CATALYST PHARMACEUTICALS (CPRX) Company Report

Catalyst Pharmaceuticals (CPRX) is a profitable commercial-stage biopharmaceutical company focused on rare diseases, reporting more than $700 million in cash and no funded debt as of January 12, 2026, with the ability to spend over $1 billion in acquisitions.
The company anticipates achieving the upper end of its 2025 guidance for overall performance, with Firdapse (LEMS treatment) performing within its range and Agamree (DMD treatment) at or slightly exceeding the upper end of its guidance.
Firdapse continues to demonstrate 15%-20% growth per quarter and has an addressable market exceeding $1 billion. The company has settled patent litigation for Firdapse with Teva and Lupin, with a trial against the last remaining defendant, Hetero, scheduled for late March 2026.
Agamree, launched in March 2024 for Duchenne muscular dystrophy, achieved 224% growth through September 30, 2025, and targets an addressable market of $1 billion.
Catalyst Pharmaceuticals is actively pursuing immediately or nearly immediately accretive acquisitions in rare diseases, targeting opportunities with peak sales of up to $500 million, and evaluated 135 business development opportunities in 2025.

Jan 12, 2026, 11:45 PM

Transcript

Catalyst Pharma Provides Business Update at JPMorgan Healthcare Conference

CPRX

Guidance Update

Legal Proceedings

M&A

Catalyst Pharma maintains strong financial flexibility with $700 million in cash and no funded debt, generating approximately $60 million to the bottom line every quarter. The company anticipates achieving the upper end of its 2025 guidance.
FIRDAPSE, the sole evidence-based treatment for LEMS, continues to grow at 15%-20% per quarter within an addressable market exceeding $1 billion. The company has settled patent litigation for FIRDAPSE with Teva and Lupin, securing IP until February 2035, with one remaining defendant, Hetero, scheduled for trial in late March.
AGAMREE, a novel corticosteroid for Duchenne muscular dystrophy, has achieved 90% penetration in the top 100 centers of excellence and an 85% conversion rate from other products. Catalyst Pharma is advancing the SUMMIT study to further differentiate AGAMREE and evaluate its long-term safety benefits.
The company is actively pursuing an acquisition strategy for immediately or nearly immediately accretive rare disease products with peak sales up to $500 million, leveraging its strong balance sheet to expand its portfolio and capabilities.

Jan 12, 2026, 11:45 PM

Transcript

Catalyst Pharmaceuticals Updates on Strong Financial Position, Product Growth, and Acquisition Strategy

CPRX

Guidance Update

M&A

Legal Proceedings

Catalyst Pharmaceuticals, a profitable rare disease biopharmaceutical company, holds over $700 million in cash with no funded debt, supporting its capacity for over $1 billion in acquisitions. The company updated its 2025 guidance to the upper end and has achieved a 37% CAGR since commercialization.
Key products, Firdapse (for LEMS) and Agamree (for Duchenne muscular dystrophy), are driving growth, with Firdapse showing 15%-20% quarterly growth and Agamree experiencing 224% growth through September 30, 2025. Both products target addressable markets of $1 billion or more.
The company is actively seeking immediately or nearly immediately accretive acquisitions in rare diseases, focusing on products with peak sales up to $500 million and expanding its scope to include products past proof of concept in development. Catalyst evaluated 135 business development opportunities in 2025.
Catalyst has successfully settled patent litigation for Firdapse with Teva and Lupin, with Hetero remaining as the last litigant for a trial scheduled in late March 2026. The company is also advancing the SUMMIT study for Agamree to further differentiate the product.

Jan 12, 2026, 11:45 PM

Transcript

Catalyst Pharmaceuticals Updates 2025 Revenue Guidance and Highlights Strategic Growth

CPRX

Guidance Update

Revenue Acceleration/Inflection

M&A

Catalyst Pharmaceuticals, Inc. reported record Q3 2025 and Year-to-Date 2025 Net Product Revenues, with 17.4% year-over-year growth for Q3 2025 and 25.6% growth for the nine months ended September 30, 2025.
The company increased its 2025 Full Year Total Revenue Guidance to between $565 million and $585 million, driven by strong performance from FIRDAPSE and AGAMREE.
Catalyst Pharmaceuticals maintains a strong financial profile with over $700 million in cash and cash equivalents and no funded debt as of December 31, 2025, providing over $1 billion in capacity for future transactions.
Strategic achievements include the settlement of FIRDAPSE patent litigation with Teva and Lupin (allowing generic entry in February 2035), the launch of FIRDAPSE in Japan, and AGAMREE's NDS approval by Health Canada.
The company is actively pursuing an acquisition strategy with financial flexibility to deploy over $1 billion towards rare disease products and clinical-stage opportunities.

Jan 12, 2026, 1:03 PM

8-K

Catalyst Pharmaceuticals Updates 2025 Revenue Guidance and Highlights Strategic Achievements

CPRX

Guidance Update

M&A

Share Buyback

Catalyst Pharmaceuticals increased its 2025 full-year total revenue guidance to between $565 million and $585 million, with specific guidance for FIRDAPSE ($355M - $360M), AGAMREE ($105M - $115M), and FYCOMPA ($100M - $110M).
The company maintains a strong financial position with over $700 million in cash and cash equivalents and no funded debt as of December 31, 2025, providing over $1 billion capacity for future transactions.
Key product developments in 2025 include updated NCCN guidelines for FIRDAPSE in LEMS, settlement of patent litigation for FIRDAPSE with licenses beginning in February 2035, and sustained demand for AGAMREE in Duchenne muscular dystrophy (DMD).
Catalyst Pharmaceuticals also repurchased over 1 million shares through December 31, 2025, under its current share repurchase program.

Jan 12, 2026, 12:00 PM

Presentation

Catalyst Pharma Discusses BD Strategy, Product Updates, and Capital Allocation at BofA Conference

CPRX

New Projects/Investments

Product Launch

Share Buyback

Catalyst Pharma is actively pursuing "buy-and-build" opportunities in rare diseases, backed by a strong balance sheet with $689 million in cash and no funded debt. The company has assessed over 100 opportunities this year, targeting products with a peak sales ceiling of approximately $500 million.
The company anticipates a positive resolution for Firdapse's intellectual property, having settled with three out of four defendants, with the final trial scheduled for March 2026. A significant financial benefit will come from the $30 million-$35 million BioMarin royalty on Firdapse ending in January 2026, which is expected to boost pre-tax income.
Agamree's launch shows strong patient uptake, with sources split 45% from Emflaza, 45% from Prednisone, and 10% naive. The estimated addressable market for Agamree is above $1 billion, and its orphan status, with patent restoration, extends to 2034.
Fycompa is facing increased generic competition, with solid dose generics entering in June 2025 and two more approved in early December 2025. A generic for the oral suspension, representing 15% of the business, is expected in mid-December 2025.
The board authorized a $200 million share repurchase program over 15 months, signaling a commitment to shareholder value while maintaining flexibility for business development.

Dec 8, 2025, 5:35 PM

Transcript

Catalyst Pharma Discusses BD Strategy, Firdapse IP, Agamree Growth, and Share Repurchase Program

CPRX

M&A

Legal Proceedings

Share Buyback

Catalyst Pharma is actively pursuing its "buy-and-build" strategy, having assessed over 100 opportunities this year for rare disease products with a sales ceiling of approximately $500 million, and is supported by $689 million in cash and no funded debt.
For Firdapse, the company has settled IP litigation with three of four defendants, with a trial for the remaining defendant scheduled for March. The BioMarin royalty on Firdapse, valued at $30 million-$35 million, is set to expire in January 2026, which is expected to boost pre-tax income.
Agamree patient sourcing is consistently split, with 45% from Emflaza, 45% from Prednisone, and 10% naive patients. The company estimates the addressable market for Agamree to be over $1 billion and is conducting a Phase 1 study with data expected after the first of the year to explore label expansion opportunities.
Fycompa is facing generic competition, with two additional solid dose generics approved last week (as of December 8, 2025) and an oral suspension generic expected to be approved in mid-December.
The board authorized a $200 million share repurchase program over 15 months, which the company states will not affect its ability to pursue business development.

Dec 8, 2025, 5:35 PM

Transcript

Catalyst Pharmaceuticals Discusses Product Portfolio, Growth Strategies, and M&A Outlook at Healthcare Conference

CPRX

New Projects/Investments

M&A

Product Launch

Catalyst Pharmaceuticals (CPRX) highlighted its three key products: Firdapse for Lambert-Eaton myasthenic syndrome (LEMS), Fycompa for epilepsy, and Agamree for Duchenne muscular dystrophy (DMD).
The company aims for 15%-20% midterm growth for Firdapse by focusing on diagnosing the 90% undiagnosed cancer-associated LEMS patients and optimizing patient retention.
Agamree for DMD has achieved 95% penetration in DMD Centers of Excellence and is projected to have a total addressable market of $1.4 billion, with ongoing studies exploring its potential beyond DMD.
CPRX maintains a "buy-and-build" acquisition strategy for de-risked rare disease products with peak sales around $500 million, supported by $689.9 million in cash and cash equivalents as of the end of September, and the capacity to deploy over $1 billion for acquisitions.

Dec 2, 2025, 6:00 PM

Transcript

Catalyst Pharmaceuticals Outlines Product Strategy and Financial Position

CPRX

Product Launch

M&A

Revenue Acceleration/Inflection

Catalyst Pharmaceuticals (CPRX) manages a portfolio including Firdapse (LEMS), Fycompa (epilepsy), and Agamree (DMD), with a strategic focus on acquiring de-risked rare disease products.
The solid dose of Fycompa lost patent protection in late May, leading to expected generic incursion and loss of price and volume, though the product has overperformed expectations. The company aims to minimize this impact by optimizing Firdapse and Agamree.
Firdapse targets a $1.2 billion total addressable market in LEMS, with an expected 15%-20% year-over-year growth in the midterm, driven by efforts to diagnose the 90% undiagnosed cancer-associated LEMS patients.
Agamree has achieved 95% penetration in Duchenne muscular dystrophy (DMD) Centers of Excellence, with a total addressable market of approximately $1.4 billion and a potential for $300 million at a 25% market share.
As of the end of September, Catalyst Pharmaceuticals reported $689.9 million in cash and cash equivalents with no funded debt, enabling it to deploy over $1 billion for strategic acquisitions.

Dec 2, 2025, 6:00 PM

Transcript

Catalyst Pharmaceuticals (CPRX) Discusses Product Portfolio, Growth Strategy, and Financial Strength

CPRX

Product Launch

M&A

Guidance Update

Catalyst Pharmaceuticals has three key products: Firdapse for Lambert-Eaton myasthenic syndrome (LEMS), Fycompa for epilepsy, and Agamree for Duchenne muscular dystrophy (DMD). The total addressable market for Firdapse in LEMS is $1.2 billion, with significant growth potential in cancer-associated LEMS where 90% of patients are currently undiagnosed. Agamree has a total addressable market of approximately $1.4 billion in DMD, with 95% penetration in Duchenne muscular dystrophy Centers of Excellence (COEs) and 100% penetration in the top 45 COEs.
The company reported $689.9 million in cash and cash equivalents with no funded debt as of the end of September. It is comfortable deploying over $1 billion for acquisitions, with an ideal target being a rare disease product with peak sales around $500 million that is immediately or nearly immediately accretive.
Catalyst Pharmaceuticals aims for 15%-20% midterm growth, driven by the performance of Firdapse and Agamree, which are expected to offset the decline from Fycompa's generic competition. Firdapse has patent protection until February 2035 for three of its four challengers.
The company operates on a "buy-and-build" strategy, focusing on acquiring de-risked products in the orphan and rare disease space, leveraging its strong infrastructure for patient support. It is also exploring opportunities to take on more regulatory risk for future growth.