CATALYST PHARMACEUTICALS, INC. Q1 FY2024 earnings call

Key Points

• Q1 '24 delivered strong performance with total revenues of $98.5 million. Cash position stood at $310.4 million as of March 31, 2024.
• FIRDAPSE showed strong double-digit growth and awaits PDUFA date for sNDA to increase max daily dose to 100 mg. Internationally, working with DyDo Pharma on FIRDAPSE Japan NDA.
• AGAMREE launched on March 13, with positive uptake trends; SUMMIT study initiated for long-term safety and quality-of-life data.
• FYCOMPA had solid Q1 net revenues of $30.4 million, with stable performance expected for the rest of 2024.
• Business development efforts focus on expanding portfolio in orphan CNS and adjacent spaces, seeking partnerships, and exploring life cycle management for AGAMREE.

In Q1 '24, Catalyst Pharmaceuticals achieved total revenues of $98.5 million. FIRDAPSE contributed net product revenues of $66.8 million, which is approximately 67.8% of the total revenue. FYCOMPA had net revenues of $30.4 million, making up about 30.9% of the total. AGAMREE, launched in mid-March, had net product revenues of $1.2 million, accounting for roughly 1.2% of the total revenue.

Reaffirmed full year 2024 total revenue guidance in the range of $455 million to $475 million.

Forward-looking statements involve risks, uncertainties, and assumptions as noted in SEC filings, including risk factors in 2023 annual report and 2024 quarterly report.

Q: Can you just share any specific doc or patient feedback on the AGAMREE experience? And then any further updates on your BD plans? How far along are you in that search? And is there a specific therapeutic area you're targeting, such as epilepsy?

A: It's a little early to get specific feedback on AGAMREE efficacy, but physicians and patients are happy with the process. BD is aggressively pursuing opportunities in the orphan space, with infrastructure supporting various orphan opportunities.

Q: On AGAMREE, you mentioned new patient enrollments, very good to hear. Can you give us some color on where you're taking patients from? Is it more EMFLAZA? Or is it more prednisone? And any color on that as well as pacing of information from the new SUMMIT study?

A: 47% of new enrollments are from EMFLAZA patients, 43% from prednisone patients. The SUMMIT study is a 5-year study, with analysis expected annually, potentially leading to product labeling updates.

Q: On FIRDAPSE, looking forward to the PDUFA date, possible dose expansion. Could you remind us of, call it, roughly what percentage of patients are at maximum dose? And how that decision, if it is positive to expand dosing, might impact demand for FIRDAPSE?

A: Currently 40% of FIRDAPSE patients are on the maximum 80 mg dose, with 4% on higher doses. Expansion could lead to an increase in average daily dose to around 65-66 mg over time.

Q: BD, going back to the prior question. It seems like you're busy with AGAMREE launch. I guess, is -- despite the interest in additional assets, is there a goal for doing that in '24? Or is that really dependent on the opportunity set?

A: Continuing to consider BD opportunities, focusing on getting AGAMREE launched successfully, and looking for accretive opportunities in the orphan space.

Q: What do you think is driving the high percentage of patients switching from prednisone in your early launch? And how do you see that evolving as this progresses?

A: High switch from prednisone is due to better safety profile. Expect mix to remain similar, with expansion into the entire corticosteroid market for DMD patients.

Q: Have a few on AGAMREE. If I recall correctly, I think you had said there were about 28 patients in the EAP program. Wondering if you could just sort of speak to what percent of those patients have been able to transition to commercial reimbursed drug. And then maybe if you could also sort of speak to the current cadence of intake forms, maybe how the current rate compares to your prelaunch experience, where you indicated there was a sort of indication of significant pent-up demand. So wondering if current cadence of intake forms sort of continues to point to that pent-up demand. And I have maybe one follow-up.

A: Over half of EAP patients have transitioned to commercial reimbursed drug. Post-launch, enrollments have been steady and higher than forecasted, indicating pent-up demand continues.

Q: You guys had mentioned a step-up in 2Q that you're expecting. Maybe you could just help contextualize that a little bit. How much of that will be driven by patients already on drug seeing a full 3 months of treatment versus expectations around new patient starts?

A: Rollover of enrollments from pre-launch to commercial, with patients taking about 4 weeks to convert to reimbursed shipments, leading to Q2 step-up from both new patient starts and existing patients completing 3 months of treatment.