Slide 1: Financial Year 2019 Results Presentation
For personal use only Cyclopharm Financial Year 2019 Results Presentation James McBrayer, CEO & Managing Director 1 Technegas® is not commercially available in the USA 3 March 2020
Slide 2: Safe Harbour Statement
Safe Harbour Statement For personal use only 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 pe
Slide 3: Company Overview
Company Overview For personal use only Cyclopharm Limited (CYC) is a leading diagnostic lung imaging company A world leader in functional lung ventilation imaging technology Recurring consumables and capital equipment revenue streams A profitable and growing company with a history of dividend
Slide 4: Our Strategic Priorities
Our Strategic Priorities For personal use only CYC has clear strategy to leverage our position as a leading player in the global nuclear medicine imaging market and lung health space to expand the use of our proprietary products and introduce new innovative technology. We will do this by: 1. Attaini
Slide 5: Technegas: World's Best Functional Lung Ventilation Imaging Agent
Technegas For personal use only 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 visuali
Slide 6: Pulmonary Embolism
Pulmonary Embolism For personal use only ~3 million Symptoms cases of PE p.a. are varied with but could be diagnosis confirmed much higher either through CTPA or 30% a nuclear medicine Nuclear Medicine using of pulmonary ventilation-perfusion 3-D imaging is the most embolisms are fatal if study accu
Slide 7: FY2019 Results Highlights
FY2019 Results Highlights For personal use only 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 PBT1 $0.89 mill
Slide 8: Building for Growth – Company Development
Building for Growth – Company Development For personal use only Technegas is a substantially de-risked commercial Technegas Revenue by Region ($ 000’s) proposition with significant upside in the USA market 16,000 Total global sales of $118 m from 2010 14,000 12,000 10,000 Technegas currently ava
Slide 9: FY2019 Operational Highlights
FY2019 Operational Highlights For personal use only Technegas Record revenues recorded in the key markets of Canada and France USFDA All internal documentation completed with a Q1 2020 USFDA submission USA Commercialisation USA entity established Indication Expansion HMRI completes recruitment – New
Slide 10: Group Underlying Performance
Group Underlying Performance For personal use only Solid Underlying Financial Results YEAR ENDED 31 DECEMBER 2019 2018 INC/(DEC) CHANGE During the year, CYC continued to implement its strategic $’000 $’000 $’000 % priorities, which are to: SALES REVENUE 14,079 13,404 675 5% GROSS MARGIN 11,619 10,85
Slide 11: Group Balance Sheet
Group Balance Sheet For personal use only Financial Foundation to Leverage Growth Strategy Year ended 31 December Low debt & cash on hand – provides balance sheet and funding ($000’s) 2019 2018 2017 1 flexibility Cash 12,660 5,855 8,690 Other current assets 6,950 9,600 8,139 Non-current Assets 12,91
Slide 12: Group Cash Position
Group Cash Position For personal use only Cash Position Funding Growth Year ended 31 December ($000’s) 2019 2018 2017 Operating Activities (489) (1,107) (682) 1 Institutional share placement of 8.5 million shares in December 2018 resulting in $9.78m at an 11.7% premium Investing Activities (821) (1,
Slide 13: Coming to America
For personal use only Coming to America 13 Technegas® is not commercially available in the USA
Slide 14: Benefits of using Technegas
Benefits of using Technegas For personal use only Easy Only need 3D images No Cost to prepare and 3 to 4 breaths provide functional contraindications effective administer imaging through to the alveolus 14 Technegas® is not commercially available in the USA
Slide 15: Superior to competitive nuclear medicine products
Superior to competitive nuclear medicine products For personal use only Technegas Easy 3 to 4 breaths 3D images No Cost-effective contraindications Xenon - 133 DTPA Tc99m True radioactive No 3D images Wet Aerosol gas limited to planar impacts efficacy and inhaled with full imaging resulting in clini
Slide 16: Superior to competitive imaging modalities
Superior to competitive imaging modalities For personal use only Technegas Easy 3 to 4 breaths 3D images No Cost-effective contraindications CTPA High radiation burden Contraindications Lower clinical Acute kidney injury (AKI) Availability sensitivity CTPA delivers at least CTPA should not be AKI oc
Slide 17: Technegas – USA Market Opportunity
Technegas – USA Market Opportunity 4,000,000 patient procedures conducted in the USA per annum to For personal use only diagnose pulmonary embolism (15% Nuclear Medicine – 85% CTPA) 600,000 Nuclear Medicine Ventilation procedures equals $90m USD 600K Nuclear Medicine Ventilation Target market
Slide 18: Technegas FDA Clinical Trial Process and Design
Technegas FDA Clinical Trial Process and Design For personal use only USFDA Clinical trial1 registered at: https://clinicaltrials.gov/ct2/show/NCT03054870?term=technegas&rank=1 Non-inferiority structural ventilation study comparing Xe133 vs. Technegas1 Approval Planned 240 patient study at 9 clinica
Slide 19: USA 2020 Commercialisation Plan
USA 2020 Commercialisation Plan For personal use only Build Inventory People Materials Resource Hire Key USA Personnel Planning underway with to include Sales and production targeting 200 Service Techengas generators roll- out per anum USFDA Regulatory Secure Customer Distribution Approval Commitmen
Slide 20: Three Value Horizons
Three Value Horizons For personal use only Horizon 1 Horizon 2 Horizon 3 0 to 5 Years 3 to 8 Years >8 Years Innovate Beyond PE Establish USA Convert CTPA Half billion Enterprise Value Double existing Nuc Med combined sufferers of Asthma and 80% Conversion of Nuc Chronic Obstructive Pulmonary Med Pro
Slide 21: Beyond PE: clinical initiatives
Beyond PE : clinical initiatives For personal use only Clinical Trials Sponsored by Cyclomedica • Hunter Medical Research Institute (Newcastle, AU): Diagnosis and response PATIENT MANAGEMENT & SCREENING to therapy in severe asthma and COPD1 Response to Therapy and Personalized Medicine • Woolcock In
Slide 22: Cyclopharm Investment Case
CYCLOPHARM INVESTMENT CASE For personal use only Profitable & First in class Recurring USFDA approval Optionality Growing proprietary product revenue set to quadruple the size into indications beyond sales to 59 countries of the existing PE business PE into chronic MedTech from consumables and furth
Slide 23: Building from a strong & well-established foundation
Building from a strong & well-established foundation For personal use only Near term opportunities providing significant growth potential beyond PE toward patient management USA Market Targeting USA CTPA Half billion nuclear medicine PE market combined sufferers of ventilation imaging opportunity to
Slide 24: Thank You
For personal use only Cyclopharm Thank You 24 Technegas® is not commercially available in the USA
Slide 25: Appendix Section
For personal use only Cyclopharm Appendix Section 25 Technegas® is not commercially available in the USA
Slide 26: What is Technegas?
What is Technegas? For personal use only Particle characteristics Manufacture and Distribution Technegas is composed of Tc-99m Technegas is produced on site at the point of patient cores encapsulated within layers of administration. graphite to form individual Technegas is manufactured by heating Te
Slide 27: Technegas Product Overview
Technegas Product Overview For personal use only Cyclopharm’s leading product is the Technegas technology system The Technegas proprietary technology provides high quality diagnostic functional lung imaging. Predominantly used to diagnose the presence of blood clots in the lung otherwise known a
Slide 28: Technegas around the world
Technegas around the world For personal use only Technegas was introduced to the medical community in 1986 1 Technegas revenues are generated in 59 countries via a combination of direct and distributor sales models Over 4.2 million patient procedures to date 1. Wiebe LI, et al. Current Radiopharmace
Slide 29: Advantages of Technegas
Advantages of Technegas For personal use only Technegas provides clinically superior outcomes to its competitors Competitive Nuclear Medicine Products Better clinical results at a fraction of the high radiation doses used in CTPA Cost-effective (angiograms) Product Comparison to Technegas No con
Slide 30: Existing Market Development Strategy
Existing Market Development Strategy For personal use only 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 Compleme
Slide 31: Technegas – The Canadian Case Study
Technegas – The Canadian Case Study For personal use only Canada is Cyclopharm’s largest single country market The Generator and Consumable Relationship Market leader for diagnosing PE Technegas Growth - Canada 50 160 Patients per Annum (thousands) 14 consecutive years of PAS growth 45 140 Represent
Slide 32: What the guidelines say about Technegas
What the guidelines say about Technegas: Endorsed by the guidelines from the European1-2 and the Canadian3 Associations of Nuclear Medicine (EANM & CANM) For personal use only “ Using 99m-Tc-Technegas is according to clinical experience better than the best aerosols ” “ Technegas facilitates interpr
Slide 33: Technegas in the recent literature
66% of references citing Technegas in Technegas in the recent literature the past 24 months are for indications Beyond PE For personal use only 1. King GG, et al. Dismantling the pathophysiology of asthma using imaging. Eur Respir Rev 2019; Pulmonol. 2018; 25(1): 48-53 28(152): pii: 1801111 16. Dima
Slide 34: Pulmonary Imaging With Technegas
For personal use only Pulmonary Imaging With 34 Technegas® is not commercially available in the USA
Slide 35: 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 analytical software have dramatically improved the sensitivity and specificity in functional lung imaging with Technegas 2019 Traditionally used in the d
Slide 36: Nuclear Medicine Imaging Technology Has Evolved Beyond CTPA in Diagnosing PE
Nuclear Medicine Imaging Technology Has Evolved Beyond CTPA in Diagnosing PE PLANAR SPECT SPECT/CT For personal use only 2020 Inherent limitations of 2-dimensional Three-dimensional imaging Integration of anatomic information imaging 1986 Overlap of anatomical segments Superior contrast resolution D
Slide 37: Radiation Dosimetry
Radiation Technique Effective dose Effective dose Breast absorbed Lung absorbed Dosimetry (mSv/MBq) (mSv) dose (mGy) dose (mGy) For personal use only Ventilation Technegas 0.015 0.30 0.13 2.2 (20MBq) 1-3 Ventilation 99mTc-DTPA 0.007 0.14 0.04 0.30 A nuclear (20MBq) 1-2 medicine V/Q Ventilation 133Xe
Slide 38: 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 is superior in Accuracy most clinical settings with better overall diagnostic performance1. In situation of acute PE, chronic PE pregnancy, paediatrics
Slide 39: Reclaiming and Expanding Pulmonary Imaging
Reclaiming and Expanding Pulmonary Imaging For personal use only Education Educating referring physicians to the facts, benefits and capabilities of nuclear medicine will bring back lung imaging to nuclear medicine Utilizing Available Technology Leveraging the state of the art techniques to include
Slide 40: Technegas Expanding Indications
For personal use only Technegas Expanding Indications 40 Technegas® is not commercially available in the USA
Slide 41: Technegas – Global Indication Expansion
Technegas – Global Indication Expansion For personal use only 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 D
Slide 42: Clinical Call for Action
Clinical Call for Action For personal use only Functional ventilation imaging using A new way of thinking about respiratory Technegas may provide useful Medicine biomarker information in assessing baseline diagnosis and response to therapy in respiratory disease Lancet Commission - After asthma: red
Slide 43: Hybrid V/Q SPECT/CT
Hybrid V/Q SPECT/CT For personal use only Ventilation SPECT Low-dose CT Fused SPECT/CT V/Q SPECT provides functional information on ventilation and perfusion of the lungs1,2 Low-dose CT provides anatomical information Lobar distribution of ventilation such as fissures delineation3 Combination of fun
Slide 44: Treatment response in asthma patient
Treatment response in asthma patient For personal use only Case 1 BASELINE METHACHOLINE CLINICAL HISTORY Bronchoconstriction after Male patient of 25 years old with life- methacholine challenge TREATMENT long asthma worsened ventilation BEFORE function and increased ventilation heterogeneity. This w
Slide 45: Planning lung volume reduction surgery
Planning lung volume reduction surgery For personal use only Case 2 CLINICAL HISTORY Male patient of 64 years old with emphysema CORONAL FUSION SAGITTAL FUSION UPPER LOBES LOWER LOBES TRANSVERSE TRANSVERSE FUSION FUSION REFERRAL Assessment of lung ventilation function before planning endoscopic lung
Slide 46: Building for Growth
For personal use only BUILDING FOR GROWTH 46 Technegas® is not commercially available in the USA