Aeon Biopharma, Inc. · AMEX:AEON
Aeon Biopharma — Investor Presentation (August 2024)
26 slides from Aeon Biopharma's investor presentation, Aug 6, 2024
Slide 1: Corporate Presentation August 2024: PrabotulinumtoxinA
Corporate Presentation August 2024 PrabotulinumtoxinA Potential biosimilar for therapeutic indications
Slide 2: Forward-Looking Statements
2 Forward-Looking Statements This presentation includes forward-looking statements. All statements other than statements of historical facts contained in this presentation, including statements concerning possible or assumed future actions, business strategies, events or results of operations, and a
Slide 3: Biosimilar Pathway - Faster to Market with Larger Potential
3 Biosimilar Pathway - Faster to Market with Larger Potential FDA Approved Manufacturing Biosimilar Pathway Substantial Existing Evidence Lower Costs & Faster to Market Limited Competition Large Market Established Regulatory Pathway Pursuing the 351(k) regulatory pathway with PrabotulinumtoxinA as b
Slide 4: Experienced Management Team
4 Leadership team with relevant industry experience and track record of success Experienced Management Team Marc Forth Chad Oh, MD Chief Executive Officer Chief Medical Officer • 25+ years of Biopharma experience • Former US Business Lead for BOTOX® Therapeutic • 16 years at Allergan dedicated to th
Slide 5: PrabotulinumtoxinA - Same kDa Molecular Weight as Botox
5 PrabotulinumtoxinA - Same 900 kDa Molecular Weight as Botox AbbVie Inc. Merz Pharma Ipsen Group Revance Molecular Size 900 kDa 900 kDa 150 kDa ~400 kDa 150 kDa Approved Therapeutic Indications 1. Chronic migraine 2. Overactive bladder 3. Detrusor overactivity 4. Pediatric detrusor overactivity 5.
Slide 6: Biosimilar Requirements for FDA Approval
6 FDA evaluates each proposed biosimilar and advises on the extent of testing to establish biosimilarity Biosimilar Requirements for FDA Approval https://www.fda.gov/drugs/biosimilars/review-and-approval https://www.fda.gov/media/82647/download 1. Establish manufacturing • PrabotulinumtoxinA approve
Slide 7: Seeking Approval as a Biosimilar to Botox for All Therapeutic Indications
7 Potential approval for all 12 therapeutic indications - >$2.5 B in US sales Seeking Approval of PrabotulinumtoxinA as a Biosimilar to Botox 1. https://www.fda.gov/drugs/biosimilars/review-and-approval Chronic migraine Overactive bladder Detrusor overactivity Pediatric detrusor overactivity Adult u
Slide 8: Botox US Therapeutic Sales Show Consistent Growth
8 $2.5B in US therapeutic sales in 2023 continues to show consistent growth Botox US Therapeutic Sales 2021-present – 95% Share of US Market Source: AbbVie quarterly earnings reports • Current indications: Organic growth in current indications driven primarily by continued investment in disease awar
Slide 9: Cervical Dystonia
Phase 2 completed Potential comparative Phase 3 to support BLA submission Cervical Dystonia
Slide 10: Cervical Dystonia - Gold Standard Indication to Establish Toxin Efficacy
10 Phase 2 successfully completed in 2022 Cervical Dystonia - Gold Standard Indication to Establish Toxin Efficacy • CD has been the foundational disorder used to establish efficacy in the therapeutic setting during clinical development of botulinum toxins • All 4 products with approved indications
Slide 11: Cervical Dystonia Phase 2 Study Design
11 Data reported September 2022 - 17 months after first patient dosed Cervical Dystonia Phase 2 Dose Ranging Study Design • First patient dosed April 2021 • Phase 2 top line data reported in September 2022 Randomized Double-Blinded Placebo-Controlled Study Randomized 20 weeks R 1-week baseline 16-we
Slide 12: TWSTRS is well-established primary endpoint for toxin approvals
12 TWSTRS is well-established primary endpoint for toxin approvals Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) • FDA accepted primary endpoint most often used in neurotoxin studies in cervical dystonia as basis for approval. • Maximum score of 85 (most severe) – Decreasing TWSTRS sco
Slide 13: Primary Efficacy Endpoint: Change from Baseline TWSTRS at Week 4
13 200 U dose will be utilized in Phase 3 Primary Efficacy Endpoint: Change from Baseline TWSTRS at Week 4 3.57 14.01* 11.28* 9.92 0 2 4 6 8 10 12 14 16 Placebo (n=14) 150 U (n=14) 250 U (n=14) 350 U (n=15) Improvement From Baseline TWSTRS (LSM) * p-value ≤ 0.05 • 150 U and 250 U demonstrated statis
Slide 14: Secondary Efficacy Endpoint at Week 4 (TWSTRS Subscales)
14 PrabotulinumtoxinA demonstrated consistency across the 3 subscales Secondary Efficacy Endpoint at Week 4 (TWSTRS – Subscales) Statistics Test Result: p=0.0258 (150 U vs. Placebo) p=0.0420 (250 U vs. Placebo) p=0.2942 (350 U vs. Placebo) Statistics Test Result: p=0.1351 (150 U vs. Placebo) p=0.133
Slide 15: Secondary Efficacy Endpoint: CGI-C and PGI-C
15 Secondary Efficacy Endpoint at Week 4: Clinical & Patient Global Impression of Change (CGI-C & PGI-C) 3.9 2.3* 2* 2.7* 0 0.5 1 1.5 2 2.5 3 3.5 4 4.5 Placebo (n=14) 150 U (n=14) 250 U (n=14) 350 U (n=15) Mean CGI-C (LSM) * p-value <0.05 Statistics Test Result: p=0.0010 (150 U vs. Placebo) p=0.0001
Slide 16: Safety Summary
16 Safety Summary * All TRTEAEs were either mild or moderate in severity and transient in nature. # All dysphagia cases were mild. AE Summary Placebo (N=14) n, % ABP-450 150 Units (N=14) n, % ABP-450 250 Units (N=16) n, % ABP-450 350 Units (N=15) n, % TOTAL ABP-450 (N=45) n, % ANY TREATMENT-EMERGENT
Slide 17: Phase 2 Data Conclusions
17 Phase 2 Data Conclusions • Phase 2 trial met primary and other key endpoints, supporting the safety and efficacy of PrabotulinumtoxinA in reducing signs and symptoms associated with CD. • PrabotulinumtoxinA demonstrated adverse event rates similar to other botulinum toxins. • Zero discontinuation
Slide 18: Proposed Comparative Phase 3 Trial in Cervical Dystonia
18 Noninferiority design to establish clinical similarity to Botox Proposed Comparative Phase 3 Trial in Cervical Dystonia Randomized Double-Blinded Active Placebo-Controlled Study Randomized 12 ± 2 weeks R 2-week screening 16-week washout of prior toxin treatment Placebo n= 50 200 U BOTOX n= 150 20
Slide 19: Biosimilar Market Landscape
Favorable regulatory environment Higher penetration with more recent launches Still limited competition and predictable pricing dynamics Biosimilar Market Landscape
Slide 20: New Biosimilar Development is Driven by Smaller Companies
20 ~80% of new biosimilars being developed at small companies, but most marketed by larger pharma New Biosimilar Development is Driven by Smaller Companies Reproduced with permission; IQVIA “Biosimilars in the United States 2023-2027” IQVIA Global Biosimilars Database, Sep 2022; IQVIA Institute, Nov
Slide 21: More Recent Biosimilar Launches are Achieving Higher Shares
21 3 launches in 2019 achieved ~70% penetration within 3 years More Recent Biosimilar Launches are Achieving Higher Shares Reproduced with permission; IQVIA “Biosimilars in the United States 2023-2027” IQVIA MIDAS, IQVIA DDD, Oct 2022; IQVIA Institute, Dec 2022
Slide 22: Stronger Uptake of Biosimilars in Buy-and-Bill Markets
22 Physicians have incentive to select one product over another Stronger Uptake of Biosimilars in Buy-and-Bill Markets Reproduced with permission; IQVIA “Biosimilars in the United States 2023-2027” IQVIA LAAD Medical Procedures Claims, Sep 2022; US Market Access Strategy Consulting, Dec 2022.
Slide 23: Biosimilar Pricing Dynamics
23 Price discounts in the 18-50% range within 3 years of launch Biosimilar Pricing Dynamics Reproduced with permission; IQVIA “Biosimilars in the United States 2023-2027” IQVIA National Sales Perspective, US Market Access Strategy Consulting, Dec 2022.
Slide 24: AEON Model Could Allow Reimbursement Based Solely on Therapeutic Pricing
24 No competitive botulinum product has a separate BLA exclusively for therapeutic indications AEON Model Could Allow Reimbursement Based Solely on Therapeutic Pricing *Average selling price Value to Physician Consistent, predictable reimbursement Value to Payor Potential to offer financial incentiv
Slide 25: Summary and Key Milestones
25 Summary and Key Milestones Key points PrabotulinumtoxinA is the most advanced 900 kDa toxin (same molecular weight as BOTOX) in development Much of the analytical characterization has been previously completed PrabotulinumtoxinA manufacturing for aesthetic indications is already FDA approved* and
Slide 26: Thank You
Thank You DoAEON BIOPHARMA