Scilex Holding Company · NASDAQ:SCLX
Scilex — Investor Presentation (September 2024)
29 slides from Scilex's investor presentation, September 2024
Slide 1: Innovative Leader in Non-Opioid Pain Therapeutics
Innovative Leader in Non-Opioid Pain Therapeutics September 2024
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: Innovative Non-Opioid Pain Therapeutics
Innovative Non-Opioid Pain Therapeutics KEY PROGRAMS PRECLINICAL PHASE 1 PHASE 2 PHASE 3 / PIVOTAL APPROVED IP MILESTONES / KEY COMMENTARY Phase 3 Platform Program IND Phase 1 Phase 2 NDA Approved Upcoming Milestones ZTlido® Pivotal (1.8% lidocaine topical system Approved for the treatment of Posthe
Slide 4: Scilex Holding Company Structure
Scilex Holding Company Structure Scilex Holding Company Ticker Symbol “SCLX” SCLX Stock Acquisition JV LLC (SCLX Shares: 60MM common Scilex Pharmaceuticals Inc. and 29MM Semnur Pharmaceuticals Inc. ZTlido®, GLOPERBA®, SP-102 (SEMDEXA ) preferred shares) ELYXYB®, SP-103 6 4
Slide 5: ZTlido
ZTlido (1.8% lidocaine topical system equivalent to 5% lidocaine for the treatment of Postherpetic Neuralgia-PHN related pain)
Slide 6: ZTlido Performance
ZTlido Performance • Based on the independent market research conducted by Syneos Health Consulting (“Syneos”), with the new campaign, health care providers (HCPs) report increased awareness and substantial intent to utilize for ZTlido® with peak sales potential projected to reach over $500 million
Slide 7: 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 8: 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 9: 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 ZTlido Preferred 0 Total Lives Later In-Negotiations Covered Negotiations 9
Slide 10: ZTlido Partnership Ex-U.S.
ZTlido Partnership Ex-U.S. • Established Middle East and NA partnership, filngs underway in UAE, Saudi Arabia and North Africa, launched planned for 2025 with minimum purchase commitment from CH Trading for $105MM for 5 years. • On July 17, 2024, Scilex Holding Company announces collaboration to lev
Slide 11: Elyxyb (celecoxib) oral solution (Acute Treatment of Migraine)
Elyxyb (celecoxib) oral solution (Acute Treatment of Migraine)
Slide 12: Elyxyb Launched in USA in 2023
Elyxyb Launched in USA in 2023 12
Slide 13: 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 13
Slide 14: Elyxyb Promotion Materials
Elyxyb Promotion Materials 14
Slide 15: ELYXYB
ELYXYB (Celecoxib) Oral Solution Episodic Migraine Treatment 15
Slide 16: Gloperba
Gloperba (colchicine USP) oral solution (For the prevention of painful gout flares in adults)
Slide 17: Gloperba Launched in USA in June 2024
Gloperba Launched in USA in June 2024 17
Slide 18: Gloperba Launched in June 2024
Gloperba Launched in June 2024 • Gloperba® is the first and only liquid oral version of the anti-gout medicine colchicine indicated for the prophylaxis of painful gout flares in adults. • Gout is a painful arthritic disorder affecting an estimated 9.2 million people in the United States. As gout cas
Slide 19: Target Patients For Gloperba Today
Target Patients For Gloperba Today • Patients with CKD Stage 3/4/5: 6 million patients • Patients with GI tolerability issues: 1 million patients • Patients who have difficulty swallowing 19
Slide 20: Gloperba solves for the Unmet Need HCPs have stated
Gloperba solves for the Unmet Need HCPs have stated For internal use only. Not to be shown to healthcare professionals. 20
Slide 21: Semnur Pharmaceuticals
Semnur Pharmaceuticals 960 San Antonio Rd, Palo Alto CA 94303 Wholly Owned Subsidiary of Scilex Holding Company (NASDAQ: SCLX)
Slide 22: Denali SPAC Transaction
Denali SPAC Transaction • Semnur Pharmaceuticals, Inc., a Wholly Owned Subsidiary of Scilex Holding Company (Nasdaq: SCLX), and Denali Capital Acquisition Corp. (Nasdaq: DECA) Announce Signing of a Merger Agreement for a Proposed Business Combination. • On August 30, 2024, Semnur Pharmaceuticals, In
Slide 23: SP-102 (SEMDEXA) On-Track to be the First Product Approved to Treat Sciatica
SP-102 (SEMDEXA ) On-Track to be the First Product Approved to Treat Sciatica • SP-102 is a preservative free, surfactant free and particulate free viscous gel formulation of dexamethasone for sciatica (lumbosacral radicular pain). • Extended local effect provides durable pain relief and significant
Slide 24: SP-102 (SEMDEXA) C.L.E.A.R. Trial Met Primary Endpoint
SP-102 (SEMDEXA ) C.L.E.A.R. Trial Met Primary Endpoint (Corticosteroid Lumbar Epidural Analgesia in Radiculopathy) Primary Endpoint (mITT) Largest prospective, double-blind, randomized study in Sciatica (n=401) Change in Average Daily Pain in Affected Leg The trial met primary, key secondary and ot
Slide 25: SP-102 (SEMDEXA) C.L.E.A.R. Trial Secondary Endpoints (ITT)
SP-102 (SEMDEXA ) C.L.E.A.R. Trial Secondary Endpoints (ITT) Key Secondary Endpoint • The Oswestry Disability Index (ODI) - gold standard for measuring degree of disability and estimating quality of life, contains 10 topics concerning intensity of pain, lifting, ability to care for oneself, ability
Slide 26: SP-102 (SEMDEXA) C.L.E.A.R. Trial – Effect Duration and Safety
SP-102 (SEMDEXA ) 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 showed continued reduction of pain beyond one month,
Slide 27: SP-102 (SEMDEXA) Milestones
SP-102 (SEMDEXA ) Milestones 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 27
Slide 28: SP-102 (SEMDEXA) Milestones
SP-102 (SEMDEXA ) Milestones Open-Label Safety Trial Q4-2024 to 1H-2026 • Open-Label Safety Trial o Up to three SP-102 injections over 24 weeks in Subjects with Lumbosacral Radicular Pain (Sciatica). o All subjects are followed for 24 weeks after the last injection. Trials to enroll ~ 650 subjects t
Slide 29: Investment Highlights
Investment Highlights ✓ 3 FDA approved Non-Opioid Acute and Chronic Pain Management Products ✓ Worldwide Commercial Rights to Most Product Candidates ✓ Strong Proprietary Platform with High Barriers to Entry ✓ Established Reimbursement Access ✓ Blockbuster Pipeline With Limited Capital Required for
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