Earnings Labs

Minerva Neurosciences, Inc. (NERV)

Q3 2016 Earnings Call· Thu, Nov 3, 2016

$6.45

+0.31%

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Transcript

Operator

Operator

Welcome to the Minerva Neurosciences third quarter 2016 conference call. At this time, all participants are in a listen-only mode. There will be a question-and-answer session following today's prepared remarks. This call is being webcast live on the Investors section of Minerva’s website at ir.minervaneurosciences.com. As a reminder, today's call is being recorded. I would now like to turn the call over to William Boni, Vice President, Investor Relations and Corporate Communications at Minerva.

William Boni

Management

Good morning. The press release with the company's third quarter financial results became available at 7:30 AM Eastern Time today and can be found on the Investors section of our website. Our quarterly report on Form 10-Q was also filed electronically with the SEC this morning and can be found on the SEC's Internet website at www.sec.gov. Joining me on the call today for Minerva are Dr. Remy Luthringer, President and Chief Executive Officer, and Mr. Geoff Race, Executive Vice President, Chief Financial Officer and Chief Business Officer. Following our prepared remarks, we will open the call for Q&A. Before we begin, I would like to remind you that today's discussion will include statements about the company's future expectations, plans, and prospects that constitute forward-looking statements for purposes of the Safe Harbor provisions under the Private Securities Litigation Reform Act of 1995. We caution that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated. These forward-looking statements are based on our current expectations and may differ materially from actual results due to a variety of factors, including, without limitation, whether any of our therapeutic products will advance further in the clinical trials process; whether, when, and to what extent results from such trials will be available; and whether and when, if at all, such products will receive final approval from the US Food and Drug Administration or equivalent foreign regulatory agencies and for which indications; whether any of our therapeutic products will be successfully marketed, if approved; whether any of our therapeutic product discovery and development efforts will be successful; our ability to achieve the results contemplated by our co-development agreements; management's ability to successfully achieve its goals; our ability to raise additional capital to fund our operations on terms acceptable to us; the sufficiency of our current cash position to fund our operations; and general economic conditions. These and other potential risks and uncertainties that could cause actual results to differ from the results predicted are more fully detailed under the caption Risk Factors in our filings with the Securities and Exchange Commission, including our quarterly report on Form 10-Q for the quarter ended September 30, 2016, filed with the Securities and Exchange Commission on November 3, 2016. Any forward-looking statements made on this call speak only as of today's date, Thursday, November 3, 2016, and the company disclaims any obligation to update any of these forward-looking statements to reflect events or circumstances that occur after today's call, except as required by law. I would now like to turn the call over to Remy Luthringer.

Remy Luthringer

Management

Thank you, Bill. And good morning, everyone. Thank you for joining us today. Today, I will focus primarily on the positive clinical data from the six-month extension of our Phase IIb trial with MIN-101 carried out in patients with negative symptoms of schizophrenia. These data were announced just last week and marked an important milestone of our compound for patients suffering from schizophrenia and other disorders with debilitating negative symptoms and for Minerva Neurosciences and its shareholders. I will also discuss the next planned steps in the development plan for MIN-101. Know that we have this newest data in hand, allowing us to prepare for Phase III. Finally, I will touch upon our other molecules – MIN-117 for major depressive disorders, MDD; MIN-202 for insomnia and MDD; and MIN-301 for Parkinson’s disease. Turning to MIN-101, on October 25, we announced positive findings from the six-month extension of our Phase IIb trial of MIN-101 monotherapy in schizophrenic patients suffering from negative symptoms that severely impair the everyday functioning. Extension phase was a 24-week open label period that followed the 12-week randomized, double-blind, placebo-controlled core phase of the trial. Results from the core phase were announced last May. They showed that the trial met its primary endpoint, with statistically significant improvement in negative symptoms as measured by the pentagonal structure model, PSM. Statistical significance was also achieved in multiple secondary endpoints that included overall general psychopathology, cognition and overall functioning. Data generated during the open label extension were intended to provide supportive evidence of efficacy maintenance and/or further improvement when treating patients over a long period of time. In addition to the assessment of efficacy, this extension phase was intended to further confirm the safety and tolerability of the drug after several months of administration. Today, we are pleased and excited to…

Geoff Race

Management

Thank you, Remy. We issued a press release earlier this morning, summarizing our operating results for the third quarter ended September 30, 2016. A more detailed discussion of our results may be found in our quarterly report on Form 10-Q filed earlier today. At September 30, 2016, the company's cash, cash equivalents and marketable securities were approximately $91.9 million compared to $32.2 million as of December 31, 2015. As we stated on the last quarterly call, we expect that our financial resources will be sufficient to fund operations into 2018. Research and development expenses were $5.9 million in the third quarter of 2016 compared to $3.8 million in the third quarter of 2015. For the nine months ended September 30, 2016, R&D expenses were $13.9 million compared to $12.3 million for the nine months ended September 30, 2015. Excluding stock-based compensation, total R&D expense related to drug development programs for the three months ended September 30, 2016 and 2015 was $5.6 million and $3.6 million respectively, an increase of $2 million. This increase in R&D expenses primarily reflects higher development expenses under the MIN-202 program for Phase II clinical trial preparation, partially offset by lower costs for our MIN-101 and MIN-117 programs as both clinical trials have concluded. Excluding stock-based compensation, total R&D expense related to drug development programs for the nine months ended September 30, 2016 and 2015 was $13.2 million and $11.9 million, respectively, an increase of $1.3 million. This increase in R&D expenses primarily reflect higher development expenses under the MIN-202 program for Phase II clinical trial preparation. Increased expenses related to our Phase IIa clinical trial of MIN-117 and increased expenses related to our MIN-301 development. This was partially offset by decreased expenses due to the completion of our Phase IIb clinical trial of MIN-101. General…

Operator

Operator

Thank you. [Operator Instructions] Our first question is from Jason Butler with JMP Securities. You may begin.

Jason Butler

Analyst

Hi. Thanks for taking the questions. And congrats on the positive data for 101. Remy, just first question, as you’re thinking about moving forward into the next study, Phase III program for 101, are you focused on both doses that you looked at in Phase II or is there – or would you only focus on one dose for Phase III?

Remy Luthringer

Management

Thank you, Jason. Clearly, we're focusing on moving forward those two doses, knowing that the pivotal dose is probably 32 mg. But we are really focusing on moving forward with two doses because – in a Phase III program, you have minimum to test two doses, so we’re focusing on the two here.

Jason Butler

Analyst

Okay, great. And then when you – again, thinking about the Phase III trial design, can you maybe put into for us the trial or the data we saw for Vraylar earlier this year in negative symptoms and the benefit there and how you think about the trial design relative to that trial in terms of duration, patient population and endpoints?

Remy Luthringer

Management

So, I think if you allow me a comment, we have, first of all, to see if the results obtained are specifically effects on negative symptoms or not. So, I think the only way to show that you have specific effects on negative symptoms is a trial where you have to compare your molecule to placebo because if you’re comparing your molecule to another molecule inducing some side effects like EPS or having an impact on the other symptoms outside negative symptoms, you cannot come to the conclusion that this is a specific effect. So, what we're planning to do is ready to move forward again to test our molecule at the different doses we are planning to use versus placebo. The duration is, at minimum, three months, double-blind phase. We're planning to have an extension – or to propose an extension to the patients, which will go up to 12 months. But, clearly, we will test our molecule versus placebo. In terms of endpoints, we still will stay with the PANSS negative score. We are currently evaluating the different ways to calculate the negative score. That is, obviously, the standard way which is coming out from the three factors. But we know very well that for these seven items constitute a negative score. Two are definitely are not describing negative symptoms. This is the reason why we went with the Pentagonal model from White. But there is also the Pentagonal model from Steve Marder [ph], which is another way to evaluate the negative symptoms. And so, as we speak, we are really working on this [indiscernible] analysis in order to select the best endpoint. But, definitely, it will come out from the PANSS.

Jason Butler

Analyst

Okay, great. And then just last question on MIN-202, can you just talk about the partnership with Janssen and the cost responsibilities for the next studies, if they’ve been determined yet?

Geoff Race

Management

Morning, Jason. This is Geoff. So, we're in the process of designing the next stage of this program. As you know, in the development agreement, there are two stages of development. There’s an initial stage, which we’ve now passed. We passed that in July of this year. And we’re now into the second stage. Minerva’s expenses are capped at $19 million through to the end of a Phase IIb study in the second stage. Now, which company will do each study is currently being discussed and organized. So, the exact allocation of responsibility and cost in the program is not yet finalized. But what we do know is that we won’t be paying any more than $19 million.

Jason Butler

Analyst

Okay, great. Thanks for taking the questions. And again, congrats on the 101 data.

Geoff Race

Management

Thanks, Jason.

Remy Luthringer

Management

Thank you.

Operator

Operator

Thank you. [Operator Instructions] I'm showing no further questions at this time. I’d like to turn the call back over to Remy Luthringer for closing remarks.

A - Remy Luthringer

Analyst

Thank you, everybody, to have joined the call today and really looking forward to update you on Minerva in the future. Thank you again.

Operator

Operator

Ladies and gentlemen, this concludes today's presentation. Thank you once again for your participation. You may now disconnect. Everyone, have a great day.