Catalyst Pharmaceuticals (NASDAQ:CPRX) reported fourth-quarter and full-year 2025 results that management said reflected continued revenue growth across its commercial portfolio, led by Firdapse and AGAMREE, and supported by Fycompa despite generic competition. Executives also outlined 2026 revenue guidance and discussed commercial initiatives aimed at expanding patient identification, improving persistence, and deepening penetration in key treatment centers.
2025 results and 2026 revenue outlook
For full-year 2025, Catalyst reported total revenues of $589.0 million, up 19.8% from $491.7 million in 2024. Management noted that 2025 exceeded prior guidance, which had been $565 million to $585 million. Net product revenue for 2025 totaled $588.8 million, up 20.3% year over year.
Looking ahead, Catalyst guided to 2026 total revenue of $615 million to $645 million. The company also provided product-level guidance:
- Firdapse: $435 million to $450 million in 2026 revenue
- AGAMREE: $140 million to $150 million
- Fycompa: $40 million to $45 million (no longer promoted as of the start of 2026 due to generic competition)
CFO Mike Kalb said the Firdapse outlook reflects an expected increase in gross-to-net, which he attributed to the Inflation Reduction Act’s impact on Medicare Part D net product revenue. He added that the IRA impact is expected to increase annually.
Firdapse performance and growth initiatives
Firdapse, which management described as the only evidence-based FDA-approved therapy for Lambert-Eaton myasthenic syndrome (LEMS), generated 2025 revenue of $358.4 million, representing 17% growth for the full year. In the fourth quarter, Firdapse net revenue was $97.6 million, up 18.3% year over year and up 5.9% compared with the third quarter of 2025.
Chief Commercial Officer Jeff Del Carmen attributed performance to commercial execution across “the patient journey,” including lead generation, conversion, diagnosis acceleration, and retention. He said Catalyst increased “data leads” of identified LEMS patients in active diagnostic stages by 40% in the fourth quarter and noted those patients represent roughly half of new starts each quarter. Del Carmen also said the company increased VGCC testing by more than a third in the second half of 2025 versus the first half, and launched a pharmacy outreach program in June designed to help newly enrolled patients achieve their optimal therapeutic dose, contributing to a reduction in early discontinuations.
In the Q&A, Del Carmen said the company believes it is about 30% penetrated in idiopathic LEMS and well under 10% penetrated in cancer-associated LEMS. He also said the pool of identified patients in the diagnostic journey has grown to more than 600, with over 50% of new enrollments coming from that group. He added that the pharmacy intervention program reduced discontinuations within the first four months of treatment by 12% after implementation.
For cancer-associated LEMS, Del Carmen said the company saw increased uptake in new positive VGCC tests ordered by oncologists in the second half of 2025. Catalyst’s focus in the first half of 2026 will be building relationships with oncology networks to integrate updated NCCN guidelines into care pathways, which management believes could translate into more addressable patients in the second half of 2026. Executives indicated they expect Firdapse growth to be supported by idiopathic LEMS in the first half of 2026, with incremental benefit from cancer-associated LEMS more weighted to the back half of the year.
AGAMREE momentum, reimbursement, and studies
AGAMREE, a corticosteroid approved for Duchenne muscular dystrophy (DMD), generated 2025 revenue of $117.1 million, representing 154.3% year-over-year growth. Fourth-quarter net product revenue was $35.3 million, up 67.5% compared with the fourth quarter of 2024 and about 9% higher than the third quarter of 2025.
Del Carmen said adoption across top DMD centers of excellence continued to expand. He stated that 100% of the top DMD centers of excellence—representing about 80% of DMD patients—have enrolled at least one patient on AGAMREE, and that 270 unique healthcare providers have submitted enrollment forms.
Management also said discontinuations and cancellations meaningfully declined in the second half of 2025, which Del Carmen attributed to increased provider familiarity and fewer market disruptions. Since launch, he said approximately 45% of AGAMREE patients have transitioned from Prednisone and 42% from Emflaza.
On patient mix, Del Carmen said the median age of new enrollees dropped by about one year in recent quarters versus launch, with the average age in the last six months closer to 11 versus 12 previously. He told analysts that about 10% of patients are coming to AGAMREE without prior steroid use, making it their first steroid for DMD treatment.
Reimbursement success rates remained above 85%, according to Del Carmen, who said step edits account for some of the remaining portion. He said Catalyst provides bridge treatment or free drug while patients work through payer requirements, and added that reimbursement rates are “closer to 90%.”
On clinical and lifecycle management efforts, CEO Rich Daly highlighted the ongoing SUMMIT study, described as a five-year follow-up study expected to evaluate approximately 250 DMD patients once enrollment is complete. The company also discussed a Phase I study evaluating dose equivalence between AGAMREE and other steroids and assessing potential immunosuppressive activity. In the Q&A, the company clarified it expects analyses from that Phase I study within the first half of 2026, and said biomarker results could help direct future lifecycle management opportunities. Daly also emphasized that endpoints discussed from external data are not currently included in AGAMREE’s label.
Fycompa contribution and promotion changes
Fycompa delivered 2025 net product revenue of $113.3 million, which management said outperformed expectations despite a loss of exclusivity in May 2025. The company expects generic competition to continue to erode results and forecast 2026 Fycompa revenue of $40 million to $45 million.
Del Carmen said Catalyst discontinued personal promotion and assistance programs for Fycompa as of December 31, 2025. Kalb added that beginning in July 2026, Catalyst will be required to pay Fycompa royalties equal to 6% of net product revenue to Eisai, per the company’s contractual arrangement.
Profitability, expenses, cash, and business development
Catalyst reported 2025 net income before income taxes of $283.5 million, up 31.1% from 2024. GAAP net income was $214.3 million, or $1.68 per diluted share, compared with $163.9 million, or $1.31 per diluted share, in 2024. Non-GAAP net income was $346.2 million, or $2.72 per diluted share, versus $276.3 million, or $2.21 per diluted share, in 2024.
Cost of sales was $87.3 million in 2025, compared with $68.8 million in 2024, primarily due to royalties. Kalb also noted a $12.5 million milestone payment obligation tied to AGAMREE reaching $100 million in net product revenue, achieved during the fourth quarter of 2025; the obligation was capitalized in the quarter and is being amortized over the asset’s estimated remaining useful life.
R&D expense was $12.7 million in 2025, essentially flat with 2024, and largely supported ongoing AGAMREE studies. The company forecast 2026 R&D expense of $17.5 million to $22.5 million, absent another acquisition. SG&A totaled $193.8 million in 2025 versus $177.7 million in 2024, driven mainly by higher compensation and headcount, along with consulting fees tied to business initiatives including business development. Catalyst expects 2026 SG&A to rise slightly, citing continued efforts to increase awareness of Firdapse for potential use in cancer-associated LEMS.
Cash and cash equivalents were $709.2 million at year-end 2025, up from $517.6 million at the end of 2024. Kalb said the increase was largely driven by $208.7 million in operating cash flow, partially offset by $17 million used in financing activities, including $25.3 million of common stock repurchased in the fourth quarter.
On business development, Daly said the company completed more than 100 assessments in 2025, with about 90% inbound. He reiterated Catalyst’s focus on on-market and near-market differentiated rare disease products, as well as late-stage development programs with positive proof of concept and a “well-characterized regulatory path.” When asked whether a deal should be expected in 2026, Daly said the company would continue a “diligent and thoughtful approach,” without committing to a specific timeline, and noted regulatory considerations as Catalyst evaluates opportunities.
About Catalyst Pharmaceuticals (NASDAQ:CPRX)
Catalyst Pharmaceuticals, Inc is a biopharmaceutical company focused on the development and commercialization of therapies for patients living with rare neuromuscular, neurological and metabolic diseases. The company’s mission centers on delivering safe and effective treatments that address unmet medical needs in small patient populations.
The company’s lead product is Firdapse® (amifampridine phosphate), a treatment approved by the U.S. Food and Drug Administration for adults with Lambert-Eaton Myasthenic Syndrome (LEMS).
