Adamas Reports Third Quarter 2016 Financial Results
"This was a milestone quarter for the company as we prepared for and submitted our New Drug Application (NDA) for ADS-5102 (amantadine hydrochloride) extended-release capsules for the potential treatment of levodopa-induced dyskinesia (LID) in patients with Parkinson's disease in October 2016," said
Recent and Upcoming Milestones
ADS-5102 (LID in Parkinson's disease)
- Submitted an NDA with the
U.S. Food and Drug Administration (FDA) for ADS-5102 for the treatment of levodopa-induced dyskinesia (LID) in patients with Parkinson's disease inOctober 2016 - Presented data from EASE LID 3, the confirmatory Phase 3 trial of ADS-5102 (amantadine hydrochloride) extended-release capsules for the treatment of LID in patients with PD, at the 4th World Parkinson Congress
ADS-5102 (multiple sclerosis walking impairment)
- Preparations on track for an end-of-Phase 2 meeting with
FDA for ADS-5102 to treat walking impairment in patients with multiple sclerosis
ADS-4101 (epilepsy)
- Expect to initiate a Phase 1 study of ADS-4101 for the treatment of partial onset epileptic seizures in healthy volunteers in the fourth quarter of 2016
NAMZARIC®
With our partner
- Announced settlement with
Amneal Pharmaceuticals related to a patent infringement litigation brought by Forest and Adamas in response to Amneal's abbreviated new drug application seeking approval to market generic versions of NAMZARIC®.
- Announced a new, expanded label and announced availability of full titration kits for NAMZARIC® (memantine HCl and donepezil HCl) for the treatment of patients with moderate to severe Alzheimer's disease who are currently taking donepezil hydrochloride 10 mg. Adamas is entitled to receive low to mid-teens royalties starting in 2020.
Corporate
- Appointed
Michael F. Bigham , Chairman and Chief Executive Officer of Paratek Pharmaceuticals, Inc., to the Board of Directors
Third Quarter 2016 Financial Results
For the quarter ended
Research and development expenses for the quarter ended
General and administrative expenses for the quarter ended
Adamas ended the quarter with
Nine-Month 2016 Financial Results
Adamas reported a net loss for the nine months ended
Research and development expenses for the nine months ended
General and administrative expenses for the nine months ended
About
Adamas is a pharmaceutical company that is developing new medicines to improve the daily lives of those affected by chronic neurologic disorders, including Alzheimer's disease, Parkinson's disease, multiple sclerosis, and epilepsy. Adamas has pioneered a platform based on an understanding of time dependent biologic effects of disease activity and drug response to achieve symptomatic relief without
additional tolerability issues. We have developed a portfolio of chrono-synchronous therapies to potentially address chronic neurologic disorders. Our lead program, ADS-5102 in development for the treatment of levodopa-induced dyskinesia (LID) in patients with Parkinson's disease, is currently being evaluated by the
NAMENDA XR® and NAMZARIC® are registered trademarks of
Forward-looking Statements
Statements contained in this press release regarding matters that are not historical facts 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 potential approval of ADS-5102 for the treatment of levodopa-induced dyskinesia in patients with Parkinson's disease, additional indications for ADS-5102, and additional products such as ADS-4101. Words such as "look forward," "on track," "expect," "potential," and similar expressions (as well as other words or expressions referencing future events, conditions, or circumstances) are intended to identify forward-looking statements. 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 our research, clinical and development
activities relating to ADS-5102 and ADS-4101, the regulatory and competitive environment and our business in general, see our Quarterly Report on Form 10-Q filed with the
— 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, | ||||||||||||||
2016 | 2015 | 2016 | 2015 | ||||||||||||
Revenue | $ | 138 | $ | 768 | $ | 535 | $ | 1,392 | |||||||
Operating expenses | |||||||||||||||
Research and development | 7,437 | 9,960 | 24,183 | 26,198 | |||||||||||
General and administrative, net | 7,344 | 5,803 | 22,043 | 16,568 | |||||||||||
Total operating expenses | 14,781 | 15,763 | 46,226 | 42,766 | |||||||||||
Loss from operations | (14,643 | ) | (14,995 | ) | (45,691 | ) | (41,374 | ) | |||||||
Interest and other income, net | 249 | 85 | 593 | 265 | |||||||||||
Loss before income taxes | (14,394 | ) | (14,910 | ) | (45,098 | ) | (41,109 | ) | |||||||
Provision (benefit) for income taxes | — | (51 | ) | — | 3 | ||||||||||
Net loss | $ | (14,394 | ) | $ | (14,859 | ) | $ | (45,098 | ) | $ | (41,112 | ) | |||
Net loss per share, basic and diluted | $ | (0.66 | ) | $ | (0.81 | ) | $ | (2.09 | ) | $ | (2.28 | ) | |||
Weighted average shares used in computing net loss per share, basic and diluted | 21,941 | 18,395 | 21,616 | 18,001 |
Unaudited Condensed Consolidated Balance Sheets (in thousands, except share and per share data) | |||||||
2016 | 2015 | ||||||
Assets | |||||||
Current assets | |||||||
Cash and cash equivalents | $ | 9,776 | $ | 33,104 | |||
Available-for-sale securities | 92,409 | 73,691 | |||||
Accounts receivable | 769 | 1,284 | |||||
Prepaid expenses and other current assets | 7,433 | 5,108 | |||||
Total current assets | 110,387 | 113,187 | |||||
Property and equipment, net | 3,078 | 2,353 | |||||
Available-for-sale securities, non-current | 43,725 | 13,165 | |||||
Other assets | 38 | 38 | |||||
Total assets | $ | 157,228 | $ | 128,743 | |||
Liabilities and stockholders' equity | |||||||
Current liabilities | |||||||
Accounts payable | $ | 5,956 | $ | 3,052 | |||
Accrued liabilities | 6,306 | 8,457 | |||||
Other current liabilities | 301 | 298 | |||||
Total current liabilities | 12,563 | 11,807 | |||||
Non-current liabilities | 600 | 749 | |||||
Total liabilities | 13,163 | 12,556 | |||||
Commitments and Contingencies | |||||||
Stockholders' equity | |||||||
Preferred stock, | — | — | |||||
Common stock, | 27 | 23 | |||||
Additional paid-in capital | 251,351 | 178,473 | |||||
Accumulated other comprehensive loss | (64 | ) | (158 | ) | |||
Accumulated deficit | (107,249 | ) | (62,151 | ) | |||
Total stockholders' equity | 144,065 | 116,187 | |||||
Total liabilities and stockholders' equity | $ | 157,228 | $ | 128,743 |
Unaudited Condensed Consolidated Statements of Cash Flows (in thousands) | |||||||
Nine Months Ended September 30, | |||||||
2016 | 2015 | ||||||
Cash flows from operating activities | |||||||
Net loss | $ | (45,098 | ) | $ | (41,112 | ) | |
Adjustments to reconcile net loss to net cash used in operating activities | |||||||
Depreciation and amortization | 562 | 306 | |||||
Stock-based compensation | 7,782 | 7,205 | |||||
Net accretion of discounts and amortization of premiums of available-for-sale securities | (332 | ) | 850 | ||||
Changes in assets and liabilities | |||||||
Accrued interest of available-for-sale securities | (119 | ) | (14 | ) | |||
Prepaid expenses and other assets | (2,325 | ) | (393 | ) | |||
Accounts receivable | 515 | (412 | ) | ||||
Accounts payable | 3,007 | (834 | ) | ||||
Accrued liabilities and other liabilities | (2,431 | ) | (469 | ) | |||
Net cash used in operating activities | (38,439 | ) | (34,873 | ) | |||
Cash flows from investing activities | |||||||
Purchases of property and equipment | (1,222 | ) | (1,131 | ) | |||
Purchases of available-for-sale securities | (95,528 | ) | (32,578 | ) | |||
Maturities of available-for-sale securities | 46,795 | 33,745 | |||||
Net cash provided by (used in) investing activities | (49,955 | ) | 36 | ||||
Cash flows from financing activities | |||||||
Proceeds from public offerings, net of offering costs | 61,822 | 9,657 | |||||
Proceeds from issuance of common stock upon exercise of stock options | 2,918 | 671 | |||||
Proceeds from employee stock purchase plan | 326 | 181 | |||||
Net cash provided by financing activities | 65,066 | 10,509 | |||||
Net decrease in cash and cash equivalents | (23,328 | ) | (24,328 | ) | |||
Cash and cash equivalents at beginning of period | 33,104 | 61,446 | |||||
Cash and cash equivalents at end of period | $ | 9,776 | $ | 37,118 |
Contact:Source:Martin Forrest VPCorporate Communications & Investor Relations 510-450-3528
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