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CURVEBEAM AI LIMITED Call Transcript 2025

Jan 28, 2025

64727_rns_2025-01-28_405c605f-35e1-4608-ab63-d53df13a0811.pdf

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QUARTERLY 4C CONFERENCE CALL 29[th] of January 2025

DISCLAIMER

Introduction

THIS DOCUMENT IS NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION, IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, IN OR INTO OR FROM THE UNITED STATES OF AMERICA OR TO ANY RESIDENT THEREOF, OR ANY OTHER JURISDICTION WHERE SUCH RELEASE, PUBLICATION OR DISTRIBUTION IS UNLAWFUL. THIS DOCUMENT IS NOT AN OFFER OR INVITATION TO BUY OR SELL SECURITIES.

This presentation has been prepared by CurveBeam AI Limited (ACN 140 706 618) ( CurveBeam or the Company ) and contains summary information about CurveBeam and the business conducted by it as at 29 January 2025. The information in this presentation is for informational purposes only, does not purport to be complete and is not a prospectus, product disclosure statement or other disclosure document for the purposes of Chapter 6D or Part 7.9 of the Corporations Act 2001 (Cth) ( Act ) or other offer document under Australian law or the law of any other jurisdiction.

The distribution of this document outside of Australia may be restricted by law and any such restrictions should be observed. This document may not be distributed or released to any person in the United States. As further detailed below, none of CurveBeam, nor its advisers ( Advisers ) nor their respective affiliates, related bodies corporate (as defined in the Act) or security holders and their respective directors, officers, employees, partners, representatives, consultants, agents or advisers (each a Limited Party and together, the Limited Parties ) guarantees or make any representation or warranty to, or takes responsibility for, the accuracy, reliability or completeness of the information contained in this presentation, to the recipient of this document (you or the Recipient), and nothing contained in this document is, or may be relied upon as, a promise or representation, whether as to the past or future. To the maximum extent permitted by law, each Limited Party disclaims any liability for any loss arising from the use of information including representations or warranties or in relation to the accuracy or completeness of the information, statements, opinions or matters, express or implied, contained in, arising out of or derived from, or for omissions from, this presentation.

Forward looking statements

The information given in this presentation is given for illustrative purposes only and should not be relied upon as (and is not) an indication of CurveBeam’s views on future performance or condition. Past performance cannot be relied upon as an indicator of future performance. This presentation contains certain forward-looking statements. The words “forecast”, “estimate”, “like”, “anticipate”, “opinion”, “should”, “could”, “may” and other similar expressions are intended to identify future earnings, financial position and performance of CurveBeam. You are cautioned not to place undue reliance on these statements. These forward-looking statements are based on estimates, projections and assumptions made by CurveBeam about circumstances and events that have not yet taken place. Although due care and attention has been used in the preparation of these statements, such forward-looking statements are based on numerous assumptions regarding CurveBeam’s present and future business strategies and the political, regulatory and economic environment in which CurveBeam will operate in the future and are subject to change without notice. Statements about market and industry trends, which are based on interpretations of current market conditions, may not be reasonable, and are not guarantees or predictions of future performance. The actual results or performance of CurveBeam may be materially different from the results or performance expressed or implied by such forward-looking statements. No representation, warranty or assurance (express or implied) is given or made in relation to any forward-looking statement by any person (including any of the Limited Parties). In particular, no representation, warranty or assurance (express or implied is given that the occurrence of the events expressed or implied in any forward-looking statement in this presentation will actually occur). Subject to any continuing obligations under applicable law, the Company expressly disclaims any obligation or undertaking to provide any updates or revisions to any forward-looking statements in this presentation to reflect any change in expectations in relation to any forward-looking statement or any change in events, conditions or circumstances on which any statement is based.

Financial information

All numbers in this presentation are stated in Australian dollars ( A$ ) unless stated otherwise.

Not an offer or financial product advice

The information contained in this presentation is for informational purposes only and should not be considered, and does not contain or purport to contain, an offer, invitation, solicitation or recommendation with respect the purchase or sale of any securities in CurveBeam nor does it constitute legal, taxation, financial product or investment advice. The general information in this presentation has been prepared without taking into account the investment objectives, financial situation or particular needs of any particular person. Recipients of the presentation must undertake their own independent investigations, consideration and evaluation. By accepting this presentation, a Recipient agrees that if it proceeds further with its investigations, consideration or evaluation of investing in CurveBeam it will not in any way rely upon this document. Neither this presentation nor any of its contents will form the basis of any contract or commitment and it is not intended to induce or solicit any person to engage in any transaction nor is it intended to be used as the basis for making an investment decision.

CurveBeam recommends that potential investors consult their professional advisors as an investment in CurveBeam is subject to investment and other known and unknown risks, some of which are beyond the control of CurveBeam or its directors and therefore any investment is considered to be speculative in nature.

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2 4C INVESTOR PRESENTATION

4C SUMMARY OF KEY ACTIVITIES

  • CurveBeam AI received purchase orders (POs) for ten ( 10) devices in Q2 FY25 , representing around A$5m in future sales for the quarter. Compared with the prior corresponding period of four (4) devices in Q2 FY24, this is a 150% increase in orders. Total device purchase orders were up by 150% on Q2 FY24 .

  • Eight (8) of the orders were for HiRise™. This is a record quarter for purchase orders for the HiRise™ . Five (5) of the HiRise orders were through Stryker.

  • Thirteen (13) POs were received for the six-month period to 31 December 2024 versus seven (7) in the pcp, up almost 100%.

  • Collaborative steps towards Enhanced HiRise’s validation for a major robotic aided surgical system made progress over the holiday period, and it continues into early 2025 with the first 5, of 10 matched datasets currently being processed. The Company remains confident in completing this by the end of Q3 FY25 .

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TM
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  • Following the signing of a non-binding Term Sheet during December, the Company has since entered a formal agreement with Stryker Australia and New Zealand , announced to the ASX yesterday. This expands commercial arrangements with Stryker into CurveBeam AI’s home market.

  • CurveBeam AI completed the Q-Sub meeting on the proposed new BMD (MDCT) FDA file on the 17th of December 2024. Continues to be a 510K filing but with more data requested – the Company estimates a 6-month delay for filing with FDA .

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3 4C INVESTOR PRESENTATION

Q U A R T E R L Y P U R C H A S E O R D E R S A N A L Y S I S

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TM
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Discontinued
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®
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Device Purchase Orders FY24Q1 FY24Q2 FY24Q3 FY24Q4 FY25Q1 FY25Q2
US 2 2 2 5 1 8
Rest of World 1 2 3 5 2 2
Total 3 4 5 10 3 10
Total Purchase Orders by Qtr by Region
12
10 10
10
8
8
6 5 5 5
4
4 3 3 3
2 2 2 2 2 2
2 1 1
0
FY24Q1 FY24Q2 FY24Q3 FY24Q4 FY25Q1 FY25Q2
US Rest of World Total
14 Purchase orders by half year comparison
12
10
Device Purchase Orders FY24 H1 FY25H1
8
US 4 9
6
Rest of World 3 4
4
Total 7 13
2
0
US Rest of World Total
FY24 H1 FY25H1
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Q U A R T E R L Y P U R C H A S E O R D E R S A N A L Y S I S

HiRise Purchase Orders FY24Q1 FY24Q2 FY24Q3 FY24Q4 FY25Q1 FY25Q2
US 2 2 0 4 0 7
Rest of World 1 2 3 3 2 1
Total 3 4 3 7 2 8

HiRise Purchase Orders by Qtr by Region

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TM
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9
8
7
6
5
4
3
2
1
0
FY24Q1 FY24Q2 FY24Q3 FY24Q4 FY25Q1 FY25Q2
US Rest of World Total
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5
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Cashflows from Operations

  • Cash used in operations for Q2 FY25 was A$2.7m versus A$5.3m in Q2 FY24 (pcp);and A$4.7m in Q1 FY25. Receipts from customers was the highest recorded to date for a quarter at A$2.6m, up from A$1.3m in Q2 FY24 (pcp) and A$2.4m in Q1 FY25.

  • Cash outflows totaled A$7.1m down from A$8.3m in Q2 FY24 (pcp), and A$7.2m in Q1 FY25. Material points to note in respect of cash outflows

  • Staff costs were up against Q1 by A$0.6m due to the quarter, including 7 fortnights payroll versus 6, and with some restructuring costs from the reorganisation announced in the Q1 quarterly update falling into Q2.

  • • Product Manufacturing and Operating Costs were down A$0.6m against Q1.

  • Cash at the end of Q2 of A$8.8m resulted in a calculation of quarters of funding of 3.2 quarters .

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  • The Company expects, based on current exchange rates, to receive a further A$6.0m in receipts from customers over H2 FY25 from existing POs as devices are shipped and installed, which before any further purchase orders in Q3 or Q4 would be expected to generate greater receipts from customers in H2 than the $5.0m in H1.

6 4C INVESTOR PRESENTATION

E N H A N C E D H I R I S E ™ P R O J E C T F O R R O B O T I C S U R G I C A L S Y S T E M S

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  • CurveBeam AI has completed the development of the Enhanced HiRise platform and is now FDA 510(k) cleared.

  • Enhanced HiRise™ WBCT scans, with higher energy X-Ray source, allows key anatomical landmarks to be identified in larger patients.

  • Key validation steps for a robotic surgical system at two upgraded US based sites were completed. Both sites have imaged patients on the enhanced HiRise™ with image quality generally at par with MDCT.

  • The Company is continuing to complete validation of the enhanced HiRise™, required for custom protocols for hip and knee robotic surgical systems. The validation made progress over the holiday period, and it continues into early 2025 with the first 5 matched datasets, of 10 currently being processed.

  • TM

  • • A step change is targeted in HiRise orders, once validation of knee & hip datasets for a robotic system is in place.

7 4C INVESTOR PRESENTATION

BMD SAAS MDCT MODULE UPDATE

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Multidetector CT (MDCT)
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  • As discussed in the quarterly activity report for Q1 FY 25, the Company’s revised BMD regulatory strategy is to clear the first BMD module on multidetector CT (MDCT) scanners, the primary technology used today for custom cut guides.

  • This change in strategy also offers earlier, expanded access to SaaS revenues from existing MDCT placements in the US market.

  • As advised, the company completed its scheduled Q-Sub meeting with the FDA on 17 December 2024 on the new BMD MDCT pathway.

  • The file remains on a 510(k) class II pathway, but additional comparison with BMD obtained from Dual energy X-ray (DXA) has been requested by the FDA for around 20-25% of the trial patients.

  • This new request will require more time to complete the file for submission to the FDA. The Company estimates a delay of 6 months for filing the BMD SaaS module (MDCT) in mid-2025, while FDA clearance is now targeted for H1 CY26.

8 4C INVESTOR PRESENTATION

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9 4C INVESTOR PRESENTATION
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IN CLOSING

  • Received purchase orders (POs) for ten (10) devices in Q2 FY25 (around A$5m in ™

  • future sales). A record quarter (FY25 Q2) for purchase orders for the HiRise .

  • A formal agreement with Stryker Australia and New Zealand expands commercial arrangements with Stryker into CurveBeam AI’s home market

  • Cash at the end of Q2 of A$8.8m resulted in a calculation of quarters of funding of 3.2 quarters.

  • The Company expects, based on current exchange rates, to receive a further A$6.0m in receipts from customers over H2 FY25 from existing POs as devices are shipped and installed.

  • Continuing to complete validation of the enhanced HiRise™ for hip and knee robotic surgical systems. The validation made progress over the holiday period with the first 5 matched datasets, of 10, currently being processed. Targeting FY25 Q3 timeline.

  • We remain confident in our pipeline over the remainder of the financial year. Management are focusing on opportunities not reliant on robotic datasets for Q3 closes.

  • BMD SaaS module, with new regulatory strategy Q-Sub feedback, FDA file submission estimated to be delayed by 6 months.

DEFINITIONS

CurveBeam AI’s key metrics are defined and interpreted as follows:

  • Purchase order – a signed purchase order (PO) for a CT scanner (device). The Company considers POs to be a key metric as it reflects actual sales at any given time.

  • Receipts from customers – any cash consideration received from a customer by CurveBeam AI. This can include initial deposits required at the time of an order being placed.

  • Revenue – Revenue is recognised after the device (e.g., HiRise™) is delivered, installed and training has been completed. Depending on the customer site requirements, there can be several months’ delay from a signed purchase order to recognition of revenue. Thus, revenue may not be reflective of sales progress in each period.

The Company will report on POs and cash receipts in its Appendix 4C (quarterly) lodgments, while revenue will be reported in Appendix 4E (full year report) and Appendix 4D (half year report).

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10 4C INVESTOR PRESENTATION
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