reimburse our customers could make it difficult for existing customers to continue using or to adopt our products and could create additional pricing pressure for us. If we are forced to lower the price we charge for our products, our gross margins will decrease, which could have a material adverse effect on our business, financial condition and results of operations and impair our ability to grow our business.


Third-party payors whether foreign or domestic, or governmental or commercial, are developing increasingly
sophisticated methods of controlling healthcare costs. In addition, no uniform policy of coverage and reimbursement
for procedures using our products exists among third-party payors. Therefore, coverage and reimbursement for procedures using our products can differ significantly from payor to payor. Payors continually review new and existing technologies for possible coverage and can, without notice, deny or reverse coverage for new or existing products and procedures. There can be no assurance that third-party payor policies will provide coverage for procedures in which our products are used. If we are not successful in reversing existing non-coverage policies, or if third-party payors that currently cover or reimburse our products and related procedures reverse or limit their coverage in the future, or if other third-party payors issue similar policies, this could have a material adverse effect on our business.


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


Implementation of further legislative or administrative reforms in the reimbursement system in the U.S. and abroad or adverse decisions relating to coverage or reimbursement could have an impact on acceptance of and demand for our products and the prices that our customers are willing to pay for them. In the event that the market will not accept current prices for our products, our sales and profits could be adversely affected. We believe that our ability to increase our market share and operate profitably in the long term may depend in part on our ability to reduce manufacturing costs on a per unit basis through high volume production using highly automated molding and assembly systems. If we are unable to reduce unit manufacturing costs, we may be unable to increase our market share for Claveour products or may lose market share to alternative products, including competitors’ products. Similarly, if we cannot reduce unit manufacturing costs of new products as production volumes increase, we may not be able to sell new products profitably or gain any meaningful market share. Any of these results would adversely affect our future results of operations.


We are subject to foreign, federal, and state data privacy and security laws, and failureFailure to protect our information systems against security breaches, service interruptions, or misappropriation of data could disrupt operations, compromise sensitive data, and expose us to liability, possibly causing our business and reputation to suffer.


We depend heavily on information technology infrastructure and systems to achieve our business objectives. Any incident that impairs or compromises this infrastructure, including security breaches, malicious attacks or more general service interruptions, could impede our ability to process orders, manufacture and ship product in a timely manner, protect sensitive data and otherwise carry on business in the normal course. Any such events could result in the loss of customers, revenue, or both, and could require us to incur significant expense to remediate, including legal claims or proceedings. Further, as cyber
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security related incidents continue to evolve, and regulatory focus on these issues continues to expand, additional investment in protective measures, and vulnerability remediation, may be required.


Our ability to execute our business strategy depends, in part, on the continued and uninterrupted performance of our information technology systems, which support our operations. Despite the implementation of security measures, our internal computer systems, and those of third parties on which we rely, are vulnerable to damage from, among others, computer viruses, malware, natural disasters, terrorism, war, telecommunication and electrical failures, cyber-attacks or cyber-intrusions over the Internet, attachments to emails, persons inside our organization, or persons with access to systems inside our organization or similar disruptive problems. The risk of a security breach or disruption, particularly through cyber-attacks or cyber intrusion, including by computer hackers, foreign governments, and cyber terrorists, has generally increased as the number, intensity and sophistication of attempted attacks and intrusions from around the world have increased. Because the techniques used to obtain unauthorized access, disable or degrade service, or sabotage systems change frequently and often are not foreseeable or recognized until launched against a target, we may be unable to anticipate these techniques or to implement adequate preventative measures. If an actual or perceived breach of our security occurs, public perception of the effectiveness of our security measures and brand could be harmed and our results of operations could be negatively affected. Data security breaches and other incidents may also result from non-technical means (e.g., actions by employees or contractors). Any such security breach may compromise information stored on our networks and may result in significant data losses or theft of personally identifiable information. Any compromise of our security could result in a violation of applicable security, privacy or data protection, consumer and other laws, regulatory or other governmental investigations, enforcement actions, and legal and financial exposure, including potential contractual liability. A number of proposed and enacted federal, state and international laws and regulations obligate companies to notify individuals of security breaches involving particular personally identifiable information, which could result from breaches experienced by us or by third parties, including collaborators, vendors, contractors or other organizations with which we expect to form strategic relationships. Any such compromise could also result in damage to our reputation and a loss of confidence in our security and privacy or data protection measures. In addition, a cybersecurity attack could result in other negative consequences, including disruption of our internal operations, increased cyber security protection costs, lost revenue, regulatory actions or litigations. Any of these effects could materially and adversely affect our business, financial condition and results of operations.

Changes in and failures to comply with foreign, federal, and state data privacy and security laws, regulations and standards may adversely affect our business, operations and financial performance.

We are also subject to various federal, state and foreign laws that protectgovern the confidentialitycollection, use, disclosure, retention and security of certain patient healthpersonal information, including patient medical records,health information. The global data protection landscape is rapidly evolving, and restrictimplementation standards and enforcement practices are likely to remain uncertain for the foreseeable future. This evolution may create uncertainty in our business, affect our or our collaborators', service providers' and contractors' ability to operate in certain jurisdictions or to collect, store, transfer, use and disclosureshare personal information, necessitate the acceptance of patientmore onerous obligations in our contracts, result in liability or impose additional costs on us. In the U.S., numerous federal and state laws and regulations could apply to our operations or the operations of our partners, including state data breach notification laws, federal and state health information by healthcare providers, such asprivacy laws, and federal and state consumer protection laws and regulations (e.g. Section 5 of the Federal Trade Commission Act (the "FTC Act")). For example, the privacy, security and breach notification rules promulgated under the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”("HIPAA"), as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, (“HITECH”), in the U.S. HIPAA established uniform standards governing the conductestablish a set of certain electronic healthcare transactions and requires certain entities, called covered entities, to comply with standards that include thenational privacy and security standards for the protection of protected health information ("PHI"). by health plans, health care clearinghouses and certain health care providers, called covered entities, and the business associates with whom such covered entities contract for services that involve creating, receiving, maintaining or transmitting PHI, as well as their covered subcontractors. HIPAA also requires business associates, such as independent contractors or agents of covered entities that have access to provide individuals with certain rights with respect to their PHI, in connection with providing a service to or on behalf of a covered entity, ofand requires covered entities to enter into a written business associate agreementscontract or other arrangement with the covered entitybusiness associate that establishes specifically what the business associate has been engaged to do and requires the business associate to safeguardcomply with the covered entity’s PHI against improper use and disclosure.requirements of HIPAA.
The HIPAA privacy regulations cover the use and disclosure of PHI by covered entities as well as business associates, which are defined to include subcontractors that create, receive, maintain, or transmit PHI on behalf of a business associate. They also set forth certain rights that an individual has with respect to his or her PHI maintained by a covered entity, including the right to access or amend certain records containing PHI, or to request restrictions on the use or disclosure of PHI. The security regulations establish requirements for safeguarding the confidentiality, integrity, and availability of PHI that is electronically transmitted or electronically stored. HITECH, among other things, established certain health information security breach notification requirements. A covered entity must notify any individual whose PHI is breached according to the specifications set forth in the breach notification rule. The HIPAA privacy and security regulations establish a uniform federal “floor” and do not supersede state laws that are more stringent or provide individuals with greater rights with respect to the privacy or security of, and access to, their records containing PHI or insofar as such state laws apply to personal information that is broader in scope than PHI as defined under HIPAA. Similarly, we may be subject to additional federal privacy laws such as Section 5 of the Federal Trade Commission Act.
HIPAA requires the notification of patients, and other compliance actions, in the event of a breach of unsecured PHI. If notification to patients of a breach is required, such notification must be provided without unreasonable delay and in no event later than 60 calendar days after discovery of the breach. In addition, if the PHI of 500 or more individuals is improperly used or disclosed, we would be required to report the improper use or disclosure to the U.S. Department of Health and Human Services ("HHS") which would post the violation on its website, and to the media.
Penalties for failure to comply with a requirement of HIPAA vary significantly depending on the nature of violation and could include civil monetary or criminal penalties.HIPAA authorizes state attorneys general to file suit on behalf of their
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residents for violations. Courts are able to award damages, costs and attorneys’ fees related to violations of HIPAA in such cases. While HIPAA does not create a private right of action allowing individuals to file suit against us in civil court for violations of HIPAA, its standards have been used as the basis for duty of care cases in state civil suits such as those for negligence or recklessness in the misuse or breach of PHI. In addition, HIPAA mandates that the Secretary of HHS conduct periodic compliance audits of HIPAA covered entities, and their business associates for compliance with the HIPAA

Certain states have also adopted privacy and security standards. It also tasks HHS with establishing a methodology whereby harmed individuals who werelaws and regulations, some of which may be more stringent than HIPAA. Such laws and regulations will be subject to interpretation by various courts and other governmental authorities, thus creating potentially complex compliance issues for us and our future customers and strategic partners. For example, California enacted the victimsCalifornia Consumer Privacy Act of breaches2018 (the "CCPA") went into effect on January 1, 2020. The CCPA applies to certain businesses that collect personal information from California residents. The CCPA gives California residents expanded rights to access and delete their personal information, opt out of unsecured PHI maycertain personal information sharing and receive a percentage of the civil monetary penalty paid by the violator.
The new EU-wide General Data Protection Regulation ("GDPR") became applicable on May 25, 2018, replacing the prior data protection laws issued by each EU member state based on the Directive 95/46/EC. Unlike the Directive (which needed to be transposed at national level), the GDPR text is directly applicable in each EU member state, resulting in a more uniform application of data privacy laws across the EU. The GDPR imposes onerous accountability obligations requiring data controllers and processors to maintain a record of their data processing and policies. It requires data controllers to be transparent and disclose to data subjects (in a concise, intelligible and easily accessible form)detailed information about how their personal information is used by requiring covered companies to provide new disclosures to California consumers (as that term is broadly defined) and provide such consumers new ways to opt-out of certain sales of personal information. The CCPA provides for civil penalties for violations, as well as a private right of action for data breaches that is expected to increase data breach litigation. Although there are limited exemptions for health-related information, including PHI maintained by covered entities and business associates, the CCPA may increase our compliance costs and potential liability. Further, the California Privacy Rights Act ("CPRA") recently passed in California. The CPRA will impose additional data protection obligations on covered businesses, including additional consumer rights processes, limitations on data uses, new audit requirements for higher risk data, and opt outs for certain uses of sensitive data. It will also create a new California data protection agency authorized to issue substantive regulations and could result in increased privacy and information security enforcement. The majority of the provisions will go into effect on January 1, 2023, and additional compliance investment and potential business process changes may be required. Similar laws have passed in Virginia and Colorado, and have been proposed in other states and at the federal level, reflecting a trend toward more stringent privacy legislation in the U.S. The enactment of such laws could have potentially conflicting requirements that would make compliance challenging. In addition, the CCPA has prompted a number of proposals for new federal and state privacy legislation that, if passed, could increase our potential liability, increase our compliance costs and adversely affect our business. If we fail to comply with applicable laws and regulations we could be subject to penalties or sanctions, including criminal penalties if we knowingly obtain or disclose individually identifiable health information from a covered entity in a manner that is not authorized or permitted by HIPAA or applicable state laws.

Furthermore, the FTC and many state Attorneys General continue to enforce federal and state consumer protection laws against companies for online collection, use, dissemination and security practices that appear to be used,unfair or deceptive. For example, according to the FTC, failing to take appropriate steps to keep consumers' personal information secure can constitute unfair acts or practices in or affecting commerce in violation of Section 5(a) of the FTC Act. The FTC expects a company's data security measures to be reasonable and appropriate in light of the sensitivity and volume of consumer information it holds, the size and complexity of its business, and the cost of available tools to improve security and reduce vulnerabilities.

Foreign data protection laws, including the GDPR, which became effective in May 2018, and EU and EEA member state data protection legislation, may also apply to health-related and other personal data obtained outside of the U.S. The GDPR imposes limitationsstrict requirements for processing the personal data of individuals within the EEA. The GDPR has and will continue to increase compliance burdens on retention of information, increases requirements pertaining to pseudonymized (i.e., key-coded) data, introduces mandatory data breach notificationus, including by mandating potentially burdensome documentation requirements and sets higher standards forgranting certain rights to individuals to control how we collect, use, disclose, retain and process data controllers to

demonstrate that they have obtained valid consent for certain data processing activities.about them. Fines for non-compliance with the GDPR are significant-the greater of EUR 20€20 million or 4% of global turnover. The GDPR provides that EU and EEA member states may introduceimpose further conditions, including limitations,obligations relating to the processing of genetic, biometric or health data, which could limit our ability to collect, use and share personal data, or could cause our compliance costs to increase, ultimately having an adverse impact on our business. WeData privacy laws in the EU and the EEA are developing rapidly and, in July 2020, the Court of Justice of the EU (the "CJEU") limited how organizations could lawfully transfer personal data from the EEA to the U.S. by invalidating the Privacy Shield for purposes of international transfers and imposing further restrictions on use of the standard contractual clauses ("SCCs"). While the CJEU upheld the adequacy of the SCCs, it made clear that reliance on them alone may not necessarily be sufficient in all circumstances. Use of the SCCs must now be assessed on a case-by-case basis taking into account the legal regime applicable in the destination country, in particular applicable surveillance laws and rights of individuals and additional measures and/or contractual provisions may need to be put in place, however, the nature of these additional measures is currently uncertain. The CJEU went on to state that if a competent supervisory authority believes that the SCCs cannot be complied with in the destination country and the required level of protection cannot be secured by other means, such supervisory authority is under an obligation to suspend or prohibit that transfer. The European Commission issued revised SCCs on June 4, 2021 to account for the decision of the CJEU and recommendations made by the European Data Protection Board. The revised SCCs must be used for relevant new data transfers from September 27, 2021; existing standard contractual clauses arrangements must be migrated to the revised clauses by December 27, 2022. There is some uncertainty around whether the revised clauses can be used for all types of data transfers, particularly whether they can be relied on for data transfers to
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non-EEA entities subject to the supervisionGDPR. The revised SCCs apply only to the transfer of localpersonal data protectionoutside of the EEA and not the UK; the UK's Information Commissioner's Office launched a public consultation on its draft revised data transfers mechanisms in August 2021. As supervisory authorities in those jurisdictionsissue further guidance on personal data export mechanisms, including circumstances where the SCCs cannot be used, and/or start taking enforcement action, we could suffer additional costs, complaints and/or regulatory investigations or fines, and/or if we are establishedotherwise unable to transfer personal data between and among countries and regions in which we operate, it could affect the manner in which we provide our services, the geographical location or otherwise subject to applicable law.
The California legislature passed the California Consumer Privacy Actsegregation of 2018 (the "CCPA") on June 28, 2018. The CCPA applies to certain businesses that collect personal information from California residents, whether directly or indirectly. The CCPA establishes several consumer rights including a right to know what personal information is being collected about themour relevant systems and whetheroperations, and to whom it is sold, a right to access their personal information and have it deleted, a right to opt out of the sale of their personal information, and a right to equal service and price regardless of exercise of these rights. Violation of the CCPA can result in civil penalties through enforcement by the California Attorney General (effective July 1, 2020) or a private right of action by consumers following a data breach (effective January 1, 2020). The law includes specific exemptions for entities and information covered by HIPAA or the Confidentiality of Medical Information Act (CMIA). However, not all personal information maintained by entities covered by HIPAA or CMIA is exempt from the CCPA. California legislators have stated that they intend to propose amendments to the CCPA before it goes into effect, and it remains unclear what, if any, modifications will be made to this legislation or how it will be interpreted. The U.S. Congress may also pass a law to pre-empt all or part of the CCPA. As passed, the effects of the CCPA potentially are significant, however, and may require us to modify our data collection or processing practices and policies and to incur substantial costs and expenses in an effort to comply. Implementing regulations from the Attorney General that may clarify the CCPA are not due until July 1, 2020 and additional amendments to the CCPA may be signed into law before then.
Failure to comply with any of these laws or to protect our information systems against security breaches, service interruptions, or misappropriation of data could disrupt operations, compromise sensitive data, and expose us to fines, penalties, other liability, and reputational harm, any of which could adversely affect our ability to operate our business and our financial results.


Expiring patents may affect our future sales.

SomeFurther, from January 1, 2021, companies have to comply with the GDPR and also the UK GDPR, which, together with the amended UK Data Protection Act 2018, retains the GDPR in UK national law. The UK GDPR mirrors the fines under the GDPR, e.g. fines up to the greater of our products are covered by patents that, if valid, give us a degree€20 million (£17.5 million) or 4% of market exclusivity during the termglobal turnover. The European Commission has adopted an adequacy decision in favor of the patent. Upon patent expiration, our competitors may introduce products using the same technology. As a result of this possible increase in competition, we may need to reduce our prices to maintain sales of our products, which would make them less profitable. If we fail to develop and successfully launch new products priorUK, enabling data transfers from EU member states to the expirationUK without additional safeguards. However, the UK adequacy decision will automatically expire in June 2025 unless the European Commission re-assesses and renews/extends that decision, and remains under review by the Commission during this period. The relationship between the UK and the EU in relation to certain aspects of patents for our existing products, our salesdata protection law remains unclear, and profits with respectit is unclear how UK data protection laws and regulations will develop in the medium to those products could decline significantly. We may notlonger term, and how data transfers to and from the UK will be able to develop and successfully launch more advanced replacement products before these and other patents expire.regulated in the long term.


If we cannot obtain additional custom tooling and equipment on a timely basis to enable us to meet demand for our products, we might be unable to increase our sales or might lose customers, in which case our sales could decline.

We expanded our manufacturing capacity substantially in recent years, and we expect that continued expansion may be necessary. Molds and automated assembly machines generally have a long lead-time with vendors, often nine months or longer. Inability to secure such tooling in a timely manner, or unexpected increases in production demands, could cause us to be unable to meet customer orders. Such inability could cause customers to seek alternatives to our products.


Increases in the cost of petroleum-based and natural gas-based productsCost volatility or loss of supply of our raw materials could have an adverse effect on our profitability.


Most of the materials used in our products are resins, plastics and other material that depend upon oil or natural gas as their raw material. Crude oil markets are affected by political uncertainty in the Middle East, and there is no assurance that crude oil supplies will not be interrupted in the future. New laws or regulations adopted in response to climate change could also increase energy costs as well as the costs of certain raw materials and components. Any such regulations or interruptions could have an adverse effect on our ability to produce, or the cost to produce, our products. Also, crude oil and natural gas prices have been volatile in recent years. Our suppliers have historically passed some of their cost increases on to us, and if such prices are sustained or increase further, our suppliers may pass further cost increases on to us. In addition to the effect on resin prices, transportation costs have increased because of the effect of higher crude oil prices, and we believe most of these costs have been passed on to us. Our ability to recover these increased costs may depend upon our ability to raise prices on our products. In the past, we have rarely raised prices and it is uncertain that we would be able to raise them to recover higher

prices from our suppliers. Our inability to raise prices in those circumstances, or to otherwise recover these costs, could have an adverse effect on our profitability.


Our business could suffer if we lose the services of key personnel.


We are dependent upon the management and leadership of our executive team, as well as other members of our senior management team. If one or more of these individuals were unable or unwilling to continue in his or her present position, our business would be disrupted and we might not be able to find replacements on a timely basis or with the same level of skill and experience, which could have an adverse effect on our business. We do not have "key person" life insurance policies on any of our employees.


The price of our common stock has been and may continue to be highly volatile due to many factors.


The market for small and mid-market capitalization companies can be highly volatile, and we have experienced significant volatility in the price of our common stock in the past. From January 20162019 through December 2018,2021, our trading price ranged from a high of $321.70$282.00 per share to a low of $85.56$148.89 per share. We believe that factors such as quarter-to-quarter fluctuations in financial results, differences between stock analysts’ expectations and actual quarterly and annual results, new product introductions by us or our competitors, acquisitions or divestitures, changing regulatory environments, litigation, changes in healthcare reimbursement policies, sales or the perception in the market of possible sales of common stock by insiders, market rumors, general economic trends (including the COVID-19 pandemic) and substantial product orders could contribute to the volatility in the price of our common stock. General economic trends unrelated to our performance such as recessionary cycles and changing interest rates may also adversely affect the market price of our common stock; the recent macroeconomic downturn could depress our stock price for some time.

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Most of our common stock is held by, or included in accounts managed by, institutional investors or managers. Several of those institutions own or manage a significant percentage of our outstanding shares, with the ten largest interests accounting for approximately 55%58% of our outstanding shares at the end of 2018.2021. If one or more of the institutions or if our other large stockholders should decide to reduce or eliminate their position in our common stock, it could cause a significant decrease in the price of our common stock.


Changes in funding forDisruptions at the FDA, and other government agencies or notified bodies caused by funding shortages or global health concerns could hinder their ability to hire, and retain, or deploy key leadership and other personnel, or otherwise prevent new or modified products and services from being developed, cleared, approved, certified, or commercialized in a timely manner, or at all, which could negatively impact our business.

The ability of the FDA to review and approve new products can be affected by a variety of factors, including government budget and funding levels, ability to hire and retain key personnel and accept the payment of user fees, and statutory, regulatory, and policy changes. Average review times at the agency have fluctuated in recent years as a result. In addition, government funding of other government agencies that fund research and development activities is subject to the political process, which is inherently fluid and unpredictable.

Disruptions at the FDA, foreign regulatory authorities and notified bodies to review and approve or certify new products can be affected by a variety of factors, including government budget and funding levels, statutory, regulatory and policy changes, a government agency's ability to hire and retain key personnel and accept the payment of user fees, and other agenciesevents that may also slowotherwise affect the time necessary for new productsgovernment's ability to be reviewed and/or approved by necessaryperform routine functions. Average review times at the FDA, other government agencies, foreign regulatory authorities and notified bodies have fluctuated in recent years as a result. In addition, government funding of other government agencies that fund research and development activities is subject to the political process, which would adversely affect our business.is inherently fluid and unpredictable. For example, over the last several years, including for 35 days beginning on December 22, 2018, the U.S. government has shut down several times and certain regulatory agencies, such as the FDA, have had to furlough critical FDA employees and stop critical activities.

Separately, in response to the COVID-19 pandemic, on March 10, 2020, the FDA announced its intention to postpone most foreign inspections of manufacturing facilities and products and on March 18, 2020, the FDA temporarily postponed routine surveillance inspections of domestic manufacturing facilities. Subsequently, in July 2020 the FDA resumed certain on-site inspections of domestic manufacturing facilities subject to a risk-based prioritization system. The FDA utilized this risk-based assessment system to assist in determining when and where it was safest to conduct prioritized domestic inspections. In May 2021, the FDA outlined a detailed plan to move toward a more consistent state of inspectional operations, and in July 2021, the FDA resumed standard inspectional operations of domestic facilities and was continuing to maintain this level of operation as of September 2021. More recently, the FDA has continued to monitor and implement changes to its inspectional activities to ensure the safety of its employees and those of the firms it regulates as it adapts to the evolving COVID-19 pandemic. Regulatory authorities and notified bodies outside the U.S. may adopt similar restrictions or other policy measures in response to the COVID-19 pandemic. If a prolonged government shutdown occurs, or if global health concerns continue to prevent the FDA, other regulatory authorities or notified bodies from conducting their regular inspections, audits, reviews, or other regulatory activities, it could significantly impact the ability of the FDA or other regulatory authorities or notified bodies to timely review and process our regulatory submissions, which could have a material adverse effect on our business.


For instance, in the EU, notified bodies must be officially designated to certify products and services in accordance with the EU Medical Devices Regulation. While several notified bodies have been designated the COVID-19 pandemic has significantly slowed down their designation process and the current designated notified bodies are facing a large amount of requests with the new regulation as a consequence of which review times have lengthened. This situation could impact our ability to grow our business in the EU and EEA.

Legal, Compliance, and Regulatory Risks


We are subject to certain federal, state and foreign fraud and abuse and transparency laws, which, if violated, could subject us to substantial penalties. Additionally, any challenge to or investigation into our practices under these laws could cause adverse publicity and be costly to respond to, and thus could harm our business.
There are numerous U.S. federal and state, as well as foreign, laws pertaining to healthcare fraud and abuse, including anti-kickback, false claims and physician transparency laws.laws regarding payments and other transfers of value made to physicians and other
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licensed healthcare professionals. Our business practices and relationships with providers are subject to scrutiny under these laws. The healthcare laws and regulations that may affect our ability to operate include, but are not limited to:


the federal Anti-Kickback Statute, which prohibits, among other things, persons and entities from knowingly and willfully soliciting, offering, receiving or providing remuneration, directly or indirectly, in cash or in kind, to induce either the referral of an individual or furnishing or arranging for a good or service, for which payment may be made, in whole or in part, under federal healthcare programs, such as Medicare and Medicaid. A person or entity does not need to have actual knowledge of the statute or specific intent to violate it to have committed a violation. The U.S. government has interpreted this law broadly to apply to the marketing and sales activities of manufacturers. Moreover, the government may assert that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the federal civil False Claims Act. Violations of the federal Anti-Kickback Statute may result in civil monetary penalties up to $100,000 for each violation, plus up to three times the remuneration involved. Civil penalties for such conduct can further be assessed under the federal False Claims Act. Violations can also result in criminal penalties, including criminal fines of up to $100,000 and imprisonment of up to 10 years. Similarly, violations can result in exclusion from participation in government healthcare programs, including Medicare and Medicaid;manufacturers;
the federal civil and criminal false claims laws and civil monetary penalties laws, including the federal civil False Claims Act, which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, claims for payment from Medicare, Medicaid or other federal healthcare programs that are false or fraudulent. These laws can apply to manufacturers who provide information on coverage, coding, and reimbursement of their products to persons who bill third-party payers. Private individuals can bring False Claims Act “qui tam”"qui tam" actions, on behalf of the government and such individuals, commonly known as “whistleblowers,”"whistleblowers," may share in amounts paid by the entity to the government in fines or settlement. When an entity is determined to have violatedMoreover, the government may assert that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the federal civil False Claims Act, the government may impose civil fines and penalties ranging from $11,181 to $22,363 for each false claim, plus treble damages, and exclude the entity from participation in Medicare, Medicaid and other federal healthcare programs;Act;
the federal Civil Monetary Penalties Law, which prohibits, among other things, offering or transferring remuneration to a federal healthcare beneficiary that a person knows or should know is likely to influence the beneficiary’s decision to order or receive items or services reimbursable by the government from a particular provider or supplier;
the federal Physician Sunshine Act under the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act, collectively referred to as the Affordable Care Act, which require certain applicable manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program ("CHIP") to report annually to the USU.S. Department of Health and Human Services Centers for Medicare and Medicaid Services ("CMS")Services' CMS information related to payments and other transfers of value to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors), certain other healthcare providers (physician assistants, nurse practitioners, clinical nurse specialists, anesthesiologist assistants, certified registered nurse anesthetists, anesthesiology assistants and certified nurse midwives, and teaching hospitals,hospitals), and applicable manufacturers and group purchasing organizations,GPOs, to report annually ownership and investment interests held by physicians and their immediate family members. Applicable manufacturers are required to submit annual reports to CMS. Failure to submit required information may result in civil monetary penalties of $11,278 per failure up to an aggregate of $169,170 per year (or up to an aggregate of $1.128 million per year for “knowing failures”), for all payments, transfers of value or ownership or investment interests that are not timely, accurately, and completely reported in an annual submission, and may result in liability under other federal laws or regulations;members;
HIPAA, which created additional federal criminal statutes that prohibit, among other things, executing a scheme to defraud any healthcare benefit program and making false statements relating to healthcare matters. Similar to the federal Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it to have committed a violation. In addition, HIPAA, as amended by HITECHviolation; and their respective implementing regulations, which impose requirements on certain covered healthcare providers, health plans and healthcare clearinghouses as well as their business associates that perform services for them that involve individually identifiable health information, relating to the privacy, security and transmission of individually identifiable health information without appropriate authorization, including mandatory contractual terms as well as directly applicable privacy and security standards and requirements. Failure to comply with the HIPAA privacy and security standards can result in civil monetary penalties up to $57,051 per violation, not to exceed $1.71 million per calendar year for non-compliance of an identical provision, and, in certain circumstances, criminal penalties with fines up to $250,000 per violation and/or imprisonment. State attorneys general can also bring a civil action to enjoin a HIPAA violation or to obtain statutory damages on behalf of residents of his or her state; and
analogous state and foreign law equivalents of each of the above federal laws, such as anti-kickback and false claims laws which may apply to items or services reimbursed by any third-party payor, including commercial insurers or patients; state laws that require device companies to comply with the industry’s voluntary compliance guidelines and the applicable compliance guidance promulgated by the federal government or otherwise restrict payments that may be made to healthcare providers and other potential referral sources; state laws that require device manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures; consumer protection and unfair competition laws, which broadly regulate marketplace

activities and activities that potentially harm customers; and state laws related to insurance fraud in the case of claims involving private insurers.


These laws and regulations, among other things, constrain our business, marketing and other promotional activities by limiting the kinds of financial arrangements, including sales programs, we may have with hospitals, physicians or other potential purchasers of our products. Due to the breadth of these laws, the narrowness of statutory exceptions and regulatory safe harbors available, and the range of interpretations to which they are subject, it is possible that some of our current or future practices might be challenged under one or more of these laws.
To enforce compliance with the healthcare regulatory laws, certain enforcement bodies have recently increased their scrutiny of interactions between healthcare companies and healthcare providers, which has led to a number of investigations, prosecutions, convictions and settlements in the healthcare industry. Responding to investigations can be time-and resource-consuming and can divert management’smanagement's attention from the business. Additionally, as a result of these investigations, healthcare providers and entities may have to agree to additional compliance and reporting requirements as part of a consent decree or corporate integrity agreement. Any such investigation or settlement could increase our costs or otherwise have an adverse effect on our business. Even an unsuccessful challenge or investigation into our practices could cause adverse publicity, and be costly to respond to. If our operations are found to be in violation of any of the healthcare laws or regulations described above or any other healthcare regulations that apply to us, we may be subject to penalties, including administrative, civil and criminal penalties, damages, fines, exclusion from participation in government healthcare programs, such as Medicare and Medicaid, imprisonment, contractual damages, reputational harm, disgorgement and the curtailment or restructuring of our operations.

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Healthcare regulation and reform measures could adversely affect our revenue and financial condition.


The healthcare industry is highly regulated and in recent years, there have been numerous changes in initiatives, laws and regulations. The federal government and all states and jurisdictions in which we currently operate regulate various aspects of our business. Changes in law or new interpretation of existing laws can have a material effect on our permissible activities and the relative costs associated with doing business. The laws and regulations that may affect our ability to operate include, without limitation, anti-kickback laws that prohibit payments or other remuneration that could be considered to induce hospitals, physicians or other potential purchasers of our products either to refer patients or to purchase, lease or order, or arrange for or recommend the purchase, lease or order, of healthcare products or services for which payment may be made under federal and state healthcare programs as well as false claims laws that prohibit filing of false or improper claims for payment. Federal laws apply to federal and state healthcare programs, such as Medicare and Medicaid, and several states have similar laws that may apply more broadly to all payors. Although we would not submit claims directly to government payors, manufacturers can be held liable under the federal and state false claim act if they are deemed to “cause” the submission of false or fraudulent claims by, for example, providing inaccurate billing or coding information to customers, price reporting, or promoting a product off-label. In addition, our activities relating to the reporting of wholesaler or estimated retail prices for our products, the reporting of prices used to calculate Medicaid rebate information and other information affecting federal, state, and third-party reimbursement for our products, and the sale and marketing of our products, are subject to scrutiny under this federal and state false claims laws. As a manufacturer of U.S. FDA-approved products reimbursable by federal healthcare programs, we are subject to the Physician Payments Sunshine Act, which requires us to annually report certain payments and other transfers of value we make to U.S.-licensed physicians and certain other healthcare professionals or U.S. teaching hospitals and any ownership or investment interests held by physicians and their immediate family members. These laws may affect our sales, marketing and other promotional activities by limiting the kinds of financial arrangements we may have with hospitals, physicians and other potential purchasers of our products. These laws are broadly written and are subject to evolving interpretations, and it is often difficult to determine how these laws will be applied to specific circumstances. In addition, any action against us for violation of these laws, even if we successfully defend against it, could cause us to incur significant legal expenses and divert our management’s attention from the operation of our business. If our operations are found to be in violation of any of the laws described above or any other governmental laws or regulations that apply to us, we may be subject to penalties, including civil and criminal penalties, damages, fines, the exclusion from participation in federal and state healthcare programs, imprisonment, or the curtailment or restructuring of our operations, any of which could adversely affect our ability to operate our business and our financial results.

Our profitability and operations are subject to risks relating to changes in government and private reimbursement programs and policies and changes in legal requirements in the U.S. and in the world. There have been, and we expect there will continue to be, a number of legislative and regulatory changes to the healthcare system that could affect our future revenues and profitability in the U.S. and abroad. Federal and state lawmakers regularly propose and, at times, enact legislation that results in significant changes to the healthcare system, some of which are intended to contain or reduce the costs of medical products and services. For example, in 2010, the Patient Protection and Affordable Care Act and the Health Care and Education Reconciliation Act (“Affordable Care Act”) wereACA was signed into law introducing comprehensive health insurance

and healthcare reforms in the U.S. Among the provisions of such legislation that may have an adverse impact on us is a 2.3% excise tax imposed on medical device manufacturers for the sale of certain medical devices to U.S. customers. The excise tax, which became effective January 1, 2013, resulted in additional expense of $2.0 million in 2015 recorded in Selling, General and Administrative expenses. Congress has temporarily suspended this medical device excise tax for two years commencing January 2018. Unless Congress changes the current law, we expect this tax to resume beginning in 2020. The Affordable Care Act alsoACA, among other things, provided incentives to programs that increase the federal government’sgovernment's comparative effectiveness research, and implemented payment system reforms including a national pilot program on payment bundling to encourage hospitals, physicians and other providers to improve the coordination, quality and efficiency of certain healthcare services through bundled payment models. Additionally, the Affordable Care ActACA has expanded eligibility criteria for Medicaid programs and created a new Patient-Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research, along with funding for such research. We do not yet know the full impact that the Affordable Care Act will have on our business.


We expect that the current Presidential Administration and U.S. Congressanticipate there will continue to seekbe proposals by legislators at both the federal and state levels, regulators and commercial payors to modify, repeal, or otherwise invalidate all, or certain provisions of, the Affordable Care Act. For example, the Tax Cuts and Jobs Acts was enacted, which, among other things, removes penalties for not complying with thereduce costs while expanding individual mandate to carry health insurance, beginning in 2019. On December 14, 2018, a U.S. District Court Judge in the Northern District of Texas, ruled that the Affordable Care Act’s individual mandate to carry insurance coverage is a critical and inseverable feature of the Affordable Care Act, and therefore, because it was repealed as part of the Tax Cuts and Jobs Act, the remaining provisions of the Affordable Care Act are invalid as well. While the Trump Administration and the Centers for Medicare & Medicaid Services, or CMS, have both stated that the ruling will have no immediate effect, it is unclear how this decision, subsequent appeals, if any, and other efforts to repeal and replace the Affordable Care Act will impact the Affordable Care Act and our business.

There is still uncertainty with respect to the impact President Trump’s administration and the U.S. Congress may have, if any, and any changes will likely take time to unfold, and could have an impact on coverage and reimbursement for healthcare items and services covered by plans that were authorized by the Affordable Care Act. In addition, other legislative changes have been proposed and adopted in the U.S. since the Affordable Care Act was enacted that reduced payments to Medicare providers. On August 2, 2011, the Budget Control Act of 2011 was signed into law, which, among other things, reduced Medicare payments to providers by 2% per fiscal year, effective on April 1, 2013 and, due to subsequent legislative amendments to the statute, will remain in effect through 2027 unless additional Congressional action is taken. On January 2, 2013, the American Taxpayer Relief Act of 2012 was signed into law, which, among other things, reduced Medicare payments to several providers, including hospitals, and increased the statute of limitations period for the government to recover overpayments to providers from three to five years. Recently, there has also been heightened governmental scrutiny over the manner in which drug manufacturers set prices for their marketed products, which has resulted in several Congressional inquiries and proposed bills designed to, among other things, bring more transparency to product pricing, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for drug products. benefits. The ultimate implementation of any healthcare reform legislation and any new laws and regulations, and its impact on us, is impossible to predict.predict, particularly in light of the new presidential administration. Any significant reforms made to the healthcare system in the U.S., or in other jurisdictions, may have an adverse effect on our financial condition and results of operations.


Our business could be materially and adversely affected if we fail to defend and enforce our patents or other proprietary rights, if our products are found to infringe patents or other proprietary rights owned by others or if the cost ofto protect our patent litigationor other proprietary rights becomes excessive or as our key patents expire.


We rely on a combination of patents, trademarks, copyrights, trade secrets, business methods, software and nondisclosure agreements to protect our proprietary intellectual property. Our efforts to protect our intellectual proprietary and proprietary rights may not be sufficient. Further, there is no assurance that patents pending will issue or that the protection from patents which have issued or may issue in the future will be broad enough to prevent competitors from introducing similar devices, that such patents, if challenged, will be upheld by the courts or that we will be able to prove infringement and damages in litigation.


We generally have multiple patents covering various features of a product, and as each patent expires, the protection afforded by that patent is no longer available to us, even though protection of features that are covered by other unexpired patents may continue to be available to us. The loss of patent protection on certain features of our products may make it possible for others to manufacture and sell products with features identical or similar to ours, which could adversely affect our business.

     If we fail to develop and successfully launch new products prior to the expiration of patents for our existing products, our sales and profits with respect to those products could decline significantly. We may not be able to develop and successfully launch more advanced replacement products before these and other patents expire.

In addition, our ability to enforce and protect our intellectual property rights may be limited in certain countries outside of the U.S., which could make it easier for competitors to obtain market position in such countries by utilizing technologies that are similar to those developed by us.



If others choose to manufacture and sell products similar to or substantially the same as our products, it could have a material adverse effect on our business through loss of unit volume or price erosion, or both, and could adversely affect our ability to secure new business.


In the past, we have faced patent infringement claims related to theour Clave products, the CLC2000 Connector and Tego.Tego Connector. We believe these claims had no merit, and all have been settled or dismissed. We may also face claims in the future. Any adverse determination on these claims related to our products, if any, could have a material adverse effect on our business.

From time to time we become aware of newly issued patents on medical devices, which we review to evaluate any infringement risk. We are aware of a number of patents for infusion connection systems that have been issued to others. While we believe these patents will not affect our ability to market our products,Additionally, there is no assurance that these or other issued or pending patents might not interfere with our right or ability to manufacture and sell our products.

There has been substantial litigation regarding patent and other intellectual property rights in the medical device industry. Patent infringement litigation, which may be necessary to enforce patents issued to us or to defend ourselves against claimed infringement of the rights of others, can be expensive and may involve a substantial commitment of our resources which may divert resources from other uses. Adverse determinations in litigation or settlements could subject us to significant liabilities to third parties, could require us to seek licenses from third parties, could prevent us from manufacturing and selling our products or could fail to prevent competitors from manufacturing products similar to ours. Any of these results could materially and adversely affect our business.

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From time to time we become aware of newly issued patents on medical devices, which we review to evaluate any infringement risk. We are aware of a number of patents for infusion connection systems that have been issued to others. While we believe these patents will not affect our ability to market our products, there is no assurance that these or other issued or pending patents might not interfere with our right or ability to manufacture and sell our products.

Our ability to market our products in the U.S. and other countries may be adversely affected if our products fail to comply with the applicable standardsrequirements of the FDA and regulatory agencies in other countries.


We and our products are subject to extensive regulation in the United StatesU.S. and elsewhere, including by the FDA and its foreign counterparts. The FDA and foreign regulatory agencies and notified bodies regulate, among other things, with respect to medical devices: design, development and manufacturing; testing, labeling, content and language of instructions for use and storage; clinical trials; product safety; establishment registration and device listing; marketing, sales and distribution; premarketpre-market clearance, approval and approval;certification; record keeping procedures; advertising and promotion; recalls and field safety corrective actions; post-market surveillance, including reporting of deaths or serious injuries and malfunctions that, if they were to recur, could lead to death or serious injury; post-market approval studies; and product import and export.


In the U.S., our medical device products are subject to clearance or approval by the U.S. FDA under the Food, Drug and Cosmetics Act ("FDC Act").Act. Before we can market a new medical device, or a new use of, new claim for, or significant modification to, an existing product, we must first receive either clearance under Section 510(k) of the FDC Act or approval of a premarket approval, or PMA application from the FDA, unless an exemption applies. Under the 510(k) process, the manufacturer must submit to the FDA a premarketpre-market notification, demonstrating that the device is "substantially equivalent," as defined in the statute,FDC Act, to a legally marketed predicate device. To be "substantially equivalent," the proposed device must have the same intended use as the predicate device, and either have the same technological characteristics as the predicate device or have different technological characteristics and not raise different questions of safety or effectiveness than the predicate device. If the manufacturer is unable to demonstrate substantial equivalence to FDA’sFDA's satisfaction, or if there is no available predicate device, then the manufacturer may be required to seek approval through the PMA application process, which is generally more costly and time consuming than the 510(k) process. Through the PMA application process, the applicant must submit data and information demonstrating reasonable assurance of the safety and effectiveness of the device for its intended use to the FDA's satisfaction. Accordingly, a PMA application typically includes, but is not limited to, extensive technical information regarding device design and development, pre-clinical and clinical trial data, manufacturing information, labeling and financial disclosure information for the clinical investigators in device studies.


Each of our currentWe currently market certain products has qualified,that have received 510(k) clearance, and we anticipate that any new products we are likely to market will qualifymay pursue 510(k) clearance for clearance under the FDA’s expedited pre-market notification procedure pursuant to Section 510(k) of the FDC Act.future products. However, certain of our new products may require a longer time for clearance than we have experienced in the past and there can be no assurance that a PMA application will not be required. Further, there is no assurance that other new products developed by us or any manufacturers that we might acquire will qualifybe eligible for expedited510(k) clearance rather than undergoing a more time consuming pre-market approval procedure or that, in any case, they will receive clearance or approval from the FDA. For example, in 2022, we acquired Smiths Medical, which has marketed its PORT-A-CATH implantable access systems pursuant to PMA approval. FDA regulatory processes are time consuming and expensive. Uncertainties as to the time required to obtain FDA clearances or approvals could adversely affect the timing and expense of new product introductions.


The regulations to which we are subject are complex and have tended to become more stringent over time. Regulatory changes could result in restrictions on our ability to continue or expand our operations, higher than anticipated costs, or lower

than anticipated sales. The FDA enforces these regulatory requirements through periodic unannounced inspections. We do not know whether we will pass any future FDA inspections. Even after we have obtained the proper regulatory clearance or approval to market a product, we have ongoing responsibilities under FDA regulations and applicable foreign laws and regulations. The FDA, state and foreign regulatory authorities have broad enforcement powers.

We do not know whether we will pass or be found compliant in any future inspections by FDA or other regulatory authorities. Our failure to comply with applicable regulatory requirements could result in enforcement action by the FDA, state or foreign regulatory authorities which may include any of the following sanctions:


untitled letters or warning letters;
fines, injunctions, consent decrees and civil penalties;
recalls, termination of distribution, administrative detention, or seizure of our products;
customer notifications or repair, replacement or refunds;
operating restrictions or partial suspension or total shutdown of production;
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delays in or refusal to grant our requests for future 510(k) clearances, PMA approvals or foreign regulatory approvals of new products, new intended uses, or modifications to existing products;
withdrawals or suspensions of current 510(k) clearances or PMAs or foreign regulatory approvals, resulting in prohibitions on sales of our products;
FDA refusal to issue certificates to foreign governments needed to export products for sale in other countries; and
criminal prosecution.


The FDA’sFDA's and other regulatory authorities’authorities' policies may change and additional government regulations may be enacted that could prevent, limit or delay regulatory approval or certification of our product candidates. We cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation or administrative action, either in the U.S. or abroad. For example, certain policies of the Trump Administration may impact our business and industry.  Namely, the Trump Administration has taken several executive actions, including the issuance of a number of Executive Orders, that could impose significant burdens on, or otherwise materially delay, FDA’s ability to engage in routine regulatory and oversight activities such as implementing statutes through rulemaking, issuance of guidance, and review and approval of marketing applications.  It is difficult to predict how these requirement will be implemented, and the extent to which they will impact the FDA’s ability to exercise its regulatory authority.  If these executive actions impose constraints on FDA’s ability to engage in oversight and implementation activities in the normal course, our business may be negatively impacted.


In addition, 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 future products under development. For example, in November 2018, FDA officials announced forthcoming steps that the FDA intendsintended to take to modernize the premarketpre-market notification pathway under Section 510(k) of the FDC Act. Among other things, the FDA announced that it plansplanned to develop proposals to drive manufacturers usingutilizing the 510(k) pathway toward the use of newer predicates. These proposals includeincluded plans to potentially sunset certain older devices that were used as predicates under the 510(k) clearance pathway, and to potentially publish a list of devices that have been cleared on the basis of demonstrated substantial equivalence to predicate devices that are more than 10 years old. The FDA also announced that it intends to finalize guidance to establish a premarket review pathway for “manufacturers of certain well-understood device types” as an alternative to the 510(k) clearance pathway and that such premarket review pathway would allow manufacturers to rely on objective safety and performance criteria recognized by the FDA to demonstrate substantial equivalence, obviating the need for manufacturers to compare the safety and performance of their medical devices to specific predicate devices in the clearance process.These proposals have not yet been finalized or adopted, and the FDA announced that it would seek public feedback prior to publication of any such proposals, and may work with Congress to implement such proposals through legislation. Accordingly, it is unclear the extent to which any proposals, if adopted, could impose additional regulatory requirements on us that could delay our ability to obtain new 510(k) clearances, increase the costs of compliance, or restrict our ability to maintain our current clearances, or otherwise create competition that may negatively affect our business.


ModificationsMore recently, in September 2019, the FDA issued revised final guidance describing an optional "safety and performance based" pre-market review pathway for manufacturers of "certain, well-understood device types" to demonstrate substantial equivalence under the 510(k) clearance pathway by demonstrating that such device meets objective safety and performance criteria established by the FDA, thereby obviating the need for manufacturers to compare the safety and performance of their medical devices to specific predicate devices in the clearance process. The FDA maintains a list of device types appropriate for the "safety and performance based pathway" and continues to develop product-specific guidance documents that identify the performance criteria for each such device type, as well as recommended testing methods, where feasible. The FDA may establish performance criteria for classes of devices for which we or our competitors seek or currently have received clearance, and it is unclear the extent to which such performance standards, if established, could impact our ability to obtain new 510(k) clearances or otherwise create competition that may negatively affect our business.

In addition, FDA and foreign regulations and guidance are often revised or reinterpreted by the FDA and foreign counterparts in ways that may significantly affect our business and our products. Any new statutes, regulations or revisions or reinterpretations of existing regulations may impose additional costs or lengthen review times of any future products or make it more difficult to obtain clearance, approval, or certification to manufacture, market or distribute our products. We cannot determine what effect changes in regulations, statutes, legal interpretation or policies, when and if promulgated, enacted or adopted may have on our business in the future. Such changes could, among other things, require: additional testing prior to obtaining clearance, approval, or certification; changes to manufacturing methods; recall, replacement or discontinuance of our products; or additional record keeping.

For instance, the EU landscape concerning medical devices recently evolved. On May 25, 2017, the EU Medical Devices Regulation entered into force, which repeals and replaces the EU Medical Devices Directive. Unlike directives, which must be implemented into the national laws of the EU member states, regulations are directly applicable (i.e., without the need for adoption of EU member state laws implementing them) in all EU member states and are intended to eliminate current differences in the regulation of medical devices among EU member states. Devices lawfully placed on the market pursuant to the EU Medical Devices Directive prior to May 26, 2021 may generally continue to be made available on the market or put into service until May 26, 2025, provided that the requirements of the transitional provisions are fulfilled. In particular, the certificate in question must still be valid. However, even in this case, manufacturers must comply with a number of new or reinforced requirements set forth in the EU Medical Devices Regulation with regard to registration of economic operators and of devices, post-market surveillance, market surveillance and vigilance requirements.

Subject to the transitional provisions and in order to sell our products in EU member states, our products must comply with the general safety and performance requirements of the EU Medical Devices Regulation, which repeals and replaces EU
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Medical Devices Directive. Compliance with these requirements is a prerequisite to be able to affix the CE mark to our products, without which they cannot be sold or marketed in the EU. See – Government Regulation. To demonstrate compliance with the general safety and performance requirements, we must undergo a conformity assessment procedure, which varies according to the type of medical device and its (risk) classification. Except for low risk medical devices (Class I), where the manufacturer can self-assess the conformity of its products with the general safety and performance requirements (except for any parts which relate to sterility, metrology or reuse aspects), a conformity assessment procedure requires the intervention of a notified body. The notified body would typically audit and examine the technical file and the quality system for the manufacture, design and final inspection of our devices. If satisfied that the relevant product conforms to the relevant general safety and performance requirements, the notified body issues a certificate of conformity, which the manufacturer uses as a basis for its own declaration of conformity. The manufacturer may require usthen apply the CE mark to obtain new clearances or approvals,the device, which allows the device to be placed on the market throughout the EU. If we fail to comply with applicable laws and ifregulations, we market modified products without obtaining necessary clearances or approvals, we maywould be requiredunable to cease marketing or recallaffix the modified products until required approvals are obtained.

Certain modifications to a cleared or approved device may require a new clearance or approval, or alternatively a notification or other submission to FDA. The FDA may not agree with our decisions regarding whether a new regulatory submission is necessary. We may make modificationsCE mark to our approved devicesproducts, which would prevent us from selling them within the EU.

The aforementioned EU rules are generally applicable in the future that we believe do not require a new clearance or approval. IfEEA. Non-compliance with the FDA disagrees with our determination and requiresabove requirements would also prevent us to submit a new submission for modifications to our previously approved products, we may be required to cease marketing or to recall the modified product until we obtain approval, and we may be subject to significant regulatory fines or penalties. In addition, the FDA may not clear or approvefrom selling our products for the indications that are necessary or desirable for successful commercialization, or could requirein these three countries.


clinical trials to support any modifications. Any delay or failure in obtaining required approvals would adversely affect our ability to introduce new or enhanced products in a timely manner, which in turn would harm our future growth.

If we or our component manufacturers fail to comply with the FDA's Quality System Regulation or Good Manufacturing Practice regulations or other requirements, our manufacturing operations could be interrupted, and our product sales and operating results could suffer.


We and some of our component manufacturers are required to comply with regulatory requirements known as the FDA's Quality System Regulation, or QSR, a complex regulatory scheme which covers the procedures and documentation of the design, testing, production, control, quality assurance, inspection, complaint handling, recordkeeping, management review, labeling, packaging, sterilization, storage and shipping of our device products. The FDA's current Good Manufacturing Practices, or cGMPs apply to the manufacture of medical device components and finished medical devices. The FDA audits compliance with these regulatory requirements through periodic announced and unannounced inspections of manufacturing and other facilities. The FDA may conduct inspections or audits at any time, and we and some of our component suppliers are subject to such inspections. Although we believe our manufacturing facilities and those of our critical component suppliers are in compliance with the QSR requirements, and with applicable cGMPs for our products, we cannot provide assurance that any future inspection will not result in adverse findings. For example, on October 1, 2021, Smiths Medical received a Warning Letter from the FDA following an inspection of Smiths Medical’s Minneapolis, Minnesota Facility on March 30, 2021. The Warning Letter cited, among other things, failures to comply with FDA's medical device reporting requirements and failures to comply with applicable portions of the QSR. Although we believe Smiths Medical will be able to successfully resolve the issues identified in the Warning Letter, there is no guarantee that Smiths Medical will be able to do so in a timely manner or that similar compliance issues will not be identified in a future FDA inspection.

If our manufacturing facilities or those of any of our component suppliers are found to be in violation of applicable laws and regulations, or we or our suppliers have significant noncompliance issues or fail to timely and adequately respond to any adverse inspectional observations or product safety issues, or if any corrective action plan that we or our suppliers propose in response to observed deficiencies is not sufficient, the FDA or foreign regulatory authorities could take enforcement action, including any of the following sanctions:


untitled letters or warning letters;
fines, injunctions, consent decrees and civil penalties;
customer notifications or repair, replacement, refunds, recall, detention or seizure of our products;
operating restrictions or partial suspension or total shutdown of production;
refusing or delaying our requests for clearance or approval or certifications of new products or modified products;
withdrawing clearances, approvals, or approvalscertifications that have already been granted;
refusal to grant export approval for our products; or
criminal prosecution.


Any of these sanctions could adversely affect our business, financial conditions and operating results.


To market our products in the European Community (“EC”),EU, we must conform to additional requirements of the EC and demonstrate conformance to establishedharmonized quality standards. A notified body would typically audit and examine a product's technical dossiers and the manufacturers' quality system (the notified body must presume that quality systems which implement the relevant harmonized standards and applicable directives. As a manufacturer that designs, manufactures and markets its own devices, we must comply with the quality management standards of– which is ISO 13485 (2012)13485:2016 for Medical Devices Quality Management Systems – conform to these requirements). Those quality standards are similarSubject to the FDA’s Quality System Regulations. Manufacturerstransitional provisions, manufacturers of medical devices must also be in conformancecomply with EC Directives such as Council Directive 93/42/EEC (“the EU Medical Device Directive”) and their applicable annexes. Those regulationsDevices
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Regulation. Compliance with these requirements assure that medical devices are both safe and effective and do not compromise the clinical condition or safety of patients, or the safety and health of users and – where applicable – other persons and meet all applicable established standards prior to being marketed in the EC. Once a manufacturer and its devices are in conformance with the Medical Device Directive, the “CE” Mark maybe affixed to its devices. The CE Mark gives devices an unobstructed entry to all the member countries of the EC.EU. There is no assurance that we will continue to meet the requirements for distribution of our products in Europe.


In May 2017,addition, the EU Medical DeviceDevices Regulation, entered into force to replaceamong other things:

strengthens the rules on placing devices on the market (e.g. reclassification of certain devices and wider scope than the EU Medical Device Directive, as amended. The Medical Device Regulation will apply after a three-year transition periodDevices Directive) and imposes stricter requirementsreinforces surveillance once they are available;
establishes explicit provisions on manufacturers' responsibilities for the marketingfollow-up of the quality, performance and salesafety of devices placed on the market;
establishes explicit provisions on importers' and distributors' obligations and responsibilities;
imposes an obligation to identify a responsible person who is ultimately responsible for all aspects of compliance with the requirements of the new regulation;
improves the traceability of medical devices throughout the supply chain to the end-user or patient through the introduction of a unique identification number, to increase the ability of manufacturers and grants EU Notified Bodies increased post-market surveillance authority. Weregulatory authorities to trace specific devices through the supply chain and to facilitate the prompt and efficient recall of medical devices that have been found to present a safety risk;
sets up a central database (Eudamed) to provide patients, healthcare professionals and the public with comprehensive information on products available in the EU; and
strengthens rules for the assessment of certain high-risk devices, such as implants, which may have to undergo a clinical evaluation consultation procedure by experts before they are placed on the market.

    As a result of these new requirements, we may be subject to risks associated with additional testing, modification, certification, or amendment of our existing market authorizations,certifications, or we may be required to modify products already installed at our customers’customers' facilities to comply with the official interpretations of these revised regulations.the EU Medical Devices Regulation.


Distribution of our products in other countries may be subject to regulation in those countries, and there is no assurance that we will obtain necessary approvals or certifications in countries in which we want to introduce our products.



The misuse or off-label use of our products may harm our reputation in the marketplace, result in injuries that lead to product liability suits or result in costly investigations, fines or sanctions by regulatory bodies if we are deemed to have engaged in the promotion of these uses, any of which could be costly to our business.


Our products have been cleared, approved or approvedcertified by the FDA, foreign regulatory authorities and notified bodies for specific indications.indications of use. We train our marketing personnel and direct sales force to not promote our products for uses outside of the FDA-cleared or approved indications for use, known as “off-label"off-label uses." We cannot, however, prevent a physician from using our products off-label, when in the physician’sphysician's independent professional medical judgment he or she deems it appropriate. There may be increased risk of injury to patients if physicians attempt to use our products off-label. Furthermore, the use of our products for indications other than those cleared or approved by the FDA or approved by any foreign regulatory body may not effectively treat such conditions, which could harm our reputation in the marketplace among physicians and patients.


If the FDA or any foreign regulatory body determinesauthorities determine that our promotional materials or training constitute promotion of an off-label use, it could request that we modify our training or promotional materials or subject us to regulatory or enforcement actions, including the issuance or imposition of an untitled letter, which is used for violators that do not necessitate a warning letter, injunction, seizure, civil fine or criminal penalties. It is also possible that other federal, state or foreign enforcement authorities might take action under other regulatory authority, such as false claims laws, if they consider our business activities to constitute promotion of an off-label use, which could result in significant penalties, including, but not limited to, criminal, civil and administrative penalties, damages, fines, disgorgement, exclusion from participation in government healthcare programs and the curtailment of our operations.


In addition, physicians may misuse our products or use improper techniques if they are not adequately trained, potentially leading to injury and an increased risk of product liability. If our products are misused or used with improper technique, we may become subject to costly litigation by our customers or their patients. As described above,

Litigation, product liability claims could divert management’s attention from our core business, be expensive to defend and result in sizeable damage awards against us that may not be covered by insurance.

Product liability claimsor product recalls could be costly to defend and could expose us to loss.

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The use of our products exposes us to an inherent risk of product liability. TheFurther, the medical device industry has historically been subject to extensive litigation over product liability claims, and we cannot offer any assurance that we will not face product liability suits.or other suits in the future. Patients, healthcare workers, healthcare providers or others who claim that our products have resulted in injury could initiate product liability litigation seeking large damage awards against us. Costs of the defense of such litigation, even if successful, could be substantial. We maintain insurance against product liability and defense costs in the amount of $10,000,000$40 million per occurrence. There is no assuranceHowever, legal proceedings are inherently unpredictable, and the outcome can result in judgments that affect how we will successfully defendoperate our business, or we may enter into settlements of claims for monetary damages that exceed our insurance coverage, if any arising with respect to products or that the insurance we carry will be sufficient.is available. A successful claim against us in excess of insurance coverage could materially and adversely affect us, and result in substantial liabilities and reputational harm. Furthermore, there is no assurance thatharm including product liability insurance will continue to be available to us on acceptable terms.

In addition, regardlessrecalls or withdrawals from the market, withdrawal of merit or eventual outcome, product liability claims may result in:

costs of litigation;
distraction of management’s attention from our primary business;
clinical trial participants, the inability to commercialize our existing or new products;
products, distraction of management’s attention from our primary business or decreased demand for our products or, if cleared or approved, products in development;development.
damage to our business reputation;
product recalls or withdrawals from the market;
withdrawal of clinical trial participants;
substantial monetary awards to patients or other claimants; or
loss of revenue.


While we may attempt to manage our product liability exposure by proactively recalling or withdrawing from the market any defective products, any recall or market withdrawal of our products may delay the supply of those products to our customers and may impact our reputation. We can provide no assurance that we will be successful in initiating appropriate market recall or market withdrawal efforts that may be required in the future or that these efforts will have the intended effect of preventing product malfunctions and the accompanying product liability that may result. Such recalls and withdrawals may also be used by our competitors to harm our reputation for safety or be perceived by patients as a safety risk when considering the use of our products, either of which could have a material adverse effect on our business, financial condition and results of operations.


Additionally, we generally offer a limited warranty for product returns which are 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 incur costssignificantly exceed the amount of our reserves. If we underestimate our potential liability for future product returns, or losses relating to other litigation.

We may from time to time be involved in litigation. Legal proceedings are inherently unpredictable, and the outcome canif unanticipated events result in judgments that affect how we operate our business, or we may enter into settlements of claims for monetary damagesreturns that exceed our insurance coverage, if any is available. Any such proceedings, regardless of merits, may result in substantial costs, the diversion of management's attention from other business concerns and additional restrictions on our business, which could disrupt our business and have an adverse effect onhistorical experience, our financial condition.condition and operating results could be materially and adversely affected.


Our products may cause or contribute to adverse medical events or be subject to failures or malfunctions that we are required to report to the FDA and foreign regulatory authorities, and if we fail to do so, we would be subject to sanctions that could harm our reputation, business, financial condition and results of operations. The discovery of serious safety issues with our products, or a recall of our products either voluntarily or at the direction of the FDA or another governmental authority, could have a negative impact on us.


We are subject to the FDA’sFDA's medical device reporting regulations and similar foreign regulations, which require us to report to the FDA and foreign regulatory authorities when we receive or become aware of information that reasonably suggests that one or more of our products may have caused or contributed to a death or serious injury or malfunctioned in a way that, if the malfunction were to recur, it could cause or contribute to a death or serious injury. The timing of our obligation to report is triggered by the date we become aware of the adverse event as well as 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 removed in time from the use of the product. If we fail to comply with our reporting obligations, the FDA or foreign regulatory authorities could take action, including warning letters, untitled letters, administrative actions, criminal prosecution, imposition of civil monetary penalties, revocation of our device clearances or approvals, seizure of our products or delay in clearance, approval, or approvalcertification of future products.


The FDA and foreign regulatory bodies have the authority to require the recall of commercialized products in the event of material deficiencies or defects in design or manufacture of a product or in the event that a product poses an unacceptable risk to health. The FDA’s authority to require a recall must be based on a finding that there is reasonable probability that the device could cause serious injury or death. We may also choose to voluntarily recall a product if any material deficiency is found. A government-mandated or voluntary recall by us could occur as a result of an unacceptable risk to health, component failures, malfunctions, manufacturing defects, labeling or design deficiencies, packaging defects or other deficiencies or failures to comply with applicable regulations. Product defects or other errors may occur in the future. For example, on June 26, 2020, Smiths Medical ASD initiated Class 1 recalls of a Medfusion Syringe Pump. Although we plan to work with the FDA to complete the Class 1 recall, and ultimately close, this product recall, we can provide no assurance that we will be able to do so

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in a timely manner, or at all. In addition, the costs associated with conducting and closing this recall, including any liabilities we may incur, could have a material adverse effect on our business, financial condition and results of operations.

Depending on the corrective action we take to redress a product’sproduct's deficiencies or defects, the FDA or foreign regulatory agencies may require, or we may decide, that we will need to obtain new clearances, approvals or approvalscertifications for the device before we may market or distribute the corrected device. Seeking such clearances, approvals or approvalscertifications may delay our ability to replace the recalled devices in a timely manner. Moreover, if we do not adequately address problems associated with our devices, we may face additional regulatory enforcement action, including FDA or foreign regulatory authorities warning letters, product seizure, injunctions, administrative penalties or civil or criminal fines.


Companies are required to maintain certain records of recalls and corrections, even if they are not reportable to the FDA.FDA or foreign regulatory authorities. We may initiate voluntary withdrawals or corrections for our products in the future that we determine do not require notification of the FDA.FDA or foreign regulatory authorities. If the FDA disagreesor foreign regulatory authorities disagree with our determinations, it could require us to report those actions as recalls and we may be subject to enforcement action. A future recall announcement could harm our reputation with customers, potentially lead to product liability claims against us and negatively affect our sales. Any corrective action, whether voluntary or involuntary, as well as defending ourselves in a lawsuit, will require the dedication of our time and capital, distract management from operating our business and may harm our reputation and financial results.

We may be required to implement a costly product recall.

In the event that any of our products proves to be defective, we can voluntarily recall, or the FDA or other regulatory agencies could require us to redesign or implement a recall of, any of our products.  We believe that any recall could result in significant costs to us and significant adverse publicity, which could harm our ability to market our products in the future. Though it may not be possible to quantify the economic impact of a recall, it could have a material adverse effect on our business, financial condition and results of operations.

We generally offer a limited warranty for product returns which are 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 and adversely affected.


Geographic Risks

We are subject to risks associated with doing business outside of the U.S.

We operate in a global market and global operations are subject to a number of risks.  Sales to customers outside of the U.S. made up approximately 25% of our revenue in 2018 and as our operations and sales located in Europe and other areas outside the U.S. increase, we may face new challenges and uncertainties, although we can give no assurance that such operations and sales will increase. In June 2016, the United Kingdom held a referendum in which voters approved an exit from the European Union (the “EU”), commonly referred to as “Brexit.” Until the terms of the UK’s exit from the EU are determined, including any transition period, it is difficult to predict its impact. It is possible that the withdrawal could, among other things, affect the legal and regulatory environments to which our businesses are subject, impact trade between the United Kingdom and the EU and other parties and create economic and political uncertainty in the region.

The risks associated with our operations outside the U.S. also include:

healthcare reform legislation;
changes in medical reimbursement policies and programs;
changes in non-U.S. government programs;
multiple non-U.S. regulatory requirements that are subject to change and that could restrict our ability to manufacture and sell our products;
possible failure to comply with anti-bribery laws such as the U.S. Foreign Corrupt Practices Act and similar anti-bribery laws in other jurisdictions;
different local medical practices, product preferences and product requirements;
possible failure to comply with trade protection and restriction measures and import or export licensing requirements;
difficulty in establishing, staffing and managing non-U.S. operations;
different labor regulations or work stoppages or strikes;
changes in environmental, health and safety laws;
potentially negative consequences from changes in or interpretations of tax laws, including changes regarding taxation of income earned outside the U.S.;
political instability and actual or anticipated military or political conflicts;
economic instability, including the European financial crisis or other economic instability in other parts of the world and the impact on interest rates, inflation and the credit worthiness of our customers;
uncertainties regarding judicial systems and procedures;
minimal or diminished protection of intellectual property in some countries;
imposition of government controls; and
regulatory changes that may place our products at a disadvantage.

These risks, individually or in the aggregate, could have an adverse effect on our results of operations and financial condition. The occurrence or allegation of these types of risks may adversely affect our business, performance, prospects, value, financial condition, and results of operations.


Any significant changes in U.S. trade, tax or other policies that restrict imports or increase import tariffs could have a material adverse effect on our results of operations.


A significant amount of our products are manufactured outside of the U.S. The U.S. government has recently initiated substantial changes in U.S. trade policy and U.S. trade agreements, including the initiation of tariffs on certain foreign goods. In response to these tariffs, certain foreign governments, including China, have instituted or are considering imposing tariffs on certain U.S. goods. For example, in 2018, the U.S. imposed tariffs on steel and aluminum as well as on goods imported from China and certain other countries, which has resulted in retaliatory tariffs by China and other countries. Additional tariffs imposed by the U.S. on a broader range of imports, or further retaliatory trade measures taken by other countries in response, could prevent or make it difficult for us to obtain the components needed for new products which would affect our sales. Increased tariffs would require us to increase our prices which likely would decrease customer and consumer demand for our products. Additionally, we are subject to income taxes in the U.S. and numerous foreign jurisdictions. Any significant changes in current U.S. trade, tax or other policies could have a material adverse effect upon our results of operations.



International sales pose additional risks related to competition with larger international companies and established local companies and our possibly higher cost structure.


We have undertaken an initiative to increase our international sales, and have distribution arrangements in all the principal countries in Western Europe, the Pacific Rim, Middle East, Latin America, Canada and South Africa. We plan to sell in most other areas of the world. We export most of our products sold internationally from the U.S. and Mexico. Our principal competitors in international markets consist of much larger companies as well as smaller companies already established in the countries into which we sell our products. Our cost structure is often higher than that of our competitors because of the relatively high cost of transporting product to some local markets as well as our competitors’ lower local labor costs in some markets.


Our international sales are subject to higher credit risks than sales in the U.S..U.S. Many of our distributors are small and may not be well capitalized. Payment terms are relatively long. The European hospitals tend to be significantly slower in payment which has resulted in an increase to our days sales outstanding from previous years. Our prices to our international distributors, outside of Europe, for product shipped to the customers from the U.S., Costa Rica or Mexico are generally denominated in U.S. dollars, but their resale prices are set in their local currency. A decline in the value of the local currency in relation to the U.S. dollar may adversely affect their ability to profitably sell in their market the products they buy from us, and may adversely affect their ability to make payment to us for the products they purchase. Legal recourse for non-payment of indebtedness may be uncertain. These factors all contribute to a potential for credit losses.


We are increasingly dependent on manufacturing in Mexico, and could be adversely affected by increased labor costs and any economic, social or political disruptions.


We continue to expand our production in Mexico.
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Most of the material we use in manufacturing is imported into Mexico, and substantially all of the products we manufacture in Mexico are exported.

Business activity in the Ensenada area has expanded significantly, providing increased employment opportunities. This could have an adverse effect on our ability to hire or retain necessary personnel and result in an increase in labor rates. We continue to take steps to compete for labor through attractive employment conditions and benefits, but there is no assurance that these steps will continue to be successful or that we will not face increasing labor costs in the future.


Any political or economic disruption in Mexico or a change in the local economies could have an adverse effect on our operations. We depend on our ability to move goods across borders quickly, and any disruption in the free flow of goods across national borders could have an adverse effect on our business. Additionally, political and social instability resulting from violence in certain areas of Mexico has raised concerns about the safety of our personnel.  These concerns may hinder our ability to send domestic personnel abroad and to hire and retain local personnel.  Such concerns may require us to conduct more operations from the U.S. rather than Mexico, which may negatively impact our operations and result in higher costs and inefficiencies.


Our operations may be adversely impacted by our exposure to risks related to foreign currency exchange rates.


We market our products in certain foreign markets through our subsidiaries and other international distributors. The related sales agreements may provide for payments in a foreign currency. Accordingly, our operating results are subject to fluctuations in foreign currency exchange rates. When the U.S. dollar weakens against these currencies, the dollar value of foreign-currency denominated revenue and expense increases, and when the dollar strengthens against these currencies, the dollar value of foreign-currency denominated revenue and expense decreases. We are exposed to foreign currency risk on outstanding foreign currency denominated receivables and payables. Changes in exchange rates may adversely affect our results of operations. Our primary foreign currency exchange rate exposures are currently with the Euro, Mexican Peso, Costa Rican Colón, and the Canadian Dollar against the U.S. dollar. The withdrawal ofDisruptions in the UK from the EUfinancial markets could also, among other things, create volatility in currency exchange rates.


We currently do not hedge against our foreign currency exchange rate risks, other than certain exposures related to the Mexican Peso and therefore believe our exposure to these risks may be higher than if we entered into hedging transactions, including forward exchange contracts or similar instruments. If we decide in the future to enter into forward foreign exchange contracts to attempt to reduce the risk related to foreign currency exchange rates, these contracts may not mitigate the potential adverse impact on our financial results due to the variability of timinglimitations and amount of payments under these contracts.difficulty forecasting future activity. In addition, these types of contracts may themselves cause financial harm to us and have inherent levels of counter-party risk over which we would have no control. During 2021, we recorded $1.0 million in foreign exchange losses due to the volatility of foreign exchange rates as a result of continued uncertainty caused by the ongoing COVID-19 pandemic.



We could be adversely affected by violations of the U.S. Foreign Corrupt Practices Act and other worldwide anti-bribery laws.


The Foreign Corrupt Practices Act and anti-bribery laws in other jurisdictions generally prohibit companies and their intermediaries from making improper payments for the purpose of obtaining or retaining business or other commercial advantage. Our policies mandate compliance with these anti-bribery laws, which often carry substantial penalties, including criminal and civil fines, potential loss of export licenses, possible suspension of the ability to do business with the federal government, denial of government reimbursement for products and exclusion from participation in government healthcare programs. We operate in jurisdictions that have experienced governmental and private sector corruption to some degree, and, in certain circumstances, strict compliance with anti-bribery laws may conflict with certain local customs and practices. We cannot assure that our internal control policies and procedures always will protect us from reckless or other inappropriate acts committed by our affiliates, employees, distributors or other agents. Violations of these laws, or allegations of such violations, could have a material adverse effect on our business, financial position and results of operations.


ChangesGeneral Risk Factors

We are subject to risks associated with doing business outside of the U.S.

We operate in tax lawsa global market and unanticipated tax liabilitiesglobal operations are subject to a number of risks. Sales to customers outside of the U.S. made up approximately 28% of our revenue in 2021 and as our operations and sales located in Europe and other areas outside the U.S. increase, we may face new challenges and uncertainties, although we can give no assurance that such operations and sales will increase.

The risks associated with our operations outside the U.S. also include:
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economic and political uncertainty;
changes in non-U.S. government programs;
multiple non-U.S. regulatory requirements that are subject to change and that could restrict our ability to manufacture and sell our products;
different local medical practices, product preferences and product requirements;
possible failure to comply with trade protection and restriction measures and import or export licensing requirements;
difficulty in establishing, staffing and managing non-U.S. operations;
different labor regulations or work stoppages or strikes;
political instability and actual or anticipated military or political conflicts;
economic instability, including the European financial crisis or other economic instability in other parts of the world and the impact on interest rates, inflation and the credit worthiness of our customers;
uncertainties regarding judicial systems and procedures;
minimal or diminished protection of intellectual property in some countries;
natural disasters or outbreak of diseases (including COVID-19); and
imposition of government controls.

These risks, individually or in the aggregate, could have an adverse effect on our results of operations and financial condition. The occurrence or allegation of these types of risks may adversely affect the Company's effective income tax rateour business, performance, prospects, value, financial condition, and profitability.results of operations.


The Company is subject to income taxes in the United States and numerous foreign jurisdictions. Although comprehensive U.S. tax legislation commonly referred to as the Tax Cuts and Jobs Act (“the Tax Act”) enacted in December 2017 lowered the U.S. corporate income tax rate to 21%, the Company's effective income tax rate in the future couldOur operating results may be adversely affected by a number of factors, including: changesunfavorable economic conditions that affect our customers’ ability to buy our products and could affect our relationships with our suppliers.

Disruptions in the mix of earnings in countries with differing statutory tax rates, changes in the valuation of deferred tax assetsfinancial markets worldwide and liabilities, changes in tax lawsother worldwide macro-economic challenges may cause our customers and suppliers to experience cash flow concerns. If job losses and the outcomeresulting loss of income tax audits in various jurisdictions aroundhealth insurance and personal savings cause individuals to forego or postpone treatment, the world. The Company regularly assesses allresulting decreased hospital use could affect the demand for our products. As a result, customers may modify, delay or cancel plans to purchase our products and suppliers may increase their prices, reduce their output or change terms of these matterssales. Additionally, if customers’ or suppliers’ operating and financial performance deteriorates, or if they are unable to determine the adequacymake scheduled payments or obtain credit, customers may not be able to pay, or may delay payment of, its tax provision, which is subjectaccounts receivable owed to significant discretion.

The Tax Act is unclear in certain respectsus and could be subjectsuppliers may impose different payment terms. Any inability of current and/or potential customers to potential amendments and technical corrections, as well as interpretations and implementing regulationspay us for our products or any demands by the Treasury and Internal Revenue Service (IRS), any of which could lessen or increase certain adverse impacts of the legislation. In addition, it is unclear how these U.S. federal income tax changes will affect state and local taxation, which often uses federal taxable income as a starting pointsuppliers for computing state and local tax liabilities. While some of the changes made by the tax legislationdifferent payment terms may adversely affect the Company in one or more reporting periodsour earnings and prospectively, other changes may be beneficial on a going forward basis.cash flow.


ITEM 1B. UNRESOLVED STAFF COMMENTS
 
None




ITEM 2. PROPERTIES


Our material properties used by us in connection with our corporate headquartersadministrative operations, manufacturing, distribution, research and the locationsdevelopment and uses of our principal manufacturing and other propertiesservice centers as of December 31, 2018,2021, are as follows:

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LocationApproximate Square FootagePrimary UseOwned/Leased
San Clemente, California, U.S.39,000Corporate Headquarters and R&DOwned
San Clemente, California, U.S.28,108Corporate HeadquartersLeased
San Diego, California, U.S.44,779Corporate Offices and R&DLeased
Lake Forest, Illinois, U.S.137,498Corporate OfficesLeased
Houten, Netherlands7,341Corporate OfficesLeased
Montreal, Canada16,414Corporate Offices/Device service centerLeased
Chennai, India36,879R&DLeased
Rydalmere, NSW Australia14,735Corporate Offices/Device service centerLeased
LocationApproximate Square FootagePrimary UseOwned/Leased
San Clemente, California, U.S.39,000Corporate Headquarters and R&DOwned
San Clemente, California, U.S.28,108Corporate HeadquartersLeased
San Diego, California, U.S.44,779Corporate Offices and R&DLeased
Lake Forest, Illinois, U.S.137,498Corporate OfficesLeased
Montreal, Canada48,065Corporate OfficesLeased
Chennai, India36,879Corporate OfficesLeased
Rydalmere, NSW Australia14,735Corporate Offices/Device service centerLeased
Austin, Texas, U.S.594,602ManufacturingOwned
Ensenada, Baja California, Mexico265,021ManufacturingOwned
La Aurora, Costa Rica626,869ManufacturingOwned
Salt Lake City, Utah, U.S.450,000ManufacturingOwned
Farmers Branch,Round Rock, Texas, U.S.66,06071,960Distribution WarehouseWarehouse/ManufacturingOwned
Dallas, Texas, U.S.610,806Distribution WarehouseLeased
King of Prussia, Pennsylvania, U.S.105,571Distribution WarehouseOwned
Round Rock, Texas, U.S.71,960Distribution WarehouseOwned
Santa Fe Springs, California, U.S.76,794Distribution WarehouseOwned
San Jose, California, U.S.Sligo, Ireland78,11926,000Device service centerLeased
Sligo, Ireland26,000Device service centerLeased


In addition to the above, we own and lease additional office and building space, research and development, and sales and support offices primarily in North America, Europe, South America, and Asia. We believe our existing facilities, both owned and leased, are in good condition and suitable for the conduct of our business.


ITEM 3. LEGAL PROCEEDINGS


Certain legal proceedings in which we are involved are discussed in Part II, Item 8. "Financial Statements and Supplementary Data" of this Annual Report on Form 10-K in Note 15. Commitments and Contingencies to the Consolidated Financial Statements, and is incorporated herein by reference.


ITEM 4. MINE SAFETY DISCLOSURES


Not applicable.


PART II



ITEM 5. MARKET FOR REGISTRANT'S COMMON EQUITY, RELATED STOCKHOLDER MATTERS, AND ISSUER PURCHASES OF EQUITY SECURITIES


Market Information for Common Stock
 
Our common stock has been traded on the NASDAQ Global Select Market under the symbol “ICUI” since our initial public offering on March 31, 1992. The following table sets forth, for the quarters indicated, the high and low sales price per share for our common stock quoted by NASDAQ: 
2018 High Low
First quarter $265.27
 $211.25
Second quarter $313.20
 $241.05
Third quarter $321.70
 $263.26
Fourth quarter $286.28
 $210.94
2017 High Low
First quarter $159.95
 $127.00
Second quarter $175.73
 $144.25
Third quarter $188.85
 $164.00
Fourth quarter $225.38
 $180.45


Dividends
 
We have never paid dividends and do not anticipate paying dividends in the foreseeable future as the Board of Directors intends to retain future earnings for use in our business to pay down our long-term debt or to purchase our
40


shares. Any future determination as to payment of dividends or purchase of our shares will depend upon our financial condition, results of operations and such other factors as the Board of Directors deems relevant.


Stockholders
 
As of January 31, 2019,2022, we had 12848 stockholders of record. This does not include persons whose stock is in nominee or “street name” accounts through brokers.


Securities authorized for issuance under equity compensation plans are discussed in Part III, Item 12 of this Annual Report on Form 10-K.



Issuer Repurchase of Equity Securities
 
The following is a summary of our stock repurchasing activity during the fourth quarter of 2018:2021:
Period 
Shares
purchased
 
Average
price paid
per share
 
Shares
purchased
as part of a
publicly
announced
program
 
Approximate
dollar value that
may yet be
purchased
under the
program(1)
10/01/2018 - 10/31/2018 
 $
 
 $7,169,000
11/01/2018 - 11/30/2018 
 $
 
 7,169,000
12/01/2018 - 12/31/2018 
 $
 
 7,169,000
Fourth quarter 2018 total 
 $
 
 $7,169,000
____________________________
(1)
Period
Shares
purchased
Average
price paid
per share
Shares
purchased
as part of a
publicly
announced
program
Our common stock purchase plan, which authorizedApproximate
dollar value that
may yet be
purchased
under the repurchase of up to $40.0
program(1)
10/01/2021 - 10/31/2021— $— — $100,000,000 
11/01/2021 - 11/30/2021— $— — $100,000,000 
12/01/2021 - 12/31/2021— $— — $100,000,000 
Fourth quarter 2021 total— $— — $100,000,000 
____________________________
(1)Our common stock purchase plan, which authorized the repurchase of up to $100.0 million of our common stock, was authorized by our Board of Directors and publicly announced on July 19, 2010.  This plan has no expiration date. We are not obligated to make any purchases under our stock purchase program. Subject to applicable state and federal corporate and securities laws, purchases under a stock purchase program may be made at such times and in such amounts as we deem appropriate. Purchases made under our stock purchase program can be discontinued at any time we feel additional purchases are not warranted.


COMPARISON OF CUMULATIVE TOTAL RETURN FROM DECEMBER 31, 2013 TO DECEMBER 31, 2018 OF ICU MEDICAL, INC., NASDAQ AND NASDAQ MEDICAL SUPPLIES INDEX
The following graph shows the total stockholder return on our common stock, based on the market pricewas authorized by our Board of the commonDirectors and publicly announced in August 2019. This plan has no expiration date. We are not obligated to make any purchases under our stock from December 31, 2013purchase program. Subject to December 31, 2018applicable state and the total returns of the NASDAQ U.S. Indexfederal corporate and NASDAQ Medical Supplies Index for the same period.securities laws, purchases under a stock purchase program may be made at such times and in such amounts as we deem appropriate. Purchases made under our stock purchase program can be discontinued at any time we feel additional purchases are not warranted.


icui123120_chart-05307a03.jpg
  12/31/2013 12/31/2014 12/31/2015 12/31/2016 12/31/2017 12/31/2018
ICU Medical, Inc. $100.00
 $128.55
 $177.02
 $231.28
 $339.04
 $360.43
NASDAQ U.S. Index $100.00
 $112.46
 $113.00
 $127.70
 $155.01
 $146.57
NASDAQ Medical Supplies Index $100.00
 $120.17
 $132.87
 $141.93
 $198.67
 $213.25
Assumes $100 invested on December 31, 2013 in ICU Medical Inc.’s common stock, the NASDAQ U.S. Index and the NASDAQ Medical Supplies Index and that all dividends, if any, were reinvested.


ITEM 6. SELECTED FINANCIAL DATARESERVED
The following selected consolidated financial data (presented in thousands, except per share amounts) is derived from our Consolidated Financial Statements. During 2017, we acquired HIS (see Note 2 to the consolidated financial statements
Not applicable. See "Changes From Prior Periodic Reports" in Part II,I, Item 81 of this Annual Report on Form 10-K). During 2018, we adopted Accounting Standards Codification ("ASC") 606, Revenue from Contracts with Customers, using the modified retrospective method applied to those contracts which were not completed as of January 1, 2018. The adoption of this standard did not have a material impact on our consolidated financial statements (see Note 4 to the consolidated financial statements in Part II, Item 8 of this Form 10-K). Our historical operating results are not necessarily indicative of future operating results and should be read in conjunction with the Consolidated Financial Statements and notes thereto, and with Item 7, Management’s Discussion and Analysis of Financial Condition and Results of Operations. 10-K.

  Year ended December 31,
  (in thousands, except per share data)
  2018 2017 2016 2015 2014
INCOME DATA:  
  
  
  
  
REVENUE  
  
  
  
  
Net sales $1,400,040
 $1,292,166
 $379,339
 $341,254
 $308,770
Other 
 447
 33
 414
 490
TOTAL REVENUE 1,400,040
 1,292,613
 379,372
 341,668
 309,260
COST OF GOODS SOLD 830,012
 866,518
 177,974
 160,871
 157,859
GROSS PROFIT 570,028
 426,095
 201,398
 180,797
 151,401
Selling, general and administrative expenses 328,146
 303,953
 89,426
 83,216
 88,939
Research and development expenses 52,867
 51,253
 12,955
 15,714
 18,332
Restructuring and strategic transaction 105,390
 77,967
 15,348
 8,451
 5,093
Contract settlement 41,613
 
 
 
 
Change in fair value of contingent earn-out 20,400
 8,000
 
 
 
Gain on sale of assets 
 
 
 (1,086) 
Legal settlements 
 
 
 1,798
 
Impairment of assets held for sale 
 
 728
 4,139
 
TOTAL OPERATING EXPENSES 548,416
 441,173
 118,457
 112,232
 112,364
INCOME (LOSS) FROM OPERATIONS 21,612
 (15,078) 82,941
 68,565
 39,037
BARGAIN PURCHASE GAIN 
 70,890
 1,456
 
 
INTEREST EXPENSE (709) (2,047) (118) (39) 
OTHER INCOME (EXPENSE), net 1,471
 (2,482) 885
 1,173
 755
INCOME BEFORE INCOME TAXES 22,374
 51,283
 85,164
 69,699
 39,792
BENEFIT (PROVISION) FOR INCOME TAXES 6,419
 17,361
 (22,080) (24,714) (13,457)
NET INCOME $28,793
 $68,644
 $63,084
 $44,985
 $26,335
NET INCOME PER SHARE  
  
  
  
  
Basic $1.41
 $3.50
 $3.90
 $2.84
 $1.72
Diluted $1.33
 $3.29
 $3.66
 $2.73
 $1.68
WEIGHTED AVERAGE NUMBER OF SHARES  
  
  
  
  
Basic 20,394
 19,614
 16,168
 15,848
 15,282
Diluted 21,601
 20,858
 17,254
 16,496
 15,647
Cash dividends per share $
 $
 $
 $
 $
CASH FLOW DATA:  
  
  
  
  
Total cash flows from operations $160,215
 $154,423
 $89,941
 $64,195
 $66,340


  As of December 31,
  (in thousands)
  2018 2017 2016 2015 2014
BALANCE SHEET DATA:  
  
  
  
  
Cash, cash equivalents and short-term investment securities $382,110
 $300,133
 $445,082
 $377,397
 $346,764
Working capital $677,747
 $654,370
 $528,560
 $462,389
 $403,801
Total assets $1,585,391
 $1,496,951
 $704,688
 $626,825
 $541,102
Stockholders’ equity $1,263,655
 $1,198,254
 $660,155
 $579,871
 $508,252

ITEM 7. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS


The following discussion should be read in conjunction with our Consolidated Financial Statements and Notes thereto.


Business Overview and Highlights


During 2018, we continued to integrate Pfizer's HIS business, which we acquired on February 3, 2017. See "Acquisitions" below for additional detail regarding the acquisition. We are now one of the world's leading pure-play infusion therapy companies. We develop, manufacturecompanies with global operations and sell innovative medical products used in infusion therapy and critical care applications. Oura wide-ranging product portfolio that includes IV solutions, IV smart pumps sets, connectors, closed system transfer devices for hazardous drugs, sterile IV solutions, cardiac monitoring systems, along with pain management and safety software technology, dedicated and nondedicated IV sets and needlefree connectors designed to help meet clinical, safety and workflow goals. In addition, we manufacture automated pharmacy IV compounding systems with workflow technology, closed system transfer devices for preparing and administering hazardous IV drugs and cardiac monitoring systems for critically ill patients.


Acquisition of Smiths Medical 2020 Limited

During September 2021, we entered into a definitive agreement to acquire Smiths Medical 2020 Limited ("Smiths Medical"), the holding company of Smiths Group plc's global medical device business and, on January 6, 2022, the acquisition closed for a purchase price of $1.9 billion in cash, 2.5 million of fully paid and non-assessable shares of our common stock, par value $0.10 per share and a potential contingent earn-out payment of $100.0 million in cash, based on our common stock performance and other considerations. Results of operations of acquired companies are included in our consolidated financial results from the date of acquisition; accordingly, Smiths Medical will be consolidated beginning in the first quarter of 2022.

41


To partially finance the acquisition, on January 6, 2022 we entered into a credit agreement with Wells Fargo Bank, National Association and other lenders. The credit agreement provides for $2.2 billion of Senior Secured Credit Facilities, including a term loan A facility of $850.0 million, a term loan B facility of $850.0 million and a revolving credit facility of $500.0 million. See "Liquidity and Capital Resources" in the remainder of this item and Note 17 in our accompanying consolidated financial statements for additional information.

COVID-19

The novel coronavirus and its variants ("COVID-19") continues to have an impact on our business operations. Our manufacturing, distribution and pump service facilities continue to operate under our business continuity plan and our precautionary safety measures implemented to maximize the safety of our employees and to mitigate disruption to our business remain in effect.

While we continually monitor the ongoing and evolving impact of the effect of the COVID-19 pandemic on our operations the overall impact will not be fully reflected in our results of operations until future periods. The duration and extent of the impact from the COVID-19 pandemic depends on future developments that cannot be fully predicted at this time, as such, the impact of the pandemic on our overall financial performance remains uncertain and cannot as yet be quantified. See “Part I. Item 1A. Risk Factors” for discussion of the risks and uncertainties associated with the COVID-19 pandemic.
Consolidated Results of Operations


The following table summarizes our total worldwide revenue by domestic and international markets by amount and as a percentage of total revenue (in millions, except percentages):

Year Ended December 31,
202120202019
$% of Revenue$% of Revenue$% of Revenue
Domestic$941.8 72 %$910.6 72 %$923.3 73 %
International374.5 28 %360.4 28 %342.9 27 %
Total Revenue$1,316.3 100 %$1,271.0 100 %$1,266.2 100 %
 Year Ended December 31,
 2018 2017 2016
 $ % of Revenue $ % of Revenue $ % of Revenue
Domestic$1,054.7
 75% $980.0
 76% $261.7
 69%
International345.3
 25% 312.6
 24% 117.7
 31%
Total Revenue$1,400.0
 100% $1,292.6
 100% $379.4
 100%


The following table sets forth, for the periods indicated, total revenue by product line as a percentage of total revenue:  

Year Ended December 31,
Product line202120202019
Infusion Consumables42 %37 %37 %
Infusion Systems27 %28 %26 %
IV Solutions27 %31 %33 %
Critical Care%%%
 100 %100 %100 %

Product line 2018 2017 2016
Infusion Consumables 35% 28% 86%
IV Solutions 36% 40% %
Infusion Systems 25% 23% %
Critical Care 4% 4% 14%
Other % 5% %
  100% 100% 100%

WeAs of December 31, 2021, we manage our product distribution in the U.S. through a network of fourtwo owned and one leased distribution facilities as well as, through direct channels, which includein combination with independent distributors and thethird-party fulfillment and logistics providers. Our end users of our products,customers, which include healthcare providers and as original equipment manufacturer suppliers. Most ofsuppliers, may order and receive our products directly from us or through an independent distributors handle the full line of our products.full-line distributor. Internationally, we manage our operations through the Netherlands, which utilizesdistribution utilizing international regional hubs and we also manage our operations through independent distributors.



AIn the U.S. a substantial amount of our products are sold to group purchasing organization ("GPO") member hospitals. We believe that as healthcare providers continue to either consolidate or join major buying organizations, the success of our products will depend, in part, on our ability, either independently or through strategic relationships to secure long-term contracts with large healthcare providers and major buying organizations.  As a result of this marketing and distribution strategy we derive most of our revenue from a relatively small number of distributors and manufacturers.  Although we believe that we are not dependent on any single distributor, large healthcare provider or major buying organization for distribution of our products, the loss of a strategic relationship with a customerany one of these organizations or a decline in demand for our products could have a material adverse effect on our operating results.


42


We believe that achievement of our growth objectives worldwide will require increased efforts by us in sales and marketing and product acquisition and development; however, there is no assurance that we will be successful in implementing our growth strategy. Product development or acquisition efforts may not succeed, and even if we do develop or acquire additional products, there is no assurance that we will achieve profitable sales of such products. Increased expenditures for sales and marketing and product acquisition and development may not yield desired results when expected, or at all. While we have taken steps to control these risks, there are certain risks that may be outside of our control, and there is no assurance that steps we have taken will succeed.


Seasonality/Quarterly Results
 
There are no significant seasonal aspects to our business.  We can experience fluctuations in net sales as a result of variations in the ordering patterns of our largest customers, which may be driven more by COVID-19 pandemic surges and its impact on hospital admissions and procedure volumes along with production scheduling and theircustomer inventory levels, and less by seasonality. Our expenses often do not fluctuate in the same manner as net sales, which may cause fluctuations in operating income that are disproportionate to fluctuations in our revenue. 

Significant Acquisitions

On February 3, 2017, we acquired 100% interest in Pfizer's HIS business for total consideration of approximately $260.0 million in cash (net of estimated working capital adjustments paid at closing) and the issuance of 3.2 million shares of our common stock. As of December, 31, 2018, Pfizer has sold all of their shares of our common stock. We partially funded the cash portion of the consideration paid with a $75 million three-year interest-only seller note. The fair value of the common shares issued to Pfizer was determined based on the closing price of our common shares on the issuance date, discounted to reflect a contractual lock-up period whereby Pfizer cannot transfer the shares, subject to certain exceptions, until the earlier of (i) the expiration of Pfizer’s services to us in the related transitional services agreement or (ii) eighteen months. Pfizer also may be entitled up to an additional $225 million in cash contingent consideration based on the achievement of performance targets for the combined company for the three years ending December 31, 2019.

See Note 2 to the consolidated financial statements in Part II, Item 8 of this Form 10-K for further details of our acquisitions.

Five-year Revolving Credit Facility ("Credit Facility")

On November 8, 2017, we entered into a five-year Revolving Credit Facility ("Credit Facility") with various lenders for $150 million, with Wells Fargo Bank, N.A. as the administrative agent. The Credit Facility has an accordion feature that would enable us to increase the borrowing capacity of the credit facility by the greater of (i) $100 million and (ii) 2.00x Total Leverage (as defined in our Credit Facility). Under the terms of the facility we will be subject to certain financial covenants pertaining to leverage and fixed charge coverage ratios, see below under "Liquidity and Capital Resources" for further details. Borrowings under the Credit Facility will bear interest, at our option, based on the Base Rate plus applicable margin or LIBOR plus an applicable margin, both tied to the leverage ratio in effect. The unused portion of the Credit Facility will be subject to a per annum commitment fee which is also calculated using the leverage ratio in effect. The Credit Facility was entered into in order to provide us with flexible funding for future acquisition and operational needs.

In connection with the Credit Facility, during 2017, we incurred $1.4 million in financing costs, which are being amortized to interest expense over the remaining term of the Credit Facility.    

See Note 11 to the consolidated financial statements in Part II, Item 8 of this Form 10-K for further information regarding the Credit Facility.



We present summarized income statement data in Item 6. Selected8. Financial Statements and Supplementary Data. The following table shows, for the three most recent years, the percentages of each income statement caption in relation to total revenues.revenues: 
  Percentage of Revenues
  2018 2017 2016
Revenue  
  
  
Net sales 100 % 100 % 100 %
Other  %  %  %
Total revenues 100 % 100 % 100 %
Gross margin 41 % 33 % 53 %
Selling, general and administrative expenses 23 % 24 % 24 %
Research and development expenses 4 % 4 % 3 %
Restructuring and transaction expense 8 % 6 % 4 %
Change in fair value of contingent earn-out 1 % 1 %  %
Contract settlement 3 %  %  %
Impairment of assets held for sale  %  %  %
Total operating expenses 39 % 35 % 31 %
Income (loss) from operations 2 % (2)% 22 %
Bargain Purchase Gain  % 5 %  %
Interest expense  %  %  %
Other (expense) income, net  %  %  %
Income before income taxes 2 % 3 % 22 %
(Benefit) Provision For Income taxes  % (1)% 6 %
Net income 2 % 4 % 16 %
 Percentage of Revenues
 202120202019
Total revenues100 %100 %100 %
Gross profit37 %36 %37 %
Selling, general and administrative expenses23 %22 %22 %
Research and development expenses%%%
Restructuring, strategic transaction and integration expenses%%%
Change in fair value of contingent earn-out— %%(4)%
Contract settlement— %— %— %
Total operating expenses28 %28 %28 %
Income from operations%%%
Interest expense— %— %— %
Other income, net— %— %%
Income before income taxes%%10 %
Provision for income taxes%%%
Net income%%%
 
Total revenues for 2018, 2017 and 2016 were $1.4$1.3 billion, $1.3 billion and $379.4 million,$1.3 billion for 2021, 2020 and 2019, respectively.


In addition to comparing changes in revenue on a U.S. GAAP basis, we also compare the changes in revenue from one period to another using constant currency. We provide constant currency information to enhance the visibility of underlying business trends, excluding the effects of changes in foreign currency translation rates. To calculate our constant currency results, we apply the average exchange rate for revenues from the prior year to the current year results. These results should be considered in addition to, not as a substitute for, results reported in accordance with GAAP. Results on a constant currency basis, as we present them, may not be comparable to similarly titled measures used by other companies and are not measures of performance presented in accordance with GAAP.

Infusion Consumables


The following table summarizes our total Infusion Consumables revenue (in millions, except percentages):
Year Ended December 31,$ change% change$ change% change
2021202020192021 over 20202020 over 2019
Infusion Consumables$555.2 $473.7 $477.6 $81.5 17.2 %$(3.9)(0.8)%

Infusion Consumables revenue increased in 2021, as compared to 2020. The increase was due to lower hospital census in 2020 driven by the onset of the COVID-19 pandemic, growth in our global oncology, U.S. core infusion and renal products
43


 Year Ended December 31, $ change % change $ change % change
 2018 2017 2016 2018 over 2017 2017 over 2016
Infusion Consumables$483.0
 $365.6
 $324.9
 $117.4
 32.1% $40.7
 12.5%
and the impact from foreign exchange.On a constant currency basis, Infusion Consumables revenue would have been $546.3 million, an increase of $72.6 million or 15.3%, as compared to 2020.


Infusion Consumables revenue decreased in 2020, as compared to 2019. The decrease was mostly driven by overall lower demand for our products due to the COVID-19 pandemic, partially offset by sales from new customers and sales of our ClearGuard HD product, which we acquired in our fourth quarter 2019 acquisition of Pursuit. On a constant currency basis, Infusion Consumables revenue was comparable at $474.0 million for 2020, as the full year impact of foreign currency was negligible.    

Infusion Systems

The following table summarizes our total Infusion Systems revenue (in millions, except percentages):
Year Ended December 31,$ change% change$ change% change
2021202020192021 over 20202020 over 2019
Infusion Systems$352.3 $359.7 $328.3 $(7.4)(2.1)%$31.4 9.6%
Infusion Systems revenue decreased in 2021, as compared to 2020. The decrease was primarily due to large volume pump sales driven by higher COVID-19-related purchases during the second and third quarters of 2020 and a decline in sales of our non-large volume pump business, which has been partially offset by higher dedicated set sales in 2021 as a result of higher hospital census and larger install base of large volume pump from new customer installations. On a constant currency basis, Infusion Systems revenue in 2021 would have been $351.4 million, a decrease of $8.3 million or 2.3%, as compared to 2020.

Infusion Systems revenue increased in 2020, as compared to 2019. The increase in revenue was primarily due to high demand for our infusion pumps during the COVID-19 pandemic, offset partially by lower demand for our dedicated infusion sets and losses of our non-core ambulatory pump business. On a constant currency basis Infusion ConsumablesSystems revenue in 2018,2020 would have been $364.7 million, an increase of $36.4 million or 11.1%, as compared to 2017 was primarily driven by three factors, (i) the classification of revenue related to certain foreign jurisdiction HIS entities with deferred closes during 2017 as "Other Revenue" for 2017, due to the fact that we were unable to allocate the revenue to a specific product line, (ii) the addition of new customers in Infusion for IV therapy and oncology products in 2018, and (iii) the completion of acquisitions in 2018. In addition, 2017 includes approximately eleven months of revenue from the point of closing of the HIS transaction to the end of the year.2019.

In 2017, our Infusion Consumables revenue included our acquired revenue from the HIS business, which included approximately eleven months of revenue from the point of closing of the transaction to the end of 2017, as well as our legacy Infusion Therapy and Oncology businesses. In 2016, our Infusion Consumables revenue as presented above consisted of our legacy Infusion Therapy and Oncology businesses.


IV Solutions


The following table summarizes our total IV Solutions revenue (in millions, except percentages):
Year Ended December 31,$ change% change$ change% change
2021202020192021 over 20202020 over 2019
IV Solutions$359.5 $389.0 $415.0 $(29.5)(7.6)%$(26.0)(6.3)%
 Year Ended December 31, $ change % change $ change % change
 2018 2017 2016 2018 over 2017 2017 over 2016
IV Solutions$508.0
 $522.0
 $
 $(14.0) (2.7)% $522.0
 *

* Not Applicable

In 2017, competitor supply constraints were significantly reduced in the second half of the year. We temporarily benefited from those supply constraints. Beginning in 2018, supply normalized, which eventually normalized customers demand. IV Solutions revenue for 2017 also includes approximately eleven months of revenue from the point of closing of the HIS transaction to the end of the year.        

Infusion Systems

The following table summarizes our total Infusion Systems revenue (in millions, except percentages):
 Year Ended December 31, $ change % change $ change % change
 2018 2017 2016 2018 over 2017 2017 over 2016
Infusion Systems$355.5
 $290.2
 $
 $65.3
 22.5% $290.2
 *

* Not Applicable
Infusion Systems revenue increasedsales decreased in 2018,2021, as compared to 2017,2020, primarily due to lower contract manufacturing sales to Pfizer and lower production volumes due to supply constraints in the revenue relatedmarket.

IV Solutions sales decreased in 2020, as compared to certain foreign jurisdiction HIS entities that had deferred closes during 2017. The revenue related2019, due to these deferred close entitieslower contract manufacturing sales to Pfizer and higher sales in 2017 was included in "Other Revenue", as we were unablethe first quarter of 2019 to allocate the revenue to a specific product line. In addition, 2017 includes approximately eleven months of revenue from the point of closing of the HIS transaction to the end of the year.non-contracted customers.


Critical Care


The following table summarizes our total Critical Care revenue (in millions, except percentages):
Year Ended December 31,$ change% change$ change% change
2021202020192021 over 20202020 over 2019
Critical Care$49.3 $48.6 $45.3 $0.7 1.4 %$3.3 7.3 %
44


 Year Ended December 31, $ change % change $ change % change
 2018 2017 2016 2018 over 2017 2017 over 2016
Critical Care$53.5
 $50.0
 $53.6
 $3.5
 7.0% $(3.6) (6.7)%


In 2018, Critical Care revenue increased for 2021, as compared to 2017,2020 due primarily due to new product shipmentshigher U.S. hospital census as a result of the Cogent patient monitor and due to timing of orders. In 2017, COVID-19 pandemic.

Critical Care revenue slightly decreased,increased in 2020, as compared to 2016, due to timing2019, primarily as a result of orders.growth in the Asia region and improved manufacturing capacity.


Revenue from Deferred Close Entities

As part of the HIS business acquisition, the closing of certain foreign jurisdictions were deferred, as such, we entered into a Net Economic Benefit agreement with Pfizer (see Note 2 to the consolidated financial statements in Part II, Item 8 of this Form 10-K for additional information). The revenue data related to these deferred closing entities was not available by product line, therefore our revenue by product line for 2017 described above did not include amounts related to these entities. All of the deferred closing entities were effectively closed in 2018, which allowed for allocation of all of the revenue to a specific product line for 2018.


The following table summarizes our revenue from our deferred close entities (in millions):

 Year Ended December 31, $ change % change $ change % change
 2018 2017 2016 2018 over 2017 2017 over 2016
Revenue from Deferred Close Entities$
 $64.4
 $
 $(64.4) * $64.4
 *

*Not meaningful.

Gross Margins


Gross margins were 37.3%, 36.3% and 37.3% for 2018, 20172021, 2020 and 2016 were 40.7%, 33.0%, and 53.1%,2019, respectively. 


The increase in gross margin in 2018,2021, as compared to 2017,2020 was primarily due to a change in product mix related to increased Infusion Consumables and increased factory efficiencies. 2017 was negatively impactedplant volumes, partially offset by the step-up of inventory from the purchase accounting related to the HIS acquisition.     increased costs for raw materials, direct labor and freight.


The decrease in gross margin in 2017,2020, as compared to 2016,2019 was primarily due to lower IV Solutions manufacturing volumes and unfavorable product mix as a result of lower demand for our consumables products during the integration of HIS, which has historically had lower gross margins than our legacy business. Additionally, there was an impact of approximately five percentage points related to the step-up of inventory from our purchase accounting and also a temporary negative impact on absorption due to our planned inventory reduction.COVID-19 pandemic.

Selling, General and Administrative ("SG&A") Expenses


The following table summarizes our SG&A expenses (in millions, except percentages):
Year Ended December 31,$ change% change$ change% change
2021202020192021 over 20202020 over 2019
SG&A$302.6 $284.0 $277.0 $18.6 6.5 %$7.0 2.5 %
 Year Ended December 31, $ change % change $ change % change
 2018 2017 2016 2018 over 2017 2017 over 2016
SG&A$328.1
 $304.0
 $89.4
 $24.1
 7.9% $214.6
 240.0%


Consolidated SG&A expenseexpenses increased in 2018,2021, as compared to 2017, primarily attributable to the impact of the integration of HIS as we incurred duplicative costs as we added resources to stand up the business that will replace the services provided under the transitional services agreement with Pfizer.2020. Compensation expense increased $19.5$7.9 million, information technology expense increased $7.7 million, realized foreign exchange lossesdealer fees increased $5.7 million, marketing expensesstock compensation increased $4.5$2.9 million, legal expenses increased $3.5$2.3 million traveland computer expenses increased $3.3 million and dealer fees increased $2.2$1.5 million. Offsetting these increases was a $23.9$2.3 million decrease in bad debt expense and $1.6 million decrease in commissions. Compensation expense increased primarily due to increased headcount and annual compensation merit increases. Dealer fees increased due to an increase in revenue from U.S. distributors in the current year. Stock compensation increased due to a change during the current year in the number of performance shares expected to vest. Legal fees increased due to additional services performed in the current year related to various legal matters. Computer expenses increased due to increased maintenance costs as well as increased hardware, software and software subscriptions based on operational needs. Bad debt expense is adjusted quarterly, if deemed necessary, based on an assessment of our accounts receivables and our expectations regarding the collectability of those accounts. Commissions decreased due to the commission plan structure in the prior year, which included certain guaranteed payments.

Consolidated SG&A expenses increased in 2020, as compared to 2019. Dealer fees increased $9.3 million, depreciation and amortization expense increased $7.1 million, compensation expense increased $5.5 million, and stock compensation increased $2.0 million. Offsetting these expense increases was a $6.3 decrease in bad debt expense, a $6.3 million decrease in travel expenses, a $3.7 million decrease in consulting expenses, and decreasesa $2.8 million decrease in other miscellaneoussales and marketing expenses. CompensationDealer fees increased due to a change to a distribution model from a direct model in Canada and an increase in headcountrevenue from new employees hired to supportdistributors. Depreciation and amortization expense increased primarily as a result of the company post-acquisition of HIS. Information technology expense increases wereincrease in amortization base due to the HIS post-acquisition needs to stand up the company. Realized foreign exchange losses increased due to changes in the rate and increased foreign monetary account balances. Marketing expenses increased primarily due to the continued integrationNovember 2019 acquisition of HIS and the post-acquisition operational activity. Legal expenses increased due to the continued integration of HIS and legal services needed to support a larger business. TravelPursuit. Compensation expense increased as a result of lower incentive compensation recognized in the operational needsprior year due to results below performance targets. Stock compensation increased in the current year due to a change in the number of performance shares estimated to vest on one of our non-executive performance awards. Bad debt expense is estimated based on an analysis of the company. Dealer fees increasedexpected losses on the accounts receivables at the reporting date, which varies from period-to-period due to the increasequality of those receivables. Travel expenses decreased in revenue.    

Consolidated SG&A expense increased $214.6 million in 2017,the current year, as compared to 2016, primarilyprior year, due to travel restrictions in response to COVID-19. Consulting expense was higher in 2019 due to charges incurred related to tax compliance and IT infrastructure expenses. Sales and marketing expenses decreased due to the impact of the HIS acquisition. Compensation increased $83.7 million, accounting and information technology fees increased $72.4 million, depreciation expense increased $16.0 million, computer hardware and software increased $11.5 million, travelCOVID-19 on trade shows, conferences, and related expenses increased $5.8 million and rent expense increased $3.3 million. Compensation increased primarily due to an increase in headcount related to the HIS acquisition, and from new employees hired to support the company post-acquisition. Accounting and information technology fees increased due to the expenses incurred under the transition services agreement with Pfizer. Depreciation expense increased due to the depreciation of the HIS assets acquired. Computer hardware and software increases were due to the post-acquisition needs to stand up the company. Travel and related expenses increased primarily due to the integration of the HIS acquisition and the post-acquisition operational activity. Rent expense increased due to the operating leases assumed on acquired HIS properties.expenses.

Research and Development ("R&D") Expenses


The following table summarizes our total R&D Expensesexpenses (in millions, except percentages):
45


 Year Ended December 31, $ change % change $ change % change
 2018 2017 2016 2018 over 2017 2017 over 2016
R&D$52.9
 $51.3
 $13.0
 $1.6
 3.1% $38.3
 294.6%
Year Ended December 31,$ change% change$ change% change
2021202020192021 over 20202020 over 2019
R&D$47.5 $42.9 $48.6 $4.6 10.7 %$(5.7)(11.7)%
    
In 2018,R&D expenses increased in 2021, as compared to 2017,2020, and decreased in 2020, as compared to 2019. Fluctuations in our R&D expenses increased due to post-acquisition operational activity attributable to a larger business and 2017 includes approximately eleven months of R&D expense from the point of closing of the transaction to the end of the year.    
In 2017, as compared to 2016, R&D expenses increasedare due to the acquisitiontiming and nature of HIS.various R&D projects. R&D expenses are primarily related to compensation and benefit expenses, consulting fees, production supplies, samples, travel costs, utilities and other miscellaneous administrative costs incurred on our R&D projects in progress during each year.

Restructuring, and Strategic Transaction and Integration Expenses


Restructuring, and strategic transaction and integration expenses were $105.4$18.0 million, $78.0$28.4 million and $15.3$80.6 million in 2018, 20172021, 2020 and 2016,2019, respectively.


Restructuring Charges


In 2018,2021, we adjusted certain facility restructuring liabilities by $2.0 million to reflect actual amounts owed resulting in annual net restructuring credits of $(1.8) million.

In 2020, restructuring charges were $4.5 million. These charges were related to (i) severance costs from the reduction in our workforce as a result of the continued integration of HIS. All material charges in regard to these restructuring activities have been paid as of December 31, 2018.

In 2017, restructuring charges were $18.8 million. These charges were related to (i) severance costs from the reduction in our workforce needed to eliminate duplicative positions created as a result of the HIS acquisition and (ii) we closed our Dominican Republic manufacturing facility and incurred expenses associated with the closure and transfer of assets and production to our Costa Rica and Mexico manufacturing facilities. We have $0.9 million in unpaid restructuring charges related to the year-ended December 31, 2017.

In 2016, restructuring charges were $1.0$7.9 million. These charges were primarily related to residual expenses for the closure ofseverance and costs related to office and other facility closures.

In 2019, restructuring charges were $8.4 million. These charges were primarily related to a one-time charge to move our Slovakian manufacturingU.S. pump service depot to our existing Salt Lake City facility and we incurred $0.2 million related to other restructuring activities.plant restructuring.

Strategic Transaction and Integration Expenses


In 2018,2021, we incurred $100.9$19.8 million in strategic transaction and integration expenses primarily related to our continued integration ofcosts associated with acquisitions, the HIS businessHospira Infusion Systems ("HIS") earn-out dispute with Pfizer, one-time costs incurred to comply with regulatory initiatives and IT systems.transaction expenses incurred in connection with entering into the definitive agreement to acquire Smiths Medical.


In 2017,2020, we incurred $59.2$20.5 million in strategic transaction and integration expenses primarily related to the integration of HIS, which included the migration of IT systems at our acquisitionAustin facility.

In 2019, we incurred $72.2 million in strategic transaction and integration expenses primarily related to the integration of the HIS business.

In 2016, Integration expenses included a one-time strategic supply chain restructuring charge of $22.1 million, which reduced our contracted commitments to our third party manufacturer and we incurred $14.3 million in strategic transaction expensescharges related to our acquisitions, primarily the acquisitionfinal Pfizer separation costs and clean-up, which included a $12.7 million non-cash write-off of the HIS business.related assets.
    
Change in fair value of contingent earn-out


At the end of the second quarter of 2021, the measurement period related to the Pursuit earn-out liability ended and in October 2021 the $26.3 million earn-out was finalized and paid to Pursuit's former shareholders. There were no changes in the fair value of our earn-outs during 2021.

In 2018,2020, the fair value revaluation of our Pursuit contingent earn-out liability resulted in an increase in value of $9.0 million.

In 2019, the fair value revaluation of our HIS contingent earn-out liability resulted in a change in fair value of $20.4 million.

In 2017,$47.4 million reducing the fair value revaluationliability balance to zero. The earn-out period ended on December 31, 2019 and as of that date we determined we did not meet the necessary performance targets that would require payout of any of the HIS earn-out liability. Pfizer disputed our determination that the performance targets requiring payout of the HIS contingent earn-out liability resultedwere not met, and the dispute entered into binding arbitration. In August 2021, the arbitrator concluded that the necessary performance targets that would require payout of the HIS earn-out were not met, and as a result Pfizer is not entitled to any payments in a loss of $8.0 million.connection with the HIS earn-out liability.


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Contract Settlement


In 2018,2021, we recorded $0.1 million in contract settlement expense. In 2020, we recorded $1.0 million in contract settlement income related to the resolution of a dispute with one of our suppliers. In2019, we incurred a $41.6$5.7 million charge related to the resolution of a dispute with a product partner, which resulted in a redefinition of our contractual arrangement and in the rights and remedies determined under such arrangement.


Impairment of Assets Held-for-Sale

During 2016, we completed the closure of our Slovakia manufacturing facility and sold the land and building held-for-sale for $3.3 million, net of costs to sell, resulting in an additional impairment loss of $0.7 million.
Bargain Purchase Gain

In 2017, in connection with the HIS acquisition, we recognized a bargain purchase gain of $70.9 million. The bargain purchase gain represented the excess of the estimated fair market value of the identifiable tangible and intangible assets acquired and liabilities assumed, net of deferred tax liabilities over the total purchase consideration. We determined that the bargain purchase gain was primarily attributable to expected restructuring costs as well as a reduction to the initially agreed upon transaction price caused primarily by revenue shortfalls across all market segments of the HIS business, negative manufacturing variance due to the drop in revenue and higher operating and required stand up costs, when compared to forecasts of the HIS business at the time that the purchase price was agreed upon.

In 2016, we recognized a bargain purchase gain of $1.5 million in connection with the Tangent acquisition. The bargain purchase gain represented the excess of the estimated fair market value of the identifiable tangible and intangible assets acquired and liabilities assumed, net of deferred tax assets over the total purchase consideration. The bargain purchase was driven by our ability to realize acquired deferred tax assets.


Interest Expense


Interest expense was $0.7$0.9 million, $2.0$1.8 million and $0.1$0.5 million in 2018, 20172021, 2020 and 2016,2019, respectively.


In 2018, the2021 and 2019, interest expense was related to amortization ofprimarily includes the financing cost incurred in 2017 in connection with the five-year Revolving Credit Facility and a related per annum commitment fee charged on the unused portion of the revolver under suchour five-year Revolving Credit Facility ("Credit Facility") and the amortization of financing costs that were incurred in 2017 in connection with entering into the Credit Facility. The per annum commitment fee was based on the consolidated total leverage ratio in effect and ranged between 0.15% to 0.30% on the unused portion of the Credit Facility (see Note 11: Long-Term Obligations in our accompanying consolidated financial statements for additional information).


In 2017, the2020, interest expense was primarily related to (i)borrowings under our Credit Facility and the $75 million seller note from Pfizer as partamortization of financing costs. Borrowing under the HIS business acquisition and (ii) the per annum commitment fee chargedCredit Facility bore interest, at our option, based on the unused portion ofBase Rate (as defined in Note 11 in our revolver under the five-year $150 million Credit Facility.

The three-year interest only seller note bore interest based onaccompanying consolidated financial statements) plus applicable margin or the London Interbank Offered Rate ("LIBOR") plus (i) 2.25% per yearapplicable margin (see Note 11: Long-Term Obligations in our accompanying consolidated financial statements for additional information).

In January 2022, we entered into senior secured credit facilities that refinanced our existing Credit Facility in full, see "Liquidity and Capital Resources" in the first 12 months,remainder of this item for additional information and (ii) 2.50% per annum thereafter. On November 8, 2017, we fully repaid the $75estimated impact to future interest expense.

Other Income, net

Other income, net was $0.8 million, $1.1 million and $7.9 million in outstanding principal under the senior note payable to Pfizer.

The per annum commitment fee is based on consolidated total leverage ratio in effect2021, 2020 and can range between 0.15% to 0.30% on the unused portion of the Credit Facility.

Other (Expense) Income

Other (expense) income was $1.5 million, $(2.5) million and $0.9 million in 2018, 2017 and 2016,2019, respectively.  In 2018,2021, other (expense) income, included $5.4net was primarily related to $2.8 million of interest income and $0.7 million of miscellaneous income partially offset by $1.7 million of loss from disposed assets and $1.0 million in foreign exchange losses. In 2020, other income, net was primarily related to interest income of $3.7 million, miscellaneous income, net of $2.8 million and gain from the disposal of property, plant and equipment of $1.8 million, which was mostly offset by $7.2 million in foreign exchange losses incurred as a result of the strengthening of the U.S. dollar from the impact of COVID-19 during the first half of the year. In 2019, other income, net was primarily due to interest income of $6.8 million related to our banking and investment accounts offset by $3.9 million loss on disposal of or write-off of property, plant and equipment.accounts.


Income taxes


Income taxes were accrued at an estimated annual effective tax rate of (29%)16%, (34%)11% and 26%12% in 2018, 20172021, 2020 and 2016,2019, respectively.


The effective tax rate in 20182021 differs from the federal statutory rate of 21% principally because of the effect of the mix of foreignU.S. and stateforeign incomes, state income taxes, global intangible low-taxed income (“GILTI”), foreign-derived intangible income (“FDII”) and tax credits. The effective tax rate for 2018 alsoin 2021 included a material tax benefit of $12.6$4.9 million related to the excess tax benefits recognized on stock option exercises and the vesting of restricted stock units during the period.


On December 22, 2017, the Tax Act was enacted into law, which includes a broad range of provisions affecting businesses. The Tax Act significantly revises how companies compute their U.S. corporate tax liability by, among other provisions, reducing the corporateeffective tax rate from 35% to 21% for tax years beginning after December 31, 2017. As2021 also included U.S. federal and state return-to-provision adjustments net of December 31, 2018, our accountingrelated reserve changes for the Tax Act is complete. As noted at 2017 year-end, we were able to reasonably estimate certain effects and, therefore, recorded provisional adjustments associated with the toll charge on undistributed foreign earnings and profits and revaluation of deferred taxes. Measurement-period adjustments for the toll charge and revaluation of deferred taxes recognized during the year ended December 31, 2018 did not have a material impact on our consolidated financial statements. The effect2020 of the measurement-period adjustments on the 2018 effective$0.9 million tax rate was approximately a three percentage point increase. We continue to evaluate various international provisions included in the Tax Actprovision primarily due to the lack of Treasury Regulationschanges in estimates for GILTI, FDII, subpart F, and ongoing guidance. These provisions were effective for us beginning on January 1, 2018, and may materially impact our effectiverelated foreign tax rate in future years. For the year ended December 31, 2018, we recorded an income tax expense of $2.4 million for the global intangible low-taxed income (GILTI) provisions. For further discussion, see Note 12 to the consolidated financial statements in Part II, Item 8 of this Form 10-K.credits along with other prior period adjustments.

The effective tax rate for 2017in 2020 differs from the federal statutory rate of 35%21% principally because of the effect of the mix of foreignU.S. and stateforeign incomes, state income taxes, global intangible low-taxed income ("GILTI"), foreign-derived intangible income ("FDII") and tax credits, and impact of the gain on bargain purchase. The tax effect of the gain on bargain purchase is treated as a discrete item part of purchase accounting and is not a component of the income tax provision.credits. The effective tax rate during 2017 alsoin 2020 included a tax benefit of $20.8$5.3 million related to the excess tax benefits recognized on stock option exercises and the vesting of restricted stock units during the period.

As of December 31, 2017, we recorded income tax expense of $3.1 million as a result of the Tax Act, which is comprised of $1.1 million of income tax expense as a result of the re-measurement of deferred tax assets and liabilities at the new lower statutory The effective tax rate for 2020 also included U.S. federal and state return-to-provision adjustments net of 21%, and a net tax expense of $2.0 million as a result of the mandatory deemed repatriation on earnings and profits of U.S.-owned foreign subsidiaries. We elected to record the mandatory repatriation and re-measurement of deferred taxes as a provisional amountrelated reserve changes for the year ended December 31, 2017, which we believe is a reasonable estimate2019 of $3.8 million tax benefit primarily due to changes in accordance with the Tax Act.estimates for GILTI, FDII, and related foreign tax credits.


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The effective tax rate for 2016in 2019 differs from the federal statutory rate of 21% principally because of the effect of the mix of U.S. and foreign andincomes, state income taxes, GILTI and tax credits, deductionscredits. The effective tax rate for domestic production activities, and2019 included a material discrete tax benefit of $7.6$9.6 million related to the excess tax benefits recognized on stock option exercises and the vesting of restricted stock units during the period. The effective tax rate for 2019 was also impacted by the repatriation of certain intellectual property and assets from a liquidation of one of our foreign subsidiaries to the U.S. parent. In accordance with the changes to the accounting for income tax effects of such intra-entity transfers of assets, we recorded a net tax benefit of $3.8 million related to the liquidation. Lastly, the effective tax rate during 2019 included a tax expense of $2.2 million related to return-to-provision adjustments for the year ended December 31, 2018 primarily due to changes in estimates for our U.S. GILTI inclusion.

Liquidity and Capital Resources


IntroductionWe regularly evaluate our liquidity and capital resources, including our access to external capital, to ensure we can adequately meet our principal cash requirements, which include working capital requirements, planned capital investments in our business, commitments, acquisition restructuring and integration expenses, investments in quality systems and quality compliance objectives, repayment of outstanding borrowings, income tax obligations and acquisition opportunities in accordance with our growth strategy.

Sources of Liquidity

Our primary sources of liquidity are cash areand cash equivalents, our short-term investment portfolio, cash flows from operating activities, proceedsour operations and access to borrowing arrangements.

Funds generated from the exercise of employee optionsoperations are held in cash and available borrowings undercash equivalents and investment securities. During 2021, our Credit Facility (as defined above). Our primary uses of cash are to meet working capital requirements, finance capital expenditures and acquisitions along with acquisition-related incremental transaction and integration costs.

During 2018, our cash, cash equivalents and short-term investment securities increased by $82.0$156.5 million from $300.1$410.8 million at December 31, 20172020 to $382.1$567.2 million at December 31, 2018. The increase was primarily due to our positive operating results and the reclassification of our long-term investment securities to short-term classification.

Future Cash Flows

Short-term

Our five-year $150 million Credit Facility provides us with fast, flexible funding for future acquisition and operational needs.

2021. Our short-term investment portfolio is invested inconsists of investment-grade corporate bonds and our primary investment goal is primarily intended to facilitate capital preservation.


WhileCredit Facilities and Access to Capital

On November 8, 2017, we can provide no assurances, we estimate that our capital expenditures in 2019 will approximate $95 million to $105 million. We anticipate making additional investments in machinery and equipment in our manufacturing operations in Costa Rica, the U.S. and Mexico to support new and existing products, in infusion products that get placed with customers

outside the U.S., and in IT to benefit world-wide operations.  We expect to use our cash and cash equivalents to fund our capital purchases.  Amounts of spending are estimates and actual spending may substantially differ from those amounts.

We believe that our existing cash, cash equivalents along with funds expected to be generated from future operations will provide us with sufficient funds to finance our current operations for the next twelve months.

Long-term

Our long-term liquidity needs include interest/commitment payments on theentered into a five year revolving Credit Facility capital expenditures related to the expansion of our business and potential acquisitionswith various lenders which includes $150.0 million in accordance with our growth strategy.

We are unable to project with certainty whether our long-term cash flow from operations and amounts available to us under our Credit Facility will be sufficient to fund our future capital expenditures and acquisitions as they arise. In the event that we experience illiquidity in our investment securities, downturns or cyclical fluctuations in our business that are more severe or longer than anticipated or if we fail to achieve anticipated revenue and expense levels, we may need to obtain or seek alternative sources of capital or financing, and we can provide no assurances that the terms of such capital or financing will be available to us on favorable terms, if at all.

Credit Facility

Our five-year Credit Facility includes $150 million borrowing capacity available for revolving credit loans and may also be used to borrow, on same-day notice under a swingline, the lesser of $10$10.0 million and the aggregate unused amount of the revolving credit available. As ofOur five-year $150.0 million Credit Facility provides us with fast, flexible funding for operational needs. There were no outstanding borrowings under the Credit Facility at December 31, 2018, we had no borrowings and $150 million of availability under the revolving credit facility.2021.


All of our obligations under the Credit Facility are guaranteed by ICU Medical, Inc. and certain of our existing subsidiaries. The obligations under the Credit Facility are secured by a pledge of 100% of the capital stock of certain subsidiaries owned by us and a security interest in substantially all of our tangible and intangible assets and the tangible and intangible assets of each guarantor.


The Credit Facility contains certain financial covenants pertaining to Consolidated Fixed Charge Coverage and Consolidated Total Leverage ratios, see below under "Financial Covenants". In addition, the Credit Facility has restrictions pertaining to limitations on debt, liens, negative pledges, loans, advances, acquisitions, other investments, dividends, distributions, redemptions, repurchases of equity interests, fundamental changes and asset sales and other dispositions, prepayments, redemptions and purchases of subordinated debt and other junior debt, transactions with affiliates, dividend and payment restrictions affecting subsidiaries, changes in line of business, fiscal year and accounting practices and amendment of organizational documents and junior debt documents.


Financial Covenants


The Credit Facility contains certain negative financial covenants, including, Consolidated Total Leverage and Consolidated Fixed Charge Coverage Ratios.


The Consolidated Leverage Ratio is defined as the ratio of Consolidated Total Funded Indebtedness on such date, to Consolidated Adjusted EBITDA, as defined under the Credit Facility Agreement, for the most recently completed four fiscal quarters. The maximum Consolidated Leverage Ratio is not more than 3.00 to 1.00.


The Consolidated Fixed Charge Coverage Ratio is defined as the ratio of: (a) Consolidated Adjusted EBITDA less the sum of (i) capital expenditures, (ii) federal, state, local and foreign income taxes paid in cash and (iii) cash restricted payments
48


made after the closing date, to (b) Consolidated Fixed Charges for the most recently completed four fiscal quarters, calculated on a pro forma basis. The minimum Consolidated Fixed Charge Coverage Ratio is 2.00 to 1.00.


We entered into Senior Secured Credit Facilities in January 2022 which terminated our existing Credit Facility, see below.

2022 Senior Secured Credit Facilities

We entered into a credit agreement with various lenders dated January 6, 2022 in connection with the closing of the Smiths Medical acquisition. The credit agreement provides for senior secured credit facilities, which include a five-year term loan A facility of $850.0 million, a seven-year term loan B facility of $850.0 million and a five-year revolving credit facility of $500.0 million. The proceeds from the term loans were used to finance a portion of the cash consideration for the Smiths Medical acquisition (see Note 17: Subsequent Events in compliance with allour accompanying consolidated financial covenantsstatements for additional information). The outstanding aggregate principal amount of the term loans is $1.7 billion as of December 31, 2018.    the issuance of this report, which includes the term loan A that will mature in January 2027 and the term loan B that will mature in January 2029. The proceeds of future borrowings under the $500.0 million revolving credit facility, which expires in January 2027, may be used as a source of liquidity to support our ongoing working capital requirements and other general corporate purposes. There are no outstanding borrowings under the $500.0 million revolving credit facility as of the issuance of this report. Our existing $150.0 million Credit Facility, described above which was set to expire in November 2022, was terminated upon entering into the new Senior Secured Credit Facilities. As part of entering into the Senior Secured Credit Facilities we were assigned issuer and term loan B facility credit ratings. At the time of this report, our issuer and term loan B credit ratings assigned and outlook were as follows:



Issuer/Term Loan B
Credit Ratings
Outlook
Moody'sBa3Stable
FitchBB/BBB-Stable
Standard & Poor'sBB/BBStable
Historical Cash Flows

We believe that our existing cash and cash equivalents along with cash flows expected to be generated from future operations and the funds received under the Senior Secured Credit Facilities will provide us with sufficient liquidity to finance our cash requirements for the next twelve months. In the event that we experience downturns, cyclical fluctuations in our business that are more severe or longer than anticipated, fail to achieve anticipated revenue and expense levels, or have significant unplanned cash expenditures, we may need to obtain or seek alternative sources of capital or financing, and we can provide no assurances that the terms of such capital or financing will be available to us on favorable terms, if at all. Our ability to generate cash flows from operations, issue debt or enter into other financing arrangements on acceptable terms could be adversely affected if there is a material decline in the demand for our products or in the solvency of our customers or suppliers, deterioration in our key financial ratios or credit ratings or other significantly unfavorable changes in conditions. See Part I. Item 1A. Risk Factors” for discussion of the risks and uncertainties associated with our debt financing.
Cash Flows from Operating Activities:

Uses of Liquidity

Capital Expenditures

Our cash provided by operations was $160.2 millioncapital expenditures relate to the expansion and maintenance of our business. While we can provide no assurances, we estimate that our capital expenditures in 2018. Net income plus adjustments for non-cash net expenses contributed $185.62022 will be in the range of $100 million to cash provided by operations. Net cash used$120.0 million. We anticipate making additional investments in operations as a result of changes in operating assetsmachinery and liabilities was $25.4 million. The changes in operating assets and liabilities included a $76.7 million increase in accounts receivable, a $29.6 million decrease in accrued liabilities, a $21.8 million increase in inventories and $20.0 million in net changes in income taxes, including excess tax benefits and deferred income taxes. Offsetting these amounts was a $97.4 million decrease in related party receivables and a $23.3 million increase in accounts payable. The increase in accounts receivable is due to the increase in revenue and timing of collections. The decrease in accrued liabilities was primarily a result of the settlement of contract liabilities. The increase in inventory was primarily due to efforts to build-up the inventory level of certain products. The net changes in income taxes was a result of the timing of payments. The decrease in related-party receivables was a result of the Transition Services Agreement with Pfizer nearing its end. The increase in accounts payable was due to the timing of payments.

Our cash provided by operations was $154.4 million in 2017. Net income plus adjustments for non-cash net expenses contributed $98.5 million to cash provided by operations. Net cash provided by operations as a result of changes in operating assets and liabilities was $55.9 million. The changes in operating assets and liabilities included a $181.7 million decrease in inventories, a $46.6 million increase in accounts payable, and a $33.8 million increase in accrued liabilities. Offsetting these cash inflows was a $95.3 million increase in related-party receivables, a $54.5 million increase in accounts receivable, a $31.8 million increase in prepaid expenses and other assets, and a $24.6 million net change in prepaid and deferred income taxes. The decrease in inventory was due to a planned inventory reduction of our acquired inventory to manage working capital needs. The increase in accounts payable was due to the increase in expenses related to the post-acquisition operations. The increase in accrued liabilities was primarily a result of increased salary and benefits due to a larger workforce. The increase in related-party receivables was primarily due to amounts paid for transitional service arrangement fees, working capital adjustments and other HIS-related amounts. The increase in prepaid expenses and other assets was primarily due to HIS post-acquisition operations. The increase in accounts receivable is due to the increase in revenue. The net changes in income taxes was a result of the timing of payments.
Cash Flows from Investing Activities

The following table summarizes the changesequipment in our investing cash flows (in thousands):

  For the Years Ended December 31, Variance 
  2018 2017 2016 2018 2017 
Investing Cash Flows:           
Purchases of property, plant and equipment $(92,720) $(74,479) $(23,361) $(18,241) $(51,118)
(1) 
Proceeds from sale of assets 765
 2
 
 763
 2
 
Proceeds from the disposal of assets held-for-sale, net 13,000
 
 3,268
 13,000
 (3,268)
(2) 
Intangible asset additions (8,059) (5,203) (1,192) (2,856) (4,011) 
Business acquisitions, net of cash acquired (1,300) (162,448) (2,584) 161,148
 (159,864)
(3) 
Purchases of investment securities (30,496) (24,743) (118,384) (5,753) 93,641
(4) 
Proceeds from sale of investment securities 15,440
 
 158,534
 15,440
 (158,534)
(5) 
Net cash (used in) provided by investing activities $(103,370) $(266,871) $16,281
 $163,501
 $(283,152) 

(1) Our purchases of property, plantmanufacturing operations in Costa Rica, Europe, Mexico and equipment will vary from period to period based on additional investments neededthe U.S. to support new and existing products and expansionin infusion pumps that get placed with customers outside the U.S. We expect to use our cash and cash equivalents to fund our capital purchases. Amounts of our manufacturing facilities.spending are estimates and actual spending may substantially differ from those amounts.


(2)2022 Acquisitions

In 2018,September 2021, we soldentered into a definitive agreement to acquire Smiths Medical and on January 6, 2022 the land and building related to our Dominican Republic manufacturing facilities acquired as partacquisition was completed. We financed the $1.9 billion cash portion of the 2017 HIS acquisition. In 2016, we sold our Slovakian manufacturing facilities for $3.3 million, netpurchase price at closing with a combination of costs to sell of $0.1 million.

(3) Our business acquisitions will vary from period to period based upon our current growth strategy and our ability to execute on desirable target companies. In 2018, we acquired the consulting arm of True Process Inc. for $1.3 million. In 2017, we

acquired HIS for $256 million in cash consideration (net of working capital adjustments), financed with existing cash balances and a three-year interest-only seller note of $75 million and we delivered 3.2 million shares of our common stock to Pfizer and we acquired Fannin for $1.5 million and MLA for $9.0 million in cash consideration. In 2016, we acquired Tangent for $2.6 million in cash.

(4) Our purchases of investment securities will vary from period to period based on current cash needs, planning for known future transactions and due to changes in our investment strategy. In 2016, we amended our investment policy to allow for the purchase of securities with final maturities in excess of one year. Accordingly, we adjusted our investment strategy to take advantage of the higher yields available on these longer term securities. Our longer term securities have maturities up to three years.

(5) The proceeds from the sale ofSenior Secured Credit Facilities and our investment securities increased in 2018, as compared to 2017, as by the end of 2016, we had liquidated all of our investment securitiescash and used the proceeds to fund the acquisition of HIS. Accordingly, we did not have an investment balance in 2017 until purchases were made in September of that year.
Cash Flows from Financing Activities
The following table summarizes the changescash equivalents. See above and Note 17: Subsequent Events in our financing cash flows (in thousands):accompanying consolidated financial statements for additional information.
49


  For the Years Ended December 31, Variance 
  2018 2017 2016 2018 2017 
Financing Cash Flows:           
Repayment of long-term obligations $
 $(75,000) $
 $75,000
 $(75,000)
(1) 
Proceeds from exercise of stock options 14,275
 32,003
 17,346
 (17,728) 14,657
(2) 
Proceeds from employee stock purchase plan 
 2,705
 2,361
 (2,705) 344
 
Purchase of treasury stock/tax withholding payments on net share settlement of equity awards (6,252) (4,057) (17,235) (2,195) 13,178
(3) 
Net cash provided by (used in) financing activities $8,023
 $(44,349) $2,472
 $52,372
 $(46,821) 

(1)Contractual Obligations

Our principal commitments at December 31, 2021 include both short and long-term future obligations.

Operating Leases

We have non-cancelable operating lease agreements where we are contractually obligated for certain lease payment amounts. For more information regarding our operating lease obligations, (see Note 5: Leases in our accompanying consolidated financial statements).

Long-term Debt Obligations

As discussed above, in January 2022, we incurred borrowings under Senior Secured Credit Facilities. The principal repayment obligations and estimated interest payments on the term loans and estimated commitment fee payments on the revolver are estimated in the below table. Interest payments on the term loans were estimated using an Adjusted Term SOFR rate and a starting applicable margin on of long-term obligations is1.75% for term loan A and 2.50% for term loan B and the revolver commitment fees were estimated using the initial rate of 0.25%. The applicable margin rate and commitment fee rate will change from time to time in accordance with a preset pricing grid based on the leverage ratio (see Note 17: Subsequent Events in our accompanying consolidated financial statements for pricing grids related to the repaymentSenior Secured Credit Facilities). We expect to fund these obligations with our existing cash and cash equivalents and cash generated from our future operations.

(in millions)
20222023202420252026Thereafter
Term Loan A Principal Payments$15.9 $21.3 $42.5 $42.5 $63.8 $664.1 
Term Loan A Interest Payments20.2 26.0 27.8 28.6 27.8 0.4 
Term Loan B Principal Payments6.4 8.5 8.5 8.5 8.5 809.6 
Term Loan B Interest Payments26.6 31.8 36.4 39.6 40.4 80.3 
Revolver Commitment Fee1.2 1.1 0.9 0.8 0.8 — 
$70.3 $88.7 $116.1 $120.0 $141.3 $1,554.4 

Minimum Purchase Obligations

On February 1, 2022, effective as of the $75 million seller note from Pfizer.January 1, 2022, upon our request, Pfizer executed a Product Addendum to our MSA agreement, see under Part I Item 1 Business Section above for further detail. The Product Addendum includes a minimum purchase obligation of $29.6 million. The Product Addendum expires on November 30, 2022.


(2) Proceeds from the exercise of stock options will vary from period to period based on the volume of options exercised and the exercise price of the specific options exercised.Other Future Capital Investments


(3) In 2018, our employees surrendered 26,307 shares of our common stock from vested restricted stock awards as consideration for approximately $6.3 million in minimum statutory withholding obligations paid on their behalf. In 2017, our employees surrendered 27,636 shares of our common stock from vested restricted stock awards as consideration for approximately $4.1 million in minimum statutory withholding obligations paid on their behalf. In 2016, we purchased 174,885 shares of our common stock under our share purchase plan on the open market for $15.3 million. Additionally in 2016, our employees surrendered 20,261 shares of our common stock from vested restricted stock awards as consideration for approximately $1.9 million in minimum statutory withholding obligations paid on their behalf.

Our common stock purchase plan, which authorized the repurchase of up to $40.0 million of our common stock, was authorized by our Board of Directors and publicly announced on July 19, 2010.  To date, we have purchased a total of $32.8 million of our stock from this plan, leaving a balance of $7.2 million available for future purchases. This plan has no expiration date. We are currently limited on share purchases in accordanceconnection with the termsJanuary 2022 acquisition of Smiths Medical we estimate the investment needed over the next three years for restructuring and conditionsintegration expenses along with spending to support quality systems and quality compliance objectives to be in the range of $200.0 million to $300.0 million. We expect to fund these obligations with our Credit Facility (see Note 11 to the consolidated financial statements in Part II, Item 8 of this Form 10-K).  cash and cash equivalents and cash generated from our operations.

Effects of InflationIndemnifications

We do not believe that inflation and changing prices had a significant impact on our results of operations for any periods presented herein.

New Accounting Pronouncements
See Note 1 to the consolidated financial statements in Part II, Item 8 of this Form 10-K.

Off Balance Sheet Arrangements


In the normal course of business, we have agreed to indemnify our officers and directors to the maximum extent permitted under Delaware law and to indemnify customers as to certain intellectual property matters related to sales of our products. There is no maximum limit on the indemnification that may be required under these agreements. Although we can provide no assurances, we have never incurred, nor do we expect to incur, any liability for indemnification.


Contractual ObligationsHistorical Cash Flows

We have contractual obligations,Cash Flows from Operating Activities

50


Our cash provided by operations was $267.5 million in 2021. Net income plus adjustments for non-cash net expenses contributed $252.5 million to cash provided by operations. Net cash provided by operations as a result of changes in operating assets and liabilities was $15.0 million. The changes in operating assets and liabilities included a $20.8 million decrease in inventories, a $13.8 million decrease in accounts receivable, a $6.3 million increase in accrued liabilities, a $2.3 million increase in accounts payable, and $0.9 million in net changes in income taxes, including excess tax benefits and deferred income taxes. Offsetting these amounts was a $21.0 million increase in other assets and a $8.0 million increase in prepaid expenses and other current assets. The decrease in inventory was primarily due to the timing of production and customer purchases. The decrease in accounts receivable is primarily due to collection efforts. The increase in accrued liabilities was primarily due to the accrual of incentive bonuses, deferred revenue collected on certain arrangements and accruals related to the Smiths Medical transaction. The increase in accounts payable was primarily due to the timing of payments. The net changes in income taxes was a result of the timing of payments. The increase in other assets was primarily due to the purchase of spare parts. The net increase in prepaid expenses and other current assets was primarily due to an increase in deferred costs.

Our cash provided by operations was $222.8 million in 2020. Net income plus adjustments for non-cash net expenses contributed $239.7 million to cash provided by operations. Net cash used in operations as a result of changes in operating assets and liabilities was $17.0 million. The changes in operating assets and liabilities included a $46.4 million decrease in accounts payable, a $29.4 million decrease in accrued liabilities, $18.0 million in net changes in income taxes, including excess tax benefits and deferred income taxes, a $16.1 million increase in other assets, and a $4.3 million increase in prepaid expenses and other current assets. Offsetting these amounts was a $78.0 million decrease in accounts receivable and a $19.2 million decrease in inventories. The decrease in accounts payable was due to the payment of integration-related expenses with extended payment terms and the timing of other payments. The decrease in accrued liabilities was due to the payment of one-time accrued supply chain reorganization costs. The increase in other assets was due to the purchase of spare parts. The net changes in income taxes was a result of the timing of payments. The increase in prepaid expenses and other current assets was primarily due to an increase in deferred costs. The decrease in accounts receivable is primarily due to collection efforts. The decrease in inventory was primarily due to improved inventory management and increased demand for certain products driven by the COVID-19 pandemic at the end of the year.

Our cash provided by operations was $101.9 million in 2019. Net income plus adjustments for non-cash net expenses contributed $213.6 million to cash provided by operations. Net cash used in operations as a result of changes in operating assets and liabilities was $111.6 million. The changes in operating assets and liabilities included a $43.7 million decrease in accrued liabilities, a $29.8 million increase in other assets, a $25.0 million increase in inventories, a $23.7 million increase in accounts receivable, and a $2.7 million decrease in accounts payable. Offsetting these amounts was a $8.6 million decrease in prepaid expenses and other current assets and $4.7 million in net changes in income taxes, including excess tax benefits and deferred income taxes. The decrease in accrued liabilities was primarily a result of the payout of accrued compensation, partially offset by an increase in certain accruals including $22.1 million in accrued costs related to the initial ramp down of IV Solution production. The increase in other assets was primarily related to the purchase of spare parts. The increase in inventory was primarily due to an increase in our finished goods safety stock. The increase in accounts receivable was mainly due to the reclassification of receivables from Pfizer and the timing of revenue and collections. Beginning in 2019, receivables from Pfizer were included in accounts receivable and not in a separate related-party receivable line item as in the prior year. As of December 31, 2018, Pfizer had sold all of approximately the amount set forth in the table below. This amount excludes inventory-related purchase orders for goods and services for current delivery and other open orders for purchases that support normal operations. The majorityits shares of our inventory purchase orders are blanket purchase orders that represent an estimated forecast of goods and services. We do not have a firm commitment liability on the blanket purchase orders. We have excluded from the table below pursuant to ASC 740-10-25 (formerly FIN 48), an interpretation of ASC 740-10 (formerly SFAS 109), a non-current income tax liability of $3.7 millioncommon stock thereby ending its related-party relationship with us. The decrease in accounts payable was due to the high degreetiming of uncertainty regardingpayments. The decrease in prepaid expenses and other current assets was primarily due to the collection of receivable amounts owed from Pfizer. The net changes in income taxes was a result of the timing of payments.
Cash Flows from Investing Activities

The following table summarizes the changes in our investing cash flows (in thousands):
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For the Years Ended December 31,Variance
20212020201920212020
Investing Cash Flows:
Purchases of property, plant and equipment$(68,542)$(92,005)$(97,312)$23,463 $5,307 (1)
Proceeds from sale of assets218 6,176 33 (5,958)6,143 (2)
Intangible asset additions(12,627)(8,385)(8,728)(4,242)343 (3)
Business acquisitions, net of cash acquired(14,452)— (76,133)(14,452)76,133 (4)
Investments in non-marketable equity securities(3,250)— — (3,250)— (5)
Purchases of investment securities(10,034)(32,825)(26,040)22,791 (6,785)(6)
Proceeds from sale of investment securities18,000 28,900 41,292 (10,900)(12,392)(7)
Net cash used in investing activities$(90,687)$(98,139)$(166,888)$7,452 $68,749 
__________________________
(1)    Our purchases of property, plant and equipment will vary from period to period based on additional investments needed to support new and existing products and expansion of our manufacturing facilities.
(2)    In 2020, we sold our Farmers Branch, Texas, U.S. distribution facility for $6.0 million.
(3)    In 2021, we recorded a $6.6 million intangible asset related to a three-year non-compete agreement with one of our international distributors, of which $2.6 million was non-cash offset with a contingent earn-out.
(4)    Our business acquisitions will vary from period to period based upon our current growth strategy and our ability to execute on desirable target companies. In 2021, we acquired a small foreign infusion systems supplier for approximately $15.4 million. In 2019, we acquired Pursuit for approximately $75.0 million in cash consideration and we acquired a small foreign distributor for approximately $4.6 million.
(5)    In 2021, we paid $3.3 million to acquire approximately a 20% non-marketable equity interest in a non public company.
(6)    Our purchases of investment securities will vary from period to period based on current cash needs, planning for known future transactions and changes in our investment strategy. Our investment policy allows for the purchase of securities with final maturities in excess of one year. If cash outflows associatedis not needed for known future transactions our investment strategy takes advantage of the long-term securities with higher yields. Typically, our longer term securities have maturities up to three years.
(7)    Proceeds from the sale of our investment securities will vary based on the maturity dates of the investments.

Cash Flows from Financing Activities
The following table summarizes the changes in our financing cash flows (in thousands):
For the Years Ended December 31,Variance
20212020201920212020
Financing Cash Flows:
Proceeds from short-term debt$— $150,000 $— $(150,000)$150,000 (1)
Repayment of short-term debt— (150,000)— 150,000 (150,000)(1)
Proceeds from exercise of stock options9,372 13,193 7,732 (3,821)5,461 (2)
Payments on finance leases(607)(357)— (250)(357)
Payment of contingent earn-out(17,300)— — (17,300)— (3)
Tax withholding payments related to net share settlement of equity awards(8,335)(12,876)(18,639)4,541 5,763 (4)
Net cash used in financing activities$(16,870)$(40)$(10,907)$(16,830)$10,867 
__________________________
(1)    During 2020, as a result of market uncertainty caused by COVID-19, we borrowed $150.0 million under our revolving Credit Facility as a precautionary measure to increase liquidity. We had fully repaid all amounts borrowed as of December 31, 2020.
(2)    Proceeds from the exercise of stock options will vary from period to period based on the volume of options exercised and the exercise price of the specific options exercised.
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(3)    During 2021, we paid $26.3 million in cash related to the settlement of the Pursuit contingent earn-out. Of the $26.3 million, the amount recorded as the acquisition date fair value, which is considered financing cash flows, was $17.3 million (see Note 8: Fair Value Measurements).
(4)    In 2021, our employees surrendered 40,350 shares of our common stock from vested restricted stock awards as consideration for approximately $8.3 million in minimum statutory withholding obligations paid on their behalf. In 2020, our employees surrendered 67,041 shares of our common stock from vested restricted stock awards as consideration for approximately $12.9 million in minimum statutory withholding obligations paid on their behalf. In 2019, our employees surrendered 80,186 shares of our common stock from vested restricted stock awards as consideration for approximately $18.6 million in minimum statutory withholding obligations paid on their behalf.

Our common stock purchase plan, which authorized the repurchase of up to $100.0 million of our common stock, was approved by our Board of Directors in August 2019. This plan has no expiration date. As of December 31, 2021, all of the $100.0 million available for purchase was remaining under the plan. We are limited on share purchases in accordance with the liabilities.terms and conditions of our Credit Facility (see Note 11: Long-Term Obligations in our accompanying consolidated financial statements).  

  (in thousands)
Contractual Obligations Total 2019 2020 2021 2022 2023 Thereafter
Commitment fee on Credit Facility $880
 $228
 $229
 $228
 $195
 $
 $
Minimum purchase obligations 5,092
 2,311
 2,306
 178
 178
 119
 
Operating leases 48,151
 8,326
 8,572
 6,489
 5,914
 5,615
 13,235
Warehouse service agreements 25,958
 7,261
 6,302
 4,797
 4,221
 3,117
 260
  $80,081
 $18,126
 $17,409
 $11,692
 $10,508
 $8,851
 $13,495
New Accounting Pronouncements

See Note 1: Basis of Presentation and Summary of Significant Accounting Policies to the Consolidated Financial Statements in Part II, Item 8 of this Annual Report on Form 10-K. 

Critical Accounting Policies and Estimates
 
Our significant accounting policies are summarized in Note 1 to the Consolidated Financial Statements. In preparing our consolidated financial statements in accordance with GAAP and pursuant to the rules and regulations of the SEC, we make estimates, assumptions and judgments that affect the reported amounts of assets, liabilities, revenue and expenses, and related disclosures of contingent assets and liabilities. We base our estimates, assumptions and judgments on historical experience and other factors that we believe are reasonable. We evaluate our estimates, assumptions and judgments on a regular basis and apply our accounting policies on a consistent basis. We believe that the estimates, assumptions and judgments involved in the accounting for investment securities, revenue recognition, accounts receivable inventories, property, plant and equipment and related depreciation, income taxes and business combinations have the most potential impact on our consolidated financial statements. Historically, our estimates, assumptions and judgments relative to our critical accounting policies have not differed materially from actual results.
 
Revenue recognition

Adoption of ASC Topic 606, “Revenue from Contracts with Customers”

We adopted ASU No. 2014-09, Revenue from Contracts with Customers (ASC Topic 606), effective January 1, 2018 using the modified retrospective method applied to those contracts which were not completed as of January 1, 2018. Due to the cumulative impact, net of tax, of adopting ASC Topic 606, we recorded a net increase of $6.3 million to opening retained earnings as of January 1, 2018. The impact is primarily related to our bundled arrangements where we sell software licenses and implementation services, in addition to equipment, consumables and solutions. Under ASC Topic 605, revenue for the equipment was recognized upon delivery and software licenses and implementation services were typically recognized over the contract term. Under ASC Topic 606, revenue for the bundled equipment, software and software implementation services are recognized upon implementation. This results in an acceleration of software related revenue, offset by a delay in the recognition of related revenue of the equipment. Under ASC Topic 605, consumables and solutions revenues were typically recognized upon delivery. Under ASC 606, consumables and solutions revenues are recognized as the customer obtains control of the asset, which is at shipping point. This results in an acceleration in the recognition of consumables and solutions revenue.

Additionally, the timing of revenue recognition for software license renewals changed under ASC Topic 606. Under ASC Topic 605, revenue related to software renewals was recognized on a ratable basis over the license period. Under ASC Topic 606, the license, which is considered functional IP, is considered to be transferred to the customer at a point in time, specifically, at the start of each annual renewal period. As a result, under ASC Topic 606, revenue related to our annual software license renewals is accelerated when compared to ASC Topic 605.
Revenue recognition ASC Topic 606


We recognize revenues when we transfer control of promised goods to our customers in an amount that reflects the consideration to which we expect to be entitled to in exchange for those goods. We offer certain volume-based rebates to our distribution customers, which we consider variable consideration when calculating the transaction price. Rebates are offered on both a fixed and tiered/variable basis. In both cases, we use information available at the time and our historical experience with each customer to estimate the most likely rebate amount. We also provide chargebacks to distributors that sell to end-customersend customers at prices determined under a contract between us and the end-customer.
end customer. Chargebacks are the difference between prices we charge our distribution customers and contracted prices we have with the end customer which are processed as credits to our distribution customers. In estimating the most likely rebate andexpected value of chargeback amounts for use in determining the transaction price, we use information available at the time, andincluding our historical experience. We also warrant products against defects and have a policy permitting the return of defective products, for which we accrue and expense at the time of sale using information available and our historical experience. Our revenues are recorded at the net sales price, which includes an estimate for variable consideration related to rebates, chargebacks and product returns.


The vast majority of our sales of Infusion Consumables, Infusion Systems, IV Solutions Infusion Systems and Critical Care products are sold on a standalone basis and control of these products transfers to the customer upon shipment.


Our software license renewals are considered to be transferred to a customer at a point in time at the start of each renewal period, therefore revenue is recognized at that time.    


Arrangements with Multiple Deliverables


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In certain circumstances, we enter into arrangements in which we provide multiple deliverables to our customers. These bundled arrangements typically consist of the sale of infusion systems equipment, along with annual software licenses and related software implementation services, as well as infusion consumables, IV solutions and extended warranties.
Our most significant judgments related to these arrangements are (i) identifying the various performance obligations and (ii) estimating the relative standalone selling price of each performance obligation, typically using a directly observable method or calculated on a cost plus margin basis method. Revenue related to the bundled equipment, software and software implementation services is recognized upon implementation. The transaction price allocated to the extended service-type warranty is recognized as revenue over the period the warranty service is provided.


Accounts receivable


Accounts receivable are stated at net realizable value. An allowance is provided for estimated collection losses based on an analysis of the age of the receivable, or on specific past due accounts for which we consider collection to be doubtful and based on current receivables where known economic conditions specific to individual significant customers may indicate collection is doubtful. We rely on prior payment trends, financial status and other factors to estimate the cash which ultimately will be received. Such amounts cannot be known with certainty at the financial statement date. We regularly review individual past due balances for collectability. Loss exposure is principally with international customers for whom normal payment terms are long in comparison to those of our other customers and to a lesser extent,with domestic distributors. Many of these distributors are relatively small and we are vulnerable to adverse developments in their businesses that can hinder our collection of amounts due. If actual collection losses exceed expectations, we could be required to accrue additional bad debt expense, which could have an adverse effect on our operating results in the period in which the accrual occurs.
 
Inventories

Inventories are stated at the lower of cost (first in, first out) or net realizable value. We need to carry many components to accommodate our rapid product delivery, and if we overestimate demand or if customer requirements change, we may have components in inventory that we may not be able to use. Most finished products are made only after we receive orders except for certain standard (non-custom) products which we will carry in inventory in expectation of future orders. For finished products in inventory, we need to estimate what may not be saleable. We regularly review inventory and reserve for slow moving items, and write off all items that we do not expect to use in manufacturing, and finished products that we do not expect to sell. If actual usage of components or sales of finished goods inventory is less than our estimates, we could be required to write off additional inventory, which could have an adverse effect on our operating results in the period in which the write-off occurs.


If our excess and obsolete reserve changed by 1% our cost of goods sold and gross margin would be impacted by $0.8 million with no impact to our gross margin percentage.

Property, plant and equipment/depreciation

Property, plant and equipment is carried at cost and depreciated on the straight-line method over the estimated useful lives. The estimates of useful lives are significant judgments in accounting for property, plant and equipment, particularly for molds and automated assembly machines that are custom made for us. We may retire them on an accelerated basis if we replace them with larger or more technologically advanced tooling. The remaining useful lives of all property, plant and equipment are reviewed regularly and lives are adjusted or assets written off based on current estimates of future use. As part of that review, property, plant and equipment is reviewed for other indicators of impairment. An unexpected shortening of useful lives of property, plant and equipment that significantly increases depreciation provisions, or other circumstances causing us to record an impairment loss on such assets, could have an adverse effect on our operating results in the period in which the related charges are recorded.

Income Taxes

We utilize the asset and liability method of accounting for income taxes as set forth in ASC 740. Under the liability method, deferred taxes are determined based on the temporary differences between the financial statement and tax basis of assets and liabilities using tax rates expected to be in effect during the years in which the basis differences reverse. A valuation allowance is recorded when it is more likely than not that some of the deferred tax assets will not be realized. In determining the need for valuation allowances we consider projected future taxable income and the availability of tax planning strategies. If in the future we determine that we would not be able to realize our recorded deferred tax assets, an increase in the valuation allowance would be recorded, decreasing earnings in the period in which such determination is made.

We are subject to income taxes throughout the U.S. and in numerous foreign jurisdictions. We recognize the financial statement benefits for uncertain tax positions as set forth in ASC 740 only if it is more-likely-than-not to be sustained in the event of challenges by relevant taxing authorities based on the technical merit of each tax position. The amounts of uncertain tax positions recognized are the largest benefits that have a greater than 50 percent likelihood of being realized upon settlement with the relevant tax authorities.

On December 22, 2017, the U.S. government enacted comprehensive tax legislation referred to as the Tax Cuts and Jobs Act (the “Tax Act”). Shortly after the Tax Act was enacted, the SEC issued Staff Accounting Bulletin No. 118, Income Tax Accounting Implications of the Tax Cuts and Jobs Act ("SAB 118"), which provides guidance on accounting for the Tax Act’s impact. SAB 118 provides a measurement period, which should not extend beyond one year from the Tax Act enactment date, during which a company acting in good faith may complete the accounting for the impacts of the Tax Act under ASC Topic 740. In accordance with SAB 118, we must reflect the income tax effects of the Tax Act in the reporting period in which the accounting under ASC Topic 740 is complete.

As noted at 2017 year-end, we were able to reasonably estimate certain effects and, therefore, recorded provisional adjustments associated with the toll charge on undistributed foreign earnings and profits and revaluation of deferred taxes. Measurement-period adjustments for the toll charge and revaluation of deferred taxes recognized during the year ended December 31, 2018 did not have a material impact on our consolidated financial statements. The effect of the measurement-period adjustments on the 2018 effective tax rate was approximately a three percentage point increase. As of December 31, 2018, our accounting for the Tax Act is complete. For further information, see Note 12 to the consolidated financial statements in Part II, Item 8 of this Form 10-K.

Business Combinations


The application of the acquisition method of accounting for business combinations requires the use of significant estimates, assumptions and judgments in the determination of the estimated fair value of assets acquired and liabilities assumed in order to properly allocate the purchase price at the acquisition date.


Although we believe the estimates, assumptions and judgments we have made are reasonable, they are based in part on historical experience, industry data, information obtained from the management of the acquired companies and assistance from independent third-party appraisal firms, and are inherently uncertain.


Examples of critical estimates in valuing certain of the tangible and intangible assets we have acquired, and certain liabilities assumed include but are not limited to:


Inventories - we used the comparative sales method, which estimates the selling price of finished goods and work-in-progress inventory, reduced by estimated costs expected to be incurred in selling the inventory and a profit on those costs. The fair value of inventory is recognized in our statements of operations as the inventory is sold. Based on internal forecasts and estimates of inventory turnover, acquisition date inventory is sold and recognized in cost of goods sold over an estimated period of six months after the acquisition date.


Property, Plant and Equipment - the fair value estimate of acquired property, plant and equipment is determined based upon the nature of the asset using either the cost approach, the sales comparison approach or the income capitalization approach. The cost approach measures the value of an asset by estimating the cost to acquire or reproduce comparable assets. The sales comparison approach measures the value of an asset through an analysis of comparable property sales. The income approach values the asset based on its earnings potential. The fair value of land was estimated using a sales comparison approach. Land and building improvements were valued using the cost approach. Personal property assets, such as, leasehold improvements, tooling, laboratory equipment, furniture and fixtures, and equipment, computer hardware, computer software, dies and molds were all valued using the cost approach. Transportation equipment and major manufacturing and equipment were valued using the sales comparison method. Construction-in-progress assets were valued based on the cost approach less adjustments for the nature of the assets. The fair value of property, plant and equipment will be recognized in our statements of operations over the expected useful life of the individual depreciable assets.


Identifiable Intangible Assets - The fair value of the significant acquired identifiable intangible assets generally is determined using varying methods under the income approach. This method starts with a forecast of all of the expected future net cash flows associated with the asset and then adjusts the forecast to present value by applying an appropriate discount rate that reflects the risk factors associated with the cash flow streams.

54



EarnoutEarn-out Liability - The fair value of the earnout wasearn-out liabilities were valued using a Monte Carlo simulation and a probability-weighted cash flow model, as appropriate (see Note 88: Fair Value Measurements to the consolidated financial statements in Part II, Item 8 of this Annual Report on Form 10-K for details).


Unanticipated events and circumstances may occur which may affect the accuracy or validity of such assumptions, estimates or actual results.


Forward Looking Statements


Various portions of this Annual Report on Form 10-K, including this Management’s Discussion and Analysis of Financial Condition and Results of Operations, and documents referenced herein, describe trends in our business and finances that we perceive and state some of our expectations and beliefs about our future. These statements about the future are “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, and we may identify them by using words such as "anticipate," "believe," "expect," "estimate," "intend," "plan," "will," "continue," "could," "may," and by similar expressions and statements about aims, goals and plans. The forward looking statements are based on the best information currently available to us and assumptions that we believe are reasonable, but we do not intend the statements to be representations as to future results. They include, without limitation, statements about:


future growth; future operating results and various elements of operating results, including future expenditures and effects with respect to sales and marketing and product development and acquisition efforts; future sales and unit volumes of products; expected increases and decreases in sales; deferred revenue; accruals for restructuring charges, future license, royalty and revenue share income; production costs; gross margins; litigation expense; future SG&A and R&D expenses; manufacturing expenses; future costs of expanding our business; income; losses; cash flow; amortization; source of funds for capital purchases and operations; future tax rates; alternative sources of capital or financing; changes in working capital items such as receivables and inventory; selling prices; and income taxes;

factors affecting operating results, such as shipments to specific customers; reduced dependence on current proprietary products; loss of a strategic relationship; change in demand; domestic and international sales; expansion in international markets, selling prices; future increases or decreases in sales of certain products and in certain markets and distribution channels; maintaining strategic relationships and securing long-term and multi-product contracts with large healthcare providers and major buying organizations; increases in systems capabilities; introduction, development and sales of new products, acquisition and integration of businesses and product lines (including the Smiths Medical business); benefits of our business; income; losses; cash flow; amortization; source of funds for capital purchases and operations; future tax rates; alternative sources of capital or financing; changes in working capital items such as receivables and inventory; selling prices; and income taxes;

factors affecting operating results, such as shipments to specific customers; reduced dependence on current proprietary products; loss of a strategic relationship; change in demand; domestic and international sales; expansion in international markets, selling prices; future increases or decreases in sales of certain products and in certain markets and distribution channels; maintaining strategic relationships and securing long-term and multi-product contracts with large healthcare providers and major buying organizations; increases in systems capabilities; introduction, development and sales of new products, acquisition and integration of businesses and product lines, including the HIS business, SwabCap (EXC) and Tangent; benefits of our

products over competing systems; qualification of our new products for the expedited Section 510(k) clearance procedure; possibility of lengthier clearance process for new products; planned increases in marketing; warranty claims; rebates; product returns; bad debt expense; amortization expense; inventory requirements; lives of property, plant and equipment; manufacturing efficiencies and cost savings; unit manufacturing costs; establishment or expansion of production facilities inside or outside of the U.S.; planned new orders for semi-automated or fully automated assembly machines for new products; adequacy of production capacity; results of R&D; our plans to repurchase shares of our common stock; asset impairment losses; relocation of manufacturing facilities and personnel; effect of expansion of manufacturing facilities on production efficiencies and resolution of production inefficiencies; the effect of costs to customers and delivery times; business seasonality and fluctuations in quarterly results; customer ordering patterns and the effects of new accounting pronouncements; and

new or extended contracts with manufacturers and buying organizations; dependence on a small number of customers; loss of larger distributors and the ability to locate other distributors; the impact of our acquisition of the HIS business; growth of our Clave products in future years; design features of Clave products; the outcome of our strategic initiatives; regulatory approvals and compliance; outcome of litigation; patent protection and intellectual property landscape; patent infringement claims and the impact of newly issued patents on other medical devices; competitive and market factors, including continuing development of competing products by other manufacturers; improved production processes and higher volume production; innovation requirements; consolidation of the healthcare provider market and downward pressure on selling prices; distribution or financial capabilities of competitors; healthcare reform legislation; use of treasury stock; working capital requirements; liquidity and realizable value of our investment securities; future investment alternatives; foreign currency denominated financial instruments; foreign exchange risk; commodity price risk; our expectations regarding liquidity and capital resources over the next twelve months; capital expenditures; plans to convert existing space; acquisitions of other businesses or product lines, indemnification liabilities and contractual liabilities.


new or extended contracts with manufacturers and buying organizations; dependence on a small number of customers; loss of larger distributors and the ability to locate other distributors; the impact of our acquisition of the Smiths Medical business; growth of our Clave products in future years; design features of Clave products; the outcome of our strategic initiatives; regulatory approvals and compliance; outcome of litigation; patent protection and intellectual property landscape; patent infringement claims and the impact of newly issued patents on other medical devices; competitive and market factors, including continuing development of competing products by other manufacturers; improved production processes and higher volume production; innovation requirements; consolidation of the healthcare provider market and downward pressure on selling prices; distribution or financial capabilities of competitors; healthcare reform legislation; use of treasury stock; working capital requirements; liquidity and realizable value of our investment securities; future investment alternatives; foreign currency denominated financial instruments; foreign exchange risk; commodity price risk; our expectations regarding liquidity and capital resources over the next twelve months; capital expenditures; plans to convert existing space; acquisitions of other businesses or product lines, indemnification liabilities and contractual liabilities.

55


Forward-looking statements involve certain risks and uncertainties, which may cause actual results to differ materially from those discussed in each such statement.  First, one should consider the factors and risks described in the statements themselves or otherwise discussed herein. Those factors are uncertain, and if one or more of them turn out differently than we currently expect, our operating results may differ materially from our current expectations.

Second, investors should read the forward looking statements in conjunction with the Risk Factors discussed in Item 1A of this Annual Report on Form 10-K.  Also, actual future operating results are subject to other important factors and risks that we cannot predict or control, including without limitation, the following:


general economic and business conditions, both in the U.S. and internationally;
unexpected changes in our arrangements with our large customers;
outcome of litigation;
fluctuations in foreign exchange rates and other risks of doing business internationally;
increases in labor costs or competition for skilled workers;
increases in costs or availability of the raw materials need to manufacture our products;
the effect of price and safety considerations on the healthcare industry;
competitive factors, such as product innovation, new technologies, marketing and distribution strength and price erosion;
the successful development and marketing of new products;
unanticipated market shifts and trends;
the impact of legislation affecting government reimbursement of healthcare costs;
changes by our major customers and independent distributors in their strategies that might affect their efforts to market our products;
the effects of additional governmental regulations;
unanticipated production problems; and
the availability of patent protection and the cost of enforcing and of defending patent claims.

the impacts of the COVID-19 pandemic on us, our business and on domestic and global economies generally;
the integration of Smiths Medical by the Company being more difficult, time-consuming or costly than expected;
general economic and business conditions, both in the U.S. and internationally;
unexpected changes in our arrangements with Pfizer or our other large customers;
outcome of litigation;
fluctuations in foreign exchange rates and other risks of doing business internationally;
increased competition for skilled workers;
decreases in availability of the raw materials need to manufacture our products;
the effect of price and safety considerations on the healthcare industry;
competitive factors, such as product innovation, new technologies, marketing and distribution strength and price erosion;
the successful development and marketing of new products;
unanticipated market shifts and trends;
the impact of legislation affecting government reimbursement of healthcare costs;
changes by our major customers and independent distributors in their strategies that might affect their efforts to market our products;
the effects of additional governmental regulations;
unanticipated production problems;
acquisition and integration expenses (including as it relates to the Smiths Medical acquisition);
the availability of patent protection and the cost of enforcing and of defending patent claims;
natural disasters and outbreak of disease or illness;
labor shortages;
supply chain constraints or disruptions;
impact of inflation on raw materials, freight charges and labor, especially in the U.S.; and
interest rate increases.

The forward looking statements in this report are subject to additional risks and uncertainties, including those detailed from time to time in our other filings with the Securities and Exchange Commission. These forward-looking statements are made only as of the date hereof and, except as required by law, we undertake no obligation to update or revise any of them, whether as a result of new information, future events or otherwise.



56


ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
 
Interest Rate Risk

If we were to incur borrowings under our Credit Facility, we would face market risk stemming from changes in interest rates.

In connection with the Smiths Medical acquisition on January 6, 2022 we entered into Senior Secured Credit Facilities totaling approximately $2.2 billion consisting of a variable-rate term loan A facility of $850.0 million, a variable-rate term loan B facility of $850.0 million and a revolving credit facility of $500.0 million. We will be exposed to changes in interest rates on all of these variable-rate debt instruments. In order to mitigate a portion of the interest rate risk exposure associated with these debt instruments in November 2021 we entered into forward-starting interest rate swaps to achieve a targeted mix of fixed and variable-rate debt (see Note 7: Derivatives and Hedging Activities to the Consolidated Financial Statements in Part II, Item 8 of this Annual Report on Form 10-K).

Foreign Exchange Risk


We havetransact business globally in multiple currencies, some of which are considered volatile. Our international revenues and expenses and working capital positions denominated in these foreign currencies expose us to the risk of fluctuations in foreign currency exchange risk relatedrates against the U.S. dollar. As the receiver of foreign currencies we are adversely affected by the strengthening of the U.S. dollar relative to foreign-denominated cash, accounts receivable and accounts payable. the foreign currency.

In our European operations, our net Euro asset position at December 31, 20182021 was approximately €61.6€35.9 million. A 10% change in the conversion of the Euro to the U.S. dollar for our cash, accounts receivable, accounts payable and accrued liabilities from the December 31, 20182021 spot rate would impact our consolidated amounts on these balance sheet items by approximately $7.1$4.1 million, or 2.6%0.9% of these net assets. In our Canadian operations, our net Canadian dollar asset position at December 31, 2018 was approximately $58.3 million. A 10% changeWe expect that in the conversionfuture, with the growth of the Canadian dollarour European distribution operations, net Euro denominated instruments will continue to the U.S. dollar for our cash, accounts receivable, accounts payable and accrued liabilities from the December 31, 2018 spot rate would impact our consolidated amounts on these balance sheet items by approximately $4.3 million, or 1.6% of these net assets.increase. We currently do not hedge our Canadian dollar or Euro foreign currency exposures.


We have manufacturing facilities and conduct business transactions denominated in the Mexican Peso. During 2017, we began toWe hedge a portion of our manufacturing spend, which reducedreduces our exposure to the foreign currency exchange risk related to the Mexican Peso (see Note 7,7: Derivatives and Hedging Activities to the consolidated financial statementsConsolidated Financial Statements in Part II, Item 8 of this Annual Report on Form 10-K).



ITEM 8.  FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA

INDEX TO CONSOLIDATED FINANCIAL STATEMENTS AND SCHEDULE
Page No.


 





57


REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM


To the stockholders and the Board of Directors of ICU Medical, Inc.



Opinion on the Financial Statements


We have audited the accompanying consolidated balance sheets of ICU Medical, Inc. and subsidiaries (the "Company") as of December 31, 20182021 and 2017, and2020, the related consolidated statements of operations, comprehensive income, stockholders' equity, and cash flows, for each of the three years in the period ended December 31, 2018,2021, and the related notes and the financial statement 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, 20182021 and 2017,2020, and the results of its operations and its cash flows for each of the three years in the period ended December 31, 2018,2021, 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, 2018,2021, based on criteria established in Internal Control - Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission and our report dated March 1, 2019,February 25, 2022, expressed an unqualified opinion on the Company's internal control over financial reporting.


Basis for Opinion


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


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



Critical Audit Matter


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

Revenue Recognition – Chargeback Reserve — Refer to Notes 1 and 4 to the financial statements

Critical Audit Matter Description

The Company recognizes revenue for product sales net of a reserve for estimated chargebacks. Chargebacks are the difference between prices the Company charges distribution customers and contracted prices the Company has with the end-customer which are processed as credits to the distribution customers.

Chargebacks are accounted for as variable consideration when determining the transaction price for purposes of recognizing revenue. The Company estimates and reserves for chargebacks as a reduction of revenue at the time of sale to its distribution customers using information available at that time, including historical experience. Accounts receivable as of December 31, 2021 of $106 million and total revenues for the year ended December 31, 2021 of $1,316 million are recorded net of estimated chargebacks.

Given the subjectivity and complexity of evaluating management’s assumptions used in the determination of the chargeback reserve, including the chargeback amount related to monthly sales to distribution customers and the time to settle chargeback obligations, auditing the chargeback reserve requires a high degree of auditor judgment and an increased extent of effort.

How the Critical Audit Matter Was Addressed in the Audit

Our audit procedures related to the chargeback reserve included the following, among others:

We tested the effectiveness of controls related to management’s assessment of assumptions related to estimating the provision for chargeback reserves, the provisioning, processing, and monitoring of chargeback transactions, and the reconciliation of chargeback reserves.

We tested chargeback estimates for purposes of determining whether revenues recognized at the time of sale were recorded in the proper period.

We evaluated the methods and assumptions used by management to estimate the chargeback reserve by:
58


Analyzing trends in the chargeback provision as a percent of revenues and the chargeback reserve as a percent of revenues.

Testing the underlying data, including historical sales to distribution customers and chargeback settlements with distribution customers, that are utilized as the basis for the chargeback reserve, to test whether the inputs to the estimate were reasonable.

Developing an expectation of the chargeback reserve based on monthly sales to distribution customers, historical experience, and the time to settle chargeback obligations, and comparing our expectation to the amount recorded by management.

Performing retrospective reviews comparing management’s estimates of expected chargeback reserves to actual amounts incurred subsequent to the dates of estimation, to assess management’s ability to reasonably estimate these obligations and to identify potential bias in management’s assessment of the reserve.


/s/ DELOITTE & TOUCHE LLP

Costa Mesa, California
February 25, 2022
/s/ Deloitte & Touche LLP
Costa Mesa, California
March 1, 2019
We have served as the Company's auditor since 2008

59


ICU MEDICAL, INC. AND SUBSIDIARIES

CONSOLIDATED BALANCE SHEETS
(Amounts in thousands, except par value data)
December 31,December 31,
2018 201720212020
ASSETS   ASSETS
CURRENT ASSETS:   CURRENT ASSETS:
Cash and cash equivalents$344,781
 $290,072
Cash and cash equivalents$552,827 $396,097 
Short-term investment securities37,329
 10,061
Short-term investment securities14,420 14,687 
TOTAL CASH, CASH EQUIVALENTS AND SHORT-TERM INVESTMENT SECURITIES382,110
 300,133
TOTAL CASH, CASH EQUIVALENTS AND SHORT-TERM INVESTMENT SECURITIES567,247 410,784 
Accounts receivable, net of allowance for doubtful accounts of $5,768 and $3,311 at December 31, 2018 and 2017, respectively176,298
 112,696
Accounts receivable, net of allowance for doubtful accounts of $7,038 and $21,490 at December 31, 2021 and 2020, respectivelyAccounts receivable, net of allowance for doubtful accounts of $7,038 and $21,490 at December 31, 2021 and 2020, respectively105,894 124,093 
Inventories311,163
 288,657
Inventories290,235 314,928 
Prepaid income taxes11,348
 10,594
Prepaid income taxes19,586 29,480 
Prepaid expenses and other current assets25,980
 41,286
Prepaid expenses and other current assets46,847 41,492 
Related-party receivable20,137
 98,807
Assets held-for-sale
 12,489
TOTAL CURRENT ASSETS927,036
 864,662
TOTAL CURRENT ASSETS1,029,809 920,777 
   
PROPERTY, PLANT AND EQUIPMENT, net432,641
 398,684
PROPERTY, PLANT AND EQUIPMENT, net468,365 466,628 
OPERATING LEASE RIGHT-OF-USE ASSETSOPERATING LEASE RIGHT-OF-USE ASSETS39,847 46,571 
LONG-TERM INVESTMENT SECURITIES2,025
 14,579
LONG-TERM INVESTMENT SECURITIES4,620 12,974 
GOODWILL11,195
 12,357
GOODWILL43,439 33,001 
INTANGIBLE ASSETS, net133,421
 143,753
INTANGIBLE ASSETS, net188,311 197,231 
DEFERRED INCOME TAXES38,654
 24,775
DEFERRED INCOME TAXES42,604 31,034 
OTHER ASSETS40,419
 38,141
OTHER ASSETS63,743 55,475 
TOTAL ASSETS$1,585,391
 $1,496,951
TOTAL ASSETS$1,880,738 $1,763,691 
LIABILITIES AND STOCKHOLDERS’ EQUITY 
  
LIABILITIES AND STOCKHOLDERS’ EQUITY  
CURRENT LIABILITIES: 
  
CURRENT LIABILITIES:  
Accounts payable$120,469
 $78,228
Accounts payable$81,128 $71,864 
Accrued liabilities128,820
 132,064
Accrued liabilities118,195 97,021 
Income tax payableIncome tax payable1,454 303 
Contingent earn-out liabilityContingent earn-out liability— 26,300 
TOTAL CURRENT LIABILITIES249,289
 210,292
TOTAL CURRENT LIABILITIES200,777 195,488 
   
CONTINGENT EARN-OUT LIABILITY47,400
 27,000
CONTINGENT EARN-OUT LIABILITY2,589 — 
OTHER LONG-TERM LIABILITIES20,592
 55,326
OTHER LONG-TERM LIABILITIES41,830 47,835 
DEFERRED INCOME TAXES721
 1,487
DEFERRED INCOME TAXES1,490 1,663 
INCOME TAX LIABILITY3,734
 4,592
INCOME TAX LIABILITY18,021 16,440 
COMMITMENTS AND CONTINGENCIES (Note 15)
 
COMMITMENTS AND CONTINGENCIES (Note 15)— — 
STOCKHOLDERS’ EQUITY: 
  
STOCKHOLDERS’ EQUITY:  
Convertible preferred stock, $1.00 par value Authorized—500 shares; Issued and outstanding— none
 
Common stock, $0.10 par value — Authorized—80,000 shares; Issued 20,492 shares at December 31, 2018 and 20,210 at December 31, 2017 and outstanding 20,491 shares at December 31, 2018 and 20,210 shares at December 31, 20172,049
 2,021
Convertible preferred stock, $1.00 par value; Authorized—500 shares; Issued and outstanding— noneConvertible preferred stock, $1.00 par value; Authorized—500 shares; Issued and outstanding— none— — 
Common stock, $0.10 par value; Authorized—80,000 shares; Issued—21,280 and 21,058 shares at December 31, 2021 and 2020, respectively, and outstanding—21,280 and 21,058 shares at December 31, 2021 and 2020, respectivelyCommon stock, $0.10 par value; Authorized—80,000 shares; Issued—21,280 and 21,058 shares at December 31, 2021 and 2020, respectively, and outstanding—21,280 and 21,058 shares at December 31, 2021 and 2020, respectively2,128 2,106 
Additional paid-in capital657,899
 625,568
Additional paid-in capital721,412 693,068 
Treasury stock, at cost(95) 
Treasury stock, at cost (119 and 209 shares, respectively)Treasury stock, at cost (119 and 209 shares, respectively)(27)(39)
Retained earnings620,747
 585,624
Retained earnings911,787 808,652 
Accumulated other comprehensive loss(16,945) (14,959)Accumulated other comprehensive loss(19,269)(1,522)
TOTAL STOCKHOLDERS' EQUITY1,263,655
 1,198,254
TOTAL STOCKHOLDERS' EQUITY1,616,031 1,502,265 
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY$1,585,391
 $1,496,951
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY$1,880,738 $1,763,691 
The accompanying notes are an integral part of these consolidated financial statements.

60


ICU MEDICAL, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF OPERATIONS
(Amounts in thousands, except per share data)

 Year ended December 31,
 2018 2017 2016
REVENUES: 
  
  
Net sales$1,400,040
 $1,292,166
 $379,339
Other
 447
 33
TOTAL REVENUE1,400,040
 1,292,613
 379,372
COST OF GOODS SOLD830,012
 866,518
 177,974
GROSS PROFIT570,028
 426,095
 201,398
OPERATING EXPENSES: 
  
  
Selling, general and administrative328,146
 303,953
 89,426
Research and development52,867
 51,253
 12,955
Restructuring, strategic transaction and integration expense105,390
 77,967
 15,348
Change in fair value of contingent earn-out20,400
 8,000
 
Contract settlement41,613
 
 
Impairment of assets held for sale
 
 728
TOTAL OPERATING EXPENSES548,416
 441,173
 118,457
INCOME (LOSS) FROM OPERATIONS21,612
 (15,078) 82,941
BARGAIN PURCHASE GAIN
 70,890
 1,456
INTEREST EXPENSE(709) (2,047) (118)
OTHER INCOME (EXPENSE), NET1,471
 (2,482) 885
INCOME BEFORE INCOME TAXES22,374
 51,283
 85,164
BENEFIT (PROVISION) FOR INCOME TAXES6,419
 17,361
 (22,080)
NET INCOME$28,793
 $68,644
 $63,084
NET INCOME PER SHARE 
  
  
Basic$1.41
 $3.50
 $3.90
Diluted$1.33
 $3.29
 $3.66
WEIGHTED AVERAGE NUMBER OF SHARES 
  
  
Basic20,394
 19,614
 16,168
Diluted21,601
 20,858
 17,254
The accompanying notes are an integral part of these consolidated financial statements.

ICU MEDICAL, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME
(Amounts in thousands)

 Year ended December 31,
 2018 2017 2016
Net income$28,793
 $68,644
 $63,084
Other comprehensive income (loss), net of tax:     
Cash flow hedge adjustments, net of tax of $317 and $224 for the years ended December 31, 2018 and 2017, respectively1,003
 (365) 
Foreign currency translation adjustment, net of tax of $0, $56 and $185 for the years ended December 31, 2018, 2017 and 2016, respectively(3,104) 6,694
 (514)
Other adjustments, net of tax of $0 for all periods115
 (16) 
Other comprehensive (loss) income, net of tax(1,986) 6,313
 (514)
Comprehensive income$26,807
 $74,957
 $62,570
 Year ended December 31,
 202120202019
TOTAL REVENUES$1,316,308 $1,271,004 $1,266,208 
COST OF GOODS SOLD824,818 809,507 794,344 
GROSS PROFIT491,490 461,497 471,864 
OPERATING EXPENSES:  
Selling, general and administrative302,583 283,953 276,982 
Research and development47,498 42,948 48,611 
Restructuring, strategic transaction and integration18,037 28,409 80,574 
Change in fair value of contingent earn-out— 9,000 (47,400)
Contract settlement127 (975)5,737 
TOTAL OPERATING EXPENSES368,245 363,335 364,504 
INCOME FROM OPERATIONS123,245 98,162 107,360 
INTEREST EXPENSE(858)(1,753)(549)
OTHER INCOME, NET799 1,085 7,896 
INCOME BEFORE INCOME TAXES123,186 97,494 114,707 
PROVISION FOR INCOME TAXES(20,051)(10,624)(13,672)
NET INCOME$103,135 $86,870 $101,035 
NET INCOME PER SHARE  
Basic$4.86 $4.16 $4.90 
Diluted$4.74 $4.02 $4.69 
WEIGHTED AVERAGE NUMBER OF SHARES  
Basic21,206 20,907 20,629 
Diluted21,781 21,591 21,545 
 
The accompanying notes are an integral part of these consolidated financial statements.



ICU MEDICAL, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
(Amounts in thousands)
61
  Common Stock       Accumulated  
      Additional     Other  
  Shares Amount 
Paid-In
Capital
 
Treasury
Stock
 
Retained
Earnings
 
Comprehensive
Income (Loss)
 Total
Balance, January 1, 2016 16,086
 $1,608
 $145,125
 $
 $453,896
 $(20,758) $579,871
Issuance of restricted stock and exercise of stock options 416
 22
 103
 17,221
 
 
 17,346
Purchase of treasury stock/treasury stock acquired in lieu of cash payment on stock option exercises/tax withholding payments related to net share settlement of equity awards (195) 
 
 (17,235) 

 

 (17,235)
Proceeds from employee stock purchase plan 31
 3
 2,358
 
 
 
 2,361
Stock compensation 
 
 15,242
 
 
 
 15,242
Foreign currency translation adjustment 
 
 
 
 
 (514) (514)
Net income 
 
 
 
 63,084
 
 63,084
Balance, December 31, 2016 16,338
 1,633
 162,828
 (14) 516,980
 (21,272) 660,155
Issuance of restricted stock and exercise of stock options 676
 66
 27,866
 4,071
 
 
 32,003
Tax withholding payments related to net share settlement of equity awards (27) 
 
 (4,057) 

 

 (4,057)
Issuance of common stock for acquisitions 3,200
 320
 412,819
 
 
 
 413,139
Proceeds from employee stock purchase plan 23
 2
 2,703
 
 
 
 2,705
Stock compensation 
 
 19,352
 
 
 
 19,352
Foreign currency translation adjustment 
 
 
 
 
 6,313
 6,313
Net income 
 
 
 
 68,644
 
 68,644
Balance, December 31, 2017 20,210
 2,021
 625,568
 
 585,624
 (14,959) 1,198,254
Cumulative effect of accounting change 
 
 
 
 6,330
 
 6,330
Issuance of restricted stock and exercise of stock options 307
 28
 8,090
 6,157
 
 
 14,275
Tax withholding payments related to net share settlement of equity awards (26) 
 
 (6,252)     (6,252)
Stock compensation 
 
 24,241
 
 
 
 24,241
Other comprehensive income, net of tax 
 
 
 
 
 (1,986) (1,986)
Net income 
 
 
 
 28,793
 
 28,793
Balance, December 31, 2018 20,491
 $2,049
 $657,899
 $(95) $620,747
 $(16,945) $1,263,655

 The accompanying notes are an integral part of these consolidated financial statements.


ICU MEDICAL, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWSCOMPREHENSIVE INCOME
(Amounts in thousands)
 Year ended December 31,
 2018 2017 2016
CASH FLOWS FROM OPERATING ACTIVITIES: 
  
  
Net income$28,793
 $68,644
 $63,084
Adjustments to reconcile net income to net cash provided by operating activities: 
  
  
Depreciation and amortization74,735
 66,569
 19,050
Provision for doubtful accounts781
 2,308
 
Provision for warranty and returns5,353
 845
 559
Stock compensation24,241
 19,352
 15,242
Loss on disposal or write-off of property, plant and equipment8,867
 3,778
 59
Contract settlement12,696
 
 
Write-off of acquired intangibles5,000
 
 
Bond premium amortization342
 103
 1,355
Debt issuance cost amortization288
 48
 
Impairment of assets held-for-sale269
 
 728
Bargain purchase gain
 (70,890) (1,456)
Change in fair value of contingent earn-out20,400
 8,000
 
Other3,856
 (220) 75
Changes in operating assets and liabilities, net of amounts acquired: 
  
  
Accounts receivable(76,742) (54,533) 744
Inventories(21,770) 181,699
 (5,501)
Prepaid expenses and other assets1,943
 (31,807) (3,028)
Related-party receivables97,443
 (95,309) 
Accounts payable23,270
 46,648
 (463)
Accrued liabilities(29,553) 33,813
 (1,221)
Income taxes, including excess tax benefits and deferred income taxes(19,997) (24,625) 714
Net cash provided by operating activities160,215
 154,423
 89,941
CASH FLOWS FROM INVESTING ACTIVITIES: 
  
  
Purchases of property, plant and equipment(92,720) (74,479) (23,361)
Proceeds from sale of assets765
 2
 
Proceeds from the disposal of assets held-for-sale, net13,000
 
 3,268
Intangible asset additions(8,059) (5,203) (1,192)
Business acquisitions, net of cash acquired(1,300) (162,448) (2,584)
Purchases of investment securities(30,496) (24,743) (118,384)
Proceeds from sale of investment securities15,440
 
 158,534
Net cash (used in) provided by investing activities(103,370) (266,871) 16,281
CASH FLOWS FROM FINANCING ACTIVITIES: 
  
  
Repayment of long-term obligations
 (75,000) 
Proceeds from exercise of stock options14,275
 32,003
 17,346
Proceeds from employee stock purchase plan
 2,705
 2,361
Purchase of treasury stock/tax withholding payments on net share settlement of equity awards(6,252) (4,057) (17,235)
Net cash provided by (used in) financing activities8,023
 (44,349) 2,472
Effect of exchange rate changes on cash(10,159) 1,787
 224
NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS54,709
 (155,010) 108,918
CASH AND CASH EQUIVALENTS, beginning of period290,072
 445,082
 336,164
CASH AND CASH EQUIVALENTS, end of period$344,781
 $290,072
 $445,082
 Year ended December 31,
 202120202019
NET INCOME$103,135 $86,870 $101,035 
Other comprehensive (loss) income, net of tax:
Cash flow hedge adjustments, net of tax of $(954), $285 and $392 for the years ended December 31, 2021, 2020 and 2019, respectively(3,021)904 1,242 
Foreign currency translation adjustment, net of tax of $0 for all periods(14,664)12,929 372 
Other adjustments, net of tax of $0 for all periods(62)47 (71)
Other comprehensive (loss) income, net of tax(17,747)13,880 1,543 
COMPREHENSIVE INCOME$85,388 $100,750 $102,578 
 
The accompanying notes are an integral part of these consolidated financial statements.



62


ICU MEDICAL, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
(Amounts in thousands)
     
 Common StockAdditional Paid-In CapitalTreasury StockRetained EarningsAccumulated Other Comprehensive (Loss) IncomeTotal
SharesAmount
Balance, January 1, 201920,491 $2,049 $657,899 $(95)$620,747 $(16,945)$1,263,655 
Issuance of restricted stock and exercise of stock options331 25 (10,870)18,577 — — 7,732 
Tax withholding payments related to net share settlement of equity awards(80)— — (18,639)— — (18,639)
Stock compensation— — 21,918 — — — 21,918 
Other comprehensive income, net of tax— — — — — 1,543 1,543 
Net income— — — — 101,035 — 101,035 
Balance, December 31, 201920,742 2,074 668,947 (157)721,782 (15,402)1,377,244 
Issuance of restricted stock and exercise of stock options383 32 167 12,994 — — 13,193 
Tax withholding payments related to net share settlement of equity awards(67)— — (12,876)— — (12,876)
Stock compensation— — 23,954 — — — 23,954 
Other comprehensive income, net of tax— — — — — 13,880 13,880 
Net income— — — — 86,870 — 86,870 
Balance, December 31, 202021,058 2,106 693,068 (39)808,652 (1,522)1,502,265 
Issuance of restricted stock and exercise of stock options262 22 1,003 8,347 — — 9,372 
Tax withholding payments related to net share settlement of equity awards(40)— — (8,335)— — (8,335)
Stock compensation— — 27,341 — — — 27,341 
Other comprehensive loss, net of tax— — — — — (17,747)(17,747)
Net income— — — — 103,135 — 103,135 
Balance, December 31, 202121,280 $2,128 $721,412 $(27)$911,787 $(19,269)$1,616,031 

 The accompanying notes are an integral part of these consolidated financial statements.
63


ICU MEDICAL, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS
(Amounts in thousands)
 Year ended December 31,
 202120202019
CASH FLOWS FROM OPERATING ACTIVITIES:  
Net income$103,135 $86,870 $101,035 
Adjustments to reconcile net income to net cash provided by operating activities:  
Depreciation and amortization89,698 85,631 76,916 
Noncash lease expense9,594 9,216 8,294 
Provision for doubtful accounts345 7,137 14,882 
Provision for warranty and returns831 (1,576)(134)
Stock compensation27,341 23,954 21,918 
Loss (gain) on disposal or write-off of property, plant and equipment1,652 (1,789)12,872 
Bond premium amortization655 231 135 
Debt issuance cost amortization240 288 288 
Change in fair value of contingent earn-out— 9,000 (47,400)
Product-related charges3,380 2,626 — 
Usage of spare parts13,046 11,191 24,301 
Other2,582 6,939 447 
Changes in operating assets and liabilities, net of amounts acquired:  
Accounts receivable13,755 78,049 (23,684)
Inventories20,815 19,196 (24,997)
Prepaid expenses and other current assets(7,973)(4,311)8,588 
Other assets(21,038)(16,069)(29,837)
Accounts payable2,347 (46,415)(2,697)
Accrued liabilities6,259 (29,379)(43,689)
Income taxes, including excess tax benefits and deferred income taxes874 (18,037)4,680 
Net cash provided by operating activities267,538 222,752 101,918 
CASH FLOWS FROM INVESTING ACTIVITIES:  
Purchases of property, plant and equipment(68,542)(92,005)(97,312)
Proceeds from sale of assets218 6,176 33 
Intangible asset additions(12,627)(8,385)(8,728)
Business acquisitions, net of cash acquired(14,452)— (76,133)
Investments in non-marketable equity securities(3,250)— — 
Purchases of investment securities(10,034)(32,825)(26,040)
Proceeds from sale of investment securities18,000 28,900 41,292 
Net cash used in investing activities(90,687)(98,139)(166,888)
CASH FLOWS FROM FINANCING ACTIVITIES:  
Proceeds from short-term debt— 150,000 — 
Repayment of short-term debt— (150,000)— 
Proceeds from exercise of stock options9,372 13,193 7,732 
Payments on finance leases(607)(357)— 
Payment of contingent earn-out(17,300)— — 
Tax withholding payments related to net share settlement of equity awards(8,335)(12,876)(18,639)
Net cash used in financing activities(16,870)(40)(10,907)
Effect of exchange rate changes on cash(3,251)2,854 (234)
NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS156,730 127,427 (76,111)
CASH AND CASH EQUIVALENTS, beginning of period396,097 268,670 344,781 
CASH AND CASH EQUIVALENTS, end of period$552,827 $396,097 $268,670 

The accompanying notes are an integral part of these consolidated financial statements.
64


ICU MEDICAL, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS - CONTINUED
(Amounts in thousands)

Year ended December 31,
202120202019
SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION
Cash paid during the year for income taxes$19,562 $31,628 $9,675 
Cash paid during the year for interest$858 $1,753 $549 
SUPPLEMENTAL DISCLOSURE OF NON-CASH INVESTING ACTIVITIES:
Accounts payable for property, plant and equipment$9,338 $2,211 $13,912 
Non-compete agreement with associated contingent earn-out liability$2,589 $— $— 
  Detail of assets acquired and liabilities assumed in acquisitions:
Fair value of assets acquired$4,592 $91,019 
Cash paid for acquisitions, net of cash acquired(14,452)(76,133)
Contingent consideration— (17,300)
Goodwill, acquired during period10,626 20,026 
          Liabilities assumed/Adjustments to liabilities assumed$766 $(17,612)
 Year ended December 31,
 2018 2017 2016
SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION     
  Cash paid during the year for income taxes$12,598
 $5,109
 $21,101
Cash paid during the year for interest$709
 $2,047
 $118
      
SUPPLEMENTAL DISCLOSURE OF NON-CASH INVESTING AND FINANCING ACTIVITIES:     
  Accounts payable for property, plant and equipment$26,522
 $5,376
 $1,566
      
  Detail of assets acquired and liabilities assumed in acquisitions:     
      Fair value of assets acquired
 $886,569
 $3,306
      Cash paid for acquisitions, net of cash acquired

 (162,448) (2,584)
Non-cash seller note

 (75,000) 
Estimated working capital adjustment

 4,253
 
Contingent consideration

 (19,000) 
Issuance of common stock for acquisitions

 (413,139) 
 Bargain purchase gain
 (70,890) (1,456)
Goodwill, acquired during period
 6,536
 
          Liabilities assumed/Adjustments to liabilities assumed
 $(156,881) $734


The accompanying notes are an integral part of these consolidated financial statements.



65




ICU MEDICAL, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS



NOTE 1. BASIS OF PRESENTATION AND SIGNIFICANT ACCOUNTING POLICIES


Basis of Presentation and Preparation
 
ICU Medical, Inc. ("ICU" or "we"), a Delaware corporation, operates in one1 business segment engaged in the development, manufacturing and sale of innovative medical devices used in vascularinfusion therapy and critical care applications. ICU'sWe are one of the world's leading pure-play infusion therapy companies with a wide-ranging product portfolio that includes intravenousIV solutions, IV smart pumps sets, connectors, closed transfer devices for hazardous drugs, cardiac monitoring systems, along with pain management and safety software technology.technology, dedicated and non-dedicated IV sets and needlefree connectors designed to help meet clinical, safety and workflow goals. We sell the majority of our products through our direct sales force and through independent distributors throughout the U. S.U.S. and internationally. Additionally, we sell our products on an original equipment manufacturer basis to other medical device manufacturers. The manufacturing for all product groups occurs in Salt Lake City, Utah, Austin, Texas, Mexico and Costa Rica.


All subsidiaries are wholly owned and are included in the consolidated financial statements.  All intercompany accounts and transactions have been eliminated. Results of operations of companies purchased are included from the dates of acquisition.


The consolidated financial statements reflect all adjustments, which are normal and recurring in nature, necessary for fair financial statement presentation. These consolidated financial statements were prepared in accordance with accounting principles generally accepted in the United States of AmericaU.S. ("GAAP"). Preparing financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amount 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. 


Certain reclassifications have been made to prior year financial statements to conform to classifications used in the current year. These reclassifications had no impact on net income, stockholders' equity or cash flows as previously reported.These reclassifications were to the effective tax rate reconciliation table, the deferred income tax assets (liabilities) table in Note 12, Income Taxes and to the revenue by geography table in Note 4, Revenue.



Cash, Cash Equivalents
 
Cash equivalents are short-term, highly liquid investments that are readily convertible to known amounts of cash and have original maturities of three months or less from the date of purchase as cash equivalents.purchase.


Accounts Receivable
 
Accounts receivable are stated at net realizable value.  An allowance is provided for estimated collection losses based on an assessment of various factors.  We consider prior payment trends, the age of the accounts receivable balances, financial status and other factors to estimate the cash which ultimately will be received.  Such amounts cannot be known with certainty at the financial statement date.  We regularly review individual past due balances for collectability.
 
Inventories
 
Inventories are stated at the lower of cost or net realizable value with cost determined using the first-in, first-out method.  Inventory costs include material, labor and overhead related to the manufacturing of medical devices.our products. 


Inventories consist of the following at December 31 (in thousands):

As of December 31,
 20212020
Raw materials$135,528 $126,499 
Work in process36,490 33,053 
Finished goods118,217 155,376 
Total$290,235 $314,928 

66

 2018 2017
Raw material$104,104
 $82,397
Work in process52,909
 42,304
Finished goods154,150
 163,956
Total$311,163
 $288,657




ICU MEDICAL, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)




Property, Plant and Equipment
 
Property, plant and equipment consistconsists of the following at December 31 (in thousands): 
As of December 31,
 20212020
Machinery and equipment$321,078 $291,331 
Land, building and building improvements243,377 241,199 
Molds60,463 60,381 
Computer equipment and software102,979 98,311 
Furniture and fixtures7,670 7,767 
Instruments placed with customers(1)
97,384 90,383 
Construction in progress72,153 53,724 
Total property, plant and equipment, cost905,104 843,096 
Accumulated depreciation(436,739)(376,468)
Property, plant and equipment, net$468,365 $466,628 
 2018 2017
Machinery and equipment$203,431
 $220,999
Land, building and building improvements212,283
 206,846
Molds59,700
 56,253
Computer equipment and software80,420
 44,408
Furniture and fixtures7,409
 7,361
Instruments placed with customers1

60,757
 15,812
Construction in progress70,864
 57,144
Total property, plant and equipment, cost694,864
 608,823
Accumulated depreciation(262,223) (210,139)
Net property, plant and equipment$432,641
 $398,684

1(1)    Instruments placed with customers consist of drug-delivery and monitoring systems placed with customercustomers under operating leases.


All property, plant and equipment are stated at cost.  We use the straight-line method for depreciating property, plant and equipment over their estimated useful lives.  Estimated useful lives are:
Buildings15 - 30 years
Building improvements15 - 30 years
Machinery, equipment and molds2 - 15 years
Furniture, fixtures and office equipment2 - 5 years
Computer equipment and software3 - 5 years
Instruments placed with customers1


3 - 710 years
 
We capitalize expenditures that materially increase the life of the related assets; maintenance and repairs are expensed as incurred. The costs and related accumulated depreciation applicable to property, plant and equipment sold or retired are removed from the accounts and any gain or loss is reflected in the statements of operations at the time of disposal. Depreciation expense was $58.1$65.9 million,, $51.6 $62.4 million and $16.3$59.3 million in the years ended December 31, 2018, 20172021, 2020 and 2016,2019, respectively.


Goodwill
 
We test goodwill for impairment on an annual basis in the month of November.November, or more frequently if an event occurs or circumstances change that would indicate that impairment may exist. Generally, we first perform a qualitative assessment to determine whether it is more likely than not that the fair value of the reporting unit is less than its carrying amount. If, based on an assessment of relevant qualitative factors, we determine that this is not the case, then the quantitative impairment test is not required to be performed. Conversely, if we determine based on the qualitative assessment that it is more likely than not that the fair value of the reporting unit is less than its carrying amount, we will perform the quantitative impairment test. For the quantitative impairment test, we calculate the estimated fair value of the reporting unit. If the estimated fair value of the reporting unit is less than its carrying amount, the goodwill of the reporting unit is determined to be impaired. An impairment charge is recorded in an amount equal to the excess of the carrying amount of goodwill exceeds the impliedover its estimated fair value, an impairment charge to current operations is recorded to reduce the carrying valuelimited to the implied estimatedtotal amount of goodwill allocated to the reporting unit. For our annual impairment test for the year ended December 31, 2021, we performed a qualitative assessment and concluded that it was more likely than not that the fair value.value of our reporting unit exceeded its carrying amount, and therefore, no further impairment testing was required. There were no accumulated impairment losses as of December 31, 20182021, 2020 and 2017.

2019.

67




ICU MEDICAL, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)




The following table presents the changes in the carrying amount of our goodwill for 20182021, 2020 and 20172019 (in thousands):
Total
Balance as of January 1, 2019$11,195 
Goodwill acquired(1)
20,026 
Other24 
Balance as of December 31, 2019$31,245 
Other(2)
1,756 
Balance as of December 31, 202033,001 
Goodwill(3)
10,626 
Currency translation(188)
Balance as of December 31, 2021$43,439 

  Total
Balance as of January 1, 2017 $5,577
Goodwill acquired(1)
 6,536
Other(2)
 244
Balance as of December 31, 2017 12,357
Goodwill acquired(3)
 1,300
Other (2)
 (2,462)
Balance as of December 31, 2018 $11,195
  ______________________________
(1)In 2017, our Fannin (UK) Limited2019, we acquired Pursuit Vascular, Inc. ("Fannin"Pursuit") acquisition, which resulted in $1.0$19.1 million of goodwill and our Medical Australia Limited ("MLA") acquisitiongoodwill. We also acquired a small foreign distributor, which resulted in $5.5$0.9 million of goodwill.

(2)    In 2018,2020, "Other" relates to a $1.9$1.3 million measurement period adjustment on our MLAto deferred taxes related to the Pursuit acquisition and foreign currency translation.
(3)    In 2017, "Other" relates to foreign currency translation.

(3) In 2018,2021, we acquired the consulting arm of True Process Inc.,a small foreign infusion systems supplier, which resulted in $1.3$10.6 million of goodwill.


Intangible Assets
 
Intangible assets, carried at cost less accumulated amortization and amortized on a straight-lined basis, were as follows (in thousands):
 Weighted-Average Amortization Life
in Years
December 31, 2021
 CostAccumulated
Amortization
Net
Patents10$27,429 $16,764 $10,665 
Customer contracts1210,412 6,196 4,216 
Non-contractual customer relationships957,316 33,004 24,312 
Trademarks4425 425 — 
Trade name1518,260 4,731 13,529 
Developed technology13152,893 49,406 103,487 
Non-compete39,100 2,356 6,744 
    Total amortized intangible assets $275,835 $112,882 $162,953 
Internally developed software*$25,358 $25,358 
Total intangible assets$301,193 $112,882 $188,311 

  
Weighted
Average
Amortization
Life in Years
 December 31, 2018
   Cost 
Accumulated
Amortization
 Net
Patents 10 $19,399
 $12,147
 $7,252
Customer contracts 9 5,319
 5,272
 47
Non-contractual customer relationships 9 57,916
 13,363
 44,553
Trademarks 4 425
 425
 
Trade name 15 7,456
 1,618
 5,838
Developed technology 11 82,857
 15,361
 67,496
    Total amortized intangible assets

   $173,372
 $48,186
 $125,186
         
IPR&D   $8,235
   $8,235
         
Total intangible assets   $181,607
 $48,186
 $133,421
* Internally developed software will be amortized when the projects are complete and the assets are ready for their intended use.

68




ICU MEDICAL, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)



 Weighted-Average Amortization Life
in Years
December 31, 2020
 CostAccumulated
Amortization
Net
Patents10$24,797 $15,056 $9,741 
Customer contracts1210,365 5,852 4,513 
Non-contractual customer relationships958,061 26,711 31,350 
Trademarks4425 425 — 
Trade name1518,270 3,500 14,770 
Developed technology13152,893 36,927 115,966 
Non-compete32,500 972 1,528 
Total amortized intangible assets $267,311 $89,443 $177,868 
Internally developed software*$19,363 $19,363 
Total intangible assets$286,674 $89,443 $197,231 

  
Weighted
Average
 December 31, 2017
  
Amortization
Life in Years
 Cost 
Accumulated
Amortization
 Net
Patents 10 $17,064
 $10,970
 $6,094
Customer contracts 9 5,319
 4,892
 427
Non-contractual customer relationships 9 55,080
 6,562
 48,518
Trademarks 4 425
 425
 
Trade name 15 7,310
 1,096
 6,214
Developed technology 11 81,846
 7,571
 74,275
Total   $167,044
 $31,516
 $135,528
         
IPR&D   $8,225
   $8,225
         
Total intangible assets   $175,269
 $31,516
 $143,753
* Internally developed software will be amortized when the projects are complete and the assets are ready for their intended use.
 
Amortization expense was $23.8 million, $23.2 million and $17.7 million in 2018, 20172021, 2020 and 2016 was $16.6 million, $15.0 million and $2.8 million,2019, respectively.


As of December 31, 20182021, estimated annual amortization for our intangible assets for each of the next five years is approximately (in thousands):

2022$25,668 
202324,191 
202423,551 
202516,057 
202615,324 
Thereafter58,162 
Total$162,953 
2019 $17,103
2020 16,126
2021 15,825
2022 15,681
2023 15,532
Thereafter 44,919
Total $125,186


Our intangible assets that are not subject to amortization are reviewed annually for impairment or more often if there are indications of possible impairment. We perform our annual intangible assets impairment test in November of each year. We did not have any intangible asset impairments in 2021, 2020 or 2019.


Long-Lived Assets
 
We periodically evaluate the recoverability of long-lived assets whenever events and changes in circumstances indicate that the carrying amount of an asset may not be fully recoverable. When indicators of impairment are present, the carrying values of the assets are evaluated in relation to the operating performance and future undiscounted cash flows of the underlying business. The net book value of the underlying asset is adjusted to fair value if the sum of the expected discounted cash flows is less than book value. Fair values are based on estimates of market prices and assumptions concerning the amount and timing of estimated future cash flows and discount rates, reflecting varying degrees of perceived risk. We did not have any long-lived asset impairments in 2021, 2020 or 2019.


Investment Securities

Short-term investments, exclusive of cash equivalents, are marketable securities intended to be sold within one year and may include trading securities, available-for-sale securities, and held-to-maturity securities (if maturing within one year at
69



ICU MEDICAL, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)

the time of acquisition). Long-term investments are marketable securities intended to be sold after one year and may include trading securities, available-for-sale securities, and held-to-maturity securities.


Investments in Available-for-sale Securities
Our investment securities are considered available-for-sale and currently consist of short-term and long-term corporate bonds. These securities are considered “investment grade” and are carried at fair value. Our investments currently consistWe assess our investment in available-for-sale debt securities for impairment each reporting period. If an unrealized loss exists, we determine whether any portion of corporate bonds. Available-for-sale securities are recorded atthe decline in fair value below the carrying value is credit-related by reviewing several factors, including, but not limited to, the extent of the fair value decline and changes in the financial condition of the issuer. We record an impairment for credit-related losses through an allowance, limited to the amount of the unrealized holdingloss. If we either intend to sell or it is more likely than not we will be required to sell the debt security before its anticipated recovery, any allowance is written off and the amortized cost basis is written down to fair value through a charge against net earnings. Unrealized gains and non-credit-related unrealized losses are recorded, net of tax, as a component of accumulatedin other comprehensive income (loss). Unrealized lossesWe did not have any investments in available-for-sale debt securities in unrealized loss positions as of December 31, 2021 or 2020.



ICU MEDICAL, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)


on available-for-sale securities are charged against net earnings when a decline in fair value is determined to be other than temporary. Our management reviews several factors to determine whether a loss is other than temporary, such as the length and extentThe amortized cost of the fair value decline, the financial condition and near term prospects of the issuer, and for equity investments, our intent and ability to hold the security for a period of time sufficient to allow for any anticipated recovery in fair value. For debt securities management also evaluates whether we haveis adjusted for the intent to sell or will likely be required to sell before its anticipated recovery.amortization of premiums computed under the effective interest method. Such amortization is included in other income, net in the consolidated statements of operations. Realized gains and losses are accounted for on the specific identification method. There have been no realized gains or losses on the disposal of these investments. The scheduled maturities of the investmentdebt securities are between 20192022 and 2020.2024. All short-term investment securities are all callable within one year.


Our investmentshort-term and long-term investments in available-for-sale securities consist of the following (in thousands):
As of December 31, 2021
Amortized CostUnrealized Holding Gains (Losses)Fair Value
Short-term corporate bonds$14,420 $— $14,420 
Long-term corporate bonds4,620 — 4,620 
Total investment securities$19,040 $— $19,040 
As of December 31, 2020
Amortized CostUnrealized Holding Gains (Losses)Fair Value
Short-term corporate bonds$14,687 $— $14,687 
Long-term corporate bonds12,974 — 12,974 
Total investment securities$27,661 $— $27,661 

Investments in Non-Marketable Equity Securities

In the third quarter of 2021, we acquired approximately a 20.0% non-marketable equity interest in a nonpublic company and entered into a three-year distribution agreement where we have the exclusive rights to market, sell and distribute the company's products in exchange for a cash payment of $3.3 million. In addition, we were granted an exclusive license for all of the seller's intellectual property. At the expiration of the distribution agreement we have the right but not the obligation to acquire the remaining interest in the business.

We apply the equity method of accounting for investments when we determine we have a significant influence, but not a controlling interest in the investee. We determine whether we have significant influence by considering key factors such as ownership interest, representation on the board of directors, participation in policy making decisions, business relationship and material intra-entity transactions, among other factors. Our equity method investment is reported at cost and adjusted each period for our share of the investee's income or (loss) and dividend paid, if any. We eliminate any intra-entity profits to the extent of our beneficial interest. We record our share of the investee's income or (loss) on a one quarter lag. We report our
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 December 31, 2018
 Amortized Cost Unrealized Holding Gains (Losses) Fair Value
Short-term corporate bonds37,329
 $
 $37,329
Long-term corporate bonds2,025
 
 2,025
Total investment securities$39,354
 $
 $39,354
      
 December 31, 2017
 Amortized Cost Unrealized Holding Gains (Losses) Fair Value
Short-term corporate bonds$10,061
 $
 $10,061
Long-term corporate bonds14,579
 
 14,579
Total investment securities$24,640
 $
 $24,640
proportionate share of the investee's income or (loss) resulting from this investment in other income, net in our consolidated statements of operations. The carrying value of our equity method investment is reported in other assets on the consolidated balance sheets. We assess our equity method investments for impairment on an annual basis or whenever events or circumstances indicate that the carrying value of the investment may not be recoverable. During 2021, there were no indications that our non-marketable equity method investment was impaired. Our recorded share of the investee's loss was not material for the year ended December 31, 2021. We did not receive any dividend distributions from this investment during 2021.


Our non-marketable equity method investment consists of the following (in thousands):

As of December 31,
20212020
Equity method investment$3,238 $— 

Income Taxes
 
Deferred taxes are determined based on the differences between the financial statements and the tax bases using rates as enacted in the laws. A valuation allowance is established if it is “more likely than not” that all or a portion of the deferred tax assets will not be realized.


We recognize interest and penalties related to unrecognized tax benefits in the tax provision. We recognize liabilities for uncertain tax positions when it is more likely than not that a tax position will not be sustained upon examination and settlement with various taxing authorities. Liabilities for uncertain tax positions are measured based upon the largest amount of benefit that is greater than 50% likely of being realized upon ultimate settlement. We have not recorded any material interest or penalties during any of the years presented.


Foreign Currency

Generally, the functional currency of our international subsidiaries is the local currency. Generally, we translate the financial statements of these subsidiaries to U.S. dollars at the exchange rate in effect at the balance sheet date and revenues and expenses are translated at the average monthly exchange rates during the year. Certain of our international subsidiaries consolidate first with another subsidiary that utilizes a functional currency other than U.S. dollars. In those cases, we follow a step by step translation process utilizing the same sequence as the consolidation process. Translation adjustments are recorded as a component of accumulated other comprehensive income (loss),loss, a separate component of stockholders' equity on our consolidated balance sheets and the effect of exchange rate changes on cash and cash equivalents are reflected on our consolidated statements of cash flows. Gains and losses for transactions denominated in a currency other than the functional currency of the entity are included in our consolidated statements of operations in selling, general and administrative expense.other income, net. Foreign currency transaction losses (gains), net were $7.9$1.0 million, $7.2 million and $(0.7) million in 2018, $1.8 million in 20172021, 2020 and less than $0.3 million in 2016.2019, respectively.





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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)



Revenue Recognition

We recognize revenues when we transfer control of promised goods to our customers in an amount that reflects the consideration to which we expect to be entitled to in exchange for those goods. We offer certain volume-based rebates to our distribution customers, which we consider variable consideration when calculating the transaction price. Rebates are offered on both a fixed and tiered/variable basis. In both cases, we use information available at the time and our historical experience with each customer to estimate the most likely rebate amount. We also provide chargebacks to distributors that sell to end-customersend customers at prices determined under a contract between us and the end-customer.
end customer. Chargebacks are the difference between prices we charge our distribution customers and contracted prices we have with the end customer which are processed as credits to our distribution customers. In estimating the most likely rebate andexpected value of chargeback amounts for use in determining the transaction price, we use information available at the time, andincluding our historical experience. We also warrant products against defects and have a policy permitting the return of defective products, for which we accrue and expense at the time of sale using information available and our historical experience. Our revenues are recorded at the net sales price, which includes an estimate for variable consideration related to rebates, chargebacks and product returns.


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The vast majority of our sales of Infusion Consumables, Infusion Systems, IV Solutions Infusion Systems and Critical Care products are sold on a standalone basis and control of these products transfers to the customer upon shipment.


Our software license renewals are considered to be transferred to a customer at a point in time at the start of each renewal period, therefore revenue is recognized at that time.
 
Arrangements with Multiple Deliverables


In certain circumstances, we enter into arrangements in which we provide multiple deliverables to our customers. These bundled arrangements typically consist of the sale of infusion systems equipment, along with annual software licenses and related software implementation services, as well as infusion consumables, IV solutions and extended warranties.
Our most significant judgments related to these arrangements are (i) identifying the various performance obligations and (ii) estimating the relative standalone selling price of each performance obligation, typically using a directly observable method or calculated on a cost plus margin basis method. Revenue related to the bundled equipment, software and software implementation services are typically combined into a single performance obligation and recognized upon implementation. As annual software licenses are renewed, we recognize revenue for the license at a point in time, at the start of each annual renewal period. The transaction price allocated to the extended service-type warranty is recognized as revenue over the period the warranty service is provided. Consumables and solutions are separate performance obligations, recognized at a point in time.
 
Shipping Costs
 
Costs to ship finished goods to our customers are included in cost of goods sold on the consolidated statements of operations.


Advertising Expenses


Advertising expenses are expensed as incurred and reflected in selling, general and administrative expenses in our consolidated statements of operations and were $0.6 million in 2018, $0.2 million, in 2017$0.2 million and $0.1 million in 2016.2021, 2020 and 2019, respectively.


Post-retirement and Post-employment Benefits
 
We sponsor a Section 401(k) retirement plan ("plan") for employees. Our contributions to our 401(k) plan were approximately $11.0 million, $10.7 million and $11.4 million in 2018, $10.3 million in 20172021, 2020 and $1.5 million in 2016. As a result of the Hospira Infusion Systems ("HIS") acquisition, we assumed certain2019, respectively. We also have post-retirement and post-employment obligations related to employees located in certain international countries. These obligations are immaterial to our financial statements taken as a whole.


Research and Development
 
The majority of our research and development costs are expensed as incurred. In certain circumstances when an asset will have an alternative future use we capitalize the costs related to those assets. Research and development costs include salaries and related benefits, consulting fees, production supplies, samples, travel costs, utilities and other miscellaneous administrative costs.


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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)



Net Income Per Share

Net income per share is computed by dividing net income by the weighted averageweighted-average number of common shares outstanding. Diluted net income per share is computed by dividing net income by the weighted averageweighted-average number of common shares outstanding plus dilutive securities. Dilutive securities include outstanding common stock options and unvested restricted stock units, less the number of shares that could have been purchased with the proceeds from the exercise of the options, using the treasury stock method. Options that are anti-dilutive, where their exercise price exceeds the average market price of the common stock, are not included in the treasury stock method calculation. Restricted stock units that are anti-dilutive are not included in the treasury stock method. There were 5,30012,354, 12,083 and 33710,760 anti-dilutive shares in 20182021, 2020 and 2017,2019, respectively. There were no anti-dilutive shares in 2016.
 
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The following table presents the calculation of net earnings per common share (“EPS”) — basic and diluted (in thousands, except per share data): 
 Year ended December 31,
 202120202019
Net income$103,135 $86,870 $101,035 
Weighted-average number of common shares outstanding (basic)21,206 20,907 20,629 
Dilutive securities575 684 916 
Weighted-average common and common equivalent shares outstanding (diluted)21,781 21,591 21,545 
EPS — basic$4.86 $4.16 $4.90 
EPS — diluted$4.74 $4.02 $4.69 
  
Year ended December 31,
(in thousands, except per share data)
  2018
2017
2016
Net income $28,793
 $68,644
 $63,084
Weighted average number of common shares outstanding (basic) 20,394
 19,614
 16,168
Dilutive securities 1,207
 1,244
 1,086
Weighted average common and common equivalent shares outstanding (diluted) 21,601
 20,858
 17,254
EPS - basic $1.41
 $3.50
 $3.90
EPS - diluted $1.33
 $3.29
 $3.66


On February 3, 2017, as part of the purchase price for the acquisition of Pfizer Inc.'s ("Pfizer") HIS business, we delivered to Pfizer 3.2 million newly issued common shares (see Note 2: Acquisitions, Strategic Transaction and Integration Expenses).

New Accounting Pronouncements

Recently Adopted0Recently Issued Accounting Standards


In March 2018,2020, the Financial Accounting Standards Board ("FASB") issued Accounting Standard Update ("ASU")ASU No. 2018-05, Income Taxes2020-04, Reference Rate Reform (Topic 740): Amendments to SEC Paragraphs Pursuant to SEC Staff Accounting Bulletin No. 118. This update adds SEC paragraphs pursuant to the SEC Staff Accounting Bulletin No. 118, which expresses the view848) - Facilitation of the staff regarding applicationEffects of Topic 740, Income Taxes, in the reporting period that includes December 22, 2017 - the dateReference Rate Reform on which the Tax Cuts and Jobs Act (the "Tax Act") was signed into law. We applied the provisions of this ASU in the prior year and it did not have a material impact on our consolidated financial statements.

In August 2017, the FASB issued ASU No. 2017-12, Derivatives and Hedging (Topic 815): Targeted Improvements to Accounting for Hedging Activities. The amendments in this update change both the designation and measurement guidance for qualifying hedging relationships and the presentation of hedge results to facilitate financial reporting that more closely reflects an entity's risk management activities. The amendments in this update also make certain targeted improvements to simplify the application of hedge accounting guidance and ease the administrative burden of hedge documentation requirements and assessing hedge effectiveness. The amendments are effective for the fiscal years, and interim reporting periods within those years, beginning on or after December 15, 2018. For cash flow and net investment hedges existing at the date of adoption, an entity should apply a cumulative-effect adjustment related to eliminating the separate measurement of ineffectiveness to accumulated other comprehensive income with a corresponding adjustment to the opening balance of retained earnings as of the beginning of the fiscal year that an entity adopts the update. We early adopted this ASU on January 1, 2018 and this ASU did not have a material impact on our consolidated financial statements or related footnote disclosures.

In May 2017, the FASB issued ASU No. 2017-09, Compensation-Stock Compensation (Topic 718): Scope of Modification Accounting.Financial Reporting. The amendments in this update provide optional guidance for a limited period of time to ease the potential burden for reference rate reform on financial reporting. Due to concerns about which changesstructural risks of interbank offered rates and, particularly, the risk of cessation of the London Interbank Offered Rate ("LIBOR"), regulators around the world have undertaken reference rate reform initiatives to identify alternative reference rates that are more observable or transaction based and less susceptible to manipulation. The amendments in this update apply only to contracts, hedging relationships, and other transactions that reference LIBOR or another reference rate expected to be discontinued as a result of reference rate reform. Optional expedients may be applied to contracts that are modified as a result of the terms or conditionsreference rate reform. Modifications of contracts within the scope of Topic 470, Debt, should be accounted for by prospectively adjusting the effective interest rate. Modifications of contracts within the scope of ASC 842, Leases, should be accounted for as a continuation of the existing contracts with no reassessments of the lease classification and the discount rate (incremental borrowing rate). Exceptions to Topic 815, Derivatives and Hedging, results in not having a dedesignation of a share-based payment award requirehedging relationship if certain criteria are met. The amendments in this ASU are effective for all entities as of March 12, 2020 through December 31, 2022. In November 2021, we entered into two forward-starting swaps whereby the variable leg of the swap references LIBOR, these swaps will be amended in early 2022 to transition to an entityalternative reference rate (see Note 7: Derivatives and Hedging Activities). The amendments in this ASU allow for certain expedients that will allow us to applyassume that our hedged interest payments are probable of occurring regardless of any expected modification accounting. Underin their terms related to reference rate reform and will allow us to continue hedge accounting for a cash flow hedge for which the hedged interest rate risk changes if the hedge is highly effective under ASC 815, Derivatives and Hedging or the optional expedient under this ASU an entity will accountis elected. The impact of this ASU on our contracts has not been and is not expected to be material.

NOTE 2. ACQUISITIONS

2019 Acquisitions

On November 2, 2019, we acquired 100% interest in Pursuit for cash consideration of approximately $75.0 million. Additionally, Pursuit's equity holders were potentially entitled up to $50.0 million in additional cash consideration contingent upon the achievement of certain sales and gross profit targets for specific customers. The earn-out paid was calculated as a percentage of gross profit achieved during the earn-out period against a pre-determined target gross profit, not to exceed $50.0 million. As of June 30, 2021, the earn-out measurement period ended and based on the actual sales and gross profit achieved during the measurement period, we calculated the actual earn-out amount to be $26.3 million. The $26.3 million earn-out calculation was finalized and accepted by Pursuit's former equity holders and was paid out in during the fourth quarter of 2021. The acquisition of Pursuit and their ClearGuard HD is a natural extension of our needlefree IV connector and other infection control technologies, which together provides us the best of breed solutions.


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effects of a modification unless (i) the fair value of the modified award is the same as the fair value of the original award immediately before the original award is modified, (ii) the vesting conditions of the modified award are the same vesting conditions as the original award immediately before the original award is modified, and (iii) the classification of the modified award as an equity instrument or a liability instrument is the same as the classification of the original award immediately before the original award is modified. The amendments in this ASU are effective prospectively for annual periods, and interim periods within those annual periods, beginning after December 15, 2017. We adopted this ASU on January 1, 2018 and this ASU did not have a material impact on our consolidated financial statements or related footnote disclosures.

In January 2017, the FASB issued ASU No. 2017-01, Business Combinations (Topic 805): Clarifying the Definition of a Business. The amendments in this update clarify the definition of a business with the objective of adding guidance to assist entities with evaluating whether transactions should be accounted for as acquisitions (or disposals) of assets or businesses. The
amendments in this update provide a screen to determine when a set (integrated set of assets and activities) is not a business. If the screen is not met, it (1) requires that to be considered a business, a set must include, at a minimum, an input and a substantive process that together significantly contribute to the ability to create output and (2) removes the evaluation of whether a market participant could replace the missing elements. The amendments in ASU 2017-01 are effective for annual periods and interim periods within those annual periods beginning after December 15, 2017. The amendments in this ASU should be applied prospectively on or after the effective date. We adopted this ASU on January 1, 2018 and this ASU did not have a material impact on our consolidated financial statements or related footnote disclosures.

In October 2016, the FASB issued ASU No. 2016-16, Income Taxes (Topic 740): Intra-Entity Transfers of Assets Other Than Inventory. Current generally accepted accounting principles prohibits the recognition of current and deferred income taxes for an intra-entity asset transfer until after the asset has been sold to an outside party. The amendments in ASU 2016-16 eliminates this prohibition. Accordingly an entity should recognize the income tax consequences of an intra-entity transfer of an asset other than inventory when the transfer occurs. Amendments in this update are effective for annual reporting periods beginning after December 15, 2017. We adopted this ASU on January 1, 2018 and this ASU did not have a material impact on our consolidated financial statements or related footnote disclosures.

In August 2016, the FASB issued ASU No. 2016-15, Statement of Cash Flows (Topic 230): Classification of Certain Cash Receipts and Cash Payments. ASU 2016-15 provides specific guidance on eight cash flow issues where current guidance is unclear or does not include any specifics on classification. The eight specific cash flow issues are: debt prepayment or debt extinguishment costs; settlement of zero-coupon debt instruments or other debt instruments with zero coupon interest rates that are insignificant in relation to the effective interest rate of the borrowing; contingent consideration payments made after a business combination; proceeds from the settlement of insurance claims; proceeds from the settlement of corporate-owned life insurance policies, including bank-owned policies; distributions received from equity method investees; beneficial interests in securitization transactions; and separately identifiable cash flows and application of the predominance principle. The amendments in ASU 2016-15 are effective for annual periods and interim periods within those annual periods beginning after December 15, 2017. Amendments should be applied using a retrospective transition method to each period presented. We adopted this ASU on January 1, 2018 and this ASU did not have a material impact on our consolidated financial statements or related footnote disclosures.

In January 2016, the FASB issued ASU No. 2016-01, Financial Instruments – Overall (Subtopic 825-10): Recognition and Measurement of Financial Assets and Financial Liabilities, which amends certain aspects of recognition, measurement, presentation and disclosure of financial instruments. This amendment requires all equity investments to be measured at fair value with changes in the fair value recognized through net income (other than those accounted for under the equity method of accounting or those that result in the consolidation of the investee). The amendments in this update are effective for fiscal years beginning after December 15, 2017. We adopted this ASU on January 1, 2018 and this ASU did not have a material impact on our consolidated financial statements or related footnote disclosures.

In May 2014, the FASB issued ASU No. 2014-09, Revenue from Contracts with Customers (Topic 606). ASU 2014-09 removes inconsistencies and weaknesses in revenue requirements, provides a more robust framework for addressing revenue issues, improves comparability of revenue recognition practices across entities, industries, jurisdictions and capital markets, provides more useful information to users of financial statements through improved disclosure requirements and simplifies the preparation of financial statements by reducing the number of requirements to which an entity must refer. This guidance requires that an entity depict the consideration by applying a five-step analysis in determining when and how revenue is recognized. The new model will require revenue recognition to depict the transfer of promised goods or services to customers in


ICU MEDICAL, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)


an amount that reflects the consideration a company expects to receive in exchange for those goods or services. On April 1, 2015, the FASB voted for a one-year deferral of the effective date of the new revenue recognition standard, ASU 2014-09. On July 15, 2015, the FASB affirmed these changes, which requires public entities to apply the amendments in ASU 2014-09 for annual reporting beginning after December 15, 2017. Subsequent to the issuance of this ASU, the FASB issued three amendments: ASU No. 2016-08, which clarifies principal versus agent considerations; ASU 2016-10, which clarifies guidance related to identifying performance obligations and licensing implementation; and ASU 2016-12, which provides narrow-scope improvements and practical expedients. All of the amendments have the same effective date mentioned above. We adopted the standard effective January 1, 2018. See Note 4, Revenue for a discussion of the impact and the required enhanced disclosures.
Recently Issued Accounting Standards

In August 2018, the FASB issued ASU No. 2018-15, Intangibles-Goodwill and Other-Internal-Use Software (Topic 350): Customer's Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement That Is a Service Contract. The amendments in this update align the requirements for capitalizing implementation costs incurred in a hosting arrangement that is a service contract with the requirements for capitalizing implementation costs incurred to develop or obtain internal-use software and hosting arrangements that include an internal use software license. Costs to develop or obtain internal-use software that cannot be capitalized under subtopic 350-40, such as training costs and certain data conversion costs, also cannot be capitalized for a hosting arrangement that is a service contract. Therefore, an entity in a hosting arrangement that is a service contract determines which project stage (that is, preliminary project stage, application development stage, or post-implementation stage) an implementation activity relates to. Costs for implementation activities in the application development stage are capitalized depending on the nature of the costs, while costs incurred during the preliminary project and post-implementation stages are expensed as the activities are performed. The amendments in this update require the entity to expense the capitalized implementation costs of a hosting arrangement that is a service contract over the term of the hosting arrangement. The amendments in this update are effective for fiscal years beginning after December 15, 2019, and interim periods within those fiscal years. The amendments in this update should be applied either retrospectively or prospectively to all implementation costs incurred after the date of adoption. We are currently evaluating the impact of this ASU on the consolidated financial statements and related disclosures.

In August 2018, the FASB issued ASU No. 2018-13, Fair Value Measurement (Topic 820): Disclosure Framework - Changes to the Disclosure Requirements for Fair Value Measurement. The amendments in this update modify the disclosure requirements in Topic 820. The amendments remove from disclosure: the amount of and reasons for transfers between Level 1 and Level 2 of the fair value hierarchy; the policy for timing of transfers between levels 3; and the valuation processes for Level 3 fair value measurements. The amendments also made the following disclosure modifications: for investments in certain entities that calculate net asset value, an entity is required to disclose the timing of liquidation of an investee’s assets and the date when restrictions from redemption might lapse only if the investee has communicated the timing to the entity or announced the timing publicly; and the amendments clarify that the measurement uncertainty disclosure is to communicate information about the uncertainty in measurement as of the reporting date. The amendments also added the following disclosure requirements: the changes in unrealized gains and losses for the period included in other comprehensive income for recurring Level 3 fair value measurements held at the end of the reporting period; and the range and weighted average of significant unobservable inputs used to develop Level 3 fair value measurements. For certain unobservable inputs, an entity may disclose other quantitative information (such as the median or arithmetic average) in lieu of the weighted average if the entity determines that other quantitative information would be a more reasonable and rational method to reflect the distribution of unobservable inputs used to develop Level 3 fair value measurements. The amendments in ASU 2018-02 are effective for fiscal years beginning after December 15, 2019. Early adoption is permitted. We are currently evaluating the impact of this ASU on the consolidated financial statements and related disclosures.

In February 2018, the FASB issued ASU No. 2018-02, Income Statement-Reporting Comprehensive Income (Topic 220): Reclassification of Certain Tax Effects from Accumulated Other Comprehensive Income. The amendments in this update allow a reclassification from accumulated other comprehensive income to retained earnings for stranded tax effects resulting from the Tax Cuts and Jobs Act. The amendments in this update also require certain disclosures about stranded tax effects. The amendments in ASU 2018-02 are effective for fiscal years beginning after December 15, 2018. Early adoption is permitted. We are not electing to reclassify from accumulated OCI to retained earnings stranded tax effects resulting from the Tax Cuts and Jobs Act (the “Tax Act”).



ICU MEDICAL, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)


In January 2017, the FASB issued ASU No. 2017-04, Intangibles-Goodwill and Other (Topic 350): Simplifying the Test for Goodwill Impairment. The amendments in this update remove the second step of the impairment test. An entity will apply a one-step quantitative test and record the amount of goodwill impairment as the excess of a reporting unit's carrying amount over its fair value, not to exceed the total amount of goodwill allocated to the reporting unit. The new guidance does not amend the optional qualitative assessment of goodwill impairment. The amendments in ASU 2017-04 are effective for the annual or interim impairment test in fiscal years beginning after December 15, 2019. Early adoption is permitted for interim or annual goodwill impairment tests performed on testing dates after January 1, 2017. This ASU is not expected to have a material impact on our consolidated financial statements or related footnote disclosures.

In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments-Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments. This update amends the FASB's guidance on the impairment of financial instruments by requiring timelier recording of credit losses on loans and other financial instruments. The ASU adds an impairment model that is based on expected losses rather than incurred losses. The ASU also amends the accounting for credit losses on available-for-sale debt securities and purchased financial assets with credit deterioration. The amendments in this update will be effective for fiscal years beginning after December 15, 2019. Early adoption is permitted as of the fiscal years beginning after December 15, 2018. The updated guidance requires a modified retrospective adoption. In November 2018, the FASB issued ASU No. 2018-19, Codification Improvements to Topic 326, Financial Instruments-Credit Losses. This update clarifies that receivables arising from operating leases are not within the scope of this guidance, instead, impairment of receivables arising from operating leases should be accounted for in accordance with the lease guidance. This update has the same effective date as ASU No. 2016-13. We are currently evaluating the impact of this ASU on the consolidated financial statements and related disclosures.

In February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842). The amendments in this update require an entity to recognize a Right Of Use asset and lease liability for all leases with terms of more than 12 months. Recognition, measurement and presentation of expenses will depend on classification as finance or operating lease. The amendments also require certain quantitative and qualitative disclosures about leasing arrangements. The updated guidance requires a modified retrospective adoption. In July 2018, the FASB issued ASU No. 2018-11, Targeted Improvements. The amendments in this update will provide entities with an additional (and optional) transition method to adopt the new lease requirements by allowing entities to initially apply the requirements by recognizing a cumulative-effect adjustment to the opening balance of retained earnings in the period of adoption. The amendments in this update also provide lessors with a practical expedient, by class of underlying asset, to not separate nonlease components from the associated lease contract. This expedient is limited to circumstances in which the nonlease components otherwise would be accounted for under the new revenue guidance and both (1) the timing and pattern of transfer are the same for the nonlease components and associated lease component and (2) the lease component, if accounted for separately, would be classified as an operating lease. If the lessor uses this practical expedient they would account for the lease contract in accordance with Topic 606 if the nonlease component is the predominant component otherwise, the lessor should account for the combined component as an operating lease in accordance with Topic 842. In July 2018, the FASB issued ASU No. 2018-10, Codification Improvements to Topic 842, Leases. This ASU clarifies certain language in ASU 2016-02 and corrects certain references and inconsistencies. In December 2018, the FASB issued ASU No. 2018-20-Leases-Narrow-Scope Improvements for Lessors. The amendments in this update permit lessors, as an accounting policy election, to not evaluate whether certain sales taxes and other similar taxes are lessor costs. If an entity takes this policy election sales taxes will be excluded from the consideration in the contract. The amendments in this update related to certain lessor costs permit lessors to exclude from variable payments, and therefore revenue, lessor costs paid by lessees directly to third parties from variable payments. The amendments also require lessors to account for costs excluded from the consideration of a contract that are paid by the lessor and reimbursed by the lessee as variable payments. A lessor will record those reimbursed costs as revenue. The amendments in this update related to recognizing variable payments for contracts with lease and nonlease components require lessors to allocate certain variable payments to the lease and nonlease components when the changes in facts and circumstances on which the variable payment is based occur. After the allocation, the amount of variable payments allocated to the lease components will be recognized as income in profit or loss in accordance with the lease guidance, while the amount of variable payments allocated to nonlease components will be recognized in accordance with other guidance. The amendments in these updates are effective for fiscal years beginning after December 15, 2018. We adopted ASU 2016-02, ASU 2018-11, ASU 2018-10 and ASU 2018-20 effective January 1, 2019. We elected the ‘package of practical expedients’, which permits us not to reassess under the new standard our prior conclusions about lease identification, lease classification and initial direct costs. We did not elect the use-of-hindsight or the practical expedient pertaining to land easements; the latter not being applicable to us. We elected the short-term lease recognition exemption for all leases that qualify. This means, for those leases that qualify, we did not recognize Right Of Use assets or lease liabilities, and this includes not


ICU MEDICAL, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)


recognizing Right Of Use assets or lease liabilities for existing short-term leases of those assets in transition. Furthermore, elected the practical expedient to not separate lease and non-lease components for all of our leases. We adopted ASU 2016-02 utilizing the modified retrospective transition method through a cumulative-effect adjustment at the beginning of the first quarter of 2019. We expect the adoption of ASU 2016-02 to result in the recognition of right-of-use assets and lease liabilities for operating leases of approximately $35.0 million to $50.0 million on our consolidated balance sheet, with no material impact to our consolidated statements of operations. We continue to evaluate the impact the adoption of this new guidance will have on our financial statements and related disclosures, in addition to the continued evaluation of business processes and internal controls related to lease accounting.


NOTE 2. ACQUISITIONS, STRATEGIC TRANSACTION AND INTEGRATION EXPENSES

Significant 2017 Acquisitions

On February 3, 2017, we acquired 100% interest in Pfizer's HIS business for total cash consideration of approximately $260.0 million (net of estimated working capital adjustments paid at closing), which was financed with existing cash balances and a $75 million three-year interest-only seller note. We also issued 3.2 million shares of our common stock. The fair value of the common shares issued to Pfizer was determined based on the closing price of our common shares on the closing date, discounted to reflect a contractual lock-up period whereby Pfizer cannot transfer the shares, subject to certain exceptions, until the earlier of (i) the expiration of Pfizer’s services to us in the related transitional services agreement or (ii) eighteen months from the closing date. Additionally, Pfizer also may be entitled up to an additional $225 million in cash contingent consideration based on the achievement of performance targets for the combined company for the three years ending December 31, 2019 ("Earnout Period"). In the event that the sum of our Adjusted EBITDA as defined in the Amended and Restated Stock and Asset Purchase Agreement between us and Pfizer (the “HIS Purchase Agreement”) for the three years in the Earnout Period (the "Cumulative Adjusted EBITDA") is equal to or exceeds approximately $1 billion ("the "Earnout Target"), then Pfizer will be entitled to receive the full amount of the earnout. In the event that the Cumulative Adjusted EBITDA is equal to or greater than 85% of the Earnout Target (but less than the Earnout Target), Pfizer will be entitled to receive the corresponding percentage of the earnout. In the event that the Cumulative Adjusted EBITDA is less than 85% of the Earnout Target, then no earnout amount will be earned by Pfizer. The initial fair value of the earn-out was determined by employing a Monte Carlo simulation in a risk neutral framework. The underlying simulated variable was adjusted EBITDA. The adjusted EBITDA volatility estimate was based on a study of historical asset volatility for a set of comparable public companies. The model includes other assumptions including the market price of risk, which was calculated as the weighted average cost of capital ("WACC") less the long term risk free rate. We believe that the acquisition of the HIS business, which includes IV pumps, solutions and consumable devices complements our pre-existing business by creating a company that has a complete infusion therapy product portfolio. We believe that the acquisition significantly enhances our global footprint and platform for continued competitiveness and growth.

With the acquisition of HIS, pre-existing long-term supply and distribution contracts between ICU and HIS were effectively terminated.

Deferred Closings

In the HIS Purchase Agreement, we agreed with Pfizer to defer the local closing of the HIS business in certain foreign jurisdictions (the “Deferred Closing Businesses”) for periods ranging by jurisdiction from 3 to 12 months after the February 3, 2017 closing date (the "Deferred Closing Period"). The net assets in these jurisdictions represent an immaterial portion of the total HIS business net assets.
At the February 3, 2017 HIS business transaction closing, we entered into a Net Economic Benefit Agreement with Pfizer under which we agreed that (i) during the Deferred Closing Period, the economic benefits and burdens of the Deferred Closing Businesses are for our account, and we are to be treated as the beneficial owner of the Deferred Closing Businesses and (ii) Pfizer would continue to operate the Deferred Closing Businesses under our direction.

All of the deferred closing businesses were effectively closed in 2017.



ICU MEDICAL, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)


Final Purchase Price
    
The following table summarizes the final purchase price and the final allocation of the purchase price related to the assets and liabilities purchased (in thousands, except per share data)thousands):

Cash consideration for acquired assets $180,785
Fair value of Seller Note 75,000
Fair value of contingent consideration payable to Pfizer (long-term) 19,000
   
Issuance of ICU Medical, Inc. common shares:  
Number of shares issued to Pfizer 3,200
Price per share (ICU's trading closing share price on the Closing Date) $140.75
Market price of ICU shares issued to Pfizer $450,400
Less: Discount due to lack of marketability of 8.3% (37,261)
Equity portion of purchase price 413,139
Total Consideration $687,924
   
Purchase Price Allocation:  
Cash and cash equivalents $31,082
Trade receivables 362
Inventories 417,622
Prepaid expenses and other assets 13,911
Property, plant and equipment 288,134
Intangible assets(1)
 131,000
Other assets 29,270
Accounts payable (12,381)
Accrued liabilities (47,936)
Long-term liabilities(2)
 (67,170)
Total identifiable net assets acquired $783,894
Deferred tax, net (25,080)
Estimated Gain on Bargain Purchase (70,890)
Estimated Purchase Consideration $687,924
Cash consideration for acquired assets, net$71,533 
Fair value of contingent consideration17,300 
Total Consideration$88,833 
Final Purchase Price Allocation:
Trade receivables$973 
Inventories2,464 
Prepaid expenses and other current assets74 
Property, plant and equipment609 
Intangible assets(1)
82,300 
Accounts payable(215)
Accrued liabilities(2,065)
Total identifiable net assets acquired$84,140 
Goodwill - not tax deductible20,462 
Deferred tax liability(15,769)
Purchase Consideration$88,833 


(1)    Identifiable intangible assets includes $48 million of customer relationships, $44included $69.0 million of developed technology, - pumps and dedicated sets, $34$10.8 million of trade name and $2.5 million of non-compete agreement. The weighted-average amortization periods for the identifiable intangible assets are as follows: approximately fifteen years for developed technology, - consumables, and $5 million of in-process research and development ("IPR&D"). The weighted amortization period for the total identifiable assets is approximately ninefifteen years for customer relationships the weighted amortization period is eighttrade name and three years for the developed technology - pumps and dedicated sets the weighted amortization period is ten years and for the developed technology - consumables the weighted amortization period is twelve years. The IPR&D is non-amortizing until the associated research and development efforts are complete.non-compete agreement.

(2) Long-term liabilities primarily consisted of contract liabilities, product liabilities and long-term employee benefits.

The fair value of the assets acquired and liabilities assumed exceeded the fair value of the consideration to be paid resulting in a bargain purchase gain. Before recognizing a gain on a bargain purchase, we reassessed the methods used in the purchase accounting and verified that we had identified all of the assets acquired and all of the liabilities assumed, and that there were no additional assets or liabilities to be considered. We also reevaluated the fair value of the contingent consideration transferred to determine that it was appropriate. We determined that the bargain purchase gain was primarily attributable to


ICU MEDICAL, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)


expected restructuring costs as well as a reduction to the initially agreed upon transaction price caused primarily by revenue shortfalls across all market segments of the HIS business, negative manufacturing variance due to the drop in revenue and higher operating and required stand up costs, when compared to forecasts of the HIS business at the time that the purchase price was agreed upon. After the continuing review of the product demand and operations of the HIS Business, including the resulting expected restructuring activities, we forecasted our estimated Adjusted EBITDA from the HIS business in 2017 to be $35 million - $40 million, which was considerably lower than the forecast contemplated in initial negotiations with Pfizer, which resulted in an estimated fair value of $19 million related to the $225 million earn out. Restructuring costs, if incurred, will be expensed in future periods (see Note 3: Restructuring Charges). The bargain purchase gain is separately stated below income from operations in the accompanying consolidated statements of operations for the year ended December 31, 2017.

The identifiable intangible assets and other long-lived assets acquired have been valued as Level 3 assets at fair market value. The estimated fair value of identifiable intangible assets were developed using the income approach and are based on critical estimates, judgments and assumptions derived from: analysis of market conditions; discount rate; discounted cash flows; royalty rates; customer retention rates; and estimated useful lives. Fixed assets were valued with the consideration of remaining economic lives. The raw materials inventory was valued at historical cost and adjusted for any obsolescence the work in process was valued at estimated sales proceeds less costs to complete and costs to sell, and finished goods inventory was valued at estimated sales proceeds less a nominal profit and costs to sell. The trade receivables, prepaid expenses and other current assets and assumed liabilities were recorded at their carrying values as of the date of the acquisition, as their carrying values approximated their fair values due to their short-term nature.


Unaudited Pro Forma InformationDuring 2019, we also acquired a small foreign distributor for approximately $4.6 million in cash.


2021 Acquisitions

During November 2021, we acquired a small foreign infusion systems supplier and paid an initial gross cash payment of approximately $15.4 million. The pro forma financial information intotal consideration and purchase price allocation is preliminary pending the table below summarizes the combined results of operations for ICU and HIS as though the companies were combined asfinalization of the beginning of fiscal 2016. The pro forma financial information for all periods presented also includes the business combination accounting effects resulting from this acquisition including our amortization charges from acquired intangible assets, nonrecurring expense relatedvaluation. In addition to the fair value adjustmentinitial cash consideration, total consideration for the acquisition includes an additional holdback of $0.5 million, to acquisition-date inventory, acquisition and integration-related costs, interest expense on the Pfizer seller note and the related tax effects as though the aforementioned companies were combined as of the beginning of fiscal 2016. The pro forma financial information as presented below is for informational purposes only and is not indicative of the results of operations that would have been achieved if the acquisitions had taken place at the beginning of fiscal 2016.

(In millions) Revenue Earnings
Actual from 2/3/2017 - 12/31/2017(3)
 $1,062
 *
2017 supplemental pro forma from 1/1/2017 - 12/31/2017(1)(2)
 $1,373
 $91
2016 supplemental pro forma from 1/1/2016 - 12/31/2016(1)(2)
 $1,418
 $99

* Impracticable to calculate.
(1) 2017 supplemental pro forma earnings were adjusted to exclude $66.3 million of nonrecurring expense related to the fair value adjustment to acquisition-date inventory, $59.2 million of acquisition and integration-related costs and $70.9 million in bargain purchase gain. 2016 supplemental pro forma earnings were adjusted to include these charges. These amounts were updated in 2018be paid two years from the 2017 disclosed amounts to incorporate information not previously available.
(2) Unaudited.
(3) Amount represents activity of HIS from thecompletion date of the acquisition.acquisition, and also a potential earn-out payment of up to $2.5 million, consisting of (i) a cash payment of $1.0 million contingent on the achievement of certain revenue targets for the annual period ending December 31, 2022 and, separately, (ii) a cash payment of $1.5 million contingent on certain product-related regulatory certifications obtained by May 26, 2024.

Strategic Transaction and Integration Expenses


In 2018, we incurred $100.9 million in transaction and integration costs primarily related to our acquisition of HIS. In 2017, we incurred $59.2 million in transaction and integration costs primarily related to our acquisition of HIS. In 2016, we incurred $14.3 million in transaction costs primarily related to our 2017 acquisition of HIS.

NOTE 3. RESTRUCTURING CHARGES

In 2018 and 2017, we incurred restructuring charges related to the acquisition of the HIS business (see Note 2: Acquisitions, Strategic Transaction and Integration Expenses). The restructuring charges were incurred as a result of integrating the acquired operations into our business and include severance costs related to involuntary employee terminations

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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)



NOTE 3. RESTRUCTURING, STRATEGIC TRANSACTION AND INTEGRATION

Restructuring, strategic transaction and integration expenses were $18.0 million, $28.4 million and $80.6 million in 2021, 2020 and 2019, respectively.

Restructuring

Restructuring charges were $(1.8) million, $7.9 million and $8.4 million in 2021, 2020 and 2019, respectively, and are included in the above restructuring, strategic transaction and integration expenses in our consolidated statement of operations.

In 2021, we adjusted certain facility exitrestructuring liabilities by $2.0 million, shown in the table below under "Other adjustments," to reflect actual amounts owed which resulted in net restructuring credits of $(1.8) million.

In 2020, restructuring charges were primarily related to severance and costs related to the closure of the Dominican Republic manufacturing facilities acquired from Pfizer. All material charges in regard to these restructuring activities have been paid as of December 31, 2018. The cumulative amount incurred to date in connection with the HIS acquisition is $23.1 million.office and other facility closures.


In 2016, we incurred an additional 0.8 million2019, restructuring charges were primarily related to theseverance and facility closure of our Slovakian manufacturing facility. Additionally, we incurred $0.2 millioncosts. These charges were primarily related to a one-time charge unrelated to the events disclosed in the table below.move our U.S. pump service depot to our existing Salt Lake City facility and other plant restructuring.


In 2015, we incurred restructuring charges related to an agreement with Dr. Lopez, a member of our Board of Directors and a former employee in our research and development department, pursuant to which we bought out Dr. Lopez's right to employment under his then-existing employment agreement, theagreement. The buy-out, including payroll taxes, will bewas paid in equal monthly installments until December 2020 and payments that will exceed one year have2020. This has been accrued under long-term liabilities in our consolidated balance sheet.fully paid as of December 31, 2020.

The following table summarizes the activity for thein our restructuring-related charges discussed above and related accrual by major type of cost (in thousands):

 Accrued Balance January 1, 2017 Charges incurred Payments Other Adjustments Accrued Balance December 31, 2017 Charges incurred Payments Other Adjustments Accrued Balance December 31, 2018
Severance pay and benefits$53
 $15,983
 $(15,104) $(17) $915
 $4,311
 $(4,549) $
 $677
Employment agreement buyout1,477
 
 (363) 
 1,114
 
 (368) (7) 739
Retention and facility closure expenses
 2,789
 (2,789) 
 
 160
 (160) 
 
 $1,530
 $18,772
 $(18,256) $(17) $2,029
 $4,471
 $(5,077) $(7) $1,416
Severance Pay and BenefitsEmployment Agreement BuyoutRetention and Facility Closure CostsTotal
Accrued balance, January 1, 2020$3,878 $460 $1,211 $5,549 
Charges incurred4,288 — 3,641 7,929 
Payments(6,331)(460)(3,570)(10,361)
Currency translation23 — 281 304 
Accrued balance, December 31, 2020$1,858 $— $1,563 $3,421 
Charges incurred140 — — 140 
Payments(969)— — (969)
Currency translation(2)— 31 29 
Other adjustments(1)
(528)— (1,429)(1,957)
Accrued balance, December 31, 2021$499 $— $165 $664 



Note 4: Revenue

Adoption of ASC Topic 606, “Revenue from Contracts with Customers”
We adopted ASU No. 2014-09, Revenue from Contracts with Customers (ASC Topic 606), effective January 1, 2018 using the modified retrospective method applied to those contracts which were not completed as of January 1, 2018. Results for reporting beginning after January 1, 2018 are presented under ASC Topic 606, while prior period amounts are not adjusted and will continue to be reported in accordance with our historic accounting under ASC Topic 605, Revenue Recognition.

Due to the cumulative impact, net of tax, of adopting ASC Topic 606, we recorded a net increase of $6.3 million to opening retained earnings as of January 1, 2018. (1)    The impact is primarilyestimated liabilities related to our bundled arrangements where we sell software licenses and implementation services, in additiona prior year's facility closure restructuring were adjusted to equipment, consumables and solutions. Under ASC Topic 605, revenue for the equipment was recognized upon delivery and software licenses and implementation services were typically recognized over the contract term. Under ASC Topic 606, revenue for the bundled equipment, software and software implementation services are recognized upon implementation. This results in an acceleration of software related revenue, offset by a delay in the recognition of related revenue of the equipment. Under ASC Topic 605, consumables and solutions revenues were typically recognized upon delivery. Under ASC 606, consumables and solutions revenues are recognized as the customer obtains control of the asset, which is at shipping point. This results in an acceleration in the recognition of consumables and solutions revenue.actual amounts owed.


Additionally, the timing of revenue recognition for software license renewals changed under ASC Topic 606. Under ASC Topic 605, revenue related to software renewals was recognized on a ratable basis over the license period. Under ASC Topic 606, the license, which is considered functional IP, is considered to be transferred to the customer at a point in time, specifically, at the start of each annual renewal period. As a result, under ASC Topic 606, revenue related to our annual software license renewals is accelerated when compared to ASC Topic 605.

Revenues are recognized when control of the promised goods or services is transferred to the customer, in an amount that reflects the consideration we expect to be entitled to in exchange for those goods or services.



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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)




Strategic Transaction and Integration Expenses

We incurred $19.8 million, $20.5 million and $72.2 million in strategic transaction and integration expenses in 2021, 2020 and 2019, respectively, which are included in restructuring, strategic transaction and integration expenses in our consolidated statement of operations. The following tables representstrategic transaction and integration expenses during 2021 were related to integration costs associated with acquisitions, the amounts byHospira Infusion Systems ("HIS") earn-out dispute with Pfizer, one-time costs incurred to comply with regulatory initiatives and transaction expenses incurred in connection with entering into a definitive agreement to acquire Smiths Medical 2020 Limited ("Smiths Medical") (see Note 17: Subsequent Events). The integration expenses during 2020 were related to the integration of HIS and included expenses for the migration of IT systems at our Austin facility. The strategic transaction and integration expenses during 2019 were primarily related to HIS, including a one-time strategic supply chain restructuring charge of $22.1 million, which each financial statement line item is affected in the current year asreduced our contracted commitments to our third party manufacturer and charges related to our Pfizer separation costs, which included a result$12.7 million non-cash write-off of applying ASC Topic 606 (in thousands):related assets.


 
For the year ended
December 31, 2018
 As Reported Without Adoption of ASC 606 Effect of Adoption
Revenue$1,400,040
 $1,388,923
 $11,117
Cost of goods sold$830,012
 $826,607
 $3,405
Gross Profit$570,028
 $562,316
 $7,712
NOTE 4: REVENUE

  As of December 31, 2018
  As Reported Without Adoption of ASC Topic 606 Effect of Adoption
Prepaid expenses and other current assets $25,980
 $32,487
 $(6,507)
Accrued liabilities $128,820
 $151,408
 $(22,588)
Deferred income taxes $38,654
 $40,653
 $(1,999)


Revenue Recognition

We report revenue on a "where sold" basis, which reflects the revenue within the country or region in which the ultimate sale is made to our external customer.    
The following table represents our revenues disaggregated by geography (in thousands):

 
For the year
ended December 31,
Geography2018 
2017 (1)
 
2016(1)
Europe, the Middle East and Africa$134,363
 $119,934
 $50,105
Other Foreign210,996
 192,640
 67,573
Total Foreign345,359
 312,574
 117,678
United States1,054,681
 980,039
 261,694
Total Revenues$1,400,040
 $1,292,613
 $379,372

(1) As noted above, prior period amounts have not been adjusted under the modified retrospective method.

Domestic sales accounted for 75%, 76% and 69% of total revenue in 2018, 2017 and 2016, respectively. International sales accounted for 25%, 24% and 31% of total revenue in 2018, 2017 and 2016, respectively.



ICU MEDICAL, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)


The following table represents our revenues disaggregated by product line (in thousands) and our disaggregated product line revenue as a percentage of total revenue:

 
For the year ended
December 31,
 2018 
2017 (1)
 
2016(1)
Product lineRevenue % of Revenue Revenue % of Revenue Revenue % of Revenue
Infusion Consumables$483,039
 35% $365,665
 28% $324,868
 86%
IV Solutions507,985
 36% 521,963
 40% 
 %
Infusion Systems355,484
 25% 290,207
 23% 
 %
Critical Care53,532
 4% 49,961
 4% 53,601
 14%
Other
 % 64,817
 5% 903
 %
Total Revenues$1,400,040
 100% $1,292,613
 100% $379,372
 100%

(1) As noted above, prior period amounts have not been adjusted under the modified retrospective method.

Our primary product lines are Infusion Consumables, Infusion Systems, IV Solutions Infusion Systems and Critical Care. The vast majority of our sales of these products are made on a stand-alone basis to hospitals group purchasing organization member hospitals, distributors and to other non-acute facilities. Our product sales are typically free on board shipping point and ownership of the product transfers to the customer upon shipment. As a result, revenuedistributors. Revenue is typically recognized upon transfer of control of the products, which we deem to be at point of shipment. However, for purposes of revenue recognition for our software licenses and renewals, we consider the control of these products to be transferred to a customer at a certain point in time; therefore, we recognize revenue at the start of the applicable license term.


Payment is typically due in full within 30 days of invoicing.delivery or the start of the contract term. Revenue is recorded in an amount that reflects the consideration we expect to be entitled to in exchange for those goods or services. We offer certain volume-based rebates to our distribution customers, which we record as variable consideration when calculating the transaction price. Rebates are offered on both a fixed and tiered/variable basis. In both cases, we use information available at the time and our historical experience with each customer to estimate the most likely rebate amount. We also provide chargebacks to distributors that sell to end-customersend customers at prices determined under a contract between us and the end-customer.
Weend customer. Chargebacks are the difference between the prices we charge our distribution customers and the contracted prices we have with the end customer which are processed as credits to our distribution customers. In estimating the expected value of chargeback amounts in order to determine the transaction price, we use information available at the time, andincluding our historical experience to estimate and record provisions for rebates and chargebacks.experience.


We also warrant products against defects and have a policy permitting the return of defective products, for which we accrue and expense at the time of sale using information available at that time and our historical experience. We also provide for extended service-type warranties, which we consider to be separate performance obligations. We allocate a portion of the transaction price to the extended service-type warranty based on its estimated relative selling price, and recognize revenue over the period the warranty service is provided. Our revenues are recorded at the net sales price, which includes an estimate for variable consideration related to rebates, chargebacks and product returns.


Arrangements with Multiple Performance Obligations


We also enter into arrangements which include multiple performance obligations, see(see Note 1,1: Basis of Presentation and Summary of Significant Accounting Policies.Policies).


The most significant judgments related to these arrangements include:


Identifying the various performance obligations of these arrangements.
Estimating the relative standalone selling price of each performance obligation, typically using a directly observable method or calculated on a cost plus margin basis method.




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ICU MEDICAL, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)



Revenue disaggregated

The following table represents our revenues disaggregated by product line (in thousands) and our disaggregated product line revenue as a percentage of total revenue:
Year ended December 31,
202120202019
Product lineRevenue% of RevenueRevenue% of RevenueRevenue% of Revenue
Infusion Consumables$555,189 42 %$473,740 37 %$477,611 37 %
Infusion Systems352,321 27 %359,691 28 %328,282 26 %
IV Solutions359,477 27 %388,971 31 %414,971 33 %
Critical Care49,321 %48,602 %45,344 %
Total Revenues$1,316,308 100 %$1,271,004 100 %$1,266,208 100 %
We report revenue on a "where sold" basis, which reflects the revenue within the country or region in which the ultimate sale is made to our external customer.    
The following table represents our revenues disaggregated by geography (in thousands):
Year ended December 31,
Geography202120202019
Europe, the Middle East and Africa$147,488 $132,763 $130,530 
Other Foreign227,011 227,614 212,336 
Total Foreign374,499 360,377 342,866 
United States941,809 910,627 923,342 
Total Revenues$1,316,308 $1,271,004 $1,266,208 

Domestic sales accounted for 72%, 72% and 73% of total revenue in 2021, 2020 and 2019, respectively. International sales accounted for 28%, 28% and 27% of total revenue in 2021, 2020 and 2019, respectively.

Contract balances


Our contract balances (deferred revenue) are recorded in accrued liabilities and other long-term liabilities in our consolidated balance sheet (see Note 10,10: Accrued Liabilities and Other Long-term Liabilities). The following table presents ourthe changes in theour contract balances for the yearyears ended December 31, 2018,2021 and 2020, (in thousands):
 Contract Liabilities
Beginning balance, January 1, 2018$(7,066)
Equipment revenue recognized6,696
Equipment revenue deferred due to implementation(4,196)
Software revenue recognized6,553
Software revenue deferred due to implementation(6,269)
Ending balance, December 31, 2018$(4,282)
Contract Liabilities
Beginning balance, January 1, 2020$(4,855)
Equipment revenue recognized14,408 
Equipment revenue deferred due to implementation(14,341)
Software revenue recognized5,721 
Software revenue deferred due to implementation(7,363)
Ending balance, December 31, 2020$(6,430)
Equipment revenue recognized10,048 
Equipment revenue deferred due to implementation(13,725)
Software revenue recognized7,261 
Software revenue deferred due to implementation(4,615)
Ending balance, December 31, 2021$(7,461)
    
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ICU MEDICAL, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)

During 2021, we recognized $5.1 million in revenue that was included in the opening contract balances as of December 31, 2020. As of December 31, 2018,2021, revenue from remaining performance obligations related to implementation of software and equipment is $2.9$5.6 million. We expect to recognize substantially all of this revenue within the next three months.to six months dependent on implementation restrictions due to the novel coronavirus and its variants ("COVID-19"). Revenue from remaining performance obligations related to annual software licenses is $1.6$1.9 million. We expect to recognize substantially all of this revenue over the next twelve months.


Costs to Obtain a Contract with a Customer


As part of the cost to obtain a contract, we may pay incremental commissions to sales employees upon entering into a sales contract. Under ASC Topic 606, we have elected to expense these costs as incurred as the period of benefit is less than one year.
Practical expedients and exemptions


In addition to the practical expedient applied to sales commissions, under ASC Topic 606, we elected to apply the practical expedient for shipping and handling costs incurred after the customer has obtained control of a good. We will continue to treat these costs as a fulfillment cost rather than as an additional promised service.


NOTE 5. IMPAIRMENT OF ASSETS HELD FOR SALELEASES


During 2016, we completedWe determine if an arrangement is a lease at inception. Our operating lease assets are separately stated in operating lease right-of-use ("ROU") assets and our financing lease assets are included in other assets on our consolidated balance sheets. Our lease liabilities are included in accrued liabilities, and other long-term liabilities on our consolidated balance sheets. We have elected not to recognize an ROU asset and lease liability for leases with terms of twelve months or less.

Lease ROU assets and lease liabilities are recognized based on the closurepresent value of the future minimum lease payments over the lease term at commencement date. Most of our Slovakia manufacturingleases do not provide an implicit rate, therefore we use our incremental borrowing rate, which is the rate incurred to borrow on a collateralized basis over a similar term based on the information available at commencement date. Our lease ROU assets exclude lease incentives and initial direct costs incurred. Our lease terms include options to extend when it is reasonably certain that we will exercise that option. All of our leases have stated lease payments, which may include fixed rental increases.
Our leases are for corporate, research and development and sales and support offices, a distribution facility, device service centers and soldcertain equipment. Our leases have original lease terms of one year to fifteen years, some of which include options to extend the land and building held-for- saleleases for $3.3 million, net of costsup to sell, resulting in an additional $0.7 million impairment charge on those assets.five years. For all of our leases, we do not include optional periods of extension in our current lease terms for the exercise of options to extend is not reasonably certain.    

The impairment charges are separately statedfollowing table presents the components of our lease cost (in thousands):
Year ended December 31,
20212020
Operating lease cost$11,251 $11,284 
Finance lease cost — interest122 91 
Finance lease cost — reduction of ROU asset648 383 
Short-term lease cost14 263 
Total lease cost$12,035 $12,021 

Interest expense on our finance leases is included in other income (expense), net in our consolidated statements of operations above income fromoperations. The reduction of the operating and finance ROU assets is included as noncash lease expense in selling, general and administrative expenses in our consolidated statements of operations.



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ICU MEDICAL, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)

The following table presents the supplemental cash flow information related to our leases (in thousands):
Year ended December 31,
20212020
Cash paid for amounts included in the measurement of lease liabilities:
Operating cash flows from operating leases$11,256 $10,185 
Operating cash flows from finance leases$122 $91 
Right-of-use assets obtained in exchange for lease obligations:
Operating leases$2,589 $20,847 
Finance leases$558 $3,062 

The following table presents the supplemental balance sheet information related to our operating leases (in thousands, except lease term and discount rate):
As of December 31,
20212020
Operating leases
Operating lease right-of-use assets$39,847$46,571
Accrued liabilities$9,009$8,740
Other long-term liabilities33,97141,019
Total operating lease liabilities$42,980$49,759
Weighted-Average Remaining Lease Term
Operating leases5.9 years6.7 years
Weighted-Average Discount Rate
Operating leases4.98 %5.02 %


The following table presents the supplemental balance sheet information related to our finance leases (in thousands, except lease term and discount rate):
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ICU MEDICAL, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)

As of December 31,
20212020
Finance leases
Finance lease right-of-use assets$2,673$2,915
Accrued liabilities$643$554
Other long-term liabilities2,0672,388
Total finance lease liabilities$2,710$2,942
Weighted-Average Remaining Lease Term
Finance leases5.6 years6.4 years
Weighted-Average Discount Rate
Finance leases4.28 %4.27 %

As of December 31, 2021, the maturities of our operating and finance lease liabilities for each of the next five years are approximately (in thousands):
Operating LeasesFinance Leases
2022$10,887 $749 
20239,453 749 
20248,488 458 
20255,129 267 
20264,842 214 
Thereafter10,577 615 
Total Lease Payments49,376 3,052 
Less imputed interest(6,396)(342)
Total$42,980 $2,710 
NOTE 6. SHARE BASEDSHARE-BASED AWARDS
 
We have a stock incentive plan for employees and directors and an employee stock purchase plan.  Shares to be issued under these plans will be issued either from authorized but unissued shares or from treasury shares.


We incur stock compensation expense for stock options, restricted stock units ("RSU"), performance restricted stock units ("PRSU") and in years prior to 2018 stock purchased under our employee stock purchase plan ("ESPP")., which was suspended in 2017. We receive a tax benefit on stock compensation expense and direct tax benefits from the exercise of stock options.options and vesting of restricted stock units. We also have indirect tax benefits upon exercise of stock options and vesting of restricted stock units related to research and development tax credits which are recorded as a reduction of income tax expense. 

The table below summarizes compensation costs and related tax benefits (in thousands):
80

  Year ended December 31,
 (In thousands) 2018 2017 2016
Stock compensation expense $24,241
 $19,352
 $15,242
Tax benefit from stock-based compensation cost $5,706
 $7,247
 $5,682
Indirect tax benefit $2,199
 $1,374
 $





ICU MEDICAL, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)



 Year ended December 31,
 (In thousands)202120202019
Stock compensation expense$27,341 $23,954 $21,918 
Tax benefit from stock-based compensation cost$6,391 $5,564 $4,840 
Indirect tax benefit$285 $1,203 $680 

As of December 31, 2018,2021, we had $28.0$31.2 million of unamortized stock compensation cost which we will recognize as an expense over a weighted-average period of approximately 0.9 years.
Stock Incentive and Stock Option Plans


Our 2011 Stock Incentive Plan ("2011 Plan") replaced our 2003 Stock Option Plan (“("2003 Plan”Plan"). Our 2011 Plan initially had 650,000 shares available for issuance, plus the remaining available shares for grant from the 2003 Plan and any shares that were forfeited, terminated or expired that would have otherwise returned to the 2003 Plan. In 2012, 2014 and 2017, our stockholders approved amendments to the 2011 plan that increased the shares available for issuance by 3,275,000, bringing the initial shares available for issuance to 3,925,000,, plus the remaining 248,700 shares that remained available for grant from the 2003 Plan. In addition, any forfeited, terminated or expired shares that would otherwise return to the 2003 Plan are available under the 2011 Plan. As of December 31, 2018,2021, the 2011 Plan has 4,188,300 shares of common stock reserved for issuance to employees, which includes 263,300 shares that transferred from the 2003 Plan. Shares issued as options or stock appreciation rights ("SARs") are charged against the 2011 Plan's share reserve as one share for one share issued. Shares subject to awards other than options and SARs are charged against the 2011 Plan's share reserve as 2.09 shares for 1 share issued. Options may be granted with exercise prices at no less than fair market value at date of grant. Options granted under the 2011 Plan may be “non-statutory"non-statutory stock options”options" which expire no more than ten years from date of grant or “incentive"incentive stock options”options" as defined in Section 422 of the Internal Revenue Code of 1986, as amended. Upon exercise of non-statutory stock options, we are generally entitled to a tax deduction on the exercise of the option for an amount equal to the excess over the exercise price of the fair market value of the shares at the date of exercise; we are generally not entitled to any tax deduction on the exercise of an incentive stock option. The 2011 Plan includes conditions whereby unvested options are cancelled if employment is terminated. 

In 2014, our Compensation Committee of the Board of Directors awarded our then new Chief Executive Officer an employment inducement option to purchase 182,366 shares of our common stock and an employment inducement grant of restricted stock units with respect to 68,039 shares of our common stock. The inducement grants were made out of our 2014 Inducement Incentive Plan ("2014 Plan").

Our 2001 Directors’ Stock Option Plan (the “Directors’ Plan”), initially had 750,000 shares reserved for issuance to members of our Board of Directors, expired in November 2011. Although no new grants may be made under the Director's Plan, grants made under the Director's Plan prior to its expiration continue to remain outstanding.  Options not vested terminate if the directorship is terminated. 


Time-based Stock Options 


To date, all options granted under the 2014 Plan, 2011 Plan 2003 Plan and Directors'2003 Plan have been non-statutory stock options. The majority of the time-based outstanding employee option grants vestvested 25% after one year from the grant date and the balance vestsvested ratably on a monthly basis over 36 months. The outstanding employee option grants are all fully vested. The majority of the outstanding options granted to non-employee directors vest one year from the grant date. The options generally expire 10 years from the grant date.



ICU MEDICAL, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)



The fair value of time-based option grants is calculated using the Black-Scholes option valuation model. The expected term for the option grants was based on historical experience and expected future employee behavior. We estimate the volatility of our common stock at the date of grant based on the historical volatility of our common stock, based on the average expected exercise term.

The table below summarizes the total time-based stock options granted, total valuation and the weighted averageweighted-average assumptions (dollars in thousands, except per option amounts):
 Year ended December 31,
 202120202019
Number of time-based options granted7,910 7,190 6,265 
Grant-date fair value of options granted (in thousands)$528 $425 $424 
Weighted-average assumptions for stock option valuation:
Expected term (years)5.55.55.5
Expected stock price volatility35.0 %35.0 %28.0 %
Risk-free interest rate0.9 %0.4 %2.2 %
Expected dividend yield— %— %— %
Weighted-average grant-price per option$200.07 $181.99 $225.27 
Weighted-average grant-date fair value per option$66.78 $59.09 $67.73 

81



ICU MEDICAL, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)

  Year ended December 31,
  2018 2017 2016
Number of time-based options granted 5,815
 8,825
 13,405
Grant date fair value of options granted (in thousands) $425
 $375
 $413
Weighted average assumptions for stock option valuation:      
Expected term (years) 5.5
 5.5
 5.5
Expected stock price volatility 24.0% 27.0% 31.8%
Risk-free interest rate 2.3% 1.1% 0.7%
Expected dividend yield % % %
Weighted average grant price per option $269.80
 $158.20
 $101.32
Weighted average grant date fair value per option $73.14
 $42.51
 $30.78

Performance Stock Options

In 2015, we granted performance stock option grants which are exercisable if the common stock price condition and the time-based vesting have been met. The 2015 performance based stock option grants vest ratably at 33% per year over three years. For the 2015 grants, the vested performance stock options became exercisable when the closing price of our common stock was equal to or more than 130% of the exercise price for 30 consecutive trading days during the term of the grant. All of the 2015 performance stock option grant's common stock price conditions have been met.

The fair value of performance option grants is calculated using the Monte Carlo Simulation. The expected term of the performance option grants is based on the expected number of years to achieve the exercisable goal trigger and assumes that the vested option will be immediately exercised or cancelled, if underwater. We estimate the volatility of our common stock at the date of grant based on the historical volatility of our common stock over a 10-year period.

The table below indicates the number of shares of 2015 performance stock options that were earned in 2016. There were no performance option grants to employees in 2018, 2017 or 2016.

  Year ended December 31,
  2018 2017 2016
Number of performance options earned 
 
 244,825
A summary of our stock option activity as of and for the year ended December 31, 20182021 is as follows:
 SharesWeighted-Average Exercise Price Per ShareWeighted-Average Contractual Life (Years)Aggregate Intrinsic Value (in thousands)
Outstanding at December 31, 2020817,800 $70.13 
Granted7,910 $200.07 
Exercised(162,612)$57.64 
Forfeited or expired— $— 
Outstanding at December 31, 2021663,098 $74.75 2.6$108,003 
Exercisable at December 31, 2021656,483 $73.48 2.5$107,761 
Vested and expected to vest, December 31, 2021663,098 $74.75 2.6$108,003 
    
  Shares Weighted Average Exercise Price Per Share Weighted Average Contractual Life (Years) Aggregate Intrinsic Value (in thousands)
Outstanding at December 31, 2017 1,416,727
 $62.30
    
Granted 5,815
 $269.80
    
Exercised (235,614) $60.60
    
Forfeited or expired 
 $
    
Outstanding at December 31, 2018 1,186,928
 $63.66
 4.9 $197,232
Exercisable at December 31, 2018 1,181,113
 $62.64
 4.8 $197,232
Vested and expected to vest, December 31, 2018 1,186,928
 $63.66
 4.9 $197,232


ICU MEDICAL, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)


The intrinsic values for options exercisable, outstanding and vested or expected to vest at December 31, 2018 is2021 are based on our closing stock price of $229.63$237.34 at December 31, 20182021 and are before applicable taxes.

The following table presents information regarding Stock Optionstock option activity:
 Year ended December 31,
(In thousands)202120202019
Intrinsic value of options exercised$27,534 $32,915 $22,976 
Cash received from exercise of stock options$9,372 $13,193 $7,732 
Tax benefit from stock option exercises$5,092 $5,179 $9,653 
  Year ended December 31,
(In thousands) 2018 2017 2016
Intrinsic value of options exercised $51,105
 $71,283
 $25,065
Cash received from exercise of stock options $14,275
 $32,003
 $17,346
Tax benefit from stock option exercises $12,617
 $20,004
 $7,556


Stock Awards


In 2018,2021, we granted performance restricted stock units ("PRSU")PRSUs to our executive officers. For the executive officers other than the Chief Executive Officer ("CEO") and the, Chief Operations Officer ("COO") and the Chief Financial Officer ("CFO"), the PRSUs will vest subject to a three-year time vesting and further subject to a determination by the Compensation Committee that the officers have met their individual performance goals for the applicable years. For the CEO, COO and the CFO, the performance shares will cliff-vest ending on March 6, 2024 and further be subject to the achievement of minimum three-year cumulative revenue and EPS targets, commencing on January 1, 2021 and ending on December 31, 2023, which when reviewed against a predetermined vesting matrix could result in 0% to 250% of the awarded units that could vest.

In 2020, we granted PRSUs to our executive officers. For the executive officers other than the CEO, COO and the CFO, the PRSUs will vest subject to a three-year time vesting and further subject to a determination by the Compensation Committee that the officers have met their individual performance goals for the applicable years. For the CEO, COO and the CFO, the performance shares will cliff-vest ending on March 6, 2023 and further be subject to the achievement of minimum three-year cumulative revenue and EPS targets, which when reviewed against a predetermined vesting matrix could result in 0% to 250% of the awarded units that could vest. On February 15, 2021, the Compensation Committee made the determination that the executive officers other than the CEO, COO and CFO met their individual performance goals for 2021, therefore one-third of their 2020 PRSU shares awarded vested during 2021. Additionally, during February 2021, the Compensation Committee, modified the potential vesting percentages related to the 2020 PRSU awards for the CEO, COO and CFO, as the original potential percentages were established immediately before the onset of the COVID-19 pandemic. The Compensation Committee determined to adjust the CEO, COO and CFO's potential to earn from between 0% and 250% of the award granted, to an increased potential to earn between 50% and 300% of the award granted, subject to the same minimum threshold revenue and EPS targets to be achieved by the Company. The additional compensation expense as a result of modifying the 2020 PRSUs granted to our CEO, COO and CFO totaled $2.1 million recognized over the remaining amortization period from the date of modification.

In 2019, we granted PRSUs to our executive officers. For the executive officers other than the CEO and the COO, the PRSUs will vest subject to a three-year time vesting and further subject to a determination by the Compensation Committee that
82



ICU MEDICAL, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)

the officers have met their individual performance goals for the applicable years. For the CEO and the COO, the performance shares will cliff-vest ending on March 6, 2022 and further subject to the achievement of a minimum Cumulative Adjusted EBITDA. If for the three year period ending on December 31, 2021 the Cumulative Adjusted EBITDA has a growth of at least 6% to 8%, 50% of the awarded units will vest. If on the vesting date the Cumulative Adjusted EBITDA has a growth of between 8% to 10%, 100% of the awarded units will vest. If on the vesting date the Cumulative Adjusted EBITDA has a growth of over 10%, 200% of the awarded units will vest. In 2019, we also granted PRSUs to one of our non-executive employees. These PRSUs will vest at the end of a three-year period ending on March 31, 2022, if certain minimum performance goals are met. On February 15, 2021, the Compensation Committee made the determination that the executive officers other than the CEO and COO met their individual performance goals for 2021, therefore one-third of their 2019 PRSU shares awarded vested during 2021. The performance period related to the 2019 CEO and COO PRSUs ended on December 31, 2021 and based on the Cumulative Adjusted EBITDA achieved during the performance period zero payout is expected, subject to Compensation Committee review and determination.

In 2018, we granted PRSUs to our executive officers. For the executive officers other than the CEO and the COO, the PRSUs were to vest subject to a three-year time vesting and further subject to a determination by the Compensation Committee that the officers have met their individual performance goals for the applicable year. For the CEO and the COO, the performance shares willwere to cliff-vest ending on February 15, 2021 and further subject to the achievement of a minimum Cumulative Adjusted EBITDA. If for the three year period ending on December 31, 2020 the Cumulative Adjusted EBITDA has a growth of at least 6% to 8%, 50% of the awarded units will vest. If on the vestvesting date the Cumulative Adjusted EBITDA has a growth of between 8% to 10%, 100% of the awarded units will vest. If on the vestvesting date the Cumulative Adjusted EBITDA has a growth of over 10%, 200% of the awarded units will vest. On February 15, 2021, the Compensation Committee made the determination that the executive officers other than the CEO and COO met their individual performance goals for 2021, therefore one-third of their 2018 PRSU shares awarded vested during 2021. Also on February 15, 2021, the Compensation Committee determined that the CEO and COO's 2018 PRSUs were earned at 100% of the awards granted.


In 2017, we granted PRSUs to our executive officers. The PRSUs willwere scheduled to vest, if at all, upon the achievement of a minimum Cumulative Adjusted EBITDA, subject to a three-year cliff vesting ending on December 31, 2019. If at that date, our Cumulative Adjusted EBITDA is at least $600 million but less than $650 million, 100% of the awarded units will vest. If our Cumulative Adjusted EBITDA is at least $650 million but less than $700 million, 200% of the awarded units will vest. If our Cumulative Adjusted EBITDA is at least $700 million, 300% of the awarded units will vest. On January 17, 2020, the Compensation Committee made the determination that the 2017 PRSU shares were earned by our executive officers at the 300% achievement level.


In 2016, we granted PRSUs to our executive officers, which will vest, ifvested on December 31, 2018. During the first quarter of 2019, the Compensation Committee determined the award granted vested at all, upon the achievement of300%, as a minimum specified compound annual growth rate ("CAGR") in adjusted EBITDA per share subject to a three-year cliff vesting ending onof greater than 12% was reached for the 3-year performance period January 1, 2016 through December 31, 2018. If at that date, our adjusted EBITDA per share CAGR is at least 8% but less than 10%, 100% of the awarded units will vest. If our adjusted EBITDA per share CAGR is at least 10% but less than 12%, 200% of the awarded units will vest. If our adjusted EBITDA per share CAGR is greater than 12%, 300% of the awarded units will vest. The Compensation Committee has up until March 15, 2019 to make a determination on the level of achievement of minimum Cumulative Adjusted EBITDA reached, the awards will vest upon the conclusion of that determination.


Restricted stock units ("RSU") are granted annually to our Board of Directors and vest on the first anniversary of the grant date.date, or the date of our annual meeting, whichever occurs first.


In 2018, 20172021, 2020 and 2016,2019, we granted RSUs to certain employees that vest ratably on the anniversary of the grant over three years. We recognize forfeitures as they occur.



The grant-date fair market value of our PRSUs and RSUs is determined by our stock price on the grant date.

ICU MEDICAL, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)



The table below summarizes our restricted stock award activity (dollars in thousands):
83



ICU MEDICAL, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)

Year ended December 31,
 Year ended December 31,
(In thousands except shares and per share amounts) 2018 2017 2016
(In thousands, except shares and per share amounts)(In thousands, except shares and per share amounts)202120202019
PRSU      PRSU
Shares granted 30,348
 20,686
 36,370
Shares granted53,246 38,633 37,657 
Shares earned 
 
 
Grant date fair value per share $248.65
 $154.75
 $86.47
Grant date fair value $7,546
 $3,201
 $3,145
Shares earned (a)
Shares earned (a)
32,013 80,654 114,032 
Grant-date fair value per shareGrant-date fair value per share$198.16 $188.34 $231.63 
Grant-date fair valueGrant-date fair value$10,551 $7,276 $8,723 
Intrinsic value vested $
 $
 $
Intrinsic value vested$6,777 $15,627 $26,445 
      
RSU      RSU
Shares granted 63,094
 107,678
 60,377
Shares granted84,388 87,830 61,856 
Grant date fair value per share $252.42
 $156.49
 $87.47
Grant date fair value $15,926
 $16,851
 $5,281
Grant-date fair value per shareGrant-date fair value per share$199.13 $188.13 $227.42 
Grant-date fair valueGrant-date fair value$16,804 $16,523 $14,067 
Intrinsic value vested $17,086
 $9,813
 $4,680
Intrinsic value vested$13,681 $12,314 $16,753 

(a)    PRSU shares earned in 2019 were related to performance awards granted to executives in 2016 and 2018, PRSU shares earned in 2020 were related to performance awards granted to executives in 2017, 2018 and 2019. PRSU shares earned in 2021 were related to performance awards granted to executives in 2018, 2019 and 2020.


The table below provides a summary of our PRSU and RSU activity as of and for the year ended December 31, 2018.2021:  
 Number of UnitsGrant-Date Fair Value Per ShareWeighted-Average Contractual Life (Years)Aggregate Intrinsic Value (in thousands)
Non-vested at December 31, 2020220,760 $209.77 
Change in units due to performance expectations (a)
24,601 $209.64 
Granted137,634 $198.75 
Vested(99,363)$219.77 
Forfeited(7,871)$196.01 
Non-vested and expected to vest at December 31, 2021275,761 $201.05 1.0$65,449 

  Number of Units Grant Date Fair Value Per Share Weighted Average Contractual Life (Years) Aggregate Intrinsic Value
Non-vested at December 31, 2017 285,503
 $116.28
    
Change in units due to performance expectations (a)
 41,372
 $154.75
    
Granted 93,442
 $251.19
    
Vested (71,868) $122.00
    
Forfeited (7,745) $181.07
    
Non-vested and expected to vest at December 31, 2018 340,704
 $155.27
 1.0 $78,236

(a)    Relates to the 20172019-2021 PRSUs granted to a non-executive employee and 2021 and 2020 CEO, COO and CFO PRSUs granted, assumes attainment of maximuman increased payout rate as set forth inbased on performance criteria.expectations.


ESPP
 
We have an ESPP under which U.S. employees may purchase up to $25,000 annually of common stock at 85% of its fair market value at the beginning or the end of a six-month offering period, whichever is lower. There are 750,000 shares of common stock reserved for issuance under the ESPP, which is subject to an annual increase of the least of 300,000 shares, two percent of the shares outstanding or such a number as determined by the Board. To date, there have been no increases. As of December 31, 2018,2021, there were 133,487 shares available for future issuance. The ESPP is intended to constitute an “employee stock purchase plan” within the meaning of Section 423 of the Internal Revenue Code. During 2017, weWe suspended our ESPP.ESPP in 2017.




ICU MEDICAL, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)


The fair value of rights to purchase shares under the ESPP is calculated using the Black-Scholes option valuation model.  The table below summarizes the number and intrinsic value of ESPP share purchases and the weighted average valuation assumptions for the 2017 and 2016 purchase periods.
  
  2017 2016
ESPP shares purchased by employees 23,426
 31,227
Intrinsic value of ESPP purchases (in thousands) $986
 $955
Weighted average assumptions for ESPP valuation:    
Expected term (in years) 0.5
 0.5
Expected stock price volatility 28.1% 32.5%
Risk-free interest rate 0.6% 0.3%
Expected dividend yield % %

NOTE 7. DERIVATIVES AND HEDGING ACTIVITIES


Hedge Accounting and Hedging Program


During the second quarterThe purposes of 2017, we implemented aour cash flow hedging program. The purpose of our hedging program isprograms are to manage the foreign currency exchange rate risk on forecasted expenses denominated in currencies other than the functional currency of the operating unit.unit, and to manage floating interest rate risk associated with future interest payments on variable-rate term loans issued in January 2022 subsequent to our fiscal year end. We do not issue derivatives for trading or speculative purposes.

84


In May 2017, we entered into a two-year cross-currency par forward contract to hedge a portion of our Mexico forecasted expenses denominated in Pesos ("MXN").
ICU MEDICAL, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)


To receive hedge accounting treatment, all hedging relationships are formally documented at the inception of the hedge, and the hedges must be highly effective in offsetting changes to future cash flows on hedged transactions. The par forward contract isand forward-starting interest rate swaps are designated and qualifiesqualify as a cash flow hedge.hedges. Our derivative instrument isinstruments are recorded at fair value on the Consolidated Balance Sheetsconsolidated balance sheets and isare classified based on the instrument's maturity date. We record changes in the fair value of the effective portion of the gain or loss on the derivative instrument as a component of Other Comprehensive (Loss) Incomeother comprehensive income (loss) and we reclassify that gain or loss into earnings in the same line item associated with the forecasted transaction and in the same period during which the hedged transaction affects earnings. The total notional amount

Foreign Currency Exchange Rate Risk
We began hedging a portion of our outstanding derivative as of December 31, 2018 was approximately 150.1 million MXN.Mexico forecasted expenses denominated in Pesos ("MXN") in May 2017 by entering into a two-year cross-currency par forward contract. The term of ourthis currency forward contract iswas May 1, 2017 to May 1, 2019. The derivative instrument matures in equal monthly amounts athad a fixed forward rate of 20.01MXN/20.01 MXN/USD over the term of the two-year contract.


In January 2018, we entered into an additionala six-month cross-currency par forward contract that extends our current hedge of a portion of our Mexico forecasted expenses denominated in MXN. The total notional amount of this outstanding derivative as of December 31, 2018 was approximately 183.9 million MXN.contract. The term of thethis six-month contract iswas May 1, 2019 to November 1, 2019. The derivative instrument matures in equal monthly amounts athad a fixed forward rate of 20.43 MXN/USD over the term of the six-month contract.


In November 2018, we entered into a one-year cross-currency par forward contract again extendingcontract. The term of the one-year hedge was November 1, 2019 to November 3, 2020. The derivative instrument matured in equal monthly amounts at a fixed forward rate of 22.11 MXN/USD.

In March 2020, we entered into a portion of our Mexico forecasted expenses denominated in MXN.one-year cross-currency par forward contract. The total notional amount of this outstanding derivative as of December 31, 20182020 was approximately 398.0436.8 million MXN. The term of thethis one-year hedge is November 1, 2019 tocontract was November 3, 2020.2020 to December 1, 2021. The derivative instrument matured in equal monthly amounts at a fixed forward rate of 24.26 MXN/USD.

In November 2021, we entered into a one-year cross-currency par forward contract. The total notional amount of this outstanding derivative as of December 31, 2021 was approximately 413.1 million MXN. The term of this one-year contract is December 1, 2021 to December 1, 2022. The derivative instrument matures in equal monthly amounts at a fixed forward rate of 22.10921.60 MXN/USD.

Floating Interest Rate Risk



In November 2021, in anticipation of entering into new senior secured credit facilities in January 2022, which includes a variable-rate term loan A and a variable-rate term loan B (see Note 17: Subsequent Events for additional information), we entered into two forward-starting interest rate swaps. Under the interest rate swap agreements we exchange, at specified intervals, the difference between fixed and floating interest amounts calculated by reference to an agreed-upon notional amount. The term loan A swap has an initial notional amount of $300.0 million, reducing to $150.0 million evenly on a quarterly basis through its final maturity in April 2027. We will pay a fixed rate of 1.49% and will receive the greater of 3-month USD LIBOR or 0%. The term loan B swap has an initial notional amount of $750.0 million, reducing to $46.9 million evenly on a quarterly basis through its final maturity in April 2026. We will pay a fixed rate of 1.31% and will receive the greater of 3-month USD LIBOR or 0.50%. These forward-starting swaps will effectively convert the relevant portion of the floating-rate term loans to fixed rates.    
ICU MEDICAL, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)



The following table presents the fair values of our derivative instruments included within the Consolidated Balance Sheetsconsolidated balance sheets (in thousands):
85



ICU MEDICAL, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)

 Derivatives
 
Consolidated Balance Sheet
Location
 
December 31,
2018
 December 31, 2017
Derivatives designated as cash flow hedging instruments     
Foreign exchange forward contract:Prepaid expenses and other current assets $187
 $
 Other assets 545
 
 Accrued liabilities 
 187
 Other long-term liabilities 
 402
Total derivatives designated as cash flow hedging instruments  $732
 $589
Derivatives Designated as Cash Flow Hedging Instruments
Consolidated Balance Sheet LocationForeign Exchange Forward ContractsForward-Starting Interest Rate SwapsGross Derivatives
(In thousands)
As of December 31, 2021
Prepaid expenses and other current assets$1,061 $— $1,061 
Other assets— — — 
Total assets$1,061 $— $1,061 
Accrued liabilities$— $— $— 
Other long-term liabilities— 1,480 1,480 
Total liabilities$— $1,480 $1,480 
As of December 31, 2020
Prepaid expenses and other current assets$3,555 $— $3,555 
Other assets— — — 
Total assets$3,555 $— $3,555 
Accrued liabilities$— $— $— 
Other long-term liabilities— — — 
Total liabilities$— $— $— 


The following table presents the amounts affecting the Consolidated Statements of Operations (in thousands):

Location of Gain in the Consolidated Statements of OperationsYear Ended December 31,
202120202019
Derivatives designated as cash flow hedging instruments:
Foreign exchange forward contractsCost of goods sold$3,444 $790 $916 
Forward-starting interest rate swapsInterest expense$— $— $— 


86

 
Line Item in the
Consolidated Statements of Operations
 Year Ended
December 31, 2018
 Year Ended
December 31, 2017
Derivatives designated as cash flow hedging instruments     
Foreign exchange forward contractsCost of goods sold $743
 $885



ICU MEDICAL, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)

We recognized the following gains (losses) on our foreign exchange contractderivative instruments designated as a cash flow hedgehedges (in thousands):

Amount of Gain (Loss) Recognized in Other Comprehensive IncomeAmount of Gain Reclassified From Accumulated Other Comprehensive Income into Income
Year Ended December 31,Year Ended December 31,
202120202019Location of Gain Reclassified From Accumulated Other Comprehensive Income into Income202120202019
Derivatives designated as cash flow hedging instruments:
Foreign exchange forward contracts$950 $1,980 $2,550 Cost of goods sold$3,444 $790 $916 
Forward-starting interest rate swaps(1,480)— — Interest expense— — — 
Total derivatives designated as cash flow hedging instruments$(530)$1,980 $2,550 $3,444 $790 $916 
  Amount of Gain Recognized in Other Comprehensive Income on Derivatives Amount of Gain Recognized in Other Comprehensive Income on Derivatives Amount of Gain Reclassified From Accumulated Other Comprehensive Income into Income
  Year Ended
December 31, 2018
 Year Ended
December 31, 2017
 Location of Gain Reclassified From Accumulated Other Comprehensive Income into Income Year Ended
December 31, 2018
 Year Ended
December 31, 2017
Derivatives designated as cash flow hedges:          
Foreign exchange forward contract $2,063
 $296
 Cost of goods sold $743
 $885
Total derivatives designated as cash flow hedging instruments $2,063
 $296
   $743
 $885


As of December 31, 2018,2021, we expect approximately $0.2an estimated $1.1 million of thein deferred gaingains on the outstanding derivativesforeign exchange forward contract and an estimated $5.6 million in deferred losses on the forward-starting interest rate swaps will be reclassified from accumulated other comprehensive income to be reclassifiedloss to net income during the next 12 months concurrent with the underlying hedged transactions also being reported in net income.




ICU MEDICAL, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)


NOTE 8. FAIR VALUE MEASUREMENTS


Fair value is the price that would be received from selling an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. Fair value is estimated by applying the following hierarchy, which prioritizes the inputs used to measure fair value into three levels and bases the categorization within the hierarchy upon the lowest level of input that is available and significant to the fair value measurement:


Level 1: quoted prices in active markets for identical assets or liabilities;
Level 2: inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices in active markets for similar assets or liabilities, quoted prices for identical or similar assets or liabilities in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities; or
Level 3: unobservable inputs that are supported by little or no market activity and that are significant to the fair values of the assets or liabilities.


DuringContingent earn-out liabilities

In the firstfourth quarter of 2017,2019, we recognized an earn-out liability uponrelated to the acquisition of HIS from Pfizer. Pfizer may bePursuit (see Note 2: Acquisitions). Pursuit's former equity holders were entitled up to $225$50.0 million in additional cash ifconsideration contingent upon the achievement of certain performancesales and gross profit targets for specific customers. The earn-out was calculated as a percentage of gross profit achieved during the combined company forearn-out period against a pre-determined target gross profit, not to exceed $50.0 million. During the three years ending December 31, 2019 are achieved. The initialearn-out period, we used a Monte Carlo simulation model to determine the fair value of the earn-out was determined by employing aliability. The Monte Carlo simulation inmodel utilized multiple input variables to determine the value of the earn-out liability including historical volatility, a risk-free interest rate, counter party credit risk neutral framework.and projected future gross profit (see the simulation input table below related to Pursuit). The underlying simulated variablehistorical volatility was adjusted EBITDA.based on the median of ICU and a certain peer group. The adjusted EBITDA volatility estimaterisk-free interest rate was equal to the yield, as of the valuation date, of the zero-coupon U.S. Treasury bill that was commensurate with the term of the earn-out. The counter party credit risk was based on a studysynthetic credit rating of historical asset volatilityB1. As of June 30, 2021, the
87



ICU MEDICAL, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)

earn-out measurement period ended. Based on the actual sales and gross profit achieved during the measurement period, we calculated the actual earn-out amount to be $26.3 million. The $26.3 million earn-out calculation was finalized and accepted by Pursuit's former equity holders and was paid out in the fourth quarter of 2021.

In August 2021, we entered into an agreement with one of our international distributors whereby that distributor would not compete with us in a specific territory for a setthree-year period that will end in September 2024. The terms of comparable public companies.the agreement include a contingent earn-out payment. The contingent earn-out payment shall not exceed $6.0 million, which will be earned based on certain revenue targets over a twelve-month measurement period determined by the highest four consecutive quarters commencing over a two-year period starting on the closing date of the agreement and provided that the distributor is in compliance with its obligations under the agreement. As of December 31, 2021, the fair value of the contingent earn-out was estimated at $2.6 million. The estimated fair value of the contingent earn-out is calculated using a probability-weighted cash flow model based on historical revenue streams and the likelihood that the revenue targets will be met.

During November 2021, we acquired a small foreign infusion systems supplier. Total consideration for the acquisition includes other assumptions includinga potential earn-out payment of up to $2.5 million, consisting of (i) a cash payment of $1.0 million contingent on the market priceachievement of risk, which was calculated ascertain revenue targets for the weighted average costannual period ending December 31, 2022 and, separately, (ii) a cash payment of capital ("WACC") less the long term risk free rate.$1.5 million contingent on certain product-related regulatory certifications obtained by May 26, 2024. The initial estimated fair value assigned toof the contingent consideration was a result of forecasted product demand of our HIS business, as discussed further in Note 2: Acquisition, Strategic Transaction and Integration Expenses. At each reporting date subsequentrelated to thethis acquisition we remeasure the earn-out using the same methodology above and recognize any changes in value. If the probability of achieving the performance target significantly changes from what we initially anticipated, the change could have a significant impact on our financial statements in the period recognized. is immaterial.

Our contingent earn-out liability isliabilities are separately stated inon our consolidated balance sheets.


The following table provides a reconciliation of theour Level 3 earn-out liabilityliabilities measured at estimated fair value based on an initial valuation and updated quarterly for the years ended December 31, 20182021, 2020 and 20172019 (in thousands):
Earn-out Liability
Contingent earn-out liability, January 1, 2019$47,400 
Acquisition date fair value estimate of earn-out(1)
17,300 
Change in fair value of contingent earn-out (included in income from operations as a separate line item)(2)
(47,400)
Contingent earn-out liability, December 31, 2019$17,300 
Change in fair value of contingent earn-out (included in income from operations as a separate line item)(3)
9,000 
Contingent earn-out liability, December 31, 2020$26,300 
Contingent earn-out — non-compete arrangement2,589 
Transfer of Pursuit earn-out liability into Level 2(4)
(26,300)
Contingent earn-out liability, December 31, 2021$2,589 

(1)    Relates to our acquisition of Pursuit (see Note 2: Acquisitions).
  Earn-out Liability
Contingent earn-out liability, January 1, 2017 $
Acquisition date fair value estimate of earn-out 19,000
Change in fair value of contingent earn-out (included in income from operations as a separate line item) 8,000
Contingent earn-out liability, December 31, 2017 27,000
Change in fair value of contingent earn-out (included in income from operations as a separate line item) 20,400
Contingent earn-out liability, December 31, 2018 $47,400

Changes(2)    The change in the fair value of the HIS earn-out subsequentrelated to our 2017 acquisition of HIS from Pfizer which was based on actual results as compared to the earn-out performance targets. This adjustment reduced the HIS earn-out to zero.
(3)    The fair value calculated at acquisition are due to a change in the forecast of the underlying target, adjusted EBITDA, andPursuit earn-out increased during 2020 primarily due to changes in other assumptions usedthe probabilities within the valuation model.
(4)    The Pursuit earn-out was transferred out of Level 3 and into Level 2 in the Monte Carlo simulation, as detailed inthird quarter of 2021 when the below table.amount of the actual payment was known, and subsequently settled during the fourth quarter of 2021.

    

88




ICU MEDICAL, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)



The following table provides quantitative information about Level 3 inputs for fair value measurement of ourthe Pursuit earn-out liability as of the acquisition date to December 31, 2018. Significant increases or decreases in these inputs in isolation could result in a significant impact on our fair value measurement:2020:


Pursuit Earn-out
Simulation Input
As of
December 31, 2018
 
As of
December 31, 2017
 At Acquisition February 3, 2017
Adjusted EBITDA Volatility30.00% 26.00% 29.00%
WACC8.25% 8.75% 10.00%
20-year risk free rate2.87% 2.58% 2.82%
Market price of risk5.24% 5.99% 6.93%
Cost of debt5.25% 4.08% 4.16%
As of
December 31, 2020
At Acquisition
November 2, 2019
Simulation Input
Revenue/Gross Profit Volatility25.00 %20.00 %
Discount Rate12.50 %15.00 %
Risk-free rate0.09 %1.55 %
Counter Party Risk3.10 %6.00 %


Investments, Foreign Currency Contracts and Interest Rate Contracts

The fair value of our investments, which consistsconsist of corporate bonds, is estimated using observable market basedmarket-based inputs such as quoted prices, interest rates and yield curves or Level 2 inputs.


The fair value of our Level 2 forward currency contractcontracts is estimated using observable market inputs such as known notional value amounts, spot and forward exchange rates. These inputs relate to liquid, heavily traded currencies with active markets which are available for the full term of the derivative.


The assets related to our Dominican Republic manufacturing facilities were classified as assets held-for-sale as of December 31, 2017. These assets are separately stated in our 2017 consolidated balance sheet. The fair value of theseour Level 3 assets was determined as part2 forward-starting interest rate swaps is estimated using a pricing model that reflects the terms of the HIS business valuationcontracts, including the period to maturity, and was basedrelies on aobservable market approach using comparable buildinginputs such as known notional value amounts and land sales data andUSD interest rate curves.

Other than the analysis of market conditions. We sold these assets during 2018.

TherePursuit earn-out liability described above, there were no transfers between levels in 20182021 or 2017.

2020.
    


ICU MEDICAL, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)


Our assets and liabilities measured at fair value on a recurring basis consisted of the following (Level 1, 2 and 3 inputs as defined above) (in thousands): 

 Fair value measurements at December 31, 2018
 
Total carrying
value
 
Quoted prices
in active
markets for
identical
assets (level 1)
 
Significant
other
observable
inputs (level 2)
 
Significant
unobservable
inputs (level 3)
Assets:       
Available for sale securities:       
Short-term$37,329
 $
 $37,329
 $
Long-term2,025
 
 2,025
 
Foreign exchange forwards:       
Prepaid expenses and other current assets187
 
 187
 
Other assets545
 
 545
 
Total Assets$40,086
 $
 $40,086
 $
        
Liabilities:       
        
Earn-out liability$47,400
 $
 $
 $47,400
Total Liabilities$47,400
 $
 $
 $47,400

Fair value measurements at December 31, 2017 Fair value measurements as of December 31, 2021
Total carrying
value
 
Quoted prices
in active
markets for
identical
assets (level 1)
 
Significant
other
observable
inputs (level 2)
 
Significant
unobservable
inputs (level 3)
Total carrying
value
Quoted prices
in active
markets for
identical
assets (level 1)
Significant
other
observable
inputs (level 2)
Significant
unobservable
inputs (level 3)
Assets:       Assets:
Available for sale securities:       
Available-for-sale debt securities:Available-for-sale debt securities:
Short-term$10,061
 $
 $10,061
 $
Short-term$14,420 $— $14,420 $— 
Long-term14,579
 
 14,579
 
Long-term4,620 — 4,620 — 
Foreign exchange forwards:Foreign exchange forwards:
Prepaid expenses and other current assetsPrepaid expenses and other current assets1,061 — 1,061 — 
Total Assets$24,640
 $
 $24,640
 $
Total Assets$20,101 $— $20,101 $— 
       
Liabilities:       Liabilities:
Contingent earn-out liability - LTContingent earn-out liability - LT$2,589 $— $— $2,589 
       
Earn-out liability$27,000
 $
 $
 $27,000
Foreign exchange forwards:       
Accrued liabilities187
 
 187
 
Forward-starting interest rate swaps:Forward-starting interest rate swaps:
Other long-term liabilities402
 
 402
 
Other long-term liabilities1,480 — 1,480 — 
Total Liabilities$27,589
 $
 $589
 $27,000
Total Liabilities$4,069 $— $1,480 $2,589 
  

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ICU MEDICAL, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)



 Fair value measurements as of December 31, 2020
 Total carrying
value
Quoted prices
in active
markets for
identical
assets (level 1)
Significant
other
observable
inputs (level 2)
Significant
unobservable
inputs (level 3)
Assets:
Available-for-sale debt securities:
Short-term$14,687 $— $14,687 $— 
Long-term12,974 — 12,974 — 
Foreign exchange forwards:
Prepaid expenses and other current assets3,555 — 3,555 — 
Total Assets$31,216 $— $31,216 $— 
Liabilities:
Earn-out liability$26,300 $— $— $26,300 
Total Liabilities$26,300 $— $— $26,300 
Our assets measured at fair value on a nonrecurring basis consisted of the following (Level 1, 2 and 3 inputs as defined above (in thousands):

 Fair value measurements at December 31, 2017
 
Total carrying
value
 
Quoted prices
in active
markets for
identical
assets (level 1)
 
Significant
other
observable
inputs (level 2)
 
Significant
unobservable
inputs (level 3)
Assets:       
Assets held-for-sale$12,489
 $
 $
 $12,489
Total Assets$12,489
 $
 $
 $12,489

NOTE 9. PREPAID EXPENSES AND OTHER CURRENT ASSETS AND RELATED-PARTY RECEIVABLEOTHER ASSETS


Prepaid expenses and other current assets consist of the following (in thousands):  
As of December 31,
 2018 2017 20212020
Deposits $1,087
 $21,940
Other prepaid expenses and receivables 12,476
 4,208
Other prepaid expenses and receivables$14,763 $14,964 
Deferred costs 1,951
 1,301
Deferred costs12,746 6,402 
Prepaid insurance and property taxes 2,666
 2,580
Prepaid insurance and property taxes6,310 6,178 
VAT/GST receivable 5,072
 8,097
VAT/GST receivable4,156 3,676 
Deferred tax charge 1,180
 1,326
Deferred tax charge4,241 3,542 
Foreign exchange forward contractForeign exchange forward contract1,061 3,555 
DepositsDeposits1,343 1,353 
Other 1,548
 1,834
Other2,227 1,822 
 $25,980
 $41,286
$46,847 $41,492 


Related-party receivablesOther assets consist of the following (in thousands):
  2018 2017
Third-party receivables due from Pfizer $4,904
 $36,425
HIS business acquisition related 15,233
 62,382
  $20,137
 $98,807
As of December 31,
 20212020
Pump lease receivables$25,941 $28,948 
Spare parts28,538 22,725 
Equity method investments3,238 — 
Deferred debt issuance costs2,827 — 
Finance lease right-of-use assets2,673 2,915 
Other526 887 
$63,743 $55,475 

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ICU MEDICAL, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)




Third-party receivables due from Pfizer relates to trade accounts receivable that have already been collected from customers by Pfizer on our behalf. HIS business acquisition related receivables include amounts due from Pfizer related to the manufacturing and supply agreements and deferred close entities and amounts we prepaid to Pfizer for operational expenses under the transition services agreement.

Pfizer became a related party to us when we issued 3.2 million shares of our common stock as partial consideration for the acquisition of HIS. As of December 31, 2018, Pfizer has sold all of its shares of our common stock. In connection with the sale of 2.5 million of the shares Pfizer held, we incurred a one-time fee payable to Pfizer in the amount of $8.0 million included in restructuring, strategic transaction and integration expense in our consolidated statement of operations.

On February 3, 2017, we entered into a transitional services agreement and two Manufacturing and Supply Agreements ("MSA's") with Pfizer, (see Note 16, Collaborative and Other Arrangements). During 2018, the revenue for goods manufactured for Pfizer was $78.2 million and the cost of product manufactured by Pfizer for us was $81.0 million. During 2017, the revenue for goods manufactured for Pfizer was $72.4 million and the cost of product manufactured by Pfizer for us was $70.2 million.

NOTE 10. ACCRUED LIABILITIES AND OTHER LONG-TERM LIABILITIES


Accrued liabilities consist of the following (in thousands):
 December 31,As of December 31,
 2018 2017 20212020
Salaries and benefits $20,538
 $20,745
Salaries and benefits$27,304 $25,786 
Incentive compensation 42,913
 40,682
Incentive compensation33,107 27,023 
Operating lease liability-STOperating lease liability-ST9,009 8,740 
Accrued professional fees

 15,996
 13,319
Accrued professional fees773 1,273 
Accrued product field action 5,316
 11,810
Consigned inventory 1,118
 5,210
Third-party inventory 1,089
 4,284
Legal accrual 1,400
 3,538
Legal accrual3,897 900 
Accrued sales taxes 2,941
 6,291
Accrued sales taxes1,980 2,146 
Warranties and Returns

 1,124
 3,360
Warranties and returnsWarranties and returns532 1,027 
Deferred revenue 3,814
 3,326
Deferred revenue12,646 5,566 
Accrued other taxes 3,213
 2,771
Accrued other taxes4,337 3,540 
Distribution fees 3,977
 725
Distribution fees5,645 5,300 
Accrued freight 10,953
 5,696
Accrued freight9,194 6,784 
Restructuring accrual 1,046
 1,290
Restructuring accrual664 3,421 
Contract settlement 2,083
 
Accrued research and development 1,451
 
Other 9,848
 9,017
Other9,107 5,515 
 $128,820
 $132,064
$118,195 $97,021 



ICU MEDICAL, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS



Other long-term liabilities consist of the following (in thousands): 

As of December 31,
 December 31, 20212020
Operating lease liability-LTOperating lease liability-LT$33,971 $41,019 
Finance lease liability-LTFinance lease liability-LT2,067 2,388 
Contract liabilities(1)
Contract liabilities(1)
202 337 
 2018 2017
Contract liabilities(1)
 $14,020
 $40,148
Deferred revenue 468
 7,099
Forward-starting interest rate swapsForward-starting interest rate swaps1,480 — 
Benefits 962
 2,104
Benefits1,369 1,183 
Accrued rent 1,779
 
Accrued rent1,262 1,462 
Contract settlement 1,667
 
Other 1,696
 5,975
Other1,479 1,446 
 $20,592
 $55,326
$41,830 $47,835 

(1)Consists of multiple contracts with customers and suppliers that were valued at below market at the time of the HIS acquisition. During 2018, the decrease to contract liabilities was primarily due to the resolution and settlement of a dispute with a product partner.


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ICU MEDICAL, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
NOTE 11. LONG-TERM OBLIGATIONS


Five-year Senior Secured Revolving Credit Facility ("Credit Facility")


On November 8, 2017, we entered into a five-year Revolving Credit Facility ("Credit Facility") with various lenders for $150$150.0 million, with Wells Fargo Bank, N.A. as the administrative agent, swingline lender and issuing lender. During March 2020, as a result of market uncertainty caused by the COVID-19 pandemic, we preemptively borrowed $150.0 million on our Credit Facility as a conservative measure to manage any potential short-term liquidity risk. As of December 31, 2018,2020, we had fully repaid all amounts borrowed. As of December 31, 2021 and 2020, we had no borrowings and $150$150.0 million of availability under the Credit Facility. The Credit Facility matures on November 8, 2022.


The Credit Facility has an accordion feature that would enable us to increase the borrowing capacity of the Credit Facility by the greater of (i) $100$100.0 million and (ii) 2.00x Total Leverage.


In connection with the Credit Facility, forduring the year ended December 31, 2017, we incurred $1.4 million in financing costs, which were capitalized and are included in prepaid expenses and other current assets and other assets inon our consolidated balance sheets, in accordance with the appropriate short-term or long-term classification. These fees are being amortized to interest expense over the remaining term of the Credit Facility.


On January 6, 2022, we completed the acquisition of Smiths Medical which was partially financed by entering into Senior Secured Credit Facilities consisting of a term loan A facility of $850.0 million, a term loan B facility of $850.0 million and a revolving credit facility of $500.0 million.

Principal payments    


Principal payments, when drawn on the Credit Facility, are made at our discretion with the entire unpaid amount due at maturity.


Interest rate


In general, borrowing under the Credit Facility (other than Swingline loans) bears interest, at our option, based on the Base Rate plus applicable margin or the London Interbank Offered Rate ("LIBOR") rate plus applicable margin, as defined below:


(A) Base Rate is defined as the highest of: (a) the Prime Rate; (b) the Federal Funds Rate plus 0.50%; and (c) the daily LIBOR (as defined below) for a one month Interest Period plus 1%.


(B) LIBOR Rate, as determined by the Administrative Agent, is defined as the rate per annum obtained by dividing (1) LIBOR by (2) 1.00 - Eurodollar Reserve Percentage.


Swingline loans will bear interest at the Base Rate plus the applicable Interest Margin. The Credit Facility has a per annum commitment fee (see table below) that will accrue on the unused amounts of the commitments under the Credit Facility.



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ICU MEDICAL, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS


The applicable interest margins and the commitment fee with respect to the Credit Facility shall be based on the Total Leverage Ratio pursuant to the following pricing grid:
LevelConsolidated Total
Leverage Ratio
Commitment
Fee
LIBOR
+
Base Rate
+
ILess than 1.00 to 1.000.15%1.25%0.25%
IIGreater than or equal to 1.00 to 1.00 but less than 2.00 to 1.000.20%1.50%0.50%
IIIGreater than or equal to 2.00 to 1.00 but less than 2.50 to 1.000.25%1.75%0.75%
IVGreater than or equal to 2.50 to 1.000.30%2.00%1.00%


Guarantors and Collateral


Our obligations under the Credit Facility are unconditionally guaranteed, on a joint and several basis, by ICU Medical, Inc. and certain of our existing subsidiaries. Our obligations are secured by: (i) 100% of the equity interests of our guarantor subsidiaries; and (ii) all of the tangible and intangible personal property and assets related to us and our guarantor subsidiaries (including, without limitation, all accounts, equipment, inventory and other goods, all instruments, intellectual property and other general intangibles, deposit accounts, securities accounts and other investment property and cash), and (iii) all products, profits and proceeds of the foregoing. Notwithstanding the foregoing, the collateral shall not include certain excluded property.


Debt Covenants


The Credit Facility contains certain financial covenants pertaining to Consolidated Fixed Charge Coverage and Consolidated Total Leverage Ratios. In addition, the Credit Facility has restrictions pertaining to limitations on debt, liens, negative pledges, loans, advances, acquisitions, other investments, dividends, distributions, redemptions, repurchases of equity interests, fundamental changes and asset sales and other dispositions, prepayments, redemptions and purchases of subordinated debt and other junior debt, transactions with affiliates, dividend and payment restrictions affecting subsidiaries, changes in line of business, fiscal year and accounting practices and amendment of organizational documents and junior debt documents.


The Consolidated Leverage Ratio is defined as the ratio of Consolidated Total Funded Indebtedness on such date, to Consolidated Adjusted EBITDA, as defined under the Credit Facility Agreement, for the most recently completed four fiscal quarters. The maximum Consolidated Leverage Ratio is not more than 3.00 to 1.00.


The Consolidated Fixed Charge Coverage Ratio is defined as the ratio of: (a) Consolidated Adjusted EBITDA less the sum of (i) capital expenditures, (ii) federal, state, local and foreign income taxes paid in cash and (iii) cash restricted payments made after the closing date, to (b) Consolidated Fixed Charges for the most recently completed four fiscal quarters, calculated on a pro forma basis. The minimum Consolidated Fixed Charge Coverage Ratio is 2.00 to 1.00.


We wereentered into Senior Secured Credit Facilities in compliance with all financial covenants as of December 31, 2018.January 2022, which terminated our existing Credit Facility (see Note 17: Subsequent Events).


Three-Year Interest-Only Senior Note

On February 3, 2017, we partially funded the acquisition of the HIS business from Pfizer with a $75 million Seller Note issued by Pfizer contemporaneous with the acquisition. We had fully repaid the seller note as of December 31, 2017.




ICU MEDICAL, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)


NOTE 12. INCOME TAXES
 
Income from continuing operations before taxes consisted of the following (in thousands): 
Year Ended December 31,
 202120202019
United States$81,484 $41,194 $32,849 
Foreign41,702 56,300 81,858 
 $123,186 $97,494 $114,707 
  Year Ended December 31,
  2018 2017 2016
United States $(8,600) $59,872
 $80,714
Foreign 30,974
 (8,589) 4,450
  $22,374
 $51,283
 $85,164

The (benefit) provision for income taxes consisted of the following (in thousands):
  Year Ended December 31,
  2018 2017 2016
Current:  
  
  
Federal $492
 $2,774
 $21,123
State 1,865
 2,263
 2,347
Foreign 9,136
 3,170
 1,118
  11,493
 8,207
 24,588
Deferred:  
  
  
Federal $(9,118) $(20,878) $(2,045)
State (3,072) (4,619) (767)
Foreign (5,722) (71) 304
  (17,912) (25,568) (2,508)
  $(6,419) $(17,361) $22,080
We have accrued for tax contingencies for potential tax assessments, and in 2018 we recognized a $4.3 million net increase, most of which related to various federal and state tax reserves.

On December 22, 2017, the Tax Act was enacted into legislation, which includes a broad range of provisions affecting businesses. The Tax Act significantly revises how companies compute their U.S. corporate tax liability by, among other provisions, reducing the corporate tax rate from 35% to 21% for tax years beginning after December 31, 2017, implementing a territorial tax system, and requiring a mandatory one-time tax on U.S. owned undistributed foreign earnings and profits known as the toll charge or transition tax.

Pursuant to the SEC Staff Accounting Bulletin ("SAB") No. 118, "Income Tax Accounting Implications of the Tax Cuts and Jobs Act" ("SAB 118"), a company selects between one of three scenarios to reflect the impact of the Tax Act in its financial statements within a measurement period. Those scenarios are (i) a final estimate which effectively closes the measurement period; (ii) a reasonable estimate leaving the measurement period open for future revisions; and (iii) no estimate as the law is still being analyzed in which case a company continues to apply its accounting on the basis of the provisions of the tax laws that were in effect immediately before the enactment of the Tax Act. SAB 118 allows for the reporting provisional amounts for certain income tax effects in scenario (ii) and (iii). The measurement period begins in the reporting period that includes the Act’s enactment date and ends when an entity has obtained, prepared, and analyzed the information that was needed in order to complete the accounting requirements under ASC Topic 740. As of December 31, 2018, our accounting for the Tax Act is complete.

The toll charge on undistributed foreign earnings and profits (the “Transition Tax”) is a tax on certain untaxed accumulated and current earnings and profits ("E&P") of our foreign subsidiaries. We were able to reasonably estimate the Transition Tax and recorded a provisional Transition Tax expense of $2.0 million for the year ended December 31, 2017. On the basis of revised E&P computations that were completed during the reporting period, we recognized an additional measurement-period adjustment of $0.6 million to the Transition Tax obligation, with a corresponding adjustment of $0.6 million to income tax expense.



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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)



The revaluation of deferredprovision (benefit) for income taxes is an adjustment to future tax obligations as a resultconsisted of the reduction of the corporate tax rate from 35% to 21%. We were able to reasonably estimate the effect of the revaluation of deferred taxes and recorded a provisional tax expense of $1.1 million for the year ended December 31, 2017. The computation of timing differences was completed during the reporting period. We recognized an additional measurement-period adjustment of $0.2 million, with a corresponding adjustment of $0.2 million to income tax expense.following (in thousands):

Year Ended December 31,
 202120202019
Current:   
Federal$20,646 $6,032 $6,851 
State3,444 2,422 2,532 
Foreign7,236 7,290 7,994 
 $31,326 $15,744 $17,377 
Deferred:   
Federal$(8,154)$(5,319)$(6,720)
State(1,815)(1,850)(325)
Foreign(1,306)2,049 3,340 
 (11,275)(5,120)(3,705)
 $20,051 $10,624 $13,672 
We continuehave accrued for tax contingencies for potential tax assessments, and in 2021 we recognized a $3.0 million net increase, most of which related to evaluate various international provisions included in the Tax Act due to the lack of final Treasury Regulationsfederal, state and ongoing guidance. These provisions include, but are not limited to, the anti-base-erosion and anti-abuseforeign tax regime (BEAT), the global intangible low-taxed income (GILTI) provisions, the foreign derived intangible income (FDII) provisions, and the changes to the deductibility of interest. These provisions were effective for us beginning on January 1, 2018, and may materially impact our effective tax rate in future years. We elected to treat the GILTI as period costs when incurred, and for the year ended December 31, 2018, we recorded an income tax expense of $2.4 million for GILTI.

reserves.
    
A reconciliation of the provision for income taxes at the statutory rate to our effective tax rate is as follows (dollars in thousands):
 Year Ended December 31,Year Ended December 31,
 2018 2017 2016 202120202019
 Amount Percent Amount Percent Amount Percent AmountPercentAmountPercentAmountPercent
Federal tax at the expected statutory rate $4,699
 21.0 % $17,950
 35.0 % $29,807
 35.0 %Federal tax at the expected statutory rate$25,869 21.0 %$20,474 21.0 %$24,088 21.0 %
State income tax, net of federal effect 927
 4.1 % (403) (0.8)% 1,795
 2.1 %State income tax, net of federal effect2,907 2.4 %2,099 2.2 %1,269 1.1 %
Tax credits (4,961) (22.2)% (2,783) (5.4)% (1,014) (1.2)%Tax credits(2,443)(2.0)%(3,269)(3.4)%(2,896)(2.5)%
Global intangible low-taxed income 2,363
 10.6 % 
  % 
  %Global intangible low-taxed income711 0.6 %163 0.2 %6,634 5.8 %
Foreign income tax differential (2,944) (13.2)% 3,481
 6.8 % (135) (0.1)%Foreign income tax differential(2,983)(2.4)%(3,888)(4.0)%(5,939)(5.2)%
Stock based compensation (11,040) (49.3)% (18,958) (37.0)% (7,720) (9.1)%
Impact of the Tax Act 826
 3.7 % 3,076
 6.0 % 
  %
IP installment sale 3,252
 14.5 % 3,367
 6.6 % 
  %
Bargain purchase gain 
  % (24,811) (48.4)% 
  %
Stock-based compensationStock-based compensation(4,263)(3.5)%(4,686)(4.8)%(8,446)(7.4)%
Foreign-derived intangible incomeForeign-derived intangible income(3,775)(3.1)%(2,718)(2.8)%(516)(0.5)%
IP installment sale and repatriationIP installment sale and repatriation— — %— — %(2,118)(1.8)%
Contingent considerationContingent consideration(29)— %1,566 1.6 %— — %
Section 162(m) 456
 2.0 % 595
 1.2 % 1,133
 1.3 %Section 162(m)1,812 1.5 %1,079 1.1 %203 0.2 %
Other 3
 0.1 % 1,125
 2.2 % (1,786) (2.1)%Other2,245 1.8 %(196)(0.2)%1,393 1.2 %
 $(6,419) (28.7)% $(17,361) (33.8)% $22,080
 25.9 % $20,051 16.3 %$10,624 10.9 %$13,672 11.9 %
 
Tax credits in 2018, 20172021, 2020 and 20162019 consist principally of research and developmental tax credits. 


Certain intellectual property and assets were repatriated in 2019 from a liquidation of foreign subsidiaries to the U.S. parent. The tax effect of the gain on bargain purchaserepatriation is treatedincluded as a discrete item part of purchase accountingIP installment sale and is not a component of the income tax provision.repatriation.



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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)



The components of our deferred income tax assets (liabilities) are as follows (in thousands):
As of December 31,
 20212020
Deferred tax asset:  
Accruals/other$6,866 $4,406 
Acquired future tax deductions5,440 7,781 
Stock-based compensation7,283 7,138 
Foreign currency translation adjustments3,360 2,406 
Tax credits11,953 12,444 
Inventory reserves8,199 8,493 
Allowance for doubtful accounts926 4,460 
Accrued restructuring131 1,293 
Chargebacks, discounts, customer concessions27,970 22,874 
Valuation allowance(2,934)(3,891)
 $69,194 $67,404 
Deferred tax liability:  
State income taxes$2,724 $2,398 
Foreign— 776 
Depreciation and amortization20,483 25,113 
Section 481(a) adjustment - change in accounting method4,873 9,746 
$28,080 $38,033 
Deferred tax asset, net$41,114 $29,371 

  December 31,
  2018 2017
Deferred tax asset:  
  
Accruals/other 11,291
 956
Contingent consideration 12,451
 7,412
Net operating loss carryforwards 12,686
 
Acquired future tax deductions 10,722
 10,580
Stock-based compensation 10,775
 8,633
Foreign currency translation adjustments 3,108
 3,425
Tax credits 14,470
 11,220
Inventory reserves 5,674
 10,658
Allowance for doubtful accounts 830
 636
Valuation allowance (5,436) (7,385)
  $76,571
 $46,135
Deferred tax liability:  
  
State income taxes $2,639
 $1,640
Foreign 612
 202
Depreciation and amortization 35,387
 21,005
  $38,638
 $22,847
     
Deferred tax asset, net $37,933
 $23,288


Tax Holidays and Carryforwards


Net operating loss ("NOL") carryforwards consist of: (a) federal NOL carryforwards of $68.9$2.5 million which will expire at various dates from 20202023 to indefinite carryforward periods, (b) state NOL carryforwards of $20.2$8.2 million which will expire at various dates from 20282022 to indifiniteindefinite carryforward periods and (c) foreign NOL carryforwards of $21.4$15.0 million which will expire at various dates from 20192022 to indefinite carryforward periods. Under Section 382 of the Internal Revenue Code, certain ownership changes limit the utilization of the NOL carryforwards, and the amount of federal NOL carryforwards recorded is the net federal benefit available.


Other carryforwards include state research and development (“R&D”), federal and state tax credit carryforwards of $7.4$16.9 million, and $13.6 million, respectively.which have an indefinite carryforward period.


A substantial portion of our manufacturing operations in Costa Rica operate under various tax holidaysholiday and tax incentive programs which willdue to expire in whole or in part in 2027. Certain of the holidays may be extended if specific conditions are met. The net impact of these tax holidaysholiday and tax incentives was an increase to our net earnings by $8.8$9.8 million or $0.41$0.45 per diluted share in 2018.2021 and by $8.0 million or $0.37 per diluted share in 2020.


Foreign currency translation adjustments, and related tax effects, are an element of “other comprehensive income” and are not included in net income other than the revaluation of the associated deferred tax asset due to the Tax Act.
    
As of December 31, 2018,2021, we have estimated $20.8$98.6 million of undistributed foreign earnings and profits. We have not provided deferred tax liabilities for foreign withholding taxes and certain state income taxes on the undistributedSuch earnings and profits from certain non-U.S. subsidiaries that will be permanently reinvested outside the United States.

Upon the distribution of foreign earnings and profits, certain foreign countries impose withholding taxes. If the foreign earnings and profits were distributed, we would needpreviously subject to accrue an additional income tax liability. However, we may also be allowed a credit against our U.S. tax liability foras a result of the Tax Act and much of any future remittances would generally be subject to no U.S. tax as a result of dividends received deductions and/or foreign tax credit relief. We intend to invest substantially all of our foreign subsidiary earnings, as well as our capital in our foreign subsidiaries, indefinitely outside of the taxes paidU.S. in foreign jurisdictions.those jurisdictions in which we incur significant additional costs upon repatriation of such amounts.



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ICU MEDICAL, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)



We are subject to taxation in the United StatesU.S. and various states and foreign jurisdictions. Our United StatesU.S. federal income tax returns for tax years 20152018 and forward are subject to examination by the Internal Revenue Service. Our principal state income tax returns for tax years 20132012 and forward are subject to examination by the state tax authorities. The total gross amount of unrecognized tax benefits as of December 31, 20182021 was $10.8$21.5 million which, if recognized, would impact the effective tax rate. We believe that adequate provision has been made for any adjustments that may result from tax examinations. However, the outcome of tax examinations cannot be predicted with certainty. As of December 31, 2018,2021, it is not possible to estimate the amount of change, if any, in the unrecognized tax benefits that is reasonably possible within the next twelve months. We recognize accrued interest and penalties related to unrecognized tax benefits as a component of income tax expense. We have not accrued any penalties or interest as of December 31, 20182021 or December 31, 2017.2020.
 
The following table summarizes our cumulative gross unrecognized tax benefits (in thousands): 
Year Ended December 31,
 202120202019
Beginning balance$18,443 $15,027 $10,824 
Increases to prior year tax positions231 502 138 
Increases to current year tax positions3,242 2,987 4,231 
Decreases to prior year tax positions— (15)(3)
Decrease related to lapse of statute of limitations(31)(58)(163)
Decrease related to settlements with tax authorities(348)— — 
Ending balance$21,537 $18,443 $15,027 

  Year Ended December 31,
  2018 2017 2016
Beginning balance $6,527
 $2,000
 $1,772
Increases to prior year tax positions 
 77
 77
Increases due to acquisitions 
 640
 
Increases to current year tax positions 4,536
 3,992
 345
Decreases to prior year tax positions (146) (12) (46)
Decrease related to lapse of statute of limitations (93) (170) (148)
Ending balance $10,824
 $6,527
 $2,000

NOTE 13. GEOGRAPHIC INFORMATION AND SIGNIFICANT CUSTOMERS


Significant Customers
 
We sell products worldwide, on credit terms on an unsecured basis, as an OEM supplier, to independent medical supply distributors and directly to the end customer. The manufacturers and distributors, in turn, sell our products to healthcare providers. For the year ended December 31, 2016, we had worldwide sales toWe do not currently derive a significant portion of our revenues from any one manufacturer, Pfizer, of 30% of consolidated revenue and as of December 31, 2016, accounts receivable from Pfizer was 23% of consolidated accounts receivable. In February 2017, we completed the acquisition of Pfizer's HIS business, which eliminated the significant earnings exposure indicated above (see Note 2: Acquisitions and Strategic Transaction Expenses).customer.


Geographic Information


The table below presents our gross long-lived assets, consisting of property, plant and equipment, by country or region (in thousands):
 As of December 31,
 20212020
Costa Rica$115,187 $104,015 
Mexico79,567 76,004 
Other LATAM36,907 37,485 
Canada4,716 4,672 
Italy12,435 11,098 
Spain13,295 8,701 
Other Europe4,171 3,795 
APAC20,452 19,836 
Total Foreign$286,730 $265,606 
United States618,374 577,490 
Worldwide Total$905,104 $843,096 


96
  As of December 31,
  2018 2017
Costa Rica $81,920
 $80,956
Mexico 64,242
 61,008
Other LATAM 22,828
 19,432
Canada 4,545
 4,362
Italy 7,819
 6,860
Spain 6,516
 5,601
Other Europe 2,427
 2,625
APAC 15,152
 5,169
Total Foreign $205,449
 $186,013
United States 489,415
 422,810
Worldwide Total $694,864
 $608,823






ICU MEDICAL, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)



NOTE 14. Stockholders' EquitySTOCKHOLDERS' EQUITY


Treasury Stock


In July 2010,August 2019, our Board of Directors approved a common stock purchase plan to purchase up to $40.0$100.0 million of our common stock. This plan has no expiration date and wedate. We have $7.2$100.0 million remaining on this purchase plan. During 2016, we purchased $15.4 million of our common stock. We did not purchase any of our common stock under our common stock purchase plan in 20182021, 2020 or 2017.2019. We used the treasury stock to issue shares for stock option exercises, restricted stock grants and employee stock purchase plan stock purchases. We are currently limited on share purchases in accordance with the terms and conditions of our Credit Facility (see Note 11: Long-Term Obligations). 


In 2018,2021, we withheld 26,30740,350 shares of our common stock from employee vested restricted stock units in consideration for $6.3$8.3 million in payments for the employee'semployees' share award income tax withholding obligations. We have 408had 119 shares remaining in treasury at December 31, 2018.2021.


In 2017,2020, we withheld 27,63667,041 shares of our common stock from employee vested restricted stock units in consideration for $4.1$12.9 million in payments for the employee'semployees' share award income tax withholding obligations. We had no209 shares remaining in treasury at December 31, 2017.2020.


In 2019, we withheld 80,186 shares of our common stock from employee vested restricted stock units in consideration for $18.6 million in payments for the employees' share award income tax withholding obligations. We had 850 shares remaining in treasury at December 31, 2019.

We use treasury stock to issue shares for stock option exercises and restricted stock grants.

Accumulated Other Comprehensive (Loss) Income (Loss)("AOCI")


The components of AOCI, net of tax, were as follows (in thousands):
  Foreign Currency Translation Adjustments Unrealized Gains on Cash Flow Hedges Other Adjustments Total
Balance as of January 1, 2017 $(21,272) $
 $
 $(21,272)
Other comprehensive income (loss) before reclassifications 6,694
 184
 (16) 6,862
Amounts reclassified from AOCI 
 (549) 
 (549)
Other comprehensive income (loss) 6,694
 (365) (16) 6,313
Balance as of December 31, 2017 $(14,578) $(365) $(16) $(14,959)
Other comprehensive (loss) income before reclassifications (3,104) 1,568
 115
 (1,421)
Amounts reclassified from AOCI 
 (565) 
 (565)
Other comprehensive (loss) income (3,104) 1,003
 115
 (1,986)
Balance as of December 31, 2018 $(17,682) $638
 $99
 $(16,945)
Foreign Currency Translation AdjustmentsUnrealized Gains (Losses) on Cash Flow HedgesOther AdjustmentsTotal
Balance as of January 1, 2019$(17,682)$638 $99 $(16,945)
Other comprehensive income (loss) before reclassifications372 1,938 (71)2,239 
Amounts reclassified from AOCI— (696)— (696)
Other comprehensive income (loss)372 1,242 (71)1,543 
Balance as of December 31, 2019$(17,310)$1,880 $28 $(15,402)
Other comprehensive income before reclassifications12,929 1,505 47 14,481 
Amounts reclassified from AOCI— (601)— (601)
Other comprehensive income12,929 904 47 13,880 
Balance as of December 31, 2020$(4,381)$2,784 $75 $(1,522)
Other comprehensive loss before reclassifications(14,664)(403)(62)(15,129)
Amounts reclassified from AOCI— (2,618)— (2,618)
Other comprehensive loss(14,664)(3,021)(62)(17,747)
Balance as of December 31, 2021$(19,045)$(237)$13 $(19,269)
 
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ICU MEDICAL, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)


NOTE 15. COMMITMENTS AND CONTINGENCIES

Lease Commitments

We have entered into various non-cancellable operating lease agreements for offices and facilities, passenger vehicles, and IT services throughout the world with original lease periods expiring primarily between 2019 and 2030 and remaining lease terms of 1 to 11 years. Some of these agreements have escalating rent payment provisions, as well as options to extend the lease for up to 5 years.

We recognize rent expense under such agreements on a straight-line basis. Our rent expense under operating leases was $11.0 million in 2018, $7.9 million in 2017 and $0.6 million in 2016. 



ICU MEDICAL, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

As of December 31, 2018, undiscounted future minimum lease payments under our non-cancelable operating leases are as follows over each of the next five years and thereafter (in millions):
2019 $8.3
2020 8.6
2021 6.5
2022 5.9
2023 5.6
Thereafter 13.2
Total $48.1

The weighted-average lease term for the operating lease liabilities is approximately 6.3 years.

Legal Proceedings

Beginning in November 2016, purported class actions were filed in the U.S. District Court for the Northern District of Illinois against Pfizer, Inc. subsidiaries, Hospira, Inc., Hospira Worldwide, Inc. and certain other defendants relating to the intravenous saline solutions part of the HIS business. Plaintiffs seek to represent classes consisting of all persons and entities in the U.S. who directly purchased intravenous saline solution sold by any of the defendants from January 1, 2013 until the time the defendants’ allegedly unlawful conduct ceases. Plaintiffs allege that U.S. manufacturer defendants conspired together to restrict output and artificially fix, raise, maintain and/or stabilize the prices of intravenous saline solution sold throughout the U.S. in violation of federal antitrust laws. Plaintiffs seek treble damages (for themselves and on behalf of the putative classes) and an injunction against defendants for alleged price overcharges for intravenous saline solution in the U.S. since January 1, 2013. On July 5, 2018, the District Court granted defendants’ motion to dismiss the operative complaint for failing to state a valid antitrust claim, but allowed the plaintiffs to file a second amended complaint. On September 6, 2018, plaintiffs filed a second amended complaint adding new allegations in support of their conspiracy claims and adding ICU as a defendant. All defendants have filed a motion to dismiss this second amended complaint. On February 3, 2017, we completed the acquisition of the HIS business from Pfizer. This litigation is the subject of a claim for indemnification against us by Pfizer and a cross-claim for indemnification against Pfizer by us under the HIS stock and asset purchase agreement (“SAPA”).

In addition, in August 2015, the New York Attorney General issued a subpoena to Hospira, Inc. requesting that the company provide information regarding certain business practices in the intravenous solutions part of the HIS business. Separately, in April 2017, we received a grand jury subpoena issued by the United States District Court for the Eastern District of Pennsylvania, in connection with an investigation by the U.S. Department of Justice, Antitrust Division. The subpoena calls for production of documents related to the manufacturing, selling, pricing and shortages of intravenous solutions, including saline, as well as communications among market participants regarding these issues. On December 10, 2018, we were informed by the U.S. Department of Justice, Antitrust Division, that their investigation has been closed.

In April 2018, the U.S. Department of Justice issued a HIPAA subpoena to Hospira, Inc., requesting production of documents and records regarding the manufacturing, production, testing, quality and validation of the Sapphire™ infusion pumps, sets and related accessories distributed by the Company.  We are coordinating with Pfizer to produce the requested records to the Department of Justice. 

In March 2018, a dispute with a product partner resulted in a redefinition of our contractual arrangement and in the rights and remedies determined under such arrangement. The resolution of the dispute resulted in a $28.9 million net charge to the consolidated statement of operations. During the fourth quarter of 2018, we incurred $12.7 million in additional contract settlement charges related to this arrangement as a result of the write-off of assets and additional expenses associated with the restructuring of products.


From time to time, we are involved in various legal proceedings, most of which are routine litigation, in the normal course of business.  Our management does not believe that the resolution of the unsettled legal proceedings that we are involved with will have a material adverse impact on our financial position or results of operations.



ICU MEDICAL, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS


Off Balance Sheet Arrangements


In the normal course of business, we have agreed to indemnify our officers and directors to the maximum extent permitted under Delaware law and to indemnify customers as to certain intellectual property matters related to sales of our products. There is no maximum limit on the indemnification that may be required under these agreements. We have never incurred, nor do we expect to incur, any liability for indemnification.


Contingencies


We have a contractualIn 2017, we recognized an earn-out arrangementliability in connection with our acquisition of the HIS business, wherebyfrom Pfizer. Pfizer may bewas entitled up to an additional $225receive between $191.3 million and $225.0 million in additional cash uponconsideration based on the achievement of certain performance targets for the combined company for the three years ending December 31, 2019. As of December 31, 2019, see (Notewe determined we did not meet the necessary performance targets that would require payout of any of the HIS earn-out liability. Pfizer disputed our determination that the performance targets requiring payout of the HIS earn-out liability were not met, therefore the dispute entered into binding arbitration. In August 2021, the arbitrator concluded that the necessary performance targets that would require payout of the HIS earn-out were not met, and as a result Pfizer is not entitled to any payments in connection with the HIS earn-out liability.

During November 2019, we acquired Pursuit (see Note 2: Acquisitions and Strategic Transaction Expenses)Acquisitions). The amountTotal consideration for the acquisition included a potential contractual earn-out of up to $50.0 million to be paid cannot be determined untilto former Pursuit equity holders, calculated based upon the achievement of certain performance targets during the earn-out period. As of June 30, 2021, the earn-out measurement period has expired.had ended and based on the actual sales and gross profit achieved during the measurement period we calculated the actual earn-out to be $26.3 million. In October 2021, the $26.3 million earn-out was finalized and paid to the former Pursuit equity holders (see Note 8: Fair Value Measurements).

In August 2021, we entered into an agreement with one of our international distributors whereby that distributor would not compete with us in a specific territory for a three-year period that will end in September 2024. The terms of the agreement include a contingent earn-out payment. The contingent earn-out shall not exceed $6.0 million, which will be earned based on certain revenue targets over a twelve-month measurement period determined by the highest four consecutive quarters commencing over a two-year period starting on the closing date of the agreement and provided that the distributor is in compliance with its obligations under the agreement. As of December 31, 2021, the fair value of the contingent earn-out was estimated at $2.6 million (see Note 8: Fair Value Measurements).

During November 2021, we acquired a small foreign infusion systems supplier. Total consideration for the acquisition includes a potential earn-out payment of up to $2.5 million, consisting of (i) a cash payment of $1.0 million contingent on the achievement of certain revenue targets for the annual period ending December 31, 2022 and, separately, (ii) a cash payment of $1.5 million contingent on certain product-related regulatory certifications obtained by May 26, 2024. The initial estimated fair value of the contingent consideration related to this acquisition is immaterial.

Commitments

We have non-cancelable operating lease agreements where we are contractually obligated to pay certain lease payment amounts (see Note 5: Leases).
    
98



ICU MEDICAL, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
NOTE 16. COLLABORATIVE AND OTHER ARRANGEMENTS
    
On February 3, 2017, we entered into two MSA's,Manufacturing and Supply Agreements ("MSAs") whereby (i) whereby Pfizer will manufacture and supply us with certain agreed upon products for an initial five-year term with a one-time two-year option to extend and (ii) whereby we will manufacture and supply Pfizer certain agreed upon products for a term of five or ten years depending on the product, also with a one-time two-year option to extend. The MSA'sMSAs provide each party with mutually beneficial interests and both of the MSA'sMSAs are to be jointly managed by both Pfizer and ICU. The initial supply price, which will be annually updated, is in full consideration for all costs associated with the manufacture, documentation, packaging and certification of the products. On January 1, 2021, we amended our MSA with Pfizer, whereby we manufacture and supply certain agreed upon products to Pfizer. The amendments included a change to the term of the agreement to end on December 31, 2024 with Pfizer's unilateral election to extend through December 31, 2025. Other changes to the terms of the MSA included (i) amendments to our level of supply of products to Pfizer, (ii) certain changes to our manufacturing lines, (iii) updates to our supply price with added volume price tiers for annual periods and (iv) certain minimum purchase requirements for certain products. On February 1, 2022, effective as of January 1, 2022, upon our request, Pfizer executed a Product Addendum (the "Product Addendum") to our MSA agreement, whereby Pfizer manufactures and supplies to us certain agreed upon products. The Product Addendum includes the supply of additional product to us subject to certain time and pricing terms and conditions. The Product Addendum includes a minimum purchase obligation of $29.6 million. The Product Addendum expires on November 30, 2022.

NOTE 17. SUBSEQUENT EVENTS

Acquisition of Smiths Medical 2020 Limited

On February 3, 2017, as partJanuary 6, 2022, we completed the acquisition of Smiths Medical, the holding company of Smiths Group plc's global medical device business, from Smiths Group International Holdings Limited (the “Seller”). In accordance with the Share Sale and Purchase Agreement (the "Purchase Agreement"), we purchased 100% of the HIS businessequity interests of Smiths Medical for approximately $1.9 billion in cash and issued of 2.5 million of fully paid and non-assessable shares of our common stock, par value $0.10 per share. The Purchase Agreement also includes a potential contingent earn-out payment of $100.0 million in cash, which is to be based upon our common stock achieving a certain volume-weighted average price for certain periods from closing to the third or fourth anniversary of closing. The acquisition of Smiths Medical adds to and complements our current product portfolio and the combining of both businesses allows us to be a scaled U.S.-based global competitor that increases the stability of the medical supply chain and allows for future growth.

At closing, in connection with the issuance of the stock consideration to the Seller, we entered into an agreement with Pfizer, whereby Pfizer will providea Shareholders Agreement (the “Shareholders Agreement”). The Shareholders Agreement imposes certain transitional services to us for finance, business technology, regulatory, human resources, global operations, procurement, quality and global commercial operation services ("Enabling Function Services"). We pay a monthly service fee for each service provided, and share equally with Pfizer inrestrictions on the Seller including prohibiting certain set-up costs and, as applicable, service exit costs. Our sharetransfers of the set-up costsshares of our common stock issued (i) for 6 months following the closing of the acquisition transaction and service exit costs,(ii) to certain of our competitors and certain other parties, as well as customary standstill limitations. Under the Shareholders Agreement, the Seller has the right to designate one individual for election to our board of directors so long as the Seller beneficially owns at least 5.0% of the total outstanding shares of our common stock.

We expect to account for the Smiths acquisition as a business combination, however the initial accounting for the business combination is incomplete. We are unable to provide preliminary estimates of asset and liability fair market values as the external valuation of the assets acquired and liabilities assumed is incomplete. We plan to file the required historical financial statements and the required pro forma financial statements of the combined results of ICU and Smiths Medical in a Form 8-K/A to amend the Current Report on Form 8-K filed on January 7, 2022 by March 22, 2022.

Issuance of Senior Secured Credit Facilities

On January 6, 2022, to partially finance the acquisition of Smiths Medical, we entered into a credit agreement (the "Credit Agreement") with Wells Fargo Bank, National Association, Wells Fargo Securities, LLC, Barclays Bank PLC and certain other financial institutions (the “Lenders”), pursuant to which, among other things, the Lenders provided us with credit facilities in the aggregate are not to exceed $22.0 million. The service fees are subject to a fee capamount of $2.2 billion consisting of (i) $62.5a five-year term loan A of $850.0 million, during the initial twelve month period(ii) a seven-year Term Loan B of $850.0 million and (ii) $31.3 million during the subsequent six month period. Only the Enabling Function Services are subject to the fee cap, any services provided after expiration(iii) a five-year Revolving Credit Facility of the agreement or services that are not Enabling Function Services may result in service fees outside the fee cap. The service fees are intended to reasonably approximate Pfizer’s cost of providing the Enabling Function Services. We may terminate, in whole only, any particular service and the fee cap would be reduced proportionate to the services terminated. Partial reduction in the provision of any specific service may be made but only with the prior written consent of Pfizer.$500.0 million.


On February 3, 2017, as part of the HIS business acquisition, we also entered into a reverse transitional services agreement, where we will provide to Pfizer certain transitional services ranging in term from three to eighteen months. Services include support for real estate, research and development, infrastructure, logistics, quality, site operations, safety, commercial and finance, and regulatory support services.Principal Payments



99




ICU MEDICAL, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)


Principal payments on the term loan A and term loan B Facilities are due on the last day of each calendar quarter commencing on June 30, 2022. The term loan A Facility will amortize in an amount equal to 2.50% of the original principal amount in the first two years, 5.00% in the third and fourth years and 7.50% in the fifth year, with a final payment of the outstanding principal balance due on the respective maturity date. The term loan B Facility will mature in twenty-seven consecutive quarterly installments in an amount equal to 0.25% of the aggregate principal amount of the term loan B outstanding on the Closing Date, with a final payment of the outstanding principal balance due on the respective maturity date. All outstanding revolving loans over the term of the revolver are to be paid by the applicable maturity date.
NOTE 17. SELECTED QUARTERLY FINANCIAL DATA - UNAUDITED
Interest Rate Terms
  Quarter Ended
  Mar. 31 Jun. 30 Sept. 30 Dec. 31
  (in thousands except per share data)
2018  
  
  
  
Total revenue $372,033
 $360,460
 $327,169
 $340,378
Gross profit $149,001
 $151,800
 $134,587
 $134,640
Net income (loss) $4,875
 $31,054
 $219
 $(7,355)
Net income (loss) per share:  
  
  
  
Basic $0.24
 $1.53
 $0.01
 $(0.36)
Diluted $0.23
 $1.44
 $0.01
 $(0.36)
2017  
  
  
  
Total revenue $247,739
 $331,514
 $343,236
 $370,124
Gross profit $88,945
 $88,062
 $111,598
 $137,490
Net income (loss) $55,863
 $(37,060) $136
 $49,705
Net income (loss) per share:  
  
  
  
Basic $3.03
 $(1.87) $0.01
 $2.47
Diluted $2.86
 $(1.87) $0.01
 $2.33

On February 3, 2017, we acquired HIS, see Note 2, Acquisitions, Strategic TransactionIn general, U.S. dollar revolving and Integration Costs.term loans under the credit facilities may bear interest, at our option, on either (1) the Base Rate, as defined in the Credit Agreement, plus the applicable margin, as indicated below or (2) Adjusted Term secured overnight financing rate, as defined in the Credit Agreement, plus applicable margin as indicated below.
Net loss
Revolving Credit Facility Commitment Fee

The revolving credit facility has a per annum commitment fee at an initial rate of 0.25% which is applied to the available amount of the revolving credit facility. The commitment fee after the quarter ending June 30, 2022 is calculated based on the leverage ratio as indicated below.

Applicable Interest Margins

The applicable interest margins with respect to revolving loans and the term loan A Facility shall initially be 1.75% for RFR Loans, as defined in the Credit Agreement. The following pricing grid for the revolving credit facility and the term loan A Facility will become effective after the quarter ended December 31, 2018 included the impact of $41.1 million in restructuring, strategic transactionending June 30, 2022 and integration expenses. We also incurred an $8.6 million non-cash chargewill be based on changes in the quarter ended December 31, 2018 associated with a contract settlement that took placeLeverage Ratio as follows:

 Leverage RatioApplicable Margin for RFR LoansApplicable Margin for Base Rate LoansCommitment Fee Rate
>4.00 to 1.02.25%1.25%0.35%
<4.00 to 1.0 but >3.00 to 1.0
2.00%1.00%0.30%
<3.00 to 1.0 but >2.50 to 1.0
1.75%0.75%0.25%
<2.50 to 1.0 but >2.00 to 1.0
1.50%0.50%0.20%
<2.00 to 1.0
1.25%0.25%0.15%

The applicable interest margins for the term loan B Facility shall initially be set at 2.50% for Eurocurrency Rate Loans. The following pricing grid will become effective on the Adjustment Date and will be based on changes in the quarter ended March 31, 2018, which is included in contract settlement. ManagementLeverage Ratio as follows:
 Leverage RatioApplicable Margin for Eurocurrency Rate LoansApplicable Margin for Base Rate Loans
>2.75 to 1.02.50%1.50%
<2.75 to 1.0
2.25%1.25%

The Credit Agreement contains customary representations and warranties and customary affirmative and negative covenants applicable to the Loan Parties and the restricted subsidiaries of the Company, concludedincluding, without limitation, restrictions on liens, indebtedness, investments, fundamental changes, dispositions, restricted payments and prepayment of junior indebtedness. The Credit Agreement contains financial covenants on the contract settlement chargerevolving credit facility and term loan A Facility that require the Loan Parties and the restricted subsidiaries of the Company to (i) not exceed a maximum secured net leverage ratio initially set at 4.50 to 1.00, with stepdowns to 4.00 to 1.00 on June 30, 2024 and (ii) a minimum interest coverage ratio of 3.00 to 1.00.

100



ICU MEDICAL, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
The Credit Agreement contains customary events of default, including, without limitation, payment defaults, covenant defaults, breaches of certain representations and warranties, cross defaults and cross-acceleration to certain material indebtedness, certain events of bankruptcy and insolvency, impairment of security, certain events under ERISA, material judgments and a change of control. If an event of default occurs and is not materialcured within any applicable grace period or is not waived, the administrative agent and the lenders are entitled to take various actions, including, without limitation, the three months ended December 31, 2018, or to any previously issued interim financial statements.acceleration of amounts due thereunder and termination of commitments under the Facilities.

101




ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE
 
None. 



ITEM 9A. CONTROLS AND PROCEDURES
 
Disclosure Controls and Procedures
 
Our principal executive officer and principal financial officer have concluded, based on their evaluation of our disclosure controls and procedures (as defined in Regulations 13a-15(e) and 15(d)-15(e) under the Securities Exchange Act of 1934) as of the end of the period covered by this Report, that our disclosure controls and procedures are effective to ensure that the information we are required to disclose in the reports that we file or submit under the Exchange Act is accumulated and communicated to our management, including our principal executive officer and principal financial officer, as appropriate to allow timely decisions regarding required disclosure and that such information is recorded, processed, summarized and reported within the time periods specified in the rules and forms of the Securities Exchange Commission.


Changes in Internal Control Over Financial Reporting


There was no change in our internal control over financial reporting that occurred during our most recent fiscal quarter that has materially affected or is reasonably likely to materially affect our internal control over financial reporting.
 
Management’s Annual Report on Internal Control over Financial Reporting
 
Management of the Company is responsible for establishing and maintaining adequate internal control over the Company’s financial reporting.
 
Management has used the criteria in Internal Control — Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission to evaluate the effectiveness of its internal control over financial reporting.
 
Based on this criteria, management of the Company has concluded that the Company has maintained effective internal control over its financial reporting as of December 31, 2018.2021.


Our independent registered public accounting firm that audited the December 31, 20182021 financial statements included in this Annual Report on Form 10-K has independently assessed the effectiveness of our internal control over financial reporting and its report is below.


Other Matters

During the fourth quarter of 2018, the entities we acquired as part of our HIS acquisition were converted from their old Enterprise Resource Planning ("ERP") systems to our global ERP platform. This ERP system conversion did not have an adverse effect on our internal control over financial reporting.
 



102


REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

To the stockholders and the Board of Directors of ICU Medical, Inc.


Opinion on Internal Control over Financial Reporting


We have audited the internal control over financial reporting of ICU Medical, Inc. and subsidiaries (the "Company"“Company”) as of December 31, 2018,2021, based on criteria established in Internal Control-IntegratedControl — 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, 2018,2021, based on criteria established in Internal Control - Integrated Framework (2013) issued by COSO.

We have also audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the consolidated financial statements as of and for the year ended December 31, 2018,2021, of the Company and our report dated March 1, 2019,February 25, 2022, expressed an unqualified opinion on those financial statements.


Basis for Opinion


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


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


Definition and Limitations of Internal Control over Financial Reporting


A company’s internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. A company’s internal control over financial reporting includes those policies and procedures that (1) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company; (2) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance with authorizations of management and directors of the company; and (3) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company’s assets that could have a material effect on the financial statements.


Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.


/s/ DELOITTE & TOUCHE LLP


Costa Mesa, California
March 1, 2019February 25, 2022

103


ITEM 9B. OTHER INFORMATION
 
None


ITEM 9C. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS

Not applicable.
PART III


ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
 
The information required by this Item 10 of Form 10-K is set forth under the captions Executive Officers, Election of Directors, Audit Committee and Compliance with Section 16(a) Beneficial Ownership Reporting Compliance in our definitive
Proxy Statement to be filed in connection with our 20192022 Annual Meeting of Stockholders, and such information is incorporated herein by reference. 
 
We have a Code of Business Conduct and Ethics for Directors and Officers. A copy is available on our website, www.icumed.com. We will disclose any future amendments to, or waivers from, the Code of Business Conduct and Ethics for Directors and Officers on our website.


ITEM 11. EXECUTIVE COMPENSATION
 
The information required by this Item 11 of Form 10-K is set forth under the caption Executive Officer and Director Compensation, Compensation Committee and Compensation Committee Interlocks and Insider Participation in our definitive Proxy Statement to be filed in connection with our 20192022 Annual Meeting of Stockholders, and such information is incorporated herein by reference.
 
ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS
 
The information required by this Item 12 of Form 10-K is set forth under the caption Security Ownership of Certain Beneficial Owners and Management and Equity Compensation Plan Information in our definitive Proxy Statement to be filed in connection with our 20192022 Annual Meeting of Stockholders, and such information is incorporated herein by reference.
        
ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE
 
The information required by this Item 13 of Form 10-K is set forth under the caption Transactions with Related Persons, Policies and Procedures Regarding Transactions with Related Persons and Director Independence in our definitive Proxy Statement to be filed in connection with our 20192022 Annual Meeting of Stockholders, and such information is incorporated herein by reference.


ITEM 14. PRINCIPAL ACCOUNTINGACCOUNTANT FEES AND SERVICES
 
The information about aggregate fees billed to us by our principal accountant, Deloitte & Touche LLP (PCAOB No. 34) as required by this Item 14 of Form 10-K is set forth under the caption Ratification of Auditors in our definitive Proxy Statement to be filed in connection with our 20192022 Annual Meeting of Stockholders, and such information is incorporated herein by reference.

104


PART IV


ITEM 15. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES
Form 10-K Page No.
The following documents are filed as part of this report:
1.Consolidated Financial Statements. See Index to Consolidated Financial Statements in Part II, Item 8 of this Form 10-K.
  
2.
Exhibits. The exhibits listed in the accompanying Exhibit Index are filed or incorporated by reference as part of this Form 10-K.
 
3.Financial Statement Schedules. The Financial Statement Schedules required to be filed as a part of this Report are: 
 
   Form 10-K Page No.
 The following documents are filed as part of this report:  
    
1.Consolidated Financial Statements. See Index to Consolidated Financial Statements in Part II, Item 8 of this Form 10-K. 
    
2.
Exhibits. The exhibits listed in the accompanying Exhibit Index are filed or incorporated by reference as part of this Form 10-K.
 
    
3.Financial Statement Schedules. The Financial Statement Schedules required to be filed as a part of this Report are:  
    
  




 
EXHIBIT INDEX
Exhibit NumberExhibit Description
StockShare Sale and Purchase Agreement, dated as of October 5, 2015, by and among Registrant, Medline Industries, Inc., Roundtable Healthcare Partners, L.P., Roundtable Healthcare Investors, L.P. and certain other sellers party thereto. Filed as Exhibit 2.1 to Registrant's Current Report on Form 8-K filed October 6, 2015, and incorporated herein by reference.

Asset Purchase Agreement made as of October 5, 2015, by and among Registrant, Excelsior Medical, LLC and Medline Industries, Inc. Filed as Exhibit 2.2 to Registrant's Current Report on Form 8-K filed October 6, 2015, and incorporated herein by reference.
Amended and Restated Stock and Asset Purchase Agreement, dated as of January 5, 2017,September 8, 2021, by and between Pfizer Inc.,Smiths Group International Holdings Limited, a Delaware corporation,private limited company incorporated in England and Wales, and ICU Medical, Inc., a Delaware corporation. Filed as an Exhibit 2.1 to Registrant’sRegistrant's Current Report on Form 8-K filed January 5, 2017,September 8, 2021, and incorporated herein by reference.

Put Option Deed from ICU Medical, Inc., a Delaware corporation to Smiths Group International Holdings Limited, a private limited company incorporated in England and Wales. Filed as an Exhibit to Registrant's Current Report on Form 8-K filed September 8, 2021, and incorporated herein by reference.
Registrant's Certificate of Incorporation, as amended and restated. Filed as an exhibit to Registrant's Current Report on Form 8-K filed on June 10, 2014, and incorporated herein by reference.
Registrant's Bylaws, as amended and restated. Filed as an Exhibit to Registrant's Current Report on Form 8-K filed August 3, 2016, and incorporated herein by reference.
Description of Securities Registered Under Section 12 of the Exchange Act. Filed as an Exhibit to Registrant's Annual Report of Form 10-K for the year ended December 31, 2019, filed March 2, 3020, and incorporated herein by reference.
Form of Indemnification Agreement with Directors and Executive Officers. Filed as an Exhibit to Registrant's Quarterly Report on Form 10-Q for the Quarter ended September 30, 2010, filed October 22, 2010 (File No. 001-34634), and incorporated herein by reference.
Amended and Restated Rights Agreement dated October 18, 2007 between Registrant and American Stock Transfer & Trust Company as Rights Agent. Filed as an Exhibit to Registrant's Registration Statement on Form 8-A/A dated October 18, 2007 (File No. 000-19974), and incorporated herein by reference.
Registrant's 2001 Directors' Stock Option Plan.* Filed as an Exhibit to Registrant's definitive Proxy Statement filed pursuant to Regulation 14A on April 3, 2002 (File No. 000-19974), and incorporated herein by reference.

Registrant's 2002 Employee Stock Purchase Plan.* Filed as an Exhibit to Registrant's definitive Proxy Statement filed pursuant to Regulation 14A on April 3, 2002 (File No. 000-19974), and incorporated herein by reference.
10.53
Registrant's 2003 Stock Option Plan.* Filed as an Exhibit to Registrant's definitive Proxy Statement filed pursuant to Regulation 14A on April 25, 2003 (File No. 000-19974), and incorporated herein by reference.Executive officer compensation*
10.64
Settlement and Release Agreement dated as of January 2, 2007 between ICU Medical, Inc. and Fulwider Patton Lee & Utecht, LLP. Filed as an Exhibit to Registrant's Annual Report on Form 10-K for the year ended December 31, 2006, filed March 1, 2007 (File No. 000-19974), and incorporated herein by reference.Non-employee director compensation*
Executive officer compensation*
Non-employee director compensation*
2008 Performance-Based Incentive Plan, as amended.* Filed as Annex A to Registrant's proxy statement filed April 3, 2013 (File No. 001-34634), and incorporated herein by reference.
Amendment No. 1 to 2001 Directors' Stock Option Plan.* Filed as an Exhibit to Registrant's Quarterly Report on Form 10-Q for the Quarter ended September 30, 2009, filed October 22, 2009 (File No. 000-19974), and incorporated herein by reference.
Amendment No. 2 to 2001 Directors' Stock Option Plan.* Filed as an Exhibit to Registrant's Quarterly Report on Form 10-Q for the Quarter ended September 30, 2009, filed October 22, 2009 (File No. 000-19974), and incorporated herein by reference.
Amendment No. 3 to 2001 Directors' Stock Option Plan.* Filed as an Exhibit to Registrant's Quarterly Report on Form 10-Q for the Quarter ended September 30, 2009, filed October 22, 2009 (File No. 000-19974), and incorporated herein by reference.
10.13
Amended and Restated ICU Medical, Inc. 2011 Stock Incentive Plan.* Filed as an Exhibit to Registrant's Quarterly Report on Form 10-Q for the Quarter ended March 31, 2018, and incorporated herein by reference.

 
105


10.147
2014 InducementFirst Amendment to ICU Medical, Inc. Amended and Restated 2011 Stock Incentive Plan.* Filed as an Exhibitexhibit to Registrant's CurrentAnnual Report on Form 8-K10-K for the year ended December 31, 2019, filed February 26, 2014March 2, 2020 (File No. 001-34634)No.001-34634) and incorporated herein by reference.
10.15.8
Amended and Restated Executive Employment Agreement, dated as of May 8, 2017, by and between ICU Medical, Inc. and Vivek Jain.* Filed as an Exhibit to Registrant's Current Report on Form 8-K filed May 8, 2017, and incorporated herein by reference.
10.169
Buy-Out AgreementLetter agreement between the Registrant and George A. Lopez, M.D.Alison Burcar, effective September 30, 2015.*April 1, 2019. Filed as an Exhibit to Registrant's CurrentQuarterly Report on Form 8-K filed October 1, 2015,10-Q for the Quarter ended March 31, 2019, and incorporated herein by reference.
10.1710
Form of Shareholder Agreement, by and between a subsidiary of Pfizer Inc. and ICU Medical Inc dated February 3, 2017. Filed as an Exhibit to Registrant’s Current Report on Form 8-K filed October 13, 2016, and incorporated herein by reference.
10.18
ICU Medical, Inc. Executive Severance Plan.* Filed as an Exhibit to Registrant’s Current Report on Form 8-K filed January 6, 2017, and incorporated herein by reference.

10.11
First Amendment to the ICU Medical, Inc. Executive Severance Plan. Filed as an Exhibit to Registrant's Current Report on Form 8-K filed January 6, 2020, and incorporated herein by reference.
10.1913
Revolving Credit Agreement, dated as of November 8, 2017,January 6, 2022, by and among ICU Medical, Inc., as borrower,Borrower, certain lenders party thereto andsubsidiaries as guarantors, Wells Fargo Bank, N.A.,National Association, as administrative agentAdministrative Agent, Wells Fargo Securities, LLC and swingline lender.Barclays Bank PLC as joint bookrunners and joint lead arrangers and the other joint bookrunners and joint lead arrangers listed therein. Filed as an Exhibit to Registrant's Quarterly Report on Form 10-Q for the Quarter ended September 30, 2017, and incorporated herein by reference.
10.20
Transitional Services Agreement, between ICU Medical, Inc. and Pfizer Inc., dated as of February 3, 2017. Filed as an Exhibit to Registrant’s Current Report on Form 8-K filed February 9, 2017, and incorporated herein by reference.January 7, 2022.
10.14
Shareholders Agreement, dated as of January 6, 2022, by and between ICU Medical, Inc. and Smiths Group International Holdings Limited. Filed as an Exhibit to Registrant's Current Report on Form 8-K filed January 7, 2022.
Subsidiaries of Registrant.
Consent of Deloitte & Touche LLP
Certification of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
Certification of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
Certifications of Chief Executive Officer and Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
 
Exhibit 101.INSThe instance document does not appear in the interactive data file because its XBRL Instance Document(Extensible Business Reporting Language) tags are embedded within the Inline XBRL document.
Exhibit 101.SCHXBRL Taxonomy Extension Schema Document
Exhibit 101.CALXBRL Taxonomy Extension Calculation Linkbase Document
Exhibit 101.LABXBRL Taxonomy Extension Label Linkbase Document
Exhibit 101.PREXBRL Taxonomy Extension Presentation Linkbase Document
Exhibit 101.DEFXBRL Taxonomy Extension Definition Linkbase Document
Exhibit 104Cover Page Interactive Data File (embedded within the Inline XBRL document).

*Executive compensation plan or other arrangement



106


SCHEDULE II
 
ICU MEDICAL, INC.
 
VALUATION AND QUALIFYING ACCOUNTS
 
  Additions  
(Amounts in thousands)
Description
Balance at
Beginning of
Period
Charged to
Costs and
Expenses
Charged to
Other Accounts
Write-off/
Disposals
Balance
at End
of Period
For the year ended December 31, 2019:     
Allowance for doubtful accounts$5,768 $14,882 $(431)$— $20,219 
Warranty and return reserve - accounts receivable$6,752 $83 $(458)$— $6,377 
Warranty and return reserve - inventory$(2,538)$(217)$(722)$— $(3,477)
Deferred tax asset valuation allowance$5,436 $— $(1,584)$(175)$3,677 
For the year ended December 31, 2020:     
Allowance for doubtful accounts$20,219 $7,137 $(5,866)$— $21,490 
Warranty and return reserve - accounts receivable$6,377 $(3,609)$(61)$— $2,707 
Warranty and return reserve - inventory$(3,477)$2,033 $(169)$— $(1,613)
Deferred tax asset valuation allowance$3,677 $— $214 $— $3,891 
For the year ended December 31, 2021:    
Allowance for doubtful accounts$21,490 $345 $(14,797)$— $7,038 
Warranty and return reserve - accounts receivable$2,707 $568 $(790)$— $2,485 
Warranty and return reserve - inventory$(1,613)$263 $(533)$— $(1,883)
Deferred tax asset valuation allowance$3,891 $— $(957)$— $2,934 


107
    Additions    
(Amounts in thousands)
Description
 
Balance at
Beginning of
Period
 
Charged to
Costs and
Expenses
 
Charged to
Other Accounts
 
Write-off/
Disposals
 
Balance
at End
of Period
For the year ended December 31, 2016:  
  
  
  
  
Allowance for doubtful accounts $1,101
 $
 $(24) $(4) $1,073
Warranty and return reserve - accounts receivable $583
 $539
 $
 $
 $1,122
Deferred tax asset valuation allowance $2,354
 $
 $
 $(2,354) $
           
For the year ended December 31, 2017:  
  
  
  
  
Allowance for doubtful accounts $1,073
 $2,308
 $90
 $(160) $3,311
Warranty and return reserve - accounts receivable $1,122
 $604
 $
 $
 $1,726
Deferred tax asset valuation allowance $
 $7,385
 $
 $
 $7,385
           
For the year ended December 31, 2018:  
  
  
  
  
Allowance for doubtful accounts $3,311
 $781
 $1,676
 $
 $5,768
Warranty and return reserve - accounts receivable $1,726
 $2,445
 $2,581
 $
 $6,752
Warranty and return reserve - inventory $(503) $2,908
 $133
   $2,538
Deferred tax asset valuation allowance $7,385
 $
 $
 $(1,949) $5,436





ITEM 16. FORM 10-K SUMMARY
None


SIGNATURE
 
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, Registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
 
ICU MEDICAL, INC.
By:/s/ Vivek Jain
Vivek Jain
Chairman of the Board and Chief Executive Officer
Dated:March 1, 2019February 25, 2022
 
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of Registrant and in the capacities and on the dates indicated.
 
108


SignatureTitleDate
/s/ Vivek JainChairman of the Board andFebruary 25, 2022
Vivek JainChief Executive Officer
(Principal Executive Officer)
/s/ Brian M. BonnellChief Financial OfficerFebruary 25, 2022
Brian M. Bonnell(Principal Financial Officer)
/s/ Kevin J. McGrodyChief Accounting OfficerFebruary 25, 2022
Kevin J. McGrody(Principal Accounting Officer)
/s/ George A. Lopez, M.D.DirectorFebruary 25, 2022
George A. Lopez, M.D.
/s/ David C. GreenbergDirectorFebruary 25, 2022
David C. Greenberg
/s/ Elisha W. FinneyDirectorFebruary 25, 2022
Elisha W. Finney
/s/ David F. HoffmeisterDirectorFebruary 25, 2022
David F. Hoffmeister
/s/ Donald M. AbbeyDirectorFebruary 25, 2022
Donald M. Abbey
Signature/s/ Laurie HernandezTitleDirectorDateFebruary 25, 2022
Laurie Hernandez
/s/ Vivek JainChairman of the Board andMarch 1, 2019
Vivek Jain/s/ Kolleen T. KennedyChief Executive OfficerDirectorFebruary 25, 2022
Kolleen T. Kennedy(Principal Executive Officer)
/s/ Scott E. LambWilliam SeegerChief Financial OfficerDirectorMarch 1, 2019February 25, 2022
Scott E. LambWilliam Seeger(Principal Financial Officer)
/s/ Kevin J. McGrodyChief Accounting OfficerMarch 1, 2019
Kevin J. McGrody(Principal Accounting Officer)
/s/ George A. Lopez, M.D.DirectorMarch 1, 2019
George A. Lopez, M.D.
/s/ Robert S. Swinney, M.D.DirectorMarch 1, 2019
Robert S. Swinney, M.D.
/s/ David C. GreenbergDirectorMarch 1, 2019
David C. Greenberg
/s/ Elisha W. FinneyDirectorMarch 1, 2019
Elisha W. Finney
/s/ Douglas E. GiordanoDirectorMarch 1, 2019
Douglas E. Giordano
/s/ David F. HoffmeisterDirectorMarch 1, 2019
David F. Hoffmeister
/s/ Donald M. AbbeyDirectorMarch 1, 2019
Donald M. Abbey

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