ANIP News & Events

Reports Q1 revenue $237.46M, consensus $207.63M. "We delivered a strong first quarter, generating $237.5M in revenue and $63.0M in adjusted non-GAAP EBITDA, with solid performance across all business units," said Nikhil Lalwani, President and CEO of ANI. "We are seeing continued momentum in demand for Cortrophin Gel and have made meaningful progress advancing our organizational expansion focused on capturing the opportunity in acute gouty arthritis flares, with the majority of our commercial team now onboarded. We remain confident in Cortrophin Gel's long-term growth potential and are well positioned to drive adoption in underpenetrated specialty indications, while the strength of our Generics business continues to support investment in our Rare Disease portfolio."

Raises FY26 revenue view to $1.080B-$1.140B from $1.055B-$1.115B. Consensus is for FY26 EPS $9.07 and for revenue $1.09B. ANI expects FY26 total company adjusted non-GAAP gross margin between 59.9% and 60.9% and anticipates approximately 21.5 million and 21.8 million shares outstanding for the purpose of calculating full year adjusted non-GAAP diluted EPS. The Company expects its annual U.S. GAAP effective tax rate to be between 26% and 28% and will continue to tax effect non-GAAP adjustments for computation of adjusted non-GAAP diluted earnings per share utilizing a tax rate of 26%.

ANI Pharmaceuticals announced the launch of Pimozide Tablets 1 mg and 2 mg. ANI's Pimozide Tablets is the generic version of the reference listed drug Orap. U.S. annual sales for Pimozide Tablets total approximately $3.1M, based on February 2026 moving annual total IQVIA data.

ANI Pharmaceuticals announced that following final approval from the FDA for its Abbreviated New Drug Application, or ANDA, the Company launched Isosorbide Mononitrate Tablet USP, 10 mg and 20 mg. ANI's Isosorbide Mononitrate Tablet USP is the generic version of the reference listed drug, or RLD, Monoket.