Adamas Reports Recent Achievements and Financial Results for the Fourth Quarter and Full-Year 2018
“We are excited to expand GOCOVRI’s impact on Parkinson’s patients with dyskinesia in 2019, after finishing 2018, our first year of commercialization, with
Recent Highlights
- In the fourth quarter of 2018 and in the full-year, fulfilled approximately 5,730 and 15,500 paid prescriptions, respectively, 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 - Continued to enroll patients in the Phase 3 controlled study of ADS-5102 (amantadine) extended release capsules for walking impairment in patients with multiple sclerosis
- Received a patent covering an OFF indication for GOCOVRI with an expiry date in 2034
Key Priorities for 2019
GOCOVRI Commercialization:
- Drive adoption and clinical conviction through commercial execution and focused education about the innovation and unique benefits of GOCOVRI
- Continue to maintain strong persistence and durable use through positive patient experience
- Advance the medical literature regarding GOCOVRI in the Parkinson’s disease treatment journey and time-dependent mechanisms of disease and action by continuing to publish data at major scientific and medical meetings, including
American Academy of Neurology (AAN) and International Parkinson andMovement Disorder Society (MDS)
Development Pipeline:
- Expect completion of enrollment for the Phase 3 INROADS study of ADS-5102 (amantadine) extended release capsules for walking impairment in patients with multiple sclerosis in the first half of 2019 and release top-line data in the second half of 2019
- Continue to advance ADS-4101 towards the objective of having an
FDA -approved medication upon the loss of exclusivity of VIMPAT® in 2022
Financial Results
Adamas reported GOCOVRI net product sales of
Research and development (R&D) expenses for the fourth quarter ended December 31, 2018, were
Selling, general and administrative (SG&A) expenses for the fourth quarter ended December 31, 2018, were
Net loss totaled
Cash Position
Adamas ended the year with
2019 Expense Guidance
For 2019, Adamas expects full-year R&D expenses to be between
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
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
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’ 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’ 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.
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 2019 expenses, its expectations 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 first half of 2019 with top-line data expected in the second half of 2019, and its expectations that Adamas will continue to advance ADS-4101 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 other 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’ Annual Report on Form 10-K filed with the
Contact:
Investors:
Marcy Nanus
Solebury Trout
646-378-2927
mnanus@soleburytrout.com
Media:
Vice President of Corporate Communications
510-450-3528
smathieson@adamaspharma.com
— Financial Tables Attached —
Unaudited Condensed Consolidated Statements of Operations
(in thousands, except per share data)
Three Months Ended December 31, |
Twelve Months Ended December 31, |
||||||||||||||
2018 | 2017 | 2018 | 2017 | ||||||||||||
Revenues: | |||||||||||||||
Product sales | $ | 13,315 | $ | 568 | $ | 34,046 | $ | 568 | |||||||
License and grant revenue | — | — | — | 3 | |||||||||||
Total revenues | 13,315 | 568 | 34,046 | 571 | |||||||||||
Costs and operating expenses: | |||||||||||||||
Cost of product sales | 435 | 17 | 633 | 17 | |||||||||||
Research and development | 10,597 | 6,445 | 39,300 | 27,168 | |||||||||||
Selling, general and administrative, net | 27,582 | 22,989 | 109,135 | 61,312 | |||||||||||
Total costs and operating expenses | 38,614 | 29,451 | 149,068 | 88,497 | |||||||||||
Loss from operations | (25,299 | ) | (28,883 | ) | (115,022 | ) | (87,926 | ) | |||||||
Interest and other income, net | 184 | 86 | 3,115 | 1,351 | |||||||||||
Interest expense | (3,768 | ) | (2,239 | ) | (19,092 | ) | (4,645 | ) | |||||||
Loss before income taxes | (28,883 | ) | (31,036 | ) | (130,999 | ) | (91,220 | ) | |||||||
Benefit for income taxes | — | (1,679 | ) | — | (1,730 | ) | |||||||||
Net loss | $ | (28,883 | ) | $ | (29,357 | ) | $ | (130,999 | ) | $ | (89,490 | ) | |||
Net loss per share, basic and diluted | $ | (1.06 | ) | $ | (1.27 | ) | $ | (4.87 | ) | $ | (3.97 | ) | |||
Weighted average shares used in computing net loss per share, basic and diluted | 27,357 | 23,056 | 26,886 | 22,558 |
Unaudited Consolidated Balance Sheet Data
(in thousands)
December 31, 2018 |
December 31, 2017 |
||||||
Cash, cash equivalents, and available-for-sale securities | $ | 210,870 | $ | 176,433 | |||
Total assets | 234,814 | 186,176 | |||||
Total current liabilities | 24,276 | 16,607 | |||||
Long-term debt | 117,457 | 102,647 | |||||
Total liabilities | 144,929 | 120,050 | |||||
Total stockholders’ equity | 89,885 | 66,126 |
Source: Adamas Pharmaceuticals, Inc.