Scilex Holding Company · NASDAQ:SCLX
Scilex — Investor Presentation (2023)
56 slides from Scilex's investor presentation, 2023
Slide 1: Innovative Leader in Non-Opioid Pain Therapeutics/Obesity/Neurodegenerative/Cardiometabolic Disease
Innovative Leader in Non-Opioid Pain Therapeutics/Obesity/ Neurodegenerative/Cardiometabolic Disease
Slide 2: Safe Harbor Statements Forward-Looking Statements
Safe Harbor Statements Forward-Looking Statements Certain statements contained in this corporate presentation (this “Presentation”), along with certain statements that may be made by management of Scilex Holding Company (together with its subsidiaries, “Scilex”) orally in presenting this material, a
Slide 3: Scilex Holding Company Structure
Scilex Holding Company Structure Scilex Holding Company Ticker Symbol “SCLX” SCLX Stock Acquisition JV LLC (SCLX Shares: 1.5MM common Scilex Pharmaceuticals Inc. Scilex Bio, Inc., majority and 830K Semnur Pharmaceuticals Inc. ZTlido®, GLOPERBA®, owned by Scilex Holding preferred shares) SP-102 (SEMD
Slide 4: Scilex Bio Obesity/Neurodegenerative/Cardiometabolic Disease
Scilex Bio Obesity/ Neurodegenerative/ Cardiometabolic Disease
Slide 5: KDS2010 (Tisolageline)
KDS2010 (Tisolageline) • Familiar old drug class – Inhibitor of Monoamine Oxidase (B) • New generation • Highly selective, highly potent, BBB permeable, and reversible inhibitor • New anti-obesity mechanism discovered • Suppresses aberrant GABA (gamma-aminobutyric acid) production in reactive astroc
Slide 6: Publications
Publications SCILEX’ HOLDING COMPANY + Nature Medicine GABA from reactive astrocytes impairs memory in mouse models of Alzheimer's disease 2014. 6.29. * Science Advances Newly developed reversible MAO-B inhibitor circumvents the shortcomings of irreversible inhibitors in Alzheimer's 2019. 3. 20. + C
Slide 7: KDS2010 Phase 1 Clinical Program Completed
KDS2010 Phase 1 Clinical Program Completed • KDS2010 well tolerated and safe for single dose (30 to 960 mg) and repeated dosing over 7 days (60 to 480 mg). • Adequate pharmacokinetics for once-daily dosing in the range of 60 to 480 mg for repeat dosing. • No food effect on pharmacokinetics, allowing
Slide 8: Phase 2 Clinical study design of KDS2010-AD
Phase 2 Clinical study design of KDS2010-AD (U.S. IND 1H 2025) Title A Randomized, Double-Blind, Placebo-Controlled, Dose-Finding, Phase 2a Clinical Trial to Evaluate the Efficacy and Safety of KDS2010 in Patients with Alzheimer’s Disease with Mild Cognitive Impairment and Mild Dementia due to Alzhe
Slide 9: Phase 2 Clinical study design of KDS2010-Obesity
Phase 2 Clinical study design of KDS2010-Obesity (U.S. IND 1H 2025) Title A Randomized, Double-blind, Placebo-controlled, Dose Finding, Phase 2a Clinical Trial to Evaluate the Efficacy and Safety of KDS2010 in Overweight or Obese Patients Indication Overweight or Obesity Drug KDS2010 Mesylate Tablet
Slide 10: KDS2010 Competitive Edge vs. GLP1
KDS2010 Competitive Edge vs. GLP1 10
Slide 11: Scilex Pharmaceuticals
Scilex Pharmaceuticals 960 San Antonio Rd, Palo Alto CA 94303 Wholly Owned Subsidiary of Scilex Holding Company (NASDAQ: SCLX)
Slide 12: Key Achievements
Key Achievements • Fifth year company anniversary • ZTlido - #1 prescribed branded non-opioid analgesic by the pain specialist • Over 1MM patients treated with ZTlido since launched • ~90% of patients are satisfied with ZTlido treatment • 88% patients felt they could do more when on ZTlido treatment
Slide 13: Scilex Business Opportunity Highlights
Scilex Business Opportunity Highlights • In US 50m patients live with chronic pain – A billion adults suffer from acute or chronic pain globally • With opioid pandemic, medical community and regulatory agency seeking non-opioid pain options • Scilex has three commercial products on the market and of
Slide 14: Innovative Non-Opioid Pain Therapeutics
Innovative Non-Opioid Pain Therapeutics KEY PROGRAMS PRECLINICAL PHASE 1 PHASE 2 PHASE 3 / PIVOTAL APPROVED IP MILESTONES / KEY COMMENTARY Phase 3 ZTlido® Platform Program IND Phase 1 Phase 2 NDA Approved Upcoming Milestones (1.8% lidocaine topical system Approved for the treatment of Postherpetic N
Slide 15: Investment Highlights
Investment Highlights 3 FDA approved Non-Opioid Acute and Chronic Pain Management Products Worldwide Commercial Rights to Most Product Candidates Strong Proprietary Platform with High Barriers to Entry Established Reimbursement Access Blockbuster Pipeline With Limited Capital Required for
Slide 16: ZTlido
ZTlido (1.8% lidocaine topical system equivalent to 5% lidocaine for the treatment of Postherpetic Neuralgia-PHN related pain)
Slide 17: ZTlido Commercialization Success
ZTlido Commercialization Success 17
Slide 18: The Gabapentinoid Market Is Massive
Confidential, not for distribution The Gabapentinoid Market Is Massive Gross sales of $370M would equate to ~1M ZTlido TRx The Neuropathic Pain Gabapentinoid market is an order of magnitude bigger than the Lidocaine patch market 88M Annualized ~44M Gabapentinoid Neuropathic 1+M scripts pain Rx ZTlid
Slide 19: ZTlido 1.8% (FDA approved for relief of PHN pain)
ZTlido® 1.8% (FDA approved for relief of PHN pain) 1 Lidocaine Patch Market Overview - +4.6mm prescriptions in 2022 - +169mm prescription lidocaine patches sold in the U.S. in 20221 2 Benefits versus Other Lidocaine Patches - Superior adhesion compared to other lidocaine patches head-to-head stu
Slide 20: The ZTlido New Campaign as the ideal add-on to Gabapentinoids
The ZTlido New Campaign as the ideal add-on to Gabapentinoids Designed to allow the brand to achieve its true potential by repositioning from Adhesion to Efficacy ZTlido is uniquely capable of optimizing gabapentinoids – doubling efficacy without the baggage/side effects of other analgesic options (
Slide 21: ZTlido Market Access Update
ZTlido Market Access Update ZTlido Covered Lives Overview Key Players - Preference 350 308 21 ZTlido Preferred 300 69 250 218 State of California (MediCal) Lidocaine Preferred 200 150 ZTlido Preferred 100 50 ZTlido Preferred 0 Total Lives Later In-Negotiations Covered Negotiations 21
Slide 22: The "New ZTlido" Opportunity: Summary
The “New ZTlido” Opportunity: Summary • Relaunching ZTlido in a 10X market potential • The Unmet Need in the neuropathic pain market/PHN – efficacy without side effects – is high. • HCP satisfaction with Gabapentinoids (gabapentin and pregabalin) is low. • ZTlido is uniquely capable of optimizing Ga
Slide 23: ZTlido LTC Opportunity
ZTlido® (lidocaine topical system) 1.8% LTC Opportunity
Slide 24: Non-Opioid Pain Opportunity in LTC
Non-Opioid Pain Opportunity in LTC • Long Term Care Skilled Nursing Facilities are an untapped opportunity for Scilex, CMS estimates there are 1.5 million residents in certified facilities across the US1 85.1% of Skilled Nursing patients are aged 65 and over, with 67.7% being women2 Chronic pain pre
Slide 25: Key Players In Skilled Nursing Facilities
Key Players In Skilled Nursing Facilities Consultant Pharmacist (Oversees all medications & completes chart reviews) Medical Payers Director (Processing & (Approves all formulary) Long Term decisions & formulary) Care Facilities Director of Prescribers Nursing (Medication (Administrative& decisions)
Slide 26: Long Term Care Key Players
Long Term Care Key Players Government (CMS) • Medicare • Medicare Advantage Programs (through Commercial Payers) • Medicaid • Dual eligible patients (Medicaid & Medicare eligible) Commercial Payers • United Healthcare and Humana represent two large Medicare Advantage plans Pharmacy Distribution Orga
Slide 27: LTC Key Influencers - GPO's and Pharmacy Providers
LTC Key Influencers - GPO’s and Pharmacy Providers GPO’s MHA (Managed Healthcare Associates), GeriMed, Innovatix/Premier, Asembia (more in Specialty space) and Vizient (Works thru GeriMed contract – Pull Thru main target once GeriMed contracted). Pharmacy Providers Omnicare – (Owned by CVS) diminish
Slide 28: LTC Associations – Influence Pain Management Associations
LTC Associations – Influence Pain Management Associations • ASCP (American Society of Consultant Pharmacist), • GAPNA (Gerontological Advanced Practice Nurses Association), • PALTC (Post- Acute LTC Medical Directors), • AAPA (American Association of Physician Assistants), • AAPACN (American Associat
Slide 29: SP-103 Phase 2
Next-Generation, Triple Strength Formulation of ZTlido 1.8% SP-103 Phase 2 Next-Generation, 5.4% Lidocaine Topical System 3x drug load (108 mg vs 36 mg lidocaine) Superior adhesion and drug formulation Triple strength localized dose of lidocaine efficiency with only 36mg of lidocaine Expecte
Slide 30: Neck Pain Market Overview
Neck Pain Market Overview Neck pain, or cervicalgia, is one of the most common pain presentations in U.S. and the 4th leading cause of disability 52.9M adults suffer from Neck Pain in the U.S. Prevalence of Neck Pain is estimated at >20% of adult population Neck pain was responsible for job absences
Slide 31: Elyxyb
Elyxyb (celecoxib) oral solution (Acute Treatment of Migraine)
Slide 32: Elyxyb Launched in USA in 2023
Elyxyb Launched in USA in 2023 32
Slide 33: Approximately 39M People with Migraine in the US
Approximately 39M People with Migraine in the US Some patients may receive both acute as well as preventive treatment Source: Prevalence by Migraine Research Foundation, 2021; Epidemiology data by DRG 33
Slide 34: Elyxyb Promotion Materials
Elyxyb Promotion Materials 34
Slide 35: ELYXYB
ELYXYB (Celecoxib) Oral Solution Episodic Migraine Treatment 35
Slide 36: Elyxyb Efficacy Comparison to CGRP Inhibitors
Elyxyb Efficacy Comparison to CGRP Inhibitors Post-hoc Indirect Comparative Analysis • Gepants are known to have a slow onset of action • At 1 hour, 5x more patients on ELYXYB will be pain free vs Ubrelvy® • At 2 hours postdose, about 2x as many patients on ELYXYB will be pain free vs. Nurtec® • ELY
Slide 37: The US Migraine Market Is Projected To Grow By 195% Between 2021 to 2026
The US Migraine Market Is Projected To Grow By 195% Between 2021 to 2026 • Scilex current forecast growth of more than 3X in 2024 compared to 2023. Source: Evaluate; Above data includes both acute and preventative therapies; Data refreshed in January 2022 37
Slide 38: Elyxyb Acute Pain Opportunity: Market Size
Elyxyb Acute Pain Opportunity: Market Size 91.6M 45.8M (Acute Pain (Diagnosed Prevalence) Prevalence) 20.7M (Acute Pain - sNDA filed in January 2025 Treated w/ Rx) >20M U.S. Patients Large market opportunity for Elyxyb in Acute Pain Confidential, not for distribution 38
Slide 39: Elyxyb Acute Pain Opportunity: Unmet Needs
Elyxyb Acute Pain Opportunity: Unmet Needs Key Unmet Needs in Acute Pain: Fast onset Need for safer and more effective treatments Non-Opioid alternatives Confidential, not for distribution 39
Slide 40: Elyxyb Regulatory Filings
HOLDING COMPANY Elyxyb Regulatory Filings
Slide 41: SP-105 US sNDA (Acute Pain)
SP-105 US sNDA (Acute Pain) • Supplement to add acute pain indication to Elyxyb® currently approved for acute treatment of migraine • Primary efficacy and safety data are PK modeling between Elyxyb® and Celebrex® • Celebrex® is approved for treatment of acute pain • PK modeling was used to (1) deter
Slide 42: SP-105 Canadian NDS (Acute Treatment of Migraine)
SP-105 Canadian NDS (Acute Treatment of Migraine) • Primarily a conversion of NDA to NDS with preparation of regionally-specific documents and modules (Premier) • Efficacy Same clinical studies conducted by DRL to support US approval • Safety DRL clinical studies Reliance on safety established for C
Slide 43: Gloperba
Gloperba (colchicine USP) oral solution (For the prevention of painful gout flares in adults)
Slide 44: Gloperba Launched in USA in June 2024
Gloperba Launched in USA in June 2024 44
Slide 45: Gloperba Launched in June 2024
Gloperba Launched in June 2024 Scilex Holding Company announces the U.S. FDA has approved the sNDA for commercial manufacturing of Gloperba® which was launched in the US in the week of June 10th 2024. • Gloperba® is the first and only liquid oral version of the anti-gout medicine colchicine indicate
Slide 46: Target Patients For Gloperba Today (excluding Cardiovascular)
Target Patients For Gloperba Today (excluding Cardiovascular) • Patients with CKD Stage 3/4/5: 6 million patients • Patients with GI tolerability issues: 1 million patients • Patients at risk of drug-to-drug interaction (DDI) • Patients who have difficulty swallowing • Cardiovasular up to 6.5 millio
Slide 47: Rheumatologists indicated they would use Gloperba in patients with CKD 3-5 and GI Sensitivity
Rheumatologists indicated that they would use Gloperba in patients with CKD 3-5 and GI Sensitivity Over 70% of gout patients suffer from CKD Number of Physicians who Expect to Prescribe GLOPERBA in Different Types of Patients Rheumatologist (n=17) CKD Stage 3-5 13 GI Intolerance / Issues 10 Swallowi
Slide 48: Rheumatologists showed high willingness to prescribe Gloperba
Rheumatologists showed high willingness to prescribe Gloperba, and even do Prior Authorization Motivation to Prescribe Gloperba Likelihood to do a PA for Gloperba HIGH: 6.1/7 (Ave.) MODERATE: 5.4/7 (Ave.) Current Level • PAs are a hassle that rheumatologists prefer not to do. • Offers precise dosing
Slide 49: Gloperba reduced dosing offers value for money
Gloperba reduced dosing offers value for money Colchicine TABLET (mg) to GLOPERBA Liquid (mL) Conversion Table The WAC price of Gloperba is $595 for a 150mL bottle. Colchicine (mg) GLOPERBA (mL) -Value for $: Will last for 60 days for patients 0.12 mg 1.0 mL with Severe renal impairment (CKD 4) - 0.
Slide 50: Gloperba solves for the Unmet Need HCPs have stated
Gloperba solves for the Unmet Need HCPs have stated For internal use only. Not to be shown to healthcare professionals. 50
Slide 51: Semnur Pharmaceuticals
Semnur Pharmaceuticals 960 San Antonio Rd, Palo Alto CA 94303 Wholly Owned Subsidiary of Scilex Holding Company (NASDAQ: SCLX)
Slide 52: SP-102 Market Opportunity
SP-102 Market Opportunity Developing SP-102 as a non-opioid injectable therapeutic for low back pain Novel viscous gel formulation, optimized for epidural injection Novel biocompatible excipient enables extended local effect On track to be the first and only FDA-approved epidural steroid product Cur
Slide 53: SEMDEXA (SP-102) On-Track to be the First Product Approved to Treat Sciatica
SEMDEXA (SP-102) On-Track to be the First Product Approved to Treat Sciatica • SP-102 is a preservative free, surfactant free and particulate free viscous gel formulation of dexamethasone for sciatica (lumbosacral radicular pain). • Extended local effect provides durable pain relief and significant
Slide 54: SP-102 Differentiated Product Profile & Positioning
SP-102 Differentiated Product Profile & Positioning 1 54
Slide 55: SEMDEXA – Broad Potential for Life Cycle Management
SEMDEXA – Broad Potential for Life Cycle Management 1 Physicians indicated there is potential opportunity for spontaneous use of SEMDEXA outside of lumbar radiculopathy which could represent an additional upside of ~50-200%* over LR 2 Additional Uses Carpel Tunnel Hip and Knee Replacements Tri
Slide 56: Nasdaq (November 11, 2022)
Nasdaq (November 11, 2022) 56
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