EX-99.1 2 adms-20160804ex991163e7b.htm EX-99.1 adms_Ex99_1

Exhibit 99.1

 

Adamas Reports Second Quarter 2016  Financial Results

 

Emeryville, Calif., August 04, 2016  — 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 dilutedResearch 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

 

Upcoming Event

·

 4th World Parkinson’s Congress, Portland, Oregon, September 20 to 23, 2016

o

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

o

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.

1


 

 

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.

 

For questions, please contact:

 

Susan Lehner

Corporate Communications & Investor Relations

Adamas Pharmaceuticals, Inc.
Phone: 510-450-3567

 

— Financial Tables Attached —

2


 

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,

 

 

    

2016

    

2015

    

2016

    

2015

 

Revenue

 

$

222

 

$

398

 

$

397

 

$

624

 

Operating expenses

 

 

 

 

 

 

 

 

 

 

 

 

 

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

 

$

(16,876)

 

$

(14,051)

 

$

(30,704)

 

$

(26,253)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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

 

 

3


 

Adamas Pharmaceuticals, Inc.

Unaudited Condensed Consolidated Balance Sheets

(in thousands, except share and per share data)

 

 

 

 

 

 

 

 

 

 

    

June 30,

    

December 31,

 

 

 

2016

 

2015

 

Assets

 

 

 

 

 

 

 

Current assets

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

109,272

 

$

33,104

 

Available-for-sale securities

 

 

46,854

 

 

73,691

 

Accounts receivable

 

 

860

 

 

1,284

 

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

 

Other assets

 

 

38

 

 

38

 

Total assets

 

$

168,640

 

$

128,743

 

Liabilities and stockholders’ equity

 

 

 

 

 

 

 

Current liabilities

 

 

 

 

 

 

 

Accounts payable

 

$

4,720

 

$

3,052

 

Accrued liabilities

 

 

7,843

 

 

8,457

 

Other current liabilities

 

 

267

 

 

298

 

Total current liabilities

 

 

12,830

 

 

11,807

 

Non-current liabilities

 

 

649

 

 

749

 

Total liabilities

 

 

13,479

 

 

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 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)

 

Accumulated deficit

 

 

(92,855)

 

 

(62,151)

 

Total stockholders’ equity

 

 

155,161

 

 

116,187

 

Total liabilities and stockholders’ equity

 

$

168,640

 

$

128,743

 

 

4


 

Adamas Pharmaceuticals, Inc.

Unaudited Condensed Consolidated Statements of Cash Flows

(in thousands)

 

 

 

 

 

 

 

 

 

 

 

Six Months Ended

 

 

 

June 30,

 

 

    

2016

    

2015

 

Cash flows from operating activities

 

 

 

 

 

 

 

Net loss

 

$

(30,704)

 

$

(26,253)

 

Adjustments to reconcile net loss to net cash used in operating activities

 

 

 

 

 

 

 

Depreciation and amortization

 

 

328

 

 

156

 

Stock-based compensation

 

 

5,184

 

 

4,582

 

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)

 

Accounts receivable

 

 

424

 

 

163

 

Accounts payable

 

 

1,525

 

 

(181)

 

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

 

 

###

 

 

5