Slide 1: Cyclopharm Limited 2018 AGM Presentation
Cyclopharm Limited A profitable and growing market leader in nuclear lung imaging 2018 AGM Presentation 29 May 2018 1
Slide 2: Chairman's Address
2018 AGM Chairman’s Address David Heaney 2
Slide 3: Managing Director's Review
2018 AGM Managing Director’s Review James McBrayer 3
Slide 4: Company Overview
Company Overview 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 payments Lead nuclea
Slide 5: Building For Growth – Company Development
Building For Growth – Company Development 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 By Q4 2018 4,000,000 pat
Slide 6: FY2017 Results Highlights
FY2017 Results Highlights 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 $8.7 million of cash re
Slide 7: 2017 Operating Highlights
2017 Operating Highlights 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 sales to resume / increas
Slide 8: Group Underlying Performance
Group Underlying Performance 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 revenue, ex China see
Slide 9: Group Balance Sheet
Group Balance Sheet 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) Cash 8,690 4,591 Funding used toward USFDA clinical trial Other current assets 8,139 6,470 Non-current Asset
Slide 10: Group Cash Position
Group Cash Position Solid Cash Generation & Funded for Growth Successful Capital Raising Year ended 31 December ($000’s) 2017 2016 Completed a fully-underwritten Entitlement Operating Activities (282) 655 Offer that raised $6.59 million after costs. Investing Activities (1,536) (2,221) Capital r
Slide 11: Building for Growth
Building for Growth Nuclear Medicine cyclopham 3
Slide 12: Our Strategic Priorities
Our Strategic Priorities 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 to distrib
Slide 13: Technegas - Product Overview
Technegas - Product Overview 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 as Pulmonary Embolism
Slide 14: Advantages of Technegas
Advantages of Technegas 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 More accurate and se
Slide 15: Technegas - USA Market Opportunity
Technegas - USA Market Opportunity 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 p.a.) Procedures p.a.
Slide 16: Technegas – The Canadian Case Study
Technegas – The Canadian Case Study 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 by early adopters • D
Slide 17: Technegas FDA Clinical Trial Process and Design
Technegas FDA Clinical Trial Process and Design 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 009 - Compares Xe133
Slide 18: USFDA Patient Recruitment Update
USFDA Patient Recruitment Update Sites Actively Enrolling Patients Washington University – St Louis, MO ( 1st patient Sept 17) 50 10 Duke University – Durham, NC ( 1st patient Nov 17) Patient Imaged to date 40 8 Morton Plant – Clearwater, FL ( 1st patient Dec 17) Active Sites 30 6 20 4 Univ
Slide 19: Pathway to US commercialisation
Pathway to US commercialisation New Manufacturing Facility Q4 2016 – Increased capacity to meet future demand & regulatory requirements Target preliminary study completion Q1 2018 – Concluded initial recruitment of 40 patients Submit preliminary study to the FDA Q2 2018 – Submit initial findin
Slide 20: Technegas Expanding Indications
Technegas Expanding Indications 20
Slide 21: Evolution of Functional Lung Ventilation Imaging
Evolution of Functional Lung Ventilation Imaging 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 diagnosis of Pulmonary Embol
Slide 22: Clinical Call for Action – A New Way of Thinking about Respiratory Medicine
Clinical Call for Action- A New Way of Thinking about Respiratory Medicine Lancet Commission ‐ After asthma: redefining airways disease, September 2017 Executive Summary: Progress in reducing hospital admissions and mortality in Functional ventilation imaging using people with asthma have stalled in
Slide 23: Existing Market Development Strategy
Existing Market 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 S
Slide 24: 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 th
Slide 25: 2018 Strategic Priorities and Outlook
2018 Strategic Priorities and Outlook 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 report to the USFDA 1H 2
Slide 26: Expected rapid adoption of Technegas in US
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 in our cyclopharm website 26
Slide 27: Formal Business
2018 AGM Formal Business David Heaney 27
Slide 28: 2018 AGM – Formal Business
2018 AGM – Formal Business Proxy’s Resolution Business For Against Abstain Discretion 1 Remuneration report 32,043,700* 10,992 108,990 21,705 2 Re-election of Vanda Gould 27,227,779* 4,935,903 - 21,705 Renewal of share buy-back capacity 3 32,154,829* 8,853 - 21,705 4 Approval of Loan Share Plan 32,0
Slide 29: Appendix
Appendix Technegas FDA Approved Trial Design Indication Expansion Hunter Medical Reseach Institute Woolcock Medical Research Institute UltraluteTM MMI Disclaimer 29
Slide 30: What is Technegas?
What is Technegas? 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 clinical outcomes, Te
Slide 31: FDA Approved Trial Design
FDA Approved Trial Design 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 opportunity to reach agreem
Slide 32: Technegas Indication expansion – Severe Asthma
Technegas Indication expansion – Severe Asthma Initiative led by Professor Peter Gibson and Professor Vanessa McDonald in partnership with the University of Newcastle, John Hunter Hospital and Hunter Medical Research Institute Targeting Clinical Applications in COPD Patients Clinical Hypothesi
Slide 33: Technegas Indication expansion – Asthma & COPD
Technegas Indication expansion – Asthma & COPD Initiative led by Professor Greg King in partnership with the Woolcock Institute of Medical Research, Sydney University, and Northern Sydney Local Health District Targeting Clinical Applications in Asthma and COPD In patients with Asthma the study
Slide 34: Ultralute
UltraluteTM 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 – UltraluteTM will extend the effective use of an Mo99 generator by up t
Slide 35: Macquarie Medical Imaging
Macquarie Medical Imaging Joint venture with: • 50% Macquarie Connect (formerly Alfred CT MRI PET Imaging) • 30% Macquarie University • 20% Cyclopharm Comprehensive suite of imaging modalities State of the art research platform Cardiac CT Ultra‐sound SPECT Growth and profitability linked to
Slide 36: Disclaimer
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 with respect to the an