ANI Pharmaceuticals' Cortrophin Multi-Year Peak Sales Outlook 2025-2026

Multi-Year Peak Sales Range for Cortrophin by Indication and Assumed Penetration Rates

Based on ANI Pharmaceuticals’ recent earnings information and management commentary for 2025 and guidance into 2026, the following insights address the multi-year peak sales range for Cortrophin Gel by indication and related penetration assumptions:

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1. Current Sales and Growth Trajectory

• Cortrophin Gel Revenue Developments:

  • 2025 full-year Cortrophin Gel net revenues reached approximately $348 million, up 76% year-over-year.
  • For 2026, ANI projects $540 million to $575 million in Cortrophin Gel net revenue, representing a 55% to 65% growth over 2025.
  • The ACTH (adrenocorticotropic hormone) therapy market approached $1 billion in sales in 2025 and is expected to grow significantly in 2026 driven by Cortrophin Gel.

  These figures clearly indicate a strong ramp-up phase and momentum in Cortrophin sales across multiple indications ¹²³⁴.

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2. Key Indications and Penetration

• Acute Gouty Arthritis Flares

  • Represented approximately 15% of Cortrophin Gel utilization in 2025.
  • ANI is deploying a 90-person dedicated organization focusing on this indication (primarily targeting around 7,000 healthcare providers identified as treating severe flares).
  • This expansion is expected to impact volumes starting in Q3 2026, with full productivity and greater sales impact anticipated in 2027 and beyond.
  • The acute gout indication is unique to Cortrophin among ACTH therapies and offers a significant underpenetrated addressable patient population of about 285,000 patients, based on estimates that only 8% of the ~3.5 million gout patients with flares receive injectable treatment annually ⁵⁶⁷⁸⁹.

• Other Specialty Indications

  • Rheumatology, nephrology, neurology, pulmonology, and ophthalmology are core specialty areas showing broad growth.
  • Expansion efforts included a larger ophthalmology sales team, with volume for Cortrophin Gel in ophthalmology doubling year-over-year in Q4 2025.
  • Approximately half of prescribers in total are new to ACTH therapy, evidencing expansion of market penetration ²⁷⁴.

• Penetration Assumptions

  • The overall ACTH market remains "significantly underpenetrated" across all indications.
  • ANI estimates that patient populations appropriate for ACT therapy are large relative to current treated patients; e.g., gout flares only partially penetrated (15% current utilization).
  • Management indicated confidence that market expansion (adding new prescribers and appropriate patients) is the primary driver, rather than share capture within existing prescribers ²¹⁰⁵¹¹.

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3. Multi-Year Peak Sales Range Considerations

• 2026 Guidance as Baseline

  • Cortrophin Gel: $540M to $575M in 2026, up 55% to 65% versus 2025.
  • Rare Disease business (driven primarily by Cortrophin) accounts for approximately 60% of ANI revenues, with total revenue guidance of $1.055B to $1.115B in 2026 showing significant rare disease weighting ¹².

• Long-Term Opportunity

  • ANI management emphasizes a "significant multiyear growth opportunity," with sales likely continuing to grow beyond the $500+ million 2026 mark as:
    • The gout-focused sales organization reaches full capacity by 2027.
    • Further penetration in underpenetrated specialties, including ophthalmology and others, continues.
    • Additional clinical evidence and patient convenience enhancements (e.g., prefilled syringes) support adoption.
  • Due to the large untreated addressable populations (e.g., millions of gout patients with only 8% injectable treatment rate) and clearest unique positioning in gout, Cortrophin’s peak sales could expand well beyond current guidance levels in the mid to long term ¹⁰⁵⁸⁴.

• Penetration Rates by Indication

  • Acute gout flares: currently ~15% of Cortrophin volume, expected to rise significantly post sales expansion.
  • Other indications (neurology, nephrology, rheumatology, pulmonology, ophthalmology): growth driven by increasing physician adoption, with many prescribers new to ACTH therapy.
  • Overall market penetration remains far below saturation, representing continued room for volume gains.

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4. Summary Table

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Conclusion

ANI Pharmaceuticals' Cortrophin Gel is on a robust upward trajectory, driven by both expansion into underpenetrated indications and significant salesforce investments — especially in acute gouty arthritis flares where Cortrophin holds a unique approved position.

• Peak sales range over the coming years is expected to exceed $575 million (2026 guidance upper bound), with meaningful upside as the gout-focused organization achieves full productivity in 2027 and penetration in other specialty indications deepens.
• The assumption of low initial penetration (~15% or less in key indications) supports a continued multiyear growth runway.
• Market expansion, not just share capture, is the primary growth thesis given the substantial underpenetrated patient populations in the ACTH therapy category.

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This analysis is based entirely on ANI’s official 2025 Q4 and full-year earnings disclosures and related management commentary from the earnings call in early 2026 ^{1210512613731415811416917}.