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What's in the Cards for Catalyst (CPRX) in Q1 Earnings?

Catalyst Pharmaceuticals, Inc.CPRX is scheduled to report first-quarter 2016 results on May 10.

Catalyst has an impressive track record so far. The company reported narrower-than-expected losses in three of the last four quarters, with a positive average surprise of 13.4%. Let's see how things are shaping up for this announcement.

Factors Influencing This Quarter

Given that Catalyst does not have any revenue generating products in its portfolio, investor focus will remain on pipeline and regulatory updates.

At present, Catalyst has three candidates under development – Firdapse, CPP-115 and CPP-109.

The company’s lead candidate, Firdapse looks interesting. A major setback came when the company received a “refusal-to-file” letter from the FDA in connection to the NDA for Firdapse. The FDA had determined that the application was not sufficiently complete after a preliminary review. Nevertheless, Catalyst recently announced that it has held a meeting with the FDA to get better clarity on the agency’s requirements. The FDA informed the company that it needs positive results from an additional adequate and well-controlled study in patients with Lambert-Eaton myasthenic syndrome (LEMS), in addition to results from the phase III trial, LMS-002. The agency is also open to discuss a study design that could efficiently accomplish the requirement with a small, short-term study. It has also requisitioned several more short-term toxicology studies, which are expected to be initiated soon.

As the company is required to conduct additional studies as per the FDA’s requirement, this will not only mean additional costs but further delay the NDA submission.

We expect the company to disclose more details during its first-quarter earnings call.

Additionally, the company is evaluating Firdapse for the treatment of neuromuscular orphan diseases such as certain forms of congenital myasthenic syndromes (CMS) and myasthenia gravis. The candidate enjoys orphan drug status for both LEMS and CMS. Catalyst is also pursuing the development of Firdapse for additional indications and has initiated an investigator-sponsored study of the candidate for the symptomatic treatment of MuSK-antibody positive myasthenia gravis (MuSK-MG).

Meanwhile, the company also expects to complete a clinical trial on Firdapse in the pediatric CMS population (ages 2–17 years). The company had approximately $52 million in cash at the end of the first quarter, which should be sufficient for additional studies.

Furthermore, Catalyst is evaluating CPP-115 in a phase Ib, multiple-dose, safety and tolerance study. According to the company, CPP-115 is a more potent form of vigabatrin, with potentially fewer side effects (visual field defects). The company is looking to develop CPP-115 for infantile spasms, epilepsy and other neurological conditions that are associated with reduced GABAergic signaling, like post-traumatic stress disorder and Tourette’s Disorder. In Dec 2016, the company announced encouraging top-line results from a phase I study on the candidate. The company is now working on preparing CPP-115 for a phase II study, which will be initiated later in 2016, subject to the availability of funding.

The company projected an increase in its R&D spending in 2016 due to clinical development efforts on Firdapse in the pediatric CMS population and MuSK-MG.

What Our Model Indicates

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

Zacks ESP: The Earnings ESP, which represents the difference between the Most Accurate estimate and the Zacks Consensus Estimate, is 0.00%, since both the Most Accurate estimate and the Zacks Consensus Estimate stand a loss of 7 cents.

Zacks Rank: Catalyst carries a Zacks Rank #3. Though this increases the predictive power of ESP, the company’s ESP of 0.00% makes surprise prediction difficult.

Conversely, we caution against stocks with a Zacks Rank #4 or #5 (Sell-rated stocks) going into an earnings announcement, especially when the company is seeing negative estimate revisions.

Stocks That Warrant a Look

Here are some health care stocks that you may want to consider, as our model shows that these have the right combination of elements to post an earnings beat this quarter:

Jazz Pharmaceuticals plc JAZZ has an Earnings ESP of +6.11% and a Zacks Rank #3. The company is expected to release first-quarter results on May 10.

Impax Laboratories Inc. IPXL has an Earnings ESP of +8.89% and a Zacks Rank #3. The company is expected to release first-quarter results on May 10.

Intrexon Corporation XON has an Earnings ESP of +17.39% and a Zacks Rank #3. The company is expected to release first-quarter results on May 10.

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CATALYST PHARMA (CPRX): Free Stock Analysis Report
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