Hello, and welcome to the Annual General Meeting of Shareholders of LivaNova Plc. Please note that today's meeting is being recorded. It's my pleasure to turn today's meeting over to Daniel Moore, Chairman of LivaNova Plc. Mr. Moore, the floor is yours.
Thank you. Good morning, ladies and gentlemen. My name is Dan Moore, and it's my pleasure to be speaking on behalf of the Board of Directors of LivaNova PLC, my 4th Annual General Meeting as Chairman of the Board of LivaNova. Welcome to shareholders who are attending the meeting in person here in London and also to all those attending virtually via the Internet. I am pleased to chair our 2nd Hybrid Annual General Meeting that is being broadcast online in order to facilitate and maximize the participation of our shareholders remotely regardless of their location in the world.
Before we start with the formal aspects of the meeting, I have a few housekeeping points. For all of you joining us in person in case of an emergency, please follow the emergency exit signs. The staff at Loch Lord LLP are available to direct and assist you accordingly. We do not expect there to be any fire alarm test during the meeting. For those in this room, I would also like to ask everyone to ensure that your phones are off or switch to silent mode.
For all of those attending or joining us remotely, please note that the virtual meeting is a live audio cast and that you can submit questions by typing your remarks in the designated box on your screen using the message icon. To ensure that the questions submitted online reach us in a timely manner, I ask all shareholders who are attending the meeting virtually to submit any questions as soon as possible. We will address questions at the end of the meeting, but well before the polls close. When asking a question either virtually or in person, 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.
For those attending in person, you should have all received a copy of the agenda and the rules of conduct for today's meeting. If you have not received these, please raise your hand. For those joining us remotely, please note that a copy of the agenda and the rules of conduct are located on the meeting center screen. Finally, for those attending in person, please join us for refreshments in this meeting room following the conclusion of this meeting. I understand from the company 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 1 p. M. And I declare LivaNova's 2019 Annual General Meeting formally open. I will start by introducing LivaNova's Board of Directors. With us today joining me in person here in London, we have our Chief Executive Officer, Mr.
Damien McDonald. Attending virtually, we have Mr. Francesco Bianchi, Mr. Bill Cozzi, Mr. Hugh Morrison, Mr.
Alfred Novak, Doctor. Sharon O'Kane and Doctor. Arthur Rosenthal. Our directors attending the meeting virtually have the technical capability to answer questions. It's also my pleasure to introduce a number of the company's officers here with us today.
Joining me, we have our General Counsel, Ms. Kiena Skeffington our Chief Financial Officer, Mr. Thad Huston our Chief Human Resources Officer, Ms. Trui Hebelink our Senior Vice President for Business Development, Mr. Matt Dodds and our company Secretary, Ms.
Catherine Moroz. We are also joined today by Larry Westall of PricewaterhouseCoopers LLP, LivaNova's independent registered public accountancy firm in the United States and are joined by Mr. John Lambert of our company's UK statutory auditors, PricewaterhouseCoopers LLP. Computershare, our transfer agent and registrar are acting as scrutineers for the voting today being represented by Ms. Michelle Davies.
Now it's my pleasure to introduce Catherine LaRose, our company secretary, who will explain the voting procedures. Catherine?
Thank you, Dan. In accordance with the articles of association of the company, voting today will be done by way of a poll on each of the resolutions put to the meeting. Based on a preliminary report from the scrutineer, of the approximately 49,300,000 shares entitled to vote at the meeting, more than 42,200,000 shares, representing approximately 85.6 percent of all the voting shares of all the shareholders entitled to vote had voted as of last night. As it will take some time to complete the polling procedure, 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 ks 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 should have been issued with a poll card. For those shareholders or anyone who has already voted, who now wishes to change the way they had voted, please raise your hand and our registrars will attend to you. For those submitting their vote electronically, please note that voting is now open and will close at 2 pm British Summer Time, which is 9 am Eastern Time. Please, would anyone requiring a polling card raise their hand now.
In the case of corporate shareholders, the poll card should be completed by your authorized corporate representatives at the meeting or by their proxy. For completeness, I should reiterate that shareholders who have already submitted proxy do not need to complete a poll card unless they want to change their vote. For those attending the meeting online, please click on the cast your vote icon in order to cast your vote. You have 3 options for each resolution. You can 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 would be grateful if you would please complete your poll card by ticking appropriate box next to the relevant resolution to indicate how you wish to cast your vote either now or once the Chairman has read through the resolutions and you've had a further opportunity to consider them and the ensuing Q and A period. Once all votes have been taken on the resolutions, please sign the poll card and put it in the black polling box on the scrutineers table. Should you require assistance, our registrars would be happy to assist you. I now give you the floor back to Dan Moore.
Thank you, Catherine.
We will now proceed to vote on the resolutions proposed to the meeting. Notice of this meeting together with LivaNova's proxy statement, UK Annual Report for the year ended December 31, 2018, the U. S. Annual Report on Form 10 ks for the year ended December 31, 2018 were posted on April 30, 2019 to shareholders of the company. Accordingly, the requisite notice of the meeting has been given.
Please remember that questions will be answered during the Q and A portion of the meeting. For those attending virtually, please remember that questions can be submitted electronically using the message icon on your screen. For those attending in person, you will have a chance to ask your question by raising your hand during the Q and A. There are 8 resolutions with proposal number 1 comprising separate resolution for the election of each of the proposed directors. Each of the resolutions being proposed is proposed as an ordinary resolution, which means each resolution requires a simple majority to be passed.
The full text of each resolution is set out in the notice of the meeting, a copy of which you will have already received. We have some additional copies in the room should anyone require 1. In accordance with the recommendation of the Board of Directors, I move the following proposals for approval by ordinary resolution. Proposal 1 is to elect by separate resolutions each of the following 10 directors for term expiring at the Annual General Meeting to be held in 2020. First, Mr.
Francesco Bianchi second, Ms. Stacy Enzing Tsang third, Mr. William A. Cozy 4th, Mr. Damian McDonald 5th, Mr.
Daniel J. Moore 6th, Mr. Hugh M. Morrison 7th, Mr. Alfred J.
Novak 8th, Doctor. Sharon O'Kane 9th, Doctor. Arthur L. Rosenthal and 10th, Ms. Andrea L.
Saeed. Please note that the profiles of all directors are included in the proxy statement. As explained, to vote, please tick the appropriate box on your poll card. For those attending virtually, please select the cast your vote icon and vote for the resolution against it and you may abstain from voting. Proposal 2 is to approve on an advisory basis LivaNova's compensation of its named executive officers as set out in the proxy statement.
This is otherwise known as USA On Pay. You are entitled to cast an advisory vote to approve the compensation of our named executive officers as disclosed in the proxy statement. Although the vote is non binding, the Board values your opinions 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 USA as the company's independent registered public accounting firm for the year ending December 31, 2019. Proposal 4 is to approve on an advisory basis the UK Director's remuneration report and the form set out in the company's UK Annual Report and accounts for the period ending December 31, 2018.
The Director's remuneration report is concerned solely with remuneration of our management and non management directors and is required under the UK Companies Act of 2,006. All UK Incorporated Companies that are quoted companies under the Companies Act are required to put their directors' remuneration report to shareholders. Proposal 5 is to approve the director's remuneration policy as set out in the UK annual report for the period ending December 31, 2018. The Director's remuneration policy is a requirement under the UK Companies Act 2,006. The policy will govern the remuneration paid to our directors, both executive and non executive for the next 3 years unless we seek your approval to amend it before them.
Proposal 6 is to receive and adopt the company's UK statutory accounts for the year ended December 31, 2018 together with the reports of the directors and the auditors thereon. Proposal number 7 is to reappoint PricewaterhouseCoopers LLP, a limited liability partnership organized under the laws of England, which we refer to as PwC UK as the company's UK statutory auditor under the UK Companies Act to hold office from the conclusion of this 2019 Annual General Meeting until the conclusion of the next General Meeting at which the annual report and accounts are laid. Proposal 8 is to authorize the directors and or the Audit and Compliance Committee of the company to determine the remuneration of PwC UK and its capacity as the company's UK statutory auditor under the company's Act of 2,006. As a reminder to vote, please tick the appropriate box on your poll card. For those attending virtually, 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've had an opportunity to consider the ensuing question and answer. As a reminder, voting will close at 2 pm British Summer Time, which is 9 am Eastern Daylight Time. I would now like to open the floor to
questions.
Hearing none or receiving none, that concludes the business of the meeting. As Catherine mentioned, the results of the voting will be published on our website and notified through a Form 8 ks 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 approximately 1:15 p.
M. British Standard Time. I now welcome Damian McDonnell, Chief Executive of LivaNova to deliver some of his remarks.
This is Matthew Dodds. Before we begin, I would like to remind you that the discussions during this meeting will include forward looking statements. Factors that could 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 statements. It is now my pleasure turn the meeting over to Damien McDonald, CEO of Livinova.
Good morning and good afternoon and thank you for joining us at our 4th Annual General Meeting. We've come a long way since the formation of Livinova in October 15. We're a $1,000,000,000 medical devices innovator focused on the head and the heart. Over the past 18 months, we have transformed the business and advanced our strategy through a continued focus on franchises where we have a strong leadership position, deprioritizing the ones where we do not and investing in areas where we can target underserved market segments that offer the potential for high growth. We like to characterize our businesses 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 an unmet patient need. Our focus is to expand globally and further penetrate the U. S.
Market through innovative product and marketing strategies. SENTEVA, our latest device is now the majority of our generator revenue globally. This is the smallest, lightest, minimally invasive responsive therapy for epilepsy on the market. The second is advanced circulatory support, which represents the TandemLife business acquired in 2018. ACS is a high growth market that exceeds $1,000,000,000 globally.
We offer a competitive and broad portfolio to treat multiple conditions. We have been investing in the U. S. Commercial distribution and plan to launch a next generation system globally in 2019. The third is commercial infrastructure in our rest of world region.
We have made significant progress in our strategy of expanding our commercial capabilities in what we define as JVACs, Japan, Brazil, Australia, China and Saudi Arabia, which collectively represent a significant high growth segment of the medical device market. In several of these markets, we have moved away from a distribution model towards more direct selling and plan to shift our model further in this direction during the remainder of 20 19 through 2020. Moving to our strategic portfolio initiatives or pipeline. I mentioned earlier, we have 4 opportunities to better serve patients in markets with high unmet need that can accelerate LivaNova's long term growth. I'll now spend a few minutes on each of these opportunities.
First, treatment resistant depression or TRD. We've been working for many years to provide VNS therapy for patients with TRD. Depression is a market that affects over 300,000,000 people worldwide and is the leading cause of disability in the U. S. TRD is a smaller subset comprised of patients who have tried 4 or more treatments and failed.
While we've had FDA approval for our device in the U. S, we have not had reimbursement coverage by Medicare and commercial insurers. We've been working with clinicians to develop additional evidences to support this coverage. In February of 2019, CMS determined it would initiate coverage for Medicare beneficiaries through coverage with evidence development by a randomized controlled study with an opportunity for broader coverage by a longitudinal study. 2nd, heart failure.
In addition to VNS for epilepsy and TRD, specialized forms of VNS may also be used to deliver autonomic regulation therapy or ART to bring a balance to cardiovascular function and treat heart failure. Heart failure affects more than 25,000,000 people worldwide, and LivaNova's VITARIA system received CE Mark approval in February of 2015 and was granted an expedited access pathway designation by the FDA in 2017. We have since made significant progress enrolling patients in a U. S. ANTHEM HFrEF clinical trial since initiating EAP study in Q4 of 2018.
3rd, obstructive sleep apnea or OSA. We 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 a patient's respiratory airway narrows or closes during sleep. Patients with OSA can experience impaired daytime function, 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.
And 4th, TMVR or transcatheter mitral valve replacement. There are no products currently available today for mitral valve replacement minimally invasively executed, and we believe we have a unique technology and design. Our team has made excellent progress with its redesign and has locked in on 2 concepts that we will choose in the coming month. The next steps will be to design to get to get a design completion, bench testing animal studies and biocompatibility studies. Our current expectation is to restart clinical trial enrollment in the first half of twenty twenty.
We left 2018 with relentless commitment to improve the patients' lives worldwide by continuing the transformation of our company. We entered 2019 in an excellent position to shape our future through neuromodulation and cardiovascular leadership and innovation. We will continue to strengthen our near term growth drivers. This will allow us to increase our investments in strategic portfolio initiatives to accelerate our long term growth. Our investments are allowing us to reach new patient populations globally and achieve market leading positions.
And with that, thank you very much, and thank you for your support.
And that concludes everything. We've got some refreshments if people would like to have a chat and a cup of tea.
And thank you very much for joining us today. Thank you, everyone.