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1 Scilex Pharmaceuticals Non-Opioid Pain Therapeutics October 2019

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Page 1: Scilex Pharmaceuticals - Sorrento Therapeutics

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Scilex Pharmaceuticals

Non-Opioid Pain Therapeutics

October 2019

Page 2: Scilex Pharmaceuticals - Sorrento Therapeutics

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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.

Page 3: Scilex Pharmaceuticals - Sorrento Therapeutics

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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

Page 4: Scilex Pharmaceuticals - Sorrento Therapeutics

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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

Page 8: Scilex Pharmaceuticals - Sorrento Therapeutics

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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

Page 10: Scilex Pharmaceuticals - Sorrento Therapeutics

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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%

4.4%

0%

2%

4%

6%

8%

10%

12%

2018

/10/

05

2018

/10/

12

2018

/10/

19

2018

/10/

26

2018

/11/

02

2018

/11/

09

2018

/11/

16

2018

/11/

23

2018

/11/

30

2018

/12/

07

2018

/12/

14

2018

/12/

21

2018

/12/

28

2019

/01/

04

2019

/01/

11

2019

/01/

18

2019

/01/

25

2019

/02/

01

2019

/02/

08

2019

/02/

15

2019

/02/

22

2019

/03/

01

2019

/03/

08

2019

/03/

15

2019

/03/

22

2019

/03/

29

2019

/04/

05

2019

/04/

12

2019

/04/

19

2019

/04/

26

2019

/05/

03

2019

/05/

10

2019

/05/

17

2019

/05/

24

2019

/05/

31

2019

/06/

07

2019

/06/

14

2019

/06/

21

2019

/06/

28

2019

/07/

05

2019

/07/

12

2019

/07/

19

2019

/07/

26

2019

/08/

02

2019

/08/

09

2019

/08/

16

2019

/08/

23

2019

/08/

30

2019

/09/

06

2019

/09/

13

2019

/09/

20

TRx

Shar

e

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

✔✔

Page 20: Scilex Pharmaceuticals - Sorrento Therapeutics

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)

Page 23: Scilex Pharmaceuticals - Sorrento Therapeutics

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SEMDEXA

Page 24: Scilex Pharmaceuticals - Sorrento Therapeutics

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

5

10

15

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