Business Overview - LivaNova's cardiopulmonary business has a global presence in over 100 countries[8, 13, 24] - The company's cardiopulmonary franchise generates approximately $500 million in revenue[8] - The total addressable market for the cardiopulmonary segment is estimated to be over $2 billion[8, 24] - The business boasts gross margins exceeding 50%[8, 10, 24] - Over 500,000 patients are treated annually with LivaNova's oxygenators[8, 12] - The company has a global HLM installed base of over 7,000 units[8, 12] - Recurring revenue accounts for over 60% of the business[8, 10] Financial Performance - LivaNova's cardiopulmonary business has stable revenues and mid-teens operating margins[10, 24] - The company spends approximately $13 to $15 million per year on CapEx[10] - In 2020, revenue breakdown by product was: HLM 29%, Oxygenators 47%, ATS 18%, and Other 6%[11] - In 2020, revenue breakdown by geography was: US 29%, EU 27%, and ROW 44%[11] Market Dynamics - Approximately 18 million heart surgeries are performed globally each year[15, 16] - On-pump procedures account for about 85% of total heart surgeries[16] - The US represents the largest individual market, accounting for approximately 25% of the total[16]

Part I [Business](index=4&type=section&id=Item%201.%20Business) LivaNova PLC is a global medical device company with Cardiovascular and Neuromodulation segments, divesting Heart Valve business, and subject to extensive regulations - LivaNova is a global medical device company with two reportable segments: **Cardiovascular** and **Neuromodulation**[19](index=19&type=chunk)[20](index=20&type=chunk) - On December 2, 2020, the company agreed to divest its Heart Valve business to Gyrus Capital, expected to close in the first half of 2021[26](index=26&type=chunk)[27](index=27&type=chunk) - The company's largest markets are the **U.S., Europe, and Japan**, utilizing direct sales and independent distributors[54](index=54&type=chunk) - Primary competitors include **Terumo Medical, Medtronic, Edwards Lifesciences, and Abbott Laboratories**[59](index=59&type=chunk) [Cardiovascular Segment](index=4&type=section&id=1.1%20Cardiovascular) The Cardiovascular segment offers cardiopulmonary, advanced circulatory support, and heart valve products, with the Heart Valve business slated for divestiture - The Cardiovascular segment includes **cardiopulmonary products, heart valves, and advanced circulatory support products**[22](index=22&type=chunk) - Cardiopulmonary products, like heart-lung machines and oxygenators, are used during procedures such as coronary artery bypass grafts[23](index=23&type=chunk) - Advanced Circulatory Support products, such as the **LifeSPARC system**, provide temporary extracorporeal life support for critically ill patients[25](index=25&type=chunk) - An agreement was made on December 2, 2020, to sell the Heart Valve business to Gyrus Capital, with the deal expected to close in the first half of 2021[26](index=26&type=chunk)[27](index=27&type=chunk) [Neuromodulation Segment](index=5&type=section&id=1.2%20Neuromodulation) The Neuromodulation segment develops VNS Therapy for epilepsy and difficult-to-treat depression, and an implantable neurostimulation device for obstructive sleep apnea - The **VNS Therapy System** is approved for drug-resistant epilepsy in patients aged four and older[32](index=32&type=chunk) - For difficult-to-treat depression (DTD), CMS provides coverage for Medicare beneficiaries via a Coverage with Evidence Development (CED) trial[37](index=37&type=chunk) - The **RECOVER clinical study** was initiated for DTD to meet CMS requirements, enrolling up to **1,000 patients** in a randomized trial and up to **5,800** in a registry[38](index=38&type=chunk) - The company acquired **ImThera Medical** in January 2018 to enter the obstructive sleep apnea market with an implantable neurostimulation device[42](index=42&type=chunk)[48](index=48&type=chunk) [R&D, Acquisitions, and Intellectual Property](index=7&type=section&id=1.3%20R%26D%2C%20Acquisitions%2C%20and%20IP) LivaNova invests in R&D for new therapies, pursues growth through strategic acquisitions, and protects innovations with over 1,100 patents worldwide - R&D efforts focus on technological leadership, product design, clinical studies, and regulatory activities, including for DTD and heart failure[44](index=44&type=chunk)[45](index=45&type=chunk) - The company relies on acquisitions and investments for new technologies, including **TandemLife** and **Miami Instruments**[46](index=46&type=chunk)[49](index=49&type=chunk)[50](index=50&type=chunk) - As of December 31, 2020, LivaNova held over **1,100 issued patents** worldwide and approximately **280 pending patent applications**[51](index=51&type=chunk) [Government Regulation](index=9&type=section&id=1.4%20Government%20Regulation) LivaNova operates under extensive global regulations, including FDA clearance, EU MDR compliance, patient privacy laws, and anti-corruption statutes - Medical devices require **510(k) clearance** or **Pre-Market Approval (PMA)** from the FDA for U.S. market entry[64](index=64&type=chunk) - The company is updating products to comply with the new **EU Medical Device Regulation (Reg MDR)**, imposing stricter requirements with a May 2024 deadline[66](index=66&type=chunk) - The company is subject to patient privacy laws like **HIPAA** in the U.S. and **GDPR** in the EU, with significant non-compliance fines[76](index=76&type=chunk) - Operations are subject to anti-corruption laws like the **U.S. FCPA** and **UK Bribery Act**, and healthcare fraud and abuse laws like the **Anti-Kickback Statute** and **False Claims Act**[81](index=81&type=chunk)[83](index=83&type=chunk) [Human Capital Management](index=14&type=section&id=1.5%20Human%20Capital%20Management) LivaNova employs nearly 4,000 people, focusing on talent retention, core values, diversity, and COVID-19 response measures like remote work and safety protocols - The company employs almost **4,000 people** worldwide, focusing on recruitment, competitive compensation, and professional training for talent retention[93](index=93&type=chunk) - An **ESG Task Force** was created in 2020 to optimize environmental, social, and governance efforts, reporting quarterly to the Nominating and Corporate Governance Committee[96](index=96&type=chunk) - As of December 31, 2020, women comprised **27%** of the Board, **27%** of the Executive Team, and **56%** of the total workforce[101](index=101&type=chunk) - In response to COVID-19, the company enabled remote work for most staff and implemented additional safety measures for on-site employees[103](index=103&type=chunk) [Risk Factors](index=15&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant risks including intense competition, supply chain issues, complex regulations, product liability, COVID-19 impacts, and financial risks related to debt and asset impairment - The company faces high competition, potential supply chain interruptions, and complex, costly government regulations[109](index=109&type=chunk)[111](index=111&type=chunk)[113](index=113&type=chunk) - Significant product liability risk exists, highlighted by ongoing litigation for the **3T Heater-Cooler product**, with a **$294.1 million** provision recognized in 2018[123](index=123&type=chunk)[125](index=125&type=chunk) - The **COVID-19 pandemic** materially impacted sales and operating results due to suspended elective medical procedures and remains a risk[145](index=145&type=chunk)[146](index=146&type=chunk) - The company may incur impairments of intangible assets and goodwill, totaling **$1.4 billion** (**56.4% of total assets**) at year-end 2020, with significant impairments in 2020 and 2019[158](index=158&type=chunk) - Risks related to debt include ability to make payments on the Term Loan and Notes, potential repurchase obligations, and restrictive covenants[168](index=168&type=chunk)[169](index=169&type=chunk)[172](index=172&type=chunk) [Unresolved Staff Comments](index=28&type=section&id=Item%201B.%20Unresolved%20Staff%20Comments) The company reports no unresolved staff comments from the SEC - None [Properties](index=28&type=section&id=Item%202.%20Properties) LivaNova's principal executive office is leased in the UK, operating approximately 1.4 million square feet of global manufacturing and research facilities, 65% of which are owned - The company has manufacturing and research facilities totaling approximately **1.4 million square feet** in six countries, with about **65%** owned[192](index=192&type=chunk) - The principal executive office is leased in the UK, with segment headquarters in the U.S. (Neuromodulation) and Italy (Cardiovascular)[192](index=192&type=chunk) [Legal Proceedings](index=28&type=section&id=Item%203.%20Legal%20Proceedings) The company is involved in material legal proceedings, including product liability for the 3T Heater-Cooler, environmental liabilities, and VNS Therapy System patent litigation - Information on material legal proceedings is incorporated by reference from Note 15 of the consolidated financial statements[194](index=194&type=chunk) [Mine Safety Disclosures](index=28&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable Part II [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=29&type=section&id=Item%205.%20Market%20for%20Registrant%27s%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) LivaNova's ordinary shares trade on NASDAQ under 'LIVN', with no current dividend intention and an expired $150.0 million share repurchase program - The company's ordinary shares are traded on the **NASDAQ Global Market** under the symbol **'LIVN'**[198](index=198&type=chunk) - The company currently has no intention to declare and pay dividends[199](index=199&type=chunk) - A **$150.0 million** share repurchase program expired on December 31, 2018, with no shares repurchased since[200](index=200&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=31&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) LivaNova's 2020 financial performance was significantly impacted by COVID-19, leading to decreased sales, a net loss, and strategic financing actions to bolster liquidity - The **COVID-19 pandemic** materially impacted 2020 sales and operating results due to delayed or suspended elective procedures[208](index=208&type=chunk)[209](index=209&type=chunk) Consolidated Results of Operations (in thousands) | | 2020 (in thousands) | 2019 (in thousands) | | :--- | :--- | :--- | | **Net sales** | **$934,241** | **$1,084,170** | | Operating loss from continuing operations | $(269,864) | $(168,870) | | Net loss from continuing operations | $(343,515) | $(155,541) | | **Net loss** | **$(345,008)** | **$(155,176)** | - The company recorded a **$180.2 million** impairment of the Heart Valves disposal group and a **$21.3 million** impairment of associated goodwill in 2020[287](index=287&type=chunk) - To bolster liquidity, the company entered a **$450.0 million** senior secured term loan and issued **$287.5 million** in cash exchangeable senior notes in June 2020[336](index=336&type=chunk)[337](index=337&type=chunk) [Results of Operations](index=37&type=section&id=7.1%20Results%20of%20Operations) In 2020, net sales decreased by 13.8% to $934.2 million due to COVID-19, leading to a widened operating loss from continuing operations of $269.9 million, exacerbated by impairments Net Sales by Segment (2020 vs. 2019, in thousands) | Segment | 2020 (in thousands) | 2019 (in thousands) | % Change | | :--- | :--- | :--- | :--- | | Cardiovascular | $577,083 | $656,646 | (12.1)% | | Neuromodulation | $354,444 | $424,547 | (16.5)% | | **Total Net Sales** | **$934,241** | **$1,084,170** | **(13.8)%** | - Cardiovascular sales declined due to reduced heart-lung machine and oxygenator sales from COVID-19, partially offset by a **32.6% increase** in Advanced Circulatory Support sales[261](index=261&type=chunk) - Neuromodulation sales declined primarily due to fewer new patient and end-of-service implants caused by COVID-19 procedure delays[265](index=265&type=chunk) - Operating loss from continuing operations widened to **$269.9 million** in 2020 from **$168.9 million** in 2019, driven by impairments, a decommissioning provision, and lower sales[256](index=256&type=chunk) [Liquidity and Capital Resources](index=47&type=section&id=7.2%20Liquidity%20and%20Capital%20Resources) As of December 31, 2020, cash and equivalents increased to $252.8 million due to new financing, despite $79.4 million net cash used in operations, with total contractual obligations of $1.28 billion Cash Flow Summary (in thousands) | Activity | 2020 (in thousands) | 2019 (in thousands) | | :--- | :--- | :--- | | Net cash (used in) operating activities | $(79,422) | $(91,142) | | Net cash used in investing activities | $(41,844) | $(41,290) | | Net cash provided by financing activities | $310,756 | $146,581 | - Total debt increased to **$655.6 million** at year-end 2020 from **$337.7 million** at year-end 2019, mainly due to new Term Loan and Exchangeable Notes[346](index=346&type=chunk) Contractual Obligations as of Dec 31, 2020 (in thousands) | Obligation | Total (in thousands) | | :--- | :--- | | Principal payments on debt | $757,177 | | Interest payments on long-term debt | $196,847 | | Operating leases | $59,667 | | Contingent consideration | $103,818 | | **Total Contractual Obligations** | **$1,280,079** | [Controls and Procedures](index=51&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management and independent auditors concluded that the company's disclosure controls and internal control over financial reporting were effective as of December 31, 2020 - The CEO and CFO concluded that disclosure controls and procedures were effective as of December 31, 2020[362](index=362&type=chunk) - Management concluded that internal control over financial reporting was effective as of December 31, 2020, based on the **COSO (2013) framework**[364](index=364&type=chunk) - **PricewaterhouseCoopers LLP** confirmed the effectiveness of internal control over financial reporting as of December 31, 2020[365](index=365&type=chunk) Part III [Directors, Executive Compensation, Security Ownership, and Principal Accountant Fees](index=53&type=section&id=Item%2010%2C%2011%2C%2012%2C%2013%2C%2014) Information for Items 10-14 is incorporated by reference from the 2021 Proxy Statement, and the company has adopted a Code of Business Conduct and Ethics - Information for Items 10, 11, 12, 13, and 14 is incorporated by reference from the **2021 Proxy Statement**[370](index=370&type=chunk)[372](index=372&type=chunk)[373](index=373&type=chunk) - The company has adopted a **Code of Business Conduct and Ethics** applicable to all employees, officers, and directors[371](index=371&type=chunk) Part IV [Exhibits, Financial Statement Schedules](index=54&type=section&id=Item%2015.%20Exhibits%2C%20Financial%20Statement%20Schedules) This section includes the consolidated financial statements, the independent auditor's report, and an index of exhibits, with financial statement schedules omitted as applicable - The Consolidated Financial Statements of LivaNova PLC and the Report of Independent Registered Public Accounting Firms are included, beginning on page **F-1**[378](index=378&type=chunk) - All financial statement schedules required by **Regulation S-X** have been omitted as not applicable or included in notes[379](index=379&type=chunk) [Financial Statements](index=61&type=section&id=Financial%20Statements) The 2020 audited financial statements show a net loss of $345.0 million on $934.2 million net sales, with total assets of $2.41 billion, and an unqualified auditor's opinion on financials and internal controls Key Financial Statement Data for FY 2020 (in thousands) | Metric | Amount (in thousands) | | :--- | :--- | | **Statement of Income:** | | | Net Sales | $934,241 | | Operating Loss from Continuing Operations | $(269,864) | | Net Loss | $(345,008) | | **Balance Sheet (End of Period):** | | | Total Assets | $2,411,351 | | Total Liabilities | $1,292,522 | | Total Stockholders' Equity | $1,118,829 | | **Cash Flow Statement:** | | | Net Cash Used in Operating Activities | $(79,422) | | Net Cash Used in Investing Activities | $(41,844) | | Net Cash Provided by Financing Activities | $310,756 | - The auditor's report from **PricewaterhouseCoopers LLP** provides an unqualified opinion on the financial statements and internal controls[394](index=394&type=chunk) - The auditor identified goodwill impairment assessment for the Cardiovascular reporting unit as a **Critical Audit Matter** due to significant management judgment in fair value estimation[402](index=402&type=chunk)[403](index=403&type=chunk)

Financial Performance - Q4 2020 - Net sales decreased by 7.7% to $270 million[15] - Cardiovascular sales decreased by 10.1% to $159.6 million[22] - Cardiopulmonary sales decreased by 10.0%[22] - Heart Valves sales decreased significantly by 27.2%[22] - Advanced Circulatory Support sales increased significantly by 50.3%[22] - Neuromodulation sales decreased by 3.8%[23] - Adjusted segment operating income was $48.6 million, representing 18.0% of sales[24] - Adjusted diluted EPS was $0.71[44] Financial Performance - Full Year 2020 - Net sales decreased by 13.7% to $934 million[18] - Adjusted diluted EPS was $3.79[65] 2021 Guidance - Worldwide net sales growth is projected to be between 8% and 13%[74] - Diluted EPS is projected to be between $1.40 and $1.90[74] - Free Cash Flow (excluding extraordinary items) is projected to be between $30 million and $50 million[74]

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: September 30, 2020 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 ...

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, 2020 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 ...

[PART I. FINANCIAL INFORMATION](index=3&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Note About Forward Looking Statements](index=3&type=section&id=Note%20About%20Forward%20Looking%20Statements) The report contains forward-looking statements subject to risks like COVID-19, regulatory changes, and market acceptance, which may cause actual results to differ materially - Forward-looking statements are not guarantees and are subject to risks including **regulatory changes**, **market acceptance failures**, **competition**, **cyber-attacks**, and **COVID-19 impact**[9](index=9&type=chunk)[10](index=10&type=chunk)[15](index=15&type=chunk) [Condensed Consolidated Financial Statements](index=5&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements) Q1 2020 saw a 3.4% sales decrease but a net income of **$37.6 million** driven by a **$44.7 million** tax benefit, with a solid balance sheet despite COVID-19 liquidity impacts [Condensed Consolidated Statements of Income (Loss)](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Income%20%28Loss%29) Q1 2020 net sales decreased to **$242.4 million**, but operating income improved to **$0.6 million**, resulting in **$38.6 million** net income from a **$44.7 million** tax benefit Condensed Consolidated Statements of Income (Loss) (in thousands) | Financial Metric | Three Months Ended March 31, 2020 | Three Months Ended March 31, 2019 | | :--- | :--- | :--- | | Net sales | $242,397 | $250,801 | | Operating income (loss) from continuing operations | $608 | $(20,779) | | Net income (loss) from continuing operations | $38,578 | $(14,849) | | Net income (loss) | $37,583 | $(14,849) | | Diluted income (loss) per share | $0.77 | $(0.31) | - Profitability significantly boosted by a **$44.7 million** income tax benefit in Q1 2020, compared to a **$6.6 million** benefit in the prior year period[17](index=17&type=chunk) [Condensed Consolidated Balance Sheets](index=7&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of March 31, 2020, total assets were **$2.45 billion**, with cash doubling to **$125.8 million**, total liabilities at **$1.06 billion**, and stockholders' equity at **$1.39 billion** Condensed Consolidated Balance Sheets (in thousands) | Balance Sheet Item | March 31, 2020 | December 31, 2019 | | :--- | :--- | :--- | | Cash and cash equivalents | $125,823 | $61,137 | | Total Current Assets | $616,922 | $549,443 | | Total Assets | $2,454,436 | $2,411,797 | | Total Current Liabilities | $529,724 | $512,553 | | Total Liabilities | $1,061,728 | $1,028,080 | | Total Stockholders' Equity | $1,392,708 | $1,383,717 | - Current litigation provision liability decreased substantially from **$146.0 million** at year-end 2019 to **$43.0 million**, reflecting 3T device litigation settlement payments[21](index=21&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Q1 2020 net cash used in operations was **$106.0 million** due to litigation payments, offset by **$183.1 million** from financing, resulting in a **$64.7 million** net increase in cash Condensed Consolidated Statements of Cash Flows (in thousands) | Cash Flow Activity | Three Months Ended March 31, 2020 | Three Months Ended March 31, 2019 | | :--- | :--- | :--- | | Net cash (used in) provided by operating activities | $(106,045) | $1,974 | | Net cash used in investing activities | $(11,085) | $(5,641) | | Net cash provided by financing activities | $183,093 | $7,589 | | Net increase in cash and cash equivalents | $64,686 | $3,572 | - Significant cash outflow from operations driven by a **$115.6 million** payment for litigation provision liability[24](index=24&type=chunk) - Company raised significant capital through financing activities, with **$162.9 million** in proceeds from long-term debt obligations[24](index=24&type=chunk) [Notes to the Condensed Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20the%20Condensed%20Consolidated%20Financial%20Statements) Notes detail COVID-19 impact, debt covenant amendments, FDA clearance for 3T Heater-Cooler devices, a **$225 million** 3T litigation settlement framework, and a **$41.3 million** CARES Act tax benefit - Significant decline in product demand in late Q1 2020 due to **COVID-19** and **postponement of elective surgeries**[27](index=27&type=chunk) - Anticipated debt covenant breach due to **COVID-19 sales reductions** was alleviated by **April 2020 amendments**, mitigating going concern doubt[28](index=28&type=chunk)[60](index=60&type=chunk)[174](index=174&type=chunk) - Received **FDA 510(k) clearance** for 3T Heater-Cooler devices in February 2020, resolving 2015 Warning Letter issues and lifting an import alert[44](index=44&type=chunk)[72](index=72&type=chunk)[139](index=139&type=chunk) - 3T device litigation settlement framework provides for up to **$225 million** in payments, with **$90 million** paid in January 2020, leaving a **$54.6 million** provision as of March 31, 2020[78](index=78&type=chunk)[81](index=81&type=chunk)[143](index=143&type=chunk) - Recorded a discrete tax benefit of **$41.3 million** in Q1 2020 from the **U.S. CARES Act**, allowing a 5-year net operating loss carryback[103](index=103&type=chunk)[173](index=173&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=31&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses **COVID-19's adverse impact** on sales, a **3.4% decrease**, but improved operating income due to contingent consideration and reduced legal costs, with debt covenant amendments strengthening liquidity [Results of Operations](index=35&type=section&id=Results%20of%20Operations) Q1 2020 net sales decreased **3.4%** to **$242.4 million**, with Cardiovascular down **2.2%** and Neuromodulation down **5.3%**, while cost of sales improved due to a **$14.8 million** fair value adjustment Net Sales by Segment (in millions) | Segment | Q1 2020 Net Sales ($M) | Q1 2019 Net Sales ($M) | % Change | | :--- | :--- | :--- | :--- | | Cardiovascular | 152.1 | 155.5 | (2.2)% | | - Cardiopulmonary | 116.4 | 121.6 | (4.3)% | | - Heart Valves | 25.2 | 25.7 | (1.8)% | | - Advanced Circulatory Support | 10.5 | 8.2 | 27.2% | | Neuromodulation | 89.7 | 94.6 | (5.3)% | | **Total** | **242.4** | **250.8** | **(3.4)%** | - Neuromodulation sales decreased primarily due to **declines in new patient implants globally** as procedures were delayed by **COVID-19**[164](index=164&type=chunk) - Cost of sales and R&D expenses as a percentage of sales decreased due to favorable net changes in contingent consideration fair value, totaling **$14.8 million** and **$11.9 million** respectively[167](index=167&type=chunk)[168](index=168&type=chunk) [Liquidity and Capital Resources](index=38&type=section&id=Liquidity%20and%20Capital%20Resources) COVID-19's anticipated impact raised substantial doubt about debt covenant compliance, but **April 2020 amendments** and cost-cutting alleviated going concern risk, despite **$106.0 million** cash use from operations - Projected sales reduction from **COVID-19** would lead to debt covenant non-compliance, raising substantial doubt about going concern ability[174](index=174&type=chunk) - April 2020 debt agreement amendments modified financial covenants, alleviating substantial doubt about the company's going concern ability for the next twelve months[174](index=174&type=chunk) Cash Flow Summary (in thousands) | Cash Flow Activity (in thousands) | Three Months Ended March 31, 2020 | | :--- | :--- | | Operating activities | $ (106,045) | | Investing activities | $ (11,085) | | Financing activities | $ 183,093 | | **Net increase in cash** | **$ 64,686** | [Quantitative and Qualitative Disclosures About Market Risk](index=39&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) Company manages market risks from **foreign currency** and **interest rates** through operations and derivatives, with no material changes since the 2019 Form 10-K - Primary market risks stem from **foreign currency exchange rates** and **interest rates**, managed through business activities and derivatives[184](index=184&type=chunk) - No material changes in the company's market risk profile from the 2019 Form 10-K information[184](index=184&type=chunk) [Controls and Procedures](index=40&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, including CEO and CFO, deemed disclosure controls and procedures effective as of **March 31, 2020**, with no material changes to internal control over financial reporting - CEO and CFO concluded disclosure controls and procedures were **effective** as of **March 31, 2020**[185](index=185&type=chunk) - No material changes occurred during the quarter affecting internal control over financial reporting[186](index=186&type=chunk) [PART II. OTHER INFORMATION](index=41&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Legal Proceedings](index=41&type=section&id=Item%201.%20Legal%20Proceedings) This section refers to Note 10 for detailed descriptions of material pending legal proceedings, including **product liability**, **environmental**, **patent**, and **tax disputes** - Report refers to "Note 10. Commitments and Contingencies" for descriptions of material pending legal and regulatory proceedings[188](index=188&type=chunk) [Risk Factors](index=41&type=section&id=Item%201A.%20Risk%20Factors) Primary risk factor update is the ongoing adverse effect of the **COVID-19 pandemic** on business, financial position, and liquidity, through deferred surgeries and supply chain disruptions - **COVID-19 outbreak** identified as a significant risk factor adversely affecting business, financial position, and liquidity[190](index=190&type=chunk) - Company expects **Q2 2020 sales and operating results** to be materially adversely impacted by the pandemic[192](index=192&type=chunk) - Pandemic could disrupt product distribution, cause temporary facility closures, and interrupt component and raw material supply[193](index=193&type=chunk) [Other Information](index=42&type=section&id=Item%205.%20Other%20Information) Company discloses two non-U.S. subsidiaries sell medical devices to distributors in Iran, generating **$0.5 million** gross revenue and **$0.2 million** net profit for Q1 2020 - Pursuant to Section 13(r) of the Exchange Act, company disclosed two non-U.S. subsidiaries sell medical devices to private distributors in Iran[199](index=199&type=chunk) Iran-Related Business Metrics (Q1 2020) | Metric | Amount (Q1 2020) | | :--- | :--- | | Gross Revenues from Iran | $0.5 million | | Net Profits from Iran | $0.2 million |

PART I [Item 1. Business](index=5&type=section&id=Item%201.%20Business) LivaNova is a global medical device company operating through Cardiovascular and Neuromodulation business franchises - LivaNova operates through two principal business franchises, which are also its reportable segments: **Cardiovascular** and **Neuromodulation**[18](index=18&type=chunk) - The Cardiovascular business develops, produces, and sells cardiopulmonary products, heart valves, and advanced circulatory support systems[20](index=20&type=chunk)[21](index=21&type=chunk)[23](index=23&type=chunk) - The Neuromodulation business markets devices for treating epilepsy, depression, and obstructive sleep apnea, with its core product being the **VNS Therapy System**[24](index=24&type=chunk)[25](index=25&type=chunk) - The company protects its intellectual property with over **1,000 issued patents** worldwide as of December 31, 2019[45](index=45&type=chunk) - In November 2019, the company announced the **termination of its Caisson transcatheter mitral valve replacement (TMVR) program**[41](index=41&type=chunk) - The company's business is subject to extensive government regulation by agencies like the **FDA** and is preparing for compliance with the new **EU Medical Device Regulation (Reg MDR)**[55](index=55&type=chunk)[60](index=60&type=chunk) [Item 1A. Risk Factors](index=15&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant risks from competition, supply chain issues, regulations, and product liability claims - The company operates in **highly competitive markets** and faces pricing pressure from managed care and provider consolidation[93](index=93&type=chunk)[94](index=94&type=chunk) - Extensive government regulations (FDA, EU's Reg MDR) present **significant compliance costs** and risks of product approval delays[97](index=97&type=chunk)[104](index=104&type=chunk) - The company is exposed to significant product liability risks, particularly from its 3T Heater-Cooler litigation, with provisions of **$294.1 million in 2018** and **$33.2 million in 2019**[108](index=108&type=chunk)[111](index=111&type=chunk) - **Cybersecurity threats** pose a risk to IT systems and products, with potential for data breaches and regulatory fines[119](index=119&type=chunk)[121](index=121&type=chunk) - International operations are subject to risks including foreign currency fluctuations, political instability, health epidemics, and **uncertainties related to Brexit**[131](index=131&type=chunk)[134](index=134&type=chunk)[151](index=151&type=chunk) - The company recorded significant impairment charges in 2019 related to the **ImThera IPR&D asset ($50.3 million)** and the discontinuation of the **Caisson business (goodwill of $42.4 million and IPR&D of $89.0 million)**[141](index=141&type=chunk) [Item 2. Properties](index=25&type=section&id=Item%202.%20Properties) The company operates 11 global facilities totaling 1.3 million square feet, with 66% of this space being owned - The company's principal executive office is leased and located in the UK[156](index=156&type=chunk) - Manufacturing and research facilities are located globally, totaling approximately **1.3 million square feet**[156](index=156&type=chunk) - Approximately **66% of the manufacturing and research facility space is owned** by the company[156](index=156&type=chunk) [Item 3. Legal Proceedings](index=25&type=section&id=Item%203.%20Legal%20Proceedings) Material legal proceedings are incorporated by reference from Note 14 of the consolidated financial statements - Details on material legal proceedings are provided in **Note 14** of the consolidated financial statements[158](index=158&type=chunk) PART II [Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=26&type=section&id=Item%205.%20Market%20for%20Registrant's%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) The company's shares trade on NASDAQ under "LIVN" with no current dividend plans or active share repurchase programs - The company's ordinary shares are traded on the NASDAQ Global Market under the symbol **"LIVN"**[162](index=162&type=chunk) - LivaNova has **no current intention to declare and pay dividends**[165](index=165&type=chunk) - A share repurchase program authorizing up to **$150.0 million** in buybacks expired on December 31, 2018[166](index=166&type=chunk) [Item 6. Selected Financial Data](index=28&type=section&id=Item%206.%20Selected%20Financial%20Data) The company reported net sales of $1.084 billion and a net loss of $155.2 million for fiscal year 2019 Selected Financial Data | Metric (In thousands, except per share data) | Year Ended Dec 31, 2019 | Year Ended Dec 31, 2018 | Year Ended Dec 31, 2017 | | :--- | :--- | :--- | :--- | | **Net sales** | $1,084,170 | $1,106,961 | $1,012,277 | | **Operating (loss) income from continuing operations** | $(168,870) | $(248,072) | $96,487 | | **Net (loss) income from continuing operations** | $(155,541) | $(178,462) | $54,465 | | **Net (loss) income** | $(155,176) | $(189,399) | $(25,089) | | **Diluted (loss) per share** | $(3.21) | $(3.91) | $(0.52) | | **Total assets** | $2,411,797 | $2,549,701 | $2,503,891 | | **Stockholders' equity** | $1,383,717 | $1,503,738 | $1,815,314 | [Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=30&type=section&id=Item%207.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Net sales decreased 2.1% in 2019, resulting in an operating loss impacted by asset impairments and negative cash flow [Results of Operations](index=35&type=section&id=Results%20of%20Operations) Net sales fell 2.1% in 2019, with a net loss of $155.5 million driven by asset impairments of $181.7 million Net Sales by Segment (in thousands) | Net Sales by Segment (in thousands) | 2019 | 2018 | % Change | | :--- | :--- | :--- | :--- | | Cardiovascular | $656,646 | $681,825 | (3.7)% | | Neuromodulation | $424,547 | $422,990 | 0.4% | | **Total Net Sales** | **$1,084,170** | **$1,106,961** | **(2.1)%** | - Cardiovascular sales declined **5.9% in Cardiopulmonary products**, partly due to exiting a Canadian distribution agreement, and **4.7% in Heart Valves**[222](index=222&type=chunk) - Neuromodulation sales growth was driven by Europe and Rest of World, offset by a **decline in U.S. sales** due to competitive dynamics[226](index=226&type=chunk) - In 2019, the company recorded impairments of **goodwill ($42.4M)** and **intangible assets ($139.3M)** related to the Caisson and ImThera programs[248](index=248&type=chunk)[249](index=249&type=chunk) - The 2018 results included a **$294.1 million litigation provision** for the 3T device, while 2019 saw an additional **$33.2 million provision** offset by an insurance recovery[253](index=253&type=chunk) [Liquidity and Capital Resources](index=46&type=section&id=Liquidity%20and%20Capital%20Resources) Operating cash flow turned negative to ($91.1 million) due to $156.9 million in litigation payments, increasing total debt Cash Flow Summary (in thousands) | Cash Flow Summary (in thousands) | 2019 | 2018 | | :--- | :--- | :--- | | Net cash (used in) provided by operating activities | $(91,142) | $120,489 | | Net cash used in investing activities | $(41,290) | $(120,556) | | Net cash provided by (used in) financing activities | $146,581 | $(42,348) | - The negative shift in operating cash flow was primarily due to **$156.9 million in 3T litigation settlement payments** made during 2019[300](index=300&type=chunk) - **Total debt increased to $337.7 million** as of Dec 31, 2019, compared to $168.3 million as of Dec 31, 2018[305](index=305&type=chunk) - As of December 31, 2019, the company had significant contractual obligations totaling **$678.3 million**, including **$90.0 million for 3T litigation settlements** due in less than one year[309](index=309&type=chunk) [Item 7A. Quantitative and Qualitative Disclosures About Market Risk](index=49&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company is exposed to foreign currency, interest rate, and credit risks, which it manages using derivatives - The company is exposed to market risks from **foreign currency exchange rates, interest rates, and credit concentration**[313](index=313&type=chunk) - A **foreign currency exchange rate risk management strategy** utilizing derivatives is in place to reduce exposure[314](index=314&type=chunk) - **Interest rate risk** on debt is managed in part through interest rate swap contracts[316](index=316&type=chunk) [Item 9A. Controls and Procedures](index=49&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective following the remediation of prior material weaknesses - Management concluded that **disclosure controls and procedures were effective** as of December 31, 2019[322](index=322&type=chunk) - Management's assessment concluded that **internal control over financial reporting was effective** as of December 31, 2019[324](index=324&type=chunk) - The company **remediated previously disclosed material weaknesses** concerning IT access controls and billing processes[327](index=327&type=chunk)[328](index=328&type=chunk) PART III [Item 10. Directors, Executive Officers and Corporate Governance](index=51&type=section&id=Item%2010.%20Directors%2C%20Executive%20Officers%20and%20Corporate%20Governance) Required information on directors, officers, and governance is incorporated by reference from the 2020 Definitive Proxy Statement - Information is incorporated by reference from the **2020 Definitive Proxy Statement**[331](index=331&type=chunk) [Item 11. Executive Compensation](index=51&type=section&id=Item%2011.%20Executive%20Compensation) Required information regarding executive compensation is incorporated by reference from the 2020 Definitive Proxy Statement - Information is incorporated by reference from the **2020 Definitive Proxy Statement**[333](index=333&type=chunk) [Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=51&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) Required information concerning security ownership is incorporated by reference from the 2020 Definitive Proxy Statement - Information is incorporated by reference from the **2020 Definitive Proxy Statement**[334](index=334&type=chunk) [Item 13. Certain Relationships and Related Transactions, and Director Independence](index=51&type=section&id=Item%2013.%20Certain%20Relationships%20and%20Related%20Transactions%2C%20and%20Director%20Independence) Required information on related party transactions is incorporated by reference from the 2020 Definitive Proxy Statement - Information is incorporated by reference from the **2020 Definitive Proxy Statement**[335](index=335&type=chunk) [Item 14. Principal Accounting Fees and Services](index=51&type=section&id=Item%2014.%20Principal%20Accounting%20Fees%20and%20Services) Required information on accounting fees is incorporated by reference from the 2020 Definitive Proxy Statement - Information is incorporated by reference from the **2020 Definitive Proxy Statement**[336](index=336&type=chunk) PART IV [Item 15. Exhibits, Financial Statement Schedules](index=52&type=section&id=Item%2015.%20Exhibits%2C%20Financial%20Statement%20Schedules) This section lists the financial statements, schedules, and exhibits filed as part of the annual report - This item contains the **Consolidated Financial Statements** and the Report of Independent Registered Public Accounting Firms[339](index=339&type=chunk) - An **index to all exhibits** filed with the Form 10-K is provided[341](index=341&type=chunk)

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: September 30, 2019 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 ...

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, 2019 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 ...

_________________________ Form 10-Q UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 (Mark One) þ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2019 ¨ 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 charter ...