SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549


(Mark One)
☒			ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
			For the fiscal year ended December 31, ~~2022~~2023
or
☐			TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
			For the transition period from ______ to ______

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

Title of each class

Trading Symbol(s)

Name of each exchange on which registered

Ordinary Shares - £1.00 par value per share

LIVN

The Nasdaq ~~Global~~Stock Market LLC

Securities registered pursuant to Section 12(g) of the Act: None

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☒ No ☐

Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes ☐ No ☒

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 filer	☒	Accelerated filer	☐
Non-accelerated filer	☐	Smaller reporting company	☐
Emerging growth company	☐

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

Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report. ☒

If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of an error to previously issued financial statements. ☐

Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b). ☐

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

The aggregate market value of the voting and non-voting common equity held by non-affiliates of the registrant was approximately ~~$3.3~~$2.8 billion (based on the closing price of these shares on the Nasdaq Global Market on June 30, ~~2022,~~2023, the last business day of the most recently completed second fiscal quarter). For purposes of this calculation, ordinary shares held by persons who hold more than 5% of the outstanding ordinary shares and shares held by executive officers and directors of the registrant have been excluded as such persons may be deemed to be affiliates.

As of February ~~17, 2023, 53,564,597~~23, 2024, 53,956,158 ordinary shares were outstanding.

DOCUMENTS INCORPORATED BY REFERENCE

Portions of the definitive proxy statement of LivaNova PLC for the ~~2023~~2024 Annual General Meeting of Shareholders, which will be filed within 120 days of December 31, ~~2022,~~2023, are incorporated by reference into Part III of this Annual Report on Form 10-K.

In this Annual Report on Form 10-K ~~“LivaNova,”~~for the year ended December 31, 2023, 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.


Abbreviation						Definition
2015 Plan						LivaNova PLC 2015 Incentive Award Plan
2020 Restructuring Plan						A plan, initiated during the fourth quarter of 2020, to reduce LivaNova’s cost structure
2021						The year ended December 31, 2021
2021 First Lien Credit Agreement						First Lien Credit Agreement for $125 million between LivaNova PLC and its wholly-owned subsidiary, Borrower, and Goldman Sachs Bank USA, as First Lien Administrative Agent and First Lien Collateral Agent, entered into on August 13, 2021
2022						The year ended December 31, 2022
2022 Plan						LivaNova PLC 2022 Incentive Award Plan
2022 Restructuring Plan						A plan, initiated during the second quarter of 2022, to implement a cost-optimization and cost reduction program to adapt to current economic conditions
2023						The year ended December 31, 2023
2024 Proxy Statement						Definitive Proxy Statement for the annual meeting of shareholders scheduled for June 11, 2024
2024 Restructuring Plan						A plan, initiated during the first quarter of 2024, to enhance LivaNova’s focus on its core Cardiopulmonary and Neuromodulation segments
A&R 2022 Plan						Amended and Restated LivaNova PLC 2022 Incentive Award Plan
ACS						Advanced Circulatory Support
ALung						ALung Technologies, Inc.
AOCI						Accumulated other comprehensive income (loss)
APAC						Asia-Pacific
ASMs						Anti-seizure medications
Audit Committee						LivaNova’s Audit and Compliance Committee
Barclays						Barclays Bank Ireland PLC
BEPS						Base Erosion and Profit Shifting
Borrower						LivaNova USA, Inc.
Bridge Loan Facility						Incremental 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
CCPA						California Consumer Privacy Act
CDC						Centers for Disease Control and Prevention
CE Mark						Conformité Européenne, French for “European Conformity”
CED						Coverage with Evidence Development
CEO						Chief Executive Officer
CFO						Chief Financial Officer
CISO						Chief Information Security Officer
CLO						Chief Legal Officer
CMS						The US Centers for Medicare & Medicaid Services
Code of Conduct						LivaNova PLC’s Code of Ethics and Business Conduct
CODM						Chief Operating Decision Maker
Court of Appeal						Court of Appeal in Milan
CPB						Cardiopulmonary bypass
CRO						Chief Risk Officer
Cyberonics						Cyberonics, Inc.
D23 study						The longest and largest naturalistic study on treatments for patients experiencing chronic and severe DTD, published by the American Journal of Psychiatry in 2017
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
DRE						Drug-resistant epilepsy
DTC						Depository Trust Company


Abbreviation						Definition
DTD						Difficult-to-treat depression
ECJ						European Court of Justice
ECMO						Extracorporeal membrane oxygenation
ESG						Environmental, social and governance
ESPP						Global Employee Share Purchase Plan
EtO						Ethylene oxide
EU						European Union
EVP						Employee Value Proposition
Exchange Act						US Securities Exchange Act of 1934, as amended
False Claims Act						US False Claims Act
FCPA						US Foreign Corrupt Practices Act of 1977
FDA						US Food and Drug Administration
FIFO						First-in-first-out
FX						Foreign currency exchange rate
GAAP						Generally Accepted Accounting Principles
GDPR						General Data Protection Regulation
Hemolung RAS						Hemolung Respiratory Assist System
HHS						The US Department of Health & Human Services
HIPAA						Health Insurance Portability and Accountability Act of 1996
HITECH						Health Information Technology and Clinical Health Act
HLM						Heart-lung machine
IBR						Incremental borrowing rate
ILBM						In-line blood monitor
ImThera						ImThera 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. 2						An incremental facility amendment to the 2021 First Lien Credit Agreement, dated July 6, 2022
Indenture						The indenture governing the Notes
Initial Term Facility						$300 million term facility under the 2021 First Lien Credit Agreement resulting from the Incremental Facility Amendment No. 2
IPR&D						In-Process Research and Development
IRC						US Internal Revenue Code
IRS						US Internal Revenue Service
IS						Information security
ISDA						International Swaps and Derivatives Association, Inc.
ISIN						National Inspectorate for Nuclear Safety and Radiation Protection, a sub-body of the Italian Ministry of Economic Development
ISMS						Information Security Management System
ISO						International Organization for Standardization
IT						Information technology
LivaNova PLC						A public limited company organized under the laws of England and Wales on February 20, 2015
LivaNova USA						LivaNova USA, Inc.
LSM						LivaNova Site Management S.r.l.
MDD						Medical Device Directive
MDL						Federal multi-district litigation in the US District Court for the Middle District of Pennsylvania
MDR						EU Medical Device Regulation
Mitral						Mitral Holdco S.à r.l.
MRI						Magnetic resonance imaging
Nasdaq						Nasdaq Global Market
NCD						Non-coverage determination


Abbreviation						Definition
NIST						National Institute of Standards and Technology
Notes						$287.5 million aggregate principal amount of 3.00% senior notes due December 2025, issued June 17, 2020
OCI						Other comprehensive income (loss)
OECD						Organization for Economic Co-operation and Development
Option Counterparties						Certain financial institutions with whom LivaNova entered into privately negotiated capped call transactions
Order						Administrative order from the Italian Ministry of the Environment received by LivaNova in 2021
OSA						Obstructive sleep apnea
OSPREY clinical trial						LivaNova’s clinical trial, “Treating Obstructive Sleep Apnea using Targeted Hypoglossal Neurostimulation”
Pillar Two						OECD BEPS Pillar Two
Plan Committee						Qualified Plan Committee
PMA						Pre-market approval
PP&E						Property, plant and equipment
Public Administrations						The Italian Ministry of the Environment and other Italian government agencies
R&D						Research and Development
RECOVER clinical study						LivaNova’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”
Report						This Annual Report on Form 10-K
RSUs						Service-based restricted stock units
S&P						Standard & Poor’s
SARs						Service-based stock appreciation rights
SDRT						UK Stamp Duty Reserve Tax
SEC						US Securities and Exchange Commission
Securities Act						US Securities Act of 1933, as amended
SG&A						Selling, general and administrative expenses
SNIA						SNIA S.p.A.
SNIA Litigation Guarantee						A first demand bank guarantee of €270.0 million in connection with the SNIA litigation
SOFR						Secured Overnight Financing Rate
Sorin						Sorin S.p.A.
Sorin spin-off						The spin-off of Sorin from SNIA in 2004
Term Facilities						The Initial Term Facility, together with the Delayed Draw Term Facility
Trust						LivaNova PLC Employee Benefit Trust
UK						United Kingdom
UK Act						Finance (No.2) Act 2023
UK Bribery Act						UK Bribery Act of 2010
US						United States of America
US GAAP						Generally Accepted Accounting Principles in the US
USD						US dollar
UTPR						Undertaxed profits rule
VNS						Vagus nerve stimulation
VNS Therapy						LivaNova Vagus Nerve Stimulation Therapy
WACC						Weighted average cost of capital
Warning Letter						FDA Warning Letter received by LivaNova on December 29, 2015

INTELLECTUAL PROPERTY, TRADEMARKS AND TRADE NAMES

This ~~report~~Report may contain references to ~~our~~LivaNova’s proprietary intellectual property, including among others:

•Trademarks for ~~our~~LivaNova’s Neuromodulation systems, the VNS Therapy™ System, the VITARIA™TM System and ~~our~~LivaNova’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™TM and TitrationAssist™TM) and Model 8103 (Symmetry™).

•Trademarks for ~~our~~LivaNova’s Cardiopulmonary ~~product~~products and systems: ~~Essenz~~™Essenz™, S5™, S3™, S5 Pro™, B-Capta™, Inspire™, Heartlink™, XTRA™, 3T Heater-Cooler™, ~~Connect~~™Connect™ and Revolution™.

•Trademarks for ~~our~~LivaNova’s advanced circulatory support systems: TandemLife™, TandemHeart™, TandemLung™, ProtekDuo™, LifeSPARC™, ~~LifeSPARC~~™ALung™, ~~ALung~~™~~, Hemolung~~™Hemolung™, Respiratory ~~Dialysis~~™Dialysis™ and ~~ActivMix~~™ActivMix™.

•Trademarks for ~~our~~LivaNova’s obstructive sleep apnea system: ImThera™ and aura6000™.

These trademarks and trade names are the property of LivaNova or the property of ~~our~~LivaNova’s consolidated subsidiaries and are protected under applicable intellectual property laws. Solely for convenience, ~~our~~LivaNova’s trademarks and ~~tradenames~~trade names referred to in this ~~Annual~~ Report ~~on Form 10-K~~ 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, ~~our~~LivaNova’s rights to these trademarks and ~~tradenames.~~trade names.

CAUTIONARY NOTE ABOUT FORWARD-LOOKING STATEMENTS

Certain statements in this ~~Annual~~ Report, ~~on Form 10-K,~~ other than statements of historical 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, as amended~~ 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, ~~our~~the Company’s actual financial results, performance, achievements or prospects may differ materially from those expressed or implied by these forward-looking statements. 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 ~~our~~the Company’s control, that could cause ~~our~~the Company’s actual results to differ materially from the forward-looking statements contained in this ~~Annual~~ Report ~~on Form 10-K. Such risks, uncertainties~~ and ~~other important factors~~ include, but are not limited ~~to: risks related to reductions, interruptions or increasing costs related~~ to, the ~~supply of raw materials~~following risks and ~~components and the distribution of finished products, including as a result of inflation and war;~~uncertainties: volatility in the global market and worldwide economic conditions, including as caused by the invasion of Ukraine, the evolving instability in the Middle East, inflation, changing interest rates, foreign exchange fluctuations, changes to existing trade agreements and relationships between the ~~U.S.~~US and other countries including the implementation of sanctions; cyber-attacks or other disruptions to the Company’s information technology systems or those of third parties with which the Company interacts; costs of complying with privacy and security of personal information requirements and laws; risks related to reductions and interruptions in the Company’s supply chain; changes in technology, including the development of superior or alternative technology or devices by competitors and/or competition from providers of alternative medical therapies; failure to obtain approvals or reimbursement in relation to ~~our~~the Company’s products; failure to establish, expand or maintain market acceptance of ~~our~~the Company’s products for the treatment of ~~our~~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 meet milestones; failure to comply with, or changes in, laws, regulations or administrative practices affecting government regulation of ~~our~~the Company’s products; risks relating to recalls, enforcement actions or product liability claims; changes or reduction in reimbursement for ~~our~~the Company’s products or failure to comply with rules relating to reimbursement of healthcare goods and services; ~~cyber-attacks or other disruptions to our information technology systems; costs of complying with privacy and security of personal information requirements and laws;~~ failure to comply with anti-bribery laws; 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; 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 our 3T and SNIA litigations;~~ product liability, intellectual property, shareholder-related, environmental-related, income tax and other litigation, disputes, losses and costs; failure to retain key personnel, prevent labor shortages, or manage labor costs; the failure of ~~our~~the Company’s R&D efforts to keep up with the rapid pace of technological development in the medical device industry; risks relating to the impact of climate change and ~~the risk of environmental, social and governance~~ESG pressures from internal and external stakeholders; the risk of quality concerns and the impacts thereof; failure to protect ~~our~~the Company’s proprietary intellectual property; ~~COVID-19’s reverberating impacts on the economy, employment, patient behaviors and supply chain, among others;~~ failure of new acquisitions to further ~~our~~the Company’s strategic objectives or strengthen ~~our~~the Company’s existing businesses; the potential for impairments of intangible assets, goodwill and ~~goodwill;~~other long-lived assets; risks relating to ~~our~~the Company’s indebtedness including under the exchangeable senior notes, ~~our~~the Company’s revolving credit facility and ~~our~~the Company’s 2022 Term Facilities, as defined herein; effectiveness of ~~our~~the Company’s internal controls over financial reporting; changes in ~~our~~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; and other unknown or unpredictable factors that could harm ~~our~~the Company’s financial performance.

See also the section titled “Risk Factors” (refer to Part I, Item 1A of this report) for further discussion of certain risks and uncertainties that could cause actual results and events to differ materially from the forward-looking statements. All forward-looking statements in this ~~Annual~~ Report ~~on Form 10-K~~ are expressly qualified in their entirety by the cautionary statements set forth above. Forward-looking statements speak only as of the date of this ~~Annual~~ Report, ~~on Form 10-K,~~ and weLivaNova expressly ~~disclaim~~disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. You are advised, however, to consult any further disclosures ~~we make~~LivaNova makes on related subjects in ~~our~~its Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. This cautionary note is applicable to all forward-looking statements contained in this report.

The following discussion and analysis should be read in conjunction with and are qualified in their entirety by reference to the discussions included in “Item 1A. Risk Factors,” “Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in this ~~Annual Report on Form 10-K.~~Report.

Description of the Business and Background

LivaNova PLC ~~headquartered in London (collectively with its subsidiaries, the “Company,” “LivaNova,” “we” or “our”),~~ is a market-leading global medical ~~device~~technology company. ~~We design, develop, manufacture~~The Company designs, develops, manufactures, markets and ~~sell~~sells products and therapies that are consistent with ~~our~~LivaNova’s mission to provide hope for patients and their families through innovative medical technologies ~~delivering~~that deliver life-changing ~~improvements for both the Head and Heart.~~

~~We were~~improvements. LivaNova is a public limited company organized under the laws of England and Wales ~~on February 20, 2015 for the purpose of facilitating the business combination of Cyberonics, Inc., a Delaware corporation,~~ and ~~Sorin S.p.A. (“Sorin”), a joint stock company organized under the laws of Italy. The business combination became effective~~is headquartered in ~~October 2015.~~London, England. LivaNova’s ordinary shares are listed for trading on the Nasdaq ~~Global Market (“Nasdaq”)~~ under the symbol “LIVN.”

For the periods presented herein, LivaNova iswas comprised of three reportable segments: Cardiopulmonary, Neuromodulation and ~~Advanced Circulatory Support (“ACS”), corresponding to our primary business units.~~ACS. “Other” includes non-allocated corporate ~~shared service~~ expenses for ~~finance, legal, human resources, information technology and corporate business development. For~~ the years ended December 31, ~~2021~~2022 and ~~2020,~~2023. For the year ended December 31, 2021, “Other” also includes the results of ~~our~~LivaNova’s Heart Valve business, which was divested on June 1, 2021.

During the first quarter of 2024, the Company reorganized its operating and reporting structure upon initiating the 2024 Restructuring Plan as further described below. In 2024, LivaNova’s ACS segment will be included within “Other,” excluding the ACS standalone cannulae and accessories business, which will be included within the Cardiopulmonary reportable segment.

For further information regarding ~~our~~LivaNova’s reportable segments, historical financial information and ~~our~~ methodology for the presentation of financial results, please refer to “Item 15. Exhibits and Financial Statement Schedules” of this ~~Annual Report on Form 10-K.~~Report.

~~Our~~LivaNova’s Cardiopulmonary segment is engaged in the design, development, ~~production~~manufacture, marketing and ~~sale~~selling of cardiopulmonary products, including ~~heart-lung machines (“HLM”),~~HLMs, oxygenators, autotransfusion systems, perfusion tubing systems, cannulae and other related accessories. It includes the ~~development of the~~ Essenz Perfusion System, ~~our~~the Company’s next-generation HLM ~~and a~~with an embedded patient monitor ~~that delivers a patient-tailored approach, supporting~~for tailored patient care strategies and sensing technology for data-driven ~~decisions~~decision making during ~~cardiopulmonary bypass~~CPB procedures. ~~In the fourth quarter of 2022, we completed the first clinical cases using Essenz in two major centers in Europe.~~

~~Cardiopulmonary bypass~~CPB is commonly used in many operations involving the heart. ~~The~~This technique enables the surgical team to oxygenate and circulate the ~~patient's~~patient’s blood, thus ~~allowing~~enabling the surgeon to operate on the heart. The most commonly performed procedures requiring ~~cardiopulmonary bypass~~CPB are conventional coronary artery bypass grafting and valve surgeries. ~~In such procedures, the patient is placed on an extracorporeal circulatory support system that temporarily functions as the patient’s heart and lungs and provides blood flow to the body. Our~~LivaNova’s products ~~include systems to~~ enable cardiopulmonary bypass, including HLMs, oxygenators, autotransfusion systems, perfusion tubing sets, cannulae and accessories, as well as related equipment and disposables for autotransfusion and autologous blood washingCPB for neonatal, pediatric, and adult patients. ~~Our primary cardiopulmonary products include:~~

Heart-lung ~~machines~~. Machines

The HLM product group includes HLMs, ~~heater coolers,~~heater-coolers, related cardiac surgery equipment and maintenance, and technical services. HLMs temporarily take over the work of the heart and/or lungs, providing blood and oxygen to the body. HLMs are most often used during ~~serious~~ procedures that require the heart to be stopped. ~~Heater coolers~~Heater-coolers are used during surgeries to warm or cool patients as part of their care. They are especially important during surgeries involving the heart and lungs.

In March 2023, LivaNova announced it had received FDA 510(k) clearance for its Essenz HLM, which enabled the commercial launch of Essenz in the US. In the same month, LivaNova also initiated a broad commercial release of Essenz in Europe following a successful limited commercial release that supported more than 200 adult, pediatric and neonatal patients in that region. Approvals in various other countries have followed.

Oxygenators and ~~perfusion tubing systems~~. Perfusion Tubing Systems

The oxygenators product group ~~which includes oxygenators and other~~is comprised of disposable devices for extracorporeal circulation, ~~includes~~including the Inspire systems. The Inspire range of products is comprised of 12 models ~~and provides~~that provide perfusionists with a customizable approach for the benefit of patients. Oxygenators exchange oxygen and carbon dioxide in the blood of patients during surgical ~~procedures. An oxygenator is typically~~procedures and are utilized by perfusionists during cardiac surgery in conjunction with a ~~HLM. Oxygenators~~HLM and can also be utilized in ~~extracorporeal membrane oxygenation (“ECMO”).~~ECMO.

Autotransfusion ~~systems~~. Systems

One of the key elements for a complete blood management strategy is autologous blood transfusion. The autotransfusion product group facilitates the collection, processing and reinfusion of the patient’s own blood lost at the surgical site.

The cannulae product ~~family~~group in the Cardiopulmonary segment is used to connect the extracorporeal circulation system to the heart of the patient during cardiac surgery. During the first quarter of 2024, as a result of the 2024 Restructuring Plan as further described below, the Company will transition all ACS standalone cannulae and accessories, including ProtekDuo and transseptal (TandemHeart) cannulae, into its Cardiopulmonary segment. The ACS cannulae are designed and used for temporary unloading of the right ventricle, for supporting the left ventricle and for connecting ECMO systems.

~~Our~~DTD. LivaNova’s principal Neuromodulation product, the ~~LivaNova Vagus Nerve Stimulation Therapy (“VNS Therapy”) System, is an implantable device authorized for the treatment of DRE and DTD. The~~ VNS Therapy System, consists of an implantable pulse generator and connective lead that ~~stimulate~~stimulates the vagus nerve; surgical equipment to assist with the implant procedure; equipment and instruction manuals enabling a treating physician to set parameters for a patient’s pulse generator; and for epilepsy, magnets to manually suspend or induce nerve stimulation. The ~~pulse generator and~~ lead ~~are surgically implanted in a subcutaneous pocket in the upper left chest area, generally during an out-patient procedure. The lead, which~~ does not need to be removed to replace a generator with a depleted ~~battery,~~battery.

The Neuromodulation segment is ~~connected to the pulse generator and tunneled under the skin to the vagus nerve~~also engaged in the ~~lower left side~~development and management of ~~the patient’s neck. Our~~clinical testing for LivaNova’s aura6000 ~~device~~System for treating ~~OSA~~OSA. The aura6000 device stimulates the hypoglossal nerve, which ~~in turn,~~ engages ~~certain~~specific tongue and palate muscles ~~in the tongue~~ to open the airway while a patient ~~is sleeping.~~sleeps.

LivaNova’s Neuromodulation segment also includes costs associated with the Company’s former Heart Failure program, which the Company began winding down during the first quarter of 2023.

There are several broad types of treatment available to patients with epilepsy: multiple ~~anti-seizure medications (“ASMs”);~~ASMs; various forms of the ketogenic diet; ~~vagus nerve stimulation (“VNS”);~~VNS; resective and ablative brain surgery; and intracranial neurostimulation. ASMs typically serve as a first-line treatment and are prescribed for virtually all patients diagnosed with epilepsy. After two ~~anti-seizure medications~~ASMs fail to deliver seizure control, the epilepsy is characterized as ~~drug-resistant, at which~~drug-resistant. At this point, adjunctive non-drug options are considered, including VNS therapy, ketogenic diet, resective or ablative surgery and other neuromodulation therapies.

In 1997, ~~our~~LivaNova’s VNS Therapy System was the first medical device treatment approved by the FDA for the treatment of ~~drug-resistant epilepsy,~~DRE, and today is the only neuromodulation device approved for use in the US in DRE patients ~~in the U.S.~~ as young as four years of age with partial onset, or focal, seizures. Other worldwide regulatory bodies have also approved the VNS Therapy System for treating patients with DRE, many without age or seizure-type restrictions. ~~Globally, VNS Therapy is the most widely reimbursed neuromodulation therapy available.~~ In 2020, ~~the U.S. Centers for Medicare and Medicaid Services (“CMS”)~~CMS expanded reimbursement for VNS Therapy use in the treatment of Dravet Syndrome and, in January 2022, expanded reimbursement for VNS Therapy use in the treatment of ~~Lennox Gastaut~~Lennox-Gastaut Syndrome.

~~We distribute~~LivaNova distributes multiple VNS Therapy Systems for the treatment of epilepsy, including Model 103 (Demipulse), Model 104 (Demipulse Duo), Model 106 (AspireSR), Model 1000 (SenTiva) and Model 1000D (SenTiva Duo) pulse generators. ~~Our~~LivaNova’s AspireSR and SenTiva generators provide the traditional benefits of VNS Therapy but add an additional stimulation capability: closed loop stimulation ~~(AutoStim™)~~(AutoStim) which responds to detection of changes in heart rate potentially indicative of a seizure. The SenTiva generator is the smallest and lightest VNS device capable of delivering responsive therapy for epilepsy and includes the additional flexibility of ~~our~~LivaNova’s Scheduled Programming and Day & Night Programming capabilities. In 2017, the SenTiva, AspireHC and AspireSR VNS Therapy devices were approved by the FDA ~~approved~~ for expanded ~~magnetic resonance imaging (“MRI”)~~MRI access ~~while~~and similar CE Mark approval followed shortly thereafter. ~~Currently, SenTiva, AspireHC and AspireSR models of VNS Therapy technology provide for this expanded MRI access.~~

In 2005, the FDA approved the VNS Therapy System for the adjunctive treatment of chronic or recurrent depression for patients 18 years or older who are experiencing a major depressive episode and have not had an adequate response to four or more antidepressant treatments. In 2007, ~~the United States (“U.S.”)~~ CMS issued a ~~national~~ non-coverage determination ~~(“NCD”) within the U.S.~~ with respect to reimbursement of the VNS Therapy System for patients with DTD, significantly limiting access ~~to this therapeutic option~~ for most patients. In 2020, ~~our~~LivaNova’s VNS Therapy System, Symmetry received CE mark approval for the treatment of DTD.

In 2017, the American Journal of Psychiatry published the results of the longest and largest naturalistic study ~~(the “D23 study”)~~ on treatments for patients experiencing chronic and severe DTD. The findings showed that the addition of the VNS Therapy System to traditional

treatment iswas effective in significantly reducing symptoms of depression and ~~well tolerated~~well-tolerated compared with traditional treatment alone. Following publication of the D23 study, weLivaNova requested that CMS to reconsider its previous NCD, and in 2018, CMS published a tracking sheet to ~~reconsider its NCD.~~reconsider.

In 2019, CMS produced a final decision providing coverage for the VNS Therapy System for Medicare beneficiaries through ~~Coverage with Evidence Development (“CED”)~~CED when offered in a CMS-approved, double-blind, randomized, placebo-controlled trial with a follow-up

duration of at least one year, as well as coverage of VNS Therapy System device replacement. The CED also includes the possibility to extend the study to a prospective longitudinal registry.

In 2019, CMS accepted the protocol for ~~our~~LivaNova’s RECOVER clinical study and the first patient was enrolled. RECOVER ~~may include up to~~includes 500 unipolar and up to 500 bipolar patients at a maximum of 100 sites in the ~~United States~~US in the randomized part of the trial and may include up to an additional 5,800 patients in an open label registry.

In 2020, we announced a research collaboration with Verily, a subsidiary of Alphabet Inc., to capture clinical biomarkers of depression within our RECOVER clinical study. Using technology and analytics by way ofMarch 2023, LivaNova randomized the Verily Study Watch and related Verily mobile phone application, LivaNova and Verily aim to gather quantitative data to further understand depressive episodes and a patient’s response to treatment. These complementary approaches are expected to help investigators better understand the impact of depression and its treatment on study participants’ lives in a more objective and multi-dimensional manner. In 2021, LivaNova and Verily announced that the first patient had been enrolled in their collaborative UNCOVER study, a subset of the RECOVER study.

~~In March 2022, LivaNova announced the 250th~~500th unipolar depression patient ~~was implanted~~into the RECOVER clinical study and subsequently completed all unipolar implants in May. Upon receipt of the 12-month follow-up data for all 500 patients, the Company expects to conduct a final analysis for the unipolar cohort, potentially culminating in 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 conducting the first interim analysis.~~ The ~~study was designed with frequent interim analyses, which occur every 25~~RECOVER clinical study’s protocol allows for a minimum of 150 and a maximum of 500 bipolar depression patients to be randomized into the study. Upon randomizing the 150th bipolar patient, a series of interim analyses are being conducted every 25 patients by an independent Statistical Analysis ~~Committee. The interim analysis assesses~~Committee to assess if predictive probability of success has been reached for the ~~unipolar~~bipolar cohort of the ~~study, at which point~~study. If any analysis reveals that the ~~randomized controlled trial (“RCT”) enrollment~~predictive probability of success has been reached, recruitment into the bipolar arm of the study will cease and ~~future patients~~LivaNova will ~~be enrolled into~~notify CMS and initiate the prospective ~~open label~~open-label longitudinal study for ~~that cohort.~~future bipolar Medicare patients. After the last patient enrolled into the ~~RCT~~RECOVER clinical study has completed 12 months of follow-up, a final analysis will be conducted on the complete ~~dataset for that respective cohort.~~ bipolar dataset.

The ~~trial,~~RECOVER clinical study, if successful, ~~will~~may potentially be used to support a peer-reviewed ~~article~~publication and reconsideration of reimbursement for the VNS Therapy System by CMS for the treatment of DTD. The reconsideration process will happen independently for the unipolar and bipolar cohorts.

Obstructive Sleep Apnea

In 2018, weLivaNova acquired full ownership of ImThera, a ~~privately held, emerging-growth~~ company developing an implantable neurostimulation device system for the treatment of obstructive sleep apnea. The device stimulates the hypoglossal nerve, which ~~in turn,~~ engages ~~certain~~specific tongue and palate muscles ~~in the tongue in order~~ to open the airway while a patient ~~is sleeping.~~sleeps.

In 2021, LivaNova received approval from the FDA to proceed with its investigational device exemption clinical study, ~~Treating Obstructive Sleep Apnea using Targeted Hypoglossal Neurostimulation (“OSPREY”),~~the OSPREY clinical trial, and the first patient was implanted in March 2022. The OSPREY ~~study~~clinical trial seeks to confirm the safety and effectiveness of the aura6000 System.

The VITARIA System was intended to treat heart failure through VNS. In 2018, after completion of pilot studies outside the U.S., we announced the first successful implantation of the VITARIA System in a patient randomized in the ANTHEM-HFrEF clinical trial, an international, multi-center, randomized trial (adaptive sample size) to evaluate the VITARIA System for the treatment of advanced heart failure. During the fourth quarter of 2022, we randomized the 500th patient in the trial which triggered the second interim analysis. The independent Data and Safety Monitoring Committee (“DSMC”) evaluated safety, a trend toward the primary endpoint and success in the three functional endpoints. This analysis determined that the U.S. FDA early filing conditions were not met, and the DSMC recommended that enrollment continue in accordance with the current study protocol. However, we conducted further evaluation of the study data and concluded that such data did not demonstrate a sufficiently strong positive impact on functional or mortality endpoints and that it was unlikely that the continuation of the study would demonstrate such an impact. As a result, on February 22, 2023, we announced that we are stopping enrollment in the ANTHEM-HFrEF clinical trial, beginning the process to close the clinical study and winding down our heart failure program.

Advanced Circulatory Support

~~Our~~LivaNova’s ACS segment iswas engaged in the design, development, ~~production~~manufacture, marketing and ~~sale~~selling of ~~leading-edge~~ temporary life support products. ~~Our ACS~~ACS’s products, which comprise the LifeSPARC ~~platform~~ and Hemolung systems, and standalone cannulae and accessories, including ProtekDuo ~~cannula,~~and transseptal (TandemHeart) cannulae, simplify temporary extracorporeal cardiopulmonary life support solutions for critically ill patients.

On January 5, 2024, the Board of Directors of LivaNova PLC approved the 2024 Restructuring Plan to enhance the Company’s focus on its core Cardiopulmonary and Neuromodulation segments. The main component of this plan is to wind down the ACS segment, which the Company anticipates will be substantially complete by the end of 2024. During the first quarter of 2024, the Company reorganized its operating and reporting structure upon initiating the 2024 Restructuring Plan and transitioned all ACS standalone cannulae and accessories, including ProtekDuo and transseptal (TandemHeart) cannulae, into its Cardiopulmonary segment. Operations for other ACS products, including LifeSPARC ~~platform includes a common compact console~~ and ~~pump that provides temporary support for emergent rescue patients in a variety~~Hemolung systems, will be discontinued by the end 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. In November 2022, the FDA approved our LifeSPARC platform for ECMO. This approval allows for our LifeSPARC platform to be used for ECMO beyond six hours for patients in acute respiratory failure or acute cardiopulmonary failure, including but not limited to those receiving treatment for COVID-19.

We previously owned a 3% equity interest in ALung Technologies, Inc. (“ALung”), a privately-held medical device company focused on creating advanced medical devices for treating respiratory failure. In May 2022, we acquired the remaining 97% of equity interests.2024. For additional information, please refer to “Note ~~4. Business Combinations” and “Note 8. Goodwill and Intangible Assets”~~6. Restructuring” in ~~our~~LivaNova’s consolidated financial statements ~~and accompanying notes beginning on page F-1 of~~included in this Annual Report on Form 10-K. As a result of the ALung transaction, our ACS segment also includes the Hemolung Respiratory Assist System (“Hemolung RAS”), which is the only FDA-cleared platform designed specifically for low-flow extracorporeal carbon dioxide removal for acute respiratory failure.Report.

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.

The Company’s R&D investment consists of product design and ~~Development (“R&D”)~~

~~Our~~development expenses, including technology, software, clinical study programs and regulatory activities. LivaNova’s markets are subject to rapid technological advances, and as such, product improvement, software advancements and innovation are necessary to maintain market leadership. ~~We direct our~~The Company directs its R&D efforts toward maintaining or achieving technological leadership in each of ~~the~~its markets ~~we serve~~ to help ensure that patients using ~~our~~the Company’s devices and therapies receive the most advanced and effective treatment ~~possible. We remain~~available. LivaNova remains committed to developing technological enhancements and new uses for existing products, ~~and~~as well as less invasive and new technologies ~~for new and emerging markets~~ to address unmet patient needs. ~~We initiate and participate in many clinical trials each year as the demand for~~LivaNova continues to engage researchers to collect clinical and health economic evidence ~~remains high. We also strive~~that support regulatory filings and value dossiers and to establish the value proposition to patients, physicians, and payors for ~~development activities to help reduce patient care costs~~its current and ~~the length of hospital stays in the future.~~

We work to continue to identify innovative technologies and continually assess the ability of our R&D programs to deliver economic value to the customer. Our current R&D expenses consist of product design and development efforts, including in relation to software and technology, clinical study programs and regulatory activities, which are essential to our strategic portfolio initiatives.future products.

Patents and Licenses

~~We rely~~LivaNova relies on a combination of patents, trademarks, copyrights, trade secrets and non-disclosure and non-competition agreements to protect ~~our~~the Company’s intellectual property. WeLivaNova generally ~~file~~files patent applications in the ~~U.S.~~US and countries where patent protection for ~~our~~LivaNova’s technology is appropriate and available. As of December 31, ~~2022, we~~2023, LivaNova held more than ~~840~~865 issued patents worldwide, with approximately ~~285~~295 pending patent applications that cover various aspects of ~~our~~the Company’s technology. Patents typically have a 20-year term from the application filing date. In addition, ~~we hold~~LivaNova holds exclusive and non-exclusive licenses to a variety of third-party technologies covered by patents and pending patent applications. There can be no assurance that pending patent applications will result in the issuance of patents, that patents issued to or licensed by usLivaNova will not be challenged or circumvented by competitors, or that these patents will be found to be valid or sufficiently broad to protect ~~our~~LivaNova’s technology or to provide usthe Company with a competitive advantage. ~~We have~~LivaNova has also obtained certain trademarks and trade names for ~~our~~the Company’s products and ~~maintain~~maintains certain details about ~~our~~its processes, products and strategies as trade secrets. In the aggregate, ~~we consider~~LivaNova considers these intellectual property assets to be of material importance to ~~our business segments and operations. We~~its business. LivaNova regularly ~~review~~reviews third-party patents and patent applications in an effort to protect ~~our~~its intellectual property and avoid disputes over proprietary rights.

~~We rely~~LivaNova relies on non-disclosure and non-competition agreements with employees, consultants and other parties to protect, in part, trade secrets and other proprietary technology. There can be no assurance that these agreements will not be breached or will be enforceable, ~~in particular due to new proposed regulation in the U.S.,~~ that weLivaNova will have adequate remedies for any breach, that others will not independently develop equivalent proprietary information or that third parties will not otherwise gain access to ~~our~~LivaNova’s trade secrets and proprietary knowledge.

For additional information, please refer to “Item 1A. Risk Factors” of this ~~Annual~~ Report, ~~on Form 10-K,~~ under the section entitled “~~We are~~LivaNova is substantially dependent on patent and other proprietary rights and failing to protect such rights or to be successful in litigation related to ~~our~~LivaNova’s rights or the rights of others may result in ~~our~~the Company’s payment of significant monetary damages and/or royalty payments, negatively impact ~~our~~LivaNova’s ability to sell current or future products or prohibit usthe Company from enforcing ~~our~~its patent and other proprietary rights against others.”

Markets and Distribution Methods

~~The three largest markets for our medical devices are the U.S., Europe and the Asia-Pacific region (“APAC”). We sell~~LivaNova sells most of ~~our~~its medical devices through direct sales representatives in the ~~U.S.~~US and a combination of direct sales representatives and independent distributors in international markets. Europe and the APAC region are the Company’s largest international markets, ~~outside~~comprising 19% and 13% of net revenue during the ~~U.S.~~year ended December 31, 2023, respectively.

~~Our~~LivaNova’s marketing and sales strategy is focused on rapid, cost-effective delivery of high-quality products to a diverse group of customers worldwide, including perfusionists, neurologists, neurosurgeons and other physicians, hospitals and other medical institutions and healthcare providers. To achieve this objective, ~~we maintain a highly knowledgeable~~LivaNova’s sales team develops and ~~dedicated sales staff that is able to foster~~preserves strong relationships with ~~our broad range of customers. We cultivate~~customers, and ~~maintain~~the Company cultivates and maintains close working relationships with professionals in the medical industry. These relationships provide usLivaNova with a detailed understanding of therapeutic and diagnostic trends, developments, ~~trends~~ and emerging opportunities, which ~~enable us~~enables the Company to respond to the changing needs of providers and patients. WeLivaNova actively ~~participate~~participates in medical meetings and ~~conduct~~conducts comprehensive training and educational activities to enhance ~~our~~its presence in the medical communities ~~we serve. We believe~~it serves. LivaNova believes that these activities also contribute to advancing the expertise of healthcare ~~professionals’ expertise.~~professionals.

~~Due to the emphasis on cost-effectiveness in healthcare delivery, the~~The current trend among hospitals and other medical device customers is to consolidate into larger purchasing groups to enhance purchasing power. As a result, customer transactions have become increasingly ~~complex. Enhanced purchasing power~~complex, which has led, and may ~~also~~continue to lead, to downward pricing pressure ~~on pricing~~ and an increase in the use of preferred vendors. ~~Our~~LivaNova’s global customer base continues to evolve in response to ~~reflect such~~these and other economic ~~changes~~developments across the geographic markets ~~we serve.~~the Company serves.

Competition and Industry

~~We compete~~LivaNova competes in the global medical device market with sales in more than 100 countries. ~~Technological~~This market is characterized by technological advances and scientific discoveries which can ~~cause~~often trigger rapid ~~change~~changes in ~~this market. Our~~market dynamics. LivaNova’s competitors ~~across our product portfolio~~ range from large manufacturers with multiple business lines to small manufacturers offering a limited selection of specialized products. ~~In addition, we face~~LivaNova faces competition from, among others, providers of alternative medical therapies, ~~such as pharmaceutical companies~~pharmaceuticals and ~~providers of cannabis derived products, among others.~~surgical interventions.

~~Product problems, physician~~Physician advisories, regulatory safety alerts and publications about ~~our~~LivaNova’s products, or competitor products, can cause major shifts in industry market share, reflecting the importance of product quality, product efficacy and quality systems in the medical device industry. In addition, ~~because of~~ developments in managed care, economically motivated customers, consolidation among healthcare providers, increased competition and declining reimbursement rates we may be increasingly ~~required~~require LivaNova to compete on the basis of price. In order to continue to compete effectively, ~~we must~~LivaNova will likely be required to continue to create or acquire advanced technology, incorporate this technology into proprietary products, obtain regulatory approvals in a timely manner, maintain high-quality manufacturing processes, and successfully market and sell these products.

~~Our~~LivaNova’s primary medical device competitors in the Cardiopulmonary, Neuromodulation and ~~Advanced Circulatory Support~~ACS product groups are Terumo Medical Corporation, Maquet Medical Systems, Medtronic plc, Haemonetics Corporation, NeuroPace, Inc. and Abbott Laboratories, Inc., although not all competitors are present in all product lines.

Production, Quality Systems and Raw Materials

~~We manufacture~~LivaNova manufactures a majority of ~~our~~its products ~~at nine manufacturing~~in facilities located in the US, Italy, Germany, ~~the U.S., Brazil~~Australia and ~~Australia. We purchase~~Brazil. LivaNova purchases raw materials and ~~many of the~~ components used in ~~our manufacturing facilities~~its products from numerous suppliers located in various ~~countries.~~countries worldwide. For quality assurance, sole source availability or cost effectiveness purposes, weLivaNova may procure certain components and raw materials from a sole supplier. ~~We work closely~~LivaNova takes countermeasures to reduce its supply chain risk, including working with ~~our~~ suppliers to ensure continuity of supply while maintaining high quality and reliability and working to minimize the instances in which ~~we rely~~the Company relies on a sole supplier and take other countermeasures to reduce our supply chain risk, but, like many companies, have experienced and continue to experience supply chain delays and interruptions, labor shortages, inflationary pressures and logistical issues. We usesupplier. LivaNova uses quality systems in the design, ~~production,~~development, manufacturing, warehousing and distribution of ~~our~~its products to ensure ~~our~~its products are safe and effective. In addition, ~~we utilize~~LivaNova utilizes environmental management systems and safety programs to protect the environment and ~~our~~the Company’s employees. For example, all of ~~our~~LivaNova’s manufacturing facilities are certified ISO 13485. Additionally, ~~our~~LivaNova’s Mirandola, Italy plant is ~~certified~~ ISO 14001 and ISO 45001 certified, and ~~our~~its Munich, Germany plant is ~~certified~~ ISO ~~14001.~~14001 certified. For additional information related to ~~our~~LivaNova’s manufacturing facilities, refer to “Item 2. Properties” in this ~~Annual Report on Form 10-K.~~Report.

Government Regulation and Other Considerations

~~Our~~LivaNova’s medical devices are subject to extensive government regulation by numerous government agencies, both within and outside the ~~U.S. To varying degrees, each of these~~US. These agencies ~~requires us~~require LivaNova to comply with laws and regulations governing the research, development, testing, manufacturing, labeling, pre-market clearance or approval, marketing, distribution, advertising, promotion, record keeping, reporting, tracking, ~~and~~ importing, and exporting of ~~our~~LivaNova’s products. ~~Our~~LivaNova’s business is also affected by ~~patient~~data privacy and security laws, cost containment initiatives, and environmental health and safety laws and regulations worldwide.

~~The laws applicable~~ LivaNova works to ~~us are subject to changing and evolving interpretations, and we continue to monitor such shifts. The Company believes it is in~~ensure compliance with such laws and regulations and ~~while~~continues to monitor the ~~impact of regulatory changes cannot be predicted with certainty, the Company does not expect compliance~~laws applicable to ~~have a material adverse effect upon the Company’s earnings, competitive position or estimated capital expenditures. However, if a governmental authority were to conclude that we~~LivaNova, which are ~~not in compliance with applicable laws and regulations, we and our officers and employees could be~~ subject to ~~severe civil~~changing and criminal penalties, including substantial fines and damages, and exclusion from participation as a supplier of products to beneficiaries covered by government programs, among other potential enforcement actions.evolving interpretations.

Product Approval and Monitoring

Many countries ~~where we sell our~~in which LivaNova sells its products subject ~~our~~the Company’s medical devices to their own product approval and requirements regarding performance, safety and quality. ~~Each~~For example, each medical device ~~we seek~~that LivaNova seeks to distribute commercially in the ~~U.S., for example,~~US must receive 510(k) clearance or ~~pre-market approval (“PMA”)~~PMA from the FDA, unless specifically exempted by the agency. The 510(k) process, also known as pre-market notification, requires usLivaNova to demonstrate that ~~our~~its new medical device is substantially equivalent to a legally marketed medical device. The PMA process, which is more costly and rigorous than the 510(k) process, requires usLivaNova to demonstrate independently that a medical device is safe and effective for its intended use. One or more clinical studies may be required to support a 510(k) application and are almost always required to support a PMA application.

The ~~European Union (“EU”)~~EU has established a single regulatory product approval process, ~~according~~pursuant to which a “~~Conformité Européenne” (French for “European Conformity”) or~~ CE Mark certifies conformity with all of the legal requirements of the regulatory process. To obtain a CE Mark, defined products must meet minimum standards of performance, safety and quality (i.e., the essential requirements), and then, according to their classification, comply with one or more of a selection of conformity assessment routes. To demonstrate compliance with the essential requirements, we must undergo a conformity assessment procedure, which varies according to the type of medical device and its classification. As a general rule, demonstration of conformity of medical devices and their manufacturers with the essential requirements must be based on, among other things, the evaluation of clinical data supporting the safety and performance of the products during normal conditions of use. The competent authorities of the EU countries separately regulate the clinical research for medical devices and the market surveillance of products placed on the market, and manufacturers with CE marked devices are subject to regular inspections to monitor compliance with the applicable directives and essential

requirements. In 2017, for example, the EU published its ~~Medical Device Regulation (“Reg MDR”),~~MDR, which ~~imposed significantly more premarket~~has resulted in significant additional pre- and post-market ~~requirements~~requirements. Certifications to EU MDR must be achieved by December 2027 or December 2028, based on the risk classification of the device. Penalties for ~~medical devices upon conclusion~~regulatory non-compliance can be severe, including fines and revocation or suspension of a ~~three-year implementation period. We have initiated a plan of action to obtain the appropriate approvals for our products~~company’s business license, mandatory price reductions and ~~intend to be fully compliant prior to the May 2024 deadline, though we understand there~~criminal sanctions.

LivaNova is ~~a proposal to extend the compliance deadline.~~

~~We are~~ also required to comply with the regulations of every other country where ~~we commercialize~~it commercializes products before wethe Company can launch or maintain new products in the market. To be sold in Japan, for example, ~~our~~LivaNova’s medical devices must undergo thorough safety examinations and demonstrate medical efficacy from the Japanese government through the Ministry of Health, Labour and Welfare before they are granted approval. In China, regulatory requirements are becoming more ~~stringent, with the China National Medical Product Administration recently increasing regulatory requirements to market and maintain products in China.~~stringent. Many countries also require that product approvals be recertified on a regular basis, generally every four to five years. The recertification process requires ~~that we~~LivaNova to evaluate any device ~~changes~~change and any new ~~regulations~~regulation or ~~standards~~standard relevant to the device and, where ~~needed,~~required, conduct appropriate testing to document continued compliance. ~~Where recertification applications are required, they must be approved in order to continue selling our products in those countries.~~

The global regulatory environment is becoming increasingly more stringent and unpredictable. Several countries that did not have regulatory requirements for medical devices have established such requirements in recent years, and other countries have expanded, or plan to expand, their existing regulations. While some regulatory bodies have pursued harmonization of global regulations, requirements continue to differ significantly among countries. ~~We expect~~LivaNova expects this global regulatory environment will continue to evolve, which could impact the Company’s cost, approval lead time, ~~and ultimately, our~~or ability to maintain existing ~~approvals~~ or obtain future ~~approvals for our products.~~product approvals.

Product and Promotional Restrictions

Both before and after ~~we release~~LivaNova releases a product for commercial distribution, ~~we have~~the Company has ongoing responsibilities under various laws and regulations governing medical devices. The FDA and other regulatory agencies in and outside the ~~U.S.~~US review ~~our~~LivaNova’s design and manufacturing practices, labeling, record keeping, and required reports of adverse experiences and other information to identify potential problems with marketed medical devices. ~~We are~~LivaNova is also subject to periodic inspections for compliance with applicable quality system regulations, which govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging, and servicing of finished medical devices intended for human use. In addition, the FDA and other ~~U.S.~~US regulatory bodies monitor the manner in which ~~we promote~~LivaNova promotes and ~~advertise our~~advertises its products. Although physicians are permitted to

use their medical judgment to prescribe medical devices for indications other than those cleared or approved by the FDA, ~~we are~~LivaNova is prohibited from promoting products for such “off-label” uses and can only market ~~our~~the Company’s products for cleared or approved uses.

Any adverse regulatory action, depending on its magnitude, may limit ~~our~~LivaNova’s ability to market and sell ~~our~~its products effectively, limit ~~our~~its ability to obtain future premarket approvals or result in a substantial modification to ~~our~~LivaNova’s business practices and operations. For additional information, see “Item 1A. Risk Factors” of this ~~Annual~~ Report, ~~on Form 10-K,~~ under the section entitled “~~Our~~LivaNova’s products are subject to complex laws and regulations, and failure to obtain product approvals, clearance or reimbursement may materially adversely affect ~~our~~LivaNova’s business, results of operations, cash flows and financial condition.”

Governmental Trade Regulations

The sale and shipment of ~~our~~LivaNova’s products and services across international borders, as well as the purchase of components and products from international sources, subject usLivaNova to extensive governmental trade regulations. Many countries control the export and re-export of goods, technology and services for public health, national security, regional stability, antiterrorism and other reasons. Some governments may also impose economic sanctions against certain countries, persons or entities. In certain circumstances, governmental authorities may require ~~that we~~LivaNova to obtain an approval before weLivaNova may export or re-export goods, technology or services to certain destinations, to certain end-users and for certain end-uses. Because ~~we are~~LivaNova is subject to extensive regulations in the countries in which ~~we operate, we are~~it operates, the Company is subject to the risk that laws and regulations could change in a way that would expose usLivaNova to additional costs, penalties or liabilities.

WeLivaNova also ~~sell~~sells and ~~provide~~provides goods, technology and services to agents, representatives and distributors who may export such items to customers and end-users, and if these third parties violate applicable export control or economic sanctions laws or regulations when engaging in transactions involving ~~our~~the Company’s products, weLivaNova may be subject to varying degrees of liability depending on the extent of ~~our~~its participation in the transaction. The activities of these third parties may cause disruption or delays in the distribution and sale of ~~our~~LivaNova’s products or result in restrictions being placed on ~~our~~the Company’s international distribution and sales of products, which may materially impact ~~our~~LivaNova’s business activities.

~~Patient~~Data Privacy and Security Laws

~~We are~~As a global medical device technology company, LivaNova may be subject to various laws worldwide that protect the privacy, security and confidentiality of certain data, including employee data and patient health information ~~including patient medical records,~~ and ~~that~~ restrict the use and

unauthorized disclosure of ~~patient health~~such information. Privacy standards are ~~becoming increasingly strict; enforcement~~often strict. Enforcement actions and financial penalties related to privacy issues in the EU ~~are growing,~~continue to grow, and new privacy and data ~~residency~~localization laws and restrictions are being passed in other countries including the ~~U.S., China, and Brazil.~~US. The management of cross-border transfers of personal information ~~among and~~ outside of EU member countries is becoming more complex, which may complicate ~~our~~LivaNova’s business and clinical research activities, as well as product offerings that involve transmission or use of patient health information. ~~We continue our efforts~~LivaNova continues to adapt its business processes to comply with those standards and requirements ~~and~~applicable to ~~adapt our business processes to those standards.~~it.

In the ~~U.S., the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”)~~US, HIPAA, as amended by the ~~Health Information Technology and Clinical Health~~HITECH Act ~~(“HITECH”)~~ and their respective implementing regulations, ~~impose~~imposes specified requirements relating to the privacy and security ~~and transmission~~ of certain individually identifiable health information. Among other things, HITECH makes certain of HIPAA’s privacy and security standards directly applicable to “business associates,” essentially defined as ~~independent contractors or agents~~service providers of covered entities that create, receive, maintain or transmit protected health information in connection with providing a service for or on behalf of a covered entity. ~~We are deemed to operate as~~In certain instances, LivaNova may be considered a business ~~associate to covered entities in certain instances.~~associate. In ~~those cases,~~such instances, the patient data that ~~we receive~~LivaNova receives may include protected health information, as defined under HIPAA. ~~Enforcement~~Related enforcement actions can be costly and may also interrupt LivaNova’s regular ~~operations of our business.~~business operations. In addition, state laws, such as the ~~California Consumer Privacy Act (“CCPA”),~~CCPA, govern the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways, thus complicating compliance and data protection efforts. Since the CCPA was enacted, other US states have enacted privacy laws. The effects of the CCPA and other recently adopted laws include an increased ability of individuals to control the use of their personal data, heightened transparency obligations, increased obligations of companies to maintain the security of data, and increased exposure to fines or damages for companies that violate these laws, including by not providing individuals their specified privacy rights or, not maintaining data security safeguards at specified levels of quality, or that experience data breaches. For additional information, see “Item 1A. Risk Factors” of this ~~Annual~~ Report, ~~on Form 10-K,~~ under the section entitled “Cyber-attacks or other disruptions to ~~our~~LivaNova’s information technology systems could lead to reduced revenue, increased costs, liability claims, fines, harm to ~~our~~LivaNova’s competitive position and loss of reputation.”

In the EU, the processing of certain data, including employee and patient information, is subject to the privacy, security and confidentiality provisions set forth in Regulation 2016/~~679 on~~679. Under the ~~protection~~GDPR, data concerning health constitutes sensitive data. The processing of ~~natural persons~~sensitive data is subject to, among other obligations, appropriate notice and consent requirements. Additional requirements apply with ~~regard~~respect to issues such as data sharing, cross-border data transfers, data security, and data breach notification. The GDPR also requires LivaNova to implement a number of accountability measures in relation to the processing of ~~personal~~sensitive data, ~~and on the free movement of such data General~~including carrying out Data Protection ~~Regulation (“GDPR”) came into effect in May 2018. One of the strictest~~Impact Assessments and most comprehensive data privacy laws in the world, the GDPR, among other things, introduced proactive compliance measures, such as the requirement to carry out a Privacy Impact Assessment, Data Transfer Impact Assessment, and appointappointing a Data Protection Officer in organizations where health data is processed on a “large scale.” Although “large scale” is not defined, it is likely that clinical trials involving substantial numbers of patients (or healthy volunteers if applicable) would mean that such requirements apply to us. In addition, the administrativeOfficer. Administrative fines ~~that can~~may be levied ~~are significantly increased,~~for non-compliance with the

~~maximum being~~ GDPR’s requirements and can reach the higher of €20 million (approximately ~~$21.4~~$22.1 million), or up to 4% of ~~our~~LivaNova’s total worldwide annual net revenue infor the ~~previous~~preceding financial year.

Cost Containment Initiatives

Government and private sector initiatives to limit the growth of healthcare costs, including price regulation, competitive pricing, bidding and tender mechanics, coverage and payment policies, comparative effectiveness of therapies, technology assessments and managed-care arrangements are continuing in many countries where ~~we do~~LivaNova does business. These changes are ~~causing the marketplace~~driving customers to ~~put~~place increased emphasis on the delivery of more cost-effective medical devices and therapies. Government programs, private healthcare insurance and managed-care plans have attempted to control costs by limiting the extent of coverage or amount of reimbursement available for particular procedures or treatments, ~~tying~~by connecting reimbursement to outcomes, by shifting to population health management and through other mechanisms designed to constrain utilization and contain costs. Hospitals ~~which purchase implants,~~ are also seeking to reduce costs through a variety of mechanisms, ~~including,~~ for example, creating centralized purchasing functions that set pricing and, in some cases, limit the number of vendors that can participate in ~~the~~a given purchasing program. Hospitals are also aligning their interests with those of physicians through employment and other arrangements, such as gainsharing, whereby a hospital agrees with physicians to share certain realized cost savings resulting from the physicians’ collective change in practice patterns, such as standardization of devices where medically appropriate, and participation in affordable care organizations. Such alignment has created ~~increasing~~increased levels of price sensitivity among customers for ~~our~~LivaNova’s products.

Some third-party payers must also approve coverage and set reimbursement levels for new or innovative devices or therapies before they ~~will~~ reimburse healthcare providers ~~who~~that use the medical devices or therapies. Even though a new medical device may be cleared for commercial distribution, weLivaNova may find limited demand for the device until coverage and sufficient reimbursement levels have been obtained from governmental and private third-party payers. In addition, some private third-party payers require that certain procedures or the use of certain products be authorized in advance as a condition of coverage.

As a result of ~~our~~LivaNova’s manufacturing efficiencies, cost controls and other cost-savings initiatives, ~~we believe we are~~the Company believes it is well-positioned to respond to changes resulting from this worldwide trend toward cost ~~containment; however,~~containment. However, uncertainty

remains as to the nature of any future legislation or other reforms, making it difficult for usLivaNova to predict the potential impact of cost-containment trends on future operating results.

Applicability of Anti-Corruption Laws and Regulations

~~Our~~LivaNova’s worldwide business is subject to the ~~U.S. Foreign Corrupt Practices Act of 1977 (the “FCPA”),~~FCPA, the UK Bribery Act ~~of 2010 (the “UK Bribery Act”)~~ and other anti-corruption laws and regulations applicable in the jurisdictions where ~~we operate.~~LivaNova operates. The FCPA can be used to prosecute companies in the ~~U.S.~~US for arrangements with physicians or other parties outside the ~~U.S.~~US if the physician or party is a government official of another country and prohibited payments are made to obtain or retain business. The UK Bribery Act prohibits both domestic and international bribery, as well as bribery across both public and private sectors. There are similar laws and regulations applicable to usLivaNova outside the ~~U.S.~~US and the UK, all of which are subject to evolving interpretations. For additional information, please refer to “Item 1A. Risk Factors” of this ~~Annual~~ Report, ~~on Form 10-K,~~ under the section entitled “~~The failure~~Failure to comply with anti-bribery laws could materially adversely affect ~~our~~LivaNova’s business and result in civil and/or criminal sanctions.”

Environmental Regulation and Management

~~We are~~LivaNova is subject to various environmental laws, directives and regulations both in the ~~U.S.~~US and ~~abroad. These laws~~abroad that have resulted in, and ~~regulations~~ could lead to, increased environmental compliance expenditures ~~increased energy~~ and ~~raw materials costs and new and/or additional investment in designs and technologies. Like other medical device companies, our~~reporting. LivaNova’s ongoing manufacturing and other operations involve the use, storage and transportation of hazardous and non-hazardous substances regulated under environmental health and safety ~~laws, including those related~~laws. In addition, governmental authorities may seek to hold LivaNova liable for successor environmental liability violations committed by any companies in which LivaNova invests or acquires or may require LivaNova to clean and remove hazardous substances at its sites that were produced by the operations of prior owners and are unrelated to the ~~transportation of hazardous substances. To the best of our knowledge at this time, we do not believe that compliance with environmental protection laws related~~Company’s current operations. For additional information, please refer to ~~our current operations, including but not limited to the Saluggia site as referenced in~~ “Note ~~14.~~13. Commitments and Contingencies” in ~~our~~LivaNova’s consolidated financial statements under the sections entitled “Saluggia Site Hazardous Substances” and ~~accompanying notes beginning on page F-1~~“SNIA Environmental Liability” and “Item 1A. Risk Factors” of this ~~Annual~~ Report, ~~on Form 10-K, will~~under the section entitled “LivaNova is subject to environmental laws and regulations and the risk of environmental liabilities, violations, protest voting and litigation in multiple jurisdictions, any of which could have a material impact on ~~our~~LivaNova’s business, results of operations, cash flows, financial position or liquidity. In addition, as noted in Note 14 to such financial statements, we are engaged in litigation with respect to historical remediation claims at sites operated by subsidiaries of SNIA, unrelated to our current operations. For more information, see “Note 14. Commitmentscondition and ~~Contingencies” to such financial statements.~~liquidity.”

We believe that sound environmental, health and safety performance contribute to our competitive strength while benefiting our customers, stockholders and employees. We are focused on continuous improvement in these areas by reducing pollution, depletion of natural resources and our overall environmental footprint. Specifically, we work to improve our energy and resource usage, ultimately seeking to reduce greenhouse gas emissions and waste.

~~Health Care~~Healthcare Fraud and Abuse and Related Laws

~~We are~~The delivery of LivaNova’s products is subject to ~~U.S.~~regulation by HHS and comparable state and non-US agencies responsible for reimbursement and regulation of healthcare products and services. LivaNova is subject to US federal and state government healthcare ~~regulation~~regulations and enforcement imposed primarily in connection with government healthcare programs, such as the Medicare and ~~government~~Medicaid programs, as well as healthcare regulations and enforcement imposed by governments in other countries in which ~~we conduct our~~LivaNova conducts business.

US federal healthcare laws apply when LivaNova or customers submit claims for items or services that are reimbursed under government healthcare programs, including laws related to kickbacks, false claims, self-referrals or other healthcare fraud. ~~The~~Specifically, the federal healthcare Anti-Kickback Statute prohibits persons from, among other things, knowingly and willfully offering or paying remuneration, directly or indirectly, to a person to induce ~~the~~them to order, purchase, ~~order,~~ lease, or ~~recommendation of~~recommend a good or service for which payment may be made in whole or in part under a federal healthcare program such as Medicare or Medicaid, unless the arrangement fits within one of several statutory exemptions or regulatory “safe harbors.” Violations of the federal Anti-Kickback Statute may result in civil monetary penalties up to $100,000 for each violation, plus up to three times the remuneration involved. Violations can also result in criminal penalties, including criminal fines of up to ~~$100,000~~$50,000 and imprisonment for up to 10 years. Finally, violations can result in exclusion from participation in government healthcare programs, including Medicare and Medicaid.

In addition to the Anti-Kickback Statute, many states have their own anti-kickback laws. Often, these laws closely follow the language of the federal law, although they do not always have the same exceptions or safe harbors. In some states, these anti-kickback laws apply with respect to all payers, including commercial health insurance companies.

Additionally, violations of the ~~U.S.~~ False Claims Act ~~(the “False Claims Act”)~~ can result in significant monetary penalties and treble damages. The ~~U.S.~~US federal government utilizes the False Claims Act, the Anti-Kickback Statute and ~~the accompanying threat of significant financial liability,~~similar laws to investigate and prosecute device, pharmaceutical and biotechnology companies in connection with the promotion of products for unapproved uses, the provision of patient and provider support (e.g., reimbursement support), and other prohibited sales and marketing practices. The ~~U.S.~~US government has obtained multi-million and multi-billion-dollar settlements under the False Claims Act, in addition to individual criminal convictions under applicable criminal statutes. Given the ~~U.S.~~US government’s success ~~with~~in prosecuting claims under the False Claims Act, ~~we anticipate~~LivaNova anticipates that the ~~U.S.~~US government will continue to devote substantial resources to investigating healthcare providers’ and manufacturers’ compliance with applicable fraud and abuse laws.

In addition to the Anti-Kickback Statute and False Claims Act, many states have their own laws related to kickbacks, false claims, self-referrals or other healthcare fraud. These laws do not always have the same exceptions or safe harbors as their federal corollaries and, in some states, apply with respect to all payers, including commercial health insurance companies.

HIPAA includes federal criminal statutes that prohibit, among other actions, knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program, including private third-party payors; knowingly and willfully embezzling or stealing from a healthcare benefit program; willfully obstructing a criminal investigation of a healthcare offense; ~~and~~or knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statement in connection with the delivery of or payment for healthcare benefits, ~~items~~products or services. Similar to the federal Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation.

There ~~has~~is also ~~been a recent trend of increased~~ federal and state regulation of, and transparency with respect to, payments made to physicians and other healthcare providers. ~~We are~~LivaNova is subject to, for example, to the Physician Payments Sunshine Act, which requires usthe Company to report annually certain payments and other transfers of value ~~we make~~it makes to ~~U.S.~~US licensed physicians, nurse practitioners, physician assistants, or ~~U.S.~~ teaching ~~hospitals annually.~~hospitals. Any failure to comply with such laws and regulations ~~hold the potential for criminal and~~may result in civil financial penalties.

In addition, as discussed above, the US and foreign government regulators enforce the FCPA and other anti-bribery laws. These laws and regulations are broad in scope and are subject to evolving interpretation. As a result, LivaNova has been, and will likely continue to be, required to incur substantial costs to investigate allegations, audit and monitor compliance, and/or alter the Company’s practices with respect to these laws. Violations or alleged violations of these laws could result in litigation, and LivaNova may be subject to criminal or civil penalties and sanctions, including substantial fines, imprisonment of current or former employees and exclusion from participation in governmental healthcare programs.

The evolving commercial compliance environment and the resulting need to build and maintain robust systems to comply with different compliance and/or reporting requirements in multiple jurisdictions ~~increase~~increases the possibility that a healthcare company may violate one or more of ~~the requirements.~~these requirements and be required to allocate significant resources to its compliance program. If ~~our~~LivaNova’s operations are found to be in violation of any of such laws or any other governmental regulations that apply to ~~us, we~~the Company, LivaNova may be subject to penalties, including, without limitation, civil and criminal penalties, damages, fines, entry into corporate integrity agreements or other monitoring agreements with governmental agencies, the curtailment or restructuring of ~~our~~its operations, and exclusion from participation in federal and state healthcare programs, any of which could adversely affect ~~our~~LivaNova’s financial results and the Company’s ability to operate ~~our business and our financial results.~~its business.

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 annual reports, among other things, certain types of dealings with Iran and other entities, including transactions or dealing with government-owned entities, even when those activities are lawful and do not involve ~~U.S.~~US persons. Two of ~~our non-U.S.~~LivaNova’s non-US subsidiaries currently sell medical devices, including cardiopulmonary and neuromodulation products, to distributors and non-governmental organizations in Iran to support patient care in that country. ~~We have~~LivaNova has limited visibility into the identity of the customers of these distributors’ and non-governmental ~~organizations’ customers~~organizations 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. ToHowever, to the best of ~~our~~its knowledge at this time, ~~we do~~LivaNova does not have any contracts or commercial arrangements with the Iranian government or other relevant entities.

~~Our~~LivaNova’s gross revenues and net profits attributable to the above-mentioned Iranian activities were ~~$0.4~~$1.0 million and ~~$0.2~~$0.5 million for the three months ended December 31, ~~2022,~~2023, respectively, and ~~$4.9~~$4.3 million and ~~$1.8~~$1.9 million for the year ended December 31, ~~2022,~~2023, respectively.

~~We believe our~~LivaNova believes its activities are consistent with applicable law, including ~~U.S.,~~US, UK, EU, and other applicable ~~sanctions~~sanction laws, though such laws are complex and continue to evolve rapidly. ~~We intend~~The Company intends to continue ~~our~~its business in Iran.

Human Capital Management

~~Our~~LivaNova has approximately 2,900 employees worldwide, representing 75 nationalities and located in 32 countries. These employees are crucial in ~~our~~achieving the Company’s mission to provide hope to ~~our~~its patients and their ~~families through delivering life-changing medical innovation for the head and the heart. In doing so, we seek to execute our business and encourage our~~families. LivaNova encourages its employees to live ~~our~~by LivaNova’s five core values: patients first, meaningful innovation, act with agility, commitment to quality and integrity, and collaborative culture. ~~These~~LivaNova evaluates itself against these values ~~are how we evaluate ourselves~~ and, ultimately, ~~achieve~~achieves success through them as an organization. They are deeply embedded in our culture, and we continually share stories embodying these values throughout the organization, by way of emailed videos, virtual and in-person town halls and leadership meetings. Our values inspire our good citizenship and how we conduct our business responsibly and sustainably while interacting with our communities, employees and the environment.

Compensation and Benefits

~~In order to~~To meet the needs of ~~our~~LivaNova’s patients and customers, ~~we endeavor~~the Company strives to attract, retain, develop and reward exceptional talent. ~~We have been successful in attracting~~LivaNova’s proactive talent ~~due, in large part, to our proactive recruitment~~acquisition strategies, competitive compensation and benefits, collaborative and rewarding work environment, leadership development programs, and professional training opportunities have been a significant driver of the Company’s success. In addition to base pay, LivaNova’s rewards, compensation, and ~~development~~benefits programs ~~for managers and employees, and health and wellness measures. Our packages~~may include, depending on jurisdiction, annual performance bonuses, stock awards, pensions, health ~~benefits~~ and ~~health~~wellbeing programs, paid time off and parental leave, financial assistance for education-related purposes, flexible working schedules, hybrid and remote working, ~~and~~ employee stock purchase plans, and employee rewards programs, among others.

~~Maintaining a culture that embodies our values and mission is of the utmost importance. We aim~~LivaNova seeks to foster a culture ~~where~~of continuous learning, ~~is continuous, and~~where open and direct ~~employee~~ communication is valued. Accordingly, weLivaNova regularly ~~conduct an anonymous~~conducts employee ~~survey~~engagement surveys, called LivaNova4You, to ~~help~~ measure ~~the~~ overall employment engagement and satisfaction ~~level of our team. The survey provides us~~and to provide the Company with actionable data ~~which allows our senior leadership to understand and identify~~for potential opportunities for improvement.

~~Our Q4 2021~~The 2023 LivaNova4You survey results ~~demonstrated~~saw an increase in overall employee engagement since the last survey in 2021. With over 90% of employees completing the survey, the results indicate an increase in employee satisfaction and growth in collaboration, including employees showing high trust and respect for each other; an increased feeling of recognition on a job well done; empowerment and the feeling of being sufficiently challenged; and flexibility in coming up with new and innovative ways to work. Employees also acknowledged an improvement in the tools and opportunities for advancement, one of our highest improving scores as compared to the previous survey.motivation. In response to feedback from the survey results, wethe executive leadership team has committed to ~~address workload, clarify internal development processes,~~improving, among other things, the digitization of work systems and ~~increase understanding around~~ the Company’s ~~benefits as they relate~~branding.

Performance Management, Leadership Development and Professional Training

LivaNova’s annual performance management process is designed to ~~employees. Throughout 2022, we implemented~~build employee skills and capabilities and develop and retain enterprise leaders for the future. It includes training to increase the quality of employee/manager talent review discussions and employee performance calibrations among leaders to drive consistency. All employees, which include full-time and part-time employees, start the year creating performance-aligned goals which are reviewed with their managers at both mid-year and year-end performance evaluation reviews.

Employees have access to an extensive training library called LivaNova University, which contains modules covering different aspects of the business. In addition, LivaNova has a range of tailored programs in ~~these~~place to develop and enhance employees’ career paths. The LivaNova Leadership Academy is a program that promotes development through three ~~key areas in response, focusing on reducing workload with~~different learning forums, Manager Fundamentals, Emerging Leaders and Advanced Leadership, to accelerate the ~~help of digitization and robotic process automation; career pathing, i.e., connecting performance, interests and potential with meaningful~~ development and succession ~~planning;~~readiness for employees chosen for the program.

LivaNova also supports the continuing education of its employees externally. In the US and developing and launching LivaNova’s employee value proposition, i.e., how we market to prospective talent and retain in a competitive job market. Our next survey will be distributed in the spring of 2023.

~~Development and Training~~

~~We attract, develop and retain~~internationally, eligible employees who are aligned with our mission and values. In doing so, our talent strategy considers performance, values, accountability, transparency and differentiation, all of which are evaluated annually within the context of our performance management system. All employees undergo a robust onboarding program, and at any time, employees havecan access to a large offering of training on ethics and integrity, quality, product and other key topics and functions in the organization. Meanwhile, newly hired operators are onboarded and trained per requirements and processes specific to their jurisdiction and the product that is manufactured in their locations. Thereafter, they receive ongoing technical training to ensure they maintain excellent standardsfinancial aid through education reimbursement programs for production and manufacturing. In 2022, we expanded our suite of trainings to include the LivaNova Business System Academy which aims to teach lean methodologies and practices, i.e., promoting the flow of value to the customer through continuous improvement and respect for people.

An important factor in the Company’s future growth is our ability to develop and retain leaders. Our annual talent review process engages our employees to establish development plans and document their skills and capabilities, while managers assess employee potential, create succession plans, and identify possible career path opportunities. In 2022, we launched the LivaNova Commercial Academy, which focuses on the development of current and future leaders by way of a leadership bootcamp that covers real world scenarios, best practices and self-reflection modules over the course of fifteen working sessions. In addition, our own LivaNova University offers both mandatory and on-demand leadership, business strategy and functional skillsapproved courses and ~~learning paths.~~

certifications completed independently. Additionally, the Company sponsors professional growth opportunities.

Finally, ~~we offer~~LivaNova offers internships and apprenticeships across functions around the globe, in partnership with universities and institutions, which ~~can, and do,~~regularly lead to full-time employment. We believe in continuing education and development regardless of nationality and origin, which is why we partner with organizations to find new talent with hopes of welcoming future, full-time employees.employment at the Company.

Diversity, Equity, and Inclusion

~~The success of~~ LivaNova ~~thrives on the diversity of perspective, thought, experience and background within our workforce. We recognize~~recognizes the value in fostering a diverse, equitable and inclusive work environment ~~that is culturally diverse~~ and ~~inclusive and strive~~strives to provide a workplace free of harassment or discrimination. Accordingly, wethe Company closely ~~monitor our~~monitors its gender metrics ~~at the Board, Executive and senior leadership level~~ on a regular basis. As of December 31, ~~2022, we~~2023, LivaNova had ~~ten~~nine Directors on ~~our~~its Board, of whom ~~40%~~three (33%) are female and ~~60%~~six (67%) are male. ~~Similarly, the Executive Team~~The executive leadership team at the end of ~~2022~~2023 consisted of 11twelve individuals, ~~approximately 27%~~ of whom two (17%) are female and ~~approximately 73%~~ten (83%) are male. Of ~~our~~the Company’s senior leadership team, which includes the executive team, vice presidents and directors, as of December 31, 2023, approximately ~~32%~~30% are female and approximately ~~68%~~70% are male. Finally, as of December 31, ~~2022,~~2023, of ~~our~~LivaNova’s approximately 2,900 employees, ~~approximately 52%~~51% are female and ~~approximately 48%~~49% are male. ~~Our~~

LivaNova’s strategy for accelerating diversity begins with creating new ways to find extraordinary ~~talent, and examples~~talent. Examples of ~~our~~the Company’s efforts include ~~accurately mapping the talent market, targeting~~networking with historically black colleges and universities, ~~creating~~posting job ~~postings that attract highly qualified~~listings on diverse ~~candidates, expanding the diversity within our~~sites, ensuring diversity-focused interview panels, and ~~guiding~~training interviewers on how to conduct a fair, unbiased interview process.

In addition, ~~we have a variety of~~LivaNova supports internal diversity affinity initiatives, ~~that span~~including the ~~globe, with a mission to empower an environment where conversations of diversity and inclusion develop a culture of belonging. In July 2022, we launched the “Global~~Global Women’s ~~Network”, a group consisting~~Network which consists of female employees across the globe ~~who convened~~that convene to discuss topics that unite and celebrate the strength of ~~our diversity. In addition,~~diversity in the workplace. Similarly, the LivaNova ~~Women's~~Women’s Network, a mentorship program created by women and for women, facilitates pairings between mentors and mentees ~~across all regions.~~in the US and Latin America. Topics range from career and financial advice to performance management and connection to the Company’s strategy. These programs provide members with new perspectives, more personalized development, and an opportunity to network with other women across the ~~organization, thereby contributing to a better corporate culture based on strong, collaborative relationships and continuous opportunities to grow and develop.~~organization.

In October 2022, we issued our Diversity and Inclusion statement: We embrace diverse perspectives, experiences and backgrounds, knowing they enrich our collaborative culture and drive our success as a company. Diversity and inclusion creates trust and a deeper sense of belonging to our LivaNova community, uniting us to make a meaningful difference in the lives of patients worldwide. The statement was distributed to all leadership teams in the company to increase awareness, create engagement, and induce discussions about the company’s diversity and inclusion achievements and suggestions on where we can improve.

~~Health and Safety~~

We are committed to the safety and well-being of our employees. We rely on our environmental, health and safety management systems as well as our managers to oversee and ensure health and safety at their respective sites and foster a workplace culture to achieve that end. For onsite employees, we continue to follow safety measures including requesting that those with COVID-19 or exposure thereto, follow the Centers for Disease Control and Prevention (“CDC”) or similar local recommendations prior to returning to work. For the remainder of our employees, we offer hybrid working patterns, allowing our employees across the globe – who can work from home – the flexibility to balance their personal and professional needs. We continue to actively monitor the COVID-19 pandemic and its variants and respond based on guidance from U.S. and global health organizations, relevant governmental guidance, and evolving practices.

Seasonality

The number of medical procedures incorporating ~~our~~LivaNova’s products is generally lower during the summer months, particularly in European countries, due to summer vacation schedules.

Available Information

~~Our~~LivaNova’s executive headquarters are located at 20 Eastbourne Terrace, London, UK W2 6LG. ~~Our~~The Company’s website address is www.livanova.com. ~~We make available free~~Free of charge ~~on or~~ through ~~our~~its website, ~~our~~LivaNova makes available its Proxy Statements on Schedule 14A, Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) of the Exchange Act, and reports relating to beneficial ownership of ~~our~~the Company’s securities filed or furnished pursuant to Section 16 of the Exchange Act, as soon as reasonably practicable after electronically filing such material with the SEC. ~~Our~~LivaNova’s website also contains the charters for each standing committee of ~~our~~its Board of ~~Directors.~~Directors in addition to the Company’s Corporate Governance Guidelines.

WeLivaNova may from time to time provide important disclosures to investors by posting them in the Investor Relations section of ~~our~~its website, as allowed by SEC rules. Information on ~~our~~LivaNova’s website is not incorporated into this ~~Annual Report on Form 10-K.~~Report.

The SEC also maintains a website at www.sec.gov that contains reports, proxy statements and other information about SEC registrants, including LivaNova.

Item 1A. Risk Factors

An investor should carefully consider the risks described below, as well as other information contained in this ~~Annual~~ Report ~~on Form 10-K~~ and in ~~our~~LivaNova’s other filings with the SEC. ~~Based on the information currently known to us, we believe the following information identifies the most significant~~The Company’s business, results of operations, cash flows and financial condition could be materially and adversely affected by any such risks ~~affecting us, but the risks and uncertainties included below are not the only ones related to our businesses.~~or uncertainties. Additional risks and uncertainties not presently known to usthe Company or that wethe Company currently ~~believe~~believes to be immaterial may also adversely affect ~~our~~its business.

Risks Relating to the ~~Company~~Company’s Business and Operations

~~Reductions~~LivaNova is subject to the risks of conducting business internationally.

LivaNova designs, develops, manufactures, markets, and ~~interruptions~~sells products globally, and the Company intends to continue to pursue growth opportunities worldwide. LivaNova’s international operations are subject to risks that are inherent in conducting business globally and under non-US laws, regulations and customs. These risks, many of which LivaNova has experienced first-hand, include: higher danger of terrorist activity, war or civil unrest; greater exposure to inflation; volatility in freight and labor costs; fluctuating interest and exchange rates; evolving sanctions; increased exposure to cyber-attacks and supply chain challenges; changing energy prices; local product changes and compliance requirements; longer payments terms and collection times for receivables in local jurisdictions; difficulty enforcing agreements; greater exposure to creditworthiness of customers and inconsistent local law enforcement of obligations; trade protection measures and import and export licensing requirements; ensuring compliance with anti-bribery laws; different labor regulations and workforce instability; selling its products through distributors and agents; and political and economic instability.

Conflicts, for example, including those in Ukraine and the Middle East, have caused the Company to assess its ability to source materials, sell product, collect payment, and comply with international sanctions in the aforementioned markets. These conflicts have increased economic and regulatory uncertainties, and a significant escalation or continuation of these conflicts could have a material impact on the Company’s operating results.

Certain of LivaNova’s subsidiaries have engaged in business dealings in countries subject to comprehensive sanctions, including Iran, Sudan and Syria in addition to ~~increasing costs have,~~Russia and Belarus. These business dealings represent an insignificant amount of LivaNova’s consolidated revenues and income but expose the Company to a heightened risk of violating applicable sanctions regulations. Violations of these regulations are punishable by civil and criminal 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. Despite best efforts to comply, there can be no assurance that LivaNova’s policies and procedures will prevent the Company from violating these regulations in every transaction in which LivaNova may ~~continue to,~~engage, and such a violation could adversely affect ~~our~~its reputation, business, results of operations, cash flows and financial condition.

~~We purchase~~LivaNova’s global operations result in revenues and expenses that are denominated in currencies other than LivaNova’s reporting currency, the USD. Fluctuations in exchange rates may impact, and have impacted, LivaNova’s results of operations and financial condition. Although LivaNova has in the past elected, and may in the future elect, to hedge certain foreign currency exposures, it is unlikely that any hedging strategy would eliminate its currency risk entirely.

In many of the countries where LivaNova operates, 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 reorganizations and staff reductions. The laws and/or collective bargaining agreements that are applicable to these agreements could have an impact on LivaNova’s flexibility, as they apply to programs to redefine and/or strategically reposition the Company’s activities. LivaNova’s ability to implement staff reduction 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 LivaNova’s business.

Any of the aforementioned risks could adversely affect LivaNova’s business, results of operations, cash flows and financial condition.

Cyber-attacks or other disruptions to LivaNova’s information technology systems could lead to reduced revenue, increased costs, liability claims, fines, harm to LivaNova’s competitive position and loss of reputation.

LivaNova is increasingly dependent on its information technology systems and those of third parties to operate its business, and certain products of the Company include integrated software and information technology. Such dependencies have been exacerbated by remote working practices. LivaNova relies on information technology systems to collect and process customer orders, manage product manufacturing and shipping, and support regulatory compliance. The Company routinely processes, stores and transmits large amounts of data, including sensitive personal information, patient health information and confidential business information. The secure processing, maintenance and transmission of this information is critical to LivaNova’s operations. The quantity and complexity of the Company’s products and information technology systems make such systems vulnerable to cyber-attacks, breakdown, interruptions, destruction, loss or compromise of data, obsolescence or incompatibility among systems or other significant disruptions. The Company has experienced, and is continually at risk of being subject to cyber-attacks and other disruptions. Programs and systems may require frequent updates or may no longer be supported, which may impact the ability of the Company’s information technology systems to operate properly or without disruption. Unauthorized persons routinely attempt to access LivaNova’s systems to disrupt, disable or degrade services, obtain proprietary or confidential information, make ransom demands, and/or remotely disrupt or access the systems of large health care providers by exploiting the Company’s systems. Furthermore, LivaNova’s security assessments of third-party vendors may be inadequate to determine whether their security protocols are sufficient to withstand a cyber-attack or other security breach. LivaNova also cannot be certain that the Company will receive timely notification of such cyber-attacks or other security breaches. Cyber-attacks or other security breaches could remain undetected for an extended period, which could potentially result in significant harm to the Company’s information technology systems, as well as unauthorized access to the information stored on and transmitted by the Company’s information technology systems. In addition, to access LivaNova’s products and services, its clients may use computers and other devices that are beyond the Company’s security control safeguards.

Unauthorized disclosure or use of, denial of access to, or other incidents involving sensitive or confidential customer, patient, employee, vendor or Company data, whether through systems failure, employee negligence, fraud, misappropriation, or cybersecurity, ransomware or malware attacks, or other intentional or unintentional acts, could expose the Company to liability under various laws and regulations across jurisdictions and increase the risk of litigation and governmental or regulatory investigation, damage LivaNova’s reputation and its competitive positioning in the marketplace, disrupt its, or the Company’s customers’ businesses, or cause LivaNova to lose customers, resulting in significant financial exposure and legal liability. Similarly, unauthorized access to or through, denial of access to, or other incidents involving LivaNova or its vendors’ information systems, whether by the Company’s employees or third parties, including a cyber-attack by criminal hackers, members of organized crime groups or state-sponsored organizations, who continuously develop and deploy viruses, ransomware, malware or other malicious software programs or social engineering attacks, has resulted and could in the future result in negative publicity, significant remediation costs, legal liability, notification requirements, and damage to LivaNova’s reputation, which could have a material adverse effect on the Company’s business, results of operations, cash flows and financial condition. Cybersecurity threats are constantly expanding and evolving, becoming increasingly sophisticated and complex, increasing the difficulty of detecting and defending against them and maintaining effective security measures and protocols. Even when a cyber-attack or other security incident is detected, the full extent of the incident may not be determined immediately. The costs to the Company to mitigate cyber-attacks and security incidents could be significant and, while the Company has implemented security measures to protect its information technology systems, its efforts to address these problems may not be successful. LivaNova’s cyber risk insurance may be insufficient to cover all losses, such as litigation costs or financial losses that exceed the Company’s policy limits or are not covered under any of its current insurance policies. Cyber risk insurance has also become more difficult and expensive to obtain, and LivaNova cannot be certain that the Company’s current levels of insurance will be available in the future on economically reasonable terms.

As previously disclosed, in November 2023, LivaNova detected a cybersecurity incident that resulted in a disruption of portions of the Company’s information technology systems. Promptly after detecting the issue, LivaNova began an investigation with assistance from external cybersecurity experts and notified law enforcement. LivaNova continues to assess the full impact of the cybersecurity event on its business, and these impacts may materially affect its results of operations, cash flows and financial condition.

The costs of complying with the requirements of federal, state, and foreign laws pertaining to the privacy and security of personal information, including health-related information and the potential liability associated with failure to do so, could materially adversely affect LivaNova’s business and results of operations.

There is significant regulatory and enforcement focus on data protection in the US (at both the federal and state level) and abroad, and an actual or alleged failure to comply with applicable US or foreign data protection regulations or other data protection standards may expose LivaNova to litigation, including class action litigation, fines, sanctions or other penalties, which could harm the Company’s reputation and adversely impact LivaNova’s business, results of operations, cash flows and financial condition. The Company collects, stores, and handles employee and patient data, including sensitive patient health information, which may present material obligations and risks to LivaNova’s business, including significantly expanded compliance burdens, costs and enforcement risks. If LivaNova does not lawfully collect, store, handle or otherwise process personal information and does not prevent data breaches, particularly given the increased risks associated with sensitive health information, LivaNova may suffer legal and regulatory consequences in addition to business consequences. As a result of its worldwide operations, the Company may be subject to various data protection and cyber-security laws and regulations in many jurisdictions, including HIPAA, the CCPA and similar state laws, and the GDPR. Other governments have enacted, amended, or are enacting similar data protection laws, including data localization laws that require data to stay within their borders and other technical and operational adaptions that may be required given the rapid changes in data protection regulation where LivaNova conducts business. The enactment of such laws could have potentially conflicting requirements that would make compliance challenging. LivaNova’s efforts to comply with applicable laws and regulations may be inadequate, and the Company may be unable to avoid enforcement actions by governmental bodies. Enforcement actions may be costly and could interrupt regular operations of LivaNova’s business. Moreover, LivaNova’s insurance coverage may be insufficient to cover all losses. In addition, there is a trend of civil lawsuits and class actions relating to compromises of personal data or other cyber-attacks pursuant to laws such as the CCPA. While LivaNova has not been named in any such lawsuits, the Company could become a target of civil litigation or government enforcement actions as a result of a compromise to or loss of data.

Reductions and interruptions in LivaNova’s supply chain have had, and may continue to have, adverse effects on LivaNova’s business, results of operations, cash flows and financial condition.

LivaNova purchases many of the components and raw materials used in manufacturing ~~our~~its products from numerous suppliers in various countries. In some cases, ~~we purchase~~LivaNova purchases 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. Any problem affecting a supplier (whether due to external or internal causes) could have a negative impact on ~~us.~~LivaNova. Difficulties and delays in manufacturing, internally, externally 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.

~~Like many companies, we are experiencing supply chain delays and interruptions, labor shortages, inflationary pressures and logistical issues.~~ While 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. Freight and labor costs at our manufacturing facilities have increased substantially in the wake of inflation globally. Moreover, the demand from industrial sectors on semiconductors is causing price increases and shortages on such items, which in turn, has impacted manufacturing in our Munich and Houston sites. In addition, the Ukraine conflict has resulted in high energy costs which are impacting suppliers and putting pressure on prices of raw materials. While we workLivaNova works closely with ~~our~~its suppliers to ensure supply continuity and minimize the instances in which ~~we rely~~LivaNova relies on a sole supplier, ~~and take other countermeasures - such as closely managing our inventory - to reduce our supply chain risk, we~~the Company cannot guarantee that ~~our~~its efforts will always be ~~successful, especially as a smaller company with lower bargaining power.~~successful. Moreover, due to strict standards and regulations governing the manufacture and marketing of ~~our~~LivaNova’s products, wethe Company may not be able to locate new supply sources quickly or at all in response to a supply reduction or interruption, ~~with~~resulting in negative effects on ~~our~~its ability to manufacture ~~our~~ products effectively and timely. To date, the Company’s supply of raw materials and the production and distribution of finished products have not been materially affected, but to the extent ~~we are~~the Company is unsuccessful in managing ~~our~~its supply chain, any such issues could have a material adverse effect on ~~our business, results of operations, cash flows and financial condition.~~

~~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 sanctions; greater exposure to inflation; rising interest rates; changes in energy prices; increased exposure to cyber-attacks and supply chain challenges; fluctuating exchange rates; local product changes and evolving requirements; longer-term receivables in local jurisdictions; difficulty enforcing agreements; greater exposure to creditworthiness of customers and local law enforcement of obligations; trade protection measures and import and export licensing requirements; failure to comply with anti-bribery laws; 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. As an example, Russia launched an invasion in Ukraine in 2022 which has negatively impacted our supply chain and operations in the region, caused the implementation of sanctions by the U.S. and other governments against Russia and Belarus and generated significant volatility and disruptions to the global markets. Any of the aforementioned risks could adversely affect our business, results of operations, cash flows and financial condition.

In addition to sanctions relating to Russia and Belarus, certain of our subsidiaries have engaged in business dealings in countries subject to comprehensive sanctions, including Iran, Sudan and Syria. 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 and criminal 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 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,LivaNova’s business, results of operations, cash flows and financial condition.

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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 may impact our results of operations and financial condition; for example in 2022, our net revenue and profitability were negatively affected by the unfavorable foreign currency exchange impact of the strengthened U.S. dollar against a number of currencies. Although in the future 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.

The global medical device industry is highly competitive, and weLivaNova may be unable to compete effectively.

~~We operate~~LivaNova operates in a highly competitive market characterized by increasingly complex products that are expensive and ~~time consuming~~time-consuming to develop and manufacture. In the product lines in which ~~we compete, we face~~LivaNova competes, the Company faces a mixture of competitors ranging from large manufacturers with multiple business lines to small manufacturers that offer a limited selection of specialized products. Development by other companies of new or improved products, processes, or technologies may make ~~our~~LivaNova’s products or proposed products less competitive. In addition, ~~we face~~LivaNova faces competition from providers of alternative medical therapies, ~~such as pharmaceutical companies~~pharmaceuticals, and ~~providers of cannabis derived products,~~surgical interventions, among others. Competitive factors ~~include~~include: product quality, reliability and performance; product technology and innovation; breadth of product lines and product services; ability to identify new market trends; changes to the regulatory environment; cost-effectiveness and price; customer support and training; capacity to recruit engineers, scientists and other qualified employees; ability to navigate the regulatory approval process in the markets in which LivaNova operates; reimbursement approval; and ~~reimbursement approval.~~effectiveness of systems and processes. Difficulties in any of these areas may ~~cause our~~have a material adverse effect on LivaNova’s business, results of operations, cash flows and financial ~~condition~~condition.

The rapid pace of technological development in the medical industry and the specialized expertise required in different areas of medicine make it difficult for one company alone to ~~suffer.~~develop a broad portfolio of technological solutions. As a result, LivaNova also relies on investments and investment collaborations to provide the Company access to new technologies. If LivaNova fails to develop new and enhanced products and services on a timely basis, the Company’s offerings will become obsolete over time, and its business and financial results would be negatively impacted. LivaNova’s success depends on several factors, including its ability to appropriately allocate the Company’s R&D funding to products and services with higher growth prospects, for example, further incorporation of software; hiring and retaining the necessary R&D talent; stimulating customer demand for and convincing customers to adopt new technologies; innovating and developing new technologies and applications; and acquiring or obtaining third-party technologies that may have valuable applications in the markets that LivaNova serves.

~~Our~~LivaNova expects to make investments where it believes that the Company can develop, or acquire, new technologies and products to further LivaNova’s strategic objectives and strengthen LivaNova’s existing businesses. Investments and investment collaborations in and with medical technology companies are inherently risky, and LivaNova cannot guarantee that any of its previous or future acquisitions, investments or investment collaborations will be successful or will not materially adversely affect LivaNova’s business, results of operations, cash flows and financial condition.

The success and continuing development of LivaNova’s products depend on maintaining strong relationships with physicians and healthcare professionals. If LivaNova fails to maintain its working relationships with physicians and other healthcare professionals, the Company’s products may not be developed and marketed in line with the needs and expectations of the professionals who use and support LivaNova’s products. Physicians assist LivaNova as researchers, marketing consultants, product consultants, inventors and public speakers, and LivaNova relies on these professionals to provide the Company with considerable knowledge and experience. If LivaNova is unable to maintain these strong relationships, the development and marketing of the Company’s products could suffer, which could have a material adverse effect on LivaNova’s business, results of operations, cash flows and financial condition.

LivaNova’s products are subject to complex laws and regulations, and failure to obtain product approvals, clearance or reimbursement may materially adversely affect ~~our~~LivaNova’s business, results of operations, cash flows and financial condition.

~~Our~~LivaNova’s medical devices and technologies, as well as ~~our~~its business activities, are subject to a complex set of regulations and rigorous enforcement, including by the FDA, ~~U.S.~~US Department of Justice, ~~Health and Human Services - Office of the Inspector General,~~HHS, and numerous other federal, state, and ~~non-U.S.~~non-US governmental authorities. The time required to obtain approvals from foreign countries may be longer or shorter than that required for FDA clearance, and requirements for such approvals may differ from FDA requirements. To varying degrees, each of these agencies requires usLivaNova to comply with laws and regulations governing the development, testing, manufacturing, labeling, reimbursement, marketing, and distribution of ~~our~~LivaNova’s products. As a part of the approval, marketing clearance ~~approval~~ or reimbursement process for new products and new indications for existing products, weLivaNova may conduct ~~numerous~~ clinical trials ~~with a variety of study designs, patient populations~~ and ~~trial endpoints.~~studies. Unfavorable or inconsistent clinical data from existing or future clinical trials, or the ~~markets’, FDA’s, the Centers for Medicare & Medicaid Services’ (“CMS’s”) or non-U.S. governmental authorities’ perception~~interpretation of such clinical data by customers and/or regulatory authorities, may adversely impact ~~our~~LivaNova’s ability to obtain product approvals and receive reimbursement. ~~Currently,~~

LivaNova, for example, ~~we are~~is currently conducting ~~the RECOVER~~ clinical ~~study -~~studies, and any delays or news regarding unfavorable or inconsistent data could have a material adverse effect on ~~our~~LivaNova’s business. Success in pre-clinical testing and early clinical studies does not always ensure that later clinical studies will be successful, as weLivaNova experienced and announced, for instance, in connection with ~~the VITARIA SYSTEM in~~stopping enrollment of the ANTHEM-HFrEF clinical trial, and weLivaNova cannot be sure that later studies will replicate the results of prior studies. Any delay or termination of ~~our~~LivaNova’s clinical studies will delay or preclude the filing of

regulatory submissions or requests for coverage determinations and, ultimately, ~~our~~LivaNova’s ability to commercialize new products or product modifications and obtain reimbursement for ~~our~~the Company’s products. It is also possible that patients enrolled in clinical studies will experience adverse side effects that are not currently part of the product’s profile, which could inhibit further marketing and development of such products.

Even if ~~we are~~LivaNova is able to obtain approval, marketing clearance and reimbursement, it may take a significant amount of time, require the expenditure of substantial resources, involve stringent clinical and pre-clinical testing and increased post-market surveillance, and/or involve modifications, repairs or replacements of ~~our~~LivaNova’s products or limitations on the proposed uses of ~~our~~its products. Ultimately, weLivaNova cannot guarantee that ~~our~~its clinical trials will be successful or that wethe Company will be able to obtain or maintain marketing clearance and/or reimbursement for new products or modifications to existing ~~products or reimbursement for new products or existing~~

products. Any such issues, whether in relation to trials, approvals, ~~reimbursement~~clearances or ~~clearances,~~reimbursement, could have a material adverse effect on ~~our~~LivaNova’s business, results of operations, cash flows and financial condition.

Failure to comply with product-related government regulations may materially adversely affect ~~our~~LivaNova’s business, results of operations, cash flows and financial condition.

Both before and after a product is commercially released, ~~we have~~LivaNova has ongoing responsibilities under FDA and other applicable ~~non-U.S.~~non-US government agency regulations. For instance, many of ~~our~~LivaNova’s facilities and procedures and those of ~~our~~its suppliers are subject to periodic inspections by the FDA, which can result, and in the past has resulted, in inspectional observations on the FDA’s Form-483, warning letters, or other forms of enforcement. If the FDA were to conclude that ~~we are~~LivaNova is not in compliance with applicable laws or regulations, or that any of ~~our~~the Company’s 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 usLivaNova to notify health professionals and others that the devices present unreasonable risks of substantial harm to the public health. For example, 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 forthSimilar consequences could follow, such as audits by ~~the FDA in the warning letter. See “Note 14. Commitments~~non-US regulators and ~~Contingencies” in our consolidated financial statements included in this Annual Report on Form 10-K for related information.~~notified bodies.

~~While we work diligently to manage our ongoing responsibilities, the~~The FDA and other ~~non-U.S.~~non-US government agencies could also assess civil or criminal penalties against ~~us, our~~LivaNova, the Company’s officers, or other employees ~~and~~and/or impose operating restrictions on a company-wide basis. The FDA could also recommend prosecution to the ~~U.S.~~US Department of Justice. An adverse regulatory action could restrict usLivaNova from effectively marketing and selling ~~our~~its products, limit ~~our~~its ability to obtain future pre-market clearances or PMAs, and result in a substantial modification to ~~our~~LivaNova’s business practices and operations. These potential consequences, as well as any adverse outcome from government investigations, could have a material adverse effect on ~~our~~LivaNova’s business, results of operations, cash flows and financial condition.

In addition, ~~in the U.S.,~~ device manufacturers are prohibited from promoting their products for uses and indications that are not 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 conditions outside the indications of our products. While physicians may exercise their discretion in prescribing a device off-label, a device manufacturer’s failure to comply with the related applicable regulations could subject usLivaNova to significant civil or criminal exposure, administrative obligations and costs, and/or other potential ~~penalties from, and/or agreements with, the federal government. Similarly,~~penalties. The EU ~~Reg~~ MDR, for example, prohibits manufacturers from misleading users and patients by suggesting uses for the device other than those stated as part of the intended purpose for which the conformity assessment was carried out.

Governmental regulations outside the ~~U.S.~~US have, and may continue to, become increasingly stringent and ~~common. In~~common as well. For example, the EU ~~for example, EU Reg~~ MDR ~~became effective in 2021, resulting~~has resulted in significant additional premarket and post-market ~~requirements which~~requirements. Certifications to EU MDR must be ~~in place~~achieved by ~~May 2024 (though there is a proposal to extend~~December 2027 or December 2028, based on the ~~compliance deadline). During this transition period,~~risk classification of the device. In the interim, the European Commission is allowing companies to use their ~~Medical Device Directive (“MDD”)~~MDD certifications. ~~We are~~LivaNova is working to obtain all appropriate approvals ~~in order to be fully compliant by the May 2024 deadline,~~as required, 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.~~license. The development and implementation of future laws and regulations may also have a material adverse effect on ~~us.~~

If our marketed medical devices are defective or otherwise pose safety risks, the FDA and similar non-U.S. governmental authorities could require their recall or initiate an enforcement action, or we may initiate a recall of our products voluntarily.

The FDA and similar non-U.S. governmental authorities may require the recall of commercialized products in the event of material deficiencies or defects in design, software or manufacture or in the event that a product poses an unacceptable risk to health. Manufacturers, on their own initiative, may recall a product with a material deficiency, and we have initiated voluntary product recalls in the past. Any recall announcement could harm our reputation with customers and negatively affect our revenue. A recall could also impair our ability to produce our products in a cost-effective and timely manner. In the future, we may initiate voluntary withdrawal, removal or repair actions that we determine do not require notification as a recall. If a regulating authority were to disagree with our determinations, it could require us to report those actions as recalls.

In addition, depending on the corrective action taken to redress a device’s deficiencies or defects, regulators may require, or we may decide, that we need to obtain new approvals or clearances for the device before we market or distribute the corrected device. Seeking such approvals or clearances may delay our ability to replace the recalled devices in a timely manner. Any corrective action, whether voluntary or involuntary, or litigation, will require the dedication of our time and capital, distract management from operating the business, and may harm our reputation and financial results. Moreover, if we do not adequately address problems associated with our devices, we may face additional regulatory enforcement action, including FDA warning letters, product seizure, injunctions, administrative penalties, or civil or criminal fines, any or all of which could have a material adverse effect on our business.

~~As a manufacturer of medical devices, we are exposed to product liability claims that could adversely affect our consolidated financial condition and tarnish our reputation.~~

We manufacture and sell medical devices, both equipment and implantables, that pose product liability risks. Component failures, manufacturing defects, software errors, design flaws or inadequate disclosure of product-related risks or product or use-related information with respect to these or other products we manufacture, or sell could result in an unsafe condition, injury to, or death of, a patient. Such an event could result in product liability claims or a recall of, or safety alert relating to, one or more of our products. For example, as described in “Note 14. Commitments and Contingencies” in our consolidated financial statements included in this Annual Report on Form 10-K, we are involved in product liability litigation relating to our cardiopulmonary 3T Heater-Cooler product that may adversely affect our financial condition and may require us to devote significant resources to our defense of these claims. Although we are defending these matters vigorously, the outcome could have a material adverse effect on our business.

We have elected to self-insure with respect to a significant portion of our product liability risks and also hold global insurance policies to cover a portion of future potential losses. Product liability claims or product recalls in the future, regardless of their ultimate outcome, could have a material adverse effect on our business and reputation and on our ability to attract and retain customers for our products, and losses from product liability claims in the future could exceed our product liability insurance coverage and lead to a material adverse effect on our financial condition and liquidity. In addition, future unanticipated large liability claims may raise substantial doubt about our ability to continue as a going concern.LivaNova.

Global healthcare policy changes and reduction in reimbursement for products may have a material adverse effect on ~~us.~~LivaNova.

In response to increases in healthcare costs, there have been and continue to be proposals by governments, regulators and ~~third party~~third-party payers to control these costs. These proposals have resulted in efforts to enact healthcare system reforms that may lead to pricing restrictions, payback requirements, limits on the amounts of reimbursement available for ~~our~~LivaNova’s products and limits on the acceptance and use of ~~our~~LivaNova’s products. ~~As previously disclosed, for~~For example, in 2015, the Italian Parliament introduced rules for entities that supply goods and services to the Italian National Healthcare ~~System. This healthcare law impacts~~System, impacting the business and financial reporting of medical technology sector companies that sell devices in Italy. A key provision of the law is 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. While ~~we are~~LivaNova is appealing the imposition of the guidelines and requests for payment pursuant to the rule weas well as waiting on the Constitutional Court in Italy to determine the constitutionality of the rule, the Company may not be successful. See “Note ~~14.~~13. Commitments and Contingencies” in ~~our~~LivaNova’s consolidated financial statements included in this ~~Annual~~ Report ~~on Form 10-K~~ for additional information.

~~Our~~LivaNova’s ability to profitably commercialize ~~our~~the Company’s products is dependent, in large part, on whether ~~third party~~third-party payers, including private healthcare insurers, managed care plans, governmental programs and others, agree to cover the costs and services associated with ~~our~~LivaNova’s products and related medical procedures in the ~~U.S.~~US and internationally. ~~Third party~~Third-party payers, including private and government insurers, are increasingly requiring evidence that medical devices are cost-effective. If ~~we are~~LivaNova is unable to demonstrate that ~~our~~the Company’s devices are cost-effective, ~~third party~~third-party payers may not reimburse the use of ~~our~~LivaNova’s products or ~~not~~ provide sufficient reimbursement for ~~our~~LivaNova’s products, which could reduce sales of ~~our~~the Company’s products to healthcare providers ~~who~~that depend upon reimbursement for payment for their services. Similarly, periodic changes to reimbursement methodologies could have an adverse impact on ~~our~~LivaNova’s business. Adoption of some or all of such healthcare policy and reimbursement proposals could have a material adverse effect on ~~our~~LivaNova’s business, results of operations, cash flows and financial position.

~~Our failure~~Failure to comply with rules relating to reimbursement of healthcare goods and services, healthcare fraud and abuse, false claims and other applicable laws or regulations may subject usLivaNova to penalties and limit patient access to ~~our~~its devices, thereby adversely impacting ~~our~~the Company’s reputation and business operations.

~~Our~~LivaNova’s devices and therapies are subject to regulation by various governmental agencies worldwide that are responsible for ~~coverage, reimbursement and regulation of~~regulating healthcare goods and services, including laws and regulations related to kickbacks, false claims, self-referrals and healthcare fraud. Because ~~our~~LivaNova’s marketing practices involve direct promotion to patients in certain jurisdictions, ~~we are~~the Company is subject to additional laws and regulations intended to prevent misleading of patients and consumers

through unethical promotional activities and related data collection practices. Any failure to comply with these laws and regulations could subject usthe Company or ~~our~~its officers and employees to criminal and civil financial penalties.

The risk of being found in violation of these laws is increased by the fact that many of them have not been fully interpreted by ~~the~~ regulatory authorities or the courts and their provisions are open to a variety of interpretations. Because of the breadth of these laws and the narrowness of the statutory exceptions and safe harbors available under such laws, it is possible that some of ~~our~~LivaNova’s business activities, including ~~our~~the Company’s relationships with surgeons and other healthcare providers, some of whom recommend, purchase and/or prescribe ~~our~~LivaNova’s devices, group purchasing organizations and ~~our~~LivaNova’s independent sales agents and distributors, could be subject to challenge under one or more of such laws. Even an unsubstantiated allegation of impropriety could adversely impact ~~our~~LivaNova’s reputation and/or business operations.

Furthermore, ~~our~~LivaNova’s devices, products and therapies are purchased principally by hospitals or physicians that typically bill various ~~third party~~third-party payers, such as governmental healthcare programs (e.g., Medicare, Medicaid and comparable ~~non-U.S.~~non-US programs), private insurance plans and managed care plans for the healthcare services provided to their patients. The ability of ~~our~~LivaNova’s customers to obtain appropriate reimbursement for products and services from ~~third party~~third-party payers is critical because it affects which products customers purchase and the prices they are willing to pay. ~~As a result, our~~LivaNova’s devices, products and therapies are subject to regulation regarding quality and cost by ~~the U.S. Department of Health and Human Services,~~HHS, including CMS, as well as comparable state and ~~non-U.S.~~non-US agencies responsible for reimbursement and regulation of healthcare goods and services, including laws and regulations related to kickbacks, false claims, self-referrals and healthcare fraud. In addition, as a manufacturer of ~~U.S.~~US FDA-approved devices reimbursable by federal healthcare programs, ~~we are~~LivaNova is subject to the Physician Payments Sunshine Act, which requires usthe Company to annually report certain payments and other transfers of value ~~we make~~LivaNova makes to ~~U.S.-licensed~~US-licensed physicians, ~~U.S.~~US teaching hospitals or other covered recipients. Any failure to comply with these laws and regulations could subject usthe Company or ~~our~~its officers and employees to criminal and civil financial penalties.

Finally, ~~we are~~LivaNova is subject to risks relating to changes in government and private medical reimbursement programs and policies and changes in legal regulatory requirements in the ~~U.S.~~US and around the world. Implementation of further legislative or administrative reforms to these reimbursement systems, or adverse decisions relating to coverage of or reimbursement for ~~our~~LivaNova’s products by administrators of these systems, could have a material adverse impact on the acceptance of and demand for ~~our~~the Company’s products and the prices that ~~our~~LivaNova’s customers are willing to pay for them.

~~Cyber-attacks~~If LivaNova’s marketed medical devices are defective or ~~other disruptions to our information technology systems~~otherwise pose safety risks, the FDA and similar non-US governmental authorities could ~~lead to reduced revenue, increased costs, liability claims, fines, harm to our competitive position~~require their recall or initiate an enforcement action, or LivaNova may initiate a recall of the Company’s products voluntarily.

The FDA and ~~loss~~similar non-US governmental authorities may require the recall of ~~reputation.~~

~~We are increasingly dependent on our information technology systems and those of third parties to operate our business, and certain~~commercialized products of ours include integrated software and information technology. Such dependencies have been exacerbated by remote working practices. We rely on information technology systems to collect and process customer orders, manage product manufacturing and shipping and support regulatory compliance, and we routinely process, store and transmit large amounts of data, including sensitive personal information, patient health information and confidential business information. The secure processing, maintenance and transmission of this information is critical to our operations but the size and complexity of our products and the information technology systems on which we rely make them vulnerable to cyber-attacks, breakdown, interruptions, destruction, loss or compromise of data, obsolescence or incompatibility among systems or other significant disruptions. Unauthorized persons routinely attempt to access our products or systems in order to disrupt, disable or degrade services, to obtain proprietary or confidential information, to make ransom demands, or to remotely disrupt or access the systems of large health care providers by exploiting our systems. We maintain an information security risk insurance policy and continue to enhance our information security programs. While we have not fallen victim to any material cyber-attacks, such an incident or an incident at a third-party vendor could compromise our networks and our information could be accessed, publicly disclosed, lost or stolen. The negative publicity resulting from such disruptions could significantly impact our reputation and stock price, and the financial consequences could have a material effect on our business.

In addition, from time to time, we may acquire or divest businesses. As a result of acquisitions, we may face risks due to implementation, modification, or remediation of controls, procedures and policies relating to data privacy and cybersecurity at the acquired company. We continue to consolidate and over time integrate the number of systems we operate, and to upgrade and expand our information system capabilities for stable and secure business operations. There can be no assurance that our process of consolidating, protecting, upgrading and expanding our systems and capabilities, continuing to build security into the design of our products, and developing new systems to keep pace with continuing changes in information processing technology will be successful or that additional systems issues will not arise in the ~~future. Similarly, we may divest and have divested portions~~event of ~~our business, resulting~~material deficiencies or defects in design, software or manufacture, or in the ~~migration of data and overlapping data obligations. As~~event that a ~~result of such divestitures, we may face risks due to migration or modification of controls, procedures and policies relating~~product poses an unacceptable risk to

2023

~~data privacy and cybersecurity internally or enroute. Any significant breakdown, intrusion, interruption, corruption or destruction of these systems, as well as any data breaches, could have~~patients’ health. Manufacturers, on their own initiative, may recall a product with a material ~~adverse effect on our business.~~

~~The costs of complying with the requirements of federal, state and foreign laws pertaining to the privacy and security of personal information, including health related information~~deficiency, and the ~~potential liability associated with failure to do so, could materially adversely affect our business and results of operations.~~

~~There is significant regulatory and enforcement focus on data protection~~Company has initiated voluntary product recalls in the U.S. (at both the state and federal level) and abroad, and an actual or alleged failure to comply with applicable U.S. or foreign data protection regulations or other data protection standards may expose us to litigation (including, in some instances, class action litigation), fines, sanctions or other penalties, whichpast. Any recall announcement could harm ~~our~~LivaNova’s reputation with customers and ~~adversely impact our~~negatively affect LivaNova’s reputation, business, results of operations, cash flows and financial ~~condition. We collect, store~~position. A recall could also impair LivaNova’s ability to produce its products in a cost-effective and ~~handle patient data, including sensitive health information,~~timely manner. In the future, LivaNova may initiate voluntary withdrawal, removal or repair actions that the Company determines do not require notification as a recall. If a regulating authority were to disagree with LivaNova’s determinations, it could require the Company to report those actions as recalls.

In addition, depending on the corrective action taken to redress a device’s deficiencies or defects, regulators may require, or LivaNova may decide, that the Company needs to obtain new approvals or clearances before it markets or distributes the corrected device. Seeking such approvals or clearances may delay LivaNova’s ability to replace the recalled device in a timely manner. Any corrective action, whether voluntary or involuntary, or related litigation will require investment of the Company’s time and ~~this regulatory environment is increasingly challenging~~capital, distract management from operating the business, and may ~~present material obligations~~harm LivaNova’s reputation and risks to our business, including significantly expanded compliance burdens, costs and enforcement risks. If we are unable to ensure personal information is lawfully collected, stored, handled and secured with reliable information technology systems to prevent data breaches, particularly given the increased risksfinancial results. Moreover, if LivaNova does not adequately address problems associated with ~~sensitive health information, we~~its devices, the Company may ~~suffer legal and~~face additional regulatory ~~consequences in addition to business consequences. Our worldwide operations mean that we are subject to various data protection and cyber-security laws and regulations in many jurisdictions,~~enforcement action, including ~~but not limited to the HIPAA, CCPA, Brazilian General Data Protection Law, and GDPR. Other governments~~FDA warning letters, product seizure, injunctions, administrative penalties, or civil or criminal fines, any of which could have enacted, amended or are enacting similar data protection laws, including data localization laws that require data to stay within their borders and other technical and operational adaptions that may be required given the rapid changes in data protection regulation where we conducta material adverse effect on LivaNova’s business. Despite programs to comply with such laws and regulations and our purchase of a cyber insurance policy, there is no guarantee that we will avoid enforcement actions by governmental bodies or that we will continue to maintain a cyber insurance policy, as result of cost, availability or other considerations. Enforcement actions may be costly and interrupt regular operations of our business. In addition, there is a trend of civil lawsuits and class actions relating to breaches of consumer data or other cyber-attacks pursuant to laws such as CCPA. While we have not been named in any such lawsuits, if a breach or loss of data occurs, we could become a target of civil litigation or government enforcement actions.

~~The failure~~Failure to comply with anti-bribery laws could materially adversely affect ~~our~~LivaNova’s business and result in civil and/or criminal sanctions.

~~Our~~LivaNova’s operations are subject to anti-corruption laws, including the UK Bribery Act, the FCPA and other anti-corruption laws that apply in countries where ~~we do business, that~~the Company does business. These laws generally prohibit usLivaNova and ~~our~~its employees and intermediaries from bribing, being bribed or making other prohibited payments to government officials or other persons to obtain or retain business or gain some other business advantage. Because of the predominance of government-administered healthcare systems in many parts of the world outside the ~~U.S.,~~US, many of ~~our~~LivaNova’s customer relationships are potentially subject to such laws.

~~We are,~~LivaNova is, therefore, exposed to the risk that ~~our~~its employees, independent contractors, principal investigators, consultants, vendors, independent sales agents, and distributors may engage in fraudulent or other illegal activity in violation of these laws and ~~our~~LivaNova’s Code of Conduct. ~~We maintain~~LivaNova maintains policies and programs to educate ~~our~~its employees and agents on these legal requirements, and to prevent and prohibit improper practices. However, existing safeguards and any future improvements may not always be effective, and ~~our~~LivaNova’s employees, consultants, sales agents, or distributors may engage in conduct for which weLivaNova could be held responsible. In addition, regulators could seek to hold usLivaNova liable for conduct committed by companies in which ~~we invest~~LivaNova invests or ~~that we acquire.~~acquires. The FCPA can pose unique challenges for manufacturers who operate in foreign cultures where conduct prohibited by the FCPA may not be viewed as illegal in local jurisdictions. It is not always possible to identify and deter misconduct by ~~our~~LivaNova’s employees and other third parties, and the precautions ~~we take~~the Company takes to detect and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses or in protecting usLivaNova from governmental investigations or other actions or lawsuits stemming from a failure to ~~be in compliance~~comply with such laws or regulations.

Global enforcement of anti-corruption laws has increased substantially in recent years, with more frequent voluntary self- disclosures by companies, aggressive investigations and enforcement proceedings by governmental agencies, and assessment of significant fines and penalties against companies and individuals. WeLivaNova cannot predict the nature, scope or effect of future regulatory requirements to which ~~our~~the Company’s international operations might be subject or the manner in which existing laws might be administered or interpreted. Any alleged or actual violations of these laws and regulations may subject usLivaNova to government scrutiny, severe criminal or civil sanctions and other liabilities, including exclusion from government contracting or government healthcare programs, and could negatively affect ~~our~~LivaNova’s reputation, business, results of operations, cash flows and financial condition.

Quality concerns with LivaNova’s processes, products, and services could harm the Company’s reputation for producing high-quality products and erode LivaNova’s competitive advantage, revenue, and market share.

Quality is extremely important to LivaNova and its customers due to the serious and costly consequences of product failure. LivaNova’s quality certifications are critical to the marketing success of the Company’s products and services. If LivaNova fails to meet these standards, the Company’s reputation could be damaged, the Company could lose customers and LivaNova’s revenue and results of operations could decline. Aside from specific customer standards, LivaNova’s success depends generally on the Company’s ability to manufacture precision-engineered components, sub-assemblies, and finished products to exact tolerances with certified materials. If LivaNova’s components fail to meet these standards or fail to adapt to evolving standards, the Company’s reputation as a manufacturer of high-quality components will be harmed, its competitive advantage could be damaged, and LivaNova could lose customers and market share.

WeLivaNova may not successfully execute or achieve the expected benefits of the Company’s 2024 Restructuring Plan and other cost saving measures the Company may take in the future which may adversely affect the Company’s business, financial condition and results of operations.

On January 5, 2024, LivaNova’s Board of Directors approved the 2024 Restructuring Plan to enhance the Company’s focus on its core Cardiopulmonary and Neuromodulation segments. As part of the 2024 Restructuring Plan, the Company will wind down the ACS segment, which is anticipated to be substantially complete by the end of 2024. The 2024 Restructuring Plan is based on the Company’s current estimates, assumptions and forecasts, which are subject to known and unknown risks and uncertainties, including assumptions regarding cost savings, cash burn rate, and effectiveness of the Company’s reduced spend. Additionally, LivaNovamay not fully achieve the expected cost savings, enhanced liquidity and other benefits anticipated from the 2024 Restructuring Plan. To the extent that the Company is unsuccessful in implementing the 2024 Restructuring Plan or other, future cost saving measures, such issues could have a material adverse effect on LivaNova’s business, reputation, result of operations, cash flows, and financial condition. For additional information on the 2024 Restructuring Plan, please refer to “Note 6. Restructuring” in LivaNova’s consolidated financial statements included in this Report.

Legal and Intellectual Property Risks

As a manufacturer of medical devices, LivaNova is exposed to product liability claims that could adversely affect its consolidated financial condition and tarnish the Company’s reputation.

LivaNova designs, develops, manufactures, markets, and sells medical devices, both equipment and implantables, that pose product liability risks. Component failures, manufacturing defects, software errors, design flaws or inadequate disclosure of product-related risks or product or use-related information, or physician misuse with respect to these or other products the Company manufactures or sells could result in an unsafe condition for, injury to, or death of, a patient. Such an event could result in product liability claims or a recall of, or safety alert relating to, one or more of LivaNova’s products. For example, as described in “Note 13. Commitments and Contingencies” in LivaNova’s consolidated financial statements included in this Report, the Company is involved in product liability litigation relating to its cardiopulmonary 3T Heater-Cooler product that may adversely affect LivaNova’s financial condition and may require the Company to devote significant resources to its defense and/or settlement of these claims. Although the Company is defending these matters vigorously, the outcome could have a material adverse effect on LivaNova’s business.

LivaNova holds global insurance policies to cover a portion of future potential product liability losses and has elected to self-insure with respect to a significant portion of the Company’s product liability risks. Product liability claims or product recalls in the future, regardless of their ultimate outcome, could have a material adverse effect on LivaNova’s business and reputation and on the Company’s ability to attract and retain customers for its products, and future losses from product liability claims could exceed LivaNova’s product liability insurance coverage and lead to a material adverse effect on the Company’s financial condition and liquidity. In addition, future unanticipated large liability claims may raise substantial doubt about LivaNova’s ability to continue as a going concern.

LivaNova is subject to environmental laws and regulations and the risk of environmental liabilities, violations, ~~protest voting~~ and litigation in multiple jurisdictions, any of which could have a material impact on ~~our~~LivaNova’s business, results of operations, cash flows, financial condition and liquidity.

Certain environmental laws assess liability on current, prior and/or related owners or operators of real property for the costs orof investigation, removal, or remediation of hazardous substances aton their properties or at properties on which they have disposed of hazardous substances. ~~It is also possible that a governmental authority may seek to hold us liable for successor liability violations committed by any companies in which we invest or that we acquire.~~ For example, ~~our~~LivaNova’s Saluggia campus contains hazardous substances as a result of nuclear installations built in 1960 under previous ownership, and the Italian Government has stated that weLivaNova will eventually be responsible for dismantling the nuclear installation on Company property, as well as delivering the aforementioned waste to a national repository. ~~In addition, we are~~It is also possible that a governmental authority may seek to hold LivaNova liable for successor liability violations committed by any companies in which LivaNova invests or acquires. For example, LivaNova is currently in litigation with the government in Italy stemming from a civil action where the Court of Appeal ~~in Milan (“Court of Appeal”)~~ declared LivaNova (formed through a merger with Sorin) liable for environmental liabilities incurred by SNIA’s (a former parent company of Sorin) other subsidiaries. In November 2021, the Court of Appeal delivered the remainder of its decision, ordering LivaNova to pay damages of approximately €453.6 million (approximately $484.9 million as of December 31, 2022). LivaNova appealed both the liability and damages decisions, which will be decided together at the Italian Supreme Court. In February 2022, the Court of Appeal granted a stay on the demand for payment from the Public Administrations pending resolution of the Company’s appeal on liability and damages. The stay was granted with the condition that the Company provide a first demand bank guarantee of €270.0 million (approximately $288.6 million as of December 31, 2022) within 30 calendar days, which was promptly delivered. See “Note ~~14.~~13. Commitments and Contingencies” in ~~our~~LivaNova’s consolidated financial statements included in this ~~Annual~~ Report ~~on Form 10-K~~ for additional information regarding these two matters. ~~Our~~LivaNova’s business, results of operations, cash flows, financial condition and liquidity could be materially adversely affected by a negative decision in the case of SNIA and could be adversely affected by an increase in anticipated costs relating to ~~transportation~~disposal of hazardous waste in Saluggia. Private parties could also bring personal injury or other claims due to the presence of, or exposure to, hazardous substances.

In addition, ~~our~~LivaNova’s operations involve the use of substances regulated under environmental laws, including for purposes of sterilization. Regulations require sterilization of ~~our~~LivaNova’s products, and ~~in 2021, we unveiled our new~~the Company operates a sterilization facility in

Colorado allowing the Company to sterilize certain of its products in-house. The ~~U.S.~~US Environmental Protection Agency and certain states have begun scrutinizing the levels of community exposure to ~~ethylene oxide (“EtO”).~~EtO, which is used in the sterilization process. Certain medical device operating facilities have been designated as “elevated risk” facilities based on emission levels of EtO. LivaNova is not on the “elevated risk” list, nor is it in violation of any current local or federal regulations. However, to the extent weLivaNova or ~~our~~its contract sterilizers are unable to sterilize ~~our~~LivaNova’s products, whether due to regulatory, legislative, or other constraints, including on the use of EtO, weLivaNova may be unable to transition to alternative internal or external resources or methods in a timely or cost-effective manner or at all, which could have a material impact on ~~our~~LivaNova’s results of operations and financial condition.

~~Our inability to attract and retain highly skilled and experienced personnel could negatively impact our ability to effectively manage and expand our business.~~

We depend heavily on the contributions of the principal members of our business, such as senior management, manufacturing, sales, marketing, and R&D positions, many of whom would be difficult to replace. Each of these persons’ individual and collective effortsLivaNova is critical to us as we continue to develop our products and expand our commercial activities and business operations. Our key personnel include our senior officers and executive management team, many of whom have very specialized scientific, medical or operational knowledge. The loss of any key personnel could negatively impact our results of operations, particularly if we experience difficulties in hiring qualified successors.

Furthermore, competition for experienced employees in the medical device industry, particularly for persons with specialized skills, can be intense. Our ability to recruit such talent will depend on a number of factors, including compensation and benefits, work location and work environment. If we cannot effectively recruit and retain qualified executives and employees, our business, results of operations, cash flows and financial condition could be adversely affected.

~~We cannot guarantee that our internal R&D efforts and those R&D efforts that rely on investments and investment collaborations will be successful.~~

Our strategy to provide a broad range of therapies to restore patients to fuller, healthier lives requires a wide variety of technologies, products and capabilities. The rapid pace of technological development in the medical industry and the specialized expertise required in different areas of medicine make it difficult for one company alone to develop a broad portfolio of technological solutions. As a result, we also rely on investments and investment collaborations to provide us access to new technologies.

If we fail to develop innovative new and enhanced products and services on a timely basis, our offerings will become obsolete over time and our business and financial results would be negatively impacted. Our success depends on several factors, including our ability to appropriately allocate our R&D funding to products and services with higher growth prospects, for example, further incorporation of software; hire and retain the necessary R&D talent; stimulate customer demand for and convince customers to adopt new technologies; innovate and develop new technologies and applications; and acquire or obtain third-party technologies that may have valuable applications in the markets that we serve.

We expect to make investments where we believe that we can stimulate the development of, or acquire, new technologies and products to further our strategic objectives and strengthen our existing businesses. Investments and investment collaborations in and with medical technology companies are inherently risky, and we cannot guarantee that any of our previous or future acquisitions, investments or investment collaborations will be successful or will not materially adversely affect our business, results of operations, cash flows and financial condition.

Increasing attention on environmental, social and governance (“ESG”) matters may have a material impact on our reputation and business operations, impose additional costs on us, and expose us to additional risks.

There is a heightened focus from stakeholders, including regulators and shareholders, on issues relating to ESG matters, including environmental stewardship, social responsibility, diversity and inclusion, and corporate governance matters. In addition, organizations that provide information to investors on corporate governance and related matters have developed ratings processes for evaluating companies on their approach to ESG matters. Unfavorable ESG ratings may lead to negative investor sentiment toward the Company, which could have a negative impact on our stock price and our access to and costs of capital. Increasing attention on ESG issues related to our business requires the continuous monitoring of various and evolving laws, regulations, standards and expectations and the associated reporting requirements. A failure to adequately meet stakeholder expectations may result in noncompliance, reputational impacts, the loss of business and a diluted market valuation. In addition, our adoption of certain standards or mandated compliance to certain requirements could necessitate additional investments that could impact our profitability.

If our ESG initiatives fail to satisfy investors, customers, or other stakeholders, our reputation, our ability to sell products and services to customers, and our attractiveness as an investment, business partner or acquirer could be negatively impacted. Similarly, our failure to fulfill our ESG goals, targets and objectives or to satisfy various reporting standards could also have similar negative impacts on our reputation, business and result of operations.

The impact of pending or existing climate change resulting from increased concentrations of carbon dioxide and other greenhouse gases in the atmosphere could present major risks to our future operations.

The physical impacts of natural disasters and extreme weather conditions, such as hurricanes, tornadoes, earthquakes, winter storms, wildfires or flooding could pose physical risks to our facilities, temporarily reduce demand, disrupt our supply chain operations and our suppliers’ operations, and negatively impact operational costs. Additionally, the impacts of climate change on global water resources may result in water scarcity, which could impact our ability to access sufficient quantities of water in manufacturing locations and result in increased costs. As new legal and regulatory requirements designed to mitigate the effects of climate change on the environment are increasing, they may impose obligations which may increase our compliance burdens and costs to meet these obligations. Individually or in the aggregate, such risks could materially negatively impact our future operations.

~~Quality concerns with our processes, goods, and services could harm our reputation for producing high-quality products and erode our competitive advantage, sales, and market share.~~

Quality is extremely important to us and our customers due to the serious and costly consequences of product failure. Our quality certifications are critical to the marketing success of our goods and services. If we fail to meet these standards, our reputation could be damaged, we could lose customers, and our revenue and results of operations could decline. Aside from specific customer standards, our success depends generally on our ability to manufacture precision-engineered components, sub-assemblies, and finished products to exact tolerances and from multiple materials. If our components fail to meet these standards or fail to adapt to evolving standards, our reputation as a manufacturer of high-quality components will be harmed, our competitive advantage could be damaged, and we could lose customers and market share.

~~We are~~ substantially dependent on patent and other proprietary rights and failing to protect such rights or to be successful in litigation related to ~~our~~LivaNova’s rights or the rights of others may result in ~~our~~the Company’s payment of significant monetary damages and/or royalty payments, negatively impact ~~our~~LivaNova’s ability to sell current or future products or prohibit usthe Company from enforcing ~~our~~its patent and other proprietary rights against others.

~~We rely~~LivaNova relies on a combination of patents, trade secrets, and non-disclosure and non-competition agreements to protect ~~our~~the Company’s proprietary intellectual property, and weLivaNova will continue to do so. While ~~we intend~~LivaNova intends to defend against any threats to ~~our~~the Company’s intellectual property, any litigation to counter the infringement, misappropriation, or unauthorized use of ~~our~~LivaNova’s intellectual property may require the expenditure of significant financial and managerial resources, which may adversely affect ~~our~~LivaNova’s business, results of operations, cash flows and financial condition. Additionally, ~~our~~LivaNova’s patents, trade secrets, or other agreements may not prevent competitors from independently developing or selling similar products and services and may not adequately deter misappropriation or improper use of ~~our~~the Company’s technology. Further, pending patent applications may not result in patents being issued to ~~us.~~LivaNova. Patents issued to or licensed by usLivaNova in the past or in the future may be challenged or circumvented by competitors and such patents may be found invalid, unenforceable or insufficiently broad to protect ~~our~~the Company’s technology, and may limit ~~our~~LivaNova’s competitive advantage. Third parties could obtain patents that may require usLivaNova to negotiate licenses to conduct ~~our~~ business, and the required licenses may not be available on reasonable terms or at all.

WeLivaNova also ~~rely~~relies on non-disclosure and non-competition agreements with certain employees, consultants and other parties to protect, in part, trade secrets and other proprietary rights. WeLivaNova cannot be certain that these agreements will not be breached, that wethe Company will have adequate remedies for any breach, that others will not independently develop substantially equivalent proprietary information, or that third parties will not otherwise gain access to ~~our~~LivaNova’s trade secrets or proprietary knowledge. Further, new proposed regulations in the ~~U.S.~~US would prohibit certain competition agreements, and if final regulations are adopted as proposed and enforced, weLivaNova may not be able to rely on such agreements with certain of ~~our~~the Company’s employees or other parties.

~~We operate~~LivaNova operates in an industry characterized by extensive patent litigation and ~~are~~has been, and is, subject to patent claims from time to time. While ~~we intend~~LivaNova intends to defend against any third-party intellectual property threats, intellectual property litigation is inherently complex and unpredictable. Such litigation can result in significant damage awards and injunctions that could prevent ~~our~~LivaNova’s manufacture and sale of affected products or require usthe Company to pay significant royalties in order to continue to manufacture or sell affected products.

In addition, the laws and intellectual property systems of certain countries in which ~~we market~~LivaNova markets some of ~~our~~its products do not protect ~~our~~the Company’s intellectual property rights to the same extent as in the ~~U.S.,~~US, which may impact ~~our~~its market position in those countries. WeLivaNova could also face competition in countries where ~~we have~~the Company has not invested in an intellectual property portfolio, or where ~~we have~~the Company has not invested in the same protection as in the ~~U.S.~~US. If ~~we are~~the Company is unable to protect ~~our~~LivaNova’s intellectual property in those countries, it could have a material adverse effect on ~~our~~LivaNova’s reputation, ~~business, results of operations, cash flows and financial condition.~~

COVID-19 has had, and may continue to have, an adverse effect on our business, results of operations, cash flows and financial condition, the nature and extent of which are uncertain and unpredictable.

While we have seen improvement in demand for our products and resumption of our clinical trials as the strength of COVID-19 and its variants have waned, the pandemic and its effects on the economy, employment, patient behaviors and supply chain, among others, has had an adverse effect on, and may continue to impact our business. Please refer to the section entitled “~~Reductions and interruptions in supply chain in addition to increasing costs have, and may continue to, adversely affect our business, results of operations, cash flows and financial condition” above.~~

The Company continues to respond to such challenges, and while we have business continuity plans in place, the impact of the ongoing challenges we are experiencing, along with their potential escalation, may adversely affect our business. The future impact of pandemic-related developments remains uncertain, and we continue to monitor relevant conditions as there can be no assurances that there will not be delays or closures of clinical sites, variable demand for products or material impacts on our supply chain should COVID-19 or its reverberating impacts on the economy strengthen or reemerge.

~~Our inability to integrate recently acquired businesses or to successfully complete and integrate future acquisitions could limit our future growth or otherwise be disruptive to our ongoing business.~~

From time to time, we acquire businesses and may pursue acquisitions in support of our strategic goals. There can be no assurance that acquisition opportunities will be available on acceptable terms or at all, or that we will be able to obtain necessary financing or regulatory approvals to complete potential acquisitions. The success of any acquisition, investment or alliance may be affected by a number of factors, including our ability to properly assess and value the potential business opportunity or to successfully integrate any businesses we may acquire into our existing business. The integration of the

operations of acquired businesses requires significant efforts, including the coordination of information technologies, human resources, R&D, sales and marketing, operations, manufacturing, legal, compliance and finance. These efforts result in additional expenses and involve significant amounts of management’s time that cannot then be dedicated to other projects. Failure to manage and coordinate the growth of the combined company successfully could also have an adverse impact on our business. In addition, we cannot be certain that our investments, alliances and acquired businesses will become profitable or remain so. If our investments, alliances or acquisitions are not successful, we may incur costs in excess of what we anticipate.

~~We may incur impairments of intangible assets and goodwill that may adversely affect our financial results.~~

We review, when circumstances warrant, the carrying amounts of our intangible assets to determine whether those carrying amounts continue to be recoverable in accordance with U.S. Generally Accepted Accounting Principles. Significant negative industry or economic trends, disruptions to our businesses, significant unexpected or planned changes in the use of assets, divestitures and market capitalization declines, among other events, may result in impairments to goodwill and other intangible assets. Recent impairments have significantly affected our financial results, and future impairments could significantly affect reported financial results.

As of December 31, 2022, the carrying value of our net intangible assets and goodwill totaled $1.1 billion, which represented 49.6% of our total assets. During the quarter ended September 30, 2022, we determined the goodwill associated with our ACS reporting unit was impaired, and as a result, recorded an impairment of $129.4 million. During the year ended December 31, 2020, we entered into a Purchase Agreement 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 that resulted in an impairment of the Heart Valves disposal group of $180.2 million and a $21.3 million goodwill impairment. For additional information, please refer to “Note 5. Divestiture of Heart Valve Business” in our consolidated financial statements and accompanying notes, beginning on page F-1 of this Annual Report on Form 10-K.

~~The success and continuing development of our products depend on maintaining strong relationships with physicians and healthcare professionals.~~

If we fail to maintain our working relationships with physicians and other healthcare professionals, our products may not be developed and marketed in line with the needs and expectations of the professionals who use and support our products. Physicians assist us as researchers, marketing consultants, product consultants, inventors and public speakers, and we rely on these professionals to provide us with considerable knowledge and experience. If we are unable to maintain these strong relationships, the development and marketing of our products could suffer, which could have a material adverse effect on our business, results of operations, cash flows and financial condition.

Inadequate funding for ~~U.S.~~US federal government agencies and government shutdowns could negatively affect ~~our~~LivaNova’s business, results of operations, cash flows and financial condition.

The ability of the FDA to review and approve new products can be affected by a variety of factors, including government ~~budget and~~ funding levels, the ability to hire and retain key personnel, government shutdowns, and statutory, regulatory and policy changes. In addition, a portion of ~~our~~LivaNova’s revenue is dependent on ~~U.S.~~US federal government healthcare program reimbursement. Any disruption in ~~U.S.~~US federal government operations, including government shutdowns, could have a material adverse effect on ~~our~~LivaNova’s business, results of operations, cash flows and financial condition.

Risks Related to ~~our~~LivaNova’s Indebtedness

Paying amounts due ~~in cash in~~with respect ~~of our~~to LivaNova’s outstanding Notes on interest payment dates, at maturity and upon exchange thereof will require a cash payment. WeLivaNova may not have sufficient cash flow from ~~our~~its business operations to pay when due or be able to raise the funds necessary to pay when due, amounts owed inwith respect ofto the Notes and/or any amounts owed under ~~our~~the Company’s revolving credit facility and term facilities, which could adversely affect ~~our~~LivaNova’s business and results of operations.

On June 17, 2020, ~~our~~LivaNova’s wholly-owned subsidiary, LivaNova USA, ~~Inc.,~~ issued ~~$287.5 million aggregate principal amount of 3.00% 2020 Cash Exchangeable Senior Notes (the “Notes”) due in 2025.~~the Notes. The ability to make scheduled payments of interest on, and principal of, to satisfy exchanges for cash in respect of, and/or to refinance ~~our~~LivaNova’s outstanding Notes or other indebtedness (including any indebtedness under ~~our~~LivaNova’s revolving credit facility or term facilities) depends on ~~our~~the Company’s future performance, which is subject to economic, financial, competitive and other factors beyond ~~our~~its control. ~~(For~~For further information on ~~our~~LivaNova’s term facilities, please refer to “Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations” of this ~~Annual~~ Report ~~on Form 10-K~~ under the section entitled “Liquidity and Capital ~~Resources”).~~Resources.” If ~~we are~~LivaNova is unable to generate enough cash flow to make payments on the Notes or other indebtedness when due, wethe Company may be required to adopt one or more alternatives, such as selling assets or obtaining additional debt financing or equity capital on

terms that may be onerous or highly dilutive. ~~Our~~LivaNova’s ability to refinance the Notes or other indebtedness, which wethe Company may need to do in order to satisfy ~~our~~its obligations thereunder, will depend on the capital markets and ~~our~~LivaNova’s financial condition at such time. WeLivaNova may not be able to engage in ~~any of these activities or engage in~~ these activities on desirable terms or at all, which could result in a default on the Notes and/or ~~our~~LivaNova’s revolving credit facility orand term facilities.

The holders of the Notes have the right to require usLivaNova to repurchase their Notes upon the occurrence of a fundamental change (as defined in the ~~indenture governing the Notes (the “Indenture”))~~Indenture) at a repurchase price equal to 100% of the principal amount of the Notes to be repurchased, plus accrued and unpaid interest, if any. Upon repurchase of the Notes, weLivaNova will be required to make cash payments as required by the Indenture. WeLivaNova may not have enough available cash or be able to obtain financing at the time ~~we are~~the Company is required to make repurchases of, or exchange of, the Notes for cash. ~~Our~~LivaNova’s failure to repurchase the Notes or exchange the Notes for cash at a time when the repurchase or exchange is required by the Indenture governing the Notes would constitute a default under such Indenture.

In addition, ~~our~~LivaNova’s indebtedness including under the Notes, combined with ~~our~~the Company’s other financial obligations and contractual commitments including those under ~~our~~LivaNova’s revolving credit facility or term facilities, could have other important consequences. For example, it could:

•Make usLivaNova more vulnerable to adverse changes in government ~~regulation~~regulations and in the ~~worldwide economic, industry~~global economy, healthcare and competitive environment;

•Limit ~~our~~the Company’s flexibility in planning for, or reacting to, changes in ~~our~~LivaNova’s business and ~~our industry;~~its markets;

•Place usthe Company at a disadvantage compared to ~~our~~LivaNova’s competitors who have less debt;

•Limit ~~our~~LivaNova’s ability to borrow additional amounts for working capital, to fund acquisitions ~~for working capital~~ and for other general corporate purposes; and

•Make ~~an acquisition~~a sale of the Company less attractive to buyers or more ~~difficult.~~difficult to complete.

Any of these factors could harm ~~our~~LivaNova’s business, results of operations, cash flows and financial condition. In addition, if ~~we incur~~LivaNova incurs additional indebtedness under the revolving credit facility or term facilities, the risks related to ~~our~~LivaNova’s business and ~~our~~its ability to repay ~~our~~the Company’s indebtedness, including under the Notes, would increase. For additional information, please refer to “Note ~~11.~~10. Financing Arrangements” in ~~the~~LivaNova’s consolidated financial statements included in this ~~Annual report on Form 10-K.~~Report.

The conditional exchange features of the Notes, if triggered, may adversely affect ~~our~~LivaNova’s liquidity and operating results.

If the conditional exchange feature of the Notes is triggered, holders of the Notes are entitled to exchange the Notes at any time during specified periods, at their option. Holders of the Notes for example, are entitled to exchange the Notes during ~~any~~the current calendar quarter if the ~~last reported sale~~closing price of LivaNova’s ordinary shares ~~with a nominal value of £1.00 per share~~ for at least 20 trading days (whether or not consecutive) during ~~a period of~~the last 30 consecutive trading days ~~ending on, and including, the last trading day~~ of the immediately preceding calendar quarter is greater than or equal to 130% of the exchange price – the exchange price being $60.98 per share and the “conversion trigger” (subject to other conditions per the Indenture) being $79.27 per share – on each applicable trading day. The exchange condition was not satisfied on December 31, ~~2022,~~2023, and therefore, exchangeability is not an option from January 1, ~~2023~~2024, through March 31, ~~2023.~~2024. If holders elect to exchange their Notes during future periods following the satisfaction of an exchange condition as laid out in the Indenture, weLivaNova would be required to settle ~~our~~its exchange obligation through the payment of cash, which could adversely affect ~~our~~the Company’s liquidity.

~~Our~~

LivaNova’s debt instruments require usLivaNova to comply with affirmative covenants and specified financial covenants and ratios and other obligations.

Certain restrictions and covenants in ~~our~~LivaNova’s debt instruments, including ~~our~~the Company’s revolving credit facility or term facilities, could affect ~~our~~its ability to operate and may limit ~~our~~its ability to react to market conditions or to take advantage of potential business opportunities as they arise. For example, such restrictions could adversely affect ~~our~~LivaNova’s ability to finance ~~our~~its operations, make strategic investments, alliances or acquisitions, ~~investments or alliances,~~ restructure ~~our~~its organization or finance capital needs. Additionally, ~~our~~LivaNova’s ability to comply with these covenants and restrictions may be affected by events beyond ~~our~~its control, such as prevailing economic, financial, regulatory and industry conditions. If any of these restrictions or covenants isare breached, weLivaNova could be in default under one or more of ~~our~~its debt instruments, which, if not cured or waived, could result in acceleration of the indebtedness under such agreements and ~~cross defaults~~cross-defaults under ~~our~~its other debt instruments. ~~(For~~For more information on these debt instruments, please refer to “Note ~~11.~~10. Financing ~~Arrangements.”)~~

Arrangements” in LivaNova’s consolidated financial statements included in this Report.

The effective interest rate and related interest expense reported in ~~our~~LivaNova’s consolidated financial statement of operations is significantly greater than the stated interest ~~rates~~rate of the Notes and may result in volatility to ~~our~~the Company’s reported financial results, which could adversely affect the price at which ~~our~~LivaNova’s ordinary shares trade.

WeLivaNova will settle exchanges of the Notes entirely in cash. Accordingly, the exchange feature that is part of the Notes is accounted for as a derivative pursuant to accounting standards relating to derivative instruments. This resulted in an initial accounting valuation of the exchange feature, which was bifurcated from the debt component of the Notes, resulting in an original issue discount. The original issue discount is amortized and recognized as a component of interest expense over the term of the Notes, which results in an effective interest rate reported in ~~our~~LivaNova’s consolidated statements of operations in excess of the stated interest rate of the Notes. Although this accounting treatment does not affect the amount of cash interest paid to holders of the Notes or ~~our~~LivaNova’s cash flows, it reduces ~~our~~the Company’s earnings and could adversely affect the price at which ~~our~~its ordinary shares trade.

Additionally, for each financial statement period after issuance of the Notes, a derivative gain or loss is and will be reported in ~~our~~LivaNova’s consolidated statements of income (loss) to the extent the valuation of the exchange feature changes from the previous period. The capped call transactions described below and elsewhere in this ~~annual report~~Report are also accounted for as derivative instruments. The valuation of the exchange feature of the Notes and capped call transactions utilizes significant observable and unobservable market inputs, including stock price, stock price volatility, risk-free interest rate, and time to expiration of the Notes. The change ~~of inputs~~in input values at the current period end ~~from~~compared to the previous period end may result in a material change ofin the ~~valuation~~respective valuations and the gain or loss resulting from the exchange feature of the Notes and capped call transactions may not completely offset each other. As such, there may be a material net impact ~~to our~~on LivaNova’s consolidated statements of operations, which could adversely affect the price at which ~~our~~its ordinary shares trade.

The arbitrage or hedging strategy by purchasers of the Notes and Option Counterparties in connection with ~~our~~LivaNova’s capped call transactions may affect the value of ~~our~~LivaNova’s ordinary shares.

~~We expect~~LivaNova expects that many investors in, and potential purchasers of, the Notes will employ, or seek to employ, an arbitrage strategy with respect to the Notes. Investors would typically implement such a strategy by selling short ~~our~~LivaNova’s ordinary shares underlying the Notes and dynamically adjusting their short position while continuing to hold the Notes. Investors may also implement this type of strategy by entering into swaps on ~~our~~LivaNova’s ordinary shares in lieu of or in addition to selling short ~~our~~the Company’s ordinary shares. This activity could decrease, ~~(or~~or reduce the size of any increase ~~in)~~in, the market price of ~~our~~LivaNova’s ordinary shares at that time.

In connection with the pricing of the Notes, weLivaNova entered into privately negotiated capped call transactions with certain financial ~~institutions (the “Option Counterparties”).~~institutions. The capped call transactions are expected generally to offset cash payments due upon exchange of the Notes in excess of the principal amount thereof in the event that the market ~~value~~price per ordinary share of the Company is at the time of exchange of the Notes is greater than the strike price under the capped call transactions, with such offset subject to a cap based on the cap price. ~~We understand~~It is LivaNova’s understanding that the Option Counterparties, or their respective affiliates, in connection with establishing their initial hedges of the capped call transactions, purchased ~~our~~LivaNova’s ordinary shares and/or entered into various derivative transactions with respect to ~~our~~the Company’s ordinary shares concurrently with or shortly after the pricing of the Notes. The Option Counterparties or their respective affiliates may modify these initial hedge positions by entering into or unwinding various derivatives with respect to ~~our~~LivaNova’s ordinary shares and/or purchasing or selling ~~our~~its ordinary shares or other ~~securities~~ of ~~ours~~LivaNova’s securities in secondary market transactions prior to the maturity of the Notes (and are likely to do so during any observation period related to an exchange of the Notes or upon a repurchase or redemption of the Notes). This activity could cause or avoid an increase or decrease in the market price of ~~our~~LivaNova’s ordinary shares at that time.

~~We are~~

LivaNova is subject to counterparty risk with respect to the capped call transactions.

The Option Counterparties are financial institutions, and ~~we are~~LivaNova is subject to the risk that they might default under the capped call transactions. ~~Our~~LivaNova’s exposure to the credit risk of the Option Counterparties is not secured by any collateral.

If an Option Counterparty becomes subject to insolvency proceedings, weLivaNova will become an unsecured creditor in those proceedings, with a claim equal to ~~our~~the Company’s exposure at that time under the capped call transactions with that Option Counterparty. ~~Our~~LivaNova’s exposure will depend on many factors but generally an increase in ~~our~~the Company’s exposure will be correlated to an increase in the market price and in the volatility of ~~our~~its ordinary shares. In addition, upon a default by an Option Counterparty, weLivaNova may suffer adverse tax consequences and may, on a net basis, have to pay more cash to settle exchanges of the Notes. WeLivaNova can provide no assurances as to the financial stability or viability of the Option Counterparties.

Risks Relating to Tax and ~~Our~~LivaNova’s Jurisdiction of Incorporation

~~We are~~LivaNova is incorporated in England and Wales and governed by their laws which may afford less protection to shareholders than under ~~U.S.~~US laws.

~~Being that we are~~LivaNova is a public limited company incorporated under the laws of England and Wales, ~~our~~and as such, the Company’s shareholders may have more difficulty protecting their interests than would shareholders of a corporation incorporated in a jurisdiction of the ~~United States.~~US. It may be difficult to enforce ~~any~~ court judgments obtained in the ~~U.S. against us in the U.K.~~US and based on the civil liability provisions of ~~U.S.~~US federal or state securities ~~laws.~~laws against LivaNova in the UK. In addition, there is also some uncertainty as to whether the UK courts ~~of U.K.~~ would recognize or enforce ~~judgements~~judgments of ~~U.S.~~US courts obtained against usLivaNova or any of ~~our~~its directors or officers.

Changes in tax laws or exposure to additional income tax liabilities could have a material impact on ~~our~~LivaNova’s results of operations and financial condition.

~~We are~~LivaNova is subject to income taxes as well as non-income-based taxes in the ~~U.S.,~~US, the UK, the EU and various other jurisdictions. ~~No assurances can be given as~~Any material change in tax laws, regulations or policies, or their interpretation and enforcement, including with respect to ~~what our worldwide~~the OECD’s Pillar Two global minimum tax rules applicable to multinational groups with global revenue over €750 million, could result in a higher effective ~~corporate~~ tax rate and have a material impact on LivaNova’s consolidated statements of income (loss) or financial condition.

LivaNova continues to monitor the adoption of Pillar Two by the taxing jurisdictions in which it operates. The UK has enacted legislation providing for a minimum effective tax rate of 15% through a multinational top-up tax and a domestic top-up tax for accounting periods beginning on or after December 31, 2023. Draft UK legislation has also been published for an undertaxed profits rule to be introduced, although not before accounting periods beginning on or after December 31, 2024. A UTPR would be a backstop rule intended to ensure that amounts of multinational top-up tax that are not collected under foreign global minimum tax rules can in certain circumstances be collected instead in the UK. LivaNova is assessing the full implication on 2024 financial results and will continue to monitor legislative developments and related guidance in the UK and other jurisdictions that may impact LivaNova’s operations. Any material changes in tax laws, regulations or policies, or their interpretation and enforcement, including with respect to Pillar Two, could result in a higher effective tax rate for LivaNova and have a material impact on its consolidated statements of income (loss) or financial condition. The content of any future legislation, the timing of additional guidance, and the reporting periods that may be ~~because of, among other things, uncertainty regarding the tax regulations and laws, enactment and enforceability thereof and policies of the jurisdictions where we operate. Our~~impacted cannot be determined at this time.

LivaNova’s actual effective tax rate may vary from ~~our~~its expectations or from historical trends and that variance may be material. ~~Our~~LivaNova’s effective tax rates could be affected by changes in the mix of earnings in countries with differing statutory tax rates, changes in the valuation of deferred tax assets and liabilities or changes in tax laws or their interpretation. ~~We are~~LivaNova is also subject to ongoing tax audits in various ~~non-U.S.~~non-US jurisdictions. Tax authorities may disagree with certain positions ~~we have~~LivaNova has taken and assess additional taxes. ~~We believe~~LivaNova believes that ~~our~~its accruals reflect the probable outcome of known contingencies. However, there can be no assurance that weLivaNova will accurately predict the outcomes of ongoing audits, and the actual outcomes of these audits could have a material impact on ~~our~~LivaNova’s consolidated statements of income (loss) or financial condition.

~~The IRS may not agree with the conclusion that we should be treated as~~As a ~~foreign corporation for U.S. federal tax purposes, and we may be required to pay substantial U.S. federal income taxes.~~

Based on our management and organizational structure, we believe that we should be regarded as a resident exclusively in the UK for tax purposes and that we are appropriately treated as a foreign corporation for U.S. federal tax purposes. Although we are incorporated in the UK, the U.S. Internal Revenue Service (the “IRS”) may assert that we should be treated as a U.S. corporation (and, therefore, a U.S. tax resident) for U.S. federal tax purposes. If we were to be treated as a U.S. corporation for U.S. federal income tax purposes, we could be subject to substantially greater U.S. tax liability than currently contemplated as a non-U.S. corporation.

~~The IRS may limit Cyberonics’ and its U.S. affiliates’ ability to utilize their U.S. tax attributes as a result of the merger of Cyberonics and Sorin.~~

The merger of Cyberonics and Sorin is considered an inversion for tax purposes. The U.S. Internal Revenue Code (“IRC”) and regulations under the IRC impose a minimum level of tax on any “inversion gain” of a U.S. corporation (and any U.S. person related to the U.S. corporation) depending on the resulting percentage ownership by U.S. persons of the merged company. The effect of this provision in the IRC is to deny the use of certain U.S. tax attributes (including net operating losses and certain tax credits) to offset U.S. tax liability, if any, attributable to such inversion gain. In our case, we believe that the former stockholders of Cyberonics own less than the IRC’s stated percentage of the Company. However, it cannot be assured that the IRS will agree with our position.

~~As an English~~ public limited company incorporated under the laws of England and Wales, certain of LivaNova’s capital structure decisions require shareholder approval, which may limit ~~our~~the Company’s flexibility to manage ~~our~~its capital structure.

~~We are~~LivaNova is a public limited company incorporated under the laws of England and Wales. Under English law, ~~our~~LivaNova’s Board of Directors may only allot shares with the prior authorization of shareholders. English law also generally provides shareholders with preemptive rights when new shares are issued for cash, which rights may be ~~excluded~~surrendered by shareholders. In addition, English law generally prohibits a public limited company from repurchasing its own shares without the prior approval

of shareholders. As a result, ~~our~~LivaNova’s shareholders must approve these authorities at an annual general meeting of shareholders. If ~~we do~~LivaNova does not receive shareholder approval of these matters, wethe Company may not be able to raise any required additional capital in a timely manner or at ~~all, if, and as needed, to fund our operations.~~all. In addition, weLivaNova may not be able to continue to grant equity awards to its directors, officers and employees under the relevant incentive plan.

Transfers of ~~our~~LivaNova’s shares, other than ~~ones~~those effected by means of the transfer of book-entry interests in ~~the Depository Trust Company (“DTC”),~~DTC, may be subject to UK Stamp Duty or ~~UK Stamp Duty Reserve Tax (“SDRT”).~~SDRT.

Transfers of ~~our~~LivaNova’s shares effected by means of the transfer of book-entry interests in DTC are not subject to UK stamp duty or SDRT. However, if a shareholder holds ~~our~~LivaNova’s shares directly rather than through DTC, any transfer of shares could be subject to UK stamp duty or SDRT at a rate of 0.5% of the consideration paid for the ~~transfer and~~transfer. In addition, certain ~~issues or~~ transfers of shares to depositories or into clearance services are charged at a rate of 1.5% of the consideration paid for the transfer, or 1.5% of the market value of the shares if there is no consideration. The transferee generally pays the UK stamp duty or SDRT. The potential for UK stamp duty or SDRT could adversely affect the trading price of ~~our~~LivaNova’s shares.

If DTC determines at any time that ~~our~~LivaNova’s shares are not eligible for continued deposit and clearance within its facilities, ~~then we believe~~LivaNova believes that ~~our~~its shares would not be eligible for continued listing on a ~~U.S.~~US securities exchange and trading in ~~our~~the Company’s shares would be disrupted. While weLivaNova would pursue alternative arrangements to preserve the listing and maintain trading, any such disruption could have a material adverse effect on the trading price of ~~our~~LivaNova’s shares.

General Risk Factors

LivaNova’s success depends on its ability to attract and retain key personnel needed to successfully operate its business and to plan for future executive transitions.

LivaNova’s ability to compete effectively depends on its ability to attract and retain key employees and maintain robust succession planning for key positions. LivaNova’s ability to recruit and retain key talent depends on many factors, including compensation and benefits, work location, work environment, industry-specific and general economic conditions and the hiring practices of competitors. If LivaNova fails to attract and retain key personnel in senior management and other positions, or if the Company’s succession planning efforts are not effective, it could have a material adverse effect on LivaNova’s business, financial condition and results of operations.

Increasing attention on sustainability matters, including environmental, social, and governance matters, may have a material impact on LivaNova’s reputation and business operations and consume additional financial and management resources.

There is a heightened focus from stakeholders, including regulators and shareholders, on issues relating to sustainability, including environmental stewardship, social responsibility, diversity and inclusion, and corporate governance matters. Increasing attention on sustainability issues related to LivaNova’s business requires the continuous monitoring of various and evolving laws, regulations, standards and expectations and the associated reporting requirements. A failure to adequately meet stakeholder expectations may result in noncompliance, reputational harm, the loss of business and access to capital, negative impact to the stock price and a diluted market valuation. In addition, the Company’s adoption of certain standards or mandated compliance with certain requirements could necessitate additional investments that could impact LivaNova’s profitability.

In addition, if LivaNova’s sustainability initiatives fail to satisfy investors, customers, or other stakeholders, the Company’s reputation, its ability to sell products and services to customers, and its attractiveness as an investment, business partner or acquirer could be negatively impacted. Similarly, LivaNova’s failure, or perceived failure, to fulfill its sustainability goals or to satisfy various reporting standards could also have a similar negative impact on the Company’s reputation, business and results of operations. Furthermore, environmental regulations are continuing to become more stringent and LivaNova may experience increased compliance burdens and costs to meet its regulatory obligations, as well as adverse impacts on raw material sourcing, manufacturing operations and the distribution of LivaNova’s products.

The physical impacts of natural disasters and extreme weather conditions, such as hurricanes, tornadoes, earthquakes, winter storms, wildfires or flooding could pose physical risks to LivaNova’s facilities, temporarily reduce demand, reduce employee productivity, increase absenteeism, disrupt the Company’s supply chain operations and its suppliers’ operations, and negatively impact operational costs. Additionally, transitional climate risks such as changing customer behaviors and changing dynamics in raw materials and utility markets, could lead to lost revenue due to inability to meet changing customer requirements, increasing costs associated with product adjustments to meet changing customer preferences, increasing costs of inputs and raw materials and increasing cost of utilities. There continues to be a lack of consistent climate legislation, which creates economic

and regulatory uncertainty. Legal, regulatory and customer requirements and preferences designed to mitigate the effects of climate change on the environment are increasing, and they may impose obligations that may increase LivaNova’s compliance burden and cost to meet these obligations. Individually or in aggregate, such risks could materially negatively impact LivaNova’s future operations.

Public health crises have had, and may continue to have, an adverse effect on LivaNova’s business, results of operations, cash flows and financial condition, the nature and extent of which are uncertain and unpredictable.

LivaNova’s global operations and business interactions with healthcare systems, providers and patients around the world expose the Company to risks associated with public health crises, including epidemics and pandemics such as COVID-19. The COVID-19 pandemic caused significant disruption to the business and financial markets. LivaNova continues to monitor the potential effects of future health epidemics on the Company’s business and operations. While the spread of COVID-19 has stabilized, LivaNova cannot guarantee that a future outbreak of this or any other widespread epidemic will not occur, which could have the effect of decreasing demand and/or increasing volatility in demand for LivaNova’s products.

If LivaNova’s business development and restructuring activities are unsuccessful, the Company may not realize the intended benefits.

LivaNova has sought, and in the future, may seek, to supplement its organic growth through strategic investments, alliances and acquisitions. Moreover, LivaNova has also sought, and in the future may seek, to divest or wind down certain assets deemed non-core to the Company’s long-term strategic objectives. For example, as part of the 2024 Restructuring Plan, the Company will wind down the ACS segment, which is anticipated to be substantially complete by the end of 2024. Such transactions are inherently risky and require significant effort and management attention. The success of any investment, alliance, acquisition or divestiture may be affected by various factors, including LivaNova’s ability to properly assess, finance, value and obtain relevant approvals for a potential business opportunity or to successfully integrate any business LivaNova may acquire. LivaNova cannot be certain that its investments, alliances and acquired businesses will achieve the financial projections supporting those investment decisions. In addition, if LivaNova’s investments, alliances, divestitures, or acquisitions are not successful, the Company may incur costs in excess of what it anticipates, including those resulting from related litigation.

As a result of acquisitions, LivaNova may face risks due to the implementation, modification, or remediation of controls, procedures and policies relating to data privacy and cybersecurity at the acquired company. In addition, failure to manage and coordinate the growth of the combined company successfully could have an adverse impact on LivaNova’s business.

Similarly, LivaNova may divest and has divested portions of its business, resulting in the migration of data and overlapping data obligations. As a result of such divestitures, LivaNova may face risks due to the migration or modification of controls, procedures and policies relating to data privacy and cybersecurity internally or enroute during migration. Any significant breakdown, intrusion, interruption, corruption or destruction of these systems, as well as any data breaches, could have a material adverse effect on LivaNova’s business.

LivaNova may incur impairments of intangible assets, goodwill and other long-lived assets that may adversely affect the Company’s financial results.

LivaNova reviews, when circumstances warrant, the carrying amounts of its intangible assets, goodwill and other long-lived assets to determine whether those carrying amounts continue to be recoverable in accordance with US GAAP. Significant negative industry or economic trends, disruptions to LivaNova’s businesses, significant unexpected or unplanned changes in the use of assets, divestitures and market capitalization declines, among other events, may result in impairments to LivaNova’s intangible assets, goodwill and other long-lived assets. Recent impairments have significantly affected LivaNova’s financial results, as could future impairments.

Item 1B. Unresolved Staff Comments

None.

Item 1C. Cybersecurity

Cyber Risk Management and Strategy

LivaNova’s enterprise risk management process consists of risk identification, evaluation, control and monitoring, and documentation. The LivaNova Board oversees risk management within the Company, and the CRO provides the framework to identify and reduce risks that may materially impact the Company’s business. As part of the CRO’s enterprise risk management

process, regular inquiries and discussions are held with the CISO, Chief Information Officer, Chief Privacy Officer, and their respective teams to review the cybersecurity risk landscape.

LivaNova’s CISO has a Master of Science in Accountancy with a specialization in risk management, in addition to over 15 years of experience in the IT Risk Advisory sector. The CISO leads the Company’s information security team, identifies cybersecurity threats, and implements countermeasures in the cybersecurity realm, considering both internal operations and the external landscape. As part of his duties, the CISO provides relevant information to the CRO in their regular discussions. The CISO also manages the Company’s ISMS program. Guided by the principles of various industry-leading standards, such as the NIST cybersecurity framework and ISO 27001, the objective of the ISMS program is to continue to strengthen LivaNova’s cyber resiliency in connection with its information systems.

As part of LivaNova’s cyber resiliency strategy and in an effort to mitigate potential cybersecurity risks, the Company employs various measures, including employee training, systems monitoring, testing and maintenance of protective systems, and contingency plans. In addition, the CISO manages a structured cyber incident response program where periodic simulation exercises are performed to prepare and train the Company’s cybersecurity incident responders. The Company deploys security tools to help bolster its defense detection capabilities, such as endpoint detection and response tools, security information and event management tools, and 24/7 monitoring. LivaNova regularly evaluates itself for appropriate business continuity and disaster recovery planning, with test scenarios that include simulations and penetration tests.

In addition, LivaNova routinely engages with third-party service providers to conduct evaluations of its security controls, whether through penetration testing or consulting on best practices to address new challenges. The Company receives threat intelligence from industry peers, government agencies, industry-specific information sharing and analysis centers, and cybersecurity associations. The Company relies heavily on its supply chain to deliver products and services to its customers, and a cybersecurity incident at a supplier, subcontractor, or service provider could materially adversely impact the Company. The Company assesses third-party cybersecurity controls through its information security program and includes security and privacy addendums to its contracts where applicable.

Historically, risks from cybersecurity threats have not materially affected the Company’s business strategy, results of operations or financial condition. As previously reported, in November 2023, the Company initiated its cyber response protocol in response to a cybersecurity incident that resulted in a disruption of portions of its information technology systems. Promptly after detecting the issue and per LivaNova’s cyber response protocol, the Company began an investigation with assistance from external cybersecurity consultants and coordinated with law enforcement. The Company continues to assess what information was impacted and to implement remediation measures to mitigate the impact of the incident.. While the Company has taken and will continue to take actions to enhance its information security framework, LivaNova cannot determine at this time the extent of the impact from this event on its business, results of operations, cash flows, or financial condition. For further information, please refer to “Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations” of this Report. Additionally, for a description of the Company’s evaluation of its disclosure controls and procedures, management’s report on internal control over financial reporting and changes in internal control over financial reporting, see “Item 9A. Controls and Procedures.”

Cyber Governance

On a quarterly basis, the CISO presents key security metrics to the Company’s IT Advisory Council, which is composed of functional leaders across the Company and is responsible for IT governance oversight in the Company. Specifically, this IT Advisory Council is responsible for establishing program strategies in alignment with LivaNova’s business objectives, as well as providing guidance on the implementation of appropriate and necessary security controls in alignment with the Information Security Policy. Among other things, the IT Advisory Council reviews summaries of information security incidents, audit findings, or other test reports, and ensures appropriate root-cause analyses are performed and corrective actions are taken. It also establishes year-over-year goals, security objectives, and priorities for the information security program.

On an annual basis, the CISO reviews the information security program achievements and reports to the Company’s IS Executive Committee, which is a cross-functional group composed of the CEO, the CFO, the CLO, and other executive leaders of the Company. Among other things, the IS Executive Committee approves the information security policy and the allocation of budget and resources to information security program initiatives, performs the annual management review of the security program, and reviews corrective action to improve the program.

As codified in its charter, the Audit Committee is responsible for reviewing the processes by which cybersecurity risks are managed and reporting any issues that arise out of such reviews to the Board. The CISO provides key security metrics to the Audit Committee on a quarterly basis, and directly to the chair of the Audit Committee on a case-by-case basis, as needed, at any time during the quarter. The Audit Committee reviews these reports, which include, among other things, external events

impacting the Company, security incidents, user training statistics, and evaluations of user readiness to address cyber incidents. Notwithstanding the Company’s approach to cybersecurity, the Company may not be successful in preventing or mitigating future cybersecurity incidents that could have a material adverse effect on the Company. While LivaNova maintains cybersecurity insurance, the costs related to cybersecurity threats or disruptions may not be fully insured. For more information on risks related to cybersecurity and data security, see Item 1A. “Risk Factors – Risks Relating to the Company’s Business and Operations.”

Item 2. Properties

~~Our~~LivaNova’s principal executive office is located in the UK and is leased by ~~us. Our~~the Company. LivaNova’s business segments ~~have headquarters located~~are headquartered in the ~~U.S.~~US for Neuromodulation and ~~Advanced Circulatory Support~~historically, ACS, and in Italy for Cardiopulmonary. ~~We have~~LivaNova has manufacturing and research facilities located in ~~Brazil,~~the US, Italy, Germany, ~~Italy,~~ Australia, and ~~the U.S. Our~~Brazil. The Company’s manufacturing and research facilities are approximately 1.0 million square feet. The manufacturing and research facilities located in the ~~U.S.,~~US, Italy and Brazil are substantially owned by ~~us.~~LivaNova. Approximately ~~46%~~45% of ~~our~~the Company’s manufacturing and research facilities by square feet are located within the ~~U.S.~~US. Approximately ~~57%~~59% of ~~our~~LivaNova’s manufacturing and research facilities by square feet are owned by usthe Company and the balance is leased.

WeLivaNova also ~~maintain 25~~maintains 31 primary administrative offices in 1821 countries. Most of these locations are leased. ~~We are~~LivaNova is using substantially all of ~~our~~the Company’s currently available productive space to develop, manufacture and market ~~our~~LivaNova’s products. ~~We believe~~LivaNova believes that all of ~~our~~its facilities are in good operating condition, suitable for their respective uses and adequate for current needs.

Item 3. Legal Proceedings

Information pertaining to certain material pending legal and regulatory proceedings and settlements is incorporated herein by reference to “Note ~~14.~~13. Commitments and Contingencies” in ~~our~~LivaNova’s consolidated financial statements and accompanying notes, beginning on page F-1 of this ~~Annual~~ Report, ~~on Form 10-K~~ and should be considered an integral part of “Item 3 of Part I” of this ~~Annual Report on Form 10-K.~~Report.

Item 4. Mine Safety Disclosures

Not applicable.

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PART II

Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities

~~Our~~LivaNova’s ordinary shares are quoted on the Nasdaq ~~Global~~Stock Market LLC under the symbol “LIVN.”

As of February ~~17, 2023,~~23, 2024, according to data provided by ~~our~~LivaNova’s transfer agent, there were 20 stockholders of record. A substantially greater number of holders of ~~our~~LivaNova’s ordinary shares are “street name” or beneficial holders, whose shares of record are held by banks, brokers and other financial institutions.

Dividend Policy

WeLivaNova currently ~~have~~has no intention to declare and pay dividends.

Issuer Purchases of Securities

None.

Stock Performance Graph

The following graph compares ~~our~~LivaNova’s five-year cumulative total return with the five-year cumulative total return of the companies on the ~~Standard & Poor’s (“~~S~~&P’s”)~~&P 500 Index and the companies on the S&P Health Care Equipment Index. This graph assumes the investment of $100 on December 31, ~~2017~~2018 and the reinvestment of all dividends since that date.

The information under the caption “Stock Performance Graph” above is not deemed to be “filed” as part of the ~~Annual~~ Report ~~on Form 10-K~~ and is not subject to the liability provisions of Section 18 of the ~~Securities~~ Exchange ~~Act of 1934, as amended (the “Exchange Act”).~~Act. Such information will not be deemed incorporated by reference into any filing ~~we make~~LivaNova makes under the Securities Act, ~~of 1933, as amended,~~ unless weLivaNova explicitly ~~incorporate~~incorporates it into such filing at such time.

Item 6. [Reserved]

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Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations

The following discussion and analysis should be read in conjunction with the consolidated financial statements and the corresponding notes included elsewhere in this ~~Annual Report on Form 10-K.~~Report. Certain percentages presented in this discussion and analysis are calculated from the underlying whole-dollar amounts and therefore may not betie to percentages recalculated from the rounded numbers used for disclosure purposes. The following discussion, analysis and comparisons generally focus on the operating results for ~~the years ended December 31,~~2023, 2022 ~~(“2022”), December 31, 2021 (“2021”)~~ and ~~December 31, 2020 (“2020”).~~2021.

~~We have~~LivaNova has elected to omit certain discussions on the earliest of the three years covered in this ~~Annual Report on Form 10-K.~~Report. Refer to Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations located in ~~our~~ LivaNova ’s Annual Report on Form 10-K for the year ended December 31, ~~2021,~~2022, filed on ~~March 1, 2022,~~February 27, 2023, for reference to discussion of ~~the fiscal year ended December 31, 2020,~~2021, the earliest of the three fiscal years presented.

Description of the Business

LivaNova PLC is a market-leading global medical technology company. The Company designs, develops, manufactures, markets and sells products and therapies that are consistent with LivaNova’s mission to provide hope for patients and their families through innovative medical technologies that deliver life-changing improvements. LivaNova is a public limited company organized under the laws of England and Wales and is headquartered in London, England. LivaNova’s ordinary shares are listed for trading on the Nasdaq under the symbol “LIVN.”

Macroeconomic Environment

The current macroeconomic environment, including foreign exchange volatility, inflationary pressures, geopolitical instability, and supply chain challenges, ~~rising inflation, and geopolitical instability,~~ has impacted and may continue to impact ~~our business. In 2022, our net revenue~~LivaNova’s business and ~~profitability were negatively affected by the unfavorable foreign currency exchange impact of the strengthened United States (“U.S.”) dollar against a number of currencies.~~profitability. Furthermore, ~~we continue~~LivaNova continues to experience supply chain delays and interruptions, labor shortages, inflationary pressures and logistical ~~issues in the wake of COVID-19. Though,~~and capacity constraints, though, to date, ~~our~~the 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.~~affected. Moreover, freight and labor costs at ~~our~~LivaNova’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 have~~LivaNova 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~~its business. ~~The future impact of pandemic-related developments remains uncertain.~~

In February 2022, 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 only 1.0% of our total net revenue for 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 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. For further discussion on these macroeconomic pressures and potential implications, refer to “Item 1A. Risk Factors” of this ~~Annual Report on Form 10-K.~~Report.

~~Description~~Cybersecurity Incident

As previously disclosed, in November 2023, LivaNova detected a cybersecurity incident that resulted in a disruption of portions of the ~~Business~~Company’s information technology systems. Promptly after detecting the issue, LivaNova began an investigation with assistance from external cybersecurity experts and coordinated with law enforcement. LivaNova took action to remediate the issue by, for example, taking certain systems offline. As a result of these and other measures, the Company believes it has contained the cybersecurity threat, though its investigation and mitigation efforts are ongoing. At this time, all of LivaNova’s manufacturing sites worldwide are operating at normal levels. The Company continues to assess the full impact of the cybersecurity event on its business, results of operations, cash flows and financial condition.

~~We are~~LivaNova incurred direct costs of approximately $2.6 million during the three and twelve months ended December 31, 2023, in connection with this incident. These costs primarily included external cybersecurity experts, legal counsel, and system restoration costs. These costs do not include business interruption or other non-direct costs, and the Company expects to incur additional costs related to this incident in the future. LivaNova maintains insurance, including cyber insurance, which is subject to certain retentions and policy limitations that may serve to limit the amount that the insurers may pay the Company when the Company makes a ~~public limited company organized under~~claim. LivaNova plans to file for reimbursement of covered costs related to this incident, but the ~~laws of England~~Company’s insurance coverage may be insufficient to cover all costs and ~~Wales~~expenses related to this cybersecurity incident, and ~~headquartered in London, England. We are a global medical device company. We design, develop, manufacture~~the insurance carrier may not cover all submitted costs and ~~sell products and therapies that are consistent with our mission~~expenses related to ~~provide hope for patients and their families through innovative medical technologies, delivering life-changing improvements for both the Head and Heart.~~

~~Background~~

We were organized under the laws of England and Wales on February 20, 2015 for the purpose of facilitating the business combination of Cyberonics, Inc., a Delaware corporation, and Sorin S.p.A. (“Sorin”), a joint stock company organized under the laws of Italy. The business combination became effective in October 2015. LivaNova’s ordinary shares are listed for trading on the Nasdaq Global Market under the symbol “LIVN.”this cybersecurity incident.

Business Segments

For the periods presented herein, LivaNova iswas comprised of three reportable segments: Cardiopulmonary, Neuromodulation and ~~Advanced Circulatory Support, corresponding to our primary business units. Other~~ACS. “Other” includes non-allocated corporate ~~shared service~~ expenses for ~~finance, legal, human resources, information technology~~the years ended December 31, 2022 and ~~corporate business development.~~2023. For the years ended December 31, 2021, ~~and 2020, Other~~“Other” also includes the results of ~~our~~LivaNova’s Heart Valve business, which was divested on June 1, 2021.

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Cardiopulmonary

~~Our~~LivaNova’s Cardiopulmonary segment is engaged in the design, development, ~~production~~manufacture, marketing and ~~sale~~selling of cardiopulmonary products, including ~~heart-lung machines (“HLM”),~~HLMs, oxygenators, autotransfusion systems, perfusion tubing systems, cannulae and other related accessories. It includes the ~~development~~Essenz Perfusion System, the Company’s next-generation HLM with an embedded patient monitor for tailored patient care strategies and sensing technology for data-driven decision making during CPB procedures.

In August 2023, LivaNova announced it had received FDA 510(k) clearance and CE Mark for its Essenz ILBM, which provides continuous measurement of essential blood parameters to perfusionists throughout CPB procedures. The ILBM is integrated into the Essenz Perfusion System, ~~our next-generation HLM~~which enables perfusionists to access and ~~a patient monitor that delivers a patient-tailored approach, supporting data-driven decisions during cardiopulmonary bypass procedures. In~~manage reliable blood parameters without the ~~fourth quarter of 2022, we completed the first clinical cases using Essenz in two major centers in Europe.~~need for additional monitors or holders.

Information on Cardiopulmonary that could potentially impact ~~our~~LivaNova’s consolidated financial statements and related disclosures is incorporated by reference to “Note ~~14.~~13. Commitments and Contingencies: FDA Warning Letter” and “Note ~~14.~~13. Commitments and Contingencies: Product Liability Litigation” in ~~the~~LivaNova’s consolidated financial statements included in this ~~Annual Report on Form 10-K.~~Report.

Neuromodulation

~~Our~~LivaNova’s Neuromodulation segment is engaged in the design, development, manufacture, marketing and ~~marketing~~selling of devices that deliver neuromodulation therapy for treating ~~drug-resistant epilepsy (“DRE”)~~DRE and ~~difficult-to-treat depression (“DTD”).~~DTD. It is also ~~encompasses~~engaged in the development and management of clinical testing of ~~our~~LivaNova’s aura6000 System for treating ~~obstructive sleep apnea (“OSA”) and, until recently, our VITARIA System~~OSA. LivaNova’s Neuromodulation segment also includes costs associated with the Company’s former Heart Failure program, which ~~was intended to treat heart failure.~~the Company began winding down during the first quarter of 2023.

Epilepsy

~~We continue~~LivaNova continues to make ~~significant~~ investments in R&D focused on improving the ~~Vagus Nerve Stimulation~~VNS Therapy ~~(“VNS Therapy”)~~ System with an enhanced pulse generator, lead and programming software, and ~~we are~~LivaNova is developing new products that provide additional features and functionality. WeLivaNova also ~~support~~supports studies for ~~our~~the Company’s product development efforts and to build clinical evidence for the VNS Therapy System.

Peer reviewed evidence published in 2021 and 2022 continues to confirm the safety, efficacy and cost effectiveness of VNS Therapy in both the adult and pediatric patient population. In January 2022, the Journal of Neurology published a meta-analysis and systematic review that demonstrated benefits of VNS Therapy in adults with DRE that demonstrates that seizure frequency improves without an increase in the rate of serious adverse events or discontinuations. These data further support consideration of VNS Therapy for people who are not responding to ~~anti-seizure medications (“ASMs”)~~ASMs and those unsuitable or unwilling to undergo surgery.

Depression and Obstructive Sleep Apnea ~~and Heart Failure~~

A discussion of ~~LivaNova’s strategic portfolio initiatives, including~~ Depression and Obstructive Sleep Apnea ~~and Heart Failure,~~ are incorporated by reference to the sections titled ~~“Depression,”~~“Depression” and “Obstructive Sleep ~~Apnea” and “Heart Failure,~~Apnea,” respectively, included within “Part I., Item 1. Business” in this ~~Annual Report on Form 10-K.~~Report.

Advanced Circulatory Support

~~Our Advanced Circulatory Support (“ACS”)~~For the periods presented herein, LivaNova’s ACS segment iswas engaged in the design, development, ~~production~~manufacture, marketing and ~~sale~~selling of ~~leading-edge~~ temporary life support products. ~~Our ACS~~ACS’s products, which comprise the LifeSPARC ~~platform~~ and Hemolung systems, and standalone cannulae and accessories, including ProtekDuo ~~cannula,~~and transseptal (TandemHeart) cannulae, simplify temporary extracorporeal cardiopulmonary life support solutions for critically ill patients.

On January 5, 2024, the Board of Directors of LivaNova PLC approved the 2024 Restructuring Plan to enhance the Company’s focus on its core Cardiopulmonary and Neuromodulation segments. The ~~LifeSPARC platform includes a common compact console~~main component of this plan is to wind down the ACS segment, which the Company anticipates will be substantially complete by the end of 2024. LivaNova recognized restructuring expense under the 2024 Restructuring Plan of $0.1 million in other operating expenses, and ~~pump~~$12.6 million for inventory obsolescence in cost of sales on its consolidated statements of income (loss) during the year ended December 31, 2023. Additionally, the Company determined that ~~provides temporary support for emergent rescue patients in a variety of settings. Designed for ease of use,~~it was more likely than not that 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. In November 2022,carrying amounts associated with the ~~FDA approved our LifeSPARC platform for extracorporeal membrane oxygenation (“ECMO”).~~ACS segment, including the long-lived assets (asset group), may not be recoverable. This ~~approval allows for our LifeSPARC platform~~was determined to be ~~used for ECMO beyond six hours for patients in acute respiratory failure or acute cardiopulmonary failure, including but not limited to those receiving treatment for COVID-19.~~a triggering event

3336

Weoccurring in the fourth quarter of 2023 requiring an impairment assessment, based on certain factors, including the results of an updated long-term financial outlook for the ACS segment. As such, LivaNova recorded impairments of the following long-lived assets during the year ended December 31, 2023, included within impairment of long-lived assets on its consolidated statements of income (loss) (in thousands):


	2023
Intangible assets:
Developed technology	$	78,067
Trade names	7,117
Property, plant and equipment	3,894
Operating lease assets	896
Total impairment of long-lived assets	$	89,974

In connection with the 2024 Restructuring Plan, LivaNova expects to incur pre-tax restructuring charges in the range of approximately $15 million to $20 million. The anticipated charges are comprised of approximately $10 million to $12 million in severance expenses and retention bonuses and approximately $5 million to $8 million in other expenses, including lease termination, facilities remediation, and asset disposal expenses. LivaNova expects the majority of the severance expenses to be incurred in the first half of 2024. Retention bonuses will be earned over the period of service, which is expected to be over the full year of 2024. All future cash payments related to these restructuring charges are expected to be paid out during 2024. These estimates are subject to change.

During the first quarter of 2024, the Company reorganized its operating and reporting structure upon initiating the 2024 Restructuring Plan and transitioned all ACS standalone cannulae and accessories, including ProtekDuo and transseptal (TandemHeart) cannulae, into its Cardiopulmonary segment. Operations for other ACS products, including LifeSPARC and Hemolung systems, will be discontinued by the end of 2024.

LivaNova previously owned a 3% equity interest in ALung, ~~Technologies, Inc. (“ALung”),~~ a privately-held medical device company focused on creating advanced medical devices for treating respiratory failure. In May 2022, weLivaNova acquired the remaining 97% of equity interests 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~~LivaNova’s existing ACS business, the assets acquired, including goodwill, ~~are~~were recognized in ~~our~~the Company’s ACS segment. ~~The goodwill for the ACS reporting unit was fully impaired during the third quarter of 2022.~~ The fair value of the contingent consideration liability as of May 2, 2022, the acquisition date, and December 31, ~~2022~~2023 was $16.8 million and ~~$15.9~~$13.8 million, respectively. Goodwill recorded in the ACS reporting unit was fully impaired during the third quarter of 2022 in connection with a revised estimate of the reporting unit’s fair value.

For additional information, please refer to “Note 4. Business ~~Combinations”~~Combinations,” “Note 6. Restructuring” and “Note 8.7. Goodwill and Intangible Assets” in ~~our~~LivaNova’s consolidated financial statements ~~and accompanying notes beginning on page F-1 of~~included in this Annual Report on Form 10-K. As a result of the ALung transaction, our ACS segment also includes the Hemolung Respiratory Assist System (“Hemolung RAS”), which is the only FDA-cleared platform designed specifically for low-flow extracorporeal carbon dioxide removal for acute respiratory failure.

In August 2022, the Centers for Medicare & Medicaid Services (“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.

~~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-owned and controlled by funds advised by Gyrus Capital S.A., a Swiss private equity firm. The Purchase Agreement provided 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 LSM at the Company’s Saluggia campus for $64.1 million. On April 9, 2021, LivaNova and the Purchaser entered into an Amended & 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 sale of the Heart Valve business closed on June 1, 2021. We received $45.5 million in 2021 and the remaining deferred purchase price of $9.5 million in 2022. Also, in 2022, we made a $4.8 million payment to Mitral upon finalizing the trade working capital and net indebtedness adjustments. During the year ended December 31, 2021, we recognized a loss from the sale of the Heart Valve business of $1.9 million, which is included within other operating expenses on the consolidated statements of income (loss).

Report.

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Results of Operations

The following table summarizes ~~our~~LivaNova’s consolidated results for the years ended December 31, 2023, 2022 ~~2021~~ and ~~2020~~2021 (in thousands):




		2022		2021		2020
Net revenue	Net revenue	$	1,021,805	$	1,035,365	$	934,241
Net revenue
Net revenue
Cost of sales
Cost of sales
Cost of sales	Cost of sales	314,577		329,371		339,478
Gross profit	Gross profit	707,228		705,994		594,763
Gross profit
Gross profit
Operating expenses:
Operating expenses:
Operating expenses:	Operating expenses:
Selling, general and administrative	Selling, general and administrative	469,243		471,904		446,561
Selling, general and administrative
Selling, general and administrative
Research and development	Research and development	155,805		183,414		152,902
Impairment of disposal group		—		—		180,160
Research and development
Research and development

Impairment of goodwill	Impairment of goodwill	129,396		—		21,269

Impairment of goodwill

Impairment of goodwill
Impairment of long-lived assets
Impairment of long-lived assets
Impairment of long-lived assets
Other operating expenses	Other operating expenses	29,536		51,460		67,770
Operating loss from continuing operations		(76,752)		(784)		(273,899)
Other operating expenses
Other operating expenses
Operating loss
Operating loss
Operating loss
Interest expense
Interest expense
Interest expense	Interest expense	(48,250)		(50,151)		(40,837)
Loss on debt extinguishment	Loss on debt extinguishment	—		(60,238)		(1,407)
Loss on debt extinguishment
Loss on debt extinguishment
Foreign exchange and other income/(expense)	Foreign exchange and other income/(expense)	49,860		(13,299)		(31,879)
Loss from continuing operations before tax		(75,142)		(124,472)		(348,022)
Income tax expense (benefit)		11,051		11,198		(960)
Foreign exchange and other income/(expense)
Foreign exchange and other income/(expense)
Loss before tax
Loss before tax
Loss before tax
Income tax (benefit) expense
Income tax (benefit) expense
Income tax (benefit) expense
Losses from equity method investments	Losses from equity method investments	(53)		(148)		(264)
Net loss from continuing operations		(86,246)		(135,818)		(347,326)
Net loss from discontinued operations, net of tax		—		—		(1,493)
Net loss		$	(86,246)	$	(135,818)	$	(348,819)
Losses from equity method investments
Losses from equity method investments
Net income (loss)
Net income (loss)
Net income (loss)

Net Revenue by Segment and Geographic Area:

The following table presents net revenue by operating segment and geographic region for the years ended December 31, 2023, 2022 ~~2021~~ and ~~2020~~2021 (in thousands, except for percentages):

(1)Includes countries in Europe where ~~we have~~the Company has a direct sales presence. Countries where sales are made through distributors are included in “Rest of World.”

(2)Other revenue primarily includes rental income not allocated to segments. For the ~~years~~year ended December 31, 2021, ~~and 2020, Other primarily~~other revenue also includes the net revenue of the Company’s Heart Valve business, which was divested on June 1, 2021.

The following table presents segment ~~(loss)~~ income ~~from continuing operations~~ for the years ended December 31, 2023, 2022 ~~2021~~ and ~~2020~~2021 (in thousands):

Total reportable segment (loss) income from continuing operations (3)

(1)Other includes corporate shared service expenses for finance, legal, human resources, information technology and corporate business development. For the years ended December 31, 2021 and 2020, Other also includes the results of the Company’s Heart Valve business, which was divested on June 1, 2021.

~~(2)~~Results for the year ended December 31, 2020 include $180.2 million and $21.3 million in impairments of the Heart Valves disposal group and allocated goodwill, respectively. Additionally, the results for the year ended December 31, 2020 include a $42.2 million decommissioning provision at our Saluggia site. Refer to “Note 5. Divestiture of Heart Valve Business” and “Note 14. Commitments and Contingencies,” respectively, in our consolidated financial statements and accompanying notes, beginning on page F-1 of this Annual Report on Form 10-K for additional information.

~~(3)~~For a reconciliation of segment ~~(loss)~~ income ~~from continuing operations~~ to ~~our~~ consolidated loss ~~from continuing operations~~ before tax, refer to “Note ~~20.~~19. Geographic and Segment Information” in ~~our~~LivaNova’s consolidated financial statements ~~and accompanying notes, beginning on page F-1 of~~included in this ~~Annual Report on Form 10-K.~~Report.

NM Indicates that variance as a percentage is not meaningful.

Cardiopulmonary net revenue for the year ended December 31, ~~2022,~~2023 increased ~~3.6%~~17.7% to ~~$500.3~~$589.0 million compared to the year ended December 31, ~~2021, primarily due to~~2022 with growth ~~in the U.S. and Rest of World regions. This growth was primarily~~across all regions, driven by ~~oxygenators due to an increase in cardiac surgery procedures~~increased HLM sales, including from Essenz Perfusion System installations, and ~~strength in heart-lung machine placements in the Rest of World region. These increases were partially offset by unfavorable foreign currency fluctuations of approximately $33.5 million.~~strong oxygenator demand.

Cardiopulmonary segment income for the year ended December 31, ~~2022,~~2023 was ~~$11.2~~$20.0 million, compared to segment ~~loss~~income of ~~$6.4~~$11.2 million for the year ended December 31, ~~2021.~~2022. The increase in segment income was primarily due to ~~a decrease in~~ the ~~litigation provision and legal costs related to our 3T Heater-Cooler device totaling $16.8 million, as well as an~~ increase in net revenue, as ~~discussed~~described above, partially offset by an increase in ~~SG&A expenses.~~

~~Cardiopulmonary net revenue for~~sales and marketing expense associated with the year ended December 31, 2021, compared to the year ended December 31, 2020, increased 8.1% to $483.0 million primarily due to growth in oxygenator sales resulting from an increase in procedure volumes, across all regions, growth in HLM sales in the U.S. region,launch of Essenz, as well as ~~the favorable impact of foreign currency fluctuations, partially offset by~~ a ~~reduction in capital equipment purchases in the Rest of World region.~~

~~Cardiopulmonary segment loss for the year ended December 31, 2021, was $6.4~~$12.7 million ~~compared to segment income for the year ended December 31, 2020, of $35.7 million. The decrease in segment income was primarily due to an~~ increase in the litigation provision related to ~~our~~LivaNova’s 3T Heater-Cooler device and related legal costs of $37.8 million, as well as an increase in sales and marketing expenses due to lower 2020 commercial related variable and discretionary spending as a result of COVID-19 during the year ended December 31, 2020 and an increase in R&D expenses due to the upcoming launch of our next-generation HLM. These increases in expenses were partially offset by an increase in net revenue, as discussed above.device.

Neuromodulation net revenue for the year ended December 31, ~~2022,~~2023 increased ~~4.6%~~9.0% to ~~$477.0~~$519.7 million compared to the year ended December 31, ~~2021, primarily due to~~2022 with growth across all regions, ~~driven by~~including new and replacement implants ~~as well as improving market dynamics, partially offset by unfavorable foreign currency fluctuations of approximately $9.7 million.~~in the US region.

Neuromodulation segment income for the year ended December 31, ~~2022,~~2023 was ~~$172.8~~$153.4 million compared to ~~$169.5~~$172.8 million for the year ended December 31, ~~2021.~~2022. The ~~increase~~decrease in segment income was primarily due to ~~an increase in~~a $29.0 million net ~~revenue, as discussed above, as well as the net favorable impact of the~~unfavorable change in fair value of the sales-based and milestone-based contingent consideration arrangement associated with the acquisition of ImThera, of $13.8 million. The increase in segment income was partially offset by increases in R&D expenses for the year ended December 31, 2022 compared to the year ended December 31, 2021 totaling $13.8 million associated with the Company’s RECOVER study and ANTHEM-HFrEF and Obstructive Sleep Apnea using Targeted Hypoglossal Neurostimulation (“OSPREY”) clinical trials, as well as an increase in SG&A ~~expenses.~~

~~Neuromodulation net revenue for the year ended December 31, 2021, compared to the year ended December 31, 2020, increased 28.7% to $456.2~~expense of $16.3 million ~~primarily due to improving market dynamics across all regions resulting from increased hospital access and patient willingness to return to clinics.~~

Neuromodulation segment income increased 55.1% for the year ended December 31, 2021, compared to the year ended December 31, 2020, primarily from an increase in net revenue, as discussed above. This increase was partially offsetdriven by ~~the net impact of the change in fair value of the sales-based and milestone-based contingent consideration arrangement associated with the acquisition of ImThera of $21.5 million, as well as~~ an increase in sales and marketing ~~expenses due to lower 2020 commercial related variable and discretionary spending as a result of COVID-19 during the year ended December 31, 2020~~expense, and an increase in R&D ~~expenses due to our DTD~~expense of $12.5 million primarily associated with the Company’s RECOVER clinical study and ~~heart failure~~OSPREY clinical ~~trials.~~

trial. These increases in expense were partially offset by the increase in net revenue, as described above.

Advanced Circulatory Support

ACS net revenue for the year ended December 31, ~~2022, decreased 29.1%~~2023 increased 2.6% to ~~$39.3~~$40.3 million compared to the year ended December 31, ~~2021, primarily due to a reduction~~2022 driven by an increase in ~~patients treated with ECMO related to fewer severe COVID-19 cases, product mix and hospital-related challenges, partially offset by growth in non-COVID-19 cases.~~case volumes.

ACS segment loss for the year ended December 31, ~~2022,~~2023 was ~~$142.6~~$117.4 million compared to ~~segment income of $2.2~~$142.6 million for the year ended December 31, ~~2021. Segment~~2022. The decrease in segment loss was ~~predominantly attributed~~primarily due to the goodwill impairment of ~~the goodwill associated with our ACS segment of~~ $129.4 ~~million. For additional information, please refer to “Note 8. Goodwill and Intangible Assets”~~million recorded in the ~~consolidated financial statements~~year ended December 31, 2022 in ~~this Annual Report on Form 10-K. Segment loss was also negatively impacted by~~connection with a revised estimate of the ~~declines in net revenue, as discussed above. These negative impacts were~~segment’s fair value, partially offset by the ~~net favorable impact~~impairment of long-lived assets of $90.0 million and the inventory obsolescence adjustment of $12.6 million recorded in the year ended December 31, 2023 associated with the wind down of the ACS segment, along with the favorable change in fair value of a regulatory milestone-based contingent consideration arrangement associated with the TandemLife acquisition of ~~$14.3~~$11.6 million.

~~ACS net revenue for the year ended December 31, 2021, compared~~ For additional information, please refer to ~~the year ended December 31, 2020, increased 31.0% to $55.5 million, resulting from continued adoption~~“Note 6. Restructuring,” “Note 7. Goodwill and ~~utilization of LifeSPARC~~Intangible Assets” and “Note 9. Fair Value Measurements” in ~~the U.S. and an increase~~LivaNova’s consolidated financial statements included in ~~procedure volumes.~~

ACS segment income increased 481.7% for the year ended December 31, 2021, compared to the year ended December 31, 2020, primarily from an increase in sales, as discussed above. This increase was partially offset by an increase in sales and marketing expenses due to lower commercial related variable and discretionary spending as a result of COVID-19 during the year ended December 31, 2020.this Report.

The following table presents costs and expenses as a percentage of net revenue for the years ended December 31, 2023, 2022 ~~2021~~ and ~~2020:~~2021:

Cost of sales ~~consisted~~consists primarily of direct labor, allocated manufacturing overhead, and the acquisition cost of raw materials, and components.

Cost of sales as a percentage of net revenue was ~~30.8%~~33.1% for the year ended December 31, ~~2022, a decrease~~2023, an increase of ~~1.0%~~2.3 percentage points compared to the year ended December 31, ~~2021.~~2022. The ~~decrease~~increase was primarily due to ~~favorable product mix, partially resulting from the sale of the Company’s Heart Valve business during the second quarter of 2021, as well as~~ the net impact of the change in fair value of sales-based contingent consideration ~~arrangements. These decreases in cost~~arrangements totaling $14.2 million as well as an inventory obsolescence adjustment of ~~sales were partially offset by increased costs driven by supply chain delays and interruptions, labor shortages, inflationary pressures and logistical issues in the wake of COVID-19.~~

Cost of sales as a percentage of net revenue was 31.8% for the year ended December 31, 2021, a decrease of 4.5% compared to the year ended December 31, 2020. The decrease was primarily due to favorable product mix, partially due to the sale of the Heart Valve business during the second quarter of 2021, unfavorable manufacturing variances$12.6 million during the year ended December 31, ~~2020, as well as a decline in product remediation expenses~~2023 associated with ~~our 3T Heater-Cooler device~~the wind down of $7.0 million. These decreases were partially offset by the net impact of the change in fair value of a sales-based contingent consideration arrangement of $4.5 million for the year ended December 31, 2021 compared to the year ended December 31, 2020.LivaNova’s ACS segment.

~~Selling, General and Administrative (“~~SG~~&A”) Expenses~~&A

SG&A expenses are comprised of sales, marketing, general and administrative activities.

SG&A expenses as a percentage of net revenue was ~~45.9%~~44.9% for the year ended December 31, ~~2022, an increase~~2023, a decrease of ~~0.3%~~1.0 percentage points compared to the year ended December 31, ~~2021,~~2022, primarily due to ~~increased~~lower stock-based compensation expense of $6.2 million in 2023, driven by the forfeiture of share-based awards associated with the departure of the Company’s former CEO, as well as recovery of legal costs ~~resulting from inflationary pressures~~associated with the Caisson litigation of $3.0 million in 2023. For additional information, please refer to “Note 13. Commitments and ~~logistical issues,~~Contingencies” in LivaNova’s consolidated financial statements included in this Report. These decreases were partially offset by ~~foreign currency fluctuations.~~the $2.6 million increase in costs associated with the previously mentioned November 2023 cybersecurity incident.

SG&A expenses as a percentage of net revenue decreased for the year ended December 31, 2021, compared to the year ended December 31, 2020, primarily due to an increase in sales which resulted in favorable operating leverage, partially offset by an increase in sales and marketing expenses due to lower commercial related variable and discretionary spending as a result of COVID-19 during the year ended December 31, 2020.

~~Research and Development~~R&D Expenses

R&D expenses consist of product design and development efforts, clinical study programs and regulatory ~~activities, which are essential to our strategic portfolio initiatives, including DTD, OSA and, until recently, heart failure.~~activities.

R&D expenses as a percentage of net revenue was ~~15.2%~~16.8% for the year ended December 31, ~~2022, a decrease~~2023, an increase of ~~2.5%~~1.6 percentage points compared to the year ended December 31, ~~2021.~~2022. The ~~decrease~~increase was primarily due to ~~a decrease in R&D expense resulting from~~ the net ~~impact of changes~~unfavorable change in the fair value of milestone-based contingent consideration arrangements ~~of $28.5 million. The aforementioned decrease in R&D expense was partially offset by increases~~totaling $27.8 million, as well as increased expenses associated with the Company’s RECOVER clinical study ~~and ANTHEM-HFrEF~~ and OSPREY clinical ~~trials~~trial totaling ~~$13.8~~$12.4 million.


	PART I	PAGE NO.
Item 1.	Business	48
Item 1A.	Risk Factors	1618
Item 1B.	Unresolved Staff Comments	3031
Item 1C.	Cybersecurity	31
Item 2.	Properties	3033
Item 3.	Legal Proceedings	3033
Item 4.	Mine Safety Disclosures	3033
	PART II
Item 5.	Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities	3134
Item 6.	[Reserved]	3134
Item 7.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	3235
Item 7A.	Quantitative and Qualitative Disclosures About Market Risk	4749
Item 8.	Financial Statements and Supplementary Data	4749
Item 9.	Changes in and Disagreements with Accountants on Accounting and Financial Disclosure	4749
Item 9A.	Controls and Procedures	4749
Item 9B.	Other Information	4749
Item 9C.	Disclosure Regarding Foreign Jurisdictions that Prevent Inspections	49
	PART III
Item 10.	Directors, Executive Officers and Corporate Governance	4850
Item 11.	Executive Compensation	4850
Item 12.	Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters	4850
Item 13.	Certain Relationships and Related Transactions, and Director Independence	4850
Item 14.	Principal Accounting Fees and Services	4850
	PART IV
Item 15.	Exhibits and Financial Statement Schedules	4951
Item 16.	Form 10-K Summary	5554


										% Change
			2022		2021		2020			2022 vs 2021		2021 vs 2020
									% Change																																															% Change
		2023																				2023									2022							2021								2023 vs 2022								2022 vs 2021
Cardiopulmonary	Cardiopulmonary
United States
United States
United States	United States		$	159,489	$	154,073	$	132,543		3.5	%	16.2	%		$	188,299			$			$	159,489			$					$	154,073			18.1				18.1		%						3.5		%
Europe (1)	Europe (1)		127,064		134,562		122,062			(5.6)	%	10.2	%	Europe (1)			156,606			127,064					127,064				134,562						134,562		23.2						23.2	%							(5.6)	%
Rest of World	Rest of World		213,761		194,344		192,127			10.0	%	1.2	%	Rest of World			244,072			213,761					213,761				194,344						194,344		14.2						14.2	%							10.0	%
			500,314		482,979		446,732			3.6	%	8.1	%
		588,977																			588,977									500,314							482,979								17.7		%						3.6		%
Neuromodulation	Neuromodulation
United States
United States
United States	United States		374,542		358,476		282,509			4.5	%	26.9	%		407,493				374,542				374,542				358,476						358,476			8.8					8.8		%						4.5		%
Europe (1)	Europe (1)		50,291		51,435		39,019			(2.2)	%	31.8	%	Europe (1)			57,435			50,291					50,291				51,435						51,435		14.2						14.2	%							(2.2)	%
Rest of World	Rest of World		52,160		46,261		32,916			12.8	%	40.5	%	Rest of World			54,782			52,160					52,160				46,261						46,261		5.0						5.0	%							12.8	%
			476,993		456,172		354,444			4.6	%	28.7	%
		519,710																			519,710									476,993							456,172								9.0		%						4.6		%
Advanced Circulatory Support	Advanced Circulatory Support
United States
United States
United States	United States		37,527		53,821		41,094			(30.3)	%	31.0	%		39,252				37,527				37,527				53,821						53,821			4.6					4.6		%						(30.3)		%
Europe (1)	Europe (1)		1,447		1,120		1,027			29.2	%	9.1	%	Europe (1)			751			1,447					1,447				1,120						1,120		(48.1)						(48.1)	%							29.2	%
Rest of World	Rest of World		327		518		200			(36.9)	%	159.0	%	Rest of World			319			327					327				518						518		(2.4)						(2.4)	%							(36.9)	%
			39,301		55,459		42,321			(29.1)	%	31.0	%
Other (2)
		40,322																			40,322									39,301							55,459								2.6		%						(29.1)		%
Other Revenue (2)														Other Revenue (2)			4,536							5,197									40,755							(12.7)		%						(87.2)		%
Totals
United States	United States		—		4,929		12,488			(100.0)	%	(60.5)	%
Europe (1)			—		14,407		31,259			(100.0)	%	(53.9)	%
Rest of World			5,197		21,419		46,997			(75.7)	%	(54.4)	%
			5,197		40,755		90,744			(87.2)	%	(55.1)	%
Totals
United States
United States	United States		571,558		571,299		468,634			—	%	21.9	%		635,044				571,558				571,558				571,299						571,299			11.1					11.1		%						0.0		%
Europe (1)	Europe (1)		178,802		201,524		193,367			(11.3)	%	4.2	%	Europe (1)			214,792			178,802					178,802				201,524						201,524		20.1						20.1	%							(11.3)	%
Rest of World	Rest of World		271,445		262,542		272,240			3.4	%	(3.6)	%	Rest of World			303,709			271,445					271,445				262,542						262,542		11.9						11.9	%							3.4	%
Total	Total		$	1,021,805	$	1,035,365	$	934,241		(1.3)	%	10.8	%	Total			$	1,153,545		$				$	1,021,805			$					$	1,035,365		12.9					12.9		%						(1.3)		%


										% Change
			2022		2021		2020			2022 vs 2021		2021 vs 2020
									% Change																																	% Change
		2023																2023					2022						2021						2023 vs 2022						2022 vs 2021
Cardiopulmonary	Cardiopulmonary		$	11,247	$	(6,429)	$	35,735		(274.9)	%	(118.0)	%	Cardiopulmonary	$	20,004	$		$	11,247	$			$	(6,429)		77.9				77.9		%				NM
Neuromodulation	Neuromodulation		172,775		169,499		109,273			1.9	%	55.1	%	Neuromodulation	153,384		172,775			172,775		169,499				169,499		(11.2)					(11.2)	%					1.9	%
Advanced Circulatory Support	Advanced Circulatory Support		(142,590)		2,195		(575)			(6596.1)	%	(481.7)	%	Advanced Circulatory Support	(117,418)		(142,590)			(142,590)		2,195				2,195		NM									NM
Other (1) (2)			(85,249)		(129,082)		(365,116)			(34.0)	%	(64.6)	%
Total reportable segment (loss) income from continuing operations (3)			$	(43,817)	$	36,183	$	(220,683)		(221.1)	%	(116.4)	%

Segment income (1)
Segment income (1)
Segment income (1)															$	55,970			$	41,432				$	165,265					35.1		%				(74.9)		%


			2022		2021
Short-term Liquidity
		2023					2023	2022
Available Short-term Liquidity
Cash and cash equivalents
Cash and cash equivalents
Cash and cash equivalents	Cash and cash equivalents		$	214,172	$	207,992
Availability under the 2021 First Lien Credit Agreement	Availability under the 2021 First Lien Credit Agreement		125,000		125,000
Availability under the Delayed Draw Term Facility			50,000		—
			$	389,172	$	332,992
Availability under the Delayed Draw Term Facility (1)
		$

Working Capital	Working Capital
Working Capital
Working Capital
Current assets
Current assets
Current assets	Current assets		$	886,136	$	679,181
Current liabilities	Current liabilities		297,398		696,970
			$	588,738	$	(17,789)
		$

Debt Obligations	Debt Obligations
Debt Obligations
Debt Obligations
Current portion of long-term debt
Current portion of long-term debt
Current portion of long-term debt	Current portion of long-term debt		$	20,892	$	226,946
Short-term unsecured borrowing arrangements	Short-term unsecured borrowing arrangements		2,542		2,727
Current debt obligations	Current debt obligations		23,434		229,673
Long-term debt obligations	Long-term debt obligations		518,067		9,849
Total debt obligations	Total debt obligations		$	541,501	$	239,522


			2022		2021		2020
		2023							2023	2022	2021
Operating activities	Operating activities		$	69,921	$	102,544	$	(79,422)
Investing activities	Investing activities		(38,414)		36,904		(41,844)
Financing activities	Financing activities		280,130		(181,483)		310,756
Effect of exchange rate changes on cash and cash equivalents	Effect of exchange rate changes on cash and cash equivalents		(4,011)		(2,805)		2,205
Net increase (decrease)	Net increase (decrease)		$	307,626	$	(44,840)	$	191,695


Description			Page No.
Report of Independent Registered Public Accounting Firm (PCAOB ID: 238)			F-1
Consolidated Statements of Income (Loss) for the Years Ended December 31, ~~2022,~~2023, December 31, ~~2021~~2022 and December 31, ~~2020~~2021			F-2
Consolidated Statements of Comprehensive Income (Loss) for the Years Ended December 31, ~~2022,~~2023, December 31, ~~2021~~2022 and December 31, ~~2020~~2021			F-3
Consolidated Balance Sheets as of December 31, ~~2022~~2023 and December 31, ~~2021~~2022			F-4
Consolidated Statements of Stockholders’ Equity for the Years Ended December 31, ~~2022,~~2023, December 31, ~~2021~~2022 and December 31, ~~2020~~2021			F-5
Consolidated Statements of Cash Flows for the Years Ended December 31, ~~2022,~~2023, December 31, ~~2021~~2022 and December 31, ~~2020~~2021			F-6
Notes to Consolidated Financial Statements			F-7


Exhibit Number			Document Description
2.1			Share and Asset Purchase Agreement, dated as of December 2, 2020, by and between LivaNova PLC and Mitral Holdco S.à.r.l., incorporated by reference to Exhibit 2.1 of the ~~Company's~~Company’s Current Report on Form 8-K, filed on December 3, 2020
2.2			Amended and Restated Share and Asset Purchase Agreement, dated as of April 9, 2021, by and between LivaNova PLC and Mitral Holdco S.à.r.l., incorporated by reference to Exhibit 2.1 of the Company’s Current Report on Form 8-K, filed on April 15, 2021
3.1			Amended Articles of Association, incorporated by reference to Exhibit 3.1 of the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2020
4.1*			Description of Securities Registered Under Section 12 of the Securities Exchange Act of 1934, as amended
4.2			Indenture, dated as of June 17, 2020, among LivaNova USA, Inc., as Issuer, LivaNova PLC, as Guarantor, and Citibank, N.A., as Trustee, incorporated by reference to Exhibit 4.1 of the ~~Company's~~Company’s current Report on Form 8-K, filed on June 17, 2020
4.3			Form of 3.00% Cash Exchangeable Senior Notes due 2025 (included in Exhibit 4.1 of the ~~Company's~~Company’s current Report on Form 8-K, filed on June 17, 2020)
10.1†			Form of Deed of Indemnification (Directors), each effective October 19, 2015, incorporated by reference to Exhibit 10.3 of the Company’s Current Report on Form 8-K, filed on October 19, 2015
10.2†			Form of Deed of Indemnification (Officers), each effective October 19, 2015, incorporated by reference to Exhibit 10.4 of the Company’s Current Report on Form 8-K, filed on October 19, 2015
10.3†			2015 Incentive Award Plan and related Sub-Plan for ~~U.K.~~UK Participants, adopted on October 16, 2015, incorporated by reference to Exhibit 10.1 of the Company’s Current Report on Form 8-K, filed on October 19, 2015
10.4†			Cyberonics, Inc. 2009 Stock Plan, as amended, incorporated by reference to Appendix A to Cyberonics, Inc.’s Proxy Statement on Schedule 14A, filed on August 2, 2012
10.5†			Amended and Restated Cyberonics, Inc. New Employee Equity Inducement Plan, as amended, incorporated by reference to Exhibit 10.3 of Cyberonics, Inc.’s Quarterly Report on Form 10-Q for the fiscal quarter ended October 24, 2008


~~10.6*†~~10.6†			Form of Stock Option Award Notification and Agreement under the Cyberonics, Inc. 2009 Stock Plan, as amended, incorporated by reference to Exhibit 10.6 of the Company’s Annual Report on Form 10-K for the year ended December 31, 2022
10.7†			CEO Employment Agreement effective January 1, 2017 between the Company and Damien McDonald, incorporated by reference to Exhibit 10.2 of the Company’s Current Report on Form 8-K, filed on February 28, 2017
10.8†			Side Letter dated January 1, 2017 between the Company and Damien McDonald, incorporated by reference to Exhibit 10.3 of the Company’s Current Report on Form 8-K, filed on February 28, 2017


10.9†			~~Service~~Damien McDonald Settlement Agreement, ~~effective May 24, 2017, between the Company and Keyna Skeffington,~~dated April 14, 2023, incorporated by reference to Exhibit ~~10.6~~10.1 of the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, ~~2017~~2023
10.10†			~~Non-Employee Director Compensation Policy, adopted December 2017, incorporated by reference to Exhibit 10.74 of the Company’s Annual Report on Form 10-K for the year ended December 31, 2017~~
~~10.11†~~			Description of 2018 Long Term Incentive Plan, incorporated by reference to Exhibit 10.1 of the Company’s Current Report on Form 8-K, filed on March 16, 2018
~~10.12†~~10.11†			Form of 2018 Long Term Incentive Plan SAR Award Agreement, incorporated by reference to Exhibit 10.3 of the Company’s Current Report on Form 8-K, filed on March 16, 2018
~~10.13†~~			~~Form of 2018 Long Term Incentive Plan PSU Award Agreement (rTSR condition), incorporated by reference to Exhibit 10.4 of the Company’s Current Report on Form 8-K, filed on March 16, 2018~~
~~10.14†~~10.12†			General Provisions of the Company’s Global Employee Share Purchase Plan dated 12 June 2018, incorporated by reference to Exhibit 10.4 of the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2018
~~10.15†~~10.13†			Description of 2019 Long Term Incentive Plan approved March 29, 2019, incorporated by reference to Exhibit 10.1 of the Company’s Current Report on Form 8-K, filed on April 1, 2019
~~10.16†~~10.14†			Form of the Company’s 2019 Long Term Incentive Plan RSU Award Agreement, incorporated by reference to Exhibit 10.2 of the Company’s Current Report on Form 8-K, filed on April 1, 2019
~~10.17†~~10.15†			Form of the Company’s 2019 Long Term Incentive Plan SAR Award Agreement, incorporated by reference to Exhibit 10.3 of the Company’s Current Report on Form 8-K, filed on April 1, 2019
~~10.18†~~10.16†			Form of the Company’s 2019 Long Term Incentive Plan PSU Award Agreement (rTSR condition), incorporated by reference to Exhibit 10.4 of the Company’s Current Report on Form 8-K, filed on April 1, 2019
~~10.19†~~10.17†			Form of the Company’s 2019 Long Term Incentive Plan PSU Award Agreement (FCF condition), incorporated by reference to Exhibit 10.5 of the Company’s Current Report on Form 8-K, filed on April 1, 2019
~~10.20†~~10.18†			Service Agreement, dated January 2, 2019, between Trui Hebbelinck and LivaNova PLC, incorporated by reference to Exhibit 10.1 of the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2019
~~10.21~~10.19			Form of Capped Call Confirmation incorporated by reference to Exhibit 10.1 of the ~~Company's~~Company’s Current Report on Form 8-K, filed on June 17, 2020
~~10.22†~~10.20†			Amendment to Outstanding 2019 and 2020 Restricted Stock Unit Awards under the LivaNova PLC 2015 Incentive Award Plan, dated June 15, 2020, incorporated by reference to Exhibit 10.10 of the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2020
~~10.23†~~10.21†			Amendment to Outstanding 2018 Restricted Stock Unit Awards under the LivaNova PLC 2015 Incentive Award Plan dated June 15, 2020, incorporated by reference to Exhibit 10.11 of the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2020
~~10.24†~~10.22†			Amendment to Outstanding 2018, 2019 and 2020 Performance Stock Unit Awards under the LivaNova PLC 2015 Incentive Award Plan, dated June 15, 2020, incorporated by reference to Exhibit 10.12 of the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2020
~~10.25†~~10.23†			Form of Long Term Incentive Plan Restricted Stock Unit Award Agreement, incorporated by reference to Exhibit 10.1 of the ~~Company's~~Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2020
~~10.26†~~10.24†			Form of Long Term Incentive Plan Performance Stock Unit Award Agreement, incorporated by reference to Exhibit 10.2 of the ~~Company's~~Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2020
~~10.27†~~10.25†			Form of Long Term Incentive Plan Stock Appreciation Right Award Agreement, incorporated by reference to Exhibit 10.3 of the ~~Company's~~Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2020
~~10.28†~~10.26†			Form of Director Restricted Stock Unit Award Grant Notice, dated June 2020 and Director Restricted Stock Unit Award Agreement under the Company’s 2015 Incentive Award Plan (Non-Employee Directors), incorporated by reference to Exhibit 10.42 of the Company’s Annual Report on Form 10-K for the year ended December 31, 2020
~~10.29†~~10.27†			Form of Non-Executive Director Appointment Letter incorporated by reference to Exhibit 10.43 of the Company’s Annual Report on Form 10-K for the year ended December 31, 2020
~~10.30†~~10.28†			Alex Shvartsburg offer of employment in the role of Vice President Strategy and Innovation, dated 21 September 2017 incorporated by reference to Exhibit 10.44 of the Company’s Annual Report on Form 10-K for the year ended December 31, 2020
~~10.31†~~10.29†			Alex Shvartsburg letter, dated January 2019, regarding compensation increase incorporated by reference to Exhibit 10.45 of the Company’s Annual Report on Form 10-K for the year ended December 31, 2020
~~10.32†~~10.30†			Alex Shvartsburg letter, dated October 2020, regarding additive compensation package for interim CFO position incorporated by reference to Exhibit 10.46 of the Company’s Annual Report on Form 10-K for the year ended December 31, 2020
~~10.33†~~10.31†			Service Agreement, effective August 1, 2021, between the Company and Alex Shvartsburg, incorporated by reference to Exhibit 10.1 of the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2021


~~10.34†~~10.32†			Letter, dated December 14, 2022, to Alex Shvartsburg regarding an increase in gross annual base salary, effective January 1, 2023, incorporated by reference to Exhibit 10.50 of the Company’s Annual Report on Form 10-K for the year ended December 31, 2022
10.33†			Marco Dolci Confirmation Letter, effective January 1, 2020, as SVP Global Operations & Global Research and Development, incorporated by reference to Exhibit 10.2 of the Company Quarterly Report on Form 10-Q for the quarter ended June 30, 2020


~~10.35†~~10.34†			Executive Employment Contract between Sorin Group Italia S.r.l. and Marco Dolci, effective April 20, 2017, incorporated by reference to Exhibit 10.1 of the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2021
~~10.36~~10.35†			~~Amended and Restated Share and Asset Purchase~~Marco Dolci Retirement Agreement, dated ~~as of April 9, 2021, by and between LivaNova PLC and Mitral Holdco S.à.r.l.,~~September 18, 2023 incorporated by reference to Exhibit ~~2.1~~10.1 of the Company’s ~~Current~~Quarterly Report on Form ~~8-K, filed on April 15, 2021~~10-Q for the quarter ended September 30, 2023
~~10.37~~10.36			First Lien Credit Agreement dated as of August 13, 2021 among LivaNova PLC, LivaNova USA, Inc., the lenders and issuing banks party thereto and Goldman Sachs Bank USA as First Lien Administrative Agent and First Lien Collateral Agent, incorporated by reference to Exhibit 10.1 of the Company’s Current Report on Form 8-K, filed on August 16, 2021
~~10.38~~10.37			Incremental Facility Amendment No. 1 to Credit Agreement, dated as of February 24, 2022, by and among LivaNova Plc, LivaNova USA, Inc., the lenders and issuing banks party thereto and Goldman Sachs Bank USA as First Lien Administrative Agent, incorporated by reference to Exhibit 10.51 of the Company’s Annual Report on Form 10-K ~~filed on March 1, 2022~~for the year ended December 31, 2021
~~10.39~~10.38			Letter of indemnity in respect of the issuance of Trade Finance guarantee by Barclays Bank Ireland PLC, Italy Branch dated March 18, 2022, by and among LivaNova PLC Italian Branch and Barclays Bank Ireland PLC, Italy Branch, incorporated by reference to Exhibit 10.1 of the ~~Company's~~Company’s Current Report on Form 8-K, filed on March 21, 2022
~~10.40~~10.39			Pledge Agreement dated as of March 18, 2022, among LivaNova PLC Italian Branch and Barclays Bank Ireland PLC, Italy Branch, incorporated by reference to Exhibit 10.2 of the ~~Company's~~Company’s Current Report on Form 8-K, filed on March 21, 2022
~~10.41~~10.40			Amendment 2 to the Credit Agreement, dated as of March 16, 2022, by and among LivaNova PLC, LivaNova USA, Inc., the Lenders and Goldman Sachs Bank USA as First Lien Administrative Agent, incorporated by reference to Exhibit 10.1 of the Company's Quarterly Report on Form 10-Q, filed on May 4, 2022
~~10.42~~10.41			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~~Company’s Current Report on Form 8-K, filed on July 6, 2022
~~10.43†~~10.42†			Amendment to the LivaNova Plc 2015 Incentive Award Plan, dated 13 June 2022, incorporated by reference to Exhibit 10.1 of the ~~Company's~~Company’s Quarterly Report on Form 10-Q, filed on August 3, 2022
~~10.44†~~			~~Retirement Agreement, dated 13 June 2022, between LivaNova Plc and Keyna Skeffington, incorporated by reference to Exhibit 10.2 of the Company's Quarterly Report on Form 10-Q, filed on August 3, 2022~~
~~10.45†~~10.43†			Form of LivaNova Plc 2022 Incentive Award Plan Stock Appreciation Right Grant Notice and Agreement, incorporated by reference to Exhibit 10.3 of the ~~Company's~~Company’s Quarterly Report on Form 10-Q, filed on August 3, 2022
~~10.46†~~10.44†			Form of LivaNova Plc 2022 Incentive Award Plan Restricted Stock Unit Award Grant Notice and Agreement, incorporated by reference to Exhibit 10.4 of the ~~Company's~~Company’s Quarterly Report on Form 10-Q, filed on August 3, 2022
~~10.47†~~10.45†			Form of LivaNova Plc 2022 Incentive Award Plan Performance Stock Unit Award Grant Notice and Agreement, incorporated by reference to Exhibit 10.5 of the ~~Company's~~Company’s Quarterly Report on Form 10-Q, filed on August 3, 2022
~~10.48†~~10.46†			Amendment to Outstanding 2021 and 2022 Performance Stock Unit Awards under the LivaNova PLC 2015 Incentive Award Plan, incorporated by reference to Exhibit 10.7 of the ~~Company's~~Company’s Quarterly Report on Form 10-Q, filed on August 3, 2022
~~10.49†~~10.47†			Amendment to relevant 2020, 2021, and 2022 Restricted Stock Unit Awards under the LivaNova PLC 2015 Incentive Award Plan, incorporated by reference to Exhibit 10.8 of the ~~Company's~~Company’s Quarterly Report on Form 10-Q, filed on August 3, 2022
~~10.50*†~~10.48†			~~Letter, dated December 14,~~Form of LivaNova PLC 2022 Incentive Award Plan Stock Appreciation Right Grant Notice and Agreement, effective February 2023, incorporated by reference to ~~Alex Shvartsburg regarding an increase in gross annual base salary, effective January 1,~~Exhibit 10.1 of the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2023
~~10.51*†~~10.49†			Form of LivaNova PLC 2022 Incentive Award Plan Restricted Stock Unit Award Grant Notice and Agreement, effective February 2023, incorporated by reference to Exhibit 10.2 of the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2023


10.50†			Form of LivaNova PLC 2022 Incentive Award Plan Performance Stock Unit Award Grant Notice and Agreement, effective February 2023, incorporated by reference to Exhibit 10.3 of the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2023
10.51†			Amendment to Form of LivaNova Plc 2022 Incentive Award Plan Stock Appreciation Right Grant Notice and Agreement, incorporated by reference to Exhibit 10.51 of the Company’s Annual Report on Form 10-K for the year ended December 31, 2022
~~10.52*†~~10.52†			Amendment to Form of LivaNova Plc 2022 Incentive Award Plan Restricted Stock Unit Award Grant Notice and Agreement, incorporated by reference to Exhibit 10.52 of the Company’s Annual Report on Form 10-K for the year ended December 31, 2022
~~10.53*†~~10.53†			Amendment to Form of LivaNova Plc 2022 Incentive Award Plan Performance Stock Unit Award Grant Notice and Agreement, incorporated by reference to Exhibit 10.53 of the Company’s Annual Report on Form 10-K for the year ended December 31, 2022
10.54†			Amended and Restated LivaNova PLC 2022 Incentive Award Plan, incorporated by reference to Exhibit 10.1 of the Company’s Current Report on Form 8-K, filed on June 16, 2023
10.55*†			Michael Hutchinson Employment Agreement, dated November 2, 2022
10.56†			William Kozy Offer Letter, dated April 19, 2023, incorporated by reference to Exhibit 10.26 of the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2023
21.1*			List of Subsidiaries of LivaNova PLC
23.1*			Consent of PricewaterhouseCoopers LLP
31.1*			Certification of the Chief Executive Officer of LivaNova PLC pursuant to Section 302 of the Sarbanes-Oxley Act of 2002


31.2*			Certification of the Chief Financial Officer of LivaNova PLC pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
32.1*			Certification of the Chief Executive Officer and of the Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
97.1*			LivaNova Incentive Clawback Policy, dated July 19, 2023
101*			Interactive Data Files Pursuant to Rule 405 of Regulation S-T formatted in Inline XBRL: (i) the Consolidated Statements of Income (Loss) for the years ended December 31, ~~2022,~~2023, December 31, ~~2021~~2022 and December 31, ~~2020,~~2021, (ii) the Consolidated Statements of Comprehensive Income (Loss) for the years ended December 31, ~~2022,~~2023, December 31, ~~2021~~2022 and December 31, ~~2020,~~2021, (iii) the Consolidated Balance Sheets as of December 31, ~~2022~~2023 and December 31, ~~2021,~~2022, (iv) the Consolidated Statements of Stockholders’ Equity for the years ended December 31, ~~2022,~~2023, December 31, ~~2021~~2022 and December 31, ~~2020,~~2021, (v) the Consolidated Statements of Cash Flows for the years ended December 31, ~~2022,~~2023, December 31, ~~2021~~2022 and December 31, ~~2020,~~2021, and (vi) the Notes to the Consolidated Financial Statements.
104*			Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101)


			~~LIVANOVA PLC~~

			~~By:~~			~~/s/ DAMIEN MCDONALD~~
						~~Damien McDonald~~
						~~Chief Executive Officer~~
						~~(Principal Executive Officer)~~


			~~LIVANOVA PLC~~

			~~By:~~			~~/s/ ALEX SHVARTSBURG~~
						~~Alex Shvartsburg~~
						~~Chief Financial Officer~~
						~~(Principal Accounting and Financial Officer)~~


	Initial Fair Value of Consideration		Measurement Period Adjustments (1)		Adjusted Fair Value of Consideration
Cash and other considerations	$	15,586	$	—	$	15,586
Contingent consideration	26,369		(9,578)		16,791
Fair value of consideration transferred	$	41,955	$	(9,578)	$	32,377


	Initial Purchase Price Allocation		Measurement Period Adjustments (1)		Adjusted Purchase Price Allocation
Developed technology - 15-year life	$	13,950	$	(11,050)	$	2,900
Goodwill	25,893		977		26,870
Other assets and liabilities, net	2,112		495		2,607
Net assets acquired	$	41,955	$	(9,578)	$	32,377


			LIVANOVA PLC

			By:			/s/ WILLIAM A. KOZY
						William A. Kozy
						Interim Chief Executive Officer and Chair of the Board of Directors
						(Principal Executive Officer)


			LIVANOVA PLC

			By:			/s/ ALEX SHVARTSBURG
						Alex Shvartsburg
						Chief Financial Officer
						(Principal Accounting and Financial Officer)


	Year Ended December 31,
	2022		2021		2020
Net revenue	$	1,021,805	$	1,035,365	$	934,241
Cost of sales	314,577		329,371		339,478
Gross profit	707,228		705,994		594,763
Operating expenses:
Selling, general & administrative	469,243		471,904		446,561
Research and development	155,805		183,414		152,902
Impairment of disposal group	—		—		180,160
Impairment of goodwill	129,396		—		21,269
Other operating expenses	29,536		51,460		67,770
Operating loss from continuing operations	(76,752)		(784)		(273,899)
Interest expense	(48,250)		(50,151)		(40,837)
Loss on debt extinguishment	—		(60,238)		(1,407)
Foreign exchange and other income/(expense)	49,860		(13,299)		(31,879)
Loss from continuing operations before tax	(75,142)		(124,472)		(348,022)
Income tax expense (benefit)	11,051		11,198		(960)
Losses from equity method investments	(53)		(148)		(264)
Net loss from continuing operations	(86,246)		(135,818)		(347,326)
Net loss from discontinued operations, net of tax	—		—		(1,493)
Net loss	$	(86,246)	$	(135,818)	$	(348,819)

Basic net loss per share:
Continuing operations	$	(1.61)	$	(2.68)	$	(7.15)
Discontinued operations	—		—		(0.03)
	$	(1.61)	$	(2.68)	$	(7.18)

Diluted net loss per share:
Continuing operations	$	(1.61)	$	(2.68)	$	(7.15)
Discontinued operations	—		—		(0.03)
	$	(1.61)	$	(2.68)	$	(7.18)

Weighted average shares used in computing net loss per share:
Basic	53,472		50,633		48,592
Diluted	53,472		50,633		48,592


ASSETS	ASSETS	2022		2021		ASSETS	2023	2022
Current Assets:	Current Assets:
Cash and cash equivalents	Cash and cash equivalents	$	214,172	$	207,992
Cash and cash equivalents
Cash and cash equivalents
Restricted cash	Restricted cash	301,446		—
Accounts receivable, net of allowance of $11,862 at December 31, 2022 and $13,512 at December 31, 2021		183,110		185,354
Accounts receivable, net of allowance of $12,019 at December 31, 2023 and $11,862 at December 31, 2022
Inventories	Inventories	129,379		105,840
Prepaid and refundable taxes	Prepaid and refundable taxes	31,708		37,621

Current derivative assets		1,333		106,629

Prepaid expenses and other current assets

Prepaid expenses and other current assets

Prepaid expenses and other current assets	Prepaid expenses and other current assets	24,988		35,745
Total Current Assets	Total Current Assets	886,136		679,181
Property, plant and equipment, net	Property, plant and equipment, net	147,187		150,066
Goodwill	Goodwill	768,787		899,525
Intangible assets, net	Intangible assets, net	368,559		399,682
Operating lease assets	Operating lease assets	35,830		40,600
Investments	Investments	16,266		16,598
Deferred tax assets	Deferred tax assets	1,384		2,197
Long-term derivative assets	Long-term derivative assets	54,393		—
Other assets	Other assets	16,231		13,102
Total Assets	Total Assets	$	2,294,773	$	2,200,951
LIABILITIES AND STOCKHOLDERS' EQUITY
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current Liabilities:	Current Liabilities:
Current Liabilities:
Current Liabilities:
Current debt obligations
Current debt obligations
Current debt obligations	Current debt obligations	$	23,434	$	229,673
Accounts payable	Accounts payable	74,310		68,000
Accrued liabilities and other	Accrued liabilities and other	75,595		88,937
Current derivative liabilities		5,886		183,109

Current litigation provision liability
Current litigation provision liability
Current litigation provision liability	Current litigation provision liability	29,481		32,845
Taxes payable	Taxes payable	16,505		15,140
Accrued employee compensation and related benefits	Accrued employee compensation and related benefits	72,187		79,266

Total Current Liabilities
Total Current Liabilities
Total Current Liabilities	Total Current Liabilities	297,398		696,970
Long-term debt obligations	Long-term debt obligations	518,067		9,849
Contingent consideration	Contingent consideration	85,292		86,830
Deferred tax liabilities	Deferred tax liabilities	8,516		7,728
Long-term operating lease liabilities	Long-term operating lease liabilities	29,548		35,919
Long-term employee compensation and related benefits	Long-term employee compensation and related benefits	16,804		19,105
Long-term derivative liabilities	Long-term derivative liabilities	85,675		—
Other long-term liabilities	Other long-term liabilities	45,849		49,905
Total Liabilities	Total Liabilities	1,087,149		906,306
Commitments and contingencies (Note 14)
Commitments and contingencies (Note 13)						Commitments and contingencies (Note 13)
Stockholders’ Equity:	Stockholders’ Equity:
Ordinary Shares, £1.00 par value: unlimited shares authorized; 53,851,979 shares issued and 53,564,664 shares outstanding at December 31, 2022; 53,761,510 shares issued and 53,263,297 shares outstanding at December 31, 2021		82,424		82,295
Ordinary Shares, £1.00 par value: unlimited shares authorized; 53,942,151 shares issued and 53,918,222 shares outstanding at December 31, 2023; 53,851,979 shares issued and 53,564,664 shares outstanding at December 31, 2022
Ordinary Shares, £1.00 par value: unlimited shares authorized; 53,942,151 shares issued and 53,918,222 shares outstanding at December 31, 2023; 53,851,979 shares issued and 53,564,664 shares outstanding at December 31, 2022
Ordinary Shares, £1.00 par value: unlimited shares authorized; 53,942,151 shares issued and 53,918,222 shares outstanding at December 31, 2023; 53,851,979 shares issued and 53,564,664 shares outstanding at December 31, 2022
Additional paid-in capital	Additional paid-in capital	2,157,724		2,117,961
Accumulated other comprehensive (loss) income		(48,119)		(7,177)
Accumulated other comprehensive loss
Accumulated deficit	Accumulated deficit	(984,030)		(897,784)
Treasury stock at cost, 287,315 ordinary shares at December 31, 2022, 498,213 ordinary shares at December 31, 2021		(375)		(650)
Treasury stock at cost, 23,929 ordinary shares at December 31, 2023, 287,315 ordinary shares at December 31, 2022
Total Stockholders’ Equity	Total Stockholders’ Equity	1,207,624		1,294,645
Total Liabilities and Stockholders’ Equity	Total Liabilities and Stockholders’ Equity	$	2,294,773	$	2,200,951


			Ordinary Shares	Ordinary Shares - Amount		Additional Paid-In Capital		Treasury Stock		Accumulated Other Comprehensive (Loss) Income		Accumulated Deficit		Total Stockholders' Equity
December 31, 2019			49,411	$	76,257	$	1,734,870	$	(1,263)	$	(19,392)	$	(412,508)	$	1,377,964
Adoption of ASU No. 2016-13			—	—		—		—		—		(639)		(639)
Stock-based compensation plans			109	140		33,189		229		—		—		33,558
Cancellation of shares			(73)	(97)		97		—		—		—		—
Net loss			—	—		—		—		—		(348,819)		(348,819)
Other comprehensive income			—	—		—		—		47,201		—		47,201
		Ordinary Shares														Ordinary Shares	Ordinary Shares - Amount	Additional Paid-In Capital	Treasury Stock	Accumulated Other Comprehensive Income (Loss)	Accumulated Deficit	Total Stockholders’ Equity
December 31, 2020	December 31, 2020		49,447	76,300		1,768,156		(1,034)		27,809		(761,966)		1,109,265
Issuance of shares	Issuance of shares		4,182	5,808		316,733		—		—		—		322,541
Stock-based compensation plans	Stock-based compensation plans		133	187		33,072		384		—		—		33,643
Net loss	Net loss		—	—		—		—		—		(135,818)		(135,818)
Other comprehensive loss	Other comprehensive loss		—	—		—		—		(34,986)		—		(34,986)
December 31, 2021	December 31, 2021		53,762	82,295		2,117,961		(650)		(7,177)		(897,784)		1,294,645
Stock-based compensation plans	Stock-based compensation plans		90	129		39,763		275		—		—		40,167
Net loss	Net loss		—	—		—		—		—		(86,246)		(86,246)
Other comprehensive loss	Other comprehensive loss		—	—		—		—		(40,942)		—		(40,942)
December 31, 2022	December 31, 2022		53,852	$	82,424	$	2,157,724	$	(375)	$	(48,119)	$	(984,030)	$	1,207,624
Stock-based compensation plans
Net income
Other comprehensive income
December 31, 2023


Supplementary Disclosures of Cash Flow Information:	Supplementary Disclosures of Cash Flow Information:
Supplementary Disclosures of Cash Flow Information:
Supplementary Disclosures of Cash Flow Information:
Cash paid for interest
Cash paid for interest
Cash paid for interest	Cash paid for interest	$	19,044	$	32,569	$	28,573
Cash paid for income taxes, net	Cash paid for income taxes, net	1,221		(13,583)		7,493


	Employee Severance and Termination Costs
	Employee Severance and Termination Costs
	Employee Severance and Termination Costs
As of December 31, 2020
As of December 31, 2020
As of December 31, 2020
Charges
Charges
Charges
Cash payments
Cash payments
Cash payments
As of December 31, 2021
As of December 31, 2021
As of December 31, 2021
Charges
Charges
Charges
Cash payments
Cash payments
Cash payments
As of December 31, 2022
As of December 31, 2022
As of December 31, 2022
Charges
Charges
Charges
Cash payments
Cash payments
Cash payments
As of December 31, 2023 (1)
As of December 31, 2023 (1)
As of December 31, 2023 (1)

	Employee Severance and Other Termination Costs		Other		Total
As of December 31, 2019	$	4,097	$	1,400	$	5,497
Charges	7,571		—		7,571
Cash payments	(5,919)		(854)		(6,773)
As of December 31, 2020	5,749		546		6,295
Charges	7,963		1,750		9,713
Cash payments	(12,876)		(2,296)		(15,172)
As of December 31, 2021	836		—		836
Charges	6,611		—		6,611
Cash payments	(5,402)		—		(5,402)
As of December 31, 2022 (1)	$	2,045	$	—	$	2,045


~~As of December 31, 2019~~	$	~~3,251~~
~~Adjustments~~	~~3,199~~
~~Remediation activity~~	~~(5,743)~~
~~Effect of changes in foreign currency exchange rates~~	~~349~~
~~As of December 31, 2020~~	~~1,056~~
~~Adjustments~~	~~712~~
~~Remediation activity~~	~~(880)~~
~~Effect of changes in foreign currency exchange rates~~	~~(81)~~
~~As of December 31, 2021~~	~~807~~

~~Remediation activity~~	~~(15)~~
~~Effect of changes in foreign currency exchange rates~~	~~(47)~~
~~As of December 31, 2022~~	$	~~745~~


	2022		2021
Finite-lived intangible assets:
Customer relationships	$	184,397	$	192,800
Developed technology	217,205		219,706
Trade names	24,368		25,154
Other intangible assets	756		616
Total gross finite-lived intangible assets	426,726		438,276
Accumulated amortization - Customer relationships	72,820		65,106
Accumulated amortization - Developed technology	80,219		68,488
Accumulated amortization - Trade names	16,483		16,500
Accumulated amortization - Other intangible assets	651		506
Total accumulated amortization	170,173		150,600
Net finite-lived intangible assets	$	256,553	$	287,676
Indefinite-lived intangible assets:
IPR&D	$	112,006	$	112,006
Goodwill	768,787		899,525
Total indefinite-lived intangible assets	$	880,793	$	1,011,531


			Minimum Life in years	Maximum Life in years
		Minimum Life in years					Minimum Life in years		Maximum Life in years
Customer relationships	Customer relationships		8	18	Customer relationships	8		18
Developed technology	Developed technology		14	17	Developed technology	14		17
Trade names			15	15


2023		$	25,372
2024	2024	25,372
2025	2025	25,372
2026	2026	25,372
2027	2027	24,957
2028
Thereafter	Thereafter	130,108
Total	Total	$	256,553


	2022		Fair Value Measurements Using Inputs Considered as:
			Level 1		Level 2		Level 3
Assets

Derivative assets - designated as cash flow hedges (interest rate swaps)	$	1,333	$	—	$	1,333	$	—

Derivative assets - capped call derivatives	54,393		—		—		54,393
Convertible notes receivable	285		—		—		285
	$	56,011	$	—	$	1,333	$	54,678

Liabilities


Derivative liabilities - freestanding instruments (foreign currency exchange rate “FX”)	$	5,886	$	—	$	5,886	$	—
Derivative liabilities - embedded exchange feature	85,675		—		—		85,675
Contingent consideration arrangements	85,292		—		—		85,292
	$	176,853	$	—	$	5,886	$	170,967


	Capped Call Derivative Asset		Convertible Notes Receivable		Embedded Exchange Feature Derivative Liability		Other Derivative Liabilities		Contingent Consideration Liability Arrangements
As of December 31, 2020	$	72,302	$	2,775	$	121,756	$	4,290	$	103,818

Payments (1)	—		—		—		—		(6,000)
Changes in fair value (2) (3)	34,327		(8)		59,944		(4,290)		564

As of December 31, 2021	106,629		2,767		181,700		—		98,382
Additions	—		—		—		—		26,369

Utilized as business combination consideration	—		(2,495)		—		—		—
Measurement period adjustments (4)	—		—		—		—		(9,578)
Changes in fair value (2) (3) (5)	(52,236)		13		(96,025)		—		(29,881)

As of December 31, 2022 - long-term	$	54,393	$	285	$	85,675	$	—	$	85,292


			2022		2021		Maturity	Interest Rate
		2023											2023					2022				Maturity				Interest Rate
Term Facilities	Term Facilities		$	289,294	$	—	July 2027	7.21%	Term Facilities	$	328,459	$		$	289,294	July 2027				July 2027				9.02%
2020 Cash Exchangeable Senior Notes	2020 Cash Exchangeable Senior Notes		239,568		225,140		December 2025	3.00%	2020 Cash Exchangeable Senior Notes	255,500		239,568			239,568		December 2025				December 2025				3.00%
Bank of America, US									Bank of America, US	1,500				1,500					January 2025				8.09%
Bank of America Merrill Lynch Banco Múltiplo S.A.	Bank of America Merrill Lynch Banco Múltiplo S.A.		6,462		6,113		July 2023	16.20%	Bank of America Merrill Lynch Banco Múltiplo S.A.	—		6,462			6,462		N/A						N/A
Mediocredito Italiano	Mediocredito Italiano		1,601		3,379		December 2023	0.50% - 3.47%	Mediocredito Italiano	—		1,601			1,601		N/A				N/A				N/A
Bank of America, U.S.			1,500		1,500		January 2023	5.45%
Other	Other		534		663
Total long-term facilities	Total long-term facilities		538,959		236,795
Total long-term facilities
Total long-term facilities
Less current portion of long-term debt
Less current portion of long-term debt
Less current portion of long-term debt	Less current portion of long-term debt		20,892		226,946
Total long-term debt obligations	Total long-term debt obligations		$	518,067	$	9,849
Total long-term debt obligations
Total long-term debt obligations


2023		$	20,914
2024	2024	15,092
2025	2025	306,301
2026	2026	26,310
2027	2027	226,875
2028
Thereafter	Thereafter	252
Total payments	Total payments	595,744
Less: Debt issuance costs	Less: Debt issuance costs	(56,785)
Total long-term facilities	Total long-term facilities	$	538,959


Description of Derivative Contract	2022		2021
FX derivative contracts to be exchanged for British Pounds	$	—	$	11,160
FX derivative contracts to be exchanged for Japanese Yen	—		6,648
FX derivative contracts to be exchanged for Euros	—		58,224
Interest rate swap contracts	210,000		—
	$	210,000	$	76,032


Description of Derivative Contract	After-tax Net Gain in AOCI		After-tax Net Gain Expected to be Reclassified to Earnings in Next 12 Months

Interest rate swap contracts	$	966	$	966


		2022
Description of Derivative Contract	Location in Earnings of Reclassified Gain or Loss	(Loss) Gain Recognized in OCI		Loss Reclassified from AOCI to Earnings
FX derivative contracts	Foreign exchange and other income/(expense)	$	(4,602)	$	(382)
FX derivative contracts	SG&A	—		(5,165)
Interest rate swap contracts	Interest expense	914		(52)
		$	(3,688)	$	(5,599)


2023		$	10,520
2024	2024	8,095
2025	2025	5,372
2026	2026	3,998
2027	2027	3,570
2028
Thereafter	Thereafter	12,747
Total lease payments	Total lease payments	44,302
Less: Amount representing interest	Less: Amount representing interest	5,375
Present value of lease liabilities	Present value of lease liabilities	$	38,927


~~As of December 31, 2019~~	$	~~170,404~~
~~Payments~~	~~(138,178)~~
~~Adjustments~~ ~~(1)~~	~~3,906~~
~~FX and other~~	~~358~~
As of December 31, 2020	$	36,490
Payments	(34,808)
Adjustments (1)	38,068
FX and other	(280)
As of December 31, 2021	39,470
Payments	(28,867)
Adjustments (1)	22,309
FX and other	(425)
As of December 31, 2022	32,487
Payments	(53,652)
Adjustments (1)	34,521
FX and other	504
As of December 31, 2023	13,860
Less current portion as of December 31, ~~2022~~2023	~~29,481~~10,756
Long-term portion as of December 31, ~~2022~~2023 (2)	$	~~3,006~~3,104