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Catalyst Pharmaceuticals, Inc. (CPRX): Business Model Canvas [Dec-2025 Updated] |
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Catalyst Pharmaceuticals, Inc. (CPRX) Bundle
You're digging into the mechanics of a specialty pharma success story, and honestly, the business model for Catalyst Pharmaceuticals, Inc. as of late 2025 boils down to disciplined commercial execution on rare disease assets, all sitting on a fortress balance sheet. They are projecting total 2025 revenue between \$565 million and \$585 million from FIRDAPSE, AGAMREE, and FYCOMPA, while sitting on a war chest of \$689.9 million in cash and equivalents as of Q3 2025. This model is built to maximize the value of their intellectual property, especially FIRDAPSE exclusivity extending to 2035, so let's break down the nine essential blocks showing exactly how they manage patient access, defend their market, and deploy that capital.
Catalyst Pharmaceuticals, Inc. (CPRX) - Canvas Business Model: Key Partnerships
You're looking at the structure that lets Catalyst Pharmaceuticals, Inc. get its specialized medicines to patients, especially given their focus on rare diseases. The Key Partnerships block is critical here, as it dictates both geographic reach and future revenue security.
Exclusive Canadian commercialization partner, KYE Pharmaceuticals
Kye Pharmaceuticals acts as Catalyst Pharmaceuticals, Inc.'s dedicated partner for the Canadian market. Kye already handles commercialization for FIRDAPSE® in Canada. Furthermore, Kye secured the exclusive Canadian commercial rights for AGAMREE® (vamorolone), with Catalyst supplying the product. Kye assumes full responsibility for funding all regulatory, marketing, and commercialization efforts for AGAMREE in Canada. Health Canada accepted the New Drug Submission (NDS) for AGAMREE with Priority Review as of April 8, 2025, with potential marketing authorization before the end of 2025. You can see how this partnership supports the expansion of Catalyst Pharmaceuticals, Inc.'s second rare disease product.
The commercial performance tied to these partnerships is clear in the 2025 figures:
| Product/Metric | Q1 2025 Net Revenue | Q2 2025 Net Revenue | Full-Year 2025 Guidance Range |
|---|---|---|---|
| FIRDAPSE® (LEMS) | $83.7 million | $168.6 million (Year-to-Date) | $355 million to $360 million |
| AGAMREE® (DMD) | $22.0 million | $27.4 million | $100 million to $110 million |
| FYCOMPA® | $35.6 million | N/A | N/A |
| Total Product Revenue, Net | $141.4 million | $146.6 million (Q2 Only) | $545 million to $565 million |
For the first half of 2025, total revenue reached $288 million. FIRDAPSE net product revenue for the first half of 2025 was $168.6 million, and based on guidance, it represents about 66% of the total expected 2025 revenue.
Lupin Ltd. for FIRDAPSE generic entry settlement in 2035
Catalyst Pharmaceuticals, Inc. settled patent litigation with Lupin Pharmaceuticals regarding a generic version of FIRDAPSE. Lupin receives a license to market its generic version no earlier than February 25, 2035, pending FDA approval. Catalyst and its licensor, SERB S.A., will receive royalties from Lupin's generic sales. This settlement resolves litigation in the U.S. District Court for the District of New Jersey and follows similar arrangements with Teva Pharmaceuticals and Inventia Life Science.
Academic and clinical research collaborators for pipeline development
The commitment to advancing therapies is supported by external data presentation, which implies research collaborations. Data developed by or in conjunction with Catalyst Pharmaceuticals, Inc. was scheduled for presentation at scientific conferences in October 2025, including:
- Child Neurology Society (CNS) Annual Meeting Poster #: 281 and 353.
- American Association of Neuromuscular & Electrodiagnostic Medicine (AANEM) Annual Meeting Poster Number: 314.
Contract Manufacturing Organizations (CMOs) for drug supply chain (implied)
While specific CMO names aren't public, Catalyst Pharmaceuticals, Inc. is responsible for the clinical and commercial supply of AGAMREE to Kye Pharmaceuticals for the Canadian market. Furthermore, management noted they were working on transitioning the U.S. manufacturing for AGAMREE to third-party manufacturers. This indicates a reliance on external manufacturing capabilities to support the commercial portfolio.
Specialty pharmacy networks for rare disease drug distribution (implied)
The distribution strategy for rare disease drugs like FIRDAPSE relies on specialized access channels. Management noted that having a specialty pharmacy is a real benefit. For AGAMREE, adoption is expanding, with 93% of the top 45 DMD centers of excellence having submitted enrollment forms as of Q2 2025. The company ended the second quarter of 2025 with a cash position of $652.8 million, reinforcing its ability to manage these complex distribution and support services.
The company's market capitalization as of early December 2025 was $2.87 billion. That's a solid base for managing these external relationships.
Finance: draft 13-week cash view by Friday.
Catalyst Pharmaceuticals, Inc. (CPRX) - Canvas Business Model: Key Activities
You're looking at the core engine driving Catalyst Pharmaceuticals, Inc.'s performance right now. It's all about maximizing the current portfolio while aggressively de-risking the future through pipeline advancement and IP defense. Here's how the key activities break down, grounded in the latest figures.
Commercialization and marketing of FIRDAPSE, AGAMREE, and FYCOMPA
The commercial teams are executing to deliver on the reaffirmed full-year 2025 revenue guidance, which is set between $565 million and $585 million. FIRDAPSE, the primary revenue driver, continues to show organic growth, hitting $92.2 million in net product revenue for the third quarter of 2025, a 16.2% increase year-over-year. AGAMREE, the newer asset, is showing strong adoption, contributing $32.4 million in Q3 2025, which is a 115.2% jump from the third quarter of 2024. FYCOMPA is facing generic erosion, with Q3 2025 revenue at $23.8 million, reflecting a 25.8% year-over-year decrease.
Here's the quick math on the product performance as of the third quarter of 2025:
| Product | Q3 2025 Net Product Revenue (Millions USD) | Year-over-Year Change (Q3 2025 vs Q3 2024) | Full-Year 2025 Net Revenue Guidance (Millions USD) |
| FIRDAPSE | $92.2 | +16.2% | $355 to $360 |
| AGAMREE | $32.4 | +115.2% | $105 to $115 |
| FYCOMPA | $23.8 | -25.8% | $100 to $110 |
The company raised the 2025 guidance for both AGAMREE (to $105 million to $115 million) and FYCOMPA (to $100 million to $110 million) despite the FYCOMPA tablet generic entry.
Advancing a diversified R&D pipeline (e.g., ARO-101, D-Fi, LV-FAH)
Catalyst Pharmaceuticals, Inc. is actively moving pipeline assets toward critical clinical milestones. This is a key activity to ensure future revenue durability beyond the current marketed portfolio. You should track these near-term events:
- ARO-101's phase II readout is expected in Q4 2025.
- A Biologics License Application (BLA) submission for D-Fi is targeted for Q4 2025.
- The phase II registration trial for LV-FAH is scheduled to begin in July 2025.
Strategic in-licensing and acquisition of new rare disease assets
The ability to pursue new assets is supported by a very strong balance sheet. As of September 30, 2025, Catalyst Pharmaceuticals, Inc. reported $689.9 million in cash and equivalents. Importantly, the company carries no material long-term debt. This financial flexibility allows for disciplined business development, even as the board authorized a $200 million share repurchase program through December 31, 2026.
Managing patient access and reimbursement programs (Catalyst Pathways®)
For FIRDAPSE, managing patient access through the Catalyst Pathways® program is a critical operational activity. This program is designed to enhance access and contribute to medication compliance and persistence. The execution here is strong; prescription approval rates remained above 90% across both government and commercial payers in Q3 2025. Furthermore, payers are cooperative, with over 85% reimbursement success reported.
Protecting and extending intellectual property for key products
Defending market exclusivity is a major activity, especially for FIRDAPSE. Catalyst Pharmaceuticals, Inc. secured a significant win by settling patent litigation with Lupin, delaying generic entry until February 25, 2035. A similar agreement with Teva also set the generic launch date at February 25, 2035. However, the litigation against Hetero remains active. For FYCOMPA, tablet exclusivity expired on May 23, 2025, with exclusivity for the oral suspension set to expire on December 15, 2025.
Finance: draft 13-week cash view by Friday.
Catalyst Pharmaceuticals, Inc. (CPRX) - Canvas Business Model: Key Resources
You're looking at the core assets that power Catalyst Pharmaceuticals, Inc. (CPRX) right now, late in 2025. It's a model built heavily on specialized, high-value pharmaceutical products backed by significant financial firepower. These resources are what allow the company to operate with a focus on rare diseases.
The most tangible resources are the FDA-approved therapies themselves. Catalyst Pharmaceuticals, Inc. markets three key products:
- FIRDAPSE (amifampridine) for Lambert-Eaton myasthenic syndrome (LEMS).
- AGAMREE (vamorolone) for Duchenne Muscular Dystrophy (DMD).
- FYCOMPA (perampanel) for certain seizure disorders.
The commercial success of these products directly fuels the entire operation. For instance, Q3 2025 total revenues hit \$148.4 million, which led the company to raise its full-year 2025 total revenue guidance to between \$565 million and \$585 million.
Financially, the balance sheet is a major asset. As of the end of the third quarter of 2025, Catalyst Pharmaceuticals, Inc. held a strong cash and cash equivalents balance of \$689.9 million and reported having no material long-term debt. This liquidity is being deployed strategically, as evidenced by the Board of Directors authorizing a new share repurchase program of up to \$200 million of common stock, set to run between October 1, 2025, and December 31, 2026. Honestly, that kind of cash position gives management serious flexibility.
The intellectual property (IP) portfolio provides the necessary moat around the flagship product. While the initial orphan exclusivity for FIRDAPSE ended in November 2025, settlements with generic manufacturers have deferred the loss-of-exclusivity risk. Specifically, agreements with Teva Pharmaceutical and Lupin Ltd. bar their generic versions from marketing until no earlier than February 2035. Other patents related to method-of-use and dosing extend protection even further, with some running to 2037.
To manage these specialized assets, Catalyst Pharmaceuticals, Inc. maintains dedicated teams. The company relies on its specialized rare disease commercial and medical affairs teams to drive adoption for FIRDAPSE and AGAMREE, supported by patient access programs like Catalyst Pathways®. This infrastructure is key to realizing the value from their product portfolio.
Here's a quick look at the Q3 2025 product revenue breakdown, which shows where the current value is concentrated:
| Product | Q3 2025 Net Product Revenue | Year-over-Year Growth Context |
| FIRDAPSE | \$92.2 million | Delivered strong, sustained growth. |
| AGAMREE | \$32.4 million | Showed 115% Y/Y revenue growth. |
| FYCOMPA | \$23.8 million | Faced generic erosion, showing a 26% decline. |
The company's strategy also leans on its ability to execute disciplined business development and maintain high margins, minimizing internal research and development expenses relative to its revenue base. That's a deliberate choice to conserve capital for acquisitions or shareholder returns, like that \$200 million buyback.
Finance: draft 13-week cash view by Friday.
Catalyst Pharmaceuticals, Inc. (CPRX) - Canvas Business Model: Value Propositions
The value propositions for Catalyst Pharmaceuticals, Inc. center on providing specialized, approved treatments for rare, chronic, and debilitating neuromuscular and neurological diseases, supported by robust patient access infrastructure.
FIRDAPSE: Only FDA-approved treatment for Lambert-Eaton Myasthenic Syndrome (LEMS)
- FIRDAPSE generated net product revenue of $92.2 million in Q3 2025, a 16.2% increase over Q3 2024 net product revenue.
- First-half 2025 net product revenue for FIRDAPSE was $168.6 million, representing a 16.9% increase year-over-year.
- Full-year 2025 net product revenue guidance for FIRDAPSE is reaffirmed between $355 million and $360 million.
- Orphan exclusivity ended in November 2025, but method-of-use and dosing patents extend to 2037.
- A patent settlement with Teva/Lupin effectively blocks generic entry until February 2035.
- Catalyst Pharmaceuticals estimates the total U.S. adult LEMS patient population at 3,000, with approximately 1,500 definitively identified in claims data as the immediate addressable market.
AGAMREE: Differentiated, novel corticosteroid for Duchenne Muscular Dystrophy (DMD)
- AGAMREE achieved net product revenue of $32.4 million in Q3 2025, rising 115% Year/Year.
- Q2 2025 net product revenue was $27.4 million, up 212.9% year-over-year since its mid-March 2024 launch.
- First-half 2025 net product revenue for AGAMREE was $49.4 million, a 398.0% increase year-over-year.
- Full-year 2025 net product revenue guidance for AGAMREE was raised to between $105 million and $115 million.
- Management stated that all top 45 DMD centers have at least one AGAMREE patient.
FYCOMPA: Established anti-epileptic drug for partial-onset and primary generalized seizures
- FYCOMPA Q3 2025 net product revenue was $23.8 million, a 25.8% decrease compared to Q3 2024 net product revenue.
- Q2 2025 net product revenue was $34.3 million, reflecting a 6.0% year-over-year decrease due to generic entry.
- Full-year 2025 net product revenue guidance for FYCOMPA was raised to between $100 million and $110 million.
- Exclusivity protection for tablets expired on May 23, 2025, with oral suspension exclusivity set to expire on December 15, 2025.
Treatment options for chronic, debilitating neuromuscular and neurological rare diseases
The portfolio delivers multiple therapies across distinct rare disease areas, contributing to overall company performance:
| Metric | Q3 2025 Amount | Year-over-Year Change (Q3) | Full-Year 2025 Guidance Range |
| Total Product Revenue, Net | $148.4 million | 17.4% increase | $565 million to $585 million (Total Revenue) |
| FIRDAPSE Net Product Revenue | $92.2 million | 16.2% increase | $355 million to $360 million |
| AGAMREE Net Product Revenue | $32.4 million | More than doubled | $105 million to $115 million |
| FYCOMPA Net Product Revenue | $23.8 million | 25.8% decrease | $100 million to $110 million |
Comprehensive patient access and financial support via Catalyst Pathways®
Catalyst Pathways® offers multiple layers of support to ensure patients can access and afford their medication:
- Catalyst Copay Assistance: Lowers out-of-pocket costs to $0/month for patients with commercial insurance.
- Catalyst Bridge Program: Offers up to 60 days of free medication if insurance coverage verification is delayed.
- Patient Assistance Program (PAP): Provides free medicine to those who qualify based on financial and other program-specific criteria.
- The program can direct patients to nonprofit organizations for Third-Party Foundation Assistance to help pay for care costs.
- The program was last updated on 09/12/2025.
- For assistance or information, the dedicated line is 1-833-422-8259, available Monday to Friday, 7AM to 7PM CT.
Catalyst Pharmaceuticals, Inc. (CPRX) - Canvas Business Model: Customer Relationships
You're looking at how Catalyst Pharmaceuticals, Inc. keeps its specialized patient base engaged and on therapy. It's all about high-touch support, especially for rare disease treatments where the journey from diagnosis to effective dose can be tough.
High-touch, dedicated support through the Catalyst Pathways® program
The Catalyst Pathways® program is the single source for personalized treatment support for FIRDAPSE®. This service guides patients through the tricky dosing and titration regimen until they reach an effective therapeutic dose. It's also the access point for the free bridge medication for patients transitioning or facing insurer complications. Catalyst Pharmaceuticals believes this program enhances access and contributes to medication compliance and persistence. The distribution model uses a very small group of exclusive specialty pharmacies, which is standard for ultra-orphan disease products, aiming to make navigating the healthcare system easier for the patient community.
Specialized field teams for physician and center of excellence engagement
Catalyst Pharmaceuticals strategically refined its commercial outreach in early 2025 by splitting its field-based force into two distinct units. One unit focuses expressly on the marketing of FIRDAPSE®, and the other is expressly focused on the marketing of AGAMREE®. This division allows for better focus on the specific market dynamics of each product. For AGAMREE®, the company is focused on securing uptake in Duchenne muscular dystrophy (DMD) centers of excellence, with Q3 2025 net product revenue reaching $32.4 million.
Direct-to-patient and direct-to-physician educational outreach (e.g., NCCN guidelines)
Physician education is closely tied to clinical guidelines, which drive physician behavior in complex fields like oncology. Catalyst's approach included efforts to update the NCCN guidelines, which is a key part of the education opportunity paired with changes in care pathways. The company also continues to make available at no-cost a LEMS voltage gated calcium channel antibody diagnostic testing program for physicians suspecting LEMS.
Maintaining high prescription approval rates, consistently above 90%
While the exact approval rate for late 2025 isn't explicitly stated as a single figure in the latest reports, the focus on the Catalyst Pathways® program and bridge medication suggests a strong commitment to overcoming payer hurdles. The company's overall financial performance reflects strong product uptake. For example, FIRDAPSE® net product revenue in Q3 2025 was $92.2 million, reflecting sustained organic growth from new patients and enhanced dosing.
Long-term patient adherence focus to ensure persistence (discontinuation rate below 20% annualized)
Ensuring patients stay on therapy is critical, and the Catalyst Pathways® program is explicitly linked to compliance and persistence. A concrete metric reflecting patient continuation for AGAMREE® shows a retention rate of 85% when sourcing patients from existing corticosteroid users. This focus on persistence contributes to the overall revenue picture, with Catalyst raising its full-year 2025 total revenue guidance to between $565 million and $585 million.
Here's a quick look at the revenue performance that underpins the commercial relationship success through Q3 2025:
| Product | Q3 2025 Net Product Revenue | FY 2025 Guidance Range (Total Revenue) |
| FIRDAPSE® | $92.2 million | $355 million to $360 million (Product Revenue Guidance) |
| AGAMREE® | $32.4 million | $100 million to $110 million (Product Revenue Guidance) |
| Total Net Product Revenue (Implied) | $148.4 million (Total Revenue Q3 2025) | $565 million to $585 million (Total Revenue Guidance) |
The commitment to patient support is further demonstrated by the resources allocated to the commercial structure:
- Commercial field-based force split into two units by early Q2 2025.
- AGAMREE® patient sourcing strategy targets a retention rate of 85%.
- FIRDAPSE® patent protection extends until February 2035.
Catalyst Pharmaceuticals, Inc. (CPRX) - Canvas Business Model: Channels
You're looking at how Catalyst Pharmaceuticals, Inc. (CPRX) gets its specialized, high-cost medicines from the lab bench to the patient's bedside in late 2025. It's a focused approach, built around rare disease specialists and direct support.
The primary mechanism for delivering its portfolio, which includes FIRDAPSE®, AGAMREE®, and FYCOMPA®, relies heavily on specialized distribution networks, which is typical for controlled, high-cost drug delivery. This ensures proper handling and access for these niche therapies.
Dedicated U.S. Field Sales Force
Catalyst Pharmaceuticals maintains a dedicated U.S. field sales force aimed squarely at neurologists and rare disease specialists. This direct engagement is crucial for educating prescribers on therapies for conditions like Lambert-Eaton myasthenic syndrome (LEMS) and Duchenne muscular dystrophy (DMD). The company's total employee count as of October 2025 was approximately 182 employees.
The commercial execution is clearly driving results; for the third quarter of 2025, Catalyst Pharmaceuticals reported net product revenues of $148.4 million. This channel is supported by the company's confidence, leading to a raised full-year 2025 total revenue guidance between $565 million and $585 million.
Canadian Commercial Channel via Exclusive Partner
For Canada, Catalyst Pharmaceuticals uses an exclusive partner, KYE Pharmaceuticals, Inc. KYE handles the commercialization, importation, and distribution there. This partnership is key for expanding the footprint beyond the U.S. market. For instance, KYE markets FIRDAPSE® in Canada. Furthermore, as of April 2025, Health Canada accepted the New Drug Submission for AGAMREE® via KYE with Priority Review, aiming for potential marketing authorization before the end of 2025.
Direct-to-Patient Support Services (Catalyst Pathways®)
A critical component supporting prescription fulfillment and persistence is the direct-to-patient support offered through the Catalyst Pathways® program. This personalized treatment support program serves as a single source for education and guidance for patients taking FIRDAPSE® and AGAMREE®. The company explicitly states this program enhances access and contributes to medication compliance and persistence.
Scientific and Medical Conferences for Data Dissemination
Disseminating clinical data is managed through scientific and medical conferences. Catalyst Pharmaceuticals was scheduled to participate in the Citi Annual Global Healthcare Conference in December 2025 and the Bank of America CNS Therapeutics Virtual Conference in November 2025. This activity supports the ongoing adoption of their products, such as AGAMREE®, which achieved net product revenue of $32.4 million in Q3 2025.
Here's a quick look at the financial performance underpinning these channel activities for the third quarter of 2025:
| Product | Q3 2025 Net Product Revenue | FY 2025 Net Product Revenue Guidance |
|---|---|---|
| FIRDAPSE® | $92.2 million | $355 million to $360 million |
| AGAMREE® | $32.4 million | $105 million to $115 million |
| FYCOMPA® | $23.8 million | $100 million to $110 million |
The company's strong financial footing supports these channel investments. As of the end of Q3 2025, Catalyst Pharmaceuticals ended with a cash position of $689.9 million and no debt. This strength allowed the Board to authorize a new share repurchase program of up to $200 million between October 1, 2025, and December 31, 2026.
The specialized nature of the market means the sales force targets specific, small populations, such as the estimated 400-500 diagnosed LEMS patients in the U.S.. For the oncology expansion of FIRDAPSE®, management noted that potentially 90% of cancer-associated LEMS patients remain undiagnosed, representing a significant opportunity.
The primary channels used by Catalyst Pharmaceuticals, Inc. include:
- Specialty pharmacies and distributors for controlled, high-cost drug delivery.
- A dedicated U.S. field sales force targeting neurologists and rare disease specialists.
- The Canadian commercial channel managed exclusively by KYE Pharmaceuticals.
- Direct-to-patient support services via the Catalyst Pathways® program.
- Scientific and medical conferences for ongoing data dissemination.
Finance: draft 13-week cash view by Friday.
Catalyst Pharmaceuticals, Inc. (CPRX) - Canvas Business Model: Customer Segments
You're hiring before product-market fit... well, Catalyst Pharmaceuticals, Inc. (CPRX) has definitely found its fit in the rare disease space, and you need to know who is buying their products as of late 2025.
The customer segments for Catalyst Pharmaceuticals, Inc. (CPRX) are highly specialized, centering on patients with rare, often debilitating, neuromuscular and neurological conditions, as well as the healthcare professionals who treat them.
Patients with Lambert-Eaton Myasthenic Syndrome (LEMS)
This segment is served primarily by FIRDAPSE, which has a strong market position, especially after the Teva settlement secured exclusivity until February 2035.
- Estimated 400 cases of LEMS in the United States at any given time.
- The global prevalence of LEMS is estimated at about 2.8 people per million worldwide or 3.67 cases per million worldwide.
- The Total Addressable Market (TAM) for LEMS is estimated by Catalyst Pharmaceuticals, Inc. (CPRX) to be over $1 billion.
- FIRDAPSE net product revenue for Q3 2025 reached $92.2 million, showing a 16.2% year-over-year increase.
- Full-year 2025 net product revenue guidance for FIRDAPSE is reaffirmed at $355 million to $360 million.
Pediatric Patients with Duchenne Muscular Dystrophy (DMD)
AGAMREE targets this segment, showing significant growth in adoption, especially in specialized centers.
- DMD affects about 1 in every 5,000 males aged 5-9 years.
- Parent Project Muscular Dystrophy (PPMD) estimates about 15,000 young men living with Duchenne in the United States.
- AGAMREE net product revenue for Q3 2025 was $32.4 million, representing a 115.2% year-over-year increase.
- Full-year 2025 net product revenue guidance for AGAMREE was raised to $105 million to $115 million.
- AGAMREE generated $46 million in net product revenue in its first 10 months of 2024.
Patients with Epilepsy (FYCOMPA)
This segment provides revenue diversification, though facing generic headwinds in 2025.
- FYCOMPA generated net product revenues of $34.3 million in Q2 2025.
- FYCOMPA revenue for Q3 2025 was $23.8 million.
- The full-year 2025 net product revenue guidance for FYCOMPA was raised to $100 million to $110 million.
- Tablet generics for FYCOMPA began hitting the market in late May 2025, with the oral suspension remaining exclusive until mid-December 2025.
Healthcare Professionals and Centers
These are the gatekeepers and decision-makers who prescribe FIRDAPSE and AGAMREE. The company is focused on education for these groups, noting that potentially 90% of cancer-associated LEMS patients remain undiagnosed.
| Customer Type | Estimated US Population/Count (Late 2025) | Relevance/Context |
|---|---|---|
| Practicing Neurologists (US) | Roughly 16,000 to 18,000 | Treat LEMS and Epilepsy patients; a projected 19% shortfall exists by 2025. |
| DMD Centers of Excellence | Specific number not found; AGAMREE is seeing penetration into nearly all of them | Key prescribers for AGAMREE for DMD patients. |
| Neuromuscular Specialists | Subset of the total neurologist population | Primary prescribers for FIRDAPSE (LEMS). |
Global Rare Disease Patient Populations via Licensing Partners
Catalyst Pharmaceuticals, Inc. (CPRX) maintains a U.S. commercial strategy but continuously evaluates opportunities to expand its global footprint, often through partners.
- A licensing partner, KYE Pharmaceuticals, Inc., received Health Canada approval for AGAMREE on October 2, 2025, marking the first therapy approved to treat DMD in Canada.
- The company is committed to in-licensing, developing, and commercializing novel medicines for people living with rare and difficult-to-treat diseases globally.
Overall, the commercial portfolio is expected to generate total revenues between $565 million and $585 million for the full year 2025.
Finance: draft 13-week cash view by Friday.
Catalyst Pharmaceuticals, Inc. (CPRX) - Canvas Business Model: Cost Structure
You're looking at the expenses Catalyst Pharmaceuticals, Inc. incurred to support its commercial and pipeline activities as of late 2025. Honestly, for a specialty pharma company like this, the cost structure is heavily weighted toward getting the existing drugs to market and supporting patients.
The primary cost buckets for Catalyst Pharmaceuticals, Inc. in the third quarter of 2025 are clearly defined in their financial reporting. These figures show where the money went to keep FIRDAPSE®, AGAMREE®, and FYCOMPA® running and to fund future work.
| Cost Category | Q3 2025 Amount (Millions USD) | Primary Driver/Context |
| Sales, General, and Administrative (SG&A) expenses | \$47.5 million | Reflecting, in part, an increase in cancer-associated LEMS activities. |
| Cost of Goods Sold (COGS) | \$22.7 million | Consisted principally of royalties, including a 5% royalty on net sales up to $100 million for 2025. |
| Research and Development (R&D) expenses | \$2.7 million | Costs mainly supported the two ongoing AGAMREE studies. |
The SG&A figure is the one that bundles most of the commercialization and marketing spend. You can see the scale of the commercial effort when you look at the product revenues that this cost base supports; for instance, FIRDAPSE® generated net product revenue of \$92.2 million in the quarter. That's a significant operational cost to maintain.
Here's a breakdown of the implied and contextual costs related to your outline points:
- Commercialization and marketing costs for three key products: These are embedded within the \$47.5 million SG&A expense for Q3 2025.
- Activities supporting AGAMREE® commercial uptake: This is a key driver of the SG&A increase year-over-year.
- Costs associated with in-licensing and business development activities: While management actively evaluates opportunities (reportedly mulled over ~100 BD assessments), the direct Q3 2025 expense for this wasn't itemized separately from SG&A.
- License and other revenue offset: This was minimal in Q3 2025 at \$27,000, compared to \$2.3 million in Q3 2024.
The quick math shows that the core operational costs (COGS + SG&A + R&D) totaled \$72.9 million for the quarter, against total revenues of \$148.4 million. The company is definitely focused on keeping R&D lean while driving commercial execution.
Finance: draft 13-week cash view by Friday.
Catalyst Pharmaceuticals, Inc. (CPRX) - Canvas Business Model: Revenue Streams
You're looking at the core money-makers for Catalyst Pharmaceuticals, Inc. as of late 2025. The business model is heavily weighted on product sales, but those licensing deals are starting to generate secondary income streams, which is key for long-term stability.
The primary revenue drivers are the net product sales from the commercial portfolio. Management has set a clear expectation for the full fiscal year 2025, which you can see broken down here:
| Product | 2025 Net Product Sales Guidance Range |
| FIRDAPSE | \$355 million to \$360 million |
| AGAMREE | \$105 million to \$115 million |
| FYCOMPA | \$100 million to \$110 million |
When you add those up, the total 2025 revenue guidance is between \$565 million and \$585 million. This reflects the company's confidence, especially after raising the outlook following strong Q3 performance. Honestly, the growth in AGAMREE is a big part of why they felt comfortable bumping that total guidance up.
The revenue streams aren't just about what Catalyst sells directly in the U.S. The international licensing agreements bring in important, often less predictable, income:
- Royalties and milestone payments from international licensing agreements.
- Specific to AGAMREE, Catalyst pays Santhera sales-based milestones up to \$105 million plus up to low-teen percentage royalties on North American sales.
- The royalty structure for AGAMREE dictates that royalty percentages increase once net sales exceed \$100 million annually.
- For FYCOMPA, royalties owed to Eisai commence after the loss of patent protection, which started with the tablet form in May 2025.
- FYCOMPA royalties to Eisai before generic entry were tiered: 12% on net sales greater than \$10 million and less than \$100 million, 17% on net sales between \$100 million and \$125 million, and 22% on net sales greater than \$125 million.
- Post-generic entry for FYCOMPA, those royalty tiers drop to 6%, 8.5%, and 11%, respectively.
- The agreement with KYE Pharmaceuticals for AGAMREE in Canada makes Catalyst eligible to receive further reimbursement, sales milestones, and sales royalties.
To be fair, the royalty stream from AGAMREE is already partially monetized; a portion of those net royalties from Catalyst to Santhera was subject to a monetization agreement secured in 2024. That's the kind of financial engineering that keeps capital flowing for near-term growth initiatives.
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