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 first quarter ended March 31, 2019, as well as
recent corporate developments.
“We remain focused on driving the growth of
GOCOVRI for the treatment of dyskinesia in patients with
Parkinson’s disease (PD) receiving levodopa-based therapy, and
completing our Phase 3 study of ADS-5102 for walking impairment in
patients with multiple sclerosis (MS) – our top two priorities for
2019,” said Dr. Gregory T. Went, Chief Executive Officer of Adamas.
“Total GOCOVRI prescriptions increased over the fourth quarter of
2018, primarily from refills driven by strong patient
persistence. We continue to observe high demand across the
top quartile of our sales territories, accounting for almost half
of all new patient starts. We expected and observed seasonal
issues associated with the start of a new calendar year for
commercial and Medicare Part D insurance plans. We believe this
initially reduced new patient starts and caused delays to refills
for existing patients, both of which recovered by the end of the
quarter, resulting in overall growth.”
Dr. Went continued, “As we have noted
previously, we believe ADS-5102 (GOCOVRI) has the potential to
deliver meaningful benefit to MS patients with impaired walking, as
well as benefitting significantly more PD patients with dyskinesia
and OFF, and that addressing the unmet needs of these two
populations offers opportunities for significant long-term value
creation. Given our desire to concentrate our resources on the
substantial opportunities in these programs, we have decided to
defer investment in ADS-4101, our earlier stage development program
in epilepsy.”
GOCOVRI commercialization
updates
- Nearly 60% of patients initiated on
GOCOVRI are continuing to take the medication at six months, an
excellent persistence rate.
- GOCOVRI generated approximately
5,820 in total prescriptions (TRx) in the first quarter of 2019, a
2% sequential increase over approximately 5,700 TRx in the fourth
quarter of 2018. The number of new patients starting on GOCOVRI,
including 140 patients receiving medication through the recently
launched free trial program, was approximately 720, compared to 760
in the fourth quarter of 2018.
- GOCOVRI net product sales were
$11.7 million. Gross-to-net was higher in the first quarter of 2019
compared to the fourth quarter of 2018 reflecting the Medicare Part
D ‘donut hole’ and other issues related to the start of a new
calendar year for commercial and Medicare Part D insurance plans.
GOCOVRI scientific updates
- New data from the Phase 3 open label study of GOCOVRI in
Parkinson’s patients with dyskinesia and OFF were presented at the
American Academy of Neurology (AAN) in Philadelphia. These
data suggest chronic GOCOVRI treatment may enable the dose of
dopaminergic medications to be modified with an improvement in
dyskinesia and OFF.
Progress of development
programs
- The INROADS Phase 3 study of
ADS-5102 for walking impairment in patients with multiple sclerosis
continues to enroll participants, with top line results expected in
the fourth quarter of 2019. Study design and baseline demographics
data were presented today at AAN.
Financial results
Net product sales
Adamas reported GOCOVRI net product sales of
$11.7 million for the first quarter of 2019, compared to $2.6
million in the same period the prior year. GOCOVRI was launched in
January 2018.
Research and Development (R&D) expenses
R&D expenses for the first quarter of 2019
were $10.2 million, compared to $7.2 million for the same period a
year ago. The increase in R&D expenses is attributable to
the Phase 3 study of ADS-5102 for the treatment of walking
impairment in patients with multiple sclerosis, partially offset by
decreased development costs associated with GOCOVRI for the
treatment of dyskinesia in patients with Parkinson’s disease.
R&D expenses for the first quarter of 2019 and the first
quarter of 2018 included $0.6 million and $0.8 million,
respectively, of stock-based compensation expense.
Selling, General and Administrative (SG&A)
expenses
SG&A expenses for the first quarter of 2019
were $27.7 million, compared to $26.4 million for the same period a
year ago. SG&A expenses for the first quarter of 2019 and
the first quarter of 2018 included $2.8 million and $3.0 million,
respectively, of stock-based compensation expense.
Net loss
Net loss totaled $29.7 million, or $1.08
per share, for the first quarter of 2019, compared to a net
loss of $35.0 million, or $1.35 per share, for the first
quarter of 2018.
Cash and investments
As of March 31, 2019, Adamas had $190.6 million
of cash, cash equivalents and available-for-sale securities,
compared to $210.9 million at December 31, 2018.
Full year 2019 expense guidance
As a result of a review of Adamas’ overall
spending level and including the deferral of investment in
ADS-4101, our earlier stage development program in epilepsy, the
Company has reduced its full year 2019 guidance for R&D and
SG&A expenses, as set forth below.
|
CurrentFull-Year Guidance |
|
PreviousFull-Year Guidance |
R&D Expenses (1) |
$25 million - $35 million |
|
$35 million - $45 million |
SG&A Expenses (2) |
$105 million - $115 million |
|
$120 million - $130 million |
Total Operating Expenses
(3) |
$130 million - $150 million |
|
$155 million - $175 million |
(1) Includes revised stock-based compensation
expense of $2 million, previously $3 million
(2) Includes revised stock-based compensation
expense of $11 million, previously $15 million
(3) Includes revised stock-based compensation
expense of $13 million, previously $18 million
Investor conference call and
webcast
Adamas will host a conference call and webcast
today, May 9, 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 August 9, 2019.
About GOCOVRI QHS
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 proven to
reduce both dyskinesia and OFF.
GOCOVRI is thought to work by reducing the
amount of glutamate hyperactivity in a region of the brain that
controls movement, in patients experiencing dyskinesia and OFF. The
NMDA receptor is activated by glutamate and causes post-synaptic
nerve signaling in this area of the brain, which is modulated by
dopamine. Levodopa therapy replaces dopamine lost in Parkinson’s
disease but may result in large fluctuations in synaptic levels of
dopamine during waking hours, further exacerbating glutamate
hyperactivity. GOCOVRI, developed by Adamas, is novel in that it
selectively blocks the NMDA receptor in a time-dependent manner.
Taken at bedtime (QHS), GOCOVRI provides an initial lag and a slow
rise in amantadine concentration during the night and a high
concentration from the morning and throughout the waking day.
Additionally, the adjunctive use of GOCOVRI does not require dose
changes to dopaminergic therapies. The most commonly observed
adverse reactions with GOCOVRI were hallucinations, dizziness, dry
mouth, peripheral edema, constipation, fall and orthostatic
hypotension.
For more information about GOCOVRI, please see
the U.S. Prescribing Information at www.GOCOVRI.com.
About ADS-5102
Adamas is currently evaluating ADS-5102 in a
Phase 3 clinical program 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, with or without
concomitant dopaminergic medications. 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 of
its 2019 expenses under “Full Year 2019 Expense Guidance” and its
expectations of top-line data from its INROADS Phase 3 study
expected in the fourth quarter of 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 May 9, 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.
Contact:
Investors: |
Media: |
Peter Vozzo |
Sarah Mathieson |
Westwicke Partners |
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 March 31, |
|
2019 |
|
2018 |
Revenues: |
|
|
|
Product sales |
$ |
11,665 |
|
|
$ |
2,553 |
|
Costs and operating
expenses: |
|
|
|
Cost of product sales |
413 |
|
|
25 |
|
Research and development |
10,214 |
|
|
7,188 |
|
Selling, general and
administrative, net |
27,688 |
|
|
26,363 |
|
Total costs and operating expenses |
38,315 |
|
|
33,576 |
|
Loss from operations |
(26,650 |
) |
|
(31,023 |
) |
Interest and other income,
net |
723 |
|
|
878 |
|
Interest expense |
(3,731 |
) |
|
(4,826 |
) |
Net loss |
$ |
(29,658 |
) |
|
$ |
(34,971 |
) |
Net loss per share, basic and
diluted |
$ |
(1.08 |
) |
|
$ |
(1.35 |
) |
Weighted average shares used
in computing net loss per share, basic and diluted |
27,453 |
|
|
25,861 |
|
Adamas Pharmaceuticals, Inc.Unaudited
Consolidated Balance Sheet Data(in thousands)
|
March 31, 2019 |
|
December 31, 2018 |
Cash, cash equivalents, and available-for-sale securities |
$ |
190,635 |
|
|
$ |
210,870 |
|
Total assets |
223,226 |
|
|
234,814 |
|
Total current liabilities |
29,830 |
|
|
24,276 |
|
Long-term debt |
119,661 |
|
|
117,457 |
|
Total liabilities |
159,310 |
|
|
144,929 |
|
Total stockholders’
equity |
63,916 |
|
|
89,885 |
|
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