Catalyst Pharmaceuticals, Inc. Q2 FY2025 earnings call

Management Statement and Operational Highlights

• Catalyst delivered record-setting Q2 2025 with total revenue $146.6 million, up 19.4% y-o-y. H1 2025 total revenue grew 30.2% to $288 million.
• Ended Q2 2025 with a cash position of $652.8 million. Confident in achieving full year 2025 revenue guidance of $545M to $565M.
• FIRDAPSE's underlying demand remains strong; AGAMREE continues to outperform expectations with strong growth.
• Welcomed Dr. Will Andrews as Chief Medical Officer and Dr. Dan Curran to the Board. Advancing business development initiatives and IP protection efforts.
• Ongoing patent litigation for FIRDAPSE with trial expected in Q4 2025 or Q1 2026. Published 2024 ESG report, underscoring commitment to sustainable growth.

Segment Performance

• FIRDAPSE: Generated net product revenue of $84.8 million in Q2 2025, a growth of $7.5 million vs Q2 2024. Year-to-date, FIRDAPSE has delivered $168.6 million in net product revenue, representing a 16.9% increase over the first half of 2024. Reaffirms full year 2025 net product revenue guidance of $355 million to $360 million.
• AGAMREE: Generated $27.4 million in net product revenue in Q2 2025, a new post-launch high and a 213% increase year-over-year from Q2 2024. First half net revenues reached $49.4 million, up 398% from the prior year. Reaffirms full year 2025 net product revenue guidance of $100 million to $110 million.
• FYCOMPA: Delivered revenue of $34.3 million in Q2 2025, reflecting a year-over-year decrease of 6%. First half 2025 revenue reached $70 million, up 4.5% from the same period last year. Full year net product revenue guidance of $90 million to $95 million remains unchanged.

Guidance

• Reaffirmed full year 2025 total revenue guidance of $545 million to $565 million.
• FIRDAPSE full year net product revenue guidance remains $355 million to $360 million.
• AGAMREE full year net product revenue guidance remains $100 million to $110 million.
• FYCOMPA full year net product revenue guidance remains $90 million to $95 million.

Risks

• Impact of Change Healthcare cybersecurity breach on prior year's growth now resolved but remains a past risk factor.
• Potential revenue erosion from generic competition for FYCOMPA.
• Uncertainty around patent litigation for FIRDAPSE with trial expected in Q4 2025 or Q1 2026.
• Tariff impacts on manufacturing, though efforts are underway to mitigate with AGAMREE manufacturing transition to U.S.
• Potential for additional generic competitors for FYCOMPA affecting future performance.

Question and Answer

• Q: Samantha Semenkow of Citibank asked about FIRDAPSE's oncology strategy and AGAMREE study metrics and impact. **A: Jeffrey Del Carmen discussed frictionless testing, NCCN guideline changes, and educational efforts for oncologists; Will Andrews mentioned the Phase I study for AGAMREE with initial results expected end of 2025 to early 2026.
• Q: Jason Gerberry of Bank of America inquired about ELEVIDYS impact on AGAMREE uptake and NCCN recommendation's commercial impact. **A: Jeffrey Del Carmen stated ELEVIDYS hasn't impacted AGAMREE uptake as steroids are foundational; Will Andrews and Jeffrey Del Carmen discussed NCCN guideline's role in educating oncologists and expected commercial impact in late 2026 and beyond.
• Q: Luke Herrmann of Baird asked about Change Healthcare disruption closure and manufacturing strategy for AGAMREE regarding tariffs. **A: Richard John Daly confirmed Change Healthcare impact is washed through, and efforts to transition AGAMREE manufacturing to U.S. to shield from tariffs are ongoing.
• Q: Jennifer Kim of Cantor asked about FIRDAPSE dose and discontinuation rates, and FYCOMPA generic exclusivity. **A: Jeffrey Del Carmen reported FIRDAPSE discontinuation rates below 20% and average dose increase; Richard John Daly discussed FYCOMPA's 180-day generic exclusivity and prudent guidance due to potential additional competitors.
• Q: Sudan Loganathan of Stephens Inc. asked about PTCT's Translarna approval impact on AGAMREE and FYCOMPA LOE strategic initiatives. **A: Jeffrey Del Carmen stated Translarna doesn't impact AGAMREE as steroids are foundational; Richard John Daly discussed ongoing business development efforts to offset FYCOMPA LOE and active evaluation of potential partners.