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 12, 2015
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Acorda Therapeutics, Inc.
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February 12, 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.
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Description
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99.1
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Press Release dated February 12, 2015
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·
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AMPYRA® (dalfampridine) Fourth Quarter Net Revenue of $109.9 Million; Full Year Net Revenue of $366.2 Million
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·
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Full Year AMPYRA 2015 Net Revenue Guidance of $405-$420 Million
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·
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Full Year 2015 Guidance for R&D Expense of $150-$160 Million
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Full Year 2015 Guidance for SG&A Expense of $180-$190 Million
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The Company expects AMPYRA 2015 full year net revenue of $405-$420 million.
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In 2015, the Company expects ZANAFLEX franchise and ex-U.S. FAMPYRA revenue of approximately $25 million, which includes sales of branded ZANAFLEX products and royalties from ex-U.S. FAMPYRA and authorized generic tizanidine hydrochloride capsules sales.
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·
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R&D expenses for the full year 2015 are expected to be $150-$160 million, excluding share-based compensation. The increase in R&D expenses in 2015 is primarily related to Phase 3 studies of dalfampridine and CVT-301. Additional expenses include continued development of PLUMIAZTM (diazepam) Nasal Spray, clinical trials for cimaglermin and rHIgM22, as well as ongoing preclinical studies.
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·
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SG&A expenses for the full year 2015 are expected to be $180-$190 million, excluding share-based compensation.
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More than 65% of new AMPYRA patients currently enroll in First Step, which provides two months of AMPYRA at no cost. The program is in its fourth year, and data show that First Step participants have higher compliance and persistency rates over time compared to non-First Step patients.
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·
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More than 100,000 people with multiple sclerosis in the United States have tried AMPYRA since its launch in 2010.
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The Company received eight Paragraph IV Certification Notice Letters advising that companies have submitted Abbreviated New Drug Applications (ANDA) to the U.S. Food and Drug Administration (FDA) requesting permission to manufacture and market a generic version of AMPYRA. Acorda has filed patent infringement suits against all ANDA filers to date, triggering a 30-month statutory stay period that restricts FDA from approving an ANDA until July 2017 at the earliest, unless a district court issues a decision adverse to all of Acorda’s asserted Orange Book patents prior to that date.
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·
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In February 2015, a hedge fund filed an inter partes review (IPR) petition with the U.S. Patent and Trademark Office, challenging one of the five AMPYRA Orange Book-listed patents. The Company will oppose the request to institute the IPR, and if it is allowed to proceed, the Company will oppose the full proceeding. The 30-month statutory stay period based on patent infringement suits filed by Acorda against ANDA filers is not impacted by this filing, and remains in effect.
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In February 2015, the Company announced safety and tolerability data from the first Phase 1 clinical trial of rHIgM22, a remyelinating antibody for treatment of multiple sclerosis. The trial, which followed participants for up to six months after receiving a single dose of rHIgM22, found no dose-limiting toxicities at any of the five dose levels studied. Based on these data, the Company plans to initiate a second Phase 1 trial of rHIgM22 in 2015.
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In December 2014, the Company initiated a Phase 3 clinical trial studying the use of dalfampridine administered twice-daily (BID) to improve walking in people who have experienced an ischemic stroke.
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The Company initiated a Phase 3 clinical trial studying the use of CVT-301 to treat OFF episodes in Parkinson’s disease in December 2014.
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The Company announced it is deferring further development of NP-1998 for neuropathic pain in 2015.
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The Company is continuing to work with the FDA to define the additional clinical work necessary for the approval of PLUMIAZ.
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In October, the Company completed the acquisition of Civitas Therapeutics, a privately-held biotechnology company, obtaining global rights to CVT-301, CVT-427 and the proprietary ARCUS® pulmonary delivery technology, including a manufacturing facility with commercial-scale capabilities based in Chelsea, MA.
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have ever had a seizure,
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have certain types of kidney problems, or
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are allergic to dalfampridine (4-aminopyridine), the active ingredient in AMPYRA.
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have kidney problems or any other medical conditions;
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are taking compounded 4-aminopyridine;
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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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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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kidney or bladder infections.
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December 31,
2014
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December 31,
2013
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Assets
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Cash, cash equivalents, short-term and long-term investments
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$ | 307,618 | $ | 367,227 | ||||
Trade receivable, net
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32,211 | 30,784 | ||||||
Other current assets
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24,052 | 17,135 | ||||||
Finished goods inventory
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26,837 | 26,172 | ||||||
Deferred tax asset
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18,420 | 127,299 | ||||||
Property and equipment, net
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46,090 | 16,525 | ||||||
Goodwill
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182,952 | - | ||||||
Intangible assets, net
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432,822 | 17,459 | ||||||
Other assets
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9,677 | 4,526 | ||||||
Total assets
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$ | 1,080,679 | $ | 607,127 | ||||
Liabilities and stockholders' equity
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Accounts payable, accrued expenses and other liabilities
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$ | 73,869 | $ | 53,491 | ||||
Deferred product revenue
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29,420 | 32,090 | ||||||
Current portion of deferred license revenue
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9,057 | 9,057 | ||||||
Current portion of revenue interest liability
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893 | 861 | ||||||
Current portion of notes payable
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1,144 | 1,144 | ||||||
Convertible senior notes
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287,699 | - | ||||||
Contingent consideration
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52,600 | - | ||||||
Non-current portion of deferred license revenue
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50,570 | 59,628 | ||||||
Deferred tax liability
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23,885 | - | ||||||
Other long-term liabilities
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11,287 | 10,503 | ||||||
Stockholders' equity
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540,255 | 440,353 | ||||||
Total liabilities and stockholders' equity
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$ | 1,080,679 | $ | 607,127 |
Three Months Ended
December 31,
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Twelve Months Ended
December 31,
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2014
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2013
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2014
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2013
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Revenues:
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Net product revenues
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$ | 110,630 | $ | 86,348 | $ | 373,292 | $ | 310,317 | ||||||||
Royalty revenues
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4,978 | 3,981 | 19,131 | 17,056 | ||||||||||||
License revenue
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2,264 | 2,264 | 9,057 | 9,057 | ||||||||||||
Total revenues
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117,872 | 92,593 | 401,480 | 336,430 | ||||||||||||
Costs and expenses:
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Cost of sales
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24,977 | 18,377 | 79,981 | 66,009 | ||||||||||||
Cost of license revenue
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158 | 158 | 634 | 634 | ||||||||||||
Research and development
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25,921 | 14,302 | 73,470 | 53,877 | ||||||||||||
Selling, general and administrative
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56,456 | 47,007 | 201,813 | 185,545 | ||||||||||||
Asset Impairment
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6,991 | - | 6,991 | - | ||||||||||||
Change in fair value of acquired contingent consideration
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2,200 | - | 2,200 | - | ||||||||||||
Total operating expenses
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116,703 | 79,844 | 365,089 | 306,065 | ||||||||||||
Operating income
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$ | 1,169 | $ | 12,749 | $ | 36,391 | $ | 30,365 | ||||||||
Other expense, net
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(3,862 | ) | (119 | ) | (8,382 | ) | (1,502 | ) | ||||||||
Income (loss) before income taxes
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(2,693 | ) | 12,630 | 28,009 | 28,863 | |||||||||||
Benefit from (provision for) income taxes
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3,024 | (6,437 | ) | (10,337 | ) | (12,422 | ) | |||||||||
Net income
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$ | 331 | $ | 6,193 | $ | 17,672 | $ | 16,441 | ||||||||
Net income per common share - basic
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$ | 0.01 | $ | 0.15 | $ | 0.43 | $ | 0.41 | ||||||||
Net income per common share - diluted
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$ | 0.01 | $ | 0.15 | $ | 0.42 | $ | 0.39 | ||||||||
Weighted average per common share - basic
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41,532 | 40,713 | 41,150 | 40,208 | ||||||||||||
Weighted average per common share - diluted
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43,135 | 42,102 | 42,544 | 41,682 |
Three Months Ended
December 31,
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Twelve Months Ended
December 31,
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2014
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2013
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2014
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2013
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GAAP net income
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$ | 331 | $ | 6,193 | $ | 17,672 | $ | 16,441 | ||||||||
Pro forma adjustments:
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Non-cash interest expense (1)
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2,065 | - | 4,291 | - | ||||||||||||
Non-cash taxes (2)
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(5,551 | ) | 5,549 | 5,981 | 9,792 | |||||||||||
Acquisition related expenses in SG&A (3)
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4,893 | - | 7,248 | - | ||||||||||||
Asset Impairment (4)
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6,991 | - | 6,991 | - | ||||||||||||
Change in fair value of acquired contingent consideration (5)
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2,200 | - | 2,200 | - | ||||||||||||
Product related payments included in R&D (6)
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- | - | - | 1,000 | ||||||||||||
Share-based compensation expenses included in R&D
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1,851 | 1,559 | 5,939 | 5,804 | ||||||||||||
Share-based compensation expenses included in SG&A
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6,943 | 5,577 | 23,498 | 19,334 | ||||||||||||
Total share-based compensation expenses
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8,794 | 7,136 | 29,437 | 25,138 | ||||||||||||
Total pro forma adjustments
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19,392 | 12,685 | 56,148 | 35,930 | ||||||||||||
Non-GAAP net income
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$ | 19,723 | $ | 18,878 | $ | 73,820 | $ | 52,371 | ||||||||
Net income per common share - basic
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$ | 0.47 | $ | 0.46 | $ | 1.79 | $ | 1.30 | ||||||||
Net income per common share - diluted
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$ | 0.46 | $ | 0.45 | $ | 1.74 | $ | 1.26 | ||||||||
Weighted average per common share - basic
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41,532 | 40,713 | 41,150 | 40,208 | ||||||||||||
Weighted average per common share - diluted
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43,135 | 42,102 | 42,544 | 41,682 | ||||||||||||
(1) Non-cash interest expense related to convertible senior notes.
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(2) $2.5 million and $0.9 million paid in cash taxes in the three months ended 2014 and 2013, respectively, and $4.4 million and $2.6 million paid in cash taxes in the twelve months ended 2014 and 2013, respectively. 2013 revised to include non-cash tax adjustments to conform with current year presentation.
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(3) Deal related expenses for Civitas acquisition.
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(4) Non-cash charge for NP-1998 impairment due to reprioritization of R&D activities in Q4 2014.
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(5) Changes in fair value of acquired contingent consideration related to Civitas transaction.
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(6) $1.0M milestone upon the FDA’s acceptance for review of the first NDA for Plumiaz pursuant to the SK license.
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