Slide 1: Capital Raising Presentation
Capital Raising Presentation Gary Phillips CEO Monday 6 August 2018 1
Slide 2: Forward looking statement
Forward looking statement This document contains forward-looking statements, including statements concerning Pharmaxis’ future financial position, plans, and the potential of its products and product candidates, which are based on information and assumptions available to Pharmaxis as of the date of
Slide 3: Capital Raising Overview
Capital Raising Overview Pharmaxis is raising A$24.0m at A$0.325 per share via a Two Tranche Placement Two Tranche Placement to sophisticated and professional investors – Tranche 1 raising A$12.4m under existing placement capacity pursuant to ASX Listing Rule 7.1 – Tranche 2 raising A$11.6m subjec
Slide 4: Capital Raising Timetable
Capital Raising Timetable An indicative timetable for the capital raising is provided below Trading halt Friday 3 August 2018 Placement announced and Company resumes trading Monday 6 August 2018 Settlement of issue of Placement Shares under Tranche 1 Monday 13 August 2018 Allotment of issue of Place
Slide 5: Business Overview
eharmaxis Business Overview
Slide 6: Pharmaxis has a successful track record of research, development and commercialisation
Pharmaxis has a successful track record of research, development and commercialisation of human healthcare products for the treatment and management of fibrotic and inflammatory diseases • Utilise global experience and extensive clinical networks to execute value adding Phase 1 and 2 clinical trials
Slide 7: Pharmaxis overview
Pharmaxis overview A globally recognised leader in drug development for fibrosis & inflammation A chemistry platform that has delivered a pipeline of oral small molecule drugs in preclinical and clinical development in diseases with large markets and high unmet need A globally respected translat
Slide 8: Senior management
Senior management Significant experience in drug development, commercialisation and partnering Gary Phillips – CEO Wolfgang Jarolimek – Drug Discovery more than 30 years of operational management more than 18 years’ experience in pharmaceutical drug experience in the pharmaceutical and healthcar
Slide 9: Pharmaxis portfolio
Pharmaxis portfolio Lead Pre Indication Discovery Phase I Phase II Phase III Marketed Optimisation Clinical Commercial Phase 3 trial met primary endpoint in 2017. Chiesi planning to file with FDA Q4 2018. Subject to FDA Bronchitol® US Cystic fibrosis approval, US partner Chiesi will launch commercia
Slide 10: A pipeline of drugs for inflammation and fibrosis
A pipeline of drugs for inflammation and fibrosis Pharmaxis has developed a commercial pipeline of small molecule drugs against high value targets Targeting multiple different pathways Pharmaxis Drug Discovery Chronic Inflammation Pharmaxis has developed a commercial pipeline of small molecule drugs
Slide 11: Key catalysts targeted for 2018/2019
Key catalysts targeted for 2018/2019 Pharmaxis value driving events 1. LOXL2 anti fibrotic program Phase 1 trials final stage to complete Q3 2018 Phase 2 enabling toxicity studies to report H2 2018 Partnering process commenced - to run through Q4 2018. 2. Boehringer Ingelheim acquired SSAO inh
Slide 12: LOXL2 inhibition program
LOXL2 inhibition program for NASH, IPF & other high value fibrotic diseases Potential indications / market size: NASH / Liver Fibrosis; $35b1 Pulmonary fibrosis (IPF); $3.5b2 Significant Excessive production and linking of market collagen fibres results in fibrosis Kidney fibrosis Cardiac
Slide 13: LOXL2 inhibitor program approaches deal ready status
LOXL2 inhibitor program approaches “deal ready” status Feature What Pharma values PXS program status Disease target Independent validation Multiple peer reviewed publications Pre clinical proof of 2 or more different Multiple supportive models across 5 different diseases. concept supportive animal m
Slide 14: LOXL2: Phase 1 Study in 2 compounds
LOXL2: Phase 1 Study in 2 compounds Positive safety and PK/PD findings in SAD1 Phase 1 trials Pharmacokinetics of one compound Both compounds were well tolerated and in SAD stage – 3 of 6 doses tested cleared for progressing to MAD2 stage Pharmacokinetic parameters of both compounds increased wi
Slide 15: LOXL2 inhibitor program – partnering process
LOXL2 inhibitor program – partnering process Positive engagement with pharma companies Pharma company interest driven by search for: Inhibitor to LOXL2 and LOXL3 enzymes, Effective anti-fibrotic drug, and/or Drugs to complement existing disease portfolio – lung, liver, kidney, heart, etc.
Slide 16: SSAO (Boehringer Ingelheim): major player in diseases caused by complications of diabetes
SSAO (Boehringer Ingelheim): Pharmaxis poised to be a major player in diseases caused by complications of diabetes Two diseases with high unmet need and large patient populations in Phase 2 studies NASH Diabetic Retinopathy Expected to become leading cause of liver transplant by 2020 Affects ~95
Slide 17: SSAO: Phase 2 trials to show clinical proof of concept in H1 2019
SSAO: Phase 2 trials to show clinical proof of concept in H1 2019 Boehringer Ingelheim responsible for clinical development and commercialisation NASH Diabetic Retinopathy Phase 2a trial expected to report Phase 2a SSAO diabetic retinopathy expected to report H1 2019 – proof H1 2019 – proof of e
Slide 18: SSAO: Boehringer Ingelheim deal
SSAO: Boehringer Ingelheim deal Deal structure illustrates value generating potential of Pharmaxis business model PLUS earn-out payments First indication (NASH) on annual net sales • Tiered percentages Commencement of Commencement of Filing, regulatory & increasing from high phase 2 phase 3 pricing
Slide 19: More programs approaching the clinic
More programs approaching the clinic Program LOX (oral) Combo SSAO/MPO Indication Severe fibrotic indications: Inflammatory bowel disease pancreatic cancer Respiratory disease myelofibrosis Commercialisation Partner after phase 2 Partner after phase 2 Status Commenced pre-clinical tox Q4
Slide 20: Pharmaxis purpose built facility
Pharmaxis purpose built facility Pharmaxis has a purpose built manufacturing and drug development facility in Sydney Manufacturing and research facilities Productive R&D drug discovery engine Team of 15 scientists specialising in amine oxidase chemistry drug discovery and pre clinical developm
Slide 21: Bronchitol for cystic fibrosis
Bronchitol for cystic fibrosis Overview Cystic fibrosis Bronchitol Business model - RoW Business model - US Patients Active ingredient Distributors responsible Phase 3 trial (CF303) – US: 30,000; mannitol delivered as an for promotion & support reported June 2017 – Europe: 37,000; inhalable
Slide 22: Shareholders & trading
Shareholders & trading Financial Information Institutional Ownership3 % ASX Code PXS BVF Partners (US) 22% Market Cap1 $101m Australian Ethical 9% Shares on Issue 320m Allan Gray 6% Employee Options1 17m Montoya Investments (UK) 6% 71m Liquidity (turnover last 12 months)1 Other Institutions 8% share
Slide 23: Financials highlights
Financials highlights A$’000 Three months ended Twelve months ended (unaudited) 30-June-18 30-June-17 30-June-18 30-June-17 Income statements Sales of Bronchitol & Aridol 1,900 866 6,094 4,823 Milestones from sale of drug - - 42,130 - Total revenue 2,213 6,945 50,831 18,001 Total expenses (9,857) (1
Slide 24: New Drug Development
New Drug Development Drug development and clinical trial expenditure by pipeline project New Drug Development Expenses Current status/planned expenditure 16,000 LOXL2: 14,000 2 compounds in phase 1 – will complete H2 12,000 2018 10,000 13 week tox for both compounds $’000 8,000 GMP material
Slide 25: Bronchitol & Aridol
Bronchitol & Aridol Segment profitability Bronchitol & Aridol EBITDA Sales 2015 2016 2017 2018 7,000 20,000 6,000 10,000 5,000 4,000 $’000 - $’000 3,000 -10,000 2,000 1,000 -20,000 - -30,000 -1,000 2015 2016 2017 2018 Sales Other revenue Expenses Aridol Bronchitol - EU Bronchitol - Australia Clinica
Slide 26: Balance sheet – 30 June 2018
Balance sheet – 30 June 2018 Assets ($50m) Liabilities ($39m) PP&E $12.5 Inventory Other $5.9 $2.4 Other $2.4 Finance lease Accounts $8.3 Cash $31.1 payable $2.1 Accounts receivable $1.8 NovaQuest financing $22.8 Finance lease over 20 Rodborough Rd (to 2024) NovaQuest financing – not repayable o
Slide 27: Summary
Summary Pharmaxis is a global leader in drug development for fibrosis & inflammation Pharmaxis have built a successful platform of small molecule drugs targeting high value fibrotic and inflammatory indications Development pipeline across various stages - one drug in two phase 2 trials, one drug
Slide 28: Pharmaxis Ltd contact details
Pharmaxis Ltd Gary Phillips 20 Rodborough Road Chief Executive Officer Frenchs Forest NSW 2086 gary.phillips@pharmaxis.com.au Australia T: +61 2 9454 7200 David McGarvey www.pharmaxis.com.au Chief Financial Officer david.mcgarvey@pharmaxis.com.au