Adamas Reports First Quarter 2019 Financial Results
- First quarter net product sales of
- GOCOVRI® total prescriptions grew to approximately 5,820 in Q1 2019
- Phase 3 study of ADS-5102 (GOCOVRI) in walking impairment in patients with multiple sclerosis on course to complete in Q4 2019
“We remain focused on driving the growth of GOCOVRI for the treatment of dyskinesia in patients with Parkinson’s disease (PD) receiving levodopa-based therapy, and completing our Phase 3 study of ADS-5102 for walking impairment in patients with multiple sclerosis (MS) – our top two priorities for 2019,” said Dr.
Dr. Went continued, “As we have noted previously, we believe ADS-5102 (GOCOVRI) has the potential to deliver meaningful benefit to MS patients with impaired walking, as well as benefitting significantly more PD patients with dyskinesia and OFF, and that addressing the unmet needs of these two populations offers opportunities for significant long-term value creation. Given our desire to concentrate our resources on the substantial opportunities in these programs, we have decided to defer investment in ADS-4101, our earlier stage development program in epilepsy.”
GOCOVRI commercialization updates
- Nearly 60% of patients initiated on GOCOVRI are continuing to take the medication at six months, an excellent persistence rate.
- GOCOVRI generated approximately 5,820 in total prescriptions (TRx) in the first quarter of 2019, a 2% sequential increase over approximately 5,700 TRx in the fourth quarter of 2018. The number of new patients starting on GOCOVRI, including 140 patients receiving medication through the recently launched free trial program, was approximately 720, compared to 760 in the fourth quarter of 2018.
- GOCOVRI net product sales were
$11.7 million. Gross-to-net was higher in the first quarter of 2019 compared to the fourth quarter of 2018 reflecting the Medicare Part D‘donut hole’ and other issues related to the start of a new calendar year for commercial and Medicare Part Dinsurance plans.
GOCOVRI scientific updates
- New data from the Phase 3 open label study of GOCOVRI in Parkinson’s patients with dyskinesia and OFF were presented at the
American Academy of Neurology(AAN) in Philadelphia. These data suggest chronic GOCOVRI treatment may enable the dose of dopaminergic medications to be modified with an improvement in dyskinesia and OFF.
- The INROADS Phase 3 study of ADS-5102 for walking impairment in patients with multiple sclerosis continues to enroll participants, with top line results expected in the fourth quarter of 2019. Study design and baseline demographics data were presented today at AAN.
Net product sales
Adamas reported GOCOVRI net product sales of
Research and Development (R&D) expenses
R&D expenses for the first quarter of 2019 were
Selling, General and Administrative (SG&A) expenses
SG&A expenses for the first quarter of 2019 were
Net loss totaled
Cash and investments
Full year 2019 expense guidance
As a result of a review of Adamas’ overall spending level and including the deferral of investment in ADS-4101, our earlier stage development program in epilepsy, the Company has reduced its full year 2019 guidance for R&D and SG&A expenses, as set forth below.
|R&D Expenses (1)||$25 million - $35 million||$35 million - $45 million|
|SG&A Expenses (2)||$105 million - $115 million||$120 million - $130 million|
|Total Operating Expenses (3)||$130 million - $150 million||$155 million - $175 million|
(1) Includes revised stock-based compensation expense of
(2) Includes revised stock-based compensation expense of
(3) Includes revised stock-based compensation expense of
Investor conference call and webcast
Adamas will host a conference call and webcast today,
About GOCOVRI QHS
GOCOVRI (amantadine) extended-release capsules is the first and only
GOCOVRI is thought to work by reducing the amount of glutamate hyperactivity in a region of the brain that controls movement, in patients experiencing dyskinesia and OFF. The NMDA receptor is activated by glutamate and causes post-synaptic nerve signaling in this area of the brain, which is modulated by dopamine. Levodopa therapy replaces dopamine lost in Parkinson’s disease but may result in large fluctuations in synaptic levels of dopamine during waking hours, further exacerbating glutamate hyperactivity. GOCOVRI, developed by Adamas, is novel in that it selectively blocks the NMDA receptor in a time-dependent manner. Taken at bedtime (QHS), GOCOVRI provides an initial lag and a slow rise in amantadine concentration during the night and a high concentration from the morning and throughout the waking day. Additionally, the adjunctive use of GOCOVRI does not require dose changes to dopaminergic therapies. The most commonly observed adverse reactions with GOCOVRI were hallucinations, dizziness, dry mouth, peripheral edema, constipation, fall and orthostatic hypotension.
For more information about GOCOVRI, please see the U.S. Prescribing Information at www.GOCOVRI.com.
Adamas is currently evaluating ADS-5102 in a Phase 3 clinical program for walking impairment in patients with multiple sclerosis. ADS-5102 was previously approved by the
Adamas’ goal is to create and commercialize a new generation of medicines intended to lessen the burden of chronic neurologic diseases on patients, caregivers and society using its deep understanding of time-dependent biology. For more information about Adamas and its unique approach to developing medicines based on time-dependent biology, please visit www.adamaspharma.com.
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 2019 expenses under “Full Year 2019 Expense Guidance” and its expectations of top-line data from its INROADS Phase 3 study expected in the fourth quarter of 2019. 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
|Peter Vozzo||Sarah Mathieson|
|Westwicke Partners||Vice President of Corporate Communications|
— Financial Tables Attached —
Unaudited Condensed Consolidated Statements of Operations
(in thousands, except per share data)
|Three Months Ended
|Costs and operating expenses:|
|Cost of product sales||413||25|
|Research and development||10,214||7,188|
|Selling, general and administrative, net||27,688||26,363|
|Total costs and operating expenses||38,315||33,576|
|Loss from operations||(26,650||)||(31,023||)|
|Interest and other income, net||723||878|
|Net loss per share, basic and diluted||$||(1.08||)||$||(1.35||)|
|Weighted average shares used in computing net loss per share, basic and diluted||27,453||25,861|
Unaudited Consolidated Balance Sheet Data
|Cash, cash equivalents, and available-for-sale securities||$||190,635||$||210,870|
|Total current liabilities||29,830||24,276|
|Total stockholders’ equity||63,916||89,885|
Source: Adamas Pharmaceuticals, Inc.