Files Annual Report on Form 20-F
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
fourth quarter and 2016 fiscal year ended December 31, 2016, and
has filed its annual report on Form 20-F for the fiscal year ended
December 31, 2016 with the U.S. Securities and Exchange Commission
(the SEC).
“We are pleased to have achieved multiple value
creating clinical and corporate milestones in the past 12 months
and are making further progress toward our goal of making important
new therapies available to patients with Parkinson’s disease,” said
Oded Lieberman, PhD, CEO of NeuroDerm. “With positive results in
our phase 2 efficacy trial of ND0612 in patients with advanced
Parkinson’s disease and productive meetings with U.S. and EU
regulatory authorities, we believe that we are well positioned to
execute our development programs for ND0612 lead product
candidates, and further advance ND0701, our apomorphine liquid
formulation, in 2017. We remain on track to submit regulatory
applications for ND0612 in the U.S. and EU in 2018, and look
forward to initiating our follow-on PK study for ND0701 in the
second half of this year.”
Upcoming Milestones
The currently anticipated timelines for the
ongoing and upcoming clinical trials are as follows:
ND0612
U.S. Regulatory Pathway
- Two PK trials: initiation expected in the second half of
2017
EU Regulatory Pathway
- iNDiGO phase III efficacy trial (trial 007): amending and
restarting based on recent feedback from the EMA; trial completion
expected in parallel with BeyoND study
U.S. and EU Regulatory Pathway
- BeyoND long term safety trial (trial 012): ongoing enrollment
expected to complete in 2017 in time to support 2018 study
completion and submission of regulatory applications
ND0701
- Follow-on PK study for ND0701: initiation expected in the
second half of 2017
- Meeting with the EU regulatory authorities: first half of
2017
Financial Results for the Quarter Ended December 31,
2016
Research and development expenses, net were $9.5
million in the three months ended December 31, 2016 compared to
$4.1 million in the same period in 2015. The increase was primarily
due to an increase in subcontractors and materials, mainly from the
Company’s ongoing clinical trials.
General and administrative expenses were $1.7
million in the three months ended December 31, 2016 compared to
$2.0 million in the same period in 2015. The decrease was primarily
due to a decrease in share-based compensation expenses.
The Company reported a net loss of $11.1 million
in the three months ended December 31, 2016 compared to $6.7
million for the same period in 2015. The increase in net loss was
primarily due to the increase in research and development expenses,
net, which was partially offset by a decrease in financial expenses
as a result of a change in our functional currency, from New Israel
Shekel to the U.S. dollar, effective January 1, 2016.
Financial Results for the Fiscal Year Ended December 31,
2016
Research and development expenses, net, were
$27.0 million for the year ended December 31, 2016 compared to
$12.8 million for the year ended December 31, 2015. The increase
was primarily due to an increase in subcontractors and materials,
mainly from ongoing clinical trials and an increase in Payroll and
related expenses.
General and administrative expenses were $6.1
million for the year ended December 31, 2016 compared to $5.2
million for the year ended December 31, 2015. The increase was
primarily due to an increase in Payroll and related expenses.
The Company reported a net loss of $32.5 million
for the year ended December 31, 2016 compared to $15.6 million for
the same period in 2015. The increase in net loss was primarily due
to the increase in research and development expenses, net, and a
decrease in financial income as a result of a change in our
functional currency, from New Israel Shekel to the U.S. dollar,
effective January 1, 2016.
As of December 31, 2016, the Company had cash
and cash equivalents and short-term bank deposits totaling $152.2
million.
The Company 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 the Company’s
business will generate positive cash flow. As of December 31, 2016,
the Company had an accumulated deficit of $180.7 million and its
activities have been funded through public and private offerings of
the Company's securities and issuance of convertible loans and
warrants.
Form 20-F Filing
NeuroDerm has filed its annual report on Form
20-F for the fiscal year ended December 31, 2016 with the SEC. The
annual report on Form 20-F, which contains NeuroDerm’s audited
financial statements, can be accessed at the SEC's website at
http://www.sec.gov as well as via the Company's investor relations
website at http://ir.neuroderm.com. The Company will deliver a hard
copy of its annual report on Form 20-F, including its complete
audited financial statements, free of charge, to its shareholders
upon request to roy@neuroderm.com.
Conference Call Details
NeuroDerm will host a conference call at 8:30
a.m. ET today to discuss the Company’s fourth quarter and fiscal
year 2016 financial results. Individuals can access the webcast in
the Events and Presentations section of the Investor Relations page
at NeuroDerm.com or by dialing 844-452-2810 (U.S.) or 574-990-9831
(outside of the U.S.). The passcode is 89081893. A webcast
will be archived on the website.
About
NeuroDerm
NeuroDerm is a clinical-stage pharmaceutical company developing
drug-device combinations for central nervous system (CNS) disorders
that are designed to overcome major deficiencies of current
treatments and achieve enhanced clinical efficacy through
continuous, controlled administration. NeuroDerm has three product
candidates in different stages of development which offer a
solution for almost every Parkinson’s disease patient from the
moderate to the very severe stage of the disease. NeuroDerm has
developed a line of levodopa and carbidopa (LD/CD) product
candidates administered through small belt pumps that deliver a
continuous, controlled dose of LD/CD. The LD/CD product candidates
are ND0612L and ND0612H, which are used for treatment of moderate
and advanced Parkinson’s disease patients, respectively, and which
are delivered subcutaneously. 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 our
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.
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 our
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 our annual report on Form 20-F for the year
ended December 31, 2016 filed with the Securities and Exchange
Commission. Any forward-looking statement made by us in this press
release speaks only as of the date hereof. Factors or events that
could cause our actual results to differ may emerge from time to
time, and it is not possible for us to predict all of them. We
undertake no obligation to publicly update any forward-looking
statements, whether as a result of new information, future
developments or otherwise.
NEURODERM LTD. |
CONSOLIDATED STATEMENTS OF FINANCIAL POSITION |
(U.S. dollars in thousands, except share data) |
|
|
|
December 31, |
Assets: |
|
|
2015 |
|
2016 |
|
|
|
|
|
|
Current
assets: |
|
|
|
|
|
Cash and
cash equivalents |
|
$ |
84,735 |
|
$ |
107,178 |
Short-term bank deposits |
|
|
15,103 |
|
45,058 |
Prepaid
expenses and receivables |
|
|
625 |
|
2,666 |
|
|
|
100,463 |
|
154,902 |
Non-current
assets: |
|
|
|
|
|
Restricted bank deposits |
|
|
104 |
|
105 |
Long-term
prepaid expenses |
|
|
149 |
|
141 |
Property,
plant and equipment, net |
|
|
152 |
|
915 |
|
|
|
405 |
|
1,161 |
Total
assets |
|
$ |
100,868 |
|
$ |
156,063 |
NEURODERM LTD. |
CONSOLIDATED STATEMENTS OF FINANCIAL POSITION |
(U.S. dollars in thousands, except share data) |
|
|
|
December 31, |
|
December 31, |
Liabilities and Shareholders’
Equity: |
|
|
2015 |
|
|
|
2016 |
|
Liabilities: |
|
|
|
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
|
|
|
Accounts
payable: |
|
|
|
|
|
|
|
|
Trade |
|
$ |
592 |
|
|
$ |
1,736 |
|
Other |
|
|
3,176 |
|
|
|
4,757 |
|
|
|
|
3,768 |
|
|
|
6,493 |
|
Shareholders payable |
|
|
44 |
|
|
|
- |
|
Total
Liabilities |
|
|
3,812 |
|
|
|
6,493 |
|
Shareholders’
Equity: |
|
|
|
|
|
|
|
|
Share
capital: |
|
|
|
|
|
|
|
|
Ordinary
Shares, NIS 0.01 par value –authorized – 160,000,000 shares at
December 31, 2015 and 2016, issued and outstanding –21,609,787 and
26,335,098 shares at December 31, 2015 and 2016, respectively |
|
|
37 |
|
|
|
49 |
|
Additional paid-in capital |
|
|
239,293 |
|
|
|
320,339 |
|
Share-based compensation capital reserve |
|
|
8,004 |
|
|
|
11,956 |
|
Accumulated deficit |
|
|
(148,238 |
) |
|
|
(180,734 |
) |
Foreign
currency translation differences |
|
|
(2,040 |
) |
|
|
(2,040 |
) |
Total
shareholders' Equity |
|
|
97,056 |
|
|
|
149,570 |
|
Total
liabilities and shareholders' Equity |
|
$ |
100,868 |
|
|
$ |
156,063 |
|
NEURODERM LTD. |
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS |
(U.S. dollars in thousands, except per share
data) |
|
|
|
Year ended December
31, |
|
|
Three months ended December 31,
(unaudited) |
|
|
|
2015 |
|
2016 |
|
2015 |
|
2016 |
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development |
|
$ |
13,715 |
|
|
$ |
27,005 |
|
|
$ |
4,310 |
|
|
$ |
9,515 |
|
Participation in
research and development |
|
|
(908 |
) |
|
|
- |
|
|
|
(183 |
) |
|
|
- |
|
Research and
development, net |
|
|
12,807 |
|
|
|
27,005 |
|
|
|
4,127 |
|
|
|
9,515 |
|
General and
administrative |
|
|
5,163 |
|
|
|
6,087 |
|
|
|
2,038 |
|
|
|
1,656 |
|
Operating
loss: |
|
|
17,970 |
|
|
|
33,092 |
|
|
|
6,165 |
|
|
|
11,171 |
|
Financial income |
|
|
2,379 |
|
|
|
616 |
|
|
|
124 |
|
|
|
85 |
|
Financial expenses |
|
|
18 |
|
|
|
20 |
|
|
|
689 |
|
|
|
10 |
|
Financial expenses
(income), net |
|
|
(2,361 |
) |
|
|
(596 |
) |
|
|
565 |
|
|
|
(75 |
) |
Net
loss |
|
|
15,609 |
|
|
|
32,496 |
|
|
|
6,730 |
|
|
|
11,096 |
|
Other
comprehensive (income) loss - |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Items
that will not be reclassified |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
to profit
or loss - |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign
currency translation differences |
|
|
1,741 |
|
|
|
- |
|
|
|
(569 |
) |
|
|
- |
|
Total
comprehensive loss |
|
$ |
17,350 |
|
|
$ |
32,496 |
|
|
$ |
6,161 |
|
|
$ |
11,096 |
|
Basic and
diluted loss per ordinary share |
|
$ |
0.82 |
|
|
$ |
1.48 |
|
|
$ |
0.31 |
|
|
$ |
0.49 |
|
NEURODERM LTD. |
CONSOLIDATED STATEMENTS OF CASH FLOWS |
(U.S. dollars in thousands) |
|
|
Year endedDecember
31, |
|
Three months endedDecember
31,(Unaudited) |
|
2015 |
|
2016 |
|
2015 |
|
2016 |
Cash flows from operating activities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
$ |
(15,609 |
) |
|
$ |
(32,496 |
) |
|
$ |
(6,730 |
) |
|
$ |
(11,096 |
) |
Adjustments in respect of: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation |
|
44 |
|
|
|
90 |
|
|
|
12 |
|
|
|
29 |
|
Share-based compensation to employees and service
providers |
|
2,913 |
|
|
|
3,952 |
|
|
|
1,046 |
|
|
|
996 |
|
Interest and exchange differences on Short- term deposits and
restricted deposits |
|
296 |
|
|
|
44 |
|
|
|
49 |
|
|
|
12 |
|
Exchange differences in respect of cash and cash
equivalents |
|
(2,184 |
) |
|
|
(34 |
) |
|
|
623 |
|
|
|
38 |
|
|
|
1,069 |
|
|
|
4,052 |
|
|
|
1,730 |
|
|
|
1,075 |
|
Changes in asset and liability items: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Decrease (increase) in prepaid expenses and receivables
(including non-current portion) |
|
(271 |
) |
|
|
(2,021 |
) |
|
|
9 |
|
|
|
(810 |
) |
Increase (decrease) in accounts payable: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Trade |
|
540 |
|
|
|
1,144 |
|
|
|
(379 |
) |
|
|
93 |
|
Other |
|
(167 |
) |
|
|
1,581 |
|
|
|
740 |
|
|
|
1,322 |
|
Payment of shareholders' interest payable |
|
(993 |
) |
|
|
(44 |
) |
|
|
- |
|
|
|
- |
|
|
|
(891 |
) |
|
|
660 |
|
|
|
370 |
|
|
|
605 |
|
Net cash used in operating activities |
|
(15,431 |
) |
|
|
(27,784 |
) |
|
|
(4,630 |
) |
|
|
(9,416 |
) |
Cash flows from investing activities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Purchase of property, plant and equipment |
|
(73 |
) |
|
|
(853 |
) |
|
|
(18 |
) |
|
|
(243 |
) |
Investment in short- term bank deposits |
|
(23,510 |
) |
|
|
(69,000 |
) |
|
|
- |
|
|
|
(45,000 |
) |
Proceeds from short-term bank deposits |
|
8,545 |
|
|
|
39,000 |
|
|
|
- |
|
|
|
8,000 |
|
Restricted bank deposits, net |
|
(54 |
) |
|
|
|
|
|
|
(54 |
) |
|
|
|
|
Net cash provided by (used in) investing activities |
|
(15,092 |
) |
|
|
(30,853 |
) |
|
|
(72 |
) |
|
|
(37,243 |
) |
Cash flows from financing activities
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Proceeds from exercise of options granted to employees |
|
122 |
|
|
|
236 |
|
|
|
76 |
|
|
|
26 |
|
Issuance of ordinary shares, net of issuance costs |
|
71,902 |
|
|
|
80,810 |
|
|
|
- |
|
|
|
80,810 |
|
Net cash provided by financing activities |
|
72,024 |
|
|
|
81,046 |
|
|
|
76 |
|
|
|
80,836 |
|
Increase (decrease) in cash and cash
equivalents |
|
41,501 |
|
|
|
22,409 |
|
|
|
(4,626 |
) |
|
|
34,177 |
|
Balance of cash and cash equivalents at beginning of the
period |
|
43,238 |
|
|
|
84,735 |
|
|
|
89,482 |
|
|
|
73,039 |
|
Foreign currency translation differences |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
in respect of cash and cash equivalents |
|
(2,188 |
) |
|
|
- |
|
|
|
502 |
|
|
|
- |
|
Exchange differences in respect of cash and |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
cash equivalents |
|
2,184 |
|
|
|
34 |
|
|
|
(623 |
) |
|
|
(38 |
) |
Balance of cash and cash equivalents at end of
period |
$ |
84,735 |
|
|
$ |
107,178 |
|
|
$ |
84,735 |
|
|
$ |
107,178 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplementary information: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest received from cash and cash equivalents and bank
deposits |
|
164 |
|
|
|
646 |
|
|
|
|
65 |
|
|
|
|
118 |
|
Investing activities not involving cash flows-Receivables due
to issuance of ordinary shares |
|
- |
|
|
|
12 |
|
|
|
|
- |
|
|
|
|
12 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NeuroDerm Contact:Oded S. Lieberman, PhD,
CEOoded@neuroderm.comTel.: +972-8-946 2729Cell: +1-617-517 6077
U.S. Investor Contact:David CareyLazar Partners
Ltd.dcarey@lazarpartners.com+212-867-1768
U.S. Media Contact:Erich SandovalLazar Partners
Ltd.esandoval@lazarpartners.com+917-497-2867
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