Acorda Therapeutics at Biotechnology Industry Organization BIO CEO & Investor Conference - Final.(Broadcast transcript)

UNIDENTIFIED SPEAKER: Good morning, I am [Tom Deedlick] I'm the [file]. I will be moderating this morning's presentation. Our first presenting company is Acorda Therapeutics. Presenting for Acorda Therapeutics is Dr. Ron Cohen, their Chief Executive Officer and President.

RON COHEN, PRESIDENT, CEO, ACORDA THERAPEUTICS: Thank, Tom. Good morning everyone. We have almost a half-full room. That is fabulous. I feel loved and wanted. I am glad to give you an update on Acorda this morning. Before I begin, I just want to remind you all that this presentation will contain forward-looking statements and I encourage you to consult our more detailed filings with the SEC.

So, Acorda is a commercial stage company. We are at a critical inflection year. This year we are building momentum for a launch of our lead drug in development, Fampridine-SR, for which we just filed an NDA.

We are capitalized very well to fund our operations. Zanaflex is a product that we are currently selling. We expect it to have been cash flow positive on an operating basis in 2008, and to do so again in 2009, so it is paying for our entire commercial organization, which gives a terrific platform for launching Fampridine-SR.

As I mentioned, we filed the NDA a couple of weeks ago. We have also talked with European regulators and believe that we have sufficient data to file an MAA through a centralized procedure in Europe, and EU and Canadian filings will follow once our commercialization strategy for those countries is established. We also are driving our GGF2 molecule toward and IND, hopefully by late this year, in a cardiac indication.

This is our pipeline. You can see Zanaflex and Fampridine-SR, which I will focus on for most of the presentation, but also we think some extremely exciting, preclinical assets, the neuregulins, remyelinating antibodies, and chondroitinase and, as I mentioned, at least one of those will be driving toward IND by late this year, and the monoclonal antibodies not far behind those.

So, moving on to Zanaflex. Just briefly, we have seen very strong performance with this product which is indicated for the treatment of spasticity, which is a terrible affliction that people with brain injury, spinal cord injury, strokes, and other conditions that damage the central nervous system get, where they get horrible, very painful, severe spasms of major muscle groups in their bodies constantly. This is one of the leading therapies for treatment of it.

We launched a new capsule formulation that we got from Elan back in 2005, and we launched it into a market that was dominated 95% by generic tablets at that point. The capsules have a different pharmacokinetic profile and we were able to make substantial inroads there.

As of September 30, 2008, the last time we reported, we had $39.4 million in gross sales and, as I said, we expect that this will have been cash flow positive for 2008. We have 65 sales professionals, who have an average of 15 years of biotech and pharma experience. A lot of the call list for the Zanaflex product is neurologists, and we expect that that his a substantial overlap with the prescribers who would be expected to prescribe Fampridine-SR if it is approved.

So, again, this gives us strategically a terrific springboard for launching new products that we develop or obtain into the neurology market and it is at no risk, because we had it paid for by the Zanaflex product and, in fact, it is throwing off some additional cash into the rest of the Company's operations. This just gives you a snapshot of the growth since we launched in April of '05 and you can see a very nice increase. We expect modest …