Catalyst Pharmaceutical Inc. - CPRX STOCK NEWS

Catalyst Pharmaceuticals (CPRX) will ring the Nasdaq Closing Bell on February 28, 2023, in celebration of International Rare Disease Day. This event aims to raise awareness for the critical needs of individuals with rare diseases, with support from advocacy groups. CEO Patrick McEnany highlighted the importance of innovative treatments for rare conditions, while advocacy leaders stressed the necessity for increased awareness and timely diagnosis. Over 25 million Americans are affected by rare diseases, necessitating urgent action and support for better treatment options. Catalyst's commitment to these communities is underscored by its product pipeline, including FIRDAPSE and FYCOMPA.

Catalyst Pharmaceuticals (Nasdaq: CPRX) reported preliminary estimates indicating 2022 total revenues of approximately $214 million, a 52% year-over-year growth. The fourth quarter revenue is estimated at $61 million, a 61% increase compared to Q4 2021. For 2023, the company forecasts total revenues between $375 million and $385 million, representing a 75% to 80% growth. FIRDAPSE net revenues for 2023 are projected at $245 million to $255 million, while FYCOMPA is expected to generate $130 million for approximately 11 months of sales. Catalyst ended 2022 with around $298 million in cash and equivalents, positioning itself to capitalize on its expanded product portfolio.

Catalyst Pharmaceuticals (Nasdaq: CPRX) has announced the acquisition of U.S. rights to FYCOMPA® (perampanel) from Eisai Co., Ltd for $160 million. This acquisition enhances Catalyst's commercial portfolio and strengthens its presence in the neurology market, particularly in the treatment of epilepsy. The addition of FYCOMPA, projected to generate approximately $136 million in net revenues for the fiscal year ending March 31, 2023, is expected to be accretive to EBITDA and EPS in 2023. The company anticipates leveraging synergies with its existing product, FIRDAPSE®, to drive organic growth.

Catalyst Pharmaceuticals (NASDAQ: CPRX) announced today that it received notice from an ANDA filer regarding a generic version of FIRDAPSE®. Teva Pharmaceuticals seeks FDA authorization to manufacture and sell this generic drug. Catalyst noted that while the FDA complies with the 11th Circuit's decision favorable to the company regarding FIRDAPSE®, the agency will continue to enforce regulations on orphan drug exclusivity. Catalyst is not affected by this new FDA position and plans to vigorously protect its intellectual property rights related to FIRDAPSE®. The FDA approved Catalyst's application expanding FIRDAPSE® label for children aged 6-17 in September 2022.

Catalyst Pharmaceuticals (NASDAQ: CPRX) announced it received a Paragraph IV Certification Notice Letter from Teva Pharmaceuticals, which seeks FDA authorization for a generic version of FIRDAPSE^®.

Teva's ANDA asserts that Catalyst's patents are invalid or not infringed. Catalyst must respond within 45 days to potentially trigger a legal battle that could delay Teva's market entry until May 2026.

Catalyst is committed to enforcing its intellectual property rights regarding FIRDAPSE^®, which is used to treat Lambert-Eaton myasthenic syndrome.

Catalyst Pharmaceuticals has announced its acquisition of the U.S. rights for FYCOMPA® (perampanel) from Eisai Co., Ltd for $160 million. The acquisition, expected to close in early 2023, will enhance Catalyst's neurology portfolio, adding a well-established product with projected net revenues of approximately $136 million for Eisai’s fiscal 2022. Additionally, an exclusive option period to evaluate a rare epilepsy compound from Eisai's pipeline is included. Catalyst anticipates that this deal will be accretive to both EBITDA and EPS in 2023.

Catalyst Pharmaceuticals (CPRX) reported a record Q3 2022 net revenue of $57.2 million, a 59.3% increase year-over-year. The company raised its full-year revenue guidance to $205-210 million. Q3 GAAP net income reached $22.7 million ($0.22 per basic share), influenced by a one-time acquisition charge of $4.1 million. Non-GAAP net income also rose to $28.6 million. Cash and investments grew to $256.1 million. Catalyst achieved important milestones, including FDA approval for pediatric use of FIRDAPSE® and the acquisition of Ruzurgi®.

Catalyst Pharmaceuticals (CPRX) has been honored with the 2022 David J. Gury Company of the Year award by BioFlorida, recognizing its significant contributions to the life sciences sector in Florida. The company is celebrated for its innovative treatment, FIRDAPSE®, aimed at patients suffering from Lambert-Eaton Myasthenic Syndrome (LEMS). Catalyst's commitment to addressing unmet medical needs underpins its mission, according to CEO Patrick J. McEnany. The award highlights Catalyst's efforts in improving patient access to essential therapies.

Catalyst Pharmaceuticals (CPRX) will release its third quarter 2022 financial results on November 9, 2022, after market close. A subsequent conference call and webcast will occur on November 10, 2022, at 8:30 AM ET, where the management team will discuss the results and provide a corporate update. FIRDAPSE®, approved in 2018, is available for treating adults and children with Lambert-Eaton myasthenic syndrome in the U.S. and Canada. Forward-looking statements highlight potential risks that may affect results significantly.