UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

☒QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

~~FOR THE QUARTERLY PERIOD ENDED SEPTEMBER~~

For the quarterly period ended September 30, ~~2017.~~

2021

☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

~~FOR THE TRANSITION PERIOD FROM TO~~

For the transition period from to .

Commission File Number 0-18592

MERIT MEDICAL SYSTEMS, ~~INC.~~

INC.

(Exact name of ~~Registrant~~registrant as specified in its charter)

Utah		87-0447695

~~Utah~~		~~87-0447695~~
(State or other jurisdiction of incorporation or organization)		(~~I.R.S.~~IRS Employer Identification No.)

1600 West Merit Parkway, South Jordan UT , Utah84095

(Address of ~~Principal Executive Offices,~~principal executive offices, including ~~Zip Code)~~

~~(801) 253-1600~~

(zip code)

Registrant’s telephone number, including area ~~code)~~

code: (801) 253-1600

Securities registered pursuant to Section 12(b) of the Act:


Title of each class	Trading Symbol	Name of exchange on which registered
Common Stock, no par	MMSI	NASDAQ Global Select Market

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

☐

Indicate by check mark whether the ~~Registrant~~registrant has submitted electronically ~~and posted on its corporate web site, if any,~~ every Interactive Data File required to be submitted ~~and posted~~ pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the ~~Registrant~~registrant was required to submit ~~and post~~ such files). Yes ý☒ No o

☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See the ~~definition~~definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and "emerging growth company" in Rule 12b-2 of the Exchange Act.



Large Accelerated Filer x ☒	Accelerated Filer o ☐	Non-Accelerated Filer o ☐	Smaller Reporting Company o ☐	Emerging Growth Company o
		~~(Do not check if a smaller reporting company)~~		☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. o

☐

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

☒

Indicate the number of shares outstanding of each of the Registrant’s classes of common stock, as of the latest practicable date.



~~Common Stock~~	~~50,198,833~~
Title or class	~~Number~~	Shares outstanding as of ~~Shares~~ ~~Outstanding at October 31, 2017~~

November 4, 2021


Common Stock, no par
	56,458,464

Table of Contents

TABLE OF CONTENTS

PART I.			FINANCIAL INFORMATION	3

~~PART I.~~			~~FINANCIAL INFORMATION~~

		Item 1.			Financial Statements (Unaudited)	3

			Consolidated Balance Sheets as of September 30, ~~2017~~2021 and December 31, ~~2016~~2020	3

			Consolidated Statements of Income (Loss) for the three and nine months ended September 30, ~~2017~~2021 and ~~2016~~2020	5

			Consolidated Statements of Comprehensive Income (Loss) for the three and nine months ended September 30, ~~2017~~2021 and ~~2016~~2020	6

			Consolidated Statements of Stockholders’ Equity for the three and nine months ended September 30, 2021 and 2020	7

			Consolidated Statements of Cash Flows for the nine months ended September 30, ~~2017~~2021 and ~~2016~~2020	7 9

			Condensed Notes to Consolidated Financial Statements	9 11

		Item 2.			~~Management's~~Management’s Discussion and Analysis of Financial Condition and Results of Operations	28 30

		Item 3.			Quantitative and Qualitative Disclosures About Market Risk	39

		Item 4.			Controls and Procedures	41 39

PART II.			OTHER INFORMATION	39

		Item 1.			Legal Proceedings	42 39

		Item 1A.			Risk Factors	42 39

		Item 6.	~~Exhibits~~		42Exhibits	40

SIGNATURES	43			41

Table of Contents

PART I - FINANCIAL INFORMATION

ITEM 1. FINANCIAL STATEMENTS

MERIT MEDICAL SYSTEMS, INC. AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
AS OF SEPTEMBER 30, 2017 AND DECEMBER 31, 2016
(In thousands)

September 30, 2017 December 31, 2016
ASSETS (unaudited)

CURRENT ASSETS:
Cash and cash equivalents $ 23,362
$ 19,171
Trade receivables — net of allowance for uncollectible accounts — 2017 — $1,547 and 2016 — $1,587 101,394
80,521
Employee receivables 147
198
Other receivables 5,900
5,445
Inventories 145,598
120,695
Prepaid expenses and other assets 20,581
6,226
Prepaid income taxes 2,792
2,525
Deferred income tax assets —
8,219
Income tax refund receivables 91
423

Total current assets 299,865
243,423

PROPERTY AND EQUIPMENT:
Land and land improvements 19,804
19,379
Buildings 144,084
139,119
Manufacturing equipment 193,061
178,110
Furniture and fixtures 49,035
43,433
Leasehold improvements 31,345
30,413
Construction-in-progress 34,625
28,180

Total property and equipment 471,954
438,634

Less accumulated depreciation (181,672 ) (162,061 )

Property and equipment — net 290,282
276,573

OTHER ASSETS:
Intangible assets:
Developed technology — net of accumulated amortization — 2017 — $67,320 and 2016 — $52,843 172,796
135,358
Other — net of accumulated amortization — 2017 — $34,985 and 2016 — $30,048 55,707
47,339
Goodwill 234,043
211,927
Deferred income tax assets 2,046
171
Other assets 32,412
28,012

Total other assets 497,004
422,807

TOTAL $ 1,087,151
$ 942,803

See condensed notes to consolidated financial statements. (continued)

MERIT MEDICAL SYSTEMS, INC. AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
AS OF SEPTEMBER 30, 2017 AND DECEMBER 31, 2016
(In thousands)

September 30, 2017 December 31, 2016
LIABILITIES AND STOCKHOLDERS’ EQUITY (unaudited)

CURRENT LIABILITIES:
Trade payables $ 32,291
$ 30,619
Accrued expenses 56,508
44,947
Current portion of long-term debt 16,962
10,000
Advances from employees 542
572
Income taxes payable 1,435
2,193

Total current liabilities 107,738
88,331

LONG-TERM DEBT 260,978
314,373

DEFERRED INCOME TAX LIABILITIES 23,764
25,981

LIABILITIES RELATED TO UNRECOGNIZED TAX BENEFITS 438
438

DEFERRED COMPENSATION PAYABLE 10,319
9,211

DEFERRED CREDITS 2,439
2,550

OTHER LONG-TERM OBLIGATIONS 14,659
3,730

Total liabilities 420,335
444,614

COMMITMENTS AND CONTINGENCIES (Notes 5, 9, 10 and 13)

STOCKHOLDERS’ EQUITY:
Preferred stock — 5,000 shares authorized as of September 30, 2017 and December 31, 2016; no shares issued

Common stock, no par value; shares authorized — 100,000; issued and outstanding as of September 30, 2017 - 50,194 and December 31, 2016 - 44,645 351,321
206,186
Retained earnings 314,602
293,885
Accumulated other comprehensive income (loss) 893
(1,882 )

Total stockholders’ equity 666,816
498,189

TOTAL $ 1,087,151
$ 942,803

See condensed notes to consolidated financial statements. (concluded)

MERIT MEDICAL SYSTEMS, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF INCOME
FOR THE THREE AND NINE MONTHS ENDED SEPTEMBER 30, 2017 AND 2016
(In thousands, except per share amounts - unaudited)

Three Months Ended September 30, Nine Months Ended September 30,
2017 2016 2017 2016
NET SALES $ 179,337
$ 156,975
$ 536,955
$ 446,123

COST OF SALES 98,823
89,160
296,358
251,354

GROSS PROFIT 80,514
67,815
240,597
194,769

OPERATING EXPENSES:
Selling, general and administrative 54,716
53,198
169,896
138,556
Research and development 12,838
11,424
38,676
33,440
Contingent consideration (benefit) expense 20
(94 ) 39
99
Acquired in-process research and development 12,061
300
12,136
400

Total operating expenses 79,635
64,828
220,747
172,495

INCOME FROM OPERATIONS 879
2,987
19,850
22,274

OTHER INCOME (EXPENSE):
Interest income 94
29
266
55
Interest expense (1,590 ) (3,022 ) (5,935 ) (6,120 )
Gain on bargain purchase (778 ) —
10,796
—
Other income (expense) — net (810 ) 1
(376 ) (445 )

Other income (expense) — net (3,084 ) (2,992 ) 4,751
(6,510 )

INCOME (LOSS) BEFORE INCOME TAXES (2,205 ) (5 ) 24,601
15,764

INCOME TAX EXPENSE (BENEFIT) 1,364
(978 ) 3,884
3,149

NET INCOME (LOSS) $ (3,569 ) $ 973
$ 20,717
$ 12,615

EARNINGS PER COMMON SHARE:
Basic $ (0.07 ) $ 0.02
$ 0.43
$ 0.28

Diluted $ (0.07 ) $ 0.02
$ 0.42
$ 0.28

AVERAGE COMMON SHARES:
Basic 50,150
44,447
48,332
44,346

Diluted 51,599
45,000
49,555
44,763

See condensed notes to consolidated financial statements.

MERIT MEDICAL SYSTEMS, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME
FOR THE THREE AND NINE MONTHS ENDED SEPTEMBER 30, 2017 AND 2016
(In thousands - unaudited)

Three Months Ended September 30, Nine Months Ended September 30,
2017 2016 2017 2016
Net income (loss) $ (3,569 ) $ 973
$ 20,717
$ 12,615
Other comprehensive income (loss):
Cash flow hedges (144 ) (103 ) 166
(984 )
Less income tax benefit (expense) 56
40
(64 ) 383
Foreign currency translation adjustment 721
454
2,925
1,259
Less income tax benefit (expense) —
—
(252 ) (210 )
Total other comprehensive income 633
391
2,775
448
Total comprehensive income (loss) (2,936 ) 1,364
23,492
13,063

See condensed notes to consolidated financial statements.

MERIT MEDICAL SYSTEMS, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS
FOR THE NINE MONTHS ENDED SEPTEMBER 30, 2017 AND 2016
(In thousands - unaudited)

Nine Months Ended September 30,
2017 2016
CASH FLOWS FROM OPERATING ACTIVITIES:
Net income $ 20,717
$ 12,615

Adjustments to reconcile net income to net cash provided by operating activities:
Depreciation and amortization 39,388
31,594
Gain on bargain purchase (10,796 ) —
Losses on sales and/or abandonment of property and equipment 219
102
Write-off of patents and intangible assets 86
90
Acquired in-process research and development 12,136
400
Fair value changes in contingent liabilities/assets —
99
Amortization of deferred credits (111 ) (128 )
Amortization of long-term debt issuance costs 514
779
Deferred income taxes (290 ) 187
Excess tax benefits from stock-based compensation —
(527 )
Stock-based compensation expense 2,883
1,913
Changes in operating assets and liabilities, net of effects from acquisitions:
Trade receivables (10,963 ) (5,166 )
Employee receivables 54
42
Other receivables (503 ) 3,385
Inventories (9,922 ) 220
Prepaid expenses and other assets (1,587 ) (452 )
Prepaid income taxes (231 ) (63 )
Income tax refund receivables 280
514
Other assets (2,992 ) (1,591 )
Trade payables (876 ) (9,018 )
Accrued expenses 4,514
1,693
Advances from employees (44 ) (50 )
Income taxes payable (764 ) (183 )
Liabilities related to unrecognized tax benefits —
(366 )
Deferred compensation payable 1,107
500
Other long-term obligations 574
(251 )

Total adjustments 22,676
23,723

Net cash provided by operating activities 43,393
36,338

CASH FLOWS FROM INVESTING ACTIVITIES:
Capital expenditures for:
Property and equipment (29,522 ) (26,492 )
Intangible assets (1,927 ) (1,594 )
Proceeds from sale of cost method investment —
1,089
Proceeds from the sale of property and equipment 9
5
Cash paid in acquisitions, net of cash acquired (103,500 ) (119,808 )

Net cash used in investing activities (134,940 ) (146,800 )

See condensed notes to consolidated financial statements. (continued)

MERIT MEDICAL SYSTEMS, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS
FOR THE NINE MONTHS ENDED SEPTEMBER 30, 2017 AND 2016
(In thousands - unaudited)

Nine Months Ended September 30,
2017 2016
CASH FLOWS FROM FINANCING ACTIVITIES:
Proceeds from issuance of common stock $ 143,069
$ 4,422
Payment of offering costs related to issuance of common stock (816 ) —
Proceeds from issuance of long-term debt 151,462
203,478
Payments on long-term debt (197,962 ) (82,658 )
Excess tax benefits from stock-based compensation —
527
Long-term debt issuance costs —
(1,948 )
Contingent payments related to acquisitions (45 ) (199 )
Payment of taxes related to an exchange of common stock —
(86 )

Net cash provided by financing activities 95,708
123,536

EFFECT OF EXCHANGE RATES ON CASH 30
67

NET INCREASE IN CASH AND CASH EQUIVALENTS 4,191
13,141

CASH AND CASH EQUIVALENTS:
Beginning of period 19,171
4,177

End of period $ 23,362
$ 17,318

SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION
Cash paid during the period for:
Interest (net of capitalized interest of $371 and $337, respectively) $ 5,953
$ 6,223

Income taxes $ 4,029
$ 2,237

SUPPLEMENTAL DISCLOSURES OF NON-CASH INVESTING AND FINANCING ACTIVITIES
Property and equipment purchases in accounts payable $ 1,394
$ 2,709

Acquisition purchases in accrued expenses and other long-term obligations $ 12,000
$ 293

Contingent receivable in exchange for sale of cost method investment $ —
$ 711

Merit common stock surrendered (0 and 14 shares, respectively) in exchange for exercise of stock options $ —
$ 346

See condensed notes to consolidated financial statements. (concluded)

MERIT MEDICAL SYSTEMS, INC. AND SUBSIDIARIES

CONSOLIDATED BALANCE SHEETS

(In thousands)


	September 30,		December 31,
ASSETS	2021		2020
		(unaudited)
Current assets:
Cash and cash equivalents	$	68,904	$	56,916
Trade receivables — net of allowance for credit losses — 2021 — $6,444 and 2020 — $5,313		150,780		146,641
Other receivables		10,659		7,774
Inventories		208,081		198,019
Prepaid expenses and other current assets		18,778		13,120
Prepaid income taxes		3,679		3,688
Income tax refund receivables		2,561		3,549
Total current assets		463,442		429,707

Property and equipment:
Land and land improvements		25,394		28,400
Buildings		190,335		188,878
Manufacturing equipment		275,155		268,894
Furniture and fixtures		62,445		61,586
Leasehold improvements		45,750		48,800
Construction-in-progress		51,756		46,889
Total property and equipment		650,835		643,447
Less accumulated depreciation		(277,379)		(260,719)
Property and equipment — net		373,456		382,728

Other assets:
Intangible assets:
Developed technology — net of accumulated amortization —2021 — $223,814 and 2020 — $193,164		287,117		318,059
Other — net of accumulated amortization — 2021 — $63,030 and 2020 — $56,943		43,820		49,856
Goodwill		362,000		363,533
Deferred income tax assets		4,581		4,597
Right-of-use operating lease assets		68,078		78,240
Other assets		40,672		37,676
Total other assets		806,268		851,961

Total assets	$	1,643,166	$	1,664,396


See condensed notes to consolidated financial statements.	(continued)

Table of Contents

MERIT MEDICAL SYSTEMS, INC. AND SUBSIDIARIES

CONSOLIDATED BALANCE SHEETS

(In thousands)


	September 30,		December 31,
LIABILITIES AND STOCKHOLDERS’ EQUITY	2021		2020
		(unaudited)
Current liabilities:
Trade payables	$	51,077	$	49,837
Accrued expenses		141,929		111,944
Current portion of long-term debt		7,500		7,500
Short-term operating lease liabilities		11,119		12,903
Income taxes payable		1,850		2,820
Total current liabilities		213,475		185,004

Long-term debt		271,181		343,722
Deferred income tax liabilities		33,238		33,312
Long-term income taxes payable		347		347
Liabilities related to unrecognized tax benefits		1,016		1,016
Deferred compensation payable		17,414		16,808
Deferred credits		1,842		1,923
Long-term operating lease liabilities		63,505		70,941
Other long-term obligations		27,772		52,748
Total liabilities		629,790		705,821

Commitments and contingencies

Stockholders' equity:
Preferred stock — 5,000 shares authorized as of September 30, 2021 and December 31, 2020; 0 shares issued		0		0
Common stock, 0 par value; shares authorized — 2021 and 2020 - 100,000; issued and outstanding as of September 30, 2021 - 56,452 and December 31, 2020 - 55,623		633,948		606,224
Retained earnings		385,644		357,803
Accumulated other comprehensive loss		(6,216)		(5,452)
Total stockholders’ equity		1,013,376		958,575

Total liabilities and stockholders’ equity	$	1,643,166	$	1,664,396


See condensed notes to consolidated financial statements.	(concluded)

Table of Contents

MERIT MEDICAL SYSTEMS, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF INCOME (LOSS)

(In thousands, except per share amounts - unaudited)


	Three Months Ended				Nine Months Ended
	September 30,				September 30,
	2021		2020		2021		2020
Net sales	$	267,021	$	243,975	$	796,259	$	705,871
Cost of sales		146,527		141,961		439,732		415,857
Gross profit		120,494		102,014		356,527		290,014

Operating expenses:
Selling, general and administrative		86,474		72,215		259,061		217,790
Research and development		16,974		13,506		50,841		42,404
Legal settlement		—		—		—		18,200
Impairment charges		0		20,585		4,283		28,305
Contingent consideration expense (benefit)		1,115		(4,356)		3,322		884
Total operating expenses		104,563		101,950		317,507		307,583

Income (loss) from operations		15,931		64		39,020		(17,569)

Other income (expense):
Interest income		104		67		668		234
Interest expense		(1,233)		(2,197)		(4,156)		(8,056)
Other expense — net		(625)		(118)		(1,796)		(1,085)
Total other expense — net		(1,754)		(2,248)		(5,284)		(8,907)

Income (loss) before income taxes		14,177		(2,184)		33,736		(26,476)

Income tax expense (benefit)		2,210		825		5,895		(1,255)

Net income (loss)	$	11,967	$	(3,009)	$	27,841	$	(25,221)

Earnings (loss) per common share
Basic	$	0.21	$	(0.05)	$	0.50	$	(0.46)
Diluted	$	0.21	$	(0.05)	$	0.49	$	(0.46)

Weighted average shares outstanding
Basic		56,302		55,505		56,033		55,386
Diluted		57,549		55,505		57,274		55,386

See condensed notes to consolidated financial statements.

Table of Contents

MERIT MEDICAL SYSTEMS, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS)

(In thousands - unaudited)


	Three Months Ended				Nine Months Ended
	September 30,				September 30,
	2021		2020		2021		2020
Net income (loss)	$	11,967	$	(3,009)	$	27,841	$	(25,221)
Other comprehensive income (loss):
Cash flow hedges		1,522		(592)		5,442		(7,875)
Income tax benefit (expense)		(377)		152		(1,349)		2,027
Foreign currency translation adjustment		(2,873)		3,545		(5,535)		1,944
Income tax benefit (expense)		346		(117)		678		(127)
Total other comprehensive income (loss)		(1,382)		2,988		(764)		(4,031)
Total comprehensive income (loss)	$	10,585	$	(21)	$	27,077	$	(29,252)

See condensed notes to consolidated financial statements.

Table of Contents

MERIT MEDICAL SYSTEMS, INC.

CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY

(In thousands - unaudited)


	Common Stock			Retained		Accumulated Other
	Shares	Amount		Earnings		Comprehensive Income (Loss)		Total
Balance — January 1, 2021	55,623	$	606,224	$	357,803	$	(5,452)	$	958,575
Net income					10,958				10,958
Other comprehensive loss							(1,730)		(1,730)
Stock-based compensation expense			3,310						3,310
Options exercised	291		5,897						5,897
Issuance of common stock under Employee Stock Purchase Plan	5		263						263
Shares issued from time-vested restricted stock units	25		—						—
Shares surrendered in exchange for payment of payroll tax liabilities	(9)		(488)						(488)
Shares surrendered in exchange for exercise of stock options	(2)		(93)						(93)
Balance — March 31, 2021	55,933		615,113		368,761		(7,182)		976,692
Net income					4,916				4,916
Other comprehensive income							2,348		2,348
Stock-based compensation expense			2,765						2,765
Options exercised	253		5,455						5,455
Issuance of common stock under Employee Stock Purchase Plan	4		258						258
Shares issued from time-vested restricted stock units	34		—						—
Balance — June 30, 2021	56,224		623,591		373,677		(4,834)		992,434
Net income					11,967				11,967
Other comprehensive loss							(1,382)		(1,382)
Stock-based compensation expense			4,411						4,411
Options exercised	225		5,806						5,806
Issuance of common stock under Employee Stock Purchase Plan	5		314						314
Shares surrendered in exchange for payment of payroll tax liabilities	(1)		(88)						(88)
Shares surrendered in exchange for exercise of stock options	(1)		(86)						(86)
Balance — September 30, 2021	56,452	$	633,948	$	385,644	$	(6,216)	$	1,013,376


See condensed notes to consolidated financial statements.	(continued)

Table of Contents

MERIT MEDICAL SYSTEMS, INC.

CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY

(In thousands - unaudited)


	Common Stock			Retained		Accumulated Other
	Shares	Amount		Earnings		Comprehensive Income (Loss)		Total
Balance — January 1, 2020	55,213	$	587,017	$	368,221	$	(5,294)	$	949,944
Net loss					(3,154)				(3,154)
Cumulative effect adjustment upon adoption of ASU 2016-13, Credit Losses					(575)				(575)
Other comprehensive loss							(9,465)		(9,465)
Stock-based compensation expense			2,641						2,641
Options exercised	174		2,369						2,369
Issuance of common stock under Employee Stock Purchase Plan	13		371						371
Shares surrendered in exchange for payment of payroll tax liabilities	(23)		(866)						(866)
Shares surrendered in exchange for exercise of stock options	(39)		(1,467)						(1,467)
Balance — March 31, 2020	55,338		590,065		364,492		(14,759)		939,798
Net loss					(19,058)				(19,058)
Other comprehensive income							2,446		2,446
Stock-based compensation expense			3,197						3,197
Options exercised	138		2,229						2,229
Issuance of common stock under Employee Stock Purchase Plan	5		235						235
Balance — June 30, 2020	55,481		595,726		345,434		(12,313)		928,847
Net loss					(3,009)				(3,009)
Other comprehensive income							2,988		2,988
Stock-based compensation expense			3,794						3,794
Options exercised	50		950						950
Issuance of common stock under Employee Stock Purchase Plan	7		267						267
Balance — September 30, 2020	55,538	$	600,737	$	342,425	$	(9,325)	$	933,837


See condensed notes to consolidated financial statements.	(concluded)

Table of Contents

MERIT MEDICAL SYSTEMS, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF CASH FLOWS

(In thousands - unaudited)


	Nine Months Ended
	September 30,
	2021		2020
CASH FLOWS FROM OPERATING ACTIVITIES:
Net income (loss)	$	27,841	$	(25,221)
Adjustments to reconcile net income (loss) to net cash provided by operating activities:
Depreciation and amortization		63,173		70,458
Gain on sale of business		—		(508)
Loss on sales and/or abandonment of property and equipment		630		1,303
Write-off of certain intangible assets and other long-term assets		4,412		28,409
Amortization of right-of-use operating lease assets		8,941		9,522
Fair value adjustments to contingent consideration		3,322		884
Amortization of deferred credits		(81)		(103)
Amortization of long-term debt issuance costs		453		453
Stock-based compensation expense		11,589		10,268
Changes in operating assets and liabilities, net of acquisitions and divestitures:
Trade receivables		(6,180)		13,049
Other receivables		(3,173)		1,170
Inventories		(11,180)		15,668
Prepaid expenses and other current assets		(6,251)		(3,929)
Prepaid income taxes		—		(35)
Income tax refund receivables		960		(8,666)
Other assets		(3,638)		(1,088)
Trade payables		1,181		(2,682)
Accrued expenses		19,575		22,591
Income taxes payable		(1,600)		1,079
Deferred compensation payable		606		541
Operating lease liabilities		(9,365)		(9,398)
Other long-term obligations		201		4,590
Total adjustments		73,575		153,576
Net cash provided by operating activities		101,416		128,355

CASH FLOWS FROM INVESTING ACTIVITIES:
Capital expenditures for:
Property and equipment		(19,612)		(35,590)
Intangible assets		(2,121)		(2,499)
Proceeds from the sale of property and equipment		1,037		33
Proceeds from sale of business		—		1,285
Cash received for settlement of current note receivable		—		250
Cash paid in acquisitions, net of cash acquired		(1,858)		(260)
Net cash used in investing activities	$	(22,554)	$	(36,781)

See condensed notes to consolidated financial statements.

(continued)

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MERIT MEDICAL SYSTEMS, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF CASH FLOWS

(In thousands - unaudited)


	Nine Months Ended
	September 30,
	2021		2020
CASH FLOWS FROM FINANCING ACTIVITIES:
Proceeds from issuance of common stock	$	17,814	$	4,954
Proceeds from issuance of long-term debt		73,251		46,051
Payments on long-term debt		(145,876)		(128,306)
Contingent payments related to acquisitions		(10,579)		(12,991)
Payment of taxes related to an exchange of common stock		(576)		(866)
Net cash used in financing activities		(65,966)		(91,158)
Effect of exchange rates on cash		(908)		(185)
Net increase in cash and cash equivalents		11,988		231

CASH AND CASH EQUIVALENTS:
Beginning of period		56,916		44,320
End of period	$	68,904	$	44,551

SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION
Cash paid during the period for:
Interest (net of capitalized interest of $345 and $679, respectively)	$	4,155	$	8,138
Income taxes		6,166		6,449

SUPPLEMENTAL DISCLOSURES OF NON-CASH INVESTING AND FINANCING ACTIVITIES
Property and equipment purchases in accounts payable	$	2,842	$	2,726
Current note receivable converted to equity investment		—		899
Proceeds from sale of business in other receivables		—		321
Merit common stock surrendered (3 and 39 shares, respectively) in exchange for exercise of stock options		179		1,467
Right-of-use operating lease assets obtained in exchange for operating lease liabilities		827		7,285


See condensed notes to consolidated financial statements.	(concluded)

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MERIT MEDICAL SYSTEMS, INC. AND SUBSIDIARIES

CONDENSED NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

(Unaudited)

1.Basis of ~~Presentation.~~Presentation and Other Items. The interim consolidated financial statements of Merit Medical Systems, Inc. ("Merit," "we" or "us") for the three and nine-month periods ended September 30, ~~2017~~2021 and ~~2016~~2020 are not audited. Our consolidated financial statements are prepared in accordance with the requirements for unaudited interim periods and, consequently, do not include all disclosures required to be made in conformity with accounting principles generally accepted in the United States of America ("(“U.S. ~~GAAP"~~GAAP”). In the opinion of our management, the accompanying consolidated financial statements contain all adjustments, consisting of normal recurring accruals, necessary for a fair presentation of our financial position as of September 30, ~~2017~~2021 and December 31, ~~2016,~~2020, and our results of operations and cash flows for the three and nine-month periods ended September 30, ~~2017~~2021 and ~~2016.~~2020. The results of operations for the three and nine-month periods ended September 30, ~~2017~~2021 and ~~2016~~2020 are not necessarily indicative of the results for a full-year period. Percentages and earnings per share amounts presented are calculated from the underlying amounts. These interim consolidated financial statements should be read in conjunction with the financial statements and risk factors included in our Annual Report on Form 10-K ~~(the "2016 Form 10-K")~~ for the year ended December 31, ~~2016,~~2020 (the “2020 Annual Report on Form 10-K”).

2. Recently Issued Financial Accounting Standards. In March 2020, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2020-04, Reference Rate Reform (Topic 848): Facilitation of the Effects of Reference Rate Reform on Financial Reporting, which ~~was filed~~provides temporary optional expedients and exceptions in accounting for modifications of contracts that reference the London interbank offered rate (“LIBOR”) or another reference rate expected to be discontinued as a result of reference rate reform. In January 2021, the FASB issued ASU 2021-01, Reference Rate Reform (Topic 848): Scope, which amends the scope of ASU 2020-04. ASU 2020-04 and ASU 2021-01 were effective as of March 12, 2020, and the provisions of these updates may be applied prospectively to transactions through December 31, 2022, when reference rate reform activity is expected to be completed. As of September 30, 2021, we had not modified any contracts as a result of reference rate reform. We are currently assessing the anticipated impact of these standards on our consolidated financial statements.

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

3. Revenue from Contracts with Customers. We recognize revenue when a customer obtains control of promised goods. The amount of revenue recognized reflects the ~~Securities~~consideration we expect to receive in exchange for these goods. Our revenue recognition policies have not changed from those disclosed in Note 1 to our consolidated financial statements in Item 8 of the 2020 Annual Report on Form 10-K.

Disaggregation of Revenue

Our revenue is disaggregated based on reporting segment, product category and ~~Exchange Commission (the "SEC"~~geographical region. We design, develop, manufacture and market medical products for interventional and diagnostic procedures. For financial reporting purposes, we report our operations in 2 operating segments: cardiovascular and endoscopy. Our cardiovascular segment consists of 4 product categories: peripheral intervention, cardiac intervention, custom procedural solutions, and original equipment manufacturer (“OEM”) ~~on March 1, 2017.~~. Within these product categories, we sell a variety of products, including cardiology and radiology devices (which assist in diagnosing and treating coronary arterial disease, peripheral vascular disease and other non-vascular diseases), as well as embolotherapeutic, cardiac rhythm management, electrophysiology, critical care, breast cancer localization and guidance, biopsy, and interventional oncology and spine devices. Our endoscopy segment consists of gastroenterology and pulmonology devices which assist in the palliative treatment of expanding esophageal, tracheobronchial and biliary strictures caused by malignant tumors.

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~~2. Inventories.~~ ~~Inventories at September 30, 2017~~

The following tables present revenue from contracts with customers by reporting segment, product category and ~~December 31, 2016 consisted of the following (in thousands):~~

September 30, December 31,
2017 2016
Finished goods $ 80,708
$ 63,852
Work-in-process 18,162
11,008
Raw materials 46,728
45,835

Total $ 145,598
$ 120,695

~~3. Stock-Based Compensation. Stock-based compensation expense before income tax expense~~geographical region for the three and nine-month periods ended September 30, ~~2017~~2021 and ~~2016, consisted of the following~~2020 (in thousands):

Three Months Ended September 30, Nine Months Ended September 30,
2017 2016 2017 2016
Cost of goods sold $ 189
$ 105
$ 453
$ 369
Research and development 110
51
262
147
Selling, general, and administrative 893
347
2,168
1,397
Stock-based compensation expense before taxes $ 1,192
$ 503
$ 2,883
$ 1,913

As of September 30, 2017, the total remaining unrecognized compensation cost related to non-vested stock options, net of expected forfeitures, was approximately $16.3 million and is expected to be recognized over a weighted average period of 3.66 years.

During the three and nine-month periods ended September 30, 2017, we granted stock-based awards representing 20,000 and approximately 1.3 million shares of our common stock, respectively. During the three and nine-month periods ended September 30, 2016, we granted stock-based awards representing 21,000 and 805,375 shares of our common stock, respectively. We use the Black-Scholes methodology to value the stock-based compensation expense for options. In applying the Black-Scholes methodology to the options granted during the nine-month periods ended September 30, 2017 and 2016, the fair value of our stock-based awards granted was estimated using the following assumptions for the periods indicated below:

Nine Months Ended September 30,
2017 2016
Risk-free interest rate 1.77% - 1.83% 1.15% - 1.40%
Expected option life 5.0 years 5.0 years
Expected dividend yield —% —%
Expected price volatility 33.81% - 34.07% 36.30% - 37.06%

For the purpose of the foregoing analysis, the average risk-free interest rate is determined using the U.S. Treasury rate in effect as of the date of grant, based on the expected term of the stock option. We determine the expected term of the stock options using the historical exercise behavior of employees. The expected price volatility was determined using a weighted average of daily

historical volatility of our stock price over the corresponding expected option life and implied volatility based on recent trends of the daily historical volatility. For options with a vesting period, compensation expense is recognized on a straight-line basis over the service period, which corresponds to the vesting period.


	Three Months Ended						Three Months Ended
	September 30, 2021						September 30, 2020
	United States		International		Total		United States		International		Total
Cardiovascular
Peripheral Intervention	$	61,282	$	39,777	$	101,059	$	55,014	$	31,764	$	86,778
Cardiac Intervention		30,562		49,251		79,813		28,661		40,428		69,089
Custom Procedural Solutions		27,895		21,540		49,435		32,048		24,381		56,429
OEM		25,025		4,372		29,397		20,293		3,824		24,117
Total		144,764		114,940		259,704		136,016		100,397		236,413

Endoscopy
Endoscopy devices		6,741		576		7,317		7,093		469		7,562

Total	$	151,505	$	115,516	$	267,021	$	143,109	$	100,866	$	243,975


	Nine Months Ended						Nine Months Ended
	September 30, 2021						September 30, 2020
	United States		International		Total		United States		International		Total
Cardiovascular
Peripheral Intervention	$	181,383	$	118,190	$	299,573	$	153,431	$	93,057	$	246,488
Cardiac Intervention		93,030		147,173		240,203		79,954		127,731		207,685
Custom Procedural Solutions		80,179		63,313		143,492		80,845		68,524		149,369
OEM		75,335		14,399		89,734		67,566		13,026		80,592
Total		429,927		343,075		773,002		381,796		302,338		684,134

Endoscopy
Endoscopy devices		21,721		1,536		23,257		20,509		1,228		21,737

Total	$	451,648	$	344,611	$	796,259	$	402,305	$	303,566	$	705,871

4. ~~Earnings Per Common Share (EPS).~~ The computation of weighted average shares outstanding and the basic and diluted earnings per common share for the following periods consisted of the following (in thousands, except per share amounts):

Three Months Nine Months

Net
Income
Shares
Per Share
Amount

Net
Income
Shares
Per Share
Amount
Period ended September 30, 2017:

Basic EPS $ (3,569 ) 50,150
$ (0.07 ) $ 20,717
48,332
$ 0.43
Effect of dilutive stock options and warrants
1,449

1,223

Diluted EPS $ (3,569 ) 51,599
$ (0.07 ) $ 20,717
49,555
$ 0.42

Stock options excluded from the calculation of common stock equivalents as the impact was anti-dilutive 200
434

Period ended September 30, 2016:

Basic EPS $ 973
44,447
$ 0.02
$ 12,615
44,346
$ 0.28
Effect of dilutive stock options and warrants
553

417

Diluted EPS $ 973
45,000
$ 0.02
$ 12,615
44,763
$ 0.28

Stock options excluded from the calculation of common stock equivalents as the impact was anti-dilutive 408
864

5. Acquisitions.On ~~September 1, 2017,~~November 6, 2020, we entered into a ~~share~~unit purchase agreement ~~with IntelliMedical Technologies Pty Ltd~~

~~("IntelliMedical")~~ to acquire the intellectual property rights associated with a steerable guidewire system. We made an initial payment of approximately $11.9 million in September 2017, and we are obligated to pay up to an additional $15 million Australian dollars if certain milestones set forth in the agreement are reached. We are also required to pay royalties equal to 6% of net sales, commencing upon the first commercial sale of the product and throughout the term of the applicable patents. We accounted for this transaction as an asset purchase. The initial payment has been included in the accompanying consolidated statements of income as acquired in-process research and development expense for the three and nine-month periods ended September 30, 2017, because both technological feasibility of the underlying research and development project had not yet been reached and such technology had no identified future alternative use as of the date of acquisition.

~~On August 4, 2017 we entered into intellectual property and asset purchase agreements with Laurane~~KA Medical, ~~S.A.S. ("Laurane"~~LLC (“KA Medical”) and its shareholders to acquire inventories and the intellectual property rights associated with Laurane's manual bone biopsy devices, manual bone marrow needles and muscle biopsy kits for an aggregate purchase price of $16.5 million. We also recorded a contingent consideration liability of $5.5 million related to royalties potentially payable to Laurane's shareholders pursuant. Subject to the terms and conditions of the ~~intellectual property~~unit purchase ~~agreement.~~agreement, we paid $10.4 million in cash at closing, net of cash acquired, subject to adjustments for working capital and other matters, with additional deferred payments consisting of $1.5 million, which we paid during the three months ended June 30, 2021, and $2.5 million, which is payable no later than 12 months following the acquisition date. KA Medical developed the Micro Plug^TM Set, a self-expanding nitinol vascular occlusion device, which is FDA-cleared in the US and CE marked in Europe. We accounted for this acquisition as a business combination. ~~The following table summarizes the aggregate purchase price (including contingent royalty payment liabilities) allocated to the assets acquired from Laurane (in thousands):~~

Preliminary Allocation
Net Assets Acquired
Inventories $ 579
Intangibles
Developed technology 14,920
Customer list 120
Goodwill 6,381

Total net assets acquired $ 22,000

We are amortizing the developed technology intangible asset over 12 years and the customer list on an accelerated basis over one year. The total weighted-average amortization period for these acquired intangible assets is 11.9 years. The sales and results of operations related to the acquisition have been included in our cardiovascular segment since the acquisition date and ~~were~~are not ~~material.~~ materially relevant to our financial statements.

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Acquisition-related costs associated with the ~~Laurane~~KA Medical acquisition, which ~~are~~were included in selling,general and administrative expenses, ~~in the accompanying consolidated statements of income,~~ were not material.

On July 3, 2017, we entered into an asset purchase agreement with Osseon LLC (“Osseon”) to acquire substantially all the assets related to Osseon’s vertebral augmentation products. We accounted for this acquisition as a business combination. The purchase price for the business was approximately $6.8 million. Acquisition-related costs associated with the Osseon acquisition, which are included in selling, general and administrative expenses in the accompanying consolidated statements of income, were not material. The results of operations related to this acquisition have been included in our cardiovascular segment since the acquisition date. During the three and nine-month periods ended September 30, 2017, our net sales of Osseon products were approximately $442,000. It is not practical to separately report the earnings related to the Osseon acquisition, as we cannot split out sales costs related solely to the products we acquired from Osseon, principally because our sales representatives sell multiple products (including the products we acquired from Osseon) in our cardiovascular business segment. The following table summarizes the preliminary purchase price allocated to the net assets acquired (in thousands):

Preliminary Allocation
Net Assets Acquired
Inventories $ 1,023
Property and equipment 58
Intangibles
Developed technology 5,400
Customer list 200
Goodwill 159

Total net assets acquired $ 6,840

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

On July 1, 2017, we entered into an exclusive license agreement with Pleuratech ApS ("Pleuratech") to acquire the rights to manufacture and sell the KatGuide chest tube insertion tool. As of September 30, 2017, we had paid $2.0 million in connection with this agreement. We are obligated to pay an additional $5.0 million if certain milestones set forth in the license agreement are met. We are also required to pay royalties equal to 6% of net sales throughout the term of the license agreement. We accounted for this transaction as an asset purchase. We recorded the amount paid upon closing as a license agreement intangible asset, which we intend to amortize over 15 years.

On June 16, 2017, we entered into an asset purchase agreement with Lazarus Medical Technologies, LLC to acquire the patent rights and other intellectual property related to the Repositionable Chest Tube^TM and related devices. As of September 30, 2017, we had paid $570,000 in connection with this agreement. We are also obligated to pay an additional $750,000 if certain milestones set forth in the purchase agreement are reached. We are also required to pay royalties equal to 6.0% of net sales throughout the

term of the purchase agreement. We accounted for this transaction as an asset purchase. We recorded the amount paid upon closing as a license agreement intangible asset, which we intend to amortize over 15 years.

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

On May 19, 2017, we entered into a business purchase agreement, termination agreement, distribution agreement and a supply agreement with Sugan Co, Ltd. ("Sugan"), a Japanese medical device distributor. Pursuant to these agreements, we terminated our former distributor agreement with Sugan and acquired the customer list Sugan used in the distribution of our products in Japan. The consideration attributed to the customer list was approximately $1.1 million, which is payable on or before December 31, 2017. The purchase price is recorded as a customer list intangible asset and the amount due to Sugan is recorded in accrued expenses within the accompanying consolidated balance sheets. We intend to amortize the customer list intangible asset on an accelerated basis over five years. In addition, we granted to Sugan the right to continue to distribute a limited number of our products, related to fluid administration, through December 31, 2021 and to manufacture and sell to Sugan certain contrast injector products during a term of four years, subject to extensions.

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

Preliminary Allocation
Adjustments ⁽¹⁾
Revised Preliminary Allocation
Net Assets Acquired
Intangibles
Developed technology $ 7,800
$ —
$ 7,800
In-process technology 850
250
1,100
Goodwill 4,323
(153 ) 4,170
Deferred tax liabilities (3,073 ) (97 ) (3,170 )

Total net assets acquired $ 9,900
$ —
$ 9,900

(1) Amounts represent adjustments to the preliminary purchase price allocation first presented in our Quarterly Report on Form 10-Q for the quarter ended June 30, 2017 resulting from our ongoing activities, including reassessment of the assets acquired and liabilities assumed, with respect to finalizing our purchase price allocation for this acquisition.

We are amortizing the developed technology intangible asset over 15 years. The sales and results of operations related to the acquisition have been included in our cardiovascular segment since the acquisition date and were not material. Acquisition-related costs associated with the VAT acquisition, which are included in selling, general and administrative expenses in the accompanying consolidated statements of income, were not material.

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

Acquisition-related costs associated with the acquisition of the Argon critical care division during the three and nine-month periods ended September 30, 2017, which are included in selling, general and administrative expenses in the accompanying consolidated statements of income, were approximately $90,000 and $2.5 million, respectively. The results of operations related to this acquisition have been included in our cardiovascular segment since the acquisition date. During the three and nine-month periods ended September 30, 2017, our net sales of Argon products were approximately $11.0 million and $30.0 million, respectively. It is not practical to separately report the earnings related to the Argon acquisition, as we cannot split out sales costs related solely to the

~~products we acquired from Argon, principally because our sales representatives sell multiple products (including the products we acquired from Argon) in our cardiovascular business segment.~~

The assets and liabilities in the initial purchase price allocation for the Argon acquisition are stated at fair value based on estimates of fair value using available information and making assumptions our management believes are reasonable. The following table summarizes the preliminary purchase price allocated to the net tangible and intangible assets acquired and liabilities assumed (in thousands), adjusted as of September 30, 2017:

Preliminary Allocation
Adjustments ⁽²⁾
Revised Preliminary Allocation
Assets Acquired
Cash and cash equivalents $ 1,436
$ —
$ 1,436
Trade receivables 8,351
—
8,351
Inventories 12,217
(995 ) 11,222
Prepaid expenses and other assets 1,275
—
1,275
Property and equipment 2,667
(348 ) 2,319
Deferred tax assets 184
19
203
Intangibles
Developed technology 2,600
(400 ) 2,200
Customer lists 1,300
200
1,500
Trademarks 1,500
(600 ) 900
Total assets acquired 31,530
(2,124 ) 29,406

Liabilities Assumed
Trade payables (2,306 ) (109 ) (2,415 )
Accrued expenses (5,083 ) —
(5,083 )
Income taxes payable (2 ) —
(2 )
Deferred income tax liabilities (999 ) (11 ) (1,010 )
Total liabilities assumed (8,390 ) (120 ) (8,510 )

Total net assets acquired 23,140
(2,244 ) 20,896

Gain on bargain purchase ⁽¹⁾
(12,243 ) 1,447
(10,796 )
Total purchase price $ 10,897
$ (797 ) $ 10,100

(1) The total fair value of the net assets acquired from Argon exceeded the purchase price, resulting in a gain on bargain purchase which was recorded within other income (expense) in our consolidated statements of income, and includes a negative adjustment of $778,000 in the three-month period ended September 30, 2017 (in addition to the negative adjustment of $669,000 in the three-month period ended June 30, 2017). We believe the reason for the provisional gain on bargain purchase was a result of the divestiture of a non-strategic, slow-growth critical care business for Argon. It is our understanding that the divestiture allows Argon to focus on its higher growth interventional portfolio.
(2) Amounts represent adjustments to the preliminary purchase price allocation first presented in our March 31, 2017 Form 10-Q resulting from our ongoing activities, including reassessment of the assets acquired and liabilities assumed, with respect to finalizing our purchase price allocation for this acquisition.

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

Given the timing of this acquisition, which closed during the first quarter of 2017, as well as the complexity of the acquisition, the entire purchase price allocation disclosed herein (as well as the gain on bargain purchase) is considered provisional at this time and is subject to adjustment to reflect information obtained about factors and circumstances that existed as of the acquisition date that if known would have affected the measurement of the amounts recognized as of that date. We continue to assess whether we have fully identified all the assets acquired and the liabilities assumed. Consequently, the measurement period remains open.

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

Acquisition-related costs associated with the Catheter Connections acquisition during the three and nine-month periods ended September 30, 2017, which are included in selling, general and administrative expenses in the accompanying consolidated statements of income, were approximately $31,000 and $482,000, respectively. The results of operations related to this acquisition have been included in our cardiovascular segment since the acquisition date. During the three and nine-month periods ended September 30, 2017, our net sales of the products acquired from Catheter Connections were approximately $2.7 million and $7.0 million, respectively. It is not practical to separately report the earnings related to the products acquired from Catheter Connections, as we cannot split out sales costs related solely to those products, principally because our sales representatives sell multiple products (including the DualCap System) in the cardiovascular business segment. The purchase price was preliminarily allocated as follows (in thousands):

Preliminary Allocation
Adjustments ⁽¹⁾
Revised Preliminary Allocation
Assets Acquired
Trade receivables $ 952
$ 7
$ 959
Inventories 2,244
(87 ) 2,157
Prepaid expenses and other assets 181
(96 ) 85
Property and equipment 1,472
—
1,472
Intangibles
Developed technology 22,900
(1,800 ) 21,100
Customer lists 100
600
700
Trademarks 2,900
—
2,900
Goodwill 7,612
1,376
8,988
Total assets acquired 38,361
—
38,361

Liabilities Assumed
Trade payables (338 ) —
(338 )
Accrued expenses (23 ) —
(23 )
Total liabilities assumed (361 ) —
(361 )

Net assets acquired $ 38,000
$ —
$ 38,000

(1) Amounts represent adjustments to the preliminary purchase price first presented in our Quarterly Report on Form 10-Q for the Quarter Ended March 31, 2017, resulting from our ongoing activities with respect to finalizing our purchase price allocation for this acquisition. The larger adjustments primarily relate to the valuation of the acquired intangible assets.

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

On July 6, 2016, we acquired all the issued and outstanding shares of DFINE Inc. ("DFINE"). The DFINE acquisition added a line of vertebral augmentation products for the treatment of vertebral compression fractures as well as medical devices used to treat metastatic spine tumors. We made an initial payment of $97.5 million to certain DFINE stockholders on July 6, 2016 and paid approximately $578,000 related to a net working capital adjustment subject to review by Merit and the preferred stockholders of DFINE. We accounted for the acquisition as a business combination. In the three-month period ended December 31, 2016, we negotiated the final net working capital adjustment, resulting in a reduction to the purchase price of approximately $1.1 million. As a result, we recorded measurement period adjustments to reduce inventories by approximately $89,000, reduce property and equipment by approximately $109,000, reduce goodwill by approximately $1.2 million, reduce accrued expenses by approximately $407,000 and increase the associated deferred tax liabilities by approximately $113,000. The measurement period for this acquisition is closed. Under U.S. GAAP, measurement period adjustments are recognized on a prospective basis in the period of

~~change, instead of restating prior periods. There was no material impact to reported earnings in connection with these measurement period adjustments.~~

Acquisition-related costs associated with the DFINE acquisition during the year ended December 31, 2016, which were included in selling, general and administrative expenses in the consolidated statements of income included in the 2016 Form 10-K, were approximately $1.6 million. The results of operations related to this acquisition have been included in our cardiovascular segment since the acquisition date. During the year ended December 31, 2016, our net sales of DFINE products were approximately $13.5 million. It is not practical to separately report the earnings related to the DFINE acquisition, as we cannot split out sales costs related solely to the DFINE products, principally because our sales representatives sell multiple products (including DFINE products) in the cardiovascular business segment.

~~The purchase price was allocated to the net tangible and intangible assets acquired and liabilities assumed, based on estimated fair values, as follows (in thousands):~~

Assets Acquired
Trade receivables $ 4,054
Other receivables 6
Inventories 8,585
Prepaid expenses 630
Property and equipment 1,630
Other long-term assets 145
Intangibles
Developed technology 67,600
Customer lists 2,400
Trademarks 4,400
Goodwill 24,818
Total assets acquired 114,268

Liabilities Assumed
Trade payables (1,790 )
Accrued expenses (5,298 )
Deferred income tax liabilities - current (701 )
Deferred income tax liabilities - noncurrent (10,844 )
Total liabilities assumed (18,633 )

Net assets acquired, net of cash received of $1,327 $ 95,635

With respect to the DFINE assets, we are amortizing developed technology over 15 years and customer lists on an accelerated basis over nine years. While U.S. trademarks can be renewed indefinitely, we currently estimate that we will generate cash flow from the acquired trademarks for a period of 15 years from the acquisition date. The total weighted-average amortization period for these acquired intangible assets is 14.8 years.

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

Assets Acquired
Inventories $ 2,455
Property and equipment 290
Intangibles
Developed technology 12,100
Trademarks 700
Customers Lists 400
Goodwill 2,555

Total assets acquired $ 18,500


Assets Acquired
Trade receivables	$	24
Other receivables		13
Inventories		216
Property and equipment		298
Other long-term assets		147
Intangible assets
Developed technology		6,000
Goodwill		8,283
Total assets acquired		14,981

Liabilities Assumed
Trade payables		(31)
Accrued expenses		(507)
Total liabilities assumed		(538)

Total net assets acquired	$	14,443

We are amortizing the developed ~~HeRO Graft~~ technology intangible asset acquired through KA Medical over ~~ten years, the related trademarks over 5.5 years, and the associated customer lists over 12~~17 years. ~~We have estimated the weighted average life~~The goodwill consists largely of the ~~intangible HeRO Graft assets acquired~~synergies expected from combining operations and is expected to be approximately 9.8 years. Acquisition-related costs related to the HeRO Graft device and other related assets during the year ended December 31, 2016, which were included in selling, general and administrative expenses in the consolidated statements ofdeductible for income included in the 2016 Form 10-K, were not material. The results of operations related to this acquisition have been included in our cardiovascular segment since the acquisition date. During the year ended December 31, 2016, our net sales of the products acquired from CryoLife were approximately $7.1 million. It is not practical to separately report the earnings related to the products acquired from CryoLife, as we cannot split out sales costs related solely to those products, principally because our sales representatives sell multiple products (including the HeRO Graft device) in the cardiovascular business segment.

The following table summarizes our consolidated results of operations for the three-month period ended September 30, 2016 and the nine-month periods ended September 30, 2017 and 2016, as well as unaudited pro forma consolidated results of operations as though the DFINE acquisition had occurred on January 1, 2015 and the acquisition of the Argon critical care division had occurred on January 1, 2016 (in thousands, except per share amounts):

Three Months Ended Nine Months Ended Nine Months Ended
September 30, 2016 September 30, 2017 September 30, 2016
As Reported Pro Forma As Reported Pro Forma As Reported Pro Forma
Net Sales $ 156,975
$ 167,321
$ 536,955
$ 539,715
$ 446,123
$ 494,589
Net Income 973
1,174
20,717
10,047
12,615
16,454
Earnings per common share:
Basic $ 0.02
$ 0.03
$ 0.43
$ 0.21
$ 0.28
$ 0.37
Diluted $ 0.02
$ 0.03
$ 0.42
$ 0.20
$ 0.28
$ 0.37

*tax purposes. The pro forma ~~results for the three-month period ended September 30, 2017 are not included in the table above because the~~

~~operating and financial results for the DFINE and Argon critical care division acquisitions were included in our consolidated statements of income for this period.~~

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

~~6. Segment Reporting.~~ We report our operations in two operating segments: cardiovascular and endoscopy. Our cardiovascular segment consists of cardiology and radiology medical device products which assist in diagnosing and treating coronary artery disease, peripheral vascular disease and other non-vascular diseases and includes embolotherapeutic, cardiac rhythm management ("CRM"), electrophysiology ("EP"), and interventional oncology and spine devices. Our endoscopy segment consists of gastroenterology and pulmonology medical device products which assist in the palliative treatment of expanding esophageal, tracheobronchial and biliary strictures caused by malignant tumors. We evaluate the performance of our operating segments based on operating income.

~~Financial information relating~~significant to our ~~reportable operating segments and reconciliations to the consolidated totals~~financial results for the three and nine-month periods ended September 30, ~~2017~~2020. Operating results attributable to the KA Medical acquisition were included in our consolidated statements of income (loss) for the three and ~~2016, are~~nine-month periods ended September 30, 2021.

5. Inventories. Inventories at September 30, 2021 and December 31, 2020 consisted of the following (in thousands):


	September 30, 2021		December 31, 2020
Finished goods	$	115,396	$	110,933
Work-in-process		33,299		19,308
Raw materials		59,386		67,778
Total inventories	$	208,081	$	198,019

6. Goodwill and Intangible Assets. The change in the carrying amount of goodwill for the nine-month period ended September 30, 2021 is detailed as follows (in thousands):


	2021
Goodwill balance at January 1	$	363,533
Effect of foreign exchange		(1,533)
Goodwill balance at September 30	$	362,000

Total accumulated goodwill impairment losses aggregated to approximately $8.3 million as of September 30, 2021 and December 31, 2020. We did 0t have any goodwill impairments for the nine-month periods ended September 30, 2021 and 2020. The total goodwill balance as of September 30, 2021 and December 31, 2020 was related to our cardiovascular segment.

Table of Contents

Three Months Ended September 30, Nine Months Ended September 30,
2017 2016 2017 2016
Net Sales ⁽¹⁾

Cardiovascular $ 172,723
$ 150,503
$ 517,140
$ 428,571
Endoscopy 6,614
6,472
19,815
17,552
Total net sales 179,337
156,975
536,955
446,123

Operating Income (Loss)⁽¹⁾

Cardiovascular (1,207 ) 1,858
14,239
19,385
Endoscopy 2,086
1,129
5,611
2,889
Total operating income 879
2,987
19,850
22,274

~~(1) Net sales~~

Other intangible assets at September 30, 2021 and ~~operating income have been adjusted from earlier reported year-to-date amounts~~December 31, 2020 consisted of the following (in thousands):


	September 30, 2021
	Gross Carrying		Accumulated		Net Carrying
	Amount		Amortization		Amount
Patents	$	25,635	$	(7,826)	$	17,809
Distribution agreements		3,250		(2,469)		781
License agreements		12,678		(7,478)		5,200
Trademarks		30,252		(14,566)		15,686
Customer lists		35,035		(30,691)		4,344
Total	$	106,850	$	(63,030)	$	43,820


	December 31, 2020
	Gross Carrying		Accumulated		Net Carrying
	Amount		Amortization		Amount
Patents	$	23,669	$	(6,460)	$	17,209
Distribution agreements		3,250		(2,319)		931
License agreements		14,453		(6,647)		7,806
Trademarks		30,273		(12,414)		17,859
Customer lists		35,154		(29,103)		6,051
Total	$	106,799	$	(56,943)	$	49,856

Aggregate amortization expense for ~~2017~~the three and ~~2016 to reflect~~nine-month periods ended September 30, 2021 was approximately $12.4 million and $37.3 million, respectively. Aggregate amortization expense for the three and nine-month periods ended September 30, 2020 was approximately $14.4 million and $44.2 million, respectively.

We evaluate long-lived assets, including amortizing intangible assets, for impairment whenever events or changes in ~~product classifications between our operating segments,~~circumstances indicate that their carrying amounts may not be recoverable. We perform the impairment analysis at the asset group for which ~~were made to be consistent with updates in~~ the ~~management~~lowest level of ~~our product portfolios in~~identifiable cash flows is largely independent of the ~~third quarter~~cash flows of ~~2017.~~

~~7. New Financial Accounting Standards~~.

~~Recently Adopted~~

~~In January 2017, the Financial Accounting Standards Board (the “FASB”) issued Accounting Standards Update (“ASU”) No. 2017-04,~~ ~~Intangibles - Goodwill~~other assets and ~~Other (Topic 350): Simplifying the Test for Goodwill Impairment, which eliminates the requirement to~~liabilities. We determine the fair value of ~~individual~~our amortizing assets ~~and liabilities of~~based on estimated future cash flows discounted back to their present value using a ~~reporting unit to measure goodwill impairment. Under these amendments, goodwill impairment testing will be performed by comparing~~discount rate that reflects the ~~fair value~~risk profiles of the ~~reporting unit~~underlying activities. During the nine-month periods ended September 30, 2021 and 2020, we identified indicators of impairment associated with ~~its carrying amount and recognizing~~certain acquired intangible assets within the asset groups based on our qualitative assessment. The primary indicator of impairment was our planned discontinuance of the Advocate™ Peripheral Angioplasty Balloon product line, sold under our license agreements with ArraVasc Limited (“ArraVasc”). We recorded an impairment charge for the ~~amount by which the~~remaining carrying amount exceeds the reporting unit’s fair value. We adopted ASU 2017-04 effective January 1, 2017 on a prospective basis, and it did not have a material impact on our consolidated financial statements forvalue of ArraVasc intangible assets of approximately $1.6 million during the nine months ended September 30, ~~2017.~~

~~In January 2017, the FASB issued ASU No. 2017-01,~~ ~~Business Combinations (Topic 805): Clarifying the Definition~~2021, all of ~~a Business~~, which ~~provides guidance~~pertained to ~~entities to assist~~our cardiovascular segment.

We recorded total impairment charges associated with ~~evaluating when a set of transferred~~intangible assets and activities is a business and provides a screen to determine when a set is not a business. Under the new guidance, when substantially all the fair value of gross assets acquired (or disposed of) is concentrated in a single identifiable asset, or group of similar assets, the assets acquired would not represent a business. Also, to be considered a business, an acquisition would have to include an input and a substantive process that together significantly contribute to the ability to produce outputs. We adopted ASU 2017-01 effective January 1, 2017 on a prospective basis. The implementation of ASU 2017-01 did not have a material impact on our ~~consolidated financial statements~~cardiovascular segment for the ~~nine months~~three and nine-month periods ended September 30, ~~2017.~~

~~In March 2016, the FASB issued ASU No. 2016-09,~~ ~~Compensation - Stock Compensation (Topic 718): Improvements to Employee Share-Based Payment Accounting, which requires companies to record excess tax benefits~~2020 of approximately $18.1 million and deficiencies in income rather than the current requirement to record them through equity. ASU 2016-09 also allows companies the option to recognize forfeitures of share-based awards when they occur rather than the previous requirement to make an estimate upon the grant of the awards. We adopted ASU 2016-09 effective January 1, 2017 on a prospective basis and, as such, no prior periods were adjusted. In accordance with the new standard and prospectively since the date we adopted ASU 2016-09, excess tax benefits from stock-based compensation$20.5 million, respectively. These expenses are ~~reported as an income tax benefit~~reflected within impairment charges in our consolidated statements of income ~~(see Note 8)~~(loss).

~~In November 2015, the FASB issued ASU No. 2015-17,~~ ~~Income Taxes (Topic 740): Balance Sheet Classification~~ The primary factors driving impairment of ~~Deferred Taxes, which requires all deferred tax~~certain intangible assets and deferred tax liabilities to be presented as noncurrent within a classified balance sheet. We adopted ASU 2015-17 effective January 1, 2017 on a prospective basis and did not reclassify presentation of prior year balances. The adoption of this standard did not have a material impact on our consolidated financial statements for the ~~nine months~~three and nine-month periods ended September 30, ~~2017.~~

~~In July 2015,~~2020 were planned closure and restructuring activities and uncertainty about future product development and commercialization associated with the ~~FASB issued ASU No. 2015-11,~~ ~~Simplifying~~acquired technologies due in part to the ~~Measurement~~economic impacts of ~~Inventory. ASU 2015-11 requires that inventory be measured at~~ the ~~lower~~COVID-19 pandemic. The intangible impairment charges related to a write-off or reduction in value of ~~cost or net realizable value. Net realizable value is the estimated selling price~~intangible assets from our August 2017 acquisition of certain assets from Laurane Medical S.A.S, our license agreements with ArraVasc Limited, intangible assets from our May 2018 acquisition of certain assets from DirectACCESS Medical, LLC, in-process technology intangible assets of Sontina Medical LLC we acquired through our February 2018 acquisition of certain divested assets from Becton, Dickinson and Company, and a customer list intangible asset from our October 2017 acquisition of ITL Healthcare Pty Ltd (“ITL”).

See Note 14 for additional details regarding impairment charges recorded in the ~~ordinary course of business, less reasonably predictable costs of completion, disposal,~~three and transportation. Inventory measured using last-in, first-out or the retail inventory method are excluded from the scope of ASU 2015-11, which is effective for fiscal years beginning after December 15, 2016, and interimnine-month periods ~~within those fiscal years. The implementation of ASU 2015-11 did not have a material impact on our consolidated financial statements for the nine months~~ ended September 30, ~~2017.~~2021 and 2020.

~~Not Yet Adopted~~

Table of Contents

~~In August 2017,~~

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

~~In October 2016, the FASB issued ASU No. 2016-16,~~ ~~Income Taxes (Topic 740)~~September 30, 2021 (in thousands): ~~Intra-Entity Transfers of Assets Other than Inventory~~, which requires the recognition of the income tax consequences of an intra-entity transfer of an asset, other than inventory, when the transfer occurs. ASU 2016-16 will be effective for us on January 1, 2018. We do not presently anticipate that the adoption of ASU 2016-16 will have a material impact on our consolidated financial statements.

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

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

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

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

We have substantially completed our impact assessment of implementing this guidance. We have evaluated each of the five steps in Topic 606, which are as follows: 1) Identify the contract with the customer; 2) Identify the performance obligations in the contract; 3) Determine the transaction price; 4) Allocate the transaction price to the performance obligations; and 5) Recognize revenue when (or as) performance obligations are satisfied. Our preliminary conclusion is that we expect to identify similar performance obligations under ASC Topic 606 as compared with deliverables and separate units of account previously identified.

The Company does not expect revenue to be affected materially in any period due to the adoption of ASC Topic 606 because the Company believes it would have sufficient information to conclude that the transaction price was fixed or determinable under current GAAP and would have recorded revenue upon shipment or delivery under either ASC Topic 605 or ASC Topic 606. Additionally, the Company does not expect cost of sales (product) to be affected materially in any period due to the adoption of Topic 606.

We continue to evaluate the impact that this new standard will have on our Original Equipment Manufacturing arrangements. There are also certain considerations related to accounting policies, business processes and internal control over financial reporting that are associated with implementing Topic 606. We are currently evaluating our policies, processes, and control framework for revenue recognition and identifying any changes that may need to be made in response to the new guidance. Disclosure requirements under the new guidance in Topic 606 have been significantly expanded in comparison to the disclosure requirements under the current guidance, including disclosures related to disaggregation of revenue into appropriate categories, performance obligations, the judgments made in revenue recognition determinations, adjustments to revenue which relate to activities from previous quarters or years, any significant reversals of revenue, and costs to obtain or fulfill contracts. Designing and implementing the appropriate controls over gathering and reporting the information required under Topic 606 is currently in process, and we anticipate it will be completed prior to January 1, 2018.


Year Ending December 31,	Estimated Amortization Expense
Remaining 2021	$	12,279
2022		48,158
2023		47,060
2024		44,126
2025		42,354

7. Income Taxes.Our provision for income taxes for the ~~three months~~three-month periods ended September 30, ~~2017~~2021 and 2020 was a tax expense of approximately $1.4 million compared to a tax benefit of $978,000 for the corresponding period of 2016. The increase in the income tax expense for the third quarter of 2017 compared to the third quarter of 2016 was primarily due to the discrete tax impact of the in-process research and development charge attributable to the IntelliMedical acquisition completed in the third quarter of 2017, which was not deductible for tax purposes.

~~Our provision for income taxes for the nine months ended September 30, 2017 and 2016 was a tax expense of approximately $3.9~~$2.2 million and ~~approximately $3.1~~$0.8 million, respectively, which resulted in an effective tax rate of ~~15.8%~~15.6% and ~~20.0%~~(37.7)%, respectively. Our provision for income taxes for the nine-month periods ended September 30, 2021 and 2020 was a tax expense (benefit) of approximately $5.9 million and ($1.3) million, respectively, which resulted in an effective tax rate of 17.5% and 4.7%, respectively. The ~~decrease~~increase in the income tax expense and the corresponding change in the effective income tax rate for the three and nine-month ~~period~~periods ended September 30, ~~2017,~~2021, when compared to the ~~corresponding period of 2016,~~prior-year periods, was primarily ~~related~~due to a ~~discrete~~pre-tax loss during the 2020 periods, as well as a change in the jurisdictional mix of earnings. Our effective tax ~~benefit related to share-based payment awards~~rate differs from the U.S. statutory rate primarily due to ~~application~~the impact of ~~ASC Update 2016-09~~global intangible low-taxed income (“GILTI”) inclusions, state income taxes, foreign taxes, other non-deductible permanent items and ~~a nontaxable gain on the bargain purchase relating to our acquisition of the critical care division of Argon.~~

discrete items (such as share-based compensation).

8. Revolving Credit Facility and ~~Long-term~~Long-Term Debt. ~~Our~~Principal balances outstanding under our long-term debt obligations as of September 30, ~~2017~~2021 and December 31, ~~2016,~~2020 consisted of the following (in thousands):

September 30, 2017 December 31, 2016
2016 Term loan $ 87,500
$ 145,000
2016 Revolving credit loans 184,000
180,000
2017 Debt facility 6,962
—
Less debt issuance costs (522 ) (627 )
Total debt 277,940
324,373
Less current portion 16,962
10,000
Long-term portion $ 260,978
$ 314,373

~~2017 Debt Facility~~


	September 30, 2021		December 31, 2020
Term loans	$	135,000	$	140,625
Revolving credit loans		144,000		211,000
Less unamortized debt issuance costs		(319)		(403)
Total long-term debt		278,681		351,222
Less current portion		7,500		7,500
Long-term portion	$	271,181	$	343,722

Third Amended and Restated Credit Agreement

On ~~February 23, 2017,~~July 31, 2019, we entered into a loan agreement with HSBC Bank USA, National Association ("HSBC Bank") whereby HSBC Bank agreed to provide us with a loan in the amount of approximately $7.0 million. The loan matures on February 1, 2018, with an extension available at our option, subject to certain conditions. The loan agreement bears interest at the three-month London Inter-Bank Offered Rate (“LIBOR”) plus 1.0%, which resets quarterly. The loan is secured by assets equal to the currently outstanding loan balance. The loan contains covenants, representations and warranties and other terms customary for loans of this nature. As of September 30, 2017, our interest rate on the loan was a variable rate of 2.32%.

~~2016 Term Loan and Revolving Credit Loans~~

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

~~The Second~~Third Amended Credit Agreement provides for a term loan of $150 million and a revolving credit commitment up to an aggregate amount of ~~$275~~$600 million, ~~which includes a reserve~~inclusive of ~~$25 million to make~~sub-facilities for multicurrency borrowings, standby letters of credit and swingline ~~loans from time to time. The term loan is payable in quarterly installments in~~loans. On July 31, 2024, all principal, interest and other amounts outstanding under the ~~amounts provided in the Second~~Third Amended Credit Agreement ~~until the maturity date of July 6, 2021, at which time the term and revolving credit loans, together with accrued interest thereon, will be due and payable.~~are payable in full. At any time prior to the maturity date, we may repay any amounts owing under all ~~revolving credit loans,~~ term loans and ~~all swingline~~revolving credit loans in whole or in part, ~~subject to certain minimum thresholds,~~ without premium or penalty, other than breakage ~~costs.~~

fees (as defined in the Third Amended Credit Agreement).

Revolving credit loans denominated in dollars and term loans made under the ~~Second~~Third Amended Credit Agreement bear interest, at our election, at either athe Base Rate or the Eurocurrency ~~Base~~ Rate (as such terms are defined in the ~~Second~~Third Amended Credit Agreement) plus the ~~applicable margin, which increases as our Consolidated Total Leverage Ratio~~Applicable Margin (as defined in the ~~Second~~Third Amended Credit Agreement) ~~increases.~~. Revolving credit loans denominated in an Alternative Currency (as defined in the ~~Second~~Third Amended Credit Agreement) bear interest at the Eurocurrency ~~rate~~Rate plus the ~~applicable margin.~~Applicable Margin. Swingline loans bear interest at the ~~base rate~~Base Rate plus the ~~applicable margin. Upon an event~~Applicable Margin

Table of ~~default,~~Contents

(as defined in the ~~interest rate may be increased by 2.0%~~Third Amended Credit Agreement). ~~The revolving credit commitment will also carry a commitment fee of 0.15% to 0.40% per annum~~Interest on each Base Rate loan is due and payable on the ~~unused portion.~~

last business day of each calendar quarter; interest on each Eurocurrency Rate loan is due and payable on the last day of each interest period applicable thereto, and if such interest period extends over three months, at the end of each three-month interval during such interest period.

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


		Covenant Requirement
			~~Covenant Requirement~~
Consolidated Total Leverage Ratio ⁽¹⁾				4.0 to 1.0
Consolidated Interest Coverage Ratio ⁽²⁾	~~July 1, 2017 through December 31, 2017~~		~~3.75~~ 3.0 to 1.0
	~~January 1, 2018 through March 31, 2018~~		~~3.5 to 1.0~~
	~~April 1, 2018 and thereafter~~		~~3.25 to 1.0~~
~~Consolidated EBITDA (2)~~			~~1.25 to 1.0~~
~~Consolidated Net Income (3)~~			$0
Facility Capital Expenditures ~~(4)~~⁽³⁾				$3050 million

(1)	Maximum Consolidated Total Net Leverage Ratio (as defined in the ~~Second~~Third Amended Credit Agreement) as of any fiscal quarter end.

(2)	Minimum ratio of Consolidated EBITDA (as defined in the ~~Second~~Third Amended Credit Agreement and adjusted for certain expenditures) to Consolidated ~~Fixed Charges~~Interest Expense (as defined in the ~~Second~~Third Amended Credit Agreement) for any period of four consecutive fiscal quarters.

(3)	~~Minimum level of Consolidated Net Income (as defined in the Second Amended Credit Agreement) for consecutive periods, and subject to certain adjustments.~~
~~(4)~~	Maximum level of the aggregate amount of all Facility Capital Expenditures (as defined in the ~~Second~~Third Amended Credit Agreement) in any fiscal year.

~~Additionally, the Second Amended Credit Agreement contains customary events of default and affirmative and negative covenants for transactions of this type. As of September 30, 2017, we~~

We believe we were in compliance with all covenants set forth in the ~~Second~~Third Amended Credit ~~Agreement.~~

Agreement as of September 30, 2021.

As of September 30, ~~2017,~~2021, we had outstanding borrowings of ~~approximately $271.5~~$279 million under the ~~Second~~Third Amended Credit Agreement, with additional available borrowings of approximately ~~$91.0~~$456 million, based on the maximum net leverage ratio ~~required~~and the aggregate revolving credit commitment pursuant to the ~~Second~~Third Amended Credit Agreement. Our interest rate as of September 30, ~~2017~~2021 was a fixed rate of ~~2.23%~~2.71% on ~~$126.3 million and a fixed rate of 2.37% on $48.8~~$75 million as a result of an interest rate ~~swaps~~swap (see Note ~~10), a variable floating rate of 2.49% on $84.5 million~~9) and a variable floating rate of ~~2.49%~~1.08% on ~~$12.0~~$204 million. Our interest rate as of December 31, ~~2016~~2020 was a fixed rate of ~~2.98%~~2.37% on ~~$130.0 million and 3.12% on $45.0~~$175 million as a result of an interest rate ~~swaps~~swap and a variable floating rate of ~~2.77%~~1.40% on ~~$150.0~~$176.6 million.

~~Future Payments~~

The foregoing fixed rates do not reflect potential future changes in the applicable margin.

Future minimum principal payments on our long-term debt, as of September 30, ~~2017, are~~2021, were as follows (in thousands):

Years Ending Future Minimum
December 31 Principal Payments
Remaining 2017 2,500
2018 19,462
2019 15,000
2020 17,500
2021 224,000
Total future minimum principal payments $ 278,462

~~10. Derivatives~~


Years Ending	Future Minimum
December 31,	Principal Payments
Remaining 2021	$	1,875
2022		8,438
2023		11,250
2024		257,437
Total future minimum principal payments	$	279,000

9. Derivatives.

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

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

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

~~Derivatives~~

Derivative Instruments Designated as Cash Flow Hedges

On ~~December 19, 2012,~~August 5, 2016, we entered into a pay-fixed, receive-variable interest rate swap ~~having an initial~~with a notional amount of ~~$150~~$175 million with Wells Fargo to fix the one-month LIBOR rate at ~~0.98%~~1.12%. The variable portion of the interest rate swap iswas tied to the one-month LIBOR rate (the benchmark interest rate). The interest ~~rates under both the interest~~ rate swap ~~and the underlying debt reset, the swap is settled with the counterparty, and interest is paid~~expired on a monthly basis. The notional amount of the interest rate swap is reduced quarterly by 50% of the minimum principal payment due under the terms of our Second Amended Credit Agreement. The interest rate swap is scheduled to expire onJuly 6, 2021.

On December ~~19, 2017.~~

~~On August 5, 2016,~~23, 2019, we entered into a pay-fixed, receive-variable interest rate swap ~~having an initial~~with a notional amount of ~~$42.5~~$75 million with Wells Fargo to fix the one-month LIBOR rate at ~~1.12%.~~1.71% for the period from July 6, 2021 to July 31, 2024. The variable portion of the interest rate swap is tied to the one-month LIBOR rate (the benchmark interest rate). On a monthly basis, the interest rates under both the interest rate swap and the underlying debt reset, the swap is settled with the counterparty, and interest is paid. The notional amount of the interest rate swap increases quarterly by an amount equal to the decrease of the hedge entered into on December 19, 2012, up to the amount of $175.0 million. The interest rate swap is scheduled to expire on July 6, 2021.

On September 30, ~~2017~~2021 and December 31, ~~2016,~~2020, our interest rate swaps qualified as cash flow hedges. The fair value of our interest rate ~~swaps at~~swap on September 30, ~~2017~~2021 was ~~an asset~~a liability of approximately ~~$4.4~~$2.5 million, which was partially offset by approximately ~~$1.7~~$0.6 million in deferred taxes. The fair value of our interest rate swaps aton December 31, ~~2016~~2020 was ~~an asset~~a liability of ~~approximately $5.0~~$4.4 million, ~~which was~~ partially offset by approximately ~~$1.9~~$1.1 million in deferred taxes.

Foreign Currency ~~Risk~~. Risk. We operate on a global basis and are exposed to the risk that our financial condition, results of operations, and cash flows could be adversely affected by changes in foreign currency exchange rates. To reduce the potential effects of foreign currency exchange rate movements on net earnings, we enter into derivative financial instruments in the form of foreign currency exchange forward contracts with major financial institutions. Our policy is to enter into foreign currency derivative contracts with maturities of up to two years. We are ~~primarily~~ exposed to foreign currency exchange rate risk with respect to transactions and balances denominated in Chinese Renminbi, Euros, British Pounds, ~~Chinese Yuan Renminbi,~~ Mexican Pesos, Brazilian Reals, Australian Dollars, Hong Kong Dollars, Swiss Francs, Swedish Krona, Canadian Dollars, ~~Singapore Dollars,~~Danish Krone, Japanese Yen, and South Korean Won, ~~and Danish Krone. Our consolidated financial statements are denominated in, and our principal currency is, the U.S. Dollar.~~among others. We do not use derivative financial instruments for trading or speculative purposes. We do not believe we are ~~not~~ subject to any credit risk contingent features related to our derivative contracts, and we seek to manage counterparty risk ~~is managed~~ by allocating derivative contracts among several major financial institutions.

~~Derivatives~~

Derivative Instruments Designated as Cash Flow Hedges

For derivative instruments that are designated and qualify as cash flow hedges, the ~~effective portion of the~~ gain or loss on the derivative instrument is temporarily reported as a component of other comprehensive income (loss) and then reclassified into earnings in the same line item associated with the forecasted transaction and in the same period or periods during which the hedged transaction affects earnings. The remaining gain or loss on the derivative instrument in excess of the cumulative change in the present value of future cash flows of the hedged item, if any (i.e., the ineffective portion) or hedge components excluded from the assessment of effectiveness, are recognized in earnings during the current period. We ~~enter~~entered into forward contracts on various foreign currencies to manage the risk associated with forecasted exchange rates which impact revenues, cost of sales, and operating expenses in various international markets. The objective of the hedges is to reduce the variability of cash flows associated with the forecasted purchase or sale of the associated foreign currencies.

We enter into approximately ~~100~~150 cash flow foreign currency ~~cash flow~~ hedges every month. As of September 30, ~~2017,~~2021 and December 31, 2020, we had entered into foreign currency forward contracts, which qualified as cash flow hedges, with ~~the following~~aggregate notional amounts ~~(in thousands~~of approximately $124.0 million and ~~in local currencies):~~$168.2 million, respectively.

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~~Currency~~	~~Symbol~~	~~Forward Notional Amount~~
~~Euro~~	~~EUR~~	~~5,555~~
~~Swiss Franc~~	~~CHF~~	~~1,088~~
~~Danish Krone~~	~~DKK~~	~~7,775~~
~~British Pound~~	~~GBP~~	~~2,550~~
~~Mexican Peso~~	~~MXN~~	~~64,425~~
~~Swedish Krona~~	~~SEK~~	~~10,805~~

~~Derivatives~~

Derivative Instruments Not Designated as Cash Flow Hedges

We forecast our net exposure in various receivables and payables to fluctuations in the value of various currencies, and we enter into foreign currency forward contracts to mitigate that exposure. We enter into approximately 20 foreign currency fair value hedges every month. As of September 30, ~~2017,~~2021 and December 31, 2020, we had entered into foreign currency forward contracts related to those balance sheet accounts with ~~the following~~aggregate notional amounts ~~(in thousands~~of approximately $92.1 million and ~~in local currencies):~~



~~Currency~~	~~Symbol~~	~~Forward Notional Amount~~
~~Euro~~	~~EUR~~	~~21,801~~
~~British Pound~~	~~GBP~~	~~1,128~~
~~Chinese Yuan Renminbi~~	~~CNY~~	~~39,954~~
~~Mexican Peso~~	~~MXN~~	~~17,537~~
~~Brazilian Real~~	~~BRL~~	~~8,500~~
~~Australian Dollar~~	~~AUD~~	~~4,599~~
~~Hong Kong Dollar~~	~~HKD~~	~~11,000~~
~~Swiss Franc~~	~~CHF~~	~~278~~
~~Swedish Krona~~	~~SEK~~	~~6,007~~
~~Canadian Dollar~~	~~CAD~~	~~1,968~~
~~Singapore Dollar~~	~~SGD~~	~~3,585~~
~~Japanese Yen~~	~~JPY~~	~~178,500~~
~~South Korean Won~~	~~KRW~~	~~1,800,000~~

$74.8 million, respectively.

Balance Sheet Presentation of ~~Derivatives.~~ Derivative Instruments. As of September 30, ~~2017~~2021 and December 31, ~~2016,~~2020, all ~~derivatives,~~derivative instruments, both those designated as hedging instruments and those that were not designated as hedging instruments, were recorded ~~gross~~ at fair value on a gross basis on our consolidated balance sheets. We are not subject to any master netting agreements.

The fair value of derivative instruments on a gross basis iswas as follows on the dates indicated (in thousands):

Fair Value
Balance Sheet Location September 30, 2017 December 31, 2016
Derivatives designated as hedging instruments
Assets
Interest rate swaps Prepaid expenses and other assets (current) $ 79
$ —
Interest rate swaps Other assets (long-term) 4,309
4,991
Foreign currency forward contracts Prepaid expenses and other assets (current) 646
116
Foreign currency forward contracts Other assets (long-term) 158
18

(Liabilities)
Foreign currency forward contracts Accrued expenses (current) $ (286 ) $ (275 )
Foreign currency forward contracts Other long-term obligations (96 ) (18 )

Derivatives not designated as hedging instruments
Assets
Foreign currency forward contracts Prepaid expenses and other assets (current) $ 485
$ 220
(Liabilities)
Foreign currency forward contracts Accrued expenses (current) (210 ) (171 )



Fair Value of Derivative Instruments Designated as Hedging Instruments	Balance Sheet Location	September 30, 2021		December 31, 2020
Assets
Foreign currency forward contracts	Prepaid expenses and other assets	$	1,237	$	1,777
Foreign currency forward contracts	Other assets (long-term)		236		424

(Liabilities)
Interest rate swaps	Accrued expenses		—		(896)
Interest rate swaps	Other long-term obligations		(2,540)		(3,462)
Foreign currency forward contracts	Accrued expenses		(1,779)		(5,281)
Foreign currency forward contracts	Other long-term obligations		(260)		(866)

Fair Value of Derivative Instruments Not Designated as Hedging Instruments	Balance Sheet Location	September 30, 2021		December 31, 2020
Assets
Foreign currency forward contracts	Prepaid expenses and other assets	$	966	$	877

(Liabilities)
Foreign currency forward contracts	Accrued expenses		(1,054)		(2,120)

Income Statement Presentation of ~~Derivatives~~

~~Derivatives~~Derivative Instruments.

Derivative Instruments Designated as Cash Flow Hedges

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


	Amount of Gain/(Loss)					Consolidated Statements				Amount of Gain/(Loss)
	Recognized in OCI					of Income (Loss)				Reclassified from AOCI
	Three Months Ended September 30,					Three Months Ended September 30,				Three Months Ended September 30,
Derivative instrument	2021		2020		Location in statements of income	2021			2020	2021			2020
Interest rate swaps	$	(18)	$	(30)	Interest expense	$	(1,233)	$	(2,197)	$	(319)	$	(425)
Foreign currency forward contracts		33		(1,324)	Revenue		267,021		243,975		(1,500)		157
					Cost of sales		(146,527)		(141,961)		312		(494)

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Amount of Gain/(Loss) recognized in OCI Amount of Gain/(Loss) reclassified from AOCI
Three Months Ended September 30, Three Months Ended September 30,
2017 2016 2017 2016
Derivative instrument Location in Statements of Income
Interest rate swaps $ 1
$ (256 ) Interest expense $ 96
$ (153 )

Foreign currency forward contracts 100
—
Revenue (101 ) —
Cost of goods sold 250
—

Amount of Gain/(Loss) recognized in OCI Amount of Gain/(Loss) reclassified from AOCI
Nine Months Ended September 30, Nine Months Ended September 30,
2017 2016 2017 2016
Derivative instrument Location in Statements of Income
Interest rate swaps $ (611 ) $ (1,503 ) Interest expense $ (8 ) $ (519 )

Foreign currency forward contracts 841
—
Revenue (141 ) —
Cost of goods sold 213
—

The net amount recognized in earnings during the three and nine-month periods ended September 30, 2017 and 2016 due to ineffectiveness and amounts excluded from the assessment of hedge effectiveness were not significant.


	Amount of Gain/(Loss)					Consolidated Statements				Amount of Gain/(Loss)
	Recognized in OCI					of Income (Loss)				Reclassified from AOCI
	Nine Months Ended September 30,					Nine Months Ended September 30,				Nine Months Ended September 30,
Derivative instrument	2021		2020		Location in statements of income	2021			2020	2021			2020
Interest rate swaps	$	619	$	(6,256)	Interest expense	$	(4,156)	$	(8,056)	$	(1,198)	$	(439)
Foreign currency forward contracts		(83)		(2,596)	Revenue		796,259		705,871		(4,674)		666
					Cost of sales		(439,732)		(415,857)		966		(1,204)

As of September 30, ~~2017,~~2021, approximately ~~$461,000,~~($1.2) million, or ~~$282,000~~($0.9) million after taxes, was expected to be reclassified from accumulated other comprehensive income (loss) to earnings in revenue and cost of sales over the succeeding twelve months. As of September 30, ~~2017,~~2021, approximately ~~$624,000,~~($1.2) million, or ~~$381,000~~($0.9) million after taxes, was expected to be reclassified from accumulated other comprehensive income (loss) to earnings in interest expense over the succeeding twelve months.

~~Derivatives~~

Derivative Instruments Not Designated as Hedging Instruments

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


		Three Months Ended September 30,				Nine Months Ended September 30,
Derivative Instrument	Location in statements of income (loss)	2021		2020		2021		2020
Foreign currency forward contracts	Other income (expense)	$	39	$	(1,294)	$	(709)	$	1,051

10. Commitments and Contingencies.

Loan Commitment. On October 11, 2019, we acquired shares of stock in Selio Medical Limited (“Selio”) representing an ownership interest of approximately 19.5%, as well as an option to purchase all ordinary shares of Selio throughout a 45-day period commencing from the date Selio receives FDA 510(k) approval of a medical device it is currently developing,and an option to purchase all remaining shares of Selio on the third anniversary date of the agreement if we elect to purchase all ordinary shares. We have also made a loan of $250,000 to Selio and committed to provide additional loans of up to €2 million at a rate of 5% per annum until one year and 45 days have passed from the date Selio receives FDA Section 510(k) approval of a medical device it is currently developing. Additional loans made to Selio pursuant to our loan agreement, together with the initial advance and all other amounts owed to us by Selio, are secured by Selio’s assets.

Deed of Settlement. In August 2021, we finalized a deed of settlement and paid approximately $6 million of contract termination costs to renegotiate certain terms of our September 1, 2017 share purchase agreement with IntelliMedical Technologies Pty. Ltd. (“Intellimedical”) and terminate certain obligations, including the obligation to make potential future payments of AU$15 million (Australian dollars), pursuant to that agreement. These costs were accrued in selling, general and administrative expenses during the second quarter of 2021.

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

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actions and claims could be materially different than the amount of the current estimates and accruals and could have a material adverse effect on our financial position, results of operations and cash flows.

Securities Litigation

On December 5, 2019, the Bucks County Employees Retirement Fund filed a complaint against Merit, our Chief Executive Officer and our Chief Financial Officer in the United States District Court for the Central District of California, individually and on behalf of all purchasers of our common stock between February 26, 2019 and October 30, 2019. On February 24, 2020, the court appointed the City of Atlanta Police Pension Fund, the Atlanta Firefighters’ Pension Fund, and the Employees’ Retirement System of the City of Baton Rouge and Parish of East Baton Rouge as Lead Plaintiffs. This action is now captioned In re Merit Medical Systems, Inc. Securities Litigation (Master File No. 8:19-cv-02326-DOC-ADS). On June 30, 2020, Lead Plaintiffs filed a consolidated class action complaint for violations of federal securities laws against Merit, our Chief Executive Officer and our Chief Financial Officer in the United States District Court for the Central District of California, individually and on behalf of all purchasers of our common stock between February 26, 2019 and October 30, 2019. The consolidated class action complaint alleges that defendants violated Sections 10(b) and 20(a) of the Exchange Act and Rule 10b-5 promulgated thereunder, and seeks unspecified damages, costs and attorneys’ fees, and equitable relief. We filed a motion to dismiss the action, which the Court denied. We intend to vigorously defend against the lawsuit. We have not recorded an expense related to this matter because any potential loss is not currently probable or reasonably estimable. Additionally, we cannot presently estimate the range of loss, if any, that may result from the matter. It is possible that the ultimate resolution of the foregoing matter, or other similar matters, if resolved in a manner unfavorable to us, may be materially adverse to our business, financial condition, results of operations or liquidity.

Shareholder Derivative Action

On June 3, 2021, Steffen Maute filed a complaint, derivatively on behalf of Merit, against Merit (as a nominal defendant), our Chief Executive Officer, our Chief Financial Officer, our former President of Europe, Middle East and Africa (“EMEA,”) and certain of our directors in the United States District Court for the District of Utah (Case No. 2:21-cv-00346-DBP). The derivative complaint alleges that the individual defendants violated their fiduciary duties owed to Merit and were unjustly enriched at the expense of and to the detriment of Merit between February 2019 and October 2019, and seeks unspecified damages, costs, and professional fees. We intend to vigorously defend against the lawsuit. The proceeding has been stayed until February 2022, subject to the right of either party seeking to lift or extend the stay. We have not recorded an expense related to this matter because any potential loss is not currently probable or reasonably estimable. Additionally, we cannot presently estimate the range of loss, if any, that may result from the matter. It is possible that the ultimate resolution of the foregoing matter, or other similar matters, if resolved in a manner unfavorable to us, may be materially adverse to our business, financial condition, results of operations or liquidity.

Legal costs for proceedings, legal actions and claims discussed, such as outside counsel fees and expenses, are charged to expense in the period(s) incurred.

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11. Earnings (Loss) Per Common Share (EPS). The computation of weighted average shares outstanding and the basic and diluted earnings (loss) per common share for the three and nine-month periods ended September 30, 2021 and 2020 consisted of the following (in thousands, except per share amounts):


	Three Months Ended				Nine Months Ended
	September 30,				September 30,
	2021		2020		2021		2020
Net income (loss)	$	11,967	$	(3,009)	$	27,841	$	(25,221)
Average common shares outstanding		56,302		55,505		56,033		55,386
Basic EPS	$	0.21	$	(0.05)	$	0.50	$	(0.46)

Average common shares outstanding		56,302		55,505		56,033		55,386
Effect of dilutive stock awards		1,247		—		1,241		—
Total potential shares outstanding		57,549		55,505		57,274		55,386
Diluted EPS	$	0.21	$	(0.05)	$	0.49	$	(0.46)

Equity awards excluded as the impact was anti-dilutive ⁽¹⁾		419		4,044		815		4,202

Three months ended September 30, Nine months ended September 30,
2017 2016 2017 2016
Derivative Instrument Location in Statements of Income
Foreign currency forward contracts Other income (expense) $ (1,459 ) $ (76 ) $ (4,150 ) $ (222 )

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

12. Stock-Based Compensation Expense. Stock-based compensation expense before income tax expense (benefit) for the three and nine-month periods ended September 30, 2021 and 2020 consisted of the following (in thousands):


	Three Months Ended				Nine Months Ended
	September 30,				September 30,
	2021		2020		2021		2020
Cost of sales
Nonqualified stock options	$	383	$	336	$	1,019	$	1,022
Research and development
Nonqualified stock options		355		304		910		851
Selling, general and administrative
Nonqualified stock options		2,071		1,948		4,512		5,377
Performance-based restricted stock units		1,193		842		2,896		1,987
Restricted stock units		409		363		1,149		395
Cash-settled performance-based share-based awards ("Liability Awards")		446		270		1,103		636
Total selling, general and administrative		4,119		3,423		9,660		8,395

Stock-based compensation expense before taxes	$	4,857	$	4,063	$	11,589	$	10,268

Nonqualified Stock Options

During the three and nine-month periods ended September 30, 2021, we granted stock options representing 530,500 and 656,350 shares of our common stock, respectively. During the three and nine-month periods ended September 30, 2020, we granted stock options representing 112,500 and 328,994 shares of our common stock, respectively. We use the Black-Scholes methodology to value the stock-based compensation expense for options. In applying the Black-Scholes

~~See Note 11 for more information about our derivatives.~~

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methodology to the option grants, the fair value of our stock-based awards granted was estimated using the following assumptions for the periods indicated below:


	Nine Months Ended
	September 30,
	2021	2020
Risk-free interest rate	0.5% - 0.7%	0.3% - 1.7%
Expected option term	4.0 years	4.0 - 5.0 years
Expected dividend yield	—	—
Expected price volatility	46.3% - 46.7%	38.7% - 45.1%

The average risk-free interest rate is determined using the U.S. Treasury rate in effect as of the date of grant, based on the expected term of the stock award. We determine the expected term of stock options using the historical exercise behavior of employees. The expected price volatility was determined using a weighted average of daily historical volatility of our stock price over the corresponding expected option term and implied volatility based on recent trends of the daily historical volatility. For awards with a vesting period, compensation expense is recognized on a straight-line basis over the service period, which corresponds to the vesting period.

We recognize stock-based compensation expense (net of a forfeiture rate), for those awards which are expected to vest, on a straight-line basis over the requisite service period. We estimate the forfeiture rate based on our historical experience and expectations about future forfeitures. As of September 30, 2021, the total remaining unrecognized compensation cost related to non-vested stock options was approximately $29.4 million, which was expected to be recognized over a weighted average period of 2.7 years.

Stock-Settled Performance-Based Restricted Stock Units (“Performance Stock Units”)

During the nine-month periods ended September 30, 2021 and 2020, we granted performance stock units to certain of our executive officers which, as amended, represent up to 128,883 and 127,060 shares of our common stock, respectively. Conversion of the performance stock units occurs at the end of the relevant performance periods, or one year after the agreement date, whichever is later. The conversion ratio is based upon attaining targeted levels of free cash flow (“FCF”) and relative shareholder return as compared to the Russell 2000 Index (“rTSR”), as defined in the award agreements.

We use Monte-Carlo simulations to estimate the grant-date fair value of the performance stock units linked to total shareholder return. The fair value of each performance stock unit was estimated as of the grant date using the following assumptions for awards granted in the periods indicated below:


	Nine Months Ended
	September 30,
	2021	2020
Risk-free interest rate	0.1% - 0.3%	1.1% - 1.3%
Performance period	1.8 - 2.8 years	0.8 - 2.8 years
Expected dividend yield	—	—
Expected price volatility	43.7% - 49.3%	40.2% - 56.1%

The risk-free interest rate of return was determined using the U.S. Treasury rate at the time of grant with a term equal to the expected term of the award. The expected volatility was based on a weighted average volatility of our stock price and the average volatility of our compensation peer group's volatilities. The expected dividend yield was assumed to be zero because, at the time of the grant, we had no plans to declare a dividend.

Compensation expense is recognized using the grant-date fair value for the number of shares that are probable of being awarded based on the performance conditions. Each reporting period, this probability assessment is updated, and cumulative catchups are recorded based on the level of FCF that is expected to be achieved. At the end of the performance period, cumulative expense is calculated based on the actual level of FCF achieved. As of September 30, 2021, the total remaining unrecognized compensation cost related to stock-settled performance stock units was approximately $5.9 million, which is expected to be recognized over a weighted average period of 1.8 years.

~~11.~~

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Liability Awards

During the nine-month periods ended September 30, 2021 and 2020, we granted liability awards to our Chief Executive Officer with total target cash incentives, each in the amount of $1.0 million. These awards entitle him to a target cash payment based upon attaining targeted levels of FCF and rTSR, as defined in the award agreements. Settlement generally occurs based upon the same performance metrics, vesting period, and performance period as our performance stock units.

The fair value of these awards is remeasured at each reporting period until the awards are settled. These awards are classified as liabilities and reported in accrued expenses and other long-term obligations within our consolidated balance sheet. As of September 30, 2021, the total remaining unrecognized compensation cost related to cash-settled performance-based share-based awards was approximately $2.1 million, which is expected to be recognized over a weighted average period of 1.8 years.

Restricted Stock Units

During the nine-month periods ended September 30, 2021 and 2020, we granted restricted stock units to our non-employee directors representing 26,226 and 33,504 shares of our common stock, respectively. The expense recognized for restricted stock units is equal to the closing stock price on the date of grant, which is recognized over the vesting period. Restricted stock units granted to each director are subject to such director’s continued service through the vesting date, which is one year from the date of grant. As of September 30, 2021, the total remaining unrecognized compensation cost related to restricted stock units was approximately $1.2 million, which will be recognized over a weighted average period of 0.7 years.

13. Segment Reporting. We report our operations in 2 operating segments: cardiovascular and endoscopy. Our cardiovascular segment consists of four product categories: peripheral intervention, cardiac intervention, custom procedural solutions, and OEM. Within these product categories, we sell a variety of products, including cardiology and radiology devices (which assist in diagnosing and treating coronary arterial disease, peripheral vascular disease and other non-vascular diseases), as well as embolotherapeutic, cardiac rhythm management, electrophysiology, critical care, breast cancer localization and guidance, biopsy, and interventional oncology and spine devices. Our endoscopy segment consists of gastroenterology and pulmonology devices which assist in the palliative treatment of expanding esophageal, tracheobronchial and biliary strictures caused by malignant tumors. We evaluate the performance of our operating segments based on net sales and operating income.

Financial information relating to our reportable operating segments and reconciliations to the consolidated totals for the three and nine-month periods ended September 30, 2021 and 2020, were as follows (in thousands):


	Three Months Ended				Nine Months Ended
	September 30,				September 30,
	2021		2020		2021		2020
Net Sales
Cardiovascular	$	259,704	$	236,413	$	773,002	$	684,134
Endoscopy		7,317		7,562		23,257		21,737
Total net sales		267,021		243,975		796,259		705,871

Operating Income (Loss)
Cardiovascular		14,411		(1,702)		33,389		(20,662)
Endoscopy		1,520		1,766		5,631		3,093
Total operating income (loss)		15,931		64		39,020		(17,569)

Total other expense - net		(1,754)		(2,248)		(5,284)		(8,907)
Income tax expense (benefit)		2,210		825		5,895		(1,255)

Net income (loss)	$	11,967	$	(3,009)	$	27,841	$	(25,221)

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14. Fair Value Measurements.

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

Our financial assets and (liabilities) carried at fair value and measured on a recurring basis as of September 30, ~~2017~~2021 and December 31, ~~2016~~,2020 consisted of the following (in thousands):


			Fair Value Measurements Using
	Total Fair		Quoted prices in		Significant other		Significant
	Value at		active markets		observable inputs		unobservable inputs
	September 30, 2021		(Level 1)		(Level 2)		(Level 3)
Interest rate contract liabilities, long-term ⁽¹⁾	$	(2,540)	$	—	$	(2,540)	$	—
Foreign currency contract assets, current and long-term ⁽²⁾	$	2,439	$	—	$	2,439	$	—
Foreign currency contract liabilities, current and long-term ⁽³⁾	$	(3,093)	$	—	$	(3,093)	$	—
Contingent consideration liabilities	$	(48,483)	$	—	$	—	$	(48,483)


			Fair Value Measurements Using
	Total Fair		Quoted prices in		Significant other		Significant
	Value at		active markets		observable inputs		unobservable inputs
	December 31, 2020		(Level 1)		(Level 2)		(Level 3)
Interest rate contract liabilities, current and long-term ⁽¹⁾	$	(4,358)	$	—	$	(4,358)	$	—
Foreign currency contract assets, current and long-term ⁽²⁾	$	3,078	$	—	$	3,078	$	—
Foreign currency contract liabilities, current and long-term ⁽³⁾	$	(8,267)	$	—	$	(8,267)	$	—
Contingent consideration liabilities	$	(55,750)	$	—	$	—	$	(55,750)

(1)	The fair value of the interest rate contracts is determined using Level 2 fair value inputs and is recorded as accrued expenses or other long-term obligations in the consolidated balance sheets.

(2)

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

(3)

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

Fair Value Measurements Using
Total Fair Quoted prices in Significant other Significant
Value at active markets observable inputs unobservable inputs
Description September 30, 2017 (Level 1) (Level 2) (Level 3)

Interest rate contracts (1) $ 4,388
$ —
$ 4,388
$ —
Foreign currency contract assets, current and long-term (2) $ 1,289
$ —
$ 1,289
$ —
Foreign currency contract liabilities, current and long-term (3) $ (592 ) $ —
$ (592 ) $ —

Fair Value Measurements Using
Total Fair Quoted prices in Significant other Significant
Value at active markets observable inputs unobservable inputs
Description December 31, 2016 (Level 1) (Level 2) (Level 3)

Interest rate contracts (1) $ 4,991
$ —
$ 4,991
$ —
Foreign currency contract assets, current and long-term (2) $ 354
$ —
$ 354
$ —
Foreign currency contract liabilities, current and long-term (3) $ (464 ) $ —
$ (464 ) $ —

(1) The fair value of the interest rate contracts is determined using Level 2 fair value inputs and is recorded as prepaid expenses and other assets (current) and other assets (long-term) in the consolidated balance sheets.

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

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

Certain of our business combinations involve the potential for the payment of future contingent consideration, generally based on a percentage of future product sales or upon attaining specified future revenue or other milestones. ~~See Note 5 for further information regarding these acquisitions.~~ The contingent consideration liability is re-measured at the estimated fair value at the end of each reporting period with the change in fair value recognized within operating expenses in the accompanying consolidated statements of ~~income.~~income (loss) for such period. We measure the initial liability and re-measure the liability on a recurring basis using Level 3 inputs as defined under authoritative guidance for fair value measurements. Changes in the fair value of our contingent consideration ~~liability~~liabilities during the three and nine-month periods ended September 30, ~~2017~~2021 and ~~2016~~,2020 consisted of the following (in thousands):


	Three Months Ended				Nine Months Ended
	September 30,				September 30,
	2021		2020		2021		2020
Beginning balance	$	57,477	$	69,100	$	55,750	$	76,709
Contingent consideration expense (benefit)		1,115		(4,356)		3,322		884
Contingent payments made		(10,090)		(130)		(10,579)		(12,991)
Effect of foreign exchange		(19)		51		(10)		63
Ending balance	$	48,483	$	64,665	$	48,483	$	64,665

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Three Months Ended September 30, Nine Months Ended September 30,
2017 2016 2017 2016
Beginning balance $ 5,572
$ 898
$ 683
$ 1,024
Contingent consideration liability recorded as the result of acquisitions (see Note 5) 5,500
—
10,400
—
Fair value adjustments recorded to income during the period 20
(193 ) 39
(136 )
Contingent payments made (15 ) (16 ) (45 ) (199 )
Ending balance $ 11,077
$ 689
$ 11,077
$ 689

The recurring Level 3 measurement of our contingent consideration liabilities and contingent receivable includes the following significant unobservable inputs at September 30, 2017 and December 31, 2016 (amounts in thousands):

Contingent consideration asset or liability Fair value at September 30, 2017 Valuation technique Unobservable inputs Range
Revenue-based payments $ 11,077

Discounted cash flow

Discount rate 9.9% - 15%
contingent liability Probability of milestone payment 100%
Projected year of payments 2017-2037

Contingent receivable $ 528

Discounted cash flow

Discount rate 10%
asset Probability of milestone payment 57%
Projected year of payments 2017-2019

Contingent consideration asset or liability Fair value at December 31, 2016 Valuation technique Unobservable inputs Range
Revenue-based payments $ 683

Discounted cash flow

Discount rate 9.9% - 15%
contingent liability Probability of milestone payment 100%
Projected year of payments 2017-2028

Contingent receivable $ 528

Discounted cash flow

Discount rate 10%
asset Probability of milestone payment 57%
Projected year of payments 2017-2019

The contingent consideration liabilities and contingent receivable are re-measured to fair value each reporting period using projected revenues, discount rates, probabilities of payment, and projected payment dates. Projected contingent payment amounts are discounted back to the current period using a discounted cash flow model. Projected revenues are based on our most recent internal operational budgets and long-range strategic plans. An increase (decrease) in either the discount rate or the time to payment, in isolation, may result in a significantly lower (higher) fair value measurement. A decrease in the probability of any milestone payment may result in lower fair value measurements.

Our determination of the fair value of the contingent consideration liabilities and contingent receivable could change in future periods based upon our ongoing evaluation of these significant unobservable inputs. We record any such change in fair value to operating expenses in our consolidated statements of income.

As of September 30, ~~2017,~~2021, approximately ~~$10.8~~$13.2 million in contingent consideration liability was included in other long-term obligations and ~~$243,000~~approximately $35.3 million in contingent consideration liability was included in accrued expenses in our consolidated balance sheet. As of December 31, ~~2016,~~2020, approximately ~~$595,000~~$36.9 million in contingent consideration liability was included in other long-term obligations and ~~$88,000~~approximately $18.8 million in contingent consideration liability was included in accrued expenses in our consolidated balance sheet. ~~The cash~~Cash paid to settle the contingent consideration liability recognized at fair value as of the applicable acquisition date ~~(including measurement-period adjustments)~~ has been reflected as a cash outflow from financing activities in the accompanying consolidated statements of cash flows.

The recurring Level 3 measurement of our contingent consideration liabilities included the following significant unobservable inputs at September 30, 2021 and December 31, 2020 (amounts in thousands):


	Fair value at
	September 30,		Valuation			Weighted
Contingent consideration liability	2021		technique	Unobservable inputs	Range	Average⁽¹⁾
Revenue-based royalty payments contingent liability	$	3,560	Discounted cash flow	Discount rate	14% - 16%	15.3%
				Projected year of payments	2021-2034	2026

Revenue milestones contingent liability	$	41,051	Monte Carlo simulation	Discount rate	10.5% - 14%	10.6%
				Projected year of payments	2021-2030	2022

Regulatory approval contingent liability	$	3,872	Scenario-based method	Discount rate	1%
				Probability of milestone payment	80%
				Projected year of payment	2024


	Fair value at
	December 31,		Valuation			Weighted
Contingent consideration liability	2020		technique	Unobservable inputs	Range	Average⁽¹⁾
Revenue-based royalty payments contingent liability	$	4,545	Discounted cash flow	Discount rate	12% - 15%	13.5%
				Projected year of payments	2021-2034	2026

Revenue milestones contingent liability	$	46,305	Monte Carlo simulation	Discount rate	7.5% - 12%	9.0%
				Projected year of payments	2021-2030	2022

Regulatory approval contingent liability	$	4,900	Scenario-based method	Discount rate	1%
				Probability of milestone payment	100%
				Projected year of payment	2021-2024	2022

(1)	Unobservable inputs were weighted by the relative fair value of the instruments. No weighted average is reported for contingent consideration liabilities without a range of unobservable inputs.

The contingent consideration liability is re-measured to fair value each reporting period. Significant increases or decreases in projected revenues, based on our most recent internal operational budgets and long-range strategic plans, discount rates or the time until payment is made would have resulted in a significantly lower or higher fair value measurement.Our determination of the fair value of the contingent consideration liability could change in future periods based upon our ongoing evaluation of these significant unobservable inputs. We intend to record any such change in fair value to operating expenses in our consolidated statements of income (loss).

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Contingent Payments to Related Parties

During the ~~three and~~ nine-month ~~periods~~period ended September 30, ~~2017,~~2020, we ~~had losses~~made contingent payments of approximately ~~$67,000,~~$800,000 to a current director of Merit and ~~$86,000, respectively, compared to losses~~former shareholder of ~~approximately $0 and $90,000 for~~Cianna Medical, Inc. (“Cianna Medical”), which we acquired in 2018. We made 0 such payments during the ~~three and~~ nine-month ~~periods~~period ended September 30, ~~2016, respectively, related~~2021. The terms of the acquisition, including contingent consideration payments, were determined prior to the ~~measurement~~appointment of ~~non-financial assets at fair value on~~the former Cianna Medical shareholder as a ~~nonrecurring basis subsequent to their initial recognition.~~

Merit director. As a former shareholder of Cianna Medical, the Merit director may be eligible for additional payments for the achievement of sales milestones specified in our merger agreement with Cianna Medical.

Fair Value of Other Assets (Liabilities)

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

~~12. Goodwill~~

Impairment Charges

We recognize or disclose the fair value of certain assets, such as non-financial assets, primarily property and ~~Intangible Assets.~~ ~~The~~equipment, right-of-use operating lease assets, equity investments, intangible assets and goodwill in connection with impairment evaluations. Such assets are reported at carrying value and are not subject to recurring fair value measurements. We review our long-lived assets for impairment whenever events or changes in circumstances indicate that the carrying amount of ~~goodwill for~~an asset may not be recoverable. Fair value is generally determined based on discounted future cash flow. All our nonrecurring valuations use significant unobservable inputs and therefore fall under Level 3 of the fair value hierarchy.

Intangible Assets. During the nine-month period ended September 30, ~~2017~~2021, we recorded an impairment charge related to acquired intangible assets of approximately $1.6 million. During the three and nine-month periods ended September 30, 2020, we recorded impairment charges related to acquired intangible assets of approximately $18.1 million and $20.5 million, respectively (see Note 6).

Right of Use Operating Lease Assets. During the nine-month periods ended September 30, 2021 and 2020, we identified changes in events and circumstances relating to certain right-of-use (“ROU”) operating lease assets. We compared the anticipated undiscounted cash flows generated by a sublease to the carrying value of the ROU operating lease and related long-lived assets and determined that the carrying values were not recoverable. Consequently, we recorded impairment losses in the nine-month periods ended September 30, 2021 and 2020 of approximately $1.4 million and $1.5 million, respectively, which is equal to the excess of the carrying value of the assets over their estimated fair value. The impairment losses in both periods were driven primarily by site consolidation decisions and changes in our projected cash flows for the ROU operating lease assets and related long-lived assets, due to changes in the real estate market as ~~follows (in thousands):~~a result of the COVID-19 pandemic. These changes include an increase in the anticipated time to identify lessees, an increase in anticipated lease concessions, and a decrease in the expected lease rates for the properties. The ROU operating lease asset impairment losses in both 2021 and 2020 pertained to our cardiovascular segment.

Equity Investments and Purchase Options. During the three and nine-month periods ended September 30, 2021, we had 0 losses related to equity investments and purchase options. During the three-month period ended September 30, 2020 we recorded $2.5 million of impairment expense related to our equity investment of 19.5 percent ownership in preferred shares of Fusion Medical Inc. (“Fusion”) due to uncertainty about future product development and commercialization associated with Fusion’s technology. In addition, during the nine-month period ended September 30, 2020, we recorded a charge of $3.5 million due to our write-off of our purchase option to acquire Bluegrass Vascular Technologies, Inc. (“Bluegrass Vascular”) due to our decision not to exercise our option to purchase the company. The write-off of this equity investment and purchase option pertained to our cardiovascular segment. Our equity investments in privately held companies, including options to acquire these companies, were approximately $14.7 million and $12.0 million as of September 30, 2021 and December 31, 2020, respectively, which are included within other long-term assets in our consolidated balance sheets. We analyze our investments in privately-held companies to determine if they should be

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2017
Goodwill balance at January 1 $ 211,927
Effect of foreign exchange 2,418
Additions as the result of acquisitions 19,698
Goodwill balance at September 30 $ 234,043

accounted for using the equity method based on our ability to exercise significant influence over operating and financial policies of the company in which we have invested. Investments not accounted for under the equity method of accounting are accounted for at cost minus impairment, if applicable, plus or minus changes in valuation resulting from observable transactions for identical or similar investments.

Property and Equipment. During the nine-month period ended September 30, 2021, we had losses of $1.3 million related to the measurement of property and equipment at fair value based on the planned discontinuance of the Advocate™ Peripheral Angioplasty Balloon product line, sold under our license agreements with ArraVasc, which pertained to our cardiovascular segment. During the nine-month period ended September 30, 2020, we recorded losses of $359,000 based on restructuring activities associated with changes to our distribution agreement with NinePoint Medical, Inc. (“NinePoint”), which pertained to our endoscopy segment.

Notes Receivable

Our outstanding long-term notes receivable, including accrued interest and our allowance for current expected credit losses, were approximately $1.9 million and $2.2 million as of September 30, 2021 and December 31, 2020, respectively. As of September 30, ~~2017, we had recorded approximately~~ ~~$8.3 million~~ ~~of accumulated goodwill impairment charges. The goodwill balances as of September 30, 2017~~2021 and December 31, ~~2016, were related~~2020, we had an allowance for current expected credit losses of approximately $1.2 million and $0.7 million, respectively, associated with these notes receivable and our contractual obligation to ~~our cardiovascular segment.~~

~~Other intangible assets at September 30, 2017~~extend credit to Selio. We assess the allowance for current expected credit losses on an individual security basis, due to the limited number of securities, using a probability of default model, which is based on relevant information about past events, including historical experience, current conditions and ~~December 31,~~ ~~2016, consisted~~reasonable and supportable forecasts that affect the expected collectability of securities, and other security specific factors. The table below presents a rollforward of the ~~following (in thousands):~~

September 30, 2017

Gross Carrying
Amount

Accumulated
Amortization

Net Carrying
Amount
Patents $ 15,972
$ (3,586 ) $ 12,386
Distribution agreements 6,626
(4,248 ) 2,378
License agreements 23,804
(4,387 ) 19,417
Trademarks 16,220
(4,342 ) 11,878
Covenants not to compete 1,028
(961 ) 67
Customer lists 25,942
(17,461 ) 8,481
In-process technology 1,100
—
1,100

Total $ 90,692
$ (34,985 ) $ 55,707

December 31, 2016

Gross Carrying
Amount

Accumulated
Amortization

Net Carrying
Amount
Patents $ 14,130
$ (3,165 ) $ 10,965
Distribution agreements 6,626
(3,527 ) 3,099
License agreements 20,695
(3,422 ) 17,273
Trademarks 12,380
(3,330 ) 9,050
Covenants not to compete 1,028
(936 ) 92
Customer lists 22,261
(15,401 ) 6,860
Royalty agreements 267
(267 ) —

Total $ 77,387
$ (30,048 ) $ 47,339

~~Aggregate amortization expense~~allowance for current expected credit losses on our notes receivable for the three and nine-month periods ended September 30, ~~2017 was~~2021 and 2020 (in thousands):


	Three Months Ended				Nine Months Ended
	September 30,				September 30,
	2021		2020		2021		2020
Beginning balance	$	1,107	$	757	$	730	$	—
Cumulative effect adjustment upon adoption of ASU 2016-13, Credit Losses		—		—		—		575
Provision for credit loss expense		113		46		490		228
Ending balance	$	1,220	$	803	$	1,220	$	803

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15. Accumulated Other Comprehensive Income (Loss). The changes in each component of accumulated other comprehensive income (loss) for the three and nine-month periods ended September 30, 2021 and 2020 were as follows:


	Cash Flow Hedges		Foreign Currency Translation		Total
Balance as of June 30, 2021	$	(3,992)	$	(842)	$	(4,834)

Other comprehensive income (loss)		15		(2,873)		(2,858)
Income taxes		(377)		346		(31)
Reclassifications to:
Revenue		1,500				1,500
Cost of sales		(312)				(312)
Interest expense		319				319
Net other comprehensive income (loss)		1,145		(2,527)		(1,382)

Balance as of September 30, 2021	$	(2,847)	$	(3,369)	$	(6,216)


	Cash Flow Hedges		Foreign Currency Translation		Total
Balance as of June 30, 2020	$	(5,190)	$	(7,123)	$	(12,313)

Other comprehensive income (loss)		(1,354)		3,545		2,191
Income taxes		152		(117)		35
Reclassifications to:
Revenue		(157)				(157)
Cost of sales		494				494
Interest expense		425				425
Net other comprehensive income (loss)		(440)		3,428		2,988

Balance as of September 30, 2020	$	(5,630)	$	(3,695)	$	(9,325)

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	Cash Flow Hedges		Foreign Currency Translation		Total
Balance as of December 31, 2020	$	(6,940)	$	1,488	$	(5,452)

Other comprehensive income (loss)		536		(5,535)		(4,999)
Income taxes		(1,349)		678		(671)
Reclassifications to:
Revenue		4,674				4,674
Cost of sales		(966)				(966)
Interest expense		1,198				1,198
Net other comprehensive income (loss)		4,093		(4,857)		(764)

Balance as of September 30, 2021	$	(2,847)	$	(3,369)	$	(6,216)


	Cash Flow Hedges		Foreign Currency Translation		Total
Balance as of December 31, 2019	$	218	$	(5,512)	$	(5,294)

Other comprehensive income (loss)		(8,852)		1,944		(6,908)
Income taxes		2,027		(127)		1,900
Reclassifications to:
Revenue		(666)				(666)
Cost of sales		1,204				1,204
Interest expense		439				439
Net other comprehensive income (loss)		(5,848)		1,817		(4,031)

Balance as of September 30, 2020	$	(5,630)	$	(3,695)	$	(9,325)

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ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

The following discussion and analysis of our financial condition and results of operations should be read in conjunction with the consolidated financial statements and related condensed notes thereto, which are included in Part I of this report. Our future financial condition and results of operations, as well as any forward-looking statements, are subject to inherent risks and uncertainties that may adversely impact our operations and financial results. These risks and uncertainties are discussed in Part I, Item 1A “Risk Factors” in the 2020 Annual Report on Form 10-K.

OVERVIEW

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

For the three-month period ended September 30, 2021, we reported sales of approximately ~~$7.0~~$267.0 million, ~~and~~ ~~$19.4~~up approximately $23.0 million or 9.4%, ~~respectively.~~compared to sales for the three-month period ended September 30, 2020 of approximately $244.0 million. For the nine-month period ended September 30, 2021, we reported sales of approximately $796.3 million, up approximately $90.4 million or 12.8%, compared to sales for the nine-month period ended September 30, 2020 of approximately $705.9 million. For the three and nine-month periods ended September 30, ~~2016, aggregate~~2021, our net sales benefitted approximately $1.4 million and $11.4 million, respectively, from foreign currency fluctuations (net of hedging) assuming applicable foreign exchange rates in effect during the comparable prior-year period.

Gross profit as a percentage of sales increased to 45.1% for the three-month period ended September 30, 2021 compared to 41.8% for the three-month period ended September 30, 2020. Gross profit as a percentage of sales increased to 44.8% for the nine-month period ended September 30, 2021 compared to 41.1% for the nine-month period ended September 30, 2020.

Net income for the three-month period ended September 30, 2021 was approximately $12.0 million, or $0.21 per share, compared to net loss of approximately ($3.0) million, or ($0.05) per share, for the three-month period ended September 30, 2020. Net income for the nine-month period ended September 30, 2021 was approximately $27.8 million, or $0.49 per share, compared to net loss of approximately ($25.2) million, or ($0.46) per share, for the nine-month period ended September 30, 2020.

Recent Developments and Trends

In addition to the trends identified in the 2020 Annual Report on Form 10-K under the heading “Management’s Discussion and Analysis of Financial Condition and Results of Operations - Overview,” our business in 2021 has been impacted, and we believe will continue to be impacted, by the following recent events and trends:

●

We experienced overall improvements in sales trends in the three-month period ended September, with wide variation across regions of the world and within certain geographic regions.

●

During the three months ended September 30, 2021, we saw continued progress of our Wrapsody ArterioVenous (AV) Access Efficacy Pivotal Study (the “WAVE Study”) of the Endovascular Stent Graft, and published the

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results from a prospective, observational, first-in-human study of the Merit WRAPSODY Endoprosthesis in CardioVascular and Interventional Radiology.

●

As part of our Foundations for Growth program we have continued to focus on scrap reduction and manufacturing efficiency across manufacturing sites, which has helped offset inflationary cost pressures in certain raw materials, shipping, and freight expenses.

●

As of September 30, 2021, we had cash on hand of approximately $68.9 million and net available borrowing capacity of approximately $456 million.

RESULTS OF OPERATIONS

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


	Three Months Ended				Nine Months Ended
	September 30,				September 30,
	2021		2020		2021		2020
Net sales	100	%	100	%	100	%	100	%
Gross profit	45.1		41.8		44.8		41.1
Selling, general and administrative expenses	32.4		29.6		32.5		30.9
Research and development expenses	6.4		5.5		6.4		6.0
Legal settlement	—		—		—		2.6
Impairment charges	—		8.4		0.5		4.0
Contingent consideration expense (benefit)	0.4		(1.8)		0.4		0.1
Income (loss) from operations	6.0		0.0		4.9		(2.5)
Other expense — net	(0.7)		(0.9)		(0.7)		(1.3)
Income (loss) before income taxes	5.3		(0.9)		4.2		(3.8)
Net income (loss)	4.5		(1.2)		3.5		(3.6)

Sales

Sales for the three-month period ended September 30, 2021 increased by 9.4%, or approximately $23.0 million, compared to the corresponding period in 2020. Sales for the nine-month period ended September 30, 2021 increased by 12.8%, or approximately $90.4 million, compared to the corresponding period in 2020. Listed below are the sales by product category within each of our financial reporting segments for the three and nine-month periods ended September 30, 2021 and 2020 (in thousands, other than percentage changes):


			Three Months Ended						Nine Months Ended
			September 30,						September 30,
	% Change		2021		2020		% Change		2021		2020
Cardiovascular
Peripheral Intervention	16.5	%	$	101,059	$	86,778	21.5	%	$	299,573	$	246,488
Cardiac Intervention	15.5	%		79,813		69,089	15.7	%		240,203		207,685
Custom Procedural Solutions	(12.4)	%		49,435		56,429	(3.9)	%		143,492		149,369
OEM	21.9	%		29,397		24,117	11.3	%		89,734		80,592
Total	9.9	%		259,704		236,413	13.0	%		773,002		684,134

Endoscopy
Endoscopy devices	(3.2)	%		7,317		7,562	7.0	%		23,257		21,737

Total	9.4	%	$	267,021	$	243,975	12.8	%	$	796,259	$	705,871

Cardiovascular Sales. Our cardiovascular sales for the three-month period ended September 30, 2021 were approximately $259.7 million, up 9.9% when compared to the corresponding period of 2020 of approximately $236.4 million. Sales for the three-month period ended September 30, 2021 were favorably affected by increased sales of:

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(a)

Peripheral intervention products, which increased by approximately $14.3 million, or 16.5%, from the corresponding period of 2020. This increase was driven primarily by sales of our radar localization, drainage, embolotherapy, angiography, intervention, and biopsy products.

(b)

Cardiac intervention products, which increased by approximately $10.7 million, or 15.5%, from the corresponding period of 2020. This increase was driven primarily by sales of our intervention, fluid management (including our Medallion® Syringes, which have seen increased demand due to COVID-19 vaccination efforts), angiography and access products.

(c)

OEM products, which increased by approximately $5.3 million, or 21.9%, from the corresponding period of 2020. This increase was driven primarily by sales of our angiography products and kits.

The foregoing increase in sales for the three-month period ended September 30, 2021 was partially offset by decreased sales of:

(d)

Custom procedural solutions products, which decreased by approximately ($7.0) million, or (12.4)%, from the corresponding period of 2020. This decrease was driven primarily by decreased sales of critical care products (including an ($8.7) million decrease in Cultura^TM nasopharyngeal swab and test kit sales) and trays, offset partially by sales of kits.

Our cardiovascular sales for the nine-month period ended September 30, 2021 were approximately $773.0 million, up 13.0% when compared to the corresponding period of 2020 of approximately $684.1 million. Sales for the nine-month period ended September 30, 2021 were favorably affected by increased sales of:

(a)

Peripheral intervention products, which increased by approximately $53.1 million, or 21.5%, from the corresponding period of 2020. This increase was driven primarily by sales of our radar localization, embolotherapy, drainage, biopsy, angiography and intervention products.

(b)

Cardiac intervention products, which increased by approximately $32.5 million, or 15.7%, from the corresponding period of 2020. This increase was driven primarily by sales of our intervention, fluid management (including our Medallion® Syringes, which have seen increased demand due to COVID-19 vaccination efforts) and angiography products.

(c)

OEM products, which increased by approximately $9.1 million, or 11.3%, from the corresponding period of 2020. This increase was driven primarily by sales of our cardiac rhythm management/electrophysiology (“CRM/EP”) products, angiography products, and coatings.

The foregoing increase in sales for the nine-month period ended September 30, 2021 was partially offset by decreased sales of:

(d)

Custom procedural solutions products, which decreased by approximately ($5.9) million, or (3.9)%, from the corresponding period of 2020. This decrease was driven primarily by sales of critical care products (including a ($11.9) million decrease in Cultura^TM nasopharyngeal swab and test kit sales) and trays, offset partially by increased sales of kits.

Endoscopy Sales. Our endoscopy sales for the three-month period ended September 30, 2021 were approximately $7.3 million, down (3.2)%, when compared to sales in the corresponding period of 2020 of approximately $7.6 million. Sales for the three-month period ended September 30, 2021 were unfavorably affected by decreased sales of our EndoMAXX® fully covered esophageal stent, offset partially by increased sales of other stents and our Elation® Balloon Dilator.

Our endoscopy sales for the nine-month period ended September 30, 2021 were approximately $23.3 million, up 7.0%, when compared to sales in the corresponding period of 2020 of approximately $21.7 million. Sales for the nine-month period ended September 30, 2021 were favorably affected by increased sales of our Elation® Balloon Dilator and other stents.

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Geographic Sales

Sales trends for the three and nine-month periods ended September 30, 2021 and 2020 were influenced by the incidence and timing of COVID-19 infections and the associated governmental and patient responses, which varied between countries and regions in both the current and prior-year periods. Listed below are sales by geography for the three and nine-month periods ended September 30, 2021 and 2020 (in thousands, other than percentage changes):


			Three Months Ended						Nine Months Ended
			September 30,						September 30,
	% Change		2021		2020		% Change		2021		2020
United States	5.9	%	$	151,505	$	143,109	12.3	%	$	451,648	$	402,305
International	14.5	%		115,516		100,866	13.5	%		344,611		303,566
Total	9.4	%	$	267,021	$	243,975	12.8	%	$	796,259	$	705,871

United States Sales.U.S. sales for the three-month period ended September 30, 2021 were approximately $151.5 million, or 56.7% of net sales, up 5.9% when compared to the corresponding period of 2020. The increase in our domestic sales in the three-month period ended September 30, 2021 compared to the three-month period ended September 30, 2020 was driven primarily by our U.S. Direct and OEM businesses.

U.S. sales for the nine-month period ended September 30, 2021 were approximately $451.6 million, or 56.7% of net sales, up 12.3% when compared to the corresponding period of 2020. The increase in our domestic sales for the nine-month period ended September 30, 2021 compared to the nine-month period ended September 30, 2020 was driven primarily by our U.S. direct business.

International Sales. International sales for the three-month period ended September 30, 2021 were approximately $115.5 million, or 43.3% of net sales, up 14.5% when compared to the corresponding period of 2020 of approximately $100.9 million. The increase in our international sales for the three-month period ended September 30, 2021, compared to the three-month period ended September 30, 2020, included increased sales in our Asia Pacific (“APAC”) operations of $6.6 million or 13.2%, in EMEA of $6.0 million or 13.6% and increased sales in the rest of the world (“ROW”) of $2.1 million of 30.6%.

International sales for the nine-month period ended September 30, 2021 were approximately $344.6 million, or 43.3% of net sales, up 13.5% when compared to the corresponding period of 2020 of approximately $303.6 million. The increase in our international sales for the nine-month period ended September 30, 2021, compared to the nine-month period ended September 30, 2020, included increased sales in APAC of $21.8 million or 14.7%, in EMEA of $15.9 million or 11.7%, and in ROW of $3.4 million or 17.2%.

Gross Profit

Our gross profit as a percentage of sales increased to 45.1% for the three-month period ended September 30, 2021, compared to 41.8% for the three-month period ended September 30, 2020. The increase in gross profit percentage was primarily due to changes in product mix, lower amortization expense (as certain intangibles from prior acquisitions became fully amortized), and improvements in manufacturing variances from operational efficiencies and increased production volume, partially offset by higher freight costs.

Our gross profit as a percentage of sales increased to 44.8% for the nine-month period ended September 30, 2021, compared to 41.1% for the nine-month period ended September 30, 2020. The increase in gross profit percentage was ~~approximately $5.7 million and $13.6 million, respectively.~~

~~Estimated~~primarily due to lower amortization expense (as certain intangibles from prior acquisitions became fully amortized), changes in product mix, decreased obsolescence expense as a percentage of sales, and improvements in manufacturing variances from operational efficiencies and increased production volume.

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Operating Expenses

Selling, General and Administrative Expense. Selling, general and administrative ("SG&A") expenses increased approximately $14.3 million, or 19.7%, for the ~~developed technology and other intangible assets~~three-month period ended September 30, 2021 compared to the corresponding period of 2020. As a percentage of sales, SG&A expenses were 32.4% for the ~~next five years consists of the following as of~~three-month period ended September 30, ~~2017 (in thousands):~~

Year Ending December 31
Remaining 2017 $ 6,745
2018 26,152
2019 25,678
2020 24,524
2021 18,013

~~13. Commitments~~2021, compared to 29.6% for the corresponding period of 2020. For the three-month period ended September 30, 2021, compared to the corresponding period of 2020, labor-related costs increased due to higher commissions and ~~Contingencies.~~ In the ordinary course of business, we are involved in various claims and litigation matters. These claims and litigation matters may include actions involving product liability, intellectual property, contractual, and employment matters. We do not believe that any such actions are likely to be, individually or in the aggregate, material to our

business, financial condition, results of operations or liquidity. However, in the event of unexpected further developments, it is possible that the ultimate resolution of these matters, or other similar matters, if unfavorable, may be materially adverse to our business, financial condition, results of operations or liquidity. Legal costs for these matters such as outside counsel fees and expenses are charged tobonus expense in the current-year period, ~~incurred.~~

~~In October 2016, we received a subpoena from the U.S. Department of Justice seeking information on certain of our marketing~~in contrast to temporary salary cuts and ~~promotional practices. We are~~furloughs in the ~~process~~prior-year period. We incurred $4.3 million of ~~responding to~~corporate transformation and restructuring costs, including consulting charges, during the ~~subpoena, which we anticipate will continue during 2017. We have incurred, and anticipate that we will continue to incur, substantial costs~~three-month period ended September 30, 2021 in connection with our Foundations for Growth program, compared to restructuring costs of $2.8 million for the ~~matter.~~three-month period ended September 30, 2020. These increased costs were offset partially by lower idle capacity costs due to increased production compared to the prior-year period.

SG&A expenses increased approximately $41.3 million, or 18.9%, for the nine-month period ended September 30, 2021 compared to the corresponding period of 2020. As a percentage of sales, SG&A expenses were 32.5% for the nine-month period ended September 30, 2021, compared to 30.9% for the corresponding period of 2020. For the nine-month period ended September 30, 2021, compared to the corresponding period of 2020, labor-related costs increased due to higher commissions and bonus expense in the current-year period, in contrast to temporary salary cuts and furloughs in the prior-year period. We incurred ~~approximately $2.1 million and $10.6~~$17.0 million of corporate transformation and restructuring costs, including consulting charges, during the nine-month period ended September 30, 2021 in connection with our Foundations for Growth program, compared to restructuring costs of $6.3 million for the nine-month period ended September 30, 2020. We also recorded approximately $6 million of contract termination costs in SG&A during the nine-month period ended September 30, 2021 to renegotiate certain terms of an acquisition agreement. These increased costs were offset partially by lower idle capacity costs due to increased production compared to the prior-year period.

Research and Development Expenses. Research and development ("R&D") expenses for the three-month period ended September 30, 2021 were approximately $17.0 million, up 25.7%, when compared to R&D expenses in the corresponding period of 2020 of approximately $13.5 million. R&D expenses for the nine-month period ended September 30, 2021 were approximately $50.8 million, up 19.9%, when compared to R&D expenses in the corresponding period of 2020 of approximately $42.4 million. The increase in R&D expenses for the three and nine-month periods ended September 30, ~~2017, respectively, responding~~2021 compared to the ~~pending subpoena~~corresponding periods in 2020 was largely due to increased clinical expenses for certain R&D projects (including our WRAPSODY AV Access Efficacy Study), increased compensation expense due to temporary salary cuts and furloughs in the prior-year periods, and higher expenses related to implementation of the Medical Device Regulation in the European Union.

Legal Settlement. We recorded a settlement in the nine-month period ended September 30, 2020 of $18.2 million in connection with an agreement in principle with the Department of Justice (“DOJ”) to fully resolve the DOJ’s investigation of certain marketing and promotional practices.

Impairment Charges. For the nine-month period ended September 30, 2021 we recorded impairment charges of approximately $4.3 million. These impairments included $1.6 million of intangible assets and $1.3 million of property and equipment due to the planned discontinuance of the Advocate™ Peripheral Angioplasty Balloon product line, sold under our license agreements with ArraVasc, and $1.4 million of impairments of certain ROU operating lease assets due to site consolidation decisions and changes in our projected cash flows for the underlying lease assets.

For the three and nine-month periods ended September 30, 2020, we recorded impairment charges of approximately $20.6 million and $28.3 million, respectively. These impairments included a $3.5 million write-off in the first quarter of 2020 of our purchase option to acquire Bluegrass Vascular due to our decision not to exercise our option to purchase this company, $0.4 million impairment in the first quarter of property and equipment related to our distribution agreement with NinePoint, $2.4 million impairment in the second quarter of the customer list intangible asset from our ITL acquisition, $1.5 million impairment in the second quarter of our right-of-use operating lease asset associated with closure of a facility in California, $2.5 million impairment in the third quarter related to our equity investment in the preferred shares of Fusion due to uncertainty about future product development and commercialization associated with the technologies, and $18.1 in the third quarter for intangible impairment charges based on planned closure and restructuring activities and uncertainty about

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future product development and commercialization associated with the acquired technologies due in part to the economic impacts of the COVID-19 pandemic.

Contingent Consideration Expense (Benefit). For the three and nine-month periods ended September 30, 2021, we recognized contingent consideration expense from changes in the estimated fair value of our contingent consideration obligations stemming from our previously disclosed business acquisitions of approximately $1.1 million and $3.3 million, respectively, compared to contingent consideration expense (benefit) of ($4.4) million and $0.9 million for the three and nine-month periods ended September 30, 2020. Expense (benefit) in each period relates to changes in the probability and timing of achieving certain revenue and operational milestones, as well as expense for the passage of time.

Operating Income (Loss)

The following table sets forth our operating income (loss) by financial reporting segment for the three and nine-month periods ended September 30, 2021 and 2020 (in thousands):


	Three Months Ended				Nine Months Ended
	September 30,				September 30,
	2021		2020		2021		2020
Operating Income (Loss)
Cardiovascular	$	14,411	$	(1,702)	$	33,389	$	(20,662)
Endoscopy		1,520		1,766		5,631		3,093
Total operating income (loss)	$	15,931	$	64	$	39,020	$	(17,569)

Cardiovascular Operating Income (Loss). Our cardiovascular operating income for the three-month period ended September 30, 2021 was approximately $14.4 million, compared to cardiovascular operating loss in the corresponding period of 2020 of approximately ($1.7) million. The increase in cardiovascular operating income during the three-month period ended September 30, 2021 compared to the corresponding period of 2020 was primarily a result of higher sales ($259.7 million compared to $236.4 million), higher gross margin and decreased impairment expense (none in the three-month period ended September 30, 2021 compared to $20.6 million in the three-month period ended September 30, 2020), partially offset by increased SG&A and R&D expenses and higher contingent consideration expense.

Our cardiovascular operating income for the nine-month period ended September 30, 2021 was approximately $33.4 million, compared to cardiovascular operating loss in the corresponding period of 2020 of approximately ($20.7) million. The increase in cardiovascular operating income during the nine-month period ended September 30, 2021 compared to the corresponding period of 2020 was primarily a result of higher sales ($773.0 million compared to $684.1 million), higher gross margin, lower impairment expense ($4.3 million for the nine-month period ended September 30, 2021 compared to $27.9 million for the nine-month period ended September 30, 2020) and the $18.2 million legal settlement expense related to the DOJ inquiry recorded in the prior-year period, partially offset by increased SG&A and R&D expenses and higher contingent consideration expense.

Endoscopy Operating Income. Our endoscopy operating income for the three-month period ended September 30, 2021 was approximately $1.5 million, compared to endoscopy operating income of approximately $1.8 million for the corresponding period of 2020. This decrease in endoscopy operating income was primarily a result of increased operating expenses (due in part to temporary salary reductions and furloughs during the three-month period ended September 30, 2020).

Our endoscopy operating income for the nine-month period ended September 30, 2021 was approximately $5.6 million, compared to endoscopy operating income of approximately $3.1 million for the corresponding period of 2020. This increase in endoscopy operating income was primarily a result of higher sales, improved gross margins (largely a result of the write-off of inventory related to the suspension of our distribution agreement with NinePoint in the first quarter of 2020, which did not repeat in 2021) and decreased impairment expense (none in the nine-month period ended September 30, 2021 compared to approximately $0.4 million in the nine-month period ended September 30, 2020).

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Other Expense

Our other expense for the three-month periods ended September 30, 2021 and 2020 was approximately ($1.8) million and ($2.2) million, respectively. The change in other expense was primarily related to decreased interest expense as a result of a lower effective interest rate and a lower average debt balance and a gain of approximately $0.5 million on the sale of the assets associated with our Hypotube product line in the third quarter of 2020.

Our other expense for the nine-month periods ended September 30, 2021 and 2020 was approximately ($5.3) million and ($8.9) million, respectively. The change in other expense was primarily related to decreased interest expense as a result of a lower effective interest rate and a lower average debt balance, an increase in interest income due to partial recoveries of loan interest from NinePoint which had previously been written off, and a gain of approximately $0.5 million on the sale of the assets associated with our Hypotube product line in the third quarter of 2020.

Effective Tax Rate

Our provision for income taxes for the three-month periods ended September 30, 2021 and 2020 was a tax expense of approximately $2.2 million and $0.8 million, respectively, which resulted in an effective tax rate of 15.6% and (37.7)%, respectively. Our provision for income taxes for the nine-month periods ended September 30, 2021 and 2020 was a tax expense (benefit) of approximately $5.9 million and ($1.3) million, respectively, which resulted in an effective tax rate of 17.5% and 4.7%, respectively. The increase in the income tax expense and the corresponding change in the effective income tax rate for the three and nine-month periods ended September 30, 2021, when compared to the prior-year periods, was primarily due to a pre-tax loss during the 2020 periods, as well as a change in the jurisdictional mix of earnings. Our effective tax rate differs from the U.S. ~~Department~~statutory rate primarily due to the impact of ~~Justice.~~GILTI inclusions, state income taxes, foreign taxes, other non-deductible permanent items and discrete items (such as share-based compensation).

Net Income (Loss)

Our net income (loss) for the three-month periods ended September 30, 2021 and 2020 was approximately $12.0 million and ($3.0) million, respectively. The increase in our net income for the three-month period ended September 30, 2021 was the result of several factors, including increased sales and improved gross margins, lower impairment expense (none in the three-month period ended September 30, 2021 compared to $20.6 million in the three-month period ended September 30, 2020), and lower interest expense, partially offset by increased SG&A expenses, increased R&D expenses and higher contingent consideration expense ($1.1 million expense in the three-month period ended September 30, 2021 compared to ($4.4) million benefit in the three-month period ended September 30, 2020).

Our net income (loss) for the nine-month periods ended September 30, 2021 and 2020 was approximately $27.8 million and ($25.2) million, respectively. This increase in our net income for the nine-month period ended September 30, 2021 was the result of several factors, including increased sales and improved gross margins, the $18.2 million legal settlement related to the DOJ inquiry recorded in the prior-year period, lower impairment expense ($4.3 million in the nine-month period ended September 30, 2021 compared to $28.3 million in the nine-month period ended September 30, 2020), and lower interest expense, partially offset by increased SG&A expenses, which included approximately $6 million of contract termination costs, higher contingent consideration expense ($3.3 million in the nine-month period ended September 30, 2021 compared to $0.9 million in the nine-month period ended September 30, 2020) and increased R&D expenses.

LIQUIDITY AND CAPITAL RESOURCES

Capital Commitments, Contractual Obligations and Cash Flows

At September 30, 2021 and December 31, 2020, our current assets exceeded current liabilities by $250.0 million and $244.7 million, respectively, and we had cash and cash equivalents of approximately $68.9 million and $56.9 million, respectively, of which approximately $63.7 million and $42.3 million, respectively, were held by foreign subsidiaries. We ~~expect~~currently believe future repatriation of cash and other property held by our foreign subsidiaries will generally not be subject to U.S. federal income tax. As a result, we are not permanently reinvested with respect to our historic unremitted foreign

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earnings. In addition, cash held by our subsidiary in China is subject to local laws and regulations that require government approval for the transfer of such funds to entities located outside of China. As of September 30, 2021, and December 31, 2020, we had cash and cash equivalents of approximately $33.6 million and $15.5 million, respectively, within our subsidiary in China.

Cash flows provided by operating activities. We generated cash from operating activities of approximately $101.4 million and $128.4 million during the nine-month periods ended September 30, 2021 and 2020, respectively. Net cash provided by operating activities decreased approximately $26.9 million for the nine-month period ended September 30, 2021 compared to the nine-month period ended September 30, 2020. Significant factors affecting operating cash flows during these periods included:

●

Net income (loss) was approximately $27.8 million and ($25.2) million for the nine-month periods ended September 30, 2021 and 2020, respectively. This improvement in earnings was offset by a decrease in the non-cash adjustment for the write-off of certain intangible and other long-term assets within the statement of cash flows of $4.4 million and $28.4 million for the nine-month periods ended September 30, 2021 and 2020, respectively.

●

Cash provided by (used for) accounts receivable was approximately ($6.2) million and $13.0 million for the nine-month periods ended September 30, 2021 and 2020, respectively, due primarily to increased sales volume during the nine-month period ended September 30, 2021 compared to the corresponding period of 2020.

●

Cash provided by (used for) inventories was approximately ($11.2) million and $15.7 million for the nine-month periods ended September 30, 2021 and 2020, respectively, due primarily to efforts to manage inventory levels to support the growth in sales and reduced production in the prior-year period during the economic downturn related to the COVID-19 pandemic.

Cash flows used in investing activities. We used cash in investing activities of approximately $22.6 million and $36.8 million for the nine-month periods ended September 30, 2021 and 2020, respectively. We used cash for capital expenditures of property and equipment of approximately $19.6 million and $35.6 million in the nine-month periods ended September 30, 2021 and 2020, respectively. Capital expenditures in each period were primarily related to investment in facilities and property and equipment to support development and production of our products, and in 2020, these investments included construction of a new manufacturing and research and development facility in South Jordan, Utah, completed in early 2020. Historically, we have incurred significant expenses in connection with facility construction, production automation, product development and the introduction of new products. We anticipate that we will spend approximately $30 to $40 million in 2021 for buildings, property and equipment.

Cash outflows invested in acquisitions for the nine-month periods ended September 30, 2021 and 2020 were approximately $1.9 million and $0.3 million, respectively. Cash paid for acquisitions for the nine-month period ended September 30, 2021 were primarily related to our settlement of the first deferred payment for our acquisition of KA Medical completed in November 2020.

Cash flows used in financing activities.Cash used in financing activities for the nine-month periods ended September 30, 2021 and 2020 was approximately $66.0 million and $91.2 million, respectively. We decreased our net borrowings by approximately $72.6 and $82.3 million for the nine-month periods ended September 30, 2021 and 2020, respectively, by paying down our debt. We completed payment of contingent consideration of $10.6 million and $13.0 million for the nine-month periods ended September 30, 2021 and 2020, respectively, which is classified as a financing activity, principally related to our acquisitions of Vascular Insights and Cianna Medical, Inc, respectively.

As of September 30, 2021, we had outstanding borrowings of approximately $279 million under the Third Amended Credit Agreement, with additional available borrowings of approximately $456 million, based on the maximum net leverage ratio and the aggregate revolving credit commitment pursuant to the Third Amended Credit Agreement. Our interest rate as of September 30, 2021 was a fixed rate of 2.71% on $75 million as a result of an interest rate swap and a variable floating rate of 1.08% on $204.0 million. Our interest rate as of December 31, 2020 was a fixed rate of 2.37% on $175 million as a result of an interest rate swap and a variable floating rate of 1.40% on $176.6 million.

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We currently believe that our existing cash balances, anticipated future cash flows from operations and borrowings under the Third Amended Credit Agreement will be ~~in a similar range in subsequent periods~~adequate to fund our current and ~~may potentially be higher, depending on~~currently planned future operations for the ~~progress of~~next twelve months and the investigation and other factors beyond our control. The investigation is ongoing and at this stage we are unable to predict its scope, duration or outcome. Investigations such as this may result in the imposition of, among other things, significant damages, injunctions, fines or civil or criminal claims or penalties against our company or individuals.

foreseeable future. In the event we pursue and complete significant transactions or acquisitions in the future, additional funds will likely be required to meet our strategic needs, which may require us to raise additional funds in the debt or equity markets.

Off-Balance Sheet Arrangements

Off-balance sheet arrangements are reported in Part II, Item 7 "Management’s Discussion and Analysis of ~~unexpected further developments, it is possible that the ultimate resolution~~Financial Condition and Results of ~~any~~Operations." of the foregoing matters, or other similar matters, if resolved in a manner unfavorable to us, may be materially adverse to our business, financial condition, results of operations or liquidity. Legal costs for these matters, such as outside counsel fees2020 Annual Report on Form 10-K. In the three and ~~expenses, are charged to expense in the period incurred.~~

~~14. Issuance of Common Stock~~. On March 28, 2017, we closed a public offering of 5,175,000 shares of common stock and received proceeds of approximately $136.6 million, which is net of approximately $8.8 million in underwriting discounts and commissions and approximately $816,000 in other direct cost incurred and paid by us in connection with this equity offering. The net proceedsnine-month periods ended September 30, 2021, there were no material changes from the ~~offering were used primarily to repay outstanding indebtedness under our Second Amended Credit Agreement (including our term loan~~information provided therein.

CRITICAL ACCOUNTING POLICIES AND ESTIMATES

Our financial results are affected by the selection and ~~revolving credit loans).~~

~~15. Subsequent Events. We have evaluated whether any subsequent events have occurred from~~application of accounting policies and methods. In the three and nine-month periods ended September 30, ~~2017~~2021, there were no changes to the ~~time~~application of ~~filing of this report that would require disclosure~~critical accounting policies previously disclosed in ~~the consolidated financial statements. We note the following event below:~~

On October 2, 2017, we entered into a share purchase agreement with ITL Healthcare Pty Ltd, a custom procedure pack business located in Melbourne, Australia. The transaction was financed with a combination of cash and existing credit facilities, which totaled approximately $11.3 million. We are currently evaluating the accounting treatment of this purchase, as well as performing the valuationPart II, Item 7 of the ~~assets acquired and the related purchase price allocation.~~

2020 Annual Report on Form 10-K.

~~ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF~~

~~OPERATIONS~~

~~Disclosure Regarding Forward-Looking Statements~~

CAUTIONARY NOTICE REGARDING FORWARD-LOOKING STATEMENTS

This ~~Report~~report includes “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). All statements in this ~~Report,~~report, other than statements of historical fact, are ~~forward-looking statements~~“forward-looking statements” for purposes of these provisions, including, without limitation, any projections of earnings, revenues or other financial items, any statements of the plans and objectives of our management for future operations, any statements concerning proposed new products or services, any statements regarding the integration, development or commercialization of the business or any assets acquired from other parties, any statements regarding future economic conditions or performance, and any statements of assumptions underlying any of the foregoing. All forward-looking statements included in this ~~Report~~report are made as of the date hereof and are based on information available to us as of such date. We assume no obligation to update any forward-looking statement. In some cases, forward-looking statements can be identified by the use of terminology such as “may,” “will,” “expects,” “plans,” “should,” “anticipates,” “intends,” “seeks,” “believes,” “estimates,” “potential,” “forecasts,” “continue,” or other forms of these words or similar words or expressions, or the negative thereof or other comparable terminology. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, projections, anticipated events and trends, the economy and other future conditions. Although we believe that the expectations reflected in the forward-looking statements contained herein are reasonable, there can be no assurance that such expectations or any of the forward-looking statements will prove to be ~~correct, and our actual~~correct. Actual results will likely ~~vary,~~differ, and ~~may vary~~could differ materially, from those projected or assumed in the forward-looking statements. Prospective investors are cautioned not to unduly rely on any such forward-looking statements.

~~Our financial condition and results of operations, as well as any forward-looking statements, are subject to inherent risks and uncertainties, including the following:~~

~~risks relating to product recalls and product liability claims;~~

~~potential restrictions on our liquidity or our ability to operate our business within the term of our current credit agreement, and the consequences of any default under that agreement;~~

~~risks relating to protecting our intellectual property, including possible infringement of our intellectual property by third parties;~~

the assertion that our technology infringes the intellectual property rights of other parties, which could cause us to incur significant legal or licensing expenses and prevent us from selling our products;

~~our potential inability to successfully manage growth through acquisitions, including the inability to commercialize technology acquired through recent, proposed or future acquisitions;~~

expenditures relating to research, development, testing and regulatory approval or clearance of our products and the risk that such products may not be developed successfully or approved for commercial use;

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

~~reforms to the 510(k) process administered by the U.S. Food and Drug Administration (the "FDA");~~

~~risks relating to our products being used in unapproved circumstances;~~

~~investigations or actions under laws targeting fraud and abuse in the healthcare industry;~~

~~potential for significant adverse changes in, or our failure to comply with, governing regulations;~~

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

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

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

~~consequences of a covenant or payment breach under our debt agreements and instruments, which could lead to an unfavorable refinance or work-out arrangement or foreclosure on our assets;~~

~~increases in the price of commodity components;~~

~~negative changes in economic and industry conditions in the United States and other countries;~~

~~termination or interruption of relationships with our suppliers, or failure of such suppliers to perform;~~

~~fluctuations in exchange rates for Euro, CNY, GBP or other foreign currencies:~~

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

~~the potential imposition of fines, penalties, or other adverse consequences if our employees or agents violate the U.S. Foreign Corrupt Practices Act or other laws or regulations;~~

~~concentration of our revenues among a few products and procedures;~~

~~development of new products and technology that could render our existing products obsolete;~~

~~market acceptance of new products;~~

~~volatility in the market price of our common stock;~~

~~modification or limitation of governmental or private insurance reimbursement policies;~~

~~changes in healthcare markets related to healthcare reform initiatives;~~

~~failures to comply with applicable environmental laws;~~

~~changes in, or loss of, key personnel;~~

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

~~work stoppage or transportation risks;~~

~~uncertainties associated with potential healthcare policy changes which may have a material adverse effect on our business and results of operations;~~

~~introduction of products in a timely fashion;~~

~~price and product competition;~~

~~availability of labor and materials;~~

~~cost increases;~~

~~fluctuations in and obsolescence of inventory; and~~

~~other factors referred to in the 2016 Form 10-K and other materials filed with the Securities and Exchange Commission.~~

All ~~subsequent~~ forward-looking statements attributable to us or persons acting on our behalf are expressly qualified in their entirety by these cautionary statements. Our actual results will likely differ, and may differ materially, from anticipated results. Financial estimates are subject to change and are not intended to be relied upon as predictions of future operating results, and we assume no obligation to update or disclose revisions to those estimates. ~~Additional factors~~If we do update or correct one or more forward-looking statements, investors and others should not conclude that ~~may have a direct bearing on our operating results are discussed in Part I, Item 1A “Risk Factors” in the 2016 Form 10-K.~~

~~Disclosure Regarding Trademarks~~

we will make additional updates or corrections.

NOTICE REGARDING TRADEMARKS

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

~~OVERVIEW~~

Table of Contents

~~The following discussion~~

ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

Quantitative and ~~analysis of our financial condition and results of operations should be read in conjunction with the consolidated financial statements and related condensed notes thereto, which~~qualitative disclosures about exchange rate risk are included in Part III, Item 7A "Quantitative and Qualitative Disclosures About Market Risk" of ~~this Report.~~

We design, develop, manufacture and market single-use medical products for interventional, diagnostic and therapeutic procedures. For financial reporting purposes, we report our operations in two operating segments: cardiovascular and endoscopy. Our cardiovascular segment consists of cardiology and radiology devices, which assist in diagnosing and treating coronary arterial disease, peripheral vascular disease and other non-vascular diseases and includes embolotherapeutic, cardiac rhythm management ("CRM"), electrophysiology ("EP"), and interventional oncology and spine devices. Our endoscopy segment consists of gastroenterology and pulmonology devices which assist in the ~~palliative treatment of expanding esophageal, tracheobronchial and biliary strictures caused by malignant tumors.~~

For the three-month period ended September 30, 2017, we reported sales of approximately $179.3 million, up approximately $22.4 million or 14.2%, over sales from the three-month period ended September 30, 2016 of approximately $157.0 million. For the nine-month period ended September 30, 2017, we reported sales of approximately $537.0 million, up approximately $90.8 million or 20.4%, over sales for the nine-month period ended September 30, 2016 of approximately $446.1 million.

Gross profit as a percentage of sales increased to 44.9% for the three-month period ended September 30, 2017 as compared to 43.2% for the three-month period ended September 30, 2016. Gross profit as a percentage of sales increased to 44.8% for the nine-month period ended September 30, 2017 as compared to 43.7% for the nine-month period ended September 30, 2016.

Net income for the three-month period ended September 30, 2017 was a loss of approximately $(3.6) million, or $(0.07) per share, as compared to income of approximately $973,000, or $0.02 per share, for the three-month period ended September 30, 2016. For the nine-month period ended September 30, 2017, net income was approximately $20.7 million, or $0.42 per share, as compared to $12.6 million, or $0.28 per share, for the nine-month period ended September 30, 2016.

~~We anticipate that our business in 2017 will continue to be impacted by the trends identified in the 2016~~2020 Annual Report on Form ~~10-K under the heading “Management’s Discussion and Analysis of Financial Condition and Results of Operations - Overview.”~~

~~RESULTS OF OPERATIONS~~

~~The following table sets forth certain operational data as a percentage of sales for~~10-K. In the three and nine-month periods ended September 30, ~~2017 and 2016, as indicated:~~

Three Months Ended September 30, Nine Months Ended September 30,
2017 2016 2017 2016
Net sales 100% 100% 100% 100%
Gross profit 44.9 43.2 44.8 43.7
Selling, general and administrative expenses 30.5 33.9 31.6 31.1
Research and development expenses 7.2 7.3 7.2 7.5
Contingent consideration expense (benefit) — (0.1) — —
Acquired in-process research and development 6.7 0.2 2.3 0.1
Income from operations 0.5 1.9 3.7 5.0
Other income (expense) - net (1.7) (1.9) 0.9 (1.5)
Income (loss) before income taxes (1.2) — 4.6 3.5
Net income (loss) (2.0) 0.6 3.9 2.8

~~Sales.~~ Sales for the three-month period ended September 30, 2017 increased by 14.2%, or approximately $22.4 million, compared to the corresponding period in 2016. Sales for the nine-month period ended September 30, 2017 increased by 20.4%, or approximately $90.8 million, compared to the corresponding period of 2016. Listed below are the net sales by product category within each of our business segments for the three and nine-month periods ended September 30, 2017 and 2016 (in thousands):

Three Months Ended September 30, Nine Months Ended September 30,
% Change 2017 2016 % Change 2017 2016
Cardiovascular ⁽¹⁾

Stand-alone devices 34.2% $ 68,724
$ 51,195
45.6% $ 203,434
$ 139,729
Custom kits and procedure trays 0.7% 30,436
30,223
2.2% 91,107
89,164
Inflation devices 9.0% 20,033
18,371
8.3% 59,329
54,774
Catheters 5.3% 31,751
30,139
12.2% 94,357
84,078
Embolization devices 9.3% 12,252
11,207
8.8% 36,936
33,937
CRM/EP 1.7% 9,527
9,368
18.9% 31,977
26,889
Total 14.8% 172,723
150,503
20.7% 517,140
428,571

Endoscopy ⁽¹⁾

Endoscopy devices 2.2% 6,614
6,472
12.9% 19,815
17,552

Total 14.2% $ 179,337
$ 156,975
20.4% $ 536,955
$ 446,123

~~(1) Net sales and operating income have been adjusted from earlier reported year-to-date amounts for 2017 and 2016 to reflect~~2021, there were no material changes ~~in product classifications between our operating segments, which were made to be consistent with updates in the management of our product portfolios in the third quarter of 2017.~~

Our cardiovascular sales for the three-month period ended September 30, 2017 were approximately $172.7 million, up 14.8%, when compared to the corresponding period for 2016 of approximately $150.5 million. Sales for the three-month period ended September 30, 2017 were favorably affected by increased sales of (a) our stand-alone devices (particularly our Map™, Medallion, and HeRO® Graft products, as well as new sales from our acquisitions of the Argon and Catheter Connections product lines) of approximately $17.5 million, up 34.2%; (b) our inflation devices of approximately $1.7 million, up 9.0%; (c) our catheters (particularly our SwiftNINJA® product line, Concierge® Guiding Catheters, and our Maestro® microcatheters) of approximately $1.6 million, up 5.3%; and (d) our embolization devices of approximately $1.0 million, up 9.3%.

Our cardiovascular sales increased approximately $88.6 million, or 20.7%, for the nine-month period ended September 30, 2017, on sales of approximately $517.1 million, compared to sales of approximately $428.6 million for the corresponding period of 2016. Sales for the nine-month period ended September 30, 2017 were favorably affected by increased sales of (i) our stand-alone devices (particularly our Map, Medallion, Vaclock, HeRO® Graft and Ensnare products, as well as new sales from our acquisitions of the DFINE, Argon and Catheter Connections product lines) of approximately $63.7 million, up 45.6%; (ii) catheters (particularly

our SwiftNINJA® product line, Concierge® guiding catheters, Performa® vessel-sizing catheters, and Maestro® microcatheters) of approximately $10.3 million, up 12.2%; and (iii) CRM/EP of approximately $5.1 million, up 18.9%.

Our endoscopy sales for the three-month period ended September 30, 2017 were approximately $6.6 million, up 2.2%, when compared to sales in the corresponding period of 2016 of approximately $6.5 million. Our endoscopy sales increased 12.9% for the nine-month period ended September 30, 2017, on sales of approximately $19.8 million, when compared to sales for the corresponding period of 2016 of approximately $17.6 million. The increase in both periods was primarily related to an increase in sales of our EndoMAXX™ fully covered esophageal stent, as well as the introduction of our Elation® balloon dilator.

~~Gross Profit.~~ Gross profit as a percentage of sales increased to 44.9% for the three-month period ended September 30, 2017, compared to 43.2% for the corresponding period of 2016. Gross profit as a percentage of sales increased to 44.8% for the nine-month period ended September 30, 2017, compared to 43.7% for the nine-month period ended September 30, 2016. The increase was primarily due to changes in product mix and increased efficiencies gained from our operations team.

~~Operating Expenses.~~ Selling, general and administrative ("SG&A") expenses increased approximately $1.5 million, or 2.9%, for the three-month period ended September 30, 2017, compared to the three-month period ended September 30, 2016. As a percentage of sales, SG&A expenses decreased to 30.5% of sales for the three-month period ended September 30, 2017, compared to 33.9% of sales for the three-month period ended September 30, 2016. SG&A expenses increased approximately $31.3 million, or 22.6%, for the nine-month period ended September 30, 2017, compared to the nine-month period ended September 30, 2016. As a percentage of sales, SG&A expenses increased to 31.6% of sales for the nine-month period ended September 30, 2017, compared to 31.1% of sales for the nine-month period ended September 30, 2016. The increase in SG&A expense was primarily related to acquisition and integration costs, legal expenses of approximately of $2.1 million and $10.6 million for the three and nine months ended September 30, 2017, respectively, incurred in responding to the pending subpoena from the ~~U.S. Department of Justice, increased headcount, increased amortization, and foreign market expansion.~~

~~Research and Development Expenses.~~ Research and development expenses for the three-month period ended September 30, 2017 were approximately $12.8 million, up 12.4% when compared to research and development expenses in the corresponding period of 2016 of approximately $11.4 million. Research and development expenses for the nine-month period ended September 30, 2017 were approximately $38.7 million , up 15.7%, when compared to research and development expenses in the corresponding period of 2016 of approximately $33.4 million. The increase in both periods was largely due to hiring additional research and development personnel to support various new core and acquired product developments.

~~Acquired in-process research and development.~~ Acquired in-process research and development expenses ("Acquired R&D") for the three-month period ended September 30, 2017 were approximately $12.1 million, up $11.8 million when compared to acquired R&D expenses in the corresponding period of 2016 of approximately $300,000. Acquired R&D expenses for the nine-month period ended September 30, 2017 were approximately $12.1 million, up $11.7 million, when compared to acquired R&D expenses in the corresponding period of 2016 of approximately $400,000. This increase was driven primarily by the acquisition of IntelliMedical and its intellectual property rights associated with a steerable guidewire system as discussed in Note 5 of the condensed notes to our consolidated financial statements.

~~Operating Income.~~ ~~The following table sets forth our operating income by business segment for the three and nine-month periods ended September 30, 2017 and 2016 (in thousands):~~

Three Months Ended September 30, Nine Months Ended September 30,
2017 2016 2017 2016
Operating Income (Loss) ⁽¹⁾

Cardiovascular (1,207 ) 1,858
14,239
19,385
Endoscopy 2,086
1,129
5,611
2,889
Total operating income 879
2,987
19,850
22,274

(1) Net sales and operating income have been adjusted from earlier reported year-to-date amounts for 2017 and 2016 to reflect changes in product classifications between our operating segments, which were made to be consistent with updates in the management of our product portfolios in the third quarter of 2017.

~~Cardiovascular Operating Income (Loss).~~ Our cardiovascular operating loss for the three-month period ended September 30, 2017 was approximately $(1.2) million, compared to our cardiovascular operating income of approximately $1.9 million for the three-month period ended September 30, 2016. The decrease in cardiovascular operating income was primarily related to the acquired in-process research and development expenses of $12.1 million attributable to the IntelliMedical acquisition and $2.1 million of legal expenses incurred in responding to the pending subpoena from the U.S. Department of Justice, which were partially offset

by increased sales and gross margin improvements. Our cardiovascular operating income for the nine-month period ended September 30, 2017 was approximately $14.2 million, compared to our cardiovascular operating income of approximately $19.4 million for the nine-month period ended September 30, 2016. The decrease in cardiovascular operating income between the nine months ended September 30, 2017 and the nine months ended September 30, 2016 was primarily related to headcount additions, $10.6 million of legal expenses incurred in responding to the pending subpoena from the U.S. Department of Justice, the acquired in-process research and development expenses of $12.1 million and acquisition and integration-related costs, which were partially offset by increased sales and gross margin improvements.

~~Endoscopy Operating Income.~~ Our endoscopy operating income for the three-month period ended September 30, 2017 was approximately $2.1 million, compared to approximately $1.1 million for the three-month period ended September 30, 2016. Our endoscopy operating income for the nine-month period ended September 30, 2017 was approximately $5.6 million, compared to approximately $2.9 million for the nine-month period ended September 30, 2016. The increases in endoscopy operating income for the three and nine-months ended September 30, 2017 were primarily the result of higher sales and gross margin improvements, partially offset by higher SG&A expenses.

~~Income Taxes.~~ Our provision for income taxes for the three months ended September 30, 2017 was a tax expense of approximately $1.4 million compared to a tax benefit of $978,000 for the corresponding period of 2016. This was primarily due to the discrete tax impact of the in-process research and development charge attributable to the IntelliMedical acquisition completed in the third quarter of 2017, which was not deductible for tax purposes. Our provision for income taxes for the nine months ended September 30, 2017 and 2016 was a tax expense of approximately $3.9 million and $3.1 million, respectively, which resulted in an effective tax rate of 15.8% and 20.0%, respectively. The decrease in the effective income tax rate for the nine-month period ended September 30, 2017, when compared to the corresponding period of 2016, was primarily related to a discrete tax benefit related to share-based payment awards due to application of ASU No. 2016-09 and a nontaxable gain on the bargain purchase recorded relating to the acquisition of the critical care division of Argon.

~~Other Income (Expense) - Net.~~ Our other income (expense) for the three-month periods ended September 30, 2017 and 2016 was expense of approximately $(3.1) million and $(3.0) million, respectively. The increase in other expense was principally the result of a reduction to the gain on bargain purchase related to the acquisition of the Argon critical care division of approximately $(778,000), which was offset by lower interest expense due to lower average debt balances.

Our other income (expense) for the nine-month periods ended September 30, 2017 and 2016 was income of approximately $4.8 million and expense of approximately $(6.5) million, respectively. The change in other income (expense) was principally the result of a gain on bargain purchase related to the acquisition of the Argon critical care division of approximately $10.8 million.

~~Net Income (Loss).~~ We experienced a net loss for the three-month period ended September 30, 2017 of approximately $(3.6) million, compared to net income for the three-month period ended September 30, 2016 of approximately $1.0 million. Our net income for the nine-month periods ended September 30, 2017 and 2016 was approximately $20.7 million and $12.6 million, respectively. The net loss for the three months ended September 30, 2017 was primarily due to the acquired in-process research and development expenses of $12.1 million primarily attributable to the IntelliMedical acquisition, which was partially offset by increased sales, gross margin improvement and a discrete tax benefit related to share-based payment awards due to application of ASU No. 2016-09 which decreased our effective income tax rate.

Our net income for the nine-month periods ended September 30, 2017 and 2016 was approximately $20.7 million and $12.6 million, respectively. The increase in net income for the nine months ended September 30, 2017 was primarily due to increased sales, gross margin improvement and the gain on bargain purchase of approximately $10.8 million related to the acquisition of the Argon critical care division and a discrete tax benefit related to share-based payment awards due to application of ASU No. 2016-09 (which decreased our effective income tax rate), which was partially offset by the acquired in-process research and development expenses of $12.1 million attributable to the IntelliMedical acquisition, approximately $10.6 million of legal expenses incurred in responding to the pending subpoena from the U.S. Department of Justice, and approximately $5.0 million of acquisition and integration-related costs.

information provided therein.

~~LIQUIDITY AND CAPITAL RESOURCES~~

~~Capital Commitments, Contractual Obligations and Cash Flows~~

At September 30, 2017 and December 31, 2016, we had cash and cash equivalents of approximately $23.4 million and $19.2 million respectively, of which $21.6 million and $18.4 million, respectively, were held by foreign subsidiaries. For each of our foreign subsidiaries, we make an evaluation as to whether the earnings are intended to be repatriated to the United States or held by the foreign subsidiary for permanent reinvestment. The cash held by our foreign subsidiaries for permanent reinvestment is

used to fund the operating activities of our foreign subsidiaries and for further investment in foreign operations. A deferred tax liability has been accrued for the earnings that are available to be repatriated to the United States.

In addition, cash held by our subsidiary in China is subject to local laws and regulations that require government approval for the transfer of such funds to entities located outside of China. As of September 30, 2017 and December 31, 2016, we had cash and cash equivalents of approximately $14.5 million and $9.5 million, respectively, held by our subsidiary in China.

~~Cash flows provided by operating activities.~~ Cash provided by operating activities during the nine-month periods ended September 30, 2017 and 2016 was primarily the result of net income excluding non-cash items offset by shifts in working capital. Our working capital as of September 30, 2017 and December 31, 2016 was approximately $192.1 million and $155.1 million, respectively. The increase in working capital as of September 30, 2017 compared to December 31, 2016 was primarily the result of increases in cash, trade receivables, inventories and prepaid expenses, which were partially offset by an increase in accrued expenses and the current portion of long-term debt. As of September 30, 2017 and December 31, 2016, we had a current ratio of 2.78 to 1 and 2.76 to 1, respectively.

During the nine-month period ended September 30, 2017, our inventory balance increased approximately $24.9 million, from approximately $120.7 million as of December 31, 2016 to approximately $145.6 million as of September 30, 2017. The increase in the inventory balance was due, in large part, to the acquisition of Catheter Connections and the critical care division of Argon. The trailing twelve-month inventory turns as of September 30, 2017 decreased to 2.92, compared to 3.00 as of September 30, 2016.

~~Cash flows provided by financing activities.~~ Net cash provided by financing activities for the nine-month period ended September 30, 2017 was approximately $95.7 million, compared to cash provided by financing activities of approximately $123.5 million for the nine-month period ended September 30, 2016, a decrease of approximately $27.8 million. The decrease in net cash provided from financing activities was primarily the result of a decrease of approximately $52.0 million in proceeds from the issuance of long-term debt in the nine months ended September 30, 2017 and an increase of approximately $115.3 million in payments on long-term debt during the same period, partially offset by our public equity offering of 5,175,000 shares of common stock. We received net proceeds of approximately $136.6 million which is net of approximately $8.8 million in underwriting discounts and commissions and approximately $816,000 in other direct cost incurred and paid by us in connection with this equity offering.

On February 23, 2017, we entered into a loan agreement with HSBC Bank, whereby HSBC Bank agreed to provide us with a loan in the amount of approximately $7.0 million. The loan matures on February 1, 2018, with an extension available at our option, subject to certain conditions. The loan agreement bears interest at the three-month LIBOR rate plus 1.0%, and resets quarterly. The loan is secured by assets equal to the currently outstanding loan balance. The loan contains covenants, representations and warranties and other terms customary for loans of this nature. Our interest rate as of September 30, 2017 was a variable rate of 2.32%.

Our Second Amended Credit Agreement provides for a term loan of $150 million and a revolving credit commitment up to an aggregate amount of $275 million, which includes a reserve of $25 million to make swingline loans from time to time. The term loan is payable in quarterly installments in the amounts provided in the Second Amended Credit Agreement until the maturity date of July 6, 2021, at which time the term and revolving credit loans, together with accrued interest thereon, will be due and payable. At any time prior to the maturity date, we may repay any amounts owing under all revolving credit loans, term loans, and all swingline loans in whole or in part, subject to certain minimum thresholds, without premium or penalty, other than breakage costs.

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

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



		~~Covenant Requirement~~
~~Consolidated Total Leverage Ratio (1)~~
	~~July 1, 2017 through December 31, 2017~~	~~3.75 to 1.0~~
	~~January 1, 2018 through March 31, 2018~~	~~3.5 to 1.0~~
	~~April 1, 2018 and thereafter~~	~~3.25 to 1.0~~
~~Consolidated EBITDA (2)~~		~~1.25 to 1.0~~
~~Consolidated Net Income (3)~~		$0
~~Facility Capital Expenditures (4)~~		~~$30 million~~

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

Additionally, the Second Amended Credit Agreement contains customary events of default and affirmative and negative covenants for transactions of this type. As of September 30, 2017, we believe we were in compliance with all covenants set forth in the Second Amended Credit Agreement.

As of September 30, 2017, we had outstanding borrowings of approximately $271.5 million under the Second Amended Credit Agreement, with available borrowings of approximately $91.0 million, based on the leverage ratio required pursuant to the Second Amended Credit Agreement. Our interest rate as of September 30, 2017 was a fixed rate of 2.23% on $126.3 million and a fixed rate of 2.37% on $48.8 million as a result of interest rate swaps (see Note 10 of the condensed notes to our consolidated financial statements), a variable floating rate of 2.49% on $84.5 million and a variable floating rate of 2.49% on $12.0 million. Our interest rate as of December 31, 2016 was a fixed rate of 2.98% on $130.0 million and 3.12% on $45.0 million as a result of interest rate swaps and a variable floating rate of 2.77% on approximately $150.0 million.

~~Cash flows used in investing activities.~~Our cash flow used in investing activities for the nine-month period ended September 30, 2017 was approximately $134.9 million, compared to approximately $146.8 million for the nine-month period ended September 30, 2016, a decrease of approximately $11.9 million. This decrease was primarily a result of a decrease of approximately $16.3 million in net cash paid for acquisitions during the nine months ended September 30, 2017, compared to the nine months ended September 30, 2016 (see Note 5 of the condensed notes to our consolidated financial statements), partially offset by a $3.0 million increase in capital expenditures for property and equipment. In the event we pursue and complete significant transactions or acquisitions in the future, additional funds will likely be required to meet our strategic needs, which may require us to raise additional funds in the debt or equity markets.

~~Capital expenditures for property and equipment were approximately $29.5 million and $26.5 million for the nine-month periods ended September 30, 2017 and 2016, respectively.~~

We currently believe that our existing cash balances, anticipated future cash flows from operations, equipment financing and borrowings under the Second Amended Credit Agreement will be adequate to fund our current and currently planned future operations for the next twelve months and the foreseeable future; however, if we pursue and complete significant transactions or acquisitions in the future, additional funds may be required to facilitate such transactions.

~~Critical Accounting Policies and Estimates~~

The SEC has requested that all registrants address their most critical accounting policies. The SEC has indicated that a “critical accounting policy” is one which is both important to the representation of the registrant’s financial condition and results and requires management’s most difficult, subjective or complex judgments, often as a result of the need to make estimates about the effect of matters that are inherently uncertain. We base our estimates on past experience and on various other assumptions our management believes to be reasonable under the circumstances, the results of which form the basis for making judgments about carrying values of assets and liabilities that are not readily apparent from other sources. Actual results will differ, and may differ materially from these estimates under different assumptions or conditions. Additionally, changes in accounting estimates could

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

~~Inventory Obsolescence.~~ On a quarterly basis, our management reviews inventory quantities on hand for unmarketable and/or slow-moving products that may expire prior to being sold. This review includes quantities on hand for both raw materials and finished goods. Based on this review, we provide adjustments for any slow-moving finished good products or raw materials that we believe will expire prior to being sold or used to produce a finished good and any products that are unmarketable. This review of inventory quantities for unmarketable and/or slow-moving products is based on forecasted product demand prior to expiration lives.

Forecasted unit demand is derived from our historical experience of product sales and production raw material usage. If market conditions become less favorable than those projected by our management, additional inventory write-downs may be required. During the years ended December 31, 2016, 2015 and 2014, we recorded obsolescence expense of approximately $3.9 million, $2.8 million, and $2.3 million, respectively, and wrote off approximately $2.8 million, $2.5 million, and $2.4 million, respectively. Based on this historical trend, we believe that our inventory balances as of September 30, 2017 have been accurately adjusted for any unmarketable and/or slow-moving products that may expire prior to being sold.

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

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

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

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

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

We evaluate the recoverability of intangible assets whenever events or changes in circumstances indicate that an asset's carrying amount may not be recoverable. This analysis requires similar significant judgments as those discussed above regarding goodwill, except that undiscounted cash flows are compared to the carrying amount of intangible assets to determine if impairment exists. All our intangible assets are subject to amortization.

Contingent consideration is an obligation by the buyer to transfer additional assets or equity interests to the former owner upon reaching certain performance targets. Certain of our business combinations involve the potential for the payment of future contingent consideration, generally based on a percentage of future product sales or upon attaining specified future revenue milestones. In connection with a business combination, any contingent consideration is recorded on the acquisition date based upon the consideration expected to be transferred in the future. We utilize a discounted cash flow method, which includes a probability factor for milestone payments, in valuing the contingent consideration liability. We re-measure the estimated liability each quarter and record changes in the estimated fair value through operating expense in our consolidated statements of income. Significant increases or decreases in our estimates could result in changes to the estimated fair value of our contingent consideration liability, as the result of changes in the timing and amount of revenue estimates, as well as changes in the discount rate or periods.

~~ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK~~

~~Currency Risk.~~Our principal market risk relates to changes in the value of the Euro (EUR), Chinese Yuan Renminbi (CNY), and British Pound (GBP) relative to the value of the U.S. Dollar (USD). We also have a limited market risk relating to the Hong Kong Dollar (HKD), Mexican Peso (MXN), Australian Dollar (AUD), Canadian Dollar (CAD), Brazilian Real (BRL), Swiss Franc (CHF), Swedish Krona (SEK), Danish Krone (DKK), Singapore Dollar (SGD), Japanese Yen (JPY), and South Korean Won (KRW). Our consolidated financial statements are denominated in, and our principal currency is, the U.S. Dollar. For the three-month period ended September 30, 2017, a portion of our net sales (approximately $53.4 million, representing approximately 29.8% of our aggregate net sales), was attributable to sales that were denominated in foreign currencies. All other international sales were denominated in U.S. Dollars. Our Euro-denominated revenue represents our largest single currency risk. However, our Euro-denominated expenses associated with our European operations (manufacturing sites, a distribution facility and sales representatives) provide a natural hedge. Accordingly, a strengthening of the U.S. Dollar against the Euro, will positively affect our net income. Excluding the effect of our hedging program, a strengthening U.S. Dollar against the Euro of 10% would increase our annual net income by approximately $2.2 million. Conversely, a weakening U.S. Dollar against the Euro of 10% would decrease our annual net income by approximately $2.2 million. A strengthening U.S. Dollar against the Chinese Yuan Renminbi of 10% would decrease our annual net income by approximately $5.5 million. Conversely, a weakening U.S. Dollar against the Chinese Yuan Renminbi of 10% would increase our annual net income by approximately $5.5 million dollars. During the three-month period ended September 30, 2017, using the foreign exchange rates in effect during the comparable prior-year period, exchange rate fluctuations of foreign currencies against the U.S. Dollar resulted in an increase in our gross revenues of approximately $1.0 million, or 0.6%, and an increase in gross margin of approximately $0.8 million, or 1.0% (or approximately 50 basis points in gross margin percentage), primarily as a result of favorable impacts to revenue due to sales denominated in EUR, CAD, BRL, and AUD, partially offset by unfavorable impacts due to decreases in manufacturing costs from our facility in Tijuana, Mexico denominated in MXN and from our facility in Ireland denominated in EUR.

We forecast our net exposure in various receivables and payables to fluctuations in value of various currencies, and we enter into foreign currency forward contracts to mitigate that exposure. As of September 30, 2017, we had entered into the following foreign currency forward contracts (which were not designated as hedging instruments) related to those balance sheet accounts (amounts in thousands and in local currencies):



~~Currency~~	~~Symbol~~	~~Forward Notional Amount~~
~~Euro~~	~~EUR~~	~~21,801~~
~~British Pound~~	~~GBP~~	~~1,128~~
~~Chinese Yuan Renminbi~~	~~CNY~~	~~39,954~~
~~Mexican Peso~~	~~MXN~~	~~17,537~~
~~Brazilian Real~~	~~BRL~~	~~8,500~~
~~Australian Dollar~~	~~AUD~~	~~4,599~~
~~Hong Kong Dollar~~	~~HKD~~	~~11,000~~
~~Swiss Franc~~	~~CHF~~	~~278~~
~~Swedish Krona~~	~~SEK~~	~~6,007~~
~~Canadian Dollar~~	~~CAD~~	~~1,968~~
~~Singapore Dollar~~	~~SGD~~	~~3,585~~
~~Japanese Yen~~	~~JPY~~	~~178,500~~
~~South Korean Won~~	~~KRW~~	~~1,800,000~~

We also forecast our net exposure related to sales and expenses denominated in foreign currencies. As of September 30, 2017, we had entered into foreign currency forward contracts, which qualified as cash flow hedges, with the following notional amounts (in thousands and in local currencies):



~~Currency~~	~~Symbol~~	~~Forward Notional Amount~~
~~Euro~~	~~EUR~~	~~5,555~~
~~Swiss Franc~~	~~CHF~~	~~1,088~~
~~Danish Krone~~	~~DKK~~	~~7,775~~
~~British Pound~~	~~GBP~~	~~2,550~~
~~Mexican Peso~~	~~MXN~~	~~64,425~~
~~Swedish Krona~~	~~SEK~~	~~10,805~~

~~See Note 10 to our consolidated financial statements for a discussion of our foreign currency forward contracts.~~

~~Interest Rate Risk.~~ As discussed in Note 9 to our consolidated financial statements, we had outstanding borrowings of approximately $271.5 million under the Second Amended Credit Agreement as of September 30, 2017. Accordingly, our earnings and after-tax cash flow are affected by changes in interest rates. As part of our efforts to mitigate interest rate risk, on December 19, 2012, we entered into a LIBOR-based interest rate swap agreement having an initial notional amount of $150.0 million with Wells Fargo to fix the one-month LIBOR rate at 0.98%. As of September 30, 2017, a notional amount of $126.3 million remained on the interest rate swap agreement, which expires on December 19, 2017. On August 5, 2016, we entered into a pay-fixed, receive-variable interest rate swap having an initial notional amount of $42.5 million with Wells Fargo to fix the one-month LIBOR rate at 1.12%. The notional amount of this interest rate swap increases quarterly by an amount equal to the decrease of the hedge entered into on December 19, 2012, up to the amount of $175 million. The interest rate swap is scheduled to expire on July 6, 2021. These instruments are intended to reduce our exposure to interest rate fluctuations and were not entered into for speculative purposes. Excluding the amount that is subject to a fixed rate under the interest rate swap and assuming the current level of borrowings remained the same, it is estimated that our interest expense and income before income taxes would change by approximately $965,000 annually for each one percentage point change in the average interest rate under these borrowings.

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

ITEM 4. CONTROLS AND PROCEDURES

Evaluation of Disclosure Controls and Procedures

Our management is responsible for establishing and maintaining adequate disclosure controls and procedures for our company. Consequently, our management, with the participation of our chief executive officer and chief financial officer, evaluated the effectiveness of our disclosure controls and procedures pursuant to Rule 13a-15 under the ~~Securities~~ Exchange Act ~~of 1934, as amended (the "Exchange Act"),~~ as of September 30, ~~2017.~~2021. In designing and evaluating the disclosure controls and procedures, management recognized that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives. In addition, the design of disclosure controls and procedures must reflect the fact that there are resource constraints and that management is required to apply its judgment in evaluating the benefits of possible controls and procedures relative to their costs.

Based on that evaluation, our chief executive officer and chief financial officer concluded that our disclosure controls and procedures are designed at a reasonable assurance level and are effective to provide reasonable assurance that information we are required to disclose in reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in Securities and Exchange Commission rules and forms, and that such information is accumulated and communicated to our management, including our chief executive officer and chief financial officer, as appropriate, to allow timely decisions regarding required disclosure.

Changes in Internal Control ~~over~~Over Financial Reporting

During the ~~quarter~~three-month period ended September 30, ~~2017,~~2021, there were no changes in our internal control over financial reporting that materially affected, or are reasonably likely to materially affect, our internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f) under the Securities Exchange Act of 1934).

~~Management will continue to evaluate our internal control over financial reporting as we execute acquisition integration activities.~~

PART II - OTHER INFORMATION

ITEM 1. LEGAL PROCEEDINGS

See Note 1310 “Commitments and Contingencies” set forth in the ~~condensed~~ notes to our consolidated financial statements included in Part I, Item 1 of this ~~Quarterly Report.~~

report.

ITEM 1A. RISK FACTORS

In addition to other information set forth in this ~~Report,~~report, readers should carefully consider the factors discussed in Part I, Item 1A. "Risk Factors" of the ~~2016~~2020 Annual Report on Form 10-K, ~~which~~as updated and supplemented below. Any of the risk factors disclosed in our reports could materially affect our business, financial condition or future results. The risks described here and in ~~the 2016~~our 2020 Annual Report on Form 10-K are not the only risks we face. Additional risks and uncertainties not currently known to us or that we currently deem to be immaterial also may materially and adversely affect our business, financial condition and/or operating ~~results.~~results, particularly in light of the precarious and unpredictable nature of the COVID-19 pandemic, containment measures, the potential for future waves of outbreaks and the related impacts to economic and operating conditions.

Table of Contents

ITEM 6. EXHIBITS

Exhibit No.		Description
3.1
~~Exhibit No.~~		~~Description~~
~~3.1~~		Second Amended and Restated Articles of ~~Incorporation dated February 28, 2017 (1)~~Incorporation*
3.2
~~3.2~~		~~Second~~ Third Amended and Restated ~~Bylaws (2)~~Bylaws*
31.1
~~10.1~~		Second Amendment to Second Amended and Restated Credit Agreement, dated March 20, 2017, entered into by and among Merit Medical Systems, Wells Fargo Bank, National Association and the lenders and subsidiary guarantors named therein (3)

~~10.2~~		~~Indemnification Agreement with Thomas J. Gunderson~~

~~31.1~~		Certification of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
31.2
~~31.2~~		Certification of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
32.1
~~32.1~~		Certification of Chief Executive Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
32.2
~~32.2~~		Certification of Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
101
~~101~~		The following financial information from the quarterly report on Form 10-Q ~~of Merit Medical Systems, Inc.~~ for the quarter ended September 30, ~~2017,~~2021, formatted in ~~XBRL (eXtensible~~Inline Extensible Business Reporting ~~Language)~~Language (iXBRL): (i) Consolidated Balance Sheets, (ii) Consolidated Statements of Income ~~(ii) Consolidated Balance Sheets,~~(Loss), (iii) Consolidated Statements of Comprehensive Income (Loss), (iv) Consolidated Statements of Stockholders’ Equity, (v) Consolidated Statements of Cash Flows, and ~~(v)~~(vi) related Condensed Notes to the Unaudited Consolidated Financial Statements,

	tagged in detail.
~~(1)~~ 104	~~Incorporated by reference from~~	Cover Page Interactive Data File (the cover page XBRL tags are embedded within the ~~Annual Report on Form 10-K filed on March 1, 2017.~~Inline XBRL document).


~~(2)~~	~~Incorporated by reference from the Current Report on Form 8-K filed on December 16, 2015.~~


~~(3)~~	~~Incorporated by reference from the Current Report on Form 8-K filed on March 20, 2017.~~

* These exhibits are incorporated herein by reference.

~~SIGNATURES~~

Table of Contents

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the ~~Registrant~~registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

MERIT MEDICAL SYSTEMS, INC.

REGISTRANT


Date: November 5, 2021	By:
~~Date:~~	~~November 9, 2017~~		/s/ FRED P. LAMPROPOULOS
				~~FRED~~ Fred P. ~~LAMPROPOULOS~~ ~~PRESIDENT AND CHIEF EXECUTIVE OFFICER~~ Lampropoulos, President and
				Chief Executive Officer

Date: November 5, 2021	~~November 9, 2017~~ By:			/s/ ~~BERNARD J. BIRKETT~~RAUL PARRA
		Raul Parra
	~~BERNARD J. BIRKETT~~ ~~CHIEF FINANCIAL OFFICER~~	Chief Financial Officer and Treasurer

MERIT MEDICAL SYSTEMS, INC. AND SUBSIDIARIES CONSOLIDATED BALANCE SHEETS AS OF SEPTEMBER 30, 2017 AND DECEMBER 31, 2016 (In thousands)

	September 30, 2017			December 31, 2016
ASSETS	(unaudited)

CURRENT ASSETS:
Cash and cash equivalents	$	23,362		$	19,171
Trade receivables — net of allowance for uncollectible accounts — 2017 — $1,547 and 2016 — $1,587	101,394			80,521
Employee receivables	147			198
Other receivables	5,900			5,445
Inventories	145,598			120,695
Prepaid expenses and other assets	20,581			6,226
Prepaid income taxes	2,792			2,525
Deferred income tax assets	—			8,219
Income tax refund receivables	91			423

Total current assets	299,865			243,423

PROPERTY AND EQUIPMENT:
Land and land improvements	19,804			19,379
Buildings	144,084			139,119
Manufacturing equipment	193,061			178,110
Furniture and fixtures	49,035			43,433
Leasehold improvements	31,345			30,413
Construction-in-progress	34,625			28,180

Total property and equipment	471,954			438,634

Less accumulated depreciation	(181,672		)	(162,061		)

Property and equipment — net	290,282			276,573

OTHER ASSETS:
Intangible assets:
Developed technology — net of accumulated amortization — 2017 — $67,320 and 2016 — $52,843	172,796			135,358
Other — net of accumulated amortization — 2017 — $34,985 and 2016 — $30,048	55,707			47,339
Goodwill	234,043			211,927
Deferred income tax assets	2,046			171
Other assets	32,412			28,012

Total other assets	497,004			422,807

TOTAL	$	1,087,151		$	942,803

See condensed notes to consolidated financial statements.				(continued)

MERIT MEDICAL SYSTEMS, INC. AND SUBSIDIARIES CONSOLIDATED STATEMENTS OF INCOME FOR THE THREE AND NINE MONTHS ENDED SEPTEMBER 30, 2017 AND 2016 (In thousands, except per share amounts - unaudited)

	Three Months Ended September 30,						Nine Months Ended September 30,
	2017			2016			2017			2016
NET SALES	$	179,337		$	156,975		$	536,955		$	446,123

COST OF SALES	98,823			89,160			296,358			251,354

GROSS PROFIT	80,514			67,815			240,597			194,769

OPERATING EXPENSES:
Selling, general and administrative	54,716			53,198			169,896			138,556
Research and development	12,838			11,424			38,676			33,440
Contingent consideration (benefit) expense	20			(94		)	39			99
Acquired in-process research and development	12,061			300			12,136			400

Total operating expenses	79,635			64,828			220,747			172,495

INCOME FROM OPERATIONS	879			2,987			19,850			22,274

OTHER INCOME (EXPENSE):
Interest income	94			29			266			55
Interest expense	(1,590		)	(3,022		)	(5,935		)	(6,120		)
Gain on bargain purchase	(778		)	—			10,796			—
Other income (expense) — net	(810		)	1			(376		)	(445		)

Other income (expense) — net	(3,084		)	(2,992		)	4,751			(6,510		)

INCOME (LOSS) BEFORE INCOME TAXES	(2,205		)	(5		)	24,601			15,764

INCOME TAX EXPENSE (BENEFIT)	1,364			(978		)	3,884			3,149

NET INCOME (LOSS)	$	(3,569	)	$	973		$	20,717		$	12,615

EARNINGS PER COMMON SHARE:
Basic	$	(0.07	)	$	0.02		$	0.43		$	0.28

Diluted	$	(0.07	)	$	0.02		$	0.42		$	0.28

AVERAGE COMMON SHARES:
Basic	50,150			44,447			48,332			44,346

Diluted	51,599			45,000			49,555			44,763

See condensed notes to consolidated financial statements.



	September 30,		December 31,
	2017		2016
Finished goods	$	80,708	$	63,852
Work-in-process	18,162		11,008
Raw materials	46,728		45,835

Total	$	145,598	$	120,695



	Three Months							Nine Months
	Net Income			Shares	Per Share Amount			Net Income		Shares	Per Share Amount
Period ended September 30, 2017:
Basic EPS	$	(3,569	)	50,150	$	(0.07	)	$	20,717	48,332	$	0.43
Effect of dilutive stock options and warrants				1,449						1,223

Diluted EPS	$	(3,569	)	51,599	$	(0.07	)	$	20,717	49,555	$	0.42

Stock options excluded from the calculation of common stock equivalents as the impact was anti-dilutive				200						434

Period ended September 30, 2016:
Basic EPS	$	973		44,447	$	0.02		$	12,615	44,346	$	0.28
Effect of dilutive stock options and warrants				553						417

Diluted EPS	$	973		45,000	$	0.02		$	12,615	44,763	$	0.28

Stock options excluded from the calculation of common stock equivalents as the impact was anti-dilutive				408						864



	Preliminary Allocation
Net Assets Acquired
Inventories	$	579
Intangibles
Developed technology	14,920
Customer list	120
Goodwill	6,381

Total net assets acquired	$	22,000



		Preliminary Allocation			Adjustments ⁽¹⁾			Revised Preliminary Allocation
	Net Assets Acquired
	Intangibles
	Developed technology	$	7,800		$	—		$	7,800
	In-process technology	850			250			1,100
	Goodwill	4,323			(153		)	4,170
	Deferred tax liabilities	(3,073		)	(97		)	(3,170		)

	Total net assets acquired	$	9,900		$	—		$	9,900

(1)	Amounts represent adjustments to the preliminary purchase price allocation first presented in our Quarterly Report on Form 10-Q for the quarter ended June 30, 2017 resulting from our ongoing activities, including reassessment of the assets acquired and liabilities assumed, with respect to finalizing our purchase price allocation for this acquisition.



		Preliminary Allocation			Adjustments ⁽²⁾			Revised Preliminary Allocation
	Assets Acquired
	Cash and cash equivalents	$	1,436		$	—		$	1,436
	Trade receivables	8,351			—			8,351
	Inventories	12,217			(995		)	11,222
	Prepaid expenses and other assets	1,275			—			1,275
	Property and equipment	2,667			(348		)	2,319
	Deferred tax assets	184			19			203
	Intangibles
	Developed technology	2,600			(400		)	2,200
	Customer lists	1,300			200			1,500
	Trademarks	1,500			(600		)	900
	Total assets acquired	31,530			(2,124		)	29,406

	Liabilities Assumed
	Trade payables	(2,306		)	(109		)	(2,415		)
	Accrued expenses	(5,083		)	—			(5,083		)
	Income taxes payable	(2		)	—			(2		)
	Deferred income tax liabilities	(999		)	(11		)	(1,010		)
	Total liabilities assumed	(8,390		)	(120		)	(8,510		)

	Total net assets acquired	23,140			(2,244		)	20,896
	Gain on bargain purchase ⁽¹⁾	(12,243		)	1,447			(10,796		)
	Total purchase price	$	10,897		$	(797	)	$	10,100

(1)	The total fair value of the net assets acquired from Argon exceeded the purchase price, resulting in a gain on bargain purchase which was recorded within other income (expense) in our consolidated statements of income, and includes a negative adjustment of $778,000 in the three-month period ended September 30, 2017 (in addition to the negative adjustment of $669,000 in the three-month period ended June 30, 2017). We believe the reason for the provisional gain on bargain purchase was a result of the divestiture of a non-strategic, slow-growth critical care business for Argon. It is our understanding that the divestiture allows Argon to focus on its higher growth interventional portfolio.
(2)	Amounts represent adjustments to the preliminary purchase price allocation first presented in our March 31, 2017 Form 10-Q resulting from our ongoing activities, including reassessment of the assets acquired and liabilities assumed, with respect to finalizing our purchase price allocation for this acquisition.



Assets Acquired
Trade receivables	$	4,054
Other receivables	6
Inventories	8,585
Prepaid expenses	630
Property and equipment	1,630
Other long-term assets	145
Intangibles
Developed technology	67,600
Customer lists	2,400
Trademarks	4,400
Goodwill	24,818
Total assets acquired	114,268

Liabilities Assumed
Trade payables	(1,790		)
Accrued expenses	(5,298		)
Deferred income tax liabilities - current	(701		)
Deferred income tax liabilities - noncurrent	(10,844		)
Total liabilities assumed	(18,633		)

Net assets acquired, net of cash received of $1,327	$	95,635



Assets Acquired
Inventories	$	2,455
Property and equipment	290
Intangibles
Developed technology	12,100
Trademarks	700
Customers Lists	400
Goodwill	2,555

Total assets acquired	$	18,500



	Three Months Ended				Nine Months Ended				Nine Months Ended
	September 30, 2016				September 30, 2017				September 30, 2016
	As Reported		Pro Forma		As Reported		Pro Forma		As Reported		Pro Forma
Net Sales	$	156,975	$	167,321	$	536,955	$	539,715	$	446,123	$	494,589
Net Income	973		1,174		20,717		10,047		12,615		16,454
Earnings per common share:
Basic	$	0.02	$	0.03	$	0.43	$	0.21	$	0.28	$	0.37
Diluted	$	0.02	$	0.03	$	0.42	$	0.20	$	0.28	$	0.37



	September 30, 2017			December 31, 2016
2016 Term loan	$	87,500		$	145,000
2016 Revolving credit loans	184,000			180,000
2017 Debt facility	6,962			—
Less debt issuance costs	(522		)	(627		)
Total debt	277,940			324,373
Less current portion	16,962			10,000
Long-term portion	$	260,978		$	314,373



Years Ending	Future Minimum
December 31	Principal Payments
Remaining 2017	2,500
2018	19,462
2019	15,000
2020	17,500
2021	224,000
Total future minimum principal payments	$	278,462



		Fair Value
	Balance Sheet Location	September 30, 2017			December 31, 2016
Derivatives designated as hedging instruments
Assets
Interest rate swaps	Prepaid expenses and other assets (current)	$	79		$	—
Interest rate swaps	Other assets (long-term)	4,309			4,991
Foreign currency forward contracts	Prepaid expenses and other assets (current)	646			116
Foreign currency forward contracts	Other assets (long-term)	158			18

(Liabilities)
Foreign currency forward contracts	Accrued expenses (current)	$	(286	)	$	(275	)
Foreign currency forward contracts	Other long-term obligations	(96		)	(18		)

Derivatives not designated as hedging instruments
Assets
Foreign currency forward contracts	Prepaid expenses and other assets (current)	$	485		$	220
(Liabilities)
Foreign currency forward contracts	Accrued expenses (current)	(210		)	(171		)



	Amount of Gain/(Loss) recognized in OCI						Amount of Gain/(Loss) reclassified from AOCI
	Three Months Ended September 30,						Three Months Ended September 30,
	2017		2016				2017			2016
Derivative instrument						Location in Statements of Income
Interest rate swaps	$	1	$	(256	)	Interest expense	$	96		$	(153	)

Foreign currency forward contracts	100		—			Revenue	(101		)	—
						Cost of goods sold	250			—



				Fair Value Measurements Using
	Total Fair			Quoted prices in		Significant other			Significant
	Value at			active markets		observable inputs			unobservable inputs
Description	September 30, 2017			(Level 1)		(Level 2)			(Level 3)

Interest rate contracts (1)	$	4,388		$	—	$	4,388		$	—
Foreign currency contract assets, current and long-term (2)	$	1,289		$	—	$	1,289		$	—
Foreign currency contract liabilities, current and long-term (3)	$	(592	)	$	—	$	(592	)	$	—

				Fair Value Measurements Using
	Total Fair			Quoted prices in		Significant other			Significant
	Value at			active markets		observable inputs			unobservable inputs
Description	December 31, 2016			(Level 1)		(Level 2)			(Level 3)

Interest rate contracts (1)	$	4,991		$	—	$	4,991		$	—
Foreign currency contract assets, current and long-term (2)	$	354		$	—	$	354		$	—
Foreign currency contract liabilities, current and long-term (3)	$	(464	)	$	—	$	(464	)	$	—



Contingent consideration asset or liability	Fair value at September 30, 2017		Valuation technique	Unobservable inputs	Range
Revenue-based payments	$	11,077	Discounted cash flow	Discount rate	9.9% - 15%
contingent liability			Discounted cash flow	Probability of milestone payment	100%
				Projected year of payments	2017-2037

Contingent receivable	$	528	Discounted cash flow	Discount rate	10%
asset			Discounted cash flow	Probability of milestone payment	57%
				Projected year of payments	2017-2019

Contingent consideration asset or liability	Fair value at December 31, 2016		Valuation technique	Unobservable inputs	Range
Revenue-based payments	$	683	Discounted cash flow	Discount rate	9.9% - 15%
contingent liability			Discounted cash flow	Probability of milestone payment	100%
				Projected year of payments	2017-2028

Contingent receivable	$	528	Discounted cash flow	Discount rate	10%
asset			Discounted cash flow	Probability of milestone payment	57%
				Projected year of payments	2017-2019



	September 30, 2017
	Gross Carrying Amount		Accumulated Amortization			Net Carrying Amount
Patents	$	15,972	$	(3,586	)	$	12,386
Distribution agreements	6,626		(4,248		)	2,378
License agreements	23,804		(4,387		)	19,417
Trademarks	16,220		(4,342		)	11,878
Covenants not to compete	1,028		(961		)	67
Customer lists	25,942		(17,461		)	8,481
In-process technology	1,100		—			1,100

Total	$	90,692	$	(34,985	)	$	55,707



Year Ending December 31
Remaining 2017	$	6,745
2018	26,152
2019	25,678
2020	24,524
2021	18,013



		Three Months Ended September 30,					Nine Months Ended September 30,
	% Change	2017		2016		% Change	2017		2016
Cardiovascular ⁽¹⁾
Stand-alone devices	34.2%	$	68,724	$	51,195	45.6%	$	203,434	$	139,729
Custom kits and procedure trays	0.7%	30,436		30,223		2.2%	91,107		89,164
Inflation devices	9.0%	20,033		18,371		8.3%	59,329		54,774
Catheters	5.3%	31,751		30,139		12.2%	94,357		84,078
Embolization devices	9.3%	12,252		11,207		8.8%	36,936		33,937
CRM/EP	1.7%	9,527		9,368		18.9%	31,977		26,889
Total	14.8%	172,723		150,503		20.7%	517,140		428,571

Endoscopy ⁽¹⁾
Endoscopy devices	2.2%	6,614		6,472		12.9%	19,815		17,552

Total	14.2%	$	179,337	$	156,975	20.4%	$	536,955	$	446,123