Scilex Holding Company · NASDAQ:SCLX
Scilex — Investor Presentation (January 2024)
41 slides from Scilex's investor presentation, January 2024
Slide 1: Innovative Leader in Non-Opioid Pain Therapeutics
Innovative Leader in Non-Opioid Pain Therapeutics (Non-Confidential)
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: Innovative Non-Opioid Pain Therapeutics
Innovative Non-Opioid Pain Therapeutics KEY PROGRAMS PRECLINICAL PHASE 1 PHASE 2 PHASE 3 / Phase PIVOTAL 3 APPROVED IP MILESTONES / KEY COMMENTARY Platform Program IND Phase 1 Phase 2 NDA Approved Upcoming Milestones ZTlido® Pivotal (1.8% lidocaine topical system Approved for the treatment of Posthe
Slide 4: Innovative Non-Opioid Pain Therapeutics
Innovative Non-Opioid Pain Therapeutics Platform Program Indications Route Phase 3 Status Market Size Future Partner Opportunity Platform Program IND Phase 1 Phase 2 NDA Approved Upcoming Milestones Pivotal ZTlido® 1.8% (Postherpetic Neuralgia-PHN) Rel i ef of Pa i n As s oci a te wi th PHN Ski n Pa
Slide 5: ZTlido
ZTlido (1.8% lidocaine topical system equivalent to 5% lidocaine for the treatment of Postherpetic Neuralgia-PHN related pain)
Slide 6: Sales Performance Fiscal Year 2023 vs. 2022
Sales Performance Fiscal Year 2023 vs. 2022 • ZTlido gross sales for the fiscal year ended December 31, 2023 were in the range of $145.0 million to $150.0 million, compared to $96.0 million for the fiscal year ended December 31, 2022, representing growth in the range of approximately 51% to 56%. • Z
Slide 7: ZTlido Commercialization Success
ZTlido Commercialization Success 7
Slide 8: 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 9: 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 62 ZTlido Preferred 0 Total Lives Later In-Negotiations Covered Negotiations 9
Slide 10: The ZTlido Solution to the Unmet Need with Gabapentinoids
The ZTlido Solution to the Unmet Need with Gabapentinoids 10 PEOPLE PRODUCT PERFORMANCE
Slide 11: 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 12: Enhanced Patient Quality of Life
Enhanced Patient Quality of Life 12 PEOPLE PRODUCT PERFORMANCE
Slide 13: Enhanced Patient Quality of Life: Real World Evidence
Enhanced Patient Quality of Life: Real World Evidence 13 PEOPLE PRODUCT PERFORMANCE
Slide 14: Elyxyb (celecoxib) oral solution (Acute Treatment of Migraine)
Elyxyb (celecoxib) oral solution (Acute Treatment of Migraine)
Slide 15: Elyxyb Launched in USA April 2023
Elyxyb Launched in USA April 2023 15
Slide 16: 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 16
Slide 17: Elyxyb Promotion Materials
Elyxyb Promotion Materials 17
Slide 18: Elyxyb Promotion Materials
Elyxyb Promotion Materials 18
Slide 19: 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 Source: Evaluate; Above data includes both acute and preventative therapies; Data refreshed in January 2022 19
Slide 20: 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 Treated w/ Rx) >20M U.S. Patients Large market opportunity for Elyxyb in Acute Pain Confidential, not for distribution 20
Slide 21: 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 21
Slide 22: Gloperba
Gloperba (colchicine USP) oral solution (For the prevention of painful gout flares in adults)
Slide 23: Gloperba Launch in USA Planned in 2024
Gloperba Launch in USA Planned in 2024 23
Slide 24: Gout Market Size Overview
Gout Market Size Overview 9.0 5.0 1.6 2.4 Sources: Chen-Xu M, et al. Arthritis Rheum. 2019;72(6):991-999; Symphony Healthcare 24
Slide 25: Gout Unmet Needs
Gout Unmet Needs Physicians are generally satisfied with the currently available prophylactic gout treatments, particularly colchicine. However, physicians acknowledged that colchicine’s ability to cause adverse GI events along with the caution that must be taken when prescribing it to patients with
Slide 26: SP-102 (SEMDEXA) Treatment of Chronic Low Back Pain/ Sciatica
SP-102 (SEMDEXA) Treatment of Chronic Low Back Pain/ Sciatica
Slide 27: Focus on Non-narcotic Pain Management Driving Growth
Focus on Non-narcotic Pain Management Driving Growth Prescription opioid abuse is at epidemic proportions in the U.S1 CURRENT PROBLEM Additionally, the CDC states that opioids do not provide clinically meaningful pain relief in patients with low back and chronic pain2 Multiple medical organiza
Slide 28: Epidural Steroid Injections (ESI) for Chronic Back Pain
Epidural Steroid Injections (ESI) for Chronic Back Pain One of the Most Common Medical Procedures / Top Pain Procedures Strong Growth Rate, Evidenced by Medicare Procedure Volumes (MM) Medicare Overall ESI Injection Volume1 1 ESIs widely reimbursed as procedure to delay or avoid back surgery 2 Tra
Slide 29: On-Track as First Epidural Steroid Injection with a Label to Treat Sciatica
On-Track as First Epidural Steroid Injection with a Label to Treat Sciatica SP-102 (SEMDEXA) is a preservative free, surfactant free and particulate free viscous gel formulation of well known corticosteroid for sciatica (subacute lumbosacral radicular pain). Extended local effect provides durable pa
Slide 30: Phase III C.L.E.A.R. Trial Achieved Objectives
Phase III C.L.E.A.R. Trial Achieved Objectives A total of 401 patients enrolled (202 SP-102 / 199 placebo) across 37 US sites The primary endpoint - change in average daily pain in the affected leg over 4 weeks LS mean (SE) of -0.52 (0.163) compared to placebo, p=0.002. Supported by: Disability Inde
Slide 31: SP-102 Regulatory Discussion(s) to Date
SP-102 Regulatory Discussion(s) to Date 1 Toxicology program complete 2 Pharmacokinetic bridge established to Reference Listed Drug 3 Phase II, additional PK / PD / Safety of repeat injection trial completed 4 CLEAR Trial completed 5 NDA 505(b)(2) application confirmed 6 Agreement with FDA on next s
Slide 32: SP-103 (5.4%, 3X lidocaine topical system) for Treatment of Acute Back Pain
SP-103 (5.4%, 3X lidocaine topical system) for Treatment of Acute Back Pain
Slide 33: 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 34: 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 35: Neck Pain: Unmet Needs
Neck Pain: Unmet Needs There is no one definitive treatment for neck pain Majority patients with neck pain are treated non- operatively, often with alternative treatments, including such treatments as acupuncture, homeopathy, and massage Nonsteroidal anti-inflammatory drugs (NSAIDs) alleviate pain b
Slide 36: SP-104 Delayed Burst Low Dose Naltrexone (Fibromyalgia)
SP-104 Delayed Burst Low Dose Naltrexone (Fibromyalgia)
Slide 37: Delayed Burst Low Dose Naltrexone (LDN) – Fibromyalgia
Delayed Burst Low Dose Naltrexone (LDN) – Fibromyalgia Fibromyalgia is a long-term condition that causes pain all over the body and affects 3% to 6% of the world population (an estimated 10 million people in the U.S., 75-90% women)1 Low Dose Naltrexone (LDN) efficacy well documented Routinely used o
Slide 38: Management
HOLDING COMPANY Management
Slide 39: Management Team
Management Team Jaisim Shah Henry Ji, PhD Dmitri Lissin, MD Steve Lincoln Chief Executive & President Executive Chairman Chief Medical Officer GC and Chief Compliance Officer 25+ years of management 25+ years of experience in the 20+ years in clinical development in 20+ years in industry, wi
Slide 40: Executive Summary Investment Highlights
Executive Summary Investment Highlights 1 3 FDA-approved Non-Opioid Acute and Chronic Pain Management Products 2 Worldwide Commercial Rights to Most Product Candidates 3 Strong Proprietary Platform with High Barriers to Entry 4 Established Reimbursement Access 5 Blockbuster Pipeline With Limited Cap
Slide 41: Nasdaq (November 11, 2022)
Nasdaq (November 11, 2022) 41
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