anavex corporate presentation
DESCRIPTION
Anavex, entrering clinical trials in Alzheimer and cancerTRANSCRIPT
October 2009October 2009
Slide: 2
Anavex Life Sciences Corp.Disclaimer
The Presentation has been prepared by Anavex Life Sciences Corp. using its best efforts to realistically and factually present the information contained. However, subjective opinion, dependence upon factors outside Anavex Life Sciences Corp.’s control and outside information sources unavoidably dictate that Anavex Life Sciences Corp. cannot warrant the information contained to be exhaustive, complete or sufficient. In addition, many factors can affect us which could significantly alter the results intended by Anavex Life Sciences Corp., rendering the information/ projections in the Presentation unattainable or substantially altered. Therefore, interested Users should conduct their own assessment and consult with their own professional advisors prior to making any investment decisions.
This Presentation does not constitute a prospectus or public offering for financing, and no guarantees are made or implied with regard to the success of Anavex Life Sciences Corp.’s proposed ventures. The Presentation is being disclosed to User for User’s discussion, review, and/or evaluation only. User also agrees not to trade in the securities of Anavex Life Sciences Corp. while in possession of any material information about Anavex Life Sciences Corp. that has not been publicly disclosed.
User agrees to hold the Presentation, and all related information and discussions, in strict confidence, except that User may disclose the Presentation to a limited number of advisors and employees of the User to the extent necessary for User to adequately evaluate the Presentation. User warrants that any such employee shall be advised of the confidential nature of the Presentation before gaining access to the same and that no such advisor or employee shall use or disclose the Presentation except as specifically permitted by this Disclaimer.
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Anavex History SummaryAnavex History Summary
σ Current pipeline of products developed over seven-years via research collaborations involving
Alexandre Vamvakides, PhD and other worldwide leaders in Sigma Receptors
σ Focus on treatments for Alzheimer’s Disease and Cancer
σ Reverse merger into OTCBB company January 2007
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Biopharmaceutical Industry SummaryBiopharmaceutical Industry Summary
σ The global pharmaceutical market grew to US $ 712 billion in 2007 at a compound annual growth rate (CAGR) of 10.0% between 1999 and 2007.
σ The leading therapy area by sales was the Central Nervous System (CNS) with 16.5% share.
σ According to URCH Publishing, the global pharmaceutical market is forecasted to grow to $ 929 billion in 2012, an equivalent compound annual growth rate (CAGR) of 5.5% over the next 5-years.
σ In addition to the revenues’ rapid growth, drug companies have enjoyed extremely high returns on investment capital in recent years as well as a favourable company survivorship rate compared with many other industries.
σ According to IMS (Global healthcare advisor), annual sales for drugs that combat Alzheimer’s disease are projected to reach US$8 billion by 2012.
Four of the seven Product Candidates Anavex have developed address diseases of the CNS with its lead candidate an Alzheimer's compoundAnavex 2-73 soon to go into Human Clinical Trials
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Company HighlightsCompany Highlightsσ Anavex Life Sciences Corp. (www.anavex.com) is an emerging Biopharmaceutical Company. It is a
global Company with headquarters in Geneva, Switzerland. It is engaged in the discovery and development of novel drugs which target the treatment of Cancer and Neurological Diseases of the Central Nervous System (CNS), such as Alzheimer's, Epilepsy and Depression.
σ Anavex have a Scientific Advisory Board of world-renowned experts, a highly skilled Management Team and an International Board of Directors.
σ Anavex has 7 product candidates in development for 8 disease indications. One of the products is in IND stage and six of them in Preclinical stage. The Company’s target is to launch Human Clinical Trials for 4 of its compounds (Alzheimer’s, Melanoma, Prostate and Epilepsy) by the beginning of 2010, while the other compounds will follow up.
σ When comparing data with the world’s leading Alzheimer’s drug Donepezil (Eisai/Pfizer), Donepezil was active at a dose of 0.5mg/kg at least, Anavex 2-73 was fully active at 0.3 mg/kg and sometimes (for some aspects) even at 0.1 mg/kg. The lower dosage logically leads to lower toxicity indication. This finding alone makes Anavex 2-73, a strong candidate for Human Clinical Trials for Alzheimer's Disease.
σ The Company has International Patents on all of its Product Candidates and has 35 new compounds in the early Pre-clinical stage of development. International Patents will be obtained for these as well as updates to Patents for existing product candidates.
σ Potential sales of the Company’s products after launch are estimated at US$6 billion.
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Sigmaceptor Platform: Anavex Product CandidatesSigmaceptor Platform: Anavex Product Candidates
Seven Anavex Product Candidates
ANAVEX 3-97 MELANOMA
ANAVEX 7-1037 PROSTATE
ANAVEX 22-1068 PANCREAS
ANAVEX 2-73 ALZHEIMERS / DIABETES
ANAVEX19-144 EPILEPSY
ANAVEX 1-41 ALZHEIMERS / DEPRESSION
ANAVEX 10-90 NEUROPATHIC PAIN
ANAVEX's SIGMACEPTOR(TM)-N program involves the development of novel drugs that target NEUROLOGICAL AND NEURODEGENERATIVE DISEASES, such as Alzheimer's disease, epilepsy, depression, pain and neuropathic pain. The company's lead candidates have shown strong evidence for anti-amnesic and neuroprotective properties in studies conducted to date. ANAVEX believes that mitochondrial dysfunction can be modulated via SIGMA RECEPTORS, a unique class of receptor molecules, to guard against oxidative stress.
ANAVEX's SIGMACEPTOR(TM)-C program involves the development of novel drugs targeting CANCER. The company's lead candidates have shown strong evidence for selective pro-apoptotic, anti-metastatic and low toxicity properties in various types of solid cancers. ANAVEX 7-1037 has already demonstrated its ability to significantly delay the growth of cancerous tumours in patient-derived xenografts during advanced pre-clinical studies.
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ANAVEX CURRENT PIPELINE PORTFOLIO PROSPECTSDevelopment Timeline and Costs 2009 - 2013
Anavex’s Total Estimated Annual R&D Costs (in US$ million)
142.662.54424.58.82.8Total R&D Costs
Total20132012201120102009 Year
Phase IIIND / Phase I / II Pre-clinical PreclinicalPre-clinicalANAVEX 10-90 Pain
Phase IIPhase IIPhase IINDPre-clinicalANAVEX 1-41 Depression
Phase II / IIIPhase IIPhase IINDPre-clinicalANAVEX 1-41 Alzheimer’s
Phase II / IIIPhase IIPhase IIND / Phase 1Pre-clinicalANAVEX 19-144 Epilepsy
Phase IIIND / Phase I / II Pre-clinical Pre-ClinicalPre-clinicalANAVEX 2-73 Diabetic Degenerations
Phase IIIPhase II / IIIPhase IIPhase I IND ANAVEX 2-73 Alzheimer’s
Phase IIIPhase II / IIIPhase I / IIPhase IPre-clinicalANAVEX 22-1068 Cancer (Indic. Pancreas)
Phase IIIPhase II / IIIPhase I / IIPhase IPre-clinical ANAVEX 7-1037 Cancer (Indic. Prostate)
Phase IIIPhase IIIPhase II / IIIPhase IIPre-clinical ANAVEX 3-97 Cancer (Indic. Melanoma)
20132012201120102009
YEARCOMPUND
Funding Requirements and Use Of Proceeds Breakdown To September 2010
Anavex Requires USD$ 10.0 mil to move four of its product candidates into Phase I and one of its candidates into Phase II of development by September 2010. Of the USD$10.0 mil, 2.0 mil will be used for listing on the AMEX stock exchange and for general administration and development costs.
The Company’s target is to launch Human Clinical Trials for four of its compounds (Alzheimer's Disease, Melanoma, Prostate Cancer and Epilepsy) by the beginning of 2010 while other compounds will follow.
SEPTEMBER 2009
PRE-IND in ALZHEIMER
PRE-IND in CANCER and EPILEPSY
No PARTNERSHIP
SEPTEMBER 2010
Phase I in ALZHEIMER
Phase II in CANCER (Melanoma) and
IND / Phase I EPILEPSY
1 PARTNERSHIP (outside Alzheimer)
SEPTEMBER 2011
Phase II in ALZHEIMER
Phase II / III in CANCER (Melanoma) and Phase I in EPILEPSY
1 PARTNERSHIP in ALZHEIMER and 2 PARTNERSHIPS outside ALZHEIMER
OTCBB Listing AMEX Listing NASDAQ Listing (current)
Business Objectives over 24-Months Sep. 2009-2011
Projected Anavex Post-Launch Turnover Breakdown 2015-2020
Compound DiseaseCurrent
Stage (2009) Sales Launch
Total Patients
2009 (,000) CAGR %
Total Patients At
Market Time(,000)
Initial Market Share
Com
pliance
Complied Market Share
Final No. Of
Expected Patients Per-Year
(,000)
Yearly Therapy Cost ($)
Projected Yearly Sales
After Launch in USD$,000
ANAVEX 3-97Cancer
MELANOMA Pre-Clinical 01/01/2016 630 5.00% 886 20.0% 50% 10.00% 88.6 5,000 443,237
ANAVEX 7-1037Cancer
PROSTATE Pre-Clinical 01/01/2018 2,200 1.55% 2,527 12.5% 65% 8.13% 205.3 3,000 615,867
ANAVEX 22-1068Cancer
PANCREAS Pre-Clinical 01/01/2015 180 3.00% 215 12.5% 50% 6.25% 13.4 18,000 241,796
ANAVEX 2-73 (Back-up ANAVEX 1-41) Alzheimer's IND 01/01/2017 17,000 3.23% 21,916 10.0% 50% 5.00% 1,095.8 1,600 1,753,282
ANAVEX 2-73Diabetic
Degeneration Pre-Clinical 01/01/2019 750 15.00% 3,034 20.0% 60% 12.00% 364.1 600 218,460
ANAVEX 19-144 Epilepsy Pre-Clinical 01/01/2018 6,300 0.71% 6,714 13.0% 80% 10.40% 698.3 1,200 837,931
ANAVEX 1-41 Depression Pre-Clinical 01/01/2019 88,000 1.90% 106,224 3.0% 60% 1.80% 1,912.0 600 1,147,224
ANAVEX 10-90Neuropathic
Pain Pre-Clinical 01/01/2020 160,000 1.40% 186,439 2.0% 50% 1.00% 1,864.4 400 745,757
Totals 275,060 327,956 6,242.0 6,003,553
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Alzheimer’s Disease
σ Currently 28 million patients worldwide, with another person afflicted every minute
σ By 2050 1 in 85 persons worldwide will be living with the disease
σ Four currently marketed meds all off patent within five-years
σ Alzheimer’s Disease is a ‘must-invest’ area for Big-Pharma
σ Only three early-stage, pure-play candidates available for Big-Pharma licensing
σ Competitive environment remarkably favorable for ANAVEX
σ Most other programs target mechanisms of action recently invalidated like anti-amyloid
1. Aricept (donepezil hydrochloride) Eisai and co-marketed with Pfizer
2. Exelon (rivastigmine) Novartis Pharmaceuticals
3. Reminyl (galantamine)
Co-developed by Shire Pharmaceuticals and the Janssen Research Foundation
4. Ebixa (memantine) Merz and marketed in Europe by Lundbeck
Company name Symbol Financing JV StatusMode of Action Phase date
Vitae Pharmaceuticals Private Upfront $ 42mMilestones $ 242m
Boehringer Ingelheim
Beta-secretase inhibitors
Pre-clinical 15/06/2009
Medivation MDVN Upfront $ 225mMilestones $ 725m
Pfizer Dimebon, mitochondrial effect
II/III 03/09/2008
Co-Mentis (formerly Athenagen)
Private Upfront $ 100mMilestones $ 760m
Astellas Beta-secretase inhibitors and
nicotinic receptor agonists
I+
discovery
25/04/2008
Neurimmune Therapeutics
Private $ 380m Biogen Idec Antibodies R&D 20/11/2007
EPIX Pharmaceuticals EPIX Upfront $ 35m Milestones $ 1200m
GlaxoSK plc 5 HTA partial agonist program
Discovery 12/12/2006
Idera Pharmaceuticals IDP Upfront 30m Milestones $ 366m
Merck & Co Toll-like receptor agonists
I 11/12/2006
AC Immune Private $ 300m Genentech Anti beta amyloid antibodies
preclinical 06/12/2006
Co-development Deals In Alzheimer’s Disease Are Large Co-development Deals In Alzheimer’s Disease Are Large Anavex In Talks To Reach That GoalAnavex In Talks To Reach That Goal
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A Competitor’s Historical Share Price ChartA Competitor’s Historical Share Price ChartMedivation (MDVN: NASDAQ) is in Phase III Clinical Trials with its Alzheimer’s Drug, Dimebon (JV with Pfizer). The Chart below shows the spike in 2008 when it was still in Phase II, before the worldwide market crash. It traded at an all-time high of USD$ 33.80 on September 5th, 2008. Recovery from the crash has been steady with the Company closing at USD$27.63 October 8th.
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Anavex’s Rich Oncology PipelineAnavex’s Rich Oncology Pipeline
σ Oncology (cancer) is a fast growing US$ 8bn market
σ ANAVEX should have 3 compounds in the clinics and ready to
partner in 18 months
σ One compound could advance directly into Phase II
σ ANAVEX will become an active target for Big Pharma:
• Phase I or II data with novel compounds
• Platform for further productivity in a new mechanism of action
Company Name Stage Market CapTherapeutic
Area
Anavex Pre-IND $ 52m Oncology, CNS, Alzheimer’s Disease
Alnylam Phase II $ 928m Oncology, others
Ardea Phase II $ 295m Oncology, Gout, HIV
Arqule Phase II $ 280m Oncology
Array Phase II $ 175m Oncology, inflammation, metabolism
Celldex Phase II $ 124m Oncology, infectious disease
Dendreon Phase II-III $ 2.4bn Oncology
Oncology Companies Comparable to Anavex in 12 - 18 months Oncology Companies Comparable to Anavex in 12 - 18 months Achieve High Market Caps Even Without Alzheimer’s CompoundAchieve High Market Caps Even Without Alzheimer’s Compound
* as at October 15, 2008 with data from Wm. Lowry Research and Yahoo Finance
Company Name Product Acquirer Date Stage Upfront MilestonesTherapeutic
Area
BiPar Sciences Incorporated
Sanofi-aventis 15/04/2009 Phase II $ 500m Oncology
Arana Therapeutics Limited
Cephalon, Inc. 27/02/2009 Phase II & preclinical
$ 207m Oncology and inflammatory
Arius Research Roche 23/07/2008 Preclinical, $ 189m Oncology and immunology
SGX Pharmaceuticals, Inc.
Eli Lilly and Co 08/07/2008 Phase I & Preclinica
$ 64m Oncology
U3 Pharma AG Daiichi Sankyo Co., Ltd.
21/05/2008 Preclinical & Research
$ 235m Oncology
Piramed Pharma Roche 15/04/2008 Phase Ib plus preclinical
$ 160m $ 175m Oncology and inflammatory
Agensys, Inc. Astellas 27/11/2007 Phase Ib plus preclinical
$ 387m $ 537m Oncology
Adnexus Therapeutics
Bristol-Myers Squibb
24/08/2007 Phase I $ 430m $ 505m Oncology
Morphotek Eisai Inc. 22/03/2007 Phase I and preclinical
$ 325m Oncology and Inflammatory and infectious
* as of October 15, 2008 with data from Wm. Lowry Research and Yahoo Finance
Recent Acquisitions Of Oncology (Cancer) Products Recent Acquisitions Of Oncology (Cancer) Products Anavex In Talks To Sign Similar Type Of DealAnavex In Talks To Sign Similar Type Of Deal
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Key ManagementKey ManagementHervé de Kergrohen, MD, MBA, Chief Executive Officer and Director• Dr. de Kergrohen has extensive experience in building and transforming organizations, with
more than 25 years in senior and executive management positions, including CEO, Chairman
or Director roles with more than 12 companies in the United States and Europe.
Alexandre Vamvakides, PhD, Scientific Founder, Chief Scientific Officer,
Chairman of Scientific Advisory Board• More than 30 years in anti-neurodegenerative (anti-Alzheimer’s), anti-epileptic, anti-
depressive research and development• Author of more than 80 published scientific papers • Institut national de la santé et de la recherche médicale (INSERM), University of Athens,
Ciba-Geigy (now Novartis), sanofi-aventis• Track record of discovery and development of novel concepts in central nervous system
(CNS), oncology and anti-inflammatory diseases
Harvey Lalach, President, CFO, Secretary and Director• Various aspects of the securities industry for over 20 years• Focused on the operation and administration of numerous start-up US and Canadian public
companies, serving in both director and officer capacities• Extensive experience in the management and governance of listed public companies
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International BoardInternational BoardHervé de Kergrohen, MD, MBA, Chief Executive Officer and Director• Dr. de Kergrohen has extensive experience in building and transforming organizations, with more than 25 years in senior and
executive management positions, including CEO, chairman or director roles with more than 12 companies in the United States and Europe.
• Life Science Investment Advisor and Board Member/ High-level Consultant at Kergrohen & Associates.• Venture Partner at with CDC Innovation, an international venture capital firm with over 415-million Euros under its management. • Founder of BioData, a biotech conference held annually in Geneva.
Cameron Durrant, MD, MBA, Chairman of the Board• Merck, GSK, Pharmacia, J&J (Worldwide Vice President, Global Strategic Marketing)• Former CEO, PediaMed; former CEO, Spherics• 2005 Ernst & Young healthcare ‘Entrepreneur of the Year’• Co-founding Board member privately held oncology company (Bexion)
Alison Ayers, MSc, Director• Worldwide Commercial Head for Oncology, Pfizer• More than 20 years of oncology-focused pharmaceutical industry experience• Business and product planning: Pharmacia, Merck, US Bioscience, BMS, Lederle Laboratories
David L. Tousley, CPA, MBA, Director• President, COO and CFO at companies including airPharma, PediaMed Pharmaceuticals, AVAX Technologies and Pasteur, Merieux,
Connaught (now sanofi-aventis)• Over $90MM in debt and equity financings• Leadership of key business development activities, including joint ventures, partnerships, acquisitions and divestitures in the US,
Europe and Australia
Harvey Lalach, President, CFO, Secretary and Director• Various aspects of the securities industry for over 20 years• Focused on the operation and administration of numerous start-up US and Canadian public companies, serving in both director and
officer capacities• Extensive experience in the management and governance of listed public companies
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Scientific Advisory Board Of World-Renowned ExpertsScientific Advisory Board Of World-Renowned Experts
Alexandre Vamvakides, PhD• Chairman of Scientific Advisory Board, also company’s Scientific Founder and Chief Scientific Officer
Jean-Jacques Bourguignon, PhD• 30 years experience in medicinal chemistry, including expertise in drug design and optimization as well as organic
and physical chemistry• Research Director (CNRS) at the Faculty of Pharmacy, Strasbourg-Illkrich, France
Tangui Maurice, PhD• 15 years in the field of neurosciences, including behavioral and molecular neuropharmacology, sigma receptors,
neuropeptides, neurosteroids, neurotrophic factors, normal/pathological aging models for Alzheimer’s and related disorders, and behavioral phenotyping of rodent models
• Former behavioral neuropharmacologist, INSERM U710, Montpellier
Mark Smith, Ph.D., FRCPath• A leading researcher and professor in the Department of Pathology at Case Western Reserve University School of
Medicine, and one of the world’s most cited researchers in the fields of Alzheimer’s disease, free radical biology and neuroscience and behavior
• Executive Director of the American Aging Association and Editor-in-Chief of the Journal of Alzheimer’s Disease having authored over 600 peer-reviewed scientific manuscripts and book chapters
• Scientific research, currently focused on investigating the pathological mechanisms underlying selective neuronal death in neurodegenerative diseases, notably Alzheimer’s disease
Slide: 20
Stock Summary – As At August 14Stock Summary – As At August 14thth, , 20092009
Funding History Summary
• Research grants, self-financed by CSO (1998-2004)
• $7.0MM pre-public by founding shareholder and affiliates (2004-2007)
• $2.5MM equity and converted debt over $3.50/share (2007)
• $1.6MM debt / $0.8MM equity (2008)
• $818,000 debt / $2,254,143 equity (2009)
Stock Symbol AVXL.OB
Shares Outstanding 20,746,761
Warrants Outstanding 986,147
Options Outstanding 3,075,000
Shares Fully Diluted 24,807,908
Market Capitalization $52.48MM
% Held by Insiders 50%
% Float 50%
Slide: 21
Anavex’s Three-Year Historical Trading Chart Anavex’s Three-Year Historical Trading Chart 2007-20092007-2009
Anavex (AVXL:OB) will move up to the AMEX exchange in Q1, 2010 as it enters into Human Clinical Trials for its Alzheimer's Compound
Anavex 2-73.