LivaNova Reports Fourth-Quarter and Full-Year 2023 Results

LivaNova PLC (NASDAQ:LIVN), a market-leading medical technology company, today reported results for the quarter and full year ended December 31, 2023 and issued guidance for 2024.

Financial Summary and Highlights¹

• Fourth-quarter revenue of $310.1 million increased 12.8 percent on a reported basis and 11.9 percent on a constant-currency basis, as compared to the prior-year period
• Fourth-quarter U.S. GAAP diluted earnings per share was $0.30 and adjusted diluted earnings per share was $0.87
• Full-year 2023 revenue of $1.15 billion increased 12.9 percent on a reported basis and increased 13.3 percent on a constant-currency basis, as compared to the prior-year period
• Full-year 2023 U.S. GAAP diluted earnings per share was $0.32 and adjusted diluted earnings per share was $2.80
• In January 2024, LivaNova initiated a wind down of the Advanced Circulatory Support segment
• In February 2024, LivaNova's Board of Directors named Vladimir A. Makatsaria the Company's Chief Executive Officer (CEO) and member of the Board of Directors, effective March 1, 2024

"We delivered strong revenue growth in both the fourth quarter and full year," said Bill Kozy, Interim Chief Executive Officer and Board Chair of LivaNova. "Our 2023 performance reflects double-digit revenue growth across all regions, an improvement in adjusted operating margin and a 17% increase in adjusted diluted earnings per share. We are pleased with these financial outcomes as well as the progress made in refining the business strategy and portfolio. As we enter 2024 with this strategic focus, we are excited to welcome Vlad Makatsaria as LivaNova's next CEO. Under his leadership, I have great confidence that LivaNova will build on these results and achieve our commitments to serving patients while creating shareholder value."

Fourth-Quarter 2023 Results

The following table summarizes revenue for the fourth quarter of 2023 by segment (in millions):

Cardiopulmonary revenue increased 18.3 percent on a reported basis and increased 17.0 percent² on a constant-currency basis versus the fourth quarter 2022 driven primarily by Essenz^TM Perfusion System sales in the Europe and U.S. regions.

Neuromodulation revenue increased 7.7 percent on a reported basis and increased 7.1 percent² on a constant-currency basis versus the fourth quarter 2022 with strength in the Europe and U.S. regions.

Advanced Circulatory Support (ACS) revenue increased 5.0 percent on a reported basis and increased 4.9 percent² on a constant-currency basis versus the fourth quarter 2022 driven by an increase in case volumes.

Earnings Analysis

On a U.S. GAAP basis, fourth-quarter 2023 operating loss was $88.0 million, as compared to operating income of $14.0 million for the fourth quarter 2022. Adjusted operating income for the fourth quarter 2023 was $48.0 million, as compared to adjusted operating income of $46.8 million for the fourth quarter 2022.

On a U.S. GAAP basis, fourth-quarter 2023 diluted earnings per share was $0.30, as compared to diluted earnings per share of $0.03 in the fourth quarter 2022. Fourth-quarter 2023 adjusted diluted earnings per share was $0.87, as compared to adjusted diluted earnings per share of $0.81 in the fourth quarter 2022.

Full-Year 2023 Results

The following table summarizes revenue for full year 2023 by segment (in millions):

Cardiopulmonary revenue increased 17.7 percent on a reported basis and increased 18.4 percent² on a constant-currency basis versus 2022 with growth across all regions, driven by increased heart-lung machine sales, including Essenz^TM Perfusion System installations, and strong oxygenator demand.

Neuromodulation revenue increased 9.0 percent on a reported basis and increased 9.1 percent² on a constant-currency basis versus 2022 with growth across all regions, including new and replacement implants in the U.S. region.

ACS revenue increased 2.6 percent on a reported basis and increased 2.5 percent² on a constant-currency basis versus 2022 driven by an increase in case volumes.

Earnings Analysis

On a U.S. GAAP basis, full-year 2023 operating loss was $68.5 million, as compared to operating loss of $76.8 million for full-year 2022. Adjusted operating income for full-year 2023 was $169.3 million, as compared to adjusted operating income of $145.1 million for full-year 2022.

On a U.S. GAAP basis, full-year 2023 diluted earnings per share was $0.32, as compared to diluted loss per share of $1.61 for full-year 2022. Full-year 2023 adjusted diluted earnings per share was $2.80, as compared to adjusted diluted earnings per share of $2.39 for full-year 2022.

Subsequent Events

On January 8, 2024, LivaNova announced its plan to wind down the ACS segment to increase the Company's strategic focus on its core Cardiopulmonary and Neuromodulation segments. The wind down is anticipated to be substantially complete by the end of 2024. During the first quarter of 2024, the Company intends to transition all ACS standalone cannulae products and related accessories into the Cardiopulmonary segment. The Company expects the wind down to result in a positive contribution to adjusted operating income in 2024 as compared to 2023.

On February 5, 2024, LivaNova announced its Board of Directors named Vladimir A. Makatsaria as the Company's CEO and a member of the Board of Directors, effective March 1, 2024. Makatsaria most recently served as Company Group Chairman at Johnson & Johnson MedTech, leading its global Ethicon surgery business. Makatsaria will succeed Kozy, who has served as Interim CEO since April 2023. Kozy will continue in his role as LivaNova Board Chair.

Full-Year 2024 Guidance

LivaNova expects revenue for full-year 2024 to grow between 4 and 5 percent on a constant-currency basis. When excluding the impact of the ACS segment wind down, the Company expects revenue for full-year 2024 to grow between 6 and 7 percent on a constant-currency basis. Foreign currency is expected to be negligible based on current exchange rates.

Adjusted diluted earnings per share for 2024 are expected to be in the range of $2.95 to $3.05, assuming a share count of approximately 55 million for full-year 2024. In 2024, the Company estimates that adjusted free cash flow will be in the range of $95 to $115 million.

Webcast and Conference Call Instructions

The Company will host a live audiocast for interested parties commencing at 1 p.m. London time (8 a.m. Eastern Time) on Wednesday, February 21, 2024 that will be accessible at www.livanova.com/events. Listeners should register in advance and log on approximately 10 minutes early to ensure proper setup. To listen to the conference call by telephone, dial +1 833 470 1428 (if dialing from within the U.S.) or +1 929 526 1599 (if dialing from outside the U.S.). The conference call access code is 206069. Within 24 hours of the audiocast, a replay will be available at www.livanova.com/events, where it will be archived and accessible for approximately 90 days.

About LivaNova

LivaNova PLC is a global medical technology company built on nearly five decades of experience and a relentless commitment to provide hope for patients and their families through medical technologies, delivering life-changing improvements for both the Head and Heart. Headquartered in London, LivaNova employs approximately 2,900 employees and has a presence in more than 100 countries for the benefit of patients, healthcare professionals and healthcare systems worldwide. For more information, please visit www.livanova.com.

Use of Non-GAAP Financial Measures

In this news release, management has disclosed financial measurements that present financial information not in accordance with GAAP. Company management uses these measurements as aids in monitoring the Company's ongoing financial performance from quarter to quarter and year to year on a regular basis and for benchmarking against other medical technology companies. Non-GAAP financial measures used by the Company may be calculated differently from, and therefore may not be comparable to, similarly titled measures used by other companies. These non-GAAP financial measures should be considered along with, but not as alternatives to, operating performance measures as prescribed by GAAP.

In this news release, the Company refers to comparable, constant-currency percent change in revenue. Management believes that referring to comparable, constant-currency percent change is the most useful way to evaluate the revenue performance of LivaNova and to compare the revenue performance of current periods to prior periods on a consistent basis. Constant-currency percent change, a non-GAAP financial measure, measures the change in revenue between current and prior-year periods using average exchange rates in effect during the applicable prior-year period.

LivaNova calculates forward-looking non-GAAP financial measures based on internal forecasts that omit certain amounts that would be included in GAAP financial measures. For example, forward-looking net revenue growth projections are estimated on a constant-currency basis and exclude the impact of foreign currency fluctuations. Forward-looking non-GAAP adjusted diluted earnings per share guidance exclude other items such as, but not limited to, changes in fair value of derivatives and contingent consideration arrangements and asset impairment charges that would be included in comparable GAAP financial measures. The most directly comparable GAAP measure for constant-currency net revenue, non-GAAP adjusted tax rate and adjusted diluted earnings per share are net revenue, the effective tax rate and earnings per share, respectively. The most directly comparable GAAP measure for adjusted free cash flow is net cash provided by operating activities. Adjusted free cash flow is defined as net cash provided by operating activities less cash used for the purchase of property, plant and equipment excluding the impact of 3T litigation settlement payments, CARES Act tax stimulus benefits and gains related to dividends received from investments and further adjusted as needed for other one-time, nonrecurring, unusual or infrequent charges, expenses or gains, including associated expenses, that may not be indicative of the Company's core business. However, non-GAAP financial adjustments on a forward-looking basis are subject to uncertainty and variability as they are dependent on many factors, including but not limited to, the effect of foreign currency exchange fluctuations, impacts from potential acquisitions or divestitures, the ultimate outcome of legal proceedings, gains or losses on the potential sale of businesses or other assets, restructuring costs, merger and integration activities, changes in fair value of derivatives and contingent consideration arrangements, asset impairment charges and the tax impact of the aforementioned items, tax law changes or other tax matters. Accordingly, forward-looking non-GAAP financial measures and reconciliations to the most directly comparable forward-looking GAAP financial measures are not available without unreasonable effort.

The Company also believes adjusted financial measures such as adjusted gross profit percentage, adjusted selling, general and administrative expense, adjusted research and development expense, adjusted other operating expenses, adjusted operating income, adjusted income tax expense, adjusted net income and adjusted diluted earnings per share, are measures by which LivaNova generally uses to facilitate management review of the operational performance of the company, to serve as a basis for strategic planning and to assist in the design of compensation incentive plans. Additionally, the Company also uses the non-GAAP liquidity measure adjusted free cash flow. Furthermore, adjusted financial measures allow investors to evaluate the Company's core performance for different periods on a more comparable and consistent basis, and with other entities in the medical technology industry by adjusting for items that are not related to the ongoing operations of the Company or incurred in the ordinary course of business.

Safe Harbor Statement

Certain statements in this news release, 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 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 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; risks relating to the impact of climate change and 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 including under the exchangeable senior notes, the Company's revolving credit facility and the Company's 2022 Term Facilities, as defined herein; effectiveness of the Company's internal controls over financial reporting; changes in the Company's profitability and/or failure to manage costs and expenses; fluctuations in future quarterly operating results and/or variations in revenue and operating expenses relative to estimates; changes in tax laws and regulations, including exposure to additional income tax liabilities; and other unknown or unpredictable factors that could harm the Company's financial performance.

The foregoing list of factors is not exhaustive. You should carefully consider the foregoing factors and the other risks and uncertainties that affect the Company's business, including those described in the "Risk Factors" section of Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other documents filed from time to time with the United States Securities and Exchange Commission by LivaNova.

Readers are cautioned not to place undue reliance on the Company's forward-looking statements, which speak only as of the date of this news release. The Company undertakes no obligation to update publicly any of the forward-looking statements in this news release to reflect actual results, new information or future events, changes in assumptions or changes in other factors affecting forward-looking statements, except to the extent required by applicable law. If LivaNova updates one or more forward-looking statements, no inference should be drawn that the Company will make additional updates with respect to those or other forward-looking statements.

Essenz is a trademark of LivaNova USA, Inc.

The following table presents the reconciliation of GAAP diluted weighted average shares outstanding, used in the computation of GAAP diluted net loss per common share, to adjusted diluted weighted average shares outstanding, used in the computation of adjusted diluted earnings per common share (in millions of shares):

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