Adamas Pharmaceuticals, Inc. (Nasdaq: ADMS), a company dedicated to
developing and delivering medicines that make a clinically
meaningful difference to people affected by neurological diseases,
today reported financial results for the fourth quarter and full
year ended December 31, 2019, as well as recent corporate
highlights.
“The progress we made last year treating
Parkinson’s disease patients with dyskinesia created a strong
foundation to build upon in 2020,” said Neil F. McFarlane, Chief
Executive Officer of Adamas. “The confidence we have in our growth
strategy for GOCOVRI is bolstered by positive physician feedback,
our recent patent settlement, strong patient persistence, and newly
published open-label data demonstrating patients taking GOCOVRI in
a real-world setting experienced reductions in both dyskinesia and
OFF time sustained for at least two years.”
Recent highlights
- GOCOVRI product sales were $16.3
million in the fourth quarter of 2019, compared to $13.9 million in
the third quarter of 2019, a 17% increase.
- GOCOVRI generated approximately
7,160 total paid prescriptions (TRx) in the fourth quarter of 2019,
an 8% increase over approximately 6,640 TRx in the third quarter of
2019. The number of new patients starting on GOCOVRI, primarily
patients receiving medication through the free trial program, was
approximately 750 in the fourth quarter of 2019, compared to 710 in
the third quarter of 2019.
- Continued strong patient
persistence of 45%-50% at 12 months for GOCOVRI in fourth quarter
2019.
- Long term data from the open-label
Phase 3 study, EASE LID 2, published in the Journal of Parkinson’s
Disease shows GOCOVRI may reduce dyskinesia and OFF as far out as 2
years, providing sustained benefits to Parkinson’s disease patients
with dyskinesia.
- In January 2020, Adamas announced a
settlement agreement with Sandoz Inc. resolving patent litigation
between the two parties relating to Sandoz’s ANDA referencing
GOCOVRI. Under the agreement Adamas granted Sandoz a non-exclusive
license to begin selling a generic version of GOCOVRI as of March
4, 2030, or earlier in certain circumstances.
- During the fourth quarter of 2019,
Adamas announced topline results from its INROADS Phase 3 trial of
ADS-5102 for multiple sclerosis patients with walking impairment.
In the first half of 2020, Adamas plans to assess the value and
potential pathway for the program, including additional data
analyses from the INROADS trial to fully characterize the profile
of ADS-5102.
Financial results
Product sales
GOCOVRI product sales were $16.3 million for the
fourth quarter of 2019, up 23% compared to $13.3 million in the
same period in 2018. GOCOVRI product sales were $54.6 million for
the year ended December 31, 2019, up 60% compared to $34.0 million
for the year ended December 31, 2018.
GOCOVRI received FDA approval in August 2017,
becoming the first and only FDA-approved medicine indicated for the
treatment of dyskinesia in patients with Parkinson’s disease
receiving levodopa-based therapy. Adamas began commercial promotion
of GOCOVRI in January 2018.
Research and Development (R&D) expenses
R&D expenses for the fourth quarter of 2019
were $5.2 million, compared to $10.6 million for the same period in
the prior year. For the year ended December 31, 2019, R&D
expenses were $30.0 million, compared to $39.3 million for the year
ended December 31, 2018. The decrease in R&D expenses in both
periods was primarily due to the completion of the GOCOVRI
development program in the fourth quarter of 2018 and the
completion of the Phase 3 INROADS trial at the end of 2019.
Selling, General and Administrative (SG&A)
expenses
SG&A expenses for the fourth quarter of 2019
were $30.3 million, compared to $27.6 million for the same period
in the prior year. For the year ended December 31, 2019,
SG&A expenses were $114.4 million, compared to $109.1 million
for the year ended December 31, 2018. SG&A expenses in both
periods were primarily attributable to sales force costs and
external spend related to GOCOVRI commercialization.
Net loss
Net loss was $23.1 million, or $0.83 per share,
basic and diluted, for the fourth quarter of 2019, compared to a
net loss of $28.9 million, or $1.06 per share, basic and diluted,
for the fourth quarter of 2018. Net loss for the fourth quarters of
2019 and 2018 included $2.1 million and $3.8 million, respectively,
in non-cash stock-based compensation expense. Net loss for the year
ended December 31, 2019, was $105.2 million, or $3.80 per share,
basic and diluted, compared with a net loss for the same period in
2018 of $131.0 million, or $4.87 per share, basic and diluted. Net
loss for full year 2019 and full year 2018 included $12.9 million
and $15.8 million, respectively, in non-cash stock-based
compensation expense.
Cash and investments
As of December 31, 2019, the Company had $132.6
million of cash, cash equivalents and available-for-sale
securities, compared to $210.9 million at December 31, 2018.
Full year 2020 expense
guidance
For 2020, the Company estimates R&D,
SG&A and stock-based compensation expenses as set forth
below:
|
|
Full Year 2020 |
|
|
|
R&D expenses1 |
|
$10 million -- $15 million |
|
|
|
SG&A expenses2 |
|
$110 million -- $120 million |
|
|
|
Total operating expenses3 |
|
$120 million -- $135 million |
1Includes stock-based compensation expense of $2
million.
2Includes stock-based compensation expense of $9
million.
3Includes stock-based compensation expense of
$11 million.
Investor conference call and
webcast
Adamas will host a conference call and webcast
today, February 25, 2020, at 4:30 p.m. ET (1:30 p.m. PT). The
conference call may be accessed by dialing (844) 215-3280
(U.S./Canada) or (484) 747-6383 (international) using the ID
4448019. The webcast can be accessed live via the investor section
of the Adamas website at
http://ir.adamaspharma.com/events-presentations and will be
available for replay until May 25, 2020.
About GOCOVRI®
GOCOVRI® (amantadine) extended release capsules
is the first and only FDA-approved medicine indicated for the
treatment of dyskinesia in patients with Parkinson’s disease
receiving levodopa-based therapy, with or without concomitant
dopaminergic medications. It is also the only medicine clinically
proven to reduce both dyskinesia and OFF.
Taken once daily at bedtime, GOCOVRI provides an
initial lag and a slow rise in amantadine concentration during the
night, resulting in a high concentration from the morning and
throughout the waking day. Additionally, in the clinical trials,
the adjunctive use of GOCOVRI did not require dose changes to
dopaminergic therapies. The most commonly observed adverse
reactions with GOCOVRI were hallucinations, dizziness, dry mouth,
peripheral edema, constipation, falls and orthostatic
hypotension.
For more information about GOCOVRI, please visit
www.GOCOVRI.com.
About Adamas Pharmaceuticals,
Inc.
At Adamas, our purpose and vision are clear:
deliver innovative medicines that make a clinically meaningful
difference for patients, caregivers and society. We are a
fully-integrated company focused on growing a portfolio of
therapies to address a range of neurological diseases. For more
information, please visit www.adamaspharma.com.
Forward-looking statements
Statements contained in this press release
regarding matters that may occur in the future 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 Adamas’ expectations of
its full year 2020 expenses, and its expectations to complete
additional analyses of the data from the INROADS trial to fully
characterize the profile of ADS-5102 for multiple sclerosis
patients with walking impairment and assess the value and potential
for the program in the first half of 2020. Such statements are
subject to risks and uncertainties, and 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 and ADS-5102, and 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 25, 2020, 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, except as required
by law.
Contact:
Investors: |
Media: |
Peter Vozzo |
Sarah Mathieson |
Westwicke |
Vice President of Corporate Communications |
443-213-0505 |
510-450-3528 |
peter.vozzo@westwicke.com |
smathieson@adamaspharma.com |
— Financial Tables Attached —
|
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, |
|
2019 |
|
2018 |
|
2019 |
|
2018 |
Revenues: |
|
|
|
|
|
|
|
Product sales |
$ |
16,348 |
|
|
|
$ |
13,315 |
|
|
|
$ |
54,637 |
|
|
|
$ |
34,046 |
|
|
Costs and operating
expenses: |
|
|
|
|
|
|
|
Cost of product sales |
442 |
|
|
|
435 |
|
|
|
2,469 |
|
|
|
633 |
|
|
Research and development |
5,180 |
|
|
|
10,597 |
|
|
|
30,034 |
|
|
|
39,300 |
|
|
Selling, general and
administrative, net |
30,285 |
|
|
|
27,582 |
|
|
|
114,369 |
|
|
|
109,135 |
|
|
Total costs and operating expenses |
35,907 |
|
|
|
38,614 |
|
|
|
146,872 |
|
|
|
149,068 |
|
|
Loss from operations |
(19,559 |
) |
|
|
(25,299 |
) |
|
|
(92,235 |
) |
|
|
(115,022 |
) |
|
Interest and other income,
net |
124 |
|
|
|
184 |
|
|
|
2,093 |
|
|
|
3,115 |
|
|
Interest expense |
(3,640 |
) |
|
|
(3,768 |
) |
|
|
(15,044 |
) |
|
|
(19,092 |
) |
|
Net loss |
$ |
(23,075 |
) |
|
|
$ |
(28,883 |
) |
|
|
$ |
(105,186 |
) |
|
|
$ |
(130,999 |
) |
|
Net loss per share, basic and
diluted |
$ |
(0.83 |
) |
|
|
$ |
(1.06 |
) |
|
|
$ |
(3.80 |
) |
|
|
$ |
(4.87 |
) |
|
Weighted average shares used
in computing net loss per share, basic and diluted |
27,890 |
|
|
|
27,357 |
|
|
|
27,677 |
|
|
|
26,886 |
|
|
|
Adamas Pharmaceuticals, Inc.Unaudited Consolidated Balance
Sheet Data(in thousands) |
|
|
December 31, 2019 |
|
December 31, 2018 |
Cash, cash equivalents, and available-for-sale securities |
$ |
132,607 |
|
|
|
$ |
210,870 |
|
Total assets |
162,158 |
|
|
|
234,814 |
|
Total current liabilities |
26,948 |
|
|
|
24,276 |
|
Long-term debt |
125,674 |
|
|
|
117,457 |
|
Total liabilities |
163,051 |
|
|
|
144,929 |
|
Total stockholders’ equity
(deficit) |
(893 |
) |
|
|
89,885 |
|
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