Earnings Labs

Minerva Neurosciences, Inc. (NERV)

Q4 2015 Earnings Call· Mon, Mar 14, 2016

$6.45

+0.31%

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Transcript

Operator

Operator

Welcome to the Minerva Neurosciences Year-End 2015 Conference Call. [Operator Instructions]. I would now like to turn the call over to William Boni, Vice President of Investor Relations and Corporate Communications at Minerva. Please proceed.

William Boni

Analyst

Good morning. A press release with the Company's fourth quarter and year-end 2015 financial results became available at 7.30 AM Eastern Time today and can be found on the Investors section of our website. Our annual report on Form 10-K 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 from Minerva are Dr. Remy Luthringer, President and Chief Executive Officer, and Mr. Geoff Race, Executive Vice President and 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 U.S. 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 SEC, including our annual report on Form 10-K for the year ended December 31, 2015, filed with the Securities and Exchange Commission on March 14, 2016. Any forward-looking statements made on this call speak only as of today's date, Monday, March 14, 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

Analyst

Thank you, Bill and Good morning everyone. Thank you for joining us today. 2015 was a year of successful pinnacle trial execution for Minerva. I'm pleased to report patient recruitment screening and enrollment proceeding on a timely basis in four clinical trials with three components during this year. As a result we’re in a position to announce data from this trial in the first half of this year. In fact we already have obtained positive results with our announcement in January of positive top-line data with MIN-202, this data relate to our Phase 2a trial in patient suffering from primary insomnia disorder without any associated [indiscernible] disorder. Today we’re pleased to summarize additional positive data with MIN-202 in our trial carried out in patient suffering from a major depressive episode and having a diagnosis of major depressive disorder or MDD. I will review details from both of these important read outs later in this call. In addition to the main Q4 results we anticipate two read outs in the second quarter of this year and in our Phase 2b trial in patients suffering from schizophrenia and from our Phase 2a trial MIN-117 in patients affected by MDD. Our goal at Minerva is to address unmet medical needs to help patients suffering from severe disorders. The aim to accomplish this by developing drugs is comes a limitation of available of therapies. Minerva is driven by data generation which will inform our decisions around future development, 2016 will be a key year in this regard. Let me now address our clinical trials in more detail beginning with MIN-101. In late 2015 we completed the enrollment of a total of 244 patients in a randomized placebo controlled double-blind parallel group design Phase 2b trial of MIN-101 to treat unmet needs in patients suffering…

Geoff Race

Analyst

Thank you, Remy. Earlier this morning we issued a press release summarizing our operating results for the fourth quarter and the year-ended December 31, 2015. A more detailed discussion of our results may be found in our annual report on Form 10-K also filed earlier today. At December 31, 2015, the Company's cash, cash equivalents and marketable securities were approximately $33.2 million compared to $18.5 million as of December 31, 2014. During the first quarter of 2016 the company received approximately $17.5 million in proceeds from certain existing shareholders who exercised warrants, granted in connection with a product placement in March 2015. Warrants for a total of approximately 3 million shares of common stock were exercised in an exercise price of $5.77 per share. As a result Minerva excepts that it's current cash, cash equivalents and marketable securities will be sufficient to fund it's operations into the second quarter of 2017. Research and development expenses were $6.3 million in the fourth quarter of 2015, compared to $3 million in the fourth quarter of 2014. R&D expenses were $18.5 million for the year-end December 31, 2015 compared to $42.9 million for the year-ended December 31, 2014. R&D expenses for the year-ended December 31, 2014 included a $22 million license fee paid to Janssen pursuant to our co-development agreement on MIN-202. R&D expenses for the year's ended December 31, 2015 and 2014 included non-cash stock-based compensation expenses of $0.6 million and $13.1 million respectively. Excluding stock-based compensation and the $22 million license fee, total R&D expenses related to drug development programs for the year's ended December 31 2015 and 2014 were $17.9 million and $7.8 million respectively, an increase of $10.1 million. This increase in R&D expenses primarily reflect increased expenses related to our Phase 2b clinical trial of MIN-101, our Phase…

Operator

Operator

[Operator Instructions]. Our first question comes from the line of Jason Butler with JMP Securities. Your line is open.

Jason Butler

Analyst

First one just on the Phase 2 trial for 101 in schizophrenia, can you just walk us through the powering assumptions for the primary endpoint? Are you powered for the total PANSS or just the negative symptom subscale? Thanks.

Remy Luthringer

Analyst

So definitely the primarily endpoint is negative symptom so the study is really powered for positive results on the negative symptoms. All the other parameters although -- overall PANSS score positive symptoms cognition are definitely secondary endpoints.

Jason Butler

Analyst

And then are there any other differences between the negative symptom subscale that you’re using for this trial and the typical negative symptoms that we think about from the PANSS, is it just negative symptom component of the PANSS?

Remy Luthringer

Analyst

In fact as we know we’re analyzing the negative symptoms in two ways, they can call the typical way or the classical way and the pentagonal way which is based on the principal component analysis. In our case as a primarily endpoint is a pentagonal score for very simple reason because drug is probably having a much broader effect on the negative symptoms and the pentagonal score seems to represent much better part of physiology of the patients.

Jason Butler

Analyst

And then just a quick question on MIN-202, can you just help us put into context the data we saw last week in terms of the anti-depressant benefit relative to currently available anti-depressants and maybe provide some color on your --regarding the independent effect from depression that you saw versus just the derivative effect on sleep?

Remy Luthringer

Analyst

Obviously it's a very good question and we’re very excited about these results. So what we have seen is when you’re analyzing the American Depression scale [ph] excluding the sleep parameters, the effect on mood is maintained. So this confirms really very well the effect is a direct effect on mood and not mediated effect on sleep.

Operator

Operator

[Operator Instructions]. And I'm not showing any further questions. I would like to turn the call back to William Boni for closing remarks.

William Boni

Analyst

Thank you everyone for participating on the call today and please don’t hesitate to give me a call directly with any questions or to follow-up on the press release issued today or the press release issued on Friday. Thank you very much.

Operator

Operator

Ladies and gentlemen thank you participating in today's conference. This does conclude the program. You may all disconnect. Everyone have a great day.