Ovid Therapeutics Inc. (OVID) Earnings Call Transcript & Summary

You may now begin.

Thank you. Good morning, everybody. I'm Jeremy Levin, Chairman of the Board of Directors and Chief Executive Officer of Ovid Therapeutics, and it's my pleasure to welcome you to the company's 2020 Annual Meeting of Stockholders, which is being held virtually for the first time due to health and safety concerns caused by the COVID-19 pandemic. It's now shortly after 11 a.m., and I'll call this meeting to order and proceed with introductions and formal business of the annual meeting. I'd like to start off by thanking everyone for joining us today. Please let me introduce the members of our senior management team who are present today: Dr. Amit Rakhit, who is our President and Chief Medical Officer; Thomas Tom Perone, General Counsel and Corporate Secretary; Jason Tardio, our Chief Commercial Officer; and Mr. Jeff Rona, our Consulting Chief Financial Officer. We're also pleased to announce and to introduce the other members of our Board of Directors who will be joining us today: Ms. Barbara Duncan and Mr. Bart Friedman. Thank you very much for coming with us. I would like also to introduce Thomas Klockner and Beth Raposo of KPMG, our independent registered public accounting firm, who are available to respond to appropriate questions. And finally, the company has appointed Peter Descovich to act as inspector of elections. Mr. Descovich has taken and subscribed the customary oath of office to execute his duties with strict impartiality. We will file his oath with the records of the meeting. The inspector of election will decide on the qualification of voters, accept their vote and, when balloting on all matters is completed, tally the final votes. To ensure that we satisfy all of the legal requirements of today's meeting, the formal portion of the meeting will be conducted from a script, and we will answer any questions at the end of the meeting. [Operator Instructions] The record date of this meeting was April 9, 2020. I have at this meeting a complete list of the stockholders of record of our common stock at the close of business on such record date, which holders were entitled to notice and are entitled to vote on the matters brought before this meeting. The list is available to you on the bottom right of the web portal of this meeting. I also have affidavit certifying that on April 23, 2020, Broadridge Financial Solutions, Inc. commenced the mailing or otherwise distributing a notice of the annual meeting and a Notice of Internet Availability of proxy materials to all stockholders of record at the close of business on April 9, 2020. I've been informed by the inspector of election that a majority of the outstanding shares entitled to vote at the meeting are either represented virtually or by proxy and accordingly, which constitute a quorum for the meeting today. Thus, we may now carry on the official business of the meeting. I will now describe the voting procedures. The time is now 11:08 on June 4, 2020, and the polls are now open for voting on all matters to be presented. Any stockholder who hasn't yet voted or wishes to change their vote may do so by clicking on the voting button on their web portal and following instructions there. Shareholders who've not sent in proxies or voted via telephone or Internet and do not want to change their vote do not need to take any further action. The polls will be closed to voting after we go through the matters to be voted upon. We'll not accept ballots, proxies, invocations or change of votes after the closing of the polls. [Voting]

There are 2 proposals to be voted on at this meeting. The first item of business is the proposal to elect 2 Class III directors to the company's Board of Directors to hold office until the 2023 Annual Meeting of Stockholders. The nominees for Class III Director are: Dr. Jeremy Levin and Dr. Karen Bernstein. The second business -- item of business today is the proposal to ratify the selection of KPMG LLP as the independent registered public accounting firm of the company for the company's fiscal year ending December 31, 2020. Now that everybody has had the opportunity to vote, I now declare the polls for the 2020 Ovid Therapeutics Annual Shareholder Meeting closed at 11:07. I will now report the results of the voting. Based upon the submission of Internet voting, all director nominees have been elected, and the appointment of KPMG LLP as the company's independent registered public accounting firm for the 2020 fiscal year has been ratified. Record of the vote for this meeting will be filed with the company's records, and a certificate of the inspection of elections will be attached to the minutes of this meeting. We would now like to open things up for stockholders' questions and comments. We'll address questions that we received on the web portal in the order of which they were received. With the formal portion of the meeting -- of the agenda now complete and there being no other business to be brought before the meeting, I will now adjourn the formal portion of the Ovid 2020 Annual Meeting of Stockholders. I will now provide a brief presentation on the corporate -- on the corporation, which will be followed by additional questions and answers. As you will see, this corporate presentation has -- in its initiation, it has the disclaimers and forward-looking statements. I would refer you to them, and they're necessary for you to read through in detail. However, I will not read through them in detail at this time but will rather pass to the next slides and indicate to you the following portions. Number one, we have a very clear mission and a value proposition. Our mission is to bring treatments to individuals with rare neurological disorders. As you can see, over the last 4 to 5 years, we have invested a substantial amount of capital and invested it well. We have a deep pipeline, which is focused on those areas. We have near-term development catalysts, which I will walk you through. We've built a very experienced leadership team, and we have a -- which has allowed us to think significantly that our products have a very substantial market potential, coupled with which we built and retain a solid cash position. Let me walk you through for 2 minutes our pipeline. As I said to you, since 2014 when the company was founded, we have actually developed a very substantial pipeline. That pipeline is built upon a number of different compounds and research programs: OV101 in the areas of Angelman and Fragile X; OV935 in the areas of rare epilepsies, CDKL5 and Dup15q and Dravet and Lennox-Gastaut and partnered with our very significant partner, Takeda. As you know, Takeda shares 50% of all costs of this program, and OVID -- and we share equally in the profits globally for this entity. OVID will lead all commercial products coming out of this part of this collaboration, and that will hopefully occur in 2023. We are looking to -- we will be the commercial partner in the United States and in Europe, the lead commercial partner. We have other early-stage programs, OV935 and OV881, which I won't spend much time on. However, I would like to say that every single program, despite COVID, have progressed. Indeed, as you'll see in my next comments, we've done a -- we are looking forward to a very robust year of results from these 3 programs. In fact, 2020 is a transformative year for Ovid. The value-creating events that will occur throughout the year started earlier this year already. We've demonstrated very conclusively positive top line Phase II data in Fragile X using OV101. Building on the STARS data several years ago, the 2 -- the positive Phase II, we have increasing confidence in our program that will deliver results for NEPTUNE, the pivotal trial results which will be delivered in Q4 in 2020. As you know, due to COVID, we're running about 3 months behind. However, we are confident of delivering our results by the end of this year, as you can see. So we're excited to see, hopefully, the first ever positive Phase III results in a -- any drug for Angelman's. And if we're fortunate in this, we'll have the opportunity to go to the FDA and seek a route forward to register this as the first drug ever and indeed the only drug in Angelman's, a very substantial potential and which will bring tremendous hope to many, many individuals across the nation. There are at least, as you know, about 23,000 families -- between 15,000 and 25,000, roughly, families in the United States. They have no therapeutics, and we are the first company to ever bring a clinical program to fruition. And hopefully, we look forward to the NEPTUNE results to demonstrate conclusively the value of OV101 in their -- for the disorder. Equally exciting, this year, we have the ARCADE study coming up exactly on time. We are quite substantially in advance there actually. We hadn't anticipated results from the ARCADE, which is 935/soticlestat. We hadn't anticipated that for some -- until 2021. But as you know, we were able to complete our trial in December of last year. And as a consequence of that, we are right on time to deliver the data in our -- in not just ARCADE, which we delivered early on this year, but moving forward to ELEKTRA, which is our top line data, will be delivered in rare epilepsies in the third quarter of 2020. Based on the fact that we've now had a positive Ib/IIa and then a positive result in -- and positive data in the ARCADE trial, we're optimistic about what we will see in the ELEKTRA trial, a double-blind, placebo-controlled trial looking at both Dravet and Lennox-Gastaut. And then in addition to that, we have the ENDYMION trial, an open-label extension in rare and ultra-rare epilepsies which will deliver the results, some of which include patients who've been on 935 for nearly 2 years, will be delivered equally well in the third quarter of 2020. So coupled to that is our strong financial background. As you can see below, we've indicated our cash position. We will have -- we now move to the rest of the year. Ovid's programs will require a set of very careful and thoughtful teach-ins. We're going to do that because we want our investors to really understand what we're doing, how we're doing it and what to expect from it. The first of these is imminent. On June 17, the company will hold a virtual teach-in to discuss our OV935 program and upcoming data releases. This will help our investors understand exactly what we're looking for. It will continue the transparency and openness that has characterized Ovid's approach to clinical trial development and data handling. And we look forward to having as many of you as possible attending that so that you will have a very clear view of what we're expecting from that 935 program and our excitement behind it. Later, in the third quarter, we'll do exactly the same for OV101, describing what we are expecting to look at and specifically with our NEPTUNE trial, why we feel so excited about it and what are -- we anticipate coming out of it. Again, as I've said to you, both these trials, we are very pleased by the progress that we've made, very pleased by the data that we've generated. And hopefully, they will yield positive results that we hope will be the future of this company. So 2020 is absolutely a transformative year for us. And as you listen to our teach-ins, we hope that you'll agree with that and that you will continue to participate and support the company. And with that, I'd like to thank you for listening to this presentation and will be delighted to answer any questions that you might have on it. Okay. In light of the fact that there are no questions and with the agenda now complete and there being no further business to be discussed, I'll now conclude the meeting. Thank you for your attendance.

Ladies and gentlemen, this concludes your meeting. You may now disconnect.