Second quarter 2021 total revenues of $22.0
million, a 17% increase over second quarter 2020
GOCOVRI new paid prescriptions of 730, a 97%
increase over second quarter 2020
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 second quarter ended June 30,
2021, and recent corporate highlights.
“We delivered a strong performance in the second quarter, with a
robust increase in demand set to fuel future growth,” said Neil F.
McFarlane, Chief Executive Officer. “We remain on track to achieve
our 2021 goals as we navigate the fluid macro environment. With the
continued momentum of our GOCOVRI launch alongside our disciplined
approach to capital allocation, we are excited about the
opportunities ahead for patients and shareholders.”
Recent portfolio highlights
- Total revenues were $22.0 million in the second quarter of
2021, an increase of 17% as compared to $18.8 million in the second
quarter of 2020.
- GOCOVRI® (amantadine) extended release capsules product sales
were $20.1 million in the second quarter of 2021, an increase of
12% as compared to $18.0 million in the second quarter of
2020.
- New paid prescriptions (NRx) of GOCOVRI were approximately 730
in the second quarter of 2021, a 97% increase over NRx of
approximately 370 in the second quarter of 2020.
- Total paid prescriptions (TRx) of GOCOVRI were approximately
9,400 in the second quarter of 2021, a 19% increase over
approximately 7,915 TRx in the second quarter of 2020.
- Strong patient persistence of 45%-50% at 12 months for the
second quarter of 2021 remains consistent.
Corporate highlights
- Recent publications in peer-reviewed journals: new data
analyses suggesting GOCOVRI may meaningfully reduce the impact of
motor symptoms on activities of daily living published in Neurology
and Therapy; and a review article by leading neurologists published
in TouchNEUROLOGY supporting GOCOVRI as a clinically significant
advance in treating motor complications.
- Announced issuance of patents for GOCOVRI, the first in a new
patent family, which cover drug product composition and method of
use.
- First international patent covering ADS-4101, an
investigational high-dose, modified release lacosamide capsule for
partial onset seizures in patients with epilepsy was issued in
Japan. This patent follows two recently issued U.S. patents. These
patents may assist efforts to continue to partner or out-license
this program.
- Received FDA approval of an sNDA for a second and alternative
packager for GOCOVRI further bolstering the Company’s supply
chain.
Financial results
Revenue
Total revenues were $22.0 million for the second quarter of
2021, consisting of GOCOVRI product sales of $20.1 million, OSMOLEX
ER product sales of $0.5 million and royalty revenue earned on net
sales of NAMZARIC® (memantine hydrochloride extended release and
donepezil hydrochloride) capsules of $1.4 million. GOCOVRI product
sales were up 12% compared to $18.0 million in the same period in
2020.
Research and Development (R&D) expenses
R&D expenses for the second quarter of 2021 were $1.4
million, compared to $2.6 million for the same period in the prior
year. The decrease in R&D expenses was primarily due to the
completion of the Company’s open-label extension trial for the
treatment of multiple sclerosis patients with walking
impairment.
Selling, General and Administrative (SG&A) expenses
SG&A expenses for the second quarter of 2021 were $29.2
million, compared to $23.2 million for the same period in the prior
year. SG&A expenses in the second quarter of 2021 were
primarily attributable to sales force costs and external spend
dedicated to GOCOVRI commercialization and the related
administrative support as well as the integration and initial
promotion of OSMOLEX ER.
Net loss
Net loss was $12.3 million, or $0.27 per share, basic and
diluted, for the second quarter of 2021, compared to a net loss of
$10.6 million, or $0.37 per share, basic and diluted, for the
second quarter of 2020. Net loss for the second quarter of 2021 and
2020 included $1.9 million and $1.7 million, respectively, in
non-cash stock-based compensation expense.
Cash and investments
As of June 30, 2021, Adamas had $118.3 million of cash, cash
equivalents and available-for-sale securities, compared to $83.4
million as of December 31, 2020. During the first quarter of 2021,
the Company raised net proceeds of approximately $66.5 million
through the sale of common stock.
Full year 2021 expense guidance
For full year 2021, Adamas is reiterating its estimates for
R&D, SG&A and stock-based compensation expenses as set
forth below:
Full Year 2021
R&D expenses
$5 million -- $10 million1
SG&A expenses
$110 million -- $120 million2
Total operating expenses
$115 million -- $130 million3
1Includes stock-based compensation expense of $1 million.
2Includes stock-based compensation expense of $8 million. 3Includes
stock-based compensation expense of $9 million.
Investor conference call and webcast
Adamas will host a conference call and webcast today, August 9,
2021, at 4:30 p.m. ET (1:30 p.m. PT). The conference call can be
accessed by dialing 1-877-407-9716 for participants in the U.S. or
Canada and 1-201-493-6779 for international callers. All callers
must provide the following Conference ID: 13720109. The webcast can
be accessed live via the investor section of the Adamas website at
https://ir.adamaspharma.com/events-presentations and will be
available for replay for approximately 30 days.
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, and as an adjunctive treatment to levodopa/carbidopa
in patients with Parkinson’s disease experiencing OFF episodes.
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 OSMOLEX ER
OSMOLEX ER® (amantadine) extended release tablets, is
FDA-approved for the treatment of Parkinson’s disease and
drug-induced extrapyramidal reactions (EPR) in adult patients.
Drug-induced EPR are involuntary, uncontrollable movements often
caused by antipsychotic drug use, that can cause significant
disruption for patients and their families.
OSMOLEX ER has an immediate release outer layer and an extended
release core and is taken in the morning. The most commonly
observed adverse reactions with OSMOLEX ER include nausea,
dizziness, lightheadedness, and insomnia.
For more information about OSMOLEX ER, please visit
www.OSMOLEX.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 2021
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, OSMOLEX ER, 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 August 9, 2021, 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.
Adamas Pharmaceuticals, Inc.
Unaudited Condensed Consolidated
Statements of Operations
(in thousands, except per share
data)
Three Months Ended June
30,
Six Months Ended June
30,
2021
2020
2021
2020
Revenues:
Product sales
$
20,557
$
17,954
$
38,535
$
32,435
Royalty revenue
1,415
840
2,748
840
Total revenues
21,972
18,794
41,283
33,275
Costs and operating expenses:
Cost of product sales
527
381
912
953
Research and development
1,448
2,550
3,260
5,015
Selling, general and administrative,
net
29,152
23,177
55,791
47,729
Total costs and operating expenses
31,127
26,108
59,963
53,697
Loss from operations
(9,155)
(7,314)
(18,680)
(20,422)
Interest and other income, net
280
215
664
299
Interest expense
(3,469)
(3,467)
(6,901)
(7,091)
Net loss
$
(12,344)
$
(10,566)
$
(24,917)
$
(27,214)
Net loss per share, basic and diluted
$
(0.27)
$
(0.37)
$
(0.62)
$
(0.97)
Weighted average shares used in computing
net loss per share, basic and diluted
45,464
28,194
40,344
28,112
Adamas Pharmaceuticals, Inc.
Unaudited Consolidated Balance
Sheet Data
(in thousands)
June 30, 2021
December 31,
2020
Cash, cash equivalents, and
available-for-sale securities
$
118,256
$
83,365
Total assets
150,644
120,029
Total current liabilities
21,824
34,867
Long-term debt
125,541
126,307
Total liabilities
154,677
170,005
Total stockholders’ deficit
(4,033)
(49,976)
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210809005601/en/
Media: Sarah Mathieson Vice President, Corporate
Communications 510-450-3528 smathieson@adamaspharma.com
Investors: Peter Vozzo Westwicke/ICR 443-213-0505
peter.vozzo@westwicke.com
Adamas Pharmaceuticals (NASDAQ:ADMS)
Historical Stock Chart
From Jun 2024 to Jul 2024
Adamas Pharmaceuticals (NASDAQ:ADMS)
Historical Stock Chart
From Jul 2023 to Jul 2024