ACOR

Acorda Therapeutics, Inc. (ACOR)

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Acorda Therapeutics, Inc. (ACOR)

Q4 2012 Earnings Call

February 13, 2013 08:30 AM ET

Executives

Tierney Saccavino - SVP, Corporate Communications

Ron Cohen - President and CEO

Dave Lawrence - CFO

Analysts

Chris Raymond - Robert Baird

Salim Syed - ISI Group

Joel Sendek - Stifel Nicolaus

David Amsellem - Piper Jaffray

Geoffrey Meacham - JPMorgan

Phil Nadeau - Cowen and Company

Presentation

Operator

Welcome to the Acorda Therapeutics Fourth Quarter and Full Year 2012 Financial Results Conference Call. (Operator Instructions). Please be advised that this call is being taped at the company's request. I would now like to introduce your host for today's call Tierney Saccavino, Senior Vice President of Corporate Communications at Acorda Therapeutics. Please go ahead.

Tierney Saccavino

Good morning everyone and welcome. With me today are Dr. Ron Cohen, our President and Chief Executive Officer; and David Lawrence, our Chief Financial Officer. Before we begin, let me remind you that this presentation includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts regarding management's expectations, beliefs, goals, plans or prospects should be considered forward-looking.

These statements are subject to risks and uncertainties that could cause actual results to differ materially including our ability to successfully market and sell AMPYRA in the U.S.; third-party payers, including governmental agencies may not reimburse for the use of AMPYRA or other products at acceptable rates or at all, and may impose restrictive prior authorization requirements that limit or block prescriptions; the risk of unfavorable results from future studies of AMPYRA or from other research and development programs including diazepam nasal spray or any other acquired or in-license programs; we may not be able to complete development of, obtain regulatory approval for or successfully market diazepam nasal spray or other products under development. The occurrence of adverse safety events with our products; delays in obtaining or failure to obtain regulatory approval or to successfully market FAMPYRA outside the US and our dependence on our collaboration partner, Biogen Idec, in connection therewith; competition, including the impact of generic competition on ZANAFLEX CAPSULES revenues; failure to protect our intellectual property or to defend against the intellectual property claims of others or to obtain third-party intellectual property licenses needed for the commercialization of our products; failure to comply with regulatory requirements could result in adverse action by regulatory agencies; and the ability to obtain additional financing to support our operations. These and other risks are described in greater detail in Acorda Therapeutics filings with the Securities and Exchange Commission. Acorda may not actually achieve the goals or plans described in its forward-looking statements, and investors should not place undue reliance on these statements. Forward-looking statements made in this presentation are made only as of the date hereof, and Acorda disclaims any intent or obligation to update any forward-looking statements made as a result of developments occurring after the date of this presentation.

Now on a housekeeping note for the Q&A, we are going to ask that everybody limit themselves to one question. And I am going to turn the call over to our CEO, Ron Cohen

Ron Cohen

Thanks Jenny, good morning, everyone. On today’s call I'll provide an update of AMPYRA's fourth quarter and our full year performance. I'll also review revenue from ZANAFLEX and our ex-U.S. partnership with Biogen. And then I'll also provide an overview of the upcoming milestones for our product development programs. Dave will then provide the financials for the quarter and review our 2013 guidance and I'll then summarize we will open up call for questions.

To recap AMPYRA's sales performance in 2012, net sales for the fourth quarter were $72.7 million and an approximate 27% increase over Q4 2011. A full year AMPYRA sales were $266.1 million which is approximately 26% over 2011 full year sales. We are very pleased with AMPYRA's performance during the year and as our 2013 guidance indicates, we see additional growth for the brand in 2013.

Turning to our additional sources of revenue, combined full year net revenue from our ZANAFLEX franchise was $23.5 million. Now this included net revenue from ZANAFLEX capsules and tablets of $13.2 million, revenue from Actavis authorized generic capsules of $7.2 million and $3.1 million in sales of generic capsules to Actavis.

In the fourth quarter of '12, net revenue from our ZANAFLEX franchise was $5.2 million which included net revenue from ZANAFLEX capsules and tablets of $1.6 million, revenue from Actavis authorized generic capsules of $2.5 million and $1.1 million in sales generic capsules to Actavis.

We received $7.1 million in FAMPYRA royalties from Biogen for the full year and $1.3 million in the fourth quarter based on net sales outside the US with Germany comprising the majority of overseas sales. As a reminder, Biogen has stated that the expect pricing to be finalized in Germany in Q1 of this year. FAMPYRA is now available for commercial sales in more than 15 countries with additional launches in regulatory filings expected in 2013.

Moving to our product development programs, we believe we have one of the most interesting pipelines in the neurology space. We have five programs including AMPYRA that are in clinical testing or expected to be by mid-2013.

In December 2012, we completed the acquisition of Neuronex Inc.; this added an important pre-NDA stage product, Diazepam nasal spray to our pipeline. This is a treatment for people with epilepsy who experience cluster seizures which are also known as acute repetitive seizures that are not controlled by their anti-epileptic medications. We had a pre-NDA meeting with the FDA last year. Pending additional clinical and CMC data, we plan to submit an NDA later this year and based on our discussions with FDA, we're proceeding with a 505 B2 filing using Diastat as the reference drug. Diastat is a rectally administered form of Diazepam and we believe that the nasal spray formulation offers a more accessible and socially acceptable alternative for both current Diastat users as well as people who have previously not used Diastat because of its mode of delivery. We'll be presenting PK data on Diazepam nasal spray in a poster at the American Academy of Neurology meeting in March. We anticipate that our current infrastructure can support sales and marketing of the product and market planning is underway.

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