Back to top

Image: Bigstock

What's in Store for Catalyst (CPRX) This Earnings Season?

Read MoreHide Full Article

Catalyst Pharmaceuticals, Inc. (CPRX - Free Report) is expected to report fourth-quarter 2017 results on Mar 21, after the market closes. 

Last quarter, the company delivered a positive surprise of 16.67%. It topped expectations in three of the last four quarters, the average positive surprise being 12.50%.

In the past one year, Catalyst’s shares have rallied 183.2% compared with the industry’s gain of 0.2%.

Factors to Consider

Catalyst does not have any revenue-generating product in its portfolio. Investor’s focus is likely to be on pipeline and regulatory updates during the fourth-quarter earnings call. Currently, the company has three candidates under development namely Firdapse, CPP-115 and CPP-109.

Catalyst’s lead pipeline candidate Firdapse is being evaluated for the symptomatic treatment of Lambert-Eaton myasthenic syndrome (“LEMS”). In February 2018, the company announced positive top-line results from a second phase III study of Firdapse. The study achieved statistical significance for both its co-primary endpoints — quantitative myasthenia gravis score (QMG) and subject global impression (“SGI”) and secondary endpoint. The top-line results showed that Firdapse has a significant magnitude of effect for treating the symptoms of LEMS.  

The company met with the FDA for a Type C meeting in February 2018 for getting Firdapse approved for LEMS. The minutes of the meeting received from the FDA reflect the FDA's advice to Catalyst that its proposed filing package will be sufficient for resubmission of an NDA for Firdapse, and Catalyst currently anticipates resubmitting its NDA for Firdapse for LEMS to the FDA by the end of the first quarter of 2018.

Additionally, the company is working on developing Firdapse for additional indications. In March 2017, Catalyst announced positive top-line results from the investigator-sponsored trial evaluating Firdapse as a treatment for myasthenia gravis patients with anti-MuSK antibodies (MuSK-MG).  In August 2017, the company received agreement from the FDA on a special protocol assessment (SPA) for a study evaluating the safety and efficacy of amifampridine phosphate treatment in patients with MuSK-MG. The company expects to initiate MuSK-MG phase III study in the first quarter of 2018.

In the first half of 2018, the company expects to report top-line data from its ongoing clinical trial evaluating Firdapse for the treatment of congenital myasthenic syndromes (“CMS”).

Markedly, Catalyst’s efforts to develop Firdapse appear encouraging given the significant commercial potential in the target markets. An approval would be a huge boost for the company.

Apart from Firdapse, Catalyst is also exploring the possibility of developing CPP-115 (a GABA aminotransferase inhibitor) for the treatment of epilepsy (initially infantile spasms) and the other selected neurological indications such as complex partial seizures and Tourette’s disorder.

Moreover, the company is working on a generic version of Sabril (vigabatrin), which is marketed by Lundbeck for the treatment of infantile spasms and complex partial seizures.

Earnings Whispers

Our proven model does not conclusively show an earnings beat for Catalyst this quarter. This is because a stock needs to have both — a positive Earnings ESP and a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 (Hold) — for this to happen. That is not the case here, as you will see below.

Zacks ESP:Catalyst has an Earnings ESP of 0.00%. That is because the Most Accurate estimate and the Zacks Consensus Estimate are pegged at a loss of 6 cents. You can uncover the best stocks to buy or sell before they’re reported with our Earnings ESP Filter.

Zacks Rank: Catalyst carries a Zacks Rank #3, which increases the predictive power of ESP. However, we need to have a positive ESP to be confident about an earnings beat. You can see the complete list of today’s Zacks #1 Rank stocks here.

Note that we caution against stocks with Zacks Ranks #4 or 5 (Sell rated) going into an earnings announcement, especially when the company is seeing a negative estimate revision.

Catalyst Pharmaceuticals, Inc. Price and EPS Surprise

Here are some companies to consider as our model shows that they have the right combination of elements to post an earnings beat in the quarter to be reported:

Celldex Therapeutics, Inc. (CLDX - Free Report) is scheduled to release fourth-quarter results on Mar 7. The Zacks #3 Ranked company has an Earnings ESP of +18.28%.

Gemphire Therapeutics is expected to release fourth-quarter 2017 results on Mar 21. The company has an Earnings ESP of +24.74% and a Zacks Rank #2.

Aptose Biosciences, Inc. (APTO - Free Report) is expected to release fourth-quarter financial numbers on Mar 27. The company has an Earnings ESP of +20% and a Zacks Rank of 3.

The Hottest Tech Mega-Trend of All

Last year, it generated $8 billion in global revenues. By 2020, it's predicted to blast through the roof to $47 billion. Famed investor Mark Cuban says it will produce "the world's first trillionaires," but that should still leave plenty of money for regular investors who make the right trades early.

See Zacks' 3 Best Stocks to Play This Trend >>

Published in