Catalyst (CPRX) Q1 Loss Narrows, Firdapse Off To A Good Start
Zacks Investment Research | May 14, 2019 02:36AM ET
Catalyst Pharmaceuticals, Inc. (NASDAQ:CPRX) 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.
Pipeline Update
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.
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Zacks Rank & Stocks to Consider
Catalyst currently has a Zacks Rank #3 (Hold).
Some better-ranked stocks worth considering are BioSpecifics Technologies Corp. (NASDAQ:BSTC) , Eisai Co., Ltd. (OTC:ESALY) and Recro Pharma, Inc. (NASDAQ:REPH) . All of them carry a Zacks Rank #1 (Strong Buy). You can see .
BioSpecifics’ earnings per share estimates have increased from $2.78 to $3.01 for 2019 in the past 60 days. The company delivered a positive earnings surprise in three of the trailing four quarters, with average of 14.21%.
Eisai’s earnings per share estimates have increased from $1.91 to $1.95 for 2019 and from $1.93 to $2.02 for 2020 in the past 60 days.
Recro Pharma’s loss per share estimates have narrowed from $3.40 to $1.94 for 2019 and from $1.51 to 56 cents for 2020 over the past 60 days. The company delivered a positive earnings surprise in the trailing four quarters, with average of 41.88%.
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