CYCLOPHARM LIMITED — AGM Information 2020

Jul 8, 2020

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Cyclopharm

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AGM Presentation 2019 Financial Year Results 9 July 2020

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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 markets for the company's products. Such statements, estimates and projections reflect various assumptions made by the directors concerning anticipated results, which assumptions may or may not prove to be correct. Cyclopharm Limited has not sought independent verification of information in this presentation.

While the directors believe they have reasonable grounds for each of the statements, estimates and projections and all care has been taken in the preparation, no representation or warranty, express or implied, is given as to the accuracy, completeness or correctness, likelihood of achievement or reasonableness of statements, estimates and projections contained in this presentation. Such statements, estimates and projections are by their nature subject to significant uncertainties, contingencies and assumptions.

To the maximum extent permitted by law, none of the Cyclopharm Limited, its directors, employees or agents, nor any other person accepts any liability, including, without limitation, any liability arising out of fault or negligence, for any loss arising from the use of information contained in this presentation. All references to dollars unless otherwise specified are to Australian dollars.

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Welcome David Heaney

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Online Attendees – Question Process

• When the Question function is available, the Q&A icon will appear at the top of the app.

• To send in a question, simply click in the ‘Ask a question’ box, type your question and the press the send arrow

• Your question will be sent immediately for review

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Online Attendees – Voting Process

• When the poll is open, the vote will be accessible by selecting the voting icon at the top of the screen

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• To vote simply select the direction in which you would like to cast your vote, the selected option will change colour.

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• There is no submit or send button, your selection is automatically recorded.

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Chairman’s Address

David Heaney

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Managing Director’s Address

James McBrayer

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CYCLOPHARM BUILDING FOR GROWTH

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Profitable &

Growing MedTech underlying business is cash positive and issuing dividends

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First in class

Technegas technology generating sales from 60 countries and named as the agent of choice in the Canadian & European EANM Guidelines

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USFDA Optionality approval expanding into set to more than indications beyond PE could dwarf the quadruple the existing CYC sales near term USA opportunity from Pulmonary Embolism (PE)

Recurring USFDA revenue approval

from high margin consumable sales similar to an annuity model

Building for Growth – Company Development

Technegas is a substantially de‐risked commercial proposition with significant upside in the USA market with target USFDA approval by 2021

• Total global sales of $118 m from 2010

• Technegas currently available in 60 countries

• Over 4,200,000 patient procedures performed since first approved

• 1,600 Technegas generators sold globally since first approved

• Approximately 182,100 patient procedures in 2019

• Europe represents 62% of global revenue in 2019

• Canada was the largest single country market by volume (45,400 patients) followed closely by France (42,500 patients) in 2019

• CYC is growing, the underlying business is profitable and the company has a history of paying dividends

• Stable gross margins of greater than 80% ‐ ( 82% in 2019 )

• Around 80% of historical revenue is recurring consumable sales ‐ ( 75% in 2019 )

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Technegas Revenue by Region ($ 000’s)
16,000
14,000
12,000
10,000
8,000
6,000
4,000
2,000
0
2010 2011 2012 2013 2014 2015 2016 2017 2018 2019
Asia Pacific Europe & Other Canada & South America
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Technegas Regional Revenue by Category ($ 000’s)
16,000
14,000
12,000
10,000
8,000
6,000
4,000
2,000
0
2010 2011 2012 2013 2014 2015 2016 2017 2018 2019
Generators PAS Service
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FY2019 Results Highlights

	Group Sales Revenue $14.08million ‐ an increase of 5% Gross Margin $11.62 million – an increase of 7% Gross Margin % 82.5% Net Loss After Tax ($2.91) million including USFDA investment Dividends 1.0 cents per share Underlying PBT1 $0.89 million FDA Trial expenses ($3.84) million Strong balance sheet $12.66 million of cash reserves as @ 31 December 2019

1. Profit Before Tax

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FY2019 Operational Highlights

Technegas Record revenues recorded in the key markets of Canada and France USFDA All internal documentation completed with a Q1 2020 USFDA submission USA Commercialisation USA entity established Indication Expansion HMRI completes recruitment – New initiatives commence in Canada and Australia R&D Tax Incentive $2.93m received November 2019 Strategic Partnerships Leveraging our infrastructure through Distribution partnerships – Draximage, Tema and Rotop Building a Team for the Future Key resources in place for growth – Sales, Quality, Regulatory and Service Guideline Development CANM and European Guidelines naming TG as the nuclear medicine ventilation imaging agent of choice for diagnosing PE Capital Raising $9.2m net of costs received in December following a strategic share placement

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Our Strategic Priorities

CYC has clear strategy to leverage our position as a leading player in the global nuclear medicine imaging market and exponentially larger 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 distribute Technegas in the USA 2. Expanding the use of Technegas beyond the traditional diagnosis of Pulmonary Embolism into significantly larger applications such as COPD[1] and Asthma, Lung Cancer and Pulmonary Hypertension for both diagnosis and patient management.

• 1. Identifying, developing and commercialising complementary innovative technology such as Ultralute[TM] 4. Leveraging our core global regulatory strengths, fiscal discipline, strong balance sheet and well developed expertise in nuclear medicine and pulmonary healthcare to seek out complementary technologies and businesses

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1. Chronic Obstructive Pulmonary Disease

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Ultralute Update

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• 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%.

• Registered as a Class 1 Medical Device on the ARTG

• Decision taken to register Ultralute[TM] as a medical device technology within Europe

• Medical Device registration expected to broaden its overall market acceptance and optimise the commercial value of this technology.

• Registration targets has been dramatically impacted by two factors: o delays in European regulators implementation the new MDR regulatory framework

• Inspections programs delayed due to COVID‐19

• Meaningful commercial sales of Ultralute™ within the medical device category in Europe are not expected until 2022.

Technegas: World’s Best Functional Lung Ventilation Imaging Agent Patient inhales extremely small carbon particles labeled with[99m] Technetium[1] The small size and hydrophobic properties demonstrates gas like‐ behavior and alveoli deposition into the lungs[2‐3] Clinicians can visualise functional ventilation using Technegas

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1. Senden TJ, et al. J Nucl Med 1997; 38: 1327‐1333

2. Fawdry RM, et al. Australas Radiol 1988; 32(2): 232‐238

3. Leblanc M, et al. CANM guidelines; Nov 2018: www.canm‐acmn.ca/guidelines

Technegas is not commercially available in the USA.

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Coming to America

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Technegas[®] is not commercially available in the USA

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Technegas – USA Market Opportunity



• 4,000,000 patient procedures conducted in the USA per annum to diagnose pulmonary embolism (15% Nuclear Medicine – 85% CTPA)

600K Nuclear Medicine Ventilation Procedures p.a. = $90m USD





• 600,000 Nuclear Medicine Ventilation procedures equals $90m USD

• Target market for Technegas in the USA equates to ~480,000 patient procedures of the total 600,000 procedures.



The USA represents the single largest market for Technegas with half of the world’s nuclear medicine departments

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15%
Nuclear Medicine 85% CTPA
600k
3.4 M
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• Subject to a successful FDA approval, the Company is targeting US commercialisation in 2021



• First priority following USFDA approval is to repeat our Canadian experience by displacing Xe133 as the standard of care diagnostic product

• 3D SPECT imaging using Technegas is proven to be clinically superior and safer than CTPA. Once commercialised Cyclopharm will target to double the existing nuclear medicine PE market dominated by CTPA from 15% to 30%.

• Once established in the USA market, the company will seek to expand the use of Technegas into disease states exponentially larger than the existing PE market

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Technegas[®] is not commercially available in the USA

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Technegas FDA Clinical Trial Process and Design

Approval Pathway

USFDA Clinical trial[1] registered at: https://clinicaltrials.gov/ct2/show/NCT03054870?term=technegas&rank=1 Non‐inferiority structural ventilation study comparing Xe133 vs. Technegas[1] Planned 240 patient study at 9 clinical sites

204 Patients enrolled as at 30 June 2020

505(b)2 New Drug Application submitted

The 505(b)2 New Drug Application is expected to be sufficient for USFDA approval Clinical Trial enrollment will continue whilst the 505(b)2 submission is being reviewed

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||||||
|---|---|---|---|---|
|1H 2018|1H 2018|1Q 2020|2H 2019|2Q 2021|
|Finalised Trial Site|Submitted Preliminary|NDA Submitted|Commence USA|Anticipated USA Launch|
|Timeline|Recruitment|Trial Results for FDA|Generator Inventory|provided successful USFDA|
|Review|Build|approval|

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1. ClinicalTrials.Gov – A comparison of Technegas and Xenon‐133 Planar Lung Imaging in Subjects referred for Ventilation Scintigraphy. https://clinicaltrials.gov/ct2/show/NCT03054870?term=technegas&rank=1

Technegas[®] is not commercially available in the USA

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USA 2020 Commercialisation Plan

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Build Inventory People
Materials Resource Hire Key USA Personnel
to include Sales and
Planning underway with
Service
production targeting 200
Techengas generators roll‐
out per anum
USFDA Regulatory Secure Customer Distribution
Approval Commitments Identify and stock 3PL
Partners for the USA
Standard Review Securing commitments
underway with in line with Technegas
anticipated 2Q 2021 Generator lead time
Approval
18 Technegas [®] is not commercially available in the USA
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Beyond PE : clinical initiatives

PATIENT MANAGEMENT & SCREENING

Response to Therapy and Personalized Medicine

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Clinical Trials Sponsored by Cyclomedica

• Hunter Medical Research Institute (Newcastle, AU): Diagnosis and response to therapy in severe asthma and COPD[1]

• Woolcock Institute (Sydney, AU): Diagnosis and response therapy in mild to moderate COPD[3]

• CHUM (Montreal, CA): Early detection of COPD in asymptomatic smokers[4]

INTERVENTIONAL THERAPIES

LVRS, ELVR, Transplant, Lung Cancer

• Dalhousie (Halifax, CA): Post‐lung transplant patients

• Firestone Institute (St. Joseph’s Healthcare Hamilton, CA): Prevalence and clinical relevance of ventilation heterogeneity and luminal cellular inflammation in lung cancer patients pre and post lung resection[2]

CHRONIC AIRWAY DISEASES

COPD – Asthma

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PULMONARY EMBOLISM (PE) VTE – CTEPH ‐ PH

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Other Non‐Sponsored Clinical Initiatives

• Macquarie University (Sydney, AU): ELVR with endobronchial valves in severe COPD patients

• Macquarie University (Sydney, AU): Bronchial Thermoplasty procedure in asthma patients

• http://investor.cyclopharm.com/site/PDF/1561_0/BetterDefiningAirwaysDiseasewithTechnegas 4. https://ichgcp.net/clinical‐trials‐registry/NCT03728712

• ACTRN12617001275358 ‐ Can functional lung ventilation imaging identify treatable traits in obstructive airway disease? 2. https://clinicaltrials.gov/ct2/show/NCT04191174?term=technegas&draw=2&rank=3

Technegas[®] is not commercially available in the USA

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Three Value Horizons

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Horizon 1 Horizon 2 Horizon 3
0 to 5 Years 3 to 8 Years >8 Years
Innovate Beyond PE
Convert CTPA
Establish USA
Half billion
combined sufferers of Asthma and
80% Conversion of Nuc Double existing Nuc Med
Chronic Obstructive Pulmonary
Procedures for PE
Med Procedures for PE
Disease globally
Trials Underway!
$90m $900m USD []
$72m
USD
$14m USD USA Revenue Estimates
AUD
20 Technegas [®] is not commercially available in the USA
Enterprise Value
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CYCLOPHARM INVESTMENT CASE

Profitable & Growing MedTech

underlying business is cash positive and issuing dividends

First in class

proprietary product sales to 60 countries with over 4.2 million studies to date

Recurring

revenue

from consumables similar to an annuity model

USFDA approval

set to quadruple the size of the existing PE business and further leverage penetration into the CTPA market

Optionality

into indications beyond PE into chronic respiratory disease management could deliver exponential growth

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Technegas[®] is not commercially available in the USA

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Cyclopharm Thank You & Business Q&A

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AGM Formal Business

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CYC AGM 2020 Resolutions

• 1 That the Remuneration Report as set out in the Annual Report of the Company for the financial year ended 31 December 2019 be adopted.

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Questions?
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CYC AGM 2020 Resolutions

2 That, for the purposes of ASX Listing Rule 14.5 and for all other purposes, Mr David James Heaney, who retires at the close of this Annual General Meeting and, being eligible, and having consented to act, be re‐elected as a Director of the Company.

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Questions?

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CYC AGM 2020 Resolutions

• 3 That pursuant to ASX Listing Rules 10.14 and 10.15, approval is given for the Directors to issue and allot a total 1,015,500 ordinary shares to Mr James McBrayer and/or his nominee, acting in his capacity as the Managing Director of the Company, and to provide him and/or his nominee financial assistance, to subscribe for those shares in the Company, on the terms summarised in the Explanatory Statement.

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Questions?

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2020 AGM Formal Business Resolution Proxies Received

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*Includes Open Useable Proxies that have instructed the Chairman to vote on their behalf and have voted in favour of the resolution.

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Technegas:
World’s Best Functional Lung
Ventilation Imaging Agent
Votes are Being Tabulated
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Cyclopharm

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Thank You

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