Minerva Neurosciences Reports Second Quarter 2020 Financial Results and Business Updates
August 03 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 June
30, 2020.
Clinical Pipeline Update
Roluperidone
On May 29, 2020, the Company announced that the Phase 3 trial of
roluperidone to treat negative symptoms in schizophrenia did not
meet its primary (reduction in PANSS Marder Negative Symptoms
Factor Score or NSFS) and key secondary (improvement in the
Personal and Social Performance Scale Total Score or PSP)
endpoints.
Although limited inferences can be drawn from these data,
unadjusted statistically significant separations from placebo were
observed in NSFS at Week 4 for both doses and at Week 8 for the 64
mg dose. The 64 mg dose was statistically significantly
different from placebo as measured by change in PSP at all other
assessment timepoints.
The patients receiving active treatment showed numerically
superior improvements in NSFS to placebo, and a higher number of
responders as measured by NSFS and total PANSS scores was observed
in the roluperidone treatment groups. The reduction in
negative symptoms scores in the 64 mg arm of roluperidone
translated into functional improvement as measured by
PSP.
Roluperidone was generally well tolerated, and Phase 3 safety
data were consistent with such data from the Phase 2b trial.
“We continue our in-depth analyses of the Phase 3 trial with
roluperidone and will be contacting the U.S. Food and Drug
Administration to request a meeting to discuss our plans regarding
the next steps in the clinical development of roluperidone,” said
Dr. Remy Luthringer, Executive Chairman and Chief Executive Officer
of Minerva. “Although the trial did not meet its primary endpoint
due, we believe, to an unexpected high placebo response, we are
encouraged by the study results. The consistency of reduction
in overall negative symptoms and in the most important subtypes of
these symptoms is similar to that observed in the previous Phase 2b
study.”
“The integrated analysis of the Phase 2b and Phase 3 data show a
highly significant separation between the two doses of roluperidone
and placebo throughout the treatment period,” said Dr.
Luthringer. “We believe the improvement in negative symptoms
and the resulting functional improvement support the potential of
roluperidone. This finding will help guide our discussions
with the FDA regarding this potential treatment for negative
symptoms, which remain one of the most important causes of everyday
disability and a critical unmet need for patients with this
disease.”
Seltorexant
On July 1, 2020, the Company announced that it exercised its
right to opt out of its agreement with Janssen Pharmaceutica NV
(Janssen) for the future development of seltorexant
(MIN-202). As a result, the Company will collect a royalty on
worldwide sales of seltorexant in all indications in the mid-single
digits, with no financial obligations to Janssen.
“With respect to seltorexant, the decision to opt out of our
agreement with Janssen at this stage of the program enables us to
retain a meaningful financial interest in the future revenue stream
of a compound with significant commercial potential while
eliminating the Company’s financial obligations to a substantial
Phase 3 program encompassing major depressive disorder and
insomnia,” said Dr. Luthringer. “Furthermore, opting out will
help align our human and financial resources with our primary focus
on defining a path to approval of our lead compound,
roluperidone.”
Second Quarter 2020 Financial Results
- Cash Position: Cash, cash equivalents,
restricted cash and marketable securities as of June 30, 2020 were
approximately $35.3 million.
- R&D Expenses: Research and development
(R&D) expenses were $5.8 million in the second quarter of 2020,
compared to $8.3 million in the second quarter of 2019, a
decrease of approximately $2.5 million.For the six months ended
June 30, 2020, R&D expenses were $13.8 million, compared to
$19.9 million for the six months ended June 30, 2019, a decrease of
approximately $6.1 million.The decreases in R&D expenses during
the quarter and six months ended June 30, 2020 primarily reflect
lower development expenses for the Phase 3 clinical trial of
roluperidone and the Phase 2b clinical trial of MIN-117.The Company
expects R&D expenses to decrease during 2020, as it has
completed the MIN-117 clinical trial and the 12-week, double-blind
portion of the Phase 3 clinical trial of roluperidone.
- G&A Expenses: General and administrative
(G&A) expenses were $5.9 million in the second quarter of 2020,
compared to $4.6 million in the second quarter of 2019, an increase
of approximately $1.3 million.For the six months ended June 30,
2020, G&A expenses were $10.1 million, compared to $9.3 million
for the same period in 2019, an increase of approximately $0.8
million.The increases in G&A expenses during the quarter and
six months ended June 30, 2020 were primarily due to increases in
non-cash stock-based compensation expenses and severance
benefits.
- Net Income/Loss: Net income was $29.5 million
for the second quarter of 2020, or net income per share of $0.75
and $0.73 basic and diluted, respectively, as compared to a net
loss of $12.5 million, or a loss per share of $0.32 basic and
diluted for the second quarter of 2019. Net income was $17.4
million for the first six months of 2020, or net income per share
of $0.44 and $0.43 basic and diluted, respectively, as compared to
a net loss of $28.3 million, or a loss per share of $0.73 basic and
diluted for the first six months of 2019.As a result of opting out
of the agreement with Janssen, the Company recognized $41.2 million
in collaborative revenue during the second quarter of 2020 which
had previously been included on the balance sheet under deferred
revenue. This amount represents the $30 million payment made
by Janssen in 2017 and $11.2 million in previously accrued
collaborative expenses forgiven by Janssen upon the effective date
of the Amendment. The Company does not have any future
performance obligations under the agreement and will recognize any
future royalty revenues in the periods of the sale of products
related to 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 8687621.
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 MDD; 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 June 30,
2020, filed with the Securities and Exchange Commission on
August 3, 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.
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CONDENSED
CONSOLIDATED BALANCE SHEET DATA |
(Unaudited) |
|
June
30, |
December 31, |
|
2020 |
2019 |
|
(in
thousands) |
ASSETS |
Current
Assets: |
|
|
Cash and
cash equivalents |
$ |
32,252 |
|
$ |
21,413 |
|
Marketable securities |
|
2,996 |
|
|
24,442 |
|
Restricted cash |
|
100 |
|
|
100 |
|
Prepaid
expenses and other current assets |
|
543 |
|
|
1,182 |
|
Total
current assets |
|
35,891 |
|
|
47,137 |
|
Equipment, net |
|
7 |
|
|
16 |
|
Other
noncurrent assets |
|
15 |
|
|
15 |
|
Operating
lease right-of-use assets |
|
184 |
|
|
262 |
|
In-process research and development |
|
15,200 |
|
|
15,200 |
|
Goodwill |
|
14,869 |
|
|
14,869 |
|
Total
Assets |
$ |
66,166 |
|
$ |
77,499 |
|
|
|
|
LIABILITIES
AND STOCKHOLDERS' EQUITY |
Current
Liabilities: |
|
|
Accounts
payable |
$ |
3,138 |
|
$ |
2,317 |
|
Accrued
expenses and other current liabilities |
|
4,080 |
|
|
4,139 |
|
Operating
leases |
|
185 |
|
|
173 |
|
Total
current liabilities |
|
7,403 |
|
|
6,629 |
|
Long-Term
Liabilities: |
|
|
Deferred
taxes |
|
1,803 |
|
|
1,803 |
|
Deferred
revenue |
|
- |
|
|
41,176 |
|
Noncurrent operating leases |
|
16 |
|
|
111 |
|
Total
liabilities |
|
9,222 |
|
|
49,719 |
|
Stockholders' Equity: |
|
|
Common
stock |
|
4 |
|
|
4 |
|
Additional paid-in capital |
|
326,298 |
|
|
314,512 |
|
Accumulated deficit |
|
(269,358 |
) |
|
(286,736 |
) |
Total
stockholders' equity |
|
56,944 |
|
|
27,780 |
|
Total
Liabilities and Stockholders' Equity |
$ |
66,166 |
|
$ |
77,499 |
|
|
|
|
|
|
|
|
|
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS |
(Unaudited) |
|
|
Three Months
Ended June 30, |
|
Six Months
Ended June 30 |
|
|
(in
thousands, except per share amounts) |
|
(in
thousands, except per share amounts) |
|
|
2020 |
2019 |
|
2020 |
2019 |
|
|
|
|
|
|
|
Collaborative revenue |
|
$ |
41,176 |
|
$ |
- |
|
|
$ |
41,176 |
|
$ |
- |
|
Operating
expenses: |
|
|
|
|
|
|
Research
and development |
|
|
5,767 |
|
|
8,320 |
|
|
|
13,849 |
|
|
19,926 |
|
General
and administrative |
|
|
5,901 |
|
|
4,584 |
|
|
|
10,090 |
|
|
9,290 |
|
Total
operating expenses |
|
|
11,668 |
|
|
12,904 |
|
|
|
23,939 |
|
|
29,216 |
|
Gain
(loss) from operations |
|
|
29,508 |
|
|
12,904 |
|
|
|
17,237 |
|
|
29,216 |
|
|
|
|
|
|
|
|
Foreign
exchange losses |
|
|
(4 |
) |
|
(7 |
) |
|
|
(13 |
) |
|
(13 |
) |
Investment income |
|
|
25 |
|
|
434 |
|
|
|
154 |
|
|
925 |
|
Net
income (loss) |
|
|
29,529 |
|
|
(12,477 |
) |
|
|
17,378 |
|
|
(28,304 |
) |
|
|
|
|
|
|
|
Net income (loss) per share,
basic |
|
$ |
0.75 |
|
$ |
(0.32 |
) |
|
$ |
0.44 |
|
$ |
(0.73 |
) |
Weighted average shares
outstanding, basic |
|
|
39,483 |
|
|
39,025 |
|
|
|
39,330 |
|
|
38,997 |
|
Net income (loss) per share,
diluted |
|
$ |
0.73 |
|
$ |
(0.32 |
) |
|
$ |
0.43 |
|
$ |
(0.73 |
) |
Weighted average shares
outstanding, diluted |
|
|
40,278 |
|
|
39,025 |
|
|
|
40,145 |
|
|
38,997 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contact:William B. BoniVP, Investor
Relations/Corp. CommunicationsMinerva Neurosciences, Inc.(617)
600-7376
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