The Ardsley, N.Y.-based company posted a net loss of -$171 million on sales of $188.4 million for the 3 months ended Dec.31, for sales growth of 34% compared with the same period last year. In explaining the company’s quarterly loss, Acorda cited a $234 million charge associated with the termination of one of its Parkinson’s therapy programs and a $24 million charge linked with a clinical trial that failed to meet key endpoints.
Adjusted to exclude 1-time items, earnings per share were 61¢, behind consensus on The Street, where analysts were looking for sales of $175 million.
Acorda was dealt a setback in August last year, after the FDA said it wouldn’t review the company’s application for Inbrija – an inhaled therapy for people with Parkinson’s disease.
Acorda resubmitted Inbrija’s NDA in December and the FDA is expected to let the company know soon if the resubmitted application is complete enough for a full year.
“We continue to prepare for the potential approval and launch of Inbrija, our investigational inhaled levodopa treatment for symptoms of off periods in people with Parkinson’s disease. We look forward to working with the FDA during the NDA review process, and to bringing this new treatment option to the Parkinson’s community to help address an important unmet need,” Acorda’s president & CEO, Dr. Ron Cohen, said in prepared remarks.
“Based on our continued market research, as well as the strength of our Phase 3 data, we believe Inbrija’s US market opportunity to be greater than $800 million.”
Acorda posted $588.3 million in sales for the full year of 2017, reporting a net loss of -$223.4 million.
ACOR shares were trading at $24.40 apiece today in mid-morning activity, down -5%.