Delaware
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000-50513
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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
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99.1
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Press Release dated April 28, 2016
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Acorda Therapeutics, Inc.
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April 28, 2016
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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.
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Description
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99.1
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Press Release dated April 28, 2016
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·
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AMPYRA® (dalfampridine) 1Q 2016 net revenue of $109.6 Million; 19% increase over 1Q 2015 net revenue of $92.4 Million
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·
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Company exceeds 90% minimum condition to close Biotie acquisition; final close expected in 2H 2016
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·
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Diversified portfolio with potential for three NDA filings by the end of 2018
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·
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AMPYRA® (dalfampridine)
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-
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AMPYRA revenues for the first quarter of 2016 were $109.6 million, up 19% from the first quarter in 2015. This represents the 12th consecutive quarter of double digit, year-over-year growth for AMPYRA, which was launched in 2010.
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-
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In March, a Markman hearing was held in the U.S. District Court for the District of Delaware related to the consolidated lawsuits that the Company filed against companies that submitted Abbreviated New Drug Applications to the FDA seeking marketing approval for AMPYRA. Also in March, the United States Patent and Trademark Office (USPTO) Patent Trials and Appeal Board (PTAB) instituted the inter partes review (IPR) of four AMPYRA patents. Rulings on the IPR petitions are expected within one year. The Company will continue to defend its intellectual property vigorously.
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·
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Dalfampridine in Post-Stroke Walking Difficulty
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-
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In March, the Company completed Phase 1 single-dose pharmacokinetic (PK) studies for three separate once-daily (QD) formulations of dalfampridine. Results for at least one of these formulations met the Company’s criteria. The multi-dose phase of PK testing will begin in the second quarter of 2016.
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-
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Given the progress in its development of a QD formulation of dalfampridine, the Company has made the decision to stop enrollment and conduct an unblinded analysis of the Phase 3 twice-daily (BID) clinical trial data, having reached 50% of its target enrollment in the study, or 270 subjects. As previously stated, unblinding the study ahead of the originally contemplated interim futility analysis was an option. Data are expected by the fourth quarter of 2016 and will be used to inform the design of planned Phase 3 trials in post-stroke.
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·
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CVT-301 in Parkinson’s Disease
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-
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In April, data from the CVT-301 Phase 2b clinical trial were one of six platform presentations highlighted during the Movement Disorders Invited Science Session at the 68th Annual Meeting of the American Academy of Neurology.
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·
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CVT-427 in Migraine
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-
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In March, the Company announced it had successfully completed a Phase 1 safety/tolerability and pharmacokinetic study for CVT-427. Based on the positive results, the Company is designing protocols for the next phase of development.
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·
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Corporate
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In January, the Company announced it had entered into an agreement to acquire Biotie Therapies Corp. The acquisition includes global rights to two clinical-stage compounds in development for treatment of Parkinson’s disease, as well as other assets.
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-
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In April, more than 90% of the outstanding shares of Biotie were tendered to the Company in a tender offer conducted pursuant to the acquisition agreement, meeting the minimum condition to closing the tender offer. The Company expects to complete the acquisition of 100% of Biotie in the second half of 2016.
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In January, the Company completed a $75 million private placement of its common stock and signed a Commitment Letter with JP Morgan for an asset-based credit facility of up to $60 million, which is expected to close in the second quarter of 2016.
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March 31,
2016
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December 31,
2015
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Assets
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Cash, cash equivalents, short-term and long-term investments
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$ | 431,414 | $ | 353,305 | ||||
Trade receivable, net
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41,623 | 31,466 | ||||||
Other current assets
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31,577 | 30,070 | ||||||
Finished goods inventory
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39,667 | 36,476 | ||||||
Deferred tax asset
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12,273 | 2,128 | ||||||
Property and equipment, net
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38,027 | 40,204 | ||||||
Goodwill
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183,636 | 183,636 | ||||||
Intangible assets, net
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430,491 | 430,856 | ||||||
Other assets
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2,986 | 3,153 | ||||||
Total assets
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$ | 1,211,694 | $ | 1,111,294 | ||||
Liabilities and stockholders' equity
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Accounts payable, accrued expenses and other liabilities
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$ | 94,830 | $ | 80,366 | ||||
Current portion of deferred license revenue
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9,057 | 9,057 | ||||||
Current portion of revenue interest liability
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- | 25 | ||||||
Current portion of notes payable
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1,117 | 1,144 | ||||||
Convertible senior notes
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292,624 | 290,420 | ||||||
Contingent consideration
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69,700 | 63,500 | ||||||
Non-current portion of deferred license revenue
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39,249 | 41,513 | ||||||
Deferred tax liability
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12,146 | 12,146 | ||||||
Other long-term liabilities
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8,959 | 10,098 | ||||||
Stockholders' equity
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684,012 | 603,025 | ||||||
Total liabilities and stockholders' equity
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$ | 1,211,694 | $ | 1,111,294 |
Three Months Ended
March 31,
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2016
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2015
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Revenues:
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Net product revenues
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$ | 110,148 | $ | 93,500 | ||||
Royalty revenues
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3,492 | 4,087 | ||||||
License revenue
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2,264 | 2,264 | ||||||
Total revenues
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115,904 | 99,851 | ||||||
Costs and expenses:
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Cost of sales
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23,186 | 18,446 | ||||||
Cost of license revenue
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159 | 159 | ||||||
Research and development
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44,570 | 30,636 | ||||||
Selling, general and administrative
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51,782 | 48,769 | ||||||
Acquisition related expenses
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7,198 | - | ||||||
Change in fair value of acquired contingent consideration
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6,200 | 3,100 | ||||||
Total operating expenses
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133,095 | 101,110 | ||||||
Operating loss
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$ | (17,191 | ) | $ | (1,259 | ) | ||
Other income (expense), net
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6,934 | (3,864 | ) | |||||
Loss before income taxes
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(10,257 | ) | (5,123 | ) | ||||
Benefit from income taxes
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9,737 | 2,038 | ||||||
Net loss
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$ | (520 | ) | $ | (3,085 | ) | ||
Net loss per common share - basic
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$ | (0.01 | ) | $ | (0.07 | ) | ||
Weighted average per common share - basic
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44,815 | 42,031 |
Three Months Ended
March 31,
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2016
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2015
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GAAP net loss
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$ | (520 | ) | $ | (3,085 | ) | ||
Pro forma adjustments:
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Non-cash interest expense (1)
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2,204 | 2,103 | ||||||
Non-cash tax benefit (2)
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(9,894 | ) | (2,781 | ) | ||||
Change in fair value of acquired contingent consideration (3)
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6,200 | 3,100 | ||||||
Acquisition related expenses (4)
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7,198 | - | ||||||
Unrealized foreign currency transaction gain (5)
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(10,289 | ) | - | |||||
Share-based compensation expenses included in R&D
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2,121 | 1,822 | ||||||
Share-based compensation expenses included in SG&A
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6,038 | 5,304 | ||||||
Total share-based compensation expenses
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8,159 | 7,126 | ||||||
Total pro forma adjustments
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3,578 | 9,548 | ||||||
Non-GAAP net income
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$ | 3,058 | $ | 6,463 | ||||
Net income per common share - basic
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$ | 0.07 | $ | 0.15 | ||||
Net income per common share - diluted
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$ | 0.07 | $ | 0.15 | ||||
Weighted average per common share - basic
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44,815 | 42,031 | ||||||
Weighted average per common share - diluted
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46,043 | 43,585 | ||||||
(1) Non-cash interest expense related to convertible senior notes.
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(2) $0.2 million and $0.7 million paid in cash taxes in the three months ended March 31, 2016 and 2015, respectively.
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(3) Changes in the fair value of the acquired contingent consideration related to the Civitas acquisition.
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(4) Transaction expenses related to the Biotie acquisition.
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(5) Unrealized foreign currency transaction gain related to the Biotie transaction included in Other income, net in the Consolidated Statements of Operations.
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