Скачать или смотреть Catalyst Pharmaceuticals, Inc. (CPRX)

Business Overview
Catalyst Pharmaceuticals is a profitable, commercial-stage biopharmaceutical company focused on treating rare neuromuscular and neurological diseases. Headquartered in Coral Gables, Florida, it currently markets three drugs in the U.S.:

Firdapse® (amifampridine) – For Lambert-Eaton Myasthenic Syndrome (LEMS); core revenue source.

Fycompa® (perampanel) – An anti-epileptic acquired from Eisai; launched in 2023.

Agamree® (vamorolone) – Approved for Duchenne Muscular Dystrophy (DMD); U.S. launch in March 2024.

The company’s strategy is based on acquiring, in-licensing, and efficiently commercializing orphan drugs for CNS-related rare diseases. Unlike most biotech peers, Catalyst generates positive earnings and free cash flow, giving it a rare combination of profitability and growth potential in the orphan-drug space.

💊 Product Portfolio and Performance
1. Firdapse®
Primary treatment for adults with LEMS.

2024 sales exceeded $250M.

Patent settlement with Teva prevents generic entry until 2035, ensuring a long runway of exclusivity.

2. Fycompa®
Approved for partial-onset seizures and generalized tonic-clonic seizures.

Q1 2025 sales: $30.4M.

Expands Catalyst’s footprint into epilepsy, though margins are narrower than Firdapse.

3. Agamree®
Steroid alternative for DMD with improved safety profile (reduced bone and growth toxicity).

Early Q1 2025 sales: $1.2M; expected to scale significantly over the next 2–3 years.

Approved in the U.S.; Canada licensing deal signed with KYE Pharmaceuticals.

💰 Financial Summary
Metric Value
FY 2024 Revenue $491.7M (+23.5% YoY)
FY 2024 Net Income $163.9M (+130% YoY)
Gross Margin ~86%
Net Margin ~33%
Q4 2024 EPS $0.70 (vs. $0.55 est)
Cash + Investments ~$310M (Q1 2025)
Debt $0 (debt-free)
Free Cash Flow ~$239M (2024)
P/E (TTM) ~15.7x
EV/EBITDA ~8.3x
ROE / ROIC ~25.6% / 29.6%

Catalyst is one of the few small/mid-cap biotech firms with strong profitability metrics, minimal financial risk, and cash to fund internal growth or M&A without dilution.

📈 Strategic Advantages
Patent Protection: Settlement with Teva extends Firdapse exclusivity to 2035.

Diversification: 3 commercial drugs reduce reliance on a single asset.

Capital Allocation: $310M cash gives flexibility for future acquisitions or pipeline expansion.

Leadership: Under CEO Richard Daly, Catalyst is pursuing additional CNS-focused in-licensing opportunities with capital efficiency.

⚠️ Risks and Challenges
Revenue Concentration: Firdapse still drives the majority of revenue.

Rising Costs: SG&A increased due to Agamree launch; pressure on short-term margins.

Competition: Fycompa faces generic risk in future, though covered by existing exclusivities for now.

Pipeline Dependence: Limited internal R&D means growth relies on external deals.

📊 Analyst Ratings and Outlook
Firm Rating Target Price
Oppenheimer Outperform $36
Citi Buy $34
Truist Buy $33
Baird Buy $29
IBD, others Bullish $30–42 range

Consensus: Strong Buy
Average Target: ~$34
This represents ~30% upside from current levels ($25.84 as of June 10, 2025).

🔜 Upcoming Catalysts
Event Timing
Agamree sales ramp-up 2025–2026
New licensing deals in CNS Announced throughout 2025
Firdapse EU expansion/partnering TBD
Generic risk for Fycompa Beyond 2026 (currently mitigated)

✅ Conclusion
Catalyst Pharmaceuticals combines high profitability, strong cash generation, and focused execution in orphan neurology markets. With patent protection on its flagship drug, growing new assets, and ample capital for acquisitions, the company is positioned for sustainable, cash-efficient growth.

It offers a rare profile: a biotech with scale, safety, and cash flow — making it attractive to both growth and value investors in the healthcare sector. Monitoring Agamree’s launch trajectory and any future M&A will be crucial.

📚 References
Investors.com – CPRX Fundamentals and Technicals

Catalyst Pharmaceuticals Q4 2024 and Q1 2025 Earnings Reports

Fierce Pharma – Agamree U.S. Launch

SEC Filings – 10-K, 10-Q (2024–2025)

Teva Patent Settlement News

Catalyst Investor Presentation – May 2025

Truist, Citi, Baird Analyst Reports on CPRX

Catalyst Canada Licensing Deal – Reddit Biotech DD

Oppenheimer Commentary – CPRX