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

(Mark One)
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended: June 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-20200630_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
Securities registered pursuant to Section 12(b) of the Act
Title of each classTrading Symbol(s)Name of each exchange on which registered
Ordinary Shares - £1.00 par value per shareLIVNNASDAQ Global Market
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.  Yes      No 
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).  Yes     No
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
 
Large accelerated filerAccelerated filer
Non-accelerated filerSmaller 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 
ClassOutstanding at July 27, 2020
Ordinary Shares - £1.00 par value per share48,666,835



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®), Model 1000 (SenTiva®) and Model 8103 (Symmetry®).
Trademarks for our Cardiopulmonary product systems: S5® heart-lung machine, S3® heart-lung machine, Inspire®, Heartlink®, XTRA® Autotransfusion System, 3T Heater-Cooler®, Connect™ and Revolution®.
Trademarks for our line of surgical tissue and mechanical valve replacements and repair products: Mitroflow®, Crown PRT®, Solo Smart™, Perceval®, Miami Instruments™, Top Hat®, Reduced Series Aortic Valves™, Carbomedics Carbo-Seal®, Carbo-Seal Valsalva®, Carbomedics Standard®, Orbis™ and Optiform®, MEMO 4D®, AnnuloFlo®, AnnuloFlex®, Bicarbon Slimline™, Bicarbon Fitline™ and Bicarbon Overline®.
Trademarks for our advanced circulatory support systems: TandemLife®, TandemHeart®, TandemLung®, ProtekDuo®, and LifeSPARC™.
Trademarks for our obstructive sleep apnea system: ImThera® and Aura6000®.
These trademarks and trade 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.

________________________________________
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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:
changes in our common stock price;
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. laws and regulations, including federal and state privacy and security laws and regulations;
failure to comply with applicable non-U.S. laws and regulations;
non-U.S. operational and economic risks and concerns;
3


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 the implementation of Brexit and/or changes to existing trade agreements and relationships between the U.S. and other countries;
risks relating to the outbreak and spread of 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 Quarterly Report on Form 10-Q, (2) our Annual Report on Form 10-K for the fiscal year ended December 31, 2019 (“2019 Form 10-K”), (3) our reports and registration statements filed and furnished from time to time with the Securities 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 six months ended June 30, 2020 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 2019 Form 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 in the United States of America (“U.S.” 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
CONDENSED CONSOLIDATED STATEMENTS OF INCOME (LOSS)
(UNAUDITED)
(In thousands, except per share amounts)
Three Months Ended June 30,Six Months Ended June 30,
2020201920202019
Net sales$182,206  $277,169  $424,603  $527,970  
Costs and expenses:
Cost of sales - exclusive of amortization56,762  74,942  125,685  159,196  
Product remediation4,269  5,113  5,735  8,060  
Selling, general and administrative98,048  127,213  218,225  252,917  
Research and development25,152  34,544  61,054  78,119  
Merger and integration expenses2,048  4,378  5,522  7,629  
Restructuring expenses794  1,332  2,374  3,865  
Impairment of intangible assets  50,295    50,295  
Amortization of intangibles9,394  9,228  19,661  18,544  
Litigation provision, net976    976    
Operating loss from continuing operations(15,237) (29,876) (14,629) (50,655) 
Interest income287  224  435  473  
Interest expense(5,715) (4,054) (10,564) (5,716) 
Foreign exchange and other losses(999) (1,851) (2,913) (1,122) 
Loss from continuing operations before tax(21,664) (35,557) (27,671) (57,020) 
Income tax expense (benefit)66,285  (6,164) 21,571  (12,778) 
Losses from equity method investments(44)   (173)   
Net loss from continuing operations(87,993) (29,393) (49,415) (44,242) 
Net income (loss) from discontinued operations, net of tax  178  (995) 178  
Net loss$(87,993) $(29,215) $(50,410) $(44,064) 
Basic (loss) income per share:
Continuing operations$(1.81) $(0.61) $(1.02) $(0.92) 
Discontinued operations  0.01  (0.02) 0.01  
$(1.81) $(0.60) $(1.04) $(0.91) 
Diluted (loss) income per share:
Continuing operations$(1.81) $(0.61) $(1.02) $(0.92) 
Discontinued operations  0.01  (0.02) 0.01  
$(1.81) $(0.60) $(1.04) $(0.91) 
Shares used in computing basic (loss) income per share48,611  48,342  48,548  48,295  
Shares used in computing diluted (loss) income per share48,611  48,342  48,548  48,295  
See accompanying notes to the condensed consolidated financial statements
5


LIVANOVA PLC AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS)
(UNAUDITED)
(In thousands)
Three Months Ended June 30,Six Months Ended June 30,
2020201920202019
Net loss$(87,993) $(29,215) $(50,410) $(44,064) 
Other comprehensive income (loss):
Net change in unrealized loss on derivatives1,029  215  (327) 205  
Tax effect(246) (52) 79  (50) 
Net of tax783  163  (248) 155  
Foreign currency translation adjustment16,651  15,376  (15,449) 11,147  
Total other comprehensive income (loss)17,434  15,539  (15,697) 11,302  
Total comprehensive loss$(70,559) $(13,676) $(66,107) $(32,762) 

See accompanying notes to the condensed consolidated financial statements
6


LIVANOVA PLC AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
(UNAUDITED)
(In thousands, except share amounts)
 June 30, 2020December 31, 2019
ASSETS
Current Assets:
Cash and cash equivalents$232,549  $61,137  
Accounts receivable, net of allowance of $15,320 at June 30, 2020 and $13,105 at December 31, 2019
186,144  257,769  
Inventories, net177,246  164,154  
Prepaid and refundable taxes41,662  37,779  
Prepaid expenses and other current assets34,838  28,604  
Total Current Assets672,439  549,443  
Property, plant and equipment, net185,670  181,354  
Goodwill902,204  915,794  
Intangible assets, net583,490  607,546  
Operating lease assets51,114  54,372  
Investments30,245  27,256  
Deferred tax assets23,148  68,676  
Other assets54,353  7,356  
Total Assets$2,502,663  $2,411,797  
LIABILITIES AND STOCKHOLDERS' EQUITY
Current Liabilities:
Current debt obligations$7,449  $77,396  
Accounts payable69,065  85,892  
Accrued liabilities and other97,238  120,100  
Current litigation provision liability37,420  146,026  
Taxes payable8,365  12,719  
Accrued employee compensation and related benefits48,827  70,420  
Total Current Liabilities268,364  512,553  
Long-term debt obligations639,189  260,330  
Contingent consideration71,236  114,396  
Litigation provision liability11,611  24,378  
Deferred tax liabilities30,106  32,219  
Long-term operating lease liabilities42,388  46,027  
Long-term employee compensation and related benefits22,398  22,797  
Long-term derivative liability71,501  61  
Other long-term liabilities12,684  15,319  
Total Liabilities1,169,477  1,028,080  
Commitments and contingencies (Note 10)
Stockholders’ Equity:
Ordinary Shares, £1.00 par value: unlimited shares authorized; 49,476,223 shares issued and 48,667,203 shares outstanding at June 30, 2020; 49,411,016 shares issued and 48,443,830 shares outstanding at December 31, 2019
76,338  76,257  
Additional paid-in capital1,750,798  1,734,870  
Accumulated other comprehensive loss(35,089) (19,392) 
Accumulated deficit(457,804) (406,755) 
Treasury stock at cost, 809,020 ordinary shares at June 30, 2020, 967,186 ordinary shares at December 31, 2019
(1,057) (1,263) 
Total Stockholders’ Equity1,333,186  1,383,717  
Total Liabilities and Stockholders’ Equity$2,502,663  $2,411,797  
See accompanying notes to the condensed consolidated financial statements
7


LIVANOVA PLC AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(UNAUDITED)
(In thousands)
Six Months Ended June 30,
20202019
Operating Activities:
Net loss$(50,410) $(44,064) 
Non-cash items included in net loss:
Deferred tax expense46,171  15,897  
Remeasurement of contingent consideration to fair value(46,034) (10,600) 
Amortization19,661  18,544  
Stock-based compensation19,034  15,596  
Depreciation13,596  15,287  
Remeasurement of derivative instruments(7,250) (3,762) 
Amortization of operating lease assets6,297  6,334  
Impairment of intangible assets  50,295  
Other5,433  5,932  
Changes in operating assets and liabilities:
Accounts receivable, net66,256  (277) 
Inventories, net(16,210) (14,284) 
Other current and non-current assets(10,263) 5,291  
Accounts payable and accrued current and non-current liabilities(47,084) (29,129) 
Taxes payable(2,150) (43,008) 
Litigation provision liability(121,194)   
Restructuring reserve(917) (5,473) 
Net cash used in operating activities(125,064) (17,421) 
Investing Activities:
Purchases of property, plant and equipment(17,955) (10,796) 
Purchase of investments(3,168) (287) 
Loans to investees(2,250)   
Acquisitions, net of cash acquired  (10,750) 
Other707  (621) 
Net cash used in investing activities(22,666) (22,454) 
Financing Activities:
Proceeds from long-term debt obligations886,899  53,777  
Repayment of long-term debt obligations(481,254) (12,125) 
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(19,970) (3,688) 
Closing adjustment payment for sale of CRM business(14,891)   
Payment of contingent consideration(5,250) (284) 
Shares repurchased from employees for minimum tax withholding(5,177) (5,714) 
Proceeds from share issuances under ESPP2,064  2,574  
Change in short-term borrowing, net(1,532) 2,355  
Other25  162  
Net cash provided by financing activities319,697  37,057  
Effect of exchange rate changes on cash and cash equivalents(555) 125  
Net increase (decrease) in cash and cash equivalents171,412  (2,693) 
Cash and cash equivalents at beginning of period61,137  47,204  
Cash and cash equivalents at end of period$232,549  $44,511  
See accompanying notes to the condensed consolidated financial statements
8


LIVANOVA PLC AND SUBSIDIARIES
NOTES TO 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 six months ended June 30, 2020 and 2019, have been prepared in accordance with U.S. 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, 2019 has been derived from audited financial statements contained in our 2019 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 statement of the operating results of LivaNova and its subsidiaries, for the three and six months ended June 30, 2020, and are not necessarily indicative of the results that may be expected for the year ending December 31, 2020. The financial information presented herein should be read in conjunction with the audited consolidated financial statements and notes thereto accompanying our 2019 Form 10-K.
Recent 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 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.
We are beginning to see signs of stabilization in certain geographies as elective surgeries resume and expect this trend to continue on a global basis during the second half 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.
Reclassifications
We have reclassified certain prior period amounts for comparative purposes. These reclassifications did not have a material effect on our financial condition, results of operations or cash flows.
Significant Accounting Policies
Our significant accounting policies are detailed in “Note 2. Basis of Presentation, Use of Accounting Estimates and Significant Accounting Policies” and “Note 3. Revenue Recognition” of our 2019 Form 10-K.

Note 2. Business Combinations
Miami Instruments
On June 12, 2019, we acquired the minimally invasive cardiac surgery instruments business from Miami Instruments, LLC (“Miami Instruments”) for cash consideration of up to $17.0 million. The related operations have been integrated into our Cardiovascular segment as a part of our Heart Valves business. Cash of $10.8 million was paid at closing with up to $6.0 million in contingent consideration based on achieving certain milestones. The purchase price allocation for the Miami Instruments acquisition was finalized during the second quarter of 2020 and resulted in no measurement period adjustments. In connection with this acquisition, we recognized $14.7 million in developed technology and in-process research and development (“IPR&D”) intangible assets and $1.5 million in goodwill.

Note 3. Discontinued Operations
On April 30, 2018, we completed the sale of our Cardiac Rhythm Management (“CRM”) business franchise 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.
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Note 4. Restructuring
We initiate 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 in the operating results of our condensed consolidated statements of income (loss).
The following table presents the accruals and other reserves recorded in connection with our restructuring plans (in thousands):
Employee Severance and Other Termination CostsOtherTotal
Balance at December 31, 2019$4,097  $1,400  $5,497  
Charges2,374    2,374  
Cash payments and other(5,327) (736) (6,063) 
Balance at June 30, 2020$1,144  $664  $1,808  

The following table presents restructuring expense by reportable segment (in thousands):
Three Months Ended June 30,Six Months Ended June 30,
2020201920202019
Cardiovascular $570  $316  $1,256  $738  
Neuromodulation 305  53  808  485  
Other(81) 963  310  2,642  
Total$794  $1,332  $2,374  $3,865  

Note 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 FDA clearance in the U.S. 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 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 implementing the vacuum canister and internal sealing upgrade program in as many countries as possible until all devices are upgraded. In October 2018, after review of information provided by us, 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.
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As a second part of the remediation plan, we continue to offer a no-charge deep disinfection service (deep cleaning service) for 3T device users 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 continuing 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 is available on a global basis.
The following table provides a reconciliation of the beginning and ending balance of the product remediation liability included within accrued liabilities and other on the condensed consolidated balance sheet (in thousands):
Balance at December 31, 2019$3,251  
Adjustments1,392  
Remediation activity(3,099) 
Effect of changes in foreign currency exchange rates(11) 
Balance at June 30, 2020$1,533  
We recognized product remediation expenses of $4.3 million and $5.1 million during the three months ended June 30, 2020 and 2019, respectively, and $5.7 million and $8.1 million during the six months ended June 30, 2020 and 2019, respectively. Product remediation expenses include internal labor costs, costs to remediate certain inspectional observations made by the FDA at our Munich facility and costs associated with the incorporation of the modification of the 3T device design into the next generation 3T device. These costs and related legal costs are expensed as incurred and are not included within the product remediation liability presented above. At June 30, 2020, our balance sheet includes a $49.0 million provision related to litigation involving our 3T device. For further information, please refer to “Note 10. Commitments and Contingencies.”

Note 6. Investments
The 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 on the condensed consolidated balance sheets (in thousands):
Equity Investments Without Readily Determinable Fair ValuesJune 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  
Rainbow Medical Ltd.1,097  1,099  
MD Start II1,121  1,121  
Highlife S.A.S.1,063  1,064  
Other770  770  
29,802  26,805  
Equity method investment443  451  
$30,245  $27,256  
(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 June 30, 2020 and December 31, 2019, respectively, which is included in 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 loan to ALung for $2.0 million, due July 10, 2021. The loan may be converted, at LivaNova’s option, to either ALung’s Series C Senior Convertible Participating Preferred
11


Stock or ALung’s Series D convertible participating preferred stock at $0.8069 per share. As of June 30, 2020, the carrying amount of the loan was $2.0 million, which is included in other assets on the condensed consolidated balance sheet.

Note 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 six months ended June 30, 2020 and 2019.
Assets and Liabilities Measured at Fair Value on a Recurring Basis
The following tables provide information by level for assets and liabilities that are measured at fair value on a recurring basis (in thousands):
Fair Value as of June 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”)$383  $  $383  $  
Derivative assets - freestanding instruments (FX)20    20    
Derivative assets - capped call derivatives44,925      44,925  
Convertible notes receivable2,267      2,267  
$47,595  $  $403  $47,192  
Liabilities:
Derivative liabilities - designated as cash flow hedges (FX)$78  $  $78  $  
Derivative liabilities - freestanding instruments (interest rate swaps)194    194    
Derivative liabilities - freestanding instruments (FX) 1,601    1,601    
Derivative liabilities - embedded exchange feature71,501      71,501  
Contingent consideration arrangements85,120      85,120  
$158,494  $  $1,873  $156,621  

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  $137,349  
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The following table provides a reconciliation of the beginning and ending balances of our recurring fair value measurements, using significant unobservable inputs (Level 3) (in thousands):
Capped Call Derivative AssetEmbedded Exchange Feature LiabilityContingent Consideration Liability ArrangementsConvertible Notes Receivable
As of December 31, 2019$  $  $137,349  $  
Additions43,096  74,951    2,267  
Payments (1)
    (6,068)   
Changes in fair value (2) (3) (4)
1,829  (3,450) (46,034)   
Effect of changes in foreign currency exchange rates    (127)   
Total at June 30, 202044,925  71,501  85,120  2,267  
Less current portion at June 30, 2020    13,884    
Long-term portion at June 30, 2020$44,925  $71,501  $71,236  $2,267  
(1)During the six months ended June 30, 2020, we paid $5.0 million under the contingent consideration arrangement for the acquisition of CardiacAssist, Inc., doing business as TandemLife (“TandemLife”). Additionally, we made the final payments for the contingent consideration arrangements with the previous acquisitions of two distributors.
(2)The contingent consideration change in fair value during the six months ended June 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 the tables below for further information regarding the fair value measurements of contingent consideration.
(3)During the six months ended June 30, 2020, the contingent consideration change in fair value resulted in a decrease of $24.4 million and $21.6 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 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 option 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. These significant inputs include 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 stock price historical volatility and implied volatility from options traded to determine expected volatility which is an unobservable input that is significant to the valuation. In general, an increase in our stock price volatility would increase the fair value of the embedded exchange feature and capped call derivatives which would result in a net loss. An increase in our stock price would also increase the fair value of the derivatives and would result in a net loss. As time to expiration of the options 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 expiration of the options change in relation to other inputs.
The stock price volatility as of June 30, 2020 was 38%. As of June 30, 2020, a 10% lower volatility, holding other inputs constant, would result in approximate fair value for the embedded exchange feature derivative of $55.2 million and a 10% higher volatility, holding other inputs constant, would result in approximate fair value of $87.2 million. As of June 30, 2020, a 10% lower volatility, holding other inputs constant would result in approximate fair value for the capped call derivatives of $37.2 million and a 10% higher volatility, holding other inputs constant, would result in approximate fair value of $46.5 million.
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Contingent Consideration Arrangements
The following table provides the fair value of our Level 3 contingent consideration arrangements by acquisition (in thousands):
June 30, 2020December 31, 2019
ImThera$71,236  $113,503  
TandemLife9,136  17,311  
Miami Instruments4,748  5,338  
Drilltex  294  
Other  903  
$85,120  $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 June 30, 2020:
ImThera AcquisitionValuation TechniqueUnobservable InputRanges
Regulatory milestone-based paymentDiscounted cash flowDiscount rate10.0%
Probability of payment85%
Projected payment year2024
Sales-based earnoutMonte Carlo simulationRisk-adjusted discount rate12.3 %-12.5%
Credit risk discount rate10.1 % -10.8%
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 June 30, 2020:
TandemLife AcquisitionValuation TechniqueUnobservable InputRanges
Regulatory milestone-based paymentsDiscounted cash flowDiscount rate9.3%
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 June 30, 2020:
Miami InstrumentsValuation TechniqueUnobservable InputRanges
Regulatory milestone-based paymentsDiscounted cash flowDiscount rate9.3 % -9.4%
Probability of payments80 % -95%
Projected payment years2020 -2021

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Note 8. Financing Arrangements
The carrying amount of our long-term debt as of June 30, 2020 and December 31, 2019 was as follows (in thousands, except interest rates):
June 30, 2020December 31, 2019MaturityInterest Rate
2020 Senior Secured Term Loan$421,941  $  June 2025
LIBOR (1% Floor)
+6.50%
2020 Cash Exchangeable Senior Notes206,119    December 20253.00%
Bank of America Merrill Lynch Banco Múltiplo S.A.6,182  8,422  July 20216.70%
Mediocredito Italiano5,578  6,222  December 20230.50 % -2.94%
Bank of America, U.S.2,029  2,004  January 20213.48%
2019 Debt Facility  184,275  
2017 European Investment Bank  103,570  
2014 European Investment Bank  28,053  
Other982  965  
Total long-term facilities642,831  333,511  
Less current portion of long-term debt3,642  73,181  
Total long-term debt$639,189  $260,330  
Revolving Credit
The outstanding principal amount of our short-term unsecured revolving credit agreements and other agreements with various banks was $3.8 million and $4.2 million, at June 30, 2020 and December 31, 2019, respectively, with interest rates ranging from 3.21% to 7.70% and loan terms ranging from 1 day to 10 months, as of June 30, 2020.
2020 Senior Secured Term Loan
On June 10, 2020, we entered into a $450.0 million five-year senior secured term loan (the “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 Term 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 certain 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 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 asset 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 consolidated 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 $28.2 million and included various legal, bank and accounting fees. Amortization of debt discount and issuance costs was $0.1 million for the three months ended June 30, 2020 and was included as part of interest 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 3.00% cash exchangeable senior notes (the “Notes”) by private placement to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended. The sale of the Notes resulted in approximately $278.2 million in net proceeds to the Company after deducting issuance costs. The Notes bear interest at a rate of 3.00% per year and interest will be
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payable semiannually in arrears on June 15 and December 15 of each year, beginning on December 15, 2020. The Notes mature on December 15, 2025 unless earlier exchanged, repurchased, or redeemed.
Debt discounts and issuance costs related to the Notes were approximately $81.8 million and included $75.0 million of discount attributable to the embedded exchange feature, discussed below, and $6.8 million of allocated issuance costs to the Notes related to legal, bank and accounting fees. Amortization of debt discount and issuance costs was $0.4 million for the three months ended June 30, 2020 and was included as part 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. The 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 reported sale price per ordinary share has been at least 130% of the exchange price then in effect for at least 20 trading days (whether or not consecutive), including the trading 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 tax-related events.
Embedded Exchange Feature
The embedded exchange feature of the Notes requires bifurcation from the Notes and is 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 was 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 $71.5 million as of June 30, 2020. See “Note 7. Fair Value Measurements.”
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 $44.9 million as of June 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 June 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 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
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during the three and six months ended June 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 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 FX derivative contracts to reduce the impact of foreign currency exchange 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 on 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, changes in the fair value of the derivative will be recorded in accumulated other comprehensive income (“AOCI”) until the hedged item is recognized in earnings upon settlement/termination. FX derivative gains and losses in AOCI are reclassified to our condensed consolidated statements of income (loss) as shown in the tables below and interest rate swap gains and losses in AOCI are reclassified to interest expense on our condensed consolidated statements of income (loss). We evaluate hedge effectiveness at inception. Cash flows from derivative contracts are reported as operating activities on our condensed consolidated statements of cash flows.
Freestanding FX Derivative Contracts
The gross notional amount of FX derivative contracts not designated as hedging instruments outstanding at June 30, 2020 and December 31, 2019 was $372.1 million and $338.0 million, respectively. These derivative contracts are designed to offset the FX effects in earnings of various intercompany loans and trade receivables. We recorded net (losses) gains for these freestanding derivatives of $(1.2) million and $1.0 million for the three months ended June 30, 2020 and 2019, respectively, and $6.9 million and $4.7 million for the six months ended June 30, 2020 and 2019, respectively. These (losses) and gains are included in foreign exchange and other losses on our condensed consolidated statement 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
The gross notional amounts of open derivative contracts designated as cash flow hedges at June 30, 2020 and December 31, 2019 were as follows (in thousands):
Description of Derivative ContractJune 30, 2020December 31, 2019
FX derivative contracts to be exchanged for British Pounds$8,369  $10,128  
FX derivative contracts to be exchanged for Japanese Yen17,177  25,342  
FX derivative contracts to be exchanged for Euros40,315  48,838  
Interest rate swap contracts (1)
  22,442  
$65,861  $106,750  
(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 twelve months are as follows (in thousands):
Description of Derivative ContractAfter-Tax Net Gain in AOCI as of June 30, 2020After-Tax Net Gain in AOCI as of Amount Expected to be Reclassified to Earnings in Next 12 Months
FX derivative contracts$265  $265  
Pre-tax gains (losses) for derivative contracts designated as cash flow hedges recognized in other comprehensive income (loss) (“OCI”) and the amount reclassified to earnings from AOCI were as follows (in thousands):
Three Months Ended June 30,
20202019
Description of Derivative ContractLocation in Earnings of Reclassified Gain or LossGains Recognized in OCIGains (Losses) Reclassified from AOCI to EarningsGains Recognized in OCIGains (Losses) Reclassified from AOCI to Earnings
FX derivative contractsForeign exchange and other losses$1,230  $520  $313  $489  
FX derivative contractsSG&A  (234)   (418) 
Interest rate swap contractsInterest expense  (85)   27  
$1,230  $201  $313  $98  
Six Months Ended June 30,
20202019
Description of Derivative ContractLocation in Earnings of Reclassified Gain or LossLosses Recognized in OCILosses Reclassified from AOCI to EarningsGains Recognized in OCIGains (Losses) Reclassified from AOCI to Earnings
FX derivative contractsForeign exchange and other losses$(850) $(85) $1,622  $2,131  
FX derivative contractsSG&A  (325)   (728) 
Interest rate swap contractsInterest expense  (113)   14  
$(850) $(523) $1,622  $1,417  
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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 and the location of derivative contracts reported on the condensed consolidated balance sheets (in thousands):
June 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$383  Accrued liabilities$78  
Total derivatives designated as hedging instruments383  78  
Derivatives Not Designated as Hedging Instruments
Interest rate swap contractsAccrued liabilities194  
FX derivative contractsPrepaid expenses and other current assets20  Accrued liabilities1,601  
Capped call derivativesOther assets44,925  
Embedded exchange featureLong-term derivative liability71,501  
Total derivatives not designated as hedging instruments44,945  73,296  
Total derivatives$45,328  $73,374  
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.”

Note 10. Commitments and Contingencies
FDA Warning Letter
On December 29, 2015, the FDA issued a 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 two 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
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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 were 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 had informed us that the import alert was limited to the 3T devices, but that the agency reserved the right to expand the scope of the import alert if future circumstances warranted 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 were 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 were reasonably related would not be approved until the violations had been corrected; however, this restriction applied 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
On October 13, 2016, the CDC and the 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 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, including a vacuum canister and internal sealing upgrade program and a deep disinfection service. This loaner program is available on a global basis. We anticipate that this program will continue until we are able to address customer needs through a broader solution that includes implementation of the risk mitigation strategies described above. We are currently implementing 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 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 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
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management to various regulatory authorities globally in November and December 2016, and furthermore, the cost associated with the plan was reasonably estimable. At June 30, 2020, the product remediation liability was $1.5 million. Refer to “Note 5. Product Remediation Liability” for additional information.
Litigation
Product Liability
The Company is currently involved in litigation involving our 3T device. The litigation includes a class action complaint in the U.S. District Court for the Middle District of Pennsylvania, federal multi-district litigation in the U.S. District Court for the Middle District of Pennsylvania, various U.S. state court cases and cases in jurisdictions outside the U.S. The class action, filed in February 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. Members of the class seek declaratory relief that the 3T devices are defective and unsafe for intended uses, medical monitoring, damages, and attorneys’ fees. 
On March 29, 2019, we announced a settlement 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 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 provides 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 July 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 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.
At June 30, 2020, the provision for these matters was $49.0 million. While the amount accrued represents our best estimate, the actual liability for resolution of these matters may vary from our estimate.
The changes in the litigation provision liability during the six months ended June 30, 2020 are as follows (in thousands):
Litigation Provision Liability
Total litigation provision liability at December 31, 2019$170,404  
Payments(122,170) 
Adjustments976  
FX and other(179) 
Total litigation provision liability at June 30, 202049,031  
Less current portion of litigation liability at June 30, 202037,420  
Long-term portion of litigation provision liability at June 30, 2020$11,611  
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”) in January 2004. SNIA subsequently became insolvent and the Italian Ministry of the Environment and the Protection of Land and Sea (the “Italian Ministry of the Environment”), sought compensation from SNIA for remediation costs relating to the environmental damage at chemical sites previously operated by SNIA’s other subsidiaries.
In September 2011 and July 2014, the Bankruptcy Court of Udine and the Bankruptcy Court of Milan, respectively, 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 or its subsidiaries in connection with their claims in the Italian insolvency proceedings. The Public Administrations appealed and in January 2016, the Court of Udine rejected the appeal. The
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Public Administrations has appealed that decision to the Supreme Court. Meanwhile, the Bankruptcy Court of 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. The Public Administrations intervened in the proceeding, with a claim for environmental damages of approximately $4 billion. On April 1, 2016, the Court of Milan dismissed all legal actions of SNIA and of the Public Administrations further requiring the Public Administrations to pay Sorin approximately €292,000 (approximately $327,318 as of June 30, 2020) for legal fees. The Public Administrations appealed the 2016 Decision to the Court of Appeal of Milan, 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 net worth received by Sorin because of the Sorin spin-off, an estimated €572.1 million (approximately $641.3 million as of June 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 costs that the Public Administrations has already borne for the clean-up of the 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 Public Administrations have appealed the decision to the Italian Supreme Court (Corte di Cassazione).
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.
Patent Litigation
On May 11, 2018, Neuro and Cardiac Technologies LLC (“NCT”), a non-practicing entity, filed a complaint in the United States District Court for the Southern District of Texas asserting that the VNS Therapy System, when used with the SenTiva 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 U.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, which is currently pending. The Court has stayed the litigation pending the outcome of 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.
Tax Litigation
In a tax audit report received on 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 $115.0 million as of June 30, 2020), 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 five equal installments, beginning in 2002. In December 2009, the Internal Revenue Office issued notices of assessment for 2004. In December 2010 and October 2011, the Internal Revenue Office issued notices of assessment for 2005 and 2006, respectively. We challenged all three 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
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this second-level decision to the Italian Supreme Court (Corte di Cassazione) on February 3, 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. On November 16, 2018, the Supreme Court returned the decisions for years 2005 and 2006 to the previous-level Court (Regional Tax Court) due to lack of substance of the motivation given in the 2nd level judgments that were appealed.
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 is €62.6 million (approximately $70.2 million as of June 30, 2020). We have continuously reassessed our potential exposure in these matters, taking into account the recent, and generally adverse, trend to Italian taxpayers in this type of litigation. Although we believe that our defensive arguments are strong, noting the adverse trend in some of the court decisions, we have recognized a reserve for an uncertain tax position for the full amount of the potential liability. On May 31, 2019, we filed an application to settle the litigation according to law N. 136/2018 and paid the required settlement balance of €1.9 million (approximately $2.1 million as of June 30, 2020). As per law N. 136/2018, the Italian Revenue Agency will review the settlement and decide to approve or reject the application by July 31, 2020. Until the settlement is approved by the Italian Revenue Agency, we will continue to reserve for the full amount of the potential liability, by recognizing a €15.5 million reserve for uncertain tax position (approximately $17.4 million as of June 30, 2020), net of the settlement payment.
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 11. Stockholders’ Equity
The tables below present the condensed consolidated statement of stockholders’ equity as of and for the three and six months ended June 30, 2020 and 2019 (in thousands):
Ordinary SharesOrdinary Shares - AmountAdditional Paid-In CapitalTreasury StockAccumulated Other Comprehensive LossAccumulated DeficitTotal Stockholders' Equity
March 31, 202049,414  $76,259  $1,739,873  $(1,090) $(52,523) $(369,811) $1,392,708  
Stock-based compensation plans62  79  10,925  33  —  —  11,037  
Net loss—  —  —  —  —  (87,993) (87,993) 
Other comprehensive income—  —  —  —  17,434  —  17,434  
June 30, 202049,476  $76,338  $1,750,798  $(1,057) $(35,089) $(457,804) $1,333,186  
March 31, 201949,329  $76,151  $1,707,117  $(1,321) $(28,713) $(266,428) $1,486,806  
Stock-based compensation plans51  66  10,103  29  —  —  10,198  
Net loss—  —  —  —  —  (29,215) (29,215) 
Other comprehensive income—  —  —  —  15,539  —  15,539  
June 30, 201949,380  $76,217  $1,717,220  $(1,292) $(13,174) $(295,643) $1,483,328  

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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  15,928  206  —  —  16,215  
Net loss—  —  —  —  —  (50,410) (50,410) 
Other comprehensive loss—  —  —  —  (15,697) —  (15,697) 
June 30, 202049,476  $76,338  $1,750,798  $(1,057) $(35,089) $(457,804) $1,333,186  
December 31, 201849,323  $76,144  $1,705,111  $(1,462) $(24,476) $(251,579) $1,503,738  
Stock-based compensation plans57  73  12,109  170  —  —  12,352  
Net loss—  —  —  —  —  (44,064) (44,064) 
Other comprehensive income—  —  —  —  11,302  —  11,302  
June 30, 201949,380  $76,217  $1,717,220  $(1,292) $(13,174) $(295,643) $1,483,328  
(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 income for the six months ended June 30, 2020 and 2019 (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 loss before reclassifications, before tax(850) (15,449) (16,299) 
Tax benefit204    204  
Other comprehensive loss before reclassifications, net of tax(646) (15,449) (16,095) 
Reclassification of loss from accumulated other comprehensive loss, before tax523    523  
Reclassification of tax benefit(125)   (125) 
Reclassification of loss from accumulated other comprehensive loss, after tax398    398  
Net current-period other comprehensive loss, net of tax(248) (15,449) (15,697) 
June 30, 2020$265  $(35,354) $(35,089) 
December 31, 2018$(944) $(23,532) $(24,476) 
Other comprehensive income before reclassifications, before tax1,622  11,147  12,769  
Tax expense(390)   (390) 
Other comprehensive income before reclassifications, net of tax1,232  11,147  12,379  
Reclassification of gain from accumulated other comprehensive loss, before tax(1,417)   (1,417) 
Reclassification of tax expense340    340  
Reclassification of gain from accumulated other comprehensive loss, after tax(1,077)   (1,077) 
Net current-period other comprehensive income, net of tax155  11,147  11,302  
June 30, 2019$(789) $(12,385) $(13,174) 
(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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Note 12. Stock-Based Incentive Plans
Stock-based incentive plans compensation expense is as follows (in thousands):
Three Months Ended June 30,Six Months Ended June 30,
2020201920202019
Service-based restricted stock units (“RSUs”)$4,250  $3,875  $8,728  $6,845  
Service-based stock appreciation rights (“SARs”)3,290  2,900  5,974  4,908  
Market performance-based restricted stock units1,035  838  1,931  1,389  
Operating performance-based restricted stock units 1,149  798  1,844  1,769  
Employee share purchase plan267  313  557  685  
Total stock-based compensation expense$9,991  $8,724  $19,034  $15,596  
During the six months ended June 30, 2020, we issued stock-based compensatory awards with terms approved by the Compensation Committee of our Board of Directors. The awards with service conditions generally vest ratably over four years, subject to forfeiture unless service conditions are met. Market performance-based awards cliff vest after three years subject to the rank of our total shareholder return for the three-year period ending December 31, 2022 relative to the total shareholder returns for a peer group of companies. Operating performance-based awards cliff vest after three years subject to the achievement of certain thresholds of cumulative adjusted free cash flow for the three year period ending December 31, 2022. Compensation expense related to awards granted during 2020 for the three and six months ended June 30, 2020 was $2.8 million and $3.2 million, respectively.
Stock-based compensation agreements issued during the six months ended June 30, 2020, representing potential shares and their weighted average grant date fair values by type follows (shares in thousands, fair value in dollars):
Six Months Ended June 30, 2020
SharesWeighted Average Grant Date Fair Value
Service-based SARs1,133  $15.73  
Service-based RSUs576  $44.36  
Market performance-based RSUs93  $39.83  
Operating performance-based RSUs93  $43.57  

Note 13. Income Taxes
Our effective income tax rate from continuing operations for the three and six months ended June 30, 2020 was (306.0)% and (78.0)% compared with 17.3% and 22.4% for the three and six months ended June 30, 2019, 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.
Compared with the three months ended June 30, 2019, the change in the effective tax rate for the three months ended June 30, 2020 was primarily attributable to a $70.0 million valuation allowance for the U.K. net operating losses and attributes, as compared to the establishment of a valuation allowance for a portion of the U.S. federal and state net operating losses during the three months ended June 30, 2019. These valuation allowances are a result of cumulative losses and the current forecast, including the extended impact of COVID-19, that it is more likely than not that we will be unable to realize the related historical deferred tax assets.
Compared with the six months ended June 30, 2019, the change in the effective tax rate for the six months ended June 30, 2020 was primarily attributable to a $42.9 million realized discrete tax benefit related to the Coronavirus Aid, Relief, and Economic Security Act (“CARES Act”) offset by the establishment of a $70.0 million valuation allowance for the U.K. net operating losses and attributes, as compared to a release of uncertain tax positions and other discrete tax items offset by the establishment of a valuation allowance for a portion of the U.S. federal and state net operating losses during the six months ended June 30, 2019.
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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 $12.9 million were unrecognized as of June 30, 2020 and December 31, 2019. It is reasonably possible that, within the next twelve months, due to the settlement of uncertain tax positions with various tax authorities and the expiration of statutes of limitations, unrecognized tax benefits could decrease by up to approximately $12.0 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 $42.9 million to account for the effect of the CARES Act during the six months ended June 30, 2020. Further regulations and notices as well as state legislative changes addressing conformity to the CARES Act are still pending.

Note 14. Earnings Per Share
Reconciliation of the shares used in the basic and diluted earnings per share computations for the three and six months ended June 30, 2020 and 2019 are as follows (in thousands):
Three Months Ended June 30,Six Months Ended June 30,
2020201920202019
Basic and diluted weighted average shares outstanding (1)
48,611  48,342  48,548  48,295  
(1)Excluded from the computation of diluted earnings per share were stock options, SARs and restricted share units totaling 4.2 million and 3.1 million for the three months ended June 30, 2020 and 2019, respectively, and 4.2 million and 3.2 million for the six months ended June 30, 2020 and 2019, respectively, because to include them would have been anti-dilutive under the treasury stock method.

Note 15. Geographic and 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 two reportable segments: Cardiovascular and Neuromodulation.
The Cardiovascular segment generates its revenue from the development, production and sale of cardiopulmonary 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, 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.
Our 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 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, and other accessories.
“Other” includes corporate shared service expenses for finance, legal, human resources, information technology and corporate business development.
Net sales of our reportable segments include 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.
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We operate under three geographic regions: U.S., Europe, and Rest of World. The table below presents net sales by operating segment and geographic region (in thousands):
Three Months Ended June 30,Six Months Ended June 30,
2020201920202019
Cardiopulmonary
United States$25,816  $41,403  $62,674  $80,526  
Europe23,294  34,320  57,528  69,881  
Rest of World51,946  54,856  97,221  101,742  
101,056  130,579  217,423  252,149  
Heart Valves
United States2,488  4,678  5,861  9,034  
Europe5,348  10,672  14,877  21,185  
Rest of World9,630  18,001  21,939  28,805  
17,466  33,351  42,677  59,024  
Advanced Circulatory Support
United States5,668  7,944  15,744  15,977  
Europe303  192  673  311  
Rest of World42  178  87  274  
6,013  8,314  16,504  16,562  
Cardiovascular
United States33,972  54,025  84,279  105,537  
Europe28,945  45,184  73,078  91,377  
Rest of World61,618  73,035  119,247  130,821  
124,535  172,244  276,604  327,735  
Neuromodulation
United States44,215  80,551  117,491  157,437  
Europe6,416  12,996  16,999  23,655  
Rest of World6,581  10,722  12,379  17,826  
57,212  104,269  146,869  198,918  
Other459  656  1,130  1,317  
Totals
United States78,187  134,576  201,770  262,974  
Europe (1)
35,361  58,180  90,077  115,032  
Rest of World68,658  84,413  132,756  149,964  
Total (2)
$182,206  $277,169  $424,603  $527,970  
(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.
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The table below presents a reconciliation of segment (loss) income from continuing operations to consolidated loss from continuing operations before tax (in thousands):
Three Months Ended June 30,Six Months Ended June 30,
2020201920202019
Cardiovascular $(9,407) $10,120  $(726) $11,109  
Neuromodulation 27,282  619  61,140  22,250  
Other(20,876) (25,677) (47,486) (53,976) 
Total reportable segment (loss) income from continuing operations(3,001) (14,938) 12,928  (20,617) 
Merger and integration expenses2,048  4,378  5,522  7,629  
Restructuring expenses794  1,332  2,374  3,865  
Amortization of intangibles9,394  9,228  19,661  18,544  
Operating loss from continuing operations(15,237) (29,876) (14,629) (50,655) 
Interest income287  224  435  473  
Interest expense(5,715) (4,054) (10,564) (5,716) 
Foreign exchange and other losses(999) (1,851) (2,913) (1,122) 
Loss from continuing operations before tax$(21,664) $(35,557) $(27,671) $(57,020) 
Assets by segment are as follows (in thousands):
June 30, 2020December 31, 2019
Cardiovascular$1,428,992  $1,546,520  
Neuromodulation 655,611  749,069  
Other418,060  116,208  
Total assets$2,502,663  $2,411,797  
Capital expenditures by segment are as follows (in thousands):
Three Months Ended June 30,Six Months Ended June 30,
2020201920202019
Cardiovascular$5,445  $4,835  $10,737  $8,386  
Neuromodulation 836  127  6,075  530  
Other364  951  2,207  1,880  
Total$6,645  $5,913  $19,019  $10,796  
The changes in the carrying amount of goodwill by segment for the six months ended June 30, 2020 were as follows (in thousands):
NeuromodulationCardiovascularTotal
December 31, 2019$398,754  $517,040  $915,794  
Foreign currency adjustments  (13,590) (13,590) 
June 30, 2020$398,754  $503,450  $902,204  
Property, plant and equipment, net by geography are as follows (in thousands):
June 30, 2020December 31, 2019
United States$64,628  $61,410  
Europe112,103  110,270  
Rest of World8,939  9,674  
Total$185,670  $181,354  
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Note 16. Supplemental Financial Information
Inventories, net consisted of the following (in thousands):
June 30, 2020December 31, 2019
Raw materials$47,384  $45,225  
Work-in-process17,810  14,581  
Finished goods112,052  104,348  
 $177,246  $164,154  
Inventories are reported net of the provision for obsolescence. This provision, which reflects normal obsolescence and includes components that are phased out or expired, totaled $13.6 million and $12.7 million at June 30, 2020 and December 31, 2019, respectively.
Accrued liabilities and other consisted of the following (in thousands):
June 30, 2020December 31, 2019
Legal and administrative costs$14,069  $11,066  
Contingent consideration (1)
13,884  22,953  
Operating lease liabilities11,135  11,110  
Contract liabilities9,432  6,728  
Research and development costs5,401  5,160  
Provisions for agents, returns and other3,729  3,922  
Derivative contract liabilities (2)
1,873  3,173  
Restructuring related liabilities (3)
1,808  4,315  
Product remediation (4)
1,533  3,251  
CRM purchase price adjustment payable to MicroPort Scientific Corporation  14,891  
Other accrued expenses34,374  33,531  
$97,238  $120,100  
(1)Refer to “Note 7. Fair Value Measurements”
(2)Refer to “ Note 9. Derivatives and Risk Management”
(3)Refer to “Note 4. Restructuring”
(4)Refer to “Note 5. Product Remediation Liability”
As of June 30, 2020 and December 31, 2019, contract liabilities of $11.2 million and $8.6 million, respectively, are included within accrued liabilities and other long-term liabilities on the condensed consolidated balance sheets.
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Note 17. New Accounting Pronouncements
Adoption of New Accounting Pronouncements
The following table provides a description of our adoption of new Accounting Standards Updates (“ASUs”) issued by the FASB and 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 accounting standards that may have an impact on our financial statements when adopted:
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.
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Item 2. Management’s Discussion and Analysis of Financial Condition and Results 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 2019 Form 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 2019 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 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 second quarter of 2020 were materially adversely impacted. We are beginning to see signs of stabilization in certain geographies as elective surgeries resume and expect this trend to continue on a global basis during the second half 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.
Further as a result of the impact of COVID-19, during the second quarter of 2020 the majority of our RECOVER clinical study sites and their corresponding surgical centers were completely closed. As a result of this, there were few new implants in our RECOVER clinical study during the quarter. Implants are expected to slowly return during the third quarter of 2020 as study sites and surgical centers reopen and resume more fully in the fourth quarter of 2020. We believe that new implants will continue to increase into 2021. In the current COVID-19 environment, we are remotely collaborating with study sites to continue certain activities that maintain engagement, including activating more sites for enrollment and also, identifying and consenting patients at existing sites. Additionally, we continue to perform follow-up visits for all patients who have been enrolled and implanted to date.
Additionally, our ANTHEM-HFrEF U.S. pivotal trial was temporarily paused in March due to COVID-19 after enrolling just over 200 patients. During the quarter, the team was able to re-initiate enrollment in more than half of the sites. We continue to focus on remote engagement to support patients, physicians, and sites.
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 projects and initiatives critical to meet the current needs
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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, 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 Cardiovascular and Neuromodulation, 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.
LivaNova is comprised of two reportable segments: Cardiovascular and Neuromodulation, corresponding to our primary therapeutic areas. Other corporate activities include corporate shared service expenses for finance, legal, human resources, information technology and corporate business 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.

Cardiovascular
Our Cardiovascular segment is engaged in the 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.
Product Remediation
On December 29, 2015, the FDA issued a Warning Letter alleging certain violations of FDA regulations applicable to medical device manufacturers at our Munich, Germany and Arvada, Colorado facilities and issued inspectional observations on FDA’s Form-483 applicable to our 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 informed us that the import alert was limited to the 3T devices, but that the agency reserved the right to expand the scope of the import alert if future circumstances warranted such action. The Warning Letter did not request that existing users cease using the 3T device, and manufacturing and shipment all of our products other than the 3T device were 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 were reasonably related would not be approved until the violations had been corrected; however, this restriction applied 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.
Product Liability
The Company is currently involved in litigation involving our 3T device. The litigation includes a class action complaint in the U.S. District Court for the Middle District of Pennsylvania, federal multi-district litigation in the U.S. District Court for the Middle District of Pennsylvania, various U.S. state court cases and cases in jurisdictions outside the U.S. The class action, filed in February 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. Members of the class seek declaratory relief that the 3T devices are defective and unsafe for intended uses, medical monitoring, damages, and attorneys’ fees. 
On March 29, 2019, we announced a settlement 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 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 provides 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 July 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 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.
At June 30, 2020, the provision for these matters was $49.0 million. While the amount accrued represents our best estimate, the actual liability for resolution of these matters may vary from our estimate.

Cardiopulmonary
In April 2020, the U.S. Food and Drug Administration issued temporary guidance that permitted several of our cardiopulmonary products to be used for Extracorporeal Membrane Oxygenation (“ECMO”) therapy greater than six hours to temporarily expand the availability of devices to address the COVID-19 pandemic. Product indications for use have been modified accordingly for many products within our Cardiopulmonary and Advanced Circulatory Support portfolios.
Also in 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 advanced Perceval Plus sutureless surgical aortic heart valve is available for commercial release in Europe, having successfully completed a one-year limited launch with initial real-world clinical data gathering. Building on the clinically proven experience with Perceval, this next-generation valve facilitates minimally invasive cardiac surgery and makes 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 drug-resistant epilepsy, DTD and obstructive sleep apnea. We are also developing and conducting clinical testing of the VITARIA System for treating heart failure through vagus nerve stimulation.
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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 ability 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 a more objective and multi-dimensional manner.
In March 2020, our VNS Therapy System, Symmetry received CE mark approval for DTD, and our first two patients outside the U.S. to receive Symmetry were implanted shortly thereafter.

Significant Accounting Policies and Critical Accounting Estimates 
In addition to our critical accounting policies provided in “Part II, Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations” included in our 2019 Form 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 17. New Accounting Pronouncements” contained in the condensed consolidated financial statements in this Quarterly Report on Form 10-Q.

Other
Brexit
On January 31, 2020, the UK departed from the EU (in a move commonly referred to as “Brexit”), and the UK will now enter 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 Brexit will depend on any agreements the UK makes to retain access to the EU markets, 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 operations.
Passage of the withdrawal bill does not change the application of existing tax laws and does not establish a clear framework for what the ultimate outcome of the transition 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 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.
We and several of our wholly owned subsidiaries that are domiciled either in the UK, various EU Member States, or in the 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 change materially, Brexit may have a material adverse impact on our future financial results and results of operations. We continue to monitor and assess the potential impact of this event and explore possible tax-planning strategies that may mitigate or eliminate potential adverse 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
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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 will 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 decision. We filed our 2018 tax return similarly, and therefore, we do not believe that the EU state aid decision will result in a material liability.

Results of Operations
The following table summarizes our condensed consolidated results of operations (in thousands):
Three Months Ended June 30,Six Months Ended June 30,
2020201920202019
Net sales$182,206  $277,169  $424,603  $527,970  
Costs and expenses:
Cost of sales - exclusive of amortization56,762  74,942  125,685  159,196  
Product remediation4,269  5,113  5,735  8,060  
Selling, general and administrative98,048  127,213  218,225  252,917  
Research and development25,152  34,544  61,054  78,119  
Merger and integration expenses2,048  4,378  5,522  7,629  
Restructuring expenses794  1,332  2,374  3,865  
Impairment of intangible assets—  50,295  —  50,295  
Amortization of intangibles9,394  9,228  19,661  18,544  
Litigation provision, net976  —  976  —  
Operating loss from continuing operations(15,237) (29,876) (14,629) (50,655) 
Interest income287  224  435  473  
Interest expense(5,715) (4,054) (10,564) (5,716) 
Foreign exchange and other losses(999) (1,851) (2,913) (1,122) 
Loss from continuing operations before tax(21,664) (35,557) (27,671) (57,020) 
Income tax expense (benefit)66,285  (6,164) 21,571  (12,778) 
Losses from equity method investments(44) —  (173) —  
Net loss from continuing operations(87,993) (29,393) (49,415) (44,242) 
Net income (loss) from discontinued operations, net of tax—  178  (995) 178  
Net loss$(87,993) $(29,215) $(50,410) $(44,064) 
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Net Sales
The table below presents net sales by operating segment and geographic region (in thousands, except for percentages):
Three Months Ended June 30,Six Months Ended June 30,
20202019% Change20202019% Change
Cardiopulmonary
United States$25,816  $41,403  (37.6)%$62,674  $80,526  (22.2)%
Europe23,294  34,320  (32.1)%57,528  69,881  (17.7)%
Rest of World51,946  54,856  (5.3)%97,221  101,742  (4.4)%
101,056  130,579  (22.6)%217,423  252,149  (13.8)%
Heart Valves
United States2,488  4,678  (46.8)%5,861  9,034  (35.1)%
Europe5,348  10,672  (49.9)%14,877  21,185  (29.8)%
Rest of World9,630  18,001  (46.5)%21,939  28,805  (23.8)%
17,466  33,351  (47.6)%42,677  59,024  (27.7)%
Advanced Circulatory Support
United States5,668  7,944  (28.7)%15,744  15,977  (1.5)%
Europe303  192  57.8 %673  311  116.4 %
Rest of World42  178  (76.4)%87  274  (68.2)%
6,013  8,314  (27.7)%16,504  16,562  (0.4)%
Cardiovascular
United States33,972  54,025  (37.1)%84,279  105,537  (20.1)%
Europe28,945  45,184  (35.9)%73,078  91,377  (20.0)%
Rest of World61,618  73,035  (15.6)%119,247  130,821  (8.8)%
124,535  172,244  (27.7)%276,604  327,735  (15.6)%
Neuromodulation
United States44,215  80,551  (45.1)%117,491  157,437  (25.4)%
Europe6,416  12,996  (50.6)%16,999  23,655  (28.1)%
Rest of World6,581  10,722  (38.6)%12,379  17,826  (30.6)%
57,212  104,269  (45.1)%146,869  198,918  (26.2)%
Other459  656  (30.0)%1,130  1,317  (14.2)%
Totals
United States78,187  134,576  (41.9)%201,770  262,974  (23.3)%
Europe (1)
35,361  58,180  (39.2)%90,077  115,032  (21.7)%
Rest of World68,658  84,413  (18.7)%132,756  149,964  (11.5)%
Total$182,206  $277,169  (34.3)%$424,603  $527,970  (19.6)%
(1)Europe sales include those countries in which we have a direct sales presence, whereas European countries in which we sell through distributors are included in “Rest of World.”
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The table below presents segment (loss) income from continuing operations (in thousands, except for percentages):
Three Months Ended June 30,Six Months Ended June 30,
20202019% Change20202019% Change
Cardiovascular$(9,407) $10,120  (193.0)%$(726) $11,109  (106.5)%
Neuromodulation 27,282  619  4,307.4 %61,140  22,250  174.8 %
Other(20,876) (25,677) (18.7)%(47,486) (53,976) (12.0)%
Total reportable segment (loss) income from continuing operations (1)
$(3,001) $(14,938) (79.9)%$12,928  $(20,617) (162.7)%
(1)For a reconciliation of segment (loss) income from continuing operations to loss 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
Cardiovascular net sales for the three and six months ended June 30, 2020 compared to the three and six months ended June 30, 2019 decreased 27.7% and 15.6%, respectively, largely due to the impact of COVID-19. The decline in net sales for the three and six month periods were due to declines in Cardiopulmonary sales of 22.6% and 13.8%. Cardiopulmonary sales of $101.1 million and $217.4 million for the three and six months ended June 30, 2020 were negatively impacted by declines in HLM and oxygenator sales and the impacts of foreign currency. 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 $17.5 million and $42.7 million for the three and six months ended June 30, 2020 declined by $15.9 million and $16.3 million, respectively, primarily due to declines in sales of Perceval and other tissue valves. Advanced Circulatory Support sales of $6.0 million for the three months ended June 30, 2020 were negatively impacted as customers delayed purchases anticipating the launch of the LifeSPARC system in the U.S during the third quarter of 2020.
Cardiovascular operating income for the three and six months ended June 30, 2020 compared to the three and six months ended June 30, 2019 decreased primarily related to a decline in net sales, as discussed above, partially offset by a decrease in 3T legal expenses.
Neuromodulation
Neuromodulation net sales for the three and six months ended June 30, 2020 compared to the three and six months ended June 30, 2019 decreased 45.1% and 26.2%, respectively. The decrease in net sales for the three and six months ended June 30, 2020 was primarily due to declines in implants globally as patients and physicians delayed implant procedures due to COVID-19.
Neuromodulation operating income for the three and six months ended June 30, 2020 increased compared to the three and six months ended June 30, 2019 due to a net reduction in the fair value of the contingent consideration liability associated with our obstructive sleep apnea business and a $50.3 million impairment of an IPR&D asset during the three and six months ended June 30, 2019, partially offset by overall declines in net sales.
Cost of Sales and Expenses
The table below presents our comparative cost of sales and significant expenses as a percentage of sales:
Three Months Ended June 30,Six Months Ended June 30,
20202019Change20202019Change
Cost of sales - exclusive of amortization31.2 %27.0 %4.2 %29.6 %30.2 %(0.6)%
Product remediation2.3 %1.8 %0.5 %1.4 %1.5 %(0.1)%
Selling, general and administrative53.8 %45.9 %7.9 %51.4 %47.9 %3.5 %
Research and development13.8 %12.5 %1.3 %14.4 %14.8 %(0.4)%
Merger and integration expenses1.1 %1.6 %(0.5)%1.3 %1.4 %(0.1)%
Restructuring expenses0.4 %0.5 %(0.1)%0.6 %0.7 %(0.1)%
Impairment of intangible assets— %18.1 %(18.1)%— %9.5 %(9.5)%
Amortization of intangibles5.2 %3.3 %1.9 %4.6 %3.5 %1.1 %
Litigation provision, net0.5 %— %0.5 %0.2 %— %0.2 %
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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 for the three months ended June 30, 2020 compared to the three months ended June 30, 2019 increased primarily due to product mix and unfavorable manufacturing variances due to the decline in demand resulting from COVID-19, partially offset by a decrease in cost of sales resulting from the net impact of the change in fair value of sales-based contingent consideration arrangements of $3.9 million.
Selling, General and Administrative
SG&A expenses consisted of sales, marketing, general and administrative activities. SG&A expenses as a percentage of net sales for the three and six months ended June 30, 2020 compared to the three and six months ended June 30, 2019 increased primarily due to a decline in net sales, partially offset by a decline in 3T legal expenses and cost containment actions.
Research and Development (“R&D”) Expenses
R&D expenses consist of product design and development efforts, clinical study programs and regulatory 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 for the three months ended June 30, 2020 compared to the three months ended June 30, 2019 increased primarily due to a decline in net sales, partially offset by a decrease in R&D expense associated with TMVR of $4.9 million, as well as a decrease in R&D expense resulting from the net impact of changes in fair value of milestone-based contingent consideration arrangements of $4.5 million and the impact of COVID-19 on our clinical studies.
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.
Amortization of Intangibles
Amortization of intangible assets consists primarily of the amortization of finite-lived intangible assets, primarily intellectual property and customer relationships. Amortization of intangibles increased for the six months ended June 30, 2020 compared to the six months ended June 30, 2019 primarily due to reclassifying the Advanced Circulatory Support IPR&D asset to developed technology upon receiving FDA approval of the LifeSPARC system during the third quarter of 2019 and commencing amortization.
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 earnings mix in various jurisdictions and the changes in tax laws, our consolidated effective income tax rate may vary substantially from one reporting period to another.
Our effective income tax rate from continuing operations for the three and six months ended June 30, 2020 was (306.0)% and (78.0)% compared with 17.3% and 22.4% for the three and six months ended June 30, 2019, 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.
Compared with the three months ended June 30, 2019, the change in the effective tax rate for the three months ended June 30, 2020 was primarily attributable to a $70.0 million valuation allowance for the U.K. net operating losses and attributes, as compared to the establishment of a valuation allowance for a portion of the U.S. federal and state net operating losses during the three months ended June 30, 2019. These valuation allowances are a result of cumulative losses and the current forecast, including the extended impact of COVID-19, that it is more likely than not that we will be unable to realize the related historical deferred tax assets.
Compared with the six months ended June 30, 2019, the change in the effective tax rate for the six months ended June 30, 2020 was primarily attributable to a $42.9 million realized discrete tax benefit related to the Coronavirus Aid, Relief, and Economic Security Act (“CARES Act”) offset by the establishment of a $70.0 million valuation allowance for the U.K. net
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operating losses and attributes, as compared to a release of uncertain tax positions and other discrete tax items offset by the establishment of a valuation allowance for a portion of the U.S. federal and state net operating losses during the six months ended June 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 $12.9 million were unrecognized as of June 30, 2020 and December 31, 2019. It is reasonably possible that, within the next twelve months, due to the settlement of uncertain tax positions with various tax authorities and the expiration of statutes of limitations, unrecognized tax benefits could decrease by up to approximately $12.0 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 $42.9 million to account for the effect of the CARES Act. Further regulations and notices as well as state legislative changes addressing conformity to the CARES Act are still pending.

Liquidity and Capital Resources
In June 2020, we raised combined net proceeds of $699.9 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 June 30, 2020, our cash and cash equivalents was $232.5 million.
Based on our current business plan, we believe that our existing cash and cash equivalents, future cash generated from operations and borrowing under our current debt facilities will be sufficient to fund our expected operating needs, working capital requirements, R&D opportunities, capital expenditures, and debt service requirements over the twelve-month period beginning from the issuance date of these condensed consolidated financial statements. Our liquidity could be adversely impacted by the factors affecting future operating results, including those referred to in “Part II, Item 1A. Risk Factors” in the 2019 Form 10-K as supplemented by the factors referred to in “Part II, Item 1A, Risk Factors” in our Quarterly Reports on Form 10-Q.
  No provision has been made for income taxes on unremitted earnings of our foreign controlled subsidiaries (non-UK subsidiaries) as of June 30, 2020. In the event of the distribution of those earnings in the form of dividends, a sale of the subsidiaries or certain other transactions, we may be liable for income taxes. However, the tax liability on future distributions should not be significant as most jurisdictions with unremitted earnings have various participation exemptions or no withholding tax.
Cash Flows
Net cash and cash equivalents provided by (used in) operating, investing and financing activities and the net increase (decrease) in the balance of cash and cash equivalents were as follows (in thousands):
Six Months Ended June 30,
 20202019
Operating activities$(125,064) $(17,421) 
Investing activities(22,666) (22,454) 
Financing activities319,697  37,057  
Effect of exchange rate changes on cash and cash equivalents(555) 125  
Net increase (decrease) in cash and cash equivalents$171,412  $(2,693) 
Operating Activities
Cash used in operating activities during the six months ended June 30, 2020 increased by $107.6 million as compared to the same prior-year period. The increase is primarily due to $122.2 million in 3T litigation settlement payments made during the six months ended June 30, 2020.
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Investing Activities
Cash used in investing activities during the six months ended June 30, 2020 increased $0.2 million as compared to the same prior-year period. The increase is primarily due to an increase in purchases of property, plant and equipment of $7.2 million and the purchase of an investment and loans to investees totaling $5.4 million, partially offset by $10.8 million in cash paid for acquisitions in 2019.
Financing Activities
Cash provided by financing activities during the six months ended June 30, 2020 increased $282.6 million as compared to the same prior-year period. The increase is primarily due to an increase in net borrowings and associated costs of $345.7 million, offset by the purchase of a capped call associated with our Notes of $43.1 million and a closing adjustment payment for the sale of our former CRM business of $14.9 million.
Off-Balance Sheet Arrangements
As of June 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 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,” and in our 2019 Form 10-K in “Part II, Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations” and “Part I, Item 1A. Risk Factors.” There have been no material changes from the information provided therein.

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 June 30, 2020. 
(b) Changes in Internal Control Over Financial Reporting
No 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 quarter ended June 30, 2020 that has materially affected, or is 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 10. Commitments and Contingencies” in our condensed consolidated financial statements included in this Quarterly Report on Form 10-Q. 

Item 1A. Risk Factors
There 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 in Part II Item 1A in our Quarterly Report on Form 10-Q for the period ended March 31, 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 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 second quarter of 2020 were materially adversely impacted. While we are beginning to see signs of stabilization in certain geographies as elective surgeries resume and expect this trend to continue on a global basis during the second half of 2020, recovery rates 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 would 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.
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. Additionally, 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.
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,
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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-Q.
Risks Related to our Term Loan and Notes
Paying amounts due in cash in respect of our outstanding Term Loan and Notes on interest payment dates, at maturity and upon exchange thereof will require a cash payment. We may not have sufficient cash flow from our business to pay when due, or raise the funds necessary to pay when due, amounts owed in respect of the Notes and Term Loan, which could adversely affect our business and results of operations.
The ability to make scheduled payments of interest on, and principal of, to satisfy exchanges for cash in respect of, and/or to refinance, our outstanding Notes and Term Loan depends on our future performance, which is subject to economic, financial, competitive and other factors beyond our control. If we are unable to generate enough cash flow to make payments on the Notes and Term Loan when due, we may be required to adopt one or more alternatives, such as selling assets or obtaining additional debt financing or equity capital on terms that may be onerous or highly dilutive. Our ability to refinance the Notes and Term Loan, which we may need to do in order to satisfy our obligations thereunder, will depend on the capital markets and our financial condition at such time. We may not be able to engage in any of these activities or engage in these activities on desirable terms, which could result in a default on the Notes and Term Loan.
The holders of the Notes have the right to require us to repurchase their Notes upon the occurrence of a fundamental change (as defined in the indenture governing the Notes (the “Indenture”)) at a repurchase price equal to 100% of the principal amount of the Notes to be repurchased, plus accrued and unpaid interest, if any. Upon repurchase of the Notes, we will be required to make cash payments in respect of the Notes being repurchased. In addition, upon a holder’s exchange of the Notes for cash in accordance with the terms of the Indenture, we would be required to make cash payments in respect of the Notes being exchanged in the manner set forth in the Indenture. We may not have enough available cash or be able to obtain financing at the time we are required to make repurchases of, or exchange of, the Notes for cash. Our failure to repurchase the Notes or exchange the Notes for cash at a time when the repurchase or exchange is required by the Indenture governing the Notes would constitute a default under such Indenture.
In addition, our indebtedness on the Notes and Term Loan, combined with our other financial obligations and contractual commitments, could have other important consequences. For example, it could:
Make us more vulnerable to adverse changes in government regulation and in the worldwide economic, industry and competitive environment;
Limit our flexibility in planning for, or reacting to, changes in our business and our industry;
Place us at a disadvantage compared to our competitors who have less debt;
Limit our ability to borrow additional amounts to fund acquisitions, for working capital and for other general corporate purposes; and
Make an acquisition of the Company less attractive or more difficult.
Any of these factors could harm our business, results of operations and financial condition. In addition, if we incur additional indebtedness, the risks related to our business and our ability to repay our indebtedness on the Notes and Term Loan would increase.
The conditional exchange features of the Notes and contingent embedded features of the Term Loan, when triggered, may adversely affect our liquidity and operating results.
If the conditional exchange feature of the Notes is triggered, holders of Notes are entitled to exchange the Notes at any time during specified periods, at their option. If holders elect to exchange their Notes during future periods following the satisfaction of an exchange condition, we would be required to settle our exchange obligation through the payment of cash, which could adversely affect our liquidity. In addition, if the contingent embedded features of the Term Loan are triggered, or if the Notes become redeemable due to the satisfaction of an exchange condition, then we could be required under applicable accounting
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rules to reclassify all or a portion of the outstanding principal amounts as a current rather than long-term liability, which would result in a material reduction of our net working capital.
Our debt instruments require us to comply with affirmative covenants and specified financial covenants and ratios.
Certain restrictions and covenants in our debt instruments could affect our ability to operate and may limit our ability to react to market conditions or to take advantage of potential business opportunities as they arise. For example, such restrictions could adversely affect our ability to finance our operations, make strategic acquisitions, investments or alliances, restructure our organization or finance capital needs. Additionally, our ability to comply with these covenants and restrictions may be affected by events beyond our control, such as prevailing economic, financial, regulatory and industry conditions. If any of these restrictions or covenants is breached, we could be in default under one or more of our debt instruments, which, if not cured or waived, could result in acceleration of the indebtedness under such agreements and cross defaults under our other debt instruments. Any such actions could result in the enforcement of our lenders’ security interests and/or force us into bankruptcy or liquidation, which could have a material adverse effect on our financial condition and results of operations.
The accounting for the Notes will result in LivaNova having to recognize interest expense significantly greater than the stated interest rates of the Notes and may result in volatility to our reported financial results, which could adversely affect the price at which our ordinary shares trade.
We will settle exchanges of the Notes entirely in cash. Accordingly, the exchange feature that is part of the Notes is accounted for as a derivative pursuant to accounting standards relating to derivative instruments. This resulted in an initial valuation of the exchange feature, which was bifurcated from the debt component of the Notes, resulting in an original issue discount. The original issue discount is amortized and recognized as a component of interest expense over the term of the Notes, which results in an effective interest rate reported in our consolidated statements of operations in excess of the stated interest rate of the Notes. Although this accounting treatment does not affect the amount of cash interest paid to holders of the Notes or our cash flows, it reduces our earnings and could adversely affect the price at which our ordinary shares trade.
Additionally, for each financial statement period after issuance of the Notes, a derivative gain or loss is and will be reported in our consolidated statements of income (loss) to the extent the valuation of the exchange feature changes from the previous period. The capped call transactions described below and elsewhere in this quarterly report are also accounted for as derivative instruments. The valuation of the exchange feature of the Notes and capped call transactions utilizes significant observable and unobservable market inputs, including stock price, stock price volatility, risk-free interest rate, and time to expiration of the Notes. The change of inputs at period end from the previous period may result in a material change of the valuation and the gain or loss resulting from the exchange feature of the Notes and capped call transactions may not completely offset each other. As such, there may be a material net impact to our consolidated statements of operations, which could adversely affect the price at which our ordinary shares trade.
The arbitrage or hedging strategy by purchasers of the Notes and Option Counterparties in connection with our capped call transactions may affect the value of our ordinary shares.
We expect that many investors in, and potential purchasers of the Notes will employ, or seek to employ, an arbitrage strategy with respect to the Notes. Investors would typically implement such a strategy by selling short our ordinary shares underlying the Notes and dynamically adjusting their short position while continuing to hold the Notes. Investors may also implement this type of strategy by entering into swaps on our ordinary shares in lieu of or in addition to selling short our ordinary shares. This activity could decrease (or reduce the size of any increase in) the market price of our ordinary shares at that time.
In connection with the pricing of the Notes, we entered into privately negotiated capped call transactions with certain financial institutions (the “Option Counterparties”). The capped call transactions are expected generally to offset cash payments due upon exchange of the Notes in excess of the principal amount thereof in the event that the market value per ordinary share of the Company is at the time of exchange of the Notes greater than the strike price under the capped call transactions, with such offset subject to a cap based on the cap price. We believe the Option Counterparties, in connection with establishing their initial hedges of the capped call transactions, purchased our ordinary shares and/or entered into various derivative transactions with respect to our ordinary shares concurrently with or shortly after the pricing of the Notes. The Option Counterparties may modify these initial hedge positions by entering into or unwinding various derivatives with respect to our ordinary shares and/or purchasing or selling our ordinary shares or other securities of ours in secondary market transactions prior to the maturity of the Notes (and are likely to do so during any observation period related to an exchange of the Notes or upon a repurchase or redemption of the Notes). This activity could cause an increase or decrease in the market price of our ordinary shares at that time.
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We are subject to counterparty risk with respect to the capped call transactions.
The Option Counterparties are financial institutions, and we are subject to the risk that they might default under the capped call transactions. Our exposure to the credit risk of the Option Counterparties is not secured by any collateral.
If an Option 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 Option Counterparty. Our exposure will depend on many factors but, generally, an increase in our exposure will be correlated to an increase in the market price and in the volatility of our ordinary shares. In addition, upon a default by an Option Counterparty, we may suffer adverse tax consequences and may, on a net basis, have to pay more cash to settle exchanges of the Notes. We can provide no assurances as to the financial stability or viability of the Option Counterparties.

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
None.

Item 3. Defaults Upon Senior Securities
None.

Item 4. Mine Safety Disclosures
Not applicable.

Item 5. Other Information
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 $3.5 million and $1.3 million for the three months ended June 30, 2020, respectively, and $4.0 million and $1.5 million for the six months ended June 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
Amended Articles of Association
Indenture, dated as of June 17, 2020, among LivaNova USA, Inc., as Issuer, LivaNova PLC, as Guarantor, and Citibank, N.A., as Trustee., incorporated by reference to Exhibit 4.1 of the Company’s Current Report on Form 8-K, filed on June 17, 2020.
Form of 3.00% Cash Exchangeable Senior Notes due 2025 (included in Exhibit 4.1)
Roy Khoury Confirmation Letter as President International Commercial and SVP, Global Strategic Marketing
Marco Dolci Confirmation Letter as SVP Global Operations & Global Research and Development
Amendment Letter, dated April 9, 2020, among LivaNova PLC and Barclays Bank PLC, as Agent, incorporated by reference to Exhibit 10.1 of the Company’s Current Report on Form 8-K, filed on April 27, 2020
Amendment Letter, dated April 23, 2020, among LivaNova PLC and Barclays Bank PLC, as Agent, incorporated by reference to Exhibit 10.2 of the Company’s Current Report on Form 8-K, filed on April 27, 2020
Amendment Letter, dated April 17, 2020, among LivaNova PLC and Banca Nazionale del Lavoro S.p.A., as Original Lender, incorporated by reference to Exhibit 10.3 of the Company’s Current Report on Form 8-K, filed on April 27, 2020
Amendment Letter, dated April 21, 2020, among LivaNova PLC and Banca Nazionale del Lavoro S.p.A., as Original Lender, incorporated by reference to Exhibit 10.4 of the Company’s Current Report on Form 8-K, filed on April 27, 2020
Amendment to Finance Contract 83.445 and Finance Contract 86.677, dated April 21, 2020, among LivaNova PLC, Sorin Group Italia S.r.l. and the European Investment Bank, incorporated by reference to Exhibit 10.6 of the Company’s Current Report on Form 8-K, filed on April 27, 2020
Credit Agreement, dated as of June 10, 2020 , among LivaNova USA, Inc., as Borrower, the Company, as Guarantor, the several lenders from time to time parties thereto, Ares Capital Corporation, as Administrative Agent, and Ares Capital Corporation, as Collateral Agent incorporated by reference to Exhibit 10.1 of the Company’s Current Report on Form 8-K, filed on June 11, 2020
Form of Capped Call Confirmation, incorporated by reference to Exhibit 10.1 of the Company’s Current Report on Form 8-K, filed on June 17, 2020
Amendment to Outstanding 2019 and 2020 Restricted Stock Unit Awards under the LivaNova PLC 2015 Incentive Award Plan, dated June 15, 2020
Amendment to Outstanding 2018 Restricted Stock Unit Awards under the LivaNova PLC 2015 Incentive Award Plan dated June 15, 2020
Amendment to Outstanding 2018, 2019 and 2020 Performance Stock Unit Awards under the LivaNova PLC 2015 Incentive Award Plan, dated June 15, 2020
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 six months ended June 30, 2020 and June 30, 2019, (ii) the Condensed Consolidated Statements of Comprehensive Income (Loss) for the three and six months ended June 30, 2020 and June 30, 2019, (iii) the Condensed Consolidated Balance Sheet as of June 30, 2020 and December 31, 2019, (iv) the Condensed Consolidated Statements of Cash Flows for the six months ended June 30 2020 and June 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)
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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: July 29, 2020By:/s/ DAMIEN MCDONALD
 Damien McDonald
  Chief Executive Officer
  (Principal Executive Officer)
 LIVANOVA PLC
   
Date: July 29, 2020By:/s/ THAD HUSTON
 Thad Huston
  Chief Financial Officer
  (Principal Financial Officer)
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