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Catalyst's (CPRX) Stock Up on 2022 Guidance for Firdapse

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Catalyst Pharmaceuticals, Inc. (CPRX - Free Report) announced preliminary total revenues for full-year 2021, including the fourth quarter.

Catalyst expects $38 million as total net product revenues for fourth-quarter 2021, indicating year-over-year growth of 24%. For full-year 2021, CPRX expects total revenues to be $141 million, indicating an increase of 18% on a year-over-year basis.

We remind investors that the figures released by the company are preliminary and unaudited. Final results will be issued upon the completion of its closing procedures and may vary from these preliminary estimates. Catalyst expects to come out with the final results by Mar 16.

Catalyst also expects a cash balance of $191 million as of 2021-end, without any funded debt.

For 2022, the  company expects total revenues for 2022 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. Investors are most likely impressed by the guidance.

Shares of Catalyst rose 16.2% following the above announcement. In fact, the stock has surged 42.2% in the past year against the industry’s decline of 33.6%.

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We note that Catalyst currently has only marketed product in its portfolio, namely Firdapse, which has been approved for the treatment of Lambert-Eaton Myasthenic Syndrome (LEMS) in adults since 2018.

In September 2021, Catalyst announced that it received a positive decision from the Appeals Court, which supported the orphan drug designation for Firdapse granted by the FDA for LEMS. The decision was a milestone for the company as 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.

Based on this decision, earlier this month, the District Court Judge granted summary judgment in Catalyst’s favor against the FDA. Resultantly, the judgment invalidated the FDA’s approval of Ruzurgi.

Catalyst also seeks to pursue label expansion for Firdapse in the United States for the treatment of LEMS in pediatric patients.

CPRX is looking to expand its pipeline beyond Firdapse, either by acquisitions or by in-licensing the rights of products or companies in 2022.

Zacks Rank & Key Picks

Catalyst currently carries a Zacks Rank #4 (Sell). A couple of better-ranked stocks in the overall healthcare sector include Axsome Therapeutics (AXSM - Free Report) , Theravance Biopharma (TBPH - Free Report) and Vir Biotechnology (VIR - Free Report) . While Vir Biotechnology sports a Zacks Rank #1 (Strong Buy), both Axsome Therapeutics and Theravance Biopharma carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Vir Biotechnology’s earnings per share estimates for 2022 have increased from $4.77 to $6.53 in the past 30 days.

Earnings of Vir Biotechnology beat estimates in two of the last four quarters and missed the mark on the other two occasions, with the average surprise being 13%.

Theravance Biopharma’s earnings per share estimates for 2022 have increased from 47 cents to 52 cents in the past 30 days.

Earnings of Theravance Biopharma beat estimates in three of the last four quarters and missed the mark on one occasion, with the average surprise being 7.3%.

Axsome Therapeutics’ loss per share estimates for 2022 have narrowed from $3.66 to $3.64 in the past 30 days.

Earnings of Axsome Therapeutics beat estimates in three of the last four quarters and missed the mark on one occasion, with the average surprise being 0.6%.

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