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 July 28, 2016
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Acorda Therapeutics, Inc.
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July 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 July 28, 2016
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·
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AMPYRA® (dalfampridine) 2Q 2016 Net Revenue of $122.1 Million; 16% Increase over 2Q 2015 Net Revenue of $105.5 Million
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·
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Company Reiterates AMPYRA 2016 Net Sales Guidance and Provides Updates on 2016 R&D and SG&A Guidance
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·
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Upcoming Clinical Trial Data on Dalfampridine in Post-Stroke Walking Difficulties (2H 2016) and CVT-301 for OFF Periods in Parkinson's Disease (1Q 2017)
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·
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The Company reiterates AMPYRA 2016 net sales guidance of $475-$485 million.
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·
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R&D guidance is revised from $165-$175 million to $195-$205 million. This guidance is a non-GAAP projection which excludes share-based compensation, as more fully described below under "Non-GAAP Financial Measures." The
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·
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SG&A guidance remains unchanged at $195-$205 million. This guidance is a non-GAAP projection which excludes share-based compensation for the Company and transaction expenses related to the Biotie acquisition, as more fully described below under "Non-GAAP Financial Measures." SG&A guidance reflects the addition of the Biotie operations, offset by reductions in current and projected SG&A expenses.
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·
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The Company expects to be approximately cash flow neutral for the second half of 2016.
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·
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AMPYRA® (dalfampridine)
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-
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AMPYRA revenues for the second quarter of 2016 were $122.1 million, up 16% from the second quarter in 2015. This represents the 13th 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 June, the United States Court of Appeals for the Federal Circuit denied a request by Mylan Pharmaceuticals for a rehearing of the Court's previous decision to uphold a lower court ruling that Acorda's Abbreviated New Drug Application (ANDA) litigation against Mylan can continue in the District Court of Delaware. Mylan has indicated that it intends to file a petition for certiorari to the United States Supreme Court.
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-
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In July, the Company submitted its responses to four Inter Partes Review (IPR) petitions to the United States Patent and Trademark Office (USPTO). A decision on the IPR is expected in March 2017.
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- | A District Court trial for Company's litigation against six generic companies seeking ANDA approvals is scheduled for September 2016.The Company has five Orange Book-listed patents on AMPYRA and will vigorously defend its intellectual property rights. |
·
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Dalfampridine in Post-Stroke Walking Difficulties (PSWD)
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-
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Data from an unblinded analysis of the current twice-daily (BID) clinical trial are expected in the fourth quarter of 2016. Data from the Phase 1 multi-dose pharmacokinetic (PK) testing for once-daily (QD) dalfampridine are also expected in the fourth quarter of 2016.
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-
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If the multi-dose PK and BID analyses are positive, the Company plans to move forward with two concurrent, pivotal Phase 3 trials of dalfampridine in PSWD in mid-2017 using a QD formulation.
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·
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CVT-301 in Parkinson's Disease
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-
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In June, data from the CVT-301 Phase 2b clinical trial were presented in three posters during the 20th International Congress of Parkinson's Disease and Movement Disorders in Berlin, Germany.
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-
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Last patient out (LPO) of the ongoing Phase 3 efficacy study is expected by the end of 2016.
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·
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CVT-427 in Migraine
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-
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Data from a Phase 1 pharmacokinetic (PK) study of CVT-427, an inhaled formulation of zolmitriptan, showed increased bioavailability and faster absorption compared to oral and nasal administration of the same active ingredient. The trial enrolled 21 healthy adults.
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-
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The data showed that median TMAX was about 12 minutes for all CVT-427 doses compared to 1.5 hours for the oral tablet and 3.0 hours for the nasal spray.
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-
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There were no serious adverse events, dose limiting toxicities, or study discontinuations due to adverse events reported after administration. The most commonly reported treatment-emergent AEs were cough, chest discomfort, headache and feeling hot. Apart from cough, single dose CVT-427 tolerability was generally consistent with the known safety profile of zolmitriptan.
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-
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The data were presented at the 58th Annual Scientific Meeting of the American Headache Society in San Diego, CA.
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-
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The Company plans to initiate a special population study in the second half of 2016, and expects to advance this program into Phase 2 in 2017.
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·
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Other Pipeline
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- | In May, development of PLUMIAZTM, an investigational therapy for the treatment of seizure clusters in people with epilepsy, was discontinued after data from the Phase 3 clinical trials did not demonstrate its bioequivalence to Diastat® (diazepam) rectal gel. |
·
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The Company has received more than 97% of Biotie's outstanding shares in the tender offer and expects to complete the purchase of 100% of Biotie's shares in the second half of this year.
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·
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In June, Biotie delisted its American Depositary Shares from the NASDAQ following the filing of an application on Form 25 with the U.S. Securities and Exchange Commission.
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·
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In July, Dr. Burkhard Blank assumed the role of Chief Medical Officer (CMO). Dr. Blank was named interim CMO in January 2016, and previously served as CMO for several biopharmaceutical companies, including Boehringer Ingelheim, Inc.
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June 30,
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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$
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137,400
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$
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353,305
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||||
Trade receivable, net
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45,886
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31,466
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||||||
Other current assets
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24,325
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30,070
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||||||
Finished goods inventory
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55,553
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36,476
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||||||
Deferred tax asset
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13,245
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2,128
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||||||
Property and equipment, net
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36,754
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40,204
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||||||
Goodwill
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284,504
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183,636
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||||||
Intangible assets, net
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751,524
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430,856
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||||||
Other assets
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8,465
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3,153
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||||||
Total assets
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$
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1,357,656
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$
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1,111,294
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||||
Liabilities and stockholders' equity
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||||||||
Accounts payable, accrued expenses and other current liabilities
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$
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125,942
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$
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80,391
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||||
Current portion of deferred license revenue
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9,057
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9,057
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||||||
Current portion of notes payable
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1,126
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1,144
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||||||
Convertible senior notes
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294,854
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290,420
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||||||
Contingent consideration
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71,700
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63,500
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||||||
Non-current portion of deferred license revenue
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36,984
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41,513
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||||||
Deferred tax liability
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101,077
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12,146
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||||||
Other long-term liabilities
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35,374
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10,098
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||||||
Total stockholder's equity - Acorda Therapeutics
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671,638
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603,025
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||||||
Noncontrolling interest
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9,904
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-
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||||||
Total Stockholders' equity
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681,542
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603,025
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||||||
Total liabilities and stockholders' equity
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$
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1,357,656
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$
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1,111,294
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Three Months Ended
June 30,
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Six Months Ended
June 30,
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|||||||||||||||
2016
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2015
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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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$
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120,695
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$
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107,565
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$
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230,842
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$
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201,064
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||||||||
Royalty revenues
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4,499
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3,878
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7,990
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7,966
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||||||||||||
License revenue
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2,264
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2,264
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4,529
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4,529
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||||||||||||
Total revenues
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127,458
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113,707
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243,361
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213,559
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Costs and expenses:
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||||||||||||||||
Cost of sales
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26,435
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22,708
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49,621
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41,155
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||||||||||||
Cost of license revenue
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159
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159
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317
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317
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Research and development
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50,293
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31,229
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94,863
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61,865
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||||||||||||
Selling, general and administrative
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53,056
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52,819
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104,838
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101,589
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Acquisition related expenses
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9,548
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-
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16,746
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-
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||||||||||||
Change in fair value of acquired contingent consideration
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2,000
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1,100
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8,200
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4,200
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||||||||||||
Total operating expenses
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141,491
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108,015
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274,585
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209,126
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Operating (loss) income
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$
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(14,033
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)
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$
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5,692
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$
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(31,224
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)
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$
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4,433
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||||||
Other (expense) income, net
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(5,896
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)
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(3,565
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)
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1,037
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(7,430
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)
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|||||||||
(Loss) income before income taxes
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(19,929
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)
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2,127
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(30,187
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)
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(2,997
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)
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|||||||||
Benefit from (provision for) income taxes
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972
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(1,130
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)
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10,709
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909
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|||||||||||
Net (loss) income
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$
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(18,957
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)
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$
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997
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$
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(19,478
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)
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$
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(2,088
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)
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|||||
Net loss attributable to noncontrolling interest
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678
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-
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678
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-
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||||||||||||
Net (loss) income attributable to Acorda Therapeutics, Inc.
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$
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(18,279
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)
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$
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997
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$
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(18,800
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)
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$
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(2,088
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)
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|||||
Net (loss) income per common share - basic
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$
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(0.40
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)
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$
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0.02
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$
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(0.42
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)
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$
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(0.05
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)
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|||||
Net loss per common share - diluted
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$
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(0.40
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)
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$
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0.02
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$
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(0.42
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)
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$
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(0.05
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)
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|||||
Weighted average per common share - basic
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45,338
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42,085
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45,077
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42,058
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||||||||||||
Weighted average per common share - diluted
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45,338
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43,282
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45,077
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42,058
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Three Months Ended
June 30,
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Six Months Ended
June 30,
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|||||||||||||||
2016
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2015
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2016
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2015
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|||||||||||||
GAAP net (loss) income
|
$
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(18,957
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)
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$
|
997
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$
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(19,478
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)
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$
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(2,088
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)
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|||||
Pro forma adjustments:
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||||||||||||||||
Non-cash interest expense (1)
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2,360
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2,128
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4,564
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4,230
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||||||||||||
Non-cash tax benefit (2)
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(3,393
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)
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550
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(13,287
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)
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(2,232
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)
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|||||||||
Change in fair value of acquired contingent consideration (3)
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2,000
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1,100
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8,200
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4,200
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||||||||||||
Acquisition related expenses (4)
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9,548
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-
|
16,746
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-
|
||||||||||||
Realized foreign currency loss (gain) (5)
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2,551
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-
|
(7,738
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)
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-
|
|||||||||||
Share-based compensation expenses included in R&D
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2,616
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2,159
|
4,737
|
3,982
|
||||||||||||
Share-based compensation expenses included in SG&A
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6,656
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6,549
|
12,694
|
11,853
|
||||||||||||
Total share-based compensation expenses
|
9,272
|
8,708
|
17,431
|
15,835
|
||||||||||||
Total pro forma adjustments
|
22,338
|
12,486
|
25,916
|
22,033
|
||||||||||||
Non-GAAP net income
|
$
|
3,381
|
$
|
13,483
|
$
|
6,438
|
$
|
19,945
|
||||||||
Net income per common share - basic
|
$
|
0.07
|
$
|
0.32
|
$
|
0.14
|
$
|
0.47
|
||||||||
Net income per common share - diluted
|
$
|
0.07
|
$
|
0.31
|
$
|
0.14
|
$
|
0.46
|
||||||||
Weighted average per common share - basic
|
45,338
|
42,085
|
45,077
|
42,058
|
||||||||||||
Weighted average per common share - diluted
|
46,028
|
43,282
|
46,036
|
43,434
|
||||||||||||
(1) Non-cash interest expense related to convertible senior notes, asset based loan, and Biotie debt.
|
||||||||||||||||
(2) $2.4 million and $0.6 million paid in cash taxes in the three months ended 2016 and 2015, respectively; $2.6 million and $1.3 million paid in cash taxes in the six months ended 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) Realized foreign currency loss (gain) related to the Biotie transaction included in Other (expense) income, net in the Consolidated Statements of Operations.
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