Adamas Pharmaceuticals, Inc. (Nasdaq: ADMS), a company dedicated to
developing and delivering medicines that make a meaningful
difference to people affected by neurological diseases, today
reported financial results for the first quarter ended March 31,
2020, as well as recent corporate highlights.
“In the first quarter of 2020, we continued to
make progress executing on our strategic priorities and treating
Parkinson’s disease patients with dyskinesia and OFF, as we
implemented a number of actions in response to the COVID-19
pandemic,” said Neil F. McFarlane, Chief Executive Officer. “While
we expect some short-term challenges as we progress through 2020,
we continue to optimize the opportunity for GOCOVRI and position
Adamas for long-term growth. Our focus remains on the patients who
rely on us, while ensuring the health and safety of our employees,
their families, and our business partners.”
Recent highlights
- GOCOVRI product sales were $14.5
million in the first quarter of 2020, an increase of 24% as
compared to $11.7 million in the first quarter of 2019.
- Total paid prescriptions (TRx) of
GOCOVRI were approximately 7,210 in the first quarter of 2020, an
increase over approximately 5,820 TRx in the first quarter of 2019
and 7,160 TRx in the fourth quarter of 2019. GOCOVRI continued to
benefit from strong patient persistence of 45%-50% at 12 months in
the first quarter of 2020.
- New paid prescriptions (NRx) of
GOCOVRI were approximately 500 in the first quarter of 2020.
- Sufficient inventory of GOCOVRI to
address patients’ needs into late 2021 with recently completed
manufacturing campaign.
- The assessment of ADS-5102 for
multiple sclerosis patients with walking impairment, which includes
FDA engagement, remains on track to be completed in the second
quarter of 2020.
Financial results
Product sales
GOCOVRI product sales were $14.5 million for the
first quarter of 2020, up 24% compared to $11.7 million in the same
period in 2019. Gross-to-net in both periods reflect annual
insurance plan resets, including the Medicare Part D coverage gap.
Research and Development (R&D) expenses
R&D expenses for the first quarter of 2020
were $2.5 million, compared to $10.2 million for the same period in
the prior year. R&D expenses in the first quarter of 2020
substantially relate to the continued clinical development and
evaluation of the ADS-5102 program. The decrease in R&D
expenses from the prior year quarter was primarily due to the
completion of the Phase 3 INROADS trial for the treatment of
multiple sclerosis patients with walking impairment at the end of
2019.
Selling, General and Administrative (SG&A)
expenses
SG&A expenses for the first quarter of 2020
were $24.6 million, compared to $27.7 million for the same period
in the prior year. SG&A expenses in the first quarter of
2020 were primarily attributable to sales force costs and external
spend dedicated to GOCOVRI commercialization and the related
administrative support. The moderate decrease from prior year
quarter was primarily attributable to fluctuations in
administrative costs.
Net loss
Net loss was $16.6 million, or $0.59 per share,
basic and diluted, for the first quarter of 2020, compared to a net
loss of $29.7 million, or $1.08 per share, basic and diluted, for
the first quarter of 2019. Net loss for the first quarters of 2020
and 2019 included $1.5 million and $3.4 million, respectively, in
non-cash stock-based compensation expense.
Cash and investments
As of March 31, 2020, the Company had $115.3
million of cash, cash equivalents and available-for-sale
securities, compared to $132.6 million at December 31, 2019.
Full year 2020 expense
guidance
The Company is reducing its full year 2020
guidance for SG&A and reaffirming guidance for R&D and
stock-based compensation expenses as set forth below:
|
|
Current Full Year 2020 |
|
Previous Full Year 2020 |
R&D expenses1 |
|
$10 million -- $15 million |
|
$10
million -- $15 million |
SG&A expenses2 |
|
$105 million -- $115 million |
|
$110
million -- $120 million |
Total operating expenses3 |
|
$115 million -- $130 million |
|
$120
million -- $135 million |
1Includes stock-based compensation expense of $1
million.
2Includes stock-based compensation expense of $9
million.
3Includes stock-based compensation expense of
$10 million.
Investor conference call and
webcast
Adamas will host a conference call and webcast
today, May 7, 2020, at 5:00 p.m. ET (2:00 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 3483897. 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 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. 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 assess the
value and potential pathway for ADS-5102 for multiple sclerosis
patients with walking impairment and provide a further update by
the end of the second quarter 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’ Quarterly
Report on Form 10-Q filed with the Securities and Exchange
Commission on May 7, 2020, particularly under the caption “Risk
Factors.” In addition, the impact that the current COVID-19
pandemic is having and will have on demand for GOCOVRI, and the
unknown duration and severity of the COVID-19 pandemic, add
additional risk and uncertainty to these forward-looking
statements. 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 |
Adamas Pharmaceuticals, Inc.Unaudited
Condensed Consolidated Statements of Operations(in thousands,
except per share data)
|
Three Months Ended March
31, |
|
2020 |
|
2019 |
Revenues: |
|
|
|
Product sales |
$ |
14,481 |
|
|
|
$ |
11,665 |
|
|
Costs and operating
expenses: |
|
|
|
Cost of product sales |
572 |
|
|
|
413 |
|
|
Research and development |
2,465 |
|
|
|
10,214 |
|
|
Selling, general and
administrative, net |
24,552 |
|
|
|
27,688 |
|
|
Total costs and operating expenses |
27,589 |
|
|
|
38,315 |
|
|
Loss from operations |
(13,108 |
) |
|
|
(26,650 |
) |
|
Interest and other income,
net |
84 |
|
|
|
723 |
|
|
Interest expense |
(3,624 |
) |
|
|
(3,731 |
) |
|
Net loss |
$ |
(16,648 |
) |
|
|
$ |
(29,658 |
) |
|
Net loss per share, basic and
diluted |
$ |
(0.59 |
) |
|
|
$ |
(1.08 |
) |
|
Weighted average shares used
in computing net loss per share, basic and diluted |
28,030 |
|
|
|
27,453 |
|
|
Adamas Pharmaceuticals, Inc.Unaudited
Consolidated Balance Sheet Data(in thousands)
|
March 31, 2020 |
|
December 31, 2019 |
Cash, cash equivalents, and
available-for-sale securities |
$ |
115,282 |
|
|
|
$ |
132,607 |
|
|
Total assets |
144,311 |
|
|
|
162,158 |
|
|
Total current liabilities |
23,778 |
|
|
|
26,948 |
|
|
Long-term debt |
126,065 |
|
|
|
125,674 |
|
|
Total liabilities |
160,164 |
|
|
|
163,051 |
|
|
Total stockholders’
deficit |
(15,853 |
) |
|
|
(893 |
) |
|
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