Slide 1: A profitable and growing market leader in nuclear lung imaging
For personal use only Cyclopharm Limited A profitable and growing market leader in nuclear lung imaging 2017 Results Presentation March 2018 1
Slide 2: Disclaimer
For personal use only Disclaimer 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
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 Strategy
Our Strategy 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. Attaining approval
Slide 5: FY2017 Results Highlights
FY2017 Results Highlights For personal use only Group Sales Revenue $13.19 million Gross Margin $10.74 million Net Loss After Tax ($1.52) million Full Year Dividends 1.0 cents per share Underlying Technegas EBITDA1 $2.64 million FDA Trial expenses ($2.58) million Strong balance sheet $
Slide 6: 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
Slide 7: Technegas - Proven Market Adoption
Technegas - Proven Market Adoption For personal use only Technegas is a substantially de-risked commercial proposition with significant upside in the US market Total global sales of $90m from 2010 Technegas currently available in 56 countries Over 200,000 patient procedures in 2017 Over 3.8
Slide 8: 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 (angiograms) Product Comparison to Technegas No contraindications
Slide 9: FDA Trial and USA Commercialisation
For personal use only FDA Trial and USA Commercialisation 9
Slide 10: Technegas - USA Market Opportunity
Technegas - USA Market Opportunity For personal use only Target market for Technegas in the USA equates to ~480,000 patient procedures of the total 600,000 600K Nuclear Medicine Ventilation procedures conducted p.a.in that market (Current Rest of the World volumes for Technegas = ~200,000 patients
Slide 11: 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 • 14 consecutive years of PAS growth • Represents a strong indicator of USA acceptance • Xe-133 rapidly displaced
Slide 12: FDA Clinical Trial Process and Design
Technegas FDA Clinical Trial Process and Design For personal use only Study Specifics: Non-inferiority structural ventilation study comparing Xe133 vs. Technegas Pathway to approval requires a two part study CYC 010 – Establishes the Inter & Intra reader variability for Xe133 – Completed CYC
Slide 13: USFDA Patient Recruitment Update
USFDA Patient Recruitment Update For personal use only Sites Actively Enrolling Patients Technegas Phase 3 Clinical Trial Recruitment Washington University – St Louis Missouri 40 15 Cumulative Patients By Site Duke University – Durham North Carolina 30 Active Sites 10 Morton Plant – Clearwater
Slide 14: Pathway to US commercialisation
Pathway to US commercialisation For personal use only New Manufacturing Facility Q4 2016 – Increased capacity to meet future demand & regulatory requirements Target preliminary study completion Q1 2018 – Conclude a preliminary study of 40 patients and receive feedback from the FDA Target FDA T
Slide 15: Technegas Expanding Indications
For personal use only Technegas Expanding Indications 15
Slide 16: 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 Traditionally used in the diagno
Slide 17: 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 18: 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 19: 2018 Strategic Priorities and Outlook
2018 Strategic Priorities and Outlook For personal use only Strategic Goals & Guidance Activity Timeframe United States • Continue patient recruitment Ongoing FDA Approval • Expand clinical trial sites Ongoing • Complete Extended Technegas particulate study 1H 2018 • Submit preliminary 40 patient re
Slide 20: Expected rapid adoption of Technegas in US
For personal use only Expected rapid adoption of Technegas in US is based on our Canadian experience and views of US Clinicians. Hear what our Clinicians have to say: Go to Testimonials @ http://cyclopharm.com.au/clinical/ 20
Slide 21: Appendix
For personal use only Appendix FY17 Results Technegas Newcastle Trial UltraluteTM MMI Disclaimer 21
Slide 22: 2017 Operating Highlights
2017 Operating Highlights For personal use only Technegas continuing to perform well – Technegas volumes performing to expectations - healthy growth in Canada and Europe. 2017 saw an expected absence of sales in China following 2016 seeding initiative and destocking in France. China and France sal
Slide 23: Group Underlying Performance
Group Underlying Performance For personal use only During the year, CYC continued to implement its Solid Underlying Financial Results strategic priorities, which are to: 1. Grow the core business, based on expanding Year ended 31 December 2017 2016 Technegas sales in existing markets; ($000’s) Sales
Slide 24: Group Balance Sheet
Group Balance Sheet For personal use only Financial Foundation to Leverage Growth Strategy Low debt & $8.7m cash on hand – provides balance sheet and funding flexibility Year ended 31 December 2017 2016 ($000’s) Funding used toward USFDA clinical trial Cash 8,690 4,591 Other current assets 8,139
Slide 25: Group Cash Position
Group Cash Position For personal use only Solid Cash Generation & Funded for Growth Successful Capital Raising Year ended 31 December ($000’s) 2017 2016 Operating Activities (282) 655 Completed a fully-underwritten Investing Activities (1,536) (2,221) Entitlement Offer that raised $6.59 Financing
Slide 26: What is Technegas?
What is Technegas? For personal use only Technegas is the world leader in functional lung ventilation Technegas is a imaging. System Technegas is a structured ultra-fine dispersion of radioactive gas In order to deliver the best like substance which is inhaled by the patient. It allows imaging for
Slide 27: FDA Approved Trial Design
FDA Approved Trial Design For personal use only De-risked clinical trial strategy - In order to mitigate regulatory risk the Company adopted the FDA Special Protocol Assessment (SPA) pathway for its US clinical trial FDA approved trial design - The SPA pathway provided the Company with the oppor
Slide 28: Indication expansion – Australian Initiative
Technegas Indication expansion – Australian Initiative For personal use only Partnership with the University of Newcastle, John Hunter Hospital and Hunter Medical Research Institute Targeting Clinical Applications in COPD Patients Clinical Hypothesis: Small airway dysfunction assessed using Te
Slide 29: Ultralute
UltraluteTM For personal use only Innovative, first-in-class, disruptive, proprietary technology used to improve radiopharmaceutical manufacturing efficiency and deliver health care cost effectiveness Technical Features • Extension of Generator life – the Ultralute will extend the effective use of a
Slide 30: Macquarie Medical Imaging
Macquarie Medical Imaging For personal use only Joint venture with: • 50% Alfred Health Solutions CT MRI PET • 30% Macquarie University • 20% Cyclopharm Comprehensive suite of imaging modalities State of the art research platform Growth and profitability linked to ramp-up Cardiac CT Ultra-so
Slide 31: Disclaimer
For personal use only Disclaimer Corporate Head Office Certain views expressed here contain information derived from publicly available sources that have not been Cyclopharm Limited independently verified. Unit 4, 1 The Crescent The presentation include certain statements, estimates and projections