ANI Pharmaceuticals (NASDAQ:ANIP) executives said at the Jefferies Healthcare Conference that the company remains focused on accelerating its transformation into a rare disease business, with Cortrophin Gel and ILUVIEN positioned as the company’s primary durable growth assets.
Chief Executive Officer Nikhil Lalwani said ANI’s full-year guidance calls for revenue of $1.08 billion to $1.14 billion and adjusted non-GAAP EBITDA of $285 million to $300 million. Based on guidance issued May 8, Lalwani said rare disease products account for approximately 60% of revenue.
Cortrophin Remains Central to Growth Outlook
Cortrophin Gel, ANI’s lead rare disease asset, was a major focus of the discussion. The company’s guidance for Cortrophin is $540 million to $575 million for the year, and Lalwani said underlying market demand remains the most important driver of sales.
He said ANI sees large, underpenetrated addressable patient populations across target indications including nephrology, neurology, pulmonology and ophthalmology, as well as acute gouty arthritis flares. For gout, Lalwani said about 9.9 million patients in the U.S. suffer from gout, but ANI defines its addressable market more narrowly as approximately 285,000 patients who have 1.5 to two flares per year and receive injectable treatment.
ANI faced insurance reverification headwinds in the first quarter, but Lalwani said those issues had been worked through as the company entered the second quarter. He also said April produced the highest number of new patient starts and dispensed volumes since launch.
Asked about May trends and third-party prescription data, Lalwani declined to provide intra-quarter guidance but said “the momentum continues.” He added that ANI has heard from investors about volatility in IQVIA data, including for products beyond Cortrophin, and said the company had provided second-quarter guidance to help investors understand what management is seeing in its internal data.
Gout Expansion Targets Primary Care and Podiatry
ANI is expanding its Cortrophin commercial effort to reach primary care physicians and podiatrists treating severe acute gouty arthritis flares. Lalwani said the company has built a roughly 90-person expansion effort, including 64 sales representatives, and that nearly 80% of the field force had been recruited, trained and deployed in May, with the remainder expected in June.
The company is targeting about 7,000 health care providers identified through claims analysis as treating patients with severe acute gouty arthritis flares. Lalwani said the expansion follows successful pilots conducted in 2025, when ANI directed 10 territories to focus on primary care and podiatry.
Lalwani described Cortrophin as a late-line or last-line option for flare management, not a disease-modifying therapy. He said appropriate patients typically have severe flares that are not controlled by therapies such as NSAIDs, colchicine or steroids, or they experience significant side effects from other treatments.
“Almost all patients that take Cortrophin have stepped through multiple other therapeutics before they’re trying Cortrophin for flare management,” Lalwani said.
He acknowledged that primary care and podiatry offices may have less experience with involved enrollment forms and prior authorization processes than some specialist offices. ANI is investing in personnel, systems and processes to support enrollment-to-fulfillment, he said.
Management Highlights Franchise Durability
Lalwani said ANI believes Cortrophin has a “strong multi-year growth runway” and described ACTH products as difficult to genericize. He cited complex formulation and a difficult path to demonstrating sameness, adding that both ACTH market participants have intellectual property extending into the early 2040s.
He also said the broader ACTH market is expected to grow as both ANI and its competitor work to expand the market. On a combined basis, Lalwani said the market is expected to grow about 30% when adding ANI’s guidance and the competitor’s guidance.
On the Inflation Reduction Act, Lalwani said the law remains an evolving landscape. He noted that ANI saw a modest tailwind in 2025 from Part D benefit redesign and inflation rebates, as reduced out-of-pocket exposure and smoothing helped access and volume, while the company also paid an inflation rebate. Regarding future drug price negotiations, he said there would be a balance between potentially improved access and lower pricing.
ILUVIEN and Generics Support Rare Disease Strategy
Lalwani said ILUVIEN, acquired through ANI’s 2024 acquisition of Alimera, is ANI’s second rare disease asset. The intravitreal implant is used to treat diabetic macular edema and chronic non-infectious uveitis affecting the posterior segment of the eye. He said ILUVIEN is synergistic with Cortrophin in ophthalmology and also has a large addressable market and multi-year growth potential.
ANI’s generics business remains part of the company’s broader capital allocation strategy. Lalwani said generics and smaller branded products generate EBITDA and cash flow that can be deployed to expand the rare disease business. The company plans to invest a high single-digit percentage of generic sales into generics research and development to support 10 to 15 new product launches annually.
Harmony Licensing Deal Adds Royalty Stream
Chief Financial Officer Stephen Carey also discussed an intellectual property licensing agreement with Harmony Biosciences involving IP developed by ANI subsidiary Novitium. Carey said ANI recorded a $15 million upfront licensing fee in the first quarter and expects to earn a $10 million development milestone between the second and third quarters for development work performed on Harmony’s behalf.
Carey said ANI will receive a low single-digit royalty on Harmony’s pitolisant franchise, including WAKIX, which he said has roughly $1 billion in annual sales. He added that the royalty applies to all formulations of pitolisant.
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.
