Adamas Reports Third Quarter 2018 Financial Results
GOCOVRI™ (amantadine) extended release capsules sales increased to
“We have established a strong foundation and remain focused on increasing the utilization of GOCOVRI in Parkinson’s disease patients with dyskinesia and OFF,” stated
Recent Highlights
- In the third quarter of 2018, fulfilled approximately 4,740 paid prescriptions of GOCOVRI, the first and only medicine approved by the
U.S. Food and Drug Administration (FDA ) indicated for the treatment of dyskinesia in patients with Parkinson’s disease receiving levodopa-based therapy - Received GOCOVRI prescriptions from approximately 1,200 distinct prescribers as of
September 30, 2018 - Presented final results from EASE LID 2, the two-year, Phase 3 open-label study of GOCOVRI in Parkinson’s disease patients with dyskinesia at the 22nd International
Congress of Parkinson’s Disease and Movement Disorders - Continued to enroll patients in the Phase 3 controlled study of ADS-5102 (amantadine) extended release capsules in multiple sclerosis patients with walking impairment and expect full enrollment in the second half of 2019
- Continued to advance the ADS-4101 (lacosamide) program and remain on track to initiate a pivotal study in patients with epilepsy in 2019
Financial Results
Adamas reported GOCOVRI net product sales of
Research and development (R&D) expenses for the third quarter ended
Selling, general and administrative (SG&A) expenses for the third quarter ended
Adamas reported a net loss of
Cash Position
Adamas ended the quarter with
Investor Conference Call and Webcast
Adamas will host a conference call and webcast today,
About GOCOVRI
GOCOVRI (amantadine) extended release capsules is the first and only
About ADS-5102
ADS-5102 is a high-dose amantadine taken once at bedtime, which delivers consistently high levels of amantadine upon waking and throughout the day. Adamas is currently evaluating ADS-5102 in a Phase 3 clinical program in multiple sclerosis patients with walking impairment. ADS-5102 was previously approved by the
About ADS-4101
ADS-4101 is an investigational drug in development for the treatment of partial onset seizures in patients with epilepsy. Derived from Adamas’ validated time-dependent biology approach to drug development, ADS-4101 is a potential high-dose, once-daily at bedtime lacosamide therapy, with a drug profile that provides high concentrations of lacosamide during the day to match the time when seizures occur most often. Lacosamide is an anti-epilepsy active ingredient previously approved by the
About Adamas Pharmaceuticals, Inc.
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. The company is focused on the commercial launch of GOCOVRI™ (amantadine) extended release capsules (previously ADS-5102), the first and only
VIMPAT® is a trademark of UCB.
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’s expectation of full enrollment of patients in the Phase 3 controlled study of ADS-5102 (amantadine) extended release capsules in multiple sclerosis patients with walking impairment in the second half of 2019, and that Adamas remains on track to initiate a pivotal study in patients with epilepsy in 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
Contacts:
Investors:
Director, Corporate Communications and Investor Relations
510-450-3567
ir@adamaspharma.com
Media:
Continuum Health Communications
203-227-0209
tclevenger@continuumhealthcom.com
— Financial Tables Attached —
Unaudited Condensed Consolidated Statements of Operations
(in thousands, except per share data)
Three Months Ended September 30, |
Nine Months Ended September 30, |
||||||||||||||
2018 | 2017 | 2018 | 2017 | ||||||||||||
Revenues: | |||||||||||||||
Product sales | $ | 10,613 | $ | — | $ | 20,731 | $ | — | |||||||
License and grant revenue | — | 1 | — | 3 | |||||||||||
Total revenues | 10,613 | 1 | 20,731 | 3 | |||||||||||
Costs and operating expenses: | |||||||||||||||
Cost of product sales | 100 | — | 198 | — | |||||||||||
Research and development | 11,709 | 6,459 | 28,703 | 20,723 | |||||||||||
Selling, general and administrative, net | 27,491 | 16,064 | 81,553 | 38,323 | |||||||||||
Total costs and operating expenses | 39,300 | 22,523 | 110,454 | 59,046 | |||||||||||
Loss from operations | (28,687 | ) | (22,522 | ) | (89,723 | ) | (59,043 | ) | |||||||
Interest and other income, net | 921 | 839 | 2,931 | 1,265 | |||||||||||
Interest expense | (5,386 | ) | (1,677 | ) | (15,324 | ) | (2,406 | ) | |||||||
Loss before income taxes | (33,152 | ) | (23,360 | ) | (102,116 | ) | (60,184 | ) | |||||||
Benefit for income taxes | — | — | — | (51 | ) | ||||||||||
Net loss | $ | (33,152 | ) | $ | (23,360 | ) | $ | (102,116 | ) | $ | (60,133 | ) | |||
Net loss per share, basic and diluted | $ | (1.22 | ) | $ | (1.04 | ) | $ | (3.82 | ) | $ | (2.69 | ) | |||
Weighted average shares used in computing net loss per share, basic and diluted | 27,266 | 22,569 | 26,728 | 22,390 |
Unaudited Consolidated Balance Sheet Data
(in thousands)
September 30, 2018 |
December 31, 2017 |
||||||
Cash, cash equivalents, and available-for-sale securities | $ | 233,197 | $ | 176,433 | |||
Total assets | 257,120 | 186,176 | |||||
Total current liabilities | 25,298 | 16,607 | |||||
Long-term debt | 115,353 | 102,647 | |||||
Total liabilities | 142,724 | 120,050 | |||||
Total stockholders’ equity | 114,396 | 66,126 |
Source: Adamas Pharmaceuticals, Inc.