Scilex Holding Company · NASDAQ:SCLX
Scilex — Investor Presentation (April 2019)
27 slides from Scilex's investor presentation, April 2019
Slide 1: Scilex Corporate Presentation
Scilex Corporate Presentation April 2019 Non-Confidential Getting Back to Normal 1
Slide 2: Forward Looking Statements
Forward Looking Statements Some statements in this presentation are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify
Slide 3: Scilex Corporate Overview
Scilex Corporate Overview Merger of 2 non-opioid pain focused companies (Scilex & Semnur) in March 2019: - Global leader in non-opioid pain management with commercial and late stage products with compelling synergies on multiple fronts - Exisiting 100+ highly experienced pain-focused salesforce, mar
Slide 4: Commercial Non-Opioid Pain Company with Late-stage Programs in Large Markets
Commercial Non-Opioid Pain Company with Late-stage Programs in Large Markets with High Unmet Need Large, Established, yet Underserved Target Markets Worldwide Commercial Rights to All Product Candidates Strong Proprietary Platform with High Barriers toEntry Established Reimbursement Access B
Slide 5: Non-Opioid Best In Class Pain Pipeline
Non-Opioid Best In Class Pain Pipeline NDA Pilot PK Phase 1 Phase 2 Phase 3 Approved Milestones Filing ZTlido® 1.8% (36mg lidocaine) US NDA approval February Strategy 28, 2018 ZTlido® 5.4% • Clinical studies planned (108 mg lidocaine) in 2019 SP-102 Dexamethasone sodium • Top line dataH1-2020 phos
Slide 6: Significant Near-Term Milestones
Significant Near-Term Milestones Multiple clinical milestones for all programs expected in the next 12 months SP-102 Phase 3 trial completion and data readout ZTlido® 3X trial start for new indication In addition, corporate development milestones may be achieved with potential collaborations
Slide 7: Target physician consists of a mix of specialists, concentrated in high volume clinics
Target physician consists of a mix of specialists, concentrated in high volume clinics Physicians treating chronic pain Neurology Significant concentration Orthopedic in high volume clinics surgeons 10% Anesthesiologists 4% • ~3,000 pain clinics Pain 32% (<1,000 interventional) Medicine 11% • Sales
Slide 8: ZTlido Product Overview
ZTlido® Product Overview Getting Back to Normal
Slide 9: ZTlido Overview
ZTlido® Overview ZTlido® (lidocaine topical system 1.8%) is a branded, non-aqueous topical lidocaine patch indicated for the treatment of pain associated with PHN 1Estimate from IMSHealth Source: SCILEX *AAN guidelines retired 9
Slide 10: ZTlido 1.8% proven bioequivalence to Lidoderm 5%
ZTlido® 1.8%— proven bioequivalence to Lidoderm 5% In clinical trials, ZTlido® with a 1.8% concentration of 36 mg of lidocaine achieved bioequivalence to Lidoderm 5% of 700 mg 5 Natural Log of Mean Lidocaine Concentration ZTlido 1.8% Lidoderm 5% 4 3 2 1 0 0 4 8 12 16 ZTLIDO 201.8% delivers 24 the sa
Slide 11: ZTlido Clinical Data: Adhesion Study ZTlido vs. Lidoderm
ZTlido® Clinical Data: Adhesion Study ZTlido® vs. Lidoderm® Post-hoc analysis of ADH-002 with Percent Adhesion scoring 10
Slide 12: ZTlido Clinical Data: Adhesion Study vs. Generic Mylan
ZTlido® Clinical Data: Adhesion Study vs. Generic Mylan 110 100 • ZTlido® 1.8% maintained a mean 90 adhesion of ≥90% over the 12-hour 90% Adhesion treatment period 80 70 % Adhesion 60 • Generic Lidocaine Patch 5% was not 50 able to achieve a mean adhesion of 50% Adhesion ≥90% at Time 0 40 • Generic
Slide 13: Lidocaine Patch Market Overview
Lidocaine Patch Market Overview Currently ~3MM Scripts and we conservatively forecast to grow in line with population growth; adhesion is among the highest unmet needs for patches The lidocaine patch • Approximately 120 million prescription lidocaine patches were sold in 2017 market was ~3M scripts
Slide 14: Commercial Strategy for the Launch of ZTlido 1.8%
Commercial Strategy for the Launch of ZTlido® 1.8% • SCILEX has built a dedicated field force of 100 highly experienced sales representatives • Targeting PCPs, pain specialists, and neurologists with this field force Sales • SCILEX is initially targeting the top plans responsible for most Rxs • Insu
Slide 15: Commercialization Strategy for ZTlido Franchise
Commercialization Strategy for ZTlido® Franchise ZTlido® 1.8% ZTlido® 5.4% (investigational) • Approval in US on February 28,2018 • Potential expanded indications for development of ZTlido® 5.4% • Launched in October 2018, supported by personal and non-personal Sales & • Current sales force can supp
Slide 16: ZTlido 5.4% - Low Back Pain
ZTlido® 5.4% - Low Back Pain Getting Back to Normal
Slide 17: ZTlido 5.4% Opportunity
ZTlido® 5.4% Opportunity 2015 = $44 B Mild – Moderate Moderate -Severe • Expanding and aging market with inadequate treatment for chronic pain including low back pain $7 B $37 B • Innovative, non-opioid, non-addictive analgesic • Significant potential as a key player in Moderate 2021 = $48.2 B CAGR
Slide 18: SP-102 Lumbar Radicular Pain
SP-102 Lumbar Radicular Pain Getting Back to Normal
Slide 19: SP-102 Opportunity Summary
SP-102 – Opportunity Summary Developing SP-102 as a non-opioid injectable therapeutic for low backpain Novel gel formulation, optimized for epidural injection Novel biocompatible excipient enables extended local effect On track to be the first FDA-approved epidural steroid product Currently used pro
Slide 20: SP-102: On-track to be the first steroid formulation with an FDA-approved label
SP-102: On-track to be the first steroid formulation with an FDA-approved label to treat back pain SP-102 Product Features ✔Potent non-particulate steroid (injectable dexamethasone sodium phosphate gel) ✔Pre-filled syringe for epidural use ✔Gel formulation for extended local release and substantial
Slide 21: SP-102 Status: Significant progress towards NDA filing in 2020
SP-102 Status: Significant preclinical, clinical,and CMC progress towards NDA filing in 2020 Clinical / Regulatory / Commercial Timelines and Strategies Preclinical hydrodynamic study in pigs confirmed extended local effect Completed with novel formulation Broad-based toxicologystudies including int
Slide 22: SP-102 CLEAR Phase 3 Study: Landmark ESI study
SP-102 CLEAR Phase 3 Study: Landmark ESIstudy with final data expected Q1-2020 Initial Treatment Safety Follow-Up Baseline Week4 Week 12 Week24 Inclusion Epidural SP-102 Radicular leg injection Optional repeat SP-102 injection Randomization (1:1) pain episode N=200 (4-9 NPRS) MRIconfirmed No prior E
Slide 23: SP-102 Market Assessment: Associated Conditions
SP-102 Market Assessment: Associated Conditions There is significant overlap among the various causes of Lumbar Radiculopathy, which contributes to the increasing use of ESI treatments. Lumbosacral Radicular Spinal Stenosis • Large patient population • Frequent Radiculopathy Pain Market Trends • Fre
Slide 24: SP-102 Expected to Obtain Medicare Reimbursement Similar to Other Injectables
SP-102 Expected to Obtain Medicare Reimbursement Similar to OtherInjectables • Good case for economic benefits associated with use of epidural steroid injections to defer more complicated treatments, such as opioids or surgicalinterventions • Medicare coverage expected and likely followed by private
Slide 25: SP-102 competitive advantage: Patents & Supply Relationships
SP-102 has competitive advantage due to Significant Investments in Patents & Supply Relationships Intellectual Property • SP-102 Method of Use: US notice of allowance in 2018 (2036 expiry) Beyond 2036 • SP-102 Formulation:Applicationpending Proprietary Excipient with • 20-year exclusive supply agree
Slide 26: Executive Management Team
Executive Management Team Names Position Experience 25+ years of senior management experience in the industry Jaisim Shah Director, Chief Executive Lead commercialization of multiple blockbusters (Rituxan®, Abilify®, Pegasys®, BuSpar®, Stadol ®, Tequin®, Cardene IV® Officer CEO, Semnur Pharma;
Slide 27: Board of Directors
Board of Directors Names Position Experience 25+ years of experience in the industry Henry Ji, Ph.D. Chairman Chair & CEO of Sorrento Therapeutics Senior positions at CombiMatrix, HGSI & Stratagene Jaisim Shah Director and CEO of Scilex CEO of Semnur & Scilex Pharmaceuticals, Board Director