Catalyst Pharmaceuticals, Inc. (CPRX - Free Report) reported a loss of 1 cent per share in the first quarter of 2019, narrower than the Zacks Consensus Estimate of a loss of 13 cents and the year-ago loss of 6 cents.
The company’s revenues of $12.4 million in the first quarter of 2019 surpassed the Zacks Consensus Estimate of $1 million. The company did not record any revenue in the year-ago quarter. Revenues came entirely from Firdapse, the company’s first approved drug for the treatment of Lambert-Eaton myasthenic syndrome (LEMS). The drug was launched in the United States in January 2019 after receiving the FDA approval in November 2018.
So far this year, Catalyst’s shares have increased 64.6% year to date compared with the industry’s growth of 6.0%.
Quarter in Detail
The company said that Firdapse had a strong start. As of May 9, 2019, the drug has been prescribed to409 unique LEMS patients. This included 81 patients previously naive to any form of amifampridine.
Research and development (R&D) expenses were $3.3 million, almost the same as $3.2 million in the year-ago quarter. The R&D costs included expenses in medical, regulatory affairs and quality assurance programs as well as expenses from the company’s Firdapse clinical trials, studies and Expanded Access Program.
General and administrative expenses totaled $8.4 million, surging 228.7% from the year-ago quarter. The increase is attributable to higherselling expenses, including the cost of the sales force and supporting personnel, product launch expenses, and market access and research expenses. The company expects selling, general and administrative expenses to increase in 2019, as it continues to build the infrastructure, and invest in commercial and patient programs to support Firdapse sales activities in 2019.
Catalyst is also working on developing Firdapse for additional indications. The company is currently conducting phase III studies, evaluating the drug for the treatment of congenital myasthenic syndromes (“CMS”) and anti-MuSK -antibody positive myasthenia gravis (MuSK-MG).
The company expects to report top-line results from the phase III MuSK-MG and CMS studies in the second half of 2019.
Catalyst is conducting a proof-of-concept study, evaluating Firdapse as a symptomatic treatment for patients with SMA type III. The company expects to report top-line results from the study in the first half of 2020.