Cyclopharm Limited · ASX:CYC
Cyclopharm — Investor Presentation (January 2021)
30 slides from Cyclopharm's investor presentation, Jan 25, 2021
Slide 1: Capital Raising for USA Commercialisation
For personal use only CYCLOPHARM CAPITAL RAISING FOR USA COMMERCIALISATION James McBrayer, CEO & Managing Director 25 January 2021 1
Slide 2: Safe Harbour Statement
Certain views expressed here contain information derived from publicly available sources that have not been independently verified. For personal use only The presentation includes certain statements, estimates and projections with respect to the anticipated future financial performance of Cyclopharm
Slide 3: Executive Summary
Executive Summary • Cyclopharm’s lead nuclear medicine product Technegas® is currently available in 60 countries • Over 4,300,000 patient procedures performed since first approved Cyclopharm Limited (CYC) is a 1,600 Technegas® generators sold globally since first approved For personal use only • 1 l
Slide 4: Building for Growth – Company Development
BUILDING FOR GROWTH – Technegas® is a substantially de-risked COMPANY DEVELOPMENT commercial proposition with significant upside in the USA market For personal use only • Total global sales of $67.6m AUD from 2015 to 2019 • Technegas® currently available in 60 countries • Over 4,300,000 patient proc
Slide 5: Technegas Around the World
TECHNEGAS® AROUND THE WORLD For personal use only Available Coming Soon Over 4.3 million Technegas® was introduced Technegas® revenues are generated in to the medical community 60 countries via a combination patient procedures in 1986 of direct and distributor sales models to date Investor Update 5
Slide 6: Pulmonary Embolism
For personal use only ~3 million Symptoms cases of PE p.a. are varied with diagnosis but could be confirmed either through much higher CTPA or a nuclear medicine ventilation-perfusion study PULMONARY EMBOLISM 30% Nuclear Medicine of pulmonary using 3-D imaging is the embolisms are fatal most accurat
Slide 7: Technegas: World's Best Functional Lung Ventilation Imaging Agent
TECHNEGAS ® World’s Best Functional Lung Ventilation Imaging Agent For personal use only Patient inhales extremely small carbon particles labeled with 99mTechnetium1 The small size and hydrophobic properties demonstrates gas like-behavior and alveoli deposition into the lungs2-3 Clinicians can visua
Slide 8: What the Guidelines Say About Technegas
“ Using 99m-Tc-Technegas is according to clinical experience better For personal use only than the best aerosols ” “ Technegas® facilitates interpretation, particularly in COPD” “ For ventilation, 99m-Tc Technegas® is the best-aerosol particularly in patients with COPD ” WHAT THE “ Liquid aerosols a
Slide 9: Radiation Dosimetry
Technique Effective Effective Breast Lung dose dose absorbed absorbed (mSv/MBq) (mSv) dose dose For personal use only (mGy) (mGy) Ventilation 0.015 0.30 0.13 2.2 RADIATION Technegas (20MBq) 1-3 DOSIMETRY Ventilation 99mTc- DTPA (20MBq) 1-2 0.007 0.14 0.04 0.30 Ventilation 133Xe 0.0014 1.12 0.09 0.89
Slide 10: Nuclear Medicine Provides Better Diagnostic Outcomes in Diagnosing PE
NUCLEAR MEDICINE PROVIDES BETTER DIAGNOSTIC OUTCOMES IN DIAGNOSING PE For personal use only • V/Q SPECT and V/Q SPECT/CT have shown that V/Q SPECT/CT Accuracy is superior in most clinical settings with better overall diagnostic performance1 NPV • In situation of acute PE, chronic PE pregnancy, paedi
Slide 11: Benefits of Using Technegas
BENEFITS OF For personal use only USING TECHNEGAS® Easy Only need 3D images NO Cost COVID-19 to prepare 3 to 4 breaths provide functional contraindications effective Safe and administer imaging through to the alveolus Investor Update 11
Slide 12: Superior to Competitive Nuclear Medicine Products
SUPERIOR TO COMPETITIVE NUCLEAR MEDICINE PRODUCTS Technegas® For personal use only Easy 3 to 4 breaths 3D images No contraindications Cost-effective Covid-19 Safe Xenon - 133 DTPA Tc99m True radioactive No 3D images Wet Aerosol gas inhaled with limited to planar impacts efficacy, bronchospasm, full
Slide 13: Superior to Competitive Imaging Modalities
SUPERIOR TO COMPETITIVE IMAGING MODALITIES Technegas® For personal use only CTPA High radiation burden Contraindications CTPA delivers at least 27 times CTPA should not be performed Easy 3 to 4 breaths more radiation to the breast as with pregnancy1-2, renal compared to V/Q SPECT1 impairment3, contr
Slide 14: The Canadian Case Study
TECHNEGAS® The Canadian Case Study Canada is Cyclopharm’s largest single country market For personal use only The Generator and Consumable Relationship 1 Market leader for diagnosing PE Technegas® Growth - Canada 50 160 2 14 consecutive years of PAS growth 45 140 40 3 Represents a strong indicator o
Slide 15: Coming to America in 2021
For personal use only COMING TO AMERICA IN 2021 15
Slide 16: Immediate Market Opportunity
600K Nuclear Medicine Ventilation 15%/600k Procedures p.a. For personal use only • 4,000,000 patient procedures conducted in the USA per annum to diagnose pulmonary embolism (15% Nuclear Medicine – 85% CTPA) • 600,000 Nuclear Medicine Ventilation procedures equals $90m USD • Target market for Techne
Slide 17: USA Reimbursement Is Established
USA REIMBURSEMENT IS ESTABLISHED For personal use only MEDICARE HOPPS (HOSPITAL OUTPATIENT PROSPECTIVE PAYMENT SYSTEM) $USD 1 Nuclear medicine lung imaging reimbursement is based on established procedures and is agnostic as to the ventilation agent used 2 Technegas® will be reimbursed for the full c
Slide 18: USA Pricing & Business Model
USA PRICING & BUSINESS MODEL Generators placed “free” for quick penetration and to build consumable revenue For personal use only • Generators to be placed at no cost to US sites • Allows for rapid market penetration Example Return Metrics For First 100 • No roadblocks from hospital administration a
Slide 19: USA Demand Established
USA Demand Established No requirement for large sales team due to pre-approval demand For personal use only 1 9 sites in the US already have generators installed from clinical trials Multiple letters from leading clinicians and front-line workers petitioning the USFDA to expedite approval of Techneg
Slide 20: USA Commercialisation Pathway
Clinical Regulatory Key Opinion Leaders engaged Pre-approval audit scheduled for the Recruit Chief Medical Officer. week of 29 March ‘21 For personal use only R&D Programs Beyond PE Underway Commercial 3PL Recruit BDM Feb 2021 Short-list distribution providers identified USA COMMERICIALI
Slide 21: Additional US Tailwinds from Use of Technegas in COVID-19
CYCLOPHARM: Technegas is viewed as the safest nuclear Additional US tailwinds from the medicine ventilation agent globally For personal use only use of Technegas in COVID-19 Potential Operator and Environmental Exposure: Xe-133 requires continuous rebreathing for up to 15 minutes. 1 DTPA requires 3-
Slide 22: Expanding Indications
For personal use only EXPANDING INDICATIONS 22
Slide 23: Beyond PE: Clinical Initiatives
BEYOND PE : Clinical Initiatives Clinical Trials Sponsored by Cyclopharm6 For personal use only • Hunter Medical Research Institute (Newcastle, AU): Diagnosis and response to therapy in severe asthma and COPD1 PATIENT MANAGEMENT • Woolcock Institute (Sydney, AU): & SCREENING Diagnosis and response t
Slide 24: Three Revenue Horizons
THREE REVENUE HORIZONS For personal use only Horizon 2* 3 to 8 Years Horizon 3 Convert CTPA >8 Years Horizon 1* $USD POTENTIAL Double existing Nuc Med Innovate Beyond PE 0 to 5 Years Procedures for PE HALF BILLION Establish USA combined sufferers of Asthma 80% Conversion of Nuc Med and Chronic Obstr
Slide 25: Key Catalysts for the Next Years
KEY Catalysts for the Next 2 Years For personal use only 1 FDA approval for Technegas expected by H1 2021 2 First sales in US announce (shortly after approval) 3 Ongoing updates on No. Generators placed in US Additional guidelines and clinical papers to come out on the use of 4 Technegas in both pul
Slide 26: Cyclopharm Investment Case
CYCLOPHARM INVESTMENT CASE For personal use only Profitable and First in Class Recurring Revenue USFDA Approval Optionality Growing MedTech Established Gold Standard From single patient Set to quadruple the size Into indications beyond PE Underlying business Proprietary product sales to consumables
Slide 27: Capital Raising Details
For personal use only CAPITAL RAISING DETAILS 27
Slide 28: Offer Details
Offer Details For personal use only Placement to institutions, sophisticated and professional investors to raise up to approximately A$30.0 million via the issue of up to 11.5m shares: Placement Issue Price A$2.60 per share Placement of up to approximately A$30.0m under the company’s existing 15% Pl
Slide 29: Offer Timetable
Offer Timetable For personal use only Trading halt Thursday, 21 January 2021 Transaction announced & Company resumes trading Monday 25 January 2021 Placement Settlement of new shares Friday, 29 January 2021 Placement Allotment of new shares Monday 1 February 2021 Investor Update 29
Slide 30: Thank You
For personal use only 30 THANK YOU