Starpharma Holdings Limited · ASX:SPL
Starpharma — Shareholder Meeting (November 2008)
32 slides from Starpharma's shareholder meeting presentation, Nov 14, 2008
Slide 1: AGM - Chairman's and CEO's presentations
AGM - Chairman’s and CEO’s presentations Melbourne; 14 November 2008: Attached is the Chairman’s address together with the For personal use only CEO’s presentation to the Annual General Meeting of Starpharma Holdings Limited (ASX:SPL, OTCQX:SPHRY), to be held at 4.00pm today. About Starpharma: Starp
Slide 2: Chairman's Address
Chairman’s Address Annual General Meeting of For personal use only Starpharma Holdings Limited, 14 November, 2008 Welcome to the Starpharma AGM for the fiscal year 2007–2008, which marks my sixth as Chairman of the Board. I am very pleased to be able to once again address you – our Company’s shareho
Slide 3: Chairman's Address (continued)
are the basis of most of our pharmaceutical applications programs, the programs under way at DNT are using different members of the dendrimer class of molecules. Our programs are wide-ranging, giving some idea of the versatility provided by the unique structure and properties of dendrimers. For exam
Slide 4: CEO Presentation
For personal use only Starpharma Holdings Limited Annual General Meeting CEO Presentation ASX:SPL OTCQX:SPHRY Dr Jackie Fairley CEO 14 November 2008
Slide 5: Forward-looking statements
For personal use only This document contains certain forward-looking statements, relating to Starpharma’s business, which can be identified by the use of forward-looking terminology such as “promising”, “plans”, “anticipated”, “will”, “project”, “believe”, “forecast”, “expected”, “estimated”, “targe
Slide 6: Achievements 2007-2008
For personal use only Achievements 2007-2008 Commercial Development – Signing of Durex® /VivaGel® Condom Coating Full Licence Agreement – Signing of drug delivery research collaboration with Stiefel – world’s largest privately– owned dermatology pharmaceutical company – First commercial product la
Slide 7: Starpharma's Commercial Partnerships
For personal use only Starpharma’s Commercial Partnerships Stratus CS® Cardiac marker diagnostic licensed to Dade Behring SuperFect® Gene transfection technology licensed to Qiagen STARBURST® Dendrimers commercially available via Sigma Aldrich Priofect® siRNA & DNA transfection reagents VivaGel® Co-
Slide 8: 2007/2008 Financials
For personal use only 2007/2008 Financials Year Ended 30 June (A$M) 2006 20071 20081 Revenue (excluding grants) 0.6 1.5 1.7 Grant Income 6.4 8.1 8.2 Net Loss after tax (7.5) (7.2) (7.5) Net increase (decrease) in cash 6.1# (3.8) (2.0) # Operating Cash Outflow (7.5) (3.4) (5.4) Cash Balance 14.3 10.1
Slide 9: VivaGel - for the Prevention of Sexually Transmitted Infections
“ An HIV vaccine may never be found” Professor Baltimore, Nobel Prizewinner and authority on HIV. For personal use only The Times February 2008 VivaGel® - for the Prevention of Sexually Transmitted Infections (STIs) Two Products in Development Early opportunity Significance to SPL Main opportunity C
Slide 10: VivaGel Condom Coating License Agreement with Durex
For personal use only VivaGel® Condom Coating License Agreement with Durex® - September 2008 Estimated total receipts in excess of A$100m Starpharma to receive: Condom Market at a Glance – royalties on SSL sales Total Sales: US$3.26B (2006) – milestones Top 4 sales: 70% of total Sales Growth: 4-5%
Slide 11: VivaGel Coated Condoms
For personal use only VivaGel® Coated Condoms Sample VivaGel® coated condoms from SSL’s manufacturing line Vi vaG el ®
Slide 12: VivaGel Clinical Trial Status - November 2008
For personal use only VivaGel® Clinical Trial Status – November 2008 No. IND Study Site(s) Status Subjects Application Objectives: Safety, tolerability and PK Prevention of Schedule: Administered vaginally, once daily for 37 Adelaide, Australia Complete HIV 7 days Objectives: Safety and acceptabilit
Slide 13: VivaGel: Human Papilloma Virus (HPV) Activity
For personal use only VivaGel®: Human Papilloma Virus (HPV) Activity HPV-5 HPV-6 HPV-11 HPV-16 HPV-18 HPV-31 HPV-45 Cutaneous Genital warts infection 3 3 Carcinoma 3 3 3 3 Gardasil® 8 3 3 3 3 8 8 Cervarix® 8 8 8 3 3 8 8 VivaGel® SPL7013* 3 3 TBD# 3 TBD# TBD# 3 *In-vitro results obtained at NCI and U
Slide 14: VivaGel: Treatment of Bacterial Vaginosis
For personal use only VivaGel® :Treatment of Bacterial Vaginosis The Market Opportunity The most common vaginal infection worldwide Causes unpleasant discharge and linked to preterm birth and increased STIs Global market for topical vaginal treatments for BV: approx. US$300M (~4m US Rx) Shor
Slide 15: VivaGel Opportunities by Indication
For personal use only VivaGel® Opportunities by Indication Indication/ Regulatory Mode Current Stage Product Approach HIV Gel Prevention Drug HSV-2 Gel Prevention Drug (genital herpes) Phase IIa : existing clinical HPV Prevention Drug data applies across all indications TBD: Drug or Contraception Pr
Slide 16: Small Molecule Drug Delivery
For personal use only Small Molecule Drug Delivery 14 Mouse Tissue Deposition 12 % administered dose per gram of tissue payload 10 8 dendrimer 6 other 4 function 2 0 r r y a rt ou ve ne m ea as Li m id H Improve partner’s existing small Tu Pl K Approach molecule drugs by attaching to Breast Cancer X
Slide 17: Protein and Peptide Drug Delivery (ADME Engineering)
For personal use only Protein and Peptide Drug Delivery (ADME Engineering) In vivo mouse model protein payload conventional insulin dendrimer other function Conjugate protein or peptide to Approach functionalised dendrimer Dendrimer + insulin Control half life of protein or peptide therapeutics Bene
Slide 18: Portfolio: siRNA Delivery - PrioFect
For personal use only Portfolio: siRNA Delivery – PrioFect® Concept: Overcome the principal obstacle to the development of RNAi-based drugs … delivery Priofect® : a delivery agent for siRNA (“Transfection”) siRNA : a means to achieve RNAi • …potential foundation for a whole new class of specific and
Slide 19: US Share Trading and Ownership
For personal use only US Share Trading and Ownership ~ 25% US shareholding Retail Institutions 33% Major shareholders include: 47% Acorn Capital The Dow Chemical Company Dow ADR 8% Platinum Partners LLC 12% GoldmanSachs-JBW /Irrewarra 8,000,000 7,000,000 OTCQX 6,000,000 5,000,000 Pre
Slide 20: Share Performance vs ASX Small Ordinaries (XSO)
For personal use only Share Performance v’s ASX Small Ordinaries (XSO) – 1 year Platinum becomes substantial Opes VivaGel Condom Full holder Prime Licence Agreement resolution with Durex BV: New Indication VivaGel® SPL Investor road-show ASX Small Priostar® Ordinaries Launch (XSO) New VivaGel clinic
Slide 21: Value Drivers for Starpharma 2008 and 2009
For personal use only Value Drivers for Starpharma 2008 and 2009 VivaGel® 9 Report positive results of UCSF/Kenya Expanded Safety/IIa trial 9 Investigate other potential applications e.g. Bacterial vaginosis Submit IND; Commence Phase II trial in Bacterial Vaginosis (BV) Complete Expanded Safety
Slide 22: Starpharma Holdings Limited
For personal use only Starpharma Holdings Limited ASX:SPL OTCQX:SPHRY Dr Jackie Fairley CEO +613 85322704 Further information: www.starpharma.com info@starpharma.com 19
Slide 23: Supplementary Information
For personal use only Supplementary Information
Slide 24: Pharmaceutical and Life Sciences Product Pipeline
For personal use only Pharmaceutical and Life Sciences Product Pipeline Lead / in Pharma & Medical Early Clinical Sales vivo undisclosed undisclosed HSV-2 prevention > VivaGel® HIV prevention > Condom coating > * Cancer > Drug Delivery Dermatological > undisclosed undisclosed ADME Engineering Protei
Slide 25: VivaGel - Development stage and plan
For personal use only VivaGel ® - Development stage and plan PRODUCT TYPE Typical In vitro In vivo In vivo Market Therapeutic Phase 1 Phase 2 Phase 3 efficacy efficacy safety entry Agent Preventative Expanded Population In vitro In vivo In vivo Market “Drug” Phase 1 Safety Based entry efficacy effic
Slide 26: VivaGel - Microbicide for the Prevention of HIV and Genital Herpes
For personal use only VivaGel® - Microbicide for the Prevention of HIV and Genital Herpes Product Topical vaginal microbicide (+ condom coating) Under development: Prevention of STIs in women Indications: Two INDs - HIV and genital herpes (HSV-2) Presentation: Applicator delivered Gel (or coating fo
Slide 27: Commercial Opportunity for Microbicides - HSV-2
For personal use only Commercial Opportunity for Microbicides – HSV-2 Genital Herpes represents a major health issue: Recurrent, lifelong viral infection Affects 22% sexually active adults in the USA and 15-20% in Europe 40-50% of women in the U.S. by 2025 (estimated) Existing prevention met
Slide 28: Microbicide toxicities and efficacies in human cervical explant cultures
For personal use only Excerpt: Microbicide toxicities and efficacies in human cervical explant cultures * *Comparing SPL7013 (VivaGel® active) and placebo against other microbicide candidates Product Toxicitya Efficacy (%)b Carraguard No 1/2 (50) N9 Yes 2/2 (100) SPL7013 (VivaGel®) No 2/2 (100) Hydr
Slide 29: Commercial Opportunity for Microbicides
For personal use only Commercial Opportunity for Microbicides Estimated Market* for Microbicides in Industry surveys confirm strong Developed Countries consumer demand Average Frequency Percentage of female US of Use Per Annum college students who would Market 25x 50x 100x 30 - 40% buy a microbicide
Slide 30: VivaGel: Significant Advantages Over Competitors
For personal use only VivaGel®: Significant Advantages Over Competitors VivaGel ® is the only microbicide being HSV-2 VivaGel® Advantages developed to prevent genital herpes • Being developed to prevent both Competitor HIV and HSV-2 Key Disadvantages Category • Highly active against clinically relev
Slide 31: RNAi Deals: Alnylam - Takeda May 2008
For personal use only RNAi Deals: Alnylam - Takeda 27 May 2008 ($150M+)
Slide 32: Investment Summary
For personal use only Investment Summary VivaGel® Development Stage: Clinical – Expanded safety / Phase IIa Indications: Prevention of transmission of HIV & HSV-2 (genital herpes) Two products: Vaginal Gel + condom coating Forecast Market Size: $1.5B – $3B p.a, untapped today; branded + public healt
Starpharma Holdings — Shareholder Meeting (November 2008) on 6ix