Catalyst Pharma beats by $0.10, beats on revs; comments on Jacobus approval
- Reports Q1 (Mar) loss of $0.01 per share, $0.10 better than the S&P Capital IQ Consensus of ($0.11); revenues were $12.45 mln vs the $2.4 mln S&P Capital IQ Consensus.
- "We are pleased that the Firdapse launch is off to an excellent start and while it is still early, with much work to be done, it is especially gratifying to see the number of patients that were previously naive to any form of amifampridine that are now being effectively treated with Firdapse. We continue to be motivated by the very positive response that we are receiving from patients and healthcare providers. Lastly, we continue to make progress in clinical development of our robust pipeline of other potential indications for Firdapse." Mr. McEnany continued, "We were extremely surprised with the FDA's decision to approve Jacobus Pharmaceuticals' NDA for amifampridine in the treatment of LEMS in a pediatric population between the ages of 6 and less than 17. According to a Jacobus spokesperson there are less than 15 pediatric LEMS patients in the U.S. We are currently assessing our options and we expect to have more to say in that regard in the coming days."
- Upcoming Milestones
- Expect top-line results from Phase 3 trial for MuSK-MG in the second half of 2019
- Expect top-line results from Phase 3 trial for CMS in the second half of 2019
- Expect top-line results for SMA Type 3 proof of concept trial in the first half of 2020
- At March 31, 2019, Catalyst had cash and cash equivalents and investments of $50.6 million and no funded-debt. Catalyst believes that its existing capital resources will be sufficient to support its planned operations for at least the next year.
