ACOR

Acorda Therapeutics, Inc. (ACOR)

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Acorda Therapeutics, Inc. (ACOR)

Q1 2010 Earnings Call Transcript

April 30, 2010 8:30 am ET

Executives

Tierney Saccavino – SVP, Corporate Communications

Ron Cohen – President and CEO

David Lawrence – CFO

Analysts

Joel Sendek – Lazard Capital Markets

Michael Yee – RBC Capital Markets

Phil Nadeau – Cowen and Company

Geoff Meacham – J.P. Morgan

Navdeep Singh – Citigroup

David Amsellem – Piper Jaffray

Josh Schimmer – Leerink Swann

Mike King – Wedbush Securities

Presentation

Operator

Welcome to the Acorda Therapeutics first quarter 2010 financial results conference call. At this time, all participants are in a listen-only mode. There will be a question-and-answer session to follow. Please be advised that this call is being taped at the company's request. Now, I would 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 Acorda Therapeutics' ability to successfully market and sell Ampyra in the United States and to successfully sell Zanaflex capsules, the risk of unfavorable results, computer studies of Ampyra, the occurrence of adverse safety events with our product, delays in obtaining or failure to obtain regulatory approval of Ampyra, outside the United States and our dependence on our collaboration partner Biogen Idec in connection there with competition, failure to protect Accorda Therapeutic intellectual property or to defend against the intellectual property claims of others, the ability to obtain additional financing in support of Acorda Therapeutics' operations and unfavorable results from our preclinical programs.

These and other risks are described in greater detail in Acorda Therapeutics' filings with the Securities and Exchange Commission. Acorda Therapeutics may not actually achieve these goals or plans described in the forward looking statements and investors should not place undue reliance on these statements. Acorda Therapeutics disclaims any intent or obligation to update any forward looking statements as a result of developments occurring after the date of this presentation. I will now turn the call over to our CEO, Ron Cohen.

Ron Cohen

Thanks, Tierney. Good morning, everyone. This morning we reported our first quarter 2010 financial results and today I will provide a brief review of the key milestones since our last quarterly report and then I will turn the call over to Dave, who will provide a financial summary and we will then open the call for your questions.

On January 22 of this year, Ampyra was approved by the FDA for the improvement of walking in patients with MS. This was demonstrated by an improvement in walking speed. In February, we announced pricing for Ampyra at $1,056 per month and the drug was launched on March 1.

We have been very pleased with the response of Ampyra's commercial event, with response to Ampyra's commercial availability with more than 2,000 physicians having written at least one prescription and a number of positive anecdotal reports coming in from the field.

Now, that said, it is still very early in the launch and there are a number of variables that will determine the sales trajectory over time. At this point, we don't have data on the filled prescriptions, we can't project if physicians will be repeat prescribers and we don't know how many patients will continue on therapy or for how long.

As we have a more complete picture, we’ll provide that to you. The pent-up demand for Ampyra has resulted in some delays processing prescription requests at our centralized hub, Ampyra patient support services with some patients waiting for up to 30 days for their initial prescription to be delivered.

In response, we have added resources at AMPYRA patient support services. The wait time has already been reduced and we expect it will continue to be reduced over time. Two points to note. First, we expect most patients who have received an initial prescription will not encounter similar waiting periods for their refills and second, this situation is not related to a shortage of drug. We believe we have adequate supply to meet commercial demand.

We are continuing to meet with both public and private managed care groups and have had more than 110 meetings to date with targeted accounts, including more than 60 since the approval of Ampyra. We are encouraged that clients are interested in meeting with us to discuss Ampyra. But at this point, we can't speculate as to what level of managed care coverage will ultimately have or with whom and similarly, we can't project what our payor mix will be including government and commercial plans since we only have very preliminary data at this point.

Turning to our Zanaflex franchise, total shipments in the first quarter were $13.4 million. Gross sales in the first quarter were $13.8 million. As per our previous guidance, we expect sales of Zanaflex capsules will continue to decline in 2010 due to managed care pressures among other factors. The 30-month stay on Apotex's paragraph 4 filing expired in March. Schedule for the remainder of the case has not yet been set.

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