EMERYVILLE, Calif., Aug. 04, 2016 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (Nasdaq:ADMS) today announced financial results for the second quarter of 2016.
“We are pleased with the progress made during the quarter, especially in our ADS-5102 program. We announced compelling clinical data in both the Phase 3 program in levodopa-induced dyskinesia, or LID, associated with Parkinson’s disease and the Phase 2 study in walking impairment associated with multiple sclerosis, or MS,” stated Gregory T. Went, Ph.D., Chairman and Chief Executive Officer of Adamas Pharmaceuticals, Inc. “We are on track to submit a new drug application to the FDA in support of ADS-5102 for the treatment of LID this year, with the aim of making ADS-5102 the first drug available for patients and caregivers facing this often debilitating and socially isolating movement disorder.”
Dr. Went continued, “We were very encouraged by the statistically significant placebo-adjusted improvement in walking speed we saw in our Phase 2 trial of ADS-5102 in MS patients—an improvement, which if repeated in subsequent clinical trials, could represent a significantly differentiated medicine over currently available treatment options. We look forward to meeting with the FDA to discuss the clinical development path forward for this program.”
Second Quarter 2016 Financial Results
For the quarter ended June 30, 2016, Adamas reported a net loss of $16.9 million, or $0.78 per share, basic and diluted, compared with a net loss for the quarter ended June 30, 2015, of $14.1 million, or $0.78 per share, basic and diluted. Research and development expenses for the quarter ended June 30, 2016, were $9.2 million, including $0.7 million in stock-based compensation expense, compared to $8.7 million for the quarter ended June 30, 2015, which also included $0.7 million in stock-based compensation expense. Research and development expenses for the current quarter included increased investment to support the preparation of the new drug application (NDA) for ADS-5102 for the treatment of LID, offset in part by the conclusion of two Phase 3 clinical trials. General and administrative expenses for the quarter ended June 30, 2016, were $8.1 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 $1.7 million in stock-based compensation expense. The increase in general and administrative expenses was due primarily to costs associated with establishing commercial capabilities in anticipation of the commercial launch of ADS-5102 for the treatment of LID associated with Parkinson’s disease, pending regulatory approval.
Six-month 2016 Financial Results
Adamas reported a net loss for the six months ended June 30, 2016, of $30.7 million, or $1.43 per share, basic and diluted, compared with a net loss for the same period in 2015 of $26.3 million, or $1.47 per share, basic and diluted. Research and development expenses for the six months ended June 30, 2016, were $16.7 million, including $1.4 million in stock-based compensation expense, compared to $16.2 million for the six months ended June 30, 2015, which included $1.5 million in stock-based compensation expense. General and administrative expenses for the six months ended June 30, 2016, were $14.7 million, including $3.8 million in stock-based compensation expense, compared to $10.8 million for the six months ended June 30, 2015, which included $3.1 million in stock-based compensation expense.
Adamas ended the quarter with $158.0 million of cash, cash equivalents, and available-for-sale securities, a reduction of $11.2 million from the end of the prior quarter.
- 4th World Parkinson’s Congress, Portland, Oregon, September 20 to 23, 2016
- Poster Presentation: Results of a Phase 3 efficacy and safety study of ADS-5102 (amantadine HCl) extended-release capsules in Parkinson’s disease patients with levodopa-induced dyskinesia (EASE LID 3) – presentation date/time pending
- Poster Presentation: ADS-5102 (amantadine HCl) extended-release capsules improves activities of daily living (ADLs) in Parkinson’s disease (PD) patients by reducing levodopa-induced dyskinesia (LID): A post-hoc analysis from the Phase 3 EASE LID study – presentation date/time pending
About Adamas Pharmaceuticals, Inc.
Adamas Pharmaceuticals, Inc. is driven to improve the lives of those affected by chronic disorders of the central nervous system. The company seeks to achieve this by modifying the pharmacokinetic profiles of approved drugs to create novel therapeutics for use alone and in fixed-dose combination products. Adamas is currently developing ADS-5102, its lead wholly-owned product candidate, for the treatment of levodopa-induced dyskinesia associated with Parkinson’s disease and for the treatment of walking impairment in patients with multiple sclerosis. The company is also evaluating ADS-4101, an extended-release version of an FDA-approved single-agent compound for the treatment of epilepsy. In addition, under a license agreement with Forest Laboratories Holdings Limited, an indirect wholly-owned subsidiary of Allergan plc, the company is eligible to receive royalties from Forest 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.
Namzaric™ is a trademark of Merz Pharma GmbH & Co. KGaA.
Namenda XR® is a registered trademark of Merz Pharma GmbH & Co. KGaA.
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 for ADS-5102 to become the first FDA-approved medicine for the treatment of LID, that Adamas is on track to submit an NDA to the FDA later this year, the potential for ADS-5102 in walking impairment in patients with MS and the expected timing of FDA discussions on that program. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as “look forward,” “on track,” “could,” “potential,” and similar expressions (as well as other words or expressions referencing future events, conditions, or circumstances) are intended to identify forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in forward-looking statements, including risks relating to research, clinical and development activities of ADS-5102 and ADS-4101, the regulatory and competitive environment, as well as risks relating to Adamas’ business in general, see Adamas’ Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on August 4, 2016. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. Adamas undertakes 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||Six Months Ended|
|June 30,||June 30,|
|Research and development||9,224||8,705||16,746||16,238|
|General and administrative, net||8,058||5,846||14,699||10,765|
|Total operating expenses||17,282||14,551||31,445||27,003|
|Loss from operations||(17,060||)||(14,153||)||(31,048||)||(26,379||)|
|Interest and other income, net||184||102||344||180|
|Loss before income taxes||(16,876||)||(14,051||)||(30,704||)||(26,199||)|
|Provision for income taxes||—||—||—||54|
|Net loss per share, basic and diluted||$||(0.78||)||$||(0.78||)||$||(1.43||)||$||(1.47||)|
|Weighted average number of shares used in computing net loss per share, basic and diluted||21,650||17,955||21,452||17,800|
|Adamas Pharmaceuticals, Inc.|
Unaudited Condensed Consolidated Balance Sheets
(in thousands, except share and per share data)
|June 30,||December 31,|
|Cash and cash equivalents||$||109,272||$||33,104|
|Prepaid expenses and other current assets||6,335||5,108|
|Total current assets||163,321||113,187|
|Property and equipment, net||3,375||2,353|
|Available-for-sale securities, non-current||1,906||13,165|
|Liabilities and stockholders’ equity|
|Other current liabilities||267||298|
|Total current liabilities||12,830||11,807|
|Commitments and Contingencies|
|Preferred stock, $0.001 par value — 5,000,000 shares authorized, and zero shares issued and outstanding at June 30, 2016 and December 31, 2015||—||—|
|Common stock, $0.001 par value — 100,000,000 shares authorized, 21,912,782 and 18,505,462 shares issued and outstanding at June 30, 2016 and December 31, 2015, respectively||27||23|
|Additional paid-in capital||247,957||178,473|
|Accumulated other comprehensive income (loss)||32||(158||)|
|Total stockholders’ equity||155,161||116,187|
|Total liabilities and stockholders’ equity||$||168,640||$||128,743|
|Adamas Pharmaceuticals, Inc.|
Unaudited Condensed Consolidated Statements of Cash Flows
|Six months ended|
|Cash flows from operating activities|
|Adjustments to reconcile net loss to net cash used in operating activities|
|Depreciation and amortization||328||156|
|Net accretion of discounts and amortization of premiums of available-for-sale securities||407||609|
|Changes in assets and liabilities|
|Accrued interest of available-for-sale securities||226||(38||)|
|Prepaid expenses and other assets||(1,227||)||(652||)|
|Accrued liabilities and other liabilities||(674||)||(2,433||)|
|Net cash used in operating activities||(24,511||)||(24,047||)|
|Cash flows from investing activities|
|Purchases of property and equipment||(1,244||)||(447||)|
|Purchases of available-for-sale securities||—||(18,435||)|
|Maturities of available-for-sale securities||37,653||10,085|
|Net cash provided by (used in) investing activities||36,409||(8,797||)|
|Cash flows from financing activities|
|Proceeds from public offerings, net of offering costs||61,822||8,507|
|Proceeds from issuance of common stock upon exercise of stock options||2,122||637|
|Proceeds from employee stock purchase plan||326||181|
|Net cash provided by financing activities||64,270||9,325|
|Net increase (decrease) in cash and cash equivalents||76,168||(23,519||)|
|Cash and cash equivalents at beginning of period||33,104||61,446|
|Cash and cash equivalents at end of period||$||109,272||$||37,927|
For questions, please contact: Susan Lehner Corporate Communications & Investor Relations Adamas Pharmaceuticals, Inc. Phone: 510-450-3567
Source:Adamas Pharmaceuticals, Inc.