Adamas Reports Second Quarter 2019 Financial Results
- Second quarter GOCOVRI® product sales of
- INROADS Phase 3 study of ADS-5102 (GOCOVRI) for walking impairment in patients with multiple sclerosis (MS) enrollment completed, with topline results expected late Q4 2019
“Total GOCOVRI prescriptions increased by approximately 6% driven by continued strong patient persistence, and new patient starts increased by approximately 2%, as compared to the first quarter of 2019,” said
Dr. Went continued, “additionally, we passed an important milestone with the completion of enrollment of approximately 590 patients in our INROADS Phase 3 study of ADS-5102 (GOCOVRI) in MS patients with walking impairment. The rapid enrollment in this trial reinforces our view that there is a significant need for additional therapies for the estimated 270,000 MS patients currently suffering from walking impairment, especially the 100,000 who have discontinued dalfampridine.”
Finally, the Company announced today that
GOCOVRI commercialization update
- GOCOVRI product sales were
$12.7 millionin the second quarter of 2019 compared to $11.7 millionin the first quarter of 2019.
- GOCOVRI generated approximately 6,160 total prescriptions (TRx) in the second quarter of 2019, a 6% sequential increase over 5,820 TRx in the first quarter of 2019. The number of new patients starting on GOCOVRI, primarily patients receiving medication through the free trial program, was approximately 740, compared to 720 in the first quarter of 2019.
- Persistence of GOCOVRI at 12 months is 45%-50%.
Vijay Shreedhar, Ph.D., joined the Company as Chief Commercial Officer, leading all commercial functions.
ADS-5102 development update
- Enrollment in the INROADS Phase 3 study of ADS-5102 for walking impairment in patients with multiple sclerosis has been completed, with topline results expected late in the fourth quarter of 2019. Study design and baseline demographics data were presented at the
American Academy of NeurologyAnnual Meeting in May 2019.
GOCOVRI product sales were
Research and Development (R&D) expenses
R&D expenses for the second quarter of 2019 were
Selling, General and Administrative (SG&A) expenses
SG&A expenses for the second quarter of 2019 were
Net loss was
Cash and investments
Investor conference call and webcast
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
For more information about GOCOVRI, please see the U.S. Prescribing Information at www.GOCOVRI.com.
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
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 regarding deepening that adoption of GOCOVRI or of topline 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||Vice President of Corporate Communications|
— Financial Tables Attached —
Unaudited Condensed Consolidated Statements of Operations
(in thousands, except per share data)
|Three Months Ended
|Six Months Ended
|Costs and operating expenses:|
|Cost of product sales||685||73||1,098||98|
|Research and development||8,598||9,806||18,812||16,994|
|Selling, general and administrative, net||25,216||27,699||52,904||54,062|
|Total costs and operating expenses||34,499||37,578||72,814||71,154|
|Loss from operations||(21,808||)||(30,013||)||(48,458||)||(61,036||)|
|Interest and other income, net||734||1,132||1,457||2,010|
|Net loss per share, basic and diluted||$||(0.90||)||$||(1.26||)||$||(1.98||)||$||(2.61||)|
|Weighted average shares used in computing net loss per share, basic and diluted||27,579||27,040||27,516||26,454|
Unaudited Consolidated Balance Sheet Data
|Cash, cash equivalents, and available-for-sale securities||$||168,647||$||210,870|
|Total current liabilities||25,717||24,276|
|Total stockholders’ equity||42,703||89,885|
Source: Adamas Pharmaceuticals, Inc.