EMERYVILLE, Calif., Nov. 03, 2016 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (Nasdaq:ADMS) today announced financial results for the quarter ended September 30, 2016.
“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 Gregory T. Went, Ph.D., Chairman and Chief Executive Officer of Adamas Pharmaceuticals, Inc. “We are pleased that our platform, which focuses on developing chrono-synchronous therapies, continues to provide potential treatments for patients with chronic neurologic disorders, including Alzheimer’s and Parkinson’s disease.”
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 in October 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 Forest Laboratories Holding Ltd. (a wholly owned subsidiary of Allergan plc), we:
- 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 September 30, 2016, Adamas reported a net loss of $14.4 million, or $0.66 per share, basic and diluted, compared with a net loss of $14.9 million, or $0.81 per share, basic and diluted, for the quarter ended September 30, 2015.
Research and development expenses for the quarter ended September 30, 2016, were $7.4 million, including $0.7 million in stock-based compensation expense, compared to $10.0 million for the quarter ended September 30, 2015, which included $0.8 million in stock-based compensation expense. Research and development expenses for the current quarter declined over the prior year’s third quarter principally due to the completion of Phase 3 clinical trials on ADS-5102 for LID in support of the recent NDA submission.
General and administrative expenses for the quarter ended September 30, 2016, were $7.3 million, including $1.9 million in stock-based compensation expense, compared to $5.8 million for the same quarter in the prior year, which included $1.8 million in stock-based compensation expense. The increase in general and administrative expenses was primarily due to increased investment in infrastructure to support anticipated commercialization of ADS-5102 for LID in the coming year.
Adamas ended the quarter with $145.9 million of cash, cash equivalents, and available-for-sale securities, a reduction of $12.1 million from the end of the prior quarter.
Nine-Month 2016 Financial Results
Adamas reported a net loss for the nine months ended September 30, 2016, of $45.1 million, or $2.09 per share, basic and diluted, compared with a net loss of $41.1 million, or $2.28 per share, basic and diluted, for the same period in 2015.
Research and development expenses for the nine months ended September 30, 2016, were $24.2 million, including $2.1 million in stock-based compensation expense, compared to $26.2 million for the nine months ended September 30, 2015, which included $2.3 million in stock-based compensation expense.
General and administrative expenses for the nine months ended September 30, 2016, were $22.0 million, including $5.6 million in stock-based compensation expense, compared to $16.6 million, including $4.9 million in stock-based compensation expense, for the same period in 2015.
About Adamas Pharmaceuticals, Inc.
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 U.S. Food and Drug Administration (FDA) for potential approval in 2017. ADS-5102 has additional opportunities to potentially provide symptomatic treatment of other chronic neurologic disorders such as multiple sclerosis walking impairment and several other indications. Our newest clinical development program, ADS-4101, is entering the clinic for the improved control of epileptic seizures. Additionally, through our license agreement with Forest Laboratories Holding Ltd. (a wholly owned subsidiary of Allergan plc), the company is eligible to receive royalties on sales of NAMENDA XR® and NAMZARIC® beginning in June of 2018 and May of 2020, respectively. For more information, please visit www.adamaspharma.com.
NAMENDA XR® and NAMZARIC® are registered trademarks of Merz Pharma GmbH & Co. KGaA.
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 Securities and Exchange Commission on November 3, 2016. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. We undertake no obligation to update any forward-looking statement in this press release.
— Financial Tables Attached —
| Adamas Pharmaceuticals, Inc. 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 | |||||||||||
| Adamas Pharmaceuticals, Inc. Unaudited Condensed Consolidated Balance Sheets (in thousands, except share and per share data) | |||||||
| September 30, 2016 | December 31, 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, $0.001 par value — 5,000,000 shares authorized, and zero shares issued and outstanding at September 30, 2016 and December 31, 2015 | — | — | |||||
| Common stock, $0.001 par value — 100,000,000 shares authorized, 21,982,429 and 18,505,462 shares issued and outstanding at September 30, 2016 and December 31, 2015, respectively | 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 | |||
| Adamas Pharmaceuticals, Inc. 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 | |||