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 third quarter ended September
30, 2020, and recent corporate highlights.
“Adamas continues to embrace operational
excellence and delivered a strong performance in a complex
environment. Our employees remain steadfast in their mission to
serve the patient community which is particularly vulnerable during
the pandemic,” said Neil F. McFarlane, Chief Executive Officer. “We
have bolstered the Company’s leadership to accelerate growth and I
remain confident in the long-term outlook of our business and in
our ability to provide benefit to patients and value to
shareholders.”
Portfolio highlights
-
Total revenues were $20.2 million in the third quarter of 2020, an
increase of 45% as compared to $13.9 million in the third quarter
of 2019.
-
GOCOVRI product sales were $19.0 million in the third quarter of
2020, an increase of 36% as compared to $13.9 million in the third
quarter of 2019.
-
Total paid prescriptions (TRx) of GOCOVRI were approximately 7,930
in the third quarter of 2020, a 19% increase over approximately
6,640 TRx in the third quarter of 2019. Third quarter TRx decreased
3% as compared to second quarter 2020 TRx of approximately 8,150,
reflecting the impact of lower new paid prescriptions (NRx) in the
prior quarter from reduced patient access to health care providers.
Strong patient persistence of 45%-50% at 12 months continued in the
third quarter of 2020.
-
New paid prescriptions (NRx) of GOCOVRI were approximately 430 in
the third quarter of 2020, a 16% increase over NRx of approximately
370 in the second quarter of 2020, reflecting a slight improvement
in patient access to health care providers in an environment
impacted by COVID-19.
-
Post-hoc data analyses presented at the 2020 Movement Disorder
Society Congress show GOCOVRI may reduce OFF time in Parkinson’s
disease patients with dyskinesia, with prolonged effects for at
least two years.
-
The U.S. Food and Drug Administration approved the supplemental new
drug application to add AMSA S.p.A. as a secondary supplier of
active pharmaceutical ingredients for GOCOVRI.
-
The Company recognized $1.2 million of royalty revenue on net sales
of NAMZARIC® in the third quarter of 2020.
Corporate highlights
-
Strengthened leadership team with the addition of Adrian Quartel,
M.D., Chief Medical Officer, and Jill Jene, Head of Corporate
Development, as well as the appointment of Anna Richo to the board
of directors.
-
Entered into a Memorandum of Understanding to settle one of the
Company’s previously disclosed class-action lawsuits in the
California Superior Court for the County of Alameda. The payment of
$7.5 million, which will be paid by the Company’s Director &
Officer liability insurance, resolves claims asserted against the
Company, its officers, directors and the other defendants. This
settlement agreement remains subject to approval by the California
State Court. A final non-appealable closure of this court action is
expected mid-2021.
Financial results
Revenue
Total revenue was $20.2 million for the third
quarter of 2020, consisting of GOCOVRI product sales of $19.0
million and royalty revenue earned on net sales of NAMZARIC of $1.2
million. GOCOVRI product sales were up 36% compared to $13.9
million in the same period in 2019.
Research and Development (R&D) expenses
R&D expenses for the third quarter of 2020
were $2.3 million, compared to $6.0 million for the same period in
the prior year. R&D expenses in the third quarter of 2020
substantially relate to the ongoing open-label study which will
conclude by the end of 2020. 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 third quarter of 2020
were $26.1 million, compared to $31.2 million for the same period
in the prior year. SG&A expenses in the third quarter of
2020 were primarily attributable to sales force costs and external
spend dedicated to GOCOVRI commercialization and the related
administrative support. The decrease from prior year quarter was
primarily attributable to certain one-time charges related to
personnel transitions incurred in the third quarter of 2019.
Net loss
Net loss was $11.9 million, or $0.42 per share,
basic and diluted, for the third quarter of 2020, compared to a net
loss of $27.6 million, or $0.99 per share, basic and diluted, for
the third quarter of 2019. Net loss for the third quarters of 2020
and 2019 included $1.6 million and $4.5 million, respectively, in
non-cash stock-based compensation expense.
Cash and investments
As of September 30, 2020, the Company had $92.5
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 updating its full year 2020
guidance for R&D, SG&A and stock-based compensation
expenses as set forth below:
|
|
Current (as of November 5, 2020) |
|
Previous (as of August 6, 2020) |
R&D expenses |
|
$9 million -- $11 million1 |
|
$8 million -- $12 million |
SG&A expenses |
|
$100 million -- $110 million2 |
|
$105 million -- $115 million |
Total operating expenses |
|
$109 million -- $121 million3 |
|
$113 million -- $127 million |
1Includes stock-based compensation expense of $1
million.
2Includes stock-based compensation expense of $6
million.
3Includes stock-based compensation expense of $7
million.
Investor conference call and
webcast
Adamas will host a conference call and webcast
today, November 5, 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
1578986. 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 December 5, 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.
NAMZARIC®
For more information, please visit
www.NAMZARIC.com.
About Adamas
At Adamas our vision is clear - to deliver
innovative medicines that reduce the burden of neurological
diseases on 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. 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
5, 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 |
|
|
— 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, |
|
|
2020 |
|
2019 |
|
2020 |
|
2019 |
Revenues: |
|
|
|
|
|
|
|
|
Product sales |
|
$ |
18,970 |
|
|
$ |
13,933 |
|
|
$ |
51,405 |
|
|
$ |
38,289 |
|
Royalty revenue |
|
1,206 |
|
|
— |
|
|
2,046 |
|
|
— |
|
Total revenues |
|
20,176 |
|
|
13,933 |
|
|
53,451 |
|
|
38,289 |
|
Costs and operating
expenses: |
|
|
|
|
|
|
|
|
Cost of product sales |
|
488 |
|
|
929 |
|
|
1,441 |
|
|
2,027 |
|
Research and development |
|
2,333 |
|
|
6,042 |
|
|
7,348 |
|
|
24,854 |
|
Selling, general and
administrative, net |
|
26,120 |
|
|
31,180 |
|
|
73,849 |
|
|
84,084 |
|
Total costs and operating expenses |
|
28,941 |
|
|
38,151 |
|
|
82,638 |
|
|
110,965 |
|
Loss from operations |
|
(8,765 |
) |
|
(24,218 |
) |
|
(29,187 |
) |
|
(72,676 |
) |
Interest and other income,
net |
|
355 |
|
|
512 |
|
|
654 |
|
|
1,969 |
|
Interest expense |
|
(3,506 |
) |
|
(3,876 |
) |
|
(10,597 |
) |
|
(11,404 |
) |
Net loss |
|
$ |
(11,916 |
) |
|
$ |
(27,582 |
) |
|
$ |
(39,130 |
) |
|
$ |
(82,111 |
) |
Net loss per share, basic and
diluted |
|
$ |
(0.42 |
) |
|
$ |
(0.99 |
) |
|
$ |
(1.39 |
) |
|
$ |
(2.97 |
) |
Weighted average shares used
in computing net loss per share, basic and diluted |
|
28,376 |
|
|
27,778 |
|
|
28,200 |
|
|
27,605 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Adamas Pharmaceuticals, Inc.Unaudited Consolidated Balance
Sheet Data(in thousands) |
|
|
September 30, 2020 |
|
December 31, 2019 |
Cash, cash equivalents, and available-for-sale securities |
$ |
92,477 |
|
|
$ |
132,607 |
|
Total assets |
132,801 |
|
|
162,158 |
|
Total current liabilities |
31,486 |
|
|
26,948 |
|
Long-term debt |
126,573 |
|
|
125,674 |
|
Total liabilities |
167,419 |
|
|
163,051 |
|
Total stockholders’
deficit |
(34,618 |
) |
|
(893 |
) |
Adamas Pharmaceuticals (NASDAQ:ADMS)
Historical Stock Chart
From May 2024 to Jun 2024
Adamas Pharmaceuticals (NASDAQ:ADMS)
Historical Stock Chart
From Jun 2023 to Jun 2024