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Acorda Therapeutics, Inc. (ACOR)
Q3 2008 Earnings Call
November 4, 2008 8:30 am ET
Tierney Saccavino - Vice President of Corporate Communications
Ron Cohen, M.D. - Founder, Chairman, Chief Executive Officer
David Lawrence, M.B.A. - Chief Financial Officer and Principal Accounting Officer
Andrew R. Blight, Ph.D. - Chief Scientific Officer
Matt Roden - J.P. Morgan
Joel Sendek - Lazard Capital Markets
Lawrence Neibor - Robert W. Baird & Co.
Philip Nadeau - Cowen & Co.
William Ho - Banc of America Securities
Previous Statements by ACOR
» Acorda Therapeutics Inc. Q4 2008 Earnings Call Transcript
» Acorda Therapeutics, Inc. Q2 2008 Earnings Call Transcript
» Acorda Therapeutics Inc. Q1 2008 Earnings Call Transcript
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 delays in obtaining or failure to obtain FDA approval of Fampridine-SR, the risk of unfavorable results from future studies of Fampridine-SR, Acorda Therapeutics' ability to successfully market and sell Fampridine-SR, if approved, and Zanaflex capsules, competition, failure to protect its intellectual property or to defend against the intellectual property claims of others, the ability to obtain additional financing to support Acorda Therapeutics' operations, and unfavorable results from its 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 the goals or plans described in its 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 statement as a result of developments occurring after the date of this presentation.
I will now turn the call over to our CEO, Ron Cohen.
Welcome everyone. This morning, we reported our third quarter ’08 financial results. During the quarter, we made significant progress on the key initiatives that will drive a quarter’s growth, most notably on Fampridine-SR regulatory activities in both US and Europe. I’m going to give you an update on these initiatives, and them I’m going to turn the call over to Dave, who will provide you with the financial summary, and then we’ll open the call for questions.
We were pleased that the data from our second phase III clinical trial, the MS-F204 study were accepted as a late breaker at the World MS Congress in September in Montreal. Among the new analyses that were presented, the poster highlighted that the walking response rate for Fampridine-SR treated patients was higher than placebo across all MS subtypes and the walking response rates were similar between study participants who were being treated with immunomodulators as well and those who were not.
The poster presentation attracted a large audience. We brought more than 300 reprints to the meeting, they were gone within the first hour, and Dr. Andrew Goodman, our principal investigator at the University of Rochester who presented the data had a crowd around him throughout the session.
We also premiered a new exhibit booth at the conference. Its goal was to educate healthcare professionals about the pathophysiology of demyelination in MS and how that contributes to walking disability. I’m pleased to report that our booth was the most crowded and popular stop on the exhibit floor throughout the conference. Over 1600 people registered at the booth to receive additional educational materials and many many hundreds more visited the booth. The booth registrants alone represented about a third of the healthcare professionals at the conference. I invite you all to visit the website that is associated with this effort, www.msmobility.org, and that will give you a better sense of some of our pre-launch awareness building and education activities.
Seperately, data from our MS-F202 phase II trial was published in the October edition of Neurology, and we’re currently working with our scientific advisors to publish the phase III data in peer-reviewed journals.
Moving on to our regulatory update, we’re on track to file the NDA in the US in the first quarter of 2009. Given the current staffing pressures under which the FDA has been forced to operate, we are evaluating whether or not it would also be advantageous to request priority review, which would be requested at the time of NDA filing if we decide that it is advantageous.
With respect to Europe, the potential market for Fampridine-SR in the EU is sizable. There are approximately 630,000 people diagnosed with MS in Europe according to the Atlas of MS, and that is collaboration between the World Health Organization and the Multiple Sclerosis International Federation, and this represents the highest estimated incidence rate of MS of any geographic region.
As we noted in this morning’s press release, Acorda conducted scientific advice meetings with regulatory authorities in 4 key EU member states to discuss the Fampridine-SR clinical program. The discussion topics included the acceptability of the outcome measures used in our phase III clinical studies and the adequacy of the program to support submission of a marketing authorization application or MAA. Based on the feedback we receive, we plan to submit a centralized MAA filing in 2009 to the EMEA, which is the European Medicines Agency, after the NDA is filed in the US.
We’re continuing to evaluate options to maximize the value of the product in Europe. We’ve launched several additional initiatives including formal market research pricing and reimbursement analyses, and also outreach to physicians, advocacy groups, payers, and other stake holders in Europe. We will also be holding discussions with potential marketing and distribution partners to further assess the relative value of partnering in Europe versus other strategies.