Aeon Biopharma, Inc. · AMEX:AEON
Aeon Biopharma — Priveterra Acquisition — SPAC Merger (May 2023)
48 slides from Aeon Biopharma's SPAC merger presentation, May 24, 2023
Slide 1: Corporate Presentation May 2023
Corporate Presentation May 2023
Slide 2: Disclaimer
2 Disclaimer About This Presentation This investor presentation (“Presentation”) does not constitute (i) a solicitation of a proxy, consent or authorization with res pect to any securities or in respect of the proposed Business Combination or (ii) an offer to sell, a solicitation of an offer to buy,
Slide 3: Disclaimer (Cont'd)
3 Disclaimer (Cont’d) Targets This Presentation contains certain long - term financial targets of the Company. Neither Priveterra’s nor the Company’s independen t auditors have audited, studied, reviewed, compiled or performed any procedures with respect to the targets for the purpose of their inclu
Slide 4: Investment Highlights
4 Investment Highlights Botulinum toxin has demonstrated utility across dozens of published uses expected to be accessible to ABP - 450; accelerated and simplified commercialization timeline due to existing aesthetic BLA (separately held by Evolus) and manufacturing site approved by FDA, EMA and Hea
Slide 5: Leadership Team with Highly Relevant Industry Experience and Track Record of Success
5 Leadership Team with Highly 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 dedicat
Slide 6: Botulinum Toxin: The Ultimate Platform Product
6 Botulinum Toxin: The Ultimate Platform Product
Slide 7: Global Therapeutic Toxin Landscape
7 Global Therapeutic Toxin Landscape AbbVie Inc. Merz Pharma Ipsen Group Molecular Size 900 kDa 900 kDa 150 kDa ~400 kDa 150 kDa Approved Indications 1. Blepharospasm 2. Strabismus 3. Cervical Dystonia 4. Hyperhidrosis 5. Spasticity 6. Chronic Migraine 7. Overactive Bladder 8. Neurogenic Detrusor Ov
Slide 8: ABP-450 Indications: Pipeline in a Product
8 Indication Current Phase 2020 2021 2022 2023 2024 Recent/Upcoming Milestones 1H 2H 1H 2H 1H 2H 1H 2H 1H 2H ABP - 450 Episodic Migraine 1 Phase 2 ongoing x IND accepted Oct 2020 x First patient treated Mar 2021 x Enrollment completed Dec 2022 • P2 data anticipated 2H 2023 Chronic Migraine 2 x IND a
Slide 9: Global Therapeutic Toxin Market – 9.9% Projected Growth Through 2027
9 Global Therapeutic Toxin Market – 9.9% Projected Growth Through 2027 • Current indications: Organic growth in current indications driven primarily by continued investment in disease awareness and growing patient populations • New indications: Development in therapeutic specialties that do not curr
Slide 10: Model Allows Reimbursement Based Solely on Therapeutic Pricing
10 No competitive product has therapeutic indications under separate BLA Model Allows Reimbursement Based Solely on Therapeutic Pricing *Average selling price Value to Physician Consistent, predictable reimbursement Value to Payor Potential to offer financial incentives • Original BLA expected to al
Slide 11: Migraine (episodic and chronic prophylaxis)
(episodic and chronic prophylaxis) Migraine
Slide 12: Migraine Market Resurgence From New Players is Benefitting Toxins
12 Migraine Market Resurgence From New Players is Benefitting Toxins New CGRPs are rapidly expanding the market driven by new product launches and promotional investment Migraine affects ~40M people in the United States & ~1B people worldwide every year, making it the third most prevalent illness in
Slide 13: Botox Still Showing Impressive YoY Growth Despite New CGRPs
13 Q1 2019 Q2 2019 Q3 2019 Q4 2019 Q1 2020 Q2 2020 Q3 2020 Q4 2020 Q1 2021 Q2 2021 Q3 2021 Q4 2021 Q1 2022 Q2 2022 Q3 2022 Q4 2022 Normalized Botox 560,178 591,747 596,955 603,957 571,818 562,773 617,901 638,988 656,238 709,350 728,967 733,767 755,091 777,729 797,475 769,050 CGRPs 252,687 365,078 46
Slide 14: Addressable Patient Population ~3x Higher with Episodic Indication
14 Addressable Patient Population ~3x Higher with Episodic Indication 1.6M Total Addressable Patients 260M People Projected 2020 US 18+ Population 1 40M Patients (15%) Estimated Migraine and severe HA Patients 9.4M Patients (24%) Episodic Migraine (6 - 14 HA/month) 4.0M Patients (10%) Chronic Migrai
Slide 15: Endpoint Expectations for Phase 2 Episodic Migraine
15 BOTOX PREEMPT2 1 Phase 3 in chronic migraine • Baseline migraine days were 19.8 days • Change from baseline (CFB) for Botox and placebo was 45% and 33%, respectively ABP - 450 Phase 2 assumptions: • Projected CFB for ABP - 450 and placebo is 45% and 33%, respectively • Treatment effect between pl
Slide 16: Phase 3 Trials for CGRPs in Episodic Migraine
16 Phase 3 Trials for CGRPs in Episodic Migraine Not intended for cross - trial comparisons; Sources: package inserts; Neurol Ther (2021) 10:469 – 497 Brand Generic Company Trial Duration Dose Primary Endpoint N Change (days) Difference from placebo p - value Aimovig erenumab STRIVE 24 Weeks 70 mg S
Slide 17: Phase 2 Migraine Study Design
17 • N = 765 • ~60 sites in US, Canada & Australia • Includes both EM & CM patients • # headache days and migraine days/month established during 4 - week baseline prior to randomization • 3 arms: 150 Units, 195 Units, PBO • 2 injection cycles, 3 months apart • 6 - month treatment duration • Novel in
Slide 18: Independent Analysis of Phase 2 Episodic and Chronic Cohorts
18 Independent Analysis of Phase 2 Episodic and Chronic Cohorts Randomization and Stratified for Episodic Migraine and Chronic Migraine Episodic Migraine N=300 <15 headache days / month And 6 - 14 migraine days / month 150 U N=100 195 U N=100 Placebo N=100 Chronic Migraine N=465 ≥ 15 headache days /
Slide 19: Smart Injection Paradigm Targeting Nerves - Differentiation from Botox
19 22 injection sites (low dose) in P3 migraine protocol focused on specific nerves vs. 31 with Botox targeting muscles Smart Injection Paradigm Targeting Nerves - Differentiation from Botox
Slide 20: Tolerability Comparison
20 Tolerability parameter (% of pts) Pooled PREEMPT studies 1 COMPEL 2 REPOSE 3 CM - PASS 4 ABP - 450 (EM) ABP - 450 (CM) DB OLE OL OL OL DB DB BoNT/A ( n = 687) PL ( n = 692) BoNT/A ( n = 1205) BoNT/A ( n = 716) BoNT/A ( n = 633) BoNT/A ( n = 1160) TEAEs 62.4** 51.7 58.3 60.9 – 41.2 Serious TEAEs 4
Slide 21: Gastroparesis
Do AEON BIOPHARMA Gastroparesis
Slide 22: Gastroparesis Opportunity for ABP-450
22 Gastroparesis Opportunity for ABP - 450 • 2019 FDA Guidance for Industry 1 • Since a well - defined and reliable patient reported outcome (PRO) is not yet available, FDA recommends that the core signs and symptoms be included as endpoints. • Anticipate initiating a Phase 2a study in 2024 • Our pr
Slide 23: Targeted Treatment for Gastroparesis
23 Provides an Opportunity for a Targeted Treatment for Gastroparesis Injections in the Pylorus and Pyloric Sphincter Region Sclerotherapy needle Esophagogastroduodenoscopy Plan to administer injections of ABP - 450 using a standard sclerotherapy needle in the pylorus and pyloric sphincter region Es
Slide 24: Posttraumatic Stress Disorder (PTSD)
Posttraumatic Stress Disorder (PTSD)
Slide 25: Posttraumatic Stress Disorder (PTSD)
25 Posttraumatic Stress Disorder (PTSD) • PTSD is well defined with broad disease awareness • A psychiatric disorder that may occur in people who experience or witness a traumatic event or events • Categories of symptoms include intrusion (involuntary memories), avoidance, alterations in cognition a
Slide 26: PTSD Associated with the Stellate Ganglion
26 Posttraumatic Stress Disorder Associated with the Stellate Ganglion Source: Image Left: Rae Olmsted KL, Bartoszek M, Mulvaney S, et al. Effect of Stellate Ganglion Block Treatment on Posttraumatic Stre ss Disorder Symptoms: A Randomized Clinical Trial. JAMA Psychiatry. 2020;77(2):130 – 138. doi:1
Slide 27: ABP-450 Pre-Clinical PTSD Study
27 Stellate ganglion (sympathetic) block using ultrasound guidance • Establish safety and preliminary efficacy signal • Rats placed in supine position under anesthesia • Administer approximately 10 - 20 µl of active, following standard protocols • Observe for 1 - 2 weeks after the injection • Monito
Slide 28: Cervical Dystonia
Lo AEON BIOPHARMA Cervical Dystonia
Slide 29: Cervical Dystonia Opportunity for ABP-450
29 Cervical Dystonia Opportunity for ABP - 450 • Potential for efficient development • Potential to allow participation in segment of on - label movement disorders • Potential to leverage into a broader muscle spasticity indication and label with a focused clinical program Important Indication for M
Slide 30: Cervical Dystonia Phase 2 Study Design
30 Open Label Extension Proposed to Occur in Parallel with Phase 3 Trial Cervical Dystonia Phase 2 Study Design - Dose Ranging • First patient dosed April 2021 • Phase 2 top line data reported in September 2022 Randomized Double - Blinded Placebo - Controlled Study 20 weeks Randomized R 1 - week bas
Slide 31: Discussion and Conclusions
31 Discussion and Conclusions • Phase 2 trial met primary and other key endpoints, supporting the safety and efficacy of ABP - 450 in reducing signs and symptoms associated with CD. • ABP - 450 demonstrated adverse event rates similar to, or lower than, other botulinum toxin products for the treatme
Slide 32: Financial Overview
LO AEON BIOPHARMA Financial Overview
Slide 33: Transaction Details
33 Transaction Details ($ in millions except per share values, assumed PMGM stock price @ $10.00) 1. Trust information as of 3/31/23. 2. AEON Cash as of 03/31/23, unaudited. 3. Ownership percentage is calculated on a fully diluted basis (utilizing the treasury stock method). Assumes no incremental f
Slide 34: Earnout Structure Aligns AEON and Sponsor Incentives
34 Earnout Structure Aligns AEON and Sponsor Incentives with Public Market Investors “Pay for Performance” Earnout Structure ABP - 450 – Clinical and Regulatory Timeline 2025 2H 1H 2026 2H 1H 2027 2H 1H 2028 2H 1H 2029 2H 1H Earnout Deadline Chronic Migraines BLA acceptance for CM prior to 06/30/28
Slide 35: AEON Target Financial Profile in 2035
35 AEON Target Financial Profile in 2035 ($ in millions) 11% 89% 5% 95% Targeted Peak Sales Ranges Target Revenue Split Ranges at Peak Sales 3 Long - Term Targeted Margin Dynamics Mid 50% Mid 70% Migraine Cervical Dystonia ~ 90/10 split between primary indications Gross Margin Operating Margin Targe
Slide 36: Valuation Benchmarking
36 Valuation Benchmarking ($ in millions) CNS Peer Set Commercial Neurotoxin Products Subset Median EV Median EV/ Peak Sales $1,775 1.1x $1,767 2.0x $202 0.1x (1) Source: Company press releases and FactSet as of 5/22/23. Peak Sales values as of 12/09/22. Note: Primarily includes companies with recen
Slide 37: Investment Highlights
37 Investment Highlights Botulinum toxin has demonstrated utility across dozens of published uses expected to be accessible to ABP - 450; accelerated and simplified commercialization timeline due to existing aesthetic BLA (separately held by Evolus) and manufacturing site approved by FDA, EMA and He
Slide 38: Appendix
Lo AEON BIOPHARMA Appendix
Slide 39: High Barriers for New Entrants to Effectively Compete
39 High Barriers for New Entrants to Effectively Compete Intellectual Property Considerations for ABP - 450 3 4 2 9 Exclusive Licensing & Supply Agreement • Under agreement, Daewoong manufactures and supplies ABP - 450 to AEON • Agreement initiated in Q4 2019 • Exclusive license granted for commerci
Slide 40: Risk Factors
40 Risk Factors Summary of Risk Factors The Company’s business is subject to numerous risks and uncertainties that represent challenges that the Company faces in con nec tion with the successful implementation of its strategy and the growth of its business. Below is an appendix to this Presentation
Slide 41: Risk Factors (Cont'd)
41 Risk Factors (Cont’d) 13. ABP - 450, if approved in any currently proposed or future therapeutic indications, will face significant competition and our fail ure to effectively compete may prevent us from achieving significant market penetration and expansion. 14. If approved, ABP - 450 may face c
Slide 42: Risk Factors (Cont'd)
42 Risk Factors (Cont’d) 28. Third - party claims of intellectual property infringement, misappropriation or violation, or challenges related to the invalidity or unenforceability of any issued patents we may obtain or in - license may prevent or delay our development and commercialization efforts o
Slide 43: After Brief Decline During COVID, Botox Resumed Growth
43 After Brief Decline During COVID, Botox Resumed Growth Among Patients Switching from a Previous Brand Definitions: • Patient cohort – Patients with at least 1 migraine diagnosis code and at least 1 treatment code on or after first diagnosis code • Look Back = 365 days, Grace = 30 days Source: Sym
Slide 44: Key Value Inflection Points
44 Key Value Inflection Points Original BLA for therapeutic indications Product platform Take share of established markets, enter new indications First launch in established market Expansion of treatment options Adoption facilitated by established 900 kDa botulinum toxin complex Replicate success in
Slide 45: Advisory Board with Highly Relevant Industry Experience
45 Advisory Board with Highly Relevant Industry Experience and Track Record of Success Experienced Advisory Board Andrew Blumenfeld, MD Michael Camilleri, MD Chris Reist, MD Migraine Gastroparesis Neuro/Psych • Director of the Headache Center of Southern California • Board - certified in Neurology b
Slide 46: Overview of Priveterra Sponsor Team
46 Overview of Priveterra Sponsor Team • Fundamental approach to proprietary investment thesis driven by innovation, transparency, long - term relationships and shareholder values • Strong track record in Life Sciences over the past two decades … building, operating and monetizing investments • Sign
Slide 47: Development Timeline Includes Multiple Clinical Near-Term Milestones
47 Development Timeline Includes Multiple Clinical Near - Term Milestones Chronic Migraine Episodic Migraine Indication Current Phase ABP - 450 Cervical Dystonia Phase 2 Phase 2 Phase 2* 2020 2H 1H 2021 2H 1H 2022 2H 1H 2023 2H 1H 1 2 3 1 1) IND accepted Oct 2020 2) First patient treated Mar 2021 3)
Slide 48: Thank you
Thank you