Cyclopharm Limited · ASX:CYC
Cyclopharm — Shareholder Meeting (May 2019)
34 slides from Cyclopharm's shareholder meeting presentation, May 21, 2019
Slide 1: Cyclopharm AGM Presentation 2018 Financial Year Results
For personal use only CYCLOPHARM (CYC) AGM Presentation 2018 Financial Year Results 21 May 2019
Slide 2: Disclaimer
Disclaimer 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 performance of
Slide 3: Chairman's Address
For personal use only Chairman’s Address David Heaney
Slide 4: Managing Director's Address
For personal use only Managing Director’s Address James McBrayer
Slide 5: Cyclopharm: Building for Growth
CYCLOPHARM For personal use only BUILDING FOR GROWTH Profitable & First in class Recurring USFDA Optionality Growing Technegas technology revenue approval expanding into MedTech generating sales from from high margin set to more than indications beyond 57 countries and consumable sales quadruple the
Slide 6: FY2018 Results Highlights
For personal use only FY2018 Results Highlights Group Sales Revenue $13.40 million Gross Margin $10.85 million Net Loss After Tax ($0.04) million including USFDA investment Total Dividend 1.0 cents per share Underlying Technegas EBITDA1 $1.90 million FDA Trial expenses ($2.96) million Strong balance
Slide 7: Operating Highlights
For personal use only Operating Highlights •Technegas is a substantially de-risked commercial proposition with significant upside in the US market CYC : 5 year Total global sales of $104 m from 2010 Technegas currently available in 57 countries Over 195,000 patient procedures in 2018 Over 4,
Slide 8: Technegas
Technegas For personal use only world’s best functional lung ventilation imaging agent Easy Only need 3D images No Cost to prepare and 3 to 4 breaths provide contraindications effective administer functional imaging through to the alveolus
Slide 9: Pulmonary Embolism
For personal use only 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 accu
Slide 10: Diagnosing Pulmonary Embolism in the USA
For personal use only Diagnosing Pulmonary Embolism in the USA OPPORTUNITY TO DISPLACE CTPA: USA = 4 million studies p.a. High radiation burden to rule out PE CTPA delivers at least 27 times more radiation to the breast as compared to V/Q SPECT Nuclear Contraindications Medicine CTPA should not be p
Slide 11: FDA Clinical Trial Process and Design
Technegas For personal use only FDA Clinical Trial Process and Design Study • Non‐inferiority structural ventilation study comparing Xe133 vs. Technegas • Special Protocol Assessment Granted Specifics • Total estimated trial cost $7.5 million USD with $5.85m USD spent to date • Assumes 240 patient s
Slide 12: Building from a strong & well established foundation
For personal use only 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 co
Slide 13: Clinical Study Strategy Beyond PE Underway
For personal use only Clinical Study Strategy Beyond PE Underway Hunter Medical Research Institute 100 patient trial targeting phenotyping and response to therapy in severe asthma. 100 patients enrolled as at 17/05/2019 Woolcock Institute 100 patient trial to commence 2Q 2019 targeting the diagnosis
Slide 14: Ultralute Update
For personal use only Ultralute Update • Ultralute™ has the potential to bring significant cost savings in the delivery of pharmaceuticals used in nuclear medicine by extending the useful life of Molybdenum‐99 (Mo‐99) generators by up to 50%. • First test sales in 2018, • Decision taken to register
Slide 15: 2019 Strategic Priorities and Outlook
For personal use only 2019 Strategic Priorities and Outlook Strategic Goals & Guidance Activity Timeframe United States Continue patient recruitment Ongoing FDA Approval & Finalise clinical trial sites (Mayo and Univ of Utah) 1H 2019 Commercialisation Finalise paediatric plan and submit to USFDA 1H
Slide 16: Cyclopharm Business Case
CYCLOPHARM For personal use only BUSINESS 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 b
Slide 17: Thank You
For personal use only Thank You
Slide 18: AGM Formal Business
For personal use only AGM Formal Business
Slide 19: 2019 AGM Formal Business
For personal use only 2019 AGM Formal Business Proxy’s Resolution Business For * Against Abstain Excluded Discretion 1 Remuneration report 28,764,048 31,617 1,854,369 13,211,332 12,185,066 2 Re-election of Tom McDonald 42,835,100 - - 13,211,332 - Removal of Nexia Sydney Audit 3 42,792,280 2,460 40,3
Slide 20: Appendix
For personal use only Appendix FY18 Results Technegas Clinical Information 20
Slide 21: Group Underlying Performance
For personal use only 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 2018 2017 Technegas into the world’s largest and new
Slide 22: Group Balance Sheet
For personal use only 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 fle
Slide 23: Group Cash Position
For personal use only 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
Slide 24: Clinical Information
For personal use only Clinical Information
Slide 25: Technegas is the preferred ventilation agent
Technegas is the preferred ventilation agent For personal use only Endorsed by the guidelines from the European5 and the Canadian6 Associations of Nuclear Medicine (EANM & CANM) “ Using 99m‐Tc‐Technegas is according to clinical experience better than the best aerosols ” “ Technegas is preferred to D
Slide 26: Superior to competitive nuclear medicine products
For personal use only 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 clinicia
Slide 27: Diagnosing Pulmonary Embolism with V/Q SPECT
Diagnosing Pulmonary Embolism with V/Q SPECT For personal use only COMPARED TO CTPA: Less radiation burden V/Q SPECT delivers 27 times less radiation to the breast as compared to CTPA11 Minimal exclusion criteria V/Q SPECT can be performed in case of pregnancy11‐12, renal impairment13, Primary imagi
Slide 28: 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 lungs14‐15 Low‐dose CT provides anatomical information Lobar distribution of ventilation such as fissures delineation16 Combination of
Slide 29: Beyond PE applications of V/Q SPECT/CT
For personal use only Beyond PE applications of V/Q SPECT/CT Diagnosis and Preoperative Preoperative assessment Planning radiation Advanced approach to follow‐up of assessment of of lung resection therapy to target tumors phenotyping chronic Pulmonary Embolism3 Endoscopic Lung candidates with while
Slide 30: Treatment response in asthma patient
Treatment response in asthma patient For personal use only Case 1 BASELINE METHACHOLINE Bronchoconstriction after CLINICAL HISTORY methacholine challenge TREATMENT Male patient of 25 years old with life‐ long asthma worsened ventilation BEFORE function and increased ventilation heterogeneity. This w
Slide 31: 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 32: Clinical Research: Ongoing studies
Clinical Research For personal use only 2018 Ongoing studies • FDA clinical trial phase 3 (Multiple sites, USA) The United States FDA (USFDA) phase 3 clinical trial is a non‐inferiority structural ventilation study comparing Technegas with Xenon‐133 in a total of 240 patients.19 • Hunter Medical Res
Slide 33: Clinical Research: Upcoming studies
Clinical Research For personal use only 2018 2019 Upcoming studies • Woolcock Institute ‐ Sydney, Australia: Ventilation SPECT as a clinical tool to determine disease characterization and treatment response in 84 patients with asthma and COPD • The Centre hospitalier de l'Université de Montréal (CHU
Slide 34: References
For personal use only References 1. Fawdry RM, et al. Initial experience with Technegas – a new ventilation agent. Australas Radiol between V/Q lung scintigraphy in SPECT technique and multislice spiral CT. J Nucl Med 2004; 45: 1988; 32(2): 232‐238 1501‐1508 2. Senden TJ, et al. The physical and che