Scilex Holding Company · NASDAQ:SCLX
Scilex — SPAC Merger (February 2022)
57 slides from Scilex's SPAC merger presentation, Feb 18, 2022
Slide 1: Scilex Holding Company: Innovative Leader in Non-Opioid Pain Therapeutics
C C on on f f i i den de t nt i i al al : : F F or or I In nt te er r na na l l S S C C I I L E LE X X P P h ha a r r m m a c a c e u t eu t i i c c a l a l s s U U s s e e O n On l l y y 1 1 Scilex Holding Company Innovative Leader in Non - Opioid Pain Therapeutics D ece m be r 2021
Slide 2: Safe Harbor 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,
Slide 3: Industry and Market Data; Important Information
undertakes no obligation to update publicly or revise any forward - looking statements for any reason after the date of this Presentation or to conform these statements to actual results or to changes in Scilex’s expectations. Industry and Market Data Certain data in this Presentation was obtained f
Slide 4: Important Information and Where to Find It
Investors and security holders of the SPAC are urged to read these materials (including any amendments or supplements thereto) and any other relevant documents in connection with the transaction that the SPAC files with the SEC when, and if, they become available because they will contain important
Slide 5: Participants in the Solicitation; Non-Solicitation
Scilex and its directors and executive officers may also be deemed to be participants in the solicitation of proxies from the shareholders of the SPAC in connection with the Proposed Business Combination. Information about Scilex’s directors and executive officers and information regarding their int
Slide 6: Agenda
Agenda 1) Scilex Holding Corporate Overview 2) ZT l i d o ® 1 . 8 % U pda t e 3) SP - 102 (SEMDEXA) for Lumbar Radicular Pain / Sciatica 4) SP - 103 (3X ZTlido) for Low Back Pain 5) DBR Low Dose Naltrexone (LDN) for Fibromyalgia 6) Company Summary Sc i l e x H o l d i n g C o m pany
Slide 7: Corporate Overview
Sc i l e x H o l d i n g C o m pany C on f i den t i a l : F or I n te r nal S C IL E X P ha r m ac eu t i c a l s U se On l y 1 0 Corporate Overview Sc i l e x H o l d i n g C o m pany
Slide 8: Vickers Strengths and Scilex Business Combination
Vickers Strengths Strong deal structuring, investing and M&A experience within the fin - tech space Significant private and public investment experience History of working within highly regulated industries requiring vast and rigorous due diligence efforts Necessary experience in working with intern
Slide 9: Management Team
Name Position(s) Experience Jaisi m S h a h CEO & President ▪ 25+ years of management experience in large Pharma and Biotech ▪ Lead commercialization of multiple blockbusters Rituxan ® , Abilify ® , Pegasys®, BuSpar ® , Tequin ▪ CEO, Semnur Pharma; CBO, Elevation; CBO, PDL BioPharma; VP, Bristol - M
Slide 10: Non-Opioid Pain Management Pipeline
Platform Program IND P h as e 1 P h as e 2 P h ase3 Piv o t al NDA Approved U p c o m in g M il es t o n es N on - O p i o i d P a i n M a n a g e m en t Z T lid o ® 1.8% (Postherpetic Neuralgia - PHN) Laun c h e d U S October 2018 SP - 102 (SEMDEXA) (Lumbar Radicular / Sciatica Pain) P i v ot a l P
Slide 11: 2021 Scilex Business Update
2021 Scilex Business Update In April 2021, Scilex received a supplemental new drug application (sNDA) approval from the FDA for ZTlido to expand the label for use in water stress conditions In 2020, ZTlido had US net sales ~$27MM, which represents a ~35% growth rate YoY 2019 ● Scilex is currently pr
Slide 12: Target Physicians 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% 4% 10% Anesthesiologists Physical Medicine& Rehab S p ec i a l i s t s I n t e r v e n
Slide 13: Scilex Holding Company Headquarters
Scilex Holding Company Headquarters - 960 San Antonio Road, Palo Alto CA 94303 - Satellite Office: 4955 Directors Place, San Diego, CA 92121 Sc i l e x H o l d i n g C o m pany
Slide 14: ZTlido 1.8% for Post-Herpetic Neuralgia
Sc i l e x H o l d i n g C o m pany C on f i den t i a l : F or I n te r nal S C IL E X P ha r m ac eu t i c a l s U se On l y 1 0 Scilex Pharmaceuticals ZTlido 1.8% for Post - Herpetic Neuralgia (PHN) Sc i l e x H o l d i n g C o m pany
Slide 15: Marketed Product: ZTlido 1.8%
US F DA APP R O V A L – F EBRU A RY 2018 COMM ER C I A L L A U N C H – OCTO BER 2018 Marketed Product: ZTlido® 1.8% (FDA approved for relief of pain associated with PHN) L i d o c a i n e P a t c h M a r k e t O v e r v i ew >3.5 million prescriptions per year More than 129 million prescription lido
Slide 16: Lidocaine Patches are as Efficacious as Gabapentinoids
Sc i l e x H o l d i n g C o m pany Lidocaine Patches are as Efficacious as Gabapentinoids
Slide 17: ZTlido Prescription Growth vs Lidocaine Market
Sc i l e x H o l d i n g C o m pany 91,421 129,384 120,542 199,144 0 50,000 100,000 150,000 200,000 2019 2020 +65.2 YoY ∆ +41.5% YoY ∆ 2,024,976 2,196,559 3,342,642 0 500,000 1,000,000 1,500,000 2,000,000 2,500,000 3,000,000 3,500,000 2019 2020 ZTlido strong prescription growth continued at faster p
Slide 18: ZTlido YTD Sales Performance Comparison
$38.5MM $51.8MM $0.0 $10.0 $20.0 $30.0 $40.0 $50.0 $60.0 YTD 2020 (Jan - Oct) YTD 2021 (Jan - Oct) ZTlido Gross Sales YTD '21 vs '20 (Jan - Oct) ZTlido YTD Sales Performance Comparison +35% ∆ Sc i l e x H o l d i n g C o m pany
Slide 19: ZTlido Reimbursement Market Access Update
Sc i l e x H o l d i n g C o m pany ZTlido Reimbursement Market Access Update: Preferred Lido patch on Medi - Cal from Jan 1. Negotiating with CVS ZTlido Market Access continuing to improve Sources: MMIT, Scilex Analysis, lives in Millions 298 Preferred 55 CVS/Aetna C o mm er c i al 58.6 ESI Commerc
Slide 20: ZTlido Patent Families
Family 1 – Expiring in 2031 ● U.S. 9,283,174 – Non - aqueous patch comprising lidocaine – Orange Book listed ● U.S. 9,925,264 – Methods of treating pain using patch – Orange Book listed ● U.S. 9,931,403 – Non - aqueous patch comprising lidocaine – Orange Book listed ● U.S. 10,765,749 – Non - aqueous
Slide 21: ZTlido Summary
ZTlido sales continues to show impressive growth 2 years after launch (growth of 35% in 2020, projected strong growth in 2021) Effective September 1, 2021, ZTlido® (lidocaine topical system) 1.8% has been added to multiple formularies, including two national PBMs (United Health and Optum Rx), a nati
Slide 22: SEMDEXA for Lumbar Radicular Sciatica Pain
Sc i l e x H o l d i n g C o m pany C on f i den t i a l : F or I n te r nal S C IL E X P ha r m ac eu t i c a l s U se On l y 1 0 SP - 102 (SEMDEXA) for Lumbar Radicular Sciatica Pain Sc i l e x H o l d i n g C o m pany
Slide 23: Epidural Steroid Injections: One of the Most Common Medical Procedures
• ESIs widely reimbursed as procedure to delay or avoid back surgery • Transforaminal ESI route (used in C.L.E.A.R. trial) majority of procedures Common Surgical Procedures (thousands) (1) Strong Growth Rate, Evidenced by Medicare Procedure Volumes 1,600 3,600 4,000 6,000 7,500 10,000 0 2, 5 00 5, 0
Slide 24: Current Problem and Multi-Modal Pain Management
“ Consultants, ASA members, and ASRA members strongly agree that eipidural steroid injections with or without local anesthetics should be used for radicular pain or radiculopathy.” - American Society of Anesthesiology Practice Guidelines for Chronic Pain Management 3 Prescription opioid abuse is at
Slide 25: Important Environmental Factors
Important Environmental Factors Fungal Meningitis Outbreak with ESI (2013 - 14) Sc i l e x H o l d i n g C o m pany
Slide 26: CDC Data: Drug Overdose Deaths Top 100K
2 6 Sc i l e x H o l d i n g C o m pany CDC Data: Drug Overdose Deaths Top 100K for First Time
Slide 27: SEMDEXA Product Profile
Well - tolerated. Key viscous excipient, long h i s t o r y o f u s e i n c l ud i n g s a f e ty and safer repeat injections Fast acting onset of effect with less spread Potent non - particulate steroid (injectable dexamethasone sodium phosphate viscous gel) P re - f il l e d s y r i ng e f
Slide 28: SEMDEXA Product Development and Regulatory
C on f i den t i a l : F or I n te r nal S C IL E X P ha r m ac eu t i c a l s U se On l y 2 7 SEMDEXA – Product Development & Regulatory Sc i l e x H o l d i n g C o m pany
Slide 29: Toxicology Program
SP - 102 Toxicology Program All tox studies completed concurrence with FDA pre - IND meeting ● No toxicology red flags in either species (dog & pig) after both single and repeat dosing No drug - related toxicity with SP - 102, local (spinal area) or systemic (including brain), macroscopic or histopa
Slide 30: Phase 1/2 Trial in Patients with Radicular Pain
- 80.0% - 60.0% - 40.0% - 20.0% 0 . 0 % 20.0 % 0 7 1 4 2 1 2 8 3 5 Phase 1/2 Open - Label Crossover Study in Patients with Radicular Pain (PK/PD Bridging) M ea n c han g e f r o m ba s e li n e i n pa in sc o r e s ( N =12) 42 49 56 D a y s f oll o w in g SP - 10 2 i n j e ct i o n SP - 102 single e
Slide 31: Phase 2 Repeat Dose Trial
NPRS: Numeric Pain Rating Scale • Clinical Response (over 50% pain reduction) with Average Leg Pain • Greater effect with second treatment, demonstrating added benefit • Cortisol Suppression Time is not extended by repeat dose • No interference with clinical decision of repeat dose administration SP
Slide 32: Pivotal Phase 3 C.L.E.A.R. Trial Topline Results
Sc i l e x H o l d i n g C o m pany SP - 102 Pivotal Phase 3 C.L.E.A.R. Trial Topline Results
Slide 33: C.L.E.A.R. Trial Objectives
SP - 102 C.L.E.A.R. Phase 3 Trial Objectives Primary objective: ● Evaluate the analgesic effect on average leg pain (as measured by the Numeric Pain Rating Scale in the affected leg) following a single transforaminal (TF) injection of SP - 102 compared to an intramuscular injection of placebo over 4
Slide 34: Phase 3 C.L.E.A.R. Trial Design
Inclusion Radicular leg pain episode ( 4 - 9 NPRS) MR I c on f ir m e d N o p ri o r ESI (epidural steroid injection) N o op i o i d s o r NSAIDs S t ab l e , > 4 a v g NPRS pain in 21 d sc r een i n g Primary Endpoint Change in mean leg pain (NPRS) over first 4 weeks Secondaries (W2, W4, W8, W12) L
Slide 35: C.L.E.A.R. Trial Sample Size and Statistical Analysis Plan
Phase 3 SP - 102 C.L.E.A.R. Trial – Sample Size Statistical Analysis Plan ● The sample size provides 90% power to detect a 1 - point difference in change from Baseline in the mean NPRS average daily leg pain score in the affected leg over 4 weeks between the 2 treatment groups. ● The sample size was
Slide 36: Phase 3 C.L.E.A.R. Trial Primary Endpoint
Comparison: SP - 102 vs. Placebo Over 4 Weeks, LS Mean (SE) - 1.08 (0.17) 95% CI - 1.42, - 0.75 p - value <0.001*** - 3 - 2.5 - 1.5 - 2 - 0.5 - 1 0.5 0 Week 1 Week 2 Week 3 Week 4 Numeric Pain Rating Scale, LS Mean Change in Average Daily Pain in Affected Leg P la c ebo n=189 SP - 102 n=154 The anal
Slide 37: Oswestry Disability Index
Oswestry Disability Index The gold standard for measuring degree of disability and estimating quality of life in a person with low back pain. Contains 10 topics concerning intensity of pain, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, soc
Slide 38: C.L.E.A.R. Trial Key Secondary Endpoints
C.L.E.A.R. Trial – Key Secondary Endpoints Comparison: SP - 102 vs. Placebo At Week 4, LS Mean (SE) - 6.28 (1.494) 95% CI - 9.22, - 3.34 p - value <0.001*** SP - 102 (N=154) Placebo (N=189) Number of subjects with repeat injection of SP - 102 (%) 70 (46%) 126 (67%) Time (days) to Repeat Injection 25
Slide 39: C.L.E.A.R. Trial Adverse Events
C.L.E.A.R. Trial – Adverse Events SP - 102/SP - 102 PBO/SP - 102 SP - 102/none PBO/none (N=104) (N=130) (N=98) (N=69) Subjects, n(%) Events Subjects, n(%) Events Subjects, n(%) Events Subjects, n(%) Events Any TEAE 34 (32.7) 72 41 (31.5) 73 25 (25.5) 46 14 (20.3) 23 Any TEAE >3% Incidence Headache 7
Slide 40: Phase 3 C.L.E.A.R. Trial Conclusions
Phase 3 SP - 102 C.L.E.A.R. Trial - Conclusions The trial met primary and key secondary endpoints with statistical significance Demonstrated clear safety profile of SP - 102 Achieved all study objectives Next steps in 2022 ● Apply for Breakthrough Therapy Designation with FDA ● Request pre - NDA mee
Slide 41: Manufacturing On-Track for NDA Submission to FDA in 2023
Commercial supply chain in place ▪ API : Dexamethasone sodium phosphate supplier in place ▪ Novel excipient : Supply from leading commercial provider, 20 - year supply agreement for specific type for use ▪ Drug product : Commercial manufacturer in place, FDA experienced with biocompatible excipient,
Slide 42: SEMDEXA Global Intellectual Property
Patent family expiring in 2036 ● U.S. 10,117,938 - methods of treating inflammation and/or pain ● U.S. 10,500,284 – composition of matter and syringe ● U.S. 11,020,485 – composition of matter ● 1 pending U.S. application E x - U . S . app li c a t i on s i n A T , AU , BE , BR , CA , CH , CN , DE ,
Slide 43: Summary SEMDEXA
Summary SP - 102 (SEMDEXA) No FDA approved products to treat Sciatica/chronic back pain. All currently used off - label products have FDA warnings not to use Scilex will meet with FDA to discuss NDA filing for SEMDEXA in 2022 Breakthrough Designation filing with Phase 3 results in 2022 Priority Revi
Slide 44: SEMDEXA Commercial Strategy and Outlook
C on f i den t i a l : F or I n te r nal S C IL E X P ha r m ac eu t i c a l s U se On l y 3 4 SEMDEXA – Commercial Strategy & Outlook Sc i l e x H o l d i n g C o m pany
Slide 45: SEMDEXA Overall Physician Impression
Source: “Lumbar Radiculopathy Market Opportunity” Quantitative Research (Nov’17); Cognitive Consulting Sc i l e x H o l d i n g C o m pany SEMDEXA Overall Physician Impression
Slide 46: SEMDEXA Broad Potential for Life Cycle Management
SEMDEXA – Broad Potential for Life Cycle Management ▪ Carpe l T unnel ▪ Trigger Point Injections ▪ Injections for Knee, Shoulders, Wrists, Ankles, Joints ▪ Cervical Radiculopathy ▪ K ne e A r t h r i tis ▪ Hip and Knee Replacements ▪ Complex Regional Pain Syndromes (CRPS) ▪ Lumbar Spinal Stenosis ▪
Slide 47: Reimbursement Scenario
SP - 102 is expected to be used in the Office setting as well as in Ambulatory Surgical Centers and Hospital Outpatient clinics Scilex expects SP - 102 to secure favorable pricing and reimbursement due to its strong product profile, meeting important unmet medical needs in pain management and lack o
Slide 48: Intellectual Property: High Barriers to Competition
Intellectual Property P r op ri e t a ry E xc i p i e n t Comp lex Ma nuf ac tu ri n g Pr oces s & Kno w - H o w for Pre - Filled Viscous Gel Full Nonclinical Safety & Clinical Package Likely Required by F D A f o r a n y A l te r n a t e Fo r m u l a t i on • SP - 10 2 Me t ho d o f U s e : U S Pa
Slide 49: Summary SEMDEXA
Summary – SP - 102 (SEMDEXA) Market with high unmet need & no FDA approved products to treat sciatica pain S c il e x wil l m ee t wi t h F D A t o d i sc u ss ND A f o r SE M DEX A i n 202 2 and pursue Breakthrough Designation and Priority Review applications SEMDEXA is a potential blockbuster prod
Slide 50: SP-103 for Low Back Pain and Delayed Release LDN for Fibromyalgia
C on f i de n t i a l : F or I n te r nal S C I L EX Pha r m ac e ut i c a l s U se On l y 31 SP - 103 for Low Back Pain & Delayed Release LDN for Fibromyalgia Sc i l e x H o l d i n g C o m pany
Slide 51: SP-103 Next-Generation 5.4% Lidocaine Topical System
x 3x drug load (108 mg vs 36 mg lidocaine) x Triple strength localized dose of lidocaine x Expected same superior adhesion and efficient formulation x Expect to initiate Phase 2 trial by January 2022 x For the treatment of acute low back pain – a substantially larger opportunity than PHN SP - 103 Ne
Slide 52: SP-104 Delayed Burst Low Dose Naltrexone for Fibromyalgia
SP - 104 Delayed Burst Low Dose Naltrexone (LDN) – Fibromyalgia Fibromyalgia is a long - term condition that causes pain all over the body and affects ~2% of general population (5 - 8 million patients, 80 - 90% women) Low Dose Naltrexone (LDN) efficacy well documented • Routinely used off - label to
Slide 53: Summary
C on f i den t i a l : F or I n te r nal S C IL E X P ha r m ac eu t i c a l s U se On l y 4 6 S umm a r y Sc i l e x H o l d i n g C o m pany
Slide 54: Acute/Chronic Pain Major Global Healthcare Problem
• Pain is reported in about 90% of the global population • 94% report pain in their back or lower back • 69% of people endure long - lasting pain which negatively impacts quality of life S ou r c e : G l oba l P a in I nde x S u mm a r y R epo r t . Sc i l e x H o l d i n g C o m pany Acute/Chronic
Slide 55: Non-Opioid Pain Management Pipeline
Platform Program IND P h as e 1 P h as e 2 P h ase3 Piv o t al NDA Approved U p c o m in g M il es t o n es N on - O p i o i d P a i n M a n a g e m en t Z T lid o ® 1.8% (Postherpetic Neuralgia - PHN) Laun c h e d U S October 2018 SP - 102 (SEMDEXA) (Lumbar Radicular / Sciatica Pain) P i v ot a l P
Slide 56: ESI Market is a Huge Opportunity for a Potential Blockbuster
Osteoarthritis intra - articular injection products Post - operative acute pain local anesthetic products 4M+ procedures / year 8M+ procedures / year 12M+ procedures / year Chronic low back pain epidural steroid gel injection Scilex SP - 102 gel in pivotal Phase 3 (completed enrollment 2021 with pos
Slide 57: Scilex Holding Summary
Scilex Holding Summary Commercial non - opioid pain management company with 3 clinical stage programs in large markets with very high unmet need Launched rapidly growing ZTlido (lidocaine topical system 1.8%) in 2018 with in - house commercial and sales team Semnur Pharma merged with Scilex in 2019