Delaware
|
|
33-0022692
|
(State or other jurisdiction of incorporation or organization)
|
|
(I.R.S. Employer Identification No.)
|
951 Calle Amanecer
|
|
|
||
San Clemente
|
,
|
California
|
|
92673
|
(Address of principal executive offices)
|
|
(Zip Code)
|
Title of each class
|
Trading Symbol
|
Name of each exchange on which registered
|
|
|
The NASDAQ Stock Market LLC
|
Common stock, par value $0.10 per share
|
ICUI
|
(Global Select Market)
|
Large Accelerated Filer
|
x
|
|
Accelerated filer
|
o
|
|
|
|
|
|
Non-accelerated filer
|
o
|
|
Small reporting company
|
☐
|
|
|
|
|
|
|
|
|
Emerging growth company
|
☐
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Page
|
Item 4
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||
|
||
|
•
|
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;
|
•
|
TegoTM hemodialysis connector used to cap and protect hemodialysis central venous catheter hubs;
|
•
|
NovaCath™ and SuperCath™ peripheral IV catheters(PIV); and
|
•
|
ClearGuard HD antimicrobial barrier caps for hemodialysis catheters.
|
•
|
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;
|
•
|
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.
|
•
|
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 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.
|
•
|
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.
|
•
|
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.
|
•
|
Including Sodium Chloride, Dextrose, Balanced Electrolyte Solutions, Lactated Ringer's, Ringer's, Mannitol, Sodium Chloride/Dextrose, Sterile Water.
|
•
|
Including Sodium Chloride Irrigation, Sterile Water Irrigation, Physiologic Solutions, Ringer's Irrigation, Acetic Acid Irrigation, Glycine Irrigation, Sorbitol-Mannitol Irrigation, Flexible Containers and Pour Bottle Options.
|
•
|
Cogent™ 2-in-1 hemodynamic monitoring system;
|
•
|
CardioFlo™ hemodynamic monitoring system;
|
•
|
TDQ™ and OptiQ™ cardiac output monitoring catheters;
|
•
|
TriOxTM venous oximetry catheters;
|
•
|
Transpac™ blood pressure transducers; and
|
•
|
SafeSet™ closed blood sampling and conservation system.
|
•
|
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
|
•
|
Austin, Texas, which produces our IV Solutions products.
|
•
|
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;
|
•
|
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 beginning in 2022, 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 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 of value” to physicians and other healthcare
|
•
|
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 significant civil monetary penalties, 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 additional fines and/or imprisonment of up to 10 years. Similarly, violations can result in exclusion from participation in government healthcare programs, including Medicare and Medicaid;
|
•
|
the federal civil and criminal false claims 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” actions, on behalf of the government and such individuals, commonly known as “whistleblowers,” may share in amounts paid by the entity to the government in fines or settlement. When an entity is determined to have violated the federal civil False Claims Act, the government may impose civil fines and penalties for each false claim, plus treble damages, and exclude the entity from participation in Medicare, Medicaid and other federal healthcare programs;
|
•
|
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 US Department of Health and Human Services Centers for Medicare and Medicaid Services ("CMS") information related to payments and other transfers of value to physicians, certain other healthcare providers beginning in 2022, and teaching hospitals, and applicable manufacturers and group purchasing organizations, 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 significant civil monetary penalties for any 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;
|
•
|
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; 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.
|
•
|
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;
|
•
|
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.
|
•
|
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 of new products or modified products;
|
•
|
withdrawing clearances or approvals that have already been granted;
|
•
|
refusal to grant export approval for our products; or
|
•
|
criminal prosecution.
|
•
|
strengthen the rules on placing devices on the market and reinforce surveillance once they are available;
|
•
|
establish explicit provisions on manufacturers’ responsibilities for the follow-up of the quality, performance, and safety of devices placed on the market;
|
•
|
improve the traceability of medical devices throughout the supply chain to the end-user or patient through a unique identification number;
|
•
|
set up a central database to provide patients, healthcare professionals, and the public with comprehensive information on products available in the EU;
|
•
|
strengthened rules for the assessment of certain high-risk devices, such as implants, which may have to undergo an additional check by experts before they are placed on the market.
|
•
|
costs of litigation;
|
•
|
distraction of management’s attention from our primary business;
|
•
|
the inability to commercialize our existing or new products;
|
•
|
decreased demand for our products or, if cleared or approved, products in 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.
|
•
|
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;
|
•
|
natural disasters or outbreak of diseases;
|
•
|
imposition of government controls; and
|
•
|
regulatory changes that may place our products at a disadvantage.
|
Location
|
|
Approximate Square Footage
|
|
Primary Use
|
|
Owned/Leased
|
San Clemente, California, U.S.
|
|
39,000
|
|
Corporate Headquarters and R&D
|
|
Owned
|
San Clemente, California, U.S.
|
|
28,108
|
|
Corporate Headquarters
|
|
Leased
|
San Diego, California, U.S.
|
|
44,779
|
|
Corporate Offices and R&D
|
|
Leased
|
Lake Forest, Illinois, U.S.
|
|
137,498
|
|
Corporate Offices
|
|
Leased
|
Montreal, Canada
|
|
16,414
|
|
Corporate Offices
|
|
Leased
|
Chennai, India
|
|
36,879
|
|
R&D
|
|
Leased
|
Rydalmere, NSW Australia
|
|
14,735
|
|
Corporate Offices/Device service center
|
|
Leased
|
|
|
|
|
|
|
|
Austin, Texas, U.S.
|
|
594,602
|
|
Manufacturing
|
|
Owned
|
Ensenada, Baja California, Mexico
|
|
265,021
|
|
Manufacturing
|
|
Owned
|
La Aurora, Costa Rica
|
|
626,869
|
|
Manufacturing
|
|
Owned
|
Salt Lake City, Utah, U.S.
|
|
450,000
|
|
Manufacturing
|
|
Owned
|
|
|
|
|
|
|
|
Round Rock, Texas, U.S.
|
|
71,960
|
|
Warehouse/Manufacturing
|
|
Owned
|
|
|
|
|
|
|
|
Farmers Branch, Texas, U.S.
|
|
66,060
|
|
Distribution Warehouse
|
|
Owned
|
King of Prussia, Pennsylvania, U.S.
|
|
105,571
|
|
Distribution Warehouse
|
|
Owned
|
Santa Fe Springs, California, U.S.
|
|
76,794
|
|
Distribution Warehouse
|
|
Owned
|
|
|
|
|
|
|
|
San Jose, California, U.S.
|
|
78,119
|
|
Device service center
|
|
Leased
|
Sligo, Ireland
|
|
26,000
|
|
Device service center
|
|
Leased
|
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)
|
||||||
10/01/2019 - 10/31/2019
|
|
—
|
|
|
$
|
—
|
|
|
—
|
|
|
$
|
100,000,000
|
|
11/01/2019 - 11/30/2019
|
|
—
|
|
|
$
|
—
|
|
|
—
|
|
|
$
|
100,000,000
|
|
12/01/2019 - 12/31/2019
|
|
—
|
|
|
$
|
—
|
|
|
—
|
|
|
$
|
100,000,000
|
|
Fourth quarter 2019 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 in August, 2019. 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.
|
|
|
Year ended December 31,
|
||||||||||||||||||
|
|
(in thousands, except per share data)
|
||||||||||||||||||
|
|
2019
|
|
2018
|
|
2017
|
|
2016
|
|
2015
|
||||||||||
INCOME DATA:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
REVENUE
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
Net sales
|
|
$
|
1,266,208
|
|
|
$
|
1,400,040
|
|
|
$
|
1,292,166
|
|
|
$
|
379,339
|
|
|
$
|
341,254
|
|
Other
|
|
—
|
|
|
—
|
|
|
447
|
|
|
33
|
|
|
414
|
|
|||||
TOTAL REVENUE
|
|
1,266,208
|
|
|
1,400,040
|
|
|
1,292,613
|
|
|
379,372
|
|
|
341,668
|
|
|||||
COST OF GOODS SOLD
|
|
794,344
|
|
|
830,012
|
|
|
866,518
|
|
|
177,974
|
|
|
160,871
|
|
|||||
GROSS PROFIT
|
|
471,864
|
|
|
570,028
|
|
|
426,095
|
|
|
201,398
|
|
|
180,797
|
|
|||||
Selling, general and administrative expenses(1)
|
|
276,982
|
|
|
320,002
|
|
|
302,169
|
|
|
89,426
|
|
|
83,216
|
|
|||||
Research and development expenses
|
|
48,611
|
|
|
52,867
|
|
|
51,253
|
|
|
12,955
|
|
|
15,714
|
|
|||||
Restructuring and strategic transaction
|
|
80,574
|
|
|
105,390
|
|
|
77,967
|
|
|
15,348
|
|
|
8,451
|
|
|||||
Contract settlement
|
|
5,737
|
|
|
41,613
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
Change in fair value of contingent earn-out
|
|
(47,400
|
)
|
|
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
|
|
364,504
|
|
|
540,272
|
|
|
439,389
|
|
|
118,457
|
|
|
112,232
|
|
|||||
INCOME (LOSS) FROM OPERATIONS
|
|
107,360
|
|
|
29,756
|
|
|
(13,294
|
)
|
|
82,941
|
|
|
68,565
|
|
|||||
BARGAIN PURCHASE GAIN
|
|
—
|
|
|
—
|
|
|
70,890
|
|
|
1,456
|
|
|
—
|
|
|||||
INTEREST EXPENSE
|
|
(549
|
)
|
|
(709
|
)
|
|
(2,047
|
)
|
|
(118
|
)
|
|
(39
|
)
|
|||||
OTHER INCOME (EXPENSE), net(1)
|
|
7,896
|
|
|
(6,673
|
)
|
|
(4,266
|
)
|
|
885
|
|
|
1,173
|
|
|||||
INCOME BEFORE INCOME TAXES
|
|
114,707
|
|
|
22,374
|
|
|
51,283
|
|
|
85,164
|
|
|
69,699
|
|
|||||
(PROVISION) BENEFIT FOR INCOME TAXES
|
|
(13,672
|
)
|
|
6,419
|
|
|
17,361
|
|
|
(22,080
|
)
|
|
(24,714
|
)
|
|||||
NET INCOME
|
|
$
|
101,035
|
|
|
$
|
28,793
|
|
|
$
|
68,644
|
|
|
$
|
63,084
|
|
|
$
|
44,985
|
|
NET INCOME PER SHARE
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
Basic
|
|
$
|
4.90
|
|
|
$
|
1.41
|
|
|
$
|
3.50
|
|
|
$
|
3.90
|
|
|
$
|
2.84
|
|
Diluted
|
|
$
|
4.69
|
|
|
$
|
1.33
|
|
|
$
|
3.29
|
|
|
$
|
3.66
|
|
|
$
|
2.73
|
|
WEIGHTED AVERAGE NUMBER OF SHARES
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
Basic
|
|
20,629
|
|
|
20,394
|
|
|
19,614
|
|
|
16,168
|
|
|
15,848
|
|
|||||
Diluted
|
|
21,545
|
|
|
21,601
|
|
|
20,858
|
|
|
17,254
|
|
|
16,496
|
|
|||||
Cash dividends per share
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
CASH FLOW DATA:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
Total cash flows from operations
|
|
$
|
101,918
|
|
|
$
|
160,215
|
|
|
$
|
154,423
|
|
|
$
|
89,941
|
|
|
$
|
64,195
|
|
|
|
As of December 31,
|
||||||||||||||||||
|
|
(in thousands)
|
||||||||||||||||||
|
|
2019
|
|
2018
|
|
2017
|
|
2016
|
|
2015
|
||||||||||
BALANCE SHEET DATA:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
Cash, cash equivalents and short-term investment securities
|
|
$
|
292,637
|
|
|
$
|
382,110
|
|
|
$
|
300,133
|
|
|
$
|
445,082
|
|
|
$
|
377,397
|
|
Working capital
|
|
$
|
633,729
|
|
|
$
|
677,747
|
|
|
$
|
654,370
|
|
|
$
|
528,560
|
|
|
$
|
462,389
|
|
Total assets
|
|
$
|
1,692,382
|
|
|
$
|
1,585,391
|
|
|
$
|
1,496,951
|
|
|
$
|
704,688
|
|
|
$
|
626,825
|
|
Stockholders’ equity
|
|
$
|
1,377,244
|
|
|
$
|
1,263,655
|
|
|
$
|
1,198,254
|
|
|
$
|
660,155
|
|
|
$
|
579,871
|
|
|
Year Ended December 31,
|
|||||||||||||||||||
|
2019
|
|
2018
|
|
2017
|
|||||||||||||||
|
$
|
|
% of Revenue
|
|
$
|
|
% of Revenue
|
|
$
|
|
% of Revenue
|
|||||||||
Domestic
|
$
|
923.3
|
|
|
73
|
%
|
|
$
|
1,054.7
|
|
|
75
|
%
|
|
$
|
980.0
|
|
|
76
|
%
|
International
|
342.9
|
|
|
27
|
%
|
|
345.3
|
|
|
25
|
%
|
|
312.6
|
|
|
24
|
%
|
|||
Total Revenue
|
$
|
1,266.2
|
|
|
100
|
%
|
|
$
|
1,400.0
|
|
|
100
|
%
|
|
$
|
1,292.6
|
|
|
100
|
%
|
Product line
|
|
2019
|
|
2018
|
|
2017
|
|||
Infusion Consumables
|
|
37
|
%
|
|
35
|
%
|
|
28
|
%
|
Infusion Systems
|
|
26
|
%
|
|
25
|
%
|
|
23
|
%
|
IV Solutions
|
|
33
|
%
|
|
36
|
%
|
|
40
|
%
|
Critical Care
|
|
4
|
%
|
|
4
|
%
|
|
4
|
%
|
Other
|
|
—
|
%
|
|
—
|
%
|
|
5
|
%
|
|
|
100
|
%
|
|
100
|
%
|
|
100
|
%
|
|
|
Percentage of Revenues
|
|||||||
|
|
2019
|
|
2018
|
|
2017
|
|||
Revenue
|
|
|
|
|
|
|
|
|
|
Net sales
|
|
100
|
%
|
|
100
|
%
|
|
100
|
%
|
Other
|
|
—
|
%
|
|
—
|
%
|
|
—
|
%
|
Total revenues
|
|
100
|
%
|
|
100
|
%
|
|
100
|
%
|
Gross margin
|
|
37
|
%
|
|
41
|
%
|
|
33
|
%
|
Selling, general and administrative expenses
|
|
22
|
%
|
|
23
|
%
|
|
24
|
%
|
Research and development expenses
|
|
4
|
%
|
|
4
|
%
|
|
4
|
%
|
Restructuring and transaction expense
|
|
6
|
%
|
|
8
|
%
|
|
6
|
%
|
Change in fair value of contingent earn-out
|
|
(4
|
)%
|
|
1
|
%
|
|
1
|
%
|
Contract settlement
|
|
—
|
%
|
|
3
|
%
|
|
—
|
%
|
Total operating expenses
|
|
28
|
%
|
|
39
|
%
|
|
35
|
%
|
Income (loss) from operations
|
|
9
|
%
|
|
2
|
%
|
|
(2
|
)%
|
Bargain Purchase Gain
|
|
—
|
%
|
|
—
|
%
|
|
5
|
%
|
Interest expense
|
|
—
|
%
|
|
—
|
%
|
|
—
|
%
|
Other income (expense), net
|
|
1
|
%
|
|
—
|
%
|
|
—
|
%
|
Income before income taxes
|
|
10
|
%
|
|
2
|
%
|
|
3
|
%
|
Provision (Benefit) For Income taxes
|
|
1
|
%
|
|
—
|
%
|
|
(1
|
)%
|
Net income
|
|
9
|
%
|
|
2
|
%
|
|
4
|
%
|
|
Year Ended December 31,
|
|
$ change
|
|
% change
|
|
$ change
|
|
% change
|
||||||||||||||||
|
2019
|
|
2018
|
|
2017
|
|
2019 over 2018
|
|
2018 over 2017
|
||||||||||||||||
Infusion Consumables
|
$
|
477.6
|
|
|
$
|
483.0
|
|
|
$
|
365.6
|
|
|
$
|
(5.4
|
)
|
|
(1.1
|
)%
|
|
$
|
117.4
|
|
|
32.1
|
%
|
|
Year Ended December 31,
|
|
$ change
|
|
% change
|
|
$ change
|
|
% change
|
||||||||||||||
|
2019
|
|
2018
|
|
2017
|
|
2019 over 2018
|
|
2018 over 2017
|
||||||||||||||
Infusion Systems
|
$
|
328.3
|
|
|
$
|
355.5
|
|
|
$
|
290.2
|
|
|
$
|
(27.2
|
)
|
|
(7.7)%
|
|
$
|
65.3
|
|
|
22.5%
|
|
Year Ended December 31,
|
|
$ change
|
|
% change
|
|
$ change
|
|
% change
|
||||||||||||||
|
2019
|
|
2018
|
|
2017
|
|
2019 over 2018
|
|
2018 over 2017
|
||||||||||||||
IV Solutions
|
$
|
415.0
|
|
|
$
|
508.0
|
|
|
$
|
522.0
|
|
|
$
|
(93.0
|
)
|
|
(18.3)%
|
|
$
|
(14.0
|
)
|
|
(2.7)%
|
|
Year Ended December 31,
|
|
$ change
|
|
% change
|
|
$ change
|
|
% change
|
||||||||||||||||
|
2019
|
|
2018
|
|
2017
|
|
2019 over 2018
|
|
2018 over 2017
|
||||||||||||||||
Critical Care
|
$
|
45.3
|
|
|
$
|
53.5
|
|
|
$
|
50.0
|
|
|
$
|
(8.2
|
)
|
|
(15.3
|
)%
|
|
$
|
3.5
|
|
|
7.0
|
%
|
|
Year Ended December 31,
|
$ change
|
|
% change
|
||||||||||||
|
2019
|
|
2018
|
|
2017
|
2018 over 2017
|
||||||||||
Revenue from Deferred Close Entities
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
64.4
|
|
$
|
(64.4
|
)
|
|
*
|
|
Year Ended December 31,
|
|
$ change
|
|
% change
|
|
$ change
|
|
% change
|
||||||||||||||||
|
2019
|
|
2018
|
|
2017
|
|
2019 over 2018
|
|
2018 over 2017
|
||||||||||||||||
SG&A
|
$
|
277.0
|
|
|
$
|
320.0
|
|
|
$
|
302.2
|
|
|
$
|
(43.0
|
)
|
|
(13.4
|
)%
|
|
$
|
17.8
|
|
|
5.9
|
%
|
|
Year Ended December 31,
|
|
$ change
|
|
% change
|
|
$ change
|
|
% change
|
||||||||||||||||
|
2019
|
|
2018
|
|
2017
|
|
2019 over 2018
|
|
2018 over 2017
|
||||||||||||||||
R&D
|
$
|
48.6
|
|
|
$
|
52.9
|
|
|
$
|
51.3
|
|
|
$
|
(4.3
|
)
|
|
(8.1
|
)%
|
|
$
|
1.6
|
|
|
3.1
|
%
|
|
|
For the Years Ended December 31,
|
|
Variance
|
|
||||||||||||||||
|
|
2019
|
|
2018
|
|
2017
|
|
2019
|
|
2018
|
|
||||||||||
Investing Cash Flows:
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Purchases of property, plant and equipment
|
|
$
|
(97,312
|
)
|
|
$
|
(92,720
|
)
|
|
$
|
(74,479
|
)
|
|
$
|
(4,592
|
)
|
|
$
|
(18,241
|
)
|
(1)
|
Proceeds from sale of assets
|
|
33
|
|
|
765
|
|
|
2
|
|
|
(732
|
)
|
|
763
|
|
|
|||||
Proceeds from the disposal of assets held-for-sale, net
|
|
—
|
|
|
13,000
|
|
|
—
|
|
|
(13,000
|
)
|
|
13,000
|
|
(2)
|
|||||
Intangible asset additions
|
|
(8,728
|
)
|
|
(8,059
|
)
|
|
(5,203
|
)
|
|
(669
|
)
|
|
(2,856
|
)
|
|
|||||
Business acquisitions, net of cash acquired
|
|
(76,133
|
)
|
|
(1,300
|
)
|
|
(162,448
|
)
|
|
(74,833
|
)
|
|
161,148
|
|
(3)
|
|||||
Purchases of investment securities
|
|
(26,040
|
)
|
|
(30,496
|
)
|
|
(24,743
|
)
|
|
4,456
|
|
|
(5,753
|
)
|
(4)
|
|||||
Proceeds from sale of investment securities
|
|
41,292
|
|
|
15,440
|
|
|
—
|
|
|
25,852
|
|
|
15,440
|
|
(5)
|
|||||
Net cash (used in) provided by investing activities
|
|
$
|
(166,888
|
)
|
|
$
|
(103,370
|
)
|
|
$
|
(266,871
|
)
|
|
$
|
(63,518
|
)
|
|
$
|
163,501
|
|
|
|
|
For the Years Ended December 31,
|
|
Variance
|
|
||||||||||||||||
|
|
2019
|
|
2018
|
|
2017
|
|
2019
|
|
2018
|
|
||||||||||
Financing Cash Flows:
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Repayment of long-term obligations
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
(75,000
|
)
|
|
$
|
—
|
|
|
$
|
75,000
|
|
(1)
|
Proceeds from exercise of stock options
|
|
7,732
|
|
|
14,275
|
|
|
32,003
|
|
|
(6,543
|
)
|
|
(17,728
|
)
|
(2)
|
|||||
Proceeds from employee stock purchase plan
|
|
—
|
|
|
—
|
|
|
2,705
|
|
|
—
|
|
|
(2,705
|
)
|
|
|||||
Purchase of treasury stock/tax withholding payments on net share settlement of equity awards
|
|
(18,639
|
)
|
|
(6,252
|
)
|
|
(4,057
|
)
|
|
(12,387
|
)
|
|
(2,195
|
)
|
(3)
|
|||||
Net cash (used in) provided by financing activities
|
|
$
|
(10,907
|
)
|
|
$
|
8,023
|
|
|
$
|
(44,349
|
)
|
|
$
|
(18,930
|
)
|
|
$
|
52,372
|
|
|
•
|
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
|
•
|
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.
|
•
|
Earn-out Liability - The fair value of the earn-out liabilities were valued using a Monte Carlo simulation (see Note 8 to the consolidated financial statements in Part II, Item 8 of this Form 10-K for details).
|
◦
|
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 Pursuit, the HIS business and SwabCap; 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.
|
•
|
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.
|
INDEX TO CONSOLIDATED FINANCIAL STATEMENTS AND SCHEDULE
|
|
|
Page No.
|
|
|
Consolidated Balance Sheets as of December 31, 2019 and 2018
|
|
Consolidated Statements of Operations for the Years Ended December 31, 2019, 2018 and 2017
|
|
Consolidated Statements of Comprehensive Income for the Years Ended December 31, 2019, 2018 and 2017
|
|
Consolidated Statements of Stockholders’ Equity for the Years Ended December 31, 2019, 2018 and 2017
|
|
Consolidated Statements of Cash Flows for the Years Ended December 31, 2019, 2018 and 2017
|
|
•
|
We tested the effectiveness of controls related to chargeback reserves, management’s assessment of assumptions related to estimating the provision for chargeback reserves, and the processing and monitoring of chargeback transactions.
|
•
|
We tested chargeback estimates for purposes of determining whether net revenue recognized at the time of sale was recorded in the proper period.
|
•
|
We evaluated the methods and assumptions used by management to estimate the chargeback reserve by:
|
◦
|
Analyzing trends in chargeback provision as a percent of revenues and the chargeback reserve as a percent of revenues.
|
◦
|
Testing the underlying data, including historical sales to distributor customers and chargeback settlements with distributor 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 our evaluation of the amount of monthly sales to distribution customers and the time to settle chargeback obligations and comparing our expectation to the amount recorded by management.
|
◦
|
Performing a retrospective review comparing management’s estimates of the expected chargeback reserves to actual amounts incurred subsequent to management’s estimates 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
|
|
March 2, 2020
|
|
|
|
We have served as the Company's auditor since 2008
|
|
|
December 31,
|
||||||
|
2019
|
|
2018
|
||||
ASSETS
|
|
|
|
||||
CURRENT ASSETS:
|
|
|
|
||||
Cash and cash equivalents
|
$
|
268,670
|
|
|
$
|
344,781
|
|
Short-term investment securities
|
23,967
|
|
|
37,329
|
|
||
TOTAL CASH, CASH EQUIVALENTS AND SHORT-TERM INVESTMENT SECURITIES
|
292,637
|
|
|
382,110
|
|
||
Accounts receivable, net of allowance for doubtful accounts of $20,219 and $5,768 at December 31, 2019 and 2018, respectively
|
202,219
|
|
|
176,298
|
|
||
Inventories
|
337,640
|
|
|
311,163
|
|
||
Prepaid income taxes
|
15,720
|
|
|
11,348
|
|
||
Prepaid expenses and other current assets
|
33,981
|
|
|
46,117
|
|
||
TOTAL CURRENT ASSETS
|
882,197
|
|
|
927,036
|
|
||
|
|
|
|
||||
PROPERTY, PLANT AND EQUIPMENT, net
|
456,085
|
|
|
432,641
|
|
||
OPERATING LEASE RIGHT-OF-USE ASSETS
|
34,465
|
|
|
—
|
|
||
LONG-TERM INVESTMENT SECURITIES
|
—
|
|
|
2,025
|
|
||
GOODWILL
|
31,245
|
|
|
11,195
|
|
||
INTANGIBLE ASSETS, net
|
211,408
|
|
|
133,421
|
|
||
DEFERRED INCOME TAXES
|
27,998
|
|
|
38,654
|
|
||
OTHER ASSETS
|
48,984
|
|
|
40,419
|
|
||
TOTAL ASSETS
|
$
|
1,692,382
|
|
|
$
|
1,585,391
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY
|
|
|
|
|
|
||
CURRENT LIABILITIES:
|
|
|
|
|
|
||
Accounts payable
|
$
|
128,629
|
|
|
$
|
120,469
|
|
Accrued liabilities
|
117,776
|
|
|
128,820
|
|
||
Income tax payable
|
2,063
|
|
|
—
|
|
||
TOTAL CURRENT LIABILITIES
|
248,468
|
|
|
249,289
|
|
||
|
|
|
|
||||
CONTINGENT EARN-OUT LIABILITY
|
17,300
|
|
|
47,400
|
|
||
OTHER LONG-TERM LIABILITIES
|
32,820
|
|
|
20,592
|
|
||
DEFERRED INCOME TAXES
|
2,091
|
|
|
721
|
|
||
INCOME TAX LIABILITY
|
14,459
|
|
|
3,734
|
|
||
COMMITMENTS AND CONTINGENCIES (Note 15)
|
—
|
|
|
—
|
|
||
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 — 20,743 shares at December 31, 2019 and 20,492 at December 31, 2018 and outstanding — 20,742 shares at December 31, 2019 and 20,491 shares at December 31, 2018
|
2,074
|
|
|
2,049
|
|
||
Additional paid-in capital
|
668,947
|
|
|
657,899
|
|
||
Treasury stock, at cost
|
(157
|
)
|
|
(95
|
)
|
||
Retained earnings
|
721,782
|
|
|
620,747
|
|
||
Accumulated other comprehensive loss
|
(15,402
|
)
|
|
(16,945
|
)
|
||
TOTAL STOCKHOLDERS' EQUITY
|
1,377,244
|
|
|
1,263,655
|
|
||
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY
|
$
|
1,692,382
|
|
|
$
|
1,585,391
|
|
|
Year ended December 31,
|
||||||||||
|
2019
|
|
2018
|
|
2017
|
||||||
REVENUES:
|
|
|
|
|
|
|
|
||||
Net sales
|
$
|
1,266,208
|
|
|
$
|
1,400,040
|
|
|
$
|
1,292,166
|
|
Other
|
—
|
|
|
—
|
|
|
447
|
|
|||
TOTAL REVENUES
|
1,266,208
|
|
|
1,400,040
|
|
|
1,292,613
|
|
|||
COST OF GOODS SOLD
|
794,344
|
|
|
830,012
|
|
|
866,518
|
|
|||
GROSS PROFIT
|
471,864
|
|
|
570,028
|
|
|
426,095
|
|
|||
OPERATING EXPENSES:
|
|
|
|
|
|
|
|
||||
Selling, general and administrative
|
276,982
|
|
|
320,002
|
|
|
302,169
|
|
|||
Research and development
|
48,611
|
|
|
52,867
|
|
|
51,253
|
|
|||
Restructuring, strategic transaction and integration expense
|
80,574
|
|
|
105,390
|
|
|
77,967
|
|
|||
Change in fair value of contingent earn-out
|
(47,400
|
)
|
|
20,400
|
|
|
8,000
|
|
|||
Contract settlement
|
5,737
|
|
|
41,613
|
|
|
—
|
|
|||
TOTAL OPERATING EXPENSES
|
364,504
|
|
|
540,272
|
|
|
439,389
|
|
|||
INCOME (LOSS) FROM OPERATIONS
|
107,360
|
|
|
29,756
|
|
|
(13,294
|
)
|
|||
BARGAIN PURCHASE GAIN
|
—
|
|
|
—
|
|
|
70,890
|
|
|||
INTEREST EXPENSE
|
(549
|
)
|
|
(709
|
)
|
|
(2,047
|
)
|
|||
OTHER INCOME (EXPENSE), NET
|
7,896
|
|
|
(6,673
|
)
|
|
(4,266
|
)
|
|||
INCOME BEFORE INCOME TAXES
|
114,707
|
|
|
22,374
|
|
|
51,283
|
|
|||
(PROVISION) BENEFIT FOR INCOME TAXES
|
(13,672
|
)
|
|
6,419
|
|
|
17,361
|
|
|||
NET INCOME
|
$
|
101,035
|
|
|
$
|
28,793
|
|
|
$
|
68,644
|
|
NET INCOME PER SHARE
|
|
|
|
|
|
|
|
||||
Basic
|
$
|
4.90
|
|
|
$
|
1.41
|
|
|
$
|
3.50
|
|
Diluted
|
$
|
4.69
|
|
|
$
|
1.33
|
|
|
$
|
3.29
|
|
WEIGHTED AVERAGE NUMBER OF SHARES
|
|
|
|
|
|
|
|
||||
Basic
|
20,629
|
|
|
20,394
|
|
|
19,614
|
|
|||
Diluted
|
21,545
|
|
|
21,601
|
|
|
20,858
|
|
|
Year ended December 31,
|
||||||||||
|
2019
|
|
2018
|
|
2017
|
||||||
Net income
|
$
|
101,035
|
|
|
$
|
28,793
|
|
|
$
|
68,644
|
|
Other comprehensive income (loss), net of tax:
|
|
|
|
|
|
||||||
Cash flow hedge adjustments, net of tax of $392, $317 and $224 for the years ended December 31, 2019, 2018 and 2017, respectively
|
1,242
|
|
|
1,003
|
|
|
(365
|
)
|
|||
Foreign currency translation adjustment, net of tax of $0 for both the years ended December 31, 2019 and 2018, and $56 for the year ended December 31, 2017
|
372
|
|
|
(3,104
|
)
|
|
6,694
|
|
|||
Other adjustments, net of tax of $0 for all periods
|
(71
|
)
|
|
115
|
|
|
(16
|
)
|
|||
Other comprehensive income (loss), net of tax
|
1,543
|
|
|
(1,986
|
)
|
|
6,313
|
|
|||
Comprehensive income
|
$
|
102,578
|
|
|
$
|
26,807
|
|
|
$
|
74,957
|
|
|
|
Common Stock
|
|
|
|
|
|
|
|
Accumulated
|
|
|
|||||||||||||||
|
|
|
|
|
|
Additional
|
|
|
|
|
|
Other
|
|
|
|||||||||||||
|
|
Shares
|
|
Amount
|
|
Paid-In
Capital
|
|
Treasury
Stock
|
|
Retained
Earnings
|
|
Comprehensive
(Loss) Income
|
|
Total
|
|||||||||||||
Balance, January 1, 2017
|
|
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
|
|
||||||
Other comprehensive income, net of tax
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
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 loss, 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
|
|
||||||
Issuance of restricted stock and exercise of stock options
|
|
331
|
|
|
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, 2019
|
|
20,742
|
|
|
$
|
2,074
|
|
|
$
|
668,947
|
|
|
$
|
(157
|
)
|
|
$
|
721,782
|
|
|
$
|
(15,402
|
)
|
|
$
|
1,377,244
|
|
|
Year ended December 31,
|
||||||||||
|
2019
|
|
2018
|
|
2017
|
||||||
CASH FLOWS FROM OPERATING ACTIVITIES:
|
|
|
|
|
|
|
|
||||
Net income
|
$
|
101,035
|
|
|
$
|
28,793
|
|
|
$
|
68,644
|
|
Adjustments to reconcile net income to net cash provided by operating activities:
|
|
|
|
|
|
|
|
||||
Depreciation and amortization
|
76,916
|
|
|
74,735
|
|
|
66,569
|
|
|||
Amortization of right-of-use assets
|
8,294
|
|
|
—
|
|
|
—
|
|
|||
Provision for doubtful accounts
|
14,882
|
|
|
781
|
|
|
2,308
|
|
|||
Provision for warranty and returns
|
(134
|
)
|
|
5,353
|
|
|
845
|
|
|||
Stock compensation
|
21,918
|
|
|
24,241
|
|
|
19,352
|
|
|||
Loss on disposal or write-off of property, plant and equipment
|
12,872
|
|
|
8,867
|
|
|
3,778
|
|
|||
Contract settlement
|
—
|
|
|
12,696
|
|
|
—
|
|
|||
Write-off of acquired intangibles
|
—
|
|
|
5,000
|
|
|
—
|
|
|||
Bond premium amortization
|
135
|
|
|
342
|
|
|
103
|
|
|||
Debt issuance cost amortization
|
288
|
|
|
288
|
|
|
48
|
|
|||
Impairment of assets held-for-sale
|
—
|
|
|
269
|
|
|
—
|
|
|||
Bargain purchase gain
|
—
|
|
|
—
|
|
|
(70,890
|
)
|
|||
Change in fair value of contingent earn-out
|
(47,400
|
)
|
|
20,400
|
|
|
8,000
|
|
|||
Usage of spare parts
|
24,301
|
|
|
7,310
|
|
|
4,820
|
|
|||
Other
|
447
|
|
|
3,856
|
|
|
(220
|
)
|
|||
Changes in operating assets and liabilities, net of amounts acquired:
|
|
|
|
|
|
|
|
||||
Accounts receivable
|
(23,684
|
)
|
|
(76,742
|
)
|
|
(54,533
|
)
|
|||
Inventories
|
(24,997
|
)
|
|
(21,770
|
)
|
|
181,699
|
|
|||
Prepaid expenses and other assets
|
8,588
|
|
|
3,719
|
|
|
(29,652
|
)
|
|||
Related-party receivables
|
—
|
|
|
97,443
|
|
|
(95,309
|
)
|
|||
Other assets
|
(29,837
|
)
|
|
(9,086
|
)
|
|
(6,975
|
)
|
|||
Accounts payable
|
(2,697
|
)
|
|
23,270
|
|
|
46,648
|
|
|||
Accrued liabilities
|
(43,689
|
)
|
|
(29,553
|
)
|
|
33,813
|
|
|||
Income taxes, including excess tax benefits and deferred income taxes
|
4,680
|
|
|
(19,997
|
)
|
|
(24,625
|
)
|
|||
Net cash provided by operating activities
|
101,918
|
|
|
160,215
|
|
|
154,423
|
|
|||
CASH FLOWS FROM INVESTING ACTIVITIES:
|
|
|
|
|
|
|
|
||||
Purchases of property, plant and equipment
|
(97,312
|
)
|
|
(92,720
|
)
|
|
(74,479
|
)
|
|||
Proceeds from sale of assets
|
33
|
|
|
765
|
|
|
2
|
|
|||
Proceeds from the disposal of assets held-for-sale, net
|
—
|
|
|
13,000
|
|
|
—
|
|
|||
Intangible asset additions
|
(8,728
|
)
|
|
(8,059
|
)
|
|
(5,203
|
)
|
|||
Business acquisitions, net of cash acquired
|
(76,133
|
)
|
|
(1,300
|
)
|
|
(162,448
|
)
|
|||
Purchases of investment securities
|
(26,040
|
)
|
|
(30,496
|
)
|
|
(24,743
|
)
|
|||
Proceeds from sale of investment securities
|
41,292
|
|
|
15,440
|
|
|
—
|
|
|||
Net cash used in investing activities
|
(166,888
|
)
|
|
(103,370
|
)
|
|
(266,871
|
)
|
|||
CASH FLOWS FROM FINANCING ACTIVITIES:
|
|
|
|
|
|
|
|
||||
Repayment of long-term obligations
|
—
|
|
|
—
|
|
|
(75,000
|
)
|
|||
Proceeds from exercise of stock options
|
7,732
|
|
|
14,275
|
|
|
32,003
|
|
|||
Proceeds from employee stock purchase plan
|
—
|
|
|
—
|
|
|
2,705
|
|
|||
Purchase of treasury stock/tax withholding payments on net share settlement of equity awards
|
(18,639
|
)
|
|
(6,252
|
)
|
|
(4,057
|
)
|
|||
Net cash (used in) provided by financing activities
|
(10,907
|
)
|
|
8,023
|
|
|
(44,349
|
)
|
|||
Effect of exchange rate changes on cash
|
(234
|
)
|
|
(10,159
|
)
|
|
1,787
|
|
|||
NET (DECREASE) INCREASE IN CASH AND CASH EQUIVALENTS
|
(76,111
|
)
|
|
54,709
|
|
|
(155,010
|
)
|
|||
CASH AND CASH EQUIVALENTS, beginning of period
|
344,781
|
|
|
290,072
|
|
|
445,082
|
|
|||
CASH AND CASH EQUIVALENTS, end of period
|
$
|
268,670
|
|
|
$
|
344,781
|
|
|
$
|
290,072
|
|
|
2019
|
|
2018
|
||||
Raw materials
|
$
|
119,709
|
|
|
$
|
104,104
|
|
Work in process
|
39,515
|
|
|
52,909
|
|
||
Finished goods
|
178,416
|
|
|
154,150
|
|
||
Total
|
$
|
337,640
|
|
|
$
|
311,163
|
|
|
2019
|
|
2018
|
||||
Machinery and equipment
|
$
|
219,057
|
|
|
$
|
203,431
|
|
Land, building and building improvements
|
230,454
|
|
|
212,283
|
|
||
Molds
|
60,155
|
|
|
59,700
|
|
||
Computer equipment and software
|
83,217
|
|
|
80,420
|
|
||
Furniture and fixtures
|
7,498
|
|
|
7,409
|
|
||
Instruments placed with customers1
|
74,434
|
|
|
60,757
|
|
||
Construction in progress
|
101,425
|
|
|
70,864
|
|
||
Total property, plant and equipment, cost
|
776,240
|
|
|
694,864
|
|
||
Accumulated depreciation
|
(320,155
|
)
|
|
(262,223
|
)
|
||
Net property, plant and equipment
|
$
|
456,085
|
|
|
$
|
432,641
|
|
|
|
Total
|
||
Balance as of January 1, 2017
|
|
$
|
5,577
|
|
Goodwill acquired(1)
|
|
6,536
|
|
|
Other
|
|
244
|
|
|
Balance as of December 31, 2017
|
|
12,357
|
|
|
Goodwill acquired(2)
|
|
1,300
|
|
|
Other(3)
|
|
(2,462
|
)
|
|
Balance as of December 31, 2018
|
|
11,195
|
|
|
Goodwill acquired(4)
|
|
20,026
|
|
|
Other
|
|
24
|
|
|
Balance as of December 31, 2019
|
|
$
|
31,245
|
|
|
|
Weighted
Average
Amortization
Life in Years
|
|
December 31, 2019
|
||||||||||
|
|
|
Cost
|
|
Accumulated
Amortization
|
|
Net
|
|||||||
Patents
|
|
10
|
|
$
|
22,322
|
|
|
$
|
13,519
|
|
|
$
|
8,803
|
|
Customer contracts
|
|
12
|
|
10,122
|
|
|
5,506
|
|
|
4,616
|
|
|||
Non-contractual customer relationships
|
|
9
|
|
57,296
|
|
|
19,787
|
|
|
37,509
|
|
|||
Trademarks
|
|
4
|
|
425
|
|
|
425
|
|
|
—
|
|
|||
Trade name
|
|
15
|
|
18,256
|
|
|
2,254
|
|
|
16,002
|
|
|||
Developed technology
|
|
13
|
|
152,354
|
|
|
24,228
|
|
|
128,126
|
|
|||
Non-compete
|
|
3
|
|
2,500
|
|
|
139
|
|
|
2,361
|
|
|||
Total amortized intangible assets
|
|
|
|
$
|
263,275
|
|
|
$
|
65,858
|
|
|
$
|
197,417
|
|
|
|
|
|
|
|
|
|
|
||||||
Internally developed software*
|
|
|
|
$
|
13,991
|
|
|
|
|
$
|
13,991
|
|
||
|
|
|
|
|
|
|
|
|
||||||
Total intangible assets
|
|
|
|
$
|
277,266
|
|
|
$
|
65,858
|
|
|
$
|
211,408
|
|
|
|
Weighted
Average
|
|
December 31, 2018
|
||||||||||
|
|
Amortization
Life in Years
|
|
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
|
|
|
|
$
|
173,372
|
|
|
$
|
48,186
|
|
|
$
|
125,186
|
|
|
|
|
|
|
|
|
|
|
||||||
Internally developed software*
|
|
|
|
$
|
8,235
|
|
|
|
|
$
|
8,235
|
|
||
|
|
|
|
|
|
|
|
|
||||||
Total intangible assets
|
|
|
|
$
|
181,607
|
|
|
$
|
48,186
|
|
|
$
|
133,421
|
|
2020
|
|
$
|
21,692
|
|
2021
|
|
22,587
|
|
|
2022
|
|
22,303
|
|
|
2023
|
|
21,461
|
|
|
2024
|
|
21,371
|
|
|
Thereafter
|
|
88,003
|
|
|
Total
|
|
$
|
197,417
|
|
|
December 31, 2019
|
||||||||||
|
Amortized Cost
|
|
Unrealized Holding Gains (Losses)
|
|
Fair Value
|
||||||
Short-term corporate bonds
|
23,967
|
|
|
$
|
—
|
|
|
$
|
23,967
|
|
|
Long-term corporate bonds
|
—
|
|
|
—
|
|
|
—
|
|
|||
Total investment securities
|
$
|
23,967
|
|
|
$
|
—
|
|
|
$
|
23,967
|
|
|
|
|
|
|
|
||||||
|
December 31, 2018
|
||||||||||
|
Amortized Cost
|
|
Unrealized Holding Gains (Losses)
|
|
Fair Value
|
||||||
Short-term corporate bonds
|
$
|
37,329
|
|
|
$
|
—
|
|
|
$
|
37,329
|
|
Long-term corporate bonds
|
2,025
|
|
|
—
|
|
|
2,025
|
|
|||
Total investment securities
|
$
|
39,354
|
|
|
$
|
—
|
|
|
$
|
39,354
|
|
|
|
Year ended December 31,
(in thousands, except per share data)
|
||||||||||
|
|
2019
|
|
2018
|
|
2017
|
||||||
Net income
|
|
$
|
101,035
|
|
|
$
|
28,793
|
|
|
$
|
68,644
|
|
Weighted average number of common shares outstanding (basic)
|
|
20,629
|
|
|
20,394
|
|
|
19,614
|
|
|||
Dilutive securities
|
|
916
|
|
|
1,207
|
|
|
1,244
|
|
|||
Weighted average common and common equivalent shares outstanding (diluted)
|
|
21,545
|
|
|
21,601
|
|
|
20,858
|
|
|||
EPS - basic
|
|
$
|
4.90
|
|
|
$
|
1.41
|
|
|
$
|
3.50
|
|
EPS - diluted
|
|
$
|
4.69
|
|
|
$
|
1.33
|
|
|
$
|
3.29
|
|
Cash consideration for acquired assets, net
|
|
$
|
71,533
|
|
Fair value of contingent consideration
|
|
17,300
|
|
|
Total Estimated Consideration
|
|
$
|
88,833
|
|
|
|
|
||
Preliminary Purchase Price Allocation:
|
|
|
||
Trade receivables
|
|
$
|
973
|
|
Inventories
|
|
2,464
|
|
|
Prepaid expenses and other current assets
|
|
74
|
|
|
Property, plant and equipment
|
|
609
|
|
|
Intangible assets(1)
|
|
82,300
|
|
|
Accounts payable
|
|
(215
|
)
|
|
Accrued liabilities
|
|
(2,065
|
)
|
|
Total identifiable net assets acquired
|
|
$
|
84,140
|
|
Goodwill - not tax deductible
|
|
19,116
|
|
|
Deferred tax liability
|
|
(14,423
|
)
|
|
Estimated Purchase Consideration
|
|
$
|
88,833
|
|
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
|
|
(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
|
|
|
Accrued Balance January 1, 2018
|
|
Charges incurred
|
|
Payments
|
|
Other Adjustments
|
|
Accrued Balance December 31, 2018
|
|
Charges incurred
|
|
Payments
|
|
Other Adjustments
|
|
Accrued Balance December 31, 2019
|
||||||||||||||||||
Severance pay and benefits
|
$
|
915
|
|
|
$
|
4,311
|
|
|
$
|
(4,549
|
)
|
|
$
|
—
|
|
|
$
|
677
|
|
|
$
|
5,634
|
|
|
$
|
(2,433
|
)
|
|
$
|
—
|
|
|
$
|
3,878
|
|
Employment agreement buyout
|
1,114
|
|
|
—
|
|
|
(368
|
)
|
|
(7
|
)
|
|
739
|
|
|
—
|
|
|
(279
|
)
|
|
—
|
|
|
460
|
|
|||||||||
Retention and facility closure expenses
|
—
|
|
|
160
|
|
|
(160
|
)
|
|
—
|
|
|
—
|
|
|
2,741
|
|
|
(1,530
|
)
|
|
—
|
|
|
1,211
|
|
|||||||||
|
$
|
2,029
|
|
|
$
|
4,471
|
|
|
$
|
(5,077
|
)
|
|
$
|
(7
|
)
|
|
$
|
1,416
|
|
|
$
|
8,375
|
|
|
$
|
(4,242
|
)
|
|
$
|
—
|
|
|
$
|
5,549
|
|
•
|
Identifying the various performance obligations of these arrangements.
|
•
|
Estimating the relative standalone selling price of each performance obligation, typically using directly observable method or calculated on a cost plus margin basis method.
|
|
For the year ended
December 31,
|
|||||||||||||||||||
|
2019
|
|
2018
|
|
2017
|
|||||||||||||||
Product line
|
Revenue
|
|
% of Revenue
|
|
Revenue
|
|
% of Revenue
|
|
Revenue
|
|
% of Revenue
|
|||||||||
Infusion Consumables
|
$
|
477,611
|
|
|
37
|
%
|
|
$
|
483,039
|
|
|
35
|
%
|
|
$
|
365,665
|
|
|
28
|
%
|
Infusion Systems
|
328,282
|
|
|
26
|
%
|
|
355,484
|
|
|
25
|
%
|
|
290,207
|
|
|
23
|
%
|
|||
IV Solutions
|
414,971
|
|
|
33
|
%
|
|
507,985
|
|
|
36
|
%
|
|
521,963
|
|
|
40
|
%
|
|||
Critical Care
|
45,344
|
|
|
4
|
%
|
|
53,532
|
|
|
4
|
%
|
|
49,961
|
|
|
4
|
%
|
|||
Other
|
—
|
|
|
—
|
%
|
|
—
|
|
|
—
|
%
|
|
64,817
|
|
|
5
|
%
|
|||
Total Revenues
|
$
|
1,266,208
|
|
|
100
|
%
|
|
$
|
1,400,040
|
|
|
100
|
%
|
|
$
|
1,292,613
|
|
|
100
|
%
|
|
For the year
ended December 31,
|
||||||||||
Geography
|
2019
|
|
2018
|
|
2017
|
||||||
Europe, the Middle East and Africa
|
$
|
130,530
|
|
|
$
|
134,363
|
|
|
$
|
119,934
|
|
Other Foreign
|
212,336
|
|
|
210,996
|
|
|
192,640
|
|
|||
Total Foreign
|
342,866
|
|
|
345,359
|
|
|
312,574
|
|
|||
United States
|
923,342
|
|
|
1,054,681
|
|
|
980,039
|
|
|||
Total Revenues
|
$
|
1,266,208
|
|
|
$
|
1,400,040
|
|
|
$
|
1,292,613
|
|
|
Contract Liabilities
|
||
Beginning balance, January 1, 2018
|
$
|
(7,066
|
)
|
Equipment revenue recognized
|
6,696
|
|
|
Equipment revenue deferred due to implementation
|
(4,196
|
)
|
|
Software revenue recognized
|
6,553
|
|
|
Software revenue deferred due to implementation
|
(6,269
|
)
|
|
Ending balance, December 31, 2018
|
$
|
(4,282
|
)
|
Equipment revenue recognized
|
8,807
|
|
|
Equipment revenue deferred due to implementation
|
(8,794
|
)
|
|
Software revenue recognized
|
3,953
|
|
|
Software revenue deferred due to implementation
|
(4,539
|
)
|
|
Ending balance, December 31, 2019
|
$
|
(4,855
|
)
|
|
For the year
ended December 31, 2019
|
||
Operating lease cost
|
$
|
10,011
|
|
|
|
||
Short-term lease cost
|
322
|
|
|
|
|
||
Total lease cost
|
$
|
10,333
|
|
|
For the year
ended December 31, 2019
|
||
Cash paid for amounts included in the measurement of lease liabilities:
|
|
||
Operating cash flows from operating leases
|
$
|
10,344
|
|
|
|
||
Right-of-use assets obtained in exchange for lease obligations:
|
|
||
Operating leases
|
$
|
3,230
|
|
|
|
As of December 31, 2019
|
||
Operating leases
|
|
|
||
Operating lease right-of-use assets
|
|
$
|
34,465
|
|
|
|
|
||
Accrued liabilities
|
|
$
|
7,362
|
|
Other long-term liabilities
|
|
28,896
|
|
|
Total operating lease liabilities
|
|
$
|
36,258
|
|
|
|
|
||
Weighted Average Remaining Lease Term
|
|
|
||
Operating leases
|
|
6 years
|
|
|
|
|
|
||
Weighted Average Discount Rate
|
|
|
||
Operating leases
|
|
5.57
|
%
|
|
Operating Leases
|
||
2020
|
$
|
8,850
|
|
2021
|
7,412
|
|
|
2022
|
6,621
|
|
|
2023
|
6,204
|
|
|
2024
|
5,896
|
|
|
Thereafter
|
7,765
|
|
|
Total Lease Payments
|
42,748
|
|
|
Less imputed interest
|
(6,490
|
)
|
|
Total
|
$
|
36,258
|
|
|
Operating Leases
|
||
2019
|
$
|
8,326
|
|
2020
|
8,572
|
|
|
2021
|
6,489
|
|
|
2022
|
5,914
|
|
|
2023
|
5,615
|
|
|
Thereafter
|
13,235
|
|
|
Total Lease Payments(1)
|
$
|
48,151
|
|
|
|
Year ended December 31,
|
||||||||||
(In thousands)
|
|
2019
|
|
2018
|
|
2017
|
||||||
Stock compensation expense
|
|
$
|
21,918
|
|
|
$
|
24,241
|
|
|
$
|
19,352
|
|
Tax benefit from stock-based compensation cost
|
|
$
|
4,840
|
|
|
$
|
5,706
|
|
|
$
|
7,247
|
|
Indirect tax benefit
|
|
$
|
680
|
|
|
$
|
2,199
|
|
|
$
|
1,374
|
|
|
|
Year ended December 31,
|
||||||||||
|
|
2019
|
|
2018
|
|
2017
|
||||||
Number of time-based options granted
|
|
6,265
|
|
|
5,815
|
|
|
8,825
|
|
|||
Grant date fair value of options granted (in thousands)
|
|
$
|
424
|
|
|
$
|
425
|
|
|
$
|
375
|
|
Weighted average assumptions for stock option valuation:
|
|
|
|
|
|
|
||||||
Expected term (years)
|
|
5.5
|
|
|
5.5
|
|
|
5.5
|
|
|||
Expected stock price volatility
|
|
28.0
|
%
|
|
24.0
|
%
|
|
27.0
|
%
|
|||
Risk-free interest rate
|
|
2.2
|
%
|
|
2.3
|
%
|
|
1.1
|
%
|
|||
Expected dividend yield
|
|
—
|
%
|
|
—
|
%
|
|
—
|
%
|
|||
Weighted average grant price per option
|
|
$
|
225.27
|
|
|
$
|
269.80
|
|
|
$
|
158.20
|
|
Weighted average grant date fair value per option
|
|
$
|
67.73
|
|
|
$
|
73.14
|
|
|
$
|
42.51
|
|
|
|
Shares
|
|
Weighted Average Exercise Price Per Share
|
|
Weighted Average Contractual Life (Years)
|
|
Aggregate Intrinsic Value (in thousands)
|
|||||
Outstanding at December 31, 2018
|
|
1,186,928
|
|
|
$
|
63.66
|
|
|
|
|
|
||
Granted
|
|
6,265
|
|
|
$
|
225.27
|
|
|
|
|
|
||
Exercised
|
|
(145,339
|
)
|
|
$
|
53.18
|
|
|
|
|
|
||
Forfeited or expired
|
|
—
|
|
|
$
|
—
|
|
|
|
|
|
||
Outstanding at December 31, 2019
|
|
1,047,854
|
|
|
$
|
66.08
|
|
|
4.1
|
|
$
|
127,556
|
|
Exercisable at December 31, 2019
|
|
1,041,589
|
|
|
$
|
65.12
|
|
|
4.0
|
|
$
|
127,556
|
|
Vested and expected to vest, December 31, 2019
|
|
1,047,854
|
|
|
$
|
66.08
|
|
|
4.1
|
|
$
|
127,556
|
|
|
|
Year ended December 31,
|
||||||||||
(In thousands)
|
|
2019
|
|
2018
|
|
2017
|
||||||
Intrinsic value of options exercised
|
|
$
|
22,976
|
|
|
$
|
51,105
|
|
|
$
|
71,283
|
|
Cash received from exercise of stock options
|
|
$
|
7,732
|
|
|
$
|
14,275
|
|
|
$
|
32,003
|
|
Tax benefit from stock option exercises
|
|
$
|
9,653
|
|
|
$
|
12,617
|
|
|
$
|
20,004
|
|
|
|
Year ended December 31,
|
||||||||||
(In thousands except shares and per share amounts)
|
|
2019
|
|
2018
|
|
2017
|
||||||
PRSU
|
|
|
|
|
|
|
||||||
Shares granted
|
|
37,657
|
|
|
30,348
|
|
|
20,686
|
|
|||
Shares earned
|
|
114,032
|
|
|
—
|
|
|
—
|
|
|||
Grant date fair value per share
|
|
$
|
231.63
|
|
|
$
|
248.65
|
|
|
$
|
154.75
|
|
Grant date fair value
|
|
$
|
8,723
|
|
|
$
|
7,546
|
|
|
$
|
3,201
|
|
Intrinsic value vested
|
|
$
|
26,445
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
|
|
|
|
|
|
||||||
RSU
|
|
|
|
|
|
|
||||||
Shares granted
|
|
61,856
|
|
|
63,094
|
|
|
107,678
|
|
|||
Grant date fair value per share
|
|
$
|
227.42
|
|
|
$
|
252.42
|
|
|
$
|
156.49
|
|
Grant date fair value
|
|
$
|
14,067
|
|
|
$
|
15,926
|
|
|
$
|
16,851
|
|
Intrinsic value vested
|
|
$
|
16,753
|
|
|
$
|
17,086
|
|
|
$
|
9,813
|
|
|
|
Number of Units
|
|
Grant Date Fair Value Per Share
|
|
Weighted Average Contractual Life (Years)
|
|
Aggregate Intrinsic Value
|
|||||
Non-vested at December 31, 2018
|
|
340,704
|
|
|
$
|
155.27
|
|
|
|
|
|
||
Change in units due to performance expectations (a)
|
|
(14,444
|
)
|
|
$
|
238.03
|
|
|
|
|
|
||
Granted
|
|
99,513
|
|
|
$
|
229.01
|
|
|
|
|
|
||
Vested
|
|
(185,662
|
)
|
|
$
|
122.55
|
|
|
|
|
|
||
Forfeited
|
|
(7,584
|
)
|
|
$
|
216.29
|
|
|
|
|
|
||
Non-vested and expected to vest at December 31, 2019
|
|
232,527
|
|
|
$
|
205.82
|
|
|
0.7
|
|
$
|
43,510
|
|
|
|
||
|
2017
|
||
ESPP shares purchased by employees
|
23,426
|
|
|
Intrinsic value of ESPP purchases (in thousands)
|
$
|
986
|
|
Weighted average assumptions for ESPP valuation:
|
|
||
Expected term (in years)
|
0.5
|
|
|
Expected stock price volatility
|
28.1
|
%
|
|
Risk-free interest rate
|
0.6
|
%
|
|
Expected dividend yield
|
—
|
%
|
|
Derivatives
|
||||||||
|
|
|
December 31,
|
||||||
|
Consolidated Balance Sheet
Location
|
|
2019
|
|
2018
|
||||
Derivatives designated as cash flow hedging instruments
|
|
|
|
|
|
||||
Foreign exchange forward contract:
|
Prepaid expenses and other current assets
|
|
$
|
2,366
|
|
|
$
|
187
|
|
|
Other assets
|
|
—
|
|
|
545
|
|
||
Total derivatives designated as cash flow hedging instruments
|
|
|
$
|
2,366
|
|
|
$
|
732
|
|
|
|
|
Year Ended December 31,
|
||||||||||
|
Line Item in the
Consolidated Statements of Operations
|
|
2019
|
|
2018
|
|
2017
|
||||||
Derivatives designated as cash flow hedging instruments
|
|
|
|
|
|
|
|
||||||
Foreign exchange forward contracts
|
Cost of goods sold
|
|
$
|
916
|
|
|
$
|
743
|
|
|
$
|
885
|
|
|
|
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,
|
|
|
|
Year Ended December 31,
|
||||||||||||||||||||
|
|
2019
|
|
2018
|
|
2017
|
|
Location of Gain Reclassified From Accumulated Other Comprehensive Income into Income
|
|
2019
|
|
2018
|
|
2017
|
||||||||||||
Derivatives designated as cash flow hedges:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Foreign exchange forward contract
|
|
$
|
2,550
|
|
|
$
|
2,063
|
|
|
$
|
296
|
|
|
Cost of goods sold
|
|
$
|
916
|
|
|
$
|
743
|
|
|
$
|
885
|
|
Total derivatives designated as cash flow hedging instruments
|
|
$
|
2,550
|
|
|
$
|
2,063
|
|
|
$
|
296
|
|
|
|
|
$
|
916
|
|
|
$
|
743
|
|
|
$
|
885
|
|
•
|
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.
|
|
|
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
|
|
Acquisition date fair value estimate of earn-out
|
|
—
|
|
|
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
|
|
|
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)
|
|
(47,400
|
)
|
|
Contingent earn-out liability, December 31, 2019
|
|
$
|
17,300
|
|
Simulation Input
|
As of
December 31, 2018
|
|
As of
December 31, 2017
|
|
At Acquisition February 3, 2017
|
|||
Adjusted EBITDA Volatility
|
30.00
|
%
|
|
26.00
|
%
|
|
29.00
|
%
|
WACC
|
8.25
|
%
|
|
8.75
|
%
|
|
10.00
|
%
|
20-year risk free rate
|
2.87
|
%
|
|
2.58
|
%
|
|
2.82
|
%
|
Market price of risk
|
5.24
|
%
|
|
5.99
|
%
|
|
6.93
|
%
|
Cost of debt
|
5.25
|
%
|
|
4.08
|
%
|
|
4.16
|
%
|
Simulation Input
|
As of
December 31, 2019
|
|
At Acquisition November 2, 2019
|
||
Revenue/Gross Profit Volatility
|
20.00
|
%
|
|
20.00
|
%
|
Discount Rate
|
15.00
|
%
|
|
15.00
|
%
|
Risk free rate
|
1.55
|
%
|
|
1.55
|
%
|
Counter Party Risk
|
6.00
|
%
|
|
6.00
|
%
|
|
Fair value measurements at December 31, 2019
|
||||||||||||||
|
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
|
$
|
23,967
|
|
|
$
|
—
|
|
|
$
|
23,967
|
|
|
$
|
—
|
|
Foreign exchange forwards:
|
|
|
|
|
|
|
|
||||||||
Prepaid expenses and other current assets
|
2,366
|
|
|
—
|
|
|
2,366
|
|
|
—
|
|
||||
Total Assets
|
$
|
26,333
|
|
|
$
|
—
|
|
|
$
|
26,333
|
|
|
$
|
—
|
|
|
|
|
|
|
|
|
|
||||||||
Liabilities:
|
|
|
|
|
|
|
|
||||||||
|
|
|
|
|
|
|
|
||||||||
Earn-out liability
|
$
|
17,300
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
17,300
|
|
Total Liabilities
|
$
|
17,300
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
17,300
|
|
|
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 debt securities:
|
|
|
|
|
|
|
|
||||||||
Short-term
|
$
|
37,329
|
|
|
$
|
—
|
|
|
$
|
37,329
|
|
|
$
|
—
|
|
Long-term
|
2,025
|
|
|
—
|
|
|
2,025
|
|
|
—
|
|
||||
Foreign exchange forwards:
|
|
|
|
|
|
|
|
||||||||
Prepaid expenses and other current assets
|
187
|
|
|
$
|
—
|
|
|
$
|
187
|
|
|
$
|
—
|
|
|
Other assets
|
545
|
|
|
$
|
—
|
|
|
$
|
545
|
|
|
$
|
—
|
|
|
Total Assets
|
$
|
39,354
|
|
|
$
|
—
|
|
|
$
|
39,354
|
|
|
$
|
—
|
|
|
|
|
|
|
|
|
|
||||||||
Liabilities:
|
|
|
|
|
|
|
|
||||||||
|
|
|
|
|
|
|
|
||||||||
Earn-out liability
|
$
|
47,400
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
47,400
|
|
Total Liabilities
|
$
|
47,400
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
47,400
|
|
|
|
December 31,
|
||||||
|
|
2019
|
|
2018
|
||||
Deposits
|
|
$
|
1,375
|
|
|
$
|
1,087
|
|
Other prepaid expenses and receivables
|
|
13,778
|
|
|
12,476
|
|
||
Receivables from Pfizer related to HIS business acquisition(1)
|
|
—
|
|
|
20,137
|
|
||
Deferred costs
|
|
3,332
|
|
|
1,951
|
|
||
Prepaid insurance and property taxes
|
|
5,450
|
|
|
2,666
|
|
||
VAT/GST receivable
|
|
4,422
|
|
|
5,072
|
|
||
Deferred tax charge
|
|
1,266
|
|
|
1,180
|
|
||
Other
|
|
4,358
|
|
|
1,548
|
|
||
|
|
$
|
33,981
|
|
|
$
|
46,117
|
|
|
|
December 31,
|
||||||
|
|
2019
|
|
2018
|
||||
Salaries and benefits
|
|
$
|
21,116
|
|
|
$
|
20,538
|
|
Incentive compensation
|
|
15,221
|
|
|
42,913
|
|
||
Accrued supply chain restructuring costs
|
|
23,119
|
|
|
—
|
|
||
Operating lease liability-ST
|
|
7,362
|
|
|
—
|
|
||
Accrued professional fees
|
|
4,782
|
|
|
15,996
|
|
||
Accrued product field action
|
|
2,096
|
|
|
5,316
|
|
||
Consigned inventory
|
|
—
|
|
|
1,118
|
|
||
Third-party inventory
|
|
—
|
|
|
1,089
|
|
||
Legal accrual
|
|
826
|
|
|
1,400
|
|
||
Accrued sales taxes
|
|
2,615
|
|
|
2,941
|
|
||
Warranties and returns
|
|
782
|
|
|
1,124
|
|
||
Deferred revenue
|
|
4,761
|
|
|
3,814
|
|
||
Accrued other taxes
|
|
4,054
|
|
|
3,213
|
|
||
Distribution fees
|
|
3,942
|
|
|
3,977
|
|
||
Accrued freight
|
|
11,238
|
|
|
10,953
|
|
||
Restructuring accrual
|
|
5,459
|
|
|
1,046
|
|
||
Contract liabilities-ST
|
|
1,935
|
|
|
—
|
|
||
Contract settlement
|
|
1,667
|
|
|
2,083
|
|
||
Accrued research and development
|
|
—
|
|
|
1,451
|
|
||
Other
|
|
6,801
|
|
|
9,848
|
|
||
|
|
$
|
117,776
|
|
|
$
|
128,820
|
|
|
|
December 31,
|
||||||
|
|
2019
|
|
2018
|
||||
Operating lease liabilities-LT
|
|
$
|
28,896
|
|
|
$
|
—
|
|
Contract liabilities(1)
|
|
472
|
|
|
14,020
|
|
||
Deferred revenue
|
|
94
|
|
|
468
|
|
||
Benefits
|
|
1,131
|
|
|
962
|
|
||
Accrued rent
|
|
1,642
|
|
|
1,779
|
|
||
Contract settlement
|
|
—
|
|
|
1,667
|
|
||
Other
|
|
585
|
|
|
1,696
|
|
||
|
|
$
|
32,820
|
|
|
$
|
20,592
|
|
Level
|
Consolidated Total
Leverage Ratio
|
Commitment
Fee
|
LIBOR
+
|
Base Rate
+
|
I
|
Less than 1.00 to 1.00
|
0.15%
|
1.25%
|
0.25%
|
II
|
Greater than or equal to 1.00 to 1.00 but less than 2.00 to 1.00
|
0.20%
|
1.50%
|
0.50%
|
III
|
Greater than or equal to 2.00 to 1.00 but less than 2.50 to 1.00
|
0.25%
|
1.75%
|
0.75%
|
IV
|
Greater than or equal to 2.50 to 1.00
|
0.30%
|
2.00%
|
1.00%
|
|
|
Year Ended December 31,
|
||||||||||
|
|
2019
|
|
2018
|
|
2017
|
||||||
United States
|
|
$
|
32,849
|
|
|
$
|
(8,600
|
)
|
|
$
|
59,872
|
|
Foreign
|
|
81,858
|
|
|
30,974
|
|
|
(8,589
|
)
|
|||
|
|
$
|
114,707
|
|
|
$
|
22,374
|
|
|
$
|
51,283
|
|
|
|
Year Ended December 31,
|
||||||||||
|
|
2019
|
|
2018
|
|
2017
|
||||||
Current:
|
|
|
|
|
|
|
|
|
|
|||
Federal
|
|
$
|
6,851
|
|
|
$
|
492
|
|
|
$
|
2,774
|
|
State
|
|
2,532
|
|
|
1,865
|
|
|
2,263
|
|
|||
Foreign
|
|
7,994
|
|
|
9,136
|
|
|
3,170
|
|
|||
|
|
17,377
|
|
|
11,493
|
|
|
8,207
|
|
|||
Deferred:
|
|
|
|
|
|
|
|
|
|
|||
Federal
|
|
$
|
(6,720
|
)
|
|
$
|
(9,118
|
)
|
|
$
|
(20,878
|
)
|
State
|
|
(325
|
)
|
|
(3,072
|
)
|
|
(4,619
|
)
|
|||
Foreign
|
|
3,340
|
|
|
(5,722
|
)
|
|
(71
|
)
|
|||
|
|
(3,705
|
)
|
|
(17,912
|
)
|
|
(25,568
|
)
|
|||
|
|
$
|
13,672
|
|
|
$
|
(6,419
|
)
|
|
$
|
(17,361
|
)
|
|
|
Year Ended December 31,
|
|||||||||||||||||||
|
|
2019
|
|
2018
|
|
2017
|
|||||||||||||||
|
|
Amount
|
|
Percent
|
|
Amount
|
|
Percent
|
|
Amount
|
|
Percent
|
|||||||||
Federal tax at the expected statutory rate
|
|
$
|
24,088
|
|
|
21.0
|
%
|
|
$
|
4,699
|
|
|
21.0
|
%
|
|
$
|
17,950
|
|
|
35.0
|
%
|
State income tax, net of federal effect
|
|
1,269
|
|
|
1.1
|
%
|
|
927
|
|
|
4.1
|
%
|
|
(403
|
)
|
|
(0.8
|
)%
|
|||
Tax credits
|
|
(2,896
|
)
|
|
(2.5
|
)%
|
|
(4,961
|
)
|
|
(22.2
|
)%
|
|
(2,783
|
)
|
|
(5.4
|
)%
|
|||
Global intangible low-taxed income
|
|
6,118
|
|
|
5.3
|
%
|
|
2,363
|
|
|
10.6
|
%
|
|
—
|
|
|
—
|
%
|
|||
Foreign income tax differential
|
|
(5,939
|
)
|
|
(5.2
|
)%
|
|
(2,944
|
)
|
|
(13.2
|
)%
|
|
3,481
|
|
|
6.8
|
%
|
|||
Stock based compensation
|
|
(8,446
|
)
|
|
(7.4
|
)%
|
|
(11,040
|
)
|
|
(49.3
|
)%
|
|
(18,958
|
)
|
|
(37.0
|
)%
|
|||
Impact of the Tax Act
|
|
—
|
|
|
—
|
%
|
|
826
|
|
|
3.7
|
%
|
|
3,076
|
|
|
6.0
|
%
|
|||
IP installment sale and repatriation
|
|
(2,118
|
)
|
|
(1.8
|
)%
|
|
3,252
|
|
|
14.5
|
%
|
|
3,367
|
|
|
6.6
|
%
|
|||
Bargain purchase gain
|
|
—
|
|
|
—
|
%
|
|
—
|
|
|
—
|
%
|
|
(24,811
|
)
|
|
(48.4
|
)%
|
|||
Section 162(m)
|
|
203
|
|
|
0.2
|
%
|
|
456
|
|
|
2.0
|
%
|
|
595
|
|
|
1.2
|
%
|
|||
Other
|
|
1,393
|
|
|
1.2
|
%
|
|
3
|
|
|
0.1
|
%
|
|
1,125
|
|
|
2.2
|
%
|
|||
|
|
$
|
13,672
|
|
|
11.9
|
%
|
|
$
|
(6,419
|
)
|
|
(28.7
|
)%
|
|
$
|
(17,361
|
)
|
|
(33.8
|
)%
|
|
||||||||
|
|
December 31,
|
||||||
|
|
2019
|
|
2018
|
||||
Deferred tax asset:
|
|
|
|
|
|
|
||
Accruals/other
|
|
2,632
|
|
|
11,109
|
|
||
Contingent consideration
|
|
—
|
|
|
12,451
|
|
||
Net operating loss carryforwards
|
|
—
|
|
|
12,686
|
|
||
Acquired future tax deductions
|
|
8,711
|
|
|
10,722
|
|
||
Stock-based compensation
|
|
9,654
|
|
|
10,775
|
|
||
Foreign currency translation adjustments
|
|
2,716
|
|
|
3,108
|
|
||
Tax credits
|
|
11,331
|
|
|
14,470
|
|
||
Inventory reserves
|
|
4,305
|
|
|
5,674
|
|
||
Allowance for doubtful accounts
|
|
4,242
|
|
|
830
|
|
||
Accrued restructuring
|
|
7,072
|
|
|
182
|
|
||
Chargebacks, discounts, customer concessions
|
|
20,975
|
|
|
—
|
|
||
Valuation allowance
|
|
(3,677
|
)
|
|
(5,436
|
)
|
||
|
|
$
|
67,961
|
|
|
$
|
76,571
|
|
Deferred tax liability:
|
|
|
|
|
|
|
||
State income taxes
|
|
$
|
2,600
|
|
|
$
|
2,639
|
|
Foreign
|
|
997
|
|
|
612
|
|
||
Depreciation and amortization
|
|
23,839
|
|
|
35,387
|
|
||
Section 481(a) adjustment - change in accounting method
|
|
14,618
|
|
|
—
|
|
||
|
|
$
|
42,054
|
|
|
$
|
38,638
|
|
|
|
|
|
|
||||
Deferred tax asset, net
|
|
$
|
25,907
|
|
|
$
|
37,933
|
|
|
|
Year Ended December 31,
|
||||||||||
|
|
2019
|
|
2018
|
|
2017
|
||||||
Beginning balance
|
|
$
|
10,824
|
|
|
$
|
6,527
|
|
|
$
|
2,000
|
|
Increases to prior year tax positions
|
|
138
|
|
|
—
|
|
|
77
|
|
|||
Increases due to acquisitions
|
|
—
|
|
|
—
|
|
|
640
|
|
|||
Increases to current year tax positions
|
|
4,231
|
|
|
4,536
|
|
|
3,992
|
|
|||
Decreases to prior year tax positions
|
|
(3
|
)
|
|
(146
|
)
|
|
(12
|
)
|
|||
Decrease related to lapse of statute of limitations
|
|
(163
|
)
|
|
(93
|
)
|
|
(170
|
)
|
|||
Ending balance
|
|
$
|
15,027
|
|
|
$
|
10,824
|
|
|
$
|
6,527
|
|
|
|
As of December 31,
|
||||||
|
|
2019
|
|
2018
|
||||
Costa Rica
|
|
$
|
96,442
|
|
|
$
|
81,920
|
|
Mexico
|
|
69,141
|
|
|
64,242
|
|
||
Other LATAM
|
|
31,905
|
|
|
22,828
|
|
||
Canada
|
|
4,769
|
|
|
4,545
|
|
||
Italy
|
|
7,921
|
|
|
7,819
|
|
||
Spain
|
|
6,411
|
|
|
6,516
|
|
||
Other Europe
|
|
3,135
|
|
|
2,427
|
|
||
APAC
|
|
17,200
|
|
|
15,152
|
|
||
Total Foreign
|
|
$
|
236,924
|
|
|
$
|
205,449
|
|
United States
|
|
539,316
|
|
|
489,415
|
|
||
Worldwide Total
|
|
$
|
776,240
|
|
|
$
|
694,864
|
|
|
|
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
|
)
|
Other comprehensive income (loss) before reclassifications
|
|
372
|
|
|
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
|
)
|
|
|
Quarter Ended
|
||||||||||||||
|
|
Mar. 31
|
|
Jun. 30
|
|
Sept. 30
|
|
Dec. 31
|
||||||||
|
|
(in thousands except per share data)
|
||||||||||||||
2019
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total revenue
|
|
$
|
330,932
|
|
|
$
|
312,282
|
|
|
$
|
307,471
|
|
|
$
|
315,523
|
|
Gross profit
|
|
$
|
135,303
|
|
|
$
|
103,869
|
|
|
$
|
118,552
|
|
|
$
|
114,140
|
|
Net income
|
|
$
|
30,998
|
|
|
$
|
22,833
|
|
|
$
|
26,563
|
|
|
$
|
20,641
|
|
Net income per share:
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Basic
|
|
$
|
1.51
|
|
|
$
|
1.11
|
|
|
$
|
1.29
|
|
|
$
|
1.00
|
|
Diluted
|
|
$
|
1.44
|
|
|
$
|
1.06
|
|
|
$
|
1.24
|
|
|
$
|
0.96
|
|
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
|
)
|
|
|
|
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 Number
|
|
Exhibit Description
|
|
Amended and Restated Stock and Asset Purchase Agreement, dated as of January 5, 2017, by and between Pfizer Inc., a Delaware corporation, and ICU Medical, Inc., a Delaware corporation. Filed as Exhibit 2.1 to Registrant’s Current Report on Form 8-K filed January 5, 2017, 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.
|
|
|
|
|
|
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.
|
|
|
|
|
10.2
|
|
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.
|
|
|
|
10.3
|
|
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.
|
|
|
|
10.4
|
|
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*
|
|
|
|
|
|
Non-employee director compensation*
|
|
|
|
|
10.7
|
|
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.
|
|
|
|
10.8
|
|
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.
|
|
|
|
10.9
|
|
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.
|
|
|
|
10.10
|
|
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.
|
|
|
|
10.11
|
|
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.
|
|
|
|
|
First Amendment to ICU Medical, Inc. Amended and Restated 2011 Stock Incentive Plan.
|
|
|
|
|
10.13
|
|
2014 Inducement Stock Incentive Plan.* Filed as an Exhibit to Registrant's Current Report on Form 8-K filed February 26, 2014 (File No. 001-34634) and incorporated herein by reference.
|
|
|
|
10.14
|
|
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.
|
|
|
|
10.15
|
|
Buy-Out Agreement between Registrant and George A. Lopez, M.D. effective September 30, 2015.* Filed as an Exhibit to Registrant's Current Report on Form 8-K filed October 1, 2015, and incorporated herein by reference.
|
|
|
|
|
Letter agreement between the Registrant and Alison Burcar, effective April 1, 2019. Filed as an Exhibit to Registrant's Quarterly Report on Form 10-Q for the Quarter ended March 31, 2019, and incorporated herein by reference.
|
|
|
|
|
10.17
|
|
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.
|
|
|
|
|
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.
|
|
|
|
|
10.19
|
|
Revolving Credit Agreement, dated as of November 8, 2017, among ICU Medical, Inc., as borrower, certain lenders party thereto and Wells Fargo Bank, N.A., as administrative agent and swingline lender. 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.
|
|
|
|
|
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.INS
|
|
The instance document does not appear in the interactive data file because its XBRL (Extensible Business Reporting Language) tags are embedded within the Inline XBRL document.
|
Exhibit 101.SCH
|
|
XBRL Taxonomy Extension Schema Document
|
Exhibit 101.CAL
|
|
XBRL Taxonomy Extension Calculation Linkbase Document
|
Exhibit 101.LAB
|
|
XBRL Taxonomy Extension Label Linkbase Document
|
Exhibit 101.PRE
|
|
XBRL Taxonomy Extension Presentation Linkbase Document
|
Exhibit 101.DEF
|
|
XBRL Taxonomy Extension Definition Linkbase Document
|
Exhibit 104
|
|
Cover Page Interactive Data File (embedded within the Inline XBRL document).
|
|
|
|
|
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, 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
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||
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
|
|
|
ICU MEDICAL, INC.
|
|
|
|
|
|
By:
|
/s/ Vivek Jain
|
|
|
Vivek Jain
|
|
|
Chairman of the Board and Chief Executive Officer
|
|
|
|
|
Dated:
|
March 2, 2020
|
Signature
|
|
Title
|
|
Date
|
|
|
|
|
|
/s/ Vivek Jain
|
|
Chairman of the Board and
|
|
March 2, 2020
|
Vivek Jain
|
|
Chief Executive Officer
|
|
|
|
|
(Principal Executive Officer)
|
|
|
|
|
|
|
|
/s/ Scott E. Lamb
|
|
Chief Financial Officer
|
|
March 2, 2020
|
Scott E. Lamb
|
|
(Principal Financial Officer)
|
|
|
|
|
|
|
|
/s/ Kevin J. McGrody
|
|
Chief Accounting Officer
|
|
March 2, 2020
|
Kevin J. McGrody
|
|
(Principal Accounting Officer)
|
|
|
|
|
|
|
|
/s/ George A. Lopez, M.D.
|
|
Director
|
|
March 2, 2020
|
George A. Lopez, M.D.
|
|
|
|
|
|
|
|
|
|
/s/ Robert S. Swinney, M.D.
|
|
Director
|
|
March 2, 2020
|
Robert S. Swinney, M.D.
|
|
|
|
|
|
|
|
|
|
/s/ David C. Greenberg
|
|
Director
|
|
March 2, 2020
|
David C. Greenberg
|
|
|
|
|
|
|
|
|
|
/s/ Elisha W. Finney
|
|
Director
|
|
March 2, 2020
|
Elisha W. Finney
|
|
|
|
|
|
|
|
|
|
/s/ David F. Hoffmeister
|
|
Director
|
|
March 2, 2020
|
David F. Hoffmeister
|
|
|
|
|
|
|
|
|
|
/s/ Donald M. Abbey
|
|
Director
|
|
March 2, 2020
|
Donald M. Abbey
|
|
|
|
|
•
|
our Bylaws establish an advance notice procedure for stockholders to submit proposed nominations of persons for election to our Board of Directors and other proposals for business to be brought before an annual meeting of our stockholders;
|
•
|
our stockholders may not act by written consent and special meetings of our stockholders may only be called by our Board of Directors, the Chairman of the Board of Directors, or the President of the Company; and
|
•
|
amendments to our Bylaws may be made by a majority of our Board of Directors and also by the affirmative vote of two-thirds of our shares outstanding and entitled to vote thereon.
|
Name
|
|
Title
|
|
|
|
||
Vivek Jain
|
|
Chairman of the Board and Chief Executive Officer
|
|
$
|
650,000
|
|
|
Christian Voigtlander
|
|
Chief Operating Officer
|
|
$
|
420,000
|
|
|
Scott E. Lamb
|
|
Chief Financial Officer
|
|
$
|
395,150
|
|
|
Daniel Woolson
|
|
Corporate Vice President, General Manager - Infusion Systems
|
|
$
|
300,000
|
|
|
Virginia Sanzone
|
|
Corporate Vice President, General Counsel
|
|
$
|
300,000
|
|
|
1.
|
The last sentence of Section 7(c) of the Plan is hereby amended and restated in its entirety as follows:
|
2.
|
This First Amendment shall be and is hereby incorporated in and forms a part of the Plan.
|
3.
|
Except as expressly provided herein, all terms and provisions of the Plan shall remain in full force and effect.
|
Name
|
|
State or Country of Incorporation
|
ICU Medical Sales, Inc.
|
|
Delaware
|
ICU Medical de Mexico, S. de R. L. de C.V.
|
|
Mexico
|
ICU Medical Europe S.r.l.
|
|
Italy
|
ICU World, Inc.
|
|
Delaware
|
ICU Medical Germany GmbH
|
|
Germany
|
ICU Medical Slovakia S.r.o.
|
|
Slovak Republic
|
ICU Medical B.V.
|
|
Netherlands
|
ICU Medical Australia Holdings Pty Limited
|
|
Australia
|
ICU Medical SA Pty Ltd
|
|
South Africa
|
EXC Holding Corp.
|
|
Delaware
|
Pursuit Vascular, Inc.
|
|
Minnesota
|
Tangent Medical Technologies, Inc.
|
|
Delaware
|
Excelsior Medical Corporation
|
|
Delaware
|
ICU Medical France S.A.S.
|
|
France
|
ICU Medical Canada Inc.
|
|
Canada
|
ICU Medical Latam LLC
|
|
Delaware
|
ICU UK Medical Limited
|
|
United Kingdom
|
ICU Medical Ireland Limited
|
|
Ireland
|
ICU Medical Argentina S.R.L.
|
|
Argentina
|
ICU Medical Costa Rica, Ltd
|
|
Bahamas
|
ICU Medical Bahamas, Ltd
|
|
Bahamas
|
ICU Medical Chile Limitada
|
|
Chile
|
Hospira Chile Limitada
|
|
Chile
|
ICU Medical Colombia Limitada
|
|
Colombia
|
ICU Medical HIS Mexico S. de R.L. de C.V.
|
|
Mexico
|
ICU Medical Peru S.R.L.
|
|
Peru
|
ICU Medical Australia Pty Limited
|
|
Australia
|
Medical Australia Pty Limited
|
|
Australia
|
Medivet Pty Ltd
|
|
Australia
|
ICU Medical Hong Kong Limited
|
|
Hong Kong
|
ICU Medical India LLP
|
|
India
|
ICU Medical Philippines, Inc.
|
|
Philippines
|
ICU Medical Unlimited Company
|
|
Ireland
|
ICU Medical Italia S.r.l.
|
|
Italy
|
ICU Medical Productos Farmacéuticos y Hospitalarios, S.L.
|
|
Spain
|
BMDI Tuta Healthcare UK Ltd
|
|
United Kingdom
|
ICU Medical Aust MLA Pty Limited
|
|
Australia
|
/s/ Deloitte & Touche LLP
|
|
|
|
Costa Mesa, California
|
|
March 2, 2020
|
|
1.
|
I have reviewed this annual report on Form 10-K of ICU Medical, Inc.;
|
2.
|
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
|
3.
|
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
|
4.
|
The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
|
a)
|
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
|
b)
|
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, 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;
|
c)
|
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
|
d)
|
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
|
5.
|
The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
|
a)
|
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
|
b)
|
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
|
Date:
|
March 2, 2020
|
/s/ Vivek Jain
|
|
|
Chief Executive Officer
|
1.
|
I have reviewed this annual report on Form 10-K of ICU Medical, Inc.;
|
2.
|
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
|
3.
|
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
|
4.
|
The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
|
a)
|
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
|
b)
|
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, 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;
|
c)
|
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
|
d)
|
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
|
5.
|
The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
|
a)
|
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
|
b)
|
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
|
Date:
|
March 2, 2020
|
/s/ Scott E. Lamb
|
|
|
Chief Financial Officer
|
(1)
|
The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
|
(2)
|
The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
|
March 2, 2020
|
/s/ Vivek Jain
|
|
Vivek Jain
|
(1)
|
The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
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(2)
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The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
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March 2, 2020
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/s/ Scott E. Lamb
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Scott E. Lamb
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