AEON Biopharma (AEON) Corporate presentation summary

Market opportunity and adoption barriers

• U.S. therapeutic neurotoxin market forecast to grow from $3.5B in 2026 to $5.1B in 2031; projected CAGR 7.7%.

• BOTOX® held ~92% of therapeutic neurotoxin market value in 2025; other brands collectively captured ~8%.

• Restricted competitor labels, operational complexity and provider economics have limited switching; BOTOX® remains the only approved option for some key conditions, including migraine.

• ~3,000 neurologists treat ~90% of U.S. neurologic BOTOX® patients; ~75 payers cover most treated patients.

ABP-450 strategy and commercial proposition

• ABP-450 is being developed as a therapeutic biosimilar targeting all BOTOX® indications under the FDA 351(k) pathway; licensed therapeutic rights cover the U.S., Canada, EU, UK and select territories.

• The target profile is clinical substitutability with the same label, dosing, dilution and workflow, subject to FDA review and approval.

• ABP-450 is expected to have a lower acquisition cost and therapeutic-only ASP; biosimilar add-on reimbursement is presented as based on BOTOX® ASP, potentially improving provider economics.

• A lower-cost comparable option could give payers greater scope to use pricing policies, utilization management or step edits in favor of ABP-450.

Biosimilar evidence and development plan

• ABP-450 and BOTOX® share a 900 kDa toxin complex; analyses found 100% amino acid sequence identity across covered regions in three ABP-450 and two BOTOX® lots.

• Reported genetic and formulation comparisons showed high similarity, including matching final-product ingredients and proportions.

• ABP-450 showed highly similar potency to BOTOX® across LD50 and cell-based potency assays; the presentation links this evidence to clinical dose predictability.

• Proposed two-stage CMAP study would assess dose response and compare biological activity in healthy volunteers; IND submission was planned for Q4 2026, with study initiation expected in Q1 2027.

• Four randomized non-inferiority studies across four indications and existing safety and immunogenicity experience may support the evidence package, subject to scientific bridging and FDA review.