Acorda Therapeutics, Inc. (NASDAQ:ACOR) Q1 2018 Earnings Conference Call - Final Transcript

May 02, 2018 • 08:30 am ET


Acorda Therapeutics, Inc. (NASDAQ:ACOR) Q1 2018 Earnings Conference Call - Final Transcript


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Welcome to the Acorda Therapeutics' First Quarter 2018 Update. [Operator Instructions] Please be advised that this call being taped at the company's request.

I will now introduce your host for today's call, Felicia Vonella, Executive Director of Investor Relations at Acorda. Please go ahead.

Felicia Vonella

Thank you so much, and good morning, everyone. Before we begin, let me remind everyone this presentation will contain forward-looking statements. Our more detailed disclosures are found in our SEC filings, which are public, and we encourage you to refer to those filings.

Let me now pass the call off to Ron Cohen. Ron?

Ron Cohen

Thanks Felicia. And good morning, everyone. Thanks for joining us.

Highlights for the quarter included acceptance of our NDA for INBRIJA by the FDA, with PDUFA date of October 5, 2018. INBRIJA is our investigational inhaled levodopa treatment for symptoms of OFF periods and people with Parkinson's disease who are taking carbidopa-levodopa regimens. And we also submitted a Marketing Authorization Application or MAA to the European Medicines Agency for INBRIJA at the end of March.

Last week, we presented new data on INBRIJA at the Annual Meeting of the American Academy of Neurology. We had four abstracts accepted for oral presentations, Dr. Stuart Isaacson and Bob Hauser presented Phase 1 safety and exploratory efficacy data for INBRIJA in early morning OFFs, which is Study 009, and Acorda's Dr. Charles Oh presented long-term safety and efficacy data from Study 005 or extension study or excuse me long-term safety study. The presentations were well received and indeed enthusiastically well received.

Turning to AMPYRA, we reported revenue of $103 million in the first quarter, this was below analyst consensus of $129 million. However, it was only slightly lower than our own internal forecast and that was primarily related to a modest expansion in inventories in the fourth quarter, although still within our contractual terms, which normalized by the end of the first quarter. Prescription demand in the first quarter was in line with our forecast as well and second quarter sales to-date and prescription demand is also in line with our internal forecast. We are therefore reiterating our net sales guidance for the full year of $330 million to $350 million.

Regarding on our AMPYRA patent appeal, we've been assigned the date of June 7th for oral argument before the Federal Appeals Court and we are looking forward to the opportunity to argue our case in court.

This table summarizes the key financials for the quarter. Of note, we ended the quarter with $333 million in cash and are well capitalized for anticipated launch of INBRIJA.

Moving to our key milestones for 2018, most important is our PDUFA date for INBRIJA on October 5th, we're preparing for approval and launch potentially in the fourth quarter of this year. And as I noted previously, we'll also have oral argument for the AMPYRA patent appeal on June 7th, with a decision anticipated in the second half of the year.

We've completed and analyzed the Phase 1 data for