ANI Pharmaceuticals touts rare-disease pivot at Barclays, guides 2026 revenue above $1B

Key Points

• Strong 2025 results and bold 2026 guidance: ANI grew ~44% revenue and ~47% adjusted EBITDA in 2025 and is guiding 2026 to $1.055–$1.115 billion in revenue, $540–$575 million in Cortrophin sales, and $275–$290 million adjusted non-GAAP EBITDA, with rare disease expected to be roughly 60% of revenue.
• Cortrophin seen as the primary growth driver: Cortrophin grew ~75% to $347 million in 2025, with management pointing to large underpenetrated indications (e.g., acute gout flares), an expanding prescriber base, product differentiation versus the competitor, and patents into the 2040s supporting a long runway.
• Generics remain an important cash engine but BD shifts to rare disease: The generics business (about $384 million in 2025) supplies cash flow and R&D investment, but ANI expects generics to be relatively flat in 2026 while prioritizing acquisitions of commercial-stage, rare-disease assets that leverage its specialty infrastructure.

ANI Pharmaceuticals NASDAQ: ANIP executives told investors at a Barclays conference that the company’s transformation toward rare disease is accelerating, supported by strong 2025 performance and guidance calling for continued growth in 2026. President and CEO Nikhil Lalwani and CFO Stephen Carey highlighted momentum in the company’s lead rare disease product, Cortrophin, and outlined commercial initiatives intended to extend that trajectory, while emphasizing that the generics segment remains an important cash flow engine.

2025 results and 2026 outlook

Lalwani said 2025 marked an important year in ANI’s shift toward rare disease, with the company growing 44% on the top line and 47% on adjusted non-GAAP EBITDA. The performance was driven primarily by the rare disease segment, particularly Cortrophin, which he said grew 75%–76% to $347 million in 2025 revenue. ANI’s generics business also grew, increasing 28% to $384 million.

For 2026, management said it expects rare disease to represent about 60% of revenue. The company guided to:

• Cortrophin revenue of $540 million to $575 million in 2026, compared with $347 million in 2025.
• Total company revenue of $1.055 billion to $1.115 billion, described as “in excess of $1 billion.”
• Adjusted non-GAAP EBITDA of $275 million to $290 million.

Lalwani said the company is balancing growth and profitability, describing expected 2026 growth of roughly 19%–26% on the top line and 20%–26% on adjusted non-GAAP EBITDA.

Cortrophin: growth runway and competitive dynamics

Much of the discussion focused on Cortrophin Gel and questions around durability. Lalwani argued that the growth opportunity is supported by significant underpenetration across multiple indications. Using acute gouty arthritis flares as an example, he said there are 9.9 million patients in the U.S. with the condition, but only 36% receive treatment annually and only 8% receive injectable treatments. ANI estimates an addressable population of 285,000 patients for that indication, compared with “less than 10,000” patients currently treated.

He said the company has expanded the physician base for ACTH therapy, noting that over 50% of Cortrophin prescribers since launch were “naive to ACTH” and had not previously written an ACTH prescription. He also said about 15% of ANI’s volume comes from acute gouty arthritis flares—an indication he said the competitor did not have during the category’s prior peak.

On the category’s history, Lalwani said the ACTH market was about $1.2 billion in 2017 before declining to roughly $600 million by 2021. He attributed the reduction to external factors, citing competitor-related issues such as litigation and bankruptcy rather than changes in clinical utility. He said that after ANI launched Cortrophin in January 2022, market decline slowed and returned to growth, with the market exiting 2025 “essentially back at the previous peak” based on fourth-quarter run rate or full-year sales.

Regarding competitive differentiation, Lalwani said both products in the category are porcine-derived but differ in formulation, peptide composition, and manufacturing processes for both active ingredient and finished-dose formulation. He noted overlapping indications between products, while stating the competitor has infantile spasms and ANI focuses commercially on acute gouty arthritis flares.

2026 cadence: sales force expansion and insurance reverifications

Carey described Cortrophin’s 2026 revenue cadence in “three layers.” First, he said the company expects continued growth based on momentum exiting 2025, though he noted a typical sequential decline in the first quarter versus the prior fourth quarter due to insurance reverifications.

Second, he said ANI is adding resources focused on the gouty arthritis flares indication, with recruitment underway and the expanded team expected to be in the field by mid-year. Carey said this should contribute to a step-up in revenue during the third and fourth quarters, with continued productivity improvements into 2027.

Third, Carey said the company observed that January insurance verification volume is taking longer due to increased workload, which could shift some volume out of January into later months. He emphasized the volume “doesn’t go away” but may move back by “a month or so,” and said the company provided additional specificity to the first quarter accordingly.

ILUVIEN: label consolidation and commercial initiatives

Lalwani said the Alimera acquisition was intended to build a therapeutic area presence in ophthalmology that is synergistic with Cortrophin commercially. He said ANI retained about 31 representatives from the transaction, added another 14, and now has about 45 reps promoting both Cortrophin and ILUVIEN to retina specialists and ophthalmologists.

He characterized 2025 as a “reset year” for ILUVIEN and said 2026 should benefit from a strengthened commercial team and marketing initiatives. He also pointed to the release of NEW DAY clinical study results, which he said the company believes will support the use of ILUVIEN earlier in the treatment of diabetic macular edema (DME).

Lalwani discussed challenges related to Medicare co-pay funding support, stating no return of that funding was assumed in guidance. However, he said ANI has had success encouraging leading retina practices to use alternate approaches for patients with Part D benefits to access ILUVIEN. He also said the company merged the label of YUTIQ into ILUVIEN, resulting in a single product indicated for both DME and chronic non-infectious uveitis in the posterior segment of the eye, which he said simplifies ordering and inventory for physician offices. Lalwani added that ILUVIEN is a long-acting intravitreal injection that delivers fluocinolone acetonide over a three-year period.

Generics, margins, and business development priorities

On generics, Lalwani said ANI has historically targeted high single-digit to low double-digit growth but has outperformed, citing a roughly 25% CAGR since 2021. He attributed performance to R&D execution, operational execution, and a U.S.-based manufacturing footprint, and said ANI invests a high single-digit percentage of generics sales into R&D, supporting 10–15 new product launches annually. For 2026, he said the company’s “orientation” is for generics to remain relatively flat following 2025’s outperformance.

Carey addressed gross margin dynamics, saying legacy brands carry the highest gross margin, generics the lowest, and rare disease sits between them due largely to a Cortrophin royalty paid to Merck. He added that 2025-to-2026 comparisons are influenced by mix changes and the non-recurrence of a 180-day prucalopride launch benefit in the first half of 2025. Carey said that as rare disease becomes a larger share of revenue, it should be accretive to gross margin, and he agreed with the characterization that 2027 could show operating leverage as 2026 investments, including sales force expansion, are annualized.

On capital allocation and business development, Lalwani said ANI sees significant organic growth opportunities but is focused on deals that expand the scope and scale of the rare disease business, with a near-term emphasis on commercial-stage assets without clinical risk. He described two categories of interest: assets synergistic with Cortrophin’s call points, and assets that can leverage ANI’s rare disease infrastructure such as patient support, specialty pharmacy distribution, hub services, medical affairs, and market access.

In closing remarks, Lalwani said he believes the long-term growth and durability of ANI’s rare disease portfolio is underappreciated. He also stated that Cortrophin has patents “into the 2040s” and reiterated his view that both Cortrophin and ILUVIEN are difficult to genericize, supporting a “long runway” for the portfolio.

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.

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