Adamas Pharmaceuticals, Inc. (Nasdaq: ADMS), a fully-integrated
pharmaceutical company pioneering time-dependent medicines for
central nervous system (CNS) disorders, today reported financial
results for the third quarter ended September 30, 2019, as well as
recent corporate developments.
“I’m impressed with the team we have in place
and their commitment to develop and commercialize medicines
intended to lessen the burden of chronic neurological diseases on
patients, caregivers and society,” said Neil F. McFarlane, Chief
Executive Officer. “We continue to identify and execute
opportunities to advance GOCOVRI’s commercial performance for the
benefit of Parkinson’s disease patients with dyskinesia and OFF.
During the quarter, driven by new patients and strong
persistence, total GOCOVRI prescriptions continued sequential
quarter-over-quarter growth.” Mr. McFarlane continued, “In
the second half of December, we plan to report topline data from
our INROADS Phase 3 study of ADS-5102 for walking impairment in
patients with multiple sclerosis. If successful, this
potential second indication for GOCOVRI could be a valuable
treatment option for these patients for whom walking impairment
remains a significant unmet need.”
Adamas corporate update
- Neil McFarlane joined Adamas as
Chief Executive Officer in September 2019.
GOCOVRI commercialization
updates
- GOCOVRI product sales were $13.9
million in the third quarter of 2019, compared to $12.7 million in
the second quarter of 2019.
- GOCOVRI generated approximately
6,640 total prescriptions (TRx) in the third quarter of 2019, an 8%
sequential increase over approximately 6,160 TRx in the second
quarter of 2019. The number of new patients starting on GOCOVRI,
primarily patients receiving medication through the free trial
program, was approximately 710 in the third quarter, compared to
740 in the second quarter of 2019.
- Continued strong patient
persistence of 45%-50% at 12 months for GOCOVRI.
ADS-5102 development update
- Topline results from the INROADS
Phase 3 study of ADS-5102 for walking impairment in patients with
multiple sclerosis (MS) are expected in the second half of December
2019.
Financial results
Product sales
GOCOVRI product sales were $13.9 million for the
third quarter of 2019, up 31% compared to $10.6 million in the same
period in 2018. GOCOVRI product sales were $38.3 million for the
nine months ended September 30, 2019, up 85% compared to $20.7
million in the first nine months of 2018.
GOCOVRI received U.S. Food and Drug
Administration (FDA) approval in August 2017, becoming the first
and only U.S. 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 third quarter of 2019
were $6.0 million, compared to $11.7 million for the same period a
year ago. For the nine months ended September 30, 2019, R&D
expenses were $24.9 million, compared to $28.7 million for the nine
months ended September 30, 2018. R&D expenses in both periods
were primarily attributable to the INROADS Phase 3 study of
ADS-5102 for the treatment of walking impairment in patients with
MS.
Selling, General and Administrative (SG&A)
expenses
SG&A expenses for the third quarter of 2019
were $31.2 million, compared to $27.5 million for the same period a
year ago. For the nine months ended September 30, 2019,
SG&A expenses were $84.1 million, compared to $81.6 million for
the nine months ended September 30, 2018. SG&A expenses in both
periods were primarily attributable to external and sales force
costs related to GOCOVRI commercialization.
Net loss
Net loss was $27.6 million, or $0.99 per share,
basic and diluted, for the third quarter of 2019, compared to a net
loss of $33.2 million, or $1.22 per share, basic and diluted, for
the third quarter of 2018. Net loss for the third quarters of 2019
and 2018 included $4.5 million and $4.1 million, respectively, in
non-cash stock-based compensation expense. Net loss for the nine
months ended September 30, 2019, was $82.1 million, or $2.97 per
share, basic and diluted, compared with a net loss for the same
period in 2018 of $102.1 million, or $3.82 per share, basic and
diluted. The net loss for the first nine months of 2019 and 2018
included $10.8 million and $12.0 million, respectively, in non-cash
stock-based compensation expense.
Cash and investments
As of September 30, 2019, Adamas had $150.2
million of cash, cash equivalents and available-for-sale
securities, compared to $210.9 million at December 31, 2018.
Investor conference call and
webcast
Adamas will host a conference call and webcast
today, November 7, 2019, at 4:30 p.m. ET (1:30 p.m. PT). 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-presentations and will be
available for replay until February 7, 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.
For more information about GOCOVRI, please visit
www.GOCOVRI.com.
About ADS-5102
Adamas is currently evaluating ADS-5102 in the
INROADS Phase 3 clinical study for walking impairment in patients
with multiple sclerosis. ADS-5102 was previously approved by the
FDA under the trade name GOCOVRI (amantadine) extended-release
capsules for the treatment of dyskinesia in patients with
Parkinson’s disease receiving levodopa-based therapy. GOCOVRI is
not FDA-approved for the treatment of walking impairment in
patients with multiple sclerosis.
About Adamas Pharmaceuticals,
Inc.
Adamas’ goal is to create and commercialize a
new generation of medicines intended to lessen the burden of
chronic neurologic diseases on patients, caregivers and society
using its deep understanding of time-dependent biology. 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 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
regarding the performance of GOCOVRI or of topline data from its
INROADS Phase 3 study expected in the second half of December 2019.
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’ Quarterly Report on Form 10-Q filed with the Securities and
Exchange Commission on November 7, 2019, 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 September
30, |
|
Nine Months Ended September
30, |
| |
2019 |
|
|
2018 |
|
|
2019 |
|
|
2018 |
|
|
Revenues: |
|
|
|
|
|
|
|
|
Product sales |
$ |
13,933 |
|
|
$ |
10,613 |
|
|
$ |
38,289 |
|
|
$ |
20,731 |
|
| Costs and operating
expenses: |
|
|
|
|
|
|
|
| Cost of product sales |
929 |
|
|
100 |
|
|
2,027 |
|
|
198 |
|
| Research and development |
6,042 |
|
|
11,709 |
|
|
24,854 |
|
|
28,703 |
|
| Selling, general and
administrative, net |
31,180 |
|
|
27,491 |
|
|
84,084 |
|
|
81,553 |
|
|
Total costs and operating expenses |
38,151 |
|
|
39,300 |
|
|
110,965 |
|
|
110,454 |
|
| Loss from operations |
(24,218 |
) |
|
(28,687 |
) |
|
(72,676 |
) |
|
(89,723 |
) |
| Interest and other income,
net |
512 |
|
|
921 |
|
|
1,969 |
|
|
2,931 |
|
| Interest expense |
(3,876 |
) |
|
(5,386 |
) |
|
(11,404 |
) |
|
(15,324 |
) |
| Net loss |
$ |
(27,582 |
) |
|
$ |
(33,152 |
) |
|
$ |
(82,111 |
) |
|
$ |
(102,116 |
) |
| Net loss per share, basic and
diluted |
$ |
(0.99 |
) |
|
$ |
(1.22 |
) |
|
$ |
(2.97 |
) |
|
$ |
(3.82 |
) |
| Weighted average shares used
in computing net loss per share, basic and diluted |
27,778 |
|
|
27,266 |
|
|
27,605 |
|
|
26,728 |
|
Adamas Pharmaceuticals, Inc.Unaudited
Consolidated Balance Sheet Data(in thousands)
| |
September 30, 2019 |
|
December 31, 2018 |
|
Cash, cash equivalents, and available-for-sale securities
|
$ |
150,240 |
|
$ |
210,870 |
| Total assets |
180,439 |
|
234,814 |
| Total current liabilities |
26,358 |
|
24,276 |
| Long-term debt |
124,078 |
|
117,457 |
| Total liabilities |
160,682 |
|
144,929 |
| Total stockholders’
equity |
19,757 |
|
89,885 |
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