ANI Pharmaceuticals (NASDAQ:ANIP) executives used a presentation at the Leerink Partners Global Healthcare Conference to outline the company’s recent performance, 2026 financial outlook, and commercial initiatives centered on its rare disease portfolio, led by Cortrophin Gel.
2025 results and 2026 guidance
Chief Executive Officer Nikhil Lalwani described ANI as a “high-growth biopharmaceutical company” that is accelerating its transformation into a “leading rare disease company,” supported by cash flow from its generics and brands business.
Looking to 2026, management guided for:
- Total revenue: $1.055 billion to $1.115 billion (approximately 19% to 26% growth)
- EBITDA: $275 million to $290 million (approximately 20% to 26% growth)
- Cortrophin Gel sales: $540 million to $575 million (up from $347 million in 2025)
- ILUVIEN sales: $78 million to $83 million (4% to 11% growth)
Management said rare disease is expected to be the primary driver of growth and to represent about 60% of 2026 revenue.
Cortrophin: growth drivers and acute gouty arthritis expansion
Lalwani said Cortrophin is an ACTH product used for certain autoimmune indications, including patients who may be steroid resistant, refractory, or have high side effect profiles. He characterized Cortrophin’s markets across several indications as large and under-penetrated.
Addressing the expected increase in Cortrophin sales from $347 million in 2025 to the 2026 guidance range, Lalwani said the “bulk” of the growth should come from existing indications and the current commercial organization. ANI’s current approach includes a portfolio team calling on rheumatology, nephrology, and neurology; a dedicated pulmonology team; and a combined team selling Cortrophin and ILUVIEN into ophthalmology.
In addition, ANI plans to launch a dedicated sales effort for acute gouty arthritis flares in mid-2026, targeting primary care physicians and podiatrists. Lalwani said the overall organization expansion totals about 90 people, including roughly 65 sales representatives and eight business leaders. He said the acute gout team’s impact should begin in the back half of 2026 after sales reps are in the field around May and June, with “full-scale impact” expected in 2027.
As rationale for focusing on acute gouty arthritis flares, Lalwani cited three points discussed during the session: ANI has an acute gouty arthritis flares indication that a competitor does not; acute gouty arthritis flares represent more than 15% of Cortrophin volume and have largely come from rheumatologists and nephrologists; and ANI conducted 10 pilot programs last year that it described as successful, providing confidence to expand.
Lalwani said ANI identified about 7,000 target healthcare providers in primary care and podiatry, supported by an algorithm intended to identify physicians seeing patients with two or more gout flares. He also provided market context, stating there are 9.9 million U.S. patients with gout, that 36% are treated annually, and that 8% of those treated receive injectables—resulting in an estimated 285,000-patient total addressable market for Cortrophin in this setting, according to ANI’s internal framing.
Near-term dynamics: seasonality and insurance reverification
In discussing quarterly patterns, Lalwani said the transition from Q4 to Q1 typically includes seasonality and insurance reverification. He added that Q1 was affected by reverification taking longer, primarily due to higher volumes: Cortrophin sales were $59 million in Q4 2024 versus $110 million in Q4 2025, which increased the number of patients moving through the process.
He said weather disruptions in some high-performing territories also contributed, noting some offices lost three to seven days during a five-to-six-week period. Management characterized the impact as shifting some revenue from Q1 into Q2. Lalwani said the company was nearing completion of the reverification process, with over 90% of patients on therapy at Dec. 31, 2025 having completed reverification.
He also pointed to February trends, saying volumes in milliliters were 25% higher than January and that February produced the second-highest number of new cases initiated “of all time,” despite being a shorter month. Management said it expects to catch up in Q2 and then build through the year.
Product and clinical initiatives: prefilled syringe and a Phase IV gout study
ANI also discussed product adoption of a prefilled syringe presentation for Cortrophin. Lalwani said it accounted for over 70% of volume toward the end of 2025 and that adoption has been broad-based across patients and prescribers, exceeding the company’s initial expectation that it would primarily benefit patients with dexterity or visual impairments.
On acute gouty arthritis flares, Lalwani detailed a Phase IV study enrolling 160 patients with two dosing arms (1.0 mL versus 0.5 mL). He said the primary endpoint compares symptom reduction at day three, with additional secondary endpoints. ANI said the study is intended to generate additional clinical evidence supporting Cortrophin’s use in acute gouty arthritis flares and could support inclusion in gout treatment guidelines. Management added that guideline inclusion could aid both prescriber awareness and reimbursement access.
ILUVIEN: strategy in DME and uveitis label expansion
Lalwani said ILUVIEN is an intravitreal therapy used for diabetic macular edema (DME) and chronic non-infectious uveitis affecting the posterior segment of the eye (NIU-PS). In DME, he described standard of care as anti-VEGF therapies and positioned ILUVIEN’s addressable population as approximately 50,000 patients who do not show an optimal response to two or more anti-VEGFs and who show a positive response to steroid trials. He said fewer than 5,000 patients receive ILUVIEN annually, which he characterized as leaving significant room for expansion.
He highlighted “NEW DAY” results involving data from over 300 patients comparing ILUVIEN with an aflibercept arm, and said clinician feedback has supported the use of ILUVIEN earlier in DME treatment. Lalwani also cited strengthened commercial execution and efforts to help patients with Medicare co-pay funding issues via alternate pathways.
Regarding the NIU-PS indication—an ILUVIEN label expansion achieved in March of the prior year—Lalwani said many retina physicians had used both ILUVIEN and YUTIQ and welcomed consolidation to a single product to stock. He added that some clinicians required time to become familiar with the ILUVIEN injector, and said access coverage secured for YUTIQ had been obtained for ILUVIEN in NIU-PS.
In closing comments on profitability and capital allocation, Lalwani and Chief Financial Officer Steve Carey said ANI is investing while maintaining its EBITDA margin profile at the midpoint of 2026 guidance. Carey said the implied operating expense increase from 2025 to 2026 is about $50 million, with a majority related to the acute care organization expansion, and management expects operating leverage into 2027. The company also reiterated a disciplined business development approach focused on expanding rare disease scope and scale, prioritizing commercial assets that may be synergistic with existing call points or that can benefit from ANI’s rare disease infrastructure.
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.
