Scilex Holding Company · NASDAQ:SCLX
Scilex — Investor Presentation (April 2024)
33 slides from Scilex's investor presentation, April 2024
Slide 1: Innovative Leader in Non-Opioid Pain Therapeutics
Innovative Leader in Non-Opioid Pain Therapeutics April 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: Key Achievements
Key Achievements • Fifth year company anniversary • ZTlido - #1 prescribed branded non-opioid analgesic by the pain specialist • Over 1MM patients treated with ZTlido since launched • ~90% of patients are satisfied with ZTlido treatment • 88% patients felt they could do more when on ZTlido treatment
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 Sales Performance Fiscal Year 2023 vs. 2022
ZTlido Sales Performance Fiscal Year 2023 vs. 2022 • 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 proje
Slide 7: The Gabapentinoid Market Is Massive
The Gabapentinoid Market Is Massive Gross sales of $370M would equate to ~1M ZTlido TRx The Neuropathic Pain Gabapentinoid market is an order of magnitude bigger than the Lidocaine patch market 88M Annualized ~44M Gabapentinoid Neuropathic 1+M scripts pain Rx ZTlido TRx Source: Symphony data 2023 7
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: The ZTlido Solution to the Unmet Need with Gabapentinoids
The ZTlido Solution to the Unmet Need with Gabapentinoids Improved patient QoL by 78% in 8-week trial of ZTlido with gabapentin In a real-world use trial, 88% patients claimed they could function better 89% patients claimed they were completely or mostly satisfied 9 PEOPLE PRODUCT PERFORMANCE
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 ZTlido Preferred 0 Total Lives Later In-Negotiations Covered Negotiations 10
Slide 11: 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 12: Neck Pain Market Overview
Neck Pain Market Overview Neck pain, or cervicalgia, is one of the most common pain presentations in U.S. and the 4th leading cause of disability 52.9M adults suffer from Neck Pain in the U.S. Prevalence of Neck Pain is estimated at >20% of adult population Neck pain was responsible for job absences
Slide 13: Elyxyb (celecoxib) oral solution (Acute Treatment of Migraine)
Elyxyb (celecoxib) oral solution (Acute Treatment of Migraine)
Slide 14: 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 14
Slide 15: Elyxyb Promotion Materials
Elyxyb Promotion Materials 15
Slide 16: ELYXYB Episodic Migraine Treatment
ELYXYB (Celecoxib) Oral Solution Episodic Migraine Treatment 16
Slide 17: Unmet Needs for Migraine Patients – Elyxyb Well Positioned to Address
Unmet Needs for Migraine Patients – Elyxyb Well Positioned to Address Up to 40% of 1st line and 2nd line prescriptions are for triptans1 Up to 60% of patients on triptans, have a suboptimal response2 Do not achieve pain freedom at 2 hours postdose Have recurrence of headache 2-24 hours postdose Disc
Slide 18: Elyxyb Efficacy Comparison to CGRP Inhibitors
Elyxyb Efficacy Comparison to CGRP Inhibitors Post-hoc Indirect Comparative Analysis • Gepants are known to have a slow onset of action • At 1 hour, 5x more patients on ELYXYB will be pain free vs Ubrelvy® • At 2 hours postdose, about 2x as many patients on ELYXYB will be pain free vs. Nurtec® • ELY
Slide 19: Acute Migraine Brand WAC Pricing
Acute Migraine Brand WAC Pricing Package Unit WAC Package WAC Per Avg annual Brand Generic Launch Route Size Price WAC Price Migraine price ∆ Oral Cambia Diclofenac Oct’16 powder for 9 Sachets $98.55 $886.97 $98.55 +10% (505b2) solution Oral Elyxyb Celecoxib Feb’21* 6 Bottles $135.00 $810.00 $135.00
Slide 20: 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 20
Slide 21: Elyxyb Acute Pain Opportunity: Market Size
Elyxyb Acute Pain Opportunity: Market Size 91.6M 45.8M (Acute Pain (Diagnosed Prevalence) Prevalence) 20.7M (Acute Pain - sNDA filing planned in Treated w/ Rx) 1H 2024 >20M U.S. Patients Large market opportunity for Elyxyb in Acute Pain Confidential, not for distribution 21
Slide 22: Gloperba
Gloperba (colchicine USP) oral solution (For the prevention of painful gout flares in adults)
Slide 23: Target Patients For Gloperba Today (excluding Cardiovascular)
Target Patients For Gloperba Today (excluding Cardiovascular) • Patients with CKD Stage 3/4/5: 6 million patients • Patients with GI tolerability issues: 1 million patients • Patients at risk of drug-to-drug interaction (DDI) • Patients who have difficulty swallowing Confidential, not for distributi
Slide 24: Rheumatologists indicated that they would use Gloperba in patients with CKD 3-5 and GI Sensitivity
Rheumatologists indicated that they would use Gloperba in patients with CKD 3-5 and GI Sensitivity Over 70% of gout patients suffer from CKD Number of Physicians who Expect to Prescribe GLOPERBA in Different Types of Patients Rheumatologist (n=17) CKD Stage 3-5 13 GI Intolerance / Issues 10 Swallowi
Slide 25: Rheumatologists showed high willingness to prescribe Gloperba, and even do Prior Authorization
Rheumatologists showed high willingness to prescribe Gloperba, and even do Prior Authorization Motivation to Prescribe Gloperba Likelihood to do a PA for Gloperba HIGH: 6.1/7 (Ave.) MODERATE: 5.4/7 (Ave.) Current Level • PAs are a hassle that rheumatologists prefer not to do. • Offers precise dosing
Slide 26: Gloperba reduced dosing offers value for money
Gloperba reduced dosing offers value for money Colchicine TABLET (mg) to GLOPERBA Liquid (mL) Conversion Table The WAC price of Gloperba is $595 for a 150mL bottle. Colchicine (mg) GLOPERBA (mL) -Value for $: Will last for 60 days for patients 0.12 mg 1.0 mL with Severe renal impairment (CKD 4) - 0.
Slide 27: SP-102 (SEMDEXA) Treatment of Chronic Low Back Pain/ Sciatica
SP-102 (SEMDEXA) Treatment of Chronic Low Back Pain/ Sciatica
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 Achieved Objectives
Phase III C.L.E.A.R. Trial Achieved Objectives A total of 401 patients enrolled (202 SP-102 / 199 placebo) across 37 US sites The primary endpoint - change in average daily pain in the affected leg over 4 weeks LS mean (SE) of -0.52 (0.163) compared to placebo, p=0.002. Supported by: Disability Inde
Slide 31: SP-102 Regulatory Discussion(s) to Date
SP-102 Regulatory Discussion(s) to Date 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 Agreement with FDA on next s
Slide 32: Investment Highlights
Investment Highlights 1 3 FDA-approved Non-Opioid Acute and Chronic Pain Management Products 2 Worldwide Commercial Rights to Most Product Candidates 3 Blockbuster Pipeline With Limited Capital Required for Commercialization 4 Established Reimbursement Access 5 Strong Proprietary Platform with High
Slide 33: Nasdaq (November 11, 2022)
Nasdaq (November 11, 2022) 34
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