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Investor PresentationCapital Raising and Phyzhon Health Distribution Agreement
30 October 2020
Introducing Hydrix
At Hydrix, our vision is to improve a billion lives.
We will achieve this vision by applying technology to develop and distribute products that enhance global health, safety and well-being.
Hydrix - powering growth and innovation
Hydrix VenturesPick winning investments in high potential medical technologies
Cash & committedin-kind base
$3.0m+Potential for
5x value uplift
Hydrix ServicesHydrix Group’s powerful product innovation engine delivers world class design, engineering and regulatory services.
FY20 revenue $15.7m
Hydrix is leveraging its powerful product innovation capability to capture more of the value it creates across multiple growth platforms
Hydrix MedicalDiagnostic, monitoring & interventional MedTech products which improve patient quality of life.
AngelMed Guardian
500,000+cardiac patient events p.a.
A$100mrevenue potentialbased on 3% capture rate
Higher margin, scalable, large market opportunity
Modest margin, good cashflow, covers group costs, provides leads
Executive Summary
Company Overview
• Diversified medtech product design services and device business – 18-year history, Melbourne based, global customers
• “One stop shop” for bringing concepts through to commercialisation for medical devices / technology
• Assisted the development of multiple devices/technologies for multiple other ASX and NASDAQ companies
• Now leveraging our expertise to capture more revenue and margin via selling Medical devices in Asia Pac
PhyzhonDistributionAgreement
• Exclusive rights to distribute Phyzhon’s product which is used in interventional cardiology in Australia and NZ
• Single use device used by cardiologists to take blood pressure measurements during surgical procedures which diagnose and manage blockages of coronary arteries - assisting with balloon and stent selection and insertion
• Synergistic and complimentary to AngelMed Guardian – selling to same cardiologist
Significant Operating Leverage In Medical Business
• Core services business delivered $15.7m revenue in FY20 despite 4Q20 COVID impact – near operating breakeven1 result for Group. Anticipate similar breakeven1 result expected in FY21 (on lower revenues due to ongoing COVID impact).
• Additional revenue from AngelMed Guardian to have material impact on bottom line in FY22 and beyond
• AngelMed Guardian – 3% market share penetration in our markets equivalent to A$100m p.a. revenue
• Phyzhon = 33% market share penetration in our markets equivalent to A$25m p.a. revenue
Capital Raising & Balance Sheet
• A$10.0m Placement at A$0.28 per share to institutional and sophisticated investors
• Support rollout, regulatory, reimbursement for AngelMed Guardian and Phyzhon in Asia Pac
• US business development to further grow services revenues and drive lead conversions
• A$3.5m to pay down all outstanding secured debt and interest - $0.3m p.a. interest saving
• Stronger balance sheet post completion with ~A$10.0m pro forma cash on hand (unsecured shareholder loans $2.75m)
1. Cash operating breakeven is EBITDA & Share-based payments for a full year and may vary on a quarterly basis, and excludes ‘buy, build, invest’ initiatives e.g., Hydrix Medical & non-recurring discretionary
Hydrix Group: FY20 Financials & Outlook
1. Includes client services revenues, and other income such as R&D tax rebates, government COVID stimulus programs
• FY20 total revenue $15.9m, at end of 1HF20, HYD was on track to achieve 15%+ YoY growth rate and deliver a full year cash operating profit2 for FY20 (recorded an $80,000 cash operating loss2)
• Due to COVID-19, changes to, slowing and deferral of existing and prospective Services client budgets
• Approximately $3m or 20% annualized full year cost saving initiatives implemented, core business cash operating cost2 ~$11.5m
• Proactively managing variable and discretionary operating costs, improving margins, while maintaining long term value proposition of inhouse “one-stop-shop” product innovation capability
• Revenue pipeline remains healthy at $50+ million, anticipate growth in 2HF21 & beyond as businesses get back to work and travel
• 1QF21 revenues $2.8m, cash operating loss2 of $0.24 v pcp $0.2m COL2 despite revenues down ~30% v. pcp
• Anticipate full year cash operating breakeven2 for FY21 on lower revenue levels than FY20 due to COVID impact
• FY22 should see material impact of AngelMed and Phyzhon sales traction post regulatory approvals
Revenue Growth1 ($m) Key Insights
2. Cash operating breakeven is EBITDA & Share-based payments for a full year and may vary on a quarterly basis, and excludes ‘buy, build, invest’ initiatives e.g., Hydrix Medical & non-recurring discretionary
FY20 near cash operating breakeven2 from Services revenue only and with COVID impact
1H$1.7
1H$6.2
1H$8.2
2H$4.0
2H$8.0
2H$7.7
$0.0
$2.0
$4.0
$6.0
$8.0
$10.0
$12.0
$14.0
$16.0
$18.0
FY18 FY19 FY20
Gross Revenues $'m
$14.2m
$15.9m
$5.9m
Hydrix Services
Powerful product innovation capability
Established 2002
60+ employees
Full-service NPD
200+ successful projects
Specialist capabilities include:
• Planning & Project Mgt
• Device Engineering
• HFE & Usability
• Prototype development
• Testing & Verification
• Quality systems
• Regulatory approvals
• Clinical evidence strategy
• Reimbursement
Hydrix Services: “Transforming Ideas into Products”‘One-stop-shop’ design & engineering to assist Clients create ‘disruptive’ leading medical technologies
Portable X-Ray Machine
Primary development partner of the first carbon nanotube mobile x-ray platform
Unique ultra-lightweight, mobile x-ray imaging systems for medical applications
Guided client from ‘concept’ to ‘commercialisation’
Bio-separation Device
Guided client from concept to commercialisation to develop a Bio-separation device for their novel fluid separation membrane technology
First application - use in human invitro fertilization (IVF)
Hip Replacement Navigation Device
Developing a novel non-invasive, intra-operative, navigation tool to assist orthopaedic surgeons position the acetabular cup during hip replacement surgery
Concept to commercialisation design, engineering and regulatory Partner, providing all program management, design, engineering, quality, clinal and regulatory guidance
Micro-X (ASX:MX1) Memphasys (ASX:MEM) Gyder Surgical (unlisted)
Hydrix Medical
Our Vision for Cardiac Patient MonitoringBuilding a synergistic portfolio of cardiac devices
Patient MonitoringCardiac monitoring devices communicate to smart phone or external device
Managed InformationEmergency tracking and alert ‘data’ transmitted through to managed cloud services network
Clinical BenefitsCritical data has been pushed via cellular and cloud networks to the receiving hospital in case of emergency admission
Secure data may be stored for GP retrieval
Data available to specialist via local login
Data available anytime, anywhere
A compelling market opportunity
• Cardiovascular disease afflicts 14% of global population*
• Leading cause of death worldwide ~31%
• Despite patient education about diet & lifestyle, it remains a global chronic health disease
* Source: WHO CVD Fact Sheet
https://www.who.int/en/news-room/fact-
sheets/detail/cardiovascular-diseases-(cvds)
Hydrix Medical – Portfolio overview
Implanted Heart Monitor
• 3rd party distribution agreement – signed March 2020.
• An implantable continuous heart monitoring device that detects Acute Coronary Syndrome (ACS) events, including silent heart attacks.
• A global ‘first of kind’ device, approved by the FDA who concluded the AngelMed Guardian “satisfies an unmet need.”
Interventional cardiology device
• Exclusive rights to distribute in Australia & New Zealand.
• Single-use device for interventional cardiology surgery to manage coronary artery blockages.
• High potential to disrupt current products and procedures, improve patient and cardiologist outcomes, reduce operating time and lower hospital costs.
Hydrix cardiac controller platform
• Hydrix cardiac controller platform (internal IP) helping tomorrow’s cardiac device companies accelerate their product research & development, and path to commercialisation.
AngelMed Guardian Phyzhon LUDO
Product 1: AngelMed Guardian® Value Proposition
Improved patient care
Detects previously untreatable silent MIs, reduces symptom to door time & detects other heart anomalies
Improved clinical experience
The device data provides actionable information complimenting standard-of-care testing
Reduced costs
Reduces false positive hospital visits. Improved preservation of left ventricular status helps decrease long-term costs
Improved health
The added confidence of heart monitoring lowers anxiety, improves sleep and helps patients to exercise
World-first technology to assist cardiologists manage patient health & well-being
Hydrix Medical’s first AngelMed Guardian implant recipient Singapore August 2020
Product 1: The AngelMed Guardian® Overview
Product: World’s first FDA approved implantable heart attack alert system using patented AI & Machine Learning algorithms– Continuous 24X7 heart monitor - detects heart-beat changes indicative of a potential heart attack and arrythmias
– FDA approved 1st generation AngelMed Guardian device in April 2018 (3-year battery) stating it “satisfies an unmet need”
– Next generation device for commercial roll-out has a 6+ year battery and in final stages of a 12-month FDA testing program --- results will be submitted to theFDA in 1QCY21 for approval
o In the interim, the FDA approved AngelMed to re-implant 260 of the clinical trial patients with the next generation device (started in September)
o The next generation devices, with the 6+year battery, are what Hydrix sold for implant in Singapore patients
Asset: In March 2020, Hydrix acquired exclusive rights to distribute in eight APAC countries (AUS, JAP, SNG, HK, MAL, THD, IND, NZ)– Purchase consideration earn-out milestones: from FDA approval through end of CY22: max. US$2m + 12m shares (3m shares were issued at completion)
– Multiple milestone tranches tied to target dates & commercial outcomes, including Regulatory approval and notional number of reimbursed implants
– 7-year initial term commences once FDA approved, renewal option, annual unit sales & regulatory approval targets
Commercialisation: Hydrix go-to-market sales and distribution strategy (indicative only)– There is no competitor product. Same surgical technique has been used for pacemaker implants for 50+ years. Large addressable market. Strong margins
– Direct-to-market in AUS & SNG – secure regulatory approvals and insurance schemes, sell direct to Cardiologists via small sales team supported by small fieldclinical engineer team (to be added), sell at retail prices (retain GP% net of partial GP$ share)
– Appoint sub-distributors in rest of markets – regulatory approval and insurance schemes and sales and field clinical engineers all by sub-distributor, Hydrixsell at lower pass-through GP%, provide base amount of training, launch and marketing support.
o Core competencies will include existing distribution of cardiac device and regulatory experience
Product 1: AngelMed Guardian® Revenue Potential
Region1 Sell Pre-Approval
RegulatorySubmission2
Potential Approval3
Population (m)
ACS4
Incidences p.a.
Australia Yes – special access scheme 1HCY20 +9-12 mos 25.1 75,000
Singapore Yes – special access scheme 1HCY20 +9-12 mos 5.7 30,000
Japan Yes – special access scheme 1HCY22 +9-12 mos 126.9 300,000
Malaysia Potential 1HCY22 +9-12 mos 32.4 85,000
New Zealand Potential 1HCY22 +9-12 mos 4.8 18,000
Hong Kong Potential 1HCY22 +9-12 mos 7.4 12,000
202.3 520,000
1. Distribution rights also include Thailand and Indonesia (not shown above)2. Contingent on FDA approval first and appointing sub-distributors who will be responsible for regulatory and reimbursement submissions 3. Regulatory authority approvals are not bound by timelines…implantable devices can take 9-15 months in these jurisdictions4. Acute Coronary Syndrome (ACS) including heart attacks (MIs)5. Estimate of average sell price A$7,500 (to be confirmed once reimbursement scheme approval and sub-distributors appointed)
Annual Sales Volume (units) Annual Sales Value (A$)5
1.0% 5.0% 1.0% 5.0%
750 3,750 $5.6m $28.1m
300 1,500 $2.2m $11.3m
3,000 15,000 $22.5m $112.5m
850 4,250 $6.3m $31.9m
180 900 $1.4m $6.8m
120 600 $0.9m $4.5m
5,200 26,000 $38.9m $195.1m
Potential Market Revenue @ 1%-5% Capture
A 3% capture rate of patient market = $100m rev p.a. (15,000 units)
Potential Market Size and Time to Commercialisation
Comparative pacemaker market size (manage electrical problems): ~85,000 units p.a. in these jurisdictionsAngelMed Guardian manages ‘plumbing problems’
Product 2: Phyzhon FFR guidewire
Product: novel and market first, fibre optic pressure sensor guidewire used for interventional cardiology procedures– Single use device used by cardiologists to take blood pressure measurements during surgical procedures which diagnose and manage blockages of coronary
arteries, including assisting with balloon and stent selection and insertion (current products are mechanical in design increasing risks to patients)
– FDA approval anticipated for 1QCY21 under an FDA 510K submission being lodged in December
– Hydrix and a Melbourne-based hospital are working with Phyzhon to complete the product’s First In Human Clinical Trial (~Jan-Mar 2021)
– Feature benefits include reduced radiation exposure for patient and medical practitioners, reproducibility of pressure readings, reduce treatment time andnumber of devices and insertions compared to current practice
– High potential to be a game changer and become a new standard of care
Asset: Hydrix has secured exclusive rights to distribute in Australia & NZ– No upfront or earn-out consideration. Hydrix is responsible for regulatory approval and go to market investment in A&NZ
– 4-year initial term commencing once TGA approved, renewal option
Commercialisation: Go-to-market sales and distribution strategy (indicative only)– Potential to disrupt competitive landscape. Improves surgical technique and patient outcomes, thereby lowering health care costs. Strong margins.
– Direct-to-market – secure TGA regulatory (NZ then grandfathered). No insurance reimbursement schemes, comes from existing hospital product spend
– Existing solution retail price ~$1,300 - $1,600
– Synergies and cross-selling with AngelMed Guardian --- same Hydrix Medical sales team will sell the AngelMed Guardian to same cardiologists
– For example, an AngelMed patient presenting with a cardiac arrest may have his/her cardiologist use Phyzhon’s device to manage coronary artery blockage,or the cardiologist may recommend the patient receive an AngelMed Guardian implant if this is their first acute coronary event.
Product 2: Phyzhon’s Revenue Potential
Region Sell Pre-Approval1
RegulatorySubmission2
Potential Approval3 Procedures4
p.a.
Pressure Measures
Taken5 p.a.
Market potential6 p.a.
Australia & NZ Yes – special access scheme 1HCY20 +6-9 mos 125,000 12,000 60,000+
1. Anticipate potential for Special User Access Scheme 2QFY21 once Investigative Cardiologist completes First In Human Clinical Trial ~end of March CY21
2. Contingent on FDA approval first (the FDA has a mandated approval timeline for predicate device approvals under this 510K)
3. Anticipate reasonable approval timeframe due to predicate devices are in market
4. Approximate number of Selective Coronary Angiogram procedures p.a.
5. Approximate number of mechanical blood pressure measures taken during coronary blockage investigations p.a. ~12,000 p.a. or 20% of Percutaneous Coronary Interventions (PCI) procedures p.a., which is low due to potential risks posed by attributes of current mechanical pressure measure products
6. Approximate number of PCIs p.a. for which a Stent is inserted is ~75% of cases. Based on the product benefits of this device, cardiologists anticipate it may significantly increase diagnostic blood pressure measurements during therapeutic PCI surgery to enhance their investigative efforts and Stent selection. Further, there is the possibility more diagnostic blood pressure measurements be taken during coronary angiogram procedures. If this practice were to progress, the potential market size could expand beyond the number of therapeutic PCI cases and include a larger number of the 125,000 coronary angiogram investigations p.a. The revenue potential estimates are based on therapeutic PCI case capture rates – if there is an increase in the standard practice of taking diagnostic blood pressure measurements, the effective market capture rate shown would be lower.
Annual Sales Value (A$)6
10.0% 33.0%
$7.5m $25.0m
Potential Market Capture Rate & Revenue Potential
At 33% potential market share uplift due to disruptive benefits - $25m rev p.a.
Potential Market Size and Time to Commercialisation
Primary competitor guidewire in use ~>50% market share has no integrated pressure measure sensor
Phyzhon’s disruptive potential --- become new gold standard of care leading to significant market demand
Hydrix Ventures
Hydrix Ventures: invest or sweat equity in high potential medtech clients
Leverage product design through market commercialisation capabilities and experience of Hydrix Services to capture more of the value that it creates for its customers
AngelMed Guardian Gyder Surgical Memphasys Cyban
<1.0% equityup to 15% equity4.6% equity 7.5% equity
Investment criteria include: (i) Hydrix Services client, (ii) high potential disruptive medical device, (iii) attractive early stage valuation, (iv) potential for distribution by Hydrix medical .
Potential News Flow
Potential news flow: next 12 months
• Further sales (implants) of AngelMed Guardian in Singapore
• First implants of AngelMed Guardian in Australia under Authorised Prescriber Scheme (“APS”) – potential Dec Qtr CY20
• AngelMed USA submission of battery testing results to FDA - Mar Qtr CY21
• FDA approval of AngelMed Guardian new battery – potential 1H CY2021
• Submit TGA (AUS & NZ) & HSA (SNG) regulatory approval for AngelMed Guardian – immediately once FDA approved
• First in Human Clinical Trials for Phyzhon – potential Mar Qtr CY21
• FDA approval of Phyzhon – Mar Qtr CY21
• Submit TGA regulatory approval for Phyzhon – immediately once FDA approved
• Appointments by Hydrix Medical of APAC sub-distributors for AngelMed Guardian - beginning 2H CY21
• AngelMed Guardian approvals for commercial sales by TGA and HSA – potential late CY21 (note +9-12 mos from FDA approval)
• AngelMed Guardian health insurance and reimbursement approvals in AUS & SNG - after regulatory approvals
• Hydrix Venture portfolio updates, including potential valuation uplifts from investee company IPOs or capital raisings
• Potential product acquisitions and/or rights to distribute high potential ‘diagnostic/monitoring/interventional’ cardiac technologies
Value Proposition: High potential for exponential product revenue growth
• Long established powerful product innovation company, >200 client programs over 18 years
• Multiple platforms for growth powered by world leading one-stop-shop new product design expertise
• Significant tail winds for innovative medtech and cardiac products --- have brought to market WORLD FIRST heart attack alert device
• COVID-led acceleration of need for ‘real time’ telehealth monitoring and management of cardiac / respiratory disease patients - world’s leading cause of death
• Well managed business - managing operating costs in line with healthy services revenue project pipeline underpins financial objective for full year cash operating breakeven1
• Stronger balance sheet post raising with cash on hand of A$7m to grow our Service business, fund our regulatory submission and commercial rollout of AngelMed Guardian and Phyzhon, and opportunistically acquire further portfolio products
• Significant operating leverage ahead with material sales of AngelMed Guardian and Phyzhon to positively impact FY22 result and beyond - $100m+ p.a potential revenue at modest market share
1. Hydrix Services + Hydrix Limited excluding ‘Buy, Build, Invest’ & discretionary & non-recurring cost initiatives and Hydrix Medical
Capital Raising – Offer Details & Timetable
Offer size & structure
• Two Tranche Placement to raise approximately A$10.0m (“Placement”) • ~$8m under existing placement capacity and ~$2m subject to shareholder approval• Bell Potter Securities is acting as Lead Manager to the Placement, Henslow as Co-Manager
Placement & Offer Price
• Placement price of $0.28 per new share, representing a discount of 13.8% to the closing price of Hydrix’s shares of $0.325 per share on 27 October 2020
Use of Proceeds
• A$10.0m Placement at A$0.28 per share to institutional and sophisticated investors • Support rollout, regulatory, reimbursement for AngelMed Guardian and Phyzhon in Asia Pac• Bring on US business development team in US to further grow services revenue and take advantage
of leads• Capitalise on opportunities to expand Hydrix Medical product revenue growth• A$3.5m to pay down all outstanding secured debt and interest - $0.3m p.a interest saving• Provide additional working capital
Timetable
• Placement Announced – 30 October 2020• Settlement of Tranche 1 Placement – 5 November 2020• Allotment of Tranche 1 Placement Shares – 6 November 2020• Settlement of Tranche 2 Placement – 16 December 2020• Allotment of Tranche 2 Placement Shares – 17 December 2020
Hydrix – a corporate snapshot
John W King Nominees & Associates 18.6 14.8%
Patagorang Pty Ltd (Roger Allen Family a/c) 6.7 5.3%
Invia Custodian Pty Ltd 6.7 5.3%
Gavin Coote related entities 2.2 1.7%
Joanne Bryant related entities 1.2 0.9%
Paul Wright related entities 0.8 0.6%
Top 20 52.9 41.9%
Ticker HYD
Share Price $0.33
Shares on Issue (m) 126.4
Options and Performance Rights (m) 17.7
Pure Asset Mgmt Warrants (m) 8.0
Market Capitalisation (diluted) (A$m) $50.2m
Capital Structure (as of 23 October 2020)
Share Price History
Major Shareholders (as of 27 October 2020) Shares (m) %
Gavin Coote (GAICD) Executive Chairman
Joanne Bryant Non-Executive Director
Julie King (GAICD) Non-Executive Director
Paul Wright (FAICD) Non-Executive Director
Board & Senior Management
0
5.00mm
10.00mm
15.00mm
20.00mm
25.00mm
30.00mm
35.00mm
40.00mm
45.00mm
0.03
0.13
0.23
0.33
0.43
0.53
Hydrix Limited (ASX:HYD) - Volume Hydrix Limited (ASX:HYD) - Share Pricing
Share
price (
$)
Volu
me (
m)
Board & Senior Management Team
Paul Wright
Non-Executive Director
Joanne Bryant
Non-Executive Director
Julie King
Non-Executive Director
Alyn Tai
Corporate Counsel & Company Secretary
Peter Lewis
Executive Vice President & Corporate Development
Paul Kelly
GM – Hydrix Medical
Medical Advisory Board
Michael Trieu
GM – Hydrix Services
Mark Langham
Group Financial Controller
Alan Morris
Group Marketing Manager
Mandy Kelly
Chief People Officer
Gavin Coote
Executive Chairman
Hydrix Board
Hydrix senior management
Hydrix’s board and leadership teams have the experience and drive to ensure the success of the Company
Disclaimer
This presentation has been prepared by Hydrix Limited (the “Company” or “Hydrix”). This presentation is being provided to investors for the sole purpose ofproviding preliminary background financial and other information to enable recipients to review the business activities of the Company. The document is notintended to constitute an invitation or an inducement to engage in any investment activity. The presentation is not intended to constitute investment advice andshould not be relied upon as such. This document is not intended as an offer or recommendation with respect to the purchase or sale of any securities in theCompany.
The content and graphical illustrations contained in the presentation are provided for information purposes and should not be relied upon to form any investmentdecisions or to predict future performance. The Company is wholly reliant upon third parties for the accuracy and completeness of the information in thepresentation and has no duty of care owed to you in relation to such information. Although the information expressed is provided in good faith and the Companybelieves that its expectations are based on reasonable assumptions, it can give no assurance that its goals will be achieved. Important factors that could causeactual results to differ materially from those included in the forward-looking statements include amongst others, unforeseen delays in product development, thetiming and extent of any changes in the associated technology and the ability of the Company to meet its stated business goals.
Prospective investors should make their own independent evaluation of an investment in the Company or seek advice from their financial adviser, accountant,lawyer, stockbroker or other professional adviser before making any investment decision. Nothing in this presentation should be construed as financial productadvice, whether personal or general, for the purposes of Section 766B of the Corporations Act, or otherwise. This presentation does not amount to, involve or implya recommendation or a statement of opinion in respect of whether to buy, sell or hold a financial product.
Neither Hydrix nor any of its or their associates or any of the Company’s directors’ (Hydrix Group) shall have any liability whatsoever for: (a) investment advice; (b) arecommendation to enter into any transaction or strategy; (c) advice that a transaction or strategy is suitable or appropriate; (d) the primary basis for anyinvestment decision; (e) a representation, warranty, guarantee with respect to the legal, accounting, tax or other implications of any transaction or strategy; or (f) tocause the Hydrix Group to be an advisor or fiduciary of any recipient of this report or other third party. None of the Hydrix Group shall be responsible for or haveany liability to you for losses or damages (whether consequential, incidental or otherwise) arising in any way for errors or omissions in, or the use of or relianceupon the information contained in this document. To the greatest extent permitted by law, we exclude all conditions and warranties that might otherwise beimplied by law with respect to the document, whether by operation of law, statute or otherwise, including as to their accuracy, completeness or fitness forpurpose. Unauthorised copying of this document is prohibited.
hydrix.com
30-32 Compark CircuitMulgrave VIC 3170Australia
ASX:HYD