Catalyst Pharmaceuticals, Inc. (CPRX - Free Report) reported earnings of 10 cents per share in the second quarter of 2019, which beat the Zacks Consensus Estimate of 3 cents. The company reported a loss of 6 cents in the year-ago quarter.
The company’s revenues of $28.8 million in the second quarter of 2019 surpassed the Zacks Consensus Estimate of $19 million. It 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 soared 167.2% year to date compared with the industry’s growth of 7.9%.
Quarter in Detail
Per the company, Firdapse had a strong start. As of Jun 30, 2019, the drug has been prescribed to 409 unique LEMS patients.
Research and development (R&D) expenses were $4.6 million, up from $3.7 million in the year-ago quarter. The R&D costs included expenses in medical, regulatory affairs and quality assurance programs along with those from the Firdapse clinical studies and Expanded Access Program.
Selling, general and administrative (SG&A) expenses totaled $8.9 million, up from $2.6 million in the year-ago quarter. The increase is attributable to higher selling expenses, including the costs of commercial system implementation of the company’s sales force and supporting personnel, product launch expenses, and market access and research costs. The company expects SG&A 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 and prosecutes its lawsuit against the FDA.
Catalyst is also working on developing Firdapse for additional indications. The company is currently conducting phase III studies on the drug for the treatment of congenital myasthenic syndromes (“CMS”) and anti-MuSK -antibody positive myasthenia gravis (MuSK-MG). It expects to complete enrollment for the MuSK-MG study in the second half of 2019 and report top-line results in the first half of 2020.
The company expects to report top-line results from the phase III CMS study 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 in the first half of 2020.
Zacks Rank & Stocks to Consider
Catalyst currently has a Zacks Rank #3 (Hold).
Some better-ranked stocks are Acorda Therapeutics Inc. (ACOR - Free Report) , Axovant Sciences Ltd. (AXGT - Free Report) and Epizyme Inc. (EPZM - Free Report) . While Acorda and Axovant carry a Zacks Rank #1 (Strong Buy), Epizyme carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Acorda’s loss per share estimates have narrowed from $3.59 to $2.74 for 2019 in the past 60 days. The company delivered a positive earnings surprise in the trailing four quarters, the average being 69.68%.
Axovant’s loss per share estimates have narrowed from $7.00 to $5.34 for 2019 and from $6.48 to $3.59 for 2020 in the past 60 days.
Epizyme’s loss per share estimates have narrowed from $1.80 to $1.79 for 2020 in the past 90 days. The company delivered a positive earnings surprise in the trailing four quarters, the average being 22.15%.
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