LivaNova PLC (LIVN) Earnings Call Transcript & Summary

Hello, and welcome to the LivaNova PLC 2020 Annual General Meeting of Shareholders. Please note that today's meeting is being recorded. [Operator Instructions] It is now my please to turn today's meeting over to Daniel Moore, Chairman of the Board of LivaNova. Mr. Moore, the floor is yours.

Thank you, Nova. Hello, and welcome to all attending LivaNova's Annual General Meeting. I'm Dan Moore, and it's my pleasure to be speaking on behalf of the Board of Directors of LivaNova for my fifth Annual General Meeting as Chairman of the Board. We are conducting this meeting virtually to ensure we are adhering to best practices in this time of social distancing. Our goal is to avoid the spread of COVID-19, while also facilitating and maximizing the participation of our shareholders remotely regardless of their location in the world. Virtual meeting is a live audio cast and you may raise questions by typing your remarks in the designated box on your screen using the message icon. To ensure the questions raised reach me in a timely manner, please submit any questions as soon as possible. We will address questions at the end of the meeting. When asking a question, please first give your name and state whether you are a shareholder, proxy or corporate representative. If you are a proxy or corporate representative, please state the name of the shareholder you are representing. Please note that a copy of the agenda and the rules of conduct can be viewed by clicking on the links on the virtual meeting website. Also for your convenience, a copy of the agenda is being displayed on the Meeting Center screen. I understand from the company's Secretary that the notice of Annual General Meeting has been sent to all shareholders and to all other people entitled to receive it and that the quorum requirements have been met. It is now just after 13:00 in London, and I am pleased to declare LivaNova's 2020 Annual General Meeting formally open. I will start by introducing LivaNova's Board of Directors: our Chief Executive Officer, Damien McDonald; Francesco Bianchi; Ms. Stacy Enxing Seng; Mr. Bill Kozy; Mr. Hugh Morrison; Mr. Alfred Novak; Dr. Sharon O'Kane; Dr. Arthur Rosenthal; and Ms. Andrea Saia. It is my pleasure to also introduce a number of the company's officers. We have our General Counsel and Company Secretary, Ms. Keyna Skeffington; our Chief Financial Officer, Mr. Thad Huston; our Chief Resources Officer, Ms. Trui Hebbelinck; and our Senior Vice President for Business Development, Mr. Matt Dodds. We are also joined today by representatives of PricewaterhouseCooper LLP, LivaNova's independent registered public accountancy firm in the United States, who will be available for questions during the Q&A portion of the meeting. We also have representatives of our company's U.K. statutory auditors, PricewaterhouseCoopers LLP, who are also available for questions. Computershare, our transfer agent registrar, is acting as Scrutineer for the voting today and is being represented by Mr. Mark Cano. Now it's my pleasure to introduce Keyna Skeffington, our General Counsel and Company Secretary, who will explain the voting procedures. Keyna?

Thank you, Dan. Based on a preliminary report from the Scrutineer, of the 48,584,653 shares entitled to vote at the meeting, more than 42,900,000 shares, representing approximately 88% of all the voting rights of the shareholders entitled to vote, voted as of the start of the meeting. The final results of the voting, including the proxy votes on each of the resolutions will be published on our website and notified through a Form 8-K filed with the U.S. Securities and Exchange Commission as soon as possible after today's meeting. Shareholders and proxies who have not yet voted by completing a proxy card and delivering it to our registrars before the meeting or by submitting a proxy via the Internet or the telephone, may vote now by clicking on the Cast Your Vote icon. The voting will close at 9:00 a.m. Eastern Time. You have 3 options for each resolution. You may vote for the proposed resolution, against the proposed resolution or you may abstain from voting on the resolution. Abstentions have no legal effect under English law and will not be counted in the calculation of the proportion of votes for or against a resolution. I now give the floor back to Dan Moore, who will present the resolutions.

Thank you, Keyna. We will now proceed to vote on the resolutions proposed for the meeting. Notice of this meeting, together with LivaNova's proxy statement, U.K. annual report for the year ended December 31, 2019, and the U.S. annual report on Form 10-K for the year ended December 31, 2019, were posted and mailed to shareholders of the company on May 20, 2020. Accordingly, requisite notice of the meeting has been given. There are 10 resolutions with proposal number one, comprising separate resolutions for the election of each of the proposed directors. Resolutions 5 and 6 are special resolutions, which means each resolution requires approval by shareholders representing at least 75% of the votes cast to be passed. All of the other resolutions are ordinary resolutions requiring approval by a simple majority of the shares present at this meeting in person and by proxy and entitled to vote to be passed. The full text for each resolution is set out in the notice of the meeting, a copy of which you have received. In accordance with the recommendation of the Board of Directors, I move the following proposals for approval. Proposal 1 is to elect by separate resolutions, each of the following 10 directors for a term expiring at the AGM to be held in 2021: Mr. Francesco Bianchi, Ms. Stacy Enxing Seng, Mr. William A. Kozy, Mr. Damien McDonald, Mr. Daniel Moore, Mr. Hugh Morrison, Mr. Alfred Novak, Dr. Sharon O'Kane, Dr. Arthur Rosenthal, and Ms. Andrea Saia. Please note that the profiles of all directors are included in the proxy statement. As explained, to vote, please select the Cast Your Vote icon and vote for the resolution, against it or you may abstain from voting. Proposal 2 is to approve, on an advisory basis, LivaNova's compensation of its named officers as set out in the proxy statement. This is otherwise known as a U.S.A. Say on Pay. You are entitled to cast an advisory vote to approve the compensation of our named officers, as disclosed in the proxy statement. Although the voting is nonbinding, the Board values your opinion and will consider the outcome of the vote in establishing compensation philosophy and making future compensation decisions. Proposal 3 is to ratify the appointment of PricewaterhouseCoopers LLP, a Delaware limited liability partnership, which we refer to as PwC U.S.A. as the company's independent registered public accounting firm for the year ending December 31, 2020. Proposal 4, briefly, authorizes the directors to allot shares in the company and to grant rights to subscribe for or to convert any security into shares in the company up to an aggregate nominal amount of GBP 9,882,722. And in addition to the amount set out above, up to an aggregate nominal amount of GBP 3,218,206 in connection with the grant or exercise of awards made under the company's incentive plans from time to time. This authority will be valid for a maximum period of 5 years and is in addition to and does not replace all subsisting authorities previously granted to the directors for the allotment of shares to the extent unused at the date of this resolution. If passed, proposal 4 would provide the company with the ability to raise additional capital and continue to grant equity awards to employees, directors, officers and consultants under its incentive plans. Proposal 5, briefly, grants that the directors -- grants the directors the power to disapply preemption rights for the allotment of equity securities presented in proposal 4 for a period of 5 years. If passed, proposal 5 would allow the company to allot new equity securities or sell treasury shares held by the company without first offering them to shareholders in proportion to their existing holdings up to the amounts set forth in proposal 4. While it is not possible for us to change the terms of proposals 4 and 5, the Board of Directors, after the posting and mailing of the proxy statement and based on advice from stakeholders and advisers, approved restrictions to its authorities for which approval sought under proposals 4 and 5. Notwithstanding that, the authority sought under proposals 4 and 5 are expressed to have a duration of 5 years. The company commits that we will not utilize those authorities for more than 18 months after the AGM, and we'll seek renewal of these authorities at our 2021 AGM. In addition, notwithstanding the higher cap expressed in proposal 5, the company commits that we will not utilize the power granted under proposal 5 to allot new equity securities, otherwise, then in accordance with the existing shareholders' preemption rights in excess of amount equal to 10% of our share capital. Proposal 6 is to approve and adopt the articles of association attached as Appendix A to the proxy statement, which we refer to as the New Articles. The New Articles, among other matters described in the proxy, set forth the voting standard for the election of directors, eliminate provisions from the existing articles of association that no longer apply and are expected to enhance corporate governance practices. Proposal 7 is to approve, on an advisory basis, the U.K. directors' remuneration report in the form set out in the company's U.K. annual report and accounts, the U.K. annual report for the period ending December 31, 2019. The Director's remuneration report is concerned solely with the remuneration of our management and nonmanagement directors and is required under the U.K. Companies Act 2006. All U.K. companies that are quoted companies under the Companies Act are required to put their directors' remuneration report to shareholders. Proposal 8 is to receive and adopt the company's audited U.K. statutory accounts for the year ended December 31, 2019, together with the reports of the directors and the auditors thereon. Proposal 9 is to reappoint PricewaterhouseCoopers LLP, a limited liability partnership organized under the laws of England, which we refer to as PwC U.K. as the company's U.K. statutory auditor under the U.K. Companies Act, to hold office from the conclusion of this 2020 Annual General Meeting until the conclusion of the next general meeting at which the annual report and accounts are laid. Proposal 10 is to authorize the directors and/or the Audit and Compliance Committee of the company to determine the remuneration of PwC U.K. in its capacity as the company's U.K. statutory auditor under the Companies Act 2006. Please select the Cast Your Vote icon and vote for the resolution, against it or you may abstain from voting. For those who have not already voted, you may vote either now or once you have had the opportunity to consider the ensuing Q&A. As a reminder, voting will close at 9:00 a.m. Eastern Daylight Time. [Voting]

I would like now to open the floor to any questions. [Operator Instructions] Does anyone have any questions they would like to raise? Keyna, do we have any questions?

There are no questions.

Well, thank you for your participation during this meeting. As Keyna mentioned, the results of the voting will be published on our website and notified through a Form 8-K filed with the U.S. Securities and Exchange Commission as soon as possible. The formal business having been conducted, I now declare the meeting closed. At this point, I would like to welcome Matt Dodds, Senior Vice President for Business Development, to read the safe harbor, after which Damien McDonald, Chief Executive Officer of LivaNova, will deliver some remarks. Matt?

Thank you, Dan. Before we begin, I would like to remind you that the discussions at this meeting will include forward-looking statements. Factors that can cause actual results to differ materially are discussed in the company's most recent filings and documents furnished to the SEC. We do not undertake to update any forward-looking statement, With that, I will turn the meeting over to Damien.

Thanks, Matt. Welcome, and thank you for joining us at our fifth Annual General Meeting. LivaNova is a $1.1 billion medical device innovator built on decades of experience in the fields of cardiovascular and neuromodulation therapies. Our mission is to provide hope for patients and their families through our innovative medical devices with the ultimate goal of improving their quality of life. During 2019, some areas of our business saw continued progress, while others were impacted by unexpected challenges. While our neuromodulation business overall had another strong year in Europe and Rest of World, a shortfall in our U.S. epilepsy business required us to reset our expectations for the year. This headwind provided us with an opportunity to reevaluate and augment our go-to-market model for this business. We believe the changes implemented put us in a stronger competitive market position. We also made several strategic choices around our portfolio and refined our company's focus on our core growth drivers, margin expansion, cash flow generation and delivering the new product pipeline. We believe that our sharpened focus positions us very well for 2020 and beyond. We like to characterize our business into near-term growth drivers and strategic portfolio initiatives. Starting with the near-term growth drivers. The first is VNS Therapy for epilepsy. With more than 120,000 patients implanted, we believe there is still significant unmet patient need. Our focus is to expand globally and further penetrate the U.S. market through our innovative products and marketing strategies. SenTiva, our latest device now represents the majority of our generator revenue globally. It is the smallest and lightest responsive therapy on the market. The second is advanced circulatory support, or ACS, which is the most exciting segment of the cardiovascular portfolio and our newest. We acquired TandemLife in 2018. The ACS market exceeds $1 billion globally. Growth is in the mid-teens, and our business has been growing above the market rate. We offer a competitive and broad portfolio to treat multiple conditions. We are about to initiate the U.S. commercial release of LifeSPARC, our next-generation pump and controller system. The new system represents a significant technological upgrade with improved ease of use, more power, better flow rate and more versatility. All of these features should allow more physicians to adopt ACS therapies within their practice. Moving to our strategic portfolio initiatives or pipeline, we have 3 opportunities to better serve patients in markets with high unmet need that can accelerate LivaNova's long-term growth. I will now spend a few minutes on each of these opportunities. First, difficult-to-treat depression, or DTD. We have been working for many years to provide VNS Therapy to patients with DTD. Depression is a market that affects over 300 million people worldwide, and it's the leading cause of disability in the U.S. DTD is a smaller subset comprised of patients who have tried 2 or more treatments and failed. While we have FDA approval for our device in the U.S., we have not had reimbursement coverage by Medicare and commercial insurers. Our DTD program had a very successful year in 2019. In early September, the U.S. Centers for Medicare and Medicaid, CMS, accepted our protocol for the RECOVER clinical study, which evaluates VNS Therapy for DTD patients. Under the coverage with evidence framework, CMS is providing reimbursement for patients in the RECOVER study, with the possibility of extending it to a larger registry, which could cover thousands of patients. In February 2020, we announced an exciting partnership with Verily Life Sciences in the RECOVER study to use their proprietary passive and active sensor technologies to explore novel quantitative data measures for assessing the efficacy of DTD treatments. Second, heart failure. In addition to VNS for epilepsy and DTD, specialized forms of VNS may also be used to deliver Autonomic Regulation Therapy, or ART, to bring balance to the cardiovascular function and treat heart failure. Heart failure affects more than 25 million people worldwide. LivaNova's VITARIA system received CE Mark approval in February 2015 and was granted an expedited access pathway designation by the FDA in 2017. Since the initiation of our ANTHEM-HFrEF pivotal trial in late 2018, patient enrollment continues to exceed our expectations, and enrollment surpassed 200 patients. In 2019, we presented results from a 60-patient feasibility study, which showed that VNS Therapy delivered improvements in heart failure symptoms with a durable effect. And third, OSA, or obstructive sleep apnea. We have purchased ImThera in January of 2018, a company that developed a small implantable neurostimulator that targets the hypoglossal nerve to treat patients with OSA. OSA is a condition in which patient's respiratory airway narrows or closes during sleep. Patients with OSA can experience impaired daytime functionality, which is often correlated with other comorbidities, such as heart failure and stroke. With our commercial and manufacturing capabilities, we believe we'll be able to bring this technology to market and improve the lives of many patients who suffer from OSA. We concluded one clinical trial and have upgraded the device in preparation for a confirmatory clinical study to launch later this year. We have been in ongoing discussions with the FDA on the study parameters. Our implementation of new systems and processes is transforming the company, and we believe our growth will trend upwards. We remain optimistic for our long-term growth potential and recognize that success begins with the execution of our 2020 goals. We entered 2020 committed to expanding our role as a medical device innovator, so we may continue providing hope for patients and their families. While these steps position LivaNova for further success, our primary objective is always improving the lives of the patients we serve. We will continue to work towards transforming LivaNova into a company that creates significant value for all of its stakeholders while continuing to bring a positive change to the patients around the world that we serve. With that, I thank you all and we'll take any additional questions. Nova, back to you for questions. And I think with that, if there are no further questions, let me thank you all again for joining us today and for your continued support of LivaNova. Thank you.

This concludes the meeting. Thank you for attending.