Cyclopharm Limited · ASX:CYC
Cyclopharm — Investor Presentation (May 2022)
35 slides from Cyclopharm's investor presentation, May 24, 2022
Slide 1: Cyclopharm Investor Presentation
For personal use only CYCLOPHARM Investor Presentation 24 May 2022 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: A World Leading Diagnostic Imaging Company
A World Leading Diagnostic Imaging Company Continued profitability and positive cash flow in 1 the core business from sales of Technegas For personal use only across 60 countries with additional revenues growing from third party distribution Over 4.4 million patient procedures to dated 2 supported b
Slide 4: Strategic Priorities
CYC’s CYC has clear strategy to leverage our position as a leading player in the global nuclear medicine imaging market and lung health STRATEGIC space to expand the use of our proprietary products and introduce For personal use only new innovative technology. We will do this by: PRIORITIES 1 Attain
Slide 5: Building for Growth
BUILDING FOR GROWTH Technegas® is a global market leader with significant growth potential in the USA For personal use only market • Total global sales of over $93.1m AUD from 2015 to 2021 ($17.7 in FY 2021) • Technegas® currently available in over 60 countries • Over 4,400,000 patient procedures pe
Slide 6: America Coming Soon
For personal use only 6 AMERICA COMING TO
Slide 7: USFDA Update
1 Pre-Approval Inspection (PAI) conducted 30 March to 7 April 2021 • Inspection based on Drug-Device Combination Product For personal use only • Currently providing USDFDA updates every 60 Days • Significant Documentation Development and Revisions accomplished to date • Facility Modifications – Work
Slide 8: USA Update: Building the Fleet
For personal use only USA UPDATE Building The Fleet 200 Technegas Generators Being Built for Market Launch 8
Slide 9: Immediate Market Opportunity
600K Nuclear Medicine Ventilation 15%/600k Procedures p.a. For personal use only • The Company estimates 4,000,000 patient procedures are conducted in the USA per annum to diagnose pulmonary embolism (15% Nuclear Medicine – 85% CTPA).Current contrast media shortages may be shifting volumes back to n
Slide 10: 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 2 Multiple letters from leading clinicians, front-line workers and the SNMMI have petitioned the USFDA for the approv
Slide 11: Technegas Viewed as Safest Nuclear Medicine Ventilation Agent
Technegas is viewed as the safest nuclear medicine ventilation agent globally Potential Operator and Environmental Exposure: 1 For personal use only Xe-133 requires continuous rebreathing for up to 15 minutes. DTPA requires 3-5 minutes of periodic administration to deliver the target dose Technegas
Slide 12: Global Shortage of CT Contrast Media
Global Shortage of CT Contrast Media Creating Opportunities for Nuclear Medicine For personal use only “VQ Lung Scanning should be considered as an alternative to CTA” 12 https://www.snmmi.org/NewsPublications/NewsDetail.aspx?ItemNumber=40478
Slide 13: USA Pricing & Business Model
USA Pricing & Business Model For personal use only Generators are to be placed at no cost removing potential 1 CAPEX roadblocks 2 Once off installation and training fee charged 3 Ongoing annual fee attributed to preventative maintenance, training and product support Business model expected to result
Slide 14: Expanding Indications
For personal use only EXPANDING INDICATIONS 14
Slide 15: Beyond PE Applications of V/Q SPECT(/CT)
Beyond PE applications of V/Q SPECT(/CT) For personal use only Diagnosis and Preoperative Preoperative Planning radiation Advanced approach Diagnosis and follow-up of assessment of assessment of therapy to target to phenotyping monitoring of Pulmonary homogeneous lung resection tumors while chronic
Slide 16: Beyond Pulmonary Embolism Initiatives Underway
Beyond Pulmonary Embolism Initiatives Underway 392 Patients enrolled globally across 6 Cyclopharm sponsored Beyond PE clinical trials7 For personal use only 1 Hunter Medical Research Institute (Newcastle, AU): Diagnosis and response to therapy in severe asthma and COPD1 100 Patient Study * 100% Recr
Slide 17: Long COVID Study Update
CYCLOPHARM: Long COVID Study Update For personal use only 1 Abstract Presented at the American Thoracic Society 2022 Conference: Long COVID3 US CDC study reports post-COVID conditions can vary from 13.3% at one month or longer after infection; 2.5% at three months or longer, based on self-reporting;
Slide 18: Three Value Horizons
THREE VALUE HORIZONS For personal use only Horizon 2* 3 to 8 Years Horizon 3 >8 Years ENTERPRISE VALUE Convert CTPA Horizon 1* 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 the total and Chronic Obs
Slide 19: Key Catalysts for the Next Years
KEY Catalysts for the Next 2 Years For personal use only 1 FDA approval for Technegas expected mid 2023 2 First sales in US announce (shortly after approval) 3 Ongoing updates on No. Generators placed in US Clinical proof of concept & validation in new substantive respiratory 4 indications 19
Slide 20: Cyclopharm Investment Case
CYCLOPHARM INVESTMENT CASE For personal use only Profitable and First in Class Recurring Revenue USFDA Approval Technegas Product Growing MedTech Established Gold Standard From single patient Set to quadruple the size expansion Underlying business Proprietary product sales to consumables of the exis
Slide 21: Thank You
For personal use only T H A N K YO U 21
Slide 22: Appendix Section
For personal use only APPENDIX SECTION Investor Update 22
Slide 23: FY 2021 Financials
For personal use only 23 FY 2021 FINANCIALS
Slide 24: 2021 Financial Highlights
For personal use only Sales Revenue Record Group Sales revenue of $17.7m, up 20.6% Third Party Distribution $4.1 million of new third‐party distribution revenue, up 89% Net Loss Before Tax $4.3 million loss (includes $1.3m from USFDA expenses) 2021 R&D Tax Incentive $2.3 million received in Jan 2022
Slide 25: 2021 Operating Highlights
Sales Revenue Record Group Sales revenue of $17.7m, up 20.6% with $4.1 million of For personal use only new third‐party distribution revenue USFDA Investment in the final stages of the USFDA regulatory approval 2021 US Commercialisation Preparations for subsequent rapid commercialization in the Unit
Slide 26: Pulmonary Imaging with Technegas
For personal use only PULMONARY IMAGING WITH Investor Update 26
Slide 27: 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 28: USA Commercialisation Pathway
Regulatory Clinical Pre-approval audit conducted CRL Response – 12 months from June 2021 to Key Opinion Leaders engaged submit CYC’s intention to continue Recruit Chief Medical Officer 2022. Type B Meeting held 27/01/22 For personal use only R&D Programs Beyond PE Underway USFDA Review
Slide 29: 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 in the USA from
Slide 30: Evolution of Functional Lung Ventilation Imaging
EVOLUTION OF FUNCTIONAL LUNG VENTILATION IMAGING For personal use only • Improvements in 3D imaging techniques, hybrid imaging and the advent of functional lung ventilation imaging utilising improved imaging techniques are analytical software have dramatically improved the sensitivity and specificit
Slide 31: Evolution of Functional Lung Ventilation Imaging
EVOLUTION OF FUNCTIONAL LUNG VENTILATION IMAGING For personal use only • Improvements in 3D imaging techniques, hybrid imaging and the advent of functional lung ventilation imaging utilising improved imaging techniques are analytical software have dramatically improved the sensitivity and specificit
Slide 32: Nuclear Medicine Imaging Technology Has Evolved Beyond CTPA
NUCLEAR MEDICINE IMAGING TECHNOLOGY HAS EVOLVED BEYOND CTPA IN DIAGNOSING PE For personal use only 1986 2022 Planar SPECT SPECT/CT • Inherent limitations of 2- • Three-dimensional imaging • Integration of anatomic dimensional imaging • Superior contrast resolution information • Overlap of anatomical
Slide 33: Third Party Products
For personal use only Third Party Products Investor Update 33
Slide 34: Cyclopharm Business Partners Around the Globe
CYCLOPHARM BUSINESS PARTNERS AROUND THE GLOBE : For personal use only 34
Slide 35: Cyclopharm: Building for Growth
For personal use only CYCLOPHARM BUILDING FOR GROWTH Investor Update 35