ANI Pharmaceuticals ANIP delivered first-quarter 2026 adjusted EPS of $2.05, up nearly 21% year over year and well ahead of the Zacks Consensus Estimate of $1.28.
Quarterly revenues totaled $237.5 million, up 20.5% from the year-ago period. The metric also beat the Zacks Consensus Estimate of $205.4 million.
The quarter reflected solid execution across the portfolio, led by continued momentum for Purified Cortrophin Gel and contributions from a newly monetized intellectual property licensing arrangement.
ANIP's Revenue Mix Tilts Toward Rare Disease and Royalties
Rare Disease and Brands' total net revenues were $128.2 million, up 36% year over year, supported by contributions from both Cortrophin Gel and Iluvien. Within that bucket, Cortrophin Gel net revenues rose 42% to $75.1 million, while Iluvien sales increased 19.5% to $19.3 million.
The reported Cortrophin sales marginally missed the Zacks Consensus Estimate of about $76 million. Per management, the drug’s sales were impacted primarily by seasonality tied to insurance re-verifications, which took longer to clear early in the quarter due to higher patient volume at physicians’ offices and weather-related physician office closures in some regions.
ANIP's shares fell more than 2% on Friday, suggesting some investors focused on the slightly softer-than-expected Cortrophin print despite the broader earnings and revenue beat. Year to date, the stock has gained about 4% against the industry’s nearly 3% decline.
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The company also reported $21.5 million in brand royalties and other revenues in the quarter, reflecting the up-front payment and early royalty income tied to its Harmony Biosciences HRMY licensing agreement. By contrast, Brands' revenues declined 51% year over year to $12.3 million as demand normalized for certain products.
In January, the company’s Novitium subsidiary entered into an agreement with Harmony Biosciences, under which ANIP out-licensed intellectual property related to pitolisant, marketed under the brand name Wakix. The agreement generated a $15 million upfront license fee and includes low single-digit royalties on sales of pitolisant-based products. It provides for an additional $10 million in development milestones that management expects to be achieved in the second and third quarters of 2026.
ANIP Generics Business Adds Steady Growth
Generics and Other net revenues were $109.2 million in the first quarter, up 6% year over year. Growth was driven primarily by Generic pharmaceutical products, which rose about 7% to $105.4 million, supported by contributions from new launches and continued strength from the partnered generic launch that began in the third quarter of 2025.
Management said ANIP launched six new generics products year to date and remains on track to deliver 10-15 new generics launches in 2026.
ANIP Details Cortrophin Demand and Gout Commercial Expansion
As the re-verification backlog cleared, the company said momentum improved in February and March and carried into April, which posted the highest new patient starts and monthly volumes dispensed since launch. The company pointed to broad-based prescribing gains across targeted specialties, including rheumatology, nephrology, neurology, pulmonology and ophthalmology.
A key 2026 growth initiative is the planned expansion into acute gouty arthritis flares via a new dedicated commercial organization. ANIP expects the majority of this team to be in the field by the end of the second quarter, targeting about 7,000 high-priority primary care and podiatry prescribers and an estimated addressable population of roughly 285,000 patients; acute gouty arthritis flares represented about 18% of total Cortrophin utilization to date.
ANIP's Profitability Reflects Royalty-Bearing Mix Pressures
On a non-GAAP basis, cost of sales increased 28% year over year to $93.1 million, tracking higher volumes and a richer mix of royalty-bearing products. Adjusted gross margin was 60.8%, down about 230 basis points from the prior-year period.
ANIP attributed the margin contraction primarily to higher sales of royalty-bearing products, including Cortrophin Gel and a partnered generic product launched in the third quarter of 2025, as well as the non-recurrence of prior-year Prucalopride revenues. Management noted that these headwinds were partly offset by initial revenues recognized under the HRMY agreement.
ANIP's Spending Ramps With Rare Disease Investments
Adjusted selling, general and administrative expenses rose 12% year over year to $71.4 million, reflecting initial marketing and recruitment spending tied to the acute gout commercial buildout and broader activity to support growth. Adjusted research and development expense remained essentially flat year over year at about $10 million.
Despite the higher operating expense run rate, adjusted EBITDA increased 24% to $63 million, supported by the revenue lift and resulting gross profit growth.
ANIP Raises 2026 Guidance & Authorizes Share Repurchases
Following the strong start to the year, the company raised its full-year 2026 outlook for total net revenues by $25 million to $1.08-$1.14 billion and lifted adjusted EBITDA guidance by $10 million to $285-$300 million. Adjusted EPS is now expected in the range of $9.19-$9.69 (previously: $8.83-$9.34), while Cortrophin Gel net revenue guidance of $540-$575 million and Iluvien guidance of $78-$83 million were reaffirmed.
On the earnings call, the company tied its higher full-year outlook partly to stronger-than-expected Generics performance exiting the first quarter and improved visibility into upcoming launches for the remainder of the year.
Separately, ANIP’s board authorized a new $100 million share repurchase program running through May 2029, adding flexibility alongside its stated focus on business development.
ANIP's Cash Position Improves as Leverage Remains Manageable
The company ended the quarter with $311.2 million in unrestricted cash and cash equivalents, up from $285.6 million at the end of 2025. Operating cash flow was $58.4 million in the first quarter, reflecting the stronger earnings profile and working-capital dynamics.
As of March 31, 2026, the company reported $625 million in principal value of outstanding debt, inclusive of senior convertible notes and a term loan. Management cited gross leverage of 2.6x and net leverage of 1.3x based on trailing 12-month adjusted non-GAAP EBITDA of $242 million, positioning the balance sheet to support continued investment and potential inorganic opportunities.
ANIP’s Zacks Rank
The stock currently carries a Zacks Rank #3 (Hold).
ANI Pharmaceuticals, Inc. Price
ANI Pharmaceuticals, Inc. price | ANI Pharmaceuticals, Inc. Quote
Our Key Picks Among Biotech Stocks
Some better-ranked stocks from the sector are Amarin Corporation AMRN and Indivior Pharmaceuticals INDV, each currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, estimates for Amarin’s 2026 loss per share have narrowed from $7.01 to $6.36. Over the same period, loss per share estimates for 2027 have improved from $5.50 to $4.64. AMRN's shares have risen 8% year to date.
Amarin’s earnings beat estimates in three of the trailing four quarters but missed the mark on one occasion, delivering an average surprise of 50.02%.
Over the past 60 days, estimates for Indivior Pharmaceuticals’ 2026 EPS have increased from $3.03 to $3.35. Over the same period, EPS estimates for 2027 have risen to $3.69 from $3.46. INDV's shares have risen 10% year to date.
Indivior Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 65.44%.
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This article originally published on Zacks Investment Research (zacks.com).