Catalyst Pharmaceuticals, Inc. Q1 FY2025 earnings call

· FIRDAPSE continued strong organic growth, with revenue of $83.7 million in Q1 2025, driven by new patient adoption and normalization of prescription activity post Change Healthcare incident. The 100 mg label expansion has increased average daily dose. · AGAMREE had solid first full year of commercial availability, with net product revenues of $22 million in Q1 2025, showing continued growth and increasing prescriber engagement. The SUMMIT Study for AGAMREE advanced with additional sites and patient enrollment. · FYCOMPA had steady demand, with $35.6 million in net product revenue, and plans to manage revenue decline post patent expiry. · Strategic initiatives include sub-license launches in Japan and Canada, settlement with Teva restricting FIRDAPSE generic entry until 2035, and focus on expanding access to therapies for underserved populations.

Catalyst Pharmaceuticals' first quarter 2025 showed strong performance across segments. FIRDAPSE generated revenue of $83.7 million in Q1 2025, a 25.3% year-over-year increase. AGAMREE had net product revenues of $22 million, up from $1.2 million in Q1 2024. FYCOMPA had net product revenue of $35.6 million, a 17.1% year-over-year growth. FIRDAPSE contributed significantly to total net revenues which grew 43.6% year-over-year to $141.4 million.

· Reaffirmed 2025 full year total revenue guidance of $545 million to $565 million. · FIRDAPSE's 2025 net product revenue forecast is between $355 million and $360 million. · AGAMREE's 2025 net revenue forecast is between $100 million and $110 million. · FYCOMPA's 2025 full year net product revenue forecast is between $90 million and $95 million.

· Impact of Change Healthcare cybersecurity incident on prior year FIRDAPSE performance. · Uncertainty in litigation with remaining first filers for FIRDAPSE intellectual property. · Potential revenue decline for FYCOMPA post patent expiry as generics enter the market.

Q: How much of FIRDAPSE's 25% growth was due to Change Healthcare impact vs. organic growth?

A: Jeff Del Carmen stated FIRDAPSE's growth was in the 15%-20% range, with Change Healthcare impact leveling out.

Q: Proportion of FYCOMPA patients on tab vs. oral suspension?

A: Richard Daly corrected it to 85% tablets and 15% oral suspension.

Q: Uptake of FIRDAPSE among small cell lung cancer patients?

A: Jeff Del Carmen said current mix of FIRDAPSE patients with cancer associated LEMS is 20%-25%, with goal to increase through antibody screening.

Q: Business development activities in macro environment?

A: Richard Daly said focus on immediately accretive opportunities, seeing inbounds at 80%, and capital markets present opportunities.

Q: AGAMREE's SUMMIT Study aspects resonating with prescribers?

A: Gary Ingenito mentioned bone health, bone density, and cardiac effects from SUMMIT Study will be key findings.

Q: FIRDAPSE market penetration and growth drivers?

A: Richard Daly and Jeff Del Carmen discussed significant market opportunity, with 25% current penetration and growth from cancer associated LEMS initiative and ongoing efforts in idiopathic LEMS.