Acorda Therapeutics, Inc. (Nasdaq:
) today announced its financial results for the first quarter ended March 31, 2014.
“The AMPYRA franchise remains strong, and we are reiterating our 2014 net sales guidance,” said Ron Cohen, M.D., Acorda Therapeutics’ President and CEO. “During the quarter, a fifth AMPYRA patent was issued and listed in the Orange Book. AMPYRA’s commercial success is supporting the development of an exciting pipeline of novel therapies. As previously announced, we are planning to initiate a Phase 3 trial for dalfampridine in post-stroke walking deficits in the second half of the year. While we were disappointed to receive a Complete Response Letter on PLUMIAZ™, we are working to address the FDA’s requests and refile our NDA. We were pleased to resume enrollment of our second clinical trial of GGF2 in chronic heart failure and to have completed the dose escalation phase of our Phase 1 rHIgM22 trial for remyelination in MS, with no serious or limiting adverse events.”
The Company reported GAAP net income of $0.7 million for the quarter ended March 31, 2014, or $0.02 per diluted share, compared to a GAAP net loss in the same quarter of 2013 of $1.1 million, or $0.03 per diluted share.
Non-GAAP net income for the quarter ended March 31, 2014 was $8.8 million, or $0.21 per diluted share. Non-GAAP net income in the same quarter of 2013 was $1.3 million, or $0.03 per diluted share. Non-GAAP net income excludes share based compensation charges and non-cash tax adjustments. A reconciliation of the GAAP financial results to non-GAAP financial results is included in the attached financial statements.
(dalfampridine) Extended Release Tablets, 10 mg
- For the quarter ended March 31, 2014, the Company reported AMPYRA net revenue of $72.5 million compared to $62.3 million for the same quarter in 2013.
(tizanidine hydrochloride), ZANAFLEX
(tizanidine hydrochloride) tablets and authorized generic capsules
- For the quarter ended March 31, 2014, the Company reported combined net revenue and royalties from ZANAFLEX and tizanidine of $3.1 million compared to $4.4 million for the same quarter in 2013.
(prolonged-release fampridine tablets)
- For the quarter ended March 31, 2014, the Company reported FAMPYRA royalties from sales outside of the U.S. of $2.4 million, compared to $2.9 million for the same quarter in 2013. Royalties in 2013 included a favorable adjustment of $1.0 million from the establishment of pricing in Germany.
Research and development (R&D) expenses
for the quarter ended March 31, 2014 were $14.5 million, including $1.1 million of share-based compensation, compared to $12.5 million including $1.2 million of share-based compensation for the same quarter in 2013.
Sales, general and administrative (SG&A) expenses
for the quarter ended March 31, 2014 were $46.9 million, including $4.7 million of share-based compensation, compared to $48.2 million including $3.8 million of share-based compensation for the same quarter in 2013.
The Company is reiterating its 2014 R&D and SG&A expense guidance, and is evaluating the impact of recent events on both R&D and SG&A expenses for 2014. The Company will provide an update on its next earnings call if there are any changes to guidance.