ANI Pharmaceuticals Targets $1B+ Sales in 2026, Pivots to Rare Disease Growth at Raymond James Conf.

ANI Pharmaceuticals (NASDAQ:ANIP) executives outlined a growth strategy centered on expanding its rare disease business while using cash flows from its generics segment to fund further investment, during a presentation at the Raymond James Conference. CEO Nikhil Lalwani and CFO Stephen Carey participated, with Lalwani delivering the prepared remarks.

Company positioning and growth outlook

Lalwani described ANI as a “profitable high-growth biopharmaceutical organization” that is “transforming into a leading rare disease company.” He said the company is projecting more than $1 billion in sales in 2026 and expects the rare disease business to represent roughly 60% of total revenues that year.

ANI reported 2025 revenue of $883 million, representing 44% year-over-year growth, and adjusted non-GAAP EBITDA of $230 million, up 47% year-over-year. Lalwani also highlighted what he called a track record of growth from 2022 through the company’s 2026 outlook, citing 36% compound annual growth in revenue through 2026 (including 2026 guidance) and 50% adjusted non-GAAP EBITDA growth over that period.

2026 guidance and strategic priorities

Management provided 2026 guidance calling 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.

Lalwani outlined three priorities for 2026:

• Accelerate transformation into a leading rare disease company, led by Cortrophin Gel and efforts to return ILUVIEN to growth.
• Continue execution in Generics, including a target cadence of 10 to 15 launches per year.
• Execute disciplined capital allocation, including potential inorganic expansion of the rare disease business, investment in a dedicated gout organization for Cortrophin, and reinvesting a high single-digit percentage of generics revenue into generics R&D.

Rare disease growth led by Cortrophin Gel

ANI’s rare disease business generated $423 million of revenue in 2025, up 84% year-over-year, according to Lalwani. The company expects rare disease revenue to grow to $618 million to $658 million in 2026—an increase of 51%—which would make it about 60% of company revenue.

The company’s lead rare disease asset, 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%.

Lalwani said Cortrophin is approved in multiple indications across specialties including neurology, nephrology, rheumatology, ophthalmology, and pulmonology, and he characterized several of these areas as under-penetrated with significant unmet need. He also described the ACTH market as a “two-player market” that approached $1 billion in 2025, growing 45% year-over-year, and said it has high regulatory and intellectual property barriers to generic entry.

As part of its commercial strategy, ANI plans to build and deploy a 90-person organization dedicated to acute gouty arthritis flares by mid-year. Lalwani said acute gouty arthritis flares represented more than 15% of Cortrophin Gel use in 2025 and that the company ran “successful pilots across 10 territories” in primary care and podiatry during 2025. He also noted that ANI is advancing a phase IV trial to support Cortrophin in acute gouty arthritis flares and continues to invest in investigator-initiated trials and preclinical work to support Cortrophin’s mechanism of action.

On patient convenience initiatives, Lalwani said ANI launched a prefilled syringe presentation for Cortrophin in 2025 and has seen “significant adoption,” and that the company is evaluating additional opportunities to enhance convenience.

ILUVIEN initiatives and headroom for growth

ANI’s second rare disease asset, ILUVIEN, is approved for diabetic macular edema (DME) and chronic non-infectious uveitis affecting the posterior segment of the eye (NIU-PS). Lalwani described DME as a leading cause of vision loss in diabetic patients and said there are more than 50,000 U.S. patients not well-served by anti-VEGF therapy, while fewer than 5,000 patients start ILUVIEN annually for DME. For NIU-PS, he cited more than 75,000 U.S. patients as candidates for treatment and similarly said fewer than 5,000 patients start ILUVIEN annually, which he described as creating significant headroom.

Lalwani said ILUVIEN is the “only longest-acting ocular therapy” approved for DME and chronic NIU-PS, delivering 36 months of continuous microdosing of fluocinolone acetonide. He said ILUVIEN returned to growth in 2025 through commercial and patient access initiatives and that ANI plans to continue that momentum with additional marketing and medical affairs investments to increase awareness of NEW DAY clinical data, expanded coverage for both indications, and growth in alternative access channels for Medicare patients.

Generics segment: cash flow engine and manufacturing footprint

Lalwani positioned the generics business as a driver of cash flow that supports investment in rare disease. He said ANI grew its generics business 12% in 2024 and 28% in 2025, supported by what he described as superior R&D capabilities, operational execution, and a U.S.-based manufacturing footprint. He cited a cadence of new launches in 2025, including a first-to-market launch of prucalopride and a partner generic launch.

ANI expects to deliver 10 to 15 new generics product launches annually and invests a high single-digit percentage of generics sales into R&D, according to Lalwani. He said the generics portfolio includes 125 product families, with the largest product expected to be less than 5% of 2026 generics revenue, emphasizing low concentration.

On manufacturing, Lalwani said ANI operates three U.S.-based sites—one in East Windsor, New Jersey, and two in Baudette, Minnesota—each in VAI or NAI status with a strong GMP track record. He said the company supplied more than 2.5 billion doses of therapeutics over the last 12 months. Lalwani added that more than 90% of revenues come from finished goods manufactured in the U.S., and that 5% of revenues have a direct reliance on China.

To close, Lalwani said ANI entered 2026 with more than $286 million in cash and 2025 year-end net leverage of 1.5x, and he reiterated the company’s expectation of sales exceeding $1 billion in 2026 alongside continued deleveraging as cash is generated.

About ANI Pharmaceuticals (NASDAQ:ANIP)

ANI Pharmaceuticals, Inc is a United States–based specialty pharmaceutical company focused on the development, manufacturing and commercialization of generic and branded prescription drugs. The company operates as an end-to-end provider, offering services that range from active pharmaceutical ingredient (API) production and formulation development to finished dosage form manufacturing and packaging.

ANI’s product portfolio encompasses injectable and oral therapies across several therapeutic areas, including endocrinology, oncology, pain management and respiratory care.