corporate presentation anthony mack, president & ceo william pedranti, coo © 2014 scilex...
TRANSCRIPT
CORPORATE PRESENTATION
ANTHONY MACK, PRESIDENT & CEO
WILLIAM PEDRANTI, COO© 2014 SCILEX Pharmaceuticals, Inc. All Rights Reserved.
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FORWARD LOOKING STATEMENTS
Certain statements contained herein may constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements by the Company are based on current expectations, estimates and projections about the Company's product, management's beliefs and certain assumptions made by management. Readers are cautioned that any such 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 by such forward-looking statements. Given these uncertainties, readers are cautioned not to place undue reliance on such forward-looking statements. Unless otherwise required by law, the Company also disclaims any obligation to update its view of any such risks or uncertainties or to announce publicly the result of any revisions to the forward-looking statements made here.
THIS DOCUMENT CONTAINS PROPRIETARY INFORMATION THAT IS THE PROPERTY OF THE COMPANY. NEITHER THIS DOCUMENT, NOR THE PROPRIETARY INFORMATION CONTAINED HEREIN, SHALL BE PUBLISHED, REPRODUCED, COPIED, DISCLOSED OR USED FOR ANY OTHER PURPOSE, OTHER THAN THE REVIEW AND CONSIDERATION OF THIS DOCUMENT.
This presentation is intended solely for investors that are accredited investors under U.S. Securities and Exchange Commission rules. This presentation is not an offer, nor the solicitation of an offer, to buy any securities. An investment in Scilex’s securities involves a high degree of risk. Before any potential investor invests in Scilex’s securities, the investor should review the private placement memorandum relating to this financing which contains more complete information about Scilex and this financing, including risks relating to any such investment. The terms of any such investment will be governed by the definitive documentation evidencing such investment.
CONFIDENTIAL - DO NOT COPY OR DISTRIBUTE
Focus on the development and commercialization of late-stage products for the treatment of pain (100+ million Americans have chronic pain) Our First product Ztlido™ is being developed for the treatment of pain associated with post-herpetic neuralgia or PHN
Strong Management Team with experience marketing multiple pain products (Lidoderm®, OxyContin®)
ZTlido™ (lidocaine patch 1.8%), is a branded, fourth-generation transdermal lidocaine patch formulated for the treatment of the pain associated with PHN, a chronic, painful condition that may follow a shingles infection
The FDA concurred that a single powered bioequivalence study of ZTlido™ vs. Lidoderm® would be sufficient for submission of ZTlido™ under Section 505(b)(2)
ZTlido™ has potential superior qualities to Lidoderm-a product (branded and generic) that generated over a billion
dollars in U.S. sales in 2013*; targeted launch is Q1 2016
(TM) ZTlido IS A TRADEMARK OF SCILEX. All other trademarks are the property of their respective owners.* IMS 2014
SCILEX INVESTMENT HIGHLIGHTS
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WE KNOW PAIN & TRANSDERMALS
SENIOR MANAGAGEMENT
Anthony Mack Chief Executive Officer
• Experienced pharmaceutical executive who has driven the successful commercialization of leading pain products (OxyContin, Lidoderm Opana ER))
• Held management positions with Purdue Pharma, Endo Pharmaceuticals, Novartis and EKR Therapeutics
• President and Founder of ProSolus Pharmaceuticals
• M.B.A. in Pharmaceutical and Healthcare Marketing and B.S. in Business Management
• More than 20 years of industry experience
William Pedranti Chief Operating Officer
• Helped raise over $200 MM through capital transactions for Spectrum Pharmaceuticals
• Over a decade of experience as legal counsel and senior executive for pharmaceutical and biotech
• Past Vice-President and General Counsel for Spectrum Pharmaceuticals. Provided corporate, transactional, regulatory and M&A advice to companies at Latham and Watkins, LLP
INDEPENDENT DIRECTORS
Eric Floyd, PhD
• VP, Global Regulatory Affairs • H. Lundbeck AS (current)• PhD, Neurophysiology
Jerrold Sendrow
• CFO & Director, 800 Travel Systems (past)• VP-Finance, Columbia Travel Group (past)
SCIENTIFIC ADVISORY BOARD
Jeffrey Gudin, MDAnesthesiologist, Pain Specialist
Charles Argoff, MD Neurologist, Pain Specialist
Srinivas Nalamachu, MD
Internal Medicine, Pain Specialist
Kip Vought Regulatory and Strategic Development Consultant
2012
2016September 2013:-Pilot PK study demonstrates potential of establishing bioequivalence to Lidoderm®
SCILEX™ Pharmaceuticals Launched
July 2012:-SCILEX held its first of three strategic meetings with its Japanese Partner
February 2013: -Commercial rights to Lidocaine transdermal tape (ZTlido™) for US and Canada
February 2014:-IND filing
Q1 2015: -Targeted NDA Filing
April 2012:
-FDA concurrence on 505(b)(2)
ZTlido™ Targete
d Launch
Q1 2016
COMPANY MILESTONES
ZTlido™ IS A TRADEMARK OF SCILEX
May 2014:-Initiated Pivotal Study
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Q3 2014: -Completed dermal safety studies -Completed all clinical studies
April 2013:-Acquired Latin American Commercial Rights to ZTlido™
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THE TRANSDERMAL MARKET FOR PAIN
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Source: Medtrack, September 2013, Copyright Informa UK; company websites
The transdermal drug delivery market is set to grow from $21 Billion in 2010 to $32 Billion by 2015. *
Pain is the largest segment in the pipeline of transdermal drugs under development.
High barriers to entry make this market attractive for branded drugs with novel delivery systems despite generics.
TRANSDERMAL MARKET OUTLOOK
ZTlido™ will seek to capitalize on the Billion Dollar market created by Lidoderm®
ZTlido 1.8%LIDOCAINE (36 MG) TRANSDERMAL TAPE
The Zero H2O Transdermal Lidocaine Tape (ZTL)
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ZTlido’s ATTRIBUTES MAKE IT POTENTIAL BEST IN CLASS FOR THE TREATMENT OF PAIN ASSOCIATED WITH PHN
36 mg lidocaine vs. 700 mg lidocaine for Lidoderm®
Less active ingredient perceived to be safer by physician
FDA concerned with disposal of used Lidoderm patches
Approximately half the manufacturing cost due to no water content
Potential to load ZTlido™ with higher lidocaine doses for maximum performance
Superior adhesiveness
Better compliance (concerns about Lidoderm® patches falling off)
Potential for indication expansion e.g. low-back pain
Superior adhesion and pliability has potential to expand market
Top prescriber survey suggests potential uses in active joints such as wrists, knees, ankles and neck
Generics (Hydrogels -Lidoderm®) cannot compete
Clinical Development Regulatory Status
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Projected timeline to approval
R&D Milestone Status/ Completion
Initial formulation with stability Completed
Small scale batch Completed
Pilot PK study Completed
Second Pilot PK Study Completed
Pre IND meeting correspondence Completed (April 2012)
Stability batch Started Nov. 2012
MiniPig Toxicity Study Completed
Third round Pilot PK Study Completed
IND Submission (Clinipace) Completed
Pivotal PK Study Completed
Photoallergy/Phototoxicity Studies Completed
Heat Overlay Study Completed
Irritation/Sensitization Study Completed
Final Clinical Study Reports December 31
NDA Submission Targeted 1Q 2015
WITH A POTENTIAL 6 TO 10 MONTH REVIEW PROCESS FOR 505(B)(2):
ZTLIDO COULD BE APPROVED AND LAUNCHED BY Q1, 2016
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Potential Future Targeted Indications*
ZTlido™ LIFE CYCLE MANAGEMENT
*Will require FDA approval
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Targeted Indication for Lifecycle Management Low Back Pain
Over 31 MM cases per year
>$50 Billion annual spent*
No. 1 cause of disability
Mostly mechanical in nature
Various treatment options: OTC medications, anti-convulsants, anti-depressants
Opioids
Neural stimulation
Nerve blocking agents (local anesthetics, steroids, anti-inflammatory, etc)
Surgery (vertebroplasty, kyphoplasty)
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POTENTIAL ZTLIDO PRODUCT PIPELINE
Regulatory Pilot PK
Phase 1
Phase 2
Phase 3 NDA
ZTlido1.8% (36 mg lidocaine)
505(b)(2) Bio-equivalence to Lidoderm 5%For the relief of pain associated with PHN
All studies completed*
Targeting Q1
2015
ZTlido 3.6%/5.4% (72/108 mg lidocaine)
Pre-IND Discussion (1H, 2015)For the relief of pain associated with PHN
Myofascial syndrome (low back pain) Pre-IND Discussion (1H, 2015)
*Final clinical study reports are expected by December 31, 2014
Potential Line Extensions Offer Dosing Flexibility
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Product Lidocaine loading
dose per patch Potential Titration
Lidoderm® (5% Hydrogel Patch) 700 mg No
ZTlido 1.8% 36 mg Yes
ZTlido ~3.6% ~72 mg Yes
ZTlido ~5.4% ~108 mg
ZTlido line extension patches can be developed for indications beyond shingles.
Line extensions allow clinicians to individualize therapy.
CONFIDENTIAL - DO NOT COPY OR DISTRIBUTE
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SCILEX™ has relationships with leading companies in their respective fields:
Japanese Research Development and Manufacturing Partner Founded in 1907
Japanese pharmaceutical research, development and manufacturing partners
Transdermal manufacturer sells to large pharma
David Rosen, Partner at Foley & Lardner LLP
Handled the pre-IND meeting correspondence with FDA
Previously worked at FDA over 10 years
Chaired 505(b)(2) initiative
Dr. Jeff Gudin, Pain Consultant
Director, Pain Management and Palliative Care, Englewood Hospital and Medical Center
President, Medical Education Consultants
Yale University School of Medicine, Fellow, Pain Management, 1996 – 1997
Richard Cohen, Chord Financial AdvisorsPast President and Member of the Board of CorMedix Inc.
Past Director and Chairman of the Audit Committee of Rodman and Renshaw
FOUNDATION OF SUCCESSFUL COLLABORATIONS
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SCILEX™ has relationships with leading companies in their respective fields:
Ken Smith, Ph.D. (IP Counsel)
Previously, Chief IP Counsel for Alpharma
VP of Intellectual Property for Sanofi-Aventis
Beckloff Associates/Cardinal Health (Manufacturing Audit)
Conducted Manufacturing Audit of Japanese Partner
cGMP Audit and Consulting
Clinipace Worldwide (CRO)
Regulatory, Pre-Clinical and Clinical
Preparing the IND; CRO chosen for ZTlido™
BDO USA LLP
Auditor
InVentiv Health Commercial Sales and Marketing Optimization Strategist
FOUNDATION OF SUCCESSFUL COLLABORATIONS
Focus on the development and commercialization of late-stage products for the treatment of pain (100+ million Americans have chronic pain). Our First product ZTlido™ will focus on the treatment of pain associated with PHN.
Strong Management Team with experience marketing multiple pain products (Lidoderm®, OxyContin®)
ZTlido™ (lidocaine patch 1.8%), is a branded, fourth-generation transdermal lidocaine patch formulated for the treatment of the pain associated with PHN, a chronic, painful condition that may follow a shingles infection
The FDA concurred that a single powered bioequivalence study of ZTlido™ vs. Lidoderm® would be sufficient for submission of ZTlido™ under Section 505(b)(2)
ZTlido™ has potential superior qualities to Lidoderm-a product (branded and generic) that generated over a billion dollars in U.S. sales in 2013*; targeted launch is Q1 2016
*IMS 2014
(TM) ZTlido IS A TRADEMARK OF SCILEX. All other trademarks are the property of their respective owners.
SCILEX INVESTMENT HIGHLIGHTS
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Contact Information
For additional information please contact:
William PedrantiSCILEX Pharmaceuticals, Inc.
101 Lindenwood Drive, Suite 225Malvern, PA 19355Cell: 949-413-2672
Office: 484-875-3032