Adamas Provides Preliminary Fourth Quarter and Full Year 2019 GOCOVRI® Product Sales and Outlines Key Priorities for 2020
January 08 2020 - 9:15AM
Adamas Pharmaceuticals, Inc. (Nasdaq: ADMS), a company dedicated to
developing and delivering medicines that make a clinically
meaningful difference to people affected by neurological diseases,
today provides preliminary unaudited fourth quarter and full year
2019 product sales for GOCOVRI® (amantadine) extended release
capsules and outlines key business priorities for 2020.
“We are pleased by our fourth quarter product
sales, which reflect recent operational improvements and the
continued advancement of GOCOVRI’s commercialization,” said Neil F.
McFarlane, Chief Executive Officer of Adamas. “In 2020, we intend
to further strengthen our operations to benefit Parkinson’s disease
patients with dyskinesia as well as OFF. Additionally, the recently
announced settlement agreement with Sandoz demonstrates the
strength of Adamas’ intellectual property. We are well-positioned
to optimize the opportunity for GOCOVRI and to invest strategically
in the growth of Adamas.”
Preliminary Unaudited Fourth Quarter and
Full-Year 2019 Product Sales for GOCOVRI
GOCOVRI product sales for the full year 2019 are
anticipated to be approximately $54.6 million compared to $34.0
million for the same period in 2018, an increase of 60%. Product
sales for 2019 were based on total prescriptions of approximately
25,780 compared to 15,500 in 2018. Adamas expects GOCOVRI product
sales to be approximately $16.3 million for the fourth quarter 2019
compared to $13.9 million for the third quarter 2019, a sequential
increase of 17%. Fourth quarter 2019 prescriptions were 7,160
compared to 6,640 prescriptions for the third quarter 2019. New
patients started on GOCOVRI in the fourth quarter 2019 was 750
compared to 710 in the preceding quarter. Adamas had approximately
$132.6 million of cash, cash equivalents, and available-for-sale
securities at December 31, 2019. These preliminary results are
based on management’s initial analysis of operations for the
quarter ended December 31, 2019. Adamas expects to report its full
financial results for the fourth quarter and fiscal year 2019 in
February 2020.
Key Priorities for 2020
GOCOVRI Commercialization
In 2020, Adamas plans to advance GOCOVRI
performance through:
- Effective differentiation of GOCOVRI by communicating its
unique clinical profile to drive health care provider adoption
under experienced commercial leadership;
- Increased demand for GOCOVRI by elevating the urgency to treat
dyskinesia and OFF in Parkinson’s disease through education about
their disruptive impact on patients, both directly and through
partnerships with advocacy organizations; and
- Reducing barriers to access and improving fulfillment to
provide an enhanced customer experience, while maintaining strong
persistence on GOCOVRI.
ADS-5102 Multiple Sclerosis Walking Impairment
Development
Adamas expects to engage with the FDA in the
first half of 2020 to discuss a potential regulatory pathway for
ADS-5102 for multiple sclerosis patients with walking impairment
based on data from the INROADS Phase 3 trial.
Management Update
Adamas announces today that Jennifer J. Rhodes,
General Counsel, Chief Business Officer, Chief Compliance Officer
and Corporate Secretary, and Rajiv Patni, M.D., Chief Medical
Officer, are leaving the company.
“I want to thank Jennifer and Rajiv for their
many contributions to Adamas over the years,” said Mr. McFarlane.
“Both have played important roles in helping transform Adamas from
a development-stage company to a fully-integrated company
delivering a meaningful difference for people affected by
neurological diseases. Adamas is positioned for growth and we will
maintain management continuity through these transitions, and
ensure effective leadership going forward.”
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 with a growing portfolio of therapies that
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 fourth quarter and full year product sales of GOCOVRI and year
end cash, cash equivalents, and available-for-sale securities, and
its expectations to advance GOCOVRI and engage with the FDA in the
first half of 2020 to discuss a potential regulatory pathway for
ADS-5102 for multiple sclerosis patients with walking impairment.
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 example, with respect to the
2019 preliminary financial results, these results are unaudited and
are subject to revision during the audit process. 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 7, 2019,
particularly under the caption “Risk Factors.” 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: Peter Vozzo Managing Director, Westwicke 443-213-0505
peter.vozzo@westwicke.com
Media: Sarah Mathieson Vice President of Corporate
Communications 510-450-3528 smathieson@adamaspharma.com
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