On May 2, 2018 Acorda Therapeutics, Inc. (Nasdaq: ACOR)reported update for the quarter ended March 31, 2018 (Press release, Acorda Therapeutics, MAY 2, 2018, View Source [SID1234525937]).
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"With FDA’s acceptance of Acorda’s NDA for INBRIJA and a PDUFA date of October 5, 2018, we are focused on preparations for the potential U.S. approval and launch," said Ron Cohen, M.D., Acorda’s President and CEO. "We are also looking forward to the opportunity to argue our case for our AMPYRA patents at the U.S. Court of Appeals on June 7."
First Quarter 2018 Financial Results
AMPYRA (dalfampridine) Extended Release Tablets, 10 mg – For the quarter ended March 31, 2018, the Company reported AMPYRA net revenue of $102.8 million compared to $112.0 million for the same quarter in 2017. The quarter over quarter reduction in net revenue was primarily related to a modest expansion in customer inventories in the fourth quarter 2017 which normalized by the end of the first quarter 2018.
Research and development (R&D) expenses for the quarter ended March 31, 2018 were $30.6 million, including $1.7 million of share-based compensation compared to $46.5 million, including $2.5 million of share-based compensation for the same quarter in 2017. Quarter-over-quarter reductions in R&D expenses are primarily the result of our corporate restructuring which occurred in 2017.
Sales, general and administrative (SG&A) expenses for the quarter ended March 31, 2018 were $47.6 million, including $4.2 million of share-based compensation compared to $52.0 million, including $5.3 million of share-based compensation for the same quarter in 2017. Quarter-over-quarter reductions in SG&A expenses are primarily the result of our corporate restructuring which occurred in 2017.
Provision for income taxes for the quarter ended March 31, 2018 was $3.5 million, including $0.5 million of cash taxes, compared to a benefit from income taxes of $0.9 million, including $1.9 million of cash taxes for the same quarter in 2017.
The Company reported a GAAP net loss of $8.2 million for the quarter ended March 31, 2018, or $0.18 per diluted share. GAAP net loss in the same quarter of 2017 was $18.9 million, or $0.41 per diluted share.
Non-GAAP net income for the quarter ended March 31, 2018 was $6.8 million, or $0.14 per diluted share. Non-GAAP net loss in the same quarter of 2017 was $3.6 million, or $0.08 per diluted share. This quarterly non-GAAP net income (loss) measure, more fully described below under "Non-GAAP Financial Measures," excludes share-based compensation charges, non-cash interest charges on our debt, 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 March 31, 2018, the Company had cash, cash equivalents and short-term investments of $333.0 million.
Guidance for 2018
The Company reiterates AMPYRA 2018 net revenue guidance of $330-$350 million. The Company expects to maintain exclusivity of AMPYRA at least through July 30, 2018; this guidance is subject to change based on the appellate court’s decision.
R&D expenses for the full year 2018 are expected to be $100-$110 million and include manufacturing expenses associated with INBRIJA. This guidance is a non-GAAP projection that excludes share-based compensation, as more fully described below under "Non-GAAP Financial Measures."
SG&A expenses for the full year 2018 are expected to be $170-$180 million. This guidance is a non-GAAP projection that excludes share-based compensation, as more fully described below under "Non-GAAP Financial Measures."
The Company expects to end 2018 with a projected year-end cash balance in excess of $300 million.
First Quarter 2018 Pipeline and Corporate Updates
INBRIJA (levodopa inhalation powder)
In February, the FDA notified the Company that it had accepted for filing the New Drug Application (NDA) for INBRIJA. Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target date of October 5, 2018 for issuing its decision on the NDA.
In March, the Company submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for INBRIJA. Acorda is seeking approval to market INBRIJA in the European Union.
In April, the Company presented new INBRIJA data from four accepted abstracts during two oral platform presentations at the American Academy of Neurology Annual Meeting in Los Angeles. A safety assessment in early morning OFF symptoms in patients with Parkinson’s disease (Study 009) was presented by Dr. Stuart H. Isaacson and Dr. Robert H. Hauser; long-term pulmonary safety and efficacy of inhaled levodopa in Parkinson’s disease (Study 005) was presented by Charles Oh, MD, VP Clinical Development at Acorda.
AMPYRA Patent Appeal
Oral argument before the U.S. Court of Appeals for the Federal Circuit has been scheduled for June 7, 2018.
rHIgM22 Update
Data from the rHIgM22 Phase 1 study in 27 people with acute relapsing multiple sclerosis showed that a single dose of rHIgM22 was not associated with any safety signals. The study’s primary endpoint was safety and tolerability of a single dose following a relapse.
The study was not powered to show efficacy and exploratory efficacy measures showed no difference between the treatment groups.
Webcast and Conference Call
The Company will host a conference call today at 8:30 a.m. ET. To participate in the conference call, please dial (833) 236-2756 (domestic) or (647) 689-4181 (international) and reference the access code 2477088. The presentation will be available on the Investors section of www.acorda.com.
A replay of the call will be available from 11:30 a.m. ET on May 2, 2018 until 11:59 p.m. ET on June 2, 2018. To access the replay, please dial (800) 585-8367 (domestic) or (416) 621-4642 (international); reference code 2477088.
Non-GAAP Financial Measures
This press release includes financial results prepared in accordance with accounting principles generally accepted in the United States (GAAP), and also certain historical and forward-looking non-GAAP financial measures. In particular, Acorda has provided non-GAAP net income, adjusted to exclude the items below, and has provided 2018 guidance for R&D and SG&A expenses on a non-GAAP basis. Non-GAAP financial measures are not an alternative for financial measures prepared in accordance with GAAP. However, the Company believes the presentation of non-GAAP net income, when viewed in conjunction with our GAAP results, provides investors with a more meaningful understanding of our ongoing and projected operating performance because this measure excludes (i) non-cash compensation charges and benefits that are substantially dependent on changes in the market price of our common stock, (ii) non-cash interest charges related to the accounting for our outstanding convertible debt which are in excess of the actual interest expense owing on such convertible debt as well as non-cash interest related to the Fampyra monetization, non-cash interest charges related to our asset based loan which was terminated in 2017 and acquired Biotie debt, (iii) changes in the fair value of acquired contingent consideration which do not correlate to our actual cash payment obligations in the relevant periods, and (iv) acquisition related expenses and related foreign currency losses and gains that pertain to a non-recurring event. The Company believes its non-GAAP net income measure helps indicate underlying trends in the Company’s business and is important in comparing current results with prior period results and understanding projected operating performance. Also, management uses this non-GAAP financial measure to establish budgets and operational goals, and to manage the Company’s business and to evaluate its performance.
In addition to non-GAAP net income, we have provided 2018 guidance for R&D and SG&A expenses on a non-GAAP basis. Due to the forward looking nature of this information, the amount of compensation charges and benefits needed to reconcile these measures to the most directly comparable GAAP financial measures is dependent on future changes in the market price of our common stock and is not available at this time. The Company believes that these non-GAAP measures, when viewed in conjunction with our GAAP results, provide investors with a more meaningful understanding of our ongoing and projected R&D and SG&A expenses. Also, management uses these non-GAAP financial measures to establish budgets and operational goals, and to manage the Company’s business and to evaluate its performance.