Sorrento Therapeutics, Inc. · OTC:SRNE
Sorrento Therapeutics — Investor Presentation (May 2019)
27 slides from Sorrento Therapeutics's investor presentation, May 21, 2019
Slide 1: Getting Back to Normal: Scilex Corporate Presentation May 2019
Getting Back to Normal Scilex Corporate Presentation May 2019 Non - Confidential 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 ident
Slide 3: Scilex Corporate Overview
Scilex Corporate Overview Merger of 2 non - opioid pain focused companies (Scilex & Semnur ) in March 2019 : - G lobal leader in non - opioid pain management with commercial and late stage products with c ompelling synergies on multiple fronts - Exisiting 100+ highly experienced pain - focused sales
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 Blockbuster Potential With Limited Capital Required for Commercialization Established Reimbursement Access Strong Proprietary Platform with High Barriers to Entry Worldwide Commercial Rights to All
Slide 5: Non-Opioid Best In Class Pain Pipeline
Program Pilot PK Phase 1 Phase 2 Phase 3 NDA Filing Approved Milestones ZTlido ® 1.8% (36 mg lidocaine) US Strategy NDA approval February 2018 ZTlido® 5.4% (108 mg lidocaine) Clinical studies planned in 2019 SP - 102 Dexamethasone sodium phosphate gel (Lumbar Radicular Pain) Top line data H1 - 2020
Slide 6: Significant Near-Term Milestones
Significant Near - Term Milestones Program 2019 2020 2021 Period 1H 1H 2H 1H 2H SP - 102 Ph 2/3 results Ph 3 results NDA Launch Launch ZTLido ® Launch 3X Trial 3X Trial File NDA Launch ▪ Multiple clinical milestones for all programs expected in the next 12 months ▪ SP - 102 Phase 3 trial completion
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 Source: Campbell Alliance Market Research; Clinical Guidelines: Lumbar Disk Herniation with Radiculopathy. NA Spine Society, 2012. http://www.guideline.gov/content.aspx?id=46414. Primary Research. 32% 16% 27% 1 1%
Slide 8: ZTlido Product Overview
Getting Back to Normal ZTlido ® Product Overview
Slide 9: ZTlido Overview
ZT lido ® Overview ZT lido ® (lidocaine topical system 1.8%) is a branded, non - aqueous topical lidocaine patch indicated for the treatment of pain associated with PHN 1 Estimate from IMS Health Source: SCILEX *AAN guidelines retired 9
Slide 10: ZTlido 1.8% achieved 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 ZTLIDO 1.8% delivers the same amount of lidocaine as Lidoderm ® 5% 2 ZTLIDO 36 mg ~15 mg lidocain e Lidode r m ® 700 mg ~15 mg lidocain e ZTlido ® 1.8% - proven bioequivalenc
Slide 11: ZTlido Clinical Data: Adhesion Study
ZT lido ® Clinical Data: Adhesion Study ZT lido ® v s . Lidoderm ® Post - hoc analysis of ADH - 002 with Percent Adhesion scoring 11
Slide 12: ZTlido Clinical Data: Adhesion Study vs. Generic Mylan
Time (Hours) 0 3 6 9 12 % Adhesion 0 10 20 30 40 50 60 70 80 90 100 110 ZTlido 1.8% Generic Lidocaine Patch 5% N=24 90% Adhesion 50% Adhesion ZTlido ® Clinical Data: Adhesion Study v s . Generic Mylan • ZTlido ® 1.8% maintained a mean adhesion of ≥90% over the 12 - hour treatment period • Generic Li
Slide 13: Lidocaine patch market overview
The lidocaine patch market was ~3M scripts in 2017 and we forecast growth to be driven by population growth • Approximately 120 million prescription lidocaine patches were sold in 2017 • Generic lidocaine patches drive market volume, accounting for >95% of TRx in 2017 • Long - term future volume gro
Slide 14: Commercial Strategy for the Launch of ZTlido 1.8%
Commercial Strategy for the Launch of ZT lido ® 1.8% Sales Payer Strategy Marketing Medical Affairs • Scilex has built a dedicated field force of 100 highly experienced sales representatives • Targeting PCPs, pain specialist, and neurologist with this field force • Scilex is initially targeting the
Slide 15: Commercialization Strategy for ZTlido Franchise
Commercialization Strategy for ZT lido ® Franchise ZT lido ® 1.8% • Approval in US on February 28, 2018 • Launched in October 2018, supported by personal and non - personal Sales & Marketing efforts • 100% share of voice in the lidocaine patch market with no actively marketing competition • Potentia
Slide 16: ZTlido 5.4% - Low Back Pain
Getting Back to Normal ZTlido ® 5.4% - Low Back Pain
Slide 17: ZTlido 5.4% Opportunity
$7 B $37 B $41 B 2021 = $48.2 B 2015 = $44 B S o ur c e: IQVIA and Scilex InternalResearch ZTlido ® 5.4% Opportunity CAGR ~ 2% $7.2 B Mild – Moderate Moderate - Severe 17 • Expanding and aging market with inadequate treatment for chronic pain including low back pain • Innovative, non - opioid, non -
Slide 18: SP-102 Lumbar Radicular Pain
Getting Back to Normal SP - 102 Lumbar Radicular Pain
Slide 19: SP-102 Opportunity Summary
SP - 102 – Opportunity Summary Developing SP - 102 as a non - opioid injectable therapeutic for low back pain 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
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 Well - tolerated. Key viscous excipient, long history of use including safety and safer repeat injections ᪵ ᪵ Fast acting onset of effect with less spread SP - 102 Product Features ᪵ Potent non -
Slide 21: SP-102 Status: 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 with novel formulation Completed Broad - based toxicology studies includi
Slide 22: SP-102 CLEAR Phase 3 Study
SP - 102 CLEAR Phase 3 Study: Landmark ESI study with final data expected Q1 - 2020 Epidural SP - 102 injection N=200 Intramuscular saline injection (placebo) N=200 Optional repeat SP - 102 injection Optional repeat SP - 102 injection Randomization (1:1) Inclusion Radicular leg pain episode ( 4 - 9
Slide 23: SP-102 Market Assessment: Associated Conditions
SP - 102 Market Assessment: Associated Conditions Pain Market Trends • Significant Indication Overlap – Spinal Stenosis can be caused by a herniated or bulging disc – Disc degeneration can lead to spondylolisthesis and disc herniation • Inconsistent Diagnoses – Imaging scan is required to determine
Slide 24: SP-102 Expected to Obtain Medicare Reimbursement Similar to Other Injectables
SP - 102 Expected to Obtain Medicare Reimbursement Similar to Other Injectables • Good case for economic benefits associated with use of epidural steroid injections to defer more complicated treatments, such as opioids or surgical interventions • Medicare coverage expected and likely followed by pri
Slide 25: SP-102 has competitive advantage due to Patents & Supply Relationships
SP - 102 has competitive advantage due to Significant Investments in Patents & Supply Relationships Intellectual Property Beyond 2036 Proprietary Excipient with No Generic Equivalent Gel Formulation, Efficacy Driven By Local Effects Limited Manufacturing Capacity & Know - How for Pre - Filled Viscou
Slide 26: Executive Management Team
Executive Management Team Names Position Experience Jaisim Shah Director, Chief Executive Officer ▪ 25+ years of senior management experience in the industry ▪ Lead commercialization of multiple blockbusters (Rituxan ® , Abilify ® , Pegasys ®, BuSpar ® , Stadol ®, Tequin ® , Cardene IV ® ▪ CEO, Semn
Slide 27: Board of Directors
Board of Directors Names Position Experience Henry Ji, Ph.D. Chairman ▪ 25+ years of experience in the industry ▪ Chair & CEO of Sorrento Therapeutics ▪ Senior positions at CombiMatrix , HGSI & Stratagene Jaisim Shah Director and CEO of Scilex Holding ▪ CEO of Semnur & Scilex Pharmaceuticals, Board
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