Scilex Holding Company · NASDAQ:SCLX
Scilex — Investor Presentation (October 2023)
43 slides from Scilex's investor presentation, October 2023
Slide 1: Innovative Leader in Non-Opioid Pain Therapeutics
Innovative Leader in Non-Opioid Pain Therapeutics
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: Executive Summary: Company Background
Executive Summary Company Background Company Overview Corporate Timeline Scilex Holding Company (“Scilex”) is an innovative revenue-generating Feb. 2018: Scilex receives final pharmaceutical firm focused on developing and commercializing non- FDA approval for ZTlido™ opioid acute and chronic pain
Slide 4: 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 5: Innovative Non-Opioid Pain Therapeutics
Executive Summary Innovative Non-Opioid Pain Therapeutics KEY PROGRAMS PRECLINICAL PHASE 1 PHASE 2 PHASE 3 / PIVOTAL Phase 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 t
Slide 6: 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 Relief of Pain Associate with PHN Skin Patch Approved $1.9B+ (WW)
Slide 7: ZTlido
ZTlido (1.8% lidocaine topical system equivalent to 5% lidocaine for the treatment of Postherpetic Neuralgia-PHN related pain)
Slide 8: Sales Performance 2022 - YTD 2023
Sales Performance 2022 - YTD 2023 YTD Q3-2023 • ZTlido gross sales were in the range of $100.0 million to $102.0 million, compared to $64.8 million for year-to-date September 2022, representing growth in the range of 54% to 57%. • ZTlido net sales were in the range of $32.0 million to $33.0 million,
Slide 9: ZTlido Commercialization Success
ZTlido Commercialization Success 9
Slide 10: 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 11: 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 11
Slide 12: The ZTlido Solution to the Unmet Need with Gabapentinoids
The ZTlido Solution to the Unmet Need with Gabapentinoids 12 PEOPLE PRODUCT PERFORMANCE
Slide 13: 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 14: Enhanced Patient Quality of Life
Enhanced Patient Quality of Life 14 PEOPLE PRODUCT PERFORMANCE
Slide 15: Enhanced Patient Quality of Life: Real World Evidence
Enhanced Patient Quality of Life: Real World Evidence 15 PEOPLE PRODUCT PERFORMANCE
Slide 16: Elyxyb (celecoxib) oral solution
Elyxyb (celecoxib) oral solution (Acute Treatment of Migraine)
Slide 17: Elyxyb Launched in USA April 2023
Elyxyb Launched in USA April 2023 17
Slide 18: 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 18
Slide 19: Elyxyb Promotion Materials
Elyxyb Promotion Materials 19
Slide 20: Elyxyb Promotion Materials
Elyxyb Promotion Materials 20
Slide 21: 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 21
Slide 22: 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 22
Slide 23: 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 23
Slide 24: Gloperba
Gloperba (colchicine USP) oral solution (For the prevention of painful gout flares in adults)
Slide 25: Gloperba Launch in USA Planned in 2024
Gloperba Launch in USA Planned in 2024 25
Slide 26: 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 26
Slide 27: 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 28: SP-102 (SEMDEXA) Treatment of Chronic Low Back Pain/ Sciatica
SP-102 (SEMDEXA) Treatment of Chronic Low Back Pain/ Sciatica
Slide 29: 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 30: 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 31: 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 32: 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 33: 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 Pending FDA meeting minutes
Slide 34: 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 35: 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 36: 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 37: 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 38: Phase II Trial Summary
Phase II Trial Summary Phase II, randomized, double-blind, placebo-controlled, parallel group, multicenter study to evaluate the safety and efficacy of SP-103 in subjects with moderate to severe acute lower back pain. Subjects are expected to apply investigational product for 12 hours per study
Slide 39: SP-104 Delayed Burst Low Dose Naltrexone (Fibromyalgia)
SP-104 Delayed Burst Low Dose Naltrexone (Fibromyalgia)
Slide 40: 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 41: Management
HOLDING COMPANY Management
Slide 42: 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 43: Nasdaq (November 11, 2022)
Nasdaq (November 11, 2022) 43
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