Scilex Holding Company · NASDAQ:SCLX
Scilex — Investor Presentation (June 2023)
42 slides from Scilex's investor presentation, Jun 22, 2023
Slide 1: Innovative Leader in Non-Opioid Pain Therapeutics (June 2023)
Innovative Leader in Non-Opioid Pain Therapeutics (June 2023) Confidential Exhibit 99.1
Slide 2: Safe Harbor 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 and Timeline
Executive Summary Company Background Scilex Holding Company (“Scilex”) is an innovative revenue-generating pharmaceutical firm focused on developing and commercializing non-opioid acute and chronic pain management products Scilex targets indications with unmet needs and large market opportunities in
Slide 4: Investment Highlights
Investment Highlights Executive Summary Established Reimbursement Access Strong Proprietary Platform with High Barriers to Entry Worldwide Commercial Rights to Most Product Candidates 3 FDA-approved Non-Opioid Acute and Chronic Pain Management Products 2 3 4 1 Blockbuster Pipeline With Limited Capit
Slide 5: Key Programs: Innovative Non-Opioid Pain Therapeutics
Platform Program IND Phase 1 ZTlido® 1.8% (Postherpetic Neuralgia-PHN) GLOPERBA® (colchicine USP) oral solution (Treatment of Gout) SP-102 (SEMDEXA) (Lumbar Radicular / Sciatica Pain) SP-103 Lidocaine Topical System 5.4% (3X) (Acute Back Pain) SP-104, Delayed Burst Low Dose Naltrexone (Fibromyalgia)
Slide 6: ZTlido (1.8% lidocaine topical system)
ZTlido (1.8% lidocaine topical system equivalent to 5% lidocaine for the treatment of Postherpetic Neuralgia-PHN related pain)
Slide 7: ZTlido Sales Performance 2022 - YTD 2023
ZTlido Sales Performance 2022 - YTD 2023 YTD May 2023 Gross sales were in the range of $49.2 million to $54.3 million, compared to $32.0 million for year-to-date May 2022, representing growth in the range of 54% to 70% Net sales were in the range of $16.0 million to $19.0 million, compared to $11.4
Slide 8: ZTlido Commercialization Success
ZTlido Commercialization Success
Slide 9: ZTlido 1.8% Benefits and Comparison to Lidoderm
ZTlido® 1.8% (FDA approved for relief of PHN pain) Only ZTlido delivers a 12-hour adhesion in a non-opioid therapy Superior adhesion versus other lidocaine patches in various head-to-head studies Only lidocaine patch proven in moderate exercise Savings & support system makes it easy to receive inexp
Slide 10: ZTlido Market Access Update
ZTlido Market Access Update ZTlido Covered Lives Overview 62 Key Players - Preference State of California (MediCal) Lidocaine Preferred ZTlido Preferred ZTlido Preferred ZTlido Preferred
Slide 11: The ZTlido Solution to the Unmet Need with Gabapentinoids
The ZTlido Solution to the Unmet Need with Gabapentinoids
Slide 12: The ZTlido New Campaign as Add-on to Gabapentinoids
The ZTlido New Campaign as the ideal add-on to Gabapentinoids Confidential, not for distribution 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
Slide 13: Enhanced Patient Quality of Life
Enhanced Patient Quality of Life
Slide 14: Enhanced Patient Quality of Life: Real World Evidence
Enhanced Patient Quality of Life: Real World Evidence
Slide 15: Elyxyb (celecoxib) oral solution
Elyxyb (celecoxib) oral solution (Acute Treatment of Migraine)
Slide 16: Elyxyb Launched in USA April 2023
Elyxyb Launched in USA April 2023
Slide 17: 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
Slide 18: Elyxyb Opportunity: Market Overview and Value Proposition
ELYXYB™ has an opportunity to address unmet need for fast-acting acute migraine therapies as patients cycle through standard therapies Sources: 1. Migraine Research Foundation, 2021; 2. Evaluate Pharma data February 16, 2023 ; 3. Lipton RB et al. Headache. 2017; 4. IQVIA NPA Monthly YTD 2022; 5. Sym
Slide 19: Elyxyb Promotion Materials
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Slide 20: Elyxyb Promotion Materials
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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
Slide 22: Gloperba (colchicine USP) oral solution
Gloperba (colchicine USP) oral solution (For the prevention of painful gout flares in adults)
Slide 23: Gloperba Launch in USA Planned in Q4 2023
Gloperba Launch in USA Planned in Q4 2023
Slide 24: Gout Market Size Overview
Gout Market Size Overview 5.0 9.0 1.6 2.4 Sources: Chen-Xu M, et al. Arthritis Rheum. 2019;72(6):991-999; Symphony Healthcare Confidential, not for distribution
Slide 25: Gout Unmet Needs
Gout Unmet Needs Gloperba HCP Market Research Source: Rheumatologists and PCPs interviewed by Percipient, November – February 2023 n=39 “A drug that doesn’t have any GI adverse events would be good. It should have no side effects. It can’t cause toxicity either, considering [tablet] colchicine is al
Slide 26: SP-102 (SEMDEXA) Treatment of Chronic Low Back Pain/Sciatica
SP-102 (SEMDEXA) Treatment of Chronic Low Back Pain/ Sciatica
Slide 27: Current Problem, Multi-Modal Pain Management and Potential for SP-102
CURRENT PROBLEM Prescription opioid abuse is at epidemic proportions in the U.S1 Additionally, the CDC states that opioids do not provide clinically meaningful pain relief in patients with low back and chronic pain2 MULTI-MODAL PAIN MANAGEMENT Multiple medical organizations recommend multi-modal ana
Slide 28: Epidural Steroid Injections for Chronic Back Pain
ESIs widely reimbursed as procedure to delay or avoid back surgery Transforaminal ESI route (used in C.L.E.A.R. trial) majority of Total ESI procedures Over 12 million ESI pain procedures per year, greater than all Cardiovascular and GI procedures Epidural Steroid Injections (ESI) for Chronic Back P
Slide 29: SP-102 (SEMDEXA) Viscous Gel Formulation
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 pain relief and significant improvement in functioning from a single injection
Slide 30: Phase III C.L.E.A.R. Trial Met Primary Endpoint
The trial met primary, key secondary and other secondary endpoints with statistical significance over placebo Achieved all study objectives, up to 3 months duration of effect with a single injection Demonstrated safety profile of SP-102 -2.5 -2 -1.5 -1 -0.5 0 Week 1 Week 2 Week 3 Week 4 Numeric Pain
Slide 31: C.L.E.A.R. Trial – Key Secondary Endpoint
C.L.E.A.R. Trial – Key Secondary Endpoint Phase III SP-102 C.L.E.A.R Trial – Secondary Endpoint Phase III Secondary Endpoint Overview The Oswestry Disability Index (ODI) - gold standard for measuring degree of disability and estimating quality of life. ODI contains 10 topics concerning intensity of
Slide 32: C.L.E.A.R. Trial – Effect Duration and Safety
SP-102 (SEMDEXA™) showed continued reduction of pain beyond one month, and the median time to open- label repeat injection was 99 days (95% CI: 78, 129 days) according to a Kaplan-Meier estimation. By contrast, off-label injectable steroids typically provide pain relief for periods ranging from less
Slide 33: C.L.E.A.R. Trial Conclusions
This is the largest prospective, randomized, double-blind, placebo-controlled study testing the effect and safety of a corticosteroid SP-102 showed meaningful pain relief with significantly large differences relative to placebo (p<0.001) for the primary and almost all secondary pain and QOL endpoint
Slide 34: SP-103 (5.4%, 3X lidocaine topical system) for Acute Back Pain
SP-103 (5.4%, 3X lidocaine topical system) for Treatment of Acute Back Pain
Slide 35: SP-103 Commercial Opportunity
SP-103 Commercial Opportunity Low Back Pain (LBP) most common between the ages of 30 and 50 Over 30MM people suffer from low back pain1 No product is FDA approved for low back pain LBP has a major economic impact in the United States, with total costs related to this condition exceeding $500 billion
Slide 36: SP-103 Next-Generation 5.4% Lidocaine Topical System
SP-103 Phase 2 Next-Generation, 5.4% Lidocaine Topical System Next-Generation, Triple Strength Formulation of ZTlido 1.8% 3x drug load (108 mg vs 36 mg lidocaine) Triple strength localized dose of lidocaine Expected same superior adhesion and efficient formulation Initiated Phase 2 trial in Q2-2022
Slide 37: SP-103 Phase II Study Design
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 day. Study days 1 through 2
Slide 38: SP-104 Delayed Burst Low Dose Naltrexone (Fibromyalgia)
SP-104 Delayed Burst Low Dose Naltrexone (Fibromyalgia)
Slide 39: Fibromyalgia and Low Dose Naltrexone
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 off-label to treat multiple types of chronic pain, inclu
Slide 40: Management
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Slide 41: Management Team
Management Team Jaisim Shah Chief Executive & President 25+ years of management experience in large Pharma and Biotech. Completed many licensing and M&A transactions Elizabeth Czerepak Chief Financial Officer & Chief Business Officer 35+ years of finance, business development and operational experti
Slide 42: Nasdaq (November 11, 2022)
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