Cyclopharm Limited · ASX:CYC
Cyclopharm — Bioshares Conference 2019
32 slides from Cyclopharm's conference presentation, Jul 27, 2019
Slide 1: Cyclopharm – Bioshares Conference
Cyclopharm 27 July 2019 Bioshares Conference Queenstown New Zealand James McBrayer, CEO & Managing Director Technegas is not commercially available in the USA.
Slide 2: Safe Harbour Statement
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 Cyclophar
Slide 3: Bioshares 2019 Session Brief – On the Cusp
Bioshares 2019 Session Brief – “On the Cusp” 1. The competitive analysis of lung imaging modalities used to assess Pulmonary Embolism 2. The comparison of each imaging technique to include the existing and future competitive advantage of VQ/SPECT and hybrid approaches including with low dose CT. 3.
Slide 4: Cyclopharm Investment Case
CYCLOPHARM INVESTMENT CASE Profitable & First in class Recurring USFDA approval Optionality Growing proprietary product revenue set to quadruple the into indications MedTech sales to 57 from consumables size of the existing PE beyond PE into chronic countries with similar to an business and further
Slide 5: Company Overview
Company Overview Technegas is a substantially de-risked commercial proposition with significant upside in the US market CYC : 5 year Technegas revenues generated in 57 countries Over 195,000 patient procedures in 2018 Over 4,200,000 patient procedures since 1986 ~1,600 Technegas generators s
Slide 6: Technegas around the world
Technegas around the world Technegas was introduced to the medical community in 1986 1 Technegas revenues are generated in 57 countries via a combination of direct and distributor sales models Over 4.2 million patient procedures to date 1. Wiebe LI, et al. Current Radiopharmaceuticals 2010; 3(1): 49
Slide 7: What is Technegas?
What is Technegas? 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 Technetium- hexagonal pl
Slide 8: Pulmonary Embolism
Pulmonary Embolism Symptoms ~3 million are varied with diagnosis confirmed cases of PE p.a. either through CTPA or but could be 30% a nuclear medicine Nuclear Medicine much higher of pulmonary ventilation-perfusion using 3-D imaging is the embolisms are fatal if study most accurate method left untre
Slide 9: Benefits of using Technegas
Benefits of using Technegas Easy Only need 3D images No Cost to prepare and 3 to 4 breaths provide contraindications effective administer functional imaging through to the alveolus Technegas is not commercially available in the USA.
Slide 10: Superior to competitive nuclear medicine products
Superior to competitive nuclear medicine products Technegas Easy 3 to 4 breaths 3D images No Cost-effective contraindications Xenon - 133 DTPA Tc99m True No 3D images Wet Aerosol radioactive gas limited to planar impacts efficacy and inhaled with full imaging resulting clinician interpretations face
Slide 11: Diagnosing Pulmonary Embolism in the USA
Diagnosing Pulmonary Embolism in the USA CTPA USA = 4 million studies p.a. High radiation burden CTPA delivers at least 27 times more to rule out PE radiation to the breast as compared to V/Q SPECT1 $90m USD Contraindications CTPA should not be performed with Nuclear Medicine pregnancy1-2, renal imp
Slide 12: Beyond CTPA in Diagnosing PE
Nuclear Medicine Imaging Technology Has Evolved Beyond CTPA in Diagnosing PE PLANAR SPECT SPECT/CT 2019 Inherent limitations of 2-dimensional Three-dimensional imaging Integration of anatomic information imaging 1986 Overlap of anatomical segments Superior contrast resolution Decrease the incidence
Slide 13: Radiation Dosimetry
Technique Effective Effective Breast Lung dose dose absorbed absorbed (mSv/MBq) (mSv) dose (mGy) dose (mGy) Radiation Dosimetry Ventilation Technegas (20MBq) 1-3 0.015 0.30 0.13 2.2 Ventilation 99mTc-DTPA 0.007 0.14 0.04 0.30 (20MBq) 1-2 Ventilation 133Xe 0.0014 1.12 0.09 0.89 A nuclear (800MBq) 1 m
Slide 14: Diagnosing PE
Nuclear Medicine provides better diagnostic outcomes in Diagnosing PE V/Q SPECT and V/Q SPECT/CT have shown that V/Q Accuracy SPECT/CT is superior in most clinical settings with better overall diagnostic performance1. NPV In situation of acute PE, chronic PE pregnancy, paediatrics and the COPD popul
Slide 15: Coming to America
Coming to America Technegas is not commercially available in the USA.
Slide 16: Technegas FDA Clinical Trial Process and Design
Technegas FDA Clinical Trial Process and Design USFDA Clinical trial1 registered at: https://clinicaltrials.gov/ct2/show/NCT03054870?term=technegas&rank=1 Study Non-inferiority structural ventilation study comparing Xe133 vs. Technegas1 Sites Planned 240 patient study at 9 clinical sites 154 Patient
Slide 17: What the guidelines say about Technegas
What the guidelines say about Technegas: Endorsed by the guidelines from the European6 and the Canadian4 Associations of Nuclear Medicine (EANM & CANM) “ Using 99m-Tc-Technegas is according to clinical experience better than the best aerosols ” “ Technegas is preferred to DTPA in patients with COPD
Slide 18: Technegas in the recent literature
66% of references citing Technegas in the recent literature Technegas in the past 24 months 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
Slide 19: Reclaiming and Expanding Pulmonary Imaging
Reclaiming and Expanding Pulmonary Imaging 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 SPECT, SPECT-CT & Quan
Slide 20: Beyond PE
: Beyond PE Clinical Trials Sponsored by Cyclomedica • Hunter Medical Research Institute (Newcastle, AU): Diagnosis and response to therapy in severe asthma and COPD1 PATIENT MANAGEMENT & SCREENING Response to Therapy and Personalized • Woolcock Institute (Sydney, AU): Diagnosis and response Medicin
Slide 21: Building from a strong & well established foundation
Building from a strong & well established foundation Near term opportunities providing significant growth potential beyond PE toward patient management USA Market Targeting USA Half billion nuclear medicine CTPA PE market combined sufferers ventilation imaging opportunity to convert of Asthma and ma
Slide 22: Enterprise Value: Three Value Horizons
Three Value Horizons Horizon 1 Horizon 2 Horizon 3 0 to 5 Years 3 to 8 Years >8 Years Establish USA Convert CTPA Double existing Nuc Innovate Beyond PE 80% Conversion of Nuc Enterprise Value Med Procedures for PE Med Procedures for PE Half billion combined sufferers of Asthma and Chronic Obstructive
Slide 23: Thank You
Cyclopharm Thank You Technegas is not commercially available in the USA.
Slide 24: Appendix Section
Appendix Section Technegas is not commercially available in the USA.
Slide 25: FY2018 Results Highlights
FY2018 Results Highlights Group Sales Revenue $13.40 million Gross Margin $10.85 million Net Loss After Tax ($0.04) million including USFDA investment Interim Dividend 1.0 cents per share Underlying Technegas EBITDA1 $1.90 million FDA Trial expenses ($2.96) million Strong balance sheet2 $9.19 millio
Slide 26: Group Underlying Performance
Group Underlying Performance Solid Underlying Financial Results During the year, CYC continued to implement its strategic priorities, which are to: 1. Accelerate the path to regulatory approval to sell Year ended 31 December Technegas into the world’s largest and new highly 2018 2017 ($000’s) prospe
Slide 27: Group Balance Sheet
Group Balance Sheet Financial Foundation to Leverage Growth Strategy During the year, CYC continued to implement its strategic priorities, which are to: Year ended 31 December Low debt & cash on hand – provides balance sheet 2018 2017 ($000’s) Cash 5,855 8,690 and funding flexibility Other current
Slide 28: Group Cash Position
Group Cash Position Cash Position Funding Growth Year ended 31 December ($000’s) 2018 2017 Capital Raising $6.59 m June 2017 with 90% Operating Activities (1,107) (682) Shareholder Participation Investing Activities (1,403) (1,136) Financing Activities (353) 5,828 Benefited from expanded R&D tax
Slide 29: Pulmonary Imaging With
Pulmonary Imaging With Technegas is not commercially available in the USA.
Slide 30: Hybrid V/Q SPECT/CT
Hybrid V/Q SPECT/CT Ventilation SPECT Low-dose CT Fused SPECT/CT V/Q SPECT provides functional information on ventilation and perfusion of the lungs14-15 Low-dose CT provides anatomical information Lobar distribution of ventilation such as fissures delineation16 Combination of functional and anatomi
Slide 31: Treatment response in asthma patient
Treatment response in asthma patient 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 was predicted by baseli
Slide 32: Planning lung volume reduction surgery
Planning lung volume reduction surgery 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 The ventilation SPECT