Adamas Pharmaceuticals, Inc. (Nasdaq:ADMS) today reported
recent achievements and financial results for the fourth quarter
and full-year ended December 31, 2017.
“I’m very proud of the accomplishments made by
the Adamas team in 2017, especially the approval and commercial
availability of GOCOVRI™, the first and only FDA-approved treatment
for dyskinesia in patients with Parkinson’s disease receiving
levodopa-based therapy,” said Gregory T. Went, Ph.D., Founder,
Chairman and Chief Executive Officer of Adamas Pharmaceuticals,
Inc. “Parkinson’s disease is a particularly burdensome and costly
disease, not only for patients, but also for their care partners
and the healthcare system, which is why it was so important to
bring to market a medicine that delivers substantial benefit in
dyskinesia as well as a secondary benefit in OFF time. We are
encouraged by the initial weeks of GOCOVRI’s full commercial launch
and are pleased with the reaction we are receiving from physicians,
patients, care partners and payers as we continue to educate them
on the unique benefits of GOCOVRI.”
Dr. Went continued, “In addition, we are now
capitalized to advance our clinical programs based upon our
time-dependent biology approach and look forward to initiating the
first Phase 3 study for ADS-5102 in multiple sclerosis patients
with walking impairment early in the second quarter of 2018, and
finalizing the clinical development pathway for ADS-4101 in
epilepsy patients with partial onset seizures.”
Recent Achievements
GOCOVRI™ (amantadine) extended release capsules
for the treatment of dyskinesia in patients with Parkinson’s
disease receiving levodopa-based therapy, with or without
concomitant dopaminergic medications
- Commenced full U.S. commercial
launch of GOCOVRI with 59 neurology account specialists in January
2018
- Received prescriptions for GOCOVRI
from over 300 distinct prescribers as of February 16, 2018, up from
100 distinct prescribers as of December 31, 2017
- Published GOCOVRI open-label
subgroup analysis in Movement Disorders Clinical Practice and
presented two posters at scientific conferences
- Received approval of a supplemental
New Drug Application for manufacturing GOCOVRI at a second
commercial site
ADS-5102 (amantadine) extended release capsules
in development for the treatment of walking impairment in patients
with multiple sclerosis
- Published Phase 2 proof-of-concept
data in Multiple Sclerosis Journal
ADS-4101 (lacosamide) modified release capsules
in development for the treatment of partial onset seizures in
patients with epilepsy
- Presented ADS-4101 Phase 1a and
Phase 1b clinical data, as well as pre-clinical rotarod data at the
American Epilepsy Society Annual Meeting in December 2017
- Scheduled a meeting with the FDA to
discuss development program
Corporate
- Concluded 2017 with $176.4 million
in cash and investments, which includes $65 million in funding from
HealthCare Royalty Partners in the fourth quarter of 2017, as part
of the $100 million royalty-backed debt agreement executed in May
2017
- Raised $134.1 million, net of
underwriting discounts, commissions, and transaction costs, through
a public offering of 3,450,000 shares of common stock at a price of
$41.50 per share in January 2018
Anticipated Milestones in the First Half
of 2018
- Initiate the first Phase 3 study
for ADS-5102 (GOCOVRI) in multiple sclerosis patients with walking
impairment
- Present GOCOVRI and ADS-4101
clinical data at the American Academy of Neurology (AAN) Annual
Meeting
- Report topline GOCOVRI data from
EASE LID 2 long-term Phase 3 open-label study
- Review ADS-4101 development program
with the FDA
- Report first full quarter of
revenues for GOCOVRI
Fourth Quarter and Full-Year 2017
Financial ResultsAdamas recorded net product sales of
GOCOVRI of $0.6 million for both the fourth quarter and full-year
ended December 31, 2017. GOCOVRI was made commercially available on
October 20, 2017 and the full commercial launch occurred on January
8, 2018. The company recognizes revenue using a sell-in method when
products are delivered to the specialty pharmacy. No product
revenues were recorded in 2016.
Adamas reported a net loss of $29.4 million, or
$1.27 per share, basic and diluted, for the fourth quarter of 2017,
compared to a net loss of $15.0 million, or $0.68 per share, basic
and diluted, for the fourth quarter of 2016. For the year ended
December 31, 2017, Adamas reported a net loss of $89.5 million, or
$3.97 per share, basic and diluted, compared to a net loss of $60.1
million, or $2.77 per share, basic and diluted, for the year ended
2016.
Research and development (R&D) expenses for
the fourth quarter ended December 31, 2017, were $6.4 million,
including $1.0 million in stock-based compensation expense,
compared to $7.0 million for the fourth quarter ended December 31,
2016, which included $0.7 million in stock-based compensation
expense. For the full-year 2017, R&D expenses were $27.2
million, including $3.6 million in stock-based compensation
expense, compared to $31.2 million for the full-year 2016, which
included $2.9 million in stock-based compensation expense. R&D
expenses for the full-year were primarily for the ongoing
open-label safety study for GOCOVRI, pre-approval manufacturing
costs, and development work for ADS-5102 (GOCOVRI) in development
for the treatment of walking impairment in patients with multiple
sclerosis and for ADS-4101 in development for the treatment of
partial onset seizures in patients with epilepsy.
Selling, general and administrative (SG&A)
expenses for the fourth quarter ended December 31, 2017, were $23.0
million, including $2.4 million in stock-based compensation
expense, compared to $8.3 million for the same quarter in the prior
year, which included $2.1 million in stock-based compensation
expense. In the full-year 2017, SG&A expenses were $61.3
million, including $9.8 million in stock-based compensation
expense, compared to $30.3 million, including $7.7 million in
stock-based compensation expense, incurred during the full-year
2016. The increase in SG&A expenses for the fourth quarter and
full-year was primarily due to growth in commercial and
administrative expenses in preparation for the commercial launch of
GOCOVRI.
On December 31, 2017, Adamas had $176.4 million
of cash, cash equivalents and available-for-sale securities, which
includes $65 million in funding the company received from
HealthCare Royalty Partners (HCR) in the fourth quarter of 2017 as
part of the $100 million royalty-backed debt agreement the company
executed in May 2017. In January 2018, the company raised $134.1
million net proceeds in a public offering.
2018 GuidanceFor 2018, Adamas
expects full-year R&D expenses to be between $45 million and
$50 million, reflecting the completion of the GOCOVRI open-label
study, initiation of the ADS-5102 Phase 3 trials in multiple
sclerosis patients with walking impairment as well as preparation
work for the ADS-4101 Phase 3 trial in epilepsy patients with
partial onset seizures. Additionally, the company expects full-year
SG&A expenses to be between $115 million and $125 million, in
support of GOCOVRI commercialization.
Investor Conference Call and
Webcast Adamas will host a conference call and webcast
today, February 22, 2018, 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 March 22, 2018.
About GOCOVRIGOCOVRI
(amantadine) extended release capsules is the first and only
medicine approved by the FDA for the treatment of dyskinesia in
patients with Parkinson’s disease receiving levodopa-based therapy,
with or without concomitant dopaminergic medications. GOCOVRI is a
high-dose 274 mg amantadine taken once-daily at bedtime, which
delivers consistently high levels of amantadine in the morning and
throughout the day when dyskinesia is most prevalent.
For more information about GOCOVRI, including
important safety information and full U.S. Prescribing Information,
please call 1-844-GOCOVRI (1-844-462-6874) or visit
www.GOCOVRI.com.
About Adamas Pharmaceuticals,
Inc.Adamas is using its deep understanding of
time-dependent biology to redefine the treatment experience for
patients suffering from chronic neurological diseases. The company
is building upon the commercial launch of GOCOVRI™ (amantadine)
extended release capsules (previously ADS-5102), the first and only
FDA-approved medicine for the treatment of dyskinesia in patients
with Parkinson’s disease, with a pipeline of differentiated
investigational programs, which includes: ADS-5102 in development
for the treatment of multiple sclerosis walking impairment; and
ADS-4101, a high-dose, modified release lacosamide in development
for the treatment of partial onset seizures in patients with
epilepsy. Adamas’ goal is to create and commercialize a new
generation of neurological medicines intended to lessen the burden
of disease on patients, caregivers and society. For more
information about Adamas and its unique approach to developing
medicines based on time-dependent biology, please visit
www.adamaspharma.com.
Forward-looking Statements
Statements contained in this press release regarding matters that
relate to future events, conditions, or circumstances 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 timing
of initiating the first Phase 3 study for ADS-5102 in multiple
sclerosis patients with walking impairment, and finalizing the
clinical development pathway for ADS-4101 in epilepsy patients with
partial onset seizures, and the statements under the captions
“Anticipated Milestones in the First Half of 2018” and “2018
Guidance.” Words such as “look forward,” “expects,” and 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 GOCOVRI, ADS-5102 and ADS-4101, the
regulatory and competitive environment and Adamas’ business in
general, see Adamas’ Annual Report on Form 10-K filed with the
Securities and Exchange Commission on February 22, 2018,
particularly under the caption “Risk Factors.” 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.
| Adamas Pharmaceuticals, Inc.Unaudited
Condensed Consolidated Statements of Operations(in thousands,
except per share data) |
| |
Three Months Ended December 31, |
|
Twelve Months Ended December 31, |
| |
2017 |
|
2016 |
|
2017 |
|
2016 |
|
Revenues: |
|
|
|
|
|
|
|
| Product sales, net |
$ |
568 |
|
|
$ |
— |
|
|
$ |
568 |
|
|
$ |
— |
|
| License and grant
revenue |
— |
|
|
37 |
|
|
3 |
|
|
572 |
|
| Total net
revenues |
|
568 |
|
|
|
37 |
|
|
|
571 |
|
|
|
572 |
|
| Costs and
operating expenses: |
|
|
|
|
|
|
|
| Cost of product
sales |
17 |
|
|
— |
|
|
17 |
|
|
— |
|
| Research and
development |
6,445 |
|
|
7,047 |
|
|
27,168 |
|
|
31,230 |
|
| Selling, general and
administrative, net |
22,989 |
|
|
8,283 |
|
|
61,312 |
|
|
30,326 |
|
| Total
costs and operating expenses |
29,451 |
|
|
15,330 |
|
|
88,497 |
|
|
61,556 |
|
| Loss from
operations |
(28,883 |
) |
|
(15,293 |
) |
|
(87,926 |
) |
|
(60,984 |
) |
| Interest and other
income, net |
86 |
|
|
218 |
|
|
1,351 |
|
|
811 |
|
| Interest expense |
(2,239 |
) |
|
— |
|
|
(4,645 |
) |
|
— |
|
| Loss before income
taxes |
(31,036 |
) |
|
(15,075 |
) |
|
(91,220 |
) |
|
(60,173 |
) |
| Benefit for income
taxes |
(1,679 |
) |
|
(115 |
) |
|
(1,730 |
) |
|
(115 |
) |
| Net loss |
$ |
(29,357 |
) |
|
$ |
(14,960 |
) |
|
$ |
(89,490 |
) |
|
$ |
(60,058 |
) |
| Net loss per share,
basic and diluted |
$ |
(1.27 |
) |
|
$ |
(0.68 |
) |
|
$ |
(3.97 |
) |
|
$ |
(2.77 |
) |
| Weighted average shares
used in computing net loss per share, basic and diluted |
23,056 |
|
|
21,992 |
|
|
22,558 |
|
|
21,711 |
|
| Adamas Pharmaceuticals, Inc.Unaudited Consolidated
Balance Sheet Data(in thousands) |
| |
December 31, 2017 |
|
December 31, 2016 |
| Cash, cash equivalents,
and available-for-sale securities |
$ |
176,433 |
|
|
$ |
135,944 |
|
| Total assets |
186,176 |
|
|
142,473 |
|
| Total current
liabilities |
16,607 |
|
|
9,743 |
|
| Long-term debt |
102,647 |
|
|
— |
|
| Total liabilities |
120,050 |
|
|
10,290 |
|
| Total stockholders’
equity |
66,126 |
|
|
132,183 |
|
Contact:
Media:
Terri Clevenger
Continuum Health Communications
203-227-0209
tclevenger@continuumhealthcom.com
Investors:
Ashleigh Barreto
Director, Corporate Communications & Investor Relations
Adamas Pharmaceuticals, Inc.
510-450-3567
ir@adamaspharma.com
Adamas Pharmaceuticals (NASDAQ:ADMS)
Historical Stock Chart
From Mar 2024 to Apr 2024
Adamas Pharmaceuticals (NASDAQ:ADMS)
Historical Stock Chart
From Apr 2023 to Apr 2024
