News Column

Acorda Therapeutics Reports 4Q and Full Year 2013 Financial Results

February 18, 2014

Acorda Therapeutics, Inc. announced its financial results for the fourth quarter and full year ended Dec. 31, 2013.

"We finished 2013 in a strong financial position with growing revenues and close to $370 million in cash. This puts the Company in an enviable position to deliver value to shareholders by advancing our pipeline and acquiring additional assets," said Ron Cohen, Acorda Therapeutics' President and CEO, in a release dated Feb. 13.

"We now have six clinical stage programs in our pipeline. Acorda is preparing for the potential approval and launch this year of Plumiaz, the proposed brand name for Diazepam Nasal Spray. We believe Plumiaz addresses a critical need for people with cluster seizures. In addition, we plan to begin a Phase 3 clinical trial of a new, once-daily formulation of dalfampridine in post-stroke walking deficits, and move forward with development of NP-1998, a Phase 3-ready therapy that represents a potential paradigm shift in the treatment of neuropathic pain."

Financial Results

The Company reported GAAP net income of $6.2 million for the quarter ended Dec. 31, 2013, or $0.15 per diluted share, including share-based compensation charges totaling $7.1 million. For the full year 2013, the Company reported GAAP net income of $16.4 million, or $0.39 per diluted share, including share-based compensation charges totaling $25.1 million. GAAP net income in the same quarter of 2012 was $133.0 million, or $3.27 per diluted share, including share- based compensation charges totaling $6.1 million and a $132.7 million non-recurring tax benefit. GAAP net income for the full year 2012 was $155.0 million, or $3.84 per diluted share, including share- based compensation charges totaling $21.4 million and a $132.7 million non-recurring tax benefit.

Non-GAAP net income for the quarter ended Dec. 31, 2013 was $13.3 million, or $0.32 per diluted share and $42.6 million, or $1.02 per diluted share for the full year 2013. Non-GAAP net income in the same quarter of 2012 was $9.8 million, or $0.24 per diluted share and $50.3 million, or $1.25 per diluted share for the full year 2012.

Ampyra (dalfampridine) Extended Release Tablets, 10 mg net revenue - For the quarter ended Dec. 31, 2013, the Company reported Ampyra net revenue of $84.6 million, compared to $72.7 million in net revenue for the same quarter in 2012. For the year ended Dec. 31, 2013, the Company reported Ampyra net revenue of $302.6 million, compared to $266.1 million in net revenue in 2012.

Zanaflex capsules(tizanidine hydrochloride), Zanaflex (tizanidine hydrochloride) tablets and authorized generic capsules net revenue and royalties - For the quarter ended Dec. 31, 2013, the Company reported that combined net revenue from Zanaflex capsules and Zanaflex tablets sales was $0.8 million, revenue from the sale of authorized generic tizanidine hydrochloride capsules to Actavis, Inc. was $0.6 million and royalties from Actavis for the sale of authorized generic tizanidine hydrochloride capsules were $1.8 million, for combined total net revenue of $3.2 million. Combined net revenue from Zanaflex capsules and Zanaflex tablets sales and royalties from Actavis were $5.2 million for the same quarter in 2012.

For the full year 2013, the Company reported that combined net revenue from Zanaflex capsules and Zanaflex tablets sales was $4.1 million, revenue from the sale of authorized generic tizanidine hydrochloride capsules to Actavis, Inc. was $3.2 million and royalties from Actavis for the sale of authorized generic tizanidine hydrochloride capsules were $7.8 million, for combined total net revenue of $15.1 million. Combined net revenue from Zanaflex capsules and Zanaflex tablets sales and royalties from Actavis were $23.5 million for the full year 2012.

FAmpyra (prolonged-release fampridine tablets) royalties - For the quarter ended Dec. 31, 2013, the Company reported FAmpyra royalties from sales outside of the U.S. of $2.2 million, compared to $1.3 million for the same quarter in 2012. For the full year 2013, the Company reported FAmpyra royalties from sales outside of the U.S. of $9.3 million, compared to $7.1 million in 2012.

Cost of sales for the quarter ended Dec. 31, 2013 were $18.4 million, compared to $16.2 million for the same quarter in 2012. Included in cost of sales for the quarter ended Dec. 31, 2013 was $0.6 million in cost of authorized generic tizanidine hydrochloride capsules sold to Actavis. Cost of sales for the full year 2013 were $66.0 million, compared to $57.0 million for the full year 2012.

Research and development expenses for the quarter ended Dec. 31, 2013 were $14.3 million, including $1.6 million of share-based compensation, compared to $18.2 million including $1.4 million of share-based compensation for the same quarter in 2012. R&D expenses for the full year 2013 were $53.9 million, including $5.8 million of share-based compensation, compared to $53.9 million including $5.1 million of share-based compensation for the full year 2012. R&D expenses for the full year 2013 included the development of the Company's pipeline products, including expenses for dalfampridine- QD, Glial Growth Factor 2, rHIgM22, AC105 and Plumiaz (Diazepam Nasal Spray).

Sales, general and administrative expenses for the quarter ended Dec. 31, 2013 were $47.0 million, including $5.6 million of share- based compensation, compared to $45.6 million including $4.6 million of share-based compensation for the same quarter in 2012. SG&A expenses for the full year 2013 were $185.5 million, including $19.3 million of share-based compensation, compared to $168.7 million including $16.3 million of share-based compensation for the full year 2012. The increase was primarily due to increases in expenses related to support for Ampyra and the dalfampridine franchise, preparations for the possible commercialization of Plumiaz (Diazepam Nasal Spray), and the development of our pipeline products.

At Dec. 31, 2013 the Company had cash, cash equivalents and short- term and long-term investments of $367.2 million.

Guidance for 2014

The following guidance does not include potential expenditures related to the acquisition of new products or other business development activities.

-The Company expects Ampyra 2014 full year net revenue of $328- $335 million.

-In 2014, the Company expects Zanaflex franchise and ex-U.S. FAmpyra revenue of approximately $25 million, which includes sales of branded Zanaflex products, royalties from ex-U.S. FAmpyra and authorized generic tizanidine hydrochloride capsules sales, and $9.1 million in amortized licensing revenue from the $110 million payment the Company received from Biogen Idec in 2009 for FAmpyra ex-U.S. development and commercialization rights.

-R&D expenses for the full year 2014 are expected to be $60-$70 million, excluding share-based compensation. R&D expenses in 2014 related to dalfampridine include a Phase 3 study in post-stroke deficits and sponsorship of investigator-initiated studies. Additional expenses include continued development of Plumiaz (Diazepam Nasal Spray) and NP-1998, clinical trials for GGF2, rHIgM22 and AC105, as well as ongoing preclinical studies.

-SG&A expenses for the full year 2014 are expected to be $180- $190 million, excluding share-based compensation. SG&A will be primarily driven by commercial and administrative costs related to Ampyra and Plumiaz (Diazepam Nasal Spray).

Ampyra Update

-Between launch in March 2010 and the end of 2013, approximately 90,000 people with multiple sclerosis in the U.S. have tried Ampyra.

-In 2013, two new U.S. Ampyra patents issued and Acorda now has four Orange Book patents providing protection up to 2027.

-The Company successfully defended a European patent for FAmpyra against an opposition.

Pipeline Update

-A New Drug Application was filed for Diazepam Nasal Spray in 2013 with the U.S. Food and Drug Administration, with potential approval and launch in 2014. The proposed trade name for this product is Plumiaz.

-In April 2013, the Company announced positive Phase 2 data for dalfampridine extended release tablets in treating post-stroke deficits. Data showed improved walking in people with post-stroke deficits. The Company met with the FDA in December 2013 and will proceed with a Phase 3 study of a once-daily formulation of dalfampridine extended release capsules pending FDA agreement on final study protocol. The study is expected to begin in the second quarter of 2014.

-Post-hoc analyses of the dalfampridine Phase 2 proof-of-concept study in post-stroke deficits will be included in a platform presentation at the 2014 International Stroke Conference. Findings from this trial were previously presented at the American Neurological Association annual meeting in October 2013.

-In April 2013, Acorda initiated a Phase 1b study of rHIgM22, a remyelinating antibody for the treatment of MS. The study is evaluating safety and tolerability in people with MS, and also includes several exploratory efficacy measures.

-In September 2013, Acorda initiated a Phase 2 trial evaluating the safety and tolerability of AC105 in people with traumatic spinal cord injury. This study also includes several exploratory efficacy measures.

-In October 2013, Acorda initiated the second clinical trial of GGF2 for the treatment of heart failure. This Phase 1b single- intravenous infusion trial will assess tolerability of three dose levels of GGF2, and also includes several exploratory efficacy measures. Trial enrollment has been paused pending review of additional preclinical data.

Corporate Update

-The Company acquired rights in the United States, Canada, Latin America and certain other markets for two neuropathic pain management assets from NeurogesX, Inc., Qutenza (capsaicin) 8 percent patch and NP-1998.

-In 2013, Acorda was ranked the second best large company to work for in the State of New York. This recognition is based on an annual survey conducted by Best Companies Group. This marks the third year in a row that Acorda was ranked in the top ten.

-Michael Rogers joined the Company as Chief Financial Officer. He is responsible for the Finance and Investor Relations departments.

-David Lawrence, who previously served as CFO, was appointed Chief of Business Operations. He is responsible for Technical Operations/Manufacturing, Project Management, Information Technology and Facilities Management.

Do not take Ampyra if you have ever had a seizure, or have certain types of kidney problems, or are allergic to dalfampridine (4-aminopyridine), the active ingredient in Ampyra.

Take Ampyra exactly as prescribed by your doctor.

You could have a seizure even if you never had a seizure before. Your chance of having a seizure is higher if you take too much Ampyra or if your kidneys have a mild decrease of function, which is common after age 50.

Your doctor may do a blood test to check how well your kidneys are working, if that is not known before you start taking Ampyra.

Ampyra may cause serious allergic reactions. Stop taking Ampyra and call your doctor right away or get emergency medical help if you have shortness of breath or trouble breathing, swelling of your throat or tongue, or hives.

Ampyra should not be taken with other forms of 4-aminopyridine (4- AP, fampridine), since the active ingredient is the same.

The most common adverse events for Ampyra in MS patients were urinary tract infection, trouble sleeping, dizziness, headache, nausea, weakness, back pain, and problems with balance.

Before taking Ampyra tell your doctor if you are pregnant or plan to become pregnant. It is not known if Ampyra will harm your unborn baby.

Tell your doctor if you are breast-feeding or plan to breast- feed. It is not known if Ampyra passes into your breast milk. You and your doctor should decide if you will take Ampyra or breast- feed. You should not do both.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit fda.gov/medwatch, or call 1- 800-FDA-1088.

Ampyra is a potassium channel blocker approved as a treatment to improve walking in patients with multiple sclerosis. This was demonstrated by an increase in walking speed. Ampyra, which was previously referred to as Fampridine-SR, is an extended release tablet formulation of dalfampridine (4-aminopyridine, 4-AP), and is known as prolonged-, modified, or sustained-release fampridine in some countries outside the United States.

In laboratory studies, dalfampridine extended release tablets has been found to improve impulse conduction in nerve fibers in which the insulating layer, called myelin, has been damaged. Ampyra is being developed and commercialized in the U.S. by Acorda Therapeutics; FAmpyra is being developed and commercialized by Biogen Idec in markets outside the U.S. based on a licensing agreement with Acorda. Ampyra and FAMPRYA are manufactured globally by Alkermes Pharma Ireland Limited, a subsidiary of Alkermes plc, based on a supply agreement with Acorda.

Ampyra is available by prescription in the United States. For more information about Ampyra, including patient assistance and co- pay programs, healthcare professionals and people with MS can contact Ampyra Patient Support Services at 888-881-1918. Ampyra Patient Support Services is available Monday through Friday, from 8 a.m. to 8 p.m. Eastern Time.

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