Nova Eye Medical Ltd · ASX:EYE
Nova Eye Medical — Investor Presentation (February 2024)
39 slides from Nova Eye Medical's investor presentation, February 2024
Slide 1: Addressing the leading causes of blindness in the developed world
Addressing the leading causes of blindness in the developed world Nova Eye Medical Limited (ASX:EYE) Capital Raising Presentation February 2024
Slide 2: Important Notice and Disclaimer
Important Notice and Disclaimer This presentation has been prepared by Nova Eye Medical Limited (ASX: EYE) (Nova Eye or Company). While the information in this presentation has been prepared in good faith and with reasonable care, no representation or warranty, express or implied, is made as to the
Slide 3: Executive Summary
Executive Summary 01 Following FDA clearance on March 30, 2023, and subsequent USA launch of the iTrackTM Advance in May 2023, Nova Eye Medical Limited (Nova Eye) has driven USA glaucoma sales revenue to US$5.1m for 1H FY24, up 65% on pcp, selling through its own sales team direct to US eye surgeons
Slide 4: Company Overview
Nova Eye Medical Company Overview
Slide 5: Large Unmet Need
Large Unmet Need Glaucoma Opportunity • 126 million(1) people with glaucoma worldwide with US$5.6 billion(1) annual expenditure of which 78%(1) is spent on medications and devices. Market for surgical devices is US$743 million(2) and forecast to reach US$1,341(2) million by 2028 • Significant medica
Slide 6: Business Segment Overview
Business Segment Overview Nova Eye Medical, Glaucoma AlphaRET, AMD Develop, market and sell comprehensive portfolio of Commercialise unique and proprietary technology Strategy Strategy glaucoma consumable surgical devices that addresses AMD with funding from a partner Key products iTrackTM Advance,
Slide 7: Glaucoma product portfolio
Addressing disease progression iTrackTM Advance (mild to moderate) Glaucoma Nova Eye Current iTrackTM Product Portfolio (mid stage) Molteno3 (Severe and Complex) nova-eye.com | 7
Slide 8: Glaucoma Disease Overview
Glaucoma Disease Overview • Glaucoma is the second leading cause of blindness in the developed world (behind cataracts)(1) • Progressive, irreversible eye disease that causes vision loss due to optic nerve damage from elevated intraocular pressure (IOP). • There is no cure for glaucoma. 2 1 • Topica
Slide 9: Glaucoma Treatment Overview
Glaucoma Treatment Overview • Traditional medication treatment paradigm is chronic medication use causes eye damage limiting future treatment options. Patient adherence to glaucoma medications is poor • Patients and surgeons are transitioning(1) Approx 50% of patients are non-compliant with from med
Slide 10: iTrack Advance
1 0 • iTrack™ Advance consumable MIGS device is redefining the treatment of glaucoma in its early stages. • Canaloplasty offers a stent-free, tissue-preserving surgical treatment for glaucoma using an injector technology • Injector technology has enhanced our original iTrack™ which has been used in
Slide 11: Clinically Significant Features iTrack Advance vs Other MIGS
Clinically Significant Features iTrackTM Advance vs Other MIGS Designed to reduce the elevated IOP associated with glaucoma by improving trabecular flow through the natural outflow pathway. Patient Implant- Preserves Device Company Procedure Natural Outflow Pathway Population free Tissue Trabecular
Slide 12: USA Sales Growth Opportunity, iTrack Advance
USA Sales Growth Opportunity, iTrack™ Advance A Active Accounts, Glaucoma (x200) B Inactive Accounts, Glaucoma (x300) C New Accounts, Glaucoma (x1200) • Nova Eye’s direct-to-surgeon sales channel is driving growth of iTrack™ Advance, Nova Eye’s flagship product. • Recruitment of additional sales rep
Slide 13: Glaucoma Device Sales in USA and outlook
Glaucoma Device Sales in USA and outlook USA sales since launch of iTrack™ Advance • US$5.1m(1) sales for the 6 months to Significant month-on-month sales growth post USA 31 December 2023 (65% growth) despite sales in launch of iTrack Advance (74% for the 4 months to 31 November and December 2023 ne
Slide 14: Growth Opportunities Outside of the USA
Growth Opportunities Outside of the USA • During H1FY24 Nova Eye has invested in market access in key territories outside the USA. New investment in sales infrastructure offers growth opportunities. • Western Europe and Canada markets with product registrations, reimbursement and sales channel in pl
Slide 15: H1 FY24 Global Sales
H1 FY24 Global Sales H1 FY23 FY23 H1 FY24 Growth on H2 FY23 (Audited) (Audited) (unaudited) PCP US Dollars ‘000’s USA 3,060 3,587 6,647 5,050 65% Western Europe 1,331 1,252 2,583 1,255 -6% Western Europe OEM sale of equipment (1) 256 - 256 - N/A China 1,050 736 1,786 315 -70% Total 5,697 5,575 11,27
Slide 16: Glaucoma Product Portfolio and Disease State
Glaucoma Product Portfolio and Disease State Portfolio of glaucoma technologies addressing different stages of the disease STAGE OF GLAUCOMA PROGRAM STATUS MILD MODERATE SEVERE COMPLEX GLAUCOMA GLAUCOMA GLAUCOMA GLAUCOMA COMMERCIAL Canaloplasty device injector Canaloplasty device injector Canaloplas
Slide 17: Glaucoma Device Product development
Glaucoma Device Product development Expanding product portfolio leveraging existing IP to expand range of device surgeries covered by reimbursement codes Extend product range to cater to the preferences of eye Glaucoma Global market size Nova Eye surgeons treating broader range of patients. surgical
Slide 18: Strong Existing Clinical Data Set Underpins Surgeon Adoption
Strong Existing Clinical Data Set Underpins Surgeon Adoption Recent Peer Review Data Publication Authors Journal Data Overview Khaimi, M (USA, Clinical • Multicenter, multi-surgeon, retrospective review of a consecutive case series Consistency in Standalone Canaloplasty Gallardo M (USA) Ophthalmolog
Slide 19: Program of Data Collection Continuing
Program of Data Collection Continuing Clinical Study Program – additional data collation de-risks exposure to future reimbursement changes Study Name Study Type Study Sites Study Details Study Synopsis • Independent cloud-based platform that collates efficacy and iTrack™ Global Prospective, 20+ site
Slide 20: Offer Details
re Offer Details
Slide 21: Offer Summary
Offer Summary Nova Eye is seeking to raise approximately A$[8.0] million via the issue of approximately [38.1] million new fully paid ordinary shares (“New Shares”) • An institutional Placement to raise up to approximately A$[3.0] million (“Placement”) Offer structure and size • A 1 for [8.0] pro-ra
Slide 22: Use of Proceeds
Use of Proceeds Glaucoma Surgical Devices:$7.0m USA sales growth - USA sales representative expansion, marketing and clinical $3.7m data program enhancement Outside USA sales growth - Expand commercial infrastructure in prospective $1.6m markets to leverage investment in market access $1.7m Broaden
Slide 23: Indicative Offer Timetable
Indicative Offer Timetable Item Date Trading Halt and announcement of the Equity Raising, lodgement of Offer Documents [Monday, 12 February 2024] Institutional Placement and Institutional Entitlement Offer opens [9am, Monday, 12 February 2024] Institutional Placement and Institutional Entitlement Of
Slide 24: Operating Results for H1FY24
Operating Results for H1FY24 FY23 (Audited) H1 FY24 (unaudited) Australian dollars (‘000’S) Group Glaucoma AlphaRET Corporate Group Glaucoma AlphaRET Corporate Group Revenue 16,661 364 17,025 10,062 77 10,139 GM 11,392 323 11,715 6,900 40 6,940 68% 69% Operating (17,676) (1,364) (2,225) (21,265) (9,
Slide 25: Balance Sheet at 31 December 2023
Balance Sheet at 31 December 2023 31 December 30 June 31 December 30 June 2023 2023 2023 (unaudited) 2023 (unaudited) (audited) $’000’s (audited) $’000’s $’000’s $’000’s Current liabilities Current assets Trade and other payables 4,149 4,311 Cash and cash equivalents 2,612 7,419 Borrowings and lease
Slide 26: Development Milestones 2024
Development Milestones 2024 Nova Eye Glaucoma Segment is addressing large • USA sales growth acceleration unmet needs and • Sales growth in markets outside the USA has a plan in place • Targeting cash flow break even by FY25 to grow • New product introduction the glaucoma business nova-eye.com | 26
Slide 27: Appendix A
Appendix A Additional materials
Slide 28: Nova Eye Glaucoma Surgical Device Reimbursement Transaction in USA
Nova Eye Glaucoma Surgical Device Reimbursement Transaction in USA Eye surgeon selects Nova Eye delivers the The operating notes are submitted to Nova Eye product product to the Facility and Medicare Administrative Contractor invoices the Facility. (MAC) responsible for that geographic area (1) Eye
Slide 29: Reimbursement for Nova Eye Products in the USA
Reimbursement for Nova Eye Products in the USA Product Facility Fee for applicable Physician Fee for surgery for 2024 (US$) applicable surgery for 2024 (US$) HOPD ASC iTrack Advance for canaloplasty $3,877 $2,045 $607 surgery Molteno3 Glaucoma Drainage $2,222 $1,183 $828 device • Fees set and review
Slide 30: Recent Developments in USA Reimbursement
Recent Developments in USA Reimbursement On 31 October 2023 WPS issued Five MACs table draft local coverage a “final” LCD and on 9 November On 8 December determinations1. (LCD) proposing the other 4 MACs did the same. 2023 the effective changes to reimbursement for They are required to give 45 days'
Slide 31: Who are the Medicare Administrative Contractors?
Who are the Medicare Administrative Contractors? • The MACs are private insurance contractors granted responsibility by the US Government Center for Medicare and Medicaid Services (CMS) to administer the health care funding allocated by Congress • MACs administer claims, review doctors’ operating no
Slide 32: Appendix B Key Risks
ac Appendix B Key Risks
Slide 33: Key Risks – Specific
Key Risks – Specific As with any share investment, there are risks associated with an investment in the Company. The numerous risk factors are both of a specific and general nature. Some risks can be mitigated by the use of safeguards and appropriate systems and controls, but some are outside the co
Slide 34: Key Risks – Specific
Key Risks – Specific Specific Risks (cont.) Product Safety and Product safety or quality failures, actual or perceived, or allegations of product contamination, even when false or unfounded, may negatively impact Nova Eye’s brands and could Liability cause consumers to choose competing products. All
Slide 35: Key Risks – Specific
Key Risks – Specific Specific Risks (cont.) Business Disruption Nova Eye is engaged in developing, manufacturing and distributing innovative medical device devices for medical applications, utilising patented technology. As a result, Nova Eye is subject to the risks inherent in such activities, incl
Slide 36: Key Risks – Specific
Key Risks – Specific Specific Risks (cont.) Health Insurance The Company derives revenue from sales of our products to physicians and surgery facilities, which typically bill all or a portion of the costs and fees associated with our products to Reimbursement risk various third-party payors, includi
Slide 37: Key Risks – Specific
Key Risks – Specific Specific Risks (cont.) Insurance Coverage Nova Eye has adequate levels of insurance to protect Nova Eye from potential losses and liabilities. There is a possibility that events may arise which are not adequately covered by existing insurance policies. In this case the Company m
Slide 38: Key Risks – General
Key Risks – General Section 2 identifies and highlights some of the general risks that potential investors should consider prior to acquiring shares in the Company. However, the following is not, and does not purport to be, a comprehensive statement of all relevant risks and is not listed in order o
Slide 39: Tom Spurling, Mark Flynn, Kate Hunt
Tom Spurling Mark Flynn Kate Hunt Managing Director Investor Relations Chief Commercial Officer M: +61 417 818 658 M: +61 416 068 733 M: +61 404 080 679 E: tspurling@nova-eye.com E: mflynn@nova-eye.com E: khunt@nova-eye.com
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