ANI Pharmaceuticals NASDAQ: ANIP reported first-quarter 2026 results that management said show continued progress in its effort to “accelerat[e] our transformation into a leading rare disease company,” led by growth in Cortrophin Gel and ILUVIEN, contributions from a new intellectual property licensing transaction with Harmony Biosciences, and steady generics performance.
Total net revenue rose 20% year over year to $237.5 million, while adjusted non-GAAP EBITDA increased 24% to $63 million, Chief Financial Officer Stephen Carey said. Adjusted non-GAAP diluted EPS was $2.05, up from $1.70 a year earlier. Following the quarter, the company raised its full-year 2026 guidance for total net revenue and adjusted EBITDA.
Rare disease growth led by Cortrophin and ILUVIEN
President and CEO Nikhil Lalwani said Cortrophin Gel net revenue was $75.1 million in the first quarter, up 42% year over year, and “consistent with the expectations we outlined during our last quarterly call.” Chris Mutz, SVP and head of Rare Disease, said performance reflected typical first-quarter seasonality tied to insurance reverifications, which “took slightly longer to clear in January and February,” partly due to increased volume in physician offices and weather-related closures in some areas.
As those reverifications cleared, Mutz said sales accelerated in February and March and carried into April. Lalwani added that April produced “the highest number of new patient starts and monthly volumes dispensed since launch.” Mutz said the company saw year-over-year growth across targeted specialties including rheumatology, nephrology, neurology, pulmonology, and ophthalmology.
Management also highlighted growth in acute gouty arthritis flares, which Mutz said is unique to Cortrophin among ACTH therapies and represented approximately 18% of total utilization. The company is expanding its commercial footprint to pursue that opportunity by targeting primary care and podiatry, with the majority of a new dedicated team hired and onboarded and expected to be fully deployed by the end of June.
Mutz described the gout opportunity as under-penetrated, citing an addressable population of 285,000 patients based on company estimates of gout prevalence, annual treatment rates, flare frequency, and injectable flare treatment usage. He said the new team will focus on about 7,000 healthcare providers who treat the most severe patients outside ANI’s prior call points.
On ILUVIEN, Carey said first-quarter net revenue was $19.3 million, up 20% year over year, and Lalwani attributed performance to commercial and patient access initiatives established in 2025. Mutz said the company is focused on data generation and education efforts, pointing to publication of NEW DAY study results in Ophthalmology for diabetic macular edema (DME). He also said ANI expects to share results from the phase IV SYNCHRONICITY study in chronic non-infectious uveitis affecting the posterior segment (NIU-PS) at a medical meeting in the third quarter of 2026.
During Q&A, Lalwani said Medicare market access challenges “have persisted since January 2025,” and that the company is exploring alternate access pathways, while also being “calibrated” in its outlook for the remainder of 2026.
Harmony Biosciences licensing deal adds upfront revenue and royalties
ANI also discussed a transaction with Harmony Biosciences tied to pitolisant intellectual property. Lalwani said ANI received a $15 million upfront license fee in the first quarter and could receive an additional $10 million milestone payment upon certain development milestones, which he and Carey said are expected to be achieved in the second and third quarters of 2026.
Carey said ANI recognized $21.5 million of revenue related to the Harmony agreement in the first quarter, consisting of the upfront fee and initial royalty income on sales of WAKIX. Carey later clarified that the royalty is due on “all pitolisant products, including WAKIX and any future products that may be introduced” that are pitolisant-based.
When asked about development timelines for a novel pitolisant formulation being pursued under a co-exclusive license involving Harmony and Novitium (ANI’s subsidiary), Lalwani said that information is confidential to the collaboration.
Generics revenues increase; gross margin pressured by mix
Generics net revenue rose 7% year over year to $105.4 million, which Carey said was driven by “continued strength in the partner generic launch that commenced in the third quarter of 2025,” along with contributions from new product launches and commercial and operational outperformance.
Lalwani said the company continues to target a cadence of 10 to 15 generics launches annually and noted that ANI had launched six new generics products year-to-date while maintaining its position as the number two player in overall CGT approvals.
Carey said non-GAAP gross margin was 60.8% in the quarter, down about 230 basis points from the prior-year period. He attributed the decline primarily to higher sales of royalty-bearing products (including Cortrophin), the partnered generic launch, non-recurrence of prior-year prucalopride revenue, and lower brand sales year over year, partially offset by initial revenue recognition under the Harmony agreement.
Raised 2026 guidance and new $100 million share repurchase authorization
On the back of first-quarter performance, ANI raised its 2026 guidance. Carey said the company now expects:
- Net revenue: $1.08 billion to $1.14 billion (up $25 million from prior guidance)
- Adjusted non-GAAP EBITDA: $285 million to $300 million (up $10 million)
- Adjusted non-GAAP EPS: $9.19 to $9.69
The company reaffirmed 2026 guidance for Cortrophin Gel net revenue of $540 million to $575 million and ILUVIEN net revenue of $78 million to $83 million. Carey also raised adjusted gross margin expectations to 59.9% to 60.9% for 2026, up 60 basis points from prior guidance.
Discussing quarterly cadence, Carey said second-quarter Cortrophin revenue is expected to represent about 21% to 23% of full-year Cortrophin revenue, with sequential gains in the third and fourth quarters aided by core team performance and the full deployment of the new gout-focused commercial team. He said second-quarter adjusted non-GAAP EBITDA is expected to be essentially in line with the first quarter, as higher Cortrophin revenue is expected to be “tempered by the non-recurrence of the $15 million upfront license fee” recognized in the first quarter.
ANI ended the quarter with $311.2 million in unrestricted cash and $625 million in principal value of outstanding debt, Carey said. Gross leverage was 2.6x and net leverage was 1.3x trailing 12-month adjusted non-GAAP EBITDA of $242 million.
As part of capital allocation, Carey announced a new three-year share repurchase program authorizing up to $100 million in buybacks, saying it reflects confidence in the balance sheet and expected cash flow generation. He said the company’s “principal goal for the excess cash on our balance sheet remains to support future business development and M&A,” and added that there is currently no plan to implement an accelerated share repurchase (ASR) within the program.
Management addresses payer dynamics, data, and business development priorities
In response to questions on payer access and rebate dynamics, Lalwani said the company is focused on expanding access in an “under-penetrated addressable market” for ACTH therapy, but added that specifics on payer landscape and rebates are competitively sensitive. He also said that over half of Cortrophin prescribers were previously “naive to ACTH.”
On third-party prescription data, Lalwani said IQVIA has historically been directionally in line with ANI’s performance but that the company cannot comment on a recent disconnect because it does not have insight into all of IQVIA’s inputs. He said ANI is emphasizing internal leading indicators, including new patient starts and monthly volumes dispensed.
On business development, Lalwani said the company is exploring ways to expand the scope and scale of its Rare Disease business, including looking at commercial assets that can leverage ANI’s rare disease infrastructure across market access, patient support, medical affairs, and marketing.
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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