Adamas Pharmaceuticals, Inc. (Nasdaq:ADMS) today reported recent
achievements and financial results for the second quarter ended
June 30, 2017.
“This is a very exciting time for Adamas, as we
are potentially at the cusp of transitioning from a company focused
on product development to a commercial entity marketing its own
medicines,” stated Gregory T. Went, Ph.D., Chairman and Chief
Executive Officer of Adamas Pharmaceuticals, Inc. “We look forward
to hearing from the FDA regarding the potential approval of
ADS-5102 for the treatment of levodopa-induced dyskinesia in people
with Parkinson’s disease. If approved, ADS-5102 will be the first
and only approved medicine for this indication.” The New Drug
Application for ADS-5102 has a PDUFA date of August 24, 2017.
Recent Achievements
- Presented expanded analysis from the ADS-5102 (amantadine
extended release capsules) open-label study at the 21st
International Congress of Parkinson's Disease and Movement
Disorders (MDS) meeting showing tolerability and durability out to
88 weeks. The new subgroup analyses also showed that patients
previously treated with immediate-release amantadine, who switched
directly to ADS-5102, experienced a statistically significant
benefit from ADS-5102 comparable to patients not previously treated
with ADS-5102.
- Published ADS-5102 Phase 3 EASE LID clinical trial data in JAMA
Neurology online. The data demonstrated that ADS-5102 significantly
reduced both dyskinesia and OFF time at six months in Parkinson's
disease patients with levodopa-induced dyskinesia.
- Presented positive Phase 1a clinical trial data in a podium
presentation at the 14th Antiepileptic Drug and Device Trials
Conference for ADS-4101 (lacosamide modified release capsules). The
Phase 1 results showed that treatment with ADS-4101 resulted in
reduced adverse events (including dizziness) compared to an
equivalent dose of VIMPAT® (lacosamide) immediate-release tablets
in healthy volunteers.
- Initiated ADS-4101 Phase 1b steady-state study to evaluate the
tolerability and pharmacodynamic profile of three ascending doses
of ADS-4101 administered once daily at bedtime compared to
ascending doses of twice daily VIMPAT (lacosamide) tablets.
Announcement of topline data from the trial is expected in the
third quarter of 2017.
- Signed $100 million royalty-backed note agreement with
HealthCare Royalty Partners.
- Appointed Alfred G. Merriweather as Chief Financial
Officer.
Second Quarter 2017 Financial
ResultsAdamas reported a net loss of $20.7 million, or
$0.93 per share, basic and diluted, for the second quarter of 2017,
compared to a net loss of $16.9 million, or $0.78 per share, basic
and diluted, for the second quarter of 2016. The net losses for the
second quarters of 2017 and 2016 included $3.8 million and $2.6
million, respectively, in non-cash stock-based compensation
expense.
Research and development expenses were $7.2
million for the second quarter of 2017, including $0.9 million in
stock-based compensation expense, compared to $9.2 million for the
comparable quarter of 2016, including $0.7 million in stock-based
compensation expense. The 22 percent 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, in addition to decreased level of
pre-commercial manufacturing activities. The decrease was offset in
part by increased activity and expense related to clinical work
associated with ADS-4101 for the treatment of partial onset
seizures in patients with epilepsy.
General and administrative expenses for the
second quarter ended June 30, 2017, were $13.1 million, including
$2.9 million in stock-based compensation expense, compared to $8.1
million for the quarter ended June 30, 2016, which included $1.9
million in stock-based compensation expense. The 62 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.
Six-month 2017 Financial
Results Adamas reported a net loss for the six months
ended June 30, 2017, of $36.8 million, or $1.65 per share, basic
and diluted, compared with a net loss for the same period in 2016
of $30.7 million, or $1.43 per share, basic and diluted. Research
and development expenses for the six months ended June 30, 2017,
were $14.3 million, including $1.7 million in stock-based
compensation expense, compared to $16.7 million for the six months
ended June 30, 2016, which included $1.4 million in stock-based
compensation expense. General and administrative expenses for the
six months ended June 30, 2017, were $22.3 million, including $4.9
million in stock-based compensation expense, compared to $14.7
million for the six months ended June 30, 2016, which included $3.8
million in stock-based compensation expense.
Cash PositionAdamas ended the
quarter with $144.9 million of cash, cash equivalents, and
available-for-sale securities, compared to $135.9 million at
December 31, 2016. This includes $35 million in funding from
HealthCare Royalty Partners received at the initial closing of the
$100 million royalty-backed loan financing.
Investor Conference Call and
Webcast Adamas will host a conference call and webcast
today, August 8, 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 September 8, 2017.
About Adamas Pharmaceuticals,
Inc.At Adamas, we believe in the power and the promise of
medicines derived from a deep understanding of time-dependent
biology. Our expertise lies in uncovering and mapping the
relationship between disease and drug activity timing patterns.
From there, we strive to create medicines with therapeutic profiles
that match the pattern of disease to drive a more significant and
durable clinical effect. This unique understanding of
time-dependent biological processes informs our every innovation,
targeting advancement in treatment of chronic neurologic disorders.
Our proprietary portfolio includes ADS-5102, a high-dose amantadine
therapy taken once-daily at bedtime, in development for the
treatment of levodopa-induced dyskinesia in people with Parkinson’s
disease as well as walking impairment in people with multiple
sclerosis, and ADS-4101, a high-dose lacosamide therapy taken
once-daily at bedtime, in development for the treatment of partial
onset seizures in patients with epilepsy. The NDA for ADS-5102 is
currently under review by the U.S. Food and Drug Administration
with a PDUFA date of August 24, 2017. 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. VIMPAT® is a trademark of UCB.
Forward-looking Statements
Statements 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 August 8, 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 June 30, |
|
Six Months Ended June 30, |
|
2017 |
|
2016 |
|
2017 |
|
2016 |
Revenue |
$ |
2 |
|
|
$ |
222 |
|
|
$ |
2 |
|
|
$ |
397 |
|
|
|
|
|
|
|
|
|
Operating
expenses |
|
|
|
|
|
|
|
Research and
development |
7,176 |
|
|
9,224 |
|
|
14,264 |
|
|
16,746 |
|
General and
administrative, net |
13,115 |
|
|
8,058 |
|
|
22,259 |
|
|
14,699 |
|
Total
operating expenses |
20,291 |
|
|
17,282 |
|
|
36,523 |
|
|
31,445 |
|
Loss from
operations |
(20,289 |
) |
|
(17,060 |
) |
|
(36,521 |
) |
|
(31,048 |
) |
Interest and other
income, net |
222 |
|
|
184 |
|
|
426 |
|
|
344 |
|
Interest expense |
(729 |
) |
|
— |
|
|
(729 |
) |
|
— |
|
Loss
before income taxes |
(20,796 |
) |
|
(16,876 |
) |
|
(36,824 |
) |
|
(30,704 |
) |
Benefit for income
taxes |
(51 |
) |
|
— |
|
|
(51 |
) |
|
— |
|
Net
loss |
$ |
(20,745 |
) |
|
$ |
(16,876 |
) |
|
$ |
(36,773 |
) |
|
$ |
(30,704 |
) |
Net loss per share,
basic and diluted |
$ |
(0.93 |
) |
|
$ |
(0.78 |
) |
|
$ |
(1.65 |
) |
|
$ |
(1.43 |
) |
Weighted average shares
used in computing net loss per share, basic and diluted |
22,392 |
|
|
21,650 |
|
|
22,300 |
|
|
21,452 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Adamas Pharmaceuticals, Inc. |
Unaudited Consolidated Balance Sheet Data |
(in thousands) |
|
|
|
|
|
June 30, 2017 |
|
December 31, 2016 |
Cash, cash equivalents,
and available-for-sale securities |
$ |
144,929 |
|
|
$ |
135,944 |
|
Total assets |
149,922 |
|
|
142,473 |
|
Total current
liabilities |
11,049 |
|
|
9,743 |
|
Long-term debt |
33,768 |
|
|
— |
|
Total liabilities |
46,018 |
|
|
10,290 |
|
Total stockholders'
equity |
103,904 |
|
|
132,183 |
|
|
|
|
|
|
|
Contact:
Ashleigh Barreto
Director, Corporate Communications & Investor Relations
Adamas Pharmaceuticals, Inc.
Phone: 510-450-3567
Email: ir@adamaspharma.com
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