Attached files
| file | filename |
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| 8-K - 8-K - Adamas Pharmaceuticals Inc | a14-19916_38k.htm |
Exhibit 99.1
ADAMAS REPORTS THIRD QUARTER 2014 FINANCIAL RESULTS
Company to Expand Focus on Treatment of CNS Movement Disorders
EMERYVILLE, Calif., November 4, 2014 — Adamas Pharmaceuticals, Inc. (Nasdaq: ADMS) today reported a net loss attributable to common stockholders of $9.6 million, or $0.57 per share, for the quarter ended September 30, 2014. In the same period last year, the company reported a net loss attributable to common stockholders of $3.4 million, or $0.36 per share. Adamas ended the current quarter with $137.5 million in cash and cash equivalents, compared to $85.6 million at December 31, 2013.
“We continue to advance ADS-5102, our lead wholly-owned product candidate, through pivotal clinical trials,” said Gregory T. Went, PhD., Chairman and Chief Executive Officer of Adamas. “We are actively enrolling subjects in multiple Phase 3 studies evaluating ADS-5102 in individuals with Parkinson’s disease who have levodopa-induced dyskinesia (LID). We are on track to complete enrollment of these studies in 2015.”
Dr. Went continued, “We have also broadened our product portfolio by prioritizing and selecting for development additional indications for our ADS-5102 product candidate, and we expect to initiate up to two studies in 2015. Of the numerous candidate indications, our focus has shifted from chronic traumatic brain injury to three specific areas, each tailored to our planned commercial infrastructure:
· hyperkinetic movement disorders similar to LID, generally characterized by abnormally heightened, sometimes uncontrollable, movements, such as Huntington’s chorea, tardive dyskinesia, and Tourette’s Syndrome;
· hypokinetic movement disorders, generally characterized by decreased bodily movement or muscle rigidity, such as walking and fatigue issues associated with multiple sclerosis and walking deficits following stroke; and
· neuropsychiatric disorders, such as depression and Alzheimer’s disease.
Our increasing focus on movement disorders reflects both the magnitude of unmet need in the treatment of these disorders and the potential clinical effect of ADS-5102 as observed in our first Phase 2/3 study in LID.”
Fiscal 2014 Third Quarter and Nine Month Results
For the quarters ended September 30, 2014, and September 30, 2013, Adamas reported total revenues of $215,000 and $161,000, respectively. Revenues recognized in both periods were from development expense reimbursement from Adamas’ collaboration with Forest Laboratories, Inc. and government grants and contracts. Research and development expenses for the quarter ended September 30, 2014, were $5.4 million, including $642,000 in stock-based compensation expense, compared to $1.4 million for the quarter ended September 30, 2013, which included $61,000 in stock-based compensation expense. The increase was related primarily to investments in the ADS-5102 clinical program. General and administrative expenses for the quarter ended September 30, 2014, were $4.4 million, including $1.4 million in stock-based compensation expense, compared to $1.6 million for the quarter ended September 30, 2013, which included $72,000 in stock-based compensation expense. The increase was due primarily to headcount-related costs, including stock-based compensation, and professional services related to being a public company.
Total revenues for the nine months ended September 30, 2014, and September 30, 2013, were $25.5 million and $31.0 million, respectively. Revenues recognized in both periods were from development milestone payments and development expense reimbursement from Adamas’ collaboration with Forest, as well as from government grants and contracts. Research and development expenses for the nine months ended September 30, 2014, were $13.3 million, including $1.7 million in stock-based compensation expense, compared to $5.0 million for the nine months ended September 30, 2013, which included
$165,000 in stock-based compensation expense. The increase was related primarily to investments in the ADS-5102 clinical program. General and administrative expenses for the nine months ended September 30, 2014, were $10.7 million, including $3.2 million in stock-based compensation expense, compared to $4.1 million for the nine months ended September 30, 2013, which included $221,000 in stock-based compensation expense. The increase was due primarily to headcount-related costs and professional services related to being a public company.
About Adamas
Adamas Pharmaceuticals, Inc. is a specialty pharmaceutical company driven to improve the lives of those affected by chronic disorders of the central nervous system. The company achieves this by modifying the pharmacokinetic profiles of approved drugs to create novel therapeutics for use alone or in fixed-dose combination products. Adamas is currently developing its lead wholly-owned product candidate, ADS-5102, for a complication of Parkinson’s disease known as levodopa-induced dyskinesia, or LID, and is evaluating other potential indications. The company’s portfolio also includes a fixed-dose combination product candidate, MDX-8704, being developed with Forest Laboratories, Inc., a subsidiary of Actavis plc, and an approved controlled-release product, Namenda XR®, which Forest developed and is marketing in the United States under an exclusive license from Adamas. For more information, please visit www.adamaspharma.com.
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. 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 “may,” “will,” “expect,” “anticipate,” “estimate,” “intend,” “poised,” and similar expressions (as well as other words or expressions referencing future events, conditions, or circumstances) are intended to identify forward-looking statements. Such statements contained in this press release include expectations regarding the timing of initiation and enrollment of our clinical trials. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in forward-looking statements, as well as risks relating to Adamas’ business in general, see Adamas’ Quarterly Report on Form 10-Q to be filed with the Securities and Exchange Commission on November 4, 2014.
Namenda XR® is a registered trademark of Merz Pharma GmbH & Co. KGaA.
For questions, please contact:
Julie Wood
Investor Relations & Corporate Communications
Adamas Pharmaceuticals, Inc.
Phone: 510-450-3528
— Financial Tables Attached —
Adamas Pharmaceuticals, Inc.
Unaudited Condensed Consolidated Statements of Operations Data
(in thousands, except per share data)
|
|
|
Three Months Ended |
|
Nine Months Ended |
| ||||||||
|
|
|
2014 |
|
2013 |
|
2014 |
|
2013 |
| ||||
|
|
|
|
|
|
|
|
|
|
| ||||
|
Revenue |
|
$ |
215 |
|
$ |
161 |
|
$ |
25,545 |
|
$ |
30,985 |
|
|
|
|
|
|
|
|
|
|
|
| ||||
|
Operating expenses |
|
|
|
|
|
|
|
|
| ||||
|
Research and development |
|
5,412 |
|
1,387 |
|
13,343 |
|
5,037 |
| ||||
|
General and administrative |
|
4,353 |
|
1,571 |
|
10,724 |
|
4,054 |
| ||||
|
Total operating expenses |
|
9,765 |
|
2,958 |
|
24,067 |
|
9,091 |
| ||||
|
Income (loss) from operations |
|
(9,550 |
) |
(2,797 |
) |
1,478 |
|
21,894 |
| ||||
|
Interest and other income (expense), net |
|
(1 |
) |
(426 |
) |
(801 |
) |
(1,414 |
) | ||||
|
Income (loss) before income taxes |
|
(9,551 |
) |
(3,223 |
) |
677 |
|
20,480 |
| ||||
|
Income tax expense |
|
(6 |
) |
(216 |
) |
(185 |
) |
(503 |
) | ||||
|
Net income (loss) |
|
$ |
(9,557 |
) |
$ |
(3,439 |
) |
$ |
492 |
|
$ |
19,977 |
|
|
|
|
|
|
|
|
|
|
|
| ||||
|
Net income (loss) attributable to common stockholders |
|
|
|
|
|
|
|
|
| ||||
|
Basic |
|
$ |
(9,557 |
) |
$ |
(3,439 |
) |
$ |
53 |
|
$ |
12,630 |
|
|
Diluted |
|
$ |
(9,557 |
) |
$ |
(3,439 |
) |
$ |
54 |
|
$ |
13,294 |
|
|
|
|
|
|
|
|
|
|
|
| ||||
|
Net income (loss) per share attributable to common stockholders |
|
|
|
|
|
|
|
|
| ||||
|
Basic |
|
$ |
(0.57 |
) |
$ |
(0.36 |
) |
$ |
0.00 |
|
$ |
1.33 |
|
|
Diluted |
|
$ |
(0.57 |
) |
$ |
(0.36 |
) |
$ |
0.00 |
|
$ |
1.19 |
|
|
|
|
|
|
|
|
|
|
|
| ||||
|
Weighted average number of shares used in computing net income (loss) attributable to common stockholders |
|
|
|
|
|
|
|
|
| ||||
|
Basic |
|
16,787 |
|
9,510 |
|
13,998 |
|
9,506 |
| ||||
|
Diluted |
|
16,787 |
|
9,510 |
|
16,769 |
|
11,194 |
| ||||
Adamas Pharmaceuticals, Inc.
Unaudited Condensed Consolidated Balance Sheet Data
(in thousands, except per share data)
|
|
|
September 30, |
|
December 31, |
| ||
|
|
|
|
|
|
| ||
|
Assets |
|
|
|
|
| ||
|
Current assets |
|
|
|
|
| ||
|
Cash and cash equivalents |
|
$ |
137,526 |
|
$ |
85,612 |
|
|
Accounts receivable |
|
120 |
|
129 |
| ||
|
Prepaid expenses and other current assets |
|
1,284 |
|
267 |
| ||
|
Total current assets |
|
138,930 |
|
86,008 |
| ||
|
Property and equipment, net |
|
443 |
|
199 |
| ||
|
Other assets |
|
70 |
|
9 |
| ||
|
Total assets |
|
$ |
139,443 |
|
$ |
86,216 |
|
|
Liabilities, convertible preferred stock and stockholders’ equity |
|
|
|
|
| ||
|
Current liabilities |
|
|
|
|
| ||
|
Accounts payable |
|
$ |
3,033 |
|
$ |
2,097 |
|
|
Accrued liabilities |
|
3,517 |
|
2,119 |
| ||
|
Other current liabilities |
|
146 |
|
2 |
| ||
|
Total current liabilities |
|
6,696 |
|
4,218 |
| ||
|
Warrant liability |
|
— |
|
6,232 |
| ||
|
Non-current liabilities |
|
— |
|
12 |
| ||
|
Total liabilities |
|
6,696 |
|
10,462 |
| ||
|
Contingencies |
|
|
|
|
| ||
|
|
|
|
|
|
| ||
|
Convertible preferred stock |
|
— |
|
19,149 |
| ||
|
|
|
|
|
|
| ||
|
Stockholders’ equity |
|
|
|
|
| ||
|
Common stock |
|
22 |
|
14 |
| ||
|
Additional paid-in capital |
|
152,805 |
|
77,163 |
| ||
|
Accumulated deficit |
|
(20,080 |
) |
(20,572 |
) | ||
|
Total stockholders’ equity |
|
132,747 |
|
56,605 |
| ||
|
Total liabilities, convertible preferred stock and stockholders’ equity |
|
$ |
139,443 |
|
$ |
86,216 |
|
Adamas Pharmaceuticals, Inc.
Unaudited Consolidated Statement of Cash Flows
(in thousands, except per share data)
|
|
|
Nine Months Ended |
| ||||
|
|
|
2014 |
|
2013 |
| ||
|
|
|
|
|
|
| ||
|
Cash flows from operating activities |
|
|
|
|
| ||
|
Net income |
|
$ |
492 |
|
$ |
19,977 |
|
|
Adjustments to reconcile net income to net cash used in operating activities |
|
|
|
|
| ||
|
Depreciation and amortization |
|
99 |
|
43 |
| ||
|
Stock-based compensation |
|
4,907 |
|
386 |
| ||
|
Change in preferred stock warrant value |
|
983 |
|
1,073 |
| ||
|
Provision for employee notes receivable |
|
— |
|
1 |
| ||
|
Issuance of common stock and vesting of restricted common stock for services received |
|
— |
|
75 |
| ||
|
Write-off of fixed assets |
|
80 |
|
— |
| ||
|
Changes in assets and liabilities |
|
|
|
|
| ||
|
Prepaid expenses and other assets |
|
(1,077 |
) |
(364 |
) | ||
|
Accounts receivable |
|
9 |
|
774 |
| ||
|
Accounts payable |
|
936 |
|
(1,933 |
) | ||
|
Accrued liabilities and other liabilities |
|
811 |
|
(193 |
) | ||
|
Deferred revenue |
|
— |
|
(29,611 |
) | ||
|
Net cash provided by (used in) operating activities |
|
7,240 |
|
(9,772 |
) | ||
|
Cash flows from investing activities |
|
|
|
|
| ||
|
Purchase of property and equipment |
|
(194 |
) |
(162 |
) | ||
|
Net cash used in investing activities |
|
(194 |
) |
(162 |
) | ||
|
Cash flows from financing activities |
|
|
|
|
| ||
|
Proceeds from public offering of common stock, net of underwriters discount |
|
45,851 |
|
— |
| ||
|
Payment of public offering costs |
|
(3,219 |
) |
— |
| ||
|
Proceeds from issuance of common stock upon exercise of stock options |
|
250 |
|
25 |
| ||
|
Proceeds from issuance of common and preferred stock upon exercise of warrants |
|
1,986 |
|
— |
| ||
|
Principal payments on convertible promissory notes |
|
— |
|
(4,000 |
) | ||
|
Net cash provided by (used in) financing activities |
|
44,868 |
|
(3,975 |
) | ||
|
Net increase (decrease) in cash and cash equivalents |
|
51,914 |
|
(13,909 |
) | ||
|
Cash and cash equivalents at beginning of period |
|
85,612 |
|
62,957 |
| ||
|
Cash and cash equivalents at end of period |
|
$ |
137,526 |
|
$ |
49,048 |
|
|
|
|
|
|
|
| ||
|
Supplemental disclosure of noncash items |
|
|
|
|
| ||
|
Accrued capital expenditures |
|
$ |
229 |
|
$ |
— |
|
|
Liability assumed in noncash stock transaction |
|
$ |
341 |
|
$ |
— |
|
###