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Acorda Therapeutics Inc. (ACOR)
Q4 2008 Earnings Call
February 24, 2009; 08:30 am ET
Ron Cohen - President & Chief Executive Officer
Dave Lawrence - Chief Financial Officer
Tierney Saccavino - Vice President of Corporate Communications
Joel Sendek - Lazard Capital Markets
Michael Yee - RBC Capital
Geoff Meacham - JP Morgan
Mark Schoenbaum - Deutsche Bank
Phil Nadeau - Cowen & Co.
Previous Statements by ACOR
» Acorda Therapeutics, Inc., Q3 2008 Earnings Call Transcript
» Acorda Therapeutics, Inc. Q2 2008 Earnings Call Transcript
» Acorda Therapeutics Inc. Q1 2008 Earnings Call Transcript
Now I’d like to introduce your host for today’s call, Tierney Saccavino, Vice President of 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 contains 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, and the ability to obtain additional financing to support Acorda Therapeutics operations, and unfavorable results from the preclinical programs.
These and other risks you are described in greater detail in the 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 upon 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.
Thank you, Tierney. Good morning everyone and welcome. This morning we reported our Q4 and year end 2008 financial results. 2008 was a year of exceptional achievement for Acorda. Today I’ll provide a brief review of some of the key milestones from ‘08 and ‘09 to-date and then I’ll turn the call over to Dave who will provide a financial summary. We’ll then open the call for questions.
Turning to our existing commercial product, the Zanaflex franchise performed well in 2008, with continued increases in sales and prescriptions. Gross sales for the fourth quarter were $14 million, up approximately 9% from Q4 2007. Total shipments were $16.5 million. For the full year, gross sales of Zanaflex Capsules and Zanaflex tablets were $53.4 million, compared to $43.6 million in gross sales for 2007.
As we had projected, the Zanaflex franchise was cash flow positive in 2008 on an operating basis, and we expect the same in 2009. This business continues to meet our strategic goal of supporting commercial operations at Acorda and providing us with the experience and infrastructure needed for a successful launch of Fampridine-SR if it’s approved.
We achieved several important milestones in our development of Fampridine-SR in 2008 and early ‘09, which I’ll review with you now briefly. We filed an NDA for Fampridine-SR on January 30, 2009. We expect that this submission, if accepted, will be subjected to standard review, which would provide a target for the FDA to complete its review within 10 months.
In June, we announced positive results from our second phase III clinical trial of Fampridine-SR, the MS-F204 trial, on walking ability in people with multiple sclerosis. These results, along with the results of our first phase III study MS-F203, were the basis for the NDA filing. As a reminder, both phase III studies were conducted under special protocol assessments or SPAs from the FDA.
In January 2008, we announced the results of a successful study Thorough QT study and the FDA requires Thorough QT studies for all new drugs seek regulatory approval. We also conducted meetings with the regulatory authorities in four European Union member states. As a result, we believe that the current data are sufficient to file a centralized Marketing Authorization Application or MAA.
We’re preparing for an MAA as we determine the commercialization pathway that will optimize our ability to provide the drug to patients who need it and maximize the value of Fampridine-SR outside the US. In this regard, we have begun meeting with potential marking partners for ex-US territories.
We’ve also been conducting initiatives to increase awareness of walking disability issues among professional and consumer audiences. These activities included a partnership with the National MS Society, to sponsor 20 Walk MS programs across the country in 2008. In 2009, Acorda will be the national sponsor of the Walk MS program with a presence at 30 of the largest Walk MS events.
On the corporate front, we added several key senior team members. Tom Wessel joined Acorda as Chief Medical Officer. Most recently Tom was the Senior Vice President of Clinical Research at Sepracor where he led the central nervous system and respiratory medicine development teams and also served as the Medical Director for the Lunesta development program. Tom’s expertise will be invaluable to us, as we move toward potential approval of Fampridine-SR and advance our preclinical products toward INDs.