Adamas Reports Recent Achievements and First Quarter 2017 Financial Results
May 09 2017 - 4:01PM
Adamas Pharmaceuticals, Inc. (Nasdaq:ADMS) today reported recent
achievements and financial results for the first quarter ended
March 31, 2017.
“In the first quarter, we continued preparing
for the potential approval and commercialization of ADS-5102,
which, if approved, will be the first and only medicine indicated
for the treatment of levodopa-induced dyskinesia in people with
Parkinson’s disease,” stated Gregory T. Went, Ph.D., Chairman and
Chief Executive Officer of Adamas Pharmaceuticals, Inc. “We are
pleased with the hire of our new Chief Operating Officer, Richard
King, who will lead our efforts toward the commercialization of
ADS-5102.”
Recent Achievements
- Deepened the Adamas management team with the appointment of
Richard A. King as Chief Operating Officer. Mr. King will lead the
commercial team as the company prepares for the August 24th PDUFA
date and launch of ADS-5102 (amantadine) extended-release capsules
for the treatment of levodopa-induced dyskinesia in people with
Parkinson’s disease.
- Presented pooled Phase 3 data of ADS-5102 at the 69th American
Academy of Neurology (AAN) Annual Meeting. Data showed that
treatment with ADS-5102 resulted in a statistically significant
reduction in levodopa-induced dyskinesia as well as OFF time in
people with Parkinson’s disease.
- Presented Phase 3 EASE LID data at the Academy of Managed Care
Pharmacy’s (AMCP) 2017 Annual Meeting showing that treatment with
ADS-5102 improved Clinician’s Global Impression of Change (CGI-C)
and Activities of Daily Living (ADL) by significantly reducing
levodopa-induced dyskinesia in people with Parkinson’s
disease.
First Quarter 2017 Financial
ResultsAdamas reported a net loss of $16.0 million, or
$0.72 per share, basic and diluted, for the first quarter of 2017,
compared to a net loss of $13.8 million, or $0.65 per share, basic
and diluted, for the first quarter of 2016. The net losses for the
first quarters of 2017 and 2016 included $2.9 million and $2.6
million, respectively, in non-cash stock-based compensation
expense. Adamas ended the quarter with $122.2 million of cash, cash
equivalents, and available-for-sale securities, compared to $135.9
million at December 31, 2016.
Research and development expenses were $7.1
million for the first quarter of 2017, including $0.8 million in
stock-based compensation expense, compared to $7.5 million for the
comparable quarter of 2016, including $0.7 million in stock-based
compensation expense. This decrease was mainly attributable to the
completion of two Phase 3 clinical trials of ADS-5102 for the
treatment of levodopa-induced dyskinesia in people with Parkinson’s
disease, offset in part by increased pre-commercial manufacturing
efforts in preparation for the commercial launch of ADS-5102 for
the treatment of levodopa-induced dyskinesia, if approved.
General and administrative expenses for the
first quarter ended March 31, 2017, were $9.1 million, including
$2.1 million in stock-based compensation expense, compared to $6.6
million for the quarter ended March 31, 2016, which included $1.9
million in stock-based compensation expense. The nearly 40 percent
increase in general and administrative expenses was primarily due
to growth in commercial headcount-related expenses and marketing
expenses in preparation for the potential commercial launch of
ADS-5102 for the treatment of levodopa-induced dyskinesia in people
with Parkinson’s disease, pending regulatory approval.
Investor Conference Call and
Webcast Adamas will host a conference call and webcast
today, May 9, 2017, at 4:30 p.m. Eastern Time. The conference call
may be accessed by dialing 844-215-3280 for participants in the
U.S. or Canada and 484-747-6383 for international callers. The
webcast can be accessed live via the investor section of the Adamas
website at http://ir.adamaspharma.com/events.cfm and will be
available for replay until June 9, 2017.
About Adamas Pharmaceuticals,
Inc.Adamas develops new medicines to improve the daily
lives of those affected by chronic neurologic disorders, including
Parkinson’s disease, multiple sclerosis, epilepsy, and Alzheimer’s
disease. Adamas has pioneered a platform to develop medicines for
chronic neurologic disorders based on an understanding of the
time-dependent biologic processes responsible for disease activity
and drug response to potentially achieve symptomatic relief without
tolerability issues. The company’s most advanced product candidate,
ADS-5102, is a high-dose amantadine, taken once daily at bedtime,
in development for the treatment of levodopa-induced dyskinesia in
people with Parkinson’s disease and walking impairment in people
with multiple sclerosis. A New Drug Application supporting ADS-5102
for the treatment of levodopa-induced dyskinesia in people with
Parkinson’s disease is under review by the U.S. Food and Drug
Administration with a PDUFA date of August 24, 2017. Adamas is
exploring other indications for ADS-5102 for further development.
Adamas is also investigating ADS-4101 for the treatment of partial
onset seizures in patients with epilepsy. Additionally, Adamas’
licensed assets are currently marketed by Allergan under the brand
names NAMENDA XR® and NAMZARIC®, and Adamas is eligible to receive
royalties on sales of these medicines beginning in June 2018 and
May 2020, respectively. For more information, please visit
www.adamaspharma.com.
NAMENDA XR® and NAMZARIC® are trademarks of Merz
Pharma GmbH & Co. KGaA.
Forward-looking
StatementsStatements contained in this press release
regarding matters that are not historical facts are
“forward-looking statements” within the meaning of the Private
Securities Litigation Reform Act of 1995, including but not limited
to, statements contained in this press release regarding the
potential approval of ADS-5102 for the treatment of
levodopa-induced dyskinesia in patients with Parkinson’s disease.
Words such as “potentially” and similar expressions (as well as
other words or expressions referencing future events, conditions,
or circumstances) are intended to identify forward-looking
statements. Because such statements are subject to risks and
uncertainties, actual results may differ materially from those
expressed or implied by such forward-looking statements. For a
description of risks and uncertainties that could cause actual
results to differ from those expressed in forward-looking
statements, including risks relating to Adamas’ research, clinical,
development, and commercial activities relating to ADS-5102 and
ADS-4101, the regulatory and competitive environment and Adamas’
business in general, see Adamas’ Quarterly Report on Form 10-Q
filed with the Securities and Exchange Commission on May 9, 2017.
Investors are cautioned not to place undue reliance on these
forward-looking statements, which speak only as of the date of this
release. Adamas undertakes no obligation to update any
forward-looking statement in this press release.
— Financial Tables Attached —
| Adamas Pharmaceuticals, Inc. |
| Unaudited Condensed Consolidated Statements of
Operations |
| (in thousands, except per share data) |
|
|
|
| |
Three Months Ended March
31, |
| |
2017 |
|
2016 |
|
Revenue |
$ |
— |
|
|
$ |
175 |
|
| Operating
expenses |
|
|
|
| Research and
development |
7,088 |
|
|
7,522 |
|
| General and
administrative, net |
9,144 |
|
|
6,641 |
|
| Total
operating expenses |
16,232 |
|
|
14,163 |
|
| Loss from
operations |
(16,232 |
) |
|
(13,988 |
) |
| Interest and other
income, net |
204 |
|
|
160 |
|
| Net loss |
$ |
(16,028 |
) |
|
$ |
(13,828 |
) |
| Net loss per share,
basic and diluted |
$ |
(0.72 |
) |
|
$ |
(0.65 |
) |
| Weighted average shares
used in computing net loss per share, basic and diluted |
22,206 |
|
|
21,253 |
|
| Adamas Pharmaceuticals, Inc. |
| Unaudited Condensed Consolidated Balance Sheets |
| (in thousands, except share and per share data) |
| |
|
|
|
| |
March 31, 2017 |
|
December 31, 2016 |
|
Assets |
|
|
|
| Current assets |
|
|
|
| Cash and
cash equivalents |
$ |
20,918 |
|
|
$ |
23,735 |
|
|
Available-for-sale securities |
91,155 |
|
|
89,917 |
|
| Accounts
receivable |
1,689 |
|
|
794 |
|
| Prepaid
expenses and other current assets |
1,474 |
|
|
2,541 |
|
| Total
current assets |
115,236 |
|
|
116,987 |
|
| Property and equipment,
net |
3,138 |
|
|
3,156 |
|
| Available-for-sale
securities, non-current |
10,086 |
|
|
22,292 |
|
| Other assets |
38 |
|
|
38 |
|
| Total
assets |
$ |
128,498 |
|
|
$ |
142,473 |
|
| Liabilities and
stockholders’ equity |
|
|
|
| Current
liabilities |
|
|
|
| Accounts
payable |
$ |
3,018 |
|
|
$ |
3,589 |
|
| Accrued
liabilities |
4,937 |
|
|
5,867 |
|
| Other
current liabilities |
306 |
|
|
287 |
|
| Total
current liabilities |
8,261 |
|
|
9,743 |
|
| Non-current
liabilities |
492 |
|
|
547 |
|
| Total
liabilities |
8,753 |
|
|
10,290 |
|
| Commitments and
Contingencies |
|
|
|
| Stockholders’
equity |
|
|
|
| Preferred stock, $0.001
par value — 5,000,000 shares authorized, and zero shares issued and
outstanding at March 31, 2017 and December 31, 2016 |
— |
|
|
— |
|
| Common stock, $0.001
par value — 100,000,000 shares authorized, 22,321,984 and
22,013,644 shares issued and outstanding at March 31, 2017 and
December 31, 2016, respectively |
27 |
|
|
27 |
|
| Additional paid-in
capital |
258,121 |
|
|
254,558 |
|
| Accumulated other
comprehensive loss |
(166 |
) |
|
(193 |
) |
| Accumulated
deficit |
(138,237 |
) |
|
(122,209 |
) |
| Total
stockholders’ equity |
119,745 |
|
|
132,183 |
|
| Total
liabilities and stockholders’ equity |
$ |
128,498 |
|
|
$ |
142,473 |
|
| Adamas Pharmaceuticals, Inc. |
| Unaudited Condensed Consolidated Statements of Cash
Flows |
| (in thousands) |
| |
|
| |
Three Months Ended March
31, |
| |
2017 |
|
2016 |
| Cash flows from
operating activities |
|
|
|
| Net loss |
$ |
(16,028 |
) |
|
$ |
(13,828 |
) |
| Adjustments to
reconcile net loss to net cash used in operating activities |
|
|
|
|
Depreciation |
284 |
|
|
137 |
|
|
Stock-based compensation |
2,884 |
|
|
2,553 |
|
| Net
accretion of discounts and amortization of premiums of
available-for-sale securities |
223 |
|
|
258 |
|
| Changes in assets and
liabilities |
|
|
|
| Accrued
interest of available-for-sale securities |
(36 |
) |
|
(105 |
) |
| Prepaid
expenses and other assets |
1,043 |
|
|
(729 |
) |
| Accounts
receivable |
(895 |
) |
|
823 |
|
| Accounts
payable |
(473 |
) |
|
57 |
|
| Accrued
liabilities and other liabilities |
(938 |
) |
|
(1,668 |
) |
| Net cash
used in operating activities |
(13,936 |
) |
|
(12,502 |
) |
| Cash flows from
investing activities |
|
|
|
| Purchases of property
and equipment |
(364 |
) |
|
(461 |
) |
| Purchases of
available-for-sale securities |
(6,992 |
) |
|
— |
|
| Maturities of
available-for-sale securities |
17,800 |
|
|
16,072 |
|
| Net cash
provided by investing activities |
10,444 |
|
|
15,611 |
|
| Cash flows from
financing activities |
|
|
|
| Proceeds from public
offerings, net of offering costs |
— |
|
|
62,030 |
|
| Proceeds from issuance
of common stock upon exercise of stock options |
675 |
|
|
163 |
|
| Net cash
provided by financing activities |
675 |
|
|
62,193 |
|
| Net
increase (decrease) in cash and cash equivalents |
(2,817 |
) |
|
65,302 |
|
| Cash and cash
equivalents at beginning of period |
23,735 |
|
|
33,104 |
|
| Cash and cash
equivalents at end of period |
$ |
20,918 |
|
|
$ |
98,406 |
|
Contact:
Martin Forrest
Vice President, Corporate Communications & Investor Relations
Adamas Pharmaceuticals, Inc.
Phone: 510-450-3528
Email: ir@adamaspharma.com
Adamas Pharmaceuticals (NASDAQ:ADMS)
Historical Stock Chart
From Aug 2024 to Sep 2024
Adamas Pharmaceuticals (NASDAQ:ADMS)
Historical Stock Chart
From Sep 2023 to Sep 2024
