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, 20222023
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
lnlogomain280x78.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 shareLIVNThe NASDAQ Stock Market LLC
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, 202221, 2023
Ordinary Shares - £1.00 par value per share53,545,73353,882,976



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



2


DEFINITIONS
In this Quarterly Report on Form 10-Q “LivaNova,”for the quarter ended June 30, 2023 (this “Report”), the following terms and abbreviations have the meanings listed below. “LivaNova” and “the Company,” “we,” “us” and “our”Company” refer to LivaNova PLC and its consolidated subsidiaries.
AbbreviationDefinition
2015 PlanLivaNova PLC 2015 Incentive Award Plan
2022 Form 10-KLivaNova PLC’s Annual Report on Form 10-K for the year ended December 31, 2022, filed with the SEC on February 27, 2023
2022 PlanLivaNova PLC 2022 Incentive Award Plan
ACSAdvanced Circulatory Support
ALungALung Technologies, Inc.
AOCIAccumulated other comprehensive income
A&R 2022 PlanAmended and Restated LivaNova PLC 2022 Incentive Award Plan
BEPSBase Erosion and Profit Shifting
Bridge Loan FacilityIncremental Facility Amendment No. 1 to the 2021 First Lien Credit Agreement, relating to a €200 million bridge loan facility, dated February 24, 2022, and repaid on July 6, 2022
CEOChief Executive Officer
CFOChief Financial Officer
CMSU.S. Centers for Medicare & Medicaid Services
Court of AppealCourt of Appeal in Milan
Delayed Draw Term Facility$50 million delayed draw term facility under the 2021 First Lien Credit Agreement resulting from the Incremental Facility Amendment No. 2
DREDrug-resistant epilepsy
DTDDifficult-to-treat depression
ECJEuropean Court of Justice
Exchange ActU.S. Securities Exchange Act of 1934, as amended
ECMOExtracorporeal membrane oxygenation
FDAU.S. Food and Drug Administration
FXForeign currency exchange rate
Hemolung RASHemolung Respiratory Assist System
ImTheraImThera Medical, Inc., acquired by LivaNova in 2018, a company developing an implantable neurostimulation device system for the treatment of obstructive sleep apnea
Incremental Facility Amendment No. 2An incremental facility amendment to the 2021 First Lien Credit Agreement, dated July 6, 2022
Initial Term Facility$300 million term facility under the 2021 First Lien Credit Agreement resulting from the Incremental Facility Amendment No. 2
ISINSub-body of the Italian Ministry of Economic Development
LivaNova USALivaNova USA, Inc.
LSMLivaNova Site Management S.r.l.
MDLFederal multi-district litigation in the U.S. District Court for the Middle District of Pennsylvania
MitralMitral Holdco S.à r.l.
Notes$287.5 million aggregate principal amount of 3.00% senior notes due December 2025, issued June 17, 2020
OCIOther comprehensive income (loss)
OECDOrganisation for Economic Co-operation and Development
OrderAdministrative order
OSAObstructive sleep apnea
OSPREY clinical trialLivaNova’s clinical trial, “Treating Obstructive Sleep Apnea using Targeted Hypoglossal Neurostimulation”
Public AdministrationsThe Italian Ministry of the Environment and other Italian government agencies
3


AbbreviationDefinition
R&DResearch and Development
RECOVER clinical studyLivaNova’s clinical study “A Prospective, Multi-center, Randomized Controlled Blinded Trial Demonstrating the Safety and Effectiveness of VNS Therapy System as Adjunctive Therapy Versus a No Stimulation Control in Subjects With Treatment-Resistant Depression”
RSUsService-based restricted stock units
SARsService-based stock appreciation rights
SECU.S. Securities and Exchange Commission
Securities ActU.S. Securities Act of 1933, as amended
SG&ASelling, general and administrative expense
SNIASNIA S.p.A.
SNIA Litigation GuaranteeA first demand bank guarantee of €270.0 million in connection with the SNIA litigation
SOFRSecured Overnight Financing Rate
Sorin spin-offThe spin-off of Sorin from SNIA in 2004
Term FacilitiesThe Initial Term Facility, together with the Delayed Draw Term Facility
UKUnited Kingdom
UK ActFinance (No.2) Act 2023
U.S.United States of America
U.S. GAAPGenerally Accepted Accounting Principles in the U.S.
USDU.S. dollar
VNSVagus nerve stimulation

INTELLECTUAL PROPERTY, TRADEMARKS AND TRADE NAMES
This report may contain references to ourLivaNova’s proprietary intellectual property, including among others:
Trademarks for ourLivaNova’s Neuromodulation systems, the VNS Therapy System, the VITARIA System and ourLivaNova’s proprietary pulse generator products: Model 102 (Pulse), Model 102R (Pulse Duo), Model 103 (Demipulse), Model 104 (Demipulse Duo), Model 106 (AspireSR), Model 1000 (SenTiva), Model 1000-D (SenTiva Duo), Model 7103 (VITARIA and TitrationAssist) and Model 8103 (Symmetry).
Trademarks for ourLivaNova’s Cardiopulmonary products and systems: Essenz™, S5, S3, S5 Pro™, B-Capta, Inspire, Heartlink, XTRA, 3T Heater-Cooler, Connect™ and Revolution.
Trademarks for ourLivaNova’s advanced circulatory support systems: TandemLife, TandemHeart, TandemLung, ProtekDuo™, LifeSPARC™, ALung™, Hemolung™, Respiratory Dialysis™ and ActivMix™.
Trademarks for ourLivaNova’s obstructive sleep apnea system: ImThera and aura6000.
These trademarks and trade names are the property of LivaNova or the property of ourLivaNova’s consolidated subsidiaries and are protected under applicable intellectual property laws. Solely for convenience, ourLivaNova’s trademarks and trade names referred to in this Quarterly Report on Form 10-Q may appear without the symbol, but such references are not intended to indicate in any way that wethe Company will not assert, to the fullest extent under applicable law, ourLivaNova’s rights to these trademarks and trade names.

24


CAUTIONARY NOTE ABOUT FORWARD-LOOKING STATEMENTS
Certain statements in this Quarterly Report on Form 10-Q, other than purelystatements of historical information,or current fact, 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”).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, ourthe Company’s actual financial results, performance, achievements or prospects may differ materially from those expressed or implied by these forward-looking statements. In some cases,Generally, 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 ourthe Company’s control, that could cause ourthe Company’s 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 following risks and uncertainties summarized below:
uncertainties: risks related to reductions, interruptions or increasing costs related to the supply of raw materials and components and the distribution of finished products, including as a result of inflation, war and war;
extreme weather; volatility in the global market and worldwide economic conditions, including volatilityas caused by the invasion of Ukraine, inflation, foreign exchange fluctuations, changes to existing trade agreements and relationships between the U.S. and other countries including the implementation of sanctions;
risks relating to the outbreak and spread of COVID-19 and its variants around the world, including market volatility, reductions in business operations and reduction in medical procedures;
non-U.S. operational and economic risks and concerns including the effect of changes in foreign exchange rates on quarterly operating results;
failure to retain key personnel, prevent labor shortages, or manage labor costs;
changes in technology, including the development of superior or alternative technology or devices by competitors and/or competition from providers of alternative medical therapies;
losses failure to obtain approvals or costs from pending,reimbursement in relation to the Company’s products; failure to establish, expand or future lawsuits and governmental investigations, including any amountmaintain market acceptance of liability or damages imposed by the Appeals Court orCompany’s products for the Supreme Courttreatment of Italy with respect to SNIA S.p.A.;
the Company’s approved indications; failure to develop and commercialize new products and the rate and degree of market acceptance of such products;
unfavorable results from clinical studies or failure to obtain approvals or maintain the current regulatory approvals for our products’ approved indications;
meet milestones; failure to comply with, or changes in, laws, regulations or administrative practices affecting government regulation of our products, including, but not limitedthe Company’s products; risks relating to U.S. Food and Drug Administration (“FDA”) laws and regulations;
recalls, enforcement actions or product liability claims; changes or reduction in customer spending patterns;
failure to establish, expand or maintain market acceptance of our productsreimbursement 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 ourCompany’s 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 obtain or maintain coverage and reimbursement for our products’ approved indications and risks related to cost containment efforts of healthcare purchasing organizations;
unfavorable results from clinical studies or failure to meet milestones;
riskscomply with rules relating to our indebtedness under the exchangeable senior notes, our revolving credit facilityreimbursement of healthcare goods and our 2022 Term Facilities, as defined herein;
effectiveness of our internal controls over financial reporting;
3


changes in our profitability and/or failure to manage costs and expenses;
fluctuations in future quarterly operating results and/or variations in sales and operating expenses relative to estimates;
services; cyber-attacks or other disruptions to ourthe Company’s information technology systems;
systems or those of third parties with which the Company interacts; costs of complying with privacy and security of personal information requirements and laws; failure to comply with anti-bribery laws; risks associated with environmental laws and regulations as well as environmental liabilities, violations, protest voting and litigation; losses or costs from pending or future lawsuits and governmental investigations, including in the case of the Company’s 3T Heater-Cooler and SNIA litigations; 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;
failure to complyretain key personnel, prevent labor shortages, or manage labor costs; the failure of the Company’s R&D efforts to keep up with applicable U.S. laws and regulations, including federal and state privacy and security laws and regulations, and applicable non-U.S. laws and regulations;
harsh weather or natural disasters, including as a resultthe rapid pace of technological development in the medical device industry; the impact of climate change that interrupt our business operations orand the business operationsrisk of our hospital-customers orenvironmental, social and governance pressures from internal and external stakeholders; the risk of quality concerns and the impacts thereof; failure to comply with evolving environmental laws;
protect the Company’s proprietary intellectual property; the potential loss of funds resulting from recent and potential future bank failures; failure of new acquisitions to further ourthe Company’s strategic objectives or strengthen ourthe Company’s existing businesses;
the potential for impairments of intangible assets and goodwill; risks relating to the Company’s indebtedness including under the exchangeable senior notes, the Company’s revolving credit facility and the Company’s 2022 Term Facilities, as defined herein; effectiveness of the Company’s internal controls over financial reporting; changes in the Company’s profitability and/or failure to manage costs and expenses; fluctuations in future quarterly operating results and/or variations in revenue and operating expenses relative to estimates; changes in tax laws and regulations, including exposure to additional income tax liabilities;
changes in our common stock price; and
activist investors causing disruptions to other unknown or unpredictable factors that could harm the business.Company’s financial performance.
Other factors that could cause ourLivaNova’s actual results to differ from our projected results are described in (1) “Part II, Item 1A. Risk Factors” and elsewhere in this and ourthe Company’s other Quarterly Reports on Form 10-Q, (2) our Annual Report onthe Company’s 2022 Form 10-K, for(3) the fiscal year ended December 31, 2021 (“2021 Form 10-K”), (3) ourCompany’s reports and registration statements filed and furnished from time to time with the Securities and Exchange Commission (“SEC”)SEC and (4) other announcements we makeLivaNova makes from time to time.
5


Readers are cautioned not to place undue reliance on ourthe Company’s forward-looking statements, which speak only as of the date hereof. We undertakeThe Company undertakes 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 ourthe Company’s unaudited condensed consolidated financial statements and related notes included elsewhere in this report. Operating results for the six months ended June 30, 20222023 are not necessarily indicative of future results, including the full fiscal year. You should also refer to ourthe Company’s “Annual Consolidated Financial Statements,” “Notes” thereto, “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and “Risk Factors” contained in our 2021LivaNova’s 2022 Form 10-K and in ourthe Company’s 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”). GAAP. The reporting currency of ourthe Company’s condensed consolidated financial statements is U.S. dollars.


USD.
46


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,Three Months Ended June 30,Six Months Ended June 30,
2022
2021 (1)
2022
2021 (1)
2023202220232022
Net sales$254,151 $264,483 $494,326 $512,086 
Net revenueNet revenue$293,882 $254,151 $557,300 $494,326 
Cost of salesCost of sales69,801 92,204 141,533 176,399 Cost of sales88,685 69,801 178,020 141,533 
Gross profitGross profit184,350 172,279 352,793 335,687 Gross profit205,197 184,350 379,280 352,793 
Operating expenses:Operating expenses:Operating expenses:
Selling, general and administrativeSelling, general and administrative116,482 122,748 235,007 238,429 Selling, general and administrative125,872 116,482 250,001 235,007 
Research and developmentResearch and development34,229 52,557 75,147 97,182 Research and development51,124 34,229 101,110 75,147 
Other operating expenses1,883 33,236 1,378 42,036 
Operating income (loss)31,756 (36,262)41,261 (41,960)
Other operating expenseOther operating expense10,825 1,883 13,135 1,378 
Operating incomeOperating income17,376 31,756 15,034 41,261 
Interest expenseInterest expense(14,388)(16,515)(22,228)(32,451)Interest expense(14,809)(14,388)(28,246)(22,228)
Foreign exchange and other income/(expense)Foreign exchange and other income/(expense)1,633 239 5,537 (6,204)Foreign exchange and other income/(expense)2,713 1,633 28,260 5,537 
Income (loss) before tax19,001 (52,538)24,570 (80,615)
Income before taxIncome before tax5,280 19,001 15,048 24,570 
Income tax expenseIncome tax expense2,515 3,908 5,052 6,552 Income tax expense4,097 2,515 6,468 5,052 
Losses from equity method investmentsLosses from equity method investments(42)(41)(81)(81)Losses from equity method investments(28)(42)(55)(81)
Net income (loss)$16,444 $(56,487)$19,437 $(87,248)
Net incomeNet income$1,155 $16,444 $8,525 $19,437 
Basic income per shareBasic income per share$0.02 $0.31 $0.16 $0.36 
Diluted income per shareDiluted income per share$0.02 $0.30 $0.16 $0.36 
Basic income (loss) per share$0.31 $(1.15)$0.36 $(1.79)
Diluted income (loss) per share$0.30 $(1.15)$0.36 $(1.79)
Shares used in computing basic income (loss) per share53,506 48,928 53,420 48,833 
Shares used in computing diluted income (loss) per share54,080 48,928 54,144 48,833 
Shares used in computing basic income per shareShares used in computing basic income per share53,803 53,506 53,713 53,420 
Shares used in computing diluted income per shareShares used in computing diluted income per share53,977 54,080 53,942 54,144 
(1)The condensed consolidated statements of income (loss) for the three and six months ended June 30, 2021 have been revised. For further details refer to “Note 1. Unaudited Condensed Consolidated Financial Statements.”
See accompanying notes to the condensed consolidated financial statements
5


LIVANOVA PLC AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OFCOMPREHENSIVE INCOME (LOSS)
(UNAUDITED)
(In thousands)
Three Months Ended June 30,Six Months Ended June 30,
2022
2021 (1)
2022
2021 (1)
Net income (loss)$16,444 $(56,487)$19,437 $(87,248)
Other comprehensive (loss) income:
Net change in unrealized loss on derivatives(1,232)(1,250)(1,927)(1,585)
Tax effect— 42 — 381 
Net of tax(1,232)(1,208)(1,927)(1,204)
Foreign currency translation adjustment(37,506)22,345 (45,766)(3,530)
Total other comprehensive (loss) income(38,738)21,137 (47,693)(4,734)
Total comprehensive loss$(22,294)$(35,350)$(28,256)$(91,982)
(1)The condensed consolidated statements of comprehensive income (loss) for the three and six months ended June 30, 2021 have been revised. For further details refer to “Note 1. Unaudited Condensed Consolidated Financial Statements.”
See accompanying notes to the condensed consolidated financial statements
6


LIVANOVA PLC AND SUBSIDIARIES
CONDENSED CONSOLIDATEDBALANCE SHEETS
(UNAUDITED)
(In thousands, except share amounts)
 June 30, 2022December 31, 2021
ASSETS
Current Assets:
Cash and cash equivalents$109,022 $207,992 
Restricted cash297,747 — 
Accounts receivable, net of allowance of $13,109 at June 30, 2022 and $13,512 at December 31, 2021176,949 185,354 
Inventories119,415 105,840 
Prepaid and refundable taxes30,917 37,621 
Current derivative assets2,520 106,629 
Prepaid expenses and other current assets35,357 35,745 
Total Current Assets771,927 679,181 
Property, plant and equipment, net143,312 150,066 
Goodwill898,070 899,525 
Intangible assets, net389,379 399,682 
Operating lease assets38,419 40,600 
Investments13,965 16,598 
Deferred tax assets2,422 2,197 
Long-term derivative assets61,608 — 
Other assets17,143 13,102 
Total Assets$2,336,245 $2,200,951 
LIABILITIES AND STOCKHOLDERS' EQUITY
Current Liabilities:
Current debt obligations$6,240 $229,673 
Accounts payable74,346 68,000 
Accrued liabilities and other83,952 88,937 
Current derivative liabilities3,232 183,109 
Current litigation provision liability30,960 32,845 
Taxes payable14,891 15,140 
Accrued employee compensation and related benefits50,272 79,266 
Total Current Liabilities263,893 696,970 
Long-term debt obligations459,792 9,849 
Contingent consideration91,840 86,830 
Deferred tax liabilities7,661 7,728 
Long-term operating lease liabilities31,857 35,919 
Long-term employee compensation and related benefits17,917 19,105 
Long-term derivative liabilities134,090 — 
Other long-term liabilities47,192 49,905 
Total Liabilities1,054,242 906,306 
Commitments and contingencies (Note 8)00
Stockholders’ Equity:
Ordinary Shares, £1.00 par value: unlimited shares authorized; 53,810,418 shares issued and 53,506,408 shares outstanding at June 30, 2022; 53,761,510 shares issued and 53,263,297 shares outstanding at December 31, 202182,359 82,295 
Additional paid-in capital2,133,258 2,117,961 
Accumulated other comprehensive loss(54,870)(7,177)
Accumulated deficit(878,347)(897,784)
Treasury stock at cost, 304,010 ordinary shares at June 30, 2022; 498,213 ordinary shares at December 31, 2021(397)(650)
Total Stockholders’ Equity1,282,003 1,294,645 
Total Liabilities and Stockholders’ Equity$2,336,245 $2,200,951 
See accompanying notes to the condensed consolidated financial statements
7


LIVANOVA PLC AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWSCOMPREHENSIVE INCOME (LOSS)
(UNAUDITED)
(In thousands)
Six Months Ended June 30,
2022
2021 (1)
Operating Activities:
Net income (loss)$19,437 $(87,248)
Non-cash items included in net income (loss):
Remeasurement of contingent consideration to fair value(27,359)10,746 
Stock-based compensation21,765 19,452 
Amortization12,917 13,353 
Amortization of debt issuance costs11,721 8,989 
Depreciation11,096 12,256 
Remeasurement of derivative instruments(5,098)13,191 
Amortization of operating lease assets4,939 8,947 
Remeasurement of Respicardia investment and loan— (4,640)
Deferred tax expense645 913 
Other1,342 1,356 
Changes in operating assets and liabilities:
Accounts receivable, net(875)(4,664)
Inventories(16,461)3,897 
Other current and non-current assets2,846 18,786 
Accounts payable and accrued current and non-current liabilities(19,387)3,558 
Taxes payable116 2,491 
Litigation provision liability(2,064)23,728 
Net cash provided by operating activities15,580 45,111 
Investing Activities:
Purchases of property, plant and equipment(11,342)(14,622)
Acquisition, net of cash acquired(8,857)— 
Purchase of investments(781)(2,097)
Proceeds from sale of Heart Valves, net of cash disposed— 41,759 
Proceeds from sale of Respicardia investment and loan— 23,057 
Other(650)(1,382)
Net cash (used in) provided by investing activities(21,630)46,715 
Financing Activities:
Proceeds from long-term debt obligations218,342 — 
Shares repurchased from employees for minimum tax withholding(8,223)(11,072)
Payment of debt issuance costs(2,861)(376)
Proceeds from share issuances under ESPP1,788 1,750 
Payment of contingent consideration— (4,387)
Repayment of long-term debt obligations(784)(1,287)
Other295 1,285 
Net cash provided by (used in) financing activities208,557 (14,087)
Effect of exchange rate changes on cash, cash equivalents and restricted cash(3,730)(1,185)
Net increase in cash, cash equivalents and restricted cash198,777 76,554 
Cash, cash equivalents and restricted cash at beginning of period207,992 252,832 
Cash, cash equivalents and restricted cash at end of period$406,769 $329,386 
Three Months Ended June 30,Six Months Ended June 30,
2023202220232022
Net income$1,155 $16,444 $8,525 $19,437 
Other comprehensive income (loss):
Net change in unrealized loss on derivatives— (1,232)(966)(1,927)
Tax effect— — — — 
Net of tax— (1,232)(966)(1,927)
Foreign currency translation adjustment5,453 (37,506)13,506 (45,766)
Total other comprehensive income (loss)5,453 (38,738)12,540 (47,693)
Total comprehensive income (loss)$6,608 $(22,294)$21,065 $(28,256)
(1)The condensed consolidated statement of cash flows for the three and six months ended June 30, 2021 have been revised. For further details refer to “Note 1. Unaudited Condensed Consolidated Financial Statements.”
See accompanying notes to the condensed consolidated financial statements
8


LIVANOVA PLC AND SUBSIDIARIES
CONDENSED CONSOLIDATEDBALANCE SHEETS
(UNAUDITED)
(In thousands, except share amounts)
 June 30, 2023December 31, 2022
ASSETS
Current Assets:
Cash and cash equivalents$222,935 $214,172 
Restricted cash311,425 301,446 
Accounts receivable, net of allowance of $11,610 at June 30, 2023 and $11,862 at December 31, 2022185,881 183,110 
Inventories156,446 129,379 
Prepaid and refundable taxes26,302 31,708 
Prepaid expenses and other current assets38,846 26,321 
Total Current Assets941,835 886,136 
Property, plant and equipment, net149,568 147,187 
Goodwill779,212 768,787 
Intangible assets, net357,420 368,559 
Operating lease assets34,169 35,830 
Investments21,726 16,266 
Deferred tax assets2,113 1,384 
Long-term derivative assets42,034 54,393 
Other assets13,478 16,231 
Total Assets$2,341,555 $2,294,773 
LIABILITIES AND STOCKHOLDERS' EQUITY
Current Liabilities:
Current debt obligations$19,074 $23,434 
Accounts payable78,212 74,310 
Accrued liabilities and other82,038 81,481 
Current litigation provision liability22,352 29,481 
Taxes payable19,842 16,505 
Accrued employee compensation and related benefits66,646 72,187 
Total Current Liabilities288,164 297,398 
Long-term debt obligations567,951 518,067 
Contingent consideration92,626 85,292 
Deferred tax liabilities8,924 8,516 
Long-term operating lease liabilities27,229 29,548 
Long-term employee compensation and related benefits16,720 16,804 
Long-term derivative liabilities53,705 85,675 
Other long-term liabilities45,628 45,849 
Total Liabilities1,100,947 1,087,149 
Commitments and contingencies (Note 7)
Stockholders’ Equity:
Ordinary Shares, £1.00 par value: unlimited shares authorized; 53,903,564 shares issued and 53,830,387 shares outstanding at June 30, 2023; 53,851,979 shares issued and 53,564,664 shares outstanding at December 31, 202282,441 82,424 
Additional paid-in capital2,169,346 2,157,724 
Accumulated other comprehensive loss(35,579)(48,119)
Accumulated deficit(975,505)(984,030)
Treasury stock at cost, 73,177 ordinary shares at June 30, 2023; 287,315 ordinary shares at December 31, 2022(95)(375)
Total Stockholders’ Equity1,240,608 1,207,624 
Total Liabilities and Stockholders’ Equity$2,341,555 $2,294,773 
See accompanying notes to the condensed consolidated financial statements
9


LIVANOVA PLC AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OFCASH FLOWS
(UNAUDITED)
(In thousands)
Six Months Ended June 30,
20232022
Operating Activities:
Net income$8,525 $19,437 
Adjustments to reconcile net income to net cash provided by operating activities:
Remeasurement of derivative instruments(25,332)(5,098)
Stock-based compensation16,290 21,765 
Amortization12,747 12,917 
Depreciation12,040 11,096 
Amortization of debt issuance costs9,535 11,721 
Remeasurement of contingent consideration to fair value7,334 (27,359)
Amortization of operating lease assets5,107 4,939 
Other198 1,987 
Changes in operating assets and liabilities:
Accounts receivable, net(707)(875)
Inventories(25,439)(16,461)
Other current and non-current assets(8,321)2,846 
Accounts payable and accrued current and non-current liabilities(4,638)(19,387)
Taxes payable2,738 116 
Litigation provision liability(7,257)(2,064)
Net cash provided by operating activities2,820 15,580 
Investing Activities:
Purchases of property, plant and equipment(13,344)(11,342)
Purchase of investments(5,409)(781)
Acquisition, net of cash acquired— (8,857)
Other614 (650)
Net cash used in investing activities(18,139)(21,630)
Financing Activities:
Proceeds from long-term debt obligations50,000 218,342 
Repayment of long-term debt obligations(11,808)(784)
Shares repurchased from employees for minimum tax withholding(5,841)(8,223)
Repayments of short-term borrowings (maturities greater than 90 days)(1,974)— 
Proceeds from share issuances under ESPP589 1,788 
Payment of debt issuance costs— (2,861)
Other(187)295 
Net cash provided by financing activities30,779 208,557 
Effect of exchange rate changes on cash, cash equivalents and restricted cash3,282 (3,730)
Net increase in cash, cash equivalents and restricted cash18,742 198,777 
Cash, cash equivalents and restricted cash at beginning of period515,618 207,992 
Cash, cash equivalents and restricted cash at end of period$534,360 $406,769 
See accompanying notes to the condensed consolidated financial statements
10


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, 20222023 and 2021,2022, 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, 20212022 has been derived from audited financial statements contained in our 2021LivaNova’s 2022 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 considered necessary for a fair statement of the operating results of LivaNova and its subsidiaries for the three and six months ended June 30, 2022,2023 and are not necessarily indicative of the results that may be expected for the year ending December 31, 2022.2023. The financial information presented herein should be read in conjunction with the audited consolidated financial statements and notes thereto accompanying our 2021LivaNova’s 2022 Form 10-K.
Global Developments
COVID-19Macroeconomic Environment
The COVID-19 pandemic (“COVID-19”) and its effects on the economy, employment, patient behaviors andcurrent macroeconomic environment, including foreign exchange volatility, supply chain among others,challenges, inflationary pressures, and geopolitical instability, has causedimpacted and may continue to cause variable demand for our products. Throughout the pandemic, healthcare customers have diverted medical resources and priorities towards the treatment of COVID-19, and public health bodies have delayed elective procedures, which has negatively impacted the usage of our products. Further, some people have avoided seeking treatment for non-COVID-19 procedures, and hospitals and clinics have experienced staffing shortages, which has negatively impacted the demand for our products. While the recovery of global cardiopulmonary procedures has resulted in stronger demand for our Cardiopulmonary products, our Neuromodulation business continues to experience ongoing COVID-19 related headwinds as described above. Our Advanced Circulatory Support (“ACS”) business has been similarly negatively impacted by a reduction in patients treated with extracorporeal membrane oxygenation (“ECMO”) related to fewer severe COVID-19 cases and hospital staffing challenges. We are monitoring the potential for various strains of the virus to cause a resumption of high levels of infection and hospitalization that, in turn, may affect the demand for our products.
Moreover, although our RECOVER study and ANTHEM-HFrEF and OSPREY clinical trials continue to progress, there may be delays or closures of sites in the future should COVID-19 or variants thereof strengthen or reemerge.
Ourimpact LivaNova’s business. LivaNova’s net salesrevenue and profitability have been negatively affected by the unfavorable foreign currency exchange impact of the strengthened U.S. dollarUSD against a number of currencies. Furthermore, we continueLivaNova continues to experience supply chain delays and interruptions, labor shortages, inflationary pressures and logistical issues in the wake of COVID-19.issues. Though, to date, ourthe Company’s supply of raw materials and the production and distribution of finished products have not been materially affected, demand and low capacity worldwide have caused longer lead times and put price pressure on key raw materials. Moreover, freight and labor costs at ourLivaNova’s manufacturing facilities have increased substantially due to COVID-related disruptions and in the wake of inflation globally. The Company continues to respond to such challenges, and while we haveLivaNova has business continuity plans in place, the impact of the ongoing challenges we are experiencing,the Company is navigating, along with their potential escalation, may adversely affect our business and the recoverability of our tangible and intangible assets. The future impact of pandemic-related developments remains uncertain.
Ukraine Invasionits business.
In February 2022, Russia launched an invasion in Ukraine, which caused usthe Company to assess ourits ability to sell in the market due to international sanctions, to consider the potential impact of raw material sourced from the region, and to determine whether we areLivaNova is able to transact in a compliant fashion. Although the regionbusiness across Russia, Ukraine and Belarus represented 1% of ourLivaNova’s total net salesrevenue for 2021,2022, the Russian invasion of Ukraine has increased economic uncertainties, and a significant escalation or continuation of the conflict could have a material, global impact on ourthe Company’s operating results. In addition, our Russian employees and local subsidiary are subject to evolving laws and regulations imposed by the Russian authorities in response to international sanctions.
9


Revision of Previously Issued Financial Statements
During the fourth quarter of 2021, the Company identified and corrected an error related to foreign currency exchange rates utilized to calculate inventory and cost of sales for the years ended December 31, 2017 through 2020 and the nine months ended September 30, 2021. Using the guidance in ASC Topic 250, Accounting Changes and Error Corrections, ASC Topic 250-S99-1, Assessing Materiality, and ASC Topic 250-S99-2, Considering the Effects of Prior Year Misstatements when Quantifying Misstatements in Current Year Financial Statements, we evaluated whether our previously issued consolidated financial statements were materially misstated due to these errors. Based upon our evaluation of both quantitative and qualitative factors, we believe that the effects of these errors were not material individually or in the aggregate to any previously reported quarterly or annual period. Accordingly, we have revised our previously issued financial statements as shown below (in thousands):
Consolidated Statements of Income (Loss)
Three Months Ended June 30, 2021Six Months Ended June 30, 2021
As Previously ReportedAdjustmentsAs RevisedAs Previously ReportedAdjustmentsAs Revised
Cost of sales$90,803 $1,401 $92,204 $173,723 $2,676 $176,399 
Operating loss(34,861)(1,401)(36,262)(39,284)(2,676)(41,960)
Loss before tax(51,137)(1,401)(52,538)(77,939)(2,676)(80,615)
Income tax expense4,140 (232)3,908 6,996 (444)6,552 
Net loss(55,318)(1,169)(56,487)(85,016)(2,232)(87,248)
Basic and diluted loss per share$(1.13)$(0.02)$(1.15)$(1.74)$(0.05)$(1.79)
Consolidated Statements of Comprehensive Income (Loss)
Three Months Ended June 30, 2021Six Months Ended June 30, 2021
As Previously ReportedAdjustmentsAs RevisedAs Previously ReportedAdjustmentsAs Revised
Net loss$(55,318)$(1,169)$(56,487)$(85,016)$(2,232)$(87,248)
Total comprehensive loss(34,181)(1,169)(35,350)(89,750)(2,232)(91,982)
Consolidated Statements of Stockholders’ Equity
As Previously ReportedAdjustmentsAs Revised
Accumulated DeficitTotal Stockholders’ EquityAccumulated DeficitTotal Stockholders’ EquityAccumulated DeficitTotal Stockholders’ Equity
June 30, 2021$(837,418)$1,040,470 $(11,796)$(11,796)$(849,214)$1,028,674 
Consolidated Statements of Cash Flows
Six Months Ended June 30, 2021
As Previously ReportedAdjustmentsAs Revised
Net loss$(85,016)$(2,232)$(87,248)
Deferred tax expense (benefit)1,357 (444)913 
Changes in operating assets and liabilities:
Inventories1,221 2,676 3,897 
Net cash used in operating activities45,111 — 45,111 
Reclassifications
We haveThe Company has reclassified certain prior period amounts on the condensed consolidated statements of income (loss), the condensed consolidated balance sheets and the condensed consolidated statements of cash flows for comparative purposes. These reclassifications did not have a material effect on ourLivaNova’s financial condition, results of operations or cash flows.
10


condition.
Significant Accounting Policies
OurLivaNova’s significant accounting policies are detailed below and in “Note 2. Basis of Presentation, Use of Accounting Estimates and Significant Accounting Policies” and “Note 3. Revenue Recognition” of our 2021LivaNova’s 2022 Form 10-K.
Restricted Cash
The Company classifies cash that is not available for use in its operations as restricted cash within current assets on the condensed consolidated balance sheet. As of June 30, 2022, our restricted cash balance totaled $297.7 million and was comprised of cash deposits with Barclays held as collateral for a first demand bank guarantee of €270.0 million (approximately $281.2 million as of June 30, 2022) to obtain the suspension of the Court of Appeal of Milan judgment for the payment of damages in connection with the SNIA litigation until review of such judgment by the Italian Supreme Court (the “SNIA Litigation Guarantee”). As security for the SNIA Litigation Guarantee, LivaNova is required to grant cash collateral to Barclays in US dollars in an amount equal to the USD equivalent of 105% of the amount of the SNIA Litigation Guarantee calibrated on a biweekly basis. For additional information regarding the SNIA litigation, please refer to “Note 8. Commitments and Contingencies.”
Note 2. Business Combinations
As of December 31, 2021, LivaNova owned a 3% investment in ALung, Technologies, Inc. (“ALung”), a privately held medical device company focused on creating advanced medical devices for treating respiratory failure. On May 2, 2022, weLivaNova acquired the remaining 97% of equity interests in ALung for a purchase price of up to $110.0 million, consisting of $10.0 million paid at closing, subject to customary adjustments, and contingent consideration of up to $100.0 million payable upon achievement of certain sales-based milestones beginning in 2023 and ending in 2027. Total consideration included approximately $5.5 million of non-cash consideration.
11


The following table presents the acquisition date fair value of the consideration transferred and the fair value of ourLivaNova’s interest in ALung prior to the acquisition, including certain measurement period adjustments (in thousands):
Cash and other considerations
Initial Fair Value of Consideration
Measurement Period Adjustments (1)
Adjusted Fair Value of Consideration
Cash and other considerations$15,586 $— $15,586 
Contingent consideration26,369 (9,578)16,791 
Fair value of consideration transferred$41,955 $(9,578)$32,377 
(1)During the third quarter of 2022, measurement period adjustments were recorded based on information obtained about facts and circumstances that existed as of the acquisition date.
$15,586 
Contingent consideration26,369 
Fair value of consideration transferred$41,955 
The following table presents the preliminary purchase price allocation at fair value for the ALung acquisition was finalized during the second quarter of 2023 and is presented in the following table, which includes certain measurement period adjustments (in thousands):
Purchase Price Allocation
Initial Purchase Price Allocation
Measurement Period Adjustments (1)
Adjusted Purchase Price Allocation
Developed technology - 15-year life$13,950 $(11,050)$2,900 
Goodwill25,893 977 26,870 
Other assets and liabilities, net2,112 495 2,607 
Net assets acquired$41,955 $(9,578)$32,377 
(1)During the third quarter of 2022, measurement period adjustments were recorded based on information obtained about facts and circumstances that existed as of the acquisition date.
Developed technology - 15-year life$13,950 
Goodwill25,893 
Other assets and liabilities, net2,112 
Net assets acquired$41,955 
Goodwill arising from the ALung acquisition, which is not deductible for tax purposes, primarily represents the synergies anticipated between ALung and ourthe Company’s ACS business. The assets acquired, including goodwill, are recognized in ourLivaNova’s ACS segment.
We recognized ALung acquisition-related expenses of approximately $4.4 million The goodwill for the ACS reporting unit was fully impaired during the three and six months ended June 30, 2022 within “Selling, general and administrative” expenses on our consolidated statementthird quarter of income (loss).2022.
The Company’s condensed consolidated financial statements include the operating results of ALung from the acquisition date. Separate post-acquisition operating results and pro forma financial information for this acquisition have not been presented as the effect was not material for disclosure purposes.
11


The contingent consideration payments are triggered upon the achievement of thresholds associated with sales of products covered by the purchase agreement and are estimated to occur during the years reflected in the table below. The sales-based earnout was valued using projected sales from ourthe Company’s internal strategic plan and is a Level 3 fair value measurement, which includes the following significant unobservable inputs (in thousands):
ALung AcquisitionFair value at May 2, 2022Valuation TechniqueUnobservable InputRanges
Sales-based earnout$26,369 Monte Carlo simulationRisk-adjusted discount rate9.7%-11.1%
Credit risk discount rate6.4%-8.0%
Revenue volatility38.5%
Projected years of earnout2023-2027
ALung AcquisitionFair value at May 2, 2022Valuation TechniqueUnobservable InputRanges
Sales-based earnout$16,791 Monte Carlo simulationRisk-adjusted discount rate7.0%-8.4%
Credit risk discount rate6.4%-8.0%
Revenue volatility25.7%
Projected years of earnout2023-2027
For a reconciliation of the beginning and ending balance of contingent consideration liabilities, refer to “Note 5.4. Fair Value Measurements.”
Note 3. Divestiture of Heart Valve Business
On December 2, 2020, LivaNova entered into a Purchase Agreement with Mitral, Holdco S.à r.l. (“Mitral”), a company incorporated under the laws of Luxembourg and wholly-ownedwholly owned and controlled by funds advised by Gyrus Capital S.A., a Swiss private equity firm. The Purchase Agreement providesprovided for the divestiture of certain of LivaNova’s subsidiaries as well as certain other assets and liabilities relating to the Company’s Heart Valve business and site management operations conducted by the Company’s subsidiary LivaNova Site Management (“LSM”)LSM at the Company’s Saluggia campus for €60.0$64.1 million.
On April 9, 2021, LivaNova and the PurchaserMitral entered into an A&R Purchase Agreement which amends and restates the originalAmended & Restated Purchase Agreement to, among other things, defer the closing of the sale and purchase of LSM by up to two years and include or amend certain additional terms relating to such deferral, including certain amendments relating to the potential hazardous substances liabilities of LSM and the related expense reimbursement provisions.
The closing On April 9, 2023, Mitral provided notice to LivaNova, consistent with the terms of the sale of the Heart Valve business occurred on June 1, 2021, and we received €34.8 million (approximately $42.5 million as of June 1, 2021), subject to customary trade working capital and net indebtedness adjustments, as set forth in the Purchase Agreement. We also received $3.0 million in December 2021 and the remaining deferred purchase price of €9.3 million in July 2022. In July 2022, we also made a €4.8 million payment to Mitral upon finalizing the trade working capital and net indebtedness adjustments. During the three and six months ended June 30, 2021, we recognized a (loss) gain from the sale of the Heart Valve business of $(0.1) million and $0.8 million, respectively, which is included within other operating expenses on the condensed consolidated statements of income (loss).
On July 29, 2022, we received a demand letter from Mitral for approximately €20.8 million ($21.2 million as of July 29, 2022) for breach of warranty claims under the A&R Purchase Agreement. Specifically, the claims allege failure to disclose certain information relating to a supplier, thereby allegedly impacting the profitability of Mitral’s business in China and Japan. We are currently assessing the merits of Mitral’s claims including whether Mitral has suffered a recoverable loss under the A&RAmended & Restated Purchase Agreement, pursuantthat they would not exercise their right to which warranty claims of this type, subject to certain exceptions, are capped at €8 million, and the amount of any such loss. The Company has not recognized a liability related to this matter because any potential loss is not currently probable.purchase LSM.
12


Note 4. Investments
Investments on the condensed consolidated balance sheets represent 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. As of June 30, 2022 and December 31, 2021, the carrying value of our investments was $14.0 million and $16.6 million, respectively.
As of December 31, 2021, LivaNova owned a 3% investment in ALung with a carrying value of $3.0 million, as well as held a note receivable due from ALung with a carrying value of $2.5 million. On May 2, 2022, we acquired the remaining 97% of equity interests in ALung. Please refer to “Note 2. Business Combinations” for further details.
In April 2021, Zoll Medical Corporation acquired Respicardia Inc., a privately funded U.S. company in which we had an equity investment and also to which we had a loan outstanding. As a result of the acquisition, we received proceeds of $23.1 million for both our investment and loan receivable, which had carrying values of $17.7 million and $0.8 million as of December 31, 2020, respectively. The Company recorded a gain of $4.6 million during the first quarter of 2021 to adjust the investment and loans receivable to fair value, which is included in “Foreign exchange and other income/(expense)” on the condensed consolidated statement of income (loss).
During the second quarter of 2021, the Company received a cash dividend from its investment in MD Start II of $3.1 million, which is included in “Foreign exchange and other income/(expense)” on the condensed consolidated statements of income (loss) for the three and six months ended June 30, 2021.
Note 5.4. Fair Value Measurements
We reviewThe Company reviews 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, 20222023 and 2021.2022.
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, 2022Fair Value Measurements Using Inputs Considered as:Fair Value as of June 30, 2023Fair Value Measurements Using Inputs Considered as:
Level 1Level 2Level 3Level 1Level 2Level 3
Assets:Assets:Assets:
Derivative assets - designated as cash flow hedges (foreign currency exchange rate “FX”)$585 $— $585 $— 
Derivative assets - freestanding instruments (FX)Derivative assets - freestanding instruments (FX)2,092 — 2,092 — Derivative assets - freestanding instruments (FX)$219 $— $219 $— 
Derivative assets - capped call derivativesDerivative assets - capped call derivatives61,608 — — 61,608 Derivative assets - capped call derivatives42,034 — — 42,034 
Convertible notes receivableConvertible notes receivable278 — — 278 Convertible notes receivable275 — — 275 
$64,563 $— $2,677 $61,886 $42,528 $— $219 $42,309 
Liabilities:Liabilities:Liabilities:
Derivative liabilities - designated as cash flow hedges (FX)$3,386 $— $3,386 $— 
Derivative liabilities - freestanding instruments (FX)Derivative liabilities - freestanding instruments (FX)— — Derivative liabilities - freestanding instruments (FX)$113 $— $113 $— 
Derivative liabilities - embedded exchange featureDerivative liabilities - embedded exchange feature134,090 — — 134,090 Derivative liabilities - embedded exchange feature53,705 — — 53,705 
Contingent consideration arrangementsContingent consideration arrangements97,392 — — 97,392 Contingent consideration arrangements92,626 — — 92,626 
$234,871 $— $3,389 $231,482 $146,444 $— $113 $146,331 

13


Fair Value as of December 31, 2021
Fair Value Measurements Using Inputs Considered as:
Fair Value as of December 31, 2022
Fair Value Measurements Using Inputs Considered as:
Level 1Level 2Level 3Level 1Level 2Level 3
Assets:Assets:Assets:
Derivative assets - designated as cash flow hedges (foreign currency exchange rate FX)
$243 $— $243 $— 
Derivative assets - freestanding instruments (FX)61 — 61 — 
Derivative assets - designated as cash flow hedges (interest rate swap)Derivative assets - designated as cash flow hedges (interest rate swap)$1,333 $— $1,333 $— 
Derivative assets - capped call derivativesDerivative assets - capped call derivatives106,629 — — 106,629 Derivative assets - capped call derivatives54,393 — — 54,393 
Convertible notes receivableConvertible notes receivable2,767 — — 2,767 Convertible notes receivable285 — — 285 
$109,700 $— $304 $109,396 $56,011 $— $1,333 $54,678 
Liabilities:Liabilities:Liabilities:
Derivative liabilities - designated as cash flow hedges (FX)$1,286 $— $1,286 $— 
Derivative liabilities - freestanding instruments (FX)Derivative liabilities - freestanding instruments (FX)$5,886 $— $5,886 $— 
Derivative liabilities - freestanding instruments (FX)427 — 427 — 
Derivative liabilities - embedded exchange featureDerivative liabilities - embedded exchange feature181,700 — — 181,700 Derivative liabilities - embedded exchange feature85,675 — — 85,675 
Contingent consideration arrangementsContingent consideration arrangements98,382 — — 98,382 Contingent consideration arrangements85,292 — — 85,292 
$281,795 $— $1,713 $280,082 $176,853 $— $5,886 $170,967 
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 AssetConvertible Notes ReceivableEmbedded Exchange Feature Derivative LiabilityContingent Consideration Liability Arrangements
As of December 31, 2021$106,629 $2,767 $181,700 $98,382 
Additions— — — 26,369 
Utilized as business combination consideration— (2,489)  
Changes in fair value (1)
(45,021)— (47,610)(27,359)
Total at June 30, 202261,608 278 134,090 97,392 
Less current portion at June 30, 2022— — — 5,552 
Long-term portion at June 30, 2022$61,608 $278 $134,090 $91,840 
Capped Call Derivative AssetConvertible Notes ReceivableEmbedded Exchange Feature Derivative LiabilityContingent Consideration Liability Arrangements
As of December 31, 2022 - long-term$54,393 $285 $85,675 $85,292 
Changes in fair value(12,359)(10)(31,970)7,334 
Total at June 30, 2023 - long-term$42,034 $275 $53,705 $92,626 
13

(1)
The decrease in fair value associated with contingent consideration arrangements during the six months ended June 30, 2022 was primarily related to the change in discount rates due to increasing interest rates and the change in probability of the regulatory milestone-based payment associated with the acquisition of TandemLife.
Embedded Exchange Feature and Capped Call Derivatives
In June 2020, the Company issued $287.5 million in cash exchangeable senior notes and entered into related capped call transactions. The cash exchangeable senior notes include an embedded exchange feature that is bifurcated from the cash exchangeable senior notes. Please refer to “Note 6.5. Financing Arrangements” for further details. The embedded exchange feature derivative is measured at fair value using a binomial lattice model and discounted cash flows that utilize observable and unobservable market data. The capped call derivative is measured at fair value using the Black-Scholes model utilizing observable and unobservable market data, including stock price, remaining contractual term, expected volatility, risk-free interest rate and expected dividend yield, as applicable.
The embedded exchange feature and capped call derivatives are classified as Level 3 as the Company uses historical volatility and implied volatility from options traded to determine expected stock price volatility, an unobservable input that is significant to the valuation. In general, an increase in ourLivaNova’s stock price or stock price volatility would increase the fair value of the embedded exchange feature and capped call derivatives which would result in an increase in expense. As time to the expiration of the derivatives decreases, the fair value of the derivatives would decrease. The future impact on net income depends on how significant inputs such as stock price, stock price volatility and time to the expiration of the derivatives change in relation to
14


other inputs. Changes in the fair value of the embedded exchange feature derivative and capped call derivatives are recognized in “Foreignforeign exchange and other income/(expense) in the condensed consolidated statements of income (loss).income.
The fair value of the embedded exchange feature derivative liability and the capped call derivative assets were $134.1was $53.7 million and $61.6$42.0 million, respectively, as of June 30, 20222023, and the stock price volatility was 54%36%. As of June 30, 2022,2023, a 10% lower volatility, holding other inputs constant, would result in approximatereduce the fair value for the embedded exchange feature derivative of $118.5liability by $13.8 million, and a 10% higher volatility, holding other inputs constant, would result in approximateincrease the fair value of $146.8by $14.4 million. As of June 30, 2022,2023, a 10% lower volatility, holding other inputs constant, would result in approximatereduce the fair value for the capped call derivatives of $65.0by $9.2 million, and a 10% higher volatility, holding other inputs constant, would result in approximateincrease the fair value of $57.4by $4.0 million.
Contingent Consideration Arrangements
The following table provides the fair value of our Level 3 contingent consideration arrangements by acquisition (in thousands):
June 30, 2022December 31, 2021
ImThera$70,283 $86,830 
ALung21,557 — 
TandemLife5,552 11,552 
$97,392 $98,382 

June 30, 2023December 31, 2022
ImThera$74,941 $69,389 
ALung17,685 15,903 
$92,626 $85,292 
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 earnouts are valued using projected sales from ourLivaNova’s internal strategic plan. These arrangements are Level 3 fair value measurements and include the following significant unobservable inputs as of June 30, 2022:
ImThera AcquisitionValuation TechniqueUnobservable InputInputs
Regulatory milestone-based paymentDiscounted cash flowDiscount rate11.8%
Probability of payment85%
Projected payment year2024
Sales-based earnoutMonte Carlo simulationRisk-adjusted discount rate14.4%
Credit risk discount rate12.4% -13.4%
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, 2022:2023:
TandemLifeImThera AcquisitionValuation TechniqueUnobservable InputInputs
Regulatory milestone-based paymentDiscounted cash flowDiscount rate10.1%9.7%
Probability of payment45%85%
Projected payment year20232025
Sales-based earnoutMonte Carlo simulationRisk-adjusted discount rate14.4% - 15.0%
Credit risk discount rate10.0% - 10.5%
Revenue volatility32.5%
Probability of payment85%
Projected years of earnout2026 - 2029
1514


The ALung business combination involved a contingent consideration arrangement composed of potential cash payments upon the achievement of certain sales-based thresholds associated with sales of products. The arrangement is a Level 3 fair value measurement and includes the following significant unobservable inputs as of June 30, 2022:2023:
ALung AcquisitionValuation TechniqueUnobservable InputInputs
Sales-based earnoutMonte Carlo simulationRisk-adjusted discount rate10.4%-11.2%
Credit risk discount rate11.0%-13.2%
Revenue volatility37.5%
Projected years of earnout2023-2027
ALung AcquisitionValuation TechniqueUnobservable InputInputs
Sales-based earnoutMonte Carlo simulationRisk-adjusted discount rate10.0% - 11.0%
Credit risk discount rate9.5% - 10.2%
Revenue volatility32.8%
Projected years of earnout2023 - 2027
Note 6.5. Financing Arrangements
The outstanding principal amount of our long-term debt as of June 30, 20222023 and December 31, 20212022 was as follows (in thousands, except interest rates):
June 30, 2022December 31, 2021MaturityInterest RateJune 30, 2023December 31, 2022MaturityInterest Rate
Term FacilitiesTerm Facilities$336,316 $289,294 July 20278.54%
2020 Cash Exchangeable Senior Notes2020 Cash Exchangeable Senior Notes$232,081 $225,140 December 20253.00%2020 Cash Exchangeable Senior Notes247,236 239,568 December 20253.00%
Bridge Loan Facility220,000 — N/A5.83%
Bank of America Merrill Lynch Banco Múltiplo S.A.Bank of America Merrill Lynch Banco Múltiplo S.A.6,499 6,113 July 202311.46%Bank of America Merrill Lynch Banco Múltiplo S.A.— 6,462 N/AN/A
Mediocredito ItalianoMediocredito Italiano2,332 3,379 December 20230.50%-2.74%Mediocredito Italiano819 1,601 December 20230.50% - 6.00%
Bank of America, U.S.Bank of America, U.S.1,500 1,500 January 20235.45%Bank of America, U.S.1,500 1,500 January 20258.31%
OtherOther585 663 Other524 534 
Total long-term facilitiesTotal long-term facilities462,997 236,795 Total long-term facilities586,395 538,959 
Less current portion of long-term debtLess current portion of long-term debt3,205 226,946 Less current portion of long-term debt18,444 20,892 
Total long-term debt$459,792 $9,849 
Total long-term debt obligationsTotal long-term debt obligations$567,951 $518,067 
Revolving Credit
The outstanding principal amount of ourLivaNova’s short-term unsecured revolving credit agreements and other agreements with various banks was $3.0$0.6 million and $2.7$2.5 million atas of June 30, 20222023 and December 31, 2021,2022, respectively, with an interest rates ranging from 3.14% to 11.63%rate of 4.24% and loan terms ranging from overnight to 364 days as of June 30, 2022.2023.
On August 13, 2021, LivaNova PLC and its wholly-owned subsidiary, LivaNova USA Inc. (the “Borrower”)as borrower, entered into a First Lien Credit Agreement with the lenders and issuing banks party thereto and Goldman Sachs Bank USA, as First Lien Administrative Agent and First Lien Collateral Agent, relating to a $125 million senior secured multi-currency revolving credit facility to be made available to the Borrower (the “2021borrower, referred to as the 2021 First Lien Credit Agreement”).Agreement. The 2021 First Lien Credit Agreement, as amended from time to time, expires on August 13, 2026, and bears interest at a rate equal to, for U.S. dollar-denominatedUSD-denominated loans, an adjusted Secured Overnight Financing Rate (“SOFR”)SOFR with a floor of 0.00%, or a Base Rate, plus, in each case, a variable margin based on the Company’s senior secured net leverage ratio.Total Net Leverage Ratio, as defined in the agreement. Interest is paid monthly or quarterly, as selected by the Borrower,borrower, with any outstanding principal due at maturity. The 2021 First Lien Credit Agreement also contemplates the payment of commitment fees on the unused portion of the commitments, at a variable percentage based on the Company’s senior secured net leverage ratio.Total Net Leverage Ratio. As of June 30, 2023 and December 31, 2022, the applicable commitment fee percentage was 0.5% per annum. The 2021 First Lien Credit Agreement is available for working capital and other general corporate purposes and, if drawn, can be repaid at any time without premium or penalty. As of June 30, 2022, we were2023, the Company was in compliance with the financial covenants contained in ourits 2021 First Lien Credit Agreement.
There were no outstanding borrowings under the 2021 First Lien Credit AgreementAgreement’s $125 million revolving credit facility as of June 30, 20222023 and December 31, 2021.2022.
Bridge Loan Facility
On February 24, 2022, LivaNova PLC and its wholly-owned subsidiary, LivaNova USA Inc., entered into an Incremental Facility Amendment No. 1 to the 2021 First Lien Credit Agreement, relating to a €200 million bridge loan facility (the “BridgeBridge Loan Facility”).Facility. On March 16, 2022, LivaNova entered into Amendment No. 2 to the 2021 First Lien Credit Agreement, which converted the available borrowings under the Bridge Loan Facility from €200 million to $220.0$220 million and converted the EURIBOR rate in the 2021 First Lien Credit Agreement to SOFR. LivaNova delivered a borrowing notice for $220.0$220 million in connection with the Bridge Loan Facility, which was funded on March 17, 2022.
15


On March 18, 2022, LivaNova PLC, acting through its Italian branch, entered into an Indemnity Letter and an Account Pledge Agreement with Barclays, further to which
16


Barclays issued the SNIA Litigation Guarantee. As security for the SNIA Litigation Guarantee, LivaNova is required to grant cash collateral to Barclays in US dollarsUSD in an amount equal to the USD equivalent of 105% of the amount of the SNIA Litigation Guarantee calibrated on a biweekly basis. The proceeds of the Bridge Loan Facility were used by LivaNova to post a portion of the cash collateral supporting the SNIA Litigation Guarantee. The cash held asCash collateral supporting the SNIA Litigation Guarantee of $297.7 million was classified as restricted cash on the condensed consolidated balance sheet was $311.4 million and $301.4 million as of June 30, 2022. The Bridge Loan Facility bears interest at an adjusted term SOFR, with a floor of 0.5%, plus 3.5% increasing by 0.25% 15 days after drawing2023 and by an additional 0.5% 90 days after drawing and every 90 days thereafter, with a maximum margin of 5.25% over adjusted SOFR. The effective interest rate of the Bridge Loan Facility at June 30,December 31, 2022, was 11.04%.respectively. For additional information regarding the SNIA litigation, please refer to “Note 8.7. Commitments and Contingencies.”
Debt discounts and issuance costs related to the Bridge Loan Facility were approximately $4.5 million. Amortization of debt discount and issuance costs for the Bridge Loan Facility was $3.6 million and $4.5 million for the three and six months ended June 30, 2022, respectively, and is included in interest expense on the condensed consolidated statement of income (loss).income.
Outstanding borrowings under the Bridge Loan Facility were $220.0 million as of June 30, 2022. The Bridge Loan Facility was repaid in full on July 6, 2022. Please refer
Term Facilities
On July 6, 2022, LivaNova and its wholly-owned subsidiary, LivaNova USA, entered into Incremental Facility Amendment No. 2. Incremental Facility Amendment No. 2 provides for LivaNova USA to, “Note 15. Subsequent Event”among other things, obtain commitments for term loan facilities from a syndicate of lenders in an aggregate principal amount of $350 million consisting of (i) the Initial Term Facility with an aggregate principal amount of $300 million and (ii) the Delayed Draw Term Facility with an additional information.aggregate principal amount of $50 million. On April 6, 2023, LivaNova drew $50 million under the Delayed Draw Term Facility for general corporate purposes.
Proceeds from the Initial Term Facility were used to repay in full the Bridge Loan Facility on July 6, 2022, with the remainder used for general corporate purposes of the Company. The Term Facilities have a maturity of the earlier of (i) five years or (ii) 91 days prior to December 15, 2025, the maturity date of the 2020 Cash Exchangeable Senior Notes, unless by that date LivaNova USA will have either redeemed or refinanced the Notes, or set aside an amount of cash equal to the then-outstanding principal amount of the Notes. The Term Facilities bear interest at a rate equal to an adjusted term SOFR plus a variable margin based on the Company’s consolidated total net leverage ratio. As of June 30, 2023, the applicable margin over Adjusted SOFR was equal to 3.50% per annum. The Term Facilities are subject to an original issue discount of 1.5% of their principal amount. The Term Facilities are subject to quarterly principal repayment, based on the following amortization schedule: (i) during the first year from the initial funding date: 1.9%; (ii) year two: 5.0%; (ii) year three: 5.0%; (iv) year four: 7.5%; and (v) year five: 10.0%, with the remainder to be paid at maturity. The effective interest rate of the Term Facilities at June 30, 2023 was 6.53%.
The 2021 First Lien Credit Agreement, as amended, contains customary representations, warranties and covenants, including the requirement to maintain a Senior Secured First Lien Net Leverage Ratio, calculated as the ratio of Consolidated Senior Secured First Lien Net Indebtedness to Consolidated EBITDA, as defined in the credit agreement, for the period of four consecutive fiscal quarters ended on the calculation date, of not more than 3.50 to 1.00 and an Interest Coverage Ratio, calculated as the ratio of Consolidated EBITDA to Consolidated Interest Expense, as defined in the credit agreement, for the period of four consecutive fiscal quarters ended on the calculation date, of not less than 3.00 to 1.00. As of June 30, 2023, the Company was in compliance with the financial covenants contained in the 2021 First Lien Credit Agreement.
Debt discounts and issuance costs related to the Initial Term Facility were approximately $9.6 million. Amortization of debt discount and issuance costs for the Initial Term Facility was $0.5 million and $1.0 million for the three and six months ended June 30, 2023, respectively, and is included in interest expense on the condensed consolidated statement of income. The unamortized discount and issuance costs related to the Initial Term Facility as of June 30, 2023 and December 31, 2022 were $7.7 million and $8.7 million, respectively. Issuance costs related to the Delayed Draw Term Facility were approximately $1.6 million. Amortization of issuance costs for the Delayed Draw Term Facility was nil and $0.5 million for the three and six months ended June 30, 2023, respectively, and is included in interest expense on the condensed consolidated statement of income. The issuance costs related to the Delayed Draw Term Facility were fully amortized as of June 30, 2023.
2020 Cash Exchangeable Senior Notes
On June 17, 2020, ourLivaNova’s wholly-owned subsidiary, LivaNova USA, Inc., issued $287.5 million aggregate principal amount of 3.00% Notes (the “Notes”) by private placement to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended.Act. The sale of the Notes resulted in approximately $278.0 million in net proceeds to the Company after deducting issuance costs. Interest is payable semiannually in arrears on June 15 and December 15 of each year. The effective interest rate of the Notes at June 30, 20222023 was 9.95%. The Notes mature on December 15, 2025 unless earlier exchanged, repurchased, or redeemed.
16


Debt discounts and issuance costs related to the Notes were approximately $82.0 million and included $75.0 million of discount attributable to the embedded exchange feature, discussed below, and $7.0 million of allocated issuance costs to the Notes related to legal, bank and accounting fees. Amortization of debt discount and issuance costs for the Notes was $3.9 million and $7.7 million for the three and six months ended June 30, 2023, respectively, and $3.5 million and $6.9 million for the three and six months ended June 30, 2022, respectively, and is included in interest expense on the condensed consolidated statement of income (loss).income. The unamortized discount related to the Notes as of June 30, 20222023 and December 31, 20212022 was $55.4$40.3 million and $62.4$47.9 million, respectively.
Holders of the Notes are entitled to exchange the Notes at any time during specified periods, at their option. This includes the right to exchange the Notes during any calendar quarter, if the last reported sale price of LivaNova’s ordinary shares, with a nominal value of £1.00 per share, is greater than or equal to 130% of the exchange price, or $79.27 per share for at least 20 trading days (whether or not consecutive) during a period of 30 consecutive trading days ending on, and including, the last trading day of the immediately preceding calendar quarter. The exchange condition was not satisfied during the quarterly period ending June 30, 2022.2023. As a result, we havethe Company has included ourits obligations from the Notes and the associated embedded exchange feature derivative as a long-term liability on the condensed consolidated balance sheet as of June 30, 2022.2023. The Notes are exchangeable solely into cash and 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 and prior to the 51st scheduled trading day immediately preceding the maturity date, 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 their stated maturity, in whole but not in part, in connection with certain tax-related events.
17


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 the unrealized gain or loss reflected within “Foreign exchange and other income/(expense)” in the condensed consolidated statements of income (loss).income. The fair value of the embedded exchange feature derivative liability was $134.1$53.7 million and $85.7 million as of June 30, 2022.2023 and December 31, 2022, respectively.
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 capped call transactions expire on December 15, 2025 and must be settled in cash. If the capped call transactions are converted or redeemed early, settlement occurs at their termination value, which is equal to their fair value at the time of the redemption. The capped call transactions 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 within “Foreignforeign exchange and other income/(expense) in the condensed consolidated statements of income (loss).income. The fair value of the capped call derivative assets was $61.6$42.0 million and $54.4 million as of June 30, 2022.2023 and December 31, 2022, respectively. As of June 30, 2022,2023, the capped call derivative assets arewere classified as long-term.
17


Note 7.6. Derivatives and Risk Management
Due to the global nature of ourLivaNova’s operations, we areLivaNova is exposed to foreign currency exchange rateFX fluctuations. We enterHistorically, the Company has entered into FX derivative contracts and interest rate swap contracts to reduce the impact of foreign currency exchangeFX and interest rate fluctuations, respectively, on earnings and cash flow. We are
LivaNova is also exposed to equity price risk in connection with ourits Notes, including exchange and settlement provisions based on the price of ourthe Company’s ordinary shares at exchange or maturity of the Notes. In addition, theThe capped call transactions associated with the Notes also include settlement provisions that are based on the price of ourLivaNova’s ordinary shares, subject to a capped price per share. We do
LivaNova does not enter into derivative contracts for speculative purposes.
We measureLivaNova measures all outstanding derivatives each period end at fair value and reportreports the fair value as either financial assets or liabilities on the condensed consolidated balance sheets. 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”)AOCI until the hedged item is recognized in earnings upon settlement/termination. FX derivative gains and losses in AOCI are reclassified to ourthe condensed consolidated statements of income (loss) as shown in the tables below. We evaluatebelow, and interest rate swap gains and losses in AOCI are reclassified to interest expense on the condensed consolidated statements of income. The Company evaluates hedge effectiveness at inception. Cash flows from derivative contracts are reported as operating activities on ourLivaNova’s 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, 20222023 and December 31, 20212022 was $117.2$160.4 million and $136.7$154.5 million, respectively. These derivative contracts are designed to offset the FX effects in earnings of various intercompany loans and trade receivables. WeFor these freestanding derivatives, LivaNova recorded net gains (losses) for these freestanding derivatives of $4.0$0.4 million and $(1.7)$4.0 million for the three months ended June 30, 20222023 and 2021,2022, respectively, and $5.0net (losses) gains $(0.9) million and $5.9$5.0 million for the six months ended June 30, 20222023 and 2021,2022, respectively. These gains and losses are included in “Foreignforeign exchange and other income/(expense)” in on the condensed consolidated statements of income (loss).income.
Counterparty Credit Risk
We areLivaNova is exposed to credit risk in the event of non-performance by the counterparties to ourthe Company’s derivatives.
The two counterparties to the capped call transactions are financial institutions. To limit ourits credit risk, weLivaNova selected financial institutions with a minimum long-term investment grade credit rating. OurLivaNova’s exposure to the credit risk of the counterparties is not
18


secured by any collateral. If a counterparty becomes subject to insolvency proceedings, wethe Company will become an unsecured creditor in those proceedings, with a claim equal to ourLivaNova’s exposure at that time under the capped call transactions with that counterparty.
To manage credit risk with respect to ourits 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.
Cash Flow Hedges
We utilizeForeign Currency Risk
Historically, LivaNova utilized FX derivative contracts, designed as cash flow hedges, to hedge the variability of cash flows associated with ourLivaNova’s 12-month U.S. dollarUSD forecasts of revenues and costs denominated in British Pound, Japanese Yen and the Euro. We transferThe Company transferred to earnings from AOCI the gain or loss realized on the FX derivative contracts at the time of invoicing. Upon the settlement of LivaNova’s foreign currency cash flow hedges in the fourth quarter of 2022 and following an in-depth analysis of the utility of the Company’s cash flow hedging program, LivaNova discontinued its foreign currency cash flow hedging program.
18


Interest Rate Risk
Historically, LivaNova entered into interest rate swaps associated with the Initial Term Facility, which qualified for and were designated as cash flow hedges. The Company’s interest rate swaps expired on April 6, 2023. LivaNova elected not to renew the interest rate swaps as interest expense associated with the Initial Term Facility is principally offset by holding a significant portion of the Initial Term Facility in a depository account, which earns a floating rate of interest.
The gross notional amounts of open derivative contracts designated as cash flow hedges at June 30, 20222023 and December 31, 20212022 were as follows (in thousands):
Description of Derivative ContractJune 30, 2022December 31, 2021
FX derivative contracts to be exchanged for British Pounds$5,416 $11,160 
FX derivative contracts to be exchanged for Japanese Yen3,334 6,648 
FX derivative contracts to be exchanged for Euros29,110 58,224 
$37,860 $76,032 
After-tax net gain associated with derivatives designated as cash flow hedges recorded in the ending balance of AOCI and the amount expected to be reclassified to earnings in the next 12 months are as follows (in thousands):
Description of Derivative ContractAfter-Tax Net Loss in AOCI as of June 30, 2022After-Tax Net Loss in AOCI as of June 30, 2022 Expected to be Reclassified to Earnings in Next 12 Months
FX derivative contracts$(2,869)$(2,869)
Description of Derivative ContractJune 30, 2023December 31, 2022
Interest rate swap contracts$— $210,000 
Pre-tax gains (losses) for derivative contracts designated as cash flow hedges recognized in other comprehensive income (loss) (“OCI”)OCI and the amount reclassified to earnings from AOCI were as follows (in thousands):
Three Months Ended June 30,Three Months Ended June 30,
202220212022
Description of Derivative ContractDescription of Derivative ContractLocation in Earnings of Reclassified Gain or LossLosses Recognized in OCIGains (Losses) Reclassified from AOCI to EarningsLosses Recognized in OCI(Losses) Gains Reclassified from AOCI to EarningsDescription of Derivative ContractLocation in Earnings of Reclassified Gain or LossLosses Recognized in OCIGains (Losses) Reclassified from AOCI to Earnings
FX derivative contractsFX derivative contractsForeign exchange and other income/(expense)$(1,116)$1,238 $(621)$(1,306)FX derivative contractsForeign exchange and other income/(expense)$(1,116)$1,238 
FX derivative contractsFX derivative contractsSG&A— (1,122)— 858 FX derivative contractsSG&A— (1,122)
$(1,116)$116 $(621)$(448)
$(1,116)$116 
Six Months Ended June 30,Six Months Ended June 30,
2022202120232022
Description of Derivative ContractDescription of Derivative ContractLocation in Earnings of Reclassified Gain or LossLosses Recognized in OCI(Losses) Gains Reclassified from AOCI to EarningsLosses Recognized in OCILosses Reclassified from AOCI to EarningsDescription of Derivative ContractLocation in Earnings of Reclassified Gain or LossLosses Recognized in OCIGains Reclassified from AOCI to EarningsLosses Recognized in OCIGains (Losses) Reclassified from AOCI to Earnings
FX derivative contractsFX derivative contractsForeign exchange and other gains (losses)$(1,758)$1,679 $(2,844)$(2,802)FX derivative contractsForeign exchange and other income/(expense)$— $— $(1,758)$1,679 
FX derivative contractsFX derivative contractsSG&A— (1,510)— 1,543 FX derivative contractsSG&A— — — (1,510)
Interest rate swap contractsInterest rate swap contractsInterest expense(433)533 — — 
$(1,758)$169 $(2,844)$(1,259)$(433)$533 $(1,758)$169 
19


We offsetThe Company offsets fair value amounts associated with ourits derivative instruments on ourthe condensed consolidated balance sheets that are executed with the same counterparty under master netting arrangements. Our nettingNetting 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, 2022Asset DerivativesLiability Derivatives
Derivatives Designated as Hedging InstrumentsBalance Sheet Location
Fair Value (1)
Balance Sheet Location
Fair Value (1)
Asset DerivativesLiability Derivatives
June 30, 2023June 30, 2023Balance Sheet Location
Fair Value (1)
Balance Sheet Location
Fair Value (1)
Derivatives Not Designated as Hedging Instruments:Derivatives Not Designated as Hedging Instruments:
Capped call derivativesCapped call derivativesLong-term derivative assets$42,034 
FX derivative contractsFX derivative contractsCurrent derivative assets$585 Current derivative liabilities$3,386 FX derivative contractsPrepaid expenses and other current assets219 Accrued liabilities and other$113 
Total derivatives designated as hedging instruments585 3,386 
Derivatives Not Designated as Hedging Instruments
FX derivative contractsCurrent derivative assets1,935 Current derivative liabilities
FX derivative contractsCurrent derivative liabilities157 
Capped call derivativesLong-term derivative assets61,608 
Embedded exchange featureEmbedded exchange featureLong-term derivative liabilities134,090 Embedded exchange featureLong-term derivative liabilities53,705 
Total derivatives not designated as hedging instrumentsTotal derivatives not designated as hedging instruments63,700 134,093 Total derivatives not designated as hedging instruments42,253 53,818 
Total derivativesTotal derivatives$64,285 $137,479 Total derivatives$42,253 $53,818 
December 31, 2021Asset DerivativesLiability Derivatives
Derivatives Designated as Hedging InstrumentsBalance Sheet Location
Fair Value (1)
Balance Sheet Location
Fair Value (1)
FX derivative contractsCurrent derivative liabilities$243 Current derivative liabilities$1,286 
Total derivatives designated as hedging instruments243 1,286 
Derivatives Not Designated as Hedging Instruments
FX derivative contractsCurrent derivative liabilities61 Current derivative liabilities427 
Capped call derivativesCurrent derivative assets106,629 
Embedded exchange featureCurrent derivative liabilities181,700 
Total derivatives not designated as hedging instruments106,690 182,127 
Total derivatives$106,933 $183,413 
19


Asset DerivativesLiability Derivatives
December 31, 2022Balance Sheet Location
Fair Value (1)
Balance Sheet Location
Fair Value (1)
Derivatives Designated as Hedging Instruments:
Interest rate swap contractsPrepaid expenses and other current assets$1,333 
Total derivatives designated as hedging instruments1,333 
Derivatives Not Designated as Hedging Instruments:
Capped call derivativesLong-term derivative assets54,393 
FX derivative contractsAccrued liabilities and other$5,886 
Embedded exchange featureLong-term derivative liabilities85,675 
Total derivatives not designated as hedging instruments54,393 91,561 
Total derivatives$55,726 $91,561 
(1)For the classification of inputs used to evaluate the fair value of our derivatives, refer to “Note 5.4. Fair Value Measurements.”
Note 8.7. 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 2 observed non-conformities with certain regulatory requirements at the Munich facility. We did not receive a Form 483 in connection with the FDA’s inspection of the Arvada facility. Following 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
20


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. With this 510(k) clearance, all actions to remediate the FDA’s inspectional observations in the Warning Letter were complete, and LivaNova awaited the FDA’s close-out inspection.
On April 28, 2022, the FDA completed its close-out inspection of the Munich, Germany facility and, at the conclusion of the inspection, issued a Form 483 which contained three inspectional observations in the areas of design validation, process validation and complaint investigations. We submitted a detailed response including our proposed corrective and preventative actions to address the FDA’s observations and a subsequent follow-up to the FDA commenting on the Form 483 observations in the context of our previous actions and remediation efforts to the 2015 Warning Letter, including the January 2016 informational Customer Letter; shipment of products pursuant to our certificate of medical necessity program; and the activities that we conducted to obtain clearance of K191402 for the modified 3T device. While our responses were designed to resolve the outstanding issues raised by the FDA, whether the FDA will accept our responses is uncertain. Refer to “Part II, Item 1A, Risk Factors” in this Form 10-Q for additional information regarding the risks surrounding receipt of the Form 483.
CDC and FDA Safety Communications and Company Field Safety Notice
On October 13, 2016, the Center for Disease Control (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 the CDC and its affiliates indicate that there appears to be genetic similarity between both patient and 3T device strains of the non-tuberculous mycobacterium (“NTM”) bacteria M. chimaera isolated in hospitals in Iowa and Pennsylvania. Citing the geographic separation between the two hospitals referenced in the investigation, the report asserts that 3T devices manufactured prior to August 18, 2014 could have been contaminated during the manufacturing process. The CDC’s HAN and FDA’s Safety Communication, issued contemporaneously with the MMWR report, each assess certain risks associated with 3T devices and provide guidance for providers and patients. The CDC notification states that the decision to use the 3T device during a surgical operation is to be taken by the surgeon based on a risk approach and on patient need. Both the CDC’s and FDA’s communications confirm that 3T devices are critical medical devices and enable doctors to perform life-saving cardiac surgery procedures.
Also on October 13, 2016, concurrent with the CDC’s HAN and FDA’s Safety Communication, we issued a Field Safety Notice Update for U.S. users of 3T devices to proactively and voluntarily contact facilities to aid in implementation of the CDC and FDA recommendations. In the fourth quarter of 2016, we initiated a program to provide existing 3T device users with a new loaner 3T device at no charge pending regulatory approval and implementation of additional risk mitigation strategies worldwide, including a vacuum canister and internal sealing upgrade program and a deep disinfection service. In April 2017, we obtained CE Mark in Europe for the design change of the 3T device, and in October 2018, the FDA concluded that we could commence the vacuum canister and internal sealing upgrade program in the U.S. 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. We are in the process of completing and closing out all recall activities with the FDA. While our vacuum canister and internal sealing upgrade program and deep cleaning service in the U.S. are substantially complete, these services will continue as a servicing option outside of the U.S.
On December 31, 2016, we recognized a liability for our product remediation plan related to our 3T device. We concluded that it was probable that a liability had been incurred upon management’s approval of the plan and the commitments made by management to various regulatory authorities globally during the fourth quarter of 2016, and furthermore, the cost associated with the plan was reasonably estimable. At June 30, 2022, the product remediation liability was $0.7 million.
21


Saluggia Site Hazardous Substances
LivaNova Site Management S.r.l. (“LSM”),LSM, formerly a subsidiary of Sorin, one of the companies that merged into LivaNova PLC in 2015, manages site services for the campus in Saluggia, Italy. In addition to being a former LivaNova manufacturing facility, the Saluggia campus is also the location of manufacturing facilities of third parties, a cafeteria for workers, and storage facilities for hazardous substances and equipment previously used in a nuclear research center, later turned nuclear medicine business, between the 1960s and the late 1990s. Pursuant to authorization from the Italian government, LSM has performed, and continues to perform, ordinary maintenance, secure the facilities, monitor air and water quality and file applicable reports with the competent environmental authorities.
DuringIn 2020, LSM received correspondence from ISIN (a sub-body of the Italian Ministry of Economic Development) requesting that, within five years, LSM demonstrate the financial capacity to meet its obligations under Italian law to clean and dismantle any contaminated buildings and equipment as well as to deliver hazardous substances to a national repository. This repository will be built by the Italian government at a location and time yet to be determined. ISIN subsequently published Technical Guide n. 30, which identifies the technical criteria, and general safety and protection requirements for the design, construction, operation and dismantling of temporary storage facilities for the hazardous substances. In January 2021, a list of 67 potential sites for the national repository was published.
Although there is no legal obligation to begin any work or deliver the hazardous substances, as the performance of these obligations is contingent on the construction of the as-yet unbuilt national repository, based on the aforementioned factors, the Company concluded its obligation to clean, dismantle, and deliver any hazardous substances to a national repository is probable and reasonably estimable. The estimated liability as of June 30, 20222023 was $35.9€34.0 million ($37.1 million), which represented the low end of the estimated range of loss of $35.9€34.0 million ($37.1 million) to $45.6 million.€43.3 million ($47.3 million) as of June 30, 2023. The estimated liability as of December 31, 20212022 was $39.3 million. The decrease in the liability from December 31, 2021 was primarily due to the effects of foreign currency changes during the six months ended June 30, 2022.
Litigation€34.2 million ($36.6 million).
Product Liability Litigation
The Company is currently involved in litigation involving ourLivaNova’s 3T Heater-Cooler device. The litigation includes federal multi-district litigation in the U.S. District Court for the Middle District of Pennsylvania,MDL, various U.S. state court cases and cases in jurisdictions outside the U.S. A class action, filed in February 2016 in the U.S. District Court for the Middle District of Pennsylvania, consisting 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, was dismissed on July 16, 2021. 
On March 29, 2019, weLivaNova announced a settlement framework that providesprovided for a comprehensive resolution of the personal injury cases pending in the multi-district litigation in U.S. federal court,MDL, the related class action in federal court, as well as certain cases in state courts across the United States. The agreement, which makesmade no admission of liability, iswas subject to certain conditions, including acceptance of the settlement by individual claimants and providesprovided for a total payment of up to $225 million to resolve the claims covered by the settlement. Per the agreed-upon terms, the firstsecond and final payment of $135$90 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 August 3, 2022, includingJuly 26, 2023, the cases encompassed in the settlement framework described above that have not yet been dismissed, we wereCompany was aware of approximately 9080 filed and unfiled claims worldwide, with the majority of the claims in various federal or state courts throughout the United States.States, including some cases removed to the MDL after the settlement described above. This number includes 613 cases that have settled but have not yet been dismissed.in the process of settling. The complaints generally seek damages and other relief based on theories
20


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.
During the three and six months ended June 30, 2023, we recorded an additional liability of $10.8 million and $12.2 million, respectively, due to new information received about the nature of certain claims. At June 30, 2023 and December 31, 2022, the provision for these matters was $36.9 million.$25.4 million and $32.5 million, respectively. While the amount accrued represents ourthe Company’s best estimate for those filed and unfiled claims that we believethe Company believes are both probable and estimable at this time, and which are a subset of the filed and unfiled claims worldwide of which we areLivaNova is currently aware, the actual liability for resolution of these matters may vary from ourthe Company’s estimate. The remaining claims for which a provision has not been recorded are remote or the potential loss is not estimable at this time.
22


Changes in the carrying amount of the litigation provision liability are as follows (in thousands):
Total litigation provision liability at December 31, 20212022$39,47032,487 
Payments(2,773)(19,407)
Adjustments (1)
70912,150 
FX and other(517)187 
Total litigation provision liability at June 30, 2022202336,88925,417 
Less current portion of litigation provision liability at June 30, 2022202330,96022,352 
Long-term portion of litigation provision liability at June 30, 20222023 (2)
$5,9293,065 
(1)Adjustments to the litigation provision are included within other operating expensesexpense on the condensed consolidated statements of income (loss).income.
(2)Included within other long-term liabilities on the condensed consolidated balance sheet.
SNIA Environmental Liability
Sorin was created as a result of a spin-off (the “Sorin spin-off”) from SNIA in January 2004, and in October 2015, Sorin was merged into LivaNova. SNIA subsequently became insolvent, and the Italian Ministry of the Environment and the Protection of Land and Sea (the “Italian Ministry of the Environment”),Public Administrations sought compensation from SNIA in an aggregate amount of approximately $4$3.8 billion for remediation costs relating to the environmental damage at chemical sites previously operated by SNIA’s other subsidiaries.
There are proceedings relating to the SNIA bankruptcy to which we areLivaNova is not a party in the Bankruptcy Court of Udine and the Bankruptcy Court of Milan. In September 2011, the Bankruptcy Court of Udine held that the Italian Ministry of the Environment and other Italian government agencies (the “Public Administrations”)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. In January 2016, the Court of Udine rejected the appeal, and the Public Administrations appealed to the Supreme Court. Similarly, in July 2014, the Bankruptcy Court of Milan held that the Public Administrations were not creditors of either SNIA or its subsidiaries. The Public Administrations appealed. In April 2022, Bankruptcy Court of Milan declared the Public Administrations to be a non-privileged creditor of SNIA for up to €454 million, and the Public Administrations appealed to the Supreme Court.
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 entered voluntarily into the proceeding, asking Sorin, as jointly liable with SNIA, to pay compensation for SNIA’s environmental damages. On April 1,In 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 $304,103$318,732 as of June 30, 2022)2023) for legal fees. The Public Administrations appealed the 2016 decisionDecision to the Court of Appeal of Milan (“Court of Appeal”).Appeal. 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 $595.8$624.5 million as of June 30, 2022)2023). WeLivaNova appealed the partial decision on liability to the Italian Supreme Court in August 2019.
In November 2021, the Court of Appeal delivered the remainder of its decision, ordering LivaNova to pay damages of approximately €453.6 million (approximately $472.4$495.1 million as of June 30, 2022)2023). WeLivaNova appealed the decision on damages in December 2021. The Italian Supreme Court scheduled a hearing for October 5, 2022 to address the appeals of liability and damages.
On February 21, 2022, the Court of Appeal notified the Company that it granted the Company a suspension with respect to the payment of damages until a decision has been reached on the appeal to the Italian Supreme Court. This suspension was subject to ourLivaNova providing a first demand bank guarantee of €270.0 million (approximately $281.2$294.7 million as of June 30, 2022)2023) within 30 calendar days, and on March 21, 2022, LivaNova delivered the guarantee, thereby satisfying the condition. Refer to “Note 6.5. Financing Arrangements” for information on the financing of the guarantee.
21


In November 2022, in response to one of a number of appeals asserted by LivaNova, the Supreme Court issued an ordinance, a procedural document, whereby the Supreme Court referred a question on interpretation of a European directive on demergers to the ECJ. Specifically, the ordinance asks the ECJ to provide a binding decision as to whether a company resulting from a demerger can be held jointly and severally liable not only for the established liabilities of the demerged company that were articulated at the time of demerger, but also for the environmental liabilities of the demerged company that materialized after the demerger which are derived from actions performed prior to the demerger. Following receipt of the binding decision from the ECJ, the Supreme Court is expected to incorporate and issue a decision in response to all of the appeals of LivaNova and counter-appeals submitted by the Public Administrations. While the timing of the decisions by the ECJ and, subsequently, the Supreme Court are uncertain, the Company believes that the effect of the ordinance will result in a delay of any final decision until at least 2024.
In 2011, Caffaro, a SNIA subsidiary, sold its Brescia chemical business to Caffaro Brescia, a third party belonging to the Todisco group, and as part of the acquisition, Caffaro Brescia agreed to secure hydraulic barriers at the site and maintain existing environmental security measures. In September 2020, Caffaro Brescia declared it was withdrawing from its agreement to maintain the environmental measures. In January 2021, weLivaNova (in addition to Caffaro Brescia, and other non-LivaNova entities) received an administrative order (“Order”)Order from the Italian Ministry of the Environment requiring usthe Company to ensure the maintenance of the environmental measures and to guarantee that such works remain fully operational, the annual management and maintenance for which is estimated at approximately €1 million per year. LivaNova’s receipt of the Order appears to be based
23


on the aforementioned Court of Appeal decision regarding ourLivaNova’s alleged joint liability with SNIA for SNIA’s environmental liabilities. OurLivaNova’s response, dated February 16, 2021, disputes the grounds upon which the Order is based. WeLivaNova also appealed the Order in the Administrative Court in Brescia.
We haveLivaNova has not recognized a liability in connection with these related matters because any potential loss is not currently probable.
Caisson Contract Litigation / Claims
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., was filed in the United States District Court for the District of Minnesota. The complaint alleged (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”)transcatheter mitral valve replacement program and the Company’s November 20, 2019 announcement that it was ending the TMVR program at the end of 2019. The lawsuit sought damages arising out of the 2017 acquisition agreement, including various regulatory milestone payments. In May 2022, the District Court granted LivaNova’s motion for summary judgment;judgment, and in response, Caisson subsequently filed a notice of appeal toJune 2023, the Eighth Circuit Court of Appeal. We intend to vigorously defend this claim.Appeal affirmed the decision. The Company has not recognized a liability relatednow considers Caisson’s claim against LivaNova to this matter because any potential loss is not currently probable or reasonably estimable.be closed.
Please refer to “Note 3. Divestiture of Heart Valve Business” for information regardingMitral Litigation
On July 29, 2022, LivaNova received a demand letter received by the Company from Mitral for approximately €20.8 million ($22.7 million as of June 30, 2023) for breach of warranty claims under the A&R Purchase Agreement. Specifically, the claims allege failure to disclose certain information relating to a supplier, thereby allegedly impacting the profitability of Mitral’s business in China and Japan. The Company does not believe that Mitral’s claims will be sustained or that LivaNova is responsible for any alleged breach of warranty. Subject to certain exceptions, warranty claims of this type are contractually capped at €8.0 million ($8.7 million as of June 30, 2023). On March 22, 2023, Mitral served a formal claim on July 29, 2022.LivaNova in the High Court of Justice Commercial Court (King’s Bench Division) alleging damages flowing from the aforementioned asserted breaches of warranties in the A&R Purchase Agreement. Although the claim is in excess of €20.8 million, Mitral acknowledges the €8.0 million cap. The Company filed its Defense on May 17, 2023. The Company has not recognized a liability related to this matter because any potential loss is not currently probable.
Italian MedTech Payback Measure
As previously disclosed, in 2015, the Italian Parliament introduced rules regarding public contracts with the National Healthcare System for the supply of goods and services. In particular, the law introduced a “payback” measure requiring companies selling medical devices in Italy to repay a percentage of the healthcare expenditures exceeding the regional maximum caps for medical devices. In the intervening years since the rules were first issued, there has been considerable uncertainty about how the law will operate and what the exact timeline is for finalization. In August 2022, a decree was published which provided guidance and timetables for the rule. The current deadline to execute payback payments is July 31, 2023. LivaNova filed an appeal at the Administrative Court against the Decree of the Ministry of Health assessing the amount payable and against the MedTech Payback Guidelines. LivaNova also filed appeals against the regions requesting payments.
22


The Company has accrued for the law since 2015 based on market and product information. As of June 30, 2023 and December 31, 2022, the total amount reserved for this matter was $7.4 million and $6.4 million, respectively; however, the actual liability could vary.
Other Matters
Additionally, we areLivaNova is the subject of various pending or threatened legal actions and proceedings that arise in the ordinary course of ourLivaNova’s 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 ourLivaNova’s consolidated net income, financial position or liquidity.
24


Note 9.8. Stockholders' Equity
The tables below present the condensed consolidated statements of stockholders’ equity as of and for the three and six months ended June 30, 20222023 and 20212022 (in thousands):
Ordinary SharesOrdinary Shares - AmountAdditional Paid-In CapitalTreasury StockAccumulated Other Comprehensive (Loss) Income
Accumulated Deficit (1)
Total Stockholders' Equity (1)
Ordinary SharesOrdinary Shares - AmountAdditional Paid-In CapitalTreasury StockAccumulated Other Comprehensive LossAccumulated Deficit
Total Stockholders' Equity (1)
March 31, 2023March 31, 202353,854 $82,424 $2,162,928 $(319)$(41,032)$(976,660)$1,227,341 
Stock-based compensation plansStock-based compensation plans50 17 6,418 224 — — 6,659 
Net incomeNet income— — — — — 1,155 1,155 
Other comprehensive lossOther comprehensive loss— — — — 5,453 — 5,453 
June 30, 2023June 30, 202353,904 $82,441 $2,169,346 $(95)$(35,579)$(975,505)$1,240,608 
March 31, 2022March 31, 202253,764 $82,298 $2,121,098 $(619)$(16,132)$(894,791)$1,291,854 March 31, 202253,764 $82,298 $2,121,098 $(619)$(16,132)$(894,791)$1,291,854 
Stock-based compensation plansStock-based compensation plans46 61 12,160 222 — — 12,443 Stock-based compensation plans46 61 12,160 222 — — 12,443 
Net incomeNet income— — — — — 16,444 16,444 Net income— — — — — 16,444 16,444 
Other comprehensive lossOther comprehensive loss— — — — (38,738)— (38,738)Other comprehensive loss— — — — (38,738)— (38,738)
June 30, 2022June 30, 202253,810 $82,359 $2,133,258 $(397)$(54,870)$(878,347)$1,282,003 June 30, 202253,810 $82,359 $2,133,258 $(397)$(54,870)$(878,347)$1,282,003 
March 31, 202149,455 $76,310 $1,770,407 $(798)$1,938 $(792,727)$1,055,130 
Stock-based compensation plans68 95 8,706 93 — — 8,894 
Net loss— — — — — (56,487)(56,487)
Other comprehensive income— — — — 21,137 — 21,137 
June 30, 202149,523 $76,405 $1,779,113 $(705)$23,075 $(849,214)$1,028,674 
Ordinary SharesOrdinary Shares - AmountAdditional Paid-In CapitalTreasury StockAccumulated Other Comprehensive (Loss) Income
Accumulated Deficit (1)
Total Stockholders' Equity (1)
December 31, 202153,762 $82,295 $2,117,961 $(650)$(7,177)$(897,784)$1,294,645 
Stock-based compensation plans48 64 15,297 253 — — 15,614 
Net income— — — — — 19,437 19,437 
Other comprehensive loss— — — — (47,693)— (47,693)
June 30, 202253,810 $82,359 $2,133,258 $(397)$(54,870)$(878,347)$1,282,003 
December 30, 202049,447 $76,300 $1,768,156 $(1,034)$27,809 $(761,966)$1,109,265 
Stock-based compensation plans76 105 10,957 329 — — 11,391 
Net loss— — — — — (87,248)(87,248)
Other comprehensive loss— — — — (4,734)— (4,734)
June 30, 202149,523 $76,405 $1,779,113 $(705)$23,075 $(849,214)$1,028,674 
(1)Accumulated deficit and total stockholders’ equity as of June 30, 2021 and net loss for the three and six months ended June 30, 2021 have been revised. For further details refer to “Note 1. Unaudited Condensed Consolidated Financial Statements.”
Ordinary SharesOrdinary Shares - AmountAdditional Paid-In CapitalTreasury StockAccumulated Other Comprehensive LossAccumulated Deficit
Total Stockholders' Equity (1)
December 31, 202253,852 $82,424 $2,157,724 $(375)$(48,119)$(984,030)$1,207,624 
Stock-based compensation plans52 17 11,622 280 — — 11,919 
Net income— — — — — 8,525 8,525 
Other comprehensive loss— — — — 12,540 — 12,540 
June 30, 202353,904 $82,441 $2,169,346 $(95)$(35,579)$(975,505)$1,240,608 
December 31, 202153,762 $82,295 $2,117,961 $(650)$(7,177)$(897,784)$1,294,645 
Stock-based compensation plans48 64 15,297 253 — — 15,614 
Net income— — — — — 19,437 19,437 
Other comprehensive loss— — — — (47,693)— (47,693)
June 30, 202253,810 $82,359 $2,133,258 $(397)$(54,870)$(878,347)$1,282,003 
2523


The table below presents the change in each component of AOCI, net of tax, and the reclassifications out of AOCI into net income (loss) for the six months ended June 30, 20222023 and 20212022 (in thousands):
Change in Unrealized Gain (Loss) on Derivatives
Foreign Currency Translation Adjustments Gain (Loss) (1)
Total
December 31, 2022December 31, 2022$966 $(49,085)$(48,119)
Other comprehensive loss before reclassifications, before taxOther comprehensive loss before reclassifications, before tax(433)13,506 13,073 
Tax benefitTax benefit— — — 
Other comprehensive loss before reclassifications, net of taxOther comprehensive loss before reclassifications, net of tax(433)13,506 13,073 
Reclassification of gain from accumulated other comprehensive loss, before taxReclassification of gain from accumulated other comprehensive loss, before tax(533)— (533)
Reclassification of tax benefitReclassification of tax benefit— — — 
Reclassification of gain from accumulated other comprehensive loss, after taxReclassification of gain from accumulated other comprehensive loss, after tax(533)— (533)
Net current-period other comprehensive loss, net of taxNet current-period other comprehensive loss, net of tax(966)13,506 12,540 
June 30, 2023June 30, 2023$— $(35,579)$(35,579)
Change in Unrealized Gain (Loss) on Derivatives
Foreign Currency Translation Adjustments Gain (Loss) (1)
Total
December 31, 2021December 31, 2021$(945)$(6,232)$(7,177)December 31, 2021$(945)$(6,232)$(7,177)
Other comprehensive loss before reclassifications, before taxOther comprehensive loss before reclassifications, before tax(1,758)(45,766)(47,524)Other comprehensive loss before reclassifications, before tax(1,758)(45,766)(47,524)
Tax benefitTax benefit— — — Tax benefit— — — 
Other comprehensive loss before reclassifications, net of taxOther comprehensive loss before reclassifications, net of tax(1,758)(45,766)(47,524)Other comprehensive loss before reclassifications, net of tax(1,758)(45,766)(47,524)
Reclassification of gain from accumulated other comprehensive loss, before taxReclassification of gain from accumulated other comprehensive loss, before tax(169)— (169)Reclassification of gain from accumulated other comprehensive loss, before tax(169)— (169)
Reclassification of tax benefitReclassification of tax benefit— — — Reclassification of tax benefit— — — 
Reclassification of gain from accumulated other comprehensive loss, after taxReclassification of gain from accumulated other comprehensive loss, after tax(169)— (169)Reclassification of gain from accumulated other comprehensive loss, after tax(169)— (169)
Net current-period other comprehensive loss, net of taxNet current-period other comprehensive loss, net of tax(1,927)(45,766)(47,693)Net current-period other comprehensive loss, net of tax(1,927)(45,766)(47,693)
June 30, 2022June 30, 2022$(2,872)$(51,998)$(54,870)June 30, 2022$(2,872)$(51,998)$(54,870)
December 31, 2020$2,319 $25,490 $27,809 
Other comprehensive loss before reclassifications, before tax(2,844)(3,530)(6,374)
Tax benefit683 — 683 
Other comprehensive loss before reclassifications, net of tax(2,161)(3,530)(5,691)
Reclassification of loss from accumulated other comprehensive income, before tax1,259 — 1,259 
Reclassification of tax benefit(302)— (302)
Reclassification of loss from accumulated other comprehensive income, after tax957 — 957 
Net current-period other comprehensive loss, net of tax(1,204)(3,530)(4,734)
June 30, 2021$1,115 $21,960 $23,075 
(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.
24


Note 10.9. 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,
2022202120222021
Service-based restricted stock units (“RSUs”)$5,882 $5,205 $11,226 $10,047 
Service-based stock appreciation rights (“SARs”)3,720 3,064 6,658 6,386 
Market performance-based restricted stock units1,003 898 1,854 1,661 
Operating performance-based restricted stock units611 239 1,396 506 
Employee share purchase plan293 510 631 852 
Total stock-based compensation expense$11,509 $9,916 $21,765 $19,452 
Stock-based awards may be granted under the 2015 Incentive Award Plan (the “2015 Plan”) and the 2022 Incentive Award Plan (the “2022 Plan”) in the form of stock options, SARs, RSUs and other stock-based and cash-based awards. As of June 30, 2022, there were 56,428 shares available for future grants to our Non-Executive Directors under the 2015 Plan and 1,900,000 shares pursuant to Options or Stock Appreciation Rights and 1,173,352 shares pursuant to other types of awards available for future grants to our employees under the 2022 Plan.
During the six months ended June 30, 2022, we2023, LivaNova issued stock-based compensatory awards with terms approved by the Compensation Committee of ourLivaNova’s Board of Directors. The awards with service conditions generally vest ratably from two toover four
26


years and are subject to forfeiture unless service conditions are met. The market performance-based awards that were issued cliff vest after three years subject to the rank of ourLivaNova’s total shareholder return for the three-year period ending December 31, 20242025 relative to the total shareholder returns for a peer group of companies. The adjusted free cash flow and return on invested capital operating performance-based awards that were issued, cliff vest after three years subject to the achievement of certain thresholds of cumulative results for the three-year period ending December 31, 2024.2025. Compensation expense related to awards granted during 20222023 for the three and six months ended June 30, 2023 was $2.4 million and $2.5 million, respectively.
Stock-based awards may be granted under the 2015 Plan and the 2022 was $3.0 million.Plan in the form of stock options, SARs, RSUs and other stock-based and cash-based awards. As of June 30, 2023, there were 8,977 shares available for future grants to LivaNova’s Non-Executive Directors under the 2015 Plan and 1,376,623 shares pursuant to Options or Stock Appreciation Rights and 914,340 shares pursuant to other types of awards available for future grants to LivaNova’s employees under the 2022 Plan. In June 2023, the Company’s shareholders approved the A&R 2022 Plan. The A&R 2022 Plan increases the aggregate number of ordinary shares that can be issued under the 2022 Plan pursuant to options or SARs from 1,900,000 to 2,250,000, and the number of ordinary shares that can be issued pursuant to awards other than options or SARs from 1,200,000 to 1,500,000.
Stock-based incentive plan compensation expense is as follows (in thousands):
Three Months Ended June 30,Six Months Ended June 30,
2023202220232022
RSUs$4,696 $5,882 $10,413 $11,226 
SARs3,706 3,720 6,827 6,658 
Market performance-based restricted stock units(1,560)1,003 (679)1,854 
Operating performance-based restricted stock units(1,429)611 (859)1,396 
Employee share purchase plan298 293 588 631 
Total stock-based compensation expense$5,711 $11,509 $16,290 $21,765 
Stock-based compensation agreements issued during the six months ended June 30, 2022,2023 representing potential shares and their weighted average grant date fair values by type is as follows (shares in thousands, fair value in dollars):
Six Months Ended June 30, 2022Six Months Ended June 30, 2023
SharesWeighted Average Grant Date Fair ValueSharesWeighted Average Grant Date Fair Value
Service-based SARsService-based SARs553,050 $34.13 Service-based SARs974,204 $19.44 
Service-based RSUsService-based RSUs291,330 $79.04 Service-based RSUs499,301 $42.79 
Market performance-based RSUsMarket performance-based RSUs44,180 $103.02 Market performance-based RSUs94,561 $38.95 
Operating performance-based RSUsOperating performance-based RSUs44,174 $82.04 Operating performance-based RSUs94,556 $42.30 
Note 11.10. Income Taxes
OurLivaNova’s effective income tax rate for the three and six months ended June 30, 20222023 was 13.2%77.6% and 20.6%43.0%, respectively, compared with (7.4)%13.2% and (8.1)%, respectively,20.6% for the three and six months ended June 30, 2021. Our2022, respectively. LivaNova’s effective income tax rate fluctuates based on, among other factors, changes in pretax income in countries with varying statutory tax rates, valuation allowances, tax credits and incentives and unrecognized tax benefits associated with uncertain tax positions.
WeLivaNova continually assessassesses the realizability of ourits worldwide deferred tax asset and valuation allowance positions, and when the need arises, we establishthe Company establishes or releasereleases valuation allowances accordingly.
Compared with the three months ended June 30, 2021, the changeThese increases in the effective tax rate for both the three and six months ended June 30, 2022 was2023 compared to the prior year periods were primarily attributable to discrete items andchanges in valuation allowances, year-over-year changes in income before tax in countries with varying statutory tax rates as compared to the discrete tax impact of the sale of the Heart Valve business during the three months ended June 30, 2021.and an audit settlement.
Compared with the six months ended June 30, 2021, the change in the effective tax rate for the six months ended June 30, 2022 was primarily attributable to discrete items and changes in income before tax in countries with varying statutory tax rates as compared to discrete items and the discrete tax impact of the sale of the Heart Valve business during the six months ended June 30, 2021.
25


We operateLivaNova operates in multiple jurisdictions throughout the world, and ourits tax returns are periodically audited or subjected to review by tax authorities. As a result, there is an uncertainty in income taxes recognized in ourLivaNova’s financial statements. Tax benefits totaling $1.6$0.5 million and $1.7$1.6 million were unrecognized as of June 30, 20222023 and December 31, 2022, respectively.
On October 8, 2021, respectively. It is reasonably possible that, withinmembers of the next twelve months, dueOECD / G20 Inclusive Framework on BEPS agreed to a Two-Pillar Solution to address tax challenges of a global economy. The Two-Pillar Solution aims to ensure multinational companies will be subject to a minimum 15% global tax rate (Pillar Two) and will reallocate profits to the settlementmarket jurisdictions where sales arise (Pillar One). As part of uncertainthe ongoing release of Pillar Two rules by various jurisdictions, the UK Act was enacted on July 11, 2023, and implements the OECD’s BEPS Pillar Two income inclusion rule including a multinational top-up tax positions with variousand a domestic top-up tax authoritiesto the minimum effective tax rate of 15% for accounting periods beginning on or after December 31, 2023. The UK Act also includes a transitional safe harbor election for accounting periods beginning on or before Dec 31, 2026. We are reviewing the draft guidance issued on June 15, 2023, and the expiration of statutes of limitations, unrecognized tax benefits could decrease by upUK Act to approximately $1.0 million.assess the full implications for 2024 and will continue to monitor related guidance in the UK and other jurisdictions that impact LivaNova’s operations.
Note 12.11. 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, 20222023 and 20212022 are as follows (in thousands):
Three Months Ended June 30,Six Months Ended June 30,Three Months Ended June 30,Six Months Ended June 30,
20222021202220212023202220232022
Basic weighted average shares outstandingBasic weighted average shares outstanding53,506 48,928 53,420 48,833 Basic weighted average shares outstanding53,803 53,506 53,713 53,420 
Add effects of share-based compensation instruments (1)
Add effects of share-based compensation instruments (1)
574 — 724 — 
Add effects of share-based compensation instruments (1)
174 574 229 724 
Diluted weighted average shares outstandingDiluted weighted average shares outstanding54,080 48,928 54,144 48,833 Diluted weighted average shares outstanding53,977 54,080 53,942 54,144 
(1)Excluded from the computation of diluted earnings per share were stock options, SARs and restricted share units totaling 2.23.5 million and 3.92.2 million for the three months ended June 30, 20222023 and 2021,2022, respectively, and 2.23.4 million and 4.12.2 million for the six months ended June 30, 20222023 and 2021,2022, respectively, because to include them would have been anti-dilutive under the treasury stock method.
27


Note 13.12. Geographic and Segment Information
We identifyLivaNova identifies operating segments based on the way we manage, evaluatehow it manages, evaluates and internally report ourreports its business activities for purposes of allocatingto allocate resources, developingdevelop and executing ourexecute its strategy and assessingassess performance. We have 3LivaNova has three reportable segments: Cardiopulmonary, Neuromodulation and ACS.
OurLivaNova’s Cardiopulmonary segment is engaged in the development, production and sale of cardiopulmonary products, including oxygenators, heart-lung machines, oxygenators, autotransfusion systems, perfusion tubing systems, cannulae and other related accessories.
OurLivaNova’s Neuromodulation segment is engaged in the design, development and marketing of devices that deliver neuromodulation therapy for treating drug-resistant epilepsy (“DRE”)DRE and difficult-to-treat depression (“DTD”).DTD. 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. It also includes the development and management of clinical testing of ourLivaNova’s aura6000 System for treating obstructive sleep apnea (“OSA”). This device stimulates the hypoglossal nerve, which in turn, engages certain muscles in the tongue in order to open the airway while a patient is sleeping. OurOSA. LivaNova’s Neuromodulation segment also includes the VITARIA System for treatingcosts associated with LivaNova’s former heart failure by stimulatingprogram, which, as previously disclosed, the right vagus nerve.Company began to wind down during the first quarter of 2023.
Our Advanced Circulatory SupportLivaNova’s ACS segment is engaged in the development, production and sale of leading-edge temporary life support products. OurLivaNova’s ACS products, which comprise the LifeSPARC platform, simplify temporary extracorporeal cardiopulmonary life support solutions for critically ill patients. The LifeSPARC platform includes a common compact console and pump that provides temporary support for emergent rescue patients in a variety of settings. OurLivaNova’s ACS segment also includes the Hemolung Respiratory Assist System (“Hemolung RAS”),RAS, which was acquired in May 2022 as part of the acquisition of ALung.
“Other” includes corporate shared service expenses for finance, legal, human resources, information technology and corporate business development. For 2021, other also includesNet revenue of the results of our Heart Valves business, which was disposed of on June 1, 2021.
Net sales of ourCompany’s reportable segments includes revenues from the sale of products that each reportable segment develops and manufactures or distributes. We defineLivaNova defines segment income as operating income before merger and integration expense, restructuring andexpense, amortization of intangibles.intangibles as well as other income and expense not allocated to segments. Other income and expense not allocated to segments primarily includes rental income and SG&A expenses for finance, legal, human resources, information technology and corporate business development.
2826


We operateLivaNova operates under 3three geographic regions: U.S., Europe, and Rest of World. The table below presents net salesrevenue by operating segment and geographic region (in thousands):
Three Months Ended June 30,Six Months Ended June 30,Three Months Ended June 30,Six Months Ended June 30,
20222021202220212023202220232022
CardiopulmonaryCardiopulmonaryCardiopulmonary
United StatesUnited States$37,865 $37,388 $75,961 $73,147 United States$46,711 $37,865 $82,825 $75,961 
Europe33,159 35,133 65,226 65,759 
Europe (1)
Europe (1)
39,169 33,159 75,452 65,226 
Rest of WorldRest of World54,796 45,355 101,708 87,689 Rest of World64,723 54,796 124,398 101,708 
125,820 117,876 242,895 226,595 150,603 125,820 282,675 242,895 
NeuromodulationNeuromodulationNeuromodulation
United StatesUnited States91,431 91,779 178,641 174,079 United States104,065 91,431 198,554 178,641 
Europe13,710 14,604 26,166 26,283 
Europe (1)
Europe (1)
15,125 13,710 28,405 26,166 
Rest of WorldRest of World12,654 11,253 23,215 20,973 Rest of World13,991 12,654 26,945 23,215 
117,795 117,636 228,022 221,335 133,181 117,795 253,904 228,022 
Advanced Circulatory SupportAdvanced Circulatory SupportAdvanced Circulatory Support
United StatesUnited States8,790 12,964 19,753 25,524 United States9,197 8,790 18,861 19,753 
Europe503 178 1,106 406 
Europe (1)
Europe (1)
165 503 245 1,106 
Rest of WorldRest of World59 133 176 337 Rest of World55 59 153 176 
9,352 13,275 21,035 26,267 9,417 9,352 19,259 21,035 
Other (1)
Other Revenue (2)
Other Revenue (2)
United StatesUnited States— 2,212 — 4,929 United States— — — — 
Europe— 6,123 — 14,407 
Europe (1)
Europe (1)
— — — — 
Rest of WorldRest of World1,184 7,361 2,374 18,553 Rest of World681 1,184 1,462 2,374 
1,184 15,696 2,374 37,889 681 1,184 1,462 2,374 
TotalsTotalsTotals
United StatesUnited States138,086 144,343 274,355 277,679 United States159,973 138,086 300,240 274,355 
Europe (2)
47,372 56,038 92,498 106,855 
Europe (1)
Europe (1)
54,459 47,372 104,102 92,498 
Rest of WorldRest of World68,693 64,102 127,473 127,552 Rest of World79,450 68,693 152,958 127,473 
Total (3)
Total (3)
$254,151 $264,483 $494,326 $512,086 
Total (3)
$293,882 $254,151 $557,300 $494,326 
(1)For 2021, other primarily includes the net sales of the Company’s Heart Valves business, which was disposed of on June 1, 2021.
(2)Europe includes thoseIncludes countries in which we haveEurope where the Company has a direct sales presence, whereas European countries in which we sellpresence. Countries where sales are made through distributors are included in Rest“Rest of World.
(2)Other revenue primarily includes rental income not allocated to segments.
(3)No single customer represented over 10% of ourthe Company’s consolidated net sales.revenue. No country’s net salesrevenue exceeded 10% of ourthe Company’s consolidated salesrevenue except for the U.S.
2927


The table below presents a reconciliation of segment income (loss) to consolidated income (loss) before tax (in thousands):
Three Months Ended June 30,Six Months Ended June 30,Three Months Ended June 30,Six Months Ended June 30,
2022
2021 (1)
2022
2021 (1)
2023202220232022
CardiopulmonaryCardiopulmonary$3,644 $(25,099)$10,539 $(23,657)Cardiopulmonary$11,381 $3,644 $18,965 $10,539 
NeuromodulationNeuromodulation51,360 38,156 88,838 72,239 Neuromodulation38,148 51,360 65,154 88,838 
Advanced Circulatory SupportAdvanced Circulatory Support3,485 (1,311)(1,953)1,082 Advanced Circulatory Support(4,750)3,485 (11,199)(1,953)
Other (2)
(19,450)(37,634)(42,532)(67,829)
Total reportable segment income (loss)39,039 (25,888)54,892 (18,165)
Segment incomeSegment income44,779 58,489 72,920 97,424 
Other expenses (3)
7,283 10,374 13,631 23,795 
Operating income (loss)31,756 (36,262)41,261 (41,960)
Other income/(expense) (1)
Other income/(expense) (1)
(27,403)(26,733)(57,886)(56,163)
Operating incomeOperating income17,376 31,756 15,034 41,261 
Interest expenseInterest expense(14,388)(16,515)(22,228)(32,451)Interest expense(14,809)(14,388)(28,246)(22,228)
Foreign exchange and other income/(expense)Foreign exchange and other income/(expense)1,633 239 5,537 (6,204)Foreign exchange and other income/(expense)2,713 1,633 28,260 5,537 
Income (loss) before tax$19,001 $(52,538)$24,570 $(80,615)
Income before taxIncome before tax$5,280 $19,001 $15,048 $24,570 
(1)SegmentOther income/(expense) primarily includes rental income, for the three and six months ended June 30, 2021 has been revised. For further details refer to “Note 1. Unaudited Condensed Consolidated Financial Statements.”
(2)Other includes corporate shared serviceSG&A expenses for finance, legal, human resources, information technology and corporate business development. For 2021, other also includes the results of the Company’s Heart Valves business, which was disposed of on June 1, 2021.
(3)Other expenses primarily consist ofdevelopment, as well as amortization of intangible assets, merger and integration expense and restructuring expense.
Assets by segment are as follows (in thousands):
June 30, 2022December 31, 2021June 30, 2023December 31, 2022
CardiopulmonaryCardiopulmonary$860,410 $921,481 Cardiopulmonary$909,837 $874,143 
NeuromodulationNeuromodulation651,085 646,394 Neuromodulation642,041 646,633 
Advanced Circulatory SupportAdvanced Circulatory Support259,515 231,846 Advanced Circulatory Support116,229 121,454 
Other565,235 401,230 
Other assets (1)
Other assets (1)
673,448 652,543 
TotalTotal$2,336,245 $2,200,951 Total$2,341,555 $2,294,773 
(1)Other assets primarily includes corporate assets not allocated to segments.
Capital expenditures by segment are as follows (in thousands):
Three Months Ended June 30,Six Months Ended June 30,Three Months Ended June 30,Six Months Ended June 30,
20222021202220212023202220232022
CardiopulmonaryCardiopulmonary$3,213 $2,671 $5,042 $5,720 Cardiopulmonary$2,543 $3,213 $7,341 $5,042 
NeuromodulationNeuromodulation46 51 130 91 Neuromodulation133 46 492 130 
Advanced Circulatory SupportAdvanced Circulatory Support— 528 684 1,084 Advanced Circulatory Support708 — 845 684 
Other2,604 2,882 5,587 4,351 
Other capital expenditures (1)
Other capital expenditures (1)
2,671 2,604 5,228 5,587 
TotalTotal$5,863 $6,132 $11,443 $11,246 Total$6,055 $5,863 $13,906 $11,443 
(1)Other capital expenditures primarily includes corporate capital expenditures not allocated to segments.
The changes in the carrying amount of goodwill by segment for the six months ended June 30, 20222023 were as follows (in thousands):
CardiopulmonaryNeuromodulationAdvanced Circulatory SupportTotal
December 31, 2021$398,245 $398,754 $102,526 $899,525 
Goodwill as a result of acquisition— — 25,893 25,893 
Foreign currency adjustments(27,348)— — (27,348)
June 30, 2022$370,897 $398,754 $128,419 $898,070 
CardiopulmonaryNeuromodulationTotal
December 31, 2022$370,033 $398,754 $768,787 
Foreign currency adjustments10,425 — 10,425 
June 30, 2023$380,458 $398,754 $779,212 
3028


Property, plant and equipment, net by geography are as follows (in thousands):
June 30, 2022December 31, 2021June 30, 2023December 31, 2022
United StatesUnited States$62,704 $60,852 United States$66,360 $63,458 
EuropeEurope76,309 85,313 Europe79,102 79,654 
Rest of WorldRest of World4,299 3,901 Rest of World4,106 4,075 
TotalTotal$143,312 $150,066 Total$149,568 $147,187 
Note 14.13. Supplemental Financial Information
Inventories consisted of the following (in thousands):
June 30, 2022December 31, 2021June 30, 2023December 31, 2022
Raw materialsRaw materials$53,019 $43,958 Raw materials$86,929 $70,027 
Work-in-processWork-in-process18,227 14,161 Work-in-process18,521 15,508 
Finished goodsFinished goods48,169 47,721 Finished goods50,996 43,844 
$119,415 $105,840  $156,446 $129,379 
As of June 30, 20222023 and December 31, 2021,2022, inventories included adjustments totaling $9.0$11.2 million and $8.9$8.2 million, respectively, to record balances at lower of cost or net realizable value.
Accrued liabilities and other consisted of the following (in thousands):
June 30, 2022December 31, 2021
Operating lease liabilities$10,245 $11,261 
Contract liabilities9,097 8,419 
Amount payable to Gyrus Capital S.A.8,767 11,418 
Legal and other administrative costs8,524 8,948 
Research and development costs6,065 5,329 
Contingent consideration (1)
5,552 11,552 
Provisions for agents, returns and other1,700 2,535 
Other accrued expenses34,002 29,475 
$83,952 $88,937 
(1)Refer to “Note 5. Fair Value Measurements”
June 30, 2023December 31, 2022
Legal and professional costs$12,071 $8,653 
Contract liabilities11,042 10,226 
Operating lease liabilities9,851 9,379 
Interest payable7,493 — 
Research and development costs6,043 7,020 
Italian medical device payback law7,401 6,414 
Royalty accrual4,362 3,950 
Provisions for agents, returns and other4,432 1,678 
Current derivative liabilities113 5,886 
Restructuring liabilities904 2,045 
Other accrued expenses18,326 26,230 
$82,038 $81,481 
As of June 30, 20222023 and December 31, 2021,2022, contract liabilities totaling $11.8$15.6 million and $9.8$14.1 million, respectively, were included within accrued liabilities and other long-term liabilities on the condensed consolidated balance sheets.
31


The table below presents the items included within “Foreign exchange and other income/(expense)” on the condensed consolidated statements of income (loss) (in thousands):
Three Months Ended June 30,Six Months Ended June 30,Three Months Ended June 30,Six Months Ended June 30,
20222021202220212023202220232022
Exchangeable Notes fair value adjustment (1)
Exchangeable Notes fair value adjustment (1)
$36,570 $(26,048)$47,610 $(52,384)
Exchangeable Notes fair value adjustment (1)
$(12,420)$36,570 $31,970 $47,610 
Capped call fair value adjustment (1)
Capped call fair value adjustment (1)
(35,109)19,408 (45,021)31,957 
Capped call fair value adjustment (1)
11,020 (35,109)(12,359)(45,021)
Investment revaluation (2)
— — — 4,640 
Dividend Income (2)
— 3,133 — 3,133 
Other derivative liabilities fair value adjustment— 923 — 4,090 
Foreign exchange rate fluctuationsForeign exchange rate fluctuations341 1,544 3,132 1,134 Foreign exchange rate fluctuations(1,230)341 (1,008)3,132 
Interest incomeInterest income57 189 77 115 Interest income5,528 57 10,064 77 
OtherOther(226)1,090 (261)1,111 Other(185)(226)(407)(261)
Foreign exchange and other income/(expense)Foreign exchange and other income/(expense)$1,633 $239 $5,537 $(6,204)Foreign exchange and other income/(expense)$2,713 $1,633 $28,260 $5,537 
(1)Refer to “Note 5.4. Fair Value Measurements”
(2)
29

Refer to “Note 4. Investments”
The table below presents a reconciliation of cash, cash equivalents and restricted cash reported on the condensed consolidated balance sheets that sum to the total of the amounts shown on the condensed consolidated statement of cash flows (in thousands):
June 30, 2022December 31, 2021June 30, 2023December 31, 2022
Cash and cash equivalentsCash and cash equivalents$109,022 $207,992 Cash and cash equivalents$222,935 $214,172 
Restricted cash (1)
Restricted cash (1)
297,747 — 
Restricted cash (1)
311,425 301,446 
Cash, cash equivalents and restricted cashCash, cash equivalents and restricted cash$406,769 $207,992 Cash, cash equivalents and restricted cash$534,360 $515,618 
(1)Restricted cash represents funds held as collateral for the SNIA Litigation Guarantee. Refer to “Note 8.7. Commitments and Contingencies.”
Note 15. Subsequent Event
On July 6, 2022, LivaNova and its wholly-owned subsidiary, LivaNova USA, Inc. ( “LivaNova USA”), entered into a new incremental facility amendment (the “Incremental Amendment No. 2”) to its 2021 First Lien Credit Agreement. The Incremental Amendment No. 2 provides for LivaNova USA to, among other things, obtain commitments for term loan facilities from a syndicate of lenders in an aggregate principal amount of $350 million consisting of (i) an initial term loan facility in an aggregate principal amount of $300 million (the “Initial Term Facility”) and (ii) a delayed draw term loan facility in an additional aggregate principal amount of $50 million, which are available in one single drawing on or after July 6 until the date that is nine months after such date (the “Delayed Draw Term Facility” and, together with the Initial Term Facility, the “Term Facilities”).
Proceeds of the Initial Term Facility were used to repay in full the Bridge Loan Facility on July 6, 2022, with the remainder to be used for general corporate purposes of the Company. The Term Facilities have a maturity of the earlier of (i) five years or (ii) 91 days prior to December 15, 2025, the maturity date of the Notes, unless by that date LivaNova USA will have either redeemed or refinanced the Notes, or set aside an amount of cash equal to the then-outstanding principal amount of the Notes. The Term Facilities bear interest at a rate equal to an adjusted term SOFR (or, alternatively, the Alternate Base Rate) plus a variable margin based on the Company’s consolidated Total Net Leverage Ratio. As of the date of effectiveness of the Incremental Amendment No. 2, the applicable margin over Adjusted SOFR was equal to 3.50% per annum. The Term Facilities are subject to an original issue discount of 1.5% of their principal amount. The Delayed Draw Term Facility also contemplates the payment of commitment fees at a variable percentage based on the Company’s Total Net Leverage Ratio. As of the date of effectiveness of the Incremental Amendment No. 2, the applicable commitment fee percentage was equal to 0.50% per annum. The Term Facilities are subject to quarterly amortization, based on the following amortization schedule: (i) year one: 2.5%; (ii) year two: 5.0%; (ii) year three: 5.00%; (iv) year four: 7.5%; and (v) year five: 10.0%, with the remainder to be paid at maturity.
The 2021 First Lien Credit Agreement, as amended, contains customary representations, warranties and covenants, including the requirement to maintain a Senior Secured First Lien Net Leverage Ratio, calculated as the ratio of Consolidated Senior Secured Indebtedness to Consolidated EBITDA, as defined in the credit agreement, for the period of four consecutive fiscal quarters ended on the calculation date, of less than 3.50 to 1.00 and an interest coverage ratio of not less than 3.00 to 1.00.
3230


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 ourthe condensed consolidated financial statements and related notes, which appear elsewhere in this document, and with our 2021LivaNova’s 2022 Form 10-K. OurLivaNova’s discussion and analysis may contain forward-looking statements that involve risks and uncertainties. OurThe Company’s 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 Part I, Item 1A. of our 2021LivaNova’s 2022 Form 10-K, as updated and supplemented by ourLivaNova’s Quarterly Reports on Form 10-Q, including in Part II, Item 1A. and elsewhere in this Quarterly Report on Form 10-Q.
The capitalized terms used below have been defined in the notes to ourLivaNova’s condensed consolidated financial statements. Instatements and the following text, the terms “LivaNova,” “the Company,” “we,” “us” and “our” refer to LivaNova PLC and its consolidated subsidiaries.“Definitions” section of this Quarterly Report on Form 10-Q.
Global DevelopmentsMacroeconomic Environment
COVID-19
COVID-19 and its effects on the economy, employment, patient behaviors andThe current macroeconomic environment, including foreign exchange volatility, supply chain among others,challenges, inflationary pressures, and geopolitical instability, has causedimpacted and may continue to cause variable demand for our products. Throughout the pandemic, healthcare customers have diverted medical resources and priorities towards the treatment of COVID-19, and public health bodies have delayed elective procedures, which has negatively impacted the usage of our products. Further, some people have avoided seeking treatment for non-COVID-19 procedures, and hospitals and clinics have experienced staffing shortages, which has negatively impacted the demand for our products. While the recovery of global cardiopulmonary procedures has resulted in stronger demand for our Cardiopulmonary products, our Neuromodulation business continues to experience ongoing COVID-19 related headwinds as described above. Our ACS business has been similarly negatively impacted by a reduction in patients treated with ECMO related to fewer severe COVID-19 cases and hospital staffing challenges. We are monitoring the potential for various strains of the virus to cause a resumption of high levels of infection and hospitalization that, in turn, may affect the demand for our products.
Moreover, although our RECOVER study and ANTHEM-HFrEF and OSPREY clinical trials continue to progress, there may be delays or closures of sites in the future should COVID-19 or variants thereof strengthen or reemerge.
Ourimpact LivaNova’s business. LivaNova’s net salesrevenue and profitability have been negatively affected by the unfavorable foreign currency exchange impact of the strengthened U.S. dollarUSD against a number of currencies. Furthermore, we continueLivaNova continues to experience supply chain delays and interruptions, labor shortages, inflationary pressures and logistical issues in the wake of COVID-19.issues. Though, to date, ourthe Company’s supply of raw materials and the production and distribution of finished products have not been materially affected, demand and low capacity worldwide have caused longer lead times and put price pressure on key raw materials. Moreover, freight and labor costs at ourLivaNova’s manufacturing facilities have increased substantially due to COVID-related disruptions and in the wake of inflation globally. The Company continues to respond to such challenges, and while we haveLivaNova has business continuity plans in place, the impact of the ongoing challenges we are experiencing,the Company is navigating, along with their potential escalation, may adversely affect our business and the recoverability of our tangible and intangible assets. The future impact of pandemic-related developments remains uncertain.
Importantly, we continue to take actions in managing the health and safety of our employees throughout the pandemic. Though there has been no Company-wide mandate to return to the office, employees are encouraged to return for purposeful collaboration. We continue to maintain enhanced safety protocols and encourage our employees to seek vaccination. 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.
Ukraine Invasionits business.
In February 2022, Russia launched an invasion in Ukraine, which caused usthe Company to assess ourits ability to sell in the market due to international sanctions, to consider the potential impact of raw material sourced from the region, and to determine whether we areLivaNova is able to transact in a compliant fashion. Although the regionbusiness across Russia, Ukraine and Belarus represented 1% of ourLivaNova’s total net salesrevenue for 2021,2022, the Russian invasion of Ukraine has increased economic uncertainties, and a significant escalation or continuation of the conflict could have a material, global impact on ourthe Company’s operating results. In addition, our Russian employees and local subsidiary are subject to evolving laws and regulations imposed by the Russian authorities in response to international sanctions.
33


Business Overview
We areLivaNova is a global medical technology company built on nearly five decades of experience and a relentless commitment to provide hope for patients and their families through medical technologies, delivering life-changing improvements for both the Head and Heart. The Company is a public limited company organized under the laws of England and Wales and headquartered in London, England. We are a global medical device company focused on the development and delivery of important products and therapies for the benefit of patients, healthcare professionals and healthcare systems throughout the world. We design, develop, manufacture and sell innovative products and therapies that are consistent with our mission to provide hope to patients through innovative technologies, delivering life-changing improvements for both the Head and Heart.
LivaNova is comprised of three reportable segments: Cardiopulmonary, Neuromodulation and ACS, corresponding to ourits primary business units. Other includes corporate shared service expenses for finance, legal, human resources, information technology and corporate business development. For 2021, other also includes the results of our Heart Valves business, which was disposed of on June 1, 2021.
For further information regarding ourLivaNova’s business segments, historical financial information and ourits 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.
Cardiopulmonary
OurLivaNova’s Cardiopulmonary segment is engaged in the development, production and sale of cardiopulmonary products, including oxygenators, heart-lung machines, oxygenators, autotransfusion systems, perfusion tubing systems, cannulae and other related accessories.
In March 2023, LivaNova announced it received FDA 510(k) clearance for its Essenz HLM. With FDA clearance, LivaNova initiated the commercial launch of Essenz in the U.S. The Company has also recently received approval for the Essenz HLM from Health Canada and the Japanese Pharmaceuticals and Medical Devices Agency. Additionally, in March 2023, LivaNova initiated a broad commercial release in Europe following a successful limited commercial release that supported more than 200 adult, pediatric and neonatal patients in Europe.
Information on Cardiopulmonary that could potentially impact ourLivaNova’s condensed consolidated financial statements and related disclosures is incorporated by reference to Part I. Note 8. Commitments and Contingencies: FDA Warning Letter, and Part I. Note 8.7. Commitments and Contingencies: Product Liability.Liability Litigation.
31


Neuromodulation
OurLivaNova’s Neuromodulation segment is engaged in the design, development and marketing of devices that deliver neuromodulation therapy for treating DRE and DTD. 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. It also includes the development and management of clinical testing of ourLivaNova’s aura6000 System for treating OSA. This device stimulates the hypoglossal nerve, which in turn, engages certain muscles in the tongue in ordermuscles to open the airway while a patient is sleeping. Oursleeps. LivaNova’s Neuromodulation segment also includes the VITARIA System for treatingcosts associated with LivaNova’s former heart failure by stimulatingprogram, which the right vagus nerve.Company began to wind down during the first quarter of 2023.
In March 2022,2023, LivaNova announcedrandomized the 250th500th unipolar depression patient was implantedinto the RECOVER clinical study and subsequently completed all implants in May. Upon receipt of the DTD12-month follow-up data for all 500 patients, the Company expects to conduct a final analysis for the unipolar cohort, culminating in a publication of the study results for that cohort.
In June 2023, LivaNova randomized the 150th bipolar depression patient into the RECOVER clinical study. This key milestone preceded conductingThe RECOVER clinical study’s protocol allows for a minimum of 150 and a maximum of 500 bipolar depression patients to be randomized into the first interim analysis. The study was designed with frequentstudy. Having randomized the 150th bipolar patient, a series of interim analyses towill be conducted by an independent Statistical Analysis Committee. The interim analyses willCommittee to assess if predictive probability of success has been reached for the unipolarbipolar cohort of the study. If any analysis reveals that the predictive probability of success has been reached, recruitment into the results will be shared withbipolar arm of the U.S. Centers for Medicare & Medicaid Services (“CMS”) with the intent that randomized controlled trial enrollment for that patient populationstudy will cease and future patientswe will be enrolled intonotify CMS of the initiation of the prospective open-label longitudinal study. study for future bipolar Medicare patients. After the last patient enrolled into the RECOVER clinical study has completed 12 months of follow-up, a final analysis will be conducted on the complete bipolar dataset.
The RECOVER clinical study, is currently under way as part of a Coverage with Evidence Development framework per the CMS National Coverage Determination process. The trial, if successful, will be used to support a peer-reviewed article and reconsideration of reimbursement for VNS Therapytherapy by CMS for the treatment of depression that is difficult to treat.DTD. The reconsideration process will happen independently for the unipolar and bipolar cohorts.
Advanced Circulatory Support
OurLivaNova’s ACS segment is engaged in the development, production and sale of leading-edge temporary life support products. OurLivaNova’s ACS products, which comprise the LifeSPARC platform, simplify temporary extracorporeal cardiopulmonary life support solutions for critically ill patients. The LifeSPARC platform includes a common compact console and pump that provides temporary support for emergent rescue patients in a variety of settings. Designed for ease of use, the system offers power and versatility for multi-disciplinary programs to support more patients in more places. The platform is accompanied by four specialized and ready-to-deploy kits, each designed to support diverse cannulation strategies. OurLivaNova’s ACS segment also includes the Hemolung RAS. The Hemolung RAS is the only FDA-cleared platform designed specifically for low-flow extracorporeal carbon dioxide removal for acute respiratory failure. The Hemolung RAS was acquired in May 2022 as part of the acquisition of ALung. In August 2022, CMS approved a New Technology Add-on Payment (“NTAP”) for our Hemolung RAS for in-patient care. The NTAP designation is awarded to novel medical technologies and services supported by clinical evidence that are expected to substantially improve the diagnosis or treatment of Medicare beneficiaries and will go into effect October 1, 2022.
34


On May 2, 2022, we acquired the remaining 97% of equity interests in ALung, a privately held medical device company focused on creating advanced medical devices for treating respiratory failure, for a purchase price of up to $110.0 million, consisting of $10.0 million paid at closing, subject to customary adjustments, and contingent considerations of up to $100.0 million payable upon achievement of certain sales-based milestones beginning in 2023 and ending in 2027. Due to synergies anticipated between ALung and our existing ACS business, the assets acquired, including goodwill, are recognized in our ACS segment. The fair value of the contingent consideration liability as of May 2, 2022, the acquisition date, and June 30, 2022 was $26.4 million and $21.6 million, respectively.
Critical Accounting Estimates 
For a discussion of ourLivaNova’s critical accounting estimates, see “Management’s Discussion and Analysis of Financial Condition and Results of Operations” that is included in the 20212022 Form 10-K.
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.
3532


Results of Operations
The following table summarizes ourLivaNova’s condensed consolidated results of operations (in thousands):
Three Months Ended June 30,Six Months Ended June 30,
2022
2021 (1)
2022
2021 (1)
Net sales$254,151 $264,483 $494,326 $512,086 
Cost of sales69,801 92,204 141,533 176,399 
Gross profit184,350 172,279 352,793 335,687 
Operating expenses:
Selling, general and administrative116,482 122,748 235,007 238,429 
Research and development34,229 52,557 75,147 97,182 
Other operating expenses1,883 33,236 1,378 42,036 
Operating income (loss)31,756 (36,262)41,261 (41,960)
Interest expense(14,388)(16,515)(22,228)(32,451)
Foreign exchange and other income/(expense)1,633 239 5,537 (6,204)
Income (loss) before tax19,001 (52,538)24,570 (80,615)
Income tax expense2,515 3,908 5,052 6,552 
Losses from equity method investments(42)(41)(81)(81)
Net income (loss)$16,444 $(56,487)$19,437 $(87,248)
(1)The condensed consolidated results for the three and six months ended June 30, 2021 have been revised. For further details refer to “Note 1. Unaudited Condensed Consolidated Financial Statements.”
Three Months Ended June 30,Six Months Ended June 30,
2023202220232022
Net revenue$293,882 $254,151 $557,300 $494,326 
Cost of sales88,685 69,801 178,020 141,533 
Gross profit205,197 184,350 379,280 352,793 
Operating expenses:
Selling, general and administrative125,872 116,482 250,001 235,007 
Research and development51,124 34,229 101,110 75,147 
Other operating expense10,825 1,883 13,135 1,378 
Operating income17,376 31,756 15,034 41,261 
Interest expense(14,809)(14,388)(28,246)(22,228)
Foreign exchange and other income/(expense)2,713 1,633 28,260 5,537 
Income before tax5,280 19,001 15,048 24,570 
Income tax expense4,097 2,515 6,468 5,052 
Losses from equity method investments(28)(42)(55)(81)
Net income$1,155 $16,444 $8,525 $19,437 
3633


Net SalesRevenue
The table below presents net salesrevenue by operating segment and geographic region (in thousands, except for percentages):
Three Months Ended June 30,Six Months Ended June 30,Three Months Ended June 30,Six Months Ended June 30,
20222021% Change20222021% Change20232022% Change20232022% Change
CardiopulmonaryCardiopulmonaryCardiopulmonary
United StatesUnited States$37,865 $37,388 1.3 %$75,961 $73,147 3.8 %United States$46,711 $37,865 23.4 %$82,825 $75,961 9.0 %
Europe33,159 35,133 (5.6)%65,226 65,759 (0.8)%
Europe (1)
Europe (1)
39,169 33,159 18.1 %75,452 65,226 15.7 %
Rest of WorldRest of World54,796 45,355 20.8 %101,708 87,689 16.0 %Rest of World64,723 54,796 18.1 %124,398 101,708 22.3 %
125,820 117,876 6.7 %242,895 226,595 7.2 %150,603 125,820 19.7 %282,675 242,895 16.4 %
NeuromodulationNeuromodulationNeuromodulation
United StatesUnited States91,431 91,779 (0.4)%178,641 174,079 2.6 %United States104,065 91,431 13.8 %198,554 178,641 11.1 %
Europe13,710 14,604 (6.1)%26,166 26,283 (0.4)%
Europe (1)
Europe (1)
15,125 13,710 10.3 %28,405 26,166 8.6 %
Rest of WorldRest of World12,654 11,253 12.5 %23,215 20,973 10.7 %Rest of World13,991 12,654 10.6 %26,945 23,215 16.1 %
117,795 117,636 0.1 %228,022 221,335 3.0 %133,181 117,795 13.1 %253,904 228,022 11.4 %
Advanced Circulatory SupportAdvanced Circulatory SupportAdvanced Circulatory Support
United StatesUnited States8,790 12,964 (32.2)%19,753 25,524 (22.6)%United States9,197 8,790 4.6 %18,861 19,753 (4.5)%
Europe503 178 182.6 %1,106 406 172.4 %
Europe (1)
Europe (1)
165 503 (67.2)%245 1,106 (77.8)%
Rest of WorldRest of World59 133 (55.6)%176 337 (47.8)%Rest of World55 59 (6.8)%153 176 (13.1)%
9,352 13,275 (29.6)%21,035 26,267 (19.9)%9,417 9,352 0.7 %19,259 21,035 (8.4)%
Other (1)
Other Revenue (2)
Other Revenue (2)
United StatesUnited States— 2,212��(100.0)%— 4,929 (100.0)%United States— — — %— — — %
Europe— 6,123 (100.0)%— 14,407 (100.0)%
Europe (1)
Europe (1)
— — — %— — — %
Rest of WorldRest of World1,184 7,361 (83.9)%2,374 18,553 (87.2)%Rest of World681 1,184 (42.5)%1,462 2,374 (38.4)%
1,184 15,696 (92.5)%2,374 37,889 (93.7)%681 1,184 (42.5)%1,462 2,374 (38.4)%
TotalsTotalsTotals
United StatesUnited States138,086 144,343 (4.3)%274,355 277,679 (1.2)%United States159,973 138,086 15.9 %300,240 274,355 9.4 %
Europe (2)
47,372 56,038 (15.5)%92,498 106,855 (13.4)%
Europe (1)
Europe (1)
54,459 47,372 15.0 %104,102 92,498 12.5 %
Rest of WorldRest of World68,693 64,102 7.2 %127,473 127,552 (0.1)%Rest of World79,450 68,693 15.7 %152,958 127,473 20.0 %
TotalTotal$254,151 $264,483 (3.9)%$494,326 $512,086 (3.5)%Total$293,882 $254,151 15.6 %$557,300 $494,326 12.7 %
(1)For 2021, other primarily includes the net sales of the Company’s Heart Valves business, which was disposed of on June 1, 2021.
(2)Europe sales include thoseIncludes countries in which we haveEurope where the Company has a direct sales presence, whereas European countries in which we sellpresence. Countries where sales are made through distributors are included in “Rest of World.”
(2)Other revenue primarily includes rental income not allocated to segments.

3734


The table below presents segment income (in thousands, except for percentages):
Three Months Ended June 30,Six Months Ended June 30,Three Months Ended June 30,Six Months Ended June 30,
2022
2021 (1)
% Change2022
2021 (1)
% Change20232022% Change20232022% Change
CardiopulmonaryCardiopulmonary$3,644 $(25,099)(114.5)%$10,539 $(23,657)(144.5)%Cardiopulmonary$11,381 $3,644 212.3 %$18,965 $10,539 80.0 %
NeuromodulationNeuromodulation51,360 38,156 34.6 %88,838 72,239 23.0 %Neuromodulation38,148 51,360 (25.7)%65,154 88,838 (26.7)%
Advanced Circulatory SupportAdvanced Circulatory Support3,485 (1,311)(365.8)%(1,953)1,082 (280.5)%Advanced Circulatory Support(4,750)3,485 (236.3)%(11,199)(1,953)473.4 %
Other (2)
(19,450)(37,634)(48.3)%(42,532)(67,829)(37.3)%
Total reportable segment income (loss) (3)
$39,039 $(25,888)(250.8)%$54,892 $(18,165)(402.2)%
Segment income (1)
Segment income (1)
$44,779 $58,489 (23.4)%$72,920 $97,424 (25.2)%
(1)Segment income for the three and six months ended June 30, 2021 has been revised. For further details refer to “Note 1. Unaudited Condensed Consolidated Financial Statements.”
(2)Other includes corporate shared service expenses for finance, legal, human resources, information technology and corporate business development. For 2021, other also includes the results of the Company’s Heart Valves business, which was disposed of on June 1, 2021.
(3)For a reconciliation of segment income (loss) to income (loss) before tax refer to “Note 13.12. Geographic and Segment Information” in the condensed consolidated financial statements in this Quarterly Report on Form 10-Q.
Cardiopulmonary
Cardiopulmonary net salesrevenue for the three and six months ended June 30, 20222023 increased 6.7%19.7% to $125.8$150.6 million and 7.2%16.4% to $242.9$282.7 million, respectively, compared to the three and six months ended June 30, 2021,2022, respectively. These increases were primarily driven by strong oxygenator sales due to an increase in cardiac surgery proceduresdemand and strength inincreased heart-lung machine sales in the Rest of World and U.S. regions. These favorable impacts were partially offset for the three and six-month comparative periods by unfavorable foreign currency fluctuations of approximately $8.9 million and $14.1 million, respectively.placements.
Cardiopulmonary segment income for the three and six months ended June 30, 20222023 was $3.6$11.4 million and $10.5$19.0 million, respectively, as compared to losses of $(25.1)$3.6 million and $(23.7)$10.5 million for the three and six months ended June 30, 2021,2022, respectively. These increases in segment income were primarily due to increasesthe increase in net sales,revenue, as discusseddescribed above, as well as a decreasepartially offset by an increase in the litigation provision related to ourLivaNova’s 3T Heater-Cooler device of $9.8 million and $11.4 million for the threethree- and six-month comparative periods, respectively, as well as an increase in sales and marketing expense associated with the launch of $28.3 million and $31.7 million, respectively, and related legal costs.Essenz.
Neuromodulation
Neuromodulation net salesrevenue for the three and six months ended June 30, 20222023 increased 0.1%13.1% to $117.8$133.2 million and 3.0%11.4% to $228.0$253.9 million, respectively, compared to the three and six months ended June 30, 2021,2022, respectively. These increases were primarily driven by the Europegrowth in new and Rest of World regions and by favorable pricing in the U.S., partially offset by lower implant volumes. Additionally, these increases in net sales were adversely impacted by unfavorable foreign currency fluctuations of approximately $2.6 million and $3.9 million versus the three and six-month comparative periods, respectively.replacement implants across all regions.
Neuromodulation segment income for the three and six months ended June 30, 20222023 was $51.4$38.1 million and $88.8$65.2 million, respectively, as compared to $38.2$51.4 million and $72.2$88.8 million for the three and six months ended June 30, 2021,2022, respectively. These increasesThe decreases in segment income were primarily due to the net unfavorable impact of the change in fair value of the sales-based and milestone-based contingent consideration arrangement associated with the acquisition of ImThera of $20.7$14.9 million and $24.2$22.1 million for the threethree- and six-month comparative periods, respectively, as well as an increase in net sales of $6.7 millionR&D expense for the three- and six-month comparative period, as discussed above.periods totaling $3.8 million and $8.8 million, respectively, associated with the Company’s RECOVER clinical study and OSPREY clinical trial. These increases in expense were partially offset by increasesthe increase in R&D expensesnet revenue, as described above.
Advanced Circulatory Support
ACS net revenue for the three months ended June 30, 2023 increased 0.7% to $9.4 million, compared to the three months ended June 30, 2022, reflecting growth in cardiac case volumes, partially offset by respiratory case declines and product mix. ACS net revenue for the six months ended June 30, 2023, decreased 8.4% to $19.3 million, compared to the six months ended June 30, 2022. The decrease in net revenue for the six-month period was primarily due to a reduction in patients treated with ECMO as a result of fewer severe COVID-19 cases and product mix, partially offset by growth in non-COVID-19 cases.
ACS segment loss for the three and six months ended June 30, 20222023, was $4.8 million and $11.2 million, respectively, as compared to the three and six months ended June 30, 2021 totalingsegment income of $3.5 million and $6.7 million, respectively, associated with the Company’s RECOVER study and ANTHEM-HFrEF and OSPREY clinical trials.
Advanced Circulatory Support
ACS net sales for the three and six months ended June 30, 2022 decreased 29.6% to $9.4 million and 19.9% to $21.0 million, respectively, compared to the three and six months ended June 30, 2021, respectively, primarily due to a reduction in patients treated with extracorporeal membrane oxygenation (ECMO) related to fewer severe COVID-19 cases and hospital staffing challenges, partially offset by growth in non-COVID-19 cases.
ACS segment income for the three months ended June 30, 2022 was $3.5 million and segment loss wasof $2.0 million for the six months ended June 30, 2022, as compared to2022. These increases in segment loss of $1.3 million forwere primarily due to the three months ended June 30, 2021 and segment incomenet unfavorable impact of $1.1 million for the six months ended June 30, 2021. Segment income/(loss) was positively impacted for the
38


three and six month comparative periods by the change in fair value of the TandemLife contingent consideration arrangement of $8.4$5.7 million and $8.8$6.0 million respectively, primarily due to the change in the probability of the regulatory milestone-based payment associated with the TandemLife acquisition. This was partially offset for the three-month comparative periods and more than offset for the six-month comparative periods due to the decline in net sales, as discussed above, and an increase in general and administrative expenses largely associated with the acquisition of ALung. For additional information, please refer to “Note 2. Business Combinations” in the condensed consolidated financial statements in this Quarterly Report on Form 10-Q. Additionally, we incurred an increase in sales and marketing expenses during the three and six months ended June 30, 2022, compared torespectively. The increase in segment loss for the six months ended June 30, 2023, was also impacted by the decrease in net revenue, as described above, partially offset by expenses associated with the acquisition of ALung incurred during the six months ended June 30, 2022.
35


Cost of Sales and Expenses
The following table presents costs and expenses as a percentage of net revenue for the three and six months ended June 30, 2021. Sales2023 and marketing expenses in 2021 were reduced as a result of lower commercial related and discretionary spending due to COVID-19.2022:
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,Three Months Ended June 30,Six Months Ended June 30,
20222021Change20222021Change20232022Change20232022Change
Cost of salesCost of sales27.5 %34.9 %(7.4)%28.6 %34.4 %(5.8)%Cost of sales30.2 %27.5 %2.7 %31.9 %28.6 %3.3 %
Selling, general and administrativeSelling, general and administrative45.8 %46.4 %(0.6)%47.5 %46.6 %0.9 %Selling, general and administrative42.8 %45.8 %(3.0)%44.9 %47.5 %(2.6)%
Research and developmentResearch and development13.5 %19.9 %(6.4)%15.2 %19.0 %(3.8)%Research and development17.4 %13.5 %3.9 %18.1 %15.2 %2.9 %
Other operating expenses0.7 %12.6 %(11.9)%0.3 %8.2 %(7.9)%
Other operating expenseOther operating expense3.7 %0.7 %3.0 %2.4 %0.3 %2.1 %
Cost of Sales
Cost of sales consists primarily of direct labor, allocated manufacturing overhead the acquisition cost ofand raw materials and components.
Cost of sales as a percentage of net salesrevenue was 27.5%30.2% and 28.6%31.9% for the three and six months ended June 30, 2022,2023, respectively, a decreasean increase of 7.4%2.7% and 5.8%3.3% compared to the three and six months ended June 30, 2021,2022, respectively. These decreasesincreases were primarily due to favorable product mix for the six-month comparative period, partially resulting from the sale of the Company’s Heart Valves business during the second quarter of 2021, as well as the net impact of the change in fair value of a sales-based contingent consideration arrangements of $17.4totaling $14.0 million and $19.2$19.0 million for the threethree- and six months ended June 30, 2022 compared to the three and six months ended June 30, 2021, respectively. These decreases were partially offset bysix-month comparative periods, respectively, as well as increased costs driven by supply chain delays and interruptions, labor shortages, inflationary pressures and logistical issuesissues. The aforementioned increases to cost of sales as a percentage of net revenue were partially offset by favorable realized price from pricing initiatives implemented in the wakesecond half of COVID-19.2022, higher volume which drove better fixed overhead absorption, as well as lower inbound freight costs.
Selling, General and Administrative (“SG&A”) ExpensesExpense
SG&A expenses areexpense is comprised of sales, marketing, and general and administrative activities.
SG&A expensesexpense as a percentage of net salesrevenue was 47.5%42.8% and 44.9% for the three and six months ended June 30, 2023, respectively, a decrease of 3.0% and 2.6% compared to the three and six months ended June 30, 2022, an increase of 0.9% compared to the six months ended June 30, 2021.respectively. The increase wasdecreases were primarily due to a decrease in stock-based compensation expense due to forfeitures of awards associated with the recent departure of the Company’s former CEO and prior year business development expensesexpense related to the acquisition of ALung. For additional information, please refer to “Note 2. Business Combinations” in the condensed consolidated financial statements in this Quarterly Report on Form 10-Q.
Research and Development (“R&D”) ExpensesExpense
R&D expenses consistexpense consists of product design and development efforts, clinical study programs and regulatory activities, which are essential to ourLivaNova’s strategic portfolio initiatives, including DTD, OSA and, until recently, heart failure.
R&D expensesexpense as a percentage of net sales were 13.5%revenue was 17.4% and 15.2%18.1% for the three and six months ended June 30, 2022,2023, respectively, reflecting decreasesan increase of 6.4%3.9% and 3.8%2.9% compared to the three and six months ended June 30, 2021,2022, respectively. These decreasesincreases were primarily due to a decline in R&D expenses resulting from changesthe net impact of the change in the fair value of milestone-based contingent consideration arrangements of $16.5totaling $12.1 million and $18.9$15.6 million for the threethree- and six months ended June 30, 2022, respectively, compared to the respective prior year periods. Additionally, R&D expenses for the three and six months ended June 30, 2022 decreased by $2.4 million and $5.9 million, respectively, compared to the respective prior yearsix-month comparative periods, as a result of the sale of the Company’s Heart Valve business on June 1, 2021. The decreases in R&D expenses due to the changes in fair value of contingent consideration arrangements and the sale of the Company’s Heart Valve business were partially offset by increases associated with the Company’s RECOVER study and ANTHEM-HFrEF and OSPREY clinical trials totaling $3.5 million and $6.7 million for the three and six months ended June 30, 2022, respectively, compared to the respective prior year periods.
39


respectively.
Other Operating ExpensesExpense
Other operating expensesexpense primarily consists of the provision for litigation involving ourLivaNova’s 3T Heater-Cooler device, restructuring expense, and merger and integration expense.
Other operating expensesexpense as a percentage of net salesrevenue was 0.7%3.7% and 0.3%2.4% for the three and six months ended June 30, 2022,2023, respectively, reflecting decreasesan increase of 11.9%3.0% and 7.9%2.1% compared to the three and six months ended June 30, 2021,2022, respectively. These favorable variancesincreases were primarily impacted by adjustmentsdue to an increase in the litigation provision related to ourLivaNova’s 3T Heater-Cooler device of $29.4$9.8 million and $32.4$11.4 million for the threethree- and six monthsix-month comparative periods, ended June 30, 2021, respectively.
For additional information, please refer to “Note 8.7. Commitments and Contingencies” in the condensed consolidated financial statements in this Quarterly Report on Form 10-Q. Additionally, other operating expenses as a percentage of net sales decreased due to a decline in restructuring expenses of $3.0 million and $9.2 million for the three and six months ended June 30, 2022, respectively, compared to the respective prior year periods.
Interest Expense
Interest expense for the three and six months ended June 30, 2022 declined2023, increased to $14.8 million and $28.2 million, respectively, compared to $14.4 million and $22.2 million, respectively, compared to $16.5 million and $32.5 million for the three and six months ended June 30, 2021,2022, respectively, primarily due to the repayment of the Company’s 2020 senior secured term loan during the third quarter of 2021,an increase in average borrowings and an increase in interest rates, partially offset by interest expense associated witha reduction in amortization of debt issuance
36


costs, as compared to the February 2022 Bridge Loan Facility.prior year three- and six-month comparative periods. For further details, refer to “Note 6.5. Financing Arrangements” in the condensed consolidated financial statements in this Quarterly Report on Form 10-Q.
Foreign Exchange and Other Income/(Expense)
Foreign exchange and other income/(expense) consist primarily of gains and losses arising from transactions denominated in a currency different from an entity’s functional currency, foreign currency exchange rateFX derivative gains and losses, and changes in the fair value of the embedded exchange feature and capped call derivatives.derivatives and interest income.
Foreign exchange and other income/(expense) resulted inwas income of $2.7 million and $28.3 million for the three and six months ended June 30, 2023, respectively, compared to income of $1.6 million and $5.5 million for the three and six months ended June 30, 2022, respectively, compared to income/(expense) of $0.2 million and $(6.2) million for the three and six months ended June 30, 2021, respectively. For further details, refer to “Note 14.13. Supplemental Financial Information” in the condensed consolidated financial statements in this Quarterly Report on Form 10-Q.
Income Taxes
LivaNova PLC is resident in the UK for tax purposes. OurLivaNova’s 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 ourthe Company’s subsidiaries conduct operations vary. OurLivaNova’s effective income tax rate fluctuates based on, among other factors, changes in pretax income in countries with varying statutory tax rates, valuation allowances, tax credits and incentives and unrecognized tax benefits associated with uncertain tax positions.
OurLivaNova’s effective income tax rate for the three and six months ended June 30, 20222023 was 13.2%77.6% and 20.6%43.0%, respectively, compared with (7.4)%13.2% and (8.1)%20.6% for the three and six months ended June 30, 2021,2022, respectively. Compared with the three months ended June 30, 2021, the changeThese increases in the effective tax rate for both the three and six months ended June 30, 2022 was2023 compared to the prior year periods were primarily attributable to discrete items andchanges in valuation allowances, year-over-year changes in income before tax in countries with varying statutory tax rates as comparedand an audit settlement.
On October 8, 2021, members of the OECD / G20 Inclusive Framework on BEPS agreed to a Two-Pillar Solution to address tax challenges of a global economy. The Two-Pillar Solution aims to ensure multinational companies will be subject to a minimum 15% global tax rate (Pillar Two) and will reallocate profits to the discrete tax impactmarket jurisdictions where sales arise (Pillar One). As part of the saleongoing release of Pillar Two rules by various jurisdictions, the Heart Valve business duringUK Act was enacted on July 11, 2023, and implements the three months ended June 30, 2021. Compared withOECD’s BEPS Pillar Two income inclusion rule including a multinational top-up tax and a domestic top-up tax to the six months ended June 30, 2021, the change in theminimum effective tax rate of 15% for accounting periods beginning on or after December 31, 2023. The UK Act also includes a transitional safe harbor election for accounting periods beginning on or before Dec 31, 2026. We are reviewing the six months endeddraft guidance issued on June 30, 2022 was primarily attributable15, 2023, and the UK Act to discrete itemsassess the full implications for 2024 and changeswill continue to monitor related guidance in income before tax in countries with varying statutory tax rates as compared to changes in valuation allowancesthe UK and other discrete items and the discrete taxjurisdictions that impact of the sale of the Heart Valve business during the six months ended June 30, 2021.LivaNova’s operations.
Liquidity and Capital Resources
Based on ourLivaNova’s current business plan, we believethe Company believes that ourits sources of liquidity, which primarily consist of cash and cash equivalents, future cash generated from operations and available borrowings under our current debt facilities,its revolving credit facility, will be sufficient to fund ourits uses of liquidity, primarily consisting of purchase obligations for expectedday-to-day operating expenses, working capital, capital expenditures, acquisitions,acquisition earn-outs and debt service requirements over the twelve-month period beginning from the issuance date of these condensed consolidated financial statements. From time to time, weLivaNova may decide to access debt and/or equity markets to optimize ourits capital structure, raise additional capital or increase liquidity as necessary. OurLivaNova’s liquidity could be adversely impacted by the factors affecting future operating results, including those referred to in “Part I, Item 1A. Risk Factors” in the 20212022 Form 10-K as supplemented by the factors referred to in “Part II, Item 1A. Risk Factors” in this Quarterly Reports on
40


Form 10-Q as well as “Note 8.7. Commitments and Contingencies” in the condensed consolidated financial statements in this Quarterly Report on Form 10-Q.
Our
37


LivaNova’s operating and working capital obligations primarily consist of liabilities arising from the normal course of business, including inventory supply contracts, the future settlement of derivative instruments and future payments of operating leases, as well as contingent consideration arrangements resulting from acquisitions and obligations associated with legal and other accruals.
The following table presents selected financial information related to ourLivaNova’s liquidity as of June 30, 20222023 and December 31, 20212022 (in thousands):
June 30, 2022December 31, 2021
Sources of liquidity
Cash and cash equivalents$109,022 $207,992 
Accounts receivable, net176,949 185,354 
Inventories119,415 105,840 
Short-term derivative assets (1)
2,520 106,629 
Long-term derivative assets (1)
61,608 — 
Availability under revolving credit facility (2)
125,000 125,000 
Short term uses of liquidity
Short-term derivative liabilities (1)
$3,232 $183,109 
Short-term debt (2)
6,240 229,673 
Short-term operating leases10,245 11,261 
Short-term contingent consideration (3)
5,552 11,552 
Short-term 3T litigation provision (4)
30,960 32,845 
Long-term uses of liquidity
Long-term debt (2)
$459,792 $9,849 
Long-term derivative liabilities (1)
134,090 — 
Long-term operating leases31,857 35,919 
Long-term contingent consideration (3)
91,840 86,830 
Long-term Saluggia site liability (4)
35,605 38,788 
Long-term 3T litigation provision (4)
5,929 6,625 
June 30, 2023December 31, 2022
Available Short-term Liquidity
Cash and cash equivalents$222,935 $214,172 
Availability under the 2021 First Lien Credit Agreement125,000 125,000 
Availability under the Delayed Draw Term Facility (1)
— 50,000 
$347,935 $389,172 
Working Capital
Current assets$941,835 $886,136 
Current liabilities288,164 297,398 
$653,671 $588,738 
Debt Obligations
Current portion of long-term debt$18,444 $20,892 
Short-term unsecured borrowing arrangements630 2,542 
Current debt obligations19,074 23,434 
Long-term debt obligations567,951 518,067 
Total debt obligations$587,025 $541,501 
(1)For additional information, please refer to “Note 7. Derivatives and Risk Management” inOn April 6, 2023, LivaNova drew the condensed consolidated financial statements in this Quarterly Report on Form 10-Q.
(2)For additional information, please refer to “Note 6. Financing Arrangements” in the condensed consolidated financial statements in this Quarterly Report on Form 10-Q.
(3)For additional information, please refer to “Note 5. Fair Value Measurements” in the condensed consolidated financial statements in this Quarterly Report on Form 10-Q.
(4)For additional information, please refer to “Note 8. Commitments and Contingencies” in the condensed consolidated financial statements in this Quarterly Report on Form 10-Q.
Significant Liquidity Matters
On February 21, 2022, the Court of Appeal notified the Company that it granted the Company a suspension with respect to the payment of damages in the amount of €453.6full $50 million (approximately $472.4 million at June 30, 2022) in the SNIA litigation until a decision has been reached on our appeal to the Italian Supreme Court. This suspension was subject to providing the SNIA Litigation Guarantee of €270.0 million (approximately $281.2 million at June 30, 2022) within 30 calendar days.
On February 24, 2022, LivaNova PLC and its wholly-owned subsidiary, LivaNova USA, Inc., entered into the Bridge Loan Facility. On March 16, 2022, LivaNova delivered a borrowing notice for $220.0 million in connection with the Bridge Loan Facility, which was funded on March 17, 2022. LivaNova used the proceeds of the Bridge Loan Facility to post a portion of the cash collateral supporting the SNIA Litigation Guarantee.
41


On March 18, 2022, LivaNova PLC, acting through its Italian branch, entered into an Indemnity Letter and an Account Pledge Agreement with Barclays, further to which Barclays issued the €270.0 million SNIA Litigation Guarantee. As security for the SNIA Litigation Guarantee, LivaNova is required to grant cash collateral to Barclays in US dollars in an amount equal to the USD equivalent of 105% of the amount of the SNIA Litigation Guarantee calibrated on a biweekly basis. At June 30, 2022, the cash collateral totaled $297.7 million and was classified as Restricted Cash on the condensed consolidated balance sheet.
On March 21, 2022, LivaNova delivered the SNIA Litigation Guarantee as required by the Court of Appeal, thereby satisfying the condition to obtain the suspension for the payment of damages in connection with the SNIA litigation until review of such judgment by the Italian Supreme Court.
On July 6, 2022, LivaNova and its wholly-owned subsidiary, LivaNova USA, entered into the Incremental Amendment No. 2 to its 2021 First Lien Credit Agreement. The Incremental Amendment No. 2 provides for LivaNova USA to, among other things, obtain commitments for term loan facilities from a syndicate of lenders in an aggregate principal amount of $350 million consisting of (i) the Initial Term Facility and (ii)under the Delayed Draw Term Facility and, together, the Term Facilities.
Proceeds of the Initial Term Facility were used to repay in full the Bridge Loan Facility on July 6, 2022, with the remainder to be used for general corporate purposes of the Company. The Term Facilities have a maturity of the earlier of (i) five years or (ii) 91 days prior to December 15, 2025, the maturity date of the Notes, unless by that date LivaNova USA will have either redeemed or refinanced the Notes, or set aside an amount of cash equal to the then-outstanding principal amount of the Notes.purposes.
Refer to “Note 6.5. Financing Arrangements” and “Note 15. Subsequent Event” in the condensed consolidated financial statements in this Quarterly Report on Form 10-Q for additional information regarding our debt and debt transactions.information.
Cash Flows
Net cash and cash equivalents provided by (used in) operating, investing and financing activities and the net increase in the balance of cash, cash equivalents and restricted cash were as follows (in thousands):
Six Months Ended June 30,Six Months Ended June 30,
20222021 20232022
Operating activitiesOperating activities$15,580 $45,111 Operating activities$2,820 $15,580 
Investing activitiesInvesting activities(21,630)46,715 Investing activities(18,139)(21,630)
Financing activitiesFinancing activities208,557 (14,087)Financing activities30,779 208,557 
Effect of exchange rate changes on cash, cash equivalents and restricted cashEffect of exchange rate changes on cash, cash equivalents and restricted cash(3,730)(1,185)Effect of exchange rate changes on cash, cash equivalents and restricted cash3,282 (3,730)
Net increase in cash, cash equivalents and restricted cashNet increase in cash, cash equivalents and restricted cash$198,777 $76,554 Net increase in cash, cash equivalents and restricted cash$18,742 $198,777 
Operating Activities
Cash provided by operating activities during the six months ended June 30, 20222023 decreased by $29.5$12.8 million as compared to the same prior-yearprior year period. The decrease was primarily due to the net change in working capital largely associated with an increase in inventory to mitigate supply chain risk, a decrease3T Heater-Cooler litigation settlement payments of $17.8 million in tax refunds associated with the Coronavirus Aid, Relief and Economic Security Act and increased payments under the Company’s short-term incentive plan. These decreases were partially offset by an increase in net income adjusted for non-cash items of $28.3 million, primarily driven by an increase in Neuromodulation and Cardiopulmonary net sales.$16.6 million.
Investing Activities
Cash provided byused in investing activities during the six months ended June 30, 20222023 decreased $68.3$3.5 million as compared to the same prior year period largelyprimarily due to proceeds received$8.9 million paid during the six months ended June 30, 2021, including $41.8 million from2022 associated with the saleacquisition of the Company’s Heart Valves business as well as proceeds from the saleALung, partially offset by an increase in purchases of LivaNova’s investment in and loan to Respicardia totaling $23.1equity investments of $4.6 million.
38


Financing Activities
Cash provided by financing activities during the six months ended June 30, 2022 increased $222.62023 decreased $177.8 million as compared to the same prior year period primarily due to neta reduction in proceeds from net borrowings under the Bridge Loan Facility of $218.3$178.6 million.
Item 3. Quantitative and Qualitative Disclosures About Market Risk
We areLivaNova is exposed to certain market risks as part of ourits 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 ourLivaNova’s consolidated financial position, results of operations or cash flows. We manageThe Company manages these risks through regular operating and
42


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 7.6. 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 2021LivaNova’s 2022 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.”
Item 4. Controls and Procedures
Disclosure Controls and Procedures
(a) Evaluation of Disclosure Controls and Procedures
We maintainLivaNova maintains a system of disclosure controls and procedures, as defined in Rules 13a-15(e) and 15d-15(e) of the Exchange Act, that areis designed to ensure that information required to be disclosed in ourthe Company’s 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”)LivaNova’s CEO and Chief Financial Officer (“CFO”),CFO, as appropriate, to allow timely decisions regarding required disclosure. OurLivaNova’s management, under the supervision and with the participation of ourits CEO and CFO, evaluated the effectiveness of the design and operation of ourthe Company’s disclosure controls and procedures as of the end of the most recent fiscal quarter reported herein. Based on that evaluation, ourLivaNova’s CEO and CFO concluded that ourthe Company’s disclosure controls and procedures were effective as of June 30, 2022.2023.
(b) Changes in Internal Control Over Financial Reporting
No changeThere have been no changes in ourLivaNova’s 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, 20222023 that hashave materially affected, or isare reasonably likely to materially affect, ourLivaNova’s internal control over financial reporting.
4339


PART II. OTHER INFORMATION
Item 1. Legal Proceedings
For a description of ourLivaNova’s material pending legal and regulatory proceedings and settlements, refer to “Note 8.7. Commitments and Contingencies” in ourthe Company’s condensed consolidated financial statements included in this Quarterly Report on Form 10-Q.
Item 1A. Risk Factors
Other than as described below, thereThere have been no material changes in ourLivaNova’s risk factors from those disclosed in Part I, Item 1A to our 2021of the Company’s 2022 Annual Report on Form 10-K.
Reductions, interruptions or increased costs in the supply10-K and Part II, Item 1A of the materials and components used in manufacturing our products may adversely affect our financial condition and business operations, particularly in the wake of COVID-19.
We maintain manufacturing operations in five countries located throughout the world and purchase many of the components and raw materials used in manufacturing these products from numerous suppliers in various countries. Any problem affecting a supplier (whether due to external or internal causes) could have a negative impact on us. Difficulties and delays in manufacturing, internally or through third-party providers or otherwise within the supply chain, may lead to voluntary or involuntary business interruptions or shutdowns, product shortages, withdrawals or suspensions of products from the market, and potential regulatory action.
In some cases, we purchase specific components and raw materials from primary or main suppliers (or in some cases, a single or sole supplier) for reasons related to quality assurance, cost-effectiveness and availability. While we work closely with our suppliers to ensure supply continuity, minimize the instances in which we rely on a sole supplier and take other countermeasures to reduce our supply chain risk, we cannot guarantee that our efforts will always be successful. Moreover, due to strict standards and regulations governing the manufacture and marketing of our products, we may not be able to locate new supply sources quickly or at all in response to a supply reduction or interruption, with negative effects on our ability to manufacture our products effectively and timely.
The COVID-19 pandemic has exacerbated this risk by, among other things, causing global supply chain shortages and an increase in freight and labor costs. Like many companies, for example, we are experiencing supply chain delays and interruptions, labor shortages, inflationary pressures and logistical issues in the wake of COVID-19. Though, to date, our supply of raw materials and the production and distribution of finished products have not been materially affected, demand and low capacity worldwide have caused longer lead times and put price pressure on key raw materials. Moreover, freight and labor costs at our manufacturing facilities have increased substantially due to COVID-related disruptions and in the wake of inflation globally. We are managing our supply chain by giving long visibility to our suppliers, conducting regular supply critical risk reviews and closely monitoring our inventory, among other things, but any problem could quickly, negatively reverberate throughout the organization. To the extent we are unsuccessful in managing our supply chain, any such issues could have a material adverse effect on our business, results of operations, financial condition, cash flows and recoverability of our tangible and intangible assets.
Failure to comply with product-related government regulations may materially adversely affect our financial condition and business operations.
Both before and after a product is commercially released, we have ongoing responsibilities under FDA and other applicable non-U.S. government agency regulations. For instance, many of our facilities and procedures and those of our suppliers are subject to periodic inspections by the FDA, which can result in inspectional observations on FDA’s Form-483, warning letters, or other forms of enforcement. If the FDA were to conclude that we are not in compliance with applicable laws or regulations, or that any of our medical products are ineffective or pose an unreasonable health risk, the FDA could ban such medical products, detain or seize adulterated or misbranded medical products, order a recall, repair, replacement, or refund of such products, refuse to grant pending PMA applications or require certificates of non-U.S. governments for exports, and/or require us to notify health professionals and others that the devices present unreasonable risks of substantial harm to the public health. In 2015, we received a warning letter from the FDA alleging certain violations of FDA regulations, which resulted in certain devices that were manufactured in Munich, Germany, to be denied admission to the U.S. until resolution of the issues set forth by the FDA in the warning letter. In April 2022, a Form 483 was issued at the conclusion of the FDA’s inspection of our Germany facility. See “Note 7. Commitments and Contingencies” in this FormCompany’s 10-Q for additional information.
If the FDA does not agree with the proposed corrective or preventive actions in the response to the Form 483, or accepts them but finds that we have not implemented them adequately, or if we otherwise fail to comply with applicable regulatory requirements, the FDA could decide not to close out the 2015 Warning Letter based on the most recent inspection, even if they
44


agree with our most recent Form 483 response. In addition, the FDA could require that a successful re-inspection be completed in the future in order to close out that Warning Letter and/or the most recent inspection. As we continue to work with the FDA, we remain subject to the terms of the 2015 Warning Letter, which subjected our legacy 3T devices to refusal of admission into the U.S. and which 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, with clearance for K191402, 3T devices manufactured in accordance with K191402 are not subjected to the import alert and the premarket approval restriction applied only to the Munich and Arvada facilities, which do not manufacture or design devices subject to Class III premarket approval.
While we work diligently to manage our ongoing responsibilities, the FDA and other non-U.S. government agencies could assess civil or criminal penalties against us, our officers or employees and impose operating restrictions on a company-wide basis. The FDA could also recommend prosecution to the U.S. Department of Justice. An adverse regulatory action could restrict us from effectively marketing and selling our products, limit our ability to obtain future pre-market clearances or PMAs, and result in a substantial modification to our business practices and operations. These potential consequences, as well as any adverse outcome from government investigations, could have a material adverse effect on our business, results of operations, financial condition, and cash flows.
In addition, in the U.S., device manufacturers are prohibited from promoting their products other than for the uses and indications set forth in the approved product labeling (so called “off-label uses”). Our VNS Therapy System, for example, is indicated in the U.S., as an adjunctive therapy in reducing the frequency of seizures in patients 4 years of age and older with partial onset seizures that are refractory to antiepileptic medications, yet a number of physicians elect to prescribe our device for certain patients suffering from generalized seizures. While physicians may exercise their discretion in prescribing a device off-label, any failure on the part of the device manufacturer to comply with off-label regulations could subject us to significant civil or criminal exposure, administrative obligations and costs, and/or other potential penalties from, and/or agreements with, the federal government.
Governmental regulations outside the U.S. have, and may continue to become, increasingly stringent and common. In the EU, for example, Reg MDR (Medical Device Regulation) became effective in May 2021, resulting in significant additional premarket and post-market requirements which must be in place by May 2024. During this transition period, the European Commission is allowing companies to use their MDD (Medical Device Directive) certifications. LivaNova is working to obtain all appropriate approvals and intends to be fully compliant by the May 2024 deadline, as penalties for regulatory non-compliance can be severe, including fines and revocation or suspension of a company’s business license, mandatory price reductions and criminal sanctions.
We are subject to the risks of conducting business internationally.
We develop, manufacture, distribute and sell our products globally, and we intend to continue to pursue growth opportunities worldwide. Our international operations are subject to risks that are inherent in conducting business globally and under non-U.S. laws, regulations and customs. These risks include possible nationalization, invasions, wars, negative consequences associated with Brexit, expropriation, importation limitations, pricing restrictions, government shutdowns and violations of laws, and the resulting issues from any such risks. In February 2022, for example, Russia launched an invasion in Ukraine which caused us to assess our ability to sell in the market due to international sanctions, to consider the potential impact of raw material sourced from the region, and to determine whether we are able to transact in a compliant fashion. Although the region represented 1% of our total net sales for 2021, the Russian invasion of Ukraine has increased economic uncertainties, and a significant escalation and/or continuation of the conflict could have a material, global impact on our operating results. In addition, our Russian employees and local subsidiary are subject to evolving laws and regulations imposed by the Russian authorities in response to international sanctions. Our profitability and operations are, and will continue to be, subject to a number of risks and potential costs, including: local product preferences and product requirements; longer-term receivables than are typical in the EU or the U.S.; difficulty enforcing agreements; creditworthiness of customers; trade protection measures and import and export licensing requirements; imposition of sanctions; different labor regulations and workforce instability; higher danger of terrorist activity, war or civil unrest; selling our products through distributors and agents; and political and economic instability. Any of the aforementioned risks could adversely affect our business, results of operations, financial conditions and cash flows.
From time to time, certain of our subsidiaries have limited business dealings in countries subject to comprehensive sanctions, including Iran, Sudan, Syria and now Russia. These business dealings represent an insignificant amount of our consolidated revenues and income, but expose us to a heightened risk of violating applicable sanctions regulations. Violations of these regulations are punishable by civil penalties including fines, denial of export privileges, injunctions, asset seizures, debarment from government contracts and revocations or restriction of licenses, as well as criminal fines and imprisonment. We have
45


established policies and procedures designed to assist with our compliance with such laws and regulations, but there can be no assurance that our policies and procedures will prevent us from violating these regulations in every transaction in which we may engage, and such a violation could adversely affect our reputation, business, results of operations, financial conditions and cash flows.
Our functional currency is the U.S. dollar; however, a portion of the revenues earned and expenses incurred by certain of our subsidiaries are denominated in currencies other than the U.S. dollar. We determine the functional currency of our subsidiaries that exist and operate in different economic and currency environments based on the primary economic environment in which the subsidiary operates, that is, the currency of the environment in which an entity primarily generates and expends cash. For transactions denominated in currencies other than our functional currencies, fluctuations in the exchange rate will impact our results of operations and financial condition. In the second quarter of 2022, our net sales and profitability were negatively affected by the unfavorable foreign currency exchange impact of the strengthened U.S. dollar against a number of currencies. Although we may elect to hedge certain foreign currency exposure, we cannot be certain that the hedging activity will eliminate our currency risk.
In addition, in many of the countries where we operate, employees are covered by various laws and/or collective bargaining agreements that endow them, through their local or national representatives, with the right to be consulted in relation to specific issues, including the downsizing or closing of departments and staff reductions. The laws and/or collective bargaining agreements that are applicable to these agreements could have an impact on our flexibility, as they apply to programs to redefine and/or strategically reposition our activities. Our ability to implement staff downsizing programs or even temporary interruptions of employment relationships is predicated on the approval of government entities and the consent of labor unions. A negative response from a works council or union-organized work stoppages by employees could have a negative impact on our business.ending March 31, 2023.
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
During the three months ended June 30, 2023, none of the Company’s directors or officers (as defined in Rule 16a-1(f) of the Securities Exchange Act of 1934) adopted, terminated or modified a Rule 10b5-1 trading arrangement or non-Rule 10b5-1 trading arrangement (as such terms are defined in Item 408 of Regulation S-K of the Securities Act of 1933).
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 dealings with government-owned entities, even when those activities are lawful and do not involve U.S. persons. One of ourLivaNova’s non-U.S. subsidiaries currently sells medical devices, including cardiopulmonary, cardiac surgery and neuromodulation products, to privately held distributors in Iran.
We haveLivaNova has 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 ourthe Company’s knowledge at this time, we doLivaNova does not have any contracts or commercial arrangements with the Iranian government.
OurLivaNova’s net salesrevenue and net profits attributable to the above-mentioned Iranian activities were $1.3$0.6 million and $0.5$0.3 million, respectively, for the three months ended June 30, 2022, respectively,2023 and $3.0$2.8 million and $1.4$1.1 million, respectively, for the six months ended June 30, 2022, respectively.2023.
We believe ourThe Company believes its 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 intendLivaNova intends to continue ourits business in Iran.

4640


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. Exhibits marked with the cross symbol (†), if any, are management contracts or compensatory plans or arrangements filed pursuant to Item 601(b)(10)(iii) of Regulation S-K.
Exhibit
Number
Document Description
Amendment to the LivaNova Plc 2015 Incentive Award Plan,Damien McDonald Settlement Agreement, dated 13 June 2022April 14, 2023
Retirement Agreement,William Kozy Offer Letter, dated 13 June 2022, between LivaNova Plc and Keyna SkeffingtonApril 19, 2023
Form ofAmended and Restated LivaNova PlcPLC 2022 Incentive Award Plan, Stock Appreciation Right Grant Notice and Agreement
Form of LivaNova Plc 2022 Incentive Award Plan Restricted Stock Unit Award Grant Notice and Agreement
Form of LivaNova Plc 2022 Incentive Award Plan Performance Stock Unit Award Grant Notice and Agreement
Incremental Facility Amendment No. 2 to Credit Agreement, dated as of July 6, 2022, by and among LivaNova Plc, LivaNova USA, Inc., the Second Incremental Term Lenders, Delayed Draw Incremental Leaders, Goldman Sachs Bank USA, the Revolving Lenders and Issuing Banks, and for purposes of Sections 8 and 10 only, the other Loan Parties as of the date hereof, incorporated by reference to Exhibit 10.1 of the Company’s Current Report on Form 8-K, filed on July 6, 2022
Amendment to Outstanding 2021 and 2022 Performance Stock Unit Awards under the LivaNova PLC 2015 Incentive Award Plan
Amendment to relevant 2020, 2021, and 2022 Restricted Stock Unit Awards under the LivaNova PLC 2015 Incentive Award PlanJune 16, 2023
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, 20222023 and 2021,2022, (ii) the Condensed Consolidated Statements of Comprehensive Income (Loss) for the three and six months ended June 30, 20222023 and 2021,2022, (iii) the Condensed Consolidated Balance Sheet as of June 30, 20222023 and December 31, 2021,2022, (iv) the Condensed Consolidated Statements of Cash Flows for the six months ended June 30, 20222023 and 2021,2022, 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)
4741


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: August 3, 2022July 26, 2023By:/s/ DAMIEN MCDONALDWILLIAM A. KOZY
 Damien McDonaldWilliam A. Kozy
  Interim Chief Executive Officer and Chair of the Board
  (Principal Executive Officer)
 LIVANOVA PLC
   
Date: August 3, 2022July 26, 2023By:/s/ ALEX SHVARTSBURG
 Alex Shvartsburg
  Chief Financial Officer
  (Principal Accounting and Financial Officer)
4842