ANI Pharmaceuticals (NASDAQ:ANIP) reported fourth-quarter and full-year 2025 results highlighting record revenue, adjusted non-GAAP EBITDA, and adjusted non-GAAP diluted EPS, driven by growth in its rare disease and generics businesses. Management also reaffirmed 2026 guidance calling for more than $1 billion in revenue and continued expansion led by Cortrophin Gel.
Record 2025 performance driven by Cortrophin and generics
Chief Executive Officer Nikhil Lalwani said 2025 featured “outstanding execution and growth,” with total company revenues up 44% year-over-year and adjusted non-GAAP EBITDA up 47%. The company’s lead rare disease product, Cortrophin Gel, posted full-year net revenue of $347.8 million, up 76% from 2024, as ANI expanded its reach in “underpenetrated specialty indications.”
ANI’s generics business also grew in 2025. Carey said fourth-quarter generics revenue was $100.8 million, up 28% year-over-year, with outperformance driven by “continued strength in the partnered generic launch” from the third quarter. Full-year generics revenue totaled $384.1 million, also up 28%, which management attributed to R&D execution and a steady cadence of new product launches.
For ILUVIEN, net revenues were $19.8 million in the fourth quarter and $74.9 million for the full year, according to Carey.
Margins and expenses reflect mix and commercial investment
Carey said non-GAAP gross margin in the fourth quarter was 59.6%, down about 400 basis points from the prior-year quarter. He attributed the decline primarily to product mix, including significant growth of royalty-bearing products such as Cortrophin Gel and a partnered generic, as well as lower brand revenues. Full-year 2025 non-GAAP gross margin was 61.6%, down about 10 basis points from 2024.
On spending, Carey noted non-GAAP SG&A rose 28% in the fourth quarter to $70.2 million, driven by investment in an expanded ophthalmology sales team promoting Cortrophin Gel and ILUVIEN, along with broader rare disease sales and marketing activities. Full-year non-GAAP SG&A increased 46% to $264.6 million.
Adjusted non-GAAP diluted EPS was $2.33 in the fourth quarter versus $1.63 a year earlier, and $7.89 for 2025 compared with $5.20 in 2024. Adjusted non-GAAP EBITDA was $65.4 million in the fourth quarter (up 31%) and $229.8 million for the year (up 47%).
Cortrophin: gout expansion, new prescribers, and evidence generation
Chris Mutz, senior vice president and head of ANI’s Rare Disease Business, said fourth-quarter “cases initiated and new patient starts reached another record high,” with broad-based growth across rheumatology, nephrology, neurology, pulmonology, and ophthalmology. He highlighted acute gouty arthritis flares as a key driver, noting this indication is “unique to Cortrophin Gel among ACTH therapies” and represented approximately 15% of total utilization in 2025.
Mutz also cited ophthalmology momentum, saying fourth-quarter Cortrophin Gel volumes in ophthalmology were more than double the year-ago period, and characterized ophthalmology as a “fast-growing” specialty with additional upside as awareness expands for severe allergic and inflammatory eye conditions.
Management said the ACTH category returned to growth after Cortrophin Gel’s 2022 launch and “approached $1 billion in sales in 2025.” ANI expects Cortrophin Gel growth of 55% to 65% in 2026, and said the broader opportunity remains tied to underpenetrated patient populations. As one example, Mutz described a gout landscape of roughly 10 million U.S. patients, with a subset of about 285,000 severe patients who receive injectable treatment for flares as ANI’s addressable population for this use case.
ANI is investing in a dedicated 90-person organization focused on acute gouty arthritis flares, aimed at expanding awareness and adoption among newly identified physicians in podiatry and primary care. Management said hiring is underway and expects deployment by mid-year. The company expects the expansion to impact volumes in the second half of 2026, with a “greater impact in 2027 as the team reaches full productivity.”
In Q&A, Lalwani said prescribers previously “naive to ACTH” represent about half of Cortrophin Gel’s prescriber base, and this cohort continues to expand. He also said treatment duration varies by indication, noting sarcoidosis typically involves longer use and more vials per patient, while acute gout flares require fewer vials per patient.
ANI also emphasized initiatives around convenience and data generation, including a Cortrophin Gel prefilled syringe launched in April 2025 and a 150-patient phase 4 study in acute gouty arthritis flares. Lalwani said results from the phase 4 trial will not be available by the time the gout-focused organization is fully launched mid-year, but the company plans to provide updates as the trial progresses.
ILUVIEN: coverage updates and access initiatives
Mutz said ANI’s retina franchise is focused on returning ILUVIEN to growth through commercial and access initiatives established in 2025. He noted ANI began promoting ILUVIEN in June 2025 under a combined label for chronic NIU-PS and DME, while the market access team worked with payers on coverage for NIU-PS.
According to Mutz, all seven Medicare administrative contractors have updated policies to cover ILUVIEN for NIU-PS, and among the top 20 commercial payers, those with ILUVIEN-specific policies have updated them to reflect both indications. The company also referenced ongoing Medicare access challenges since January 2025 related to limited funding from patient support foundations, which impacted Medicare patients’ co-pay support across retina products.
Management said it has been working with retina practices on pathways to access ILUVIEN for eligible Medicare patients under Medicare Part D using a specialty pharmacy approach similar to Cortrophin Gel. In Q&A, ANI said it is seeing prominent practices adopt this alternative workflow. The company also said its 2026 guidance does not assume foundation funding returns “in any meaningful way.”
2026 guidance: over $1 billion revenue with rare disease around 60%
ANI reaffirmed 2026 guidance calling for net revenue of $1.055 billion to $1.115 billion, representing approximately 19% to 26% year-over-year growth. The company expects rare disease to account for about 60% of total revenue, and forecasts Cortrophin Gel net revenue of $540 million to $575 million (55% to 65% growth) and ILUVIEN net revenue of $78 million to $83 million (4% to 11% growth).
Carey guided to adjusted non-GAAP EBITDA of $275 million to $290 million (20% to 26% growth) and adjusted non-GAAP EPS of $8.83 to $9.34 (12% to 18% growth). Adjusted gross margin is expected to be 59.3% to 60.3% in 2026, which Carey said reflects higher forecast sales of royalty-bearing products, the non-recurrence of revenue from a first-half 2025 180-day exclusivity launch of prucalopride, and expectations for lower brand sales.
On quarterly cadence, Carey said Cortrophin Gel revenue is expected to be seasonally lower in the first quarter due to insurance reverifications, which are taking “slightly longer” than last year amid increased patient volume and some weather-related office closures. He said January was impacted, but the company has since seen a “25% jump in volumes dispensed” and an acceleration in new patient starts in February. ANI expects Cortrophin revenue contributions tied to the gout-focused expansion to begin in the third quarter and build through the fourth quarter.
The company ended the fourth quarter with $285.6 million in unrestricted cash and reported operating cash flow of $185.2 million for 2025. As of December 31, 2025, ANI had $629.1 million in principal value of outstanding debt, with gross leverage of 2.7x and net leverage of 1.5x based on full-year adjusted non-GAAP EBITDA.
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.
