Starpharma Holdings Limited · ASX:SPL
Starpharma — Shareholder Meeting (November 2016)
45 slides from Starpharma's shareholder meeting presentation, Nov 29, 2016
Slide 1: AGM Chairman's address and CEO presentation
For personal use only AGM Chairman’s address and CEO presentation Melbourne, Australia; 29 November 2016: 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 3.00pm today. Starpha
Slide 2: Forward Looking Statements
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”, “anticipated”, “will”, “project”, “believe”, “forecast”, “expected”, “estimated”, “
Slide 3: Chairman's Address
Chairman’s Address Starpharma Holdings Limited Annual General Meeting For personal use only 29 November 2016 Good afternoon and welcome to Starpharma’s Annual General Meeting for 2016. Our last financial year saw further significant progress across our portfolio and it is now very clear that Starpha
Slide 4: Chairman's Address (continued)
In our VivaGel® portfolio, we signed a license and supply agreement with Aspen Pharmacare for the sales and marketing for VivaGel® BV for the treatment and rapid relief of bacterial vaginosis in Australia and New Zealand and our product launch preparations are now well advanced with the launch due i
Slide 5: Chairman's Address (continued)
The foundations of a successful company in this industry is a combination of superior products, strong commercial partnerships, and the ability to continually achieve the right level of funding and investor mix, and strong management and leadership. Given the broad applicability of our platform, we
Slide 6: AGM 2016 CEO Presentation
For personal use only STARPHARMA HOLDINGS LIMITED ASX:SPL; OTCQX:SPHRY AGM 2016 CEO Presentation 29 November 2016
Slide 7: Important notice and disclaimer
Important notice and disclaimer 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”,
Slide 8: Overview: Starpharma Holdings Limited
Overview: Starpharma Holdings Limited (ASX:SPL) For personal use only • Melbourne-based ASX300 company; Market Cap ~A$250M • Unique proprietary polymer (dendrimer) platform • Deep portfolio of products targeting three large, high-value markets • Proven track record of commercialisation - the VivaGel
Slide 9: Global Leader in Dendrimer Products
Global Leader in Dendrimer Products For personal use only Starpharma’s products, programs and commercial partnerships with leading companies Starpharma’s Dendrimer Platform ~120 granted patents VivaGel® Portfolio DEP® Drug Delivery Agrochemicals VivaGel® Internal DEP® Partnered DEP® Priostar® Improv
Slide 10: Year in Review
Year in Review For personal use only September 2015 September 2015 October 2015 November 2015 December 2015 Multiproduct DEP® license; EU Marketing Approval Additional US Targeted DEP® Second AZ DEP® AZ elects first candidate for Granted for VivaGel® VivaGel® patent outperforms leading candidate ele
Slide 11: Key financials FY 2016
Key financials FY 2016 For personal use only • Total revenue and other income $4.6M (+173% - includes first US$2M DEP® AZ milestone) Key Financial Data FY 2016 FY 2015 AUD $M AUD $M • Cash Burn $17.5M (increased due to significant clinical programs in FY2016) Total revenue & other income 4.6 1.7 • N
Slide 12: Pipeline and Developments
Pipeline and Developments For personal use only Pre Ph I Ph II Ph III Reg Mkt VivaGel® portfolio VivaGel® BV – Treatment and Symptom Relief VivaGel® BV – Prevention of Recurrence VivaGel® coated condoms Commercial interest from global VivaGel® active – Viral Conjunctivitis ophthalmic companies Oncol
Slide 13: DEP Drug Delivery
For personal use only DEP® Drug Delivery
Slide 14: DEP Drug Delivery Dual Strategy
DEP® Drug Delivery For personal use only Dual Strategy Provides technical, IP and financial leverage Increases commercial opportunities Reduces invested capital De-risks • Application to established drugs • New patents based on DEP® Internal provide patent life extension Programs • Self funded • Ret
Slide 15: DEP Platform - Multiple and reproducible benefits
DEP® Platform - Multiple and reproducible benefits demonstrated in internal and partnered programs For personal use only Standard Drugs DEP® Drugs Enhanced Drug Properties THERAPEUTIC WINDOW PK/PD/Solubility THERAPEUTIC WINDOW In multiple programs* DEP® has demonstrated: • a reduction or elimination
Slide 16: AstraZeneca multiproduct license and new program
AstraZeneca multiproduct license and new program – Partnered DEP® momentum building For personal use only • AZ multiproduct 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 receiv
Slide 17: AstraZeneca multiproduct license - Partnered DEP momentum
AstraZeneca multiproduct license and new program – Partnered DEP® momentum building For personal use only “ AstraZeneca has a deep- rooted heritage in Oncology.. The Company is committed to advancing New Oncology as one of AstraZeneca’s Growth Platforms….. In addition to core capabilities, the Compa
Slide 18: DEP Docetaxel: Multiple benefits
DEP® Docetaxel: Multiple benefits For personal use only Docetaxel (Taxotere®) is a blockbuster cancer drug Sales: US$3.1B (2012) DEP® docetaxel vs. Taxotere® Docetaxel is used in major cancer types including 1. Elimination of major dose-limiting side effect breast, prostate, lung and ovarian can
Slide 19: DEP Docetaxel Clinical Program
DEP® Docetaxel Clinical Program For personal use only Phase 1 Clinical Trial (open label study - 25-30 cancer patients - various solid tumours) Phase 2 Clinical Trial (in advanced planning) Current Status: • Final phase of enrolment underway; >80% recruited • Large UK site recently opened to: PROPOS
Slide 20: DEP Cabazitaxel: Multiple benefits
DEP® Cabazitaxel: Multiple benefits For personal use only About cabazitaxel (Jevtana®) • 2014 sales: US$427m (est. US$500m by 2018) • Primary indication – Prostate cancer • In clinical development for other cancers including Breast, Bladder, Head & Neck • Dose Limiting Toxicity – neutropenia (FDA “B
Slide 21: DEP Platform - highly reproducible benefits
DEP® Platform - highly reproducible benefits For personal use only DEP® benefits as seen in preclinical studies with DEP® docetaxel and DEP ® cabazitaxel Improved Efficacy Improved Safety Improved Survival DEP® docetaxel DEP® docetaxel DEP® docetaxel DEP® cabazitaxel DEP® cabazitaxel DEP® cabazitaxe
Slide 22: Starpharma's DEP Irinotecan
Starpharma’s DEP® Irinotecan For personal use only • Irinotecan (Camptosar®) is a major cancer drug primarily used for the treatment of advanced colorectal cancer (peak sales US$1.1B) • Colorectal cancer is one of the most common cancers and an area of significant unmet need with few treatment optio
Slide 23: Targeted DEP outperforms leading treatments in Ovarian Cancer Model
Targeted DEP® outperforms leading treatments in Ovarian Cancer Model For personal use only Targeted DEP® • SPL’s novel antibody-targeted DEP® conjugate resulted in complete tumour regression and 100% survival in an Efficacy of HER2-targeted DEP® Conjugate vs Kadcyla® ovarian cancer model and Hercept
Slide 24: VivaGel: VivaGel BV and VivaGel Condom
For personal use only VivaGel® VivaGel® BV VivaGel® Condom
Slide 25: VivaGel Portfolio
VivaGel® Portfolio For personal use only • VivaGel® is a proprietary antimicrobial dendrimer active in HIV, HSV, HPV and bacterial vaginosis (BV) • VivaGel® BV is under development for two BV indications – Treatment of BV and Prevention of Recurrent BV • Treatment is approved in EU, ANZ license sign
Slide 26: VivaGel Condom: A compelling World-First Product
VivaGel® Condom: A compelling World-First Product For personal use only • Typical condom use associated with estimated: ~80% reduction in HIV, 30% reduction in genital herpes (HSV-2) and ~70% reduction in risk of HPV infection • VivaGel® Condom: contains the potent antiviral and reduces risk of expo
Slide 27: VivaGel Condom license for the Chinese Government Market
VivaGel® Condom license for the Chinese Government Market For personal use only • Exclusive license and supply agreement signed with Shenyang Sky and Land Latex Co. Ltd. for manufacture and sale of VivaGel® condoms to the Chinese Government market (July 2016) • New market opportunity for VivaGel® co
Slide 28: Bacterial Vaginosis and VivaGel BV: Two Attractive Commercial Opportunities
Bacterial Vaginosis and VivaGel® BV: Two Attractive Commercial Opportunities For personal use only Bacterial Vaginosis (BV): • Most common vaginal infection worldwide • ~29% women infected in US; up to 51% in some groups • Current therapies have low cure rates and nasty side effects • Recurrent BV (
Slide 29: VivaGel BV: Two Attractive Commercial Opportunities
VivaGel® BV: Two Attractive Commercial Opportunities For personal use only • Acute use product • Global market est. >US$750 M VivaGel® BV • EU marketing approval achieved – Treatment of BV, including rapid relief of BV symptoms Treatment & • Regulatory approval underway in multiple regions • License
Slide 30: Current treatments for Bacterial Vaginosis are inadequate
Current treatments for Bacterial Vaginosis (BV) are inadequate… For personal use only Current treatment options • Antibiotics – metronidazole or clindamycin • pH Modifiers – lactic acid, ascorbic acid • Probiotics – lactobacillus • Antiseptics – Povidone-iodine Limitations × Significant side effects
Slide 31: VivaGel BV - A breakthrough product for BV
VivaGel® BV – A breakthrough product for BV For personal use only A new approach to the treatment First product developed specifically of BV, management of symptoms for women who suffer from BV and prevention of BV recurrence VivaGel® BV: key features Patient Benefits Treatment of BV Topical Ra
Slide 32: VivaGel BV inhibits biofilms - a novel mechanism
VivaGel® BV inhibits biofilms - a novel mechanism and expanded commercial opportunity For personal use only • Recent studies show that VivaGel® BV disrupts and prevents the formation of biofilms by BV causing bacteria • Biofilm inhibition is a different mechanism from conventional antibiotics and ha
Slide 33: Positive Developments for VivaGel BV: New FDA Endpoint & GAIN Act
Positive Developments for VivaGel® BV: New FDA Endpoint for BV Treatment &GAIN Act For personal use only 1% SPL7013 Gel EOT TOC FDA Primary Endpoint (2012) : (2-5 (2-3 At TOC : 2-3 weeks after treatment ceased 7 DAY Rx PERIOD days weeks post post Placebo Gel Rx) Rx) Guidance reviews are one of sever
Slide 34: VivaGel BV: Commercial Status and Plans
VivaGel® BV: Commercial Status and Plans For personal use only • Leveraging • EU approved EU approval • NDA in • Multiple Term preparation • Multiple Term Sheets & Sheets & • Multiple Term negotiations Sheets & negotiations underway • Leveraging negotiations underway EU approval underway • Multiple
Slide 35: VivaGel BV Prevention of Recurrence Phase 3 program
VivaGel® BV Prevention of Recurrence Phase 3 program For personal use only SPA granted by FDA Two double-blind, multi-centre, randomised ~600 patients/trial Primary Endpoint: USA, Canada, Europe, Asia, Mexico Recurrence of BV at or by week 16 1% SPL7013 Gel SCREENING BASELINE Oral Metronidazole WEEK
Slide 36: Priostar Agrochemicals
For personal use only Priostar® Agrochemicals
Slide 37: Priostar Agrochemicals Dual Strategy
Priostar® Agrochemicals Dual Strategy For personal use only • Application to established Internal agrochemicals (e.g. Glyphosate) Priostar® • Self funded • Returns through licensing Programs • Patent life extension • Application to partner actives – either generic or proprietary Partnered • Platform
Slide 38: Priostar Agrochemicals Target Market
Priostar® Agrochemicals Target Market For personal use only Global crop protection market dynamics Large addressable target markets1,2 create opportunities for Priostar® Fungicides ~US$1.5bn A range of actives including: Propiconazole Market US$51 billion (2015) and forecast to Tebuconazole grow
Slide 39: Adama Licenses Priostar for Novel 2,4-D Products
Adama Licenses Priostar® for Novel 2,4-D Products For personal use only • Adama has licensed SPL’s Priostar® for novel, improved 2,4-D products for the US market • Priostar® enhanced product expected to provide better flexibility, weed control and improved safety • SPL to receive royalties; Adama to
Slide 40: Priostar enhanced glyphosate formulation
Priostar® enhanced glyphosate formulation Better product performance: increased efficacy For personal use only Priostar® enhanced glyphosate more effective in hard-to-kill weeds than comparable marketed formulation (glyphosate global sales >US$5B) Increased efficacy Increased weed control effectiv
Slide 41: Priostar Formulation - major herbicide
Priostar® Formulation - major herbicide Better product performance: increased efficacy For personal use only Class of herbicides with global sales of over US$2B in 2015 Trial of Priostar® herbicide^ formulation in rice: Selective herbicide Increased efficacy (100% weed control) applied post-planti
Slide 42: Priostar Formulation - leading insecticide
Priostar® Formulation - leading insecticide Better product performance: removal of solvent For personal use only Priostar® formulation of leading insecticide^ (global sales >US$350M) Greener formulation Reduced formulation odour Improved crop and operator safety profile Less solvent released i
Slide 43: Significant market opportunities - multiple options for returns
Significant market opportunities – multiple options for returns For personal use only VivaGel® Portfolio DEP® Drug Delivery Portfolio Priostar® Agrochemicals • AstraZeneca deal: • first product est. • Branded global US$450M (US$126M + royalties) condom market in • Priostar® applications • subsequent
Slide 44: Outlook
Outlook For personal use only VivaGel® Portfolio DEP® Drug Delivery Priostar® Agrochemicals • Launch of VivaGel® BV in Europe, Australia and elsewhere • Completion of DEP® docetaxel Phase 1 clinical trial • Progress with Adama 2,4-D • Further regulatory approvals for • Commencement of Phase 2 for Pr
Slide 45: For personal use only
For personal use only VivaGel® Portfolio DEP® Drug Delivery Priostar® Agrochemicals www.starpharma.com investor.relations@starpharma.com PAGE 39
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