- NDA submitted for INBRIJA™ (levodopa inhalation powder)
- Tozadenant Phase 3 data expected Q1 2018
- AMPYRA® (dalfampridine) 2Q 2017 net revenue of $131.6 Million; 8% increase over 2Q 2016
- AMPYRA 2017 net sales guidance of $535 - $545 million reiterated
- Projected year-end cash balance greater than $200 million
ARDSLEY, N.Y.--(BUSINESS WIRE)--Acorda Therapeutics, Inc. (Nasdaq:ACOR) provided a financial and pipeline update for the second quarter ended June 30, 2017.
“INBRIJA and tozadenant are being developed as therapies with complementary roles for people with Parkinson’s. They have the potential to position Acorda as a leader in Parkinson’s therapy, creating substantial value for shareholders,” said Ron Cohen, M.D., Acorda's President and CEO.
“We submitted our NDA for INBRIJA on schedule. This key milestone was achieved thanks to intensive work by many dedicated Acorda associates. We expect the FDA to notify us by the end of September if the submission is accepted for full review. Commercial preparations for the launch of INBRIJA are well underway and we expect to submit a Marketing Authorization Application to the European Medicines Agency by the end of 2017. We are also on track to announce top-line data from our Phase 3 study of tozadenant in the first quarter of 2018.”
Second Quarter 2017 Financial Results
AMPYRA® (dalfampridine) Extended Release Tablets, 10 mg - For the quarter ended June 30, 2017, the Company reported AMPYRA net revenue of $131.6 million compared to $122.1 million for the same quarter in 2016.
FAMPYRA® (prolonged-release fampridine tablets) - For the quarter ended June 30, 2017, the Company reported FAMPYRA royalties from sales outside of the U.S. of $2.9 million compared to $2.7 million for the same quarter in 2016.
Research and development (R&D) expenses for the quarter ended June 30, 2017 were $51.2 million, including $3.0 million of share-based compensation and $5.6 million of restructuring expenses, compared to $50.3 million, including $2.6 million of share-based compensation for the same quarter in 2016.
Sales, general and administrative (SG&A) expenses for the quarter ended June 30, 2017 were $49.3 million, including $7.8 million of share-based compensation and $2.0 million of restructuring expenses, compared to $53.1 million, including $6.7 million of share-based compensation for the same quarter in 2016.
Provision for income taxes for the quarter ended June 30, 2017 was $5.5 million, including $5.8 million of cash taxes, compared to a benefit from income taxes of $1.0 million, including $2.4 million of cash taxes, for the same quarter in 2016.
The Company reported a GAAP net loss attributable to Acorda of $8.2 million for the quarter ended June 30, 2017, or $0.18 per diluted share. GAAP net loss in the same quarter of 2016 was $18.3 million, or $0.40 per diluted share.
Non-GAAP net income for the quarter ended June 30, 2017 was $13.3 million, or $0.29 per diluted share. Non-GAAP net loss in the same quarter of 2016 was $9.7 million, or $0.21 per diluted share. This quarterly non-GAAP net income measure, more fully described below under “Non-GAAP Financial Measures,” excludes share-based compensation charges, unrealized foreign currency losses (gains), non-cash interest charges on our debt, restructuring expenses, changes in the fair value of acquired contingent consideration, and acquisition-related expenses. A reconciliation of the GAAP financial results to non-GAAP financial results is included with the attached financial statements.
At June 30, 2017, the Company had cash and cash equivalents of $141.1 million.
Guidance for 2017
- The Company reiterates AMPYRA 2017 net revenue of $535-$545 million.
- R&D expenses for the full year 2017 are expected to be $160-$170 million. This guidance is a non-GAAP projection that excludes share-based compensation and restructuring costs, as more fully described below under “Non-GAAP Financial Measures.”
- SG&A expenses for the full year 2017 are expected to be $170-$180 million. This guidance is a non-GAAP projection that excludes share-based compensation and restructuring costs, as more fully described below under “Non-GAAP Financial Measures.”
- The Company expects to be cash flow positive in 2017, with a projected year-end cash balance in excess of $200 million.
Second Quarter 2017 Highlights
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INBRIJA (levodopa inhalation powder) in Parkinson’s disease
- In June, the Company submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for INBRIJA. The NDA was submitted as a 505(b)(2) application.
- In June, data from the Phase 3 SPAN-PD clinical trial of INBRIJA was presented at the International Congress of Parkinson’s Disease and Movement Disorders (MDS).
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Tozadenant in Parkinson’s disease
- In June, data from clinical and preclinical studies of tozadenant were presented at the 2017 International Congress of Parkinson’s Disease and Movement Disorders (MDS). One of the three posters presented, “Efficacy of tozadenant in animal models of non-motor symptoms of Parkinson's disease,” was selected by MDS for the Blue Ribbon Session, which highlights the best scientific posters at the conference.
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AMPYRA (dalfampridine)
- In May, the Company filed a notice of appeal to the United States District Court for the District of Delaware, initiating the appeal process pertaining to the AMPYRA patents that were invalidated by the Court in March 2017. Acorda’s opening brief is due on August 7, 2017.
- The Company expects to maintain exclusivity of AMPYRA at least through July 2018.
Webcast and Conference Call
The Company will host a conference call today at 8:30 a.m. ET to review its second quarter 2017 results.
