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Pharma Co. Achieves Record Sales of LEMS Drug in Q2
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Shares of Catalyst Pharmaceuticals Inc. traded 24% higher to a new 52-week high after the company reported that in Q2/22 net product revenues from sales of its FIRDAPSE® increased 57.7% YoY to $53.0 million. FIRDAPSE® has been approved by both the U.S. FDA and Health Canada as a treatment for adult patients with Lambert-Eaton myasthenic syndrome, a rare autoimmune disease in which a person's immune system attacks its body's own tissues at the neuromuscular junction.

After U.S. markets closed yesterday, commercial-stage biopharmaceutical company Catalyst Pharmaceuticals Inc. (CPRX:NASDAQ), which is engaged in developing, licensing and commercializing new medicines for patients with rare diseases, announced financial and operating results for the second quarter of 2022 ended June 30,2022.

The company highlighted that this latest quarter represents its fifth consecutive quarter of sequential revenue growth during which it earned record revenues from sales of its leading product FIRDAPSE®.

The company's Chairman and CEO Patrick J. McEnany commented, "Catalyst's performance in the first half of the year and into the third quarter continues to be on a strong footing, and we have gained great momentum toward achieving our key strategic objectives for the year … We are pleased with the continued uptake of FIRDAPSE and patient demand, partially resulting from the favorable Appellate Court ruling that removed Ruzurgi from the market on February 1, 2022, as well as robust organic growth, which is providing strong operational growth in line with our total revenue guidance for 2022."

The company reported that for Q2/22, net product revenue increased by 57.7% to $53.0 million, compared to $33.6 million in in Q2/21. The firm stated that the gains were drive by "the transition of Ruzurgi patients converting to FIRDAPSE treatment and robust organic growth."

The company stated that in Q2/22, operating income grew by 80.4% to $28.6 million, compared to $15.8 million in Q2/21.

The firm listed that it earned net Income of $21.6 million, or $0.20 per diluted share in Q2/22, versus net income of $12.2 million, or $0.11 per diluted share in Q2/21.

The firm mentioned that as of June 30, 2022, in held cash and other liquid assets of $220.8 million and did not have any funded debt.

Catalyst Pharmaceuticals advised that has settled its prior disputes with Jacobus Pharmaceuticals in the U.S. and has reached a resolution related to the approval of Ruzurgi. The settlement allowed Catalyst to acquire the rights to develop and commercialize Ruzurgi in the U.S. and Mexico.

The firm added that it is currently working to extend patent protection for FIRDAPSE until February 25, 2037. The company indicated also that the FDA had accepted its supplemental New Drug Application of FIRDAPSE for review as a treatment for pediatric LEMS patients.

The company advised that in March 2021 it initiated a share repurchase program and since that time has repurchased a total of 3.2 million shares of its common stock in the open market at an average price of $5.92 per share equal to total aggregate purchases of around $19.0 million.

Catalyst Pharma offered some forward guidance and advised that it is continuing its estimates for FY/22 revenues of $195-205 million, which it said represents 38-45% increase over total revenues in FY21. The company added that expects FY/22 adjusted EBITDA of $100-105 million.

Chairman and CEO McEnany added that, "At this time we are comfortable stating that our revenue guidance for the year is expected to be at the upper end of our previous total revenue forecast."

Catalyst Pharmaceuticals is a commercial-stage biopharmaceutical firm based in in Coral Gables, Fla. The firm focuses on developing and commercializing medicines for therapeutics for rare and chronic neuromuscular and neurological diseases. In 2018, the U.S. Food and Drug Administration (FDA) approved the firm's New Drug Application (NDA) for its FIRDAPSE (amifampridine) 10 mg tablets for use in treating adults with Lambert-Eaton myasthenic syndrome (LEMS).

The product is now available by prescription for commercial sale in the U.S. and has also been approved by Health Canada in adults with LEMS.

Catalyst Pharmaceuticals started the day with a market cap of around $1.09 billion with approximately 102.82 million shares outstanding and a short interest of about 6.85%. CPRX shares opened nearly 13% higher today at $11.97 (+$1.37, +12.92%) over yesterday's $10.60 closing price and reached a new 52-week high price this afternoon of $13.19. The stock has traded today between $11.61 and $13.19 per share and is currently trading at $13.17 (+$2.57, +24.25%).

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