LivaNova PLC
For the period ended Mar 31, 2024. Filed May 3, 2024.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Mar 31, 2024 · Filed May 3, 2024
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Definitions
In this Quarterly Report on Form 10-Q for the quarter ended March 31, 2024, the following terms and abbreviations have the meanings listed below. “LivaNova” and “the Company” refer to LivaNova PLC and its consolidated subsidiaries.
| Abbreviation | Definition |
|---|---|
| 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 |
| 2023 Form 10-K | LivaNova PLC’s Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC on February 29, 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 |
| 2025 Capped Calls | Privately negotiated capped call transactions entered into with certain financial institutions |
| 2025 Notes | $287.5 million aggregate principal amount 3.00% unsecured cash exchangeable senior notes due 2025 by private placement to qualified institutional buyers pursuant to Rule 144A under the Securities Act, issued by LivaNova USA on June 17, 2020 |
| 2025 Notes Repurchase Transaction | Repurchase of $230.0 million aggregate principal amount of the 2025 Notes in privately-negotiated transactions from proceeds from the issuance of the 2029 Notes |
| 2029 Capped Calls | Privately negotiated capped call transactions entered into with certain financial institutions |
| 2029 Notes | $345.0 million aggregate principal amount 2.5% unsecured convertible senior notes due 2029 by private placement to qualified institutional buyers pursuant to Rule 144A under the Securities Act, issued by LivaNova PLC on March 8, 2024 |
| ACS | Advanced Circulatory Support |
| ALung | ALung Technologies, Inc. |
| AOCI | Accumulated other comprehensive income |
| Barclays | Barclays Bank Ireland PLC |
| BEPS | Base Erosion and Profit Shifting |
| Borrower | LivaNova USA, Inc. |
| Capped Call Transactions | The 2025 Capped Calls and the 2029 Capped Calls |
| CEO | Chief Executive Officer |
| CFO | Chief Financial Officer |
| CODM | Chief Operating Decision Maker |
| Convertible Notes Measurement Period | Any specified ten consecutive trading day measurement period |
| Court of Appeal | Court of Appeal in Milan |
| CPB | Cardiopulmonary bypass |
| 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 |
| DTD | Difficult-to-treat depression |
| ECJ | European Court of Justice |
| EU | European Union |
| Exchange Act | U.S. Securities Exchange Act of 1934, as amended |
| FX | Foreign currency exchange rate |
| GAAP | Generally Accepted Accounting Principles |
| HLM | Heart-lung machine |
| 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 |
| Incremental Facility Amendment No. 3 | An incremental facility amendment to the 2021 First Lien Credit Agreement, dated March 8, 2024 |
| Abbreviation | Definition |
|---|---|
| Initial Term Facility | $300 million term facility under the 2021 First Lien Credit Agreement resulting from the Incremental Facility Amendment No. 2 |
| ISIN | National Inspectorate for Nuclear Safety and Radiation Protection, a sub-body of the Italian Ministry of Economic Development |
| 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. |
| MDL | Federal multi-district litigation in the U.S. District Court for the Middle District of Pennsylvania |
| Nasdaq | Nasdaq Global Market |
| OCI | Other comprehensive income (loss) |
| OECD | Organization for Economic Co-operation and Development |
| Option Counterparties | Certain financial institutions with whom LivaNova USA or LivaNova PLC, as applicable, has entered into the 2025 Capped Calls and 2029 Capped Calls |
| 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 |
| Public Administrations | The Italian Ministry of the Environment and other Italian government agencies |
| R&D | Research and Development |
| Report | This Quarterly Report on Form 10-Q |
| RSUs | Service-based restricted stock units |
| SARs | Service-based stock appreciation rights |
| SEC | U.S. Securities and Exchange Commission |
| Securities Act | U.S. 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 |
| 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 |
| UK | United Kingdom |
| UK Act | Finance (No.2) Act 2023 |
| U.S. | United States of America |
| U.S. GAAP | Generally Accepted Accounting Principles in the U.S. |
| USD | U.S. dollar |
| UTPR | Undertaxed profits rule |
| VNS Therapy | LivaNova Vagus Nerve Stimulation Therapy |
INTELLECTUAL PROPERTY, TRADEMARKS AND TRADE NAMES
This report may contain references to LivaNova’s proprietary intellectual property, including among others:
Trademarks for LivaNova’s Neuromodulation systems, the VNS Therapy™ System, the VITARIA™ System and 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™ and TitrationAssist™) and Model 8103 (Symmetry™).
Trademarks for LivaNova’s Cardiopulmonary products and systems: Essenz™, S5™, S3™, S5 Pro™, B-Capta™, Inspire™, Heartlink™, XTRA™, 3T Heater-Cooler™, Connect™ and Revolution™.
Trademarks for LivaNova’s advanced circulatory support systems: TandemLife™, TandemHeart™, TandemLung™, ProtekDuo™, LifeSPARC™, ALung™, Hemolung™, Respiratory Dialysis™ and ActivMix™.
Trademarks for LivaNova’s obstructive sleep apnea system: ImThera™ and aura6000™.
These trademarks and trade names are the property of LivaNova or the property of LivaNova’s consolidated subsidiaries and are protected under applicable intellectual property laws. Solely for convenience, LivaNova’s trademarks and trade names referred to in this Report may appear without the™ symbol, but such references are not intended to indicate in any way that the Company will not assert, to the fullest extent under applicable law, LivaNova’s rights to these trademarks and trade names.
CAUTIONARY NOTE ABOUT FORWARD-LOOKING STATEMENTS
Certain statements in this Report, 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 and Section 21E of the Exchange Act. These statements include, but are not limited to, LivaNova’s plans, objectives, strategies, financial performance and outlook, trends, the amount and timing of future cash distributions, prospects or future events and involve known and unknown risks that are difficult to predict. As a result, 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 the Company’s control, that could cause the Company’s actual results to differ materially from the forward-looking statements contained in this Report, and include, but are not limited to, the following risks and 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. 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 relating to supply chain pressures; 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 the Company’s products; failure to establish, expand or maintain market acceptance of the Company’s products for the treatment of 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 the Company’s products; risks relating to recalls, enforcement actions or product liability claims; changes or reduction in reimbursement for the Company’s products or failure to comply with rules relating to reimbursement of healthcare goods and services; 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; 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 the Company’s R&D efforts to keep up with the rapid pace of technological development in the medical device industry; the risks relating to the impact of climate change and the risk of ESG pressures from internal and external stakeholders; the risk of quality concerns and the impacts thereof; failure to protect the Company’s proprietary intellectual property; failure of new acquisitions to further the Company’s strategic objectives or strengthen the Company’s existing businesses; the potential for impairments of intangible assets, goodwill and other long-lived assets; risks relating to the Company’s indebtedness; effectiveness of the Company’s internal controls over financial reporting; changes in the Company’s profitability and/or failure to manage costs and expenses; fluctuations in future quarterly operating results and/or variations in revenue and operating expenses relative to estimates; changes in tax laws and regulations, including exposure to additional income tax liabilities; and other unknown or unpredictable factors that could harm the Company’s financial performance.
Other factors that could cause LivaNova’s actual results to differ from projected results are described in (1) “Part II, Item 1A. Risk Factors” and elsewhere in this and the Company’s other Quarterly Reports on Form 10-Q, (2) the Company’s 2023 Form 10-K, (3) the Company’s reports and registration statements filed and furnished from time to time with the SEC and (4) other announcements LivaNova makes from time to time.
Readers are cautioned not to place undue reliance on the Company’s forward-looking statements, which speak only as of the date hereof. The Company undertakes no obligation to update or revise any forward-looking statements after the date they are made, whether as a result of new information, future events or otherwise. You should read the following discussion and analysis in conjunction with the Company’s unaudited condensed consolidated financial statements and related notes included elsewhere in this report. Operating results for the three months ended March 31, 2024, are not necessarily indicative of future results, including the full fiscal year. You should also refer to the Company’s “Annual Consolidated Financial Statements,” “Notes” thereto, “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and “Risk Factors” contained in LivaNova’s 2023 Form 10-K and in the Company’s Quarterly Reports on Form 10-Q.
Financial Information and Currency of Financial Statements
All of the financial information included in this quarterly report has been prepared in accordance with U.S. GAAP. The reporting currency of the Company’s condensed consolidated financial statements is USD.
PART I. FINANCIAL INFORMATION
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.