Scilex Holding Company · NASDAQ:SCLX
Scilex — Investor Presentation (July 2023)
42 slides from Scilex's investor presentation, July 2023
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: 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: ZTlido
ZTlido (1.8% lidocaine topical system equivalent to 5% lidocaine for the treatment of Postherpetic Neuralgia-PHN related pain)
Slide 7: Sales Performance 2022 - YTD 2023
Sales Performance 2022 - YTD 2023 YTD Q2-2023 • ZTlido gross sales were in the range of $64.2 million to $67.3 million, compared to $39.4 million for year-to-date June 2022, representing growth in the range of 63% to 71%. • ZTlido net sales were in the range of $20.5 million to $23.0 million, compar
Slide 8: ZTlido Commercialization Success
ZTlido Commercialization Success 8
Slide 9: 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 10: 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 10
Slide 11: The ZTlido Solution to the Unmet Need with Gabapentinoids
The ZTlido Solution to the Unmet Need with Gabapentinoids 11 PEOPLE PRODUCT PERFORMANCE
Slide 12: 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 13: Enhanced Patient Quality of Life
Enhanced Patient Quality of Life 13 PEOPLE PRODUCT PERFORMANCE
Slide 14: Enhanced Patient Quality of Life: Real World Evidence
Enhanced Patient Quality of Life: Real World Evidence 14 PEOPLE PRODUCT PERFORMANCE
Slide 15: Elyxyb (celecoxib) oral solution (Acute Treatment of Migraine)
Elyxyb (celecoxib) oral solution (Acute Treatment of Migraine)
Slide 16: Elyxyb Launched in USA April 2023
Elyxyb Launched in USA April 2023 16
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 17
Slide 18: Market Overview and Value Proposition
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 • 39 million people suffer from migraines in the US, of which 9 million (23%) are on acute Rx therapies1 • US oral migraine mar
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: Gloperba
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 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 Confidential, not for distribution 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 Met Primary Endpoint
Phase III C.L.E.A.R. Trial Met Primary Endpoint Phase III Primary Endpoint Overview Phase III SP-102 C.L.E.A.R Trial – Primary Endpoint Change in Average Daily Pain in Affected Leg The trial met primary, key secondary and other Numeric Pain Rating Scale, LS Mean 0 secondary endpoints with statistica
Slide 31: C.L.E.A.R. Trial – Key Secondary Endpoint
C.L.E.A.R. Trial – Key Secondary Endpoint Phase III Secondary Endpoint Overview Phase III SP-102 C.L.E.A.R Trial – Secondary Endpoint The Oswestry Disability Index (ODI) - gold standard Oswestry Disability Index Percentage for measuring degree of disability and estimating Change from Baseline at Wee
Slide 32: 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 33: Phase III SP-102 C.L.E.A.R. Trial – Conclusions and Summary
Phase III 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) fo
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 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
Slide 36: 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 37: 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 38: SP-104 Delayed Burst Low Dose Naltrexone (Fibromyalgia)
SP-104 Delayed Burst Low Dose Naltrexone (Fibromyalgia)
Slide 39: 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 40: Management
HOLDING COMPANY Management
Slide 41: Management Team
Management Team Jaisim Shah Elizabeth Czerepak Dmitri Lissin, MD Steve Lincoln Chief Executive & President Chief Financial Officer & Chief Chief Medical Officer GC and Chief Compliance Officer Business Officer 25+ years of management 35+ years of finance, business 20+ years in clinical develop
Slide 42: Nasdaq (November 11, 2022)
Nasdaq (November 11, 2022) 42
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