AEON Biopharma, Inc 8-K, filed Oct 7, 2024
AEON Biopharma, Inc. (AEON)
About this 8-K
AEON Biopharma, Inc filed this 8-K on October 7, 2024.
Items reported
- Item 7.01: Regulation FD disclosure
- Item 9.01: Financial statements and exhibits
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CURRENT REPORT
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Item 7.01. Regulation FD Disclosure.
On October 7, 2024, AEON Biopharma, Inc. (the “Company” or “AEON”) made available in the investor relations section of its website a new corporate presentation (the “Corporate Presentation”), a copy of which is furnished as Exhibit 99.1 to this Current Report on Form 8-K (this “Report”). Information from the Corporate Presentation may also be used by the management of the Company in future meetings regarding the Company. For important information about forward-looking statements in the Corporate Presentation, see the slide titled “Forward-Looking Statements” in Exhibit 99.1 attached hereto.
The information furnished in this Item 7.01 of this Report (including Exhibit 99.1) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Exchange Act, regardless of any general incorporation language in such filing, unless expressly incorporated by specific reference in such a filing.
Item 9.01. Financial Statement and Exhibits.
(d) Exhibits.
Exhibit No. | Description | ||||||||
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99.1 | Corporate Presentation of AEON Biopharma, Inc., dated October 2024. | ||||||||
104 | | Cover Page Interactive Data File (embedded within the Inline XBRL document) | |||||||
| Corporate Presentation October 2024 PrabotulinumtoxinA Potential biosimilar for therapeutic indications |
| 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 any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. These statements may involve known and unknown risks, uncertainties and other important factors that may cause the actual results, performance or achievements of AEON Biopharma, Inc. (“AEON”) to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. These statements may be preceded by, followed by or include the words “believes”, “estimates”, “expects”, “projects”, “forecasts”, “may”, “will”, “should”, “seeks”, “plans”, “scheduled”, “anticipates” or “intends” or similar expressions. The forward-looking statements in this presentation are only predictions. AEON has based these forward-looking statements largely on AEON’s current expectations and projections about future events and financial trends that AEON believes may affect its business, financial condition and results of operations. These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by AEON and its management, are inherently uncertain. Factors that may cause actual results to differ materially from current expectations include, but are not limited to: (i) the outcome of any legal proceedings that may be instituted against AEON or others; (ii) AEON’s future capital requirements; (iii) AEON’s ability to raise financing in the future; (iv) AEON’s ability to continue to meet continued stock exchange listing standards; (v) the ability of AEON to implement its strategic initiatives, including the continued development of ABP-450 and potential submission of a Biologics License Application for therapeutic uses of ABP-450; (vi) the ability of AEON to satisfy regulatory requirements; (vii) the ability of AEON to defend its intellectual property; (viii) the possibility that AEON may be adversely affected by other economic, business, regulatory, and/or competitive factors; and (ix) other risks and uncertainties set forth in the section entitled “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in AEON’s Annual Report on Form 10-K for the year ended December 31, 2023 and any current or periodic reports filed with the Securities and Exchange Commission (the "SEC"), which are available on the SEC’s website at www.sec.gov. Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified and some of which are beyond AEON’s control, you should not rely on these forward-looking statements as predictions of future events. The events and circumstances reflected in AEON’s forward-looking statements may not be achieved or occur, and actual results could differ materially from those projected in the forward-looking statements. Moreover, AEON operates in an evolving environment and a competitive industry. New risks and uncertainties may emerge from time to time, and it is not possible for management to predict all risks and uncertainties, nor can AEON assess the impact of all factors on AEON’s business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements AEON may make in this presentation. As a result of these factors, although AEON believes that the expectations reflected in its forward-looking statements are reasonable, AEON cannot assure you that the forward-looking statements in this presentation will prove to be accurate. Except as required by applicable law, AEON does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances, or otherwise. AEON qualifies all of its forward-looking statements by these cautionary statements. You should view this presentation completely and with the understanding that the actual future results, levels of activity, performance, events and circumstances of AEON may be materially different from what is expected. This presentation concerns anticipated products that are under clinical investigation and which have not yet been approved for marketing by the FDA. These anticipated products are currently limited by Federal law to investigational use, and no representation is made as to their safety or effectiveness for the purposes for which they are being investigated. Certain information contained in this presentation relates to or is based on studies, publications, surveys and other data obtained from third-party sources and AEON’s own internal estimates and research. AEON has not independently verified, and makes no representation as to the adequacy, fairness, accuracy or completeness of, any information obtained from third-party sources. In addition, all of the market data included in this presentation involves a number of assumptions and limitations, and there can be no guarantee as to the accuracy or reliability of such assumptions. Finally, AEON’s own internal estimates and research have not been verified by any independent source. AEON Biopharma and the AEON Biopharma logo are trademarks of AEON Biopharma, Inc. All other trademarks used herein are the property of their respective owners. |
| 3 Biosimilar Pathway - Faster to Market With Broader Indication Potential FDA Approved Manufacturing Biosimilar Pathway Substantial Existing Evidence Next Steps & Limited IP Risk Limited Competition/Large Market Established Regulatory Pathway Pursuing the 351(k) regulatory pathway with PrabotulinumtoxinA as biosimilar to Botox Potential to receive approval for all Botox therapeutic indications (12 currently) Only one other known biosimilar in active development Botox revenue ~$2.5B for US therapeutic indications – growing high single digits Aligned with the FDA on the regulatory pathway during Q3 2024 meeting Comparative analytical assessment (CAA) studies anticipated to commence in Q4 2024 PrabotulinumtoxinA approved in 2019 under aesthetic-only BLA (separately held by Evolus) Manufacturing site approved by FDA, EMA and Health Canada for aesthetic product Previous analytical characterization provides evidence supporting functional and structural “similarity” Successfully completed Phase 2 study (September 2022) in cervical dystonia Plan to conduct BPD* Type 2 meeting with FDA in 2025 to review the results from the CAA studies and confirm the remainder of the proposed study package No neurotoxin composition-of-matter patents minimizes litigation risk BPD: Biosimilar (Biological) Product Development |
| 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 the entire BOTOX® franchise • 7 years at TAP Pharmaceuticals responsible for Lupron Depot (Urology, Oncology and Gynecology) • 30+ years of combined experience in academia and the pharmaceutical industry • Responsible for multiple IND, NDA, and BLA submissions • Chief, Division of Allergy and Immunology at Harbor-UCLA Medical Center • Associate Professor, Department of Pediatrics at UCLA School of Medicine • Published multiple scientific papers, books, book chapters, and abstracts, including 38 peer-reviewed original scientific papers • 12+ years of legal experience in corporate governance, mergers & acquisitions and capital markets • Associate General Counsel of Glaukos Corporation, responsible for business development activities, capital markets, corporate governance and SEC reporting • Counsel at O’Melveny & Myers EVP, Chief Legal Officer & Secretary Alex Wilson Jennifer Sy VP, Corporate Controller • 18+ years of finance and accounting experience in biotech, healthcare, technology and software industries • Senior management roles, responsible for establishing stream-lined accounting and financial reporting functions for publicly-traded and privately-held companies • Extensive experience in SPAC mergers, SEC reporting and ERP implementations |
| 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. Adult upper limb spasticity 6. Adult lower limb spasticity 7. Pediatric upper limb spasticity 8. Pediatric lower limb spasticity 9. Cervical dystonia 10. Axillary hyperhidrosis 11. Blepharospasm 12. Strabismus None 1. Blepharospasm 2. Cervical dystonia 3. Adult upper limb spasticity 4. Chronic sialorrhea 1. Cervical dystonia 2. Spasticity 1. Cervical dystonia In Development 1. Episodic Migraine 2. Essential Tremor 3. IC/BPS Biosimilar Undisclosed 1. Neurogenic detrusor overactivity 2. Migraine (episodic & chronic) 1. Adult upper limb spasticity FDA Approved US Share 95% 2% 2% Sources: Decision Resources Group Therapeutic Botulinum Toxin Market Analysis Global 2021 |
| 6 FDA evaluates each proposed biosimilar and advises on the extent of testing to establish biosimilarity Biosimilar Requirements for FDA Approval 1. Manufacturing facilities for therapeutics use would require separate regulatory inspection https://www.fda.gov/drugs/biosimilars/review-and-approval https://www.fda.gov/media/82647/download 1. Establish manufacturing • PrabotulinumtoxinA approved in 2019 as Jeuveau and manufactured by Daewoong1 2. Analytical characterization • Physiochemical and functional assays supportive of “similarity” • Comparative analytical studies to confirm structural and functional similarity 3. Animal studies • Toxicology and pharmacology information 4. Clinical studies • Phase 2 in cervical dystonia • Potential comparative Phase 3 program with clinical efficacy endpoint 1. Aligned on conducting comparative analytical studies 2. Plan to meet in 2025 to review results and confirm remainder of the proposed study package Animal Studies Safety and Efficacy Studies Human Studies Analytical Physiochemical and Functional Assays Comparative Analytical Assessment Nonclinical Comparative Clinical Studies Clinical Pharmacology 》 FDA meeting in Q3 2024: |
| 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 upper limb spasticity Adult lower limb spasticity Pediatric upper limb spasticity Pediatric lower limb spasticity Cervical dystonia Axillary hyperhidrosis Blepharospasm Strabismus • A biosimilar can meet the requirements for approval based on data from a clinical study that demonstrates safety and effectiveness in an appropriate condition1 • FDA may approve a biosimilar for indications without direct clinical studies in those indications if the manufacturer provides adequate scientific justification1 ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ |
| 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 awareness and growing patient populations • New indications: Development in therapeutic specialties that do not currently have a toxin treatment option • Improved reimbursement: Favorable dynamics to facilitate coverage at current and projected pricing levels Anticipated Volume Growth Drivers Y/Y growth in high single digits US therapeutic revenue annualizing >$2.5 billion $429 $488 $534 $561 $500 $557 $584 $614 $587 $614 $626 $649 $611 $669 17% 14% 9% 9% 17% 10% 7% 6% 4% 9% 0 0.02 0.04 0.06 0.08 0.1 0.12 0.14 0.16 0.18 0.2 $300 $350 $400 $450 $500 $550 $600 $650 $700 Q1'21 Q2'21 Q3'21 Q4'21 Q1'22 Q2'22 Q3'22 Q4'22 Q1'23 Q2'23 Q3'23 Q4'23 Q1'24 Q2'24 Y/Y Growth Revenue ($ mil) US Therapeutic Botox Sales Revenue Growth |
| Phase 2 completed Potential comparative Phase 3 to support BLA submission Cervical Dystonia |
| 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 • Regulatory endpoints well-established Foundational Indication • ~50,000 US patients • Cervical dystonia is a chronic condition with no cure • Painful and debilitating twisting movements of neck and shoulders • Botulinum toxin injection is the standard of care • Established outcome measures and regulatory pathway The Disorder • Phase 2 program was successfully completed in 2022 • Anticipate Phase 3 program would include a head-to-head comparison to Botox® to demonstrate therapeutic equivalence if there are residual uncertainties after completion of analytical assessments Phase 3-Ready Sources: Company estimates based on 2017 US Census Projections Defazio, Descriptive Epidemiology of Cervical Dystonia (2013) Richardson, American Academy of Neurology - Dystonia Treatment (2017) |
| 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-week washout of prior toxin treatment Open Label Extension Study Placebo n= 15 150 Units ABP-450 n= 15 250 Units ABP-450 n= 15 350 Units ABP-450 n= 15 4 treatments of ABP-450 52 weeks Primary: • Safety of ABP-450 Secondary: • Change in TWSTRS • PGI-C and CGI-C • PGI-S and CGI-S Exploratory: • C-SSRS • Dysphagia Score Endpoints • N = 60 • 40 sites in US • 3 doses; 4 arms • 1 injection in randomized portion • 4 injections in OLE • 20-week primary endpoint • 72 weeks total Study Design |
| 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 score indicates improvement – 3 subscales: severity, disability, and pain • Validated outcome parameter • Change from baseline in TWSTRS score was utilized in Aeon Phase 2 study and will be primary endpoint for Phase 3. |
| 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 statistically significant improvement over placebo. p=0.0070 (150 U vs. Placebo) p=0.0406 (250 U vs. Placebo) p=0.0864 (350 U vs. Placebo) • Treatment effect between active doses was not statistically significant. p=0.4624 (150 U vs. 250 U) p=0.2598 (150 U vs. 350 U) p=0.7071 (250 U vs. 350 U) |
| 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=0.1332 (250 U vs. Placebo) p=0.1081 (350 U vs. Placebo) Statistics Test Result: p=0.0027 (150 U vs. Placebo) p=0.4290 (250 U vs. Placebo) p=0.2173 (350 U vs. Placebo) Disability Subscale Pain Subscale Severity Subscale 1.02 4.53* 4.24* 2.62 0 1 2 3 4 5 Placebo (n=14) 150 U (n=14) 250 U (n=14) 350 U (n=15) Improvement From Baseline DS (LSM) 1.27 3.56 3.58 3.69 0 0.5 1 1.5 2 2.5 3 3.5 4 Placebo (n=14) 150 U (n=14) 250 U (n=14) 350 U (n=15) Improvement From Baseline PS (LSM) 1.91 5.89* 2.94 3.45 0 1 2 3 4 5 6 7 Placebo (n=14) 150 U (n=14) 250 U (n=14) 350 U (n=15) Improvement From Baseline SS (LSM) |
| 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 (250 U vs. Placebo) p=0.0095 (350 U vs. Placebo) 4 2.6* 2.2* 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 PGI-C (LSM) * p-value <0.05 Statistics Test Result: p=0.0017 (150 U vs. Placebo) P<0.0001 (250 U vs. Placebo) p=0.0028 (350 U vs. Placebo) Clinical Global Impression of Change Patient Global Impression of Change PrabotulinumtoxinA demonstrated statistically significant improvement on both PRO instruments |
| 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 ADVERSE EVENT (TEAE) 9 (64.3%) 8 (57.1%) 12 (75%) 11 (73.3%) 31 (68.9%) ANY SERIOUES TEAE 0 0 0 0 0 ANY TREATEMENT-RELATED TEAEs* (TRTEAE) 2 (14.3%) 3 (21.4%) 8 (50%) 5 (33.3%) 16 (35.6%) Dysphagia# 0 0 2 (12.5%) 3 (20%) 5 (11.1%) Muscular Weakness 0 2 (14.3%) 0 1 (6.7%) 3 (6.7%) Headache 0 0 1 (6.3%) 1 (6.7%) 2 (4.4%) Joint swelling 0 0 1 ( 6.3%) 0 1 ( 2.2%) Neck pain 1 ( 7.1%) 0 1 ( 6.3%) 0 1 ( 2.2%) Torticollis 0 0 1 ( 6.3%) 0 1 ( 2.2%) Nausea 0 0 1 ( 6.3%) 0 1 ( 2.2%) Dizziness 0 0 1 ( 6.3%) 0 1 ( 2.2%) Head discomfort 0 1 ( 7.1%) 0 0 1 ( 2.2%) Presyncope 0 0 0 1 ( 6.7%) 1 ( 2.2%) Feeling abnormal 0 0 1 ( 6.3%) 0 1 ( 2.2%) Injection site pain 1 ( 7.1)% 1 ( 7.1%) 0 0 1 ( 2.2%) Injection site pruritus 0 0 1 ( 6.3%) 0 1 ( 2.2%) Malaise 0 0 1 ( 6.3%) 0 1 ( 2.2%) Diplopia 0 0 1 ( 6.3%) 0 1 ( 2.2%) Rash macular 0 0 0 1 ( 6.7%) 1 ( 2.2%) |
| 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 discontinuations due to Treatment-Emergent Adverse Events (TEAEs) • Low rate of treatment-related TEAEs (TRAEs) • Zero dysphagia cases in the 150 U arm and low rate of dysphagia (11%) and muscle weakness (6.7%) overall • All TRAEs were mild to moderate in severity and transient in nature • PrabotulinumtoxinA demonstrated efficacy similar to other botulinum toxins. • TWSTRS at Week 4 improved 14.01 points in 150 U; 11.28 points in 250 U; 9.92 points in 350 U; 3.57 points in placebo – Statistical significance in lower dose arms (150 U and 250 U) vs. placebo and numerical improvement in high dose arm (350 U) vs. placebo • Patient Global Impression of Change (PGI-C) demonstrated statistically significant improvement in all three ABP-450 dose groups over placebo • Clinical Global Impression of Change (CGI-C) demonstrated statistically significant improvement in all three ABP-450 dose groups over placebo |
| Favorable regulatory environment Higher penetration with more recent launches Still limited competition and predictable pricing dynamics Biosimilar Market Landscape |
| 19 ~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 2022. |
| 20 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 |
| 21 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. |
| 22 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. |
| 23 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 incentives AEON BLA only for therapeutic indications • Potential therapeutic-only BLA could allow AEON’s ASP* to be unencumbered by pricing pressures from aesthetic indications that hamper the competition’s reimbursement structure • Physicians could receive consistent and favorable reimbursement from payors • Flexibility to provide targeted economic incentives to payors and/or providers that competition cannot Removing influence of price competition seen in the aesthetics market |
| 24 Summary and Key Milestones Key points PrabotulinumtoxinA is the most advanced 900 kDa toxin (same molecular weight as BOTOX) in development Substantial analytical characterization has been previously completed PrabotulinumtoxinA manufacturing for aesthetic indications is already FDA approved* and well-established Positive Phase 2 results demonstrate PrabotulinumtoxinA safety and efficacy in cervical dystonia Approval as biosimilar provides potential access to all 12 therapeutic BOTOX indications Upcoming events Q4 2024 – Initiate comparative analytical studies 2025 – Expect to conduct a Biosimilar Biological Product Development (BPD) Type 2 meeting with FDA to review the results from the analytical studies and confirm remainder of proposed study package ✓ ✓ ✓ ✓ ✓ *Developed and commercialized under brand name Jeuveau® (Evolus, Inc.) |
| Thank You |
