CORPORATE PRESENTATION - SCILEX Pharmaceuticals

Report
CORPORATE PRESENTATION
ANTHONY MACK, PRESIDENT & CEO
WILLIAM PEDRANTI, COO
© 2014 SCILEX Pharmaceuticals, Inc. All Rights Reserved.
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
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SCILEX INVESTMENT HIGHLIGHTS
 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
3
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
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, MD
•
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
Charles Argoff, MD
Srinivas Nalamachu, MD
Kip Vought
Anesthesiologist, Pain Specialist
Neurologist, Pain Specialist
Internal Medicine, Pain Specialist
Regulatory and Strategic
Development Consultant
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COMPANY MILESTONES
September 2013:
-Pilot PK study demonstrates potential of
establishing bioequivalence to Lidoderm®
April 2013:
-Acquired Latin American Commercial 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
ZTlido™
Targeted
Launch
Q1 2016
2016
Q1 2015:
-Targeted NDA Filing
Q3 2014:
-Completed dermal safety
studies
-Completed all clinical studies
May 2014:
-Initiated Pivotal Study
February 2014:
-IND filing
SCILEX™ Pharmaceuticals
Launched
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ZTlido™ IS A TRADEMARK OF SCILEX
THE TRANSDERMAL MARKET FOR PAIN
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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.
TRANSDERMAL MARKET OUTLOOK
High barriers to entry make this
market attractive for branded
drugs with novel delivery
systems despite generics.
Source: Medtrack, September 2013, Copyright Informa UK; company websites
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The Zero H2O Transdermal
Lidocaine Tape (ZTL)
ZTlido™ will seek to capitalize on the Billion Dollar
market created by Lidoderm®
CONFIDENTIAL - DO NOT COPY OR DISTRIBUTE
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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
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Clinical Development
Regulatory Status
10
Projected
timeline to
approval
R&D Milestone
Initial formulation with stability
Completed
Small scale batch
Completed
Pilot PK study
Completed
Second Pilot PK Study
Completed
Pre IND meeting correspondence
Stability batch
WITH A POTENTIAL 6 TO 10
MONTH REVIEW PROCESS
FOR 505(B)(2):
ZTLIDO COULD BE
APPROVED AND
LAUNCHED BY Q1, 2016
Status/ Completion
Completed (April 2012)
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
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Potential Future Targeted
Indications*
ZTlido™ LIFE CYCLE MANAGEMENT
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*Will require FDA approval
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
ZTlido1.8%
(36 mg lidocaine)
505(b)(2) Bio-equivalence to Lidoderm 5%
For the relief of pain associated with PHN
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)
Phase 3
NDA
All studies
completed*
Targeting
Q1
2015
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*Final clinical study reports are expected by December 31, 2014
Potential Line Extensions Offer Dosing Flexibility
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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FOUNDATION OF SUCCESSFUL COLLABORATIONS
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 Advisors
Past President and Member of the Board of CorMedix Inc.
Past Director and Chairman of the Audit Committee of Rodman and Renshaw
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FOUNDATION OF SUCCESSFUL COLLABORATIONS
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
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SCILEX INVESTMENT HIGHLIGHTS
 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
(TM) ZTlido IS A TRADEMARK OF SCILEX. All other trademarks are the property of their respective
owners.
*IMS 2014
18
Contact Information
For additional information please contact:
William Pedranti
SCILEX Pharmaceuticals, Inc.
101 Lindenwood Drive, Suite 225
Malvern, PA 19355
Cell: 949-413-2672
Office: 484-875-3032
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