Catalyst Pharmaceuticals, Inc. Q3 FY2025 earnings call

Management Statement and Operational Highlights

• Portfolio Performance: Catalyst reported record Q3 2025 revenue of $148.4 million, up 15.3% YOY, driven by FIRDAPSE, AGAMREE, and FYCOMPA. Cash position was $689.9 million with no debt.
• Strategic Initiatives: Board authorized a $200M share buyback. Catalyst Pathways provides personalized treatment support. Actively evaluating business development opportunities across rare disease areas.
• Commercial Execution: FIRDAPSE continues growth in idiopathic and cancer-associated LEMS. AGAMREE shows strong adoption with over 45 DMD centers of excellence enrolled. FYCOMPA shows resilience post-generic entry with adjusted guidance.

Segment Performance

• FIRDAPSE: Generated revenue of $92.2 million in Q3 2025, a 16.2% year-over-year increase. It remains the only evidence-based approved product for Lambert-Eaton myasthenic syndrome (LEMS) and is on track to meet full year net product revenue guidance of $355 million to $360 million.
• AGAMREE: Recorded net product revenue of $32.4 million in Q3 2025, a 115.2% year-over-year increase. It continues to see strong adoption across DMD centers of excellence and has had its full year net product revenue guidance raised to $105 million to $115 million.
• FYCOMPA: Had revenue of $23.8 million in Q3 2025, a 25.8% year-over-year decrease. Despite generic entry, its full year net product revenue guidance has been raised to $100 million to $110 million.

Guidance

• Raised 2025 total revenue guidance to between $565 million and $585 million.
• FIRDAPSE full year net product revenue guidance remains between $355 million and $360 million.
• AGAMREE full year net product revenue guidance raised to between $105 million and $115 million.
• FYCOMPA full year net product revenue guidance raised to between $100 million and $110 million.

Risks

• IP litigation risks, including pending case against Hetero USA, Inc. set for March 2026.
• Generic competition impact on FYCOMPA revenue erosion as more generics enter the market.
• Challenges in fully penetrating and converting all DMD centers of excellence for AGAMREE.
• Uncertainty in market adoption of FIRDAPSE in cancer-associated LEMS despite NCCN guideline updates.

Q: Congratulations on the great quarter. First question is on FIRDAPSE. I'm wondering as you start to penetrate and really put a lot of effort into the oncology portion of the LEMS business, are you able to share any anecdotes or data points that you have thus far that can really help us begin to quantify how those efforts are progressing? And then on FYCOMPA, do you have a sense of what proportion of the patients are expected to stay loyal to branded FYCOMPA? I'm just trying to figure out as these additional generics come to the market, how much erosion we're looking at for this fourth quarter?

A: Thanks for the question, Sam. For the first one, Jeff Del Carmen mentioned they will share leading indicators in future quarters, focusing on testing, NCCN guideline updates, and physician education. On FYCOMPA, Jeffrey Del Carmen stated they expect additional erosion from generics but some patients will remain loyal, with no specific percentage provided.

Q: This is Asim, on for June. Just a couple from us. Just on the FYCOMPA stickiness, why are patients choosing to stay on FYCOMPA longer? What are you hearing from them? And can you remind us how many generics are currently in the market and how many you could expect by year-end? And then just on FIRDAPSE, are you actively seeing oncology practices following the updated NCCN guidelines? Or would you say that's more of a 2026 story?

A: Jeffrey Del Carmen said patients are afraid of switching medications for antiseizure medications and prefer the brand they've been on. Teva's generic is at a 17+% discount. On FIRDAPSE, Jeffrey Del Carmen stated adoption of NCCN guidelines is more of a 2026 story, with current efforts focusing on screening and care pathway changes.

Q: Congrats on another strong quarter. I wanted to ask on AGAMREE, if you've seen any changes in the prescriber base. It's been talked about before how as people get more acquainted with longer-term data from AGAMREE and real world data, more prescribers may be inclined to come on and give their patients AGAMREE. Have you seen any change in the breakdown there or any new prescribers? And more so on AGAMREE, just given the scope of what the differentiated steroid can do, are you exploring any other opportunities outside of Duchenne?

A: Jeffrey Del Carmen said AGAMREE has strong adoption with top 45 DMD centers of excellence enrolling patients and 257 health care providers prescribing. Will Andrews mentioned evaluating life cycle management opportunities for add-on indications in rare disorders beyond Duchenne.

Q: The first one is on AGAMREE. I believe you mentioned that you've reached nearly all of the DMD centers of excellence. So maybe if you can provide some more color on the depth of prescribing versus breadth? And what feedback are you getting from physicians and payers about the profile? And what do you see as the main hurdle to full conversion in this patient population? And then on FIRDAPSE, just the growth is pretty strong on a year-over-year basis, and you reaffirmed your full year guidance for that product rather than raising it. So that sort of implies a sequential slowdown. Just wondering if this reflects conservatism? Or are you anticipating that true slowdown in 4Q? And can you elaborate on which growth driver, whether it's new patients, enhanced dosing or persistence is contributing the most to your year-over-year growth?

A: Jeffrey Del Carmen said prescribing varies across DMD centers, with some having multiple patients and others a few. Payer reception is strong with over 85% reimbursement. On FIRDAPSE, growth drivers include focused field force, VGCC antibody testing expansion, data sources, and machine learning, with conservatism in guidance due to sequential considerations.

Q: Congrats on the great quarter. My first question is just like roughly with the 17% off the WAC when Teva came in, what's the expected discount on FYCOMPA after more tablet and suspension generics enter later this year? And how does that discount curve look? And then my second one is kind of just on FIRDAPSE. With Hetero moving to trial slated for March 2026, what was the general sentiment during the Markman hearing considering that Teva and Lupin kind of decided to settle?

A: Richard John Daly said there's a mix shift with generic entry, losing volume and shifting to more Medicaid. Steven Miller said the Markman hearing was routine with items pushed to trial, and they remain confident in IP enforceability.