ANI Pharmaceuticals (ANIP) investor relations material

Rare disease strategy and Egetis acquisition

• Cortrophin and ILUVIEN are established rare-disease growth assets in under-penetrated markets; Cortrophin IP extends to 2043, while ILUVIEN has high barriers to genericization.

• EMCITATE adds a first-in-class, FDA-approved treatment for peripheral thyrotoxicosis in MCT8 deficiency; it is also approved in Europe and launched in Germany.

• EMCITATE has $300M+ peak-sales potential, a stronger operating-margin profile than the existing assets, and patents through 2045; R&D is developing it for RTH beta.

• Rare disease accounted for >50% of net revenue in 2026; the goal is for a substantial majority of sales to come from rare disease by decade-end.

• Tender offer requires 90% shareholder approval; holders of 42% have provided irrevocables. Closing targeted by end-2026 or early Q1 2027, subject to antitrust and customary approvals.

Cortrophin demand and outlook

• New case initiations rose 85% in June–October vs. January–May; gout cases initiated in Q3 were 2x Q2 after adding 64 reps, a ~50% sales-force expansion fully operational by end-June.

• Q3 revenue was $138.7M vs. prior guidance of $143M–$153M; FY2026 revenue guidance is $480M–$500M, up 38%–44% vs. $347M in 2025.

• Specialty-pharmacy capacity constrained enrollment-to-paid-drug conversion; added regional pharmacies, expanded pharmacy support, and doubled the field reimbursement team, with shorter fill times in late Q3 and early Q4.

• Nearly 40% of gout prescribers initiated >2 cases; new prescribers grew 67% in Q3 vs. Q2 2026. Ophthalmology volumes doubled YoY, with demand across other established specialties.

• Phase 4 gout study is expanding sites and aims to support appropriate use and potential inclusion in ACR and other guidelines as a late-line therapy.

ILUVIEN and clinical evidence

• Phase 4 SYNCHRONICITY met BCVA and CST primary endpoints at 6 and 24 months; tolerability was consistent with prior trials, and results are being incorporated into promotional materials.

• ILUVIEN provides up to three years of durability with a single implant, reducing treatment burden for chronic non-infectious posterior-segment uveitis patients.

• In DME, the cited addressable population is 50,000+; in NIU-PS, it is ~75,000. Fewer than 5,000 patients annually are treated with ILUVIEN in each market.