Adamas Reports Second Quarter 2018 Financial Results
- GOCOVRI™ (amantadine) extended release capsules product sales reached
for the second quarter -
“We continue to be pleased with the progress of the GOCOVRI launch in its second quarter of commercialization. It is still early days and our focus remains on educating physicians on the unique profile of GOCOVRI and raising awareness of dyskinesia among people with Parkinson’s disease,” stated
Recent Highlights
- Fulfilled approximately 3,430 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, in the second quarter of 2018 - Received GOCOVRI prescriptions from approximately 970 distinct prescribers through
June 30, 2018 - Enrolled the first patient in INROADS3, the Phase 3 open-label INvestigational Research Study Of ADS-5102 (amantadine) extended release capsules in multiple sclerosis (MS) walking impairment
- Continued to enroll patients in INROADS, the Phase 3 placebo-controlled trial of ADS-5102 in MS walking impairment
- Presented new GOCOVRI data analysis of Phase 3 controlled data demonstrating that GOCOVRI reduces transitions between Parkinson’s disease diary states throughout the day
- Continued to advance the ADS-4101 (lacosamide) program for the treatment of partial onset seizures in patients with epilepsy by establishing manufacturing capabilities to enable further clinical development
- Launched “Dyskinesia is a Jerk™,” a disease education campaign to raise awareness for Parkinson’s disease dyskinesia
Financial Results
Adamas reported GOCOVRI net product sales of
Research and development (R&D) expenses for the second quarter ended
Selling, general and administrative (SG&A) expenses for the second 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-daily at bedtime, which delivers consistently high levels of amantadine upon waking and throughout the day. 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
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 the commercial acceptance of GOCOVRI, the potential clinical benefits of GOCOVRI or about Adamas’ ongoing or planned clinical development programs, including ADS-5102 and ADS-4101 because such statements are subject to risks and uncertainties, 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
Contact:
Investors:
Director, Corporate Communications & Investor Relations
510-450-3567
ir@adamaspharma.com
Media:
Continuum Health Communications
203-227-0209
tclevenger@continuumhealthcom.com
— Financial Tables Attached —
Adamas Pharmaceuticals, Inc. Unaudited Condensed Consolidated Statements of Operations (in thousands, except per share data) |
|||||||||||||||
Three Months Ended June 30, |
Six Months Ended June 30, |
||||||||||||||
2018 | 2017 | 2018 | 2017 | ||||||||||||
Revenues: | |||||||||||||||
Product sales | $ | 7,565 | $ | — | $ | 10,118 | $ | — | |||||||
License and grant revenue | — | 2 | — | 2 | |||||||||||
Total revenues | 7,565 | 2 | 10,118 | 2 | |||||||||||
Costs and operating expenses: | |||||||||||||||
Cost of product sales | 73 | — | 98 | — | |||||||||||
Research and development | 9,806 | 7,176 | 16,994 | 14,264 | |||||||||||
Selling, general and administrative, net | 27,699 | 13,115 | 54,062 | 22,259 | |||||||||||
Total costs and operating expenses | 37,578 | 20,291 | 71,154 | 36,523 | |||||||||||
Loss from operations | (30,013 | ) | (20,289 | ) | (61,036 | ) | (36,521 | ) | |||||||
Interest and other income, net | 1,132 | 222 | 2,010 | 426 | |||||||||||
Interest expense | (5,112 | ) | (729 | ) | (9,938 | ) | (729 | ) | |||||||
Loss before income taxes | (33,993 | ) | (20,796 | ) | (68,964 | ) | (36,824 | ) | |||||||
Benefit for income taxes | — | (51 | ) | — | (51 | ) | |||||||||
Net loss | $ | (33,993 | ) | $ | (20,745 | ) | $ | (68,964 | ) | $ | (36,773 | ) | |||
Net loss per share, basic and diluted | $ | (1.26 | ) | $ | (0.93 | ) | $ | (2.61 | ) | $ | (1.65 | ) | |||
Weighted average shares used in computing net loss per share, basic and diluted | 27,040 | 22,392 | 26,454 | 22,300 |
Adamas Pharmaceuticals, Inc. Unaudited Consolidated Balance Sheet Data (in thousands) |
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June 30, 2018 |
December 31, 2017 |
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Cash, cash equivalents, and available-for-sale securities | $ | 256,277 | $ | 176,433 | |||
Total assets | 276,246 | 186,176 | |||||
Total current liabilities | 21,682 | 16,607 | |||||
Long-term debt | 111,283 | 102,647 | |||||
Total liabilities | 133,686 | 120,050 | |||||
Total stockholders’ equity | 142,560 | 66,126 |
Source: Adamas Pharmaceuticals, Inc.