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Acorda Provides Financial And Pipeline Update For 2015 Third Quarter AMPYRA

The following excerpt is from the company's SEC filing.

(dalfampridine) 3Q 2015 Net Revenue of $117.0 Million; 21% increase over 3Q 2014

Raising Full Year 2015 Guidance for AMPYRA Net Revenue from $410-$420 Million to $420-$430 Million

Company Remains Cash Flow Positive While Funding Late Stage Pipeline

ARDSLEY, N.Y. – October 22, 2015 – Acorda Therapeutics, Inc. (Nasdaq: ACOR) today provided a financial and pipeline update for the third quarter ended September 30, 2015.

“AMPYRA continued to grow robustly in the third quarter, supporting our ongoing investment in an exciting late stage pipeline, while the Company remained cash flow positive. Our top priority is the successful development of our clinical pipeline,” said Ron Cohen, M.D., Acorda Therapeutics’ President and CEO. “We expect several data milestones in 2016 for our most advanced programs, led by CVT-301 for the treatment of off episodes in Parkinson’s disease, PLUMIAZ for seizure clusters in epilepsy and dalfampridine for the treatment of post-stroke walking deficits.”

“We were also encouraged by positive developments in defending our intellectual property around AMPYRA. Our legal team has been recognized nationally for its achievements in the area of patent litigation.”

Financial Results

The Company reported GAAP net income of $3.9 million for the quarter ended September 30, 2015, or $0.09 per diluted share. GAAP net income in the same quarter of 2014 was $12.0 million, or $0.28 per diluted share.

Non-GAAP net income for the quarter ended September 30, 2015 was $13.5 million, or $0.31 per diluted share. Non-GAAP net income in the same quarter of 2014 was $27.6 million, or $0.65 per diluted share. Non-GAAP net income excludes share based compensation charges, non-cash convertible debt, changes in the fair value of acquired contingent consideration, acquisition related expenses, the impact of a change in accounting policy for Zanaflex revenue recognition, and non-cash tax expenses. 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 September 30, 2015, the Company reported AMPYRA net revenue of $117.0 million compared to $96.4 million for the same quarter in 2014.

ZANAFLEX CAPSULES

(tizanidine hydrochloride), ZANAFLEX® (tizanidine hydrochloride) tablets and authorized generic capsules - For the quarter ended September 30, 2015, the Company reported combined net revenue and royalties from ZANAFLEX and tizanidine of $26.0 million compared to $4.5 million for the same quarter in 2014.

Net revenue for Zanaflex for the quarter ended September 30, 2015 includes the impact of a one-time net adjustment of $22.2 million, representing the cumulative impact of the Company’s conversion from the sell-through to the sell-in method of revenue recognition. Under the sell-in method of revenue recognition, revenue is recognized when the product is shipped to the distributor, whereas, under the sell-through method, revenue is recognized when the product is prescribed to the patient. Going forward, Zanaflex revenue will be recognized under the sell-in method of revenue recognition.

FAMPYRA

(prolonged-release fampridine tablets) - For the quarter ended September 30, 2015, the Company reported FAMPYRA royalties from sales outside of the U.S. of $2.5 million compared to $2.5 million for the same quarter in 2014.

Research and development (R&D) expenses for the quarter ended September 30, 2015 were $43.4 million, including $2.3 million of share-based compensation, compared to $16.6 million including $1.4 million of share-based compensation for the same quarter in 2014.

The Company reiterated 2015 R&D guidance of 140-$150 million.

This guidance excludes share-based compensation.

Sales, general and administrative (SG&A) expenses for the quarter ended September 30, 2015 were $51.1 million, including $6.7 million of share-based compensation, compared to $47.8 million including $5.8 million of share-based compensation for the same quarter in 2014.

The Company reiterated 2015 SG&A guidance of $180-$190 million.

Provision for income taxes for the quarter ended September 30, 2015 was $17.8 million, including $0.8 million of cash taxes, compared to $4.5 million, including $0.6 million of cash taxes for the same quarter in 2014.

At September 30, 2015 the Company had cash, cash equivalents and investments of $323.4 million. The Company expects to be cash flow positive in 2015.

Quarterly Highlights

AMPYRA (dalfampridine)

In August, the Company announced that the United States Patent and Trademark Office (USPTO) Patent Trials and Appeal Board (PTAB) denied the institution of the two inter partes review (IPR) petitions against two of its AMPYRA patents. These patents are two of five Orange Book-listed patents that apply to AMPYRA. The filing party has moved for reconsideration of the PTAB’S decision.

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In September, four IPR petitions were filed with the PTAB by the same party, challenging the validity of four of the five AMPYRA Orange Book-listed patents. The Company will oppose these IPR petitions, and if one or more is allowed to proceed, the Company will defend its patents against them.

In October, the Company announced it had entered into two settlement agreements with Actavis Laboratories FL (“Actavis”), Inc. and Sun Pharmaceutical Industries Ltd. and its subsidiary (collectively, “Sun”) to resolve pending patent litigation related to AMPYRA. As a result of the settlement agreements, both Actavis and Sun will be permitted to market a generic version of AMPYRA in the United States at a specified date in...


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