Slide 1: Cyclopharm Shareholder Update
CYCLOPHARM SHAREHOLDER UPDATE James McBrayer, CEO & Managing Director 23 September 2020 1
Slide 2: Safe Harbour Statement
Certain views expressed here contain information derived from publicly available sources that have not been independently verified. The presentation includes certain statements, estimates and projections with respect to the anticipated future financial performance of Cyclopharm Limited and as to the
Slide 3: Company Overview
COMPANY OVERVIEW Cyclopharm Limited (CYC) is a leading diagnostic lung imaging company Lead nuclear medicine product Technegas® is currently available in 60 countries with significant 1 opportunity to expand into the USA with sales targeted for 2021 following completion of USFDA New Drug Application
Slide 4: Our Strategic Priorities
OUR STRATEGIC CYC has clear strategy to leverage our position as a leading player in the global nuclear medicine imaging market and lung health PRIORITIES space to expand the use of our proprietary products and introduce new innovative technology. We will do this by: 1 Attaining approval to distribu
Slide 5: Cyclopharm Investment Case
CYCLOPHARM INVESTMENT CASE Profitable and First in Class Recurring Revenue USFDA Approval Optionality Growing MedTech Proprietary product sales to From consumables similar Set to quadruple the size Into indications beyond PE Underlying business 60 countries with over 4.2 to an annuity model of the e
Slide 6: Cyclopharm Update – September 2020
Cyclopharm Update – 23 September 2020 Clinical Trial CYC-009 Independent Data Efficacy Monitoring Committee (DEMC) determine Primary and Secondary Endpoints have been met Clinical trial to be terminated based on success FDA – NDA Review Midcycle review completed by FDA Iterative Q&A process
Slide 7: Technegas
TECHNEGAS ® World’s Best Functional Lung Ventilation Imaging Agent 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 visualise functional ventil
Slide 8: Pulmonary Embolism
~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 accurate method of if left un
Slide 9: Building for Growth – Company Development
BUILDING FOR GROWTH – COMPANY DEVELOPMENT Technegas® is a substantially de-risked Technegas® Revenue by Region ($ 000’s) commercial proposition with significant upside in the USA market 16,000 14,000 12,000 10,000 8,000 • Total global sales of $118 m from 2010 Technegas® currently available in 60 co
Slide 10: Technegas Around the World
TECHNEGAS® AROUND THE WORLD Available Coming Soon Over 4.2 million Technegas® was introduced Technegas® revenues are generated in to the medical community 60 countries via a combination patient procedures in 1986 1 of direct and distributor sales models to date Investor Update 10
Slide 11: Coming to America
TECB6&NEGAS" COMING TO AMERICA
Slide 12: 600K Nuclear Medicine Ventilation Procedures p.a.
600K Nuclear Medicine Ventilation 15%/600k Procedures p.a. • 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 Technegas® in the USA equate
Slide 13: Benefits of Using Technegas
BENEFITS OF USING TECHNEGAS® Easy Only need 3D images NO Cost to prepare 3 to 4 breaths provide functional contraindications effective and administer imaging through to the alveolus Investor Update 13
Slide 14: Superior to Competitive Nuclear Medicine Products
SUPERIOR TO COMPETITIVE NUCLEAR MEDICINE PRODUCTS Technegas® Easy 3 to 4 breaths 3D images No contraindications Cost-effective Xenon - 133 DTPA Tc99m True radioactive No 3D images Wet Aerosol gas limited to planar impacts efficacy and inhaled with full imaging resulting in clinician interpretations
Slide 15: Superior to Competitive Imaging Modalities
SUPERIOR TO COMPETITIVE IMAGING MODALITIES Technegas® 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, contrast media allergy3, di
Slide 16: The Canadian Case Study
TECHNEGAS® The Canadian Case Study Canada is Cyclopharm’s largest single country market 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 of USA acceptance 120 P
Slide 17: USA 2021 Commercialisation Plan
USA 2021 COMMERCIALISATION PLAN* USFDA Regulatory Approval Secure Customer Commitments Service and Distribution Submission of 505(b)2 NDA March 2020 Securing commitments in Secure service capabilities line with Technegas® and stock 3PL Partners for Approval to file May 2020 Generator lead time USA l
Slide 18: Beyond PE: Clinical Initiatives
BEYOND PE : clinical initiatives Clinical Trials Sponsored by Cyclomedica • 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 therapy in mild to mode
Slide 19: Helping in the Fight Against COVID-19
CYCLOPHARM: Helping in the fight against COVID-19 100-patient clinical trial designed to use ventilation perfusion SPECT-CT with Technegas*: Primary Endpoint: To investigate and characterize the extent of COVID-19 infection related ventilation 1 and perfusion injury at ≤4-weeks and 6-months post inf
Slide 20: Three Value Horizons
THREE VALUE HORIZONS 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 Nuc Med and Chronic Obstructive Procedures for PE
Slide 21: Building from a Strong and Well-Established Foundation
USA Market nuclear medicine ventilation imaging market to diagnose PE equal to $90m USD with reimbursement already in place BUILDING FROM A STRONG AND Targeting USA CTPA PE Market opportunity to convert CTPA to WELL-ESTABLISHED nuclear medicine imaging by shifting market to SPECT imaging FOUNDATION
Slide 22: Thank You
THANK YOU 22
Slide 23: Appendix
APPENDIX 23
Slide 24: 2019 Financials
2019 FINANCIALS 24
Slide 25: FY2019 Results Highlights
FY2019 RESULTS HIGHLIGHTS Group Sales Revenue $14.08 million - an increase of 5% Gross Margin $11.62 million – an increase of 7% Gross Margin % 82.5% Net Loss After Tax ($2.91) million including USFDA investment Dividends 1.0 cents per share Underlying Technegas® $0.89 million PBT1 FDA Trial expense
Slide 26: FY2019 Operational Highlights
FY2019 OPERATIONAL HIGHLIGHTS Technegas® Application in determining ventilation pre and post lung reduction intervention USFDA All internal documentation completed with a Q1 2020 USFDA submission USA USA entity established Commercialisation Indication Expansion HMRI completes recruitment – New initi
Slide 27: Group Underlying Performance
GROUP UNDERLYING PERFORMANCE Solid Underlying Financial Results YEAR ENDED 31 DECEMBER 2019 2018 INC/(DEC) CHANGE $’000 $’000 $’000 % During the year, CYC continued to implement SALES REVENUE 14,079 13,404 675 5% its strategic priorities, which are to: GROSS MARGIN 11,619 10,855 764 7% GROSS MARGIN
Slide 28: Group Balance Sheet
GROUP BALANCE SHEET Financial Foundation to Leverage Growth Strategy Low debt and cash on hand – 1 provides balance sheet and Year ended 31 December ($000’s) 2019 2018 2017 funding flexibility Cash 12,660 5,855 8,690 Other current assets 6,950 9,600 8,139 Non-current Assets 12,918 8,082 6,548 Fundin
Slide 29: Group Cash Position
GROUP CASH POSITION Cash Position Funding Growth Institutional share placement of 8.5 million Year ended 31 December ($000’s) 2019 2018 2017 1 shares in December 2018 resulting in $9.78m at an 11.7% premium Operating Activities (489) (1,107) (682) Investing Activities (821) (1,403) (1,136) Financing
Slide 30: Product Profile
-Cé&§NEGAS” Product Profile
Slide 31: Technegas Product Overview
TECHNEGAS Product Overview Cyclopharm’s leading product is the Technegas technology system • The Technegas® proprietary technology • The Technegas® images provide the provides high quality diagnostic functional clinician an understanding of how well the lung imaging. patient’s lungs are functioning
Slide 32: What is Technegas?
WHAT IS TECHNEGAS? PARTICLE MANUFACTURE AND CHARACTERISTICS DISTRIBUTION Technegas® is composed of Tc-99m cores Technegas® is produced on site at the point of encapsulated within layers of graphite to form patient administration. individual hexagonal plate-like particles.1 Technegas® is manufactured
Slide 33: Advantages of Technegas
ADVANTAGES OF TECHNEGAS® Competitive Nuclear Medicine Products Technegas® provides a safer clinically superior outcomes to its competitors Product Comparison to Technegas® • Technegas product characteristics, Delivery System and etremely short administration time combined significantly reducing risk
Slide 34: Existing Marketing Development Strategy
EXISTING MARKETING DEVELOPMENT STRATEGY • Sales and marketing program targeting referring respiratory physicians • Implemented educational programs for Distributors • Updating Technegas® distribution contracts to include detailing to respiratory physicians • Leveraging New Complementary Technologies
Slide 35: What the Guidelines Say About Technegas
“ Using 99m-Tc-Technegas is according to clinical experience better 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 are inferior for SPECT
Slide 36: Technegas
TECHNEGAS® 66% of references citing Technegas® in the past 24 months In recent literature are for indications Beyond PE 1. King GG, et al. Dismantling the pathophysiology of asthma using imaging. Eur Respir Rev 2019; 16. Dimastromatteo J, et al. Molecular imaging of pulmonary diseases. Respir Res 20
Slide 37: Pulmonary Imaging with Technegas
PULMONARY IMAGING witH + = Cé&N E-GAS"
Slide 38: Evolution of Functional Lung Ventilation Imaging
EVOLUTION OF FUNCTIONAL LUNG VENTILATION IMAGING • 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 specificity expanding the potent
Slide 39: Nuclear Medicine Imaging Technology Has Evolved Beyond CTPA
NUCLEAR MEDICINE IMAGING TECHNOLOGY HAS EVOLVED BEYOND CTPA IN DIAGNOSING PE 1986 2020 Planar SPECT SPECT/CT • Inherent limitations of 2- • Three-dimensional imaging • Integration of anatomic dimensional imaging • Superior contrast resolution information • Overlap of anatomical segments • Improved a
Slide 40: Radiation Dosimetry
Technique Effective Effective Breast Lung dose dose absorbed absorbed (mSv/MBq) (mSv) dose dose (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 (800MBq) 1 A nuclear
Slide 41: Nuclear Medicine Provides Better Diagnostic Outcomes in Diagnosing PE
NUCLEAR MEDICINE PROVIDES BETTER DIAGNOSTIC OUTCOMES IN DIAGNOSING PE • 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, paediatrics and the PPV COP
Slide 42: Reclaiming and Expanding Pulmonary Imaging
RECLAIMING AND EXPANDING PULMONARY IMAGING Utilizing Available Education Technology Educating referring physicians to Leveraging the state of the art the facts, benefits and capabilities of techniques to include SPECT, SPECT- nuclear medicine will bring back CT & Quantification Software lung imaging
Slide 43: Expanding Indications
EXPANDING INDICATIONS + = Cé&aN E-GAS"
Slide 44: Technegas Global Indication Expansion
TECHNEGAS Global Indication Expansion Applications in chronic disease has the potential to dwarf the use of Technegas in Pulmonary Embolism. In 2015 Cyclopharm commenced a clinical program targeting Technegas indication expansion to include: Chronic Obstructive Pulmonary Disease Asthma • 30x the siz
Slide 45: Clinical Call for Action
CLICNICAL CALL FOR ACTION A new way of thinking about respiratory Medicine Functional ventilation imaging using Technegas® may provide useful biomarker information in assessing baseline diagnosis and response to therapy in respiratory disease Lancet Commission - After asthma: redefining airways dise
Slide 46: Hybrid V/Q SPECT/CT
HYBRID V/Q SPECT/CT Combination of functional and V/Q SPECT provides functional Low-dose CT provides anatomical information allow for information on ventilation and anatomical information such objective results through perfusion of the lungs1,2 as fissures delineation3 quantitative software2,3 VENTI
Slide 47: Treatment Response in Asthma Patient
TREATMENT RESPONSE BASELINE METHACHOLINE IN ASTHMA PATIENT TREATMENT BEFORE CLINICAL HISTORY Male patient of 25 years old Bronchoconstriction after methacholine challenge worsened with life-long asthma ventilation function and increased ventilation heterogeneity. This was predicted by baseline perip
Slide 48: Planning Lung Volume Reduction Surgery
PLANNING LUNG VOLUME REDUCTION SURGERY CORONAL FUSION SAGITTAL FUSION UPPER LOBES LOWER LOBES TRANSVERSE TRANSVERSE FUSION FUSION CLINICAL HISTORY Male patient of 64 years old with emphysema The ventilation SPECT/CT scan reveals the function of the lower lobes is severely affected. The left oblique
Slide 49: Cyclopharm Building for Growth
CYCLOPHARM BUILDING FOR GROWTH 49