Cyclopharm Limited · ASX:CYC
Cyclopharm — Bell Potter Healthcare Conference (December 2024)
41 slides from Cyclopharm's conference presentation, December 2024
Slide 1: Bell Potter Healthcare Conference
Bell Potter Healthcare Conference James McBrayer CEO & Managing Director
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: Step change in US demand for Technegas following CMS reimbursement
Step change in US demand for TechnegasTM following successful reimbursement in the United 1 States through the Center for Medicare and Medicaid Services (CMS) resulting in an 82% Increase in pipeline opportunities since July 2024. 2 Technegas installed at 9 USA sites with another 14 at implementatio
Slide 4: Technegas Overview
3 cyclopher ™ Tecnnegas Overview —
Slide 5: Technegas introduced clinically in 1986, available in 66 countries
Technegas was introduced clinically in 1986 Technegas generators are available now in 66* countries via a combination of direct and distributor sales models Over 4.9 million patient procedures to date Leveraging global infrastructure with Business Partner Product distribution *Czech Republic grants
Slide 6: Functional imaging showing where oxygen is distributed within the lung
Functional Imaging showing where Oxygen is distributed within the lung Technegas is composed of 99mTc cores encapsulated within layers of graphite to form individual hexagonal plate-like particles.1-2 Technegas is manufactured by heating Technetium-99m in a carbon crucible within an argon environmen
Slide 7: Technegas is the functional ventilation imaging agent of choice
Technegas is the nuclear medicine functional ventilation imaging 1 agent of choice - Technegas shows true functional ventilation with operational and clinical advantages over competitive agents. Technegas unlocks the clinical potential of Nuclear Medicine 2 Imaging by leveraging state of the art tec
Slide 8: Unique Drug + Device + Service combination = regulatory barrier to entry
Unique Drug + Device + Service combination = regulatory barrier to entry Technegas comprises the following components USFDA Drug-Device SYSTEM PER PATIENT CONSUMABLES SUPPORT Combination product TECHNEGAS PLUS SYSTEM TECHNEGAS ® SYSTEM PACK Technegas (Crucible) Technegas® Contacts Training Razor - R
Slide 9: Technegas USA Expansion
Technegas USA Expansion
Slide 10: Potential applications across the entire field of respiratory medicine
Potential applications across the entire field of respiratory medicine Technegas (kit for the preparation of technetium Tc99m labeled carbon inhalation aerosol) for oral inhalation use – NDA 022335 ------------------USFDA APPROVED INDICATIONS AND USAGE------------------- TECHNEGAS, when used with so
Slide 11: 600K nuclear medicine ventilation procedures p.a. in the USA for PE
600K Nuclear Medicine Ventilation Procedures p.a. in the USA* for PE 15%/600k Estimated 4,000,000 pulmonary embolism procedures in the USA p/a 1 (15% Nuclear Medicine / 85% CTPA) 2 ~600,000 (15%) Nuclear Medicine procedures represents an initial US$90m addressable market 3 Initial target for Techneg
Slide 12: 82% increase in pipeline opportunities following CMS approval
82% increase in pipeline opportunities following CMS approval from1 July Recurring revenue generating from 9 US TechnegasTM Sales Initial Additional Total Potential 1 Technegas installed systems – 14 additional Pipeline: 14 Nov 2024 Installation* Sites+ Installations sites at implementation stage Re
Slide 13: 6-8 month process from new product approval to installation
~ 6-8 Month Process from New Product Approval to Installation 1 2 3 4 5 6 7 Engagement & External New Product Administration IT Integration Facilities Installation and Clinical Provider Approval Approval Training Approval Engagement • RFQ • Pharmacy & • Financial Approval IT Systems Address: • Locat
Slide 14: Technegas in the USA Leveraging a Strong Foundation
Technegas in the USA Leveraging a Strong Foundation
Slide 15: SNMMI Technegas Press Release – USA Catching up with the R.O.W.
SNMMI Technegas Press Release – USA Catching up with the R.O.W. FDA Approves Widely Used Imaging Agent for Respiratory Disease “Recognised standard for ventilation studies” September 29, 2023 Reston, VA—The U.S. Food and Drug Administration (FDA) has approved the imaging agent Technegas for use in v
Slide 16: 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 WHAT THE in patients with COPD ” “ Liquid aerosols are inferior for SPECT
Slide 17: Technegas the ventilation imaging agent of choice in established markets
Technegas - the ventilation imaging agent of choice in established markets Five-country survey conducted before Technegas USA launch highlights that: 85% of nuclear medicine ventilation studies ex-USA are performed using Technegas Xenon-133 has been displaced in all markets where Technegas is availa
Slide 18: V/Q SPECT/CT shown superior compared to CTPA
Accuracy NPV Radiation Dose mSv Nuclear Medicine vs CTPA PPV 20 Specificity Sensitivity 3.1 1 0% 25% 50% 75% 100% V/Q SPECT/CT V/Q SPECT CTPA V/Q Planar VQ SPECT or Planar VQ SPECT/ CT CTPA Diagnostic ability of V/Q SPECT/CT1, V/Q SPECT1, CTPA1 and V/Q Planar2 to detect PE (adapted from Hess and al,
Slide 19: Understanding the US Opportunity
Understanding the US Opportunity
Slide 20: Placement Model to Expedite Consumable Demand
Placement Model to Expedite Consumable Demand US$7k one-off installation and Targeting 2,000 of the 8,000 US nuclear medicine training fee departments. 300 sites by the end of 2025. US$7k p.a. technology fee, System Placement model supports rapid uptake by US customers by removing the initial capita
Slide 21: Exponential Growth Opportunity Over The Next Decade
Exponential Growth Opportunity Over The Next Decade USA PE Pulmonary Embolism: Timeline Market Share Market size 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 to Technegas 0 - 8 years 30% US$180m* Timelin
Slide 22: USA Commercialisation Pathway
USA Commercialisation Pathway
Slide 23: US commercialisation readiness: clinical, regulatory, commercial, operations
Regulatory Clinical Australian Site Manufacturing Approved Key Opinion Leaders engaged USFDA Approval Granted Medical Affairs Director Recruited State Pharmaceutical Wholesale Licenses being Clinical Affairs Director Recruited Granted R&D Programs Beyond PE Underway US Regulatory sup
Slide 24: Beyond PE: Blue Sky
Beyond PE: Blue Sky 24
Slide 25: 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 26: >US$1.1bn global market size
>US$1.1bn global market size* Diagnosis and Advanced approach Preoperative Preoperative Planning Use of alternate follow-up of to phenotyping chronic assessment of assessment of radiation therapy isotopes to make Pulmonary airways diseases such homogeneous lung resection to target tumors GalligasTM
Slide 27: Cyclopharm sponsored Beyond PE clinical trials
7 Cyclopharm sponsored Beyond PE clinical trials – US approval expected to drive clinician led studies Hunter Medical Research Institute (Newcastle, AU): Diagnosis and response to therapy in severe asthma and COPD1 1 100 Patient Study * 100% Recruited * Study Published6, Woolcock Institute (Sydney,
Slide 28: Ventilation Heterogeneity Is a Treatable Trait in Severe Asthma
“Because of its sensitivity in the ‘silent zone’ of the lung – the notoriously difficult to see small airways that are 2mm – 4mm in diameter – this test helps us see if the drugs we are giving patients for severe asthma are working.” “Ventilation “There are four different types of drugs given to sev
Slide 29: Cyclopharm Investment Case
Cyclopharm Investment Case 29
Slide 30: Outlook – By Dec 2025 300 Technegas installations in the USA
Outlook - By Dec 2025 300 Technegas Installations in the USA generating additional ongoing revenues Profitable and First in Class USFDA Approval Granted Recurring Revenue Technegas Product expansion Growing MedTech Established Gold Standard Set to quadruple the size From single patient Indications B
Slide 31: Questions
Questions 31
Slide 32: Presentation Attachments
Presentation Attachments 01 Canadian Case Study 02 Competitive Product Comparison 03 Competitive Imaging Technology Comparison 04 Technegas in Recent Literature 05 Third Party Business Products 06 2024 First Half Financials
Slide 33: The Canadian Case Study - a strong indicator of USA acceptance
The Canadian Case Study - a strong indicator of USA acceptance Canada is Cyclopharm’s largest single country 1 market to date Technegas® is market leader for diagnosing PE 2 and is nearing 100% nuclear medicine market share 3 Xe-133 rapidly displaced by early adopters 4 Close correlation with the nu
Slide 34: Technegas vs Xenon-133 vs DTPA Tc99m
Technegas® Easy 3 to 4 breaths 3D images No contraindications Covid-19 Xenon - 133 DTPA Tc99m Wet Aerosol True radioactive No 3D images impacts efficacy, bronchospasm, gas inhaled with limited to planar COVID-19 concerns full face mask imaging resulting in lower sensitivity & specificity Creates hot
Slide 35: Technegas is the "V" in "V/Q"
Technegas is the “V” in “V/Q” V/Q COMPARED TO CTPA: Less radiation burden V/Q SPECT delivers 27 times less radiation to the breast as compared to CTPA6 Minimal exclusion criteria V/Q SPECT can be performed in case of pregnancy6-7, renal impairment8, contrast Primary imaging Detects PE media allergy8
Slide 36: Technegas in recent literature references
1. King GG, et al. Dismantling the pathophysiology of asthma using imaging. Eur Respir Rev 12. Dimastromatteo J, et al. Molecular imaging of pulmonary diseases. Respir Res 2018; 2019; 28(152): pii: 1801111 19(1): 17 2. Yang L, et al. Changes in ventilation and perfusion following lower lobe endoscop
Slide 37: Third-Party Products Overview
Third-Party Products Overview Attachment Section 5–
Slide 38: Leveraging our Sales, Service & Regulatory Footprint in our Direct Markets
Leveraging our Sales, Service & Regulatory Footprint in our Direct Markets Third-Party Products comprise the following components Direct sales and Service in 17 Consumables and Equipment Sales SUPPORT out of 66 approved markets Radiopharmaceuticals Hotcells for Radiopharmaceutical Patient Injectors
Slide 39: 2024 First Half Financial Results
2024 First Half Financial Results Attachment Section 6 –
Slide 40: H1 2024 Financial Overview
Sales Revenue $12.27m - (pcp $14.91m) Sales consistent at $7.46m – expected result excluding • Technegas one-off gains pcp H1 2024 • Third Party Distribution $4.81m of third‐party distribution revenue, a decrease of (33.8%) Financial 1H 2024 pcp Consumable and Service Revenue up 4% pcp 1. 2022 Techn
Slide 41: H1 2024 Trading Overview and Underlying Business
H1 2024 Trading Overview and Underlying Business An established global nuclear medicine company Cyclopharm H1 2024 Trading Highlights Half Year Sales Trending by Product Group Sales consistent at $7.46m compared Technegas to pcp 2024 H1 $4.81m of third‐party distribution Third Party revenue, impacte
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