ANI Pharmaceuticals (NASDAQ:ANIP) outlined plans to accelerate its shift toward rare disease medicines while maintaining profitability and cash generation from its generics business, according to remarks made during a company presentation and Q&A session. Management described the company as a “profitable, high-growth biopharmaceutical organization” and said it is working to transform into a “leading rare disease company.”
2026 outlook calls for first year above $1 billion in revenue
The company said it is projecting more than $1 billion in revenue in 2026, with net revenue guidance of $1.055 billion to $1.115 billion, representing 24% to 28% growth. Adjusted non-GAAP EBITDA guidance was $275 million to $290 million, or 24% to 27% growth, which management said would keep EBITDA margins around 26% even as the company increases investment spending.
2025 performance highlighted strong growth in rare disease and generics
Looking back at 2025, the company reported net revenue of $854 million to $873 million, which it said represented more than 39% growth, and adjusted non-GAAP EBITDA of $221 million to $228 million, up more than 42%. Management said growth was driven primarily by rare disease, which generated more than 84% year-over-year top-line growth, while the generics business delivered more than 20% top-line growth.
Management also stated that since 2022 the company has more than tripled revenue and more than quadrupled adjusted non-GAAP EBITDA.
Cortrophin Gel: under-penetrated indications and expansion in gout
ANI emphasized that Purified Cortrophin Gel is a purified corticotropin used as a late-line option for certain chronic autoimmune disorders and is approved across multiple indications in neurology, nephrology, rheumatology, ophthalmology, and pulmonology. The company described those areas as under-penetrated, creating what it called a “multi-year growth opportunity.”
Management said the overall ACTH market has two players and grew 45% year-over-year in 2025 to about $992 million. The company added that it believes there are substantial barriers to genericization for ACTH therapies due to regulatory and IP factors, noting that both companies have Orange Book-listed patents “into the 2040s.”
Several commercial and clinical initiatives were highlighted:
- Expanded commercial efforts: Management said a 2025 expansion of the commercial team will have a full-year impact in 2026.
- Gout-focused deployment: ANI said it is building a 90-person organization dedicated to acute gouty arthritis flares, expected to be deployed around mid-2026. The company said it expects the team to begin contributing in the back half of 2026, with a “full-scale impact” in 2027 and 2028.
- Phase 4 trial: The company said it is advancing a phase 4 study in acute gouty arthritis flares with Dr. Hyon Choi and Massachusetts General Hospital, with the goal of generating additional evidence and potentially supporting adoption in ACR treatment guidelines.
- Patient convenience: Management pointed to a prefilled syringe launched in 2025 and said adoption has been broader than initially expected. The company cited that roughly 70% of enrollments in Q3 were for the prefilled syringe, and said it continues to evaluate further convenience enhancements.
On the gout opportunity, ANI said it estimates an addressable population of about 285,000 U.S. patients with severe acute gouty arthritis flares, derived from approximately 10 million gout patients, annual treatment rates, flare frequency, and the share receiving injectable flare treatment. The company said it is the only approved ACTH therapy for acute gouty arthritis flares, and noted the gout indication represented about 15% of its 2025 usage, primarily coming from specialists such as rheumatologists and nephrologists. ANI also said it ran 10 pilots across 10 territories in 2025 targeting primary care/internal medicine and podiatry, which it described as successful, helping inform the broader mid-2026 deployment. The company said it has identified about 7,000 physician targets for the gout initiative.
Iluvien: “reset year” in 2025, return to growth targeted in 2026
ANI’s second rare disease asset, Iluvien, was described as a long-acting intravitreal implant approved for diabetic macular edema (DME) and chronic non-infectious uveitis affecting the posterior segment (NIU-PS). The company said in DME there are more than 50,000 U.S. patients not well served by anti-VEGF therapy, while Iluvien sees fewer than 5,000 patient starts annually in the U.S. ANI cited a similar dynamic in NIU-PS, with more than 75,000 candidates and fewer than 5,000 annual patients receiving Iluvien.
Management characterized 2025 as a “reset year” for Iluvien and said 2026 efforts are aimed at returning the product to growth. Initiatives discussed included strengthening the commercial team, expanded peer-to-peer education and new promotional materials, and increased marketing and medical affairs investment to raise awareness of results from the New Day clinical study, which management said read out in mid-2025. ANI also said 2026 guidance assumes no return of foundation funding for Medicare copay support, and it is pursuing alternate access pathways for certain Medicare patients, including situations where Medicare Part D drug benefits can be used with added workflow in physician offices.
Generics business positioned as cash engine; gross margin factors discussed
ANI said its generics business provides strong cash flows supported by superior R&D, operational execution, and a U.S. manufacturing footprint, including three U.S.-based manufacturing facilities. The company said it can support a cadence of 10 to 15 new product launches annually and typically invests a high single-digit percentage of generics revenue in generics R&D. It also said it manufactured and supplied more than 2.5 billion doses of therapeutics over the last 12 months.
However, management said that after strong performance in 2025—when generics grew in the low 20% range—generics in 2026 are expected to be “largely flattish” versus 2025, describing 2025 as effectively capturing “two-year growth.”
During the discussion of margins, management said 2026 gross margin guidance is 59.3% to 60.3%, down from 2025’s 61% to 62%, attributing the shift to three factors: the expiration of a 180-day exclusivity period in 2025 for prucalopride that carried “brand-type” margins, brand upside in 2025 not assumed in guidance, and an increase in Cortrophin royalties owed to Merck from the low 20% range in 2025 to the high 20% range in 2026. Management emphasized that despite roughly $50 million of incremental operating expense tied to the gout commercial expansion, the company expects to maintain EBITDA margin in 2026 and to gain operating leverage in later years.
On capital allocation, ANI said it expects to prioritize expanding the scope and scale of its rare disease business, with future acquisitions likely focused on commercial assets or those without clinical risk, though possibly with regulatory risk. Management said it generated $140 million of net cash in 2025, ending the year with approximately $285 million in cash, and cited net leverage below 1.7x. The company said it intends to continue building cash to support future business development and M&A in rare disease.
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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