Adamas Pharmaceuticals, Inc.
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Adamas Reports Recent Achievements and Financial Results for the Fourth Quarter and Full-Year 2016

EMERYVILLE, Calif., Feb. 28, 2017 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (Nasdaq:ADMS) today reported recent achievements and financial results for the fourth quarter and full-year ended December 31, 2016

"We expect 2017 to be a pivotal year as we transform from an R&D-focused company to a commercial organization as we anticipate FDA approval of ADS-5102 for the treatment of levodopa-induced dyskinesia. If approved, we expect to launch ADS-5102 in the second half of 2017, providing Parkinson's patients with the first and only medicine indicated for the treatment of levodopa-induced dyskinesia," said Gregory T. Went, Ph.D., Chairman and Chief Executive Officer of Adamas Pharmaceuticals, Inc. "In addition, we are continuing to develop ADS-5102 in additional indications, as well as to advance the clinical development of ADS-4101 for the treatment of partial onset seizures in patients with epilepsy, the fourth chrono-synchronous targeted therapy to emerge from our drug development platform."

Recent Achievements
ADS-5102 (amantadine hydrochloride) extended release capsules

ADS-4101(lacosamide) capsules

Corporate

Anticipated Milestones

Fourth Quarter and Full-Year 2016 Financial Results
Adamas reported a net loss of $15.0 million, or $0.68 per share, basic and diluted, for the fourth quarter of 2016, compared to a net loss of $10.7 million, or $0.58 per share, basic and diluted, for the fourth quarter of 2015. For the year ended December 31, 2016, Adamas reported a net loss of $60.1 million, or $2.77 per share, basic and diluted, compared to a net loss of $51.8 million, or $2.86 per share, basic and diluted, for 2015.

For the quarter ended December 31, 2016, Adamas recorded revenues of $37,000 compared to $0.5 million in the corresponding period of 2015. Adamas recorded total revenues of $0.6 million for the full-year 2016, compared to $1.9 million during the same period of 2015. The decrease reflected the reduction in reimbursements for activities Adamas employees performed related to a license agreement with Allergan.

Research and development (R&D) expenses for the quarter ended December 31, 2016, were $7.0 million, including $0.7 million in stock-based compensation expense, compared to $9.7 million for the quarter ended December 31, 2015, which included $0.9 million in stock-based compensation expense. For the full-year 2016, R&D expenses were $31.2 million, including $2.9 million in stock-based compensation expense, compared to $35.9 million for the full-year 2015, which included $3.2 million in stock-based compensation expense. R&D expenses for the full-year declined over the prior period primarily due to the completion of Phase 3 clinical trials of ADS-5102 for LID in patients with Parkinson's disease.  

General and administrative (G&A) expenses for the quarter ended December 31, 2016, were $8.3 million, including $2.1 million in stock-based compensation expense, compared to $6.9 million for the same quarter in the prior year, which included $1.9 million in stock-based compensation expense. In the full-year 2016, G&A expenses were $30.3 million, including $7.7 million in stock-based compensation expense, compared to $23.5 million, including $6.8 million in stock-based compensation expense, incurred during the full-year 2015. The increase in G&A expenses for the fourth quarter and full-year was primarily due to increased investment in infrastructure to support the anticipated commercialization of ADS-5102 for LID in Parkinson's disease.

On December 31, 2016, Adamas had $135.9 million of cash, cash equivalents and available-for-sale securities compared to $120.0 million at December 31, 2015. On January 6, 2016, Adamas raised net proceeds of $61.8 million from the sale of 2,875,000 shares of common stock through a follow-on public offering.

About Adamas Pharmaceuticals, Inc.
Adamas develops new medicines to improve the daily lives of those affected by chronic neurologic disorders, including Parkinson's disease, multiple sclerosis, epilepsy and Alzheimer's disease. Adamas has pioneered a platform to develop medicines, called chrono-synchronous therapies, for chronic neurologic disorders based on an understanding of the time-dependent biologic processes responsible for disease activity and drug response to potentially achieve symptomatic relief without tolerability issues. The company's most advanced product candidate, ADS-5102, is in development for levodopa-induced dyskinesia (LID) in patients with Parkinson's disease and walking impairment. An NDA supporting ADS-5102 for the treatment of LID in patients with Parkinson's disease is under review by the FDA, with a PDUFA date of August 24, 2017. Adamas is exploring other indications for ADS-5102 for further development. Adamas is also investigating ADS-4101 for the treatment of partial onset seizures in patients with epilepsy. Additionally, Adamas' licensed assets, NAMENDA XR® and NAMZARIC®, are currently marketed by Allergan, and Adamas is eligible to receive royalties on sales of these medicines beginning in June 2018 and May 2020, respectively. For more information, please visit www.adamaspharma.com.

VIMPAT® is a trademark of UCB. Namenda XR® and Namzaric® are 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 and commercial launch of ADS-5102 for treatment of levodopa-induced dyskinesia in patients with Parkinson's disease, the potential for additional clinical development programs for ADS-5102 including walking impairment in multiple sclerosis and other indications, that 2017 will be a pivotal year as Adamas transforms from an R&D-focused company to a commercial organization, the advancement of ADS-4101 in clinical development, and the statements under the heading "Anticipated Milestones." Words such as "expect," "anticipate," 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 Adamas' research, clinical, development and commercial activities relating to ADS-5102 and ADS-4101, the regulatory and competitive environment and Adamas' business in general, see Adamas' Annual Report on Form 10-K filed with the Securities and Exchange Commission on February 28, 2017. 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 Consolidated Statements of Operations
(in thousands, except per share data)
 
  Three Months Ended
December 31,
 Twelve Months Ended
December 31,
  2016 2015 2016 2015
Revenue $37  $524  $572  $1,916 
Operating expenses        
Research and development 7,047  9,697  31,230  35,895 
General and administrative, net 8,283  6,890  30,326  23,458 
Total operating expenses 15,330  16,587  61,556  59,353 
Loss from operations (15,293) (16,063) (60,984) (57,437)
Interest and other income, net 218  98  811  363 
Loss before income taxes (15,075) (15,965) (60,173) (57,074)
Benefit for income taxes (115) (5,275) (115) (5,272)
Net loss $(14,960) $(10,690) $(60,058) $(51,802)
          
Net loss per share, basic and diluted $(0.68) $ (0.58) $(2.77) $(2.86)
         
Weighted average shares used in computing net loss
  per share, basic and diluted
 21,992  18,438  21,711  18,111 




Adamas Pharmaceuticals, Inc.
Unaudited Consolidated Balance Sheets
(in thousands, except share and per share data)
 
  December 31,
2016
 December 31,
2015
Assets    
Current assets    
Cash and cash equivalents $23,735  $33,104 
Available-for-sale securities 89,917  73,691 
Accounts receivable 794  1,284 
Prepaid expenses and other current assets 2,541  5,108 
Total current assets 116,987  113,187 
Property and equipment, net 3,156  2,353 
Available-for-sale securities, non-current 22,292  13,165 
Other assets 38  38 
Total assets $142,473  $128,743 
Liabilities and stockholders' equity     
Current liabilities    
Accounts payable $3,589  $ 3,052 
Accrued liabilities 5,867  8,457 
Other current liabilities 287  298 
Total current liabilities 9,743  11,807 
Non-current liabilities 547  749 
Total liabilities 10,290  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 December 31, 2016 and December 31, 2015
    
Common stock, $0.001 par value — 100,000,000 shares authorized, 22,013,644
  and 18,505,462 shares issued and outstanding at December 31, 2016 and
  December 31, 2015, respectively
 27  23 
Additional paid-in capital 254,558  178,473 
Accumulated other comprehensive loss (193) (158)
Accumulated deficit (122,209) (62,151)
Total stockholders' equity 132,183  116,187 
Total liabilities and stockholders' equity $142,473  $128,743 




Adamas Pharmaceuticals, Inc.
Unaudited Consolidated Statements of Cash Flows
(in thousands)
 
  Twelve Months Ended
December 31,
  2016 2015
Cash flows from operating activities    
Net loss $(60,058) $(51,802)
Adjustments to reconcile net loss to net cash used in operating activities    
Depreciation 808  435 
Stock-based compensation 10,571  9,956 
Net accretion of discounts and amortization of premiums of available-for-
  sale securities
 (301) 875 
Changes in assets and liabilities    
Accrued interest of available-for-sale securities (2) 110 
Prepaid expenses and other assets 2,643   (4,416)
Accounts receivable 490  (760)
Accounts payable 502  (788)
Accrued liabilities and other liabilities (2,721) (820)
Net cash used in operating activities (48,068) (47,210)
Cash flows from investing activities    
Purchases of property and equipment (1,624) (1,399)
Purchases of available-for-sale securities (103,528) (59,828)
Maturities of available-for-sale securities 78,443  69,285 
Net cash provided by (used in) investing activities  (26,709) 8,058 
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 2,966  746 
Proceeds from employee stock purchase plan 620  407 
Net cash provided by financing activities 65,408  10,810 
Net decrease in cash and cash equivalents (9,369) (28,342)
Cash and cash equivalents at beginning of period 33,104  61,446 
Cash and cash equivalents at end of period $23,735  $33,104 

 

Contact:

Martin Forrest

Vice President, Corporate Communications & Investor Relations

Adamas Pharmaceuticals, Inc.

510-450-3528

ir@adamaspharma.com

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Source: Adamas Pharmaceuticals, Inc.

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