ANI Pharmaceuticals (ANIP) investor relations material

Business transformation and financial performance

• Achieved a 44% increase in total revenue and 47% growth in adjusted non-GAAP EBITDA in 2025, driven by Rare Disease assets, especially Cortrophin, which grew 75%-76% to $347 million in revenue.

• Rare Disease now represents 60% of total revenue, with Cortrophin projected to reach $540-$575 million in 2026; total company revenue guidance for 2026 is $1.055-$1.115 billion, with EBITDA of $275-$290 million.

• Generics business grew 28% in 2025 to $384 million, expected to remain flat in 2026 after a strong year, supported by ongoing R&D investment and new product launches.

• Brands business, though only 4% of revenue, continues to generate EBITDA and cash flow to support Rare Disease growth.

• Gross margin expected to benefit from Rare Disease mix shift, with margin leverage anticipated as sales force expansion costs annualize by 2027.

Rare Disease portfolio and growth drivers

• Cortrophin's growth is underpinned by a large, underpenetrated addressable market across multiple indications, with less than 10,000 patients treated out of a 285,000-patient potential in acute gouty arthritis flares.

• ACTH market rebounded from $600 million in 2021 to previous peak levels by 2025, with growth driven by new patient access and prescribers new to ACTH.

• Cortrophin and its competitor have different formulations and indications; Cortrophin focuses on acute gouty arthritis flares, which the competitor does not have.

• Both Cortrophin and ILUVIEN are considered difficult to genericize, supporting long-term durability.

• ILUVIEN benefited from label consolidation and the NEW DAY study, with commercial momentum expected to build in 2026.

Operational and strategic initiatives

• Expanded sales force for Cortrophin by 90 reps in 2026 to drive growth in acute gouty arthritis flares, with revenue step-up expected in the second half of the year.

• ILUVIEN sales team expanded to 45 reps, now promoting both Cortrophin and ILUVIEN to retina specialists and ophthalmologists.

• Commercial and marketing initiatives, including leveraging clinical study data, are expected to support earlier use of ILUVIEN in diabetic macular edema.

• Generics business continues to invest in R&D, launching 10-15 new products annually to sustain performance.

• Capital allocation prioritizes Rare Disease, with Generics and Brands providing cash flow for reinvestment.