Starpharma Holdings Limited · ASX:SPL
Starpharma — Shareholder Meeting (November 2019)
40 slides from Starpharma's shareholder meeting presentation, Nov 21, 2019
Slide 1: AGM Chairman's address and CEO's presentation
AGM Chairman’s address and CEO’s presentation Melbourne, Australia; 21 November 2019: 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. The AGM will be recorded an
Slide 2: Chairman's Address
Chairman’s Address Starpharma Holdings Limited Annual General Meeting 21 November 2019 Good afternoon, On behalf of the Starpharma Board, it is with great pleasure that I welcome you to the 2019 Annual General Meeting. Starpharma’s commercial strategy is now yielding a deep portfolio of high value p
Slide 3: Chairman's Address (continued)
We look forward to revenues growing from our VivaGel® products, and though it’s typical that these revenues will take some time to build, we expect these will play an important role in enabling the Company to underwrite its growing proprietary dendrimer platform. Starpharma’s DEP® platform is unique
Slide 4: Chairman's Address: small talented team of 45 people
The success of Starpharma relies on a small and talented team of 45 people who work diligently and expertly across our diverse portfolio. I commend Jackie Fairley for her determination and leadership and the whole Starpharma team for their tenacity and commitment, in bringing a product all the way f
Slide 5: 2019 Annual General Meeting: CEO Presentation
2019 ANNUAL GENERAL MEETING CEO PRESENTATION, DR JACKIE FAIRLEY 21 NOVEMBER 2019 2
Slide 6: Important notice and disclaimer
Important notice and disclaimer 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”, “estimate
Slide 7: Dendrimer platform delivers significant optionality with multiple revenue streams
Starpharma’s dendrimer platform delivers significant optionality with multiple potential revenue streams, valuable products & clinical-stage assets Starpharma is an ASX300 company (market cap ~$480M) with a proven record of development & commercialisation incl. successful partnerships with leading g
Slide 8: Deep portfolio of high-value assets including products on market
Deep portfolio of high-value assets including products on market PRODUCTS ON MARKET VivaGel® BV is licensed in more than The VivaGel® condom 160 countries and currently for sale in has been launched in the UK, Europe & Australia - further Japan, Canada & launches and regulatory submissions Australia
Slide 9: Strategy provides exceptional optionality from the DEP platform
Starpharma’s strategy provides exceptional optionality from the DEP® platform underpinned by marketed, proprietary products BUILD DEP® PORTFOLIO Strategic investment in high-value DEP® products & add additional value via combinations Exploring other therapeutic opportunities for dendrimers (e.g. rad
Slide 10: Recent highlights - significant milestones across DEP and VivaGel
Recent highlights - significant milestones across DEP® and VivaGel® Betafem® BV Gel / Betadine BV TM Gel Development and Commenced phase 1 / Positive interim results DEP® portfolio launched in UK/Europe & Fleurstat Option Agreement 2 DEP® irinotecan trial observed in patients expanded with new BVgel
Slide 11: Financial summary
Financial summary FY 2019 FY 2018 FY19 REVENUE - $2.7M Key Financial Data A$M A$M Revenue and other income 2.7 5.0 Loss from period (14.3) (10.3) Net operating cash outflows (10.3) (10.2) Net cash burn1 (10.1) (9.9) Cash as at 30 Sep 2019 Closing Cash (30 June) $36.8M 41.3 51.3 excludes FY19 $4.9M R
Slide 12: Overview VivaGel Portfolio DEP Outlook
1 Overview 2 VivaGel® Portfolio 3 DEP® 4 Outlook 9
Slide 13: VivaGel BV - a breakthrough product for the management of BV
VivaGel® BV - a breakthrough product for the management of BV - the most common vaginal infection worldwide Management of BV is an area of significant unmet need: • Untreated, BV is associated with miscarriage, infertility & PID as well as having a significant impact on quality of life 1 in 3 Curren
Slide 14: VivaGel BV licensed in >160 countries
VivaGel® BV licensed in >160 countries Approved; around the FY20 world On market launches Global market for BV treatment est. to NORTH be US$750M and AMERICA EUROPE MIDDLE prevention est. to EAST be US$1B annually ASIA Launched in the AFRICA UK, Europe & Aus Approved in South NZ East Asia and New Ap
Slide 15: Fleurstat BVgel successful marketing campaign
Fleurstat BVgel successful marketing campaign - highly targeted direct and online initiatives More than 2,700 Australian pharmacies currently stock 784 Display points Fleurstat BVgel nationally e.g. washrooms, Described as one of Aspen’s most positively received new product gyms launches, with high
Slide 16: Fleurstat BVgel - Australian market feedback
Fleurstat BVgel - Australian market feedback “We are very impressed with health care practitioner and consumer feedback on the product, and in the market uptake of Fleurstat BVgel at this early stage of a major launch. We see a great future ahead.” Rob Barnes, Head of Consumer OTC, Aspen “I spoke to
Slide 17: BETADINE has a market leading position in Feminine Care
BETADINE® has a market leading position in Feminine Care, trusted by women globally VivaGel® BV is part of an established feminine care range under Mundipharma’s Betadine® brand Launched in Europe by Mundipharma, under the brand name Betadine BV™ Launched in the UK under the brand name Betafem® BV G
Slide 18: VivaGel BV in the US – dual strategy to achieve approval of the NDA
VivaGel® BV in the US – dual strategy to achieve approval of the NDA • Options thoroughly explored; ongoing support from a team of expert FDA consultants (regulatory, statistical, clinical, legal; several ex-FDA) • Additional information and statistical analyses of existing data already provided to
Slide 19: VivaGel BV opportunity in the US
VivaGel® BV opportunity in the US Significant positive feedback Dr Belvia Carter, VivaGel® BV Clinical Trial from clinicians & patients in Principal Investigator and Ob-Gyn, US support of VivaGel® BV – confirming BV is an area of significant unmet medical need “VivaGel® BV is a wonderful product whi
Slide 20: VivaGel BV supply
VivaGel® BV supply Partners pay for STARPHARMA’S SUPPLY STRATEGY: product on standard supply • utilises 3rd parties for trading terms, manufacture and supply with additional royalties paid STARPHARMA • modest capital quarterly in requirements with Starpharma purchases arrears. inventory, mainly API,
Slide 21: VivaGel condom launched in Japan and recently approved in Europe
VivaGel® condom launched in Japan and recently approved in Europe • VivaGel® condom is being marketed under Okamoto’s leading and highly successful Zero Zero Three (003) brand • Starpharma receives royalties based on sales of the VivaGel® condom and also revenue on supply of SPL7013 active • First r
Slide 22: Overview VivaGel Portfolio DEP Outlook
1 Overview 2 VivaGel® Portfolio 3 DEP® 4 Outlook 19
Slide 23: Starpharma's DEP strategy creates significant optionality and upside
Starpharma’s DEP® strategy creates significant optionality and upside DEP® strategy provides technical, IP and financial leverage, as well as increasing commercial opportunities, improving ROI and de-risking development INTERNAL DEP® PARTNERED DEP® • Application to • Application to partners’ establi
Slide 24: DEP platform enhances commercial and therapeutic value of a wide range of drugs
Starpharma’s DEP® platform enhances the commercial and therapeutic value of a wide range of drugs DEP® BENEFITS 3 x w e e k ly in je c t io n s Improved Efficacy Reproducible results with many candidates ) 3 1400 M e a n T u m o u r V o lu m e (m m & tumour types DEP® has 1200 1000 V e h ic le G e m
Slide 25: DEP platform for partnering
DEP® platform for partnering DEP® can be used by partners to improve novel drugs or life-cycle management DEP® nanoparticles Starpharma can be used to attaches the enhance the features partner’s drug to the Licences are of novel drugs that dendrimer may otherwise limit structured creating a clinical
Slide 26: AstraZeneca's DEP programs: AZD0466 IND approved by FDA
AstraZeneca’s DEP® programs: AZD0466 IND approved by FDA; clinical trial start expected CY19 & new DEP® agreement signed IND approved by FDA & AstraZeneca expects to commence phase 1 later Multiple commercial this year DEP® programs 1st AZ DEP® candidate (AZD0466) • Up to US$124M milestones + • US$4
Slide 27: DEP Internal: Multiple clinical-stage assets with high commercial value potential
DEP® Internal: Multiple clinical-stage assets with high commercial value potential DEP® DOCETAXEL: Enhanced version of docetaxel (Taxotere®) – widely used for breast, lung & prostate cancer Docetaxel (Taxotere®) is a blockbuster cancer drug with peak global sales >US$3.1B despite having multiple US
Slide 28: DEP pipeline targets significant needs and opportunities in cancer
Starpharma’s DEP® pipeline targets significant needs and opportunities in cancer Lung cancer is the most Pancreatic cancer is the 4th common type of cancer leading cause of cancer death throughout the world NSCLC globally accounts for 84% of all lung Median survival is 4.8 months & cancers median 5-
Slide 29: DEP docetaxel phase 2 program – positive interim results
DEP® docetaxel phase 2 program – positive interim results with two new sites added and Gemzar® combination planned Open-label, two-stage design to Monotherapy arm Combination (DEP® docetaxel & Vargatef®) allow for exploration of efficacy of DEP® docetaxel as a • 27 patients treated • 10 patients tre
Slide 30: Case study: DEP docetaxel in advanced lung cancer
Case study: DEP® docetaxel in advanced lung cancer • Lung cancer is the most common cancer globally Stage IV metastatic • Non-Small Cell Lung Cancer (NSCLC) accounting for lung cancer 84% of all lung cancers (NSCLC) patient: • Stage IV lung cancer patients have a 5 year survival rate of 4.7%1. 46 ye
Slide 31: Combination benefit: DEP docetaxel + gemcitabine outperformed standard of care
Combination benefit: DEP® docetaxel + gemcitabine outperformed standard of care gemcitabine & Abraxane® in human pancreatic cancer model Leading pancreatic cancer Mean Tumour Volume 1400 therapies, gemcitabine & Mean Tumour Volume (mm3) 1200 Abraxane® are standard 1000 of care (SOC) & in 800 Vehicle
Slide 32: DEP cabazitaxel phase 1/2 program – positive interim results
DEP® cabazitaxel phase 1 / 2 program – Phase 1 nearing completion with positive interim results PHASE 1 / 2 2 NEW SITES CURRENTLY BEING ADDED RECRUITING Phase 1 (dose-escalation) is nearing completion • 14 patients dosed • Multiple cycles of DEP® cabazitaxel (up to 15 cycles) at 6 dose levels; no st
Slide 33: Clinical case study: DEP cabazitaxel in advanced prostate cancer
Clinical case study: DEP® cabazitaxel in advanced prostate cancer Prostate cancer is the second most commonly occurring cancer in men: ~1 in 7 men will be diagnosed with prostate cancer in their lifetime. Stage III Prostate PSA level following DEP® cabazitaxel Cancer Patient: • Stable Disease >47 12
Slide 34: DEP irinotecan phase 1/2 program underway
DEP® irinotecan phase 1 / 2 program underway PHASE 1 / 2 CURRENTLY RECRUITING DEP® irinotecan incorporates the Phase 1: Open-label dose-escalation irinotecan active moiety (SN38) • Several patients dosed, multiple cycles and is an improved version of Camptosar® • No Dose Limiting Toxicities observed
Slide 35: DEP combinations with marketed oncology agents add further value
DEP® combinations with marketed oncology agents add further value Combination therapies are widely regarded as the future of oncology Improved DEP® combination Cancer type efficacy S u D H L -4 (D L B C L X e n o g r a ft M o d e l) (human xenograft) (compared to current 5 x w e e k ly in je c tio n
Slide 36: New Candidate: DEP gemcitabine outperforms in pancreatic cancer model
New Candidate: DEP® gemcitabine significantly outperforms alone and in combination in human pancreatic cancer model • DEP® gemcitabine is a DEP® version of DEP® gemcitabine: Lilly’s Gemzar® (gemcitabine) - a well- established anti-cancer drug, which had • resulted in significantly greater tumour pea
Slide 37: DEP ADCs further build the value of the DEP platform
DEP® ADCs further build the value of the DEP® platform 2018 sales of Roche’s Kadcyla® Starpharma’s DEP® technology provides enhanced >US$1B and Adcetris US$870 therapeutic benefits to ADCs including: million. • greater homogeneity Strong corporate activity in ADCs is • site specific attachment as il
Slide 38: Overview VivaGel Portfolio DEP Outlook
1 Overview 2 VivaGel® Portfolio 3 DEP® 4 Outlook 35
Slide 39: Outlook
Outlook VIVAGEL® COMMERCIAL OUTCOMES • Commercial roll-out of VivaGel® BV in Europe, South East Asia, NZ & other markets • Dual strategy to address FDA request for confirmatory data • Further VivaGel® BV licences for India, Canada & Israel • Further regulatory approvals for VivaGel® BV Products on m
Slide 40: www.starpharma.com
eo . ~ starpharma He WWW.STARPHARMA.COM
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