UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 _________________________ Form 10-Q (Mark One) ☑ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended: June 30, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _______________ to _______________ Commission file number: 001-37599 LivaNova PLC (Exact name of registrant as specified in its char ...

Financial Data and Key Metrics Changes - Revenue for the second quarter was $294 million, an increase of 16% compared to the same period in 2022 [9][21] - Adjusted diluted earnings per share rose to $0.78 from $0.53 in the second quarter of 2022 [10] - Adjusted effective tax rate increased to 10% from 5% year-over-year [10] - Cash balance at June 30 was $223 million, up from $214 million at year-end 2022 [10] - Total debt increased to $587 million from $542 million at year-end 2022 [10] Segment Results and Key Metrics Changes - Cardiopulmonary segment revenue was $151 million, a 21% increase year-over-year, driven by higher demand for oxygenators and heart-lung machines [5][6] - Epilepsy revenue increased by 14% year-over-year, with U.S. epilepsy revenue growing 15% due to higher total implants and favorable product mix [6][23] - DTD revenue for the second quarter was $1 million, with expectations of $6 million to $8 million for the full year 2023 [7] Market Data and Key Metrics Changes - U.S. epilepsy revenue growth was supported by 838 new patient implants, a 13% increase year-over-year, and 1,947 replacements, an 8% increase [21][23] - The Rest of World region achieved 15% growth in epilepsy revenue, led by Turkey and China [23] - The company expects global epilepsy revenue to grow 6% to 8% for the full year 2023 [23] Company Strategy and Development Direction - The company is focused on patient acquisition in epilepsy and maintaining market position in cardiopulmonary [11][12] - The commercial rollout of Essenz is progressing, with expectations for increased contributions following software launches [22] - The company anticipates cardiopulmonary revenue growth of 11% to 13% for the full year 2023 [22] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the first half execution contributing to financial performance and emphasized the importance of patient focus and operational execution [12] - The company acknowledged that revenue growth in the second half of 2023 may not reflect the first half's performance due to competitor supply chain recoveries [9] - Management is committed to selecting the right individual for the CEO position to lead the company forward [4] Other Important Information - The company is actively monitoring the impact of the RECOVER study and anticipates publication of results by late 2024 [7] - R&D expenses for the second quarter were $48 million, consistent with the previous year, reflecting continued investment in strategic initiatives [47] Q&A Session Summary Question: What is the outlook for end-of-service revenues? - Management noted that programs are in place to help physicians identify end-of-service devices, which is expected to drive higher replacement rates [15][31] Question: How is the Essenz launch progressing? - The company is in commercial launch mode, with evaluations ongoing in major institutions in Europe and the U.S. [56][57] Question: What are the expectations for the Bipolar cohort in the RECOVER trial? - The interim analysis for the Bipolar cohort was completed, and the company expects to enroll about 25 patients per quarter [87] Question: How does the company view the competitive landscape? - Management acknowledged that competitors are beginning to ship products again, which may impact future growth [30][85] Question: What is the expected impact of pricing programs on revenue? - The company indicated that pricing programs implemented in the second half of 2022 are expected to have a favorable impact on revenue moving forward [9][36]

Kits used for cardiac procedures grew year over year, offset by respiratory case declines and product mix. | --- | --- | --- | --- | |---------------------------------------------------------------------|-------|---------|----------| | Adjusted Free Cash Flow Reconciliation ($M) 1Q 2023 | | 2Q 2023 | 2023 YTD | | Net cash provided by operating activities | $20.8 | $(17.9) | $2.8 | | Less: Purchases of plant, property and equipment (7.7) (5.7) (13.3) | | | | | Less: Cash received from tax stimulus (9.9) — (9 ...

LivaNova PLC (NASDAQ:LIVN) Q1 2023 Earnings Conference Call May 3, 2023 8:00 AM ET Company Participants Matthew Dodds - Senior Vice President of Corporate Development William Kozy - Chairman & Interim Chief Executive Officer Alex Shvartsburg - Chief Financial Officer Conference Call Participants Rick Wise - Stifel Financial Michael Polark - Wolfe Research Matthew Taylor - Jefferies Adam Maeder - Piper Sandler Mike Matson - Needham & Company Operator Good day ladies and gentlemen and welcome to the LivaNova ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 _________________________ Form 10-Q (Mark One) ☑ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended: March 31, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _______________ to _______________ Commission file number: 001-37599 LivaNova PLC (Exact name of registrant as specified in its cha ...

Product Development and Clinical Trials - LivaNova's Cardiopulmonary segment includes the development of the Essenz Perfusion System, with successful clinical cases completed in two major centers in Europe during Q4 2022[23]. - The VNS Therapy System is the only neuromodulation device approved for drug-resistant epilepsy patients in the U.S. as young as four years old, with global reimbursement expanding in 2020 and 2022[30]. - The VITARIA System for heart failure was halted after the 500th patient was randomized in the ANTHEM-HFrEF trial, as data did not show a strong positive impact on functional or mortality endpoints[41]. - The LifeSPARC platform received FDA approval in November 2022 for ECMO use beyond six hours for patients in acute respiratory failure, including those treated for COVID-19[42]. - The OSPREY clinical study for the aura6000 System began in March 2022, aiming to confirm safety and effectiveness for treating obstructive sleep apnea[40]. - The RECOVER clinical study, initiated in 2019, aims to gather clinical biomarkers of depression and includes up to 500 unipolar and 500 bipolar patients[36]. - In March 2022, LivaNova announced the 250th unipolar depression patient was implanted in the RECOVER study, leading to the first interim analysis[38]. - The Hemolung RAS received CMS approval for a New Technology Add-on Payment in August 2022, recognizing its potential to improve treatment for Medicare beneficiaries[44]. Financial Performance - In 2022, the company reported net revenue of $1,021.8 million, a slight decrease of 1.3% from $1,035.4 million in 2021[208]. - Gross profit for 2022 was $707.2 million, compared to $706.0 million in 2021, indicating a stable gross margin despite revenue decline[208]. - Operating loss from continuing operations was $76.8 million in 2022, a significant increase from a loss of $0.8 million in 2021[208]. - The company recognized a net loss of $86.2 million in 2022, an improvement from a net loss of $135.8 million in 2021[208]. - The company reported a total reportable segment loss from continuing operations of $43.8 million for 2022, compared to a profit of $36.2 million in 2021[210]. Market and Competitive Environment - The company faces increasing competition in the medical device market from both large manufacturers and small specialized firms[53]. - The current trend among hospitals is to consolidate into larger purchasing groups, enhancing purchasing power and potentially pressuring pricing[52]. - The company operates in a highly competitive medical device market, facing competition from both large manufacturers and alternative therapies, which could impact its market position[107]. Regulatory Compliance and Legal Risks - The company is subject to extensive government regulations, including compliance with the FDA's 510(k) clearance or pre-market approval (PMA) for medical devices sold in the U.S.[59]. - The company aims to be fully compliant with the EU's Medical Device Regulation (Reg MDR) by the May 2024 deadline[60]. - The company is required to comply with various patient privacy and security laws, including HIPAA in the U.S. and GDPR in the EU[68]. - The company is subject to various healthcare regulations, including the federal Anti-Kickback Statute, which can impose civil penalties of up to $100,000 per violation[77]. - The company has previously received a warning letter from the FDA regarding regulatory compliance, which has impacted its ability to market certain devices[111]. - The company may face civil or criminal penalties for non-compliance with product-related regulations, which could restrict its marketing capabilities and affect its financial condition[112]. - The company is involved in product liability litigation related to its cardiopulmonary 3T Heater-Cooler product, which may adversely affect its financial condition and require significant resources for defense[117]. Operational Challenges - The company has experienced supply chain delays and interruptions, labor shortages, and inflationary pressures[56]. - The company continues to face macroeconomic challenges, including supply chain disruptions and rising inflation, impacting overall business performance[191]. - The company is experiencing supply chain delays and interruptions, labor shortages, and inflationary pressures, which have led to longer lead times and price pressures on key raw materials[102]. Research and Development - The company is committed to R&D for technological advancements and new product development to maintain market leadership and address unmet patient needs[45]. - Research and development expenses were $155.8 million in 2022, down from $183.4 million in 2021, reflecting a strategic focus on key projects[208]. - The company relies on investments and collaborations for R&D, which are inherently risky and may not guarantee success[139]. Human Resources and Diversity - The company employs approximately 2,900 individuals globally, with a gender distribution of approximately 52% female and 48% male as of December 31, 2022[93]. - The Executive Team at the end of 2022 consisted of 11 individuals, with approximately 27% being female[93]. - The company has established a "Global Women's Network" to empower female employees and promote diversity and inclusion within the organization[94]. - The company has launched the LivaNova Commercial Academy to develop current and future leaders through a comprehensive leadership bootcamp[91]. - The company has a proactive recruitment strategy and offers competitive compensation packages, including health benefits and flexible working arrangements[87]. Environmental and Social Governance (ESG) - The company is focused on continuous improvement in environmental performance, aiming to reduce greenhouse gas emissions and overall environmental footprint[76]. - The company is subject to increased scrutiny regarding ESG matters, which could impact reputation and access to capital[140]. - Environmental liabilities related to hazardous substances at the company's Saluggia campus could lead to significant financial impacts, including a court-ordered payment of approximately €453.6 million (approximately $484.9 million) for environmental damages[133]. Currency and Economic Risks - In 2022, the company's net revenue and profitability were negatively affected by unfavorable foreign currency exchange impacts due to a strengthened U.S. dollar against several currencies[105]. - The company experienced unfavorable foreign currency fluctuations impacting revenues by approximately $33.5 million in Cardiopulmonary and $9.7 million in Neuromodulation for 2022[211][215]. - The Russian market represented only 1.0% of total net revenue in 2022, but geopolitical tensions have increased economic uncertainties[192]. Financial Instruments and Debt - The company issued $287.5 million aggregate principal amount of 3.00% Cash Exchangeable Senior Notes due in 2025[156]. - The effective interest expense reported is significantly greater than the stated interest rates of the Notes, which may lead to volatility in reported financial results[162]. - The company is subject to counterparty risk with respect to capped call transactions, which could affect financial stability[166]. - The company’s debt instruments impose affirmative covenants and specified financial ratios that could limit operational flexibility and strategic opportunities[161]. Strategic Challenges - The company may face challenges in integrating acquired businesses, which could disrupt ongoing operations and limit growth[150]. - Changes in global healthcare policies and reimbursement reductions may adversely impact the company's business, particularly in Italy where a "payback" measure requires repayment of a percentage of healthcare expenditures exceeding regional caps[119]. - The company's ability to commercialize products depends on third-party payers agreeing to cover costs; failure to demonstrate cost-effectiveness could reduce sales[120].

LivaNova PLC (NASDAQ:LIVN) Q4 2022 Results Earnings Conference Call February 22, 2023 8:00 AM ET Company Participants Matthew Dodds - Senior Vice President, Corporate Development Damien McDonald - Chief Executive Officer Alex Shvartsburg - Chief Financial Officer Conference Call Participants Rick Wise - Stifel Financial Michael Polark - Wolfe Research Matthew Taylor - Jefferies LLC Adam Maeder - Piper Sandler Mike Matson - Needham & Company, LLC Matt Miksic - Barclays Capital Operator Good day, ladies and g ...

Safe Harbor In this presentation, "LivaNova," "the Company," "we," "us" and "our" refer to LivaNova PLC and its consolidated subsidiaries. This report may contain references to our proprietary intellectual property, including among others: • Trademarks for our advanced circulatory support systems: TandemLife™, TandemHeart™, TandemLung™, ProtekDuo™, LifeSPARC™, ALung™, Hemolung™, Respiratory Dialysis™ and ActivMix™. Agenda Financial Results Financial Results 4Q22 Financial Summary Adjusted SG&A % 4Q21 4Q22 • ...

Liva\Nova | --- | --- | --- | --- | |--------------------------------|-------|-------|-------| | | | | | | Health innovation that matters | | | | Third Quarter 2022 Earnings Presentation November 2, 2022 Safe Harbor 2 Certain statements in this presentation, other than purely historical information, are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, as a ...

Financial Data and Key Metrics Changes - The company achieved a revenue growth of 5% in Q3 2022, with total revenue reaching $253 million compared to the previous year [9][28] - Adjusted gross margin was 70%, consistent with Q3 2021, but impacted by supply chain challenges and inflationary pressures [29] - Adjusted operating income decreased to $37 million from $46 million year-over-year, with an operating income margin of 15% down from 18% [31] - Adjusted diluted earnings per share were $0.58, down from $0.66 in Q3 2021 [33] - The company recorded a $129 million non-cash goodwill impairment charge for the ACS reporting unit [33] Segment Performance Changes - Cardiopulmonary segment revenue was $121 million, a 7% increase year-over-year, driven by high-single digit growth in oxygenator revenue [10][11] - Epilepsy revenue increased by 11%, with growth across all regions, primarily from replacement implants [12][13] - ACS revenue was $9 million, a significant decrease of 44% year-over-year, primarily due to a decline in severe COVID cases [17][21] Market Performance Changes - US epilepsy revenue grew 9% year-over-year, with total implants up mid-single digits [13] - The rest of the world region for epilepsy saw a 28% growth, led by Brazil [15] - The company expects global epilepsy revenue to grow 6% to 8% for the full year [16] Company Strategy and Industry Competition - The company is navigating macro headwinds including supply chain issues, inflation, and foreign exchange volatility [9] - Strategic portfolio initiatives include ongoing studies like the RECOVER study and ANTHEM-HFrEF trial, with expectations for continued progress [23][25] - The company plans to add two additional dedicated teams for epilepsy in Q4 to enhance market penetration [16] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about improving procedure trends globally, particularly in the US [47] - The company maintains its guidance for 2022, expecting constant currency revenue growth of 4% to 6% and adjusted EPS of $2.25 to $2.45 [36] - Management highlighted the potential impact of foreign exchange rates on future earnings, estimating a $0.35 EPS headwind [36][50] Other Important Information - The company’s cash balance at September 30 was $506 million, significantly up from $208 million at year-end 2021 [34] - Total debt increased to $540 million, primarily due to a $300 million term loan facility executed in July [34] - The FDA classified a field action related to the LifeSPARC controller as a Class I recall, but the device remains safe for use [20] Q&A Session Summary Question: Epilepsy performance drivers and backlog - Management noted improved market conditions and a backlog of approximately 300 patients remaining for EOS [42][44] Question: 2023 growth outlook - Management expects improving procedure trends but acknowledges ongoing macro challenges [47] Question: Essenz launch updates - The Essenz program is progressing well, with clinical cases expected before year-end in Europe [53] Question: ACS business confidence - Management indicated a modest improvement expected in Q4, with a focus on non-COVID cases [57] Question: RECOVER study interim analysis - Management remains confident in achieving statistical significance, even if the full 500 patients are required [60][81] Question: Retaining sales force amid ACS headwinds - Management has taken steps to retain the sales team and is optimistic about non-COVID business growth [65] Question: SG&A and R&D expense increases - The increase in expenses is attributed to the timing of spending, with lower expenses in the prior year due to pandemic impacts [67][68]