ANI Pharmaceuticals Stock Soars on 29.6% Revenue Growth and Rare Disease Expansion

Key Highlights

Table of Contents

Fourth-quarter revenue expanded 29.6% year-over-year to $247.1M on rare disease momentum.
Cortrophin generated $111.4M in Q4 revenue with expanding use across medical specialties.
ILUVIEN contributed $19.8M as enhanced coverage drove better market penetration.
Generic drug sales increased 28.2% to $100.8M, supported by new product rollouts and partnerships.
Full-year 2026 projections call for $1.06–$1.12B in revenue with adjusted EBITDA reaching $290M.

Shares of ANI Pharmaceuticals (ANIP) demonstrated impressive strength following the release of robust fourth-quarter financial results that showcased acceleration across multiple business divisions. Trading closed at $77.15 before gaining additional ground to $78.68 during pre-market hours. The pharmaceutical company achieved record annual revenue while solidifying its standing in specialized rare disease treatments.

ANI Pharmaceuticals, Inc., ANIP

Rare Disease Division Powers Revenue Acceleration

The rare disease business unit generated $131.3 million during the quarter, representing a substantial 50.8% year-over-year increase. Cortrophin Gel accounted for the majority of this growth, delivering net sales of $111.4 million in the three-month period. ILUVIEN contributed an additional $19.8 million while helping to broaden market reach.

Demand for Cortrophin Gel remained robust as physicians across multiple disciplines adopted the treatment. The product gained traction in neurology, rheumatology, nephrology and ophthalmology practices. Notably, prescriptions for acute gouty arthritis flares continued their upward trajectory and now comprise over 15% of total utilization. Management plans to expand the rare disease sales force during mid-2026 to capitalize on emerging growth opportunities.

ILUVIEN’s performance benefited from enhanced insurance coverage and intensified commercial initiatives. Strategic investments in market development facilitated improved patient access and drove higher adoption rates across approved uses. The company anticipates sustained progress as distribution channels reach full maturity.

Generic Portfolio Delivers Substantial Growth Through Strategic Launches

The generic pharmaceuticals division posted $100.8 million in quarterly sales, marking a 28.2% increase compared to the same period last year. A significant partnered product launch initiated during the third quarter contributed meaningfully to this performance. Several additional generic products introduced throughout 2025 also bolstered segment results.

Royalty income experienced a decline attributed to reduced contributions from specific service arrangements. Despite this headwind, the overall segment demonstrated operational resilience across ANI’s generic drug platform. The company maintains a consistent cadence of introducing new generic medications to the market.

Brand product revenue fell to $12.3 million as demand for certain products returned to normalized levels. This decline was anticipated and reflects the conclusion of elevated sales periods experienced in previous quarters. Management remains committed to maintaining steady performance across the brand portfolio.

Strong Margin Expansion and Profitability Improvements

Consolidated revenue for the quarter totaled $247.1 million, representing a 29.6% gain versus the prior-year period. Gross margin on a GAAP basis improved significantly due to the elimination of purchase accounting adjustments that impacted earlier periods. Non-GAAP gross margin experienced modest compression as higher sales of royalty-bearing products altered the revenue composition.

Operating expenditures rose in response to increased headcount and the buildout of infrastructure supporting rare disease and ophthalmology initiatives. Research and development spending declined somewhat due to timing shifts in ongoing development programs. The company maintained its commitment to investing in projects designed to fuel long-term expansion.

Net income for the quarter reached $27.5 million, representing a dramatic reversal from the loss recorded in the comparable year-ago period. Adjusted diluted earnings per share advanced to $2.33 as revenue growth and margin improvements drove profitability higher. Adjusted EBITDA climbed to $65.4 million, posting a 30.6% increase.

Management Reiterates Ambitious 2026 Financial Targets

ANI Pharmaceuticals maintained its 2026 revenue guidance range of $1.055 billion to $1.115 billion. Cortrophin Gel alone is forecast to deliver up to $575 million as the company scales new initiatives targeting specialty physicians and primary care providers. ILUVIEN sales are projected to climb as high as $83 million.

The company anticipates adjusted EBITDA will expand to $290 million, demonstrating ongoing margin enhancement. Earnings per share guidance suggests additional improvement as the business benefits from operational leverage. ANI concluded 2025 with solid liquidity and produced $185.2 million in operating cash flow for the full year.

Management’s strategic vision centers on establishing ANI as a premier rare disease-focused pharmaceutical company while preserving operational excellence in both generic and branded drug operations.