CATALYST PHARMACEUTICALS (CPRX) Company Report

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.

Dec 2, 2025, 6:00 PM

Transcript

Catalyst Pharmaceuticals Updates Guidance and Highlights Product Growth at Jefferies Conference

CPRX

Guidance Update

Share Buyback

Legal Proceedings

Catalyst Pharmaceuticals (CPRX) reported strong financial performance with a 35% compound annual growth rate and updated top-line guidance of $565-$585 million for the year, supported by a $689 million cash balance and no funded debt.
The company's key product, Firdapse, for Lambert-Eaton myasthenic syndrome (LEMS), has a $1 billion addressable market opportunity in the US, with patent settlements extending to February 2035 and recent NCCN guideline updates in August 2025 supporting its use.
Agamree, for Duchenne muscular dystrophy (DMD), is showing superiority over standard-of-care steroids and was recently approved in Canada, while Fycompa for epilepsy is outperforming expectations despite generic competition.
Catalyst is actively pursuing growth through business development, aiming for immediately accretive opportunities, and has initiated a $200 million share repurchase program.

Nov 17, 2025, 2:00 PM

Transcript

Catalyst Pharmaceuticals Highlights Strong Performance, Product Opportunities, and Strategic Initiatives

CPRX

Guidance Update

Share Buyback

Legal Proceedings

Catalyst Pharmaceuticals (CPRX) reported strong financial performance, with total net product revenue growing 17.4% year-over-year and 25.6% for the first nine months, and updated guidance to $565-$585 million in top-line revenue.
The company maintains a strong financial position with $689 million in cash and no funded debt, enabling aggressive market actions and growth.
Key product Firdapse, for Lambert-Eaton myasthenic syndrome (LEMS), has a patent settlement extending to February 2035 and an addressable market opportunity of approximately $1 billion in the US.
Agamree, for Duchenne muscular dystrophy (DMD), presents a potential $1 billion opportunity and is undergoing the Summit trial to demonstrate superiority over standard-of-care steroids.
CPRX announced a $200 million share repurchase program and settled litigation with three out of four litigants in its patent case.

Nov 17, 2025, 2:00 PM

Transcript

Catalyst Pharmaceuticals Highlights Strong Financial Performance and Strategic Initiatives

CPRX

Guidance Update

Share Buyback

Revenue Acceleration/Inflection

Catalyst Pharmaceuticals, a profitable, commercially focused rare disease company, reported a 37% compound annual growth rate since 2019 and holds $689.0 million in cash on its balance sheet with no funded debt.
The company updated its top-line revenue guidance to $565-$585 million and announced a $200 million share repurchase program of up to $200 million over 15 months.
Key products include Firdapse for Lambert-Eaton myasthenic syndrome (LEMS), which has a $1 billion market opportunity and patent protection until February 2035, and Agamree for Duchenne muscular dystrophy (DMD), also a billion-dollar opportunity.
Recent achievements include updated NCCN guidelines for small-cell lung cancer (SCLC) to include VGCC testing for LEMS suspicion, which supports Firdapse, and Canadian approval for Agamree.

Nov 17, 2025, 2:00 PM

Transcript

Catalyst Pharmaceuticals Announces Record Q3 2025 Results and Raises Full-Year Guidance

CPRX

Earnings

Guidance Update

Share Buyback

Catalyst Pharmaceuticals reported record Q3 2025 total revenue of $148.4 million, marking a 15.3% year-over-year increase, driven by strong performance from Firdapse and AGAMREE.
The company ended Q3 2025 with a strong cash position of $689.9 million and no debt, and its Board authorized a new share buyback program of up to $200 million between October 1, 2025, and December 31, 2026.
Catalyst raised its 2025 total revenue guidance to between $565 million and $585 million.
Firdapse revenue grew 16.2% year-over-year to $92.2 million, and AGAMREE revenue surged 115.2% year-over-year to $32.4 million in Q3 2025, with full-year guidance for AGAMREE raised to between $105 million and $115 million.
The company settled Firdapse patent litigation with Lupin, granting a license for generic market entry in February 2035, and a trial for the remaining patent case against Hetero USA Incorporated is scheduled for March 2026.

Nov 6, 2025, 1:30 PM

Transcript

Catalyst Pharmaceuticals Reports Strong Q3 2025 Results and Raises Full-Year Guidance

CPRX

Earnings

Guidance Update

Share Buyback

Catalyst Pharmaceuticals reported Q3 2025 total revenues of $148.4 million and GAAP net income of $52.8 million ($0.42 diluted EPS).
The company raised its full-year 2025 total revenue guidance to between $565 million and $585 million.
FIRDAPSE net product revenue increased 16.2% to $92.2 million in Q3 2025, and AGAMREE net product revenue was $32.4 million, while FYCOMPA net product revenue decreased 25.8% to $23.8 million due to generic competition.
Catalyst Pharmaceuticals announced a share repurchase program of up to $200 million, with $8.4 million repurchased as of November 5, 2025, and held cash and cash equivalents of $689.9 million as of September 30, 2025.