First quarter 2021 total revenues of $19.3
million, a 33% increase over first quarter 2020
GOCOVRI New paid prescriptions of 590, an 18%
increase over first 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 first quarter ended March 31,
2021, and recent corporate highlights.
“Our commercial execution is effectively raising awareness of
GOCOVRI and its expanded label, enabling more patients, caregivers
and physicians to make GOCOVRI their treatment of choice in
Parkinson’s related motor complications,” said Neil F. McFarlane,
Chief Executive Officer. “We are also delighted to expand our
commercial footprint beyond Parkinson’s disease, leveraging OSMOLEX
ER to benefit patients with drug-induced extrapyramidal reactions.
Despite continued market disruption, the growth of our products and
our strong cash position gives us confidence in our ability to
deliver long-term shareholder value.”
Recent portfolio highlights
- Total revenues were $19.3 million in the first quarter of 2021,
an increase of 33% as compared to $14.5 million in the first
quarter of 2020.
- GOCOVRI® (amantadine) extended release capsules product sales
were $17.7 million in the first quarter of 2021, an increase of 22%
as compared to $14.5 million in the first quarter of 2020.
- Total paid prescriptions (TRx) of GOCOVRI were approximately
8,735 in the first quarter of 2021, a 21% increase over
approximately 7,205 TRx in the first quarter of 2020.
- Strong patient persistence of 45%-50% at 12 months continued in
the first quarter of 2021.
- New paid prescriptions (NRx) of GOCOVRI were approximately 590
in the first quarter of 2021, an 18% increase over NRx of
approximately 500 in the first 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.
- Reached 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.
- Closed the settlement of patent litigation with Osmotica
Pharmaceuticals plc. and acquisition of the global rights to
OSMOLEX ER® (amantadine) extended release tablets in January 2021.
OSMOLEX ER product sales were $0.3 million in the first quarter of
2021.
Corporate highlights
- New data analyses published in peer-reviewed journal Frontiers
in Neurology in March 2021 and presented at the American Academy of
Neurology 73rd Annual Meeting, April 17-22, 2021 demonstrated
GOCOVRI treatment more than doubled ON time without dyskinesia in
patients with Parkinson’s disease.
- Presented data at AAN April 2021 highlighting that, despite the
widespread prevalence and impact of OFF episodes and dyskinesia,
there remains significant misunderstanding by people with
Parkinson’s and their care partners of these motor complications
and appropriate management strategies.
- Adamas launched the national ‘Picture More Time℠’ disease
education campaign to raise awareness and understanding of motor
complications and their associated negative social and emotional
impacts.
- Patents issued (U.S. Patent: 10,973,783 and 10,987,324) in
April 2021 covering ADS-4101, an investigational high-dose,
modified release lacosamide capsule for partial onset seizures in
patients with epilepsy. Efforts continue to partner or out-license
this program.
Financial results
Revenue
Total revenue was $19.3 million for the first quarter of 2021,
consisting of GOCOVRI product sales of $17.7 million, OSMOLEX ER
product sales of $0.3 million and royalty revenue earned on net
sales of NAMZARIC® (memantine hydrochloride extended release and
donepezil hydrochloride) capsules of $1.3 million. GOCOVRI product
sales were up 22% compared to $14.5 million in the same period in
2020.
Research and Development (R&D) expenses
R&D expenses for the first quarter of 2021 were $1.8
million, compared to $2.5 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 first quarter of 2021 were $26.6
million, compared to $24.6 million for the same period in the prior
year. SG&A expenses in the first 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 $12.6 million, or $0.36 per share, basic and
diluted, for the first quarter of 2021, compared to a net loss of
$16.6 million, or $0.59 per share, basic and diluted, for the first
quarter of 2020. Net loss for the first quarters of 2021 and 2020
included $1.7 million and $1.5 million, respectively, in non-cash
stock-based compensation expense.
Cash and investments
As of March 31, 2021, Adamas had $127.4 million of cash, cash
equivalents and available-for-sale securities, compared to $83.4
million at December 31, 2020. During the first quarter of 2021,
Adamas raised net proceeds of approximately $7.2 million under an
at-the-market offering. In addition, in February 2021, Adamas sold
14,375,000 shares of its common stock through an underwritten
public offering at a price of $4.40 per share, resulting in net
proceeds to Adamas of approximately $59.3 million.
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, May 10,
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: 13718098. 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, 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 May 10, 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
March 31,
2021
2020
Revenues:
Product sales
$
17,978
$
14,481
Royalty revenue
1,333
—
Total revenues
19,311
14,481
Costs and operating expenses:
Cost of product sales
385
572
Research and development
1,812
2,465
Selling, general and administrative,
net
26,639
24,552
Total costs and operating expenses
28,836
27,589
Loss from operations
(9,525
)
(13,108
)
Interest and other income, net
384
84
Interest expense
(3,432
)
(3,624
)
Net loss
$
(12,573
)
$
(16,648
)
Net loss per share, basic and diluted
$
(0.36
)
$
(0.59
)
Weighted average shares used in computing
net loss per share, basic and diluted
35,167
28,030
Adamas Pharmaceuticals, Inc.
Unaudited Consolidated Balance
Sheet Data
(in thousands)
March 31, 2021
December 31,
2020
Cash, cash equivalents, and
available-for-sale securities
$
127,436
$
83,365
Total assets
169,247
120,029
Total current liabilities
29,176
34,867
Long-term debt
126,159
126,307
Total liabilities
163,310
170,005
Total stockholders’ equity (deficit)
5,937
(49,976
)
Source: Adamas Pharmaceuticals, Inc.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210510005819/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
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