Starpharma Holdings Limited · ASX:SPL
Starpharma — Shareholder Meeting (November 2015)
43 slides from Starpharma's shareholder meeting presentation, Nov 19, 2015
Slide 1: AGM – Chair address and CEO presentation
For personal use only AGM – Chair address and CEO presentation Melbourne, Australia; 19 November 2015: 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 2.00pm today. Starpharma
Slide 2: For personal use only
and commercialization of the product candidates could be affected by, among other things, unexpected trial results, including additional analysis of existing data, and new data; unexpected regulatory actions or delays, or government regulation generally; our ability to obtain or maintain patent or o
Slide 3: Chairman's Address
Chairman’s Address Starpharma Holdings Limited For personal use only Annual General Meeting 19 November 2015 Good afternoon and welcome to Starpharma’s Annual General Meeting for 2015. It is with pleasure that I welcome you to this Annual General Meeting after what has been another very successful y
Slide 4: For personal use only
including the company’s wholly‐owned DEPTM docetaxel product, remains unencumbered and available for licensing in the vast majority of oncology and other applications for future deals. This For personal use only supports Starpharma’s strategy and intent to sign multiple such partnerships for DEP™ in
Slide 5: For personal use only
substantial regulatory progress in other commercially important geographies and Starpharma expects the VivaGel® condom will be approved and launched into a number of additional markets For personal use only over the coming year. Good progress has been made in agrochemicals with a number of new Prios
Slide 6: CEO Presentation
Dr. Jackie Fairley CEO For personal use only STARPHARMA HOLDINGS LIMITED ASX:SPL; OTCQX:SPHRY 2015 AGM CEO Presentation 19 November 2015
Slide 7: For personal use only
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 8: Summary
Summary Three business areas: DEP™ drug delivery platform, VivaGel® and Agrochemicals supporting a deep portfolio of products under development or on market For personal use only • DEP™ drug delivery platform has the potential to produce a portfolio of new DEP™ products with multiple revenue streams
Slide 9: Starpharma is a global leader in dendrimer nanoparticles
Starpharma is a global leader in dendrimer nanoparticles Starpharma’s portfolio: a mix of internal programs and commercial partnerships with leading companies For personal use only Starpharma’s Dendrimer Platform >80 granted patents VivaGel® Portfolio DEP™ Drug Delivery Agrochemicals VivaGel® BV DEP
Slide 10: 2014-15: Substantial and strategically important milestones achieved
2014-15: Substantial and strategically important milestones achieved For personal use only Multi-product Licence signed with AstraZeneca: SEP 2015 development, launch and sales milestones for the first AstraZeneca DEP™ product of up to USD$126m plus royalties (USD$93m plus royalties for 2nd and subs
Slide 11: Recent Media Coverage for SPL
Recent Media Coverage for SPL BROADCAST For personal use only MEDIA AstraZeneca deal lifts Australia Looks to Health Starpharma shares Care as Remedy for 21pc Resource-Slump Doldrums Australia is taking a page from Silicon Starpharma boss Jackie Fairley Valley’s playbook as it seeks to said her lice
Slide 12: Starpharma's Product Portfolio
Starpharma’s Product Portfolio EU Approval Sept. ‘15 For personal use only Res PC PhI PhII PhIII Reg. Mkt BV Symptomatic VivaGel® BV Relief Antimicrobial BV Prevention of VivaGel® BV / Antiviral Recurrence (SPL7013) VivaGel® Condom DEP™ docetaxel Drug Delivery (various cancers) DEP™ oxaliplatin DEP™
Slide 13: DEP Drug Delivery
For personal use only DEP™ Drug Delivery
Slide 14: DEP Drug Delivery Platform
DEP™ Drug Delivery Platform • DEP™ dendrimer (nanoparticle) delivery technology shows broad commercial applicability For personal use only • Internal development and partnered program allows for accelerated development and increased returns • Applicable to both currently marketed/generic and proprie
Slide 15: Starpharma's DEP Platform in Drug Delivery
Starpharma’s DEP™ Platform in Drug Delivery A highly versatile platform with significant commercial and therapeutic benefits For personal use only Patent protection /extension Commercial Innovative treatment options Benefits Competitive product advantages Robust, scalable manufacturing Flexi
Slide 16: Dual Strategy
Dual Strategy DEP™ Drug Delivery Provides technical, IP and financial leverage Increases commercial opportunities For personal use only Reduces invested capital De-risks • Application to established drugs Internal • Self funded • Return through licensing Programs after early clinical development • e
Slide 17: DEP Delivery License with AstraZeneca
Starpharma’s DEP™ Delivery License with AstraZeneca (LON:AZN) For personal use only • AZ multi-product license for use of DEP™ delivery platform for the development and commercialisation of proprietary AZ compounds directed at a defined family of targets • SPL eligible to receive development, launch
Slide 18: DEP Docetaxel: Multiple Benefits
Starpharma’s DEP™ Docetaxel: Multiple Benefits For personal use only • Docetaxel (Taxotere®) is a blockbuster chemotherapeutic DEP™ docetaxel vs. Taxotere® • Docetaxel sales: US$3.1B (2012) 1. Elimination of major dose-limiting • Docetaxel is used in major cancer types including breast, side effect
Slide 19: DEP Docetaxel Clinical Program
DEP™ Docetaxel Clinical Program Phase 1 Clinical Trial: Encouraging anticancer activity and no neutropenia For personal use only • Underway at 4 Australian sites*; open label study, estimated sample of 25-30 cancer patients (various solid tumours) Current Status: • DEP™ docetaxel administered intrav
Slide 20: DEP Docetaxel Preclinical Findings
DEP™ Docetaxel Preclinical Findings: Multiple advantages - Better efficacy and less toxicity For personal use only T1/2 and Targeting Safety Efficacy Improved Survival Tumour accumulation Patents filed will offer coverage to 2032 (potential for further filings) 15
Slide 21: DEP Docetaxel Pharmacokinetics in Humans
DEP™ Docetaxel Pharmacokinetics (PK) in Humans cf. Taxotere®^ Enhanced PK in humans For personal use only 1. Extended duration of exposure with DEP™ docetaxel • DEP™ docetaxel plasma half-life substantially longer (~8 x) than Taxotere® (~150x longer in the initial, rapid phases of plasma clearance)
Slide 22: Compelling Product Benefits for DEP Docetaxel
Compelling Product Benefits for DEP™ Docetaxel For personal use only Aspect DEP™ docetaxel Starpharma Benefit SPL dendrimer manufacture is readily scalable Manufacture Standard chemistry and validated through extensive FDA input Important for drug approval, storage and Stability Excellent stability
Slide 23: Targeted DEP Conjugates (TDCs)
Targeted DEP™ Conjugates (TDCs) A new approach to drug conjugate design For personal use only Starpharmas Targeted DEP™ conjugates Can use small molecule, whole antibody, antibody fragments or antibody mimetics Bind with high affinity and specificity Highly efficacious in cancer model in vivo
Slide 24: Targeted DEP outperforms leading treatments in ovarian cancer model
Targeted DEP™ outperforms leading treatments in ovarian cancer model For personal use only • SPL’s novel antibody-targeted DEP™ conjugate resulted in complete tumour regression and 100% survival in an ovarian cancer model • The antibody-targeted DEP™ conjugate (using Herceptin as the targeting group
Slide 25: DEP Platform and Further Development Candidates
DEP™ Platform and Further Development Candidates For personal use only • SPL’s dendrimer enhanced product (DEP™) nanoparticle technology has broad applicability, especially in oncology allows for new patent filings creating proprietary products • Proof of DEP™ concept for docetaxel, cabazitaxel,
Slide 26: DEP Cabazitaxel Pre-clinical Efficacy
DEP™ Cabazitaxel Pre-clinical Efficacy For personal use only About Cabazitaxel (Jevtana ®) • 2014 sales: US$363m (est. US$500m by 2018) • Primary indication – Prostate cancer • In clinical development for various other cancer including Breast, Bladder, Head and Neck and others • Dose Limiting Toxici
Slide 27: VivaGel BV & VivaGel Condom
For personal use only VivaGel® BV & VivaGel® Condom
Slide 28: VivaGel Portfolio
VivaGel® Portfolio • VivaGel® is a proprietary antimicrobial dendrimer active in HIV/HSV/HPV and Bacterial Vaginosis For personal use only • VivaGel® BV (bacterial vaginosis) • Symptomatic Relief – EU approved, commercial discussions underway; launch expected 2016 • Prevention of Recurrent BV – Phas
Slide 29: Bacterial Vaginosis and VivaGel BV: Two product opportunities
Bacterial Vaginosis and VivaGel® BV: Two product opportunities For personal use only “It was like gone almost overnight” Bacterial Vaginosis (BV): “I would definitely use it again.” “The next day I noticed a huge difference.” “I would use it….I will use it • Most common vaginal infection wor
Slide 30: VivaGel BV: Two attractive commercial opportunities
VivaGel® BV: Two attractive commercial opportunities For personal use only • Acute use product • EU marketing approval achieved – population of approx. 260 million women VivaGel® BV • Multiple partnering discussions well-advanced ; 2016 launch Symptomatic expected; commercial manufacture underway Re
Slide 31: VivaGel BV Treatment & Symptomatic Relief of BV
VivaGel® BV Treatment & Symptomatic Relief of BV For personal use only • VivaGel® BV gains EU approval for the treatment and rapid relief of BV • Allows for marketing in 28 EU countries & EFTA countries (population >260m women) • EU approval will be used as the basis for obtaining marketing approval
Slide 32: VivaGel BV Commercial Discussions
VivaGel® BV Commercial Discussions For personal use only Commercial discussions underway including advanced agreement negotiations and multiple term sheets Territories covered by commercial negotiations for VivaGel® BV (Symptomatic relief and PoR products) 27
Slide 33: BV Prevention of Recurrence Phase 3 Program
BV Prevention of Recurrence Phase 3 Program For personal use only Two double-blind, multi-centre, randomised trials ~600 pts per trial SPA granted by ~100 sites across USA, Canada, FDA Europe, Asia, Mexico PERIODIC STUDY VISITS “Enriched” R-BV population: Nugent Score 4-10 Primary Endpoint: Recurren
Slide 34: VivaGel Condom: A compelling, world-first product
THE VivaGel® Condom: A compelling, world-first product WORLD’S FIRST ANTI-VIRAL For personal use only CONDOM • Based on innovative, Australian technology • Typical condom use associated with an estimated: – 80% reduction in HIV infection, only a 30% lower risk of genital herpes (HSV-2) infection, an
Slide 35: Geographic Breakdown of Global Branded Condom Sales
Geographic Breakdown of Global Branded Condom Sales* For personal use only * Global Retail Audit Report – IMS, AC Nielsen, IRI 30
Slide 36: VivaGel Condom – International Consumer Market Research
VivaGel® Condom – International Consumer Market Research^ For personal use only International (USA, Europe, Asia, South America) consumer market research showed a very positive response and likelihood to purchase the VivaGel® condom: – 85% found the concept very interesting/interesting; Confirms str
Slide 37: Agrochemicals
For personal use only Agrochemicals
Slide 38: Starpharma's Priostar Agrochemical Programs
Starpharma’s Priostar® Agrochemical Programs Partnered Priostar® Programs Internal Priostar® Programs For personal use only • Multiple new agreements have been signed or • Regulatory compliant field trials of Priostar® enhanced extended with major agrochemical companies for versions of several major
Slide 39: Priostar Dendrimer Glyphosate Field Trial data
Priostar® Dendrimer Glyphosate Formulation 540g/ha 270g/ha Field Trial data For personal use only Glyphosate 450 (Commercial) Priostar® glyphosate formulations have demonstrated a number of key benefits in field trials: • Better overall effectiveness • Early feedback of effectiveness to grower • Mor
Slide 40: Priostar enhanced herbicide performance
Priostar® enhanced herbicide performance For personal use only 100 With Dendrimer Without dendrimer Improved performance 80 % control (brown-out) 60 40 20 0 7 DAA 14 DAA 21 DAA Faster action Herbicide With Dendrimer Better efficacy (1.7l/ha) Undisclosed leading herbicide sales ~$400m (active s
Slide 41: Starpharma Holdings – Key Financials (A$)
Starpharma Holdings – Key Financials (A$) For personal use only Key Financial Data FY 2015 FY 2014 (Financial Year to 30 June) AU$M AU$M Total revenue and income 1.7 1.3 R&D Tax Incentive 3.4 4.2 Net loss after tax (19.0) (14.6) Cash outflow from operations (13.6) (9.8) Cash at 30 September 2015 $26
Slide 42: Expected News Flow
Expected News Flow For personal use only VivaGel® Portfolio: • Further regulatory approvals for VivaGel® BV Symptomatic Relief product • Commercial agreements for VivaGel® BV Symptomatic Relief product marketing (multiple territories) • Launch VivaGel® BV Symptomatic Relief • Progress and completion
Slide 43: For Further Information
For Further Information For personal use only Dr Jackie Fairley, CEO +61 3 8532 2704 Investor.relations@starpharma.com Twitter: @Starpharma_ASX VivaGel® Drug Delivery Agrochemicals 38
Starpharma Holdings — Shareholder Meeting (November 2015) on 6ix