NeuroDerm Ltd. (NASDAQ:NDRM), a clinical stage pharmaceutical
company developing drug-device combinations for central nervous
system (CNS) disorders, today announced financial results for the
second quarter ended June 30, 2017.
Recent Highlights
- On July 24, 2017, NeuroDerm entered into a definitive agreement
to be acquired by Mitsubishi Tanabe Pharma Corporation (MTPC) for
US$1.1 billion in cash. A special meeting of shareholders to
approve the transaction is expected to be held on September 12,
2017. Assuming typical regulatory and shareholder approval
timeframes, NeuroDerm currently anticipates the transaction will
close in the fourth quarter of 2017.
- On June 6, 2017, NeuroDerm announced that the main design
elements for the amended iNDiGO phase III efficacy trial (trial
007) for ND0612 were accepted by the European Medicines Agency
(EMA).
- Presented ND0612 complete phase II data from trial 006 in a
late-breaking session at the 21st International Congress of
Parkinson’s Disease and Movement Disorders, which took place June
4-8, 2017. ND0612 head-to-head pilot PK results and ND0701
first-in-man PK results were also presented.
- Complete trial 006 data were also presented at the 3rd Congress
of the European Academy of Neurology (EAN).
“Presenting complete data from trial 006 and
having the main design elements for the amended iNDiGO phase III
efficacy trial accepted by the European Medicines Agency were
important milestones in the development of ND0612,” said Oded S.
Lieberman, PhD, CEO of NeuroDerm. “Their attainment helps to
clarify the regulatory pathway for ND0612, and brings this
potentially transformative Parkinson’s disease therapy closer to
patients who urgently need new treatment options. MTPC has the
expertise, resources and commitment to make ND0612 broadly and
rapidly available, and we look forward to it continuing to build on
the important progress that we have made to date in the development
of this novel product candidate.”
Financial Results for the Quarter Ended June 30,
2017
Research and development expenses, net were
$11.1 million in the three months ended June 30, 2017 compared to
$5.6 million in the same period in 2016. The increase was
primarily due to an increase in subcontractors and materials,
mainly from clinical studies and due to production costs related to
the Company’s levodopa product candidates and due to an increase in
payroll and related expenses, including share-based compensation
expenses.
General and administrative expenses were $4.2
million in the three months ended June 30, 2017 compared to $1.4
million in the same period in 2016. The increase was primarily due
to an increase in payroll and related expenses, including
share-based compensation expenses.
The Company reported a net loss of $14.9 million
in the three months ended June 30, 2017 compared to $7.0 million
for the same period in 2016. The increase in net loss was
primarily due to the increase in research and development expenses,
net.
As of June 30, 2017, the Company had cash and
cash equivalents and short-term bank deposits totaling $131.5
million.
NeuroDerm is a clinical-stage pharmaceutical
company with a limited operating history, has not yet generated
revenue from its operations and continues to incur significant
research and development and other expenses related to its ongoing
operations. Accordingly, there is no assurance that NeuroDerm’s
business will generate positive cash flow. As of June 30,
2017, NeuroDerm had an accumulated deficit of $208.7 million and
its activities have been funded through public and private
offerings of the company’s securities and issuance of convertible
loans and warrants.
Suspension of Financial Results
Conference CallsAs announced on July 24, 2017, NeuroDerm
entered into an agreement under which Mitsubishi Tanabe Pharma
Corporation (TSE Code: 4508) (“MTPC”), a publicly traded company on
the Tokyo Stock Exchange, will acquire NeuroDerm for US$39 per
share in cash. In light of the pending transaction, the
Company will not host a financial results conference call for this
period or for future periods.
About NeuroDermNeuroDerm is a
clinical-stage pharmaceutical company developing central nervous
system (CNS) product candidates that are designed to overcome major
deficiencies of current treatments and achieve enhanced clinical
efficacy through continuous, controlled administration.
NeuroDerm’s main focus is in Parkinson’s disease, where it has
three clinical stage product candidates in development which offer
a solution for almost every Parkinson’s disease patient, from
moderate to the very severe stage of the disease. The primary
product candidates are a line of levodopa and carbidopa (LD/CD)
products administered through small belt pumps that deliver a
continuous, controlled dose of LD/CD. The LD/CD product
candidates, ND0612L and ND0612H, are aimed at the treatment of
moderate and advanced Parkinson’s disease patients, respectively,
and are delivered subcutaneously. NeuroDerm is also designing a
patch pump for future use. In addition, NeuroDerm is
developing ND0701, a novel subcutaneously delivered apomorphine
formulation for patients who suffer from moderate to severe
Parkinson’s disease and who do not respond well to LD/CD.
NeuroDerm is headquartered in the Weizmann Science Park in Rehovot,
Israel.
Forward-Looking StatementsThis
press release contains forward-looking statements, within the
meaning of the safe harbor provisions of the Private Securities
Litigation Reform Act of 1995, Section 27A of the Securities Act of
1933, as amended, and Section 21E of the Securities Exchange Act of
1934, as amended that involve risks and uncertainties. Such
forward-looking statements may include projections regarding
NeuroDerm’s future performance and may be identified by words like
“anticipate,” “assume,” “believe,” “continue,” “could,” “estimate,”
“expect,” “intend,” “may,” “plan,” “potential,” “predict,”
“project,” “future,” “will,” “seek” and similar terms or
phrases. These forward-looking statements include, but are
not limited to, statements about the expected timing of the
shareholder meeting to approve the acquisition and the timing of
the closing of the acquisition. The forward-looking
statements contained in this press release are based on
management’s current expectations and projections about future
events. There are important factors that could cause NeuroDerm’s
actual results, levels of activity, performance or achievements to
differ materially from the results, levels of activity, performance
or achievements expressed or implied by the forward-looking
statements. In particular, you should consider the risks
provided under “Risk Factors” in NeuroDerm’s annual report on Form
20-F for the year ended December 31, 2016 filed with the Securities
and Exchange Commission. Forward-looking statements with
respect to the acquisition are subject to risks and uncertainties
that may cause actual outcomes to differ materially from those
contemplated by the forward-looking statements, including:
(1) NeuroDerm may be unable to obtain required regulatory
approvals or satisfy other conditions to the closing of the
proposed acquisition; (2) the proposed acquisition may involve
unexpected costs, liabilities or delays; (3) the occurrence of any
event, change or other circumstances that could give rise to the
termination of the merger agreement related to the acquisition; (5)
risks that the proposed acquisition disrupts current plans and
operations and the potential difficulties in employee retention as
a result of the proposed acquisition; (6) impact of the acquisition
on relationships with NeuroDerm’s commercial counter-parties and
(7) other risks that may adversely impact the consummation of the
acquisition, which may result in the acquisition not being
consummated within the expected time period or at all, as well as
the risks described in NeuroDerm’s filings with the SEC.
Any forward-looking statement made by us in this press
release speaks only as of the date hereof. Factors or events
that could cause actual results to differ may emerge from time to
time, and it is not possible for the company to predict all of
them. NeuroDerm undertakes no obligation to publicly update
any forward-looking statements, whether as a result of new
information, future developments or otherwise.
NEURODERM LTD.STATEMENTS OF
FINANCIAL POSITION(Unaudited)(U.S. dollars in thousands,
except share data) |
|
|
December 31, |
June 30, |
Assets: |
2016 |
|
2017 |
|
|
|
|
Current
Assets: |
|
|
Cash and cash
equivalents |
$ |
107,178 |
$ |
18,176 |
|
Short- term bank
deposits |
|
45,058 |
|
113,287 |
|
Prepaid expenses
and receivables |
|
2,666 |
|
3,007 |
|
|
|
154,902 |
|
134,470 |
|
Non-Current
Assets: |
|
|
Restricted bank
deposit |
|
105 |
|
174 |
|
Long-term
prepaid expenses |
|
141 |
|
145 |
|
Property, plant
and equipment, net |
|
915 |
|
1,175 |
|
|
|
1,161 |
|
1,494 |
|
Total
Assets |
$ |
156,063 |
$ |
135,964 |
|
NEURODERM LTD.STATEMENTS OF
FINANCIAL POSITION(Unaudited)(U.S. dollars in thousands,
except share data) |
|
|
December 31, |
June 30, |
Liabilities
and Shareholders’ Equity: |
|
2016 |
|
|
2017 |
|
|
|
|
Liabilities: |
|
|
|
|
|
Current
Liabilities: |
|
|
Accounts
payable: |
|
|
Trade |
$ |
1,736 |
|
$ |
3,148 |
|
Other |
|
4,757 |
|
|
4,455 |
|
Total
Liabilities |
|
6,493 |
|
|
7,603 |
|
Shareholders’
Equity: |
|
|
Share
capital: |
|
|
Ordinary
Shares, NIS 0.01 par value – authorized – 160,000,000 shares at
December 31, 2016 and June 30, 2017, issued and outstanding –
26,335,098 shares and 26,345,938 at December 31, 2016 and June 30,
2017, respectively |
|
49 |
|
|
49 |
|
Additional paid-in capital |
|
320,339 |
|
|
320,392 |
|
Share-based compensation capital reserve |
|
11,956 |
|
|
18,682 |
|
Accumulated deficit |
|
(180,734 |
) |
|
(208,722 |
) |
Foreign
currency translation differences |
|
(2,040 |
) |
|
(2,040 |
) |
Total
Shareholders' Equity |
|
149,570 |
|
|
128,361 |
|
Total
Liabilities and Shareholders' Equity |
$ |
156,063 |
|
$ |
135,964 |
|
NEURODERM LTD.STATEMENTS OF
COMPREHENSIVE LOSS (Unaudited)(U.S. dollars in thousands,
except per share data) |
|
|
|
Six months ended June 30, |
Three months ended June 30, |
|
|
|
2016 |
|
|
2017 |
|
|
2016 |
|
|
2017 |
|
Operating expenses: |
|
|
|
|
Research
and development |
$ |
9,686 |
|
$ |
21,445 |
|
$ |
5,556 |
|
$ |
11,305 |
|
Participation in research and development |
|
- |
|
|
(156 |
) |
|
- |
|
|
(156 |
) |
Research
and development, net |
|
9,686 |
|
|
21,289 |
|
|
5,556 |
|
|
11,149 |
|
General and
administrative |
|
3,000 |
|
|
7,486 |
|
|
1,448 |
|
|
4,212 |
|
Operating loss |
|
12,686 |
|
|
28,775 |
|
|
7,004 |
|
|
15,361 |
|
Financial
income |
|
391 |
|
|
806 |
|
|
56 |
|
|
435 |
|
Financial
expenses |
|
5 |
|
|
19 |
|
|
2 |
|
|
11 |
|
Financial
income, net |
|
(386 |
) |
|
(787 |
) |
|
(54 |
) |
|
(424 |
) |
Net
loss |
$ |
12,300 |
|
$ |
27,988 |
|
$ |
6,950 |
|
$ |
14,937 |
|
Basic and diluted loss per ordinary share |
$ |
0.57 |
|
$ |
1.06 |
|
$ |
0.32 |
|
$ |
0.57 |
|
NEURODERM LTD.STATEMENTS OF
CASH FLOWS(Unaudited)(U.S. dollars in thousands) |
|
|
Six months ended June 30, |
Three months ended June 30, |
|
2016 |
2017 |
2016 |
2017 |
|
|
|
|
|
Cash Flows From
Operating Activities: |
|
|
|
|
Net
loss |
$ |
(12,300 |
) |
$ |
(27,988 |
) |
$ |
(6,950 |
) |
$ |
(14,937 |
) |
Adjustments in respect of: |
|
|
|
|
Depreciation |
|
31 |
|
|
84 |
|
|
20 |
|
|
41 |
|
Share-based compensation to employees and service providers |
|
1,924 |
|
|
6,726 |
|
|
1,129 |
|
|
3,462 |
|
Interest
and exchange differences on bank deposits and restricted bank
deposits |
|
28 |
|
|
(492 |
) |
|
(46 |
) |
|
(209 |
) |
Exchange
differences in respect of cash and cash equivalents |
|
(60 |
) |
|
(152 |
) |
|
106 |
|
|
(59 |
) |
|
|
(10,377 |
) |
|
(21,822 |
) |
|
(5,741 |
) |
|
(11,702 |
) |
Changes
in asset and liability items: |
|
|
|
|
Increase
in prepaid expenses and receivables (including non-current
portion) |
|
(817 |
) |
|
(297 |
) |
|
(337 |
) |
|
(7 |
) |
Increase
(decrease) in accounts payable: |
|
|
|
|
Trade |
|
948 |
|
|
1,412 |
|
|
341 |
|
|
1,306 |
|
Other |
|
93 |
|
|
(302 |
) |
|
(253 |
) |
|
(483 |
) |
|
|
224 |
|
|
813 |
|
|
(249 |
) |
|
816 |
|
Net cash
used in operating activities |
|
(10,153 |
) |
|
(21,009 |
) |
|
(5,990 |
) |
|
(10,886 |
) |
Cash flows from
investing activities: |
|
|
|
|
Purchase
of property, plant and equipment |
|
(57 |
) |
|
(344 |
) |
|
(20 |
) |
|
(118 |
) |
Investment in short- term bank deposits |
|
(24,000 |
) |
|
(120,250 |
) |
|
- |
|
|
(39,000 |
) |
Proceeds
from short-term bank deposits |
|
23,000 |
|
|
52,500 |
|
|
8,000 |
|
|
46,250 |
|
Restricted bank deposits, net |
|
- |
|
|
(56 |
) |
|
- |
|
|
(56 |
) |
Net cash
provided by (used in) investing activities |
|
(1,057 |
) |
|
(68,150 |
) |
|
7,980 |
|
|
7,076 |
|
Cash flows from
financing activities: |
|
|
|
|
Proceeds
from exercise of options granted to employees |
|
107 |
|
|
5 |
|
|
107 |
|
|
2 |
|
Net cash
provided from financing activities |
|
107 |
|
|
5 |
|
|
107 |
|
|
2 |
|
Increase
(decrease) in cash and cash equivalents |
|
(11,103 |
) |
|
(89,154 |
) |
|
2,097 |
|
|
(3,808 |
) |
Balance of cash
and cash equivalents at beginning of period |
|
84,735 |
|
|
107,178 |
|
|
71,701 |
|
|
21,925 |
|
Exchange
differences in respect of cash and |
|
|
|
|
cash equivalents |
|
60 |
|
|
152 |
|
|
(106 |
) |
|
59 |
|
Balance of cash
and cash equivalents at end of period |
$ |
73,692 |
|
$ |
18,176 |
|
$ |
73,692 |
|
$ |
18,176 |
|
Supplementary
information: |
|
|
|
|
Interest
received from cash and cash equivalents and bank deposits |
$ |
363 |
|
$ |
251 |
|
$ |
133 |
|
$ |
215 |
|
Investing
activities not involving cash flows-Purchasing of property, plant
and equipment on credit |
$ |
498 |
|
|
- |
|
$ |
498 |
|
|
- |
|
NeuroDerm Contact:Oded S.
Lieberman, PhD, CEOoded@neuroderm.com Tel.: +972-8-946
2729Cell: +1-617-517 6077
U.S. Investor Contact:David
CareyLazar Partners
Ltd.dcarey@lazarpartners.com +212-867-1762
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