© 2014 SCILEX Pharmaceuticals, Inc. All Rights Reserved.
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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.
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Focus on the development and commercialization of late-stage products for the treatment of pain (100+ million
Americans have chronic pain)
Particular focus on high barrier to entry products such as transdermals ($32 Billion U.S. Market in 2015)*
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 post-herpetic neuralgia, or 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 $1.45 billion in U.S. sales in 2013**; potential launch is 2H 2015
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(TM) Ztlido IS A TRADEMARK OF SCILEX. All other trademarks are the property of their respective owners.
* http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2995530/
** IMS 2014
Anthony Mack
Chief Executive Officer
MANAGEMENT TEAM
• Experienced pharmaceutical executive who has driven the successful commercialization of leading pain products
• 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 financial transactions
• 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
Richard Cohen
Chief Financial Officer
• Past President and Member of the Board of
CorMedix Inc.
• Former Member of the Board of Dune Energy Inc.
• Past Director and Chairman of the Audit
Committee of Rodman and Renshaw
Eric Floyd, PhD
Jerrold Sendrow
BOARD OF DIRECTORS
• VP, Global Regulatory Affairs
• H. Lundbeck AS (current)
• PhD, Neurophysiology
• CFO & Director, 800 Travel Systems (past)
• VP-Finance, Columbia Travel Group (past)
SCIENTIFIC ADVISORY BOARD
Jeffrey Gudin, MD
Anesthesiologist, Pain Specialist
Charles Argoff, MD
Neurologist, Pain Specialist
Srinivas Nalamachu, MD
Internal Medicine, Pain Specialist
Kip Vought
Regulatory and Strategic
Development Consultant
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September, 2013 :
-Pilot PK study demonstrates evidence of bioequivalence to Lidoderm®
April, 2013:
-Acquired Latin American Rights to Ztlido ™
February, 2013 :
-Commercial rights to Lidocaine transdermal tape (Ztlido™) for US and Canada
July, 2012 :
-SCILEX held its first of three strategic meetings with its
Japanese Partner
April, 2012 :
-FDA concurrence on 505(b)( 2 )
2012
™
Q1, 2015:
-NDA Filing
Q3, 2014:
-Potential Initial Public Offering
-Commenced dermal safety studies of its Ztlido™
Q2, 2014
-Pivotal Study (May)
SCILEX™ Pharmaceuticals
Launched
Q1, 2014 :
-IND filing (Feb)
Ztlido™ IS A TRADEMARK OF SCILEX
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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.
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Introducing….
The Z ero H
2
O T ransdermal
L idocaine Patch
Potential Benefits:
• Superior Adhesiveness
• Better pliability & flexibility
• ZTL 1.8% (36 mg lidocaine) delivers equivalent analgesic intensity as
Lidoderm 5% (700 mg lidocaine)
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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
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WITH A POTENTIAL 10
MONTH REVIEW PROCESS
FOR 505(B)(2):
ZTLIDO™ COULD BE
APPROVED BY H2, 2015
R&D Budget and FDA Expense
Initial formulation with stability
Pilot PK study
Second Pilot PK Study
Pre IND meeting correspondence
Stability batch
MiniPig Toxicity Study
Third Pilot PK Study
IND Submission (Clinipace)
Pivotal PK Study
Photoallergy/Phototoxicity Studies
Heat Overlay Study
Irritation/Sensitization Study
Final Audited Reports Due
NDA Submission
Status/ Completion
Completed
Completed
Completed
Completed (April 2012)
Started Nov. 2012
Completed
Completed
Completed
Completed
Completed
Completed
Completed
November 2014
Expected 1Q 2015
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Product
Lidocaine loading dose per patch vs. Ztlido™ potential loading dose
Titration
Lidoderm® (Lidocaine Patch
5%) Hydrogel Patch
Ztlido™ 1.8%
Ztlido `3.6%
Ztlido `5.4%
700 mg
36 mg
72 mg
108 mg
No
Yes
Yes
Ztlido™ has the potential to gain regulatory approval for applications for the treatment of pain associated with PHN. Multiple strengths would enable clinicians to adjust the dosage, hence, the patient’s therapy may be individualized.
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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, antidepressants
Opioids
Neural stimulation
Nerve blocking agents (local anesthetics, steroids, anti-inflammatory, etc)
Surgery (vertebroplasty, kyphoplasty)
* http://www.ninds.nih.gov/disorders/backpain/detail_backpain.htm
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Ztlido™1.8%
(36 mg lidocaine)
Ztlido 3.6%/5.4%
(72/108 mg lidocaine)
Myofascial syndrome
(low back pain)
Regulatory Pilot PK Phase 1 Phase 2 Phase 3
505(b)(2) Bio-equivalence to Lidoderm 5%
For the treatment of pain associated with
PHN
Pre-IND Discussion (H2, 2014)
For the treatment of pain associated with PHN
Pivotal BE
Study
Started
May, 2014
Pre-IND Discussion (H1, 2015)
NDA
Q1
2015
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Focus on the development and commercialization of late-stage products for the treatment of pain (100+ million
Americans have chronic pain)
Particular focus on high barrier to entry products such as transdermals ($32 Billion U.S. Market in 2015)*
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 post-herpetic neuralgia, or 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 $1.45 billion in U.S. sales in 2013**; potential launch is 2H 2015
15
(TM) Ztlido IS A TRADEMARK OF SCILEX. All other trademarks are the property of their respective owners.
* http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2995530/
** IMS 2014
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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
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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
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