Scilex Holding Company · NASDAQ:SCLX
Scilex — Investor Presentation (March 2023)
26 slides from Scilex's investor presentation, March 2023
Slide 1: Innovative Leader in Non-Opioid Pain Therapeutics
Innovative Leader in Non-Opioid Pain Therapeutics (March 2023)
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: Innovative Non-Opioid Pain Therapeutics
Innovative Non-Opioid Pain Therapeutics Platform Program Indications Status Future Market Size Future Partner Opportunity ZTlido® 1.8% (Postherpetic Relief of Pain Associate with PHN Approved Potential Global Opportunity $1.9B Potential to sell up to 90 countries Neuralgia-PHN) except for Japan GLOP
Slide 4: Innovative Non-Opioid Pain Therapeutics
Innovative Non-Opioid Pain Therapeutics PhasePhase 3 3 NDA PlatformPlatform Program Program IND IND Phase Phase11 Phase 2 2 Phase PivotalPivotal Approved ApprovedUpcoming Milestones NDA Upcoming Milestones ZTlido® 1.8% ZTlido® 1.8% (Postherpetic 505(b)(2) Launched in the U.S. in October 2018 (Posthe
Slide 5: Commercial
HOLDING COMPANY Commercial
Slide 6: Marketed Product: ZTlido 1.8%
Marketed Product: ZTlido® 1.8% (FDA approved for relief of pain associated with PHN) ® Lidocaine Patch Market Overview >4.6 million prescriptions in 2022 More than 169 million prescription lidocaine patches were US FDA APPROVAL – FEBRUARY 2018 sold in the US in 2022 according to Symphony Healthcare
Slide 7: Migraine Market Overview and ELYXYB's Value Proposition
Migraine Market Overview and ELYXYB™’s Value Proposition ELYXYB™ has an opportunity to address unmet need for fast-acting acute migraine therapies as patients continue to cycle through many standard therapiesGLOPERBA Sources: 1. Migraine Research Foundation, 2021; 2. Evaluate Pharma data February 16
Slide 8: FDA Approved GLOPERBA Commercial Opportunity
FDA Approved GLOPERBA Commercial Opportunity Gout is a painful arthritic disorder affecting GLOPERBA offers unique first and only liquid formulation over 8 million people in the United States.1 with greater ability for flexible dosing 5.5 million patients experiencing with 2+ flares per year and req
Slide 9: Focus on Non-narcotic Pain Management Driving ESI Growth
Focus on Non-narcotic Pain Management Driving ESI Growth Current Prescription opioid abuse is at epidemic proportions in the U.S.1 Additionally, research shows that opioids do not provide clinically Problem meaningful pain relief in patients with low back and radicular pain.2 Multiple Medical Organi
Slide 10: 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 11: Epidural Steroid Injections for Back Pain - Top Pain Procedure in the U.S.
Epidural Steroid Injections for Back Pain - One of the Most Common Medical Procedures, Top Pain Procedure in the U.S. Strong Growth Rate, Evidenced by Medicare Procedure Volumes Medicare Overall ESI Injection Volume(1) • ESIs widely reimbursed as procedure to delay or avoid back surgery • Transforam
Slide 12: Clinical
HOLDING COMPANY Clinical
Slide 13: History of Serious Spinal Adverse Events (SSAEs) with Current ESIs
History of Serious Spinal Adverse Events (SSAEs) with Current ESIs 13
Slide 14: SP-102 (SEMDEXA) On-Track to be the First Epidural Steroid with a Label
SP-102 (SEMDEXA) On-Track to be the First Epidural Steroid with a Label to Treat Sciatica SP-102 (SEMDEXA) is a preservative free, surfactant free and particulate free viscous gel formulation of dexamethasone for sciatica (subacute lumbosacral radicular pain). Extended local effect provides durable
Slide 15: SP-102 Phase 3 C.L.E.A.R. Trial Met Primary Endpoint
SP-102 (SEMDEXA) Phase 3 C.L.E.A.R. Trial Met Primary Endpoint Phase 3 SP-102 C.L.E.A.R Trial – Primary Endpoint The trial met primary, key secondary Change in Average Daily Pain in Affected Leg and other secondary endpoints with 0.5 statistical significance over placebo Numeric Pain Rating Scale, L
Slide 16: C.L.E.A.R. Trial – Key Secondary Endpoint
C.L.E.A.R. Trial – Key Secondary Endpoint The Oswestry Disability Index (ODI) - gold standard for measuring degree of disability and estimating quality of life. ODI contains 10 topics concerning intensity of pain, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function
Slide 17: C.L.E.A.R. Trial – Effect Duration and Safety
C.L.E.A.R. Trial – Effect Duration and Safety SP-102 Time to Repeat Injection (Return of Moderate-Severe Pain) Month 1 Month 2 Month 3 Month 4 Month 5 Primary Endpoint Allowance for Open-Label Repeat Injection of SP-102 SP-102 (SEMDEXA™) showed continued reduction of pain beyond one month, and the m
Slide 18: Hierarchical Testing of Endpoints
Hierarchical Testing of Endpoints mITT Population √ reflects statistically significant result at α=0.05 √ 1. Mean change from Baseline to Week 4 in the mean NPRS average pain score in the affected leg (Primary Efficacy Endpoint) √ 2. Change in ODI total score from Baseline to Week 4 (Key Secondary E
Slide 19: Phase 3 SP-102 C.L.E.A.R. Trial – Conclusions and Summary
Phase 3 SP-102 C.L.E.A.R. Trial – Conclusions and Summary 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
Slide 20: SP-103 Phase 2
SP-103 is a Next-Generation, Triple Strength Formulation of ZTlido 1.8% Targeting Acute Low Back Pain Opportunity SP-103 Phase 2 Next-Generation, 5.4% Lidocaine TopicalSystem 3x drug load (108 mg vs 36 mg lidocaine) Superior adhesion and drug Triple strength localized dose of formulation effic
Slide 21: Phase 2 SP-103 Trial Summary
Phase 2 SP-103 Trial Summary Phase 2, 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 s
Slide 22: SP-104 Delayed Burst Low Dose Naltrexone (LDN) – Fibromyalgia
SP-104 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 world population (an estimated 10 million people in the U.S., 75-90% women)1 Low Dose Naltrexone (LDN) efficacy well documented Routinely use
Slide 23: SP-104 Data
SP-104 Data SP-104-01 Trial: PK of Delayed Release Naltrexone 10 Plasma Concentration (ng/mL) SP-104 (fasted) 100 Plasma Concentration (ng/mL) SP-104 (fasted) 1 SP-104 (fed) 10 RLD (fasted) 1 Naltrexone Naltrexone 0.1 0.1 0.01 0.01 0.001 0.001 0.0001 0.0001 0 20 40 60 80 0 20 40 60 80 Time (hr) Ti
Slide 24: Summary: Commercial Non-Opioid Pain Company with Late-stage Programs
Summary: Commercial Non-Opioid Pain Company with Late-stage Programs in Large Untapped Markets 3 FDA approved acute and chronic pain management Worldwide Commercial Rights to All Product Candidates Strong Proprietary Platform with High Barriers to Entry Established Reimbursement Access Block
Slide 25: Management Team
HOLDING COMPANY Management Team
Slide 26: Accomplished Executive Team
Accomplished Executive Team Name Position(s) Experience 25+ years of management experience in large Pharma andBiotech. Completed many licensing and M&A transactions Jaisim Shah CEO & President Lead commercialization of multiple blockbusters including Rituxan®, Abilify®, Pegasys®, Tequin CEO, S
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