Catalyst Pharmaceuticals, Inc. Q4 FY2024 earnings call

• 2024 was an exceptional year with record revenue growth, total revenues up 23.5% to $491.7 million and Q4 2024 revenues at a record $141.8 million.
• Successful launch of AGAMREE in March 2024, with 2024 full-year net product revenue of $46 million.
• FIRDAPSE had sustained momentum, 14 consecutive quarters of 15%+ growth, with 2024 full-year net product revenue at $306 million.
• FYCOMPA had 2024 full-year net product revenue of $137.3 million, impacted by gross to net changes.
• Strategic priorities include buy and build approach, international strategy with sublicensee launches and licensee track, and focus on patient engagement services like Catalyst Pathways.

For the full-year 2024, total revenues grew to $491.7 million. Full-year net product revenue was $489.3 million. In Q4 2024, total revenues and net product revenues reached record highs of $141.8 million and $141.8 million respectively. FIRDAPSE had full-year 2024 net product revenue of $306 million, with Q4 2024 net product revenue at $82.5 million. AGAMREE had full-year 2024 net product revenue of $46 million, with Q4 2024 net sales at $21.1 million. FYCOMPA had full-year 2024 net product revenue of $137.3 million, with Q4 2024 net product revenue at $38.2 million. For 2025, FIRDAPSE is forecasted to have net product revenue between $355 million and $360 million, AGAMREE between $100 million and $110 million, and FYCOMPA between $90 million and $95 million.

• 2025 total revenue forecasted between $545 million and $565 million.
• FIRDAPSE 2025 net product revenue forecasted between $355 million and $360 million.
• AGAMREE 2025 net product revenue forecasted between $100 million and $110 million.
• FYCOMPA 2025 net product revenue forecasted between $90 million and $95 million.

• Ongoing patent litigation for FIRDAPSE with remaining two generic first filers.
• Market and regulatory challenges including evolving healthcare policies and shifting competitive landscape.
• Generic entry impact on FYCOMPA's revenue starting in 2025.

Q: Charles Duncan asked about FIRDAPSE guidance, new patient adds, and low discontinuation rate, and why FIRDAPSE guidance is more precise.

A: Jeff Del Carmen responded about over 500 pipeline leads for FIRDAPSE, steady new patient adds, 15% annual discontinuation rate, and confidence in forecasting due to steady enrollments.

Q: Unidentified Analyst asked about AGAMREE new indications and M&A in gene therapy.

A: Gary Ingenito discussed AGAMREE's new indication work and Richard Daly spoke about gene therapy M&A considerations, emphasizing CMC and market need.

Q: Asim Rana asked about gross net change for FIRDAPSE in 2025 and proportion of FIRDAPSE patients on 100mg dose.

A: Michael Kalb said 2025 gross to net for FIRDAPSE expected 3%-3.5% increase, and Jeff Del Carmen said about 20% of patients are on 100mg dose.

Q: Benjamin Paluch asked about AGAMREE demand drivers and FIRDAPSE revenue from small cell lung cancer patients.

A: Jeff Del Carmen spoke about AGAMREE demand drivers from transitions and FIRDAPSE revenue from small cell lung cancer being minimal in 2025 but growing in out years.

Q: Joseph Catanzaro asked about queuing effect in DMD and splitting sales force.

A: Jeff Del Carmen explained queuing effect from ELEVIDYS label expansion and splitting sales force for focused approach on FIRDAPSE and AGAMREE.

Q: Joel Beatty asked about AGAMREE generic erosion and SG&A increase.

A: Jeff Del Carmen said no significant generic erosion impact on AGAMREE and Michael Kalb said SG&A increase not quantified yet.

Q: Rohan asked about FIRDAPSE IP protections and FYCOMPA commercialization.

A: Richard Daly spoke about FIRDAPSE IP protections and sustained investment, and AGAMREE commercialization and FYCOMPA generic erosion impact.