ANI Pharmaceuticals’ Earnings Call Highlights Record Growth

Ani Pharmaceuticals ((ANIP)) has held its Q3 earnings call. Read on for the main highlights of the call.

ANI Pharmaceuticals’ recent earnings call showcased a robust performance, marked by record-breaking revenue and substantial growth, particularly in the Rare Disease and Generics segments. Despite some challenges in the ILUVIEN segment and Medicare funding affecting Retina products, the company demonstrated strong cash flow and effective debt management, leading to an increase in financial guidance.

Record Revenue and Growth

ANI Pharmaceuticals achieved record revenue, adjusted EBITDA, and adjusted EPS in Q3 2025. The company’s total revenues increased by an impressive 54% year-over-year and 46% on an organic basis, underscoring its strong market position and operational efficiency.

Cortrophin Gel Revenue Surge

The Cortrophin Gel segment was a standout performer, with net revenue nearly doubling compared to Q3 2024. This surge contributed to a 70% year-over-year growth in adjusted EBITDA. The company expects Cortrophin Gel to continue its upward trajectory, projecting a 75% to 78% year-over-year growth, generating revenues of $347 million to $352 million.

Generics Business Performance

ANI Pharmaceuticals’ Generics business also showed strong performance, driven by an opportunistic partner generic launch. This success is expected to result in full-year growth in the low 20% range, highlighting the company’s strategic market positioning in the generics sector.

Increased Financial Guidance

Reflecting its strong performance, ANI Pharmaceuticals raised its full-year 2025 financial guidance. The company now anticipates net revenues to grow by 39% to 42% and adjusted EBITDA to increase between 42% and 46% compared to 2024, signaling confidence in its continued growth trajectory.

Cash Flow and Debt Management

The company ended Q3 with $262.6 million in unrestricted cash, up from $217.8 million in Q2, and successfully reduced its net leverage to 1.7x trailing 12-month adjusted EBITDA. This demonstrates ANI Pharmaceuticals’ effective cash flow management and prudent debt reduction strategy.

ILUVIEN Sales Decline

ILUVIEN sales faced challenges due to reduced access for Medicare patients and the utilization of remaining YUTIQ units. The company views 2025 as a reset year for ILUVIEN, with expectations for growth in 2026.

Challenges with Medicare Funding

Medicare patients’ access to Retina products was impacted by insufficient funding for co-pay foundations, affecting ILUVIEN sales. This highlights the external challenges faced by ANI Pharmaceuticals in maintaining product accessibility.

Generics Margin Pressure

The gross margin for a partner generic product was lower than typical due to a profit share element, which impacted overall margins. This indicates the competitive pressures within the generics market.

Forward-Looking Guidance

ANI Pharmaceuticals’ forward-looking guidance remains optimistic, with projected net revenue growth of 39% to 42% and organic growth of 34% to 37% compared to 2024. The company anticipates significant contributions from Cortrophin Gel and expects continued strength in its Generics business, driven by strategic launches and market opportunities.

In summary, ANI Pharmaceuticals’ earnings call highlighted a strong performance with record revenue and growth across key segments. Despite some challenges, the company raised its financial guidance, reflecting confidence in its strategic direction and market opportunities. Investors and market watchers will be keenly observing ANI Pharmaceuticals’ continued execution of its growth strategies.