Cyclopharm Limited · ASX:CYC
Cyclopharm — Corporate Update (October 2023)
22 slides from Cyclopharm's corporate update, Oct 5, 2023
Slide 1: USFDA approval of Technegas opens US$180m+ market
USFDA approval of Technegas® opens US$180m+ market 5 October 2023 Webinar 2.00 pm Registration: https://cyclopharm-au.zoom.us/webinar/register/WN_O9FZzUFoSHuOz1cLQIxsMA 1
Slide 2: 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 Cyclopharm Limited and as to the
Slide 3: USFDA approval highlights
USFDA approval highlights: • Formal Approval granted – 29 September 2023 • US is the largest single nuclear medicine market globally • US$180m+ market potential for diagnosing Pulmonary Embolism with Technegas • Immediate rollout across USA to meet demand • USA approval marks 65th country market for
Slide 4: Technegas around the world
Technegas® around the world Technegas® was introduced to the medical community in 1986 Technegas® generators are available in 65 countries via a combination of direct and distributor sales models Over 4.7 million patient procedures to date 4
Slide 5: USFDA Launch
USFDA Launch Readying the Fleet 4 October 2023 5
Slide 6: USA Commercialisation
USA Commercialisation USFDA Approval 29 September 2023 200 Generators for launch – National network service provider selected components purchased and built with CYC service and installation program to sub-assembly level training commenced 3rd Party distribution provider selected – 2000 target nucle
Slide 7: Novel Economic Model
Novel Economic Model Placement Model to Expedite Consumable Demand $5k one-off installation System Placement model supports rapid and training fee uptake by US customers by removing initial capital outlay to drive implementation of the $7k p.a. technology technology Initial focus on clinical trial a
Slide 8: US Market Dynamics
US Market Dynamics 8
Slide 9: Largest addressable market globally
Largest addressable market globally 600K Nuclear Medicine Ventilation Procedures p.a. in the USA* Cyclopharm estimates 4,000,000 pulmonary embolism procedures 15%/600k 1 in the USA per annum (15% Nuclear Medicine / 85% CTPA) ~600,000 Nuclear Medicine Ventilation procedures represents an 2 initial $9
Slide 10: Three Distinct Value Horizons
Three Distinct Value Horizons Exponential Growth Opportunity Over The Next Decade USA PE US$ Revenue Pulmonary Embolism: Timeline Market Share potential p.a. Horizon 1 – Full displacement of existing 1 nuclear medicine tests for PE 0 - 5 years 15% US$90m Horizon 2 – Commence converting CTPA exams 2
Slide 11: US Customer Demand Established
US Customer Demand Established Over 420 Expressions of interest already recieved 1 First sales in US are imminent followed by regular updates on Generators placed in US Reimbursement is already established – reimbursement framework is based on 2 procedure codes Leading clinicians, front-line workers
Slide 12: Compelling US Clinical Support
Compelling US Clinical Support Society of Nuclear Medicine and Molecular Imaging Press Release FDA Approves Widely Used Imaging Agent for Respiratory Disease “Recognised standard for September 29, 2023 ventilation studies” Reston, VA—The U.S. Food and Drug Administration (FDA) has approved the imagi
Slide 13: Hierarchy of Evidence
Hierarchy of Evidence Technegas has the Highest Standard of Clinical Evidence to Drive Adoption in Traditional & Beyond PE Applications 13
Slide 14: Track Record - Rapid adoption of Technegas
Track Record - Rapid adoption of Technegas® The Canadian Case Study - a strong indicator of USA acceptance Canada is Cyclopharm’s largest single 1 country market to date Technegas® is market leader for 2 diagnosing PE Xe-133 rapidly displaced by early 3 adopters Close correlation with the number of
Slide 15: Beyond PE
Beyond PE US Entry to Accelerate Exponential Global Growth Potential 15
Slide 16: Indication Expansion – The Importance, Urgency & Opportunity Beyond PE
Indication Expansion – The Importance, Urgency & Opportunity Beyond PE 1 Lung Disease in 2019 accounted for 6 million deaths worldwide (12% of all deaths) 2 COPD and Lower Respiratory Infections and Lung Cancer will be the 3rd, 4th and 6th largest causes of death by 2030. “Over and underdiagnosis of
Slide 17: Beyond PE applications of V/Q SPECT(/CT)
Beyond PE applications of V/Q SPECT(/CT) Diagnosis and Preoperative Preoperative Planning Advanced approach Use of alternate Diagnosis and follow-up of assessment of assessment of radiation therapy to phenotyping chronic isotopes to make monitoring of Pulmonary homogeneous lung resection to target t
Slide 18: Key Catalysts for the Next 2 Years
KEY Catalysts for the Next 2 Years 1 First sales in the USA announced 2 Ongoing updates on Systems placed in the USA 3 Clinical proof of concept & validation in new substantive Beyond PE respiratory indications Continued growth in the other existing 64 established country 4 markets 18
Slide 19: Cyclopharm Investment Case
CYCLOPHARM INVESTMENT CASE Profitable and First in Class USFDA Approval Granted Recurring Revenue Technegas Product Growing MedTech Established Gold Standard Set to quadruple the size From single patient expansion Underlying business Proprietary product of the existing PE business, consumables Indic
Slide 20: Thank you
Thank you 20
Slide 21: What the guidelines say about Technegas
“Using 99m-Tc-Technegas is according to clinical experience better than the best aerosols” “Technegas® facilitates interpretation, particularly in COPD” “For ventilation, 99m-Tc Technegas® is the best-aerosol particularly in patients with COPD” WHAT THE “Liquid aerosols are inferior for SPECT and sh
Slide 22: CYC Business Case Summary
CYC Business Case Summary Cyclopharm Limited • Cyclopharm’s lead nuclear medicine product Technegas® is currently available in 65 countries 1 (CYC) is a leading • Over 4,700,000 patient procedures performed since first approved with 1,700 Technegas® generators sold globally diagnostic lung imaging •