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 February 11, 2016
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Acorda Therapeutics, Inc.
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February 11, 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 February 11, 2016
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·
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AMPYRA® (dalfampridine) 4Q 2015 Net Revenue of $122 Million; 11% increase over 4Q 2014
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·
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AMPYRA Full-Year Net Revenue of $437 Million, 19% increase over 2014
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·
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AMPYRA 2016 Net Sales Guidance of $475-$485 Million
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·
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Biotie acquisition will expand Parkinson’s disease franchise; will add three clinical stage compounds, including promising Phase 3 program
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·
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The Company expects AMPYRA 2016 full year net revenue of $475-$485 million.
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·
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R&D expenses for the full year 2016 are expected to be $165-$175 million, excluding share-based compensation.
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·
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SG&A expenses for the full year 2016 are expected to be $195-$205 million, excluding share-based compensation.
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·
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Business Development
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-
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On January 19, the Company announced that it entered into an agreement to acquire Biotie Therapies Corp., including worldwide rights to tozadenant, an oral adenosine A2a receptor antagonist currently in Phase 3 development in Parkinson’s disease. The transaction, valued at approximately $363 million, is expected to close in the third quarter of 2016.
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·
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AMPYRA (dalfampridine)
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-
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In December 2015 and January 2016, respectively, the Company announced it had entered into two settlement agreements, with Aurobindo Pharma Ltd. and Par Pharmaceutical, Inc., to resolve pending patent litigation related to AMPYRA. As a result of the settlement agreements, both Aurobindo and Par will be permitted to market a generic version of AMPYRA in the United States at a specified date in 2027, or potentially earlier under certain circumstances.
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·
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CVT-427
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-
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In December, the Company initiated and completed a Phase 1 study of CVT-427 for the treatment of acute migraine. The Company will provide an update by end of the first quarter 2016.
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·
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Corporate
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-
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In December, the Company presented analyses from a study showing the effect of rescue medication for seizure clusters on both clinical outcomes and healthcare resource utilization. The analyses were presented at the 69th Annual Meeting of the American Epilepsy Society in Philadelphia, PA.
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-
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In January 2016, Chief Medical Officer (CMO) Enrique Carrazana, M.D. left the Company. Burkhard Blank, M.D., has assumed the position of interim CMO.
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December 31,
2015
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December 31,
2014
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Assets
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Cash, cash equivalents, short-term and long-term investments
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$ | 353,305 | $ | 307,618 | ||||
Trade receivable, net
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31,466 | 32,211 | ||||||
Other current assets
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30,070 | 24,052 | ||||||
Finished goods inventory
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36,476 | 26,837 | ||||||
Deferred tax asset
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2,128 | 2,806 | ||||||
Property and equipment, net
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40,204 | 46,090 | ||||||
Goodwill
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183,636 | 182,952 | ||||||
Intangible assets, net
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430,856 | 432,822 | ||||||
Other assets
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8,202 | 9,677 | ||||||
Total assets
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$ | 1,116,343 | $ | 1,065,065 | ||||
Liabilities and stockholders' equity
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Accounts payable, accrued expenses and other liabilities
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$ | 80,366 | $ | 73,869 | ||||
Deferred product revenue
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- | 29,420 | ||||||
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 | 893 | ||||||
Current portion of notes payable
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1,144 | 1,144 | ||||||
Convertible senior notes
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295,469 | 287,699 | ||||||
Contingent consideration
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63,500 | 52,600 | ||||||
Non-current portion of deferred license revenue
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41,513 | 50,570 | ||||||
Deferred tax liability
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12,146 | 8,271 | ||||||
Other long-term liabilities
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10,098 | 11,287 | ||||||
Stockholders' equity
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603,025 | 540,255 | ||||||
Total liabilities and stockholders' equity
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$ | 1,116,343 | $ | 1,065,065 |
Three Months Ended
December 31,
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Twelve Months Ended
December 31,
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2015
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2014
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2015
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2014
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Revenues:
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Net product revenues
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$ | 123,717 | $ | 110,630 | $ | 466,111 | $ | 373,292 | ||||||||
Royalty revenues
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4,921 | 4,978 | 17,492 | 19,131 | ||||||||||||
License revenue
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2,264 | 2,264 | 9,057 | 9,057 | ||||||||||||
Total revenues
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130,902 | 117,872 | 492,660 | 401,480 | ||||||||||||
Costs and expenses:
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Cost of sales
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26,401 | 24,977 | 92,297 | 79,981 | ||||||||||||
Cost of license revenue
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159 | 158 | 634 | 634 | ||||||||||||
Research and development
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43,988 | 25,921 | 149,209 | 73,470 | ||||||||||||
Selling, general and administrative
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52,984 | 56,456 | 205,630 | 201,813 | ||||||||||||
Asset Impairment
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- | 6,991 | - | 6,991 | ||||||||||||
Change in fair value of acquired contingent consideration
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3,500 | 2,200 | 10,900 | 2,200 | ||||||||||||
Total operating expenses
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127,032 | 116,703 | 458,670 | 365,089 | ||||||||||||
Operating income
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$ | 3,871 | $ | 1,169 | $ | 33,990 | $ | 36,391 | ||||||||
Other expense, net
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(3,216 | ) | (3,862 | ) | (14,621 | ) | (8,382 | ) | ||||||||
Income (loss) before income taxes
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655 | (2,693 | ) | 19,369 | 28,009 | |||||||||||
Benefit from (provision for) income taxes
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8,550 | 3,024 | (8,311 | ) | (10,337 | ) | ||||||||||
Net income
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$ | 9,205 | $ | 331 | $ | 11,058 | $ | 17,672 | ||||||||
Net income per common share - basic
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$ | 0.22 | $ | 0.01 | $ | 0.26 | $ | 0.43 | ||||||||
Net income per common share - diluted
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$ | 0.21 | $ | 0.01 | $ | 0.25 | $ | 0.42 | ||||||||
Weighted average per common share - basic
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42,624 | 41,532 | 42,230 | 41,150 | ||||||||||||
Weighted average per common share - diluted
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44,179 | 43,135 | 43,621 | 42,544 |
Three Months Ended
December 31,
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Twelve Months Ended
December 31,
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2015
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2014
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2015
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2014
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GAAP net income
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$ | 9,205 | $ | 331 | $ | 11,058 | $ | 17,672 | ||||||||
Pro forma adjustments:
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Non-cash interest expense (1)
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2,178 | 2,065 | 8,562 | 4,291 | ||||||||||||
Non-cash tax expense (2)
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(11,095 | ) | (5,551 | ) | 3,614 | 5,981 | ||||||||||
Change in fair value of acquired contingent consideration (3)
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3,500 | 2,200 | 10,900 | 2,200 | ||||||||||||
Change in revenue recognition - Zanaflex capsules & tablets (4)
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- | - | (21,633 | ) | - | |||||||||||
Acquisition related expenses (5)
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- | 4,893 | - | 7,248 | ||||||||||||
Asset Impairment (6)
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- | 6,991 | - | 6,991 | ||||||||||||
Share-based compensation expenses included in R&D
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2,243 | 1,851 | 8,474 | 5,939 | ||||||||||||
Share-based compensation expenses included in SG&A
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6,476 | 6,943 | 24,992 | 23,498 | ||||||||||||
Total share-based compensation expenses
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8,719 | 8,794 | 33,466 | 29,437 | ||||||||||||
Total pro forma adjustments
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3,302 | 19,392 | 34,909 | 56,148 | ||||||||||||
Non-GAAP net income
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$ | 12,507 | $ | 19,723 | $ | 45,967 | $ | 73,820 | ||||||||
Net income per common share - basic
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$ | 0.29 | $ | 0.47 | $ | 1.09 | $ | 1.79 | ||||||||
Net income per common share - diluted
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$ | 0.28 | $ | 0.46 | $ | 1.05 | $ | 1.74 | ||||||||
Weighted average per common share - basic
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42,624 | 41,532 | 42,230 | 41,150 | ||||||||||||
Weighted average per common share - diluted
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44,179 | 43,135 | 43,621 | 42,544 |
(1) Non-cash interest expense related to convertible senior notes.
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(2) $2.5 million and $2.5 million paid in cash taxes in the three months ended 2015 and 2014, respectively, and $4.7 million and $4.4 million paid in cash taxes in the twelve months ended 2015 and 2014, respectively.
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(3) Changes in fair value of the acquired contingent consideration related to the Civitas acquisition.
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(4) Change from "sell-through" (deferred) method of revenue recognition to "sell-in" (traditional) method of revenue recognition.
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(5) Transaction related expenses for the Civitas acquisition.
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(6) Non-cash charge for NP-1998 impairment due to reprioritization of R&D activities in Q4 2014.
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