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Catalyst (CPRX) Reports Q3 Loss as Expected & Pipeline Update

Zacks

Catalyst Pharmaceuticals, Inc. CPRX reported a loss of 8 cents per share in the third quarter of 2018, in-line with 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 21.2% compared with the industry’s 2.7% decline.


Quarter in Detail

Research and development (R&D) expenses were $4.5 million, up 67.8% from the year-ago quarter. Costs during the first nine months of 2018 increased due to rise in consulting expenses as Catalyst prepared to submit its new drug application (NDA) for Firdapse during the first quarter of 2018, milestone expenses in connection with the acceptance of Catalyst’s NDA submission in May 2018. They also included expenses from Catalyst’s medical affairs program, and compensation and related personnel costs, as Catalyst expands its headcount to support currently ongoing trials and programs.

General and administrative expenses totaled $3.6 million, up 127.5% from the year-ago quarter. The increase in expenses is attributable to higher pre-commercialization expenses, headcount costs and corporate expenses as Catalyst builds its infrastructure and commercial programs to prepare for a potential launch of Firdapse in 2019.

Pipeline Update

Currently, Catalyst has two candidates under development — Firdapse and CPP-115.

The FDA accepted the NDA for Firdapse, which the company had resubmitted 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.

Catalyst expects top-line results from Firdapse’s phase III study for MuSK antibody positive myasthenia gravis in the second half of 2019.

The company also expects top-line results from the phase III congenital myasthenic syndromes (CMS) (CMS-001) study in the second half of 2019.

Zacks Rank & Stocks to Consider

Catalyst has a Zacks Rank #3 (Hold).

Some top-ranked stocks worth considering are Bristol-Myers Squibb Company BMY, Eli Lilly and Company LLY and Merck & Co. Inc. MRK. While Bristol-Myers sports a Zacks Rank #1 (Strong Buy), Lilly and Merck carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Bristol-Myers’ earnings per share estimates have increased from $3.59 to $3.84 for 2018 and from $3.83 to $4.07 for 2019 over the past 60 days. The company delivered a positive earnings surprise in all of the trailing four quarters with an average beat of 11.99%.

Lilly’s earnings per share estimates have increased from $5.42 to $5.51 for 2018 and from $5.69 to $5.79 for 2019 over the past 60 days. The company delivered a positive earnings surprise in all of the trailing four quarters with an average beat of 10.03%. Shares of the company have increased 30.4% year to date.

Merck’s earnings per share estimates have increased from $4.26 to $4.34 for 2018 and from $4.58 to $4.71 for 2019 over the past 60 days. The company delivered a positive earnings surprise in all of the trailing four quarters with an average beat of 3.96%. Shares of the company have increased 34.1% year to date.

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