ANI Pharmaceuticals Inc. (NASDAQ: ANIP) reported fourth‑quarter 2025 results that surpassed consensus estimates, with revenue of $247.1 million, up 29.6% from $190.6 million a year earlier. Net income rose to $27.5 million, and diluted earnings per share reached $2.33, a $0.33 beat over the $2.00 consensus estimate and a 42.9% increase from the prior year. Adjusted EBITDA climbed to $65.4 million, up 30.6% from Q4 2024, reflecting strong operating leverage in the company’s high‑margin rare‑disease portfolio.
The Rare Disease segment drove the majority of the growth, generating $131.3 million in revenue, a 50.8% increase from Q4 2024, largely powered by continued demand for Cortrophin Gel. Generics revenue reached $100.8 million, up 28.2% from the prior year, while the ILUVIEN retina franchise declined 28% from the previous year. The company’s focus on rare‑disease products has translated into higher margin contributions and a larger share of total revenue.
Gross margin for the quarter fell to 59.6%, a decline of about 400 basis points from the prior year, driven by a shift toward lower‑margin product mix and increased commercial investment. Despite the margin compression, the company maintained strong operating leverage, as evidenced by the 30.6% rise in adjusted EBITDA.
Management reaffirmed its 2026 sales guidance at $1.055 billion to $1.115 billion, well above the consensus estimate of $982.5 million. Guidance for Cortrophin Gel sales was set at $540 million to $575 million, and ILUVIEN at $78 million to $83 million, underscoring confidence that the rare‑disease portfolio will continue to represent roughly 60% of total revenue.
President and CEO Nikhil Lalwani said, '2025 was a year of significant growth for our Rare Disease and Generics businesses, which drove expansion to both our top- and bottom-line.' He added, 'We are building on this momentum as we continue to focus on our key 2026 priority of accelerating our transformation into a leading Rare Disease company, supported by strong execution in Generics and disciplined capital deployment.'
Investors responded positively to the earnings beat and confident guidance, though some analysts noted the margin compression and ILUVIEN decline as potential headwinds that the company will need to address in the coming quarters.
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