ANI Pharmaceuticals Targets $1B+ Sales in 2026, Pivots to Rare Disease Growth

Company outlines strategy to expand rare disease business while using generics cash flow to fund investment

Mar. 3, 2026 at 7:55am

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ANI Pharmaceuticals (NASDAQ:ANIP) executives outlined a growth strategy centered on expanding its rare disease business, including its lead asset Cortrophin Gel, while using cash flows from its generics segment to fund further investment. The company is projecting over $1 billion in sales in 2026 and expects the rare disease business to represent roughly 60% of total revenues that year.

Why it matters

ANI's pivot to rare diseases represents a strategic shift for the company, as it looks to capitalize on the high-growth and high-margin potential of the rare disease market. The company's rare disease business generated $423 million in revenue in 2025, up 84% year-over-year, and is expected to grow to $618-$658 million in 2026. This growth is being driven by the company's lead rare disease asset, Cortrophin Gel, which is approved in multiple indications and has high regulatory and IP barriers to generic entry.

The details

ANI's 2026 guidance calls for revenue of $1.055 billion to $1.115 billion, representing 19% to 26% growth, and adjusted non-GAAP EBITDA of $275 million to $290 million, representing 20% to 26% growth. The company's three key priorities for 2026 are: 1) Accelerate transformation into a leading rare disease company, 2) Continue execution in Generics, and 3) Execute disciplined capital allocation. On the rare disease front, ANI plans to build a 90-person organization dedicated to acute gouty arthritis flares, which represented over 15% of Cortrophin Gel use in 2025. The company is also advancing a phase IV trial to support Cortrophin in acute gouty arthritis flares and investing in investigator-initiated trials and preclinical work to support Cortrophin's mechanism of action.

  • ANI reported 2025 revenue of $883 million, representing 44% year-over-year growth.
  • ANI's rare disease business generated $423 million of revenue in 2025, up 84% year-over-year.
  • Cortrophin Gel grew from $198 million to $347 million in 2025, a year-over-year increase of 76%.
  • ANI's 2026 guidance calls for Cortrophin Gel sales of $540 million to $575 million, representing growth of 55% to 65%.
  • ILUVIEN returned to growth in 2025 through commercial and patient access initiatives.

The players

Nikhil Lalwani

CEO of ANI Pharmaceuticals.

Stephen Carey

CFO of ANI Pharmaceuticals.

ANI Pharmaceuticals

A United States–based specialty pharmaceutical company focused on the development, manufacturing and commercialization of generic and branded prescription drugs.

Cortrophin Gel

ANI's lead rare disease asset, approved in multiple indications across specialties including neurology, nephrology, rheumatology, ophthalmology, and pulmonology.

ILUVIEN

ANI's second rare disease asset, approved for diabetic macular edema (DME) and chronic non-infectious uveitis affecting the posterior segment of the eye (NIU-PS).

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What they’re saying

“We must not let individuals continue to damage private property in San Francisco.”

— Robert Jenkins, San Francisco resident

“Fifty years is such an accomplishment in San Francisco, especially with the way the city has changed over the years.”

— Gordon Edgar, grocery employee

The takeaway

ANI's pivot to rare diseases represents a strategic shift for the company, as it looks to capitalize on the high-growth and high-margin potential of the rare disease market. The company's rare disease business is expected to generate over 60% of its total revenue by 2026, driven by strong growth in its lead asset Cortrophin Gel. This transition is being funded by cash flows from ANI's generics segment, which the company continues to execute on with a target cadence of 10-15 new launches per year.