ANI Pharmaceuticals Poised for Growth with Cortrophin Gel Sales and Gout Treatment Expansion

ANI Pharmaceuticals, Inc. (NASDAQ: ANIP) is projecting significant revenue growth in 2026, driven largely by its rare disease portfolio, particularly Cortrophin Gel. The company anticipates total revenue between $1.055 billion and $1.115 billion, with Cortrophin Gel sales reaching $540 million to $575 million, up from $347 million in 2025. This growth is fueled by existing indications and a new strategic push into the acute gouty arthritis market.

Financial Outlook for 2026

ANI Pharmaceuticals provided financial guidance for 2026 during a presentation at the Leerink Partners Global Healthcare Conference. Key projections include:

• Total Revenue: $1.055 billion to $1.115 billion (approximately 19% to 26% growth)
• EBITDA: $275 million to $290 million (approximately 20% to 26% growth)
• Cortrophin Gel Sales: $540 million to $575 million
• ILUVIEN Sales: $78 million to $83 million (4% to 11% growth)

Rare disease products are expected to contribute approximately 60% of the company’s total revenue in 2026.

Expanding Cortrophin Gel’s Reach

Cortrophin Gel (repository corticotropin injection USP) is an ACTH product used for various autoimmune indications, including cases where patients are steroid-resistant or experience significant side effects from steroids [1]. ANI Pharmaceuticals is strategically expanding its market penetration for Cortrophin Gel through several key initiatives:

• Prefilled Syringe Adoption: Over 70% of Cortrophin Gel volume is now administered using the prefilled syringe format, exceeding initial expectations [2].
• Phase 4 Clinical Trial: A 160-patient Phase 4 clinical study is underway to evaluate Cortrophin Gel’s efficacy in acute gouty arthritis flares. This study aims to support guideline inclusion and improve reimbursement access [3].
• Acute Gouty Arthritis Sales Push: ANI plans to launch a dedicated sales team targeting approximately 7,000 primary care physicians and podiatrists in mid-2026. This team will consist of roughly 65 sales representatives and eight business leaders [3].

Targeting the Acute Gouty Arthritis Market

ANI Pharmaceuticals has identified a total addressable market (TAM) of approximately 285,000 patients for Cortrophin Gel in the acute gouty arthritis setting. This estimate is based on the following data:

• 9.9 million U.S. Patients with gout
• 36% of gout patients are treated annually
• 8% of those treated receive injectable medications

The company believes this market is currently under-penetrated and represents a significant growth opportunity. Cortrophin Gel is indicated as a short-term adjunctive therapy during acute gouty arthritis flares [4].

Addressing Q1 Challenges and Looking Ahead

ANI Pharmaceuticals experienced some headwinds in the first quarter of 2026 due to insurance reverification delays and weather disruptions. However, management anticipates these challenges will be largely resolved in the second quarter, with continued growth throughout the year. February volumes were 25% higher than January, and the company reported the second-highest number of new cases initiated on record.

ILUVIEN Expansion

ANI Pharmaceuticals too highlighted progress with ILUVIEN, an intravitreal therapy for diabetic macular edema (DME) and chronic non-infectious uveitis affecting the posterior segment of the eye. The company is focused on expanding ILUVIEN’s use to patients who haven’t responded optimally to other treatments and improving access through commercial execution and patient support programs.