Catalyst (CPRX) Q2 2025: Agamree Revenue Jumps 213% as Oncology Push Accelerates

2025-08-07 | By EarningsIQ Research

Catalyst’s Q2 saw Agamree revenue surge 213% as the company doubled down on oncology expansion for Ferdaps and managed Ficompa’s generic erosion. Strategic sales force investments and updated NCCN guidelines position the portfolio for continued momentum, with guidance reaffirmed and new growth drivers emerging for 2026.

Summary

• Agamree Outpaces Expectations: Revenue tripled as conversion and retention rates strengthened across DMD centers.
• Ferdaps Oncology Penetration Accelerates: Updated NCCN guidelines and targeted HCP education set up next-phase growth.
• Guidance Reaffirmed Amid Ficompa LOE: Portfolio execution and BD pipeline offset generic headwinds and support long-term growth.

Performance Analysis

Catalyst delivered another record-setting quarter, with total revenue reaching $146.6 million, up modestly year over year. The portfolio’s core growth engine, Ferdaps, generated $84.8 million, continuing its multi-quarter growth trajectory and reflecting strong demand and adherence in both neurology and oncology segments. First-half performance for Ferdaps was up 16.9% YoY, normalizing after last year’s temporary Q1-to-Q2 volume shift caused by the Change Healthcare cyber incident.

The headline was Agamree, which posted $27.4 million in net product revenue, a 213% increase YoY, driven by robust conversion from legacy steroids and high patient retention (90%). The product is now adopted by 93% of top DMD centers, with strong payer alignment and broad prescriber engagement. Ficompa, while still contributing $34.3 million, declined 6% YoY as generic competition began to erode its base. Cash generation was another highlight, with cash and equivalents rising to $652.8 million, providing ample flexibility for R&D and business development as Ficompa’s exclusivity wanes.

• Agamree Momentum Surges: Post-launch revenue and retention rates outpaced expectations, with key centers and HCPs rapidly adopting the therapy.
• Ferdaps Oncology Expansion: Updated NCCN guidelines and frictionless BGCC antibody testing are accelerating patient identification and expanding the addressable market.
• Ficompa Faces Generic Decline: Erosion from the first generic entrant is underway, but mitigation strategies and cautious guidance remain in place.

SG&A and R&D expenses rose as Catalyst invested in dual dedicated sales forces and ongoing Agamree studies, but these costs were offset by operational leverage and strong gross margins. The company reaffirmed full-year guidance, citing positive leading indicators and robust commercial execution across the portfolio.

Executive Commentary

Strategic Positioning

1. Oncology Expansion for Ferdaps

Catalyst is leveraging updated NCCN guidelines for small cell lung cancer to accelerate Ferdaps penetration in oncology. The company rolled out a three-step strategy: frictionless in-office BGCC antibody testing, broad HCP education, and integration of new care pathways with leading oncology practices. With over 90% of cancer-associated LEMS patients undiagnosed, management sees a significant opportunity to expand the addressable market and drive growth into 2026 and beyond.

2. Agamree Commercial Execution

Agamree’s rapid adoption is underpinned by focused provider education, payer engagement, and a dedicated field team. The product’s unique positioning as a differentiated steroid for Duchenne muscular dystrophy has allowed it to capture patients transitioning from both branded and generic competitors. Ongoing real-world evidence studies and a Phase I switching trial are expected to further validate and expand Agamree’s clinical footprint.

3. Ficompa Life-Cycle and Business Development

Ficompa’s loss of exclusivity (LOE) is being actively managed, with only one generic competitor in the market and management taking a prudent approach to guidance. To offset future erosion, Catalyst is aggressively pursuing business development (BD) opportunities, describing the current environment as one of the best for asset acquisition in years. Inbound deal flow remains strong, and BD is viewed as a critical lever for sustaining long-term growth as Ficompa’s contribution declines.

4. Operational Investments and Infrastructure

SG&A and sales force investments reflect a deliberate effort to scale commercial reach, especially in oncology and rare disease segments. The addition of new leadership in medical affairs and the board further strengthens Catalyst’s capability to execute on clinical, regulatory, and commercial fronts.

5. Portfolio Protection and Manufacturing Strategy

Patent litigation for Ferdaps continues, with key hearings scheduled for Q4 2025. On the manufacturing side, Catalyst is proactively transitioning Agamree production to the US to shield against potential pharma tariffs, mirroring the already domestic production of Ferdaps. This move is designed to ensure supply chain resilience and minimize future cost risk.

Key Considerations

Catalyst’s Q2 was defined by a clear pivot toward growth levers that will define its mid-term trajectory, as legacy revenue faces generic erosion and new launches ramp. Commercial execution, strategic investments, and a robust balance sheet set up a multi-year runway, but execution on expansion and BD will be critical to offset headwinds.

Key Considerations:

• Oncology Opportunity Scale: The oncology segment for Ferdaps is still early, with revenue mix expected to grow meaningfully only after 2026 as diagnostic initiatives and education take hold.
• Agamree Differentiation: High adoption and retention are promising, but sustained payer support and clinical data from ongoing studies will be needed to entrench market share.
• Generic Risk Management: Ficompa guidance remains prudent, with management expecting additional generic entrants by year-end, potentially impacting Q4 sales.
• Cost Structure Evolution: SG&A is expected to rise in the second half as sales force and educational investments ramp, but these are positioned as growth enablers rather than margin headwinds.
• Business Development as a Growth Lever: Management’s emphasis on BD and portfolio expansion is a direct response to future Ficompa revenue loss, with a strong pipeline of opportunities under review.

Risks

Key risks include: the pace of oncology revenue mix shift for Ferdaps, successful differentiation and reimbursement for Agamree in a competitive DMD market, and the timing and magnitude of Ficompa generic erosion. Patent litigation outcomes and manufacturing transitions add operational and regulatory uncertainty. Business development execution risk remains high, as inorganic growth must be both accretive and aligned with Catalyst’s rare disease focus.

Forward Outlook

For Q3 2025, Catalyst guided to:

• Continued growth in Ferdaps and Agamree, with oncology initiatives ramping.
• Ficompa revenue decline as additional generics potentially enter the market by December.

For full-year 2025, management reaffirmed guidance:

• Total revenue of $545 million to $565 million.
• Ferdaps net product revenue of $355 million to $360 million.
• Agamree net product revenue of $100 million to $110 million.
• Ficompa net product revenue of $90 million to $95 million.

Management highlighted that leading indicators for new patient starts, refill volumes, and HCP engagement remain strong, and that oncology expansion and BD will be the primary growth drivers into 2026.

Takeaways

Catalyst’s Q2 underscores a transition phase, with high-growth assets and new market segments offsetting legacy erosion and supporting a multi-year growth story.

• Portfolio Diversification: Agamree’s acceleration and oncology expansion for Ferdaps are critical to offsetting Ficompa’s generic-driven decline.
• Execution on Expansion: Dedicated sales forces and updated guidelines are translating into stronger HCP engagement, but the pace of oncology revenue growth will be a key watchpoint.
• Business Development Imperative: With Ficompa’s LOE, inorganic growth is now a core strategic lever, and execution on BD will shape the company’s long-term value creation.

Conclusion

Catalyst’s Q2 2025 results reflect a company in the midst of a strategic shift, as it leverages commercial momentum, new clinical data, and business development to drive the next wave of growth. While legacy headwinds persist, the balance sheet and execution discipline position Catalyst to deliver on its long-term vision.

Industry Read-Through

Catalyst’s results highlight key themes for the rare disease and specialty pharma sector: rapid post-launch adoption is possible with targeted provider education and payer engagement, but sustained growth requires ongoing investment and differentiation. The oncology channel remains underpenetrated for rare disease therapies, but updated guidelines and streamlined diagnostics are unlocking new market opportunities. Generic erosion risk is a structural challenge, making business development and portfolio diversification essential for mid-cap pharma players. Manufacturing localization and supply chain resilience are now core strategic priorities across the industry, especially as tariff and regulatory risks rise.

CPRX Healthcare Pharmaceuticals Rare Disease Oncology Business Development DMD Generic Risk