Acorda Therapeutics Inc. (ACOR)
Q1 2008 Earnings Call
May 5, 2008 8:00 am ET
Tierney Saccavino - VP, Corporate Communications
Ron Cohen - President, CEO
Dave Lawrence - CFO
Joel Sendek - Lazard Capital Markets
Matt Roden - JPMorgan
David Amsellem - Friedman, Billings, Ramsey
Ram Selvaraju - Rodman & Renshaw
Philip Nadeau - Cowen and Company
Caroline Stewart - Piper Jaffray
Previous Statements by ACOR
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Now I'd like to introduce your host for today’s call, Tierney Saccavino, Vice President, Corporate Communications at Acorda Therapeutics. Please go ahead.
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. These statements are subject to risks and uncertainties that could cause actual results to differ materially, including the risk of unfavorable results for future studies of Fampridine-SR, delays in obtaining or failure to obtain FDA approval of Fampridine-SR, Acorda Therapeutics' ability to successfully market and sell 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 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.
Thanks, Tierney. Good morning everyone. This morning we reported first quarter 2008 financial results. During the quarter we made solid progress on the key initiatives that will drive the quarter’s growth. The agenda for the call is presented on this slide. I will provide an update on these initiatives, and then I’ll turn the call over to Dave who’ll provide you with the financial summary. We’ll then open the call for your questions.
In January, we were pleased to announce the successful results of our Thorough QT Study. This is a human cardiac study required for all new chemical entities seeking approval from the FDA. Fampridine-SR, at both the therapeutic and super therapeutic doses was found to be no different from placebo. We are now awaiting data from our second Phase III trial of Fampridine-SR in MS, which we expect to be available in the second half of the current quarter, Q2 2008.
As we previously announced, we expect by the end of this year to determine the quarters strategy regarding Fampridine-SR’s commercial development in Europe. As part of this process, we have submitted materials requesting meetings with key EU member states to help inform how we will proceed in Europe.
In the first quarter, we also acquired assets from Neurorecovery, Inc. This acquisition will enable us to explore additional therapeutic indications for Fampridine-SR in peripheral neuropathies, as well as provide access to pre-clinical compounds that may have utility in nervous system disorders. We also made good progress in preparing the modules that will be needed for our NDA filing, which we are targeting for the first quarter of 2009, pending the data from our second Phase III study.
With respect to our pre-launch programs, one of our key pre-launch goals is to substantially raise awareness of and appreciation for the impact that walking disability has on the lives of people with MS, among both healthcare providers and consumers.
In March, we published a Harris poll on mobility issues at MS. This was in collaboration with National MS Society. This poll highlighted the significant impact that mobility issues have on quality of life, safety and financial and emotional health among many people living with MS. A key finding in the poll was that 64% of the responders reported trouble walking, inability to walk or loosing balance at least twice a weak.
This year Acorda is a national sponsor of the National MS Society's 'Walk MS Program'. The program we've developed for these walks is called 'I Walk Because'. This program gives a voice to the MS community, allowing to them articulate why and for whom they participate in these walks.
As part of our sponsorship, Acorda has a boot presence at 10 of the largest walks around the country and we allow walkers to record videos, which were then posted on the website www.iwalkbecause.org. I was part of the team that staffed the boot at our opening walk at Dallas and I found it to be one of the most moving experiences I have had at Acorda.
I encourage you to take a look at the testimonials recorded on the website, I believe you will find that it provides a deeply personal sense of the impact that MS has on people's lives, and of the commitment of the MS community to developing new therapies for this dreadful disease.
We also unveiled our MS walking awareness program for healthcare providers, at the American Academy of Neurology's annual meeting this year. This program allows MS professionals to experience a simulation of how walking disability affects real world situations, such as crossing a busy street of a traffic light. These efforts will continue at major medical meetings throughout the year.