Fourth Quarter 2020 total revenues of $21.0
million, a 29% increase over fourth quarter 2019
Full Year 2020 total revenues of $74.5 million,
a 36% increase over 2019
Second indication received February 2021 for
GOCOVRI as an adjunctive treatment to levodopa/carbidopa in
Parkinson’s disease patients experiencing OFF episodes
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 fourth quarter and full year
ended December 31, 2020, and recent corporate highlights.
“We are excited with the opportunities ahead of us, including
the continued growth of GOCOVRI which is now the first and only
medication approved to treat both OFF and dyskinesia motor
complications in Parkinson’s disease,” said Neil F. McFarlane,
Chief Executive Officer. “Bolstered by the launch of a second
indication, GOCOVRI is now approved to treat approximately 400,000
to 500,000 Parkinson’s patients. The significant progress made
across the business in 2020 fueled positive momentum into 2021, and
we are leveraging this as we continue to successfully execute our
long-term growth strategy.”
Recent portfolio highlights
- Total revenues were $21.0 million in the fourth quarter of
2020, an increase of 29% as compared to $16.3 million in the fourth
quarter of 2019.
- GOCOVRI® (amantadine) extended release capsules product sales
were $19.8 million in the fourth quarter of 2020, an increase of
21% as compared to $16.3 million in the fourth quarter of
2019.
- Total paid prescriptions (TRx) of GOCOVRI were approximately
8,165 in the fourth quarter of 2020, a 14% increase over
approximately 7,160 TRx in the fourth quarter of 2019.
- Strong patient persistence of 45%-50% at 12 months continued in
the fourth quarter of 2020.
- New paid prescriptions (NRx) of GOCOVRI were approximately 510
in the fourth quarter of 2020, a 19% increase over NRx of
approximately 430 in the third quarter of 2020.
- In February 2021, the U.S. Food and Drug Administration
approved a second indication for GOCOVRI as an adjunctive treatment
to levodopa/carbidopa in Parkinson’s disease patients experiencing
OFF episodes.
Corporate highlights
- In January 2021, closed the settlement of patent litigation
with Osmotica Pharmaceuticals plc. and completed the acquisition of
the global rights to OSMOLEX ER® (amantadine) extended release
tablets, expanding Adamas’ neurology portfolio.
- Amended certain key terms of the Royalty-Backed Loan agreement
with HealthCare Royalty Partners, which became effective with the
closing of the acquisition of OSMOLEX ER.
- In February 2021, announced a settlement agreement with Zydus
Worldwide DMCC and Zydus Pharmaceuticals (USA) Inc. (“Zydus”)
resolving patent litigation between the two parties relating to
Zydus’ ANDA referencing GOCOVRI. Under the agreement Adamas granted
Zydus a non-exclusive license to begin selling a generic version of
GOCOVRI as of March 4, 2030, or earlier in certain
circumstances.
Financial results
Revenue
Total revenue was $21.0 million for the fourth quarter of 2020,
consisting of GOCOVRI product sales of $19.8 million and royalty
revenue earned on net sales of NAMZARIC® (memantine hydrochloride
extended release and donepezil hydrochloride) capsules of $1.2
million. GOCOVRI product sales were up 21% compared to $16.3
million in the same period in 2019.
Total revenue was $74.5 million for full year 2020, consisting
of GOCOVRI product sales of $71.2 million and royalty revenue
earned on net sales of NAMZARIC of $3.3 million. GOCOVRI product
sales were up 30% compared to $54.6 million in 2019.
Research and Development (R&D) expenses
R&D expenses for the fourth quarter of 2020 were $2.4
million, compared to $5.2 million for the same period in the prior
year. R&D expenses in the fourth quarter of 2020 substantially
relate to the ongoing open-label study which concluded at 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.
R&D expenses for full year 2020 were $9.7 million, compared
to $30.0 million in 2019. The decrease in R&D expenses from
2019 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 fourth quarter of 2020 were $33.0
million, compared to $30.3 million for the same period in the prior
year. SG&A expenses in the fourth quarter of 2020 were
primarily attributable to sales force costs and external spend
dedicated to GOCOVRI commercialization and the related
administrative support. The fourth quarter of 2020 includes
approximately $5.0 million related to one-time charges associated
with the settlement of patent litigation and acquisition of the
global rights to OSMOLEX ER.
SG&A expenses for 2020 were $106.8 million, compared to
$114.4 million for the same period in the prior year. The decrease
from 2019 was primarily attributable to certain one-time charges
related to personnel transitions incurred in the third quarter of
2019.
Net loss
Net loss was $18.3 million, or $0.64 per share, basic and
diluted, for the fourth quarter of 2020, compared to a net loss of
$23.1 million, or $0.83 per share, basic and diluted, for the
fourth quarter of 2019. Net loss for the fourth quarters of 2020
and 2019 included $1.6 million and $2.1 million, respectively, in
non-cash stock-based compensation expense.
Net loss was $57.4 million, or $2.03 per share, basic and
diluted, for full year 2020, compared to a net loss of $105.2
million, or $3.80 per share, basic and diluted, for 2019. Net loss
for 2020 and 2019 included $6.4 million and $12.9 million,
respectively, in non-cash stock-based compensation expense.
Cash and investments
As of December 31, 2020, Adamas had $83.4 million of cash, cash
equivalents and available-for-sale securities. Subsequent to
December 31, 2020, and through February 16, 2021, Adamas raised net
proceeds of approximately $7.2 million under an at-the-market
offering.
Full year 2021 expense guidance
For full year 2021, Adamas estimates 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, February
23, 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: 13716505. 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 in adult patients. OSMOLEX ER
is contraindicated in patients with end-stage renal disease (i.e.,
creatinine clearance below 15 mL/min/1.73 m2). The most common
adverse reactions reported in ≥5% of patients at the recommended
dosage of immediate-release amantadine were nausea,
dizziness/lightheadedness, and insomnia.
For more information about OSMOLEX ER, including the full
Prescribing Information, 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 and ADS-5102, and the regulatory and
competitive environment and Adamas’ business in general, see
Adamas’ Annual Report on Form 10-K filed with the Securities and
Exchange Commission on February 23, 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
December 31,
Twelve Months Ended
December 31,
2020
2019
2020
2019
Revenues:
Product sales
$
19,761
$
16,348
$
71,166
$
54,637
Royalty revenue
1,249
—
3,295
—
Total revenues
21,010
16,348
74,461
54,637
Costs and operating expenses:
Cost of product sales
597
442
2,038
2,469
Research and development
2,398
5,180
9,746
30,034
Selling, general and administrative,
net
32,992
30,285
106,841
114,369
Total costs and operating expenses
35,987
35,907
118,625
146,872
Loss from operations
(14,977
)
(19,559
)
(44,164
)
(92,235
)
Interest and other income, net
94
124
748
2,093
Interest expense
(3,390
)
(3,640
)
(13,987
)
(15,044
)
Net loss
$
(18,273
)
$
(23,075
)
$
(57,403
)
$
(105,186
)
Net loss per share, basic and diluted
$
(0.64
)
$
(0.83
)
$
(2.03
)
$
(3.80
)
Weighted average shares used in computing
net loss per share, basic and diluted
28,617
27,890
28,305
27,677
Adamas Pharmaceuticals, Inc.
Unaudited Consolidated Balance
Sheet Data
(in thousands)
December 31,
2020
December 31,
2019
Cash, cash equivalents, and
available-for-sale securities
$
83,365
$
132,607
Total assets
120,029
162,158
Total current liabilities
34,867
26,948
Long-term debt
126,307
125,674
Total liabilities
170,005
163,051
Total stockholders’ deficit
(49,976
)
(893
)
Source: Adamas Pharmaceuticals, Inc.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210223005961/en/
Media: Sarah Mathieson Vice President, Corporate
Communications 510-450-3528 smathieson@adamaspharma.com
Investors: Peter Vozzo Managing Director, Westwicke/ICR
443-213-0505 peter.vozzo@westwicke.com
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