CORAL GABLES, Fla., Nov. 09, 2020 (GLOBE NEWSWIRE) -- Catalyst Pharmaceuticals, Inc. (Nasdaq:CPRX), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating, chronic neuromuscular and neurological diseases, today reported financial results for the third quarter ended September 30, 2020 and provided a business update.

“I am pleased to report on a very productive third quarter and on our continued commercial execution under challenging conditions and remain confident that we will continue to see more success as physicians and other providers adapt to this virtual working environment. Also, we are very encouraged by the number of new LEMS patient starts that were initiated over the past 2 months and are hopeful that this is the beginning of a trend,” said Patrick J. McEnany, Chairman and Chief Executive Officer of Catalyst Pharmaceuticals. Mr. McEnany added, “Additionally, during the third quarter we were excited to announce the issuance of our U.S. patent for Firdapse®, which we believe significantly fortifies our intellectual property position. We continue to work diligently alongside partners to protect Firdapse® and to ensure that we are able to advance and make available therapeutics for patients suffering from rare neurological conditions.”

Q3-20 Financial Results

• Product revenue, net in the third quarter of 2020 was $29.2 million, compared to $30.9 million for the third quarter of 2019.
• Operating income for the third quarter of 2020 was $11.7 million, compared to $13.8 million in the third quarter of 2019.
• Reported net income of $43.3 million, or $0.42 per basic and $0.41 per diluted share, in the third quarter of 2020, compared with net income of $13.6 million, or $0.13 per basic and diluted share, for the third quarter of 2019.
• Net income in the third quarter of 2020 includes $31.3 million ($0.30 per basic and $0.29 per diluted share) of benefit from recording of deferred tax asset, upon reversal of valuation allowance.
• Research and development expenses for the third quarter of 2020 were $3.7 million as compared to $4.6 million for the third quarter of 2019.
• Selling, general and administrative expenses for the third quarter of 2020 totaled $10.0 million as compared to $8.1 million in the third quarter of 2019.

Corporate Highlights and Milestones

• U.S. Patent for Firdapse® for "Methods of Administering 3,4-Diaminopyridine" issued.
• District Court’s ruling against us in our lawsuit versus the FDA.
• Appeal to the 11^th Circuit Court of Appeals has been made in lawsuit versus FDA and court has granted request for an expedited hearing.
• Executed license agreement with KYE Pharmaceuticals to make Firdapse® available to LEMS patients in Canada.
• Launched legal challenge to Health Canada’s decision to overlook Firdapse® data exclusivity.
• Actively engaged in evaluation of potential acquisition of products or companies.

Other Firdapse® Development Programs

• Enrollment in proof-of-concept spinal muscular atrophy type-3 study has been completed and we expect to report top-line data before year-end.
• Continuing the evaluation of the data from the MuSK-MG trial to determine the future of the program.
• Firdapse® long-acting formulation development program continues on schedule.
• Proof-of-concept studies for other additional neuromuscular indications are expected to commence in the near future.

COVID-19 Impact

• Issued a no travel and remote work policy for all Catalyst employees on March 16th.
• Diligently working to reduce COVID-19 impact on new patient starts, enrollments and revenues.
• We believe that our current base of LEMS patients on reimbursed Firdapse® remains fairly stable and very compliant to their medication regimen.
• Have not experienced any disruptions in the supply chain or production of Firdapse® and believe the safety stock of Firdapse® is more than adequate for currently anticipated needs.
• Proudly partnered with First Responder’s Children’s Foundation/COVID-19 Emergency Response Fund, which provides emergency grants to support frontline emergency and healthcare workers and their families enduring financial hardship during this COVID-19 pandemic.

Balance Sheet and Key Activities in 2020

At September 30, 2020, Catalyst had cash and cash equivalents and investments of $127.1 million and no funded debt.

The Company plans to continue investing in the following key activities in 2020 and 2021:

• Expansion of U.S. commercialization of Firdapse®.
• On-going development programs evaluating Firdapse® for the treatment of MuSK-MG and SMA Type 3, and our Expanded Access Program for Firdapse®.
• Continue support for our Firdapse® long-acting formulation and other development programs.
• Support Canada pre-commercialization activities for Firdapse®.
• Continue Japan regulatory activities to seek marketing authorization for Firdapse®.

More detailed financial information and analysis may be found in the Company's Quarterly Report on Form 10-Q, which was filed with the Securities and Exchange Commission (SEC) on November 9, 2020.

About Catalyst Pharmaceuticals

Catalyst Pharmaceuticals is a commercial-stage biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating, chronic neuromuscular and neurological diseases, including Lambert-Eaton myasthenic syndrome (LEMS), anti-MuSK antibody positive myasthenia gravis (MuSK-MG) and spinal muscular atrophy (SMA) Type 3. Catalyst's new drug application for Firdapse® (amifampridine) 10 mg tablets for the treatment of adults with LEMS was approved in November 2018 by the U.S. Food & Drug Administration ("FDA"), and Firdapse® is commercially available in the United States. Further, Canada’s national healthcare regulatory agency, Health Canada, recently approved the use of Firdapse® (amifampridine) for the treatment of patients in Canada with LEMS.

Firdapse® is currently being evaluated in clinical trials for the treatment of MuSK-MG and SMA Type 3 and has received Orphan Drug Designation from the FDA for myasthenia gravis.