Introduction

Catalyst Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing medications for rare diseases. The company currently markets three approved drug products - FIRDAPSE®, FYCOMPA®, and AGAMREE®.

Financial Highlights

• Total revenue for Q1 2024 was $98.5 million, up 15% from $85.4 million in Q1 2023
  • FIRDAPSE® net sales were $66.8 million, up 16%
  • FYCOMPA® net sales were $30.4 million
  • AGAMREE® net sales were $1.2 million since its launch on March 13, 2024
• Net income was $23.3 million compared to $29.6 million in Q1 2023
• Cash and cash equivalents were $310.4 million as of March 31, 2024

Products

FIRDAPSE® is Catalyst’s lead product for Lambert-Eaton Myasthenic Syndrome (LEMS). Net sales grew 16% in Q1 2024 due to increased patients and dosage. An application is pending with the FDA to increase maximum daily dosage from 80 mg to 100 mg.

FYCOMPA® was acquired from Eisai in January 2023. It is used to treat certain types of seizures in patients with epilepsy aged 4 and older. Net sales were $30.4 million in Q1 2024.

AGAMREE® is for Duchenne Muscular Dystrophy (DMD) and was licensed from Santhera Pharmaceuticals in July 2023. It was approved by the FDA in October 2023 and launched in the U.S. in March 2024. Net sales were $1.2 million in the first few weeks after launch.

Financial Position

• Cash balance provides funding for at least 12 months of operations
• Potential to raise additional funds through stock offerings if needed for business development activities

Business Outlook

• Focus on commercializing current products and expanding to new markets globally
• Seeking to acquire or license additional late-stage drug products for rare diseases
• Clinical trials underway to expand indications for AGAMREE®
• Ongoing litigation to defend patents and exclusivity for FIRDAPSE® and FYCOMPA®

Financial Results

Revenue

• Total revenue increased 15% to $98.5 million in Q1 2024
  • FIRDAPSE® net sales up 16% due to increased patients and dosage
  • FYCOMPA® contributed $30.4 million
  • AGAMREE® added $1.2 million after March launch
• Expect fluctuations quarter-to-quarter based on product sales

Expenses

• Cost of Sales: $12.5 million in Q1 2024 compared to $9.9 million in Q1 2023
  • Primarily royalties based on net revenue
• R&D Expenses: Decreased 28% to $2.6 million in Q1 2024
  • Continuing programs to support commercial products
• SG&A Expenses: Increased 58% to $46.9 million in Q1 2024
  • Investments in commercial team and launch activities for AGAMREE®
  • Patient support services

Net Income & EPS

• Net income was $23.3 million in Q1 2024 compared to $29.6 million in Q1 2023
• Earnings per share (EPS) was $0.19 diluted in Q1 2024 versus $0.26 diluted in Q1 2023

Cash Flow & Balance Sheet

• Cash balance increased to $310.4 million as of March 31, 2024
• Cash provided by operations was $31.9 million in Q1 2024
• Recent stock offering raised $140.7 million in net proceeds
• Sufficient liquidity for at least 12 months of operations

Key Risks & Uncertainties

Catalyst faces risks and uncertainties including:

• Competition from generic versions of products after exclusivity periods expire
• Outcomes of ongoing litigation to defend intellectual property
• Reimbursement decisions from government and private health insurers
• Additional financing needs for business development activities
• Results of clinical trials and product development programs
• Supply chain continuity for manufacturing and distribution
• Cybersecurity threats

The company aims to mitigate these risks through business strategy execution and prudent financial planning. However, future results are unpredictable and may differ substantially from expectations.