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Catalyst (CPRX) Q4 Earnings Lag Estimates, Revenues Rise Y/Y

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Catalyst Pharmaceuticals, Inc. (CPRX - Free Report) reported earnings of 9 cents per share for the fourth quarter of 2021, which was lower than the Zacks Consensus Estimate of 12 cents. The company had reported earnings of 11 cents in the year-ago quarter.

Adjusted earnings (adjusted for stock-based compensation, depreciation and tax provision) came in at 13 cents per share in the reported quarter compared with 10 cents a year ago.

Total revenues of $38.3 million slightly beat the Zacks Consensus Estimate of $38.2 million and rose 24% from the year-ago quarter’s $30.9 million. The top line primarily comprised sales of Firdapse (amifampridine), the company’s first approved drug for the treatment of Lambert-Eaton myasthenic syndrome (LEMS), and nominal license and other revenues.

Shares of Catalyst Pharmaceuticals have gained 16.5% in the year so far against the industry’s decrease of 15.1%.

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Quarter in Detail

Firdapse generated sales worth $38 million in the fourth quarter, up 24% year over year. License and other revenues were nominal at $0.04 million in the reported quarter.

Research and development (R&D) expenses of $5 million increased from $4 million reported in the year-ago quarter.

Selling, general and administrative (SG&A) expenses totaled $13 million, in line with the figure reported in the year-ago quarter.

As of Dec 31, 2021, CPRX had cash, cash equivalents and investments worth $191 million compared with $174.8 million as of Sep 30, 2021.

Full-Year Results

For 2021, Catalyst generated total revenues of $141 million, reflecting an increase of 18% year over year.

For the same period, CPRX reported earnings of 37 cents per share compared with the year-ago earnings of 71 cents per share.

2022 Guidance

For 2022, the company expects total revenues in the range of $195-$205 million, suggesting a 38-45% increase from 2021. It also expects cash operating expenses for 2022 in the range of $65-$70 million.

The guidance assumes continued recovery in macro-economic and healthcare activity throughout 2022 from the COVID pandemic.

Update on Firdapse

CPRX achieved a major milestone in September 2021, when it received a positive decision from the Appeals Court, which supported the orphan drug designation for Firdapse granted by the FDA for LEMS. The FDA had previously approved Jacobus Pharmaceutical Company's drug, Ruzurgi to treat LEMS in pediatric patients, violating the orphan drug designation granted to Firdapse. The Appeals Court also denied Jacobus’ petition for rehearing its ruling and issued a mandate to the District Court to grant summary judgment in the company’s favor. The District Court granted summary judgment last month, thereby making the FDA’s approval to Ruzurgi in LEMS invalid.

Earlier this month, the company received a similar favorable decision from the Canadian Federal Court, which also set aside the approval of Ruzurgi for LEMS in Canada.

The company is focused on expanding the commercialization of Firdapse in the United States. It intends to file a supplemental new drug application for Firdapse to treat pediatric patients with LEMS before the end of first-quarter 2022.

Catalyst had entered into an exclusive license and supply agreement with DyDo Pharma in June 2021 to develop/commercialize Firdapse for the treatment of LEMS in Japan. Dydo initiated a phase III study evaluating Firdapse for LEMS in Japan in December 2021.

Zacks Rank & Stocks to Consider

Catalyst Pharmaceuticals currently has a Zacks Rank #2 (Buy). Some other top-ranked stocks in the overall healthcare sector include BioDelivery Sciences , Kaleido Biosciences and Vertex Pharmaceuticals (VRTX - Free Report) , each carrying a Zacks Rank #2 at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

BioDelivery Sciences’ earnings per share estimates for 2022 have increased from 33 cents to 38 cents in the past 30 days. Shares of BDSI have surged 80% year to date.

Earnings of BioDelivery Sciences beat estimates in three of the last four quarters and missed the mark on a single occasion, the average surprise being 33.7%.

Kaleido Biosciences’ loss per share estimates for 2022 have narrowed from $1.89 to $1.64 in the past 30 days. Earnings of Kaleido Biosciences beat estimates in three of the last four quarters and missed the mark on a single occasion, but delivered a negative average earnings surprise of 5.1%.

Vertex Pharmaceuticals’ earnings per share estimates for 2022 have increased from $14.33 to $14.52 in the past 30 days. Shares of VRTX have risen 13.2% year to date.

Earnings of Vertex Pharmaceuticals beat estimates in each of the last four quarters, with the average being 10%.


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