ANI Pharmaceuticals — Third Quarter 2026 Earnings Summary

Financial Performance:

• Total net revenues reached $290.8 million for the quarter, a 27.6% increase year-over-year compared to $227.8 million in Q3 2025.
• GAAP net income available to common shareholders was $35.1 million ($1.51 per diluted share), up from $26.3 million ($1.13 per diluted share) in the prior year period.
• Adjusted non-GAAP EBITDA was $83.3 million, representing a 39.8% year-over-year increase.
• Adjusted non-GAAP diluted earnings per share were $2.70, compared to $2.04 in the same period last year.
• GAAP gross margin improved to 61.6% from 59.0% year-over-year; non-GAAP gross margin increased to 61.8% from 59.2%.
• Cash flow from operations was $198.8 million on a year-to-date basis.
• As of September 30, 2026, the company held $420.8 million in unrestricted cash and cash equivalents and $616.9 million in principal value of outstanding debt.

Guidance and Future Outlook:

• Revised 2026 total company revenue guidance to $1,085 million – $1,125 million (previously $1,080 million – $1,140 million).
• Revised 2026 Cortrophin Gel revenue guidance to $480 million – $500 million (previously $520 million – $540 million).
• Raised 2026 adjusted non-GAAP EBITDA guidance to $290 million – $300 million (previously $285 million – $300 million).
• Raised 2026 adjusted non-GAAP diluted EPS guidance to $9.37 – $9.71 (previously $9.19 – $9.69).
• Management targets approximately 40% year-over-year growth for Cortrophin Gel in 2026.
• Full year 2026 adjusted non-GAAP gross margin is expected between 60.3% and 61.0%.
• Expected annual U.S. GAAP effective tax rate is between 27% and 29%.

Business Segments and Product Lines:

• Rare Disease: Net revenues increased 35.8% to $160.9 million.
  • Cortrophin Gel revenues grew 36.1% to $138.7 million, driven by gout expansion and progress in Nephrology, Neurology, Rheumatology, Ophthalmology, and Pulmonology.
  • New gout patient cases doubled quarter-over-quarter, with a 67% increase in new prescribers.
  • ILUVIEN revenues increased 34.1% to $22.3 million, driven by increased volumes and international shipment phasing.
  • Phase 4 SYNCHRONICITY trial data for ILUVIEN in chronic non-infectious uveitis was presented at the American Academy of Ophthalmology conference.
• Generics: Net revenues increased 10.7% to $104.5 million, driven by strong demand and 16 new product launches year-to-date.
• Brands: Net revenues decreased 6.5% to $10.0 million due to decreased demand for certain products.
• Brand Royalties and Other: Recognized $11.5 million, including $9.5 million in royalties on pitolisant-based products and $2.0 million in development milestones.

Market and Competitive Landscape:

• Cortrophin Gel growth is supported by momentum in the gout expansion and existing specialty areas.
• Revenue conversion in existing specialties and gout was slower than expected due to capacity constraints in the specialty pharmacy network, prompting network expansion.
• Generics business continues to outperform driven by new product launches and market demand.

Risks and Challenges:

• Capacity constraints in the specialty pharmacy network have slowed revenue conversion despite strong demand.
• Forward-looking statements carry risks including potential delays in regulatory approvals, supply chain disruptions, single-source manufacturing reliance, and changes in regulatory policies.
• Risks include the ability to achieve market acceptance levels necessary for profitability and the successful completion of the proposed Egetis acquisition.

Management Commentary and Tone:

• CEO Nikhil Lalwani described the quarter as delivering "strong financial results" while advancing the transformation into a leading Rare Disease company.
• Management expressed confidence in executing capital allocation strategies through share repurchases and the Egetis acquisition.
• The tone indicates a focus on delivering 2026 guidance and advancing the Egetis acquisition toward closing.

Other Key Points:

• Announced a recommended public offer to acquire Egetis Therapeutics AB for SEK 11.25 per share, representing a 27% premium to the 60-day VWAP.
• The Egetis offer value is approximately $560.1 million, reflecting an enterprise value of approximately $434.1 million after adjusting for the net proceeds of Egetis's $190.0 million Rare Pediatric Disease Priority Review Voucher sale.
• The acquisition would add EMCITATE (tiratricol), an FDA-approved treatment for MCT8 deficiency, to ANI's portfolio.
• Share repurchase program: Repurchased $20.0 million in common stock year-to-date (275,635 shares total through November 2, 2026).
• The Egetis acceptance period is expected to commence around November 20, 2026, and expire around December 18, 2026.