Starpharma Holdings Limited · ASX:SPL
Starpharma — Shareholder Meeting (November 2013)
41 slides from Starpharma's shareholder meeting presentation, Nov 22, 2013
Slide 1: AGM – Chair address and CEO's presentation
For personal use only AGM – Chair address and CEO’s presentation Melbourne, Australia; 22 November 2013: Attached is the Chairman’s address together with the CEO’s presentation to the Annual General Meeting of Starpharma Holdings Limited (ASX:SPL, OTCQX:SPHRY), to be held at 4.00pm today. Starpharma
Slide 2: Forward Looking Statements
Danny Rose Mob: +61 407 25 00 88 www.starpharma.com drose@buchanwe.com.au Forward Looking Statements 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”, “anticipa
Slide 3: Chairman's Address
Chairman’s Address Starpharma Holdings Limited Annual General Meeting For personal use only 22 November 2013 Good afternoon and welcome to the annual general meeting of Starpharma. As mentioned in my opening remarks, unfortunately our Chairman Peter Bartels is unable to be with us today following a
Slide 4: Chairman's Address (continued)
viewed appropriately within the broader context of a suite of high-potential opportunities for Starpharma. That being said, the Phase 2 trial results for VivaGel as a preventive for recurrent infection were highly positive and, in all of these studies, VivaGel was seen to deliver excellent symptomat
Slide 5: CEO Presentation
For personal use only CEO Presentation Starpharma Holdings Limited Annual General Meeting 22 November 2013
Slide 6: 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 7: Starpharma's Dendrimer Platform
Significant optionality: Potential for multiple and parallel revenue streams For personal use only Starpharma’s Dendrimer Platform ~100 granted patents VivaGel® Portfolio Drug Delivery Agrochemicals Condom Bacterial STI Dendrimer Partnered Improved Partnered coating vaginosis Prevention Enhanced Del
Slide 8: Pharmaceutical Development Pipeline
Pharmaceutical Development Pipeline For personal use only Res PC PhI PhII PhIII Reg. Mkt BV Symptomatic VivaGel® Relief** BV Prevention of VivaGel® Antimicrobial Recurrence / Antiviral VivaGel® (SPL7013)* Viral Conjunctivitis (SPL7013)* Partnered - VivaGel® Ansell and Coated Condom Okamoto Docetaxel
Slide 9: 2012-2013 Highlights
2012-2013 Highlights For personal use only VivaGel® Portfolio Drug Delivery Agrochemicals Corporate Phase 2 prevention of Dendrimer-docetaxel Makhteshim Agan $5.4m R&D tax recurrent BV infection Improved efficacy and reduction in partnership incentive payment trial completed dose limiting toxicity.
Slide 10: Starpharma - In The News
Starpharma - In The News “I believe the stock can double in value For personal use only over the next year or so.” Brendon Lau, Business Journalist “this will be a total game changer” Matthijs Smith, Analyst, Canaccord Genuity “3 biotech stocks for a healthy portfolio” Motley Fool And covered by man
Slide 11: Corporate and financial information
Corporate and financial information Key Financial Data FY 2013 FY 2012 AUD $M AUD $M For personal use only CAGR 3 year 5 year (Financial Year to 30 June) Total revenue and income 2.4 2.9 SPL 7% 28% R&D Tax Incentive 8.7 1.3 ASX 300 4% 6% Net loss after tax (5.2) (13.7) Cash outflow from (9.8) (9.8)
Slide 12: Drug Delivery
For personal use only Drug Delivery
Slide 13: Dendrimers in drug delivery: Nanoparticles with multiple advantages
Dendrimers in drug delivery: Nanoparticles with multiple advantages Maximising commercial opportunity through differentiation and value add For personal use only Multiple Partners including: Target Profile Dendrimer-Docetaxel Dendrimer-Oxaliplatin Enhanced Pharmacokinetics Plasma half life >60x Taxo
Slide 14: Starpharma's Dendrimer-Docetaxel: Multiple benefits
Starpharma’s Dendrimer-Docetaxel: Multiple benefits For personal use only • Docetaxel (Taxotere®) is a blockbuster chemotherapeutic: docetaxel sales US$3.1Bi (2012) • Docetaxel is used in major cancer types including breast, prostate and lung cancer Dendrimer-Docetaxel vs. Taxotere® • Docetaxel is i
Slide 15: Docetaxel polysorbate 80 hypersensitivity and black box warning
The frequency of hypersensitivity reactions, anaphylaxis and fluid retention with docetaxel, despite premedication, led the For personal use only FDA to issue a “black box” warning on the package insert. “100% of the patients in Japan and the United States who died of docetaxel-associated anaphylaxi
Slide 16: Dendrimer-Docetaxel: Better efficacy and less toxicity
Dendrimer-Docetaxel: Better efficacy and less toxicity For personal use only Efficacy: Breast Cancer Model* • Dendrimer–Docetaxel shows significantly better efficacy than Taxotere ® Improved Efficacy: At 94 days: Saline Control 19d Dendrimer-Docetaxel 19d – 60% Dendrimer-docetaxel mice - no evidence
Slide 17: Dendrimer-Docetaxel: Longer half-life, tumor targeting and reduced neutropenia
Dendrimer-Docetaxel: Multiple benefits - Longer half-life, tumor targeting and reduced neutropenia For personal use only • Dendrimer-Docetaxel formulation extends plasma half life by >60 fold vs. Taxotere® enabling sustained delivery of docetaxel ( 39 hours vs. 30 mins) • Dendrimer–Docetaxel formula
Slide 18: Dendrimer-Docetaxel: Proposed Phase 1 Clinical Trial
Dendrimer-Docetaxel: Proposed Phase 1 Clinical Trial For personal use only • Standard Phase 1 design: Dose escalation and expansion study in cancer patients (various tumours) • Estimated sample size: 25-30 patients • Trial activities well advanced, ethics underway, CRO selected and planned commencem
Slide 19: Dendrimer Enhanced Oxaliplatin: Multiple benefits
Starpharma’s Dendrimer Enhanced Oxaliplatin: Multiple benefits • Dendrimer Enhanced Oxaliplatin is a proprietary dendrimer version of blockbuster For personal use only cancer drug, oxaliplatin (ELOXATIN®, Sanofi) • Oxaliplatin sales ~ US$2B (2012) • Neuropathy is reported in ~90% patients and Neutro
Slide 20: Dendrimer Enhanced Oxaliplatin: Improved efficacy and reduced toxicity
Dendrimer Enhanced Oxaliplatin (DEO): Improved efficacy and reduced toxicity For personal use only • In a colon cancer model* Dendrimer-Enhanced Oxaliplatin achieved: – significantly better tumour-inhibiting efficacy cf. ELOXATIN® – reduced bone marrow toxicity (neutropenia and thrombocytopenia) cf.
Slide 21: Dendrimer Enhanced Oxaliplatin: Reduced neurotoxicity
Dendrimer Enhanced Oxaliplatin (DEO): Reduced neurotoxicity For personal use only • 85-95% of ELOXATIN® treated patients experience peripheral neuropathy (dose-limiting toxicity) SPL’s Dendrimer Enhanced Oxaliplatin nanoparticle formulation resulted in significantly reduced neurotoxicity cf. Eloxati
Slide 22: Broad potential for dendrimers to improve major drugs
Broad potential for dendrimers to improve major drugs For personal use only • Starpharma’s dendrimer nanoparticle technology has broad applicability • Analysis shows dendrimers applicable to >50% of leading pharmaceuticals Nanomedicine-based • Significant potential in oncology oncology drug sales ex
Slide 23: Dendrimers for drug delivery – proteins and peptide drugs
Dendrimers for drug delivery – proteins and peptide drugs e.g.Insulin For personal use only Opportunity Technical Approach Performance US$43B conventional insulin Global diabetes market (2013) (Reuters) In vivo mouse Dendrimer model + insulin Insulin dendrimer Market Share 2010 (Business Insights) C
Slide 24: VivaGel® Portfolio
For personal use only VivaGel® Portfolio
Slide 25: Bacterial Vaginosis: An attractive commercial opportunity and unmet need
Bacterial Vaginosis (BV): An attractive commercial opportunity and unmet need For personal use only • Bacterial Vaginosis (BV): the most common vaginal infection worldwide • ~29% women infected in US^; up to 51% in certain demographics • Caused by overgrowth of pathogenic bacteria* & reduction of no
Slide 26: VivaGel® for Bacterial Vaginosis: Two product opportunities
VivaGel® for Bacterial Vaginosis: Two product opportunities For personal use only Drivers of Value Significant Competitive Development and Market Size Advantages Commercial Progress • Unmet need • Positive Phase 2 Trial results • No Approved • Phase 3 Planning well advanced Prevention of BV Products
Slide 27: BV Prevention of Recurrence: Partnering and market opportunity
BV Prevention of Recurrence: Partnering and market opportunity for VivaGel® For personal use only “It was like gone almost overnight” “I would definitely use it again.” “The next day I noticed a huge difference.” “ VivaGel® has the potential to tap into a large uncontested market with a product that
Slide 28: BV Prevention of Recurrence: Results summary
Phase 2 BV Prevention of Recurrence: Results summary For personal use only • Double-blind exploratory Phase 2 trial in 205 US women (VivaGel® vs. placebo) • 1% VivaGel® demonstrated reduced risk of recurrent BV and delayed time to first recurrence (35d vs. 5d) • More than 80% of 1% VivaGel® users re
Slide 29: BV Prevention of Recurrence results – key findings
Phase 2 BV Prevention of Recurrence results – key findings For personal use only Time to Recurrence Symptom Relief Subject Reported BV Symptoms Since Last Visit 25 1% SPL7013 Gel 20 Placebo Gel % w ith Sym ptom s 15 10 * 5 * 0 k4 k8 2 6 k1 k1 ee ee ee ee W W W W * (P ≤ 0.05) vs. placebo 25
Slide 30: BV Prevention of Recurrence: Proposed Phase 3 Trial Design
BV Prevention of Recurrence : Proposed Phase 3 Trial Design For personal use only PERIODIC STUDY VISITS Primary Endpoint: Recurrence of BV at any scheduled or unscheduled visit 1% SPL7013 Gel SCREENING BASELINE WEEK 16 Oral Metronidazole 1:1 randomization ASSESS 7 days PRIMARY ENDPOINT Placebo Gel 1
Slide 31: VivaGel®: Symptomatic Relief of BV
VivaGel®: Symptomatic Relief of BV (7day acute use) For personal use only Key Findings: • VivaGel® (once a day for 7 days) demonstrated statistically significant Clinical Cure and effectiveness in treating symptoms of BV at the end of treatment (2-5 days: EOT) • Primary FDA endpoint for Treatment (C
Slide 32: Symptomatic Relief Data and Patient Experiences
Phase 3 Symptomatic Relief Data and Patient Experiences “It was like gone almost overnight” For personal use only Resolution of Symptoms at EOT – Patient SPL7013-015 SPL7013-016 100 1.0% SPL7013 Gel - 015 “The next day I noticed a huge HEC Placebo Gel - 015 difference.” – Patient 80 ** ** % with Res
Slide 33: VivaGel®-coated condom: A compelling and differentiated product
VivaGel®-coated condom: A compelling and differentiated product For personal use only • Condom coated with patented antiviral (VivaGel®) which has been shown to kill ≥ 99.99% HIV & Herpes • Licensed to Ansell and Okamoto • Consumer research, product positioning, package design, manufacturing validat
Slide 34: VivaGel®-coated condom: A compelling and differentiated product
VivaGel®-coated condom: A compelling and differentiated product For personal use only • Consumer research confirms strong interest in a condom that can Ansell has partnered also inactivate STIs with Starpharma to validate a process of • In recent consumer research 86% of participants rated the coati
Slide 35: SPL7013 – A potential treatment for Viral conjunctivitis
SPL7013 – A potential treatment for Viral conjunctivitis New Data: For personal use only • Adenovirus conjunctivitis is the most common viral SPL7013 shows superior antiviral performance conjunctivitis • Painful, highly contagious and can lead to serious • SPL7013, tested in a validated rabbit model
Slide 36: Agrochemicals
For personal use only Agrochemicals
Slide 37: Dendrimers in Agrochemicals
US$47B Crop protection Dendrimers in Agrochemicals market (2012) Phillips McDougall For personal use only Dendrimers enhance existing agrochemicals Significance for the agrochemical industry: and create patentable formulations in at least two ways: • Number of new actives in development by the indus
Slide 38: Progress in Starpharma's Agrochemical Program
Progress in Starpharma’s Agrochemical Program Update on Internal Development Programs For personal use only Partnered Programs • Agreements now signed with majority of top 10 • SPL is developing its own complete formulations of selected agrochem companies and many others. generic actives with enhanc
Slide 39: Dendrimers: Multiple products with parallel revenue streams
Dendrimers: Multiple products with parallel revenue streams For personal use only Product/ Commercial Strategy / Potential Market SPL Application Partnering Status ($USD) Returns VivaGel® • Prevention Recurrence >$1B Royalty/milestones Bacterial Late stage license(s) • Symptomatic relief ~ $350M Roy
Slide 40: Expected Short-Medium Term Newsflow
Expected Short-Medium Term Newsflow For personal use only VivaGel® Portfolio: • Commence Phase 3 Prevention of Recurrence BV VivaGel® trial • Progress regulatory submissions for Symptomatic Relief BV product in selected regions • Advance license discussions for Symptomatic Relief BV product • VivaGe
Slide 41: A platform technology with broad optionality and applicability
A platform technology with broad optionality and applicability For personal use only Drug Delivery VivaGel® Lead internal program: Lead internal dendrimer-docetaxel program: (Taxotere®) VivaGel ® for the treatment and Partnered development prevention of Bacterial programs: Vaginosis. Partnered devel
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