Scilex Pharmaceuticals - Sorrento Therapeutics
Transcript of Scilex Pharmaceuticals - Sorrento Therapeutics
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Scilex Pharmaceuticals
Non-Opioid Pain Therapeutics
October 2019
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Certain statements contained herein may constitute "forward-looking statements" within the meaning of the PrivateSecurities Litigation Reform Act of 1995. These forward-looking statements by the Company are based on current(as of March 2018) intentions, expectations, estimates and projections about the Company's products indevelopment, management's beliefs and certain assumptions made by management. Readers are cautioned that anysuch forward-looking statements are not guarantees of future performance and are subject to certain risks,uncertainties and assumptions that are difficult to predict. Because such statements involve risks and uncertainties,the actual results and performance of the Company may differ materially from the results expressed or implied bysuch forward-looking statements. Given these uncertainties, readers are cautioned not to place undue reliance onsuch forward-looking statements. Unless otherwise required by law, the Company also disclaims any obligation toupdate its view of any such risks or uncertainties.
THIS DOCUMENT CONTAINS PROPRIETARY INFORMATION THAT IS THE PROPERTY OF THE COMPANY.NEITHER THIS DOCUMENT, NOR THE PROPRIETARY INFORMATION CONTAINED HEREIN, SHALL BEPUBLISHED, REPRODUCED, COPIED, DISCLOSED OR USED FOR ANY OTHER PURPOSE, OTHER THANTHE REVIEW AND CONSIDERATION OF THIS DOCUMENT.
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1) Corporate Overview
2) Ztlido 1.8% Product Overview
3) SEMDEXA for Lumbar Radicular Pain (Sciatica)
4) SP-103 for Chronic Low Back Pain
5) Management and Board
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1. Corporate Overview
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ZTlido 1.8% is a best-in-class lidocaine topical product rapidly gaining momentum in the market, supported by our fully-integrated commercial organization● Strong first year in-market with rapidly accelerating commercial trajectory – strong net sales growth of 63%
in 2Q 2019 over 1Q● Demonstrably superior performance versus competition
SEMDEXA is a pivotal Phase 3 candidate for sciatica with blockbuster potential● Non-opioid injectable therapeutic on track to be the first and only FDA-approved epidural steroid product● Poised to enter a large market – over 10 million epidural steroid injections per year in the U.S.● Phase 3 is >60% enrolled; topline results expected 2H 2020
SP-103 is a highly differentiated lidocaine topical system designed to a deliver a localized dose of lidocaine that is threefold higher than any other topical product● Leverages the same proven adhesion and formulation technology as ZTlido● Will pursue chronic low back pain indication – substantially larger opportunity than ZTlido● Phase 2 anticipated to begin in 2H 2019
Highly experienced management and Board, backed by global venture leaders, including Vivo Capital, Frazier Healthcare Partners and Canaan
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Platform Program IND Phase 1 Phase 2 Phase3 Pivotal NDA Approved Upcoming Milestones
Non-Opioid Pain
Management
ZTlido® 1.8% (Postherpetic
Neuralgia-PHN)Launched October 2018
SEMDEXA (SP-102)(Lumbar Radicular /
Sciatica Pain)Phase 3 top line data expected2H 2020
SP-103Lidocaine Topical System 5.4% (3X)
(Chronic Low BackPain)
Initiating Phase 2 in 2H 2019
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2. ZTlido 1.8% Product Overview
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US FDA APPROVAL – FEBRUARY 2018
COMMERCIAL LAUNCH – OCTOBER2018
Lidocaine Patch MarketOverview
>3 million prescriptions per year
More than 114 million prescription lidocaine patches were sold in the US in 2018 according to IMS
Benefits vs. other lidocaine pain patches
Superior adhesion vs. other lidocaine patches in varioushead-to-head studiesOnly lidocaine patch proven during moderate exercise
Properties ZTlido® 1.8% Lidoderm® 5%
Bioavailability ~45% ~3+2%
Weight 2 g 14 g
Thickness 0.8 mm 1.7 mm
Lidocaine content 36 mg 700 mg
Adhesive Non-aqueous Water-based
®
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6.19% 12.14%0.90%
15.37%
1.80% 7.33%
68.05%
0%10%20%30%40%50%60%70%80%
Estradiol Fentanyl Androderm(testosterone)
Nicotine Nitroglycerin Clonidine Lidocaine Patch
Perc
enta
ge o
f Pat
ient
s R
epor
ting
Adhe
sion
Issu
es
Total Number of Cases 1,002 16,380 3,000 787 111 1,227 1,709
Notes: Numbers on top of bars represent total number of individual case safety reports, which could have been sent in by HCPs, consumers, and manufacturers and may have been double counted. Disclaimer: FDA does not receive reports for every adverse event or medication error that occurs with a product, there may be instances of duplicate reporting, and there is no certainty that reported event was due to product. FAERS data cannot be used to calculate the incidence of an adverse event or medication error in the U.S. population.
Product adhesion is widely reported as an adverse event for lidocaine patches
Sources: FDA Adverse Events Reporting System (FAERS) Public Dashboard
Percentage of total cases reported to the FDA Adverse Events Reporting System (FAERS) that relate to product adhesion
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1Data from a 12 patient 12-hour study
Adhesion Scores Over Time (Lower Score Demonstrates Better Adhesion)
The recommended scoring system for adhesion of transdermal patches are indicated as follows:
0 = ≥ 90% adhered (essentially no lift off the skin)1 = ≥ 75% to < 90% adhered (some edges only lifting off the skin)2 = ≥ 50% to < 75% adhered (less than half of the patch lifting off the skin)3 = > 0% to < 50% adhered but not detached (more than half of the patch lifting off the skin without falling off)4 = 0% adhered - patch detached (patch completely off theskin)
Adhesion scores recorded just prior to patch removal to ensure adequate adhesion of the test articles
For more information on ZTlido® including safety information, please visit www.ztlido.com
®
®
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The lidocaine patch market was ~3+M scripts (normalized) in 2018 and we forecast growth to be driven by population growth
• Approximately 114 million prescription lidocaine patches were sold in 2018• Generic lidocaine patches drive market volume, accounting for >95% of TRx in
2018• Long-term future volume growth will be driven by growth in the key population
of patients aged 45+• Opioid market issues/retraction create an opportunity (22% opioid use in PHN*)
The unmet need for lidocaine patches is highest for patch adhesion, prescription reimbursement, and analgesic efficacy
• Poor adhesion is the leading problem for lidocaine patches as reported bypatients to the FDA Adverse Event Reporting System
• Physicians indicate that adhesion improvement is a worth-while benefit topatients
• Challenge with lidocaine patch prescriptions is patient access
Currently ~3+MM Scripts and we conservatively forecast to grow in line with population growth; adhesion is among the highest unmet needs for patches
*Gudin J, et al. Poster 1 presented at AMCP Managed Care & Specialty Pharmacy Annual Meeting, San Francisco, CA, 19-22 April, 2016.
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$2.9
$4.7
$0.0
$0.5
$1.0
$1.5
$2.0
$2.5
$3.0
$3.5
$4.0
$4.5
$5.0
Q1'19 Q2'19$M
ZTlido 1.8% Quarterly Net Sales
63% QoQ ∆Q1’19 vs Q2’19
0
2,000
4,000
6,000
8,000
10,000
12,000
14,000
Oct-18 Nov-18 Dec-18 Jan-19 Feb-19 Mar-19 Apr-19 May-19 Jun-19 Jul-19 Aug-19
ZTlido Monthly Prescription Trend
TRx (Normalized) NRx (Normalized)
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2,990
2,279
0
500
1,000
1,500
2,000
2,500
3,000
3,500
ZTlido Weekly Prescription Trend
Normalized TRx Normalized NRx
-1% Weekly ∆
Month Avg Daily TRx Avg Daily NRx
May 438 350
June 443 348
July 507 379
Aug 556 428
Sep (thru 9/20) 610 464
4.4%
5.4%
0.0%
1.0%
2.0%
3.0%
4.0%
5.0%
6.0%
ZTlido Market Share Trend
ZTlido Market Share % ZTlido NRx Market Share %
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ZTlido 1.8% has been cannibalizing Mylan by ~ 22%, Lidoderm by ~ 40%, since launch;
Source: IQVIA
2.3%
7.9%
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TRx
Shar
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Lidoderm Mylan ZTLido
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Good coverage early and getting betterFormulary coverage: Over two-thirds of lives covered or in negotiation
● ~130 million lives covered● ~70 million lives in negotiation● ~100 million lives for future consideration
Current formulary status on key accountsContracts Tier Effective Date Lives● TriCare T3 10/1/18 7,289,531
● ESI Commercial T2 11/1/18 28,471,830
● Anthem T3 No STEP 11/1/18 17,040,924● VA/DoD Full FSS agreement By Facility 3/1/19 4,768,716
● ESI Medicare T2 1/1/19 1,011,162
● Cigna Commercial T2 3/1/19 7,326,190● Medi-Cal FSS T1 9/1/19 2,400,000
● Florida Medicaid T1 10/1/19 3,500,000
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• SCILEX has built a dedicated field force of 110 highly experienced salesrepresentatives
• Targeting PCPs, pain specialists, and neurologists with this field force
• SCILEX is initially targeting the top plans responsible for most Rxs• Insurance assistance programs will be offered to minimize the co-pay out of
pocket expenses for eligible patients
• Implement a multi-channel marketing approach to raise awareness of Ztlido1.8%, including print, digital, PR and other media
• Robust peer to peer branded product presentations at medical conferences
• SCILEX will leverage a team of MSLs to drive the engagement of physiciansthrough advocacy development with KOLs, data publications & presentations andclinical development planning
Sales
Payer Strategy
Marketing
Medical Affairs
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3. SEMDEXA for Lumbar Radicular (Sciatica) Pain
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Fast Track status granted by FDA
Top-line data expected in 2H 2020
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Potent non-particulate steroid (injectable dexamethasone sodium phosphate gel)
Gel formulation for extended local release and substantial magnitude of pain relief
Well-tolerated. Key viscous excipient, long history of use including safety
Fast acting onset of effect with less spread and safer repeat injections
No preservatives, no surfactants, no particulates. Non-opioid and non-addictive
Pre-filled syringe for epidural use
Projected 24 month shelf life
SEMDEXA Product Features
✔
✔
✔
✔✔
✔
✔
20-80.0%
-60.0%
-40.0%
-20.0%
0.0%
20.0%
0 7 14 21 28 35 42 49 56
Phase 1/2 Open-Label Crossover Study in Patients with Radicular Pain (PK/PD Bridging)Mean change from baseline in pain scores (N=12)
Days following SP-102 injection
SEMDEXA single epidural injection
IV dexamethasone single injection (for PK/PD comparison)
Leg painBack pain
Continued pain reduction over 28 days
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• 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
NPRS: Numeric Pain Rating Scale
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Inclusion
Radicular legpain episode(4-9 NPRS)
MRI confirmed
No prior ESI
No opioids or NSAIDs
Stable, >4 avg NPRS pain in 21d screening
Primary EndpointChange in mean leg pain(NPRS) over first 4 weeks
Secondaries (W2, W4, W8, W12) Leg pain (NPRS, avg & worst pain), disability (ODI), time to repeat injection
(Corticosteroid Lumbar Epidural Analgesia for Radiculopathy)
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SEMDEXA
24Source: “Lumbar Radiculopathy Market Opportunity” Quantitative Research (Nov’17); Cognitive Consulting
SEMDEXA
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The U.S. ESI market is large and is expected to grow as estimated that more than 40% of adults suffer from chronic pain
Sources: http://updates.pain-to pics.o rg/2012/01/harms-o f-epidural-stero id-injectio ns.html?pfstyle=wp, Accessed: Nov 2014,: Manchikanti. Department of Health and Human Services. Office of the Inspector General. http://oig.hhs.gov/oei/reports/oei-05-09-00030.pdf; Opioid Abuse in Chronic Pain — Misconceptions and Mitigation Strategies, Volkow, et al.; NEJM, March 31, 2016.
The use of epidural injections for Lumbar Radiculopathy is being increasingly recognized as an important alternative to opioids, helping to mitigate opioid risks
Lumbar Radicular ESI procedures represent
88% of total ESI procedures.
The U.S. ESI market is large and is
expected to continue to grow as it is
estimated that more than 40% of adults suffer from chronic
pain.
8.9 9.3 9.7 10.1 10.4 10.8 11.2 11.6 12.0 12.4
0
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2011 2012 2013 2014 2015 2016 2017 2018 2019 2020Total ESIs Forecasted ESIs Projected ESIs
Total Projected Epidural Steroid Injection ProceduresNumber of Services (millions)
Estimated Total ESI & Lumbar Radicular ESI (LR ESI)
04,000,0008,000,000
12,000,00016,000,00020,000,000
2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 2026 2027 2028 2029 2030Total ESI Market Size LR ESI Sub-Total
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Important Treatment Attributes SEMDEXA Kenalog (triamcinolone)
Depo-Medrol(methylprednisolone)
Decacron(dexamethasone)
Celestone (betamethasone)
FDA-approved for lumbosacralradicular pain – – – – –
Robust clinical data demonstrating safety and efficacy – – – –
Fast onset of effect in LR with low spread – – – –
Confirmed duration of efficacy – – – –
Reduction in disability in LR – – – –
Safe to administer repeat injections
Minimal risk of neurologic AEs – – –
Novel formulation with prolonged residency time at injection site – – – –
No Surfactants – – – –
No Preservatives – – – –
No Particulates – – –
Prefilled Syringe – – – –
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• 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 privatepayers
• Expect payer reimbursement for SEMDEXA in the office setting through establishment of a Medicare reimbursement code and in the outpatient clinic (OPPS) setting through transitional pass-through payments
• Multiple examples of reimbursed injectables support thesis:
(1) Calculated based on the Medicare Payment Allowances Limits for Medicare Part B Drugs (April 2016) and standard dosing assumptions.
Selected Reimbursed Injectables
Zilretta (triamcinolone
acetonide)
Botox (onabotulinum-
toxinA)
Gel-One (Hyaluronan)
SynviscOne (Hyalurona)
Monovisc (Hyalurona)
Prialt (ziconotide)
Cost (Strength) $566.62 (1u/32mg) $579 (100u) $1,024 (30mg/3ml) $1,184.71 (8mg/7ml) $1,094 (22mg/1ml) $3,527.35(100mcg/1ml)
Indication OA Kneepain Neuromuscular block-various OA kneepain OA kneepain OA kneepain Severe chronicpain
J Code J3490 J0585 J7326 J7325 J73227 J2278
Estimated Reimbursement
per use (1)$500.00 $571.70
(100units) $571.96 $615.79 $934.44
$3,664(17 mcg /
dayfor one month)
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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 Viscous Gel
Full Preclinical & Clinical Package Likely Required by FDA For Alternate Formulation or Steroid
• SEMDEXA Method of Use: US notice of allowance in 2018 (2036 expiry)• SEMDEXA Formulation: Applicationallowed; ex-US major markets pending
• 20-year exclusive supply agreement in place for novel excipient
• Sterile Injectable products typically require clinical trials (not just bioequivalence) for generics approval
• Specialized equipment and know-how for sterile viscous gel products
• 6-9 years @ $50-100M spend, no generic switch
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4. SP-103 for Chronic Low Back Pain
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3x drug load (108 mg vs 36 mg lidocaine)
Triple strength localized dose of lidocaine
Expected same superior adhesion and efficient formulation
Expect to initiate Phase 2 trial in 2H 2019
For the treatment of chronic low back pain –a substantially larger opportunity than PHN
SP-103Next-Generation, 5.4%
Lidocaine Topical System
Superior adhesion and drug formulation efficiency
Safe, convenient, functional pain treatment
Indicated for relief of pain associated with post-herpetic neuralgia (shingles pain)
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34M Adults 18+cLBP Prevalent Patients
16.5M DiagnosedcLBP Prevalent Patients
13.2M Drug-Treated cLBP Patients
>13M drug-treated patients estimated in U.S. for cLBP No currently FDA approved therapies for cLBP
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5. Management and Board
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Name Position(s) Experience
Jaisim Shah Director, CEO
25+ years of senior management experience in the industry
Lead commercialization of multiple blockbusters (Rituxan®, Abilify®, Pegasys®, BuSpar®, Stadol ®, Tequin®, Cardene IV®
CEO, Semnur Pharma; CBO Elevation; CBO PDL BioPharma; VP Bristol-Myers, Dir Roche
Suresh Khemani SVP, Commercial
25+ years of senior management experience in the industry
Senior management positions at BMS, Chiron, PDL, Knopp Bioscience
Board member of Full Spectrum Genetics, an antibody technology company
Dmitri Lissin, MD SVP, Chief Medical officer 20+ years in clinical development in pain & CNS diseases VP Clinical, Xenoport; VP Clinical, Durect
Suketu Desai, Ph.D. SVP, Chief Technical Officer 25+ years in manufacturing / CMC, with expertise in viscous solution products VP Manufacturing / CMC, Allergan; VP Cephalon / Teva, Johnson & Johnson
Michael Faerm Chief Business Officer,Interim Chief Financial Officer
20+ years in Biopharma Equity Research, Investment Banking, and Corporate Development CBO Innoviva, Senior Analyst, Equity Research Wells Fargo, Credit Suisse, Business Dev Forest Labs
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Name Position(s) 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 CEO of Semnur & Scilex Pharmaceuticals, Board Director Sorrento, Celularity, Scilex
CBO Elevation Pharmaceuticals, Facet Biotech, PDL BioPharma, VP BMS & Dir Roche
Alex Wu, Ph.D. Director Ex- President & CEO of Crown Bioscience International
Former Head of Asian Activities for Burrill & Company
Kenji Hakoda Director Pharmaceutical Division Director and Chief Operating Officer at Itochu Chemical Frontier Corp.
20+ years of management experience
Mahendra Shah, Ph.D. Director 30+ years mgmt. experience as founder and executive officer of numerous biotechnology companies
Managing Director, ViVo Capital
Brent Ahrens, M.A. Director General Partner, Canaan Partners
25+ years of experience in the industry
Scott Whitcup, M.D. Director Founder and CEO Akrivista and Whitecap Biosciences
Former EVP R&D, Allergan; Clinical Director of National Eye Institute of the NIH
Elizabeth Czerepak Director CFO and CBO of Genevant Sciences; director of Spectrum Pharmaceuticals
Former CFO/EVP Corp Dev of Altimmune; CFO/CBO of Isarna Therapeutics; CFO of Cancer Genetics