Catalyst Gives Preliminary Firdapse Estimates & Other Updates

Catalyst Pharmaceuticals, Inc. (NASDAQ:CPRX) provided a corporate update, including preliminary net revenues, for 2019.

The company’s only FDA-approved product Firdapse’s launch has been strong. The company has exceeded all expectations for the number of patients who are currently being treated with Firdapse, including the individuals who have received a medicine to treat Lambert-Eaton myasthenic syndrome (LEMS) for the first time.

Catalyst, thus, expects Firdapse net product revenues for the treatment of LEMS to be about $30 million for the fourth quarter of 2019 and net product revenues of about $102 million for the drug for 2019.

Shares of the company have surged 71.1% in the past year compared with the industry’s growth of 0.2%.

The company expects 2020 Firdapse net product revenues in the range of $135-$155 million.

For 2020, the company expects Research & Development and Selling, General & Administrative expenses of $65 million, which includes approximately $4 million in non-cash compensation.

The company is also working on developing Firdapse for additional indications. Catalyst initiated an investigator-sponsored phase II/III study on the drug for the symptomatic treatment of MuSK-antibody positive MG. It expects to report top-line results from this study in the first half of 2020. If positive, the company expects to file a supplemental new drug application (sNDA) with the FDA by the end of the year.

Firdapse is also being evaluated in a study for the potential treatment of Spinal Muscular Atrophy (SMA) Type 3 patients.

Additionally, the company expects additional neuromuscular conditions to be studied in 2020. These include Kennedy's disease and hereditary neuropathy with liability to pressure palsies (HNPP).

Catalyst aims to expand its portfolio through business development and develop a formal process for evaluating additional rare disease opportunities.

Zacks Rank & Key Picks

Catalyst currently carries a Zacks Rank #3 (Hold).

A few better-ranked stocks in the medical drugs sector are AcelRx Pharmaceuticals, Inc. (NASDAQ:ACRX) , Assertio Therapeutics, Inc. (NASDAQ:ASRT) and Corcept Therapeutics Inc. (NASDAQ:CORT) , all sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

AcelRx’s loss per share estimates have narrowed from 72 cents to 70 cents for 2019 and from 67 cents to 62 cents for 2020 in the past 60 days. The company delivered a positive earnings surprise in the trailing four quarters by 24.24%, on average.

Assertio delivered a positive earnings surprise in the trailing four quarters by 26.88%, on average.

Corcept’s earnings per share estimates have increased from 73 cents to 77 cents for 2019 and from 93 cents to 98 cents for 2020 in the past 60 days. The company delivered a positive earnings surprise in the trailing four quarters by 20.02%, on average.

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