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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Acorda Therapeutics Inc | NASDAQ:ACOR | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.00 | 0.00% | 0.661 | 0.565 | 0.5878 | 0 | 01:00:00 |
Delaware
|
000-50513
|
13-3831168
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||
(State or other jurisdiction
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(Commission
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(I.R.S. Employer
|
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of incorporation)
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File Number)
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Identification No.)
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||
420 Saw Mill River Road, Ardsley, NY
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10502
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|||
(Address of principal executive offices)
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(Zip Code)
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|||
Registrant’s telephone number, including area code: (914) 347-4300
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Exhibit No.
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Description
|
99.1
|
Press Release dated April 30, 2015
|
Acorda Therapeutics, Inc.
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||
April 30, 2015
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By:
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/s/ Michael Rogers
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Name: Michael Rogers
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||
Title: Chief Financial Officer
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Exhibit No.
|
Description
|
99.1
|
Press Release dated April 30, 2015
|
|
·
|
AMPYRA® (dalfampridine) First Quarter Net Revenue of $92.4 Million;
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·
|
The U.S. District Court in Delaware, which is adjudicating Abbreviated New Drug Application (ANDA) challenges to certain AMPYRA patents, has scheduled a Markman hearing for March 2016 and set a trial date for September 2016.
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·
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Petitions for Inter Partes Review (IPR) of two AMPYRA patents have been submitted to the United States Patent and Trademark Office (USPTO). The Company is responding to these filings.
|
·
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The Company has five Orange Book-listed patents on AMPYRA, and will vigorously defend its intellectual property rights.
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·
|
In March, the Company presented new analyses of data from the first Phase 1 clinical trial of cimaglermin alfa, an investigational drug for heart failure, at the America College of Cardiology (ACC) 64th Annual Scientific Session and Expo. The poster contained new analyses of ejection fraction measures, which found that cimaglermin produced a dose-dependent benefit at multiple time points for up to three months following a single infusion. Additional information on adverse events, demographics, and analysis of hemodynamic and echo parameters were also reported. Data from the second clinical trial of cimaglermin in people with heart failure is expected in the second half of 2015.
|
·
|
In April, the Company presented data from a Phase 1 clinical trial of rHIgM22, a remyelinating antibody being studied for the treatment of multiple sclerosis (MS). Safety data showed rHIgM22 was well-tolerated in each of the five tested doses, supporting additional clinical development. In addition, testing detected rHIgM22 in cerebrospinal fluid (CSF), indicating the drug’s access to the central nervous system. These data were presented at the 67th American Academy of Neurology Annual Meeting. The Company expects to begin a second Phase 1 trial in relapsing MS patients in the second quarter of 2015.
|
·
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have ever had a seizure,
|
·
|
have certain types of kidney problems, or
|
·
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are allergic to dalfampridine (4-aminopyridine), the active ingredient in AMPYRA.
|
·
|
have kidney problems or any other medical conditions;
|
·
|
are taking compounded 4-aminopyridine;
|
·
|
are pregnant or plan to become pregnant. It is not known if AMPYRA will harm your unborn baby;
|
·
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are breast-feeding or plan to breast-feed. It is not known if AMPYRA passes into your breast milk. You and your doctor should decide if you will take AMPYRA or breast-feed. You should not do both;
|
·
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are taking any other medicines.
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·
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severe allergic reactions. Stop taking AMPYRA and call your doctor right away or get emergency medical help if you have shortness of breath or trouble breathing, swelling of your throat or tongue, or hives;
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·
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kidney or bladder infections.
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March 31,
2015
|
December 31,
2014
|
|||||||
Assets
|
||||||||
Cash, cash equivalents, short-term and long-term investments
|
$ | 299,697 | $ | 307,618 | ||||
Trade receivable, net
|
30,551 | 32,211 | ||||||
Other current assets
|
27,288 | 24,052 | ||||||
Finished goods inventory
|
45,831 | 26,837 | ||||||
Deferred tax asset
|
20,469 | 18,420 | ||||||
Property and equipment, net
|
45,919 | 46,090 | ||||||
Goodwill
|
182,952 | 182,952 | ||||||
Intangible assets, net
|
432,155 | 432,822 | ||||||
Other assets
|
14,120 | 9,677 | ||||||
Total assets
|
$ | 1,098,982 | $ | 1,080,679 | ||||
Liabilities and stockholders' equity
|
||||||||
Accounts payable, accrued expenses and other liabilities
|
$ | 82,094 | $ | 73,869 | ||||
Deferred product revenue
|
29,121 | 29,420 | ||||||
Current portion of deferred license revenue
|
9,057 | 9,057 | ||||||
Current portion of revenue interest liability
|
749 | 893 | ||||||
Current portion of notes payable
|
1,144 | 1,144 | ||||||
Convertible senior notes
|
289,607 | 287,699 | ||||||
Contingent consideration
|
55,700 | 52,600 | ||||||
Non-current portion of deferred license revenue
|
48,306 | 50,570 | ||||||
Deferred tax liability
|
23,885 | 23,885 | ||||||
Other long-term liabilities
|
10,299 | 11,287 | ||||||
Stockholders' equity
|
549,020 | 540,255 | ||||||
Total liabilities and stockholders' equity
|
$ | 1,098,982 | $ | 1,080,679 |
Three Months Ended
March 31,
|
||||||||
2015
|
2014
|
|||||||
Revenues:
|
||||||||
Net product revenues
|
$ | 93,500 | $ | 74,463 | ||||
Royalty revenues
|
4,087 | 3,791 | ||||||
License revenue
|
2,264 | 2,264 | ||||||
Total revenues
|
99,851 | 80,518 | ||||||
Costs and expenses:
|
||||||||
Cost of sales
|
18,446 | 15,529 | ||||||
Cost of license revenue
|
159 | 159 | ||||||
Research and development
|
30,636 | 14,522 | ||||||
Selling, general and administrative
|
48,769 | 46,892 | ||||||
Change in fair value of acquired contingent consideration
|
3,100 | - | ||||||
Total operating expenses
|
101,110 | 77,102 | ||||||
Operating (loss) income
|
$ | (1,259 | ) | $ | 3,416 | |||
Other (expense) income, net
|
(3,864 | ) | 80 | |||||
(Loss) income before income taxes
|
(5,123 | ) | 3,496 | |||||
Benefit from (provision for) income taxes
|
2,038 | (2,793 | ) | |||||
Net (loss) income
|
$ | (3,085 | ) | $ | 703 | |||
Net (loss) income per common share - basic
|
$ | (0.07 | ) | $ | 0.02 | |||
Net (loss) income per common share - diluted
|
$ | (0.07 | ) | $ | 0.02 | |||
Weighted average per common share - basic
|
42,031 | 40,934 | ||||||
Weighted average per common share - diluted
|
42,031 | 42,235 |
Three Months Ended
March 31,
|
||||||||
2015
|
2014
|
|||||||
GAAP net (loss) income
|
$ | (3,085 | ) | $ | 703 | |||
Pro forma adjustments:
|
||||||||
Non-cash interest expense (1)
|
2,103 | - | ||||||
Non-cash taxes (2)
|
(2,781 | ) | 2,333 | |||||
Change in fair value of acquired contingent consideration (3)
|
3,100 | - | ||||||
Share-based compensation expenses included in R&D
|
1,822 | 1,104 | ||||||
Share-based compensation expenses included in SG&A
|
5,304 | 4,653 | ||||||
Total share-based compensation expenses
|
7,126 | 5,757 | ||||||
Total pro forma adjustments
|
9,548 | 8,090 | ||||||
Non-GAAP net income
|
$ | 6,463 | $ | 8,793 | ||||
Net income per common share - basic
|
$ | 0.15 | $ | 0.21 | ||||
Net income per common share - diluted
|
$ | 0.15 | $ | 0.21 | ||||
Weighted average per common share - basic
|
42,031 | 40,934 | ||||||
Weighted average per common share - diluted
|
43,585 | 42,235 | ||||||
(1) Non-cash interest expense related to convertible senior notes.
|
||||||||
(2) $0.7 million and $0.5 million paid in cash taxes in the three months ended 2015 and 2014, respectively.
|
||||||||
(3) Changes in fair value of acquired contingent consideration related to Civitas transaction.
|
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