AEON Biopharma : Corporate Deck (Final May 2026)

Published: 2026-05-14 16:23:25 ET AEON

Published on 05/14/2026 at 04:23 pm EDT

NYSEAMERICAN: AEON

CORPORATE PRESENTATION / MAY 2026

Developing ABP-450 as the first clinically substitutable therapeutic alternative to BOTOX®

→ Licensed exclusive rights to commercialize all BOTOX® therapeutic indications in the U.S., Canada, EU, UK and select international territories

→ Advancing full-label Extrapolation Strategy under the FDA's 351(k) biosimilar pathway for ABP-450 covering all BOTOX® therapeutic indications

BOTOX® has remained the dominant player despite branded competition and expiration of key patents

→ Lack of full label for branded BOTOX® competitors serves as a significant hurdle for market adoption

→ A true biosimilar that could be substituted for BOTOX® has remained elusive given manufacturing complexity associated with toxins

ABP-450 is a validated botulinum toxin platform with established clinical data and FDA inspected manufacturing facility

→ Manufactured by Daewoong Pharmaceuticals in compliance with cGMP

Identical product profile as Jeuveau®, approved and marketed for cosmetic indications by Evolus, Inc.

→ Composition and mechanism of action (MoA) supports similarity to BOTOX®

Same 900kDa size, 100% amino acid sequence identity, genetic & formulation parity, and highly similar potency supports clinical dose predictability

Led by newly appointed seasoned management team with demonstrated experience in toxins and capital formation

→ Rob Bancroft (CEO) served as the former BOTOX® leader responsible for competitive strategy and long-range asset maximization

→ John Bencich (CFO) led Achieve Life Sciences (CEO & CFO) and Oncogenex Pharmaceuticals (CFO); brings growth and capital strategy experience

Recent highlights and upcoming catalyst

→ January FDA Type 2a feedback provides a clear framework to complete remaining analytical work

→ Type 2b meeting planned for 2H26 to align on comparative clinical study requirements

Despite >30 years of growth, no clinically substitutable alternative has threatened BOTOX® - until now

W H A T D R I V E S A D OPT I ON A T SC A LE

Full-Label Parity

Captures all 12 indications at approval

→ Competes for the entire therapeutic market from day one

→ Avoids the restricted labels that have constrained prior competitors

Clinical Equivalence

No change to physician workflow

→ Same dosing, preparation, and administration as BOTOX®

→ Prior competitors required changes →

limited adoption

Switching is Rewarded

Aligned economics drive adoption

→ Improves physician margin per treatment

→ Payers incentivized to reinforce switching behavior

Adoption at scale + structurally limited follow-on competition → durable share

The U.S. market accounts for ~86% of global therapeutic neurotoxin sales

Therapeutic Botulinum Market Value in the U.S.

〉Strong Market Growth

Total therapeutic toxin market value in the U.S.

$3.5B $3.8B

7.7%

CAGR

$4.1B

$4.4B

$4.8B

$5.1B

has grown by >75% since 2020

〉Key Tailwinds:

Durable demand across large, chronic indications (esp. neurological)

Expanding diagnosis and treatment rates

2026 2027 2028 2029 2030 2031

〉Key Headwinds:

Payer pressure and tightening utilization controls

Provider margin compression under buy-and-bill dynamics

Clarivate. Market Insights US Therapeutic Botulinum Toxin Market. 2025.

Restricted labels have limited competitor adoption and scale

Other brands collectively captured <8%

of market value in 2025

No competitor has meaningfully challenged BOTOX's® full therapeutic label

"BOTOX is the only one that truly covers everything."

- Neurologist, 200+ BOTOX® patients/yr

BOTOX® accounted for

therapeutic neurotoxin market value in 2025

The lack of viable alternatives reinforces provider dependence, which can result in financial losses

Clinical Limitation

〉 Non-BOTOX® neurotoxin labels are significantly narrower

- BOTOX® remains the only approved option for key conditions (e.g., migraine)

Operational Complexity

〉 Risk of error and workflow complexity increase when managing multiple products

Financial Burden

〉 High-volume injectors can experience significant financial loss while using BOTOX®

"BOTOX is the only one that truly covers everything. Dysport, XEOMIN, DAXXIFY they're all missing some of the major indications, so we use them less." - Neurologist, 200+ BOTOX® patients/yr

"Every toxin has different units and dilution. We try not to maintain multiple workflows. It's a huge operational headache and creates room for error."

Neurologist, 300+ BOTOX® patients/yr

"Sometimes, if we're lucky, we can make $5 per vial, but often we don't. My coffee costs $6, how could I be happy with $5?"

Neurologist, 200+ BOTOX® patients/yr

Minimal price leverage to reduce overall toxin cost due to lack of viable BOTOX® alternatives

Lack of clinically substitutable alternatives eliminates traditional cost levers

The Payers Dilemma

Heavy spend concentrated in BOTOX®, with rising utilization and no ability to slow volume

With no pricing leverage, payers increasingly rely on PA enforcement as the only practical control

"For us, BOTOX represents well over 65% of the total neurotoxin dollars and they're all clinically appropriate, so there really isn't anything we can do to slow the use."

Medical Director, National Plan with 10M+ lives covered

"Non-BOTOX products really haven't shown any superiority over BOTOX. Clinically they don't differentiate, and total-dollar-wise they're sometimes even higher than BOTOX, so there isn't a reason for us to try to push providers toward them."

Medical Director, National Plan with 10M+ lives covered

Payers trapped in a cycle with no viable levers to curb rising toxin costs

AEON is taking a different approach

Equivalence to BOTOX® across every relevant dimension -

same label, same dosing, same dilution, same outcomes, same coverage, same workflow.

Differentiation forces competitors to fight

three decades of cumulative BOTOX® investment, experience, and habit.

Biosimilarity allows AEON to leverage it.

Share moves when switching happens - and switching becomes rational under specific conditions

Clinical Substitution

〉 Equivalent outcomes across all indications

Operational Simplicity

〉 No change to dosing, preparation, or workflow

Economic Alignment

〉 Lower cost for payers, improved provider economics

Responses received through qualitative interviews (N=6) conducted by Kx Advisors between November-December 2025.

Switching Becomes Rational When...

〉FDA confirms clinical comparability

〉workflow remains unchanged

〉economics improve for both payers and providers

"If a product has the full BOTOX® indications, and it's identical and cheaper, I'd consider switching entirely."

-Neurologist, >300 BOTOX® patients/year

Current competitors are restricted to a subset of indications - limiting adoption and scale

91.9% share* 4.4% share* 3.1% share* <1% share*

AbbVie Inc.

Merz Pharma

Ipsen Group

Crown Laboratories

1989

2010

2009

2023

Full Label Parity (targeted)

1. Chronic migraine

1. Blepharospasm

1. Cervical dystonia

2. Overactive bladder

2. Cervical dystonia

2. Upper limb spasticity

3. Detrusor overactivity

3. Adult upper limb spasticity

(adults)

4. Pediatric detrusor overactivity

4. Chronic sialorrhea

3. Lower limb spasticity

Therapeutic Label

5. Adult upper limb spasticity

(pediatric)

(FDA Approved

6. Adult lower limb spasticity

Indications)

7. Pediatric upper limb spasticity

8. Pediatric lower limb spasticity

9. Cervical dystonia

10. Axillary hyperhidrosis

11. Blepharospasm

12. Strabismus

Full-label access is required to compete at scale - and no competitor has it today

ABP-450 is designed to offer operational simplicity with the same vial size, dilution, and dosing

Switching Friction Index

ABP-450 Xeomin® Daxxify® Dysport®

Biosimilarity lowers switching friction - by design

〉Biosimilar designation signals equivalence across clinical and operational domains

- Dose, dilution, safety, immunogenicity, outcomes, patient ed

"If it's basically the same as BOTOX in how we use it, same workflow, same mixing, same injection, then switching wouldn't be an issue, it'd be a no-brainer"

- Neurologist, 300+ BOTOX® patients/yr

Friction reduces physician confidence and drives workflow disruption

LEGEND - OPERATIONAL DIFFERENCES

Patient Ed

Label

Dose

Reconstitution

Reimbursement & ASP dynamics favor biosimilar products and reward switching

Therapeutic-Only ASP Restores Margin Integrity

BOTOX ASP: depressed due to aesthetic price discounts

CMS Structurally Improves Biosimilar Add-On Payment

Add-on payment calculated on BOTOX ASP, not ABP-450 ASP

Lower Acquisition Cost

ABP-450 expected to price below BOTOX

BOTOX®

Biosimilar

Acquisition cost

Higher

Lower

ASP Calculation

Blended

(therapeutic + aesthetic)

Therapeutics

-only

Reimbursement

ASP + 6%

(+6% based on Botox ASP1)

Provider Margin

Lower

Higher

Biosimilars structurally improve physician economics for buy-and-bill products through improved add-on payment and lower acquisition costs

ABP-450 unlocks new payer leverage and meaningful cost savings

ABP-450 delivers immediate cost savings, addressing a category that has grown unchecked for years

Unlock

The Payers Dilemma

For the first time ever, a lower cost, comparable toxin would allow payers to use pricing levers

"If neurologists want to use BOTOX, we can't steer them away. But if FDA deems the biosimilar as identical to BOTOX, we have something comparable that we can point them to"

Medical Director, National Plan with 10M+ lives covered

"If a biosimilar is cheaper and does the same thing as BOTOX and providers can use it in the exact same way, we'd absolutely move volume towards it."

Medical Director, National Plan with 10M+ lives covered

ABP-450 gives plans the flexibility to apply brand-specific

policies, potentially introduce UM or step edits in favor of ABP-450 unavailable to them today

"If the ASP is at least 20% lower, I can move a lot of share to the biosimilar."

- Medical Director, Regional Plan with 3M+ lives covered

~3,000 neurologists treat the vast majority of neurologic BOTOX® patients in the U.S.

Implications for Commercial Strategy

〉Neurology represents >70% of the total therapeutic toxin market

〉~3,000 neurologists treat ~90% of neurologic BOTOX® patients

〉~75 payers cover the majority of treated patients

→ A small number of physicians and payers control the majority of the U.S. toxin market

PurpleLab 2024 Claims Data as of Wednesday, 12/10/25, 11:00 am EST, DRG, Piper Sandler

Payers, physicians, patients each gain from ABP-450's advantage

Target Profile:

Proven Science Comparable Outcomes Full Label Parity

Better Economics

Payers:

Restores cost control and formulary leverages through full label biosimilar competition

Physicians:

Improves physician economics with no change to clinical workflow

Patients:

Lowers out-of-pocket costs while maintaining

equivalent treatment effectiveness

Unlike other biosimilars, this molecule presents unique manufacturing and analytical challenges

Manufacturing at Scale

→ Very Few Can Do It

Biosecure handling and specialized infrastructure required

U.S. cGMP production requires tightly controlled, consistently reproducible processes

→ Few platforms can reliably manufacture at scale in the U.S.

Analytical Validation

A Molecular Paradox

Large. Complex. Vanishingly small.

~900 kDa multi-protein complex

~1:100,000 vs. excipients (trace API levels in DP)

Same starting material → highly variable results

→ Hard to Prove

API at trace levels must be isolated from the finished product

Requires highly sensitive and advanced analytical techniques

→ Difficult to demonstrate biosimilarity with precision

These constraints limit credible entrants -AEON has already navigated the most critical steps

ABP-450 Biosimilar Development Program

The Daewoong 900 kDa toxin powering Jeuveau® also anchors ABP-450's therapeutic biosimilar strategy

Aesthetics Therapeutics

Jeuveau® ABP-450

〉 Exclusive aesthetic rights

〉 FDA approval in moderate to severe glabellar (frown) lines; $274.5m sales in 20251

〉 Exclusive therapeutic rights2

〉 Seeking all 12 FDA-approved indications for BOTOX®

This shared toxin heritage means AEON is building its biosimilar strategy on a known molecule, known manufacturing, and known safety - not on a blank page

Approved worldwide, manufactured at scale - forming the backbone of ABP-450's U.S. biosimilar entry

2 34

12 69+ WW

regulatory approvals1

FDA & EMA approved

manufacturing facility

Approved by regulators in

North America, EU, APAC, LATAM, MENA

Disclaimer

AEON Biopharma Inc. published this content on May 14, 2026, and is solely responsible for the information contained herein. Distributed via Public Technologies (PUBT), unedited and unaltered, on May 14, 2026 at 20:22 UTC.