Catalyst Pharmaceuticals Delivers Mixed Q3 Results While Raising 2023 Outlook

Catalyst Pharmaceuticals, Inc. CPRX, a biopharmaceutical company headquartered in Coral Gables, Florida, has reported contrasting results for the third quarter of 2023. Despite missing earnings estimates with a loss of 29 cents per share against the anticipated 24 cents, the company's sales exceeded expectations. In contrast, the same quarter last year recorded earnings of 20 cents per share. Adjusted for certain items, earnings came to 49 cents per share, a significant increase from the previous year's 26 cents.

Revenues Surge, Firdapse and Fycompa Lead the Way

CPRX's revenues reached an impressive $102.7 million, surpassing the expected $100 million and marking a substantial 79.5% jump from last year's $57.2 million. This rise was mainly fueled by Firdapse and Fycompa sales, as well as minimal licensing income. Firdapse sales grew 15.8% year-over-year, bringing in $66.2 million, while Fycompa, acquired from Eisai Co., Ltd., contributed $36.4 million — topping estimates and reflecting a 5.2% quarterly increase.

Expense and R&D Investments

The cost of sales saw a 46.6% annual increase to $14.2 million, while research and development expenses surged, primarily due to an $81.5 million charge for in-process research and development (IPR&D) tied to the acquisition of Agamree (vamorolone) in July 2023. Selling, general, and administrative expenses also climbed to $33.6 million, a reflection of the commercial efforts surrounding Fycompa's launch in the U.S. market.

Strengthened Financial Position and Raised Guidance

In light of these results, CPRX has revised its full-year 2023 revenue guidance upwards, now expecting between $390 million to $395 million. The revised forecast signifies a notable 82-84% growth from 2022, incorporating the impressive sales of Fycompa.

Clinical Developments and Regulatory Progress

The third quarter saw several developments for CPRX, including FDA approval for vamorolone, planned to be marketed as Agamree, for Duchenne Muscular Dystrophy. Additionally, the FDA accepted the supplemental new drug application for Firdapse’s label expansion, with a decision expected by June 2024.

Peers in the Biopharma Landscape

Other biopharmaceutical companies such as Ligand Pharmaceuticals LGND, headquartered in San Diego, California, Apellis Pharmaceuticals APLS, located in Waltham, Massachusetts, and Anixa Biosciences ANIX, based in San Jose, California, also present attractive investment opportunities. LGND currently holds a Zacks Rank #1 (Strong Buy), while APLS and ANIX are both marked with a Zacks Rank #2 (Buy).

The stock performance of these companies varies, with LGND experiencing a noticeable dip and APLS and ANIX also seeing declines this year. However, each company has shown varying degrees of earnings surprises in recent quarters, offering promise for potential investors.

Following the announcement, CPRX shares saw a 6% increase in after-market hours, reflecting investor confidence boosted by the raised guidance for 2023.

Catalyst, Earnings, Firdapse, Fycompa, Revenue, Guidance, Stock, Pharmaceuticals, Biotechnology, Investment, Healthcare, LGND, APLS, ANIX, CPRX, Therapeutics