Earnings Labs

Minerva Neurosciences, Inc. (NERV)

Q1 2017 Earnings Call· Sat, May 6, 2017

$6.45

+0.31%

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Transcript

Operator

Operator

Welcome to the Minerva Neurosciences’ First Quarter 2017 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 of Investor Relations and Corporate Communications at Minerva. Please proceed.

William Boni

Management

Good morning. A press release with the company's first quarter 2017 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 and when 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; the timing and outcome of future interactions with the U.S. and foreign regulatory bodies; 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 Securities and Exchange Commission, including our quarterly report on Form 10-Q for the quarter ended March 31, 2017, filed with the Securities and Exchange Commission on May 4, 2017. Any forward-looking statements made on this call speak only as of today's date, Thursday, May 4, 2017, 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. Thanks for joining us today. Today, I will briefly discuss the latest step in the advancement of MIN-101 on its clinical development paths. I am pleased to report that Minerva recently has an end of Phase II meeting with the U.S. Food and Drug Administration, during which we discussed the current MIN-101 package, particularly the Phase IIb results we obtained in patients with a diagnosis of schizophrenia with negative symptoms and the Phase III IV clinical development of MIN-101. We shared with the FDA the complete package of clinical, pre-clinical and CMC data generated to date with MIN-101. Our discussion included as well the potential content of our Phase III and Phase IV development plan, particularly focusing on the target population and study design including primary and secondary outcome measures which might be adverse. We plan to initiate Phase III development of MIN-101 in schizophrenia in the second half of 2017. The meeting allowed us to share our view on the potential contribution of MIN-101 as a new treatment paradigm for people diagnosed with schizophrenia and not functioning well due to the presence of negative symptoms. The considerable amount of recent scientific literature is being accumulated reinforcing the facts of negative symptoms is the target of MIN-101 represents a significant unmet need for patients, the families of patients and physicians. These symptoms contribute substantially to both quality of life and functional outcomes for the large worldwide population of patients suffering from this disease. I will move on with brief comments on our other programs. Our second clinical stage compound is MIN-117 in development to address unmet medical needs in patients suffering from major depressive disorder, MDD. Based upon clinical and pre-clinical findings, we believe MIN-117 may demonstrate the safety profile comparable to placebo…

Geoff Race

Management

Thank you, Remy. This morning we issued a press release summarizing our operating results for the first quarter of 2017. A more detailed discussion of our results may be found in our quarterly report on Form 10-Q filed with the SEC earlier today. Net loss was $10.6 million for the first quarter of 2017 or a loss per share of $0.30 basic and diluted, compared to a net loss of $8 million, or a loss per share of $0.29 basic and diluted, for the same period in 2016. Research and development expenses were $7.6 million in the first quarter of 2017, compared to $5.4 million in the first quarter of 2016. R&D expenses in the three months ended March 31, 2017 and 2016 included non-cash stock based compensation expenses of $0.5 million and $0.2 million respectively. This increase in R&D expenses primarily reflects higher development expenses under the MIN-202 program for Phase II clinical trial preparation and an increase in non-cash stock based compensation expenses. These amounts were partially offset by lower costs, due to the completion of our Phase IIb clinical trial of MIN-101 and the completion of our Phase IIa clinical trial of MIN-117. General and administrative expenses were at $2.9 million in the third quarter of 2017, compared to $2.4 million in the first quarter of 2016. G&A expenses in the three months ended March 31, 2017 and 2016 include a non-cash stock based compensation expenss of $0.8 million and $0.6 million respectively. This increase in general and administrative expenses was primarily due to an increase in legal and professional fees, an increase in non-cash stock-based compensation expenses, and increased personnel costs during the three months ended March 31, 2017. Cash, cash equivalents and marketable securities as of March 31, 2017 were approximately $85.4 million. Since December 31, 2016, warrants with respect to approximately 1.6 million shares were exercised by certain institutional stockholders for proceeds of $9.3 million received by the company. The warrants were issued in connection with a private placement that took place in March 2015 and they expired on March 20, 2017. The company believes that its existing cash, cash equivalents and marketable securities will be sufficient to meet its cash commitments for at least the next 12 months. Now, I would like to turn the call over to the operator for any questions. Operator?

Operator

Operator

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

Jason Butler

Analyst

Hi, thank you for taking the questions. Just first one on MIN-101, do you – have you received the meeting minutes back from the FDA yet? And is that point at which you plan to be able to provide giving updates on trial design? Or do you think you're going to need additional interactions with FDA before finalizing the Phase III program? Thanks.

Remy Luthringer

Management

Jason, thank you for the question. So what we're doing at this point, we are really interoperating the feedback we received during the meeting into our Phase III development plan and we’d really expect to announce details of the plan in a very near future. So this is what we are currently doing.

Jason Butler

Analyst

Okay, great and then just a question on MIN-202. When do you expect the next clinical trials to begin? Could that still be in 2017?

Remy Luthringer

Management

Yeah, yeah, so clearly I mean those – to be very clear those preparations submission work and [indiscernible] is currently ongoing. So the trials will really start all-in 2017 definitely, Jason.

Jason Butler

Analyst

Okay, great. Thanks for taking the questions.

Remy Luthringer

Management

You're welcome, Jason.

Operator

Operator

Thank you. [Operator Instructions] And I'm showing no questions at this time.

Remy Luthringer

Management

I guess I have to conclude. So I wanted to thank you all for your participation of today’s call and we are really looking forward to update you very soon on our progress. So, thank you again everybody.