Catalyst Pharmaceuticals, Inc. (CPRX - Free Report) reported a loss of 6 cents per share in the second quarter of 2018, narrower than the Zacks Consensus Estimate of a loss of 8 cents but wider than the year-ago loss of 5 cents.
Being a development-stage company, Catalyst does not have any approved product in its portfolio yet. Hence, the company did not generate any revenues in the quarter.
So far this year, Catalyst’s shares have lost 23.8% against the industry’s 1.3% growth.
Quarter in Detail
Research and development (R&D) expenses were $3.7 million, up 51.1% from the year-ago quarter. Costs during the first six months of 2018 increased due to rise in consulting expenses as Catalyst prepared to submit its NDA for Firdapse during the first quarter of 2018, milestone expenses in connection with the acceptance of Catalyst’s new drug application (NDA) submission in May 2018. They also includedexpenses from Catalyst’s medical affairs program, and compensation and related personnel costs, as Catalyst’s expands its headcount to support currently ongoing trials and programs.
General and administrative expenses totaled $2.6 million, up 52.1% from the year-ago quarter. The increase in expenses is attributable to higher pre-commercialization expenses, headcount and corporate expenses as Catalyst builds up its infrastructure and commercial programs to prepare for a potential launch of Firdapse in 2019.
Currently, Catalyst has two candidates under development — Firdapse and CPP-115.
The FDA accepted the NDA for Firdapse, which the company had resubmitted during the previous quarter, for the treatment of Lambert-Eaton myasthenic syndrome (LEMS). The FDA also granted a priority review status to the NDA and an action date of Nov 28, 2018 is set for the same. The company expects to launch Firdapse in early 2019 assuming approval.
The company also expects top-line results from Firdapse’s phase III study for MuSK antibody positive myasthenia gravis in the second half of 2019.
The company expects top-line results from the phase III congenital myasthenic syndromes (CMS) (CMS-001) study in the first half of 2019.
Zacks Rank & Stocks to Consider
Catalyst has a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Vertex Pharmaceuticals (VRTX - Free Report) , Seattle Genetics (SGEN - Free Report) and Galapagos NV (GLPG - Free Report) . All the stocks carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Vertex’s earnings per share estimates moved up from $3.16 to $3.79 for 2018 and from $4.33 to $4.58 for 2019 in the last 30 days. The company delivered a positive earnings surprise in all of the trailing four quarters, with an average beat of 27.5%. Share price of the company has increased 18.4% in a year.
Seattle Genetics’ 2018 loss per share estimates narrowed from $1.81 to 83 cents and from 81 cents to 39 cents in the last 30 days. The company delivered a positive earnings surprise in three of the trailing four quarters, with an average beat of 12.93%. The company’s shares have rallied 36.3% year to date.
Galapagos’ loss per share estimates narrowed from $3.88 to $3.79 for 2018 and from $3.00 to $2.86 for 2019 over the last 30 days. The company delivered a positive earnings surprise in two of the trailing four quarters, with an average beat of 6.01%. The company’s shares have increased 19.4% so far this year.
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