Scilex Holding Company · NASDAQ:SCLX
Scilex — Investor Presentation (March 2023)
31 slides from Scilex's investor presentation, March 2023
Slide 1: Innovative Leader in Non-Opioid Pain Therapeutics (March 2023)
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: Nasdaq (Scilex IPO November 11, 2022, SCLX)
Nasdaq (Scilex IPO November 11, 2022, SCLX) 3
Slide 4: Scilex Headquarters: Palo Alto, California
Scilex Headquarters: Palo Alto, California 4
Slide 5: 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 6: Commercial Products
HOLDING COMPANY Commercial Products
Slide 7: ZTlido Launch in USA 2019
ZTlido Launch in USA 2019 GpsciLex’ HOLDING COMPANY ¢ aiffing to Improve the World of Non-Opioid Management
Slide 8: ZTlido Sales Performance 2022-YTD23
ZTlido Sales Performance 2022-YTD23 YTD and February 2023 • Gross sales for February 2023 were in the range of $8.6 million to $8.8 million, compared to $5.1 million in February 2022, representing growth in the range of 68% to 72% • Net sales for February 2023 were in the range of $3.3 million to $3
Slide 9: 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 10: ZTlido Market Access Update
ZTlido Market Access Update ZTlido Market Access continues to improve 308 21 69 218 • CVS/Caremark – ZTlido Preferred brand – No PA/SE • State of California (MediCal) – Preferred lidocaine patch • Express Scripts – Preferred brand • Optum/United Healthcare – Preferred 62 brand – for all neuropathic
Slide 11: Elyxyb Launch in USA Q2, 2023
Elyxyb Launch in USA Q2, 2023 11
Slide 12: 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 13: Gloperba Launch in USA in Q4, 2023
Gloperba Launch in USA in Q4, 2023 13
Slide 14: 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 15: Focus on Non-narcotic Pain Management Driving Growth
Focus on Non-narcotic Pain Management Driving Growth Current Prescription opioid abuse is at epidemic proportions in the U.S.1 Additionally, CDC states that opioids do not provide clinically Problem meaningful pain relief in patients with low back and chronic pain.2 Multiple Medical Organizations Re
Slide 16: Epidural Steroid Injections (ESI) for Back Pain
Epidural Steroid Injections (ESI) for Back Pain - One of the Most Common Medical Procedures, Top Pain Procedure 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 • Transforaminal E
Slide 17: SEMDEXA (SP-102) Market Opportunity
SEMDEXA (SP-102) Market Opportunity SEMDEXA non-opioid injectable therapeutic for low back pain has completed pivotal Phase 3 Clinical Trials and FDA granted Fast Track Novel viscous biologic gel formulation, optimized for epidural injection Novel biocompatible excipient enables extended local effec
Slide 18: Clinical
HOLDING COMPANY Clinical
Slide 19: SEMDEXA On-Track to be the First Epidural Steroid with a Label to Treat Sciatica
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 well know corticosteroid for sciatica (subacute lumbosacral radicular pain). Extended local effect provides durabl
Slide 20: SP-102 (SEMDEXA) 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 21: 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 22: 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 23: 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 24: 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 25: 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 26: 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 27: Large Market Innovative Non-Opioid Pain Therapeutics
Large Market 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 f
Slide 28: Nasdaq (November 11, 2022)
Nasdaq (November 11, 2022) 28
Slide 29: Commercial Non-Opioid Pain Company with 3 FDA Approved Products & Pipeline Programs
Commercial Non-Opioid Pain Company with 3 FDA Approved Products & Pipeline Programs in High Unmet Need 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 Reimbursem
Slide 30: Management Team
HOLDING COMPANY Management Team
Slide 31: 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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