Acorda Therapeutics, Inc. (ACOR)
Q2 2008 Earnings Call Transcript
August 5, 2008 8:30 am ET
Jeff Macdonald – Director, Corporate Communications
Ron Cohen – President and CEO
David Lawrence – CFO
Andy Blight – Chief Scientific Officer
Joel Sendek – Lazard Capital Markets
Matt Roden – JPMorgan
Ram Selvaraju – Rodman & Renshaw
Larry Neibor – Baird
Eric Chen [ph] – Banc of America Securities
Caroline Stewart – Piper Jaffray
Previous Statements by ACOR
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Thanks, Eric. Good morning, everyone, and welcome. With me today to discuss our second quarter financial results, which we recorded this morning are Dr. Ron Cohen, our President and Chief Financial [ph] Officer, and Mr. 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 historically facts regarding management’s expectations, beliefs, goals, plans, or prospects should be considered forward-looking.
These statements are subject to risks and uncertainties that would cause actual results to differ materially, including the 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 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, Jeff. Welcome everyone. Today I’ll provide an update on Fampridine-SR and Zanaflex Capsules, and then I’ll turn the call over to Dave who will provide the financial summary. And we’ll then open the call for your questions.
In June, we were pleased to announce successful results of our second Phase 3 study of Fampridine-SR in MS. In that study, a significantly greater portion of people taking Fampridine-SR in the trial had a consistent improvement in walking speed compared to people taking placebo. 42.9% for Fampridine-SR versus 9.3% for placebo as measured by the Timed 25-foot Walk, and this was statistically significant with the p-value less than 0.0001. Consistent improvement in walking speed was the primary endpoint of the study, as outlined in the SPA for the study.
Previous studies had validated this endpoint for clinical meaningfulness and showed the Timed Walk responders also had statistically significant improvements in three different measures of clinical impact, including a 12-item MS Walking Scale and both Subject and Clinician Global Impressions. The studies only prospectively define secondary outcome measure, leg strength showed a statistically significant increase in the Fampridine-SR Timed Walk responders compared to placebo at a p-value of 0.028. These results were consistent with those of the previous Fampridine-SR Phase 3 clinical trial, which was also conducted under an SPA.
I’m pleased to report that an abstract on the most recently completed study has been accepted as a late breaker at the World Congress on Treatment and Research in Multiple Sclerosis that will be held in September in Montreal. We expect to file our NDA in the first quarter of 2009. Earlier this year, we submitted a request to FDA for Fast Track designation for Fampridine-SR, which the FDA did not grant.
We plan to request consideration for priority review at the time that we file our NDA and we will submit additional data analyses at that time in support of this request. Fast Track provides for additional interactions with the FDA during drug development and the option of submitting an NDA in sections rather than all components simultaneously, where priority review provides for a six-month rather than a ten-month PDUFA review period for an NDA.
As we previously announced, we’ve begun to meet with regulatory authorities in several EU member states to obtain their initial feedback on Fampridine-SR, and we are conducting market and reimbursement analyses in the EU as well. These initiatives will inform our commercial strategy for Fampridine-SR in Europe, which we expect to determine by the end of the year.
Moving to Zanaflex, our Zanaflex business continued to perform well this quarter, generating a combined $13.1 in gross sales for the Capsules and tablets, and combined shipments to wholesalers of $16 million. We expect the Zanaflex commercial operations to be net cash flow positive this year.
The Zanaflex business has been integral to our strategy in allowing us to fund the development of an outstanding sales and marketing operation, focusing on our target prescribers, while mitigating financial risk. This in turn has positioned us to launch Fampridine-SR in the US if it’s approved as well as other products that may be approved in the future.