CATALYST PHARMACEUTICALS, INC. Q2 FY2024 earnings call

Regulatory - In May, US approval for FIRDAPSEE's expanded maximum daily dose of 100 milligrams; Japan NDA decision for FIRDAPSEE expected end of Q3 or beginning of Q4 2024. ### Clinical - Summit study for AGAMREE, a five-year initiative to collect long-term safety and quality of life data, is on track with site identification and initiation. ### Business Development - Entered license agreement with Kye Pharma for AGAMREE commercialization in Canada; focus on buy and build plan, portfolio diversification, and ex-US expansion through partnerships.

In the second quarter of 2024, Catalyst Pharmaceuticals achieved total revenues of $122.7 million, a 23.2% increase over Q2 2023. FIRDAPSEE contributed Q2 net sales of $77.4 million, a 19.2% increase year-over-year, with full year 2024 guidance between $295 million and $310 million. FYCOMPA had Q2 net revenues of $36.5 million, with full year guidance between $130 million and $135 million. AGAMREE had Q2 product net revenues of $8.7 million, with full year 2024 net product revenue guidance revised to $35 million to $40 million from the prior $25 million to $30 million range.

- Reiterated full year 2024 net product guidance for FIRDAPSEE and FYCOMPA. ### - Revised AGAMREE full year 2024 net product revenue guidance to $35 million to $40 million from $25 million to $30 million. ### - Updated total revenue guidance to the upper-end of the $455 million to $475 million range due to strong performance of FIRDAPSEE, FYCOMPA, and AGAMREE.

- Ongoing litigation related to FIRDAPSEE; management states they are working diligently to bring cases to a favorable outcome for Catalyst.

Q: Charles Duncan asked about bolus in AGAMREE sales and summer trends.

A: Jeffrey Del Carmen said there was pent-up demand leading to Q2 sales, and continued strong interest with no downward trend in summer.

Q: Charles Duncan inquired about FIRDAPSEE's higher dose adoption.

A: Jeffrey Del Carmen explained about the 100mg dose expansion and its impact on average daily dose.

Q: Samantha Semenkow asked about FIRDAPSEE refill rates and litigation.

A: Steven Miller noted working on litigation favorably and refill rates normalized.

Q: Jason Gerberry asked about Biz Dev funding.

A: Steven Miller and Michael Kalb discussed cash usage and potential leverage for transformational deals.

Q: Unidentified Analyst asked about FIRDAPSEE refill rates and 100mg dose impact.

A: Jeffrey Del Carmen explained refill rate normalization and the gradual impact of the 100mg dose.

Q: Leland Gershall asked about AGAMREE patient switching.

A: Michael Kalb said it's center-specific.

Q: Joe Catanzaro asked about FIRDAPSEE new patient starts and portfolio inquiries.

A: Michael Kalb discussed pipeline and inbound inquiries making up about 30-35% of opportunities