Minerva Neurosciences Reports Third Quarter 2020 Financial Results And Business Updates
November 02 2020 - 7:30AM
Minerva Neurosciences, Inc. (NASDAQ: NERV), a clinical-stage
biopharmaceutical company focused on the development of therapies
to treat central nervous system (CNS) disorders, today reported key
business updates and financial results for the quarter ended
September 30, 2020.
Clinical program
update
Roluperidone
The U.S. Food and Drug Administration (FDA) has granted Minerva
a Type C meeting scheduled to take place via teleconference on
November 10, 2020. This meeting will provide an
opportunity for the Company to review clinical data generated to
date with roluperidone, including the recently completed
double-blind part of the Phase 3 trial for the treatment of
negative symptoms in schizophrenia, and to solicit recommendations
from the FDA regarding these data and the readiness of the
roluperidone data package to support a New Drug Application
submission. The Company expects to provide an update in
mid-late December 2020 following receipt of the official minutes of
the meeting.
“The objective of our upcoming meeting with the FDA is to
discuss and define a path forward for roluperidone, Minerva’s lead
product,” said Dr. Remy Luthringer, Executive Chairman and Chief
Executive Officer of Minerva. “Negative symptoms continue to
represent the leading unmet need in the treatment of schizophrenia,
as well as significant symptoms in a number of other psychiatric
disorders. Our analyses of the recently announced Phase 3 trial top
line results, in conjunction with the database we have generated to
date, support our confidence in roluperidone’s potential to be a
novel treatment in this space.”
Third Quarter
2019 Financial
Results
- Cash Position: Cash, cash equivalents and
restricted cash as of September 30, 2020 were approximately $32.6
million.
- R&D Expenses: Research and development
(R&D) expenses for the three and nine months ended September
30, 2020 were $4.6 million and $18.5 million, respectively,
compared to $9.7 million and $29.6 million for the same periods in
2019. The decreases in R&D expenses primarily reflect lower
development expenses for the Phase 3 clinical trial of roluperidone
and the completion of the Phase 2b clinical trial of MIN-117 in
December 2019. The Company expects R&D expenses to decrease
during 2020 as compared to 2019 following the completion of the
MIN-117 clinical trial as well as the 12-week, double-blind portion
of the Phase 3 clinical trial of roluperidone.
- G&A Expenses: General and
administrative (G&A) expenses for the three and nine months
ended September 30, 2020 were $3.5 million and $13.5 million,
respectively, compared to $4.6 million and $13.9 million for the
same periods in 2019. The decrease in G&A expenses in the
three-month period was primarily due to a decrease in non-cash
stock-based compensation expenses and lower commercial expenses,
and the decrease in G&A expenses in the nine-month period was
primarily due to lower commercial expenses.
- Net
Loss/Income: Net loss
for the three months ended September 20, 2020 was $8.1 million, or
a loss per share of $0.19 basic and diluted, compared to a net loss
of $14.0 million, or a loss per share of $0.36 basic and diluted
for the three months ended September 30, 2019. For the nine months
ended September 30, 2020, net income was $9.3 million, or $0.23
basic and diluted, compared to a net loss of $42.3 million, or net
loss per share of $1.08 basic and diluted for the nine months ended
September 30, 2019.
Collaborative revenue was $41.2 million for the nine months
ended September 30, 2020 compared to zero for the same period in
2019, an increase of $41.2 million. The increase in collaborative
revenue was the result of the Company’s opting out of its
co-development and license agreement with Janssen for seltorexant.
That revenue was recognized during the second quarter of 2020 as
there are no future performance obligations under the
agreement.
Conference Call
Information:
Minerva Neurosciences will host a conference call and live audio
webcast today at 8:30 a.m. Eastern Time to discuss the quarter and
recent business activities. To participate, please dial (877)
312-5845 (domestic) or (765) 507-2618 (international) and refer to
conference ID number 9459728.
The live webcast can be accessed under “Events and
Presentations” in the Investors and Media section of Minerva’s
website at ir.minervaneurosciences.com. The archived webcast will
be available on the website beginning approximately two hours after
the event for 90 days.
About Minerva Neurosciences:
Minerva’s portfolio of compounds includes: roluperidone
(MIN-101), in clinical development for schizophrenia; a potential
royalty stream from seltorexant (MIN-202 or JNJ-42847922), in
clinical development for insomnia and major depressive disorder;
and MIN-301, in pre-clinical development for Parkinson’s disease.
Minerva’s common stock is listed on the NASDAQ Global Market under
the symbol “NERV.” For more information, please visit
www.minervaneurosciences.com.
Forward-Looking Safe Harbor Statement
This press release contains forward-looking statements which are
subject to the safe harbor provisions of the Private Securities
Litigation Reform Act of 1995, as amended. Forward-looking
statements are statements that are not historical facts, reflect
management’s expectations as of the date of this press release, and
involve certain risks and uncertainties. Forward-looking statements
include statements herein with respect to the timing and scope of
future clinical trials and results of clinical trials with
roluperidone (MIN-101); the clinical and therapeutic potential of
this compound; the likelihood of future sales and a royalty stream
from seltorexant; the timing and outcomes of future interactions
with U.S. and foreign regulatory bodies; our ability to
successfully develop and commercialize our therapeutic products;
the sufficiency of our current cash position to fund our
operations; and management’s ability to successfully achieve its
goals. 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
roluperidone will advance further in the clinical trials process
and whether and when, if at all, it 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; management’s ability to successfully
achieve its goals; our ability to raise additional capital to fund
our operations on terms acceptable to us; 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, 2020, filed with the Securities and Exchange Commission on
November 2, 2020. Copies of reports filed with
the SEC are posted on our website at
www.minervaneurosciences.com. The forward-looking statements in
this press release are based on information available to us as of
the date hereof, and we disclaim any obligation to update any
forward-looking statements, except as required by law.
CONDENSED CONSOLIDATED BALANCE SHEET DATA |
(Unaudited) |
|
September 30, |
December 31, |
|
|
2020 |
|
|
2019 |
|
|
(in thousands) |
ASSETS |
Current Assets: |
|
|
Cash and cash equivalents |
$ |
32,516 |
|
$ |
21,413 |
|
Marketable securities |
|
- |
|
|
24,442 |
|
Restricted cash |
|
100 |
|
|
100 |
|
Prepaid expenses and other current assets |
|
2,374 |
|
|
1,182 |
|
Total current assets |
|
34,990 |
|
|
47,137 |
|
Equipment, net |
|
3 |
|
|
16 |
|
Other noncurrent assets |
|
15 |
|
|
15 |
|
Operating lease right-of-use assets |
|
143 |
|
|
262 |
|
In-process research and development |
|
15,200 |
|
|
15,200 |
|
Goodwill |
|
14,869 |
|
|
14,869 |
|
Total Assets |
$ |
65,220 |
|
$ |
77,499 |
|
|
|
|
LIABILITIES AND STOCKHOLDERS' EQUITY |
Current Liabilities: |
|
|
Accounts payable |
$ |
702 |
|
$ |
2,317 |
|
Accrued expenses and other current liabilities |
|
4,536 |
|
|
4,139 |
|
Operating leases |
|
157 |
|
|
173 |
|
Total current liabilities |
|
5,395 |
|
|
6,629 |
|
Long-Term Liabilities: |
|
|
Deferred taxes |
|
1,803 |
|
|
1,803 |
|
Deferred revenue |
|
- |
|
|
41,176 |
|
Noncurrent operating leases |
|
- |
|
|
111 |
|
Total liabilities |
|
7,198 |
|
|
49,719 |
|
Stockholders' Equity: |
|
|
Common stock |
|
4 |
|
|
4 |
|
Additional paid-in capital |
|
335,489 |
|
|
314,512 |
|
Accumulated deficit |
|
(277,471) |
|
|
(286,736) |
|
Total stockholders' equity |
|
58,022 |
|
|
27,780 |
|
Total Liabilities and Stockholders' Equity |
$ |
65,220 |
|
$ |
77,499 |
|
|
|
|
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS |
|
|
|
|
(Unaudited) |
|
|
|
|
|
|
|
|
Three Months Ended September 30, |
|
Nine Months Ended September 30 |
|
|
(in thousands, except per share amounts) |
|
(in thousands, except per share amounts) |
|
|
|
2020 |
|
|
2019 |
|
|
|
2020 |
|
|
2019 |
|
|
|
|
|
|
|
|
Collaborative revenue |
|
$ |
- |
|
$ |
- |
|
|
$ |
41,176 |
|
$ |
- |
|
Operating expenses: |
|
|
|
|
|
|
Research and development |
|
|
4,639 |
|
|
9,674 |
|
|
|
18,488 |
|
|
29,600 |
|
General and administrative |
|
|
3,452 |
|
|
4,608 |
|
|
|
13,541 |
|
|
13,898 |
|
Total operating expenses |
|
|
8,091 |
|
|
14,282 |
|
|
|
32,029 |
|
|
43,498 |
|
Gain (loss) from operations |
|
|
(8,091) |
|
|
14,282 |
|
|
|
9,147 |
|
|
43,498 |
|
|
|
|
|
|
|
|
Foreign exchange losses |
|
|
(27) |
|
|
(5) |
|
|
|
(41) |
|
|
(18) |
|
Investment income |
|
|
5 |
|
|
325 |
|
|
|
159 |
|
|
1,250 |
|
Income loss before income taxes |
|
|
(8,113) |
|
|
(13,962) |
|
|
|
9,265 |
|
|
(42,266) |
|
|
|
|
|
|
|
|
Net income (loss) per share,
basic |
|
$ |
(0.19) |
|
$ |
(0.36) |
|
|
$ |
0.23 |
|
$ |
(1.08) |
|
Weighted average shares
outstanding, basic |
|
|
41,918 |
|
|
39,025 |
|
|
|
40,199 |
|
|
39,007 |
|
Net income (loss) per share,
diluted |
|
$ |
(0.19) |
|
$ |
(0.36) |
|
|
$ |
0.23 |
|
$ |
(1.08) |
|
Weighted average shares
outstanding, diluted |
|
|
41,918 |
|
|
39,025 |
|
|
|
40,478 |
|
|
39,007 |
|
Contact:
William B. Boni VP, Investor Relations/ Corp. Communications
Minerva Neurosciences, Inc. (617) 600-7376
Minerva Neurosciences (NASDAQ:NERV)
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