Catalyst raises 2025 revenue guidance to $565M–$585M while launching $200M share buyback program

Earnings Call Insights: Catalyst Pharmaceuticals (CPRX) Q3 2025

MANAGEMENT VIEW

* Richard John Daly, President and CEO, stated that "Catalyst delivered outstanding third quarter 2025 results with accelerating momentum, strong demand for our rare disease therapies and continued progress on key strategic growth priorities." He reported total revenue of $148.4 million, an increase of 15.3% year-over-year, driven by strong performances from FIRDAPSE and AGAMREE, as well as patient retention for FYCOMPA.
* Daly announced a new share buyback program: "our Board of Directors authorized a new share buyback program to repurchase up to $200 million of shares of Catalyst's outstanding common stock between October 1, 2025, and December 31, 2026." He emphasized that this can be executed without affecting business development strategies.
* The company raised its 2025 total revenue guidance to between $565 million and $585 million.
* FIRDAPSE generated $92.2 million in revenue, a 16.2% year-over-year increase. Daly highlighted expansion opportunities, noting, "potentially 90% of cancer-associated LEMS patients remain undiagnosed."
* AGAMREE's net product revenue was $32.4 million in Q3 2025, up 115.2% year-over-year, driven by high patient retention and growing adoption. FYCOMPA revenue was $23.8 million, reflecting continued demand despite generic entry.
* Jeffrey Del Carmen, Chief Commercial Officer, said, "Q3 2025 marked another record-setting quarter for our commercial organization, generating net product revenue of $148.4 million, a 17.4% increase compared to Q3 2024."
* Michael Kalb, CFO, stated, "Our total revenues for the third quarter of 2025 were $148.4 million, an approximate 15.3% increase when compared to total revenues of $128.7 million for the third quarter of 2024."

OUTLOOK

* Catalyst raised its 2025 total revenue guidance to between $565 million and $585 million, up from the previous range.
* FIRDAPSE full-year revenue guidance was reaffirmed at $355 million to $360 million.
* AGAMREE full-year outlook was raised to $105 million–$115 million.
* FYCOMPA full-year revenue guidance was raised to $100 million–$110 million.
* Management repeated confidence in meeting or exceeding these targets, emphasizing continued growth from both organic drivers and new market segments.

FINANCIAL RESULTS

* Total revenues for Q3 2025 were $148.4 million, up from $128.7 million in Q3 2024.
* FIRDAPSE revenue reached $92.2 million; AGAMREE generated $32.4 million; FYCOMPA produced $23.8 million.
* GAAP net income was $52.8 million, or $0.42 per diluted share. Non-GAAP net income was $86.1 million, or $0.68 per diluted share.
* Cash and cash equivalents at quarter-end were $689.9 million, with no debt.
* Cost of sales was $22.7 million. R&D expense was $2.7 million, and SG&A expenses totaled $47.5 million.

Q&A

* Samantha Semenkow, Citigroup: Asked about oncology penetration for FIRDAPSE and FYCOMPA patient loyalty. Jeffrey Del Carmen responded that leading indicators for oncology penetration will be shared in future quarters and described ongoing education and partnerships. On FYCOMPA, Del Carmen explained that "a lot of patients are afraid that to switch medications for antiseizure medications…they like to stay on the brand that they've been on for the last 10, 12-plus years."
* Asim Rana, Truist Securities: Asked about FYCOMPA stickiness and NCCN guideline adoption. Del Carmen noted Teva as the only generic competitor and stated, "it's a relatively good market for us when competing against Teva's product." NCCN guideline adoption is anticipated to be a "2026 story," with discussions ongoing.
* Rohan Mathur, Oppenheimer: Asked about AGAMREE prescriber base and additional indications. Del Carmen reported strong adoption across centers of excellence. William Andrews, Chief Medical Officer, said, "We are evaluating life cycle management opportunities for consideration of add-on indications for AGAMREE."
* Pavan Patel, Bank of America: Asked about AGAMREE's depth of prescribing and FIRDAPSE growth drivers. Del Carmen stated, "it truly does vary across all the centers of excellence" and highlighted high payer reception. For FIRDAPSE, he detailed multiple growth levers, including machine learning for patient identification and pharmacy intervention programs.
* Kesav Chandrasekhar, Stephens Inc.: Asked about FYCOMPA price discounting and FIRDAPSE patent litigation. Richard Daly described the expected mix shift and price impact with additional generics. Steven Miller, COO & CSO, said the Markman hearing was "relatively routine" and management remains confident in defending IP.

SENTIMENT ANALYSIS

* Analyst questions were generally positive, focusing on growth drivers, product uptake, and execution, with some probing on guidance conservatism and patent litigation.
* Management maintained a confident and upbeat tone, particularly in prepared remarks, with repeated confirmation of guidance and growth expectations. Phrases like "we are confident" and "we remain highly disciplined" were prominent.
* Compared to the previous quarter, both analysts and management maintained a positive tone, though analysts pressed for more granular forward-looking insights on oncology and AGAMREE's prospects.

QUARTER-OVER-QUARTER COMPARISON

* The company raised overall 2025 revenue guidance (previously $545 million–$565 million). AGAMREE and FYCOMPA full-year guidance were also increased.
* Both quarters emphasized the oncology expansion strategy for FIRDAPSE, but this quarter provided more detail on execution and the timing of impact (2026).
* Product-level growth remained strong, with AGAMREE showing continued acceleration. Commercial execution themes, patient identification, and payer engagement persisted as key focus areas.
* Management tone remained confident and consistent, with an added element of discipline regarding the new share buyback program. Analyst tone remained constructive but with increased focus on timing and sustainability of growth drivers.

RISKS AND CONCERNS

* Management highlighted ongoing generic erosion risk for FYCOMPA and confirmed expectations for continued revenue impact as more generics enter the market.
* The FIRDAPSE patent litigation with Hetero USA, Inc. remains unresolved, with a trial date in March 2026. Management stated, "we will vigorously defend our IP for all of our products."
* Analysts raised concerns about the ability to sustain growth amid generic competition and the adoption timeline for updated NCCN oncology guidelines.

FINAL TAKEAWAY

Catalyst Pharmaceuticals concluded the third quarter of 2025 with record revenues, strong operational momentum, and a raised full-year revenue outlook. The launch of a $200 million share buyback program signals confidence in the company’s growth trajectory and ongoing strategic investments. Management emphasized a disciplined approach to commercial execution, portfolio expansion, and intellectual property protection, aiming to drive continued value for shareholders and patients into 2026 and beyond.

Read the full Earnings Call Transcript [https://seekingalpha.com/symbol/cprx/earnings/transcripts]

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