LivaNova(LIVN)

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LivaNova(LIVN) - 2021 Q2 - Earnings Call Transcript
2021-07-28 17:18
LivaNova PLC (NASDAQ:LIVN) Q2 2021 Earnings Conference Call July 28, 2021 8:00 AM ET Company Participants Matthew Dodds - SVP, Corporate Development Damien McDonald - CEO Alex Shvartsburg - Interim CFO Lindsey Little - Senior Director, IR Conference Call Participants Rick Wise - Stifel Mike Matson - Needham & Company Adam Maeder - Piper Sandler Michael Polark - Baird Anthony Petrone - Jefferies Matt Taylor - UBS Scott Bardo - Berenberg Company Operator Good day, ladies and gentlemen, and welcome to LivaNova ...
LivaNova(LIVN) - 2021 Q2 - Earnings Call Presentation
2021-07-28 14:47
alth innovation f Second Quarter 2021 Earnings Performance July 28, 2021 Starr, VNS Therapy Patient 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 and Section 21E of the Securities Exchange Act of 1934, as amended (the "Exchange Act"). These statements include, but are not limited to, LivaNova's plans, objectives, str ...
LivaNova(LIVN) - 2021 Q1 - Earnings Call Transcript
2021-05-01 15:13
LivaNova PLC (NASDAQ:LIVN) Q1 2021 Earnings Conference Call April 28, 2021 7:00 AM ET Company Participants Matthew Dodds - Senior Vice President of Corporate Development Damien McDonald - Chief Executive Officer Alex Shvartsburg - Interim Chief Financial Officer Melissa Farina - Vice President of Investor Relations Conference Call Participants Rick Wise - Stifel Adam Maeder - Piper Sandler Anthony Petrone - Jefferies Michael Polark - Baird Scott Bardo - Berenberg Matthew Taylor - UBS Mike Matson - Needham ...
LivaNova(LIVN) - 2021 Q1 - Earnings Call Presentation
2021-04-30 12:09
First Quarter 2021 Earnings Performance April 28, 2021 Rosario, a VNS Therapy Patient Health innovation that matters 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 and Section 21E of the Securities Exchange Act of 1934, as amended (the "Exchange Act"). These statements include, but are not limited to, LivaNova's plans ...
LivaNova(LIVN) - 2021 Q1 - Quarterly Report
2021-04-28 19:08
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, 2021 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 ...
LivaNova (LIVN) Cardiopulmonary Technology Presentation - Slideshow
2021-04-20 18:23
1 LivaNova Education Series: Cardiopulmonary Nearly Half a Century of Technology Intended for Investor Use Only - Not Intended for Use by Patients or HCPs 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 and Section 21E of the Securities Exchange Act of 1934, as amended (the "Exchange Act"). These statements include, bu ...
LivaNova(LIVN) - 2020 Q4 - Annual Report
2021-03-01 20:32
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)
LivaNova(LIVN) - 2020 Q4 - Earnings Call Presentation
2021-02-26 13:58
Fourth Quarter and Full-Year 2020 Earnings Performance February 24, 2021 6IEN G Health innovation that matters 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 and Section 21E of the Securities Exchange Act of 1934, as amended (the "Exchange Act"). These statements include, but are not limited to, LivaNova's plans, obje ...
LivaNova(LIVN) - 2020 Q3 - Quarterly Report
2020-10-29 18:58
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 ...
LivaNova(LIVN) - 2020 Q2 - Quarterly Report
2020-07-29 21:27
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 ...