Minerva Neurosciences Reports Fourth Quarter and Fiscal Year 2023 Financial Results and Business Updates
February 22 2024 - 7:00AM
Minerva Neurosciences, Inc. (Nasdaq: NERV), a clinical-stage
biopharmaceutical company focused on the development of therapies
to treat central nervous system disorders, today reported business
updates and financial results for the fourth quarter and year ended
December 31, 2023.
Corporate Update
On May 8 2023, the U.S. Food and Drug Administration (FDA)
confirmed acceptance for filing of Minerva’s New Drug Application
(NDA) for roluperidone for the treatment of negative symptoms of
schizophrenia. The Company was advised of a Prescription Drug User
Fee Act (PDUFA) goal date of February 26, 2024 and has continued to
work with the FDA during its review of the NDA.
“Minerva achieved a significant milestone in 2023, with the
acceptance of our NDA for roluperidone, which if approved will be
the first ever medication for negative symptoms of schizophrenia to
receive regulatory approval. This milestone also brings hope to the
patients, families and physicians caring for those experiencing
negative symptoms of schizophrenia who currently have no treatment
options,” said Dr. Remy Luthringer, Executive Chairman and
Chief Executive Officer of
Minerva.
Fourth Quarter and Year End Financial
Results
- Research and development (R&D) expense:
For the three months ended December 31, 2023 and 2022, R&D
expense was $4.7 million and $3.2 million, respectively. R&D
expense was higher versus the prior year period primarily due to
costs associated with the FDA’s review of the Company’s NDA and
higher compensation expenses. For the years ended December 31, 2023
and 2022, R&D expense was $12.7 million and $14.6 million,
respectively. The decrease in R&D expense versus the prior year
was primarily due to lower costs related to the preparation of our
NDA for roluperidone, which was submitted during 2022, and lower
non-cash stock compensation costs, partially offset by higher
compensation expenses.
- General and administrative (G&A) expense:
For the three months ended December 31, 2023 and 2022, G&A
expense was $2.5 million and $1.9 million, respectively. G&A
expense was higher versus the prior year period primarily due to
higher compensation expenses and professional service fees. For the
years ended December 31, 2023 and 2022, G&A expense was $10.4
million and $10.6 million, respectively. The decrease in G&A
expense versus the prior year was primarily due to lower non-cash
stock compensation costs and insurance costs, partially offset by
higher professional service fees and compensation expenses.
- Non-cash interest expense: For the three
months ended December 31, 2023 and 2022, non-cash interest expense
for the sale of future royalties was $2.2 million and $1.9 million,
respectively. For the years ended December 31, 2023 and 2022,
non-cash interest expense was $8.3 million and $7.4 million,
respectively. The increase for both the fourth quarter and year
ended December 31, 2023 versus the prior year periods was primarily
due to the amortization of non-cash interest expense for the
difference between the balance of the liability related to the sale
of future royalties and the estimated amount of future royalties to
be received over the royalty period.
- Net loss: Net loss was $9.0 million for the
three months ended December 31, 2023, or net loss per share of
$1.19 basic and diluted, as compared to net loss of $6.7 million,
or net loss per share of $1.26 basic and diluted, for the three
months ended December 31, 2022. Net loss was $30.0 million for the
year ended December 31, 2023, or net loss per share of $4.61 basic
and diluted, as compared to net loss of $32.1 million, or net loss
per share of $6.01 basic and diluted for the year ended December
31, 2022.
- Cash Position: Cash, cash equivalents and
restricted cash at December 31, 2023, were approximately $41.0
million, as compared to $36.2 million at December 31, 2022.
About Minerva Neurosciences
Minerva Neurosciences, Inc. (Nasdaq: NERV) is a clinical-stage
biopharmaceutical company focused on developing product candidates
to treat central nervous system (CNS) diseases. Our goal is to
transform the lives of patients with improved therapeutic options.
Minerva’s portfolio of compounds includes roluperidone (f/k/a
MIN-101), for negative symptoms of schizophrenia, and MIN-301, for
Parkinson’s disease. For more information, please visit our
website.
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, but are not limited to, statements herein with respect to
the regulatory progress and therapeutic potential of roluperidone
for the treatment of negative symptoms in patients with
schizophrenia. 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
the FDA will require additional trials or data which may
significantly delay and put at risk our efforts to obtain
regulatory approval; whether the FDA may meet expected review
timelines for our NDA; whether roluperidone will be successfully
marketed if approved; management’s ability to successfully achieve
its goals; our ability to raise additional capital to fund our
operations and corporate objectives on terms acceptable to us;
general economic conditions; and other factors that are described
under the caption “Risk Factors” in our filings with the Securities
and Exchange Commission, including our Annual Report on Form 10-K
for the year ended December 31, 2023, filed with
the Securities and Exchange Commission on February 22, 2024.
Copies of reports filed with the SEC are posted on our
website at http://ir.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.
Contact:
Investor inquiries:Frederick AhlholmChief
Financial OfficerMinerva Neurosciences,
Inc.info@minervaneurosciences.com
Media inquiries: Helen ShikPrincipalShik
Communications LLChelen@shikcommunications.com
CONDENSED CONSOLIDATED BALANCE SHEET DATA |
(Unaudited) |
|
December 31, 2023 |
December 31, 2022 |
|
(in thousands) |
ASSETS |
Current assets: |
|
|
Cash and cash equivalents |
$ |
40,913 |
|
$ |
36,094 |
|
Restricted cash |
|
100 |
|
|
100 |
|
Refundable regulatory fee |
|
- |
|
|
3,117 |
|
Prepaid expenses and other current assets |
|
989 |
|
|
848 |
|
Total current assets |
|
42,002 |
|
|
40,159 |
|
Equipment and capitalized software, net |
|
29 |
|
|
59 |
|
Goodwill |
|
14,869 |
|
|
14,869 |
|
Total assets |
$ |
56,900 |
|
$ |
55,087 |
|
|
|
|
LIABILITIES AND STOCKHOLDERS' (DEFICIT)
EQUITY |
Current liabilities: |
|
|
Accounts payable |
$ |
1,805 |
|
$ |
969 |
|
Accrued expenses and other current liabilities |
|
1,535 |
|
|
408 |
|
Total current liabilities |
|
3,340 |
|
|
1,377 |
|
Long-term liabilities: |
|
|
Liability related to the sale of future royalties |
|
82,017 |
|
|
73,734 |
|
Total liabilities |
|
85,357 |
|
|
75,111 |
|
Stockholders' (deficit) equity: |
|
|
Common stock |
|
1 |
|
|
1 |
|
Additional paid-in capital |
|
368,357 |
|
|
346,785 |
|
Accumulated deficit |
|
(396,815 |
) |
|
(366,810 |
) |
Total stockholders' (deficit) equity |
|
(28,457 |
) |
|
(20,024 |
) |
Total liabilities and stockholders' (deficit) equity |
$ |
56,900 |
|
$ |
55,087 |
|
|
|
|
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS |
(Unaudited) |
|
|
|
|
|
|
|
|
Three Months Ended December 31,(in
thousands, except per shareamounts) |
|
Twelve Months Ended December 31,(in
thousands, except per shareamounts) |
|
|
|
2023 |
|
|
2022 |
|
|
|
2023 |
|
|
2022 |
|
Operating expenses: |
|
|
|
|
|
|
Research and development |
|
$ |
4,721 |
|
$ |
3,190 |
|
|
$ |
12,705 |
|
$ |
14,649 |
|
General and administrative |
|
|
2,451 |
|
|
1,880 |
|
|
|
10,414 |
|
|
10,582 |
|
Total operating expenses |
|
|
7,172 |
|
|
5,070 |
|
|
|
23,119 |
|
|
25,231 |
|
Loss from operations |
|
|
(7,172 |
) |
|
(5,070 |
) |
|
|
(23,119 |
) |
|
(25,231 |
) |
|
|
|
|
|
|
|
Foreign exchange (losses) gains |
|
|
(19 |
) |
|
(28 |
) |
|
|
(40 |
) |
|
(28 |
) |
Investment income |
|
|
359 |
|
|
297 |
|
|
|
1,437 |
|
|
557 |
|
Non-cash interest expense for the sale of future royalties |
|
|
(2,190 |
) |
|
(1,925 |
) |
|
|
(8,283 |
) |
|
(7,407 |
) |
Net loss |
|
$ |
(9,022 |
) |
$ |
(6,726 |
) |
|
$ |
(30,005 |
) |
$ |
(32,109 |
) |
|
|
|
|
|
|
|
Net loss per share, basic and
diluted |
|
$ |
(1.19 |
) |
$ |
(1.26 |
) |
|
$ |
(4.61 |
) |
$ |
(6.01 |
) |
Weighted average shares
outstanding, basic and diluted |
|
|
7,569 |
|
|
5,340 |
|
|
|
6,506 |
|
|
5,340 |
|
|
|
|
|
|
|
|
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