UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
_________________________
Form 10-Q

(Mark One)
þ

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended September 30, 2017
or
¨
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from _______________ to _______________
(Mark One)
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended: September 30, 2020
or
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from _______________ to _______________

Commission file number: 001-37599
livn-20200930_g1.jpg
LivaNova PLC
(Exact name of registrant as specified in its charter)
England and Wales ...................98-1268150
(State or other jurisdiction of ..........(I.R.S. Employer
incorporation or organization) ........Identification No.)
20 Eastbourne Terrace, London, United Kingdom, W2 6LG
(Address of principal executive offices) .......................(Zip Code)
Registrant’s telephone number, including area code: (44) (0) 203 325-0660
England and Wales98-1268150
(State or other jurisdiction of
incorporation or organization)
(I.R.S. Employer
Identification No.)
20 Eastbourne Terrace
London, United Kingdom
W2 6LG
(Address of principal executive offices)

(Zip Code)

(44) (0) 20 3325 0660
Registrant’s telephone number, including area code:

Securities registered pursuant to Section 12(b) of the Act:
Act
Title of each classTrading Symbol(s)Name of each exchange on which registered
Ordinary Shares - £1.00 par value per shareThe LIVNNASDAQ StockGlobal Market LLC
Title of Each Class of StockName of Each Exchange on Which Registered

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.  Yes þNo ¨
Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).  Yes þNo ¨
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer”filer,” “smaller reporting company” and “smaller reporting“emerging growth company” in Rule 12b-2 of the Exchange Act.
 
Large accelerated filer
þ

Accelerated filer¨
Non-accelerated filer
¨ (Do not check if a smaller reporting company)
Smaller reporting company¨
Emerging growth company¨
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act

¨
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act).  Yes ¨No þ
ClassOutstanding at October 27, 20172020
Ordinary Shares - £1.00 par value per share48,211,55948,596,417





LIVANOVA PLC
TABLE OF CONTENTS
PART I. FINANCIAL INFORMATIONPAGE NO.
PART II. OTHER INFORMATION

In this Quarterly Report on Form 10-Q, “LivaNova,” “the Company,” “we,” “us” and “our” refer to LivaNova PLC and its consolidated subsidiaries.
This report may contain references to our proprietary intellectual property, including among others:
Trademarks for our VNS therapy systems, the VNS Therapy® System, the VITARIA® System and our proprietary pulse generator products: Model 102 (Pulse®), Model 102R (Pulse Duo®), Model 103 (Demipulse®), Model 104 (Demipulse Duo®), Model 105 (AspireHC®), Model 106 (AspireSR®) and Model 1000 (SenTiva™).
Trademarks for our oxygenatorVNS therapy systems, the VNS Therapy® System, the VITARIA® System and our proprietary pulse generator products: Model 102 (Pulse®), Model 102R (Pulse Duo®), Model 103 (Demipulse®), Model 104 (Demipulse Duo®), Model 105 (AspireHC®), Model 106 (AspireSR®), Model 1000 (SenTiva®) and Model 8103 (Symmetry®).
Trademarks for our Cardiopulmonary product systems: Inspire™S5® heart-lung machine, S3® heart-lung machine, Inspire®, Heartlink™Heartlink®, XTRA® Autotransfusion System, 3T Heater-Cooler®, Connect™ and Connect™Revolution®.
Trademarks for our line of surgical tissue and mechanical valve replacements and repair products: Mitroflow™Mitroflow®, Crown PRT™PRT®, Solo Smart™, Perceval™Perceval®, Miami Instruments™, Top Hat™Hat®, Reduced Series Aortic Valves™, Carbomedics Carbo-Seal™Carbo-Seal®, Carbo-Seal Valsalva™Valsalva®, Carbomedics Standard™Standard®, Orbis™ and Optiform™Optiform®, MEMO 4D®, AnnuloFlo®, AnnuloFlex®, Bicarbon Slimline™, Bicarbon Fitline™ and Mitral valve repair products: Memo 3D™, Memo 3D ReChord™, AnnuloFlo™ and AnnuloFlex™Bicarbon Overline®.
Trademarks for our implantable cardiac pacemakers and associated services: REPLY 200™, ESPRIT™, KORA 100™, KORA 250™, SafeR™, the REPLY CRT-P™, the remedé® System.
Trademarks for our Implantable Cardioverter Defibrillators and associated technologies: the INTENSIA™, PLATINIUM™, and PARADYM®product families.
Trademarks for our cardiac resynchronization therapy devices, technologies services: SonR®, SonRtip™, SonR CRT™, the INTENSIA™, PARADYM RF™, PARADYM 2™and PLATINIUM™ product families and the Respond CRT™ clinical trial.
Trademarks for heart failure treatment product: Equilia®.
Trademarks for our bradycardia leads: BEFLEX™ (active fixation)advanced circulatory support systems: TandemLife®, TandemHeart®, TandemLung®, ProtekDuo®, and XFINE™ (passive fixation)LifeSPARC™.
Trademarks for our obstructive sleep apnea system: ImThera® and Aura6000®.
These trademarks and tradenamestrade names are the property of LivaNova or the property of our consolidated subsidiaries and are protected under applicable intellectual property laws. Solely for convenience, our trademarks and tradenames referred to in this Quarterly Report on Form 10-Q may appear without the ® or symbols, but such references are not intended to indicate in any way that we will not assert, to the fullest extent under applicable law, our rights to these trademarks and tradenames.



2



NOTE ABOUT FORWARD LOOKING STATEMENTS
Certain statements in this Quarterly Report on Form 10-Q, other than purely historical information, are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). These statements include, but are not limited to, LivaNova’s plans, objectives, strategies, financial performance and outlook, trends, the amount and timing of future cash distributions, prospects or future events and involve known and unknown risks that are difficult to predict. As a result, our actual financial results, performance, achievements or prospects may differ materially from those expressed or implied by these forward-looking statements. In some cases, you can identify forward-looking statements by the use of words such as “may,” “could,” “seek,” “guidance,” “predict,” “potential,” “likely,” “believe,” “will,” “should,” “expect,” “anticipate,” “estimate,” “plan,” “intend,” “forecast,” “foresee” or variations of these terms and similar expressions, or the negative of these terms or similar expressions. Such forward-looking statements are necessarily based on estimates and assumptions that, while considered reasonable by LivaNova and its management based on their knowledge and understanding of the business and industry, are inherently uncertain. These statements are not guarantees of future performance, and stockholders should not place undue reliance on forward-looking statements. There are a number of risks, uncertainties and other important factors, many of which are beyond our control, that could cause our actual results to differ materially from the forward-looking statements contained in this Quarterly Report on Form 10-Q, and include but are not limited to the risks and uncertainties summarized below:
Risks related to our business:
changes in our common stock price;
activist investors causing disruptions to the business;
changes in our profitability;
regulatory activities and announcements, including the failure to obtain regulatory approvals for our new products;
effectiveness of our internal controls over financial reporting;
fluctuations in future quarterly operating results;
failure to comply with, or changes in, laws, regulations or administrative practices affecting government regulation of our products, including, but not limited to, U.S. Food and Drug Administration (“FDA”) laws and regulations;
failure to establish, expand or maintain market acceptance of our products for the treatment of our approved indications;
any legislative or administrative reform to the healthcare system, including the U.S. Medicare or Medicaid systems or international reimbursement systems, that significantly reduces reimbursement for our products or procedures or denies coverage for such products or procedures or enhances coverage for competitive products or procedures, as well as adverse decisions by administrators of such systems on coverage or reimbursement issues relating to our products;
failure to maintain the current regulatory approvals for our products’ approved indications;
failure to obtain or maintain coverage and reimbursement for our products’ approved indications;
unfavorable results from clinical studies;
variations in sales and operating expenses relative to estimates;
our dependence on certain suppliers and manufacturers to provide certain materials, components and contract services necessary for the production of our products;
product liability, intellectual property, shareholder-related, environmental-related, income tax and other litigation, disputes, losses and costs;
protection, expiration and validity of our intellectual property;
changes in technology, including the development of superior or alternative technology or devices by competitors;
competition from providers of alternative medical therapies, such as pharmaceutical companies and providers of cannabis;
cyber-attacks or other disruptions to our information technology systems;
failure to comply with applicable U.S. domestic laws and regulations, including federal and state privacy and security laws and regulations;
failure to comply with applicable non-U.S. lawlaws and regulations;
3


non-U.S. operational and economic risks and concerns;
failure to attract or retain key personnel;


failure of new acquisitions to further our strategic objectives or strengthen our existing businesses;
losses or costs from pending or future lawsuits and governmental investigations;
changes in accounting rules that adversely affect the characterization of our consolidated financial position, results of operations or cash flows;
changes in customer spending patterns;
continued volatility in the global market and worldwide economic conditions, including volatility caused by Brexit and/or changes to existing trade agreements and relationships between the implementationU.S. and other countries;
risks relating to the outbreak and spread of Brexit;COVID-19 around the world;
changes in tax laws, including changes related to Brexit, or exposure to additional income tax liabilities;
harsh weather or natural disasters that interrupt our business operations or the business operations of our hospital-customers; and
failure of the market to adopt new therapies or to adopt new therapies quickly.
Other factors that could cause our actual results to differ from our projected results are described in (1) “Part II, Item 1A. Risk Factors” and elsewhere in this and our other Quarterly ReportReports on Form 10-Q, (2) our Annual Report on Form 10-K for the fiscal year ended December 31, 20162019 (“20162019 Form 10-K”), (3) our reports and registration statements filed and furnished from time to time with the SECSecurities and Exchange Commission (“SEC”) and (4) other announcements we make from time to time.
Readers are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date hereof. We undertake no obligation to update or revise any forward-looking statements after the date they are made, whether as a result of new information, future events or otherwise. You should read the following discussion and analysis in conjunction with our unaudited condensed consolidated financial statements and related notes included elsewhere in this report. Operating results for the three and nine months ended September 30, 20172020 are not necessarily indicative of future results, including the full fiscal year. You should also refer to our “Annual Consolidated Financial Statements,” “Notes” thereto, “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and “Risk Factors” contained in our 20162019 Form 10-K.10-K and in our Quarterly Reports on Form 10-Q.
Financial Information and Currency of Financial Statements
All of the financial information included in this quarterly report has been prepared in accordance with generally accepted accounting principles generally accepted in the United States or of America (“U.S. GAAP.” and such principles, “U.S. GAAP”). The reporting currency of our condensed consolidated financial statements is U.S. dollars.






4


PART I. FINANCIAL INFORMATION
Item 1. Financial Statements
LIVANOVA PLC AND SUBSIDIARIES’SUBSIDIARIES
CONDENSED CONSOLIDATEDSTATEMENTS OF INCOME (LOSS)
(UNAUDITED)
(In thousands, except per share amounts)
Three Months Ended September 30,Nine Months Ended September 30,
2020201920202019
Net sales$240,083 $268,610 $664,686 $796,580 
Costs and expenses:
Cost of sales - exclusive of amortization86,467 86,128 212,152 245,324 
Product remediation1,133 3,076 6,868 11,136 
Selling, general and administrative99,199 123,015 317,424 375,932 
Research and development47,368 45,904 108,422 124,023 
Merger and integration expenses1,094 6,716 6,616 14,345 
Restructuring expenses(349)698 2,025 4,563 
Impairment of intangible assets50,295 
Amortization of intangibles9,685 11,146 29,346 29,690 
Litigation provision, net2,994 (33,834)3,970 (33,834)
Operating (loss) income from continuing operations(7,508)25,761 (22,137)(24,894)
Interest income47 151 482 624 
Interest expense(14,673)(4,774)(25,237)(10,490)
Foreign exchange and other gains (losses)3,420 327 507 (795)
(Loss) income from continuing operations before tax(18,714)21,465 (46,385)(35,555)
Income tax (benefit) expense(3,990)(10,653)17,581 (23,431)
Losses from equity method investments(48)(221)
Net (loss) income from continuing operations(14,772)32,118 (64,187)(12,124)
Net (loss) income from discontinued operations, net of tax(995)178 
Net (loss) income$(14,772)$32,118 $(65,182)$(11,946)
Basic (loss) income per share:
Continuing operations$(0.30)$0.66 $(1.32)$(0.25)
Discontinued operations(0.02)
$(0.30)$0.66 $(1.34)$(0.25)
Diluted (loss) income per share:
Continuing operations$(0.30)$0.66 $(1.32)$(0.25)
Discontinued operations(0.02)
$(0.30)$0.66 $(1.34)$(0.25)
Shares used in computing basic (loss) income per share48,652 48,395 48,582 48,329 
Shares used in computing diluted (loss) income per share48,652 48,820 48,582 48,329 
See accompanying notes to the condensed consolidated financial statements
5
  Three Months Ended September 30, Nine Months Ended September 30,
  2017 2016 2017 2016
Net sales $309,664
 $295,268
 $916,156
 $903,284
Cost of sales 108,233
 106,454
 318,584
 360,675
Product remediation 1,642
 689
 2,573
 2,243
Gross profit 199,789
 188,125
 594,999
 540,366
Operating expenses:        
Selling, general and administrative 121,177
 109,233
 353,943
 345,744
Research and development 31,393
 32,175
 104,051
 94,076
Merger and integration expenses 2,013
 7,576
 7,743
 20,537
Restructuring expenses 792
 4,381
 12,060
 37,219
Amortization of intangibles 12,350
 11,775
 35,445
 33,959
Total operating expenses 167,725
 165,140
 513,242
 531,535
Income from operations 32,064
 22,985
 81,757
 8,831
Interest income 199
 585
 724
 1,119
Interest expense (1,421) (3,495) (5,314) (6,665)
Gain on acquisition of Caisson Interventional, LLC 
 
 39,428
 
Foreign exchange and other gains (losses) 491
 1,216
 957
 (2)
Income before income taxes 31,333
 21,291
 117,552
 3,283
Income tax expense 1,913
 9,731
 10,881
 16,891
Losses from equity method investments (1,590) (13,129) (20,072) (19,382)
Net income (loss) $27,830
 $(1,569) $86,599
 $(32,990)
         
Basic income (loss) per share $0.58
 $(0.03) $1.80
 $(0.67)
Diluted income (loss) per share $0.57
 $(0.03) $1.79
 $(0.67)
Shares used in computing basic income (loss) per share 48,181
 49,075
 48,130
 49,016
Shares used in computing diluted income (loss) per share 48,534
 49,075
 48,339
 49,016




LIVANOVA PLC AND SUBSIDIARIES’SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OFCOMPREHENSIVE INCOME (LOSS)
(UNAUDITED)
(In thousands)
Three Months Ended September 30,Nine Months Ended September 30,
2020201920202019
Net (loss) income$(14,772)$32,118 $(65,182)$(11,946)
Other comprehensive income (loss):
Net change in unrealized gain (loss) on derivatives1,640 (870)1,313 (665)
Tax effect(393)209 (314)159 
Net of tax1,247 (661)999 (506)
Foreign currency translation adjustment23,457 (27,775)8,008 (16,628)
Total other comprehensive income (loss)24,704 (28,436)9,007 (17,134)
Total comprehensive income (loss)$9,932 $3,682 $(56,175)$(29,080)

See accompanying notes to the condensed consolidated financial statements
6
  Three Months Ended September 30, Nine Months Ended September 30,
  2017 2016 2017 2016
Net income (loss) $27,830
 $(1,569) $86,599
 $(32,990)
Other comprehensive income (loss):        
Net change in unrealized gain (loss) on derivatives (1,980) 2,042
 (5,923) (5,224)
Tax effect 473
 (673) 1,756
 1,513
Net of tax (1,507) 1,369
 (4,167) (3,711)
Foreign currency translation adjustment, net of tax 39,106
 (1,805) 111,123
 32,598
Total other comprehensive income (loss) 37,599
 (436) 106,956
 28,887
Total comprehensive income (loss) $65,429
 $(2,005) $193,555
 $(4,103)





LIVANOVA PLC AND SUBSIDIARIES’SUBSIDIARIES
CONDENSED CONSOLIDATEDBALANCE SHEETS
(UNAUDITED)
(In thousands, except share amounts)
 September 30, 2020December 31, 2019
ASSETS
Current Assets:
Cash and cash equivalents$227,811 $61,137 
Accounts receivable, net of allowance of $16,241 at September 30, 2020 and $13,105 at December 31, 2019191,892 257,769 
Inventories178,091 164,154 
Prepaid and refundable taxes43,316 37,779 
Prepaid expenses and other current assets32,026 28,604 
Total Current Assets673,136 549,443 
Property, plant and equipment, net190,509 181,354 
Goodwill918,478 915,794 
Intangible assets, net583,818 607,546 
Operating lease assets52,834 54,372 
Investments30,358 27,256 
Deferred tax assets22,673 68,676 
Other assets49,942 7,356 
Total Assets$2,521,748 $2,411,797 
LIABILITIES AND STOCKHOLDERS' EQUITY
Current Liabilities:
Current debt obligations$13,953 $77,396 
Accounts payable71,596 85,892 
Accrued liabilities and other98,308 120,100 
Current litigation provision liability34,790 146,026 
Taxes payable10,118 12,719 
Accrued employee compensation and related benefits52,994 70,420 
Total Current Liabilities281,759 512,553 
Long-term debt obligations637,109 260,330 
Contingent consideration79,603 114,396 
Litigation provision liability11,510 24,378 
Deferred tax liabilities28,362 32,219 
Long-term operating lease liabilities43,124 46,027 
Long-term employee compensation and related benefits23,109 22,797 
Long-term derivative liabilities59,588 61 
Other long-term liabilities6,792 15,319 
Total Liabilities1,170,956 1,028,080 
Commitments and contingencies (Note 10)
Stockholders’ Equity:
Ordinary Shares, £1.00 par value: unlimited shares authorized; 49,402,628 shares issued and 48,596,417 shares outstanding at September 30, 2020; 49,411,016 shares issued and 48,443,830 shares outstanding at December 31, 201976,338 76,257 
Additional paid-in capital1,758,468 1,734,870 
Accumulated other comprehensive loss(10,385)(19,392)
Accumulated deficit(472,576)(406,755)
Treasury stock at cost, 806,211 ordinary shares at September 30, 2020; 967,186 ordinary shares at December 31, 2019(1,053)(1,263)
Total Stockholders’ Equity1,350,792 1,383,717 
Total Liabilities and Stockholders’ Equity$2,521,748 $2,411,797 
See accompanying notes to the condensed consolidated financial statements
7
  September 30, 2017 December 31, 2016
  (Unaudited)  
ASSETS    
Current Assets:    
Cash and cash equivalents $65,158
 $39,789
Accounts receivable, net 314,041
 275,730
Inventories 214,593
 183,489
Prepaid and refundable taxes 58,969
 60,615
Assets held for sale 14,117
 4,477
Prepaid expenses and other current assets 55,176
 55,973
Total Current Assets 722,054
 620,073
Property, plant and equipment, net 213,769
 223,842
Goodwill 781,070
 691,712
Intangible assets, net 717,646
 609,197
Investments 46,380
 61,092
Deferred tax assets, net 4,356
 6,017
Other assets 117,855
 130,698
Total Assets $2,603,130
 $2,342,631
LIABILITIES AND STOCKHOLDERS' EQUITY    
Current Liabilities:    
Current debt obligations $52,074
 $47,650
Accounts payable 102,651
 92,952
Accrued liabilities and other 92,212
 75,567
Taxes payable 28,954
 22,340
Accrued employee compensation and related benefits 80,466
 78,302
Total Current Liabilities 356,357
 316,811
Long-term debt obligations 71,853
 75,215
Deferred income taxes liability 152,133
 172,541
Long-term employee compensation and related benefits 33,957
 31,668
Other long-term liabilities 74,404
 39,487
Total Liabilities 688,704
 635,722
Commitments and contingencies (Note 9) 
 
Stockholders’ Equity:    
Ordinary Shares, £1.00 par value: unlimited shares authorized; 48,250,361 shares issued and 48,200,257 shares outstanding at September 30, 2017; 48,156,690 shares issued and 48,028,413 shares outstanding at December 31, 2016 74,697
 74,578
Additional paid-in capital 1,731,565
 1,719,893
Accumulated other comprehensive income (loss) 38,469
 (68,487)
Retained earnings (deficit) 72,024
 (14,575)
Treasury stock at cost, 50,104 shares at September 30, 2017 and 128,277 shares at December 31, 2016 (2,329) (4,500)
Total Stockholders’ Equity 1,914,426
 1,706,909
Total Liabilities and Stockholders’ Equity $2,603,130
 $2,342,631




LIVANOVA PLC AND SUBSIDIARIES’SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OFCASH FLOWS
(UNAUDITED)
(In thousands)
Nine Months Ended September 30,
20202019
Operating Activities:
Net loss$(65,182)$(11,946)
Non-cash items included in net loss:
Deferred tax expense (benefit)41,133 (26,422)
Remeasurement of contingent consideration to fair value(31,176)(2,425)
Amortization29,346 29,690 
Stock-based compensation26,845 24,127 
Depreciation22,206 23,115 
Remeasurement of derivative instruments(17,654)(2,948)
Amortization of operating lease assets9,813 8,961 
Impairment of intangible assets50,295 
Other5,876 7,638 
Changes in operating assets and liabilities:
Accounts receivable, net65,401 5,433 
Inventories(12,141)(18,181)
Other current and non-current assets(15,360)9,575 
Accounts payable and accrued current and non-current liabilities(49,547)(28,964)
Taxes payable(615)(14,367)
Litigation provision liability(124,158)(140,823)
Restructuring reserve(1,194)(6,766)
Net cash used in operating activities(116,407)(94,008)
Investing Activities:
Purchases of property, plant and equipment(28,445)(16,801)
Purchase of investments(3,175)(287)
Loans to investees(2,250)
Acquisitions, net of cash acquired(10,750)
Purchases of intangible assets(3,186)
Other533 505 
Net cash used in investing activities(33,337)(30,519)
Financing Activities:
Proceeds from long-term debt obligations886,899 193,490 
Repayment of long-term debt obligations(481,360)(12,330)
Proceeds from short term borrowings (maturities greater than 90 days)46,717 
Repayments of short term borrowings (maturities greater than 90 days)(44,838)
Purchase of capped call(43,096)
Debt issuance costs(20,412)(3,795)
Closing adjustment payment for sale of CRM business(14,891)
Payment of contingent consideration(8,860)(17,989)
Shares repurchased from employees for minimum tax withholding(5,277)(6,183)
Proceeds from share issuances under ESPP2,063 2,574 
Change in short-term borrowing, net(1,043)(2,173)
Other25 147 
Net cash provided by financing activities315,927 153,741 
Effect of exchange rate changes on cash and cash equivalents491 (1,105)
Net increase in cash and cash equivalents166,674 28,109 
Cash and cash equivalents at beginning of period61,137 47,204 
Cash and cash equivalents at end of period$227,811 $75,313 
See accompanying notes to the condensed consolidated financial statements
8
  Nine Months Ended September 30,
  2017 2016
Operating Activities:  
  
Net income (loss) $86,599
 $(32,990)
Non-cash items included in net income (loss):    
Depreciation 27,880
 30,193
Amortization 35,445
 33,959
Stock-based compensation 14,261
 15,575
Deferred income tax benefit (27,270) (10,224)
Losses from equity method investments 20,072
 19,382
Gain on acquisition of Caisson Interventional, LLC (39,428) 
Impairment of property, plant and equipment 4,581
 
Amortization of income taxes payable on inter-company transfers of property 23,831
 17,114
Other 3,364
 8,765
Changes in operating assets and liabilities:    
Accounts receivable, net (19,107) (11,040)
Inventories (11,006) 20,607
Other current and non-current assets (17,846) (25,845)
Restructuring reserve (12,753) 14,961
Accounts payable and accrued current and non-current liabilities (14,958) (31,109)
Net cash provided by operating activities 73,665
 49,348
Investing Activities:  
  
Purchases of property, plant and equipment and other (24,004) (28,928)
Acquisition of Caisson Interventional, LLC, net of cash acquired (14,194) 
Proceeds from sale of cost method investment 3,192
 
Proceeds from asset sales 5,346
 222
Purchases of cost and equity method investments (5,209) (8,059)
Loans to cost and equity method investees (6,928) (6,595)
Purchases of short-term investments 
 (7,054)
Maturities of short-term investments 
 14,051
Net cash used in investing activities (41,797) (36,363)
Financing Activities:    
Change in short-term borrowing, net (18,054) (33,831)
Proceeds from short-term borrowing (maturities greater than 90 days) 20,000
 
Repayment of long-term debt obligations (11,615) (11,354)
Proceeds from exercise of stock options 3,221
 7,888
Repayment of trade receivable advances 
 (23,848)
Proceeds from long-term debt obligations 
 7,994
Share repurchases 
 (11,053)
Other (3,552) 1,208
Net cash used in financing activities (10,000) (62,996)
Effect of exchange rate changes on cash and cash equivalents 3,501
 1,030
Net increase (decrease) in cash and cash equivalents 25,369
 (48,981)
Cash and cash equivalents at beginning of period 39,789
 112,613
Cash and cash equivalents at end of period $65,158
 $63,632




LIVANOVA PLC AND SUBSIDIARIES
NOTESTO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
Note 1. Unaudited Condensed Consolidated Financial Statements
Basis of Presentation
The accompanying condensed consolidated financial statements of LivaNova as of, and for the three and nine months ended September 30, 20172020 and September 30, 2016,2019, have been prepared in accordance with generally accepted accounting principles in the United States of America (“U.S.” and such principles, “U.S. GAAP”) GAAP for interim financial information and the instructions to Form 10-Q and Article 10 of Regulation S-X. The accompanying condensed consolidated balance sheet of LivaNova at December 31, 20162019 has been derived from audited financial statements contained in our 20162019 Form 10-K, but does not include all of the information and footnotes required by U.S. GAAP for complete financial statements. In the opinion of management, the condensed consolidated financial statements reflect all adjustments (consisting of only normal recurring adjustments) considered necessary for a fair presentationstatement of the operating results of LivaNova and its subsidiaries, for the three and nine months ended September 30, 2017,2020, and are not necessarily indicative of the results that may be expected for the year ending December 31, 2017.2020. The financial information presented herein should be read in conjunction with the audited consolidated financial statements and notes thereto accompanying our 20162019 Form 10-K.
DescriptionRecent Developments Regarding COVID-19
Due to the COVID-19 pandemic (“COVID-19”), we have experienced and may continue to experience significant and unpredictable reductions in the demand for our products as healthcare customers have diverted medical resources and priorities towards the treatment of COVID-19. In addition, public health bodies have delayed elective procedures during the MergersCOVID-19 pandemic, which has negatively impacted the usage of our products, including the number of Neuromodulation procedures. Further, some people are avoiding seeking treatment for non-COVID-19 emergency procedures, which has also negatively impacted the demand for our products.
On October 19, 2015 LivaNova becameWe are seeing signs of stabilization in certain geographies as elective surgeries resume and expect this trend to continue on a global basis during the holding companyfourth quarter of the combined businesses of Cyberonics, Inc. (“Cyberonics”)2020. We expect elective procedure recovery rates to vary by country, and Sorin S.p.A. (“Sorin”) (the “Mergers”). Based on the structure of the Mergers, management determined that Cyberonics was considered to be the accounting acquirerimpacted by COVID-19 case volumes, hospital occupancy and predecessorstaffing levels, patient’s willingness to re-book previously deferred procedures, travel restrictions, transportation limitations, quarantine restrictions, economic uncertainty and potential COVID-19 resurgence.
Reclassifications
We have reclassified certain prior period amounts for accountingcomparative purposes.
Reclassification These reclassifications did not have a material effect on our financial condition, results of Prior-Year Comparative Period Presentation
To conform the condensed consolidated statement of income (loss) for the three and nine months ended September 30, 2016, to the current period presentation, we reclassified $0.7 million and $2.2 million, respectively, of Litigation Related Expenses to the Product Remediation line, and $1.7 million and $2.5 million, respectively, of Litigation Related Expenses to Selling, General and Administrative Expenses.
To conform the condensed consolidated balance sheet as of December 31, 2016 to the current period presentation, we reclassified $4.5 million of Assets Held for Sale, relating to our plan to exit the Costa Rica manufacturing operation, to a separate line item in the condensed consolidated balance sheet from Prepaid Expenses and Other Current Assets. We received $4.9 million in proceeds from the sale of our Costa Rica manufacturing operation during the nine months ended September 30, 2017.
To conform the condensed consolidated statement ofoperations or cash flows for the nine months ended September 30, 2016 to the current period presentation, certain amounts were reclassified within Operating Activities. Commencing with nine months ended September 30, 2017, Loans to Equity and Cost Method Investees of 6.9 million were presented as Investing Activities. To conform the condensed consolidated statement of cash flows for the nine months ended September 30, 2016 to the current period presentation, Loans to Equity and Cost Method Investees of $6.6 million were reclassified from Financing Activities to Investing Activities.flows.
Significant Accounting Policies
Our significant accounting policies are detailed in "Note 2:“Note 2. Basis of Presentation, Use of Accounting Estimates and Significant Accounting Policies"Policies” and “Note 3. Revenue Recognition” of our 20162019 Form 10-K. A further explanation of our Foreign Currency accounting policy is discussed below:
Foreign Currency
Our functional currency is the U.S. dollar, however, a portion of the revenues earned and expenses incurred by certain of our subsidiaries are denominated in currencies other than the U.S. dollar. We determine the functional currency of our subsidiaries that exist and operate in different economic and currency environments based on the primary economic environment in which the subsidiary operates, that is, the currency of the environment in which an entity primarily generates and expends cash. Our significant foreign subsidiaries are located in Europe and the U.S. The functional currency of our significant European subsidiaries is the Euro and the functional currency of our significant U.S. subsidiaries is the U.S. dollar.



Assets and liabilities for subsidiaries whose functional currency is not the U.S. dollar are translated into U.S. dollars based on a combination of both current and historical exchange rates, while their revenues earned and expenses incurred are translated into U.S. dollars at average period exchange rates. Translation adjustments are included as ‘Accumulated other comprehensive income (loss)’ (“AOCI”) in the condensed consolidated balance sheets. Gains and losses arising from transactions denominated in a currency different from an entity’s functional currency are included in ‘Foreign exchange and other (losses) gains’ in our condensed consolidated statements of income (loss).
Note 2. AcquisitionsBusiness Combinations
In support of our strategic growth initiatives, on May 2, 2017,Miami Instruments
On June 12, 2019, we acquired the remaining 51% equity interests in Caisson Interventional,minimally invasive cardiac surgery instruments business from Miami Instruments, LLC (“Caisson”Miami Instruments”) for a purchase price of up to $72.0 million, net of $6.3 million of debt forgiveness, consisting of $18.0 million paid at closing, $14.4 million to be paid after 12 months, and contingentcash consideration of up to $39.6 million to be paid on$17.0 million. The related operations have been integrated into our Cardiovascular segment as a schedule driven primarily by regulatory approvals and a sales-based earnout.
Caisson, a clinical-stage medical device company based in Maple Grove, Minnesota, is focused on the design, development and clinical evaluation of a novel transcatheter mitral valve replacement (“TMVR”) implant device with a fully transvenous delivery system.
The following table presents the acquisition date fair-value of the consideration transferred and the fair valuepart of our interestHeart Valves business. Cash of $10.8 million was paid at closing with up to $6.0 million in Caisson prior to the acquisition (in thousands):
Cash (1)
 $15,660
Debt forgiven (2)
 6,309
Deferred consideration (1)
 12,994
Contingent consideration (1)
 29,303
Fair value of consideration transferred 64,266
Fair value of our interest prior to the acquisition (2)
 52,505
Fair value of total consideration $116,771
(1)
Concurrent with the acquisition, we recognized $5.8 million of post-combination compensation expense. Of this amount, $2.4 million is reflected as a reduction of $18.0 million in cash paid at closing of the acquisition, while $3.4 million increased the deferred consideration and contingent consideration liabilities recognized at the date of the acquisition to a total of $14.1 million and $31.7 million, respectively.
(2)On the acquisition date, we remeasured the notes receivable from Caisson and our existing investment in Caisson at fair value and recognized a pre-tax non-cash gain of $1.3 million and $38.1 million, respectively, which are included in ‘Gain on acquisition of Caisson Interventional, LLC’ in the condensed consolidated statements of income (loss).
contingent consideration based on achieving certain milestones. The following table presents the preliminary purchase price allocation at fair value for the CaissonMiami Instruments acquisition (in thousands):
Cash and cash equivalents $1,468
In-process research and development 89,000
Goodwill 42,417
Other assets 918
Current liabilities 1,023
Deferred income tax liabilities, net 16,009
Net assets acquired $116,771
Acquired goodwill of $9.6 million is expected to be deductible for tax purposes. Additionally, $3.0 million of the initial cash payment was deposited in escrow for future claims indemnification. Of this amount, $2.0 million is included in ‘Prepaid expenses and other current assets’ and the remaining $1.0 million is included in ‘Other long-term assets’ on the condensed consolidated balance sheet as of September 30, 2017.
We recognized acquisition-related expenses of approximately $1.0 million for legal and valuation expensesfinalized during the nine months ended September 30, 2017. These expenses are included within ‘Selling, generalsecond quarter of 2020 and administrative’ expensesresulted in the condensed consolidated statements of income (loss). Additionally, the results of Caisson for theno measurement period of May 2, 2017 through September 30, 2017 added no revenue and $16.9adjustments. In connection with this acquisition, we recognized $14.7 million in expensesdeveloped technology and in-process research and development (“IPR&D”) intangible assets and $1.5 million in our condensed consolidated statement of income (loss).goodwill.



The contingent consideration arrangements are composed of potential cash payments upon the achievement of certain regulatory milestones and a sales-based earnout associated with sales of products covered by the purchase agreement. The sales-based earnout was valued using projected sales from our internal strategic plans. Both arrangements are Level 3 fair value measurements and include the following significant unobservable inputs (in thousands):
Caisson Acquisition Fair value at May 2, 2017 Valuation Technique Unobservable Input Ranges
Regulatory milestone-based payments $14,883
 Discounted cash flow Discount rate 2.6% - 3.4%
      Probability of payment 90-95%
      Projected payment years 2018-2023
         
Sales-based earnout 16,805
 Monte Carlo simulation Discount rate 11.5-12.7%
      Sales volatility 36.9%
      Projected years of sales 2019-2033
  $31,688
      
The following table provides a reconciliation of the beginning and ending balance of the contingent consideration liability, which consisted of arrangements that arose from the Caisson acquisition and other previous acquisitions that also included contingent consideration (in thousands):
Balance at December 31, 2016 $3,890
Purchase price - Caisson contingent consideration 31,688
Payments (1,841)
Changes in fair value 231
Effect of changes in foreign currency exchange rates 249
Balance at September 30, 2017 (1)
 $34,217
(1)The contingent consideration liability represents contingent payments related to three acquisitions: the first and second acquisitions, in September 2015, were Cellplex PTY Ltd. in Australia and the commercial activities of a local distributor in Colombia. The contingent payments for the first acquisition are based on achievement of sales targets by the acquiree through June 30, 2018 and the contingent payments for the second acquisition are based on sales of cardiopulmonary disposable products and heart lung machines of the acquiree through December 2019. The third acquisition, Caisson, occurred in May 2017 and is discussed above. Refer to “Note 6. Fair Value Measurements.”
Note 3. Discontinued Operations
On April 30, 2018, we completed the sale of our Cardiac Rhythm Management (“CRM”) business to MicroPort Cardiac Rhythm B.V. and MicroPort Scientific Corporation (“MicroPort”) for total cash proceeds of $195.9 million, less cash transferred of $9.2 million, subject to a closing working capital adjustment. In March 2020, we finalized the working capital adjustment and as a result, made a $16.4 million payment to MicroPort during the first quarter of 2020 and incurred an additional $1.0 million loss on sale, net of a $0.1 million tax benefit.
9



Note 4. Restructuring
Our 2015 and 2016 Reorganization Plans (the “Plans”) were initiated October 2015 and March 2016, respectively, in conjunction with the completion of the Mergers. We initiated theseinitiate restructuring plans to leverage economies of scale, streamline distribution and logistics, and strengthen operational and administrative effectiveness in order to reduce overall costs. Costs associated with these plans were reported as ‘Restructuring expenses’restructuring expenses in ourthe operating results in theof our condensed consolidated statements of income (loss). We estimate that the Plans will result in
The following table provides a net reduction of 326 personnel of which 292 have occurred as of September 30, 2017.
In March 2017, we committed to a plan to sell our Suzhou Industrial Park facility in Shanghai, China. As a result of this exit plan we recorded an impairmentreconciliation of the buildingbeginning and equipment of $4.6 million and accrued $0.5 million of additional costs, primarily related to employee severance, during the nine months ended September 30, 2017. In addition, the remaining carrying valueending balance of the land, buildingaccruals and equipment was reclassified to ‘Assets held for sale’other reserves recorded in March 2017,connection with a balance of $14.1 million as of September 30, 2017,our restructuring plans included within accrued liabilities and other and other long-term liabilities on the condensed consolidated balance sheet.


The following table presents restructuring expense accrual detailsheet (in thousands):
Employee Severance and Other Termination CostsOtherTotal
Balance at December 31, 2019$4,097 $1,400 $5,497 
Charges2,025 2,025 
Cash payments and other(4,880)(792)(5,672)
Balance at September 30, 2020$1,242 $608 $1,850 
  Employee Severance and Other Termination Costs Other Total
Balance at December 31, 2016 $21,092
 $3,056
 $24,148
Charges 7,126
 4,934
 12,060
Cash payments and adjustments (23,804) (5,480) (29,284)
Balance at September 30, 2017 $4,414
 $2,510
 $6,924

The following table presents restructuring expense by reportable segment (in thousands):
Three Months Ended September 30,Nine Months Ended September 30,
2020201920202019
Cardiovascular$$783 $1,265 $1,521 
Neuromodulation43 (171)851 314 
Other(401)86 (91)2,728 
Total$(349)$698 $2,025 $4,563 

  Three Months Ended September 30, Nine Months Ended September 30,
  2017 2016 2017 2016
Cardiac Surgery $441
 $916
 $6,944
 $5,878
Cardiac Rhythm Management (391) 571
 (1,750) 16,592
Neuromodulation 14
 2,882
 513
 7,017
Other 728
 12
 6,353
 7,732
Total $792
 $4,381
 $12,060
 $37,219
Note 4.5. Product Remediation Liability
On December 29, 2015, we received an FDA Warning Letter (the “Warning Letter”) alleging certain violations of FDA regulations applicable to medical device manufacturing at our Munich, Germany and Arvada, Colorado facilities. On October 13, 2016, the CDC and FDA separately released safety notifications regarding 3T Heater-Cooler devices in response to which we issued a Field Safety Notice Update for U.S. users of our 3T Heater-Cooler devices to proactively and voluntarily contact facilities to facilitate implementation of the CDC and FDA recommendations.
At December 31, 2016, we recognized a liability for a product remediation plan related to our 3T Heater-Cooler device (“3T device”). The remediation plan we developed consists primarily of a modification of the 3T device design to include internal sealing and the addition of a vacuum system to new and existing devices. These changes are intended to address regulatory actions and to reduce further the risk of possible dispersion of aerosols from 3T devices in the operating room. We concluded that it was probable that a liability had been incurred upon management’s approval of the plan and the commitments made by management to various regulatory authorities globally in November and December 2016, and furthermore, the cost associated with the plan was reasonably estimable. The deployment of this solution for commercially distributed devices has been dependent upon final validation and verification of the design changes and approval or clearance by regulatory authorities worldwide, including FDAworldwide. It is reasonably possible that our estimate of the remediation liability could materially change in future periods due to the various significant assumptions involved such as customer behavior, market reaction and the timing of approvals or clearance in the U.S. by regulatory authorities worldwide.
In April 2017, we obtained CE Mark in Europe for the design change, of the 3T device and in May 2017 we completed our first vacuum canister and internal sealing upgrade on a customer-owned device. We are currently implementingIn October 2018, the FDA concluded that we could commence the vacuum canister and internal sealing upgrade program in the U.S., and on February 25, 2020, LivaNova received clearance for K191402, a 510(k) for the 3T devices that addressed issues contained in the 2015 Warning Letter along with design changes that further mitigate the potential risk of aerosolization. Concurrent with this clearance, (1) 3T devices manufactured in accordance with K191402 will not be subjected to the import alert previously issued by the FDA and (2) LivaNova initiated a correction to distribute the updated Operating Instructions cleared under K191402. We continue to implement the vacuum canister and internal sealing upgrade program in as many countries as possible throughout the remainder of 2017. until all devices are upgraded.
10


As a second part of the remediation plan, we also intendcontinue to performoffer a no-charge deep disinfection service (deep cleaning service) for 3T device users who have reported confirmed M. chimaera mycobacterium contamination. Although the deep disinfection service is not yet available in the U.S., it is currently offered in many countries around the world and will be expanded to additional geographies as we receive the required regulatory approvals. The deep disinfection service was rolled out in Europe in the second half of 2015, and in April 2018, the FDA agreed to allow us to move forward with the deep cleaning service in the U.S., thereby adding to the growing list of countries around the world in which we offer this service. Finally, we are continuingcontinue to offer the loaner program for 3T devices, initiated in the fourth quarter of 2016, to provide existing 3T device users with a new loaner 3T device at no charge pending regulatory approval and implementation of the vacuum system addition and deep disinfection service worldwide. This loaner program began in
The following table provides a reconciliation of the U.S.beginning and is being made available progressively on a global basis, prioritizing and allocating devices to 3T device users based on pre-established criteria.
Changes in the carrying amountending balance of the product remediation liability are as followsincluded within accrued liabilities and other on the condensed consolidated balance sheet (in thousands):
Balance at December 31, 2016 $33,487
Adjustments (15)
Remediation activity (5,672)
Effect of changes in foreign currency exchange rates 2,446
Balance at September 30, 2017 (1)
 $30,246
(1)
Balance at December 31, 2019
At$3,251 
Adjustments2,301 
Remediation activity(3,982)
Effect of changes in foreign currency exchange rates145 
Balance at September 30, 2017, the product remediation liability balance is held within ‘Accrued liabilities and other’ and ‘Other long-term liabilities’ on the condensed consolidated balance sheet. Refer to “Note 15. Supplemental Financial Information.”2020$1,715 
It is reasonably possible thatWe recognized product remediation expenses of $1.1 million and $3.1 million during the three months ended September 30, 2020 and 2019, respectively, and $6.9 million and $11.1 million during the nine months ended September 30, 2020 and 2019, respectively. Product remediation expenses include internal labor costs, costs to remediate certain inspectional observations made by the FDA at our estimateMunich facility and costs associated with the incorporation of the remediation liability could materially change in future periods due to the various significant assumptions involved, such as customer behavior, market reaction and the timingmodification of approvals or clearance by regulatory authorities worldwide. We recognize changes in estimates on a prospective basis. At this stage, no liability has


been recognized with respect to any lawsuits involving us related to the 3T device whiledesign into the next generation 3T device. These costs and related legal costs are expensed as incurred.incurred and are not included within the product remediation liability presented above. At September 30, 2020, our balance sheet includes a $46.3 million provision related to litigation involving our 3T device. For further information, please refer to “Note 9.10. Commitments and Contingencies - 3T Heater-Cooler Devices.Contingencies.

Note 5.6. Investments
Cost-Method Investments
Our cost-methodThe following table details the carrying value of our investments in equity securities of non-consolidated affiliates without readily determinable fair values for which we do not exert significant influence over the investee. These equity investments are reported at cost minus impairment, if any, plus or minus changes resulting from observable price changes in orderly transactions for the identical or similar investment of the same issuer. The below equity investments are included in ‘Investments’ ininvestments on the condensed consolidated balance sheets and consist of our equity positions in the following privately-held companies (in thousands):
Equity Investments Without Readily Determinable Fair ValuesSeptember 30, 2020December 31, 2019
Respicardia Inc. (1)
$17,706 $17,706 
ALung Technologies, Inc. (2)
3,000 
Ceribell, Inc.3,000 3,000 
ShiraTronics, Inc.2,045 2,045 
MD Start II1,169 1,121 
Rainbow Medical Ltd.1,145 1,099 
Highlife S.A.S.1,109 1,064 
Other770 770 
29,944 26,805 
Equity method investment414 451 
$30,358 $27,256 
  September 30, 2017 December 31, 2016
Respicardia Inc. (1)
 $21,129
 $17,518
ImThera Medical, Inc. (2)
 12,000
 12,000
Rainbow Medical Ltd. (3)
 4,178
 3,733
MD Start II 1,179
 526
Other (4)
 150
 
  $38,636
 $33,777
(1)Respicardia Inc. (“Respicardia”) is a privately funded U.S. company developing an implantable device designed to restore a more natural breathing pattern during sleep in patients with central sleep apnea ("CSA") by transvenously stimulating the phrenic nerve. We have a loan outstanding to Respicardia with a carrying amount of $1.5(1)Respicardia Inc. (“Respicardia”) is a privately funded U.S. company developing an implantable device designed to restore a more natural breathing pattern during sleep in patients with central sleep apnea by transvenously stimulating the phrenic nerve. We have a loan outstanding to Respicardia, with a carrying amount of $0.8 million and $0.6 million as of September 30, 2017, which is included in ‘Prepaid expenses and other current assets’ on the condensed consolidated balance sheet.
(2)ImThera Medical Inc. (“ImThera”) is a privately funded U.S. company developing a neurostimulation device system for the treatment of obstructive sleep apnea. We have a loan outstanding to ImThera as of September 30, 2017, with a carrying amount of $1.0 million, which is included in ‘Other assets’ on the condensed consolidated balance sheet.
(3)
Rainbow Medical Ltd. is a private Israeli venture capital company that seeds and grows companies developing medical devices in a diverse range of medical fields.
(4)During the nine months ended September 30, 2017, we sold our investment in Istituto Europeo di Oncologia S.R.L, for a gain of $3.2 million. This gain is included in ‘Foreign exchange and other gains (losses)’ in the condensed consolidated statement of income (loss).
Equity Method Investments
Our equity-method investments are included in ‘Investments’ in the condensed consolidated balance sheets and consist of our equity position in the following entities (in thousands, except for percent ownership):
  
% Ownership (1)
 September 30, 2017 December 31, 2016
MicroPort Sorin CRM (Shanghai) Co. Ltd. (2)
 49.0% $6,948
 $4,867
Highlife S.A.S. (3)
 38.0% 779
 6,009
Caisson Interventional LLC (4)
 
 
 16,423
Other   17
 16
Total   $7,744
 $27,315
(1)Ownership percentages as of September 30, 2017.
(2)During the three months ended September 30, 2017 we invested an additional $4.5 million in MicroPort Sorin CRM (Shanghai) Co. Ltd.
(3)Highlife S.A.S is a privately held clinical-stage medical device company located in France and is focused on the development of a unique transcatheter mitral valve replacement system to treat patients with mitral regurgitation. During the three months ended September 30, 2017, we recognized an impairment of our investment in, and notes receivable from, Highlife. See the paragraph below for further details.
(4)On May 2, 2017, we acquired the 51% remaining equity interests in Caisson Interventional LLC (“Caisson”), and we began consolidating the results of Caisson as of the acquisition date. Refer to “Note 2. Acquisitions” and to “Note 6. Fair Value Measurements” for further information.
Highlife Impairment
We recognized an impairment of our equity-method investment in, and notes receivable from, Highlife S.A.S. (“Highlife”) during the nine months ended September 30, 2017. Certain factors, including a revision in our investment strategy, indicated that the carrying value of our aggregate investment might not be recoverable2020 and that the decrease in value of our aggregate investment was other than temporary. We, therefore, estimated the fair value of our investment and notes receivable using the


market approach. The estimated fair value of our aggregate investment was below our carrying value by $13.0 million. This aggregate impairment was included in ‘Losses from equity method investments’ in the condensed consolidated statements of income (loss). The updated carrying value of our notes receivable from Highlife at September 30, 2017 was $0.8 million andDecember 31, 2019, respectively, which is included in ‘Other assets’prepaid expenses and other current assets on the condensed consolidated balance sheet.
(2)During the first quarter of 2020, we invested in ALung Technologies, Inc. (“ALung”). ALung is a privately held medical device company focused on creating advanced medical devices for treating respiratory failure. ALung’s Hemolung Respiratory Assist System is a dialysis-like alternative or supplement to mechanical ventilation which removes carbon dioxide directly from the blood in patients with acute respiratory failure. During the second quarter of 2020, we provided a convertible loan to ALung for $2.0 million, due July 10, 2021. As of September 30, 2020, the carrying amount of the loan was $2.0 million, which is included in prepaid expenses and other current assets on the condensed consolidated balance sheet.
11



Note 6.7. Fair Value Measurements
We review the fair value hierarchy classification on a quarterly basis. Changes in the ability to observe valuation inputs may result in a reclassification of levels for certain securities within the fair value hierarchy. There were no transfers between Level 1, Level 2, or Level 3 during the nine months ended September 30, 2020 and 2019.
Assets and Liabilities Measured at Fair Value on a Recurring Basis
The following table providestables provide information by level for assets and liabilities that are measured at fair value on a recurring basis (in thousands):
Fair Value as of September 30, 2020Fair Value Measurements Using Inputs Considered as:
Level 1Level 2Level 3
Assets:
Derivative assets - designated as cash flow hedges (foreign currency exchange rate “FX”)$1,787 $$1,787 $
Derivative assets - freestanding instruments (FX)4,052 4,052 
Derivative assets - capped call derivatives38,999 38,999 
Convertible notes receivable2,301 2,301 
$47,139 $$5,839 $41,300 
Liabilities:
Derivative liabilities - freestanding instruments (interest rate swaps)$139 $$139 $
Derivative liabilities - freestanding instruments (FX)85 85 
Derivative liabilities - embedded exchange feature59,398 59,398 
Derivative liabilities - other1,350 1,350 
Contingent consideration arrangements96,174 96,174 
$157,146 $$224 $156,922 

Fair Value as of December 31, 2019Fair Value Measurements Using Inputs Considered as:
Level 1Level 2Level 3
Assets:
Derivative assets - designated as cash flow hedges (FX)$535 $$535 $
Derivative assets - freestanding instruments (FX)26 26 
$561 $$561 $
Liabilities:
Derivative liabilities - designated as cash flow hedges (FX)$169 $$169 $
Derivative liabilities - designated as cash flow hedges (interest rate swaps)374 374 
Derivative liabilities - freestanding instruments (FX)3,137 3,137 
Contingent consideration arrangements137,349 137,349 
$141,029 $$3,680 $137,349 
12


  Fair Value
as of
 Fair Value Measurements Using Inputs Considered as:
  September 30, 2017 Level 1 Level 2 Level 3
Liabilities:        
Derivative liabilities - designated as cash flow hedges (foreign currency exchange rate "FX") $724
 $
 $724
 $
Derivative liabilities - designated as cash flow hedges (interest rate swaps) 1,807
 
 1,807
 $
Derivative liabilities - freestanding instruments (FX) 1,456
 
 1,456
 
Contingent consideration 34,217
 
 
 34,217
  $38,204
 $
 $3,987
 $34,217
  Fair Value
as of
 Fair Value Measurements Using Inputs Considered as:
  December 31, 2016 Level 1 Level 2 Level 3
Assets:        
Derivative assets - designated as cash flow hedges (FX) $4,911
 $
 $4,911
 $
Derivative assets - freestanding instruments (FX) 3,358
 
 3,358
 
  $8,269
 $
 $8,269
 $
         
Liabilities:        
Derivative liabilities - designated as cash flow hedges (FX) $942
 $
 $942
 $
Derivative liabilities - designated as cash flow hedges (interest rate swaps) 1,392
 
 1,392
 
Contingent consideration 3,890
 
 
 3,890

 $6,224
 $
 $2,334
 $3,890
OurThe following table provides a reconciliation of the beginning and ending balances of our recurring fair value measurements, using significant unobservable inputs (level(Level 3), relate solely to our (in thousands):
Capped Call Derivative AssetEmbedded Exchange Feature Derivative LiabilityOther Derivative LiabilitiesContingent Consideration Liability ArrangementsConvertible Notes Receivable
As of December 31, 2019$$$$137,349 $
Additions43,096 74,951 2,267 
Payments (1)
(9,868)
Changes in fair value (2) (3) (4)
(4,097)(15,553)1,350 (31,176)34 
Effect of changes in foreign currency exchange rates(131)
Total at September 30, 202038,999 59,398 1,350 96,174 2,301 
Less current portion at September 30, 20201,160 16,571 2,044 
Long-term portion at September 30, 2020$38,999 $59,398 $190 $79,603 $257 
(1)During the nine months ended September 30, 2020, we paid $8.8 million under the contingent consideration liability.arrangement for the acquisition of CardiacAssist, Inc., doing business as TandemLife (“TandemLife”). Additionally, we made final payments under contingent consideration arrangements resulting from the acquisitions of 2 distributors.
(2)The contingent consideration change in fair value during the nine months ended September 30, 2020 is primarily due to a one-year delay in the projected achievement of a certain regulatory milestone and timing of sales-based earnout payments for ImThera Medical Inc. (“ImThera”), and the impact of an increase in discount rates utilized in the valuation of contingent consideration. Refer to “Note 2. Acquisitions”the tables below for further information regarding the fair value measurements of contingent consideration.
(3)During the nine months ended September 30, 2020, the contingent consideration change in fair value resulted in a discussiondecrease of the changes$19.2 million and $12.0 million recorded to cost of sales - exclusive of amortization and research and development, respectively.
(4)Changes in the fair value of the embedded exchange feature derivative and capped call derivatives are recognized in foreign exchange and other gains (losses) in the condensed consolidated statements of income (loss).
Embedded Exchange Feature and Capped Call Derivatives
In June 2020, the Company issued $287.5 million in cash exchangeable senior notes and entered into related capped call transactions. The cash exchangeable senior notes include an embedded exchange feature that is bifurcated from the cash exchangeable senior notes. Please refer to “Note 8. Financing Arrangements” for further details. The embedded exchange feature derivative is measured at fair value using a binomial lattice model and discounted cash flows that utilize observable and unobservable market data. The capped call derivative is measured at fair value using the Black-Scholes model utilizing observable and unobservable market data, including stock price, remaining contractual term, expected volatility, risk-free interest rate and expected dividend yield, as applicable.
The embedded exchange feature and capped call derivatives are classified as Level 3 as the Company uses historical volatility and implied volatility from options traded to determine expected stock price volatility which is an unobservable input that is significant to the valuation. In general, an increase in our stock price or stock price volatility would increase the fair value of the embedded exchange feature and capped call derivatives which would result in an increase in expense. As time to the expiration of the derivatives decreases with passage of time, the fair value of the derivatives would decrease. The future impact on net income depends on how significant inputs such as stock price, stock price volatility and time to the expiration of the derivatives change in relation to other inputs.
The stock price volatility as of September 30, 2020 was 37%. As of September 30, 2020, a 10% lower volatility, holding other inputs constant, would result in approximate fair value for the embedded exchange feature derivative of $42.4 million and a 10% higher volatility, holding other inputs constant, would result in approximate fair value of $76.4 million. As of September 30, 2020, a 10% lower volatility, holding other inputs constant would result in approximate fair value for the capped call derivatives of $29.3 million and a 10% higher volatility, holding other inputs constant, would result in approximate fair value of $42.3 million.
13


Contingent Consideration Arrangements
The following table provides the fair value of our Level 3 contingent consideration liability.

arrangements by acquisition (in thousands):

September 30, 2020December 31, 2019
ImThera$79,603 $113,503 
TandemLife11,672 17,311 
Miami Instruments4,899 5,338 
Drilltex294 
Other903 
$96,174 $137,349 
The ImThera business combination involved contingent consideration arrangements composed of potential cash payments upon the achievement of a certain regulatory milestone and a sales-based earnout associated with sales of products. The sales-based earnout is valued using projected sales from our internal strategic plan. Both arrangements are Level 3 fair value measurements and include the following significant unobservable inputs as of September 30, 2020:
ImThera AcquisitionValuation TechniqueUnobservable InputRanges
Regulatory milestone-based paymentDiscounted cash flowDiscount rate8.3%
Probability of payment85%
Projected payment year2024
Sales-based earnoutMonte Carlo simulationRisk-adjusted discount rate12.2 %-12.5%
Credit risk discount rate8.5 % -9.2%
Revenue volatility32.5%
Probability of payment85%
Projected years of earnout2025-2028
The TandemLife business combination involved a contingent consideration arrangement composed of potential cash payments upon the achievement of certain regulatory milestones. The arrangement is a Level 3 fair value measurement and includes the following significant unobservable inputs as of September 30, 2020:
TandemLife AcquisitionValuation TechniqueUnobservable InputRanges
Regulatory milestone-based paymentDiscounted cash flowDiscount rate7.6 %-7.7%
Probability of payments70 %-100%
Projected payment years2020-2021
The Miami Instruments business combination involved a contingent consideration arrangement composed of potential cash payments upon the achievement of certain regulatory milestones. The arrangement is a Level 3 fair value measurement and includes the following significant unobservable inputs as of September 30, 2020:
Miami InstrumentsValuation TechniqueUnobservable InputRanges
Regulatory milestone-based paymentsDiscounted cash flowDiscount rate7.6 %-7.7%
Probability of payments80 %-95%
Projected payment years2020 -2021

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Note 7.8. Financing Arrangements
The outstanding principalcarrying amount of our long-term debt as of September 30, 2020 and December 31, 2019 was as follows (in thousands, except interest rates):
September 30, 2020December 31, 2019MaturityInterest Rate
2020 Senior Secured Term Loan$422,960 $June 2025LIBOR (1% Floor)+6.50%
2020 Cash Exchangeable Senior Notes208,954 December 20253.00%
Bank of America Merrill Lynch Banco Múltiplo S.A.6,000 8,422 July 20215.61%
Mediocredito Italiano5,835 6,222 December 20230.50 % -2.77%
Bank of America, U.S.2,011 2,004 January 20212.08%
2019 Debt Facility184,275 
2017 European Investment Bank103,570 
2014 European Investment Bank28,053 
Other1,041 965 
Total long-term facilities646,801 333,511 
Less current portion of long-term debt9,692 73,181 
Total long-term debt$637,109 $260,330 
  September 30, 2017 December 31, 2016 Maturity Interest Rate
European Investment Bank (1)
 $78,590
 $78,987
 June 2021 0.95%
Mediocredito Italiano (3)
 7,719
 7,276
 December 2023 0.50% - 3.07%
Banca del Mezzogiorno (2)
 6,490
 6,747
 December 2019 0.50% - 3.15%
Bpifrance (ex-Oséo) 1,603
 1,909
 October 2019 2.58%
Region Wallonne 831
 798
 December 2023 and June 2033 0.00% - 2.45%
Mediocredito Italiano - mortgages and other 742
 799
 September 2021 and September 2026 0.40% - 0.65%
Total debt 95,975
 96,516
    
Less current portion of long-term debt 24,122
 21,301
    
Total long-term debt $71,853
 $75,215
    
(1)The European Investment Bank (“EIB”) loan was obtained in July 2014 to support product development projects. The interest rate for the EIB loan is reset by the lender each quarter based on the Euribor. Interest payments are paid quarterly and principal payments are paid semi-annually.
(2)The Banca del Mezzogiorno loan was obtained in January 2015 to support R&D projects as a part of the Large Strategic Project program of the Italian Ministry of Education.
(3)We obtained the Mediocredito Italiano Bank loan in July 2016 as part of the Fondo Innovazione Teconologica program implemented by the Italian Ministry of Education.
Revolving Credit
The outstanding principal amount of our short-term unsecured revolving credit agreements and other agreements with various banks was $28.0$4.3 million and $26.4$4.2 million, at September 30, 20172020 and December 31, 2016,2019, respectively, with interest rates ranging from 0.2%3.21% to 10.5%7.20% and loan terms ranging from one dayovernight to 365 days.10 months, as of September 30, 2020.
European Investment Bank Financing Agreement2020 Senior Secured Term Loan
On June 29, 2017,10, 2020, we entered into a new finance contract$450.0 million five-year senior secured term loan (the “Finance Contract”“Term Loan”) through our wholly owned subsidiary LivaNova USA Inc., with funds managed by affiliates of Ares Management Corporation, as administrative agent and collateral agent, resulting in cash proceeds of approximately $421.7 million, net of discounts and issuance costs. The obligations under the EIBTerm Loan are guaranteed on a senior secured basis by each of LivaNova’s existing and future wholly owned material subsidiaries, and are secured by a perfected first priority security interest in substantially all tangible and intangible assets of LivaNova and certain U.S. and UK subsidiaries of LivaNova, subject in each case to support financingcertain exceptions contained in the Term Loan. Borrowings under the Term Loan bear interest at a variable annual rate equal to the three-month LIBOR rate (subject to a 1% floor), plus an applicable margin of 6.5% per annum. The effective interest rate of the Term Loan at September 30, 2020 was 9.0%. The Term Loan will mature on June 30, 2025 and includes certain affirmative, negative and financial covenants. The financial covenants under the Term Loan state (i) the net revenue of LivaNova PLC, LivaNova USA, Inc. and any restricted subsidiaries on a consolidated basis shall not be lower than $700 million for each trailing 12 month period, such threshold to decrease pro rata (not below $550 million) upon prepayments of the Term Loan made by LivaNova USA, Inc. out of the proceeds of certain R&D projects. The Finance Contract hasasset sales, and (ii) the total secured leverage ratio (as defined in the debt agreement) for LivaNova PLC, LivaNova USA, Inc. and any restricted subsidiaries on a borrowing baseconsolidated basis shall not be greater than the applicable ratio set forth below:
Test PeriodTotal Secured Leverage Ratio
4 Quarters ending June 30, 2020 through each fiscal quarter thereafter until (and including) the fiscal quarter ending June 30, 20215.625:1.00
4 Quarters ending September 30, 2021 and ending each fiscal quarter thereafter4.5:1.00
Debt discounts and issuance costs related to the Term Loan were approximately $28.3 million and included various legal, bank and accounting fees. Amortization of €100debt discount and issuance costs was $1.1 million (or approximately $118and $1.3 million USD equivalent)for the three and can be drawnnine months ended September 30, 2020, respectively, and was included in up to two tranches, each in a minimuminterest expense on the condensed consolidated statement of income (loss).
2020 Cash Exchangeable Senior Notes
On June 17, 2020, our wholly-owned subsidiary, LivaNova USA, Inc., issued $287.5 million aggregate principal amount of €503.00% cash exchangeable senior notes (the “Notes”) by private placement to qualified institutional buyers pursuant to Rule
15


144A under the Securities Act of 1933, as amended. The sale of the Notes resulted in approximately $278.0 million (orin net proceeds to the Company after deducting issuance costs. Interest is payable semiannually in arrears on June 15 and December 15 of each year, beginning on December 15, 2020. The effective interest rate of the Notes at September 30, 2020 was 9.9%. The Notes mature on December 15, 2025 unless earlier exchanged, repurchased, or redeemed.
Debt discounts and issuance costs related to the Notes were approximately $59$82.0 million USD equivalent)and included $75.0 million of discount attributable to the embedded exchange feature, discussed below, and $7.0 million of allocated issuance costs to the Notes related to legal, bank and accounting fees. Amortization of debt discount and issuance costs was $3.0 million and $3.4 million for the three and nine months ended September 30, 2020 and is included in interest expense on the condensed consolidated statement of income (loss).
The Notes are exchangeable at the option of the holders only under certain circumstances and solely into cash in an amount based on the trading prices of LivaNova’s ordinary shares during a related observation period. The Notes are not exchangeable into ordinary shares of LivaNova or any other security under any circumstances. The initial exchange rate for the Notes is 16.3980 ordinary shares per $1,000 principal amount of Notes (equivalent to an initial exchange price of approximately $60.98 per share). Drawdowns must occur by December 30, 2018, andThe exchange rate is subject to adjustment in certain circumstances, as set forth in the indenture governing the Notes.
The Company may redeem the Notes at its option, on or after June 20, 2023, in whole or in part, if the last repayment date of any tranche will be no earlier than four years and no later than eight years after the disbursementreported sale price per ordinary share has been at least 130% of the relevant tranche. Loans underexchange price then in effect for at least 20 trading days (whether or not consecutive), including the Finance Contract are subjecttrading day immediately preceding the date on which the Company provides notice of redemption, during any 30 consecutive trading day period ending on, and including, the trading day immediately preceding the date on which the Company provides notice of redemption, at a redemption price equal to 100% of the principal amount of the Notes to be redeemed, plus accrued and unpaid interest to, but excluding, the redemption date. Additionally, the Company may redeem the Notes at its option, prior to December 15, 2025, in whole but not in part, in connection with certain covenantstax-related events.
Embedded Exchange Feature
The embedded exchange feature of the Notes requires bifurcation from the Notes and other termsis accounted for as a derivative liability. The fair value of the Notes’ embedded exchange feature derivative at the time of issuance was $75.0 million and conditions. No loan drawdowns have occurredwas recorded as debt discount on the Notes. This discount is amortized as interest expense using the effective interest method over the term of the Notes. The Notes’ embedded exchange feature derivative is carried on the condensed consolidated balance sheets at its estimated fair value and is adjusted at the end of each reporting period, with unrealized gain or loss reflected in the consolidated statements of income (loss). The fair value of the embedded exchange feature derivative liability was $59.4 million as of September 30, 2017.2020.
Capped Call Transactions
In connection with the pricing of the Notes, the Company entered into privately negotiated capped call transactions with certain of the initial purchasers of the Notes or their respective affiliates. The capped call transactions cover, subject to anti-dilution adjustments substantially similar to those applicable to the Notes, the number of LivaNova’s ordinary shares underlying the Notes and are expected generally to offset any cash payments the Company is required to make upon exchange of the Notes in excess of the principal amount thereof in the event that the market value per ordinary share, as measured under the capped call transactions, is greater than the strike price of the capped call transactions, with such offset being subject to an initial cap price of $100.00 per share. The aggregate cost of the capped calls derivative assets was $43.1 million. The capped call transactions expire on December 15, 2025 and must be settled in cash. The capped calls are carried on the condensed consolidated balance sheets as a derivative asset at their estimated fair value and are adjusted at the end of each reporting period, with unrealized gain or loss reflected in the condensed consolidated statement of income (loss). The fair value of capped call derivative assets was $39.0 million as of September 30, 2020.
The current and non-current classification is evaluated at each balance sheet date and may change depending on whether any exchange conditions are met. As of September 30, 2020, no exchange conditions have been met and the Notes, embedded exchange feature derivative liability, and the capped call derivative assets are classified as non-current. Please refer to “Note 7. Fair Value Measurements” for details on the valuation of the embedded exchange feature derivative liability and capped call derivative assets.
Extinguishment of Debt
The Company used the net proceeds from the Term Loan, together with a portion of the net proceeds of the Notes, after fees, discounts, commissions and other expenses, to repay outstanding indebtedness under the Company’s 2017 European Investment Bank loan, 2014 European Investment Bank loan, Banca Nazionale del Lavoro S.p.A loan, and 2019 Debt Facility and related
16


expenses. The Company repaid approximately $528.0 million in aggregate outstanding principal, accrued interest and associated fees, including breakage fees and legal fees. The Company recognized a loss on debt extinguishment of $1.4 million during the nine months ended September 30, 2020. The loss on debt extinguishment was recognized in foreign exchange and other losses in the condensed consolidated statements of income (loss).
The remainder of the proceeds from the concurrent financing transactions were used to pay the cost of capped call transactions and for general corporate purposes.

Note 8.9. Derivatives and Risk Management
Due to the global nature of our operations, we are exposed to foreign currency exchange rate fluctuations. In addition, due to certain loans with floating interest rates, we are also subject to the impact of changes in interest rates on our interest payments. We enter into foreign currency exchange rate (“FX”)FX derivative contracts and interest rate swap contracts to reduce the impact of foreign currency rate and interestexchange rate fluctuations on earnings and cash flow. We are also exposed to equity price risk in connection with our Notes, including exchange and settlement provisions based on the price of our ordinary shares at exchange or maturity of the Notes. In addition, the capped call transactions associated with the Notes also include settlement provisions that are based on the price of our ordinary shares, subject to a capped price per share.
We measure all outstanding derivatives each period end at fair value and report the fair value as either financial assets or liabilities inon the condensed consolidated balance sheets. We do not enter into derivative contracts for speculative purposes. At inception of the contract, the derivative is designated as either a freestanding derivative or a hedge. Derivatives that are not designated as hedging instruments are referred to as freestanding derivatives with changes in fair value included in earnings.
If the derivative qualifies for hedge accounting, depending on the nature of the hedge and hedge effectiveness, changes in the fair value of the derivative will either be recognized immediately in earnings or recorded in accumulated other AOCIcomprehensive income (“AOCI”) until the hedged item is recognized in earnings upon settlement/termination. FX derivative gains and losses in AOCI are reclassified to theour condensed consolidated statementstatements of income (loss) as shown in the tables below and interest rate swap gains and losses in AOCI are reclassified to interest expense in the consolidated statement of income (loss).below. We evaluate hedge effectiveness at inception and on an ongoing basis. If a derivative is no longer expected to be highly effective, hedge accounting is discontinued. Hedge ineffectiveness, if


any, is recorded in earnings.inception. Cash flows from derivative contracts are reported as operating activities in theon our condensed consolidated statements of cash flows.
Freestanding FX Derivative FX Contracts
The gross notional amount of freestanding derivativesFX derivative contracts not designated as hedging instruments outstanding at September 30, 20172020 and December 31, 20162019 was $239.0$332.2 million and $489.1$338.0 million, respectively. These derivative contracts are designed to offset the FX effects in earnings of various intercompany loans our EIB loan, and trade receivables. We recorded net losses(losses) gains for these freestanding derivatives of $0.7$(11.7) million and $7.9$3.1 million for the three months ended September 30, 2020 and 2019, respectively, and $(4.8) million and $6.8 million for the nine months ended September 30, 2017, respectively,2020 and net gains (losses) of $(1.8) million and $0.4 million for the three and nine months ended September 30, 2016,2019, respectively. These gains(losses) and lossesgains are included in ‘Foreignforeign exchange and other gains (losses)’ in the on our condensed consolidated statementsstatement of income (loss).
Counterparty Credit Risk
We are exposed to credit risk in the event of non-performance by the counterparties to our derivatives at maturity.
The two counterparties to the capped call transactions are financial institutions. To limit our credit risk, we selected financial institutions with a minimum long-term investment grade credit rating. Our exposure to the credit risk of the counterparties is not secured by any collateral. If a counterparty becomes subject to insolvency proceedings, we will become an unsecured creditor in those proceedings, with a claim equal to our exposure at that time under the capped call transactions with that counterparty.
To manage credit risk with respect to our other derivatives, the Company selects and periodically reviews counterparties based on credit ratings, limits its exposure with respect to each counterparty, and monitors the market positions. However, if one or more of these counterparties were in a liability position to the Company and were unable to meet their obligations, any transactions with the counterparty could be subject to early termination, which could result in substantial losses for the Company.
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Cash Flow Hedges
NotionalThe gross notional amounts of open derivative contracts designated as cash flow hedges at September 30, 2020 and December 31, 2019 were as follows (in thousands):
Description of Derivative ContractSeptember 30, 2020December 31, 2019
FX derivative contracts to be exchanged for British Pounds$7,610 $10,128 
FX derivative contracts to be exchanged for Japanese Yen16,023 25,342 
FX derivative contracts to be exchanged for Euros36,553 48,838 
Interest rate swap contracts (1)
22,442 
$60,186 $106,750 
Description of Contract September 30, 2017 December 31, 2016
FX derivative contracts to be exchanged for British Pounds $16,928
 $6,663
FX derivative contracts to be exchanged for Japanese Yen 44,618
 57,840
FX derivative contracts to be exchanged for Canadian Dollars 13,341
 
Interest rate swap contracts 62,917
 63,246
  $137,804
 $127,749
(1)Interest rate swap contracts were de-designated upon the repayment of the 2014 European Investment Bank loan. Refer to “Note 8. Financing Arrangements.”
After-tax net loss associated with derivatives designated as cash flow hedges recorded in the ending balance of AOCI and the amount expected to be reclassified to earnings in the next 12twelve months are as follows (in thousands):
Description of Contract September 30, 2017 Net Amount Expected to be Reclassified to Earnings in the Next 12 Months
FX derivative contracts $(287) $(287)
Interest rate swap contracts (261) (69)
  $(548) $(356)
Description of Derivative ContractAfter-Tax Net Gain in AOCI as of September 30, 2020After-Tax Net Gain in AOCI as of Amount Expected to be Reclassified to Earnings in Next 12 Months
FX derivative contracts$1,512 $1,512 
Pre-tax gains (losses) for derivative contracts designated as cash flow hedges recognized in Other Comprehensive Income (Loss)other comprehensive income (loss) (“OCI”) and the amount reclassified to earnings from AOCI were as follows (in thousands):
Three Months Ended September 30,
20202019
Description of Derivative ContractLocation in Earnings of Reclassified Gain or LossGains Recognized in OCI(Losses) Gains Reclassified from AOCI to EarningsLosses Recognized in OCIGains (Losses) Reclassified from AOCI to Earnings
FX derivative contractsForeign exchange and other gains (losses)$1,482 $(692)$(689)$963 
FX derivative contractsSG&A534 (742)
Interest rate swap contractsInterest expense— — (40)
$1,482 $(158)$(689)$181 
Nine Months Ended September 30,
20202019
Description of Derivative ContractLocation in Earnings of Reclassified Gain or LossGains Recognized in OCI(Losses) Gains Reclassified from AOCI to EarningsGains Recognized in OCIGains (Losses) Reclassified from AOCI to Earnings
FX derivative contractsForeign exchange and other gains (losses)$632 $(777)$933 $3,094 
FX derivative contractsSG&A209 (1,470)
Interest rate swap contractsInterest expense(113)(26)
$632 $(681)$933 $1,598 
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    Three Months Ended September 30,
    2017 2016
Description of Contract Location in Earnings of Reclassified Gain or Loss Losses Recognized in OCI (Losses) Gains Reclassified from AOCI to Earnings (Losses) Gains Recognized in OCI Losses Reclassified from AOCI to Earnings
FX derivative contracts Foreign exchange and other (losses) gains $(2,537) $(1,623) $2,535
 $2,795
FX derivative contracts SG&A 
 269
 
 (1,876)
Interest rate swap contracts Interest expense 
 797
 263
 (163)
    $(2,537) $(557) $2,798
 $756


    Nine Months Ended September 30,
    2017 2016
Description of Contract Location in Earnings of Reclassified Gain or Loss Losses Recognized in OCI (Losses) Gains Reclassified from AOCI to Earnings Losses Recognized in OCI Gains (Losses) Reclassified from AOCI to Earnings
FX derivative contracts Foreign exchange and other (losses) gains $(10,124) $(6,833) $(5,932) $2,943
FX derivative contracts SG&A 
 1,623
 
 (3,437)
Interest rate swap contracts Interest expense 
 1,009
 (38) (252)
    $(10,124) $(4,201) $(5,970) $(746)
We offset fair value amounts associated with our derivative instruments on our condensed consolidated balance sheets that are executed with the same counterparty under master netting arrangements. Our netting arrangements include a right to set off or net together purchases and sales of similar products in the settlement process.
The following tables present the fair value on a gross basis, and the location of derivative contracts reported inon the condensed consolidated balance sheets (in thousands):
September 30, 2020Asset DerivativesLiability Derivatives
Derivatives Designated as Hedging InstrumentsBalance Sheet Location
Fair Value (1)
Balance Sheet Location
Fair Value (1)
FX derivative contractsPrepaid expenses and other current assets$1,775 
FX derivative contractsAccrued liabilities12 
Total derivatives designated as hedging instruments1,787 
Derivatives Not Designated as Hedging Instruments
Interest rate swap contractsAccrued liabilities$139 
FX derivative contractsPrepaid expenses and other current assets4,052 Accrued liabilities51 
FX derivative contractsPrepaid expense and other current assets34 
Capped call derivativesOther assets38,999 
Embedded exchange featureLong-term derivative liability59,398 
Other derivativesAccrued liabilities1,160 
Other derivativesLong-term derivative liability190 
Total derivatives not designated as hedging instruments43,051 60,972 
Total derivatives$44,838 $60,972 
December 31, 2019Asset DerivativesLiability Derivatives
Derivatives Designated as Hedging InstrumentsBalance Sheet Location
Fair Value (1)
Balance Sheet Location
Fair Value (1)
Interest rate swap contractsAccrued liabilities$313 
Interest rate swap contractsLong-term derivative liability61 
FX derivative contractsPrepaid expenses and other current assets$148 Accrued liabilities169 
FX derivative contractsAccrued liabilities387 
Total derivatives designated as hedging instruments535 543 
Derivatives Not Designated as Hedging Instruments
FX derivative contractsAccrued liabilities26 Accrued liabilities3,104 
FX derivative contractsPrepaid expenses and other current assets33 
Total derivatives not designated as hedging instruments26 3,137 
Total derivatives$561 $3,680 
(1)For the classification of inputs used to evaluate the fair value of our derivatives, refer to “Note 7. Fair Value Measurements.”

19
September 30, 2017 Liability Derivatives
Derivatives Designated as Hedging Instruments Balance Sheet Location 
Fair Value (1)
Interest rate swap contracts Accrued liabilities $875
Interest rate swap contracts Other long-term liabilities 932
FX derivative contracts Accrued liabilities 724
Total derivatives designated as hedging instruments 
 2,531
Derivatives Not Designated as Hedging Instruments 
 
FX derivative contracts Accrued liabilities 1,456
Total derivatives not designated as hedging instruments 
 1,456
  
 $3,987


December 31, 2016 Asset Derivatives Liability Derivatives
Derivatives Designated as Hedging Instruments Balance Sheet Location 
Fair Value (1)
 Balance Sheet Location 
Fair Value (1)
Interest rate swap contracts Prepaid expenses and other current assets $
 Accrued liabilities $942
Interest rate swap contracts Other assets 
 Other long-term liabilities 1,392
FX derivative contracts Prepaid expenses and other current assets 4,911
 Accrued liabilities 
Total derivatives designated as hedging instruments   4,911
   2,334
Derivatives Not Designated as Hedging Instruments        
FX derivative contracts Prepaid expenses and other current assets 3,358
 Accrued liabilities 
Total derivatives not designated as hedging instruments   3,358
   
    $8,269
   $2,334
(1)For the classification of input used to evaluate the fair value of our derivatives, refer to “Note 6. Fair Value Measurements.”


Note 9.10. Commitments and Contingencies
3T Heater-Cooler Devices
FDA Warning Letter.
On December 29, 2015, the FDA issued LivaNova a Warning Letter (the “Warning Letter”) alleging certain violations of FDA regulations applicable to medical device manufacturers at our Munich, Germany and Arvada, Colorado facilities.
The FDA inspected the Munich facility from August 24, 2015 to August 27, 2015 and the Arvada facility from August 24, 2015 to September 1, 2015. On August 27, 2015, the FDA issued a Form 483 identifying two2 observed non-conformities with certain regulatory requirements at the Munich facility. We did not receive a Form 483 in connection with the FDA’s inspection of the Arvada facility. Following the receipt of the Form 483, we provided written responses to the FDA describing corrective and preventive actions that were underway or to be taken to address the FDA’s observations at the Munich facility. The Warning Letter responded in part to our responses and identified other alleged violations related to the manufacture of our 3T Heater-Cooler device that were not previously included in the Form 483.
The Warning Letter further stated that our 3T devices and other devices we manufactured at our Munich facility arewere subject to refusal of admission into the U.S. until resolution of the issues set forth by the FDA in the Warning Letter. The FDA hashad informed us that the import alert iswas limited to the 3T devices, but that the agency reservesreserved the right to expand the scope of the import alert if future circumstances warrantwarranted such action. The Warning Letter did not request that existing users cease using the 3T device, and manufacturing and shipment of all of our products other than the 3T device remainwere unaffected by the import limitation. To help clarify these issues for current customers, we issued an informational Customer Letter in January 2016 and that same month agreed with the FDA on a process for shipping 3T devices to existing U.S. users pursuant to a certificate of medical necessity program.
Finally, the Warning Letter stated that premarket approval applications for Class III devices to which certain Quality System regulation deviations identified in the Warning Letter arewere reasonably related willwould not be approved until the violations havehad been corrected. However,corrected; however, this restriction appliesapplied only to the Munich and Arvada facilities, which do not manufacture or design devices subject to Class III premarket approval.
On February 25, 2020, LivaNova received clearance for K191402, a 510(k) for the 3T devices that addressed issues contained in the 2015 Warning Letter along with design changes that further mitigate the potential risk of aerosolization. Concurrent with this clearance, (1) 3T devices manufactured in accordance with K191402 will not be subjected to the import alert and (2) LivaNova initiated a correction to distribute the updated Operating Instructions cleared under K191402.
We continue to work diligently to remediate the FDA’s inspectional observations for the Munich facility, as well as the additional issues identified in the Warning Letter. We take these matters seriously and intend to respond timely and fully to the FDA’s requests.
CDC and FDA Safety Communications and Company Field Safety Notice Update
On October 13, 2016, the Centers for Disease ControlCDC and Prevention (“CDC”) andthe FDA separately released safety notifications regarding the 3T devices. The CDC’s Morbidity and Mortality Weekly Report (“MMWR”) and Health Advisory Notice (“HAN”) reported that tests conducted by the CDC and its affiliates indicate that there appears to be genetic similarity between both patient and 3T device strains of the non-tuberculous mycobacterium (“NTM”) bacteria M. chimaera isolated in hospitals in Iowa and Pennsylvania. Citing the geographic separation between the two hospitals referenced in the investigation, the report asserts that 3T devices manufactured prior to August 18, 2014 could have been contaminated during the manufacturing process. The CDC’s HAN and FDA’s Safety Communication, issued contemporaneously with the MMWR report, each assess certain risks associated with 3T devices and provide guidance for providers and patients. The CDC notification states that the decision to use the 3T device during a surgical operation is to be taken by the surgeon based on a risk approach and on patient need. Both the CDC’s and FDA’s communications confirm that 3T devices are critical medical devices and enable doctors to perform life-saving cardiac surgery procedures.
Also on October 13, 2016, concurrent with the CDC’s HAN and FDA’s Safety Communication, we issued a Field Safety Notice Update for U.S. users of 3T devices to proactively and voluntarily contact facilities to aid in implementation of the CDC and FDA recommendations. In the fourth quarter of 2016, we initiated a program to provide existing 3T device users with a new loaner 3T device at no charge pending regulatory approval and implementation of additional risk mitigation strategies worldwide.worldwide, including a vacuum canister and internal sealing upgrade program and a deep disinfection service. This loaner program began in the U.S. and is being made available progressively on a global basis, prioritizing and allocating devices to 3T device users based on pre-established criteria.basis. We anticipate that this program will continue until we are able to address customer needs through a broader solution that includes implementation of one or more of the risk mitigation strategies described above. We are currently underimplementing the vacuum and sealing upgrade program in as many countries as possible until all devices are upgraded. On October 11, 2018, after review of information provided by us, the FDA concluded that we could commence the vacuum and
20


sealing upgrade program in the U.S., and on February 25, 2020, LivaNova received clearance for K191402, a 510(k) for the 3T devices that addressed issues contained in the 2015 Warning Letter along with design changes that further mitigate the potential risk of aerosolization. Furthermore, we continue to offer a no-charge deep disinfection service (deep cleaning service) for 3T device users as we receive the required regulatory agencies.approvals. The deep disinfection service was rolled out in Europe in the second half of 2015, and on April 12, 2018, the FDA agreed to allow us to move forward with the deep cleaning service in the U.S. thereby adding to the growing list of countries around the world in which we offer this service.
On December 31, 2016, we recognized a liability for our product remediation plan related to our 3T device. We concluded that it was probable that a liability had been incurred upon management’s approval of the plan and the commitments made by management to various regulatory authorities globally in November and December 2016, and furthermore, the cost associated with the plan was reasonably estimable. At September 30, 2017,2020, the product remediation liability was $30.2$1.7 million. Refer to “Note 4.5. Product Remediation Liability” for additional information.


Litigation
On February 12, 2016, LivaNova was alerted thatProduct Liability
The Company is currently involved in litigation involving our 3T device. The litigation includes a class action complaint had been filed in the U.S. District Court for the Middle District of Pennsylvania, with respect to our 3T devices. The plaintiffs namedfederal multi-district litigation in the complaint underwent open heart surgeries at WellSpan York HospitalU.S. District Court for the Middle District of Pennsylvania, various U.S. state court cases and Penn State Milton S. Hershey Medical Centercases in 2015, andjurisdictions outside the complaint alleges that: (i) patients were exposed to a harmful form of bacteria, known as nontuberculous mycobacterium (“NTM”), from our 3T devices; and (ii) we knew or should have known that design or manufacturing defects in 3T devices can lead to NTM bacterial colonization, regardless of the cleaning and disinfection procedures used (and recommended by us).U.S. The class of plaintiffsaction, filed in the complaintFebruary 2016, consists of all Pennsylvania residents who underwent open heart surgery at WellSpan York Hospital and Penn State Milton S. Hershey Medical Center between 2011 and 2015 and who currently are asymptomatic for NTM infection.
On October 23, 2017, Members of the U.S. District Court for the Middle District of Pennsylvania issued an order certifying a class with respect to the named plaintiffs. The class action, which is currently against Sorin Group Deutschland GmbH and Sorin Group USA, Inc. seeks: (i)seek declaratory relief findingthat the 3T devices are defective and unsafe for intended uses; (ii)uses, medical monitoring; (iii) general damages;monitoring, damages, and (iv) attorneys’ fees. Other lawsuits related to surgeries in which
On March 29, 2019, we announced a 3T device allegedly was used have been filed elsewheresettlement framework that provides for a comprehensive resolution of the personal injury cases pending in the multi-district litigation in U.S., federal court, the related class action pending in federal court, as well as certain cases in Canada,state courts across the United States. The agreement, which makes no admission of liability, is subject to certain conditions, including acceptance of the settlement by individual claimants and Europe, againstprovides for a total payment of up to $225 million to resolve the claims covered by the settlement. Per the agreed-upon terms, the first payment of $135 million was paid into a qualified settlement fund in July 2019 and the second payment of $90 million was paid in January 2020. Cases covered by the settlement are being dismissed as amounts are disbursed to individual plaintiffs from the qualified settlement fund.
Cases in state courts in the U.S. and in jurisdictions outside the U.S. continue to progress. As of October 29, 2020, including the cases encompassed in the settlement framework described above that have not yet been dismissed, we are aware of approximately 85 filed and unfiled claims worldwide, with the majority of the claims in various LivaNova entities.federal or state courts throughout the United States. This includes cases that have settled but have not yet been dismissed. The complaints generally seek damages and other relief based on theories of strict liability, negligence, breach of express and implied warranties, failure to warn, design and manufacturing defect, fraudulent and negligent misrepresentation or concealment, unjust enrichment, and violations of various state consumer protection statutes.
We are defending each ofAt September 30, 2020, the provision for these claims vigorously. Givenmatters was $46.3 million. While the relatively early stageamount accrued represents our best estimate, the actual liability for resolution of these matters we cannot give any assurances that additional legal proceedings makingmay vary from our estimate.
The changes in the same or similar allegations will not be filed against us or one of our subsidiaries, nor thatlitigation provision liability during the resolution of these complaints or other related litigation will not have a material adverse effect on our business, results of operations, financial condition or liquidity. We have not recognized an expense related to damages in connection with these matters because any potential loss is not currently probable or reasonably estimable. In addition we cannot reasonably estimate a range of potential loss, if any, that may result from these matters.nine months ended September 30, 2020 are as follows (in thousands):
Other
Litigation Provision Liability
Total litigation provision liability at December 31, 2019$170,404 
Payments(128,128)
Adjustments3,970 
FX and other54 
Total litigation provision liability at September 30, 202046,300 
Less current portion of litigation liability at September 30, 202034,790 
Long-term portion of litigation provision liability at September 30, 2020$11,510 
SNIA Litigation
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Environmental Liability
Our subsidiary, Sorin S.p.A. (“Sorin”) was created as a result of a spin-off (the “Sorin spin-off”) from SNIA S.p.A. (“SNIA”). The Sorin spin-off, which involved SNIA’s medical technology division, in January 2004. SNIA subsequently became effective on January 2, 2004. Pursuant to the Italian Civil Code, in a spin-off transaction, the parentinsolvent and the spun-off company can be held jointly liable, up to the actual value of the shareholders’ equity conveyed or received, for certain indebtedness or liabilities of the pre-spin-off company. We estimate that the value of the shareholders’ equity received by Sorin was approximately €573 million (approximately $676 million).
We believe and have argued before the relevant fora that Sorin is not jointly liable with SNIA for its alleged SNIA debts and liabilities. Specifically, between 1906 and 2010, SNIA’s subsidiaries Caffaro Chimica S.r.l. and Caffaro S.r.l. and their predecessors (the “SNIA Subsidiaries”), conducted certain chemical operations (the “Caffaro Chemical Operations”), at sites in Torviscosa, Brescia and Colleferro, Italy (the “Caffaro Chemical Sites”). These activities allegedly resulted in substantial and widely dispersed contamination of soil, water and ground water. In connection with SNIA’s Italian insolvency proceedings, the Italian Ministry of the Environment and the Protection of Land and Sea (the “Italian Ministry of the Environment”), sought compensation from SNIA in an aggregate amount of €3.4 billion (approximately $4.0 billion) for remediation costs relating to the environmental damage at the Caffaro Chemical Sites.chemical sites previously operated by SNIA’s other subsidiaries.
In September 2011 and July 2014, the Bankruptcy Court of Udine and in July 2014, the Bankruptcy Court of Milan, eachrespectively, held (in proceedings to which we are not parties) that the Italian Ministry of the Environment and other Italian government agencies (the “Public Administrations”) were not creditors of either SNIA Subsidiaries or SNIAits subsidiaries in connection with their claims in the context of their Italian insolvency proceedings. InThe Public Administrations appealed and in January 2016, the Court of Udine rejected the appeal brought by the Italian Public Administrations.appeal. The Public Administrations havehas appealed that second loss in pending proceedings beforedecision to the Italian Supreme Court. The appeal byMeanwhile, the Public Administrations before theBankruptcy Court of Milan remains pending.Milan’s decision has been appealed.
In January 2012, SNIA filed a civil action against Sorin in the Civil Court of Milan asserting joint liability of a parent and a spun-off company. SNIA’s civil action against Sorin also named theThe Public Administrations intervened in the Italian Ministryproceeding, with a claim for environmental damages of the Environment and other Italian government agencies, as defendants, in order to have them bound to the final ruling.
approximately $4 billion. On April 1, 2016, the Court of Milan dismissed all legal actions of SNIA and of the Public Administrations against Sorin, further requiring the Public Administrations to pay Sorin €300,000 (or approximately $353,910),€292,000 (approximately $342,000 as of September 30, 2020) for legal fees (of which SNIA is jointly liable for €50,000) (the “2016 Decision”).
On June 21, 2016, thefees. The Public Administrations appealed the 2016 Decision to the Court of Appeal of Milan. The first hearingMilan, and on March 5, 2019, the Court of Appeal issued a partial decision on the merits declaring Sorin/LivaNova jointly liable with SNIA for SNIA’s environmental liabilities in an amount up to the fair value of the appeal proceedings was held in December 2016,net worth received by Sorin because of the Sorin spin-off, an estimated €572.1 million (approximately $669.1 million as of September 30, 2020). Additionally the Court issued a separate order, staying the proceeding until a panel of three experts can assess the environmental damages, the costs of clean-up, and the final hearing is now scheduledcosts that the Public Administrations has already borne for November 22, 2017. After the hearing,clean-up of the parties will file their final briefs,sites to allow the Court to decide on the second claim of the Public Administration against LivaNova, (i.e., to refund the Public Administrations for the SNIA environmental liabilities). Both LivaNova and the Court is expected to render itsPublic Administrations have appealed the decision in mid-2018. SNIA did not file an appeal.


We (as successor to Sorin in the litigation) continue to believe that the risk of material loss relating to the SNIA litigation is not probable as a result of the reasoning contained in, and legal conclusions reached in, the recent court decisions described above. We also believe that the amount of potential losses relating to the SNIA litigation is, in any event, not estimable given that the underlying alleged damages, related remediation costs, allocation and apportionment of any such responsibility, which party is responsible, and various time periods involving different parties, all remain issues in dispute and that no final decision on a remediation plan has been approved. As a result, we have not made any accrual in connection with the SNIA litigation.
Pursuant to European Union (“EU”), United Kingdom (“UK”) and Italian cross-border merger regulations applicable to the Mergers, legacy Sorin liabilities, including any potential liabilities arising from the claims against Sorin relating to the SNIA litigation, are assumed by us as successor to Sorin. Although we believe the claims against Sorin in connection with the SNIA litigation are without merit and continue to contest them vigorously, there can be no assurance as to the outcome. A finding during any appeal or novel proceedings that we are liable for environmental damage at the Caffaro Chemical Sites or its alleged cause(s) could have a material adverse effect on our results of operations, financial condition and/or liquidity.
Environmental Remediation Order
On July 28, 2015, Sorin and other direct and indirect shareholders of SNIA received an administrative order (the “Remediation Order”) from the Italian Ministry of the Environment (the “Ministry”), directing them to promptly commence environmental remediation efforts at the Caffaro Chemical Sites (as described above). We (as successor to Sorin) believe that we should not be liable for damages relating to the Caffaro Chemical Operations pursuant to the Italian statute on which the Remediation Order relies because, inter alia, the statute does not apply to activities occurring prior to 2006, the date on which the statute was enacted. (Sorin was spun off from SNIA in 2004.) Additionally, we believe that Sorin should not be subject to the Remediation Order because Italian environmental regulations only permit such an order to be imposed on an “operator” of a remediation site, and Sorin never operated any activity at any of the industrial sites concerned and, further, was never identified in any legal proceeding as an operator at any of the Caffaro Chemical Sites and could not and in fact did not cause any environmental damage at any of the Caffaro Chemical Sites.
Accordingly, we (as successor to Sorin) alongside other parties, challenged the Remediation Order before the AdministrativeSupreme Court of Lazio in Rome (the “TAR”)(Corte di Cassazione).
On March 21, 2016 the TAR annulled the Remediation Order based on the fact that (i) the Remediation Order lacks any detailed analysis of the causal link between the alleged damage and our activities, a pre-condition to imposition of the measures proposed in the Remediation Order, (ii) the situation of the Caffaro site does not require urgent safety measures, because no new pollution events have occurred and no additional information or evidence of a situation of contamination exists, and (iii) there was no proper legal basis for the Remediation Order, and in any event, the Ministry failed to verify the legal elements that could have led to a conclusion of legal responsibility of the recipients of the Remediation Order.
The TAR decisions described above have been appealed by the Ministry before the Council of State. No information on the timing of the first hearing of this appeal is presently available. We have not recognized an expense in connection with this matter because any potential loss is not currently probable or reasonably estimable. In addition, we cannot reasonably estimate a range of potential loss, if any, that may result from this matter.
Opposition to Merger ProceedingsPatent Litigation
On July 28, 2015, the Public Administrations filed an opposition proceeding to the proposed merger between SorinMay 11, 2018, Neuro and Cyberonics (the “Merger”Cardiac Technologies LLC (“NCT”), beforea non-practicing entity, filed a complaint in the Commercial CourtsUnited States District Court for the Southern District of Milan, askingTexas asserting that the Court to prohibitVNS Therapy System, when used with the executionSenTiva Model 1000 generator, infringes the claims of U.S. Patent No. 7,076,307 owned by NCT. The complaint requests damages that include a royalty, costs, interest, and attorneys’ fees. On September 13, 2018, we petitioned the Patent Trial and Appeal Board of the Merger. In its initial decisionU.S. Patent and Trademark Office (the “Patent Office”) for an inter partes review (“IPR”) of the validity of the ‘307 patent, and on May 18, 2020, the Patent Office issued a Final Written Decision determining that all challenged claims are unpatentable. NCT is appealing the Final Written Decision. On March 24, 2020, we were granted our request for an ex parte reexamination of the ‘307 patent, and in August, 20, 2015, the Court authorizedPatent Office issued a Non-Final Rejection of all of the Merger and the Public Administrations did not appeal this decision. The proceeding then continued as a civil case, with the Public Administration seeking damages against us. The Commercial Court of Milan delivered a decision in October 2016, fully rejecting the Public Administration’s request and awarding us €200,000 (approximately $228,000) in damages for frivolous litigation, plus €200,000 (approximately $228,000) in legal fees. The Public Administrations has appealed this decision to the Court of Appeal of Milan. The final hearing is scheduled on January 17, 2018.‘307 claims. The Court has stayed the litigation pending the outcome of Appeal is likely to make a decision in mid-June 2018.the IPR appeal proceeding. We have not recognized an expense in connection with this matter because any potential loss is not currently probable or reasonably estimable. In addition, we cannot reasonably estimate a range of potential loss, if any, that may result from this matter.

Contract Litigation

On November 25, 2019, LivaNova received notice of a lawsuit initiated by former members of Caisson Interventional, LLC (“Caisson”), a subsidiary of the Company acquired in 2017. The lawsuit, Todd J. Mortier, as Member Representative of the former Members of Caisson Interventional, LLC v. LivaNova USA, Inc., is currently pending in the United States District Court for the District of Minnesota. The complaint alleges (i) breach of contract, (ii) breach of the covenant of good faith and fair dealing and (iii) unjust enrichment in connection with the Company’s operation of Caisson’s Transcatheter Mitral Valve Replacement (“TMVR”) program and the Company’s November 20, 2019 announcement that it was ending the TMVR program at the end of 2019. The lawsuit seeks damages arising out of the 2017 acquisition agreement, including various regulatory milestone payments. We intend to vigorously defend this claim. The Company has not recognized an expense related to this matter because any potential loss is not currently probable or reasonably estimable. In addition, we cannot reasonably estimate a range of potential loss, if any, that may result from this matter.
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Tax Litigation
In a tax audit report received inon October 30, 2009, the Regional Internal Revenue Office of Lombardy (the “Internal Revenue Office”) informed Sorin Group Italia S.r.l. that, among several issues, it was disallowing in part (for a total of €102.6 million (approximately $121.0 million), related to tax years 2002 through 2006) a tax-deductible write down of the investment in the U.S. company, Cobe Cardiovascular Inc., which Sorin Group Italia S.r.l. recognized in 2002 and deducted in five5 equal installments, beginning in 2002. In December 2009, the Internal Revenue Office issued notices of assessment for 2002, 2003 and 2004. The assessments for 2002 and 2003 were automatically voided for lack of merit. In December 2010 and October 2011, the Internal Revenue Office issued notices of assessment for 2005 and 2006, respectively. We challenged all three3 notices of assessment (for 2004, 2005 and 2006) before the relevant Provincial Tax Courts.
The preliminary challenges filed for 2004, 2005 and 2006 were denied at the first jurisdictional level. We appealed these decisions. The appeal submitted against the first-level decision for 2004 was successful. The Internal Revenue Office appealed this second-level decision to the Italian Supreme Court (Corte di Cassazione) in February 2017. The Italian Supreme Court’s decision is pending.
The appeals submitted against the first-level decisions for 2005 and 2006 were rejected. We appealed these adverse decisions to the Italian Supreme Court, where the matters are still pending.
In November 2012, the Internal Revenue Office served a notice of assessment for 2007, and in July 2013, served a notice of assessment for 2008. In these matters the Internal Revenue Office claims an increase in taxable income due to a reduction (similar to the previous notices of assessment for 2004, 2005 and 2006) of the losses reported by Sorin Group Italia S.r.l. for the 2002, 2003 and 2004 tax periods, and subsequently utilized in 2007 and 2008. We challenged both notices of assessment. The Provincial Tax Court of Milan has stayed its decision for years 2007 and 2008 pending resolution of the litigation regarding years 2004, 2005, and 2006. The total amount of losses in dispute iswas €62.6 million (approximately $73.8 million)$73.2 million as of September 30, 2020). We have continuously reassessed our potential exposure in these matters, taking into accountOn May 31, 2019, we filed an application to settle the recent,litigation according to law N. 136/2018 and generally adverse, trend topaid the required settlement balance of €1.9 million. As per law N. 136/2018, the Italian taxpayers in this type of litigation. Although we believe that our defensive arguments are strong, notingRevenue Agency reviewed the adverse trend in some ofsettlement and accepted the court decisions, we haveapplication by default on July 31, 2020. We recognized a benefit of €5.4 million, approximately $6.5 million, during the third quarter of 2020 as compared to the previously recognized reserve for an uncertain tax position of €17.0€15.5 million. The difference of €10.1 million (approximately $20.0 million)$11.8 million as of September 30, 2020) was a fully valued deferred tax asset for net operating losses, the reversal of which does not impact the condensed consolidated statement of income (loss).
Other Matters
Additionally, we are the subject of various pending or threatened legal actions and proceedings that arise in the ordinary course of our business. These matters are subject to many uncertainties and outcomes that are not predictable and that may not be known for extended periods of time. Since the outcome of these matters cannot be predicted with certainty, the costs associated with them could have a material adverse effect on our consolidated net income, financial position or liquidity.



Note 10.11. Stockholders’ Equity
Comprehensive incomeThe tables below present the condensed consolidated statement of stockholders’ equity as of and for the three and nine months ended September 30, 2020 and 2019 (in thousands):
Ordinary SharesOrdinary Shares - AmountAdditional Paid-In CapitalTreasury StockAccumulated Other Comprehensive LossAccumulated DeficitTotal Stockholders' Equity
June 30, 202049,476 $76,338 $1,750,798 $(1,057)$(35,089)$(457,804)$1,333,186 
Stock-based compensation plans— — 7,670 — — 7,674 
Cancellation of shares(73)— — — — — — 
Net loss— — — — — (14,772)(14,772)
Other comprehensive income— — — — 24,704 — 24,704 
September 30, 202049,403 $76,338 $1,758,468 $(1,053)$(10,385)$(472,576)$1,350,792 
June 30, 201949,380 $76,217 $1,717,220 $(1,292)$(13,174)$(295,643)$1,483,328 
Stock-based compensation plans— 8,262 10 — — 8,272 
Net income— — — — — 32,118 32,118 
Other comprehensive loss— — — — (28,436)— (28,436)
September 30, 201949,381 $76,217 $1,725,482 $(1,282)$(41,610)$(263,525)$1,495,282 

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Ordinary SharesOrdinary Shares - AmountAdditional Paid-In CapitalTreasury StockAccumulated Other Comprehensive LossAccumulated DeficitTotal Stockholders' Equity
December 31, 201949,411 $76,257 $1,734,870 $(1,263)$(19,392)$(406,755)$1,383,717 
Adoption of ASU No. 2016-13 (1)
— — — — — (639)(639)
Stock-based compensation plans65 81 23,598 210 — — 23,889 
Cancellation of shares(73)— — — — — — 
Net loss— — — — — (65,182)(65,182)
Other comprehensive income— — — — 9,007 — 9,007 
September 30, 202049,403 $76,338 $1,758,468 $(1,053)$(10,385)$(472,576)$1,350,792 
December 31, 201849,323 $76,144 $1,705,111 $(1,462)$(24,476)$(251,579)$1,503,738 
Stock-based compensation plans58 73 20,371 180 — — 20,624 
Net loss— — — — — (11,946)(11,946)
Other comprehensive loss— — — — (17,134)— (17,134)
September 30, 201949,381 $76,217 $1,725,482 $(1,282)$(41,610)$(263,525)$1,495,282 
(1)Refer to “Note 17. New Accounting Pronouncements”
The table below presents the change in each component of AOCI, net of tax, and the reclassifications out of AOCI into net earningsincome for the nine months ended September 30, 20172020 and September 30, 20162019 (in thousands):
Change in Unrealized Gain (Loss) on Derivatives
Foreign Currency Translation Adjustments Gain (Loss) (1)
Total
December 31, 2019$513 $(19,905)$(19,392)
Other comprehensive income before reclassifications, before tax632 8,008 8,640 
Tax expense(152)(152)
Other comprehensive income before reclassifications, net of tax480 8,008 8,488 
Reclassification of loss from accumulated other comprehensive loss, before tax681 681 
Reclassification of tax benefit(162)(162)
Reclassification of loss from accumulated other comprehensive loss, after tax519 519 
Net current-period other comprehensive income, net of tax999 8,008 9,007 
September 30, 2020$1,512 $(11,897)$(10,385)
December 31, 2018$(944)$(23,532)$(24,476)
Other comprehensive income (loss) before reclassifications, before tax933 (16,628)(15,695)
Tax expense(224)(224)
Other comprehensive income (loss) before reclassifications, net of tax709 (16,628)(15,919)
Reclassification of gain from accumulated other comprehensive loss, before tax(1,598)(1,598)
Reclassification of tax expense383 383 
Reclassification of gain from accumulated other comprehensive loss, after tax(1,215)(1,215)
Net current-period other comprehensive loss, net of tax(506)(16,628)(17,134)
September 30, 2019$(1,450)$(40,160)$(41,610)
(1)Taxes are not provided for foreign currency translation adjustments as translation adjustments are related to earnings that are intended to be reinvested in the countries where earned.
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  Change in Unrealized Gain (Loss) on Derivatives 
Foreign Currency Translation Adjustments Gain (Loss) (1)
 Total
As of December 31, 2016 $3,619
 $(72,106) $(68,487)
Other comprehensive (loss) income before reclassifications, before tax (10,124) 111,123
 100,999
Tax benefit 2,784
 
 2,784
Other comprehensive (loss) income before reclassifications, net of tax (7,340) 111,123
 103,783
Reclassification of loss from accumulated other comprehensive income, before tax 4,201
 
 4,201
Tax benefit (1,028) 
 (1,028)
Reclassification of loss from accumulated other comprehensive income, after tax 3,173
 
 3,173
Net current-period other comprehensive (loss) income, net of tax (4,167) 111,123
 106,956
As of September 30, 2017 $(548) $39,017
 $38,469
       
As of December 31, 2015 $888
 $(55,116) $(54,228)
Other comprehensive (loss) income before reclassifications, before tax (5,970) 32,598
 26,628
Tax benefit 1,792
 
 1,792
Other comprehensive (loss) income before reclassifications, net of tax (4,178) 32,598
 28,420
Reclassification of loss from accumulated other comprehensive income, before tax 746
 
 746
Tax benefit (279) 
 (279)
Reclassification of loss from accumulated other comprehensive income, after tax 467
 
 467
Net current-period other comprehensive (loss) income, net of tax (3,711) 32,598
 28,887
As of September 30, 2016 $(2,823) $(22,518) $(25,341)
(1)Taxes are not provided for foreign currency translation adjustments as translation adjustments are related to earnings that are intended to be reinvested in the countries where earned.


Note 11.12. Stock-Based Incentive Plans
Stock-based incentive plans compensation expense is as follows (in thousands):
Three Months Ended September 30,Nine Months Ended September 30,
 Three Months Ended September 30, Nine Months Ended September 30,2020201920202019
 2017 2016 2017 2016
Service-based stock appreciation rights ("SARs") $2,535
 $1,983
 $6,001
 $6,567
Service-based restricted stock units ("RSUs") 2,225
 2,517
 6,718
 8,419
Service-based restricted stock units (“RSUs”)Service-based restricted stock units (“RSUs”)$4,410 $3,583 $13,139 $10,428 
Service-based stock appreciation rights (“SARs”)Service-based stock appreciation rights (“SARs”)3,211 2,896 9,185 7,804 
Market performance-based restricted stock units 301
 14
 482
 17
Market performance-based restricted stock units814 757 2,745 2,146 
Operating performance-based restricted stock units 636
 254
 1,060
 572
Operating performance-based restricted stock units(962)983 882 2,752 
Employee share purchase planEmployee share purchase plan337 312 894 997 
Total stock-based compensation expense $5,697
 $4,768
 $14,261
 $15,575
Total stock-based compensation expense$7,810 $8,531 $26,845 $24,127 
During the nine months ended September 30, 2017,2020, we executedissued stock-based compensatory award agreementsawards with contract terms agreed upon by us and the respective individuals, as approved by the Compensation Committee of our Board of


Directors. AwardsThe awards with service conditions generally vest ratably over four years, subject to forfeiture unless service conditions are met. Market performance-based awards cliff vest ratably over fourafter three years subject to forfeiture unless certain future pricesthe rank of our shares ontotal shareholder return for the NASDAQ Stock Market exceed certain threshold prices inthree-year period ending December 31, 2022 relative to the first year following the grant date. And finally, operatingtotal shareholder returns for a peer group of companies. Operating performance-based awards cliff vest ratably over fourafter three years subject to forfeiture unlessthe achievement of certain thresholds of cumulative adjusted net sales and adjusted net income are metfree cash flow for fiscalthe three year 2017.period ending December 31, 2022. Compensation expense related to award agreements executedawards granted during 20172020 for the three and nine months ended September 30, 2017 were $2.02020 was $3.3 million and $3.2$6.6 million, respectively.
Stock-based compensation agreements executedissued during the nine months ended September 30, 2017,2020, representing potential shares and their weighted average grant date fair values by type follows (shares in thousands, fair value in dollars):
Nine Months Ended September 30, 2020
SharesWeighted Average Grant Date Fair Value
Service-based SARs1,133 $15.73 
Service-based RSUs599 $44.42 
Market performance-based RSUs93 $39.83 
Operating performance-based RSUs93 $43.57 
  Nine Months Ended September 30, 2017
  Shares Weighted Average Grant Date Fair Value
Service-based SARs 639
 $17.03
Service-based RSUs 108
 $57.37
Market performance-based RSUs 158
 $25.29
Operating performance-based RSUs 189
 $56.18

Note 12.13. Income Taxes
During the three and nine months ended September 30, 2017, we recorded consolidated income tax expense of $1.9 million and $10.9 million, respectively, with consolidated effective income tax rates of 6.1% and 9.3%, respectively.
Our consolidated effective income tax rate from continuing operations for the three and nine months ended September 30, 2017 included the impact of various discrete tax items, including a net $4.0 million deferred tax benefit due to the release of valuation allowances on tax losses upon the completion of a reorganization of our legal entities in the U.S.2020 was 21.3% and a $2.1 million tax benefit from the resolution of prior period tax matters. Discrete tax items(37.9)% compared with (49.6)% and 65.9% for the nine months ended September 30, 2017 also included the acquisition of Caisson and the $38.1 million non-taxable gain recognized to re-measure our existing equity investment in Caisson at fair value on the acquisition date, a $3.9 million deferred tax benefit associated with certain temporary differences arising from the Mergers and the recognition of a $3.0 million deferred tax asset related to a reserve for an uncertain tax position recognized in a prior year, in addition to various other discrete items.
During the three and nine months ended September 30, 2016, we recorded consolidated income tax expense of $9.7 million and $16.9 million, respectively, with consolidated2019, respectively. Our effective income tax rate fluctuates based on, among other factors, changes in pretax income in countries with varying statutory tax rates, changes in valuation allowances, changes in tax credits and incentives, and changes in unrecognized tax benefits associated with uncertain tax positions.
We continually assess the realizability of 45.7%our worldwide deferred tax asset and 514.5%valuation allowance positions, and when the need arises, we establish or release valuation allowances accordingly.
Compared with the three months ended September 30, 2019, the change in the effective tax rate for the three months ended September 30, 2020 was primarily attributable to a discrete tax benefit due to the release of the uncertain tax position upon the settlement of tax litigation in Italy offset by a valuation allowance for certain jurisdictions outside the U.S., respectively. Theas compared to a U.S. federal tax benefit from a return to provision reconciliation, partially offset by the establishment of a valuation allowance for a portion of the U.S. federal and state net operating losses during the three months ended September 30, 2019. We established valuation allowances as it is more likely than not that we will be unable to realize the related historical deferred tax assets.
Compared with the nine months ended September 30, 2019, the change in the effective tax rate for the nine months ended September 30, 20162020 was impactedprimarily attributable to a $42.4 million realized discrete tax benefit related to the Coronavirus Aid, Relief, and Economic Security Act (“CARES Act”) and the discrete tax benefit due to the release of the uncertain tax position upon the settlement of tax litigation in Italy offset by the recordingestablishment of a $74.5 million valuation allowancesallowance for the U.K. and
25


other jurisdictions outside the U.S., as compared to a release of $23.9uncertain tax positions and a U.S. federal tax benefit from a return to provision reconciliation, partly offset by the establishment of a valuation allowance for a portion of the U.S. federal and state net operating losses and attributes during the nine months ended September 30, 2019.
We operate in multiple jurisdictions throughout the world, and our tax returns are periodically audited or subjected to review by tax authorities. As a result, there is an uncertainty in income taxes recognized in our financial statements. Tax benefits totaling $4.0 million relatedand $12.9 million were unrecognized as of September 30, 2020 and December 31, 2019, respectively. It is reasonably possible that, within the next twelve months, due to certainthe settlement of uncertain tax jurisdictions, including Francepositions with various tax authorities and the UK, in which we did not recordexpiration of statutes of limitations, unrecognized tax benefits generatedcould decrease by their operatingup to approximately $0.7 million.
We monitor income tax developments in countries where we conduct business. On March 27, 2020, the U.S. enacted the CARES Act which provided for a 5-year loss carryback for losses incurred in 2018-2020. We recorded a discrete tax benefit of $42.4 million to account for the effect of the CARES Act during the nine months ended September 30, 2020. Further regulations and notices as well as state legislative changes addressing conformity to the tax expense generated by profitable operations in higher tax jurisdictions, such as the U.S. and Germany, offset by tax savings from our inter-company financing as part of our 2015 tax restructuring.

CARES Act are still pending.


Note 13. Net Income (Loss)14. Earnings Per Share
The following table sets forthReconciliation of the shares used in the basic and diluted earnings per share computations for the three and nine months ended September 30, 2020 and 2019 are as follows (in thousands):
Three Months Ended September 30,Nine Months Ended September 30,
2020201920202019
Basic weighted average shares outstanding48,652 48,395 48,582 48,329 
Add effects of share-based compensation instruments (1)
425 
Diluted weighted average shares outstanding48,652 48,820 48,582 48,329 
(1)Excluded from the computation of basic and diluted net income (loss)earnings per share (in thousands, except perwere stock options, SARs and restricted share data):units totaling 4.1 million and 1.4 million for the three months ended September 30, 2020 and 2019, respectively, and 4.2 million and 3.2 million for the nine months ended September 30, 2020 and 2019, respectively, because to include them would have been anti-dilutive under the treasury stock method.

  Three Months Ended September 30, Nine Months Ended September 30,
  2017 2016 2017 2016
Numerator:        
Net income (loss) $27,830
 $(1,569) $86,599
 $(32,990)
         
Denominator:        
Basic weighted average shares outstanding 48,181
 49,075
 48,130
 49,016
Add effects of share-based compensation instruments (1)
 353
 
 209
 
Diluted weighted average shares outstanding 48,534
 49,075
 48,339
 49,016
Basic income (loss) per share $0.58
 $(0.03) $1.80
 $(0.67)
Diluted income (loss) per share $0.57
 $(0.03) $1.79
 $(0.67)
(1)
Excluded from the computation of diluted earnings per share for the three and nine months ended September 30, 2017 were 1.6 million stock options and SARs outstanding as of September 30, 2017, because to include them would have been anti-dilutive. Excluded from the computation of diluted earnings per share for the three and nine months ended September 30, 2016 were approximately 2.3 million stock options, SARs and restricted share units outstanding as of September 30, 2016, because to include them would have been anti-dilutive due to the net losses.
Note 14.15. Geographic and Segment Information
Segment Information
We identify operating segments based on the way we manage, evaluate and internally report our business activities for purposes of allocating resources, developing and executing our strategy, and assessing performance. We have three2 reportable segments: Cardiac Surgery, Neuromodulation,Cardiovascular and Cardiac Rhythm Management.Neuromodulation.
The Cardiac SurgeryCardiovascular segment generates its revenue from the development, production and sale of cardiovascular surgery products. Cardiac Surgerycardiopulmonary products, heart valves and related products and advanced circulatory support. Cardiopulmonary products include oxygenators, heart-lung machines, autotransfusion systems, perfusion tubing systems, cannulae and other related accessories. Heart valves include mechanical heart valves, and tissue heart valves.valves, related repair products and minimally invasive surgical instruments. Advanced circulatory support includes temporary life support controllers and product kits that can include a combination of pumps, oxygenators, and cannulae.
TheOur Neuromodulation segment generates its revenue from the design, development and marketing of neuromodulation therapy systems for the treatment of drug-resistant epilepsy, difficult-to-treat depression (“DTD”) and treatment resistant depression.obstructive sleep apnea. Neuromodulation products include the VNS Therapy System, which consists of an implantable pulse generator, a lead that connects the generator to the vagus nerve, surgical equipment to assist with the implant procedure, equipment to enable the treating physician to set the pulse generator stimulation parameters for the patient, instruction manuals and magnets to suspend or induce stimulation manually.
The Cardiac Rhythm Management segment generates its revenue from the development, manufacturing and marketing of products for the diagnosis, treatment, and management of heart rhythm disorders and heart failure. Cardiac Rhythm Management products include high-voltage defibrillators, cardiac resynchronization therapy devices and low-voltage pacemakers.other accessories.
“Other” includes Corporatecorporate shared servicesservice expenses for finance, legal, human resources, and information technology and Corporatecorporate business development (“New Ventures”). New Ventures, which includes our recent Caisson acquisition, is focused on new growth platforms and identification of other opportunities for expansion.development.
Net sales of our reportable segments include end-customer revenues from the sale of products they each develop and manufacture or distribute. We define segment income as operating income before merger and integration, restructuring and amortization of intangibles.

26



NetWe operate under 3 geographic regions: U.S., Europe, and Rest of World. The table below presents net sales by operating segment and income from operations by segmentgeographic region (in thousands):
Three Months Ended September 30,Nine Months Ended September 30,
2020201920202019
Cardiopulmonary
United States$33,549 $39,054 $96,223 $119,580 
Europe29,947 30,052 87,475 99,933 
Rest of World43,704 50,908 140,925 152,650 
107,200 120,014 324,623 372,163 
Heart Valves
United States3,129 4,626 8,990 13,660 
Europe7,945 9,572 22,822 30,757 
Rest of World10,062 14,679 32,001 43,484 
21,136 28,877 63,813 87,901 
Advanced Circulatory Support
United States12,331 6,313 28,075 22,290 
Europe162 186 835 497 
Rest of World49 36 136 310 
12,542 6,535 29,046 23,097 
Cardiovascular
United States49,009 49,993 133,288 155,530 
Europe38,054 39,810 111,132 131,187 
Rest of World53,815 65,623 173,062 196,444 
140,878 155,426 417,482 483,161 
Neuromodulation
United States79,854 88,433 197,345 245,870 
Europe10,475 10,425 27,474 34,080 
Rest of World8,079 13,685 20,458 31,511 
98,408 112,543 245,277 311,461 
Other797 641 1,927 1,958 
Totals
United States128,863 138,426 330,633 401,400 
Europe (1)
48,529 50,235 138,606 165,267 
Rest of World62,691 79,949 195,447 229,913 
Total (2)
$240,083 $268,610 $664,686 $796,580 
  Three Months Ended September 30, Nine Months Ended September 30,
Net Sales: 2017 2016 2017 2016
Cardiac Surgery $159,822
 $148,518
 $457,612
 $453,012
Neuromodulation 91,016
 89,504
 275,190
 260,901
Cardiac Rhythm Management 58,411
 56,768
 182,235
 188,057
Other 415
 478
 1,119
 1,314
  $309,664
 $295,268
 $916,156
 $903,284
(1)Europe sales include those countries in which we have a direct sales presence, whereas European countries in which we sell through distributors are included in Rest of World.
(2)No single customer represented over 10% of our consolidated net sales. No country’s net sales exceeded 10% of our consolidated sales except for the U.S.
27

  Three Months Ended September 30, Nine Months Ended September 30,
Income from Operations: 2017 2016 2017 2016
Cardiac Surgery $23,807
 $17,791
 $63,490
 $29,197
Neuromodulation 45,932
 47,049
 139,357
 134,871
Cardiac Rhythm Management 5,427
 (4,598) 13,536
 (14,432)
Other (27,947) (13,525) (79,378) (49,090)
Total Reportable Segments’ Income from Operations 47,219
 46,717
 137,005
 100,546
Merger and integration expenses 2,013
 7,576
 7,743
 20,537
Restructuring expenses 792
 4,381
 12,060
 37,219
Amortization of intangibles 12,350
 11,775
 35,445
 33,959
Income from operations $32,064
 $22,985
 $81,757
 $8,831

The following tables present our assets and capitaltable below presents a reconciliation of segment income from continuing operations to consolidated (loss) income from continuing operations before tax (in thousands):
Three Months Ended September 30,Nine Months Ended September 30,
2020201920202019
Cardiovascular$(7,311)$36,180 $(8,037)$47,289 
Neuromodulation21,154 30,010 82,294 52,260 
Other(10,921)(21,869)(58,407)(75,845)
Total reportable segment income from continuing operations2,922 44,321 15,850 23,704 
Merger and integration expenses1,094 6,716 6,616 14,345 
Restructuring expenses(349)698 2,025 4,563 
Amortization of intangibles9,685 11,146 29,346 29,690 
Operating (loss) income from continuing operations(7,508)25,761 (22,137)(24,894)
Interest income47 151 482 624 
Interest expense(14,673)(4,774)(25,237)(10,490)
Foreign exchange and other gains (losses)3,420 327 507 (795)
(Loss) income from continuing operations before tax$(18,714)$21,465 $(46,385)$(35,555)
Assets by segment are as follows (in thousands):
September 30, 2020December 31, 2019
Cardiovascular$1,463,523 $1,546,520 
Neuromodulation668,899 749,069 
Other389,326 116,208 
Total assets$2,521,748 $2,411,797 
Capital expenditures by segment are as follows (in thousands):
Assets: September 30, 2017 December 31, 2016
Cardiac Surgery $1,414,260
 $1,277,799
Neuromodulation 564,785
 611,085
Cardiac Rhythm Management 351,390
 341,998
Other 272,695
 111,749
  $2,603,130
 $2,342,631
  Three Months Ended September 30, Nine Months Ended September 30,
Capital expenditures: 2017 2016 2017 2016
Cardiac Surgery $5,541
 $6,465
 $13,292
 $16,774
Neuromodulation 370
 1,781
 2,348
 5,602
Cardiac Rhythm Management 1,537
 1,591
 4,343
 2,786
Other 1,633
 2,435
 4,021
 3,766
  $9,081
 $12,272
 $24,004
 $28,928


Three Months Ended September 30,Nine Months Ended September 30,
2020201920202019
Cardiovascular$7,040 $5,178 $17,777 $13,564 
Neuromodulation1,210 136 7,285 666 
Other967 691 3,174 2,571 
Total$9,217 $6,005 $28,236 $16,801 
The changes in the carrying amount of goodwill by reportable segment for the nine months ended September 30, 20172020 were as follows (in thousands):
NeuromodulationCardiovascularTotal
December 31, 2019$398,754 $517,040 $915,794 
Foreign currency adjustments2,684 2,684 
September 30, 2020$398,754 $519,724 $918,478 
  Neuromodulation Cardiac Surgery Cardiac Rhythm Management Other Total
December 31, 2016 $315,943
 $375,769
 $
 $
 $691,712
Goodwill as a result of acquisitions (1)
 
 
 
 42,418
 42,418
Foreign currency adjustments 
 46,940
 
 
 46,940
September 30, 2017 $315,943
 $422,709
 $
 $42,418
 $781,070
(1)Goodwill recognized as a result of the Caisson acquisition. Refer to “Note 2. Acquisitions.”
Geographic Information
We operate under three geographic regions: United States, Europe, and Rest of world. Net sales to external customers by geography are determined based on the country the products are shipped to and are as follows (in thousands):
  Three Months Ended September 30, Nine Months Ended September 30,
Net Sales 2017 2016 2017 2016
United States $122,208
 $123,810
 $366,115
 $362,358
Europe (1) (2)
 92,953
 91,245
 294,338
 301,727
Rest of world 94,503
 80,213
 255,703
 239,199
Total (3)
 $309,664
 $295,268
 $916,156
 $903,284
(1)
Net sales to external customers in the UK include $9.6 million and $26.8 millionfor the three and nine months ended September 30, 2017, respectively and $8.8 million and $27.9 million for the three and nine months ended September 30, 2016, respectively.
(2)Includes those countries in Europe where we have a direct sales presence. Countries where sales are made through distributors are included in ‘Rest of world’.
(3)No single customer represented over 10% of our consolidated net sales. Except for the U.S. and France, no country’s net sales exceeded 10% of our consolidated net sales. French sales were $29.6 million and $96.6 million for the three and nine months ended September 30, 2017, respectively, and $28.9 million and $95.9 million for the three and nine months ended September 30, 2016, respectively.
Property, plant and equipment, net by geography are as follows (in thousands):
September 30, 2020December 31, 2019
United States$64,620 $61,410 
Europe116,746 110,270 
Rest of World9,143 9,674 
Total$190,509 $181,354 

28
PP&E September 30, 2017 December 31, 2016
United States $62,630
 $61,279
Europe 137,682
 130,777
Rest of world 13,457
 31,786
Total $213,769
 $223,842


Note 15.16. Supplemental Financial Information
Accounts receivable, net, consisted of the following (in thousands):
  September 30, 2017 December 31, 2016
Trade receivables from third parties $326,498
 $285,336
Allowance for bad debt (12,457) (9,606)
  $314,041
 $275,730


Inventories consisted of the following (in thousands):
September 30, 2020December 31, 2019
Raw materials$48,325 $45,225 
Work-in-process18,949 14,581 
Finished goods110,817 104,348 
 $178,091 $164,154 

 September 30, 2017 December 31, 2016
Raw materials $51,628
 $47,704
Work-in-process 39,873
 32,316
Finished goods 123,092
 103,469
  $214,593
 $183,489
Inventories are reported netAs of the provision for obsolescence which totaled $13.7 million and $9.8 million at September 30, 20172020 and December 31, 2016, respectively.
Prepaid expenses2019, inventories include adjustments totaling $14.5 million and other current assets consisted$12.7 million, respectively, to record balances at lower of the following (in thousands):
  September 30, 2017 December 31, 2016
Income taxes payable on inter-company transfers of property (1)
 $19,445
 $19,445
Deposits and advances to suppliers 7,298
 5,417
Earthquake grant receivable 4,983
 4,748
Unbilled receivables 4,363
 
Escrow deposit - Caisson 2,000
 
Current loans and notes receivable 1,553
 7,093
Derivative contract assets 
 8,269
Other prepaid expenses 15,534
 11,001
  $55,176
 $55,973
(1)
The income taxes payable on intercompany transfers of property asset is the asset account created to defer the income tax effect of an intercompany intellectual property sale pursuant to ASC 810-10-45-8.
Other assets consisted of the following (in thousands):
  September 30, 2017 December 31, 2016
Income taxes payable on inter-company transfers of property (1)
 $109,971
 $124,551
Investments (2)
 2,316
 2,537
Loans and notes receivable 1,964
 2,029
Escrow deposit - Caisson 1,000
 
Guaranteed deposits 777
 940
Other 1,827
 641
  $117,855
 $130,698
(1)The income taxes payable on intercompany transfers of property asset is the asset account created to defer the income tax effect of an intercompany intellectual property sale pursuant to ASC 810-10-45-8.
(2)Primarily cash surrender value of company owned life insurance policies.


cost or net realizable value.
Accrued liabilities and other consisted of the following (in thousands):
September 30, 2020December 31, 2019
Contingent consideration (1)
$16,571 $22,953 
Legal and administrative costs14,034 11,066 
Operating lease liabilities11,941 11,110 
Contract liabilities7,723 6,728 
Research and development costs5,328 5,160 
Provisions for agents, returns and other3,772 3,922 
Restructuring related liabilities (2)
1,813 4,315 
Product remediation (3)
1,715 3,251 
Derivative contract liabilities (4)
1,338 3,173 
CRM purchase price adjustment payable to MicroPort Scientific Corporation14,891 
Other accrued expenses34,073 33,531 
$98,308 $120,100 
  September 30, 2017 December 31, 2016
Product remediation liability (1)
 $20,060
 $23,464
Deferred compensation - Caisson acquisition 14,137
 
Legal and other administrative costs 7,863
 6,184
Provisions for agents, returns and other 8,505
 7,271
Restructuring related liabilities 5,098
 16,859
Product warranty obligations 1,747
 2,736
Royalty costs 2,048
 2,503
Escrow indemnity liability - Caisson 2,000
 
Deferred income 4,752
 
Government grants 1,275
 1,708
Derivative contract liabilities (2)
 3,055
 942
Research and development costs 1,173
 839
Other 20,499
 13,061
  $92,212
 $75,567
(1)Refer to “Note 4. Product Remediation Liability.”
(2)Refer to “Note 8. Derivatives and Risk Management.”
(1)Refer to “Note 7. Fair Value Measurements”
Other(2)Refer to “Note 4. Restructuring”
(3)Refer to “Note 5. Product Remediation Liability”
(4)Refer to “ Note 9. Derivatives and Risk Management”
As of September 30, 2020 and December 31, 2019, contract liabilities of $9.5 million and $8.6 million, respectively, are included within accrued liabilities and other long-term liabilities consisted ofon the following (in thousands):condensed consolidated balance sheets.
29

 September 30, 2017 December 31, 2016
Contingent consideration (1)
 $34,217
 $3,890
Uncertain tax positions 12,349
 11,108
Product remediation liability (2)
 10,186
 10,023
Government grants 5,889
 3,803
Derivative contract liabilities (3)
 932
 1,392
Escrow indemnity liability - Caisson 1,000
 
Unfavorable operating leases (4)
 256
 1,672
Other 9,575
 7,599
  $74,404
 $39,487
(1)The contingent consideration liability represents contingent payments related to three acquisitions: the first and second acquisitions, in September 2015, were Cellplex PTY Ltd. in Australia and the commercial activities of a local distributor in Colombia. The contingent payments for the first acquisition are based on achievement of sales targets by the acquiree through June 30, 2018 and the contingent payments for the second acquisition are based on sales of cardiopulmonary disposable products and heart lung machines of the acquiree through December 2019. Refer to “Note 6. Fair Value Measurements.” The third acquisition, Caisson, occurred in May 2017. Refer to “Note 2. Acquisitions.”
(2)Refer to “Note 4. Product Remediation Liability.”
(3)Refer to “Note 8. Derivatives and Risk Management.”
(4)Unfavorable operating leases represent the adjustment to recognize future lease obligations at their estimated fair value in conjunction with the Mergers.


Note 16.17. New Accounting Pronouncements
In May 2014, the FinancialAdoption of New Accounting Pronouncements
The following table provides a description of our adoption of new Accounting Standards BoardUpdates (“FASB”ASUs”) issued ASC Update (“ASU”) No. 2014-09, Revenue from Contracts with Customers. Update No. 2014-09 requires an entity to recognizeby the amount of revenue to which it expects to be entitled for the transfer of promised goods or services to customersFASB and will replace most existing revenue recognition guidance when it becomes effective. This new standard is effective for annual reporting periods beginning after December 15, 2017, and interim periods within that reporting period. The standard permits the use of either the retrospective or cumulative effect transition method. We will adopt the new standard under the cumulative effect transition method.


Based on the Company’s evaluation performed to date, we believe the timing of revenue recognition for products and related revenue streams within our Neuromodulation and Cardiac Rhythm Management segments will not materially change. The Company continues to evaluate the impact of the adoption on our condensed financial statements:
Issue Date & StandardDescriptionDate of AdoptionEffect on Financial Statements or Other Significant Matters
June 2016
ASU No. 2016-13, Financial Instruments—Credit Losses (Topic 326)
The amendments in this update require a financial asset (or a group of financial assets) measured at amortized cost basis to be presented at the net amount expected to be collected. We adopted the update effective
January 1, 2020, applying this standard to our accounts receivable by use of a provision matrix approach. This approach utilizes historical loss rates based on the number of days past due, adjusted to reflect current economic conditions and forecasts of future economic conditions.
January 1, 2020
We recognized the following cumulative-effect adjustments, including to retained earnings, upon adoption at January 1, 2020:
Accounts receivable, net decreased $0.6 million and accumulated deficit increased $0.6 million.
January 2017
ASU No. 2017-04, 
Intangibles-Goodwill and Other (Topic 350): Simplifying the Test for Goodwill Impairment
This update removes step 2 of the goodwill impairment test that compares the implied fair value of goodwill with its carrying amount. Instead, an impairment test is performed by comparing the fair value of a reporting unit with its carrying amount. An impairment charge will be recorded by the amount a reporting unit’s carrying amount exceeds its fair value.January 1, 2020There was no material impact to our consolidated financial statements as a result of adopting this ASU.
August 2018
ASU No. 2018-13, Fair Value Measurement (Topic 820): Changes to the Disclosure Requirements for Fair Value Measurement
This update removes, modifies and adds certain disclosure requirements related to fair value measurements.January 1, 2020There was no material impact to our consolidated financial statements as a result of adopting this ASU.
August 2018
ASU No. 2018-15, Intangibles—Goodwill and Other—Internal-Use Software (Subtopic 350-40): Customer’s Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement That Is a Service Contract
This update clarifies and aligns the accounting for implementation costs for hosting arrangements with the requirements for capitalizing implementation costs incurred to develop or obtain internal-use software.January 1, 2020There was no material impact to our consolidated financial statements as a result of adopting this ASU.
Future Adoption of New Accounting Pronouncements
The following table provides a description of future adoptions of new standard on the timing of when revenue will be recognized for equipment sales and certain services performed within our Cardiac Surgery segment specifically related to heart-lung machines and preventive maintenance contracts on cardiopulmonary equipment.
Upon adoption of the new standard, we expect to implement new internal controls related to our accounting policies and procedures, including review controls to ensure contractual terms and conditionsstandards that may require consideration under the standard are properly identified and analyzed. During the fourth quarter of 2017, we expect to finalize ourhave an impact assessment and redesign impacted processes, policies and controls.
In January 2016, the FASB issued ASU No. 2016-01, Financial Instruments-Overall (Subtopic 825-10): Recognition and Measurement of Financial Assets and Financial Liabilities. Update 2016-01 requires equity investments that do not result in consolidation and are not accounted for under the equity method to be measured at fair value with changes recognized in net income. However, an entity may elect to measure equity investments that do not have readily determinable fair values at cost minus impairment, if any, plus or minus changes resulting from observable price changes in orderly transactions for the identical or a similar investment of the same issuer. The amendments, in addition, reduce complexity of the impairment assessment of equity investments without readily determinable fair values with regard to the other-than-temporary impairment guidance. The amendments also require separate presentation of financial assets and financial liabilities by measurement category and form of financial asset and liability. This guidance is effective for fiscal years beginning after December 15, 2017, including interim periods within those fiscal years. Early application of certain provisions is permitted. We are currently evaluating the effect this standard will have on our consolidated financial statements and related disclosures.when adopted:
In February 2016, the FASB issued ASU No. 2016-02, Leases. This guidance requires lessees to recognize most leases on their balance sheets as lease liabilities with corresponding right-of-use assets. While many aspects of lessor accounting remain the same, the new standard makes some changes, such as eliminating the current real estate-specific guidance. The new standard requires lessees and lessors to classify most leases using a principle generally consistent with that of “IAS 17 - Leases,” which is similar to U.S. GAAP but without the use of bright lines. The standard also changes what is considered initial direct costs. Entities are required to use a modified retrospective approach for leases that exist or are entered into after the beginning of the earliest comparative period in the financial statements. The standard is effective for annual periods beginning after December 15, 2018 and interim periods within that year. Early adoption is permitted. We are currently evaluating the effect this standard will have on our consolidated financial statements and related disclosures.
Issue Date & StandardDescriptionProjected Date of AdoptionEffect on Financial Statements or Other Significant Matters
August 2018
ASU No. 2018-14, Compensation—Retirement Benefits—Defined Benefit Plans—General(Subtopic 715-20): Changes to the Disclosure Requirements for Defined Benefit Plans
This update adds and removes certain disclosure requirements related to defined benefit plans. This ASU is to be implemented on a retrospective basis for all periods presented with early adoption permitted.January 1, 2021We do not expect the adoption of this update to have a material effect on our condensed consolidated financial statement disclosures.
In March 2016, the FASB issued ASU No. 2016-09, Compensation—Stock Compensation: Improvements to Employee Share-Based Payment Accounting. This simplified the accounting for certain aspects of share-based payment transactions including the income tax consequences, classification of awards as either equity or liabilities and classification on the statement of cash flows. We adopted the amendments of ASU 2016-09 (each “an Amendment”) effective January 1, 2017, using the following methods:
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We adopted the Amendment that requires all of the tax effects related to the settlement of share based compensation awards to be recorded through the income statement on a prospective basis. The adoption of this Amendment did not have a material effect on income tax expense for the nine months ended September 30, 2017.


We adopted the Amendment related to cash flow presentation of tax-related cash flows resulting from share based payments on a prospective basis. The Amendment stipulates that all tax-related cash flows resulting from share based payments are to be reported as operating activities in the statement of cash flows, rather than, under past requirements, to present gross windfall tax benefits as an inflow from financing activities and an outflow from operating activities.
Under the Amendment related to forfeitures, entities are permitted to make a company-wide accounting policy election to either estimate forfeitures each period, as required prior to this Amendment’s effective date, or to account for forfeitures as they occur. We elected to continue to account for forfeitures using the estimation method.
We adopted the Amendment related to the timing of when excess tax benefits are recognized, which requires that all windfalls and shortfalls be recognized when they arise. There were no unrecognized excess tax benefits prior to the adoption of the Amendment.
In August 2016, the FASB issued ASU No. 2016-15, Classification of Certain Cash Receipts and Cash Payments(Topic 230 -Statement of Cash Flows). Update 2016-15 provides guidance on the presentation and classification of certain cash receipts and cash payments in the statement of cash flows including debt prepayment or debt extinguishment costs, settlement of zero-coupon debt instruments, contingent consideration payments made after a business combination,


proceeds from the settlement of insurance claims, proceeds from the settlement of corporate-owned life insurance policies, and distributions received from equity method investees. The amendments are effective for fiscal years beginning after December 15, 2017, and interim periods within those fiscal years. The amendments should be applied using a retrospective transition method to each period presented. We are currently evaluating the effect this standard will have on our consolidated financial statements and related disclosures.
In October 2016, the FASB issued ASU No. 2016-16, Income Taxes - Intra-Entity Transfers of Assets Other Than Inventory (Topic 740). This update simplifies the accounting for the income tax consequences of transfers of assets from one unit of a corporation to another unit or subsidiary by eliminating an accounting exception that prevents the recognition of current and deferred income tax consequences for such “intra-entity transfers” until the assets have been sold to an outside party. The amendment should be applied using a modified retrospective transition method by means of a cumulative-effect adjustment directly to retained earnings as of the beginning of the period in which the guidance is adopted. The rule is effective for annual periods after December 15, 2017, including interim periods within those annual reporting periods. We currently estimate the cumulative-effect reduction to retained earnings to be approximately $65.2 million upon adoption at January 1, 2018.
In January 2017, the FASB issued ASU No. 2017-04, Intangibles-Goodwill and Other - Simplifying the Test for Goodwill Impairment (Topic 350). This update removes step 2 of the goodwill impairment test that compares the implied fair value of goodwill with its carrying amount. Instead, an impairment test is performed by comparing the fair value of a reporting unit with its carrying amount. An impairment charge will be recorded by the amount a reporting unit’s carrying amount exceeds its fair value. The rule is effective for annual periods after December 15, 2019, including interim periods within those annual reporting periods. We are currently evaluating the impact of adopting this update on our consolidated financial statements.
In March 2017, the FASB issued ASU No. 2017-01, Business Combinations (Topic 805)—Clarifying the Definition of a Business. This update clarifies when a set of assets and activities is a business. The amendments provide a screen to determine when a set is not a business. The screen requires that when substantially all of the fair value of the gross assets acquired is concentrated in a single identifiable asset or a group of similar identifiable assets, the set is not a business. If the screen is not met, the amendments in this Update (1) require that to be considered a business, a set must include, at a minimum, an input and a substantive process that together significantly contribute to the ability to create output and (2) remove the evaluation of whether a market participant could replace missing elements. This update is effective for annual periods after December 15, 2017, including interim periods within those annual reporting periods. We are currently evaluating the impact of adopting this update on our consolidated financial statements.
In March 2017, the FASB issued ASU No. 2017-07, Compensation—Retirement Benefits (Topic 715): Improving the Presentation of Net Periodic Pension Cost and Net Periodic Post Retirement Benefit Cost. This update requires that an employer report the service cost component in the same line item or items as other compensation costs arising from services rendered by the pertinent employees during the period. The other components of net benefit cost are required to be presented in the income statement separately from the service cost component and outside a subtotal of income from operations, if one is presented. If a separate line item or items are used to present the other components of net benefit cost, that line item or items must be appropriately described. If a separate line item or items are not used, the line item or items used in the income statement to present the other components of net benefit cost must be disclosed. The amendments in this Update also allow only the service cost component to be eligible for capitalization when applicable. This Update is effective for annual periods after December 15, 2017, including interim periods within those annual reporting periods. We are currently evaluating the impact of adopting this update on our consolidated financial statements.
Item 2. Management’sDiscussion and Analysis of Financial Condition andResults of Operations
The following discussion and analysis should be read in conjunction with our condensed consolidated financial statements and related notes which appear elsewhere in this document and with our Annual Report on2019 Form 10-K for the year ended December 31, 2016 (“2016 Form 10-K”).10-K. Our discussion and analysis may contain forward-looking statements that involve risks and uncertainties. Our actual results may differ materially from those anticipated in these forward-looking statements as a result of certain factors, including those set forth under “Risk Factors” in Item 1A of our 20162019 Form 10-K, as updated and supplemented by our Quarterly Reports on Form 10-Q, including in Part 2, Item 1A and elsewhere in this quarterly report.Quarterly Report on Form 10-Q.
The capitalized terms used below have been defined in the notes to our condensed consolidated financial statements. In the following text, the terms “LivaNova,” “the Company,” “we,” “us” and “our” refer to LivaNova PLC and its consolidated subsidiaries.



COVID-19
Due to the COVID-19 pandemic, we have experienced and may continue to experience significant and unpredictable reductions in the demand for our products as healthcare customers have diverted medical resources and priorities towards the treatment of COVID-19. In addition, public health bodies have delayed elective procedures during the COVID-19 pandemic, which has negatively impacted the usage of our products, including the number of Neuromodulation procedures. Further, some people are avoiding seeking treatment for non-COVID-19 emergency procedures, which has also negatively impacted the demand for our products.
While the ultimate health and economic impact of the COVID-19 pandemic is highly uncertain, our sales and operating results for the third quarter of 2020 were materially adversely impacted. We are seeing signs of stabilization in certain geographies as elective surgeries resume and expect this trend to continue on a global basis during the fourth quarter of 2020. We expect elective procedure recovery rates to vary by country, and to be impacted by COVID-19 case volumes, hospital occupancy and staffing levels, patient’s willingness to re-book previously deferred procedures, travel restrictions, transportation limitations, quarantine restrictions, economic uncertainty and potential COVID-19 resurgence. Further cancellations or delays could materially adversely impact our business, results of operations and overall financial performance.
Our business operations have been affected by a range of external factors related to the COVID-19 pandemic that are not within our control. For example, many jurisdictions have imposed a wide range of restrictions on the physical movement of our employees and vendors to limit the spread of COVID-19. If the COVID-19 pandemic has a substantial impact on our employees or vendors attendance or productivity, our operations may suffer, and in turn our results of operations and overall financial performance may be harmed.
During the second quarter of 2020 the majority of our RECOVER clinical study sites and their corresponding surgical centers were completely closed, though we continued to maintain engagement, including activating more sites for enrollment and also, identifying and consenting patients at existing sites. During the third quarter, sites and surgical centers began to open and currently 90% are completely open. We presently expect implants to continue to return during the fourth quarter of 2020 as study sites are able to progress consented patients and will resume more fully in 2021. However, there can be no assurance that there will not be additional closures of such sites in the future.
Additionally, our ANTHEM-HFrEF international pivotal trial was temporarily paused in March due to COVID-19 restrictions after randomizing just over 200 patients. During the second quarter of 2020, we were able to re-initiate enrollment and screening activities in more than half of the sites and continue to progress as we monitor relevant conditions at medical centers participating in the trial.
We have taken numerous steps, and will continue to take further actions, in our approach to addressing the COVID-19 pandemic. We have successfully implemented our business continuity plans, and our management team is responding to changes in our environment quickly and effectively. We have not closed any of our manufacturing plants. Additionally, the supply of raw materials and the distribution of finished products remain operational with no known or foreseen constraints. As a result of the COVID-19 pandemic, we instructed employees at many of our facilities across the globe to work from home on a temporary basis and have implemented travel restrictions. We have incurred additional expenses in connection with our response to the COVID-19 pandemic, including manufacturing inefficiencies and costs related to enabling our employees to support our customers while working remotely.
We believe that implementing cost reduction efforts will help us mitigate the impact that reduced revenues may have on our fiscal 2020 operating income. We are reducing expenses by evaluating whether projects and initiatives are critical to meet the
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current needs of the Company, protecting strategic priorities for future growth, reducing discretionary spending and tightening management of personnel costs.
Given the dynamic nature of these circumstances, the full impact of the COVID-19 pandemic on our ongoing business, results of operations and overall financial performance cannot be reasonably estimated at this time.
For further discussion on COVID-19, refer to “Part II, Item 1A. Risk Factors” in this Quarterly Report on Form 10-Q.

Business Overview
We are a public limited company organized under the laws of England and Wales, headquartered in London, United Kingdom.England. We are a global medical device company focused on the development and delivery of important therapeutic solutions for the benefit of patients, healthcare professionals and healthcare systems throughout the world. Working closely with medical professionals in the fields of Cardiac Surgery,Cardiovascular and Neuromodulation, and Cardiac Rhythm Management, we design, develop, manufacture and sell innovative therapeutic solutions that are consistent with our mission to improve our patients’ quality of life, increase the skills and capabilities of healthcare professionals and minimize healthcare costs.
Business Franchises
We operate our business through threeLivaNova is comprised of two reportable segments: Cardiac Surgery,Cardiovascular and Neuromodulation, and Cardiac Rhythm Management. Our three reportable segments correspondcorresponding to our Business Franchises and each Business Franchise corresponds to one of our three mainprimary therapeutic areas aligned to best serve our customers. Corporateareas. Other corporate activities include corporate shared service expenses for finance, legal, human resources, information technology and corporate business development (“New Ventures”). New Ventures is focused on new growth platforms and identification of other opportunities for expansion and investment.development.
For further information regarding our business segments, historical financial information and our methodology for the presentation of financial results, please refer to the condensed consolidated financial statements and accompanying notes of this Quarterly Report on Form 10-Q.

Cardiac Surgery Update
On October 5, 2015, we announced the initiation of PERSIST-AVR, the first international, prospective post-market randomized multi-center clinical study evaluating the Perceval sutureless aortic valve compared to standard sutured bioprostheses in patients with aortic valve disease. The Perceval valve, the only sutureless biological aortic valve replacement (“AVR”) on the market today, employs a unique self-anchoring frame that enables the surgeon to replace the diseased valve without suturing it into place. The studyCardiovascular
Our Cardiovascular segment is expected to enroll 1,234 patients within a two-year enrollment period and patients will be followed until five years post procedure. In January 2017, the independent study, “Aortic Valve Replacement With Sutureless Perceval Bioprosthesis: Single-Center Experience With 617 Implants,” was presented to The Society of Thoracic Surgeons. The study found AVR procedures conducted with the Perceval sutureless valve resulted in low mortality and excellent hemodynamic performance for patients.
In January 2016, we announced FDA approval of the Perceval sutureless valve. While we have been selling Perceval in other parts of the world for several years, we began commercial distribution of the deviceengaged in the United States last year, with the first implant announced on March 8, 2016. The Perceval valve has been implanted in more than 25,000 patients in more than 310 hospitals in 34 countries across the world.development, production and sale of cardiopulmonary products, heart valves and advanced circulatory support products. Cardiopulmonary products include oxygenators, heart-lung machines, autotransfusion systems, perfusion tubing systems, cannulae and other related accessories. Heart valves include mechanical heart valves, tissue heart valves, related repair products and minimally invasive surgical instruments. Advanced circulatory support includes temporary life support controllers and product kits that can include a combination of pumps, oxygenators, and cannulae.
In early February 2016, we announced that we received FDA approval of our CROWN PRTvalve for the treatment of aortic valve disease. TheCROWN PRTvalve uses a stented aortic bioprosthesis technology and features a surgeon-friendly design, with optimized hemodynamics and a patented phospholipid reduction treatment (“PRT”), designed to enhance valve durability. We anticipate launching the CROWN PRT valve in the U.S. later this year.Product Remediation
In March 2017, we committed to a plan to sell our Suzhou Industrial Park facility in Shanghai, China, an emerging market greenfield project for the local manufacture of Cardiopulmonary disposable products in Suzhou Industrial Park in China. As a result of this exit plan, we recorded an impairment of the building and equipment of $4.6 million and accrued $0.5 million of additional costs, primarily related to employee severance, during the nine months ended September 30, 2017, included in ‘Restructuring expenses’ in the condensed consolidated statement of income (loss). In addition, the land, building and equipment were recorded as ‘Assets held for sale’ on the condensed consolidated balance sheet, with a carrying value of $14.1 million as of September 30, 2017.
In September 2017, we received FDA 510(k) clearance for the U.S. market launch of our Optiflow Arterial Cannulae Family. Optiflow aortic arch cannulae provide improved hydrodynamics with a novel dispersive tip design that improves blood flow characteristics resulting in reduced wall shear stress (“WSS”) profiles. Optiflow Arterial cannulae feature a unique basket tip with large openings that allow a more physiologically compatible dispersive design. This design has been shown to significantly reduce WSS and turbulence, thereby improving hydrodynamics and potentially reducing ischemic complications from extracorporeal circulation during cardiac surgery.
3T Heater-Cooler Devices
FDA Warning Letter.
On December 29, 2015, the FDA issued LivaNova a Warning Letter (the “Warning Letter”) alleging certain violations of FDA regulations applicable to medical device manufacturers at our Munich, Germany and Arvada, Colorado facilities.


The FDA inspected the Munich facility from August 24, 2015 to August 27, 2015facilities and the Arvada facility from August 24, 2015 to September 1, 2015. On August 27, 2015, the FDA issued a Form 483 identifying two observed non-conformities with certain regulatory requirements at the Munich facility. We did not receive a Form 483 in connection with theinspectional observations on FDA’s inspection of the Arvada facility. Following the receipt of the Form 483, we provided written responses to the FDA describing corrective and preventive actions that were underway or to be taken to address the FDA’s observations at the Munich facility. The Warning Letter responded in partForm-483 applicable to our responses and identified other alleged violations not previously included in the Form 483.Munich, Germany facility.
The Warning Letter further stated that our 3T devices and other devices we manufactured at our Munich facility are subject to refusal of admission into the U.S. until resolution of the issues set forth by the FDA in the Warning Letter. The FDA has informed us that the import alert iswas limited to the 3T devices, but that the agency reservesreserved the right to expand the scope of the import alert if future circumstances warrantwarranted such action. The Warning Letter did not request that existing users cease using the 3T device, and manufacturing and shipment of all of our products other than the 3T device remainwere unaffected by the import limitation. To help clarify these issues for current customers, we issued an informational Customer Letter in January 2016 and that same month agreed with the FDA on a process for shipping 3T devices to existing U.S. users pursuant to a certificate of medical necessity program.
Finally, the Warning Letter stated that premarket approval applications for Class III devices to which certain Quality System regulation deviations identified in the Warning Letter arewere reasonably related willwould not be approved until the violations havehad been corrected. However,corrected; however, this restriction appliesapplied only to the Munich and Arvada facilities, which do not manufacture or design devices subject to Class III premarket approval.
On February 25, 2020, LivaNova received clearance for K191402, a 510(k) for the 3T devices that addressed issues contained in the 2015 Warning Letter along with design changes that further mitigate the potential risk of aerosolization. Concurrent with this clearance, (1) 3T devices manufactured in accordance with K191402 will not be subjected to the import alert and (2) LivaNova initiated a correction to distribute the updated Operating Instructions cleared under K191402.
We continue to work diligently to remediate the FDA’s inspectional observations for the Munich facility, as well as the additional issues identified in the Warning Letter. We take these matters seriously and intend to respond timely and fully to the
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FDA’s requests. For further information refer to “Note 10. Commitments and Contingencies” in our condensed consolidated financial statements included in this Quarterly Report on Form 10-Q.
CDC and FDA Safety Communications andProduct Liability
The Company Field Safety Notice Update
On October 13, 2016 the Centers for Disease Control and Prevention (“CDC”) and FDA separately released safety notifications regarding the 3T devices. The CDC’s Morbidity and Mortality Weekly Report (“MMWR”) and Health Advisory Notice (“HAN”) reported that tests conducted by CDC and its affiliates indicate that there appears to be genetic similarity between both patient and 3T device strains of the non-tuberculous mycobacterium (“NTM”) bacteria M. chimaera isolatedis currently involved in hospitals in Iowa and Pennsylvania. Citing the geographic separation between the two hospitals referenced in the investigation, the report asserts that 3T devices manufactured prior to August 18, 2014 could have been contaminated during the manufacturing process. The CDC’s HAN and FDA’s Safety Communication, issued contemporaneously with the MMWR report, each assess certain risks associated with 3T devices and provide guidance for providers and patients. The CDC notification states that the decision to use the 3T device during a surgical operation is to be taken by the surgeon based on a risk approach and on patient need. Both the CDC’s and FDA’s communications confirm that 3T devices are critical medical devices and enable doctors to perform life-saving cardiac surgery procedures.
Also on October 13, 2016, we issued a Field Safety Notice Update for U.S. users of 3T devices to proactively and voluntarily contact facilities to aid in implementation of the CDC and FDA recommendations. In the fourth quarter of 2016, we initiated a program to provide existing 3T device users with a new loaner 3T device at no charge pending regulatory approval and implementation of additional risk mitigation strategies worldwide. This loaner program began in the U.S. and is being made available progressively on a global basis, prioritizing and allocating devices to 3T device users based on pre-established criteria. We anticipate that this program will continue until we are able to address customer needs through a broader solution that includes implementation of one or more of the risk mitigation strategies currently under review with regulatory agencies.
On December 31, 2016, we recognized a liability for our product remediation plan related tolitigation involving our 3T device. We concluded that it was probable that a liability had been incurred upon management’s approval of the plan and the commitments made by management to various regulatory authorities globally in November and December 2016, and furthermore, the cost associated with the plan was reasonably estimable. At September 30, 2017, the product remediation liability was $30.2 million. Refer to “Note 4. Product Remediation Liability” for additional information.


Litigation
On February 12, 2016, LivaNova was alerted thatThe litigation includes a class action complaint had been filed in the U.S. District Court for the Middle District of Pennsylvania, with respect to our 3T devices. The plaintiffs namedfederal multi-district litigation in the complaint underwent open heart surgeries at WellSpan York HospitalU.S. District Court for the Middle District of Pennsylvania, various U.S. state court cases and Penn State Milton S. Hershey Medical Centercases in 2015, andjurisdictions outside the complaint alleges that: (i) patients were exposed to a harmful form of bacteria, known as nontuberculous mycobacterium (“NTM”), from our 3T devices; and (ii) we knew or should have known that design or manufacturing defects in 3T devices can lead to NTM bacterial colonization, regardless of the cleaning and disinfection procedures used (and recommended by us).U.S. The class of plaintiffsaction, filed in the complaintFebruary 2016, consists of all Pennsylvania residents who underwent open heart surgery at WellSpan York Hospital and Penn State Milton S. Hershey Medical Center between 2011 and 2015 and who currently are asymptomatic for NTM infection.
On October 23, 2017, Members of the U.S. District Court for the Middle District of Pennsylvania issued an order certifying a class with respect to the named plaintiffs. The class action, which is currently against Sorin Group Deutschland GmbH and Sorin Group USA, Inc. seeks: (i)seek declaratory relief findingthat the 3T devices are defective and unsafe for intended uses; (ii)uses, medical monitoring; (iii) general damages;monitoring, damages, and (iv) attorneys’ fees. Other lawsuits related to surgeries in which
On March 29, 2019, we announced a 3T device allegedly was used have been filed elsewheresettlement framework that provides for a comprehensive resolution of the personal injury cases pending in the multi-district litigation in U.S., federal court, the related class action pending in federal court, as well as certain cases in Canada,state courts across the United States. The agreement, which makes no admission of liability, is subject to certain conditions, including acceptance of the settlement by individual claimants and Europe, againstprovides for a total payment of up to $225 million to resolve the claims covered by the settlement. Per the agreed-upon terms, the first payment of $135 million was paid into a qualified settlement fund in July 2019 and the second payment of $90 million was paid in January 2020. Cases covered by the settlement are being dismissed as amounts are disbursed to individual plaintiffs from the qualified settlement fund.
Cases in state courts in the U.S. and in jurisdictions outside the U.S. continue to progress. As of October 29, 2020, including the cases encompassed in the settlement framework described above that have not yet been dismissed, we are aware of approximately 85 filed and unfiled claims worldwide, with the majority of the claims in various LivaNova entities.federal or state courts throughout the United States. This includes cases that have settled but have not yet been dismissed. The complaints generally seek damages and other relief based on theories of strict liability, negligence, breach of express and implied warranties, failure to warn, design and manufacturing defect, fraudulent and negligent misrepresentation or concealment, unjust enrichment, and violations of various state consumer protection statutes.
We are defending each ofAt September 30, 2020, the provision for these claims vigorously. Givenmatters was $46.3 million. While the relatively early stageamount accrued represents our best estimate, the actual liability for resolution of these matters we cannot give any assurancesmay vary from our estimate.

Cardiopulmonary
In April 2020, the U.S. Food and Drug Administration issued temporary guidance that additional legal proceedings making the same or similar allegations will not be filed against us or onepermitted several of our subsidiaries, nor thatcardiopulmonary products to be used for Extracorporeal Membrane Oxygenation (“ECMO”) therapy greater than six hours to temporarily expand the resolutionavailability of these complaints or other related litigation will not have a material adverse effect on our business, results of operations, financial condition or liquidity. We have not recognized an expense relateddevices to damages in connection with these matters because any potential loss is not currently probable or reasonably estimable. In addition we cannot reasonably estimate a range of potential loss, if any, that may result from these matters.
Neuromodulation Update
Epilepsy
Our product development efforts are directed toward improvingaddress the VNS Therapy System and developing new products that provide additional features and functionality. We are conducting ongoing product development activities to enhance the VNS Therapy System pulse generator, lead and programming software. We will be required to obtain appropriate U.S. and international regulatory approvals, and clinical studies may be a prerequisite to regulatory approvals for some products.
In June 2017, the FDA approved our VNS Therapy deviceCOVID-19 pandemic. Product indications for use in patients who are at least four years of agehave been modified accordingly for many products within our Cardiopulmonary and have partial onset seizures that are refractory to antiepileptic medications. VNS Therapy is the first and only FDA-approved device for drug-resistant epilepsy in this pediatric population. Previously, VNS Therapy was approved by the FDA for patients 12 years or older.
In addition, in June 2017, we received FDA approval, and in August CE Mark approval, for our VNS Therapy device for expanded magnetic resonance imaging (“MRI”) labeling affirming VNS Therapy as the only epilepsy device approved by the FDA for MRI scans. Currently, SenTiva, AspireHC and AspireSR models of VNS Therapy technology provide for this expanded MRI access.
In October 2017, we obtained FDA approval to market our SenTiva VNS Therapy System, which consists of the SenTiva implantable generator and the next-generation VNS Therapy Programming System. SenTiva is the smallest and lightest responsive therapy for epilepsy. The new VNS Therapy Programming System features a wireless wand and new user interface on a small tablet. Together, the components offer patients with drug-resistant epilepsy a physician-directed customizable therapy with smart technology and proven results that reduce the number of seizures, lessen the duration of seizures and enable a faster recovery.
Depression
In March 2017, the American Journal of Psychiatry published the results of the longest and largest naturalistic study on effective treatments for patients experiencing chronic and severe depression. The findings showed that the addition of VNS Therapy to traditional treatment methods is effective in reducing symptoms in patients with treatment-resistant depression.
Cardiac Rhythm Management (“CRM”) Update
In September 2017, we announced that we had commenced a process to explore strategic options to realize the full value of our CRM Business Franchise. While our Board of Directors has approved examining strategic options, amongst which is the possibility of divestiture, no commitment to a plan of sale has been made. Accordingly, the CRM business franchise was not reported as an asset held for sale as of September 30, 2017.


Advanced Circulatory Support portfolios.
Also in September 2017,April 2020, our Bi-Flow ECMO cannula received CE Mark for ECMO procedures where femoral artery cannulation can be applied. Bi-Flow previously received CE Mark in 2019 for cardiac surgery procedures requiring femoral artery cannulation. Now validated for up to 29 days of use, Bi-Flow ECMO is designed to reduce the risk of limb ischemia for patients receiving ECMO.
Heart Valves
In July 2020, we announced that the Company’s Shanghai-based joint venture MicroPort Sorin Cardiac Rhythm Management Co. Ltd. obtained approvaladvanced Perceval Plus sutureless surgical aortic heart valve is available for its familycommercial release in Europe, having successfully completed a one-year limited launch with initial real-world clinical data gathering. This next-generation valve facilitates minimally invasive cardiac surgery to make sutureless aortic valve replacement available to a wide patient population. Key innovations with Perceval Plus include the anticalcification treatment for valve durability, along with design changes intended to improve patient outcomes.

Neuromodulation
Our Neuromodulation segment designs, develops and markets Neuromodulation therapy for the treatment of Rega™ pacemakers from the China Fooddrug-resistant epilepsy, DTD and Drug Administration.
New Ventures Update
Heart failure
With respect to heart failure, New Ventures is focused on the developmentobstructive sleep apnea. We are also developing and conducting clinical testing of the VITARIA®VITARIA System for treating heart failure through vagus nerve stimulation.
We received CE Mark approval
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Depression
In February 2020, we announced a research collaboration with Verily, an Alphabet company, to capture measures of depression within our RECOVER clinical study. Through this initial research collaboration, LivaNova and Verily aim to gather quantitative data on patient behavior using technology and analytics developed by Verily to further understand depressive episodes and a patient’s response to treatment. RECOVER clinical sites will have the VITARIA Systemability to offer patients the Verily Study Watch, a wearable device designed to capture physiological and environmental data for clinical research, and a Verily mobile phone application. These complementary approaches are expected to help investigators better understand the impact of depression and its treatment on study participants’ lives in February 2015 for patients who have moderate to severe heart failure (New York Heart Association Class II/III) with left ventricular dysfunction (ejection fraction < 40%)a more objective and who remain symptomatic despite stable, optimal heart failure drug therapy. The VITARIA System provides a specific method of VNS called autonomic regulation therapy (“ART”), and it includes the same elements as themulti-dimensional manner.
In March 2020, our VNS Therapy System, - pulse generator, lead, programming wandSymmetry received CE mark approval for DTD, and software, programming computer, tunneling tool and accessory pack - without the patient kit with magnets. We conducted a pilot study, ANTHEM-HF,our first two patients outside the United States, which concluded in 2014. The study results support the safety and efficacy of ART delivered by the VITARIA System. We submitted the resultsU.S. to our European Notified Body, DEKRA, and on February 20, 2015, we received CE Mark approval. The VITARIA System is not approved in the U.S. During 2014, we also initiated a second pilot study, ANTHEM-HFpEF, to study ART in patients experiencing symptomatic heart failure with preserved ejection fraction. This pilot study is currently underway outside the United States.receive Symmetry were implanted shortly thereafter.
Obstructive sleep apnea
ImThera Medical, Inc. (“ImThera”) is a privately held, emerging-growth company developing an implantable neurostimulation device system for the treatment of obstructive sleep apnea. We have an investment of $12.0 million in ImThera, and a $1.0 million note receivable due from ImThera for a loan made during the nine months ended September 30, 2017 to fund operating expenses.
Mitral valve regurgitation
Mitral regurgitation (“MR”) occurs when the heart’s mitral valve does not close tightly, which allows blood to flow backwards in the heart. This reduces the amount of blood that flows to the rest of the body, making the patient feel tired or out of breath. Treatment depends on the nature and the severity of MR. In certain cases, heart surgery may be needed to repair or replace the valve. Left untreated, severe mitral valve regurgitation can cause heart failure or heart rhythm problems (arrhythmias).
On May 2, 2017, we agreed to pay up to $72.0 million to acquire the remaining 51% equity interests in Caisson in support of our strategic growth initiatives. Caisson is developing a device for treating mitral regurgitation through replacement of the native mitral valve using a fully transvenous delivery system. As a result of our acquisition of Caisson, we began consolidating the results of Caisson as of May 2, 2017. In April 2016, we obtained FDA approval of an Investigational Device Exemption study using Caisson technology for treating mitral regurgitation heart failure with transcatheter mitral valve replacement and we are currently executing against a defined clinical data development plan designed to enable commercialization of the Caisson technology.
We are also invested in two mitral valve startups. Cardiosolutions Inc. and Highlife. Cardiosolutions, a startup headquartered in the U.S. in which we have held an interest since 2012, is developing an innovative spacer technology for treating mitral regurgitation. Highlife, headquartered in France, is focused on developing devices for treating mitral regurgitation through percutaneous replacement of the native mitral valve. We recognized an impairment of our equity method investment in, and notes receivable from, Highlife during the nine months ended September 30, 2017. The estimated fair value of our investment and notes receivable were below our carrying value by $13.0 million.
Significant Accounting Policies and Critical Accounting Estimates 
There have been no material changesIn addition to our critical accounting policies from the information provided in “Part II, Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations” included in our 20162019 Form 10-K. 10-K, refer to “Significant Accounting Policies” within “Note 1. Unaudited Condensed Consolidated Financial Statements” included in this Quarterly Report on Form 10-Q.
The accompanying unaudited condensed consolidated financial statements of LivaNova and its consolidated subsidiaries have been prepared in accordance with U.S. GAAP on an interim basis.
New accounting pronouncements are disclosed in “Note 16.17. New Accounting Pronouncements” contained in the condensed consolidated financial statements in this Quarterly Report on Form 10-Q.



Other
Brexit
On June 23, 2016,January 31, 2020, the UK held a referendum in which voters approved an exitdeparted from the EU (in a move commonly referred to as “Brexit.” On March 29, 2017,“Brexit”), and the UK government gave formal noticeentered a transition period that is scheduled to end on December 31, 2020. During the transition period, the UK will cease to be an EU member but the trading relationship will remain the same under the EU's rules. Although the long-term effects of its intentionBrexit will depend on any agreements the UK makes to leaveretain access to the EU formally commencing the negotiations regarding the termsmarkets, Brexit has created additional uncertainties that may ultimately result in new regulatory costs and challenges for medical device companies and increased restrictions on imports and exports throughout Europe. This could adversely affect our ability to conduct and expand our operations in Europe and may have an adverse effect on our business, financial condition and results of withdrawal between the UK and the EU. The withdrawal must occur within two years, unless the deadline is extended. The negotiation process will determine the future termsoperations.
Passage of the UK’s relationship with the EU. The notificationwithdrawal bill does not change the application of existing tax laws and does not establish a clear framework for what the ultimate outcome of the negotiations and legislative processtransition period will be.
Various tax reliefs and exemptions that apply to transactions between EU Member States under existing tax laws may cease to apply to transactions between the UK and EU Member States when the UK ultimately withdraws from the EU.transition period is over. It is unclear at this stage if or when any new tax treaties between the UK and the EU or individual EU Member States will replace those reliefs and exemptions. It is also unclear at this stage what financial, trade and legal implications will ensue from Brexit and how Brexit may ultimately affect us, our customers, suppliers, vendors, or our industry.
SeveralWe and several of our wholly owned subsidiaries that are domiciled either in the UK, various EU Member States, or in the United Sates, and our parent company, LivaNova PLC,U.S., are party to intercompany transactions and agreements under which we receive various tax reliefs and exemptions in accordance with applicable international tax laws, treaties and regulations. If certain treaties applicable to our transactions and agreements are not renegotiated or replaced with new treaties containing terms, conditions and attributes similar to those of the existing treaties,change materially, Brexit may have a material adverse impact on our future financial results and results of operations. During the two-year negotiation period, we willWe continue to monitor and assess the potential impact of this event and explore possible tax-planning strategies that may mitigate or eliminate any such potential adverse impact. impacts.
We will not account for the impact of Brexit in our income tax provisions until there are material changes in tax laws or treaties between the UK and other countries.
European Union State Aid Challenge
On October 26, 2017, the European Commission (“EC”) announced that an investigation would be opened with respect to the UK’s controlled foreign company (“CFC”) rules for the period January 1, 2013 through December 31, 2018. Under the CFC rules, financing profits of entities controlled by UK parent companies are taxed when the funding originates in the UK, or Significant People Functions relating to the financing are located in the UK. The provisions under investigation provide group finance exemptions related to the profits of entities involved in financing of the non-UK group activities. On April 2, 2019, the
34


EC concluded that “when financing income from a foreign group company, channeled through an offshore subsidiary, is financed with UK connected capital and there are no UK activities involved in generating the finance profits, the group finance exemption is justified and does not constitute State aid under EU rules.” However, in relation to Significant People Functions, “when financing income from a foreign group company, channeled through an offshore subsidiary, derives from UK activities, the group finance exemption is not justified and constitutes State aid under EU rules.” Her Majesty’s Revenue and Customs (“HMRC”) has stated that they do not consider the timing and form of the UK’s exit from the EU or individualwill have a practical impact on the requirement to recover the alleged aid. On June 14, 2019, the UK filed an appeal to the Commission’s decision. On July 5, 2019, HMRC began the first step in the recovery process to identify beneficiaries and sent letters asking for information. Based upon our assessment of the technical arguments as to whether the exemption is State aid, together with no UK activities involved in our financing, no uncertain tax position reserve has been recognized related to this matter. Furthermore, in December 2019, we amended our 2017 tax return filing to avail ourselves of different rules to determine UK taxation, which are not subject to the EU Member States are enacted ordecision. We filed our 2018 tax return similarly, and therefore, we do not believe that the withdrawal becomes effective.EU state aid decision will result in a material liability.
The Trump Administration has included as part of its agenda a potential reform of U.S. tax laws.  On September 27, 2017, the White House released its “Unified Framework for Fixing Our Broken Tax Code” (the “Framework”), which was developed by the Trump Administration, the House Committee on Ways and Means, and the Senate Committee on Finance and which includes specific goals for lower business tax rates. The Framework calls for a 20% corporate tax rate and international reforms that include a territorial tax system and a one-time mandatory repatriation tax. The Framework proposes 100% expensing of new investments in depreciable assets for five years, effective after September 27, 2017, while partially limiting the tax deduction for net business interest expense. Additionally, the Framework would repeal the section 199 domestic manufacturing deduction and “numerous other special exclusions and deductions” but would retain the research tax credit. The content of any final legislation, the timing for enactment, and the reporting periods that would be impacted cannot be determined at this time.



Results of Operations
We are reporting, in this Quarterly Report on Form 10-Q, the results for LivaNova and its consolidated subsidiaries for the three and nine months ended September 30, 2017, as compared to the three and nine months ended September 30, 2016.
The following table summarizes our condensed consolidated results of operations (in thousands):
Three Months Ended September 30,Nine Months Ended September 30,
2020201920202019
Net sales$240,083 $268,610 $664,686 $796,580 
Costs and expenses:
Cost of sales - exclusive of amortization86,467 86,128 212,152 245,324 
Product remediation1,133 3,076 6,868 11,136 
Selling, general and administrative99,199 123,015 317,424 375,932 
Research and development47,368 45,904 108,422 124,023 
Merger and integration expenses1,094 6,716 6,616 14,345 
Restructuring expenses(349)698 2,025 4,563 
Impairment of intangible assets— — — 50,295 
Amortization of intangibles9,685 11,146 29,346 29,690 
Litigation provision, net2,994 (33,834)3,970 (33,834)
Operating (loss) income from continuing operations(7,508)25,761 (22,137)(24,894)
Interest income47 151 482 624 
Interest expense(14,673)(4,774)(25,237)(10,490)
Foreign exchange and other gains (losses)3,420 327 507 (795)
(Loss) income from continuing operations before tax(18,714)21,465 (46,385)(35,555)
Income tax (benefit) expense(3,990)(10,653)17,581 (23,431)
Losses from equity method investments(48)— (221)— 
Net (loss) income from continuing operations(14,772)32,118 (64,187)(12,124)
Net (loss) income from discontinued operations, net of tax— — (995)178 
Net (loss) income$(14,772)$32,118 $(65,182)$(11,946)

35

  Three Months Ended September 30, Nine Months Ended September 30,
  2017 2016 2017 2016
Net sales $309,664
 $295,268
 $916,156
 $903,284
Cost of sales 108,233
 106,454
 318,584
 360,675
Product remediation 1,642
 689
 2,573
 2,243
Gross profit 199,789
 188,125
 594,999
 540,366
Operating expenses:        
Selling, general and administrative 121,177
 109,233
 353,943
 345,744
Research and development 31,393
 32,175
 104,051
 94,076
Merger and integration expenses 2,013
 7,576
 7,743
 20,537
Restructuring expenses 792
 4,381
 12,060
 37,219
Amortization of intangibles 12,350
 11,775
 35,445
 33,959
Total operating expenses 167,725
 165,140
 513,242
 531,535
Income from operations 32,064
 22,985
 81,757
 8,831
Interest income 199
 585
 724
 1,119
Interest expense (1,421) (3,495) (5,314) (6,665)
Gain on acquisition of Caisson Interventional, LLC 
 
 39,428
 
Foreign exchange and other gains (losses) 491
 1,216
 957
 (2)
Income before income taxes 31,333
 21,291
 117,552
 3,283
Income tax expense 1,913
 9,731
 10,881
 16,891
Losses from equity method investments (1,590) (13,129) (20,072) (19,382)
Net income (loss) $27,830
 $(1,569) $86,599
 $(32,990)



Net Sales
The table below illustratespresents net sales by operating segment and market geographygeographic region (in thousands, except for percentages):
Three Months Ended September 30,Nine Months Ended September 30,
20202019% Change20202019% Change
Cardiopulmonary
United States$33,549 $39,054 (14.1)%$96,223 $119,580 (19.5)%
Europe29,947 30,052 (0.3)%87,475 99,933 (12.5)%
Rest of World43,704 50,908 (14.2)%140,925 152,650 (7.7)%
107,200 120,014 (10.7)%324,623 372,163 (12.8)%
Heart Valves
United States3,129 4,626 (32.4)%8,990 13,660 (34.2)%
Europe7,945 9,572 (17.0)%22,822 30,757 (25.8)%
Rest of World10,062 14,679 (31.5)%32,001 43,484 (26.4)%
21,136 28,877 (26.8)%63,813 87,901 (27.4)%
Advanced Circulatory Support
United States12,331 6,313 95.3 %28,075 22,290 26.0 %
Europe162 186 (12.9)%835 497 68.0 %
Rest of World49 36 36.1 %136 310 (56.1)%
12,542 6,535 91.9 %29,046 23,097 25.8 %
Cardiovascular
United States49,009 49,993 (2.0)%133,288 155,530 (14.3)%
Europe38,054 39,810 (4.4)%111,132 131,187 (15.3)%
Rest of World53,815 65,623 (18.0)%173,062 196,444 (11.9)%
140,878 155,426 (9.4)%417,482 483,161 (13.6)%
Neuromodulation
United States79,854 88,433 (9.7)%197,345 245,870 (19.7)%
Europe10,475 10,425 0.5 %27,474 34,080 (19.4)%
Rest of World8,079 13,685 (41.0)%20,458 31,511 (35.1)%
98,408 112,543 (12.6)%245,277 311,461 (21.2)%
Other797 641 24.3 %1,927 1,958 (1.6)%
Totals
United States128,863 138,426 (6.9)%330,633 401,400 (17.6)%
Europe (1)
48,529 50,235 (3.4)%138,606 165,267 (16.1)%
Rest of World62,691 79,949 (21.6)%195,447 229,913 (15.0)%
Total$240,083 $268,610 (10.6)%$664,686 $796,580 (16.6)%
(1)Europe sales include those countries in which we have a direct sales presence, whereas European countries in which we sell through distributors are included in “Rest of World.”

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  Three Months Ended September 30,  
  2017 2016 % Change
Cardiac Surgery      
United States $44,991
 $46,768
 (3.8)%
Europe (1)
 40,429
 38,009
 6.4%
Rest of world 74,402
 63,741
 16.7%
  159,822
 148,518
 7.6%
Neuromodulation      
United States 76,286
 74,864
 1.9%
Europe (1)
 8,057
 8,489
 (5.1)%
Rest of world 6,673
 6,151
 8.5%
  91,016
 89,504
 1.7%
Cardiac Rhythm Management      
United States 931
 2,178
 (57.3)%
Europe (1)
 44,468
 44,747
 (0.6)%
Rest of world 13,012
 9,843
 32.2%
  58,411
 56,768
 2.9%
Other 415
 478
 (13.2)%
  $309,664
 $295,268
 4.9%
  Nine Months Ended September 30,  
  2017 2016 % Change
Cardiac Surgery      
United States $129,160
 $133,995
 (3.6)%
Europe (1)
 126,028
 128,229
 (1.7)%
Rest of world 202,424
 190,788
 6.1%
  457,612
 453,012
 1.0%
Neuromodulation      
United States 231,350
 220,892
 4.7%
Europe (1)
 25,500
 24,208
 5.3%
Rest of world 18,340
 15,801
 16.1%
  275,190
 260,901
 5.5%
Cardiac Rhythm Management      
United States 5,605
 7,471
 (25.0)%
Europe (1)
 142,811
 149,141
 (4.2)%
Rest of world 33,819
 31,445
 7.5%
  182,235
 188,057
 (3.1)%
Other 1,119
 1,314
 (14.8)%
  $916,156
 $903,284
 1.4%
(1)Includes those countries in Europe where LivaNova has a direct sales presence. Countries where sales are made through distributors are included in ‘Rest of world’.


The table below illustratespresents segment income (loss) from continuing operations (in thousands)thousands, except for percentages):
Three Months Ended September 30,Nine Months Ended September 30,
20202019% Change20202019% Change
Cardiovascular$(7,311)$36,180 (120.2)%$(8,037)$47,289 (117.0)%
Neuromodulation21,154 30,010 (29.5)%82,294 52,260 57.5 %
Other(10,921)(21,869)(50.1)%(58,407)(75,845)(23.0)%
Total reportable segment income from continuing operations (1)
$2,922 $44,321 (93.4)%$15,850 $23,704 (33.1)%
  Three Months Ended September 30,  
  2017 2016 % Change
Cardiac Surgery $23,807
 $17,791
 33.8 %
Neuromodulation 45,932
 47,049
 (2.4)%
Cardiac Rhythm Management 5,427
 (4,598) 218.0 %
Other (27,947) (13,525) (106.6)%
Total Reportable Segment's Income from Operations (1)
 $47,219
 $46,717
 1.1 %
(1)For a reconciliation of segment income from continuing operations to (loss) income from continuing operations before tax refer to “Note 15. Geographic and Segment Information” in the condensed consolidated financial statements in this Quarterly Report on Form 10-Q.
Cardiovascular
  Nine Months Ended September 30,  
  2017 2016 % Change
Cardiac Surgery $63,490
 $29,197
 117.5 %
Neuromodulation 139,357
 134,871
 3.3 %
Cardiac Rhythm Management 13,536
 (14,432) 193.8 %
Other (79,378) (49,090) (61.7)%
Total Reportable Segment's Income from Operations (1)
 $137,005
 $100,546
 36.3 %
(1)
For a reconciliation of segment operating income to consolidated operating income refer to “Note 14. Geographic and Segment Information” in the condensed consolidated financial statements in this Quarterly Report on Form 10-Q.
Cardiac SurgeryCardiovascular net sales increased by 7.6% and 1.0% for the three and nine months ended September 30, 2017, as2020 compared to the three and nine months ended September 30, 2016, respectively. Net2019 decreased 9.4% and 13.6%, respectively, largely due to the impact of COVID-19. The decline in net sales increased $11.3 million for the three months ended September 30, 2017, as compared to the prior-year periodand nine month periods were due to growthdeclines in both cardiopulmonary product revenue and heart valve revenue and favorable foreign currency exchange rate fluctuations. Cardiopulmonary sales increased 7.6%of 10.7% and 12.8%, or $8.7respectively. Cardiopulmonary sales of $107.2 million for the three months ended September 30, 2017, due to strength in heart-lung machines as a result of geographic sales expansion and continued progress towards upgrading customers from older machines to our current S5 device. Heart valve sales increased by 7.7%, or $2.6$324.6 million for the three months ended September 30, 2017, as compared to the prior-year period due primarily to increased demand for the Perceval sutureless tissue valve in the U.S. and quarter over quarter improvement in Europe, which more than offset declines in mechanical heart valve sales globally. Cardiac Surgery net sales increased $4.6 million for the nine months ended September 30, 2017, as compared to the nine months ended September 30, 2016, due primarily to growth of $5.3 million in cardiopulmonary product revenue, partially offset by a decline in heart value revenues. Year-to-date cardiopulmonary product sales increased over the prior-year period due to heart-lung machine sales expansion outside of the U.S. and Europe. Cardiac Surgery operating income for the three months ended September 30, 2017 increased 33.8% over the prior-year period primarily due to increased operating leverage from the $11.3 million increase in sales. The 117.5% increase in operating income for the nine months ended September 30, 2017 over the prior-year period was primarily driven by inventory fair value step-up amortization of $25.2 million that was recognized during the nine months ended September 30, 2016. The inventory fair value step-up was fully amortized by September 30, 2016.
Neuromodulation net sales increased by 1.7% and 5.5% for the three and nine months ended September 30, 2017, as2020 were negatively impacted by declines in HLM and oxygenator sales. HLM sales were negatively impacted due to COVID-19 impacts on hospital budgets for capital equipment, while Oxygenator sales were negatively impacted by a decline of non-emergent cardiac surgery procedures globally. Heart Valves sales of $21.1 million and $63.8 million for the three and nine months ended September 30, 2020 declined by $7.7 million and $24.1 million, respectively, primarily due to declines in sales of Perceval and other tissue valves due to a decline in cardiac surgery procedures globally due to COVID-19. Advanced Circulatory Support sales of $12.5 million and $29.0 million for the three and nine months ended September 30, 2020 increased 91.9% and 25.8%, respectively, resulting from the full U.S. commercial release of LifeSPARC during the third quarter of 2020.
Cardiovascular operating income for the three and nine months ended September 30, 2020 compared to the three and nine months ended September 30, 2016, respectively. The increase in net sales2019 decreased primarily due to the receipt of $1.5insurance recovery proceeds related to the litigation involving our 3T device of $33.8 million forduring the three months ended September 30, 2017, over the prior-year period was primarily due to increased average selling prices driven by continued AspireSR penetration of the U.S. market,2019 as well as a decline in net sales, as discussed above, partially offset by a declinedecrease in unit sales due to hurricane-related impacts in the U.S. and customer anticipation of the SenTiva system, our new generation VNS Therapy System, which launched in October 2017. The increase in3T legal expenses.
Neuromodulation
Neuromodulation net sales of $14.3 million for the three and nine months ended September 30, 2017 over2020 compared to the prior-year periodthree and nine months ended September 30, 2019 decreased 12.6% and 21.2%, respectively. The decrease in net sales for the three and nine months ended September 30, 2020 was primarily due to strongdeclines in both new patient sales and price premiums partially offset by hurricane-related impacts in the U.S.end of service implants globally as patients and customer anticipation of the SenTiva system. The decrease in physicians delayed implant procedures due to COVID-19.
Neuromodulation operating income for the three months ended September 30, 2017 as2020 compared to the prior-year period wasthree months ended September 30, 2019 decreased primarily duerelated to increased selling, general and administrative costs driven bya decline in net sales, force expansion and marketing efforts in the U.S. The increase inas discussed above. Neuromodulation operating income for the nine months ended September 30, 2017 as2020 increased compared to the prior-year period was primarily driven by increased operating leverage as a result of higher net sales, partially offset by the increased costs associated with sales force expansion and marketing efforts in the U.S.
Cardiac Rhythm Management net sales increased by 2.9% for the three months ended September 30, 2017, as compared to the prior-year period primarily due to favorable foreign currency exchange rate fluctuations. Additionally, growth of the


PLATINIUM Cardiac Resynchronization Therapy devices (CRT-Ds) in Europe and continued demand for KORA 250 pacemakers in Japan were mostly offset by a decrease in Implantable Cardiac Defibrillator (ICD) sales. Cardiac Rhythm Management net sales decreased by 3.1% for the nine months ended September 30, 2017, as compared to the prior-year period. This decline was primarily2019 due to a decreasean increase in ICD sales and reduced sales inoperating income resulting from the U.S. and Europe, bothnet impact of which reflect athe change in customer preferences. Cardiac Rhythm Management operating income increased $10.0 million andfair value of contingent consideration arrangements of $28.0 million for the three and nine months ended September 30, 2017, respectively, as compared to the prior-year periods. The increase for the three months ended September 30, 2017 over the prior-year period was due to cost reductions resulting from prior restructuring actions, improvements in selling, general and administrative costs driven by reductions in the overall sales force and increased net sales. The increase for the nine months ended September 30, 2017well as compared to the prior-year period was driven by inventory fair value step-up amortizationa $50.3 million impairment of $10.0 million that was recognizedan IPR&D asset during the nine months ended September 30, 2016, cost reductions resulting from prior restructuring actions and cost reductions associated with a reduction in the overall sales force2019, partially offset by decreased sales during the nine months ended September 30, 2017.overall declines in net sales.
‘Other’ comprises the results from our corporate and new ventures activity. Operating loss from Other increased $14.4 million for the three months ended September 30, 2017, as compared to the prior-year period, primarily due to $3.9 million of Caisson related expenses and $12.9 million in increased Corporate costs. Operating loss from Other increased $30.3 million for the nine months ended September 30, 2017, as compared to the prior-year period, primarily due to $17.9 million of increased Caisson-related expenses and increased Corporate costs of $20.3 million. Increased Corporate costs during the three and nine months ended September 30, 2017 includes $2.8 million and $8.3 million in legal costs, respectively, primarily associated with litigation related to our 3T devices and investments in building out global capabilities including international expansion, and project-related expenses.
37


Cost of Sales and Expenses
The table below illustratespresents our comparative cost of sales and majorsignificant expenses as a percentage of sales:
  Three Months Ended September 30,  
  2017 2016 Change
Cost of sales 35.0% 36.1% (1.1)%
Product remediation 0.5% 0.2% 0.3 %
Gross profit 64.5% 63.7% 0.8 %
Operating expenses:      
Selling, general and administrative 39.1% 37.0% 2.1 %
Research and development 10.1% 10.9% (0.8)%
Merger and integration expenses 0.7% 2.6% (1.9)%
Restructuring expenses 0.3% 1.5% (1.2)%
Amortization of intangibles 4.0% 4.0%  %
Three Months Ended September 30,Nine Months Ended September 30,
 Nine Months Ended September 30,  20202019Change20202019Change
 2017 2016 Change
Cost of sales 34.8% 39.9% (5.1)%
Cost of sales - exclusive of amortizationCost of sales - exclusive of amortization36.0 %32.1 %3.9 %31.9 %30.8 %1.1 %
Product remediation 0.3% 0.2% 0.1 %Product remediation0.5 %1.1 %(0.6)%1.0 %1.4 %(0.4)%
Gross profit 64.9% 59.8% 5.1 %
Operating expenses:      
Selling, general and administrative 38.6% 38.3% 0.3 %Selling, general and administrative41.3 %45.8 %(4.5)%47.8 %47.2 %0.6 %
Research and development 11.4% 10.4% 1.0 %Research and development19.7 %17.1 %2.6 %16.3 %15.6 %0.7 %
Merger and integration expenses 0.8% 2.3% (1.5)%Merger and integration expenses0.5 %2.5 %(2.0)%1.0 %1.8 %(0.8)%
Restructuring expenses 1.3% 4.1% (2.8)%Restructuring expenses(0.1)%0.3 %(0.4)%0.3 %0.6 %(0.3)%
Impairment of intangible assetsImpairment of intangible assets— %— %— %— %6.3 %(6.3)%
Amortization of intangibles 3.9% 3.8% 0.1 %Amortization of intangibles4.0 %4.1 %(0.1)%4.4 %3.7 %0.7 %
Litigation provision, netLitigation provision, net1.2 %(12.6)%13.8 %0.6 %(4.2)%4.8 %
Cost of Sales - Exclusive of Amortization
Cost of sales consisted primarily of direct labor, allocated manufacturing overhead and the acquisition cost of raw materials and components. Cost of sales as a percentage of net sales decreased by 1.1% to 35.0% and by 5.1% to 34.8% for the three and nine months ended September 30, 2017, respectively, as2020 compared to the prior-year periods. The cost improvement for the three and nine months ended September 30, 2017 reflects management’s focus on cost efficiencies2019 increased primarily due to improve gross margin. The cost improvementproduct mix and unfavorable manufacturing variances of $7.0 million and $13.0 million for the three and nine months ended September 30, 2020, respectively, due to the decline in demand resulting from COVID-19 with these increases for the nine months ended September 30,2020 compared to the nine months ending September 30, 2017 was primarily due to inventory fair value step-up amortization in the prior year, which accounted for 3.9% of the2019 partially offset by a decrease in our cost of sales as a percentage ofresulting from the net sales, as well as the previously mentioned cost efficiencies. The total amount recognized for amortizationimpact of the change in fair value step-up in inventory for the nine months ended September 30, 2016 was $35.2of sales-based contingent consideration arrangements of $18.3 million. The fair value step-up in inventory basis was fully amortized by September 30, 2016.
Sales,Selling, General and Administrative (“SG&A”) Expenses
SG&A expenses consisted of sales, marketing, general and administrative activities. SG&A expenses as a percentage of net sales for the three months ended September 30, 2017 increased2020 compared to the three months ended September 30, 2019 decreased primarily due to sales and marketing cost reductions resulting from COVID-19 as well as a decrease in 3T legal expenses, the settlement of tax litigation that resulted in the reversal of a tax penalty of $4.3 million in the third quarter of 2020 and cost containment actions.
Merger and Integration (“M&I”) Expenses
M&I expenses consist primarily of costs associated with computer systems integration efforts, organizational structure integration, synergy and tax planning. M&I expenses as a percentage of net sales by 2.1% to 39.1%, as compared to the prior-year period, and was consistent at 38.6% for the ninethree months ended September 30, 2017, as2020 compared to the prior-year period. The 2.1% increase was largely attributablethree months ended September 30, 2019 decreased primarily due to litigation related tothe completion of certain integration activities associated with our 3T devicesmerger and other legal matters.acquisitions.
Research and Development (“R&D”) Expenses
R&D expenses consistedconsist of product design and development efforts, clinical trialstudy programs and regulatory activities.activities, which are essential to our strategic portfolio initiatives, including DTD, obstructive sleep apnea and heart failure. R&D expenses as a percentage of net sales was consistent for the three months ended September 30, 2017, as2020 compared to the prior-year period, and increased by 1.0% to 11.4% for the nine months ended September 30, 2017, as compared to the prior-year period. The increase is due to the acquisition of Caisson, inclusive of $5.8 million in post-combination compensation expense recognized concurrent with the acquisition of Caisson, and $6.4 million in compensation expense associated with the retention of the employees of Caisson.
Merger and Integration Expenses
Merger and integration expenses consisted primarily of consulting costs associated with computer systems integration efforts, organization structure integration, synergy and tax planning, as well as the integration of internal controls for the two legacy organizations. In addition, integration expenses include retention bonuses, branding and renaming efforts and lease cancellation penalties in Milan and Brussels.
Merger and integration expenses as a percentage of net sales decreased by 1.9% to 0.7% for the three months ended September 30, 2017 as compared to the prior-year period, and decreased by 1.5% to 0.8% for the nine months ended September 30, 2017 as compared to the prior-year period. These decreases were2019 increased primarily due to a continued decline in integration activities.
Restructuring Expenses
Restructuring expenses were primarily due to our efforts under our 2015 and 2016 Reorganization Plans and the Suzhou, China exit plan, to leverage economies of scale, eliminate duplicate corporate expenses and streamline distributions, logistics and office functions in order to reduce overall costs. Restructuring expenses as a percentage of net sales decreased by 1.2% to 0.3% and 2.8% to 1.3% foras well as an increase in R&D expense resulting from the three and nine months ended September 30, 2017, respectively, as compared to the prior-year periods due to a continued declinenet impact of changes in restructuring activities.
Gain on Caisson Acquisition
On May 2, 2017, we acquired the remaining 51% equity interests in Caisson which we previously accounted for under the equity method. On the acquisition date, we remeasured our notes receivable due from Caisson and our existing investment in Caisson at fair value and recognized a pre-tax non-cash gain of $1.3milestone-based contingent consideration arrangements of $6.3 million, and $38.1 million, respectively.
Foreign Exchange and Other Gains (Losses)
Foreign exchange and other gains were $0.5 million and $1.2 million for the three months ended September 30, 2017 and September 30, 2016, respectively. The gains were primarily due to net foreign currency gains associated with foreign currency commercial transactions, freestanding foreign currency forward contracts, intercompany debt, and third-party financial assets and liabilities. The gains of $1.0 million for the nine months ended September 30, 2017 included a $3.2 million gain on a sale of the cost-method investment, Istituto Europeo di Oncologia S.R.L, partially offset by net foreign currency exchange losses$2.8 million in R&D expenses incurred in the prior year period associated with the Company’s former TMVR program, the impact of $2.2 million.COVID-19 on our clinical studies, as well as a decrease in certain 2019 costs for increased investment in Epilepsy.

Impairment of Intangible Assets

During the second quarter of 2019, we determined that LivaNova would experience a delay in the estimated commercialization date of the Company’s obstructive sleep apnea product currently under development. This delay constituted a triggering event that required an impairment evaluation of the IPR&D asset arising from the ImThera acquisition. Based on the assessment performed, we determined that the IPR&D asset was impaired and as a result, recorded an impairment of $50.3 million, which is included in our Neuromodulation segment.
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Litigation Provision, Net
In July 2019, we entered into agreements with our insurance carriers to recover $33.8 million under our product liability insurance policies related to the litigation involving our 3T device. The insurance recovery was received and recognized during the third quarter of 2019.
Income Taxes
LivaNova PLC is domiciled and resident in the UK. Our subsidiaries conduct operations and earn income in numerous countries and are subject to the laws of taxing jurisdictions within those countries, and the income tax rates imposed in the tax jurisdictions in which our subsidiaries conduct operations vary. As a result of the changes in the overall level of our income, the deployment ofearnings mix in various tax strategiesjurisdictions and the changes in tax laws, our consolidated effective income tax rate may vary substantially from one reporting period to another.
During the three and nine months ended September 30, 2017, we recorded consolidated income tax expense of $1.9 million and $10.9 million, respectively, with consolidatedOur effective income tax rates of 6.1% and 9.3%, respectively.
Our consolidated effective income tax rate from continuing operations for the three and nine months ended September 30, 2017 included the impact of various discrete tax items including a net $4.0 million deferred tax benefit due to the release of valuation allowances on tax losses upon the completion of a reorganization of our legal entities in the U.S.2020 was 21.3% and a $2.1 million tax benefit from the resolution of prior period tax matters. Discrete tax items(37.9)% compared with (49.6)% and 65.9% for the nine months ended September 30, 2017 also included the acquisition of Caisson and the $38.1 million non-taxable gain recognized to re-measure our existing equity investment in Caisson at fair value on the acquisition date, a $3.9 million deferred tax benefit associated with certain temporary differences arising from the Mergers and the recognition of a $3.0 million deferred tax asset related to a reserve for an uncertain tax position recognized in a prior year, in addition to various other discrete items.
During the three and nine months ended September 30, 2016, we recorded consolidated income tax expense of $9.7 million and $16.9 million, respectively, with consolidated2019, respectively. Our effective income tax rate fluctuates based on, among other factors, changes in pretax income in countries with varying statutory tax rates, changes in valuation allowances, changes in tax credits and incentives, and changes in unrecognized tax benefits associated with uncertain tax positions.
We continually assess the realizability of 45.7%our worldwide deferred tax asset and 514.5%valuation allowance positions, and when the need arises, we establish or release valuation allowances accordingly.
Compared with the three months ended September 30, 2019, the change in the effective tax rate for the three months ended September 30, 2020 was primarily attributable to a discrete tax benefit due to the release of the uncertain tax position upon the settlement of tax litigation in Italy offset by a valuation allowance for certain jurisdictions outside the U.S., respectively. Theas compared to a U.S. federal tax benefit from a return to provision reconciliation, partially offset by the establishment of a valuation allowance for a portion of the U.S. federal and state net operating losses during the three months ended September 30, 2019. We established valuation allowances as is more likely than not that we will be unable to realize the related historical deferred tax assets.
Compared with the nine months ended September 30, 2019, the change in the effective tax rate for the nine months ended September 30, 20162020 was impactedprimarily attributable to a $42.4 million realized discrete tax benefit related to the CARES Act and the discrete tax benefit due to the release of the uncertain tax position upon the settlement of tax litigation in Italy offset by the recordingestablishment of a $74.5 million valuation allowancesallowance for the U.K. and other jurisdictions outside the U.S., as compared to a release of $23.9 million relateduncertain tax positions and a U.S. federal tax benefit from a return to certain tax jurisdictions, including Franceprovision reconciliation, partly offset by the establishment of a valuation allowance for a portion of the U.S. federal and the UK, in which we did not record tax benefits generated by theirstate net operating losses as well as the tax expense generated by profitable operations in higher tax jurisdictions, such as the U.S. and Germany, offset by tax savings from our inter-company financing as part of our 2015 tax restructuring.
Losses from Equity Method Investments
Losses from equity method investments were $1.6 million and $20.1 millionattributes during the three and nine months ended September 30, 2017, respectively. Losses for the three months ended September 30, 2017 were due to our equity method investee losses, primarily from Highlife and MicroPort. Losses for the nine months ended September 30, 2017 included the impairment of our investment in, and notes receivable from, Highlife of $13.0 million, which consisted of the investment impairment of $4.7 million and the notes receivable impairment of $8.3 million. We recognized losses of $13.1 million and $19.4 million during the three and nine months ended September 30, 2016, respectively, primarily due to a $9.2 million impairment of our investment in Respicardia and losses from our equity method investees.2019.

Liquidity and Capital Resources
In June 2020, we raised combined net proceeds of $699.7 million from our Term Loan and Notes borrowings. Additionally, we utilized the combined net proceeds to repay $525.4 million of aggregate outstanding principal. Refer to “Note 8. Financing Arrangements” in the condensed consolidated financial statements in this Quarterly Report on Form 10-Q for additional information regarding our debt and debt transactions. As of September 30, 2020, our cash and cash equivalents was $227.8 million.
Based on our current business plan, we believe that our existing cash and cash equivalents, future cash generated from operations and available borrowing capacity under our creditcurrent debt facilities will be sufficient to fund our expected operating needs, working capital requirements, R&D opportunities, capital expenditures, and debt service requirements over the next 12 months. We regularly review our capital needs and consider various investing and financing alternatives to support our requirements. Refer to “Note 7. Financing Arrangements” intwelve-month period beginning from the issuance date of these condensed consolidated financial statements in this Quarterly Report on Form 10-Q for additional information regarding our debt.statements. Our liquidity could be adversely affectedimpacted by the factors affecting future operating results, including those referred to in “Part II, - Item 1A. Risk Factors” in 2016the 2019 Form 10-K.10-K as supplemented by the factors referred to in “Part II, Item 1A, Risk Factors” in our Quarterly Reports on Form 10-Q.
On June 29, 2017, we entered into a new Finance Contract with the EIB to support financing of certain of our R&D projects. The Finance Contract has a borrowing base of €100 million (or approximately $118 million) and can be drawn in up to two tranches, each in a minimum amount of €50 million (or approximately $59 million). Drawdowns must occur by December 30, 2018 and the last repayment date of any tranche will be no earlier than four years and no later than eight years after the disbursement of the relevant tranche. Loans under the Finance Contract are subject to certain covenants and other terms and conditions.
No provision has been made for income taxes on unremitted earnings of our foreign controlled subsidiaries (non-UK subsidiaries) as of September 30, 2017.2020. In the event of the distribution of those earnings in the form of dividends, a sale of the subsidiaries or certain other transactions, we may be liable for income taxes. However, the tax liability on future distributions should not be significant as most jurisdictions with unremitted earnings have various participation exemptions or no withholding tax.

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Cash Flows
Net cash and cash equivalents provided by (used in) operating, investing and financing activities and the net increase (decrease) in the balance of cash and cash equivalents were as follows (in thousands):
 Nine Months Ended September 30,Nine Months Ended September 30,
 2017 2016 20202019
Operating activities $73,665
 $49,348
Operating activities$(116,407)$(94,008)
Investing activities (41,797) (36,363)Investing activities(33,337)(30,519)
Financing activities (10,000) (62,996)Financing activities315,927 153,741 
Effect of exchange rate changes on cash and cash equivalents 3,501
 1,030
Effect of exchange rate changes on cash and cash equivalents491 (1,105)
Net increase (decrease) $25,369
 $(48,981)
Net increase in cash and cash equivalentsNet increase in cash and cash equivalents$166,674 $28,109 
Operating Activities
Cash provided byused in operating activities during the nine months ended September 30, 20172020 increased $24.3by $22.4 million as compared to the same prior-year period. The increase wasis primarily the result of an increasedue to a decrease in net income of $119.6 million,adjusted for non-cash items, partially offset by a $43.2 million change in operating assets and liabilities, a $39.4 million gain recognized in conjunction with the acquisition of Caisson and a $17.0 million increase in deferred income tax benefit.improved working capital management.
Investing Activities
Cash used in investing activities during the nine months ended September 30, 20172020 increased $5.4$2.8 million as compared to the same prior-year period. The increase wasis primarily due to an increase in purchases of property, plant and equipment of $11.6 million and the resultpurchase of netan investment and loans to investees totaling $5.1 million, partially offset by $10.8 million in cash paid for the acquisition of Caisson of $14.2acquisitions and $3.2 million as well as $14.1 million received from maturities of short-term investments in the prior-year period, offset by $7.1 million infor purchases of short-term investmentsintangible assets in the prior-year period.2019.
Financing Activities
Cash used inprovided by financing activities during the nine months ended September 30, 2017 decreased $53.02020 increased $162.2 million as compared to the same prior-year period. The decrease wasincrease is primarily the resultdue to an increase in net borrowings and associated costs of $210.8 million and a decrease in net debt repaymentspayments of $27.5contingent consideration of $9.1 million, partially offset by the purchase of a decrease in share repurchasescapped call associated with our Notes of $11.1$43.1 million and a closing adjustment payment for the repaymentsale of trade receivable advancesour former CRM business of $23.8 million in the prior-year period, offset by a reduction in proceeds from stock option exercises of $4.7$14.9 million.
Off-Balance Sheet Arrangements
As of September 30, 2020, we did not have any off-balance sheet arrangements.
Contractual Obligations
Except for the financing transactions discussed in “Note 8. Financing Arrangements,” we had no material changes in our contractual commitments and obligations from amounts listed under “Part II, Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations - Liquidity and Capital Resources” in our 2019 Form 10-K.

Item 3. Quantitative and Qualitative Disclosures About Market Risk
We are exposed to certain market risks as part of our ongoing business operations, including risks from foreign currency exchange rates, equity price risk, interest rate risks and concentration of procurement suppliers that could adversely affect our consolidated financial position, results of operations or cash flows. We manage these risks through regular operating and financing activities and, at certain times, derivative financial instruments. Quantitative and qualitative disclosures about these risks are included in this Quarterly Report on Form 10-Q in “Part I, Note 8”,9. Derivatives and Risk Management,” “Part I, Item 2. Management’s Discussion and Analysis of Financial Conditions and Results of Operations” and “Part II, Item 1A. Risk Factors”,Factors,” and in our 20162019 Form 10-K in “Part II, Item 7A7. Management’s Discussion and Analysis of Financial Condition and Results of Operations.”Operations” and “Part I, Item 1A. Risk Factors”. There have been no material changes from the information provided therein.Factors.”

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Item 4. Controls and Procedures
Disclosure Controls and Procedures
(a) Evaluation of Disclosure Controls and Procedures
We maintain a system of disclosure controls and procedures, as defined in Rules 13a-15(e) and 15d-15(e) of the Exchange Act, that are designed to ensure that information required to be disclosed in our reports filed under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms. This information is also accumulated and communicated to management, including our Chief Executive Officer (“CEO”) and Chief Financial Officer (“CFO”), as appropriate, to allow timely decisions regarding required disclosure. Our management, under the supervision and with the participation of our CEO and CFO, evaluated the effectiveness of the design and operation of our disclosure controls and procedures as of the end of the most recent fiscal quarter reported herein. Based on that evaluation, our CEO and CFO concluded that our disclosure controls and procedures were effective as of September 30, 2017.


2020.
(b) Changes in Internal Control Over Financial Reporting
We deployed a new enterprise resource planning (ERP) software system, SAP, to our U.S. locations during the quarter ended September 30, 2017. In conjunction with the implementation of SAP, we reorganized certain U.S. legal entities were to align with our strategic and operational focus. Our internal controls have been updated to reflect these changes. There have been no other changesNo change in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-5(f) under the Exchange Act) occurred during the period covered by this Quarterly Report on Form 10-Qquarter ended September 30, 2020 that havehas materially affected, or areis reasonably likely to materially affect, our internal control over financial reporting.

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PART II. OTHER INFORMATION

Item 1. Legal Proceedings
For a description of our material pending legal and regulatory proceedings and settlements, refer to “Note 9.10. Commitments and Contingencies” in our condensed consolidated financial statements included in this Quarterly Report on Form 10-Q.

Item 1A. RISKFACTORSRiskFactors
Our business faces many risks. Any of the risks referenced belowThere have been no material changes in our risk factors from those disclosed in Part I, Item 1A to our 2019 Annual Report on Form 10-K or elsewhere in thisPart II Item 1A in our Quarterly Report on Form 10-Q for the period ended March 31, 2020 and June 30, 2020, except as noted below. Those risk factors disclosed in addition to the other information set forth in this report, could materially affect our business, financial condition, or results of operations.
Risks Related to our Business
Shareholder activists could cause a disruption to our business.
In mid-October 2020, an activist investor indicated its concerns with, among other things, our capital allocation, reporting transparency on sub segment operating margins, corporate governance and leadership. In the future, our business, operating results or financial condition could be adversely affected because activist proposals can be a significant distraction for our management and employees and may require us to expend significant time and resources. Shareholder activists may create uncertainty for our employees, investors and customers, additional risk and uncertainties with respect to our financial position, operations, strategies and management, and may adversely affect our ability to attract and retain key employees. Any perceived uncertainties as to our future direction also may affect the market price and volatility of our securities.
Risks Related to COVID-19
COVID-19 has had, and we expect will continue to have, an adverse effect on our business, results of operations, financial condition and cash flows, the nature and extent of which are uncertain and unpredictable.
The continuing global spread of COVID-19, including corresponding preventative and precautionary measures that we and other businesses, communities and governments are taking to mitigate the spread of the disease, has led to unprecedented restrictions on, disruptions in, and other related impacts on business. In addition to travel restrictions put in place in early 2020, countries, states and governments may continue to close borders, impose prolonged quarantines or other restrictions and requirements on travel, and further limit our ability to conduct business in-person as we did prior to COVID-19.
Per “Recent Developments Regarding COVID-19” within “Note 1. Unaudited Condensed Consolidated Financial Statements” and “COVID-19” under “Item 2. Management’s Discussion and Analysis of Financial Conditions and Results of Operations,” our sales and operating results for the third quarter of 2020 were materially adversely impacted. While we are seeing signs of stabilization in certain geographies as elective surgeries resume and expect this trend to continue on a global basis during the fourth quarter of 2020, recovery rates may vary and the ultimate health and economic impact of COVID-19 is uncertain. In certain geographies, hospital systems continue to prioritize treatment of COVID-19 patients and otherwise comply with government guidelines, thereby resulting in the suspension or cancellation of elective medical procedures, which has caused a reduction in sales of these products. To the extent individuals and hospital systems continue to de-prioritize, delay or cancel these procedures, or if unemployment or loss of insurance coverage adversely impacts an individual’s ability to pay for our products and services, our business, cash flows, financial condition and results of operations will continue to be negatively affected. Further, the COVID-19 pandemic is straining hospital systems around the world, resulting in adverse financial impacts to those systems that could result in reduced future expenditures for our products. Clinical trials generally have paused or slowed enrollment due to facility closures and governmental restrictions, which will delay enrollment and timelines, and although many facilities have begun to reopen, there can be no assurance that there will not be additional closures in the future.
As we noted in “COVID-19” under “Item 2. Management’s Discussion and Analysis of Financial Conditions and Results of Operations,” we have not closed any of our manufacturing plants. The supply of raw materials and the distribution of finished products remain operational with no known or foreseen constraints. Regardless, there can be no assurance that any of our facilities will not need to shut down in the future, or that the supply of components, raw materials, and services may be interrupted or insufficient as a direct result of the COVID-19 outbreak. Any disruption of our operations or those of our suppliers could impact our sales and operating results.
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In addition, COVID-19 has impacted and may further impact the global economy and capital markets, including by negatively impacting demand for our products, foreign currency exchange rates, and interest rates, each of which may adversely impact our business. We could experience loss of sales and profits due to delayed payments or insolvency of healthcare professionals, hospitals and other customers, suppliers and vendors facing liquidity issues. As a result, we may be compelled to take additional measures to preserve our cash flow.
Finally, COVID-19 could adversely impact our ability to retain key employees and the continued service and availability of skilled personnel necessary to run our productions and operations, including our executive officers and other members of our management team, as well as the ability of our third-party suppliers, manufacturers, distributors and vendors to retain their key employees. To the extent our management or other personnel are impacted in significant numbers by COVID-19 and are not available to perform their job duties, we could experience delays in, or the suspension of, our manufacturing operations, research and product development activities, regulatory work streams, clinical development programs and other important commercial functions.
While the impact of COVID-19 has had, and we expect it to continue to have, an adverse effect on our business, results of operations, financial condition and cash flows, the nature and extent of such impact is uncertain and unpredictable. For more information on the impact of COVID-19 on the Company and LivaNova’s mitigation measures, please refer to “Recent Developments Regarding COVID-19” within “Note 1. Unaudited Condensed Consolidated Financial Statements,” “COVID-19” under “Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations,” Part I, Item 1A to our 2019 Annual Report on Form 10-K, and Part II, Item 1A in our Quarterly Reports on Form 10-Qs or our other SEC filings could have a material impact on our business and consolidated financial position or results of operations. Additional risks and uncertainties not presently known to us or that we currently believe to be immaterial may also impair our business operations.
For additional detailed discussion of risk factors that should be understood by any investor contemplating investment in our stock, please refer to “Part I. Item 1A. Risk Factors” in our 2016 Form 10-K and elsewhere as described in this Report on Form 10-Q.
The results of the UK’s referendum on withdrawal from the EU may have a negative effect on global economic conditions, financial markets and our business, which could reduce the price of our ordinary shares.
On June 23, 2016, the UK held a referendum in which voters approved an exit from the EU, commonly referred to as “Brexit.” On March 29, 2017, the UK Government gave formal notice of its intention to leave the EU, formally commencing the negotiations regarding the terms of withdrawal between the UK and the EU. The withdrawal must occur within two years, unless the deadline is extended or a withdrawal agreement is negotiated sooner. The negotiation process will determine the future terms of the UK’s relationship with the EU. The notification does not change the application of existing tax laws, and does not establish a clear framework for what the ultimate outcome of the negotiations and legislative process will be.
Various tax reliefs and exemptions that apply to transactions between EU Member States under existing tax laws may cease to apply to transactions between the UK and EU Member States when the UK ultimately withdraws from the EU. It is unclear at this stage if or when any new tax treaties between the UK and the EU or individual EU Member States will replace those reliefs and exemptions. It is also unclear at this stage what financial, trade and legal implications the withdrawal of the UK from the EU will have and how Brexit may affect us, our customers, suppliers, vendors, or our industry.
Several of our wholly-owned subsidiaries that are domiciled either in the UK, various EU Member States, or in the United States, and our parent company, LivaNova PLC, are party to intercompany transactions and agreements under which we receive various tax reliefs and exemptions. If certain treaties applicable to our transactions and agreements are not renegotiated or replaced with new treaties containing terms, conditions and attributes similar to those of the existing treaties, the departure of the UK from the EU may have a material adverse impact on our future financial results and results of operations. During the two-year negotiation period, We will monitor and assess the potential impact of this event and explore possible tax-planning strategies that may mitigate or eliminate any such potential adverse impact. We will not account for the impact of Brexit in our income tax provisions until changes in tax laws or treaties between the UK and the EU or individual EU Member States are enacted or the withdrawal becomes effective.
Our acquisition of Caisson may fail to further our strategic objectives or strengthen our existing businesses.
Acquisitions of medical technology companies are inherently risky, and we cannot guarantee that such acquisitions will be successful or will not materially adversely affect our consolidated earnings, financial condition, and/or cash flows. Caisson is in the early stages of clinical development, and therefore, there are risks inherent in the outcome of the clinical studies or regulatory approvals that may impact Caisson’s success. Further, our integration of Caisson’s operations requires significant efforts, including the coordination of information technologies, research and development, operations and finance. These efforts result in additional expenses and significant supervision by management. Our failure to manage and coordinate the growth of Caisson successfully could have an adverse impact on our business. In addition, we cannot be certain that the acquisition will become profitable or remain so. These effects, individually or in the aggregate, could cause a deterioration of our credit rating and result in increased borrowing costs and interest expense.



Item 2.Unregistered Sales of Equity Securities and Use of Proceeds
NoneNone.

Item 3. Defaults Upon Senior Securities
None.

Item 4. Mine Safety Disclosures
Not applicable.

Item 5. Other Information
None.

Disclosure Pursuant to Section 13(r) of the Exchange Act of 1934

Section 13(r) of the Exchange Act requires issuers to disclose in their quarterly reports certain types of dealings with Iran, including transactions or dealing with government-owned entities, even when those activities are lawful and do not involve U.S. persons. One of our non-U.S. subsidiaries currently sells medical devices, including cardiac surgery and cardiopulmonary products, to privately held distributors in Iran.
We have limited visibility into the identity of these distributors’ customers in Iran. It is possible that their customers include entities, such as government-owned hospitals or sub-distributors, that are owned or controlled directly or indirectly by the Iranian government. To the best of our knowledge at this time, we do not have any contracts or commercial arrangements with the Iranian government.
Our gross revenues and net profits attributable to the above-mentioned Iranian activities were $2.3 million and $0.8 million for the three months ended September 30, 2020, respectively, and $6.3 million and $2.3 million for the nine months ended September 30, 2020, respectively.
We believe our activities are consistent with applicable law, including U.S., EU, and other applicable sanctions laws, though such laws are complex and continue to evolve rapidly. We intend to continue our business in Iran.
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Item 6. Exhibits
The exhibits marked with the asterisk symbol (*) are filed or furnished (in the case of Exhibit 32.1) with this Quarterly Report on Form 10-Q. The exhibits marked with the cross symbol (†) are management contracts or compensatory plans or arrangements filed pursuant to Item 601(b)(10)(iii) of Regulation S-K.
Exhibit
Number
Document Description
Form of Long Term Incentive Plan Restricted Stock Unit Award Agreement
Form of Long Term Incentive Plan Performance Stock Unit Award Agreement
Form of Long Term Incentive Plan Stock Appreciation Right Award Agreement
Certification of the Chief Executive Officer of LivaNova PLC pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
Certification of the Chief Financial Officer of LivaNova PLC pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
Certification of the Chief Executive Officer and Chief Financial Officer of LivaNova PLC pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
101*Interactive Data Files Pursuant to Rule 405 of Regulation S-T formatted in Inline XBRL: (i) the Condensed Consolidated Statements of Income (Loss) for the three and nine months ended September 30, 2020 and September 30, 2019, (ii) the Condensed Consolidated Statements of Comprehensive Income (Loss) for the three and nine months ended September 30, 2020 and September 30, 2019, (iii) the Condensed Consolidated Balance Sheet as of September 30, 2020 and December 31, 2019, (iv) the Condensed Consolidated Statements of Cash Flows for the nine months ended September 30 2020 and September 30, 2019, and (vi) the Notes to the Condensed Consolidated Financial Statements
104*Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101)
44
Exhibit
Number
 
Document Description
 
 Report or Registration Statement
SEC File or
Registration
Number
Exhibit
Reference
3.2 LivaNova Plc Current Report on Form 8-K, filed on June 15, 2017001-375993.1
31.1*    
31.2*    
32.1*    
101*Interactive Data Files Pursuant to Rule 405 of Regulation S-T: (i) the Condensed Consolidated Statement of Income (Loss) for the three and nine months ended September 30, 2017 and September 30, 2016, (ii) the Condensed Consolidated Statement of Comprehensive Income for the three and nine months ended September 30, 2017 and September 30, 2016, (iii) the Condensed Consolidated Balance Sheet as of September 30, 2017 and December 31, 2016, (iv) the Condensed Consolidated Statement of Cash Flows for the nine months ended September 30, 2017 and September 30, 2016, and (vi) the Notes to the Condensed Consolidated Financial Statements.     





SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
LIVANOVA PLC
Date: October 29, 2020By:/s/ DAMIEN MCDONALD
Damien McDonald
Chief Executive Officer
(Principal Executive Officer)
LIVANOVA PLC
Date: October 29, 2020By:/s/ THAD HUSTON
Thad Huston
Chief Financial Officer
(Principal Financial Officer)
Date: November 2, 2017


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