ORTHOCELL LIMITED — AGM Information 2024

Nov 28, 2024

==> picture [594 x 138] intentionally omitted <==

Annual General Meeting Addresses by Chair and Managing Director

Perth, Australia; 29 November 2024: Regenerative medicine company Orthocell Limited (ASX: OCC, “Orthocell” or the “Company”) is pleased to attach copies of the addresses to be given by the Chair and Managing Director and Chief Executive Officer at Orthocell’s Annual General Meeting (AGM) today.

Release authorised by:

Paul Anderson CEO and MD, Orthocell Ltd

For more information, please contact:

General & Investor enquiries

Media enquiries

Paul Anderson

Orthocell Limited CEO and MD P: +61 8 9360 2888 E: paulanderson@orthocell.com.au

Haley Chartres H^CK Director

P: +61 423 139 163 E: haley@hck.digital

==> picture [594 x 111] intentionally omitted <==

CHAIR’S ADDRESS

Fellow shareholders, thank you for joining me today, at the close of my first full financial year as the Chair of Orthocell. The 2024 financial year has been a very successful period of revenue growth and operational execution. Our revenue grew by 30.8 % over the previous financial year, our first quarter in FY25 marked record growth, and the current quarterly trajectory bodes very well for a continued growth outlook. Our market capitalisation now exceeds ~$194 million, which is over double what it was 12 months ago, and the Company’s imminent entry into the USA market with Remplir™ will create a major scale opportunity.

There are not many opportunities to enter the Biotech sector in Australia with a company that has a strong balance sheet, no debt, growing revenues, unique patents, no ongoing cash diluting royalties and strong corporate governance. Strong corporate governance of companies is critical to sustainable success, and we are regularly reminded of this by both good and bad examples in corporate markets. I assure shareholders that strong governance is our highest priority, and I would like to take this opportunity, along with our CEO and MD Paul Anderson, to reinforce the governance and operational progress achieved in the last 12 months and to update investors on the next phases of our commercialisation strategy for Orthocell.

The board’s approach is to govern Orthocell at the appropriate level for its size and to ensure our governance standards reflect our intention, which is to be a much larger and expansive company over the next few years. In the last 12 months we have completed a full board renewal and attracted world-class directors; implemented appropriate governance policies; and carried out a detailed independent remuneration review of the executive team and key management personnel. The current board of directors all have specific areas of expertise of direct benefit to the Company, and they have been actively assisting the management team to refine the strategy and achieve milestones. Our two founders, Paul Anderson (Chief Executive Officer and Managing Director) and Professor Ming Hao Zheng (Chief Scientific Officer), remain committed to being active participants in the next phases of the Company’s growth.

This approach to governance was pivotal in the success of our recent $17 million share placement at 60 cents, which I’m happy to report was significantly oversubscribed. The top 20 Orthocell shareholders are a robust register of long-term investors who have a genuine interest in a medical device company that has the potential to become an ASX 250 company. We now have ~$32.8 million (as at 31st October) in cash reserves to sustain the business in its major expansion into the USA.

Our strategy to de-risk the Company by focusing on the most significant and immediate opportunities has borne fruit. The recent strengthening of the balance sheet, increased focus on regulatory applications for the global expansion of our core products Remplir™ and Striate™ has been rewarded with a growing share price and significantly more interest from institutional and sophisticated investors. We have also focused on delivering, alongside our distributors, quarter on quarter revenue growth. We expect this achievement to continue and accelerate with additional international market launches underway, and several regulatory submissions completed or pending approval.

Orthocell proudly manufactures its unique products in Western Australia which allows for the capture of the full profit margin. Australia is a globally trusted manufacturing location for medical products and Orthocell’s products, being small in size and weight with a three-year shelf life, can be distributed at a low cost, making the expansion to new markets both feasible and expedient. Orthocell currently has nine international regulatory approvals and is about to lodge its US FDA application for Remplir in this very large and growing nerve repair market currently worth US$1.6 billion. I would like to emphasise that the USA nerve repair market

==> picture [594 x 111] intentionally omitted <==

provides the most compelling opportunity in the history of the Company. We remain on schedule to submit the Remplir US 510(k) application in Q4 CY24, with progression into US FDA approval expected US FDA approval in the first quarter of 2025 and sales soon thereafter.

Many years of research and development have now produced a Company on the threshold of a major global breakthrough in revenue. The next 12 months will be pivotal for Orthocell and we believe it will be the most exciting year of development since the Company’s first international regulatory approval, received in January 2021. Our first international employees have commenced in the USA and the preparation work for our USA entry in Q4 2025 is well underway.

Paul and the team have done a great job in continually raising the profile of the Company with institutional investors and the media. I will accompany Paul to the USA in early 2025 where we have arranged to meet international investors, potential USA distributors, our new employees, and selected Media for the planned USA launch.

I will now touch on our financial performance.

Financial performance

Orthocell reported increasing quarter on quarter revenue and annual revenue of $6.76 million in FY24, up 30.8% from the previous year (FY23) of $5.17 million. This was primarily driven by 55.3% growth in product sales revenue to $3.01 million in FY24 from $1.94 million in FY23.

I would like to direct your attention to our growing quarterly revenue, and particularly the compound quarterly growth rate of 9.1% over the previous 8 quarters to Q1 FY25. Sales growth shows clear traction with new and existing surgeons, underpinned by the excellent performance of Striate+ and Remplir in clinical practice.

Paul will discuss the strong performance of our distributors in more detail shortly.

==> picture [136 x 11] intentionally omitted <==

----- Start of picture text -----

Figure 1 – Quarterly Revenue
----- End of picture text -----

==> picture [463 x 231] intentionally omitted <==

----- Start of picture text -----

CQGR [] : 9.1%
Quarterly revenue has
grown by 9.10%
compounded for the
last eight quarters
following the product
launches in Q2 FY23.
----- End of picture text -----*

*CQGR = Compound Quarterly Growth Rate

==> picture [594 x 138] intentionally omitted <==

With $32.8 million in cash and our R&D tax incentive rebate expected prior to the end of the financial year, the Company is now very well positioned to earn interest revenue whilst preparing for a moderate increase to expenses with the USA launch.

The intent is to maximise returns on expense outlay and make sure we expand in appropriate phases and for this purpose we will monitor the revenue to expense ratios. The critical measure to manage is the net cash burn and we do not wish this to increase as we expand into global markets. It is however critical to maximise the revenue opportunities as they develop. The current cash position of $32.8 million is more than sufficient to bring the Company towards a net positive position.

The total revenue to net expense ratio in FY2022 was 18%, in FY2023 50% and in FY2024 55% and this ratio will increase in line with revenue growth as we build the bridge to a cash flow positive Company.

Orthocell will continue to utilise distributors rather than build its own sales force as we believe this is a more efficient use of capital. The next steps for Orthocell is to maximise revenue from Striate and Remplir whilst maintaining moderate R&D developments in our pipeline of existing innovations.

It is likely that in the 2025 financial year post the successful launch of Remplir in the USA we will then look to expand our pipeline of new products. The executive team will also continue to monitor interest from international companies in partnering on our innovations.

I now invite Paul Anderson to address the AGM.

About Orthocell Ltd

Registered Office – Building 191 Murdoch University, 90 South Street, Murdoch WA 6150 Australia

Orthocell is a regenerative medicine company focused on regenerating mobility for patients by developing products for the repair of a variety of bone and soft tissue injuries. Orthocell’s portfolio of products include a platform of collagen medical devices which facilitate tissue reconstruction and healing in a variety of dental and orthopaedic reconstructive applications. Striate+™ was the first product approved for dental GBR applications, is cleared for use in US FDA (510k), Australia (ARTG), New Zealand (WAND), UK (UKCA Mark) and Europe (CE Mark) and is distributed globally by BioHorizons Implant Systems Inc. Remplir™, for peripheral nerve reconstruction, recently received approval and reimbursement in Australia and is distributed exclusively by Device Technologies in the Australian market. SmrtGraft™, for tendon repair, is available in Australia under Special Access Scheme or participation in a clinical trial. The Company’s other major products are autologous cell therapies which aim to regenerate damaged tendon and cartilage tissue. Orthocell is accelerating the development of its tendon cell therapy in the US with technology transfer and FDA engagement to confirm the path to the US market and prepare for partnering discussions.

For more information on Orthocell, please visit www.orthocell.com or follow us on Twitter @Orthocellltd and LinkedIn www.linkedin.com/company/orthocell-ltd

Forward Looking Statement

Any statements in this press release about future expectations, plans and prospects for the Company, the Company’s strategy, future operations, and other statements containing the words “anticipate,” “believe,” “estimate, ”expect,” “intend,” “may,” “plan,” “predict,” “project,” “target, ”potential,” “will,” “would,” “could,” “should,” “continue,” and similar expressions, constitute forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the Company’s ability to successfully develop its product candidates and timely complete its planned clinical programs and the Company’s ability to obtain marketing approvals for is product candidates. In addition, the forward-looking statements included in this press release represent the Company’s views as of the date hereof. The Company anticipates that subsequent events and developments will cause the Company’s views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date hereof.

==> picture [255 x 97] intentionally omitted <==

Managing Director’s AGM Presentation

29[th] November 2024

==> picture [60 x 39] intentionally omitted <==

Disclaimer

This presentation prepared by Orthocell Ltd (“Company”) does not constitute, or form part of, an offer to sell or the solicitation of an offer to subscribe for or buy any securities, nor the solicitation of any vote or approval in any jurisdiction, nor shall there be any sale, issue or transfer of the securities referred to in this presentation in any jurisdiction in contravention of applicable law. Persons needing advice should consult their stockbroker, bank manager, solicitor, accountant or other independent financial advisor.

This document is confidential and has been made available in confidence. It may not be reproduced,disclosed to third partiesor made publicin any way or used for any purpose other than in connection with the proposed investment opportunity withoutthe express written permission of the Company.

This presentation shouldnot be relied upon as a representation of any matterthat an advisoror potential investor shouldconsider in evaluating the Company.The Company and its related bodiescorporate or any of its directors, agents,officers or employees do not make any representation or warranty, express or implied,as to the accuracy or completeness of any information, statements or representations

contained in this presentation, and theydo not accept any liability whatsoever (including in negligence) for any information, representation or statement made in or omitted from this presentation.

This document contains certain forward looking statements which involve known and unknown risks, delays and uncertainties not under the Company’s control which may cause actual results, performance or achievements of the Company to be materially different from the results, performance or expectations implied by these forward looking statements. The Company makes no representation or warranty, express or implied, as to or endorsement of the accuracy or completeness of any information, statements or representations contained in this presentation with respect to the Company.

It is acknowledged that the Company will not undertake any obligation to release publicly any revisions or updates to these forward-looking statements to reflect events, circumstances or unanticipated events occurring after the date of this presentation except as required by law or by any appropriate regulatory authority.

2

==> picture [60 x 39] intentionally omitted <==

Orthocell at a glance

Well-funded Australian medical device company with growing international revenue and US approval of breakthrough nerve repair device pending

BEST IN CLASS PRODUCTS APPROVED IN EIGHT JURISDICTIONS

Bone / Striate[+] : US, EU/UK, AUS, NZ and CAN Nerve / Remplir: AUS, NZ and SGP

==> picture [44 x 44] intentionally omitted <==

MANUFACTURED IN AUSTRALIA

Scaled facility certified to manufacture in major jurisdictions under strict quality standards (i.e. MDSAP and MDR)

==> picture [34 x 36] intentionally omitted <==

GROWING RECORD REVENUE

Second consecutive quarter of record revenue, reporting $2.03m in the September 24 Quarter

>US$4 Billion p.a. TAM[1]

Large, under penetrated markets in bone and nerve repair alone

STRONG BALANCE SHEET, NO DEBT, NO ROYALTIES

REMPLIR USA APPROVAL 1Q CY25

Well-funded Company retaining all revenue benefits maximising cashflow

On track to submit US approval application and commence sales in US$1.6 billion market

1 Addressable markets include AUS, USA, EU/UK, SGP, CAN, BRZ, JAP & THA. Referenced papers were used to estimate procedures per annum. Papers used included both US and OUS databases and studies.

3

==> picture [60 x 39] intentionally omitted <==

Corporate snapshot

Current analyst risk-adjusted valuations per share of $1.00 and $1.28/sh

==> picture [420 x 382] intentionally omitted <==

----- Start of picture text -----

ASX: OCC TRADING INFORMATION
Share Price (as @ 28 [th] November) $0.81
12 month low/high $0.33/$0.83
Shares outstanding 239M
Market Capitalisation ~$194M
Cash (31 Oct) $32.8M
Debt (31 Oct) Nil
Substantial Shareholders %
Founders & Management ~11%
Institutions & HNW’s (Sankofa, Regal Funds ~16%
Mgt, Austral Capital, Thesis Asset Mgt, Frazis
Capital, Private Portfolio Mgr’s, FundBPO)
----- End of picture text -----

==> picture [421 x 276] intentionally omitted <==

----- Start of picture text -----

12 Month Share Price and Volume
Volume (m) Price ($)
6.0 $0.90
$0.80
5.0
$0.70
4.0 $0.60
$0.50
3.0
$0.40
2.0 $0.30
$0.20
1.0
$0.10
- -
Nov-23 Jan-24 Mar-24 May-24 Jul-24 Sep-24 Nov-24
Volume Share Price
----- End of picture text -----

AU$32.8m

==> picture [39 x 33] intentionally omitted <==

STRONG BALANCE SHEET, NO DEBT, NO ROYALTIES

4

==> picture [60 x 39] intentionally omitted <==

Growing Revenue

FY24 revenue of $6.76 million, up 30.76% from the previous year (FY23) of $5.17 million.

Total Revenue

==> picture [394 x 272] intentionally omitted <==

----- Start of picture text -----

$8,000,000
CAGR 93%
$7,000,000
$6,000,000
$5,000,000
$4,000,000
$3,000,000
$2,000,000
$1,000,000
-

FY2022 FY2023 FY2024
----- End of picture text -----*

Key Highlights

• US Striate+ and AUS Remplir product sales commenced in November 2022 and now ahead of expectations

• Quarterly revenue has grown by 9.10% compounded for the last eight quarters following the product launches in November 2022

• Second consecutive quarter of record revenue , reporting $2.03m in the September 24 Quarter up 7.96% on the $1.88 million achieved in the June 24 Quarter

*** US Striate and AUS Remplir sales commenced in November 2022**

5

==> picture [60 x 39] intentionally omitted <==

Highly Credentialed Board

Recent appointments of John Van Der Wielen and Professor Fiona Wood AM places Orthocell in a strong position to drive its products into global markets and accelerate revenue growth

6

==> picture [137 x 88] intentionally omitted <==

==> picture [511 x 434] intentionally omitted <==

SMRT Manufacturing DEVELOPING AND MANUFACTURING BIOLOGICAL MEDICAL DEVICES

==> picture [96 x 37] intentionally omitted <==

==> picture [60 x 39] intentionally omitted <==

Collagen medical device platform

Our collagen medical device platform is comprised of a range of acellular, type 1 collagen devices for the surgical repair of bone, nerve, tendon and cartilage

==> picture [823 x 337] intentionally omitted <==

----- Start of picture text -----

BONE NERVE TENDON
Striate+ membrane Remplir nerve wrap SmrtGraft scaffold
Dental bone and tissue repair Peripheral nerve repair Tendon repair
Revenue generating in Revenue generating in AUS launch
US, EU/UK AU & CAN AUS & NZ CY 2025
----- End of picture text -----

8

==> picture [60 x 39] intentionally omitted <==

SMRT manufacturing

Orthocell develops and manufactures innovative collagen medical devices that deliver the highest quality surgical repair of bone, nerve, tendon and cartilage

SMRT manufacturing process

Barrier function prevents infiltration of cells not involved in tissue repair but enables the passage of bioactive molecules and proteins

• Pure collagen

Decellularization process removes all cellular and genetic material

• Mimic human collagen

Natural collagen structure is preserved creating the ideal environment for cellular attachment and proliferation

• No immunogenic reaction

Devices integrate and degrade commensurate with the tissue healing process

==> picture [522 x 238] intentionally omitted <==

----- Start of picture text -----

1 1
2
3
Porous network of collagen Bioactive chamber supports
fibres promotes cellular new tissue formation and
attachment and proliferation integration
----- End of picture text -----

9

==> picture [60 x 39] intentionally omitted <==

Australian manufacturer

Scaled facility certified to manufacture medical devices to major jurisdictions under strict international quality standards (i.e. MDSAP and MDR)

==> picture [242 x 170] intentionally omitted <==

==> picture [242 x 157] intentionally omitted <==

==> picture [566 x 334] intentionally omitted <==

10

==> picture [137 x 88] intentionally omitted <==

Remplir REDEFINING NERVE REPAIR

==> picture [96 x 37] intentionally omitted <==

==> picture [510 x 433] intentionally omitted <==

==> picture [60 x 39] intentionally omitted <==

Remplir: Nerve repair breakthrough

Current repair methods can place delicate nerve tissue under tension, causing scarring, fibrosis and neuroma formation

==> picture [824 x 338] intentionally omitted <==

----- Start of picture text -----

1860s 2000s 2020s
Suturing Conduits Next generation
infl
sep
Success
50-70% 55% 85%
Rates
----- End of picture text -----

12

==> picture [60 x 39] intentionally omitted <==

Remplir: Redefining nerve repair Collagen nerve wrap approved and reimbursed in Australia. Intended for use in peripheral nerve repair

==> picture [515 x 210] intentionally omitted <==

• ✓ Exceptional handling characteristics

✓ Mimics epineurium (nerve outer layer)

✓ Reducing sutures

==> picture [37 x 142] intentionally omitted <==

GUIDING PREDICTABLE OUTCOMES IN PERIPHERAL NERVE REPAIR

✓ Returns nerve to pre-injured state

13

==> picture [60 x 39] intentionally omitted <==

Remplir: surgical technique

A breakthrough product guiding predictable outcomes in peripheral nerve repair and return of muscle function

==> picture [262 x 127] intentionally omitted <==

----- Start of picture text -----

1
----- End of picture text -----

Damaged peripheral nerve after traumatic injury to limb

==> picture [262 x 127] intentionally omitted <==

----- Start of picture text -----

2
----- End of picture text -----

Damaged section of nerve is removed, and ends bought together without tension

==> picture [262 x 127] intentionally omitted <==

----- Start of picture text -----

3
----- End of picture text -----

Remplir is wrapped around nerve, reducing suture requirements and facilitating optimal coaptation

==> picture [262 x 127] intentionally omitted <==

----- Start of picture text -----

4
----- End of picture text -----

Remplir easily confirms to the repair site while mimicking the nerve’s natural epineurium

==> picture [262 x 127] intentionally omitted <==

----- Start of picture text -----

5
----- End of picture text -----

Remplir creates a protected healing environment allowing new axons to reconnect

==> picture [262 x 127] intentionally omitted <==

----- Start of picture text -----

6
----- End of picture text -----

Healed nerve restores function to affected limb

14

==> picture [60 x 39] intentionally omitted <==

Remplir: indications Remplir is the only device that can be used for either connecting severed nerves, protecting damaged nerves or capping amputated nerves

==> picture [411 x 284] intentionally omitted <==

==> picture [112 x 111] intentionally omitted <==

==> picture [112 x 112] intentionally omitted <==

==> picture [112 x 111] intentionally omitted <==

CONNECT

Trauma: motor vehicle, power tool, surgical injuries, sports and military related accidents

PROTECT

Compression: blunt trauma, revisions surgeries (e.g. carpal/cubital tunnel)

CAP

Amputation: amputations, stump neuroma, mastectomies, schwannoma

15

==> picture [60 x 39] intentionally omitted <==

Remplir: compelling clinical results Patients regained voluntary muscle movement within 12 months, increasing strength and range of motion at 24 months

==> picture [399 x 314] intentionally omitted <==

----- Start of picture text -----

100%
80%
60% 76%
85%
40%
20%
0%
Baseline Month 12 Month 24
-20%
-40%
-60%
-80%
No function Useful function Minimal function
-100%
----- End of picture text -----

We are now seeing a consistent return of arm and hand function following nerve transfer surgery with Remplir. Remplir is increasing the success rate and efficiency of nerve transfer surgery. - Leading Australian orthopaedic nerve specialist and clinical trial lead, Dr Alex O’Beirne

FINAL RESULTS

Useful Function

Voluntary movement with improved strength and range of motion

85% (23 of 27) of nerve repairs resulted in functional recovery of muscles controlled by the repaired nerve

Minimal Function

Voluntary movement restored, limited strength and range of movement

No Function

No voluntary movement

16

==> picture [76 x 49] intentionally omitted <==

Meet Jasmine McGough

In a single moment, on 5 July 2022, time stopped for Jasmine McGough. The vibrant 14-year-old from Perth was doing what she loved most, riding her mountain bike on a trail with her family in Margaret River, when she hit a log and fell in a particularly harsh position on her back. She fractured her C5 vertebrae. Five months after her accident, Jas underwent a nerve transfer procedure with accomplished orthopedic surgeon, Dr Alex O’Beirne. A year on from the procedure, Jas has already reclaimed significant movement and function. This is her story.

==> picture [886 x 498] intentionally omitted <==

CLICK TO PLAY VIDEO

==> picture [60 x 39] intentionally omitted <==

Successful launch with growing revenue

==> picture [142 x 34] intentionally omitted <==

AUS commercial launch[1 ] of Remplir with Device Technologies, reimbursed in the private healthcare system in November 2022, with sales unit volumes exceeding expectations

Remplir product revenue since AUS market launch

==> picture [444 x 209] intentionally omitted <==

----- Start of picture text -----

$1,200,000
$1,000,000
$800,000
$600,000
$400,000
$200,000
$0
FY23 FY24
----- End of picture text -----

• 127% growth in Remplir revenue from $457K in FY23 to $1.04M in FY24

• Product sales to Device Technology significantly exceeding guidance – over 161 orthopaedic and plastic reconstructive surgeons

• Adoption drivers - enables less suturing, creation of the optimal healing microenvironment and facilitation of free gliding within the repair site during the critical healing period

• Orthocell supplies Device Technologies (DVT) with Remplir products, and DVT exclusively market and distribute Remplir in Australia.

19

==> picture [60 x 39] intentionally omitted <==

US FDA APPROVAL EXPECTED Q1 CY25 TO US$1.6 BILLION MARKET

Annual US nerve reconstructions

Over 700,000[1] peripheral nerve repair procedures in the US per year, 90% undertaken using suture only method.

==> picture [38 x 36] intentionally omitted <==

• Current devices are not widely adopted due to suboptimal outcomes – Axogen, Integra and Stryker collectively sell ~70k units per year (10% of procedures)

• Top-line results from Remplir US market authorisation (510k) study on track for December 24

• 510K regulatory application on track for December 24

• Remplir US approval anticipated 1Q CY25

6,516 4,475 2,309 56,700 630,000 Suturing Axogen Stryker Integra Others

1. Referenced papers used to estimate peripheral nerve procedures in the US per annum. Papers used included both US and OUS databases and studies

20

==> picture [60 x 39] intentionally omitted <==

US Sales and Medical Affairs Executives

Orthocell has appointed two experienced US-based executives, John Walker and Phillip Edmondson, to drive the market launch and sales of Remplir following the expected US FDA approval in the first quarter of 2025

==> picture [107 x 31] intentionally omitted <==

----- Start of picture text -----

John Walker
Vice President – Sales
----- End of picture text -----

==> picture [156 x 31] intentionally omitted <==

----- Start of picture text -----

Phillip Edmondson
Vice President – Medical Affairs
----- End of picture text -----

Mr Walker is a highly experienced sales executive, who has successfully led global product launches and sales strategies, most notably helping to lead the growth of nerve repair device sales at Axogen.

Mr Edmondson is an award-winning medical affairs professional, who excels in creating product awareness, building advocacy and implementing successful medical education programs that contribute to sales growth.

21

==> picture [60 x 39] intentionally omitted <==

Remplir: Path to partnering

Orthocell is underpinned by a proven business model for innovating, developing, launching and successfully partnering medical device products

Scale Organisation US Approval Brand Ambassadors Data Package Sales and Marketing Executive team Pilot study Scientific narrative Published preclinical Positioning strategy Manufacturing facility Pre-submission meeting KOL panel design Published clinical Pricing strategy Quality system Animal surgeries KOL engagement strategy TGA approval Customer segmentation Third party logistics In-life assessments In-country collaboration PMCF Promotion plan Organisational team Data analysis Centres of excellence In country study Launch collateral ERP implementation 510k submission Clinician advocacy program Medical education program Hire in-country team US team training material Engage distributors Establish key accounts

Scale Organisation

22

==> picture [60 x 39] intentionally omitted <==

Remplir: Market Expansion

Regulatory approval for Remplir in Singapore achieved in 2H CY24 with a further four applications planned in Canada, Thailand, EU & UK in the next 6-12 months

Approved in Australia, New Zealand and Singapore

==> picture [804 x 289] intentionally omitted <==

----- Start of picture text -----

Regulatory Applications 2024 2025 2026
Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
Singapore
✓
Planned Expected
USA
Submission Approval
Planned Expected
Canada
Submission Approval
Planned Expected
Thailand
Submission Approval
Planned Expected
EU + UK
Submission Approval
Planned Expected
Brazil
Submission Approval
----- End of picture text -----

23

==> picture [60 x 39] intentionally omitted <==

Remplir: Large addressable market in nerve reconstruction

Remplir is a breakthrough product on track to be the global market leader in peripheral nerve repair – a retail market estimated to exceed US$3.5 billion¹ per annum

==> picture [876 x 287] intentionally omitted <==

----- Start of picture text -----

Total Addressable Retail Est. procedures
Market (US$m) p.a. at peak (‘000)
$85 $35 39.2
$247
93.9
164.7
$421
280.7 728
$75
$7 US$3.5b $1,602 2.0k
50.1
7.3
$1,022
681
AU/NZ USA EU/UK SGP CAN BRZ JAP THA Targeting a 20% share of the US$3.5 billion total
----- End of picture text -----

Targeting a 20% share of the US$3.5 billion total addressable retail market

1. Addressable markets include AUS,USA, EU/UK, SGP, CAN, BRZ, JAP, THA. Referenced papers were used to estimate procedures per annum. Papers used included both US and OUS databases and studies

24

==> picture [137 x 88] intentionally omitted <==

==> picture [198 x 49] intentionally omitted <==

GROWING BETTER BONE IN DENTAL APPLICATIONS

==> picture [96 x 37] intentionally omitted <==

==> picture [510 x 433] intentionally omitted <==

==> picture [60 x 39] intentionally omitted <==

Striate+ premium dental membrane Next generation dental membrane for high quality bone repair

• Striate+ is a sterile, resorbable collagen membrane for use in dental bone and tissue regeneration procedures.

• Striate+ is designed to protect the bone defect from ingrowth of gingival tissue, to provide a favourable environment for osteogenesis and to assure reliable formation of high-quality bone.

==> picture [190 x 148] intentionally omitted <==

----- Start of picture text -----

1
----- End of picture text -----

Preparation of repair site. Defect site is filled with bone graft

2 Striate+ placed over defect and implant abutment installed

==> picture [402 x 176] intentionally omitted <==

----- Start of picture text -----

3 4
Wound closure Crown placement 3-6
----- End of picture text -----

Crown placement 3-6 months later

26

==> picture [60 x 39] intentionally omitted <==

Striate+ global license and manufacturing agreement Innovation backed by world-class KOL’s and an exclusive licensing deal with fifth largest global provider of dental products, BioHorizons

• AU $21.5 million in upfront cash received net of fees in consideration of the global license granted

• Major validation of Striate+ and the Device Platform – opens the doors to the largest healthcare markets, reduces execution risk and provides a clear sight to revenue growth

• Establishes the manufacturing business - enables the scale up of manufacturing alongside the expected rapid growth in purchase orders from BioHorizons

• Access to global distribution network – BioHorizons is a global operator and a subsidiary of Henry Schein Inc. (NASDAQ: HSIC. US $11bn market capitalisation) enabling access to an international network of distribution partners. For e.g. First private label called perFORM launched by ACE Southern, September 18, 2023[1]

==> picture [221 x 80] intentionally omitted <==

==> picture [180 x 143] intentionally omitted <==

==> picture [181 x 143] intentionally omitted <==

1. ACE Southern is a subsidiary of Henry Schein and will market and distribute perFORM on the same terms and conditions as BioHorizons is marketing and distributing Striate+

27

==> picture [60 x 39] intentionally omitted <==

Successful Striate+ launch, revenue growing US commercial launch[1] of Striate+ dental barrier membrane in November 2022, sales unit volumes now exceeding expectations

Striate+ product sales + license revenue since US market launch

==> picture [359 x 189] intentionally omitted <==

----- Start of picture text -----

$3.5 M
$3.0 M
$2.5 M
FY23 FY24
----- End of picture text -----

• Gaining excellent traction and growing revenue in US, Europe, UK and Australia, supported by an outstanding 98.6% success rate from the Striate+ dental implant post-marketing clinical study

• 14% growth in Striate+ revenue from $2.99M in FY23 to $3.41M in FY24

• Forecast product sales to BioHorizons now exceeded expectations, driven by a high performing distributor and the surgeons’ preference for a high-quality dental membrane that is easier to use and facilitates better, more efficient bone growth

• Orthocell supplies BioHorizons with Striate+ products, and BioHorizons exclusively market and distribute Striate+ globally.

28

==> picture [60 x 39] intentionally omitted <==

Striate+ Market Expansion

Orthocell is working with BioHorizons to accelerate access into the large markets of Brazil and Singapore and to achieve further regulatory approvals into multiple other markets where they have established accounts and/or distribution networks

Approved in Australia, USA, EU, UK and Canada

Approved in Australia, USA, EU, UK and Canada	Approved in Australia, USA, EU, UK and Canada	Approved in Australia, USA, EU, UK and Canada
Regulatory Applications 2024 2025 2026
Q1 Q2 Q3 Q4	Q1 Q2 Q3 Q4	Q1 Q2 Q3 Q4
Brazil Submitted	Expected Approval
Singapore Submitted	Expected Approval
Colombia	Planned Submission E A	xpected pproval
Market Expansion 2024 2025 2026
Q1 Q2 Q3 Q4	Q1 Q2 Q3 Q4	Q1 Q2 Q3 Q4
Germany	Planned Launch
Austria	Planned Launch
Switzerland	Planned Launch

29

==> picture [60 x 39] intentionally omitted <==

Striate+ revenue growing in US, EU/UK & AUS – and beyond Significant opportunity to secure 20% share of the US$732M[1] global dental barrier membrane market which would generate ~US $40 million in recurring wholesale revenue to Orthocell

Market Share Drivers

• Global distributor BioHorizons and ACE Southern[1] collectively control ~20% of the US market

• Accelerating market access into the large markets of Canada, Brazil and Singapore.

• Achieving further Striate+ regulatory approvals into multiple other new large markets

• High quality product gaining excellent traction and growing revenue in US, Europe, UK and Australia

==> picture [164 x 34] intentionally omitted <==

----- Start of picture text -----

Total Addressable Retail
Market (US$m)
----- End of picture text -----

==> picture [257 x 266] intentionally omitted <==

----- Start of picture text -----

$34
$114
$65
US$732M $300
$35
$6
$180
AU/NZ USA EU/UK SGP CAN BRZ JAP
----- End of picture text -----

Targeting a 20% share of the US$732M total addressable retail market

1. ACE Southern is a subsidiary of Henry Schein and will market and distribute perFORM on the same terms and conditions as BioHorizons is marketing and distributing Striate+

30

==> picture [60 x 39] intentionally omitted <==

Upcoming catalysts[1]

Remplir – redefining nerve repair Data for US FDA approval 4Q CY24 US FDA submission lodged 4Q CY24 Canada submission lodged 4Q CY24 US FDA market approval 1Q CY25 First sales Singapore 1Q CY25 EU+UK, Thailand & Brazil submissions lodged 2H CY25 Striate+ – growing better bone Columbia submission lodged 1Q CY25 Germany, Austria, Switzerland market launch ~~1Q CY25~~ Brazil product registration 2Q CY25 Singapore product registration 3Q CY25

31

1. Timelines may be subject to change due to circumstances not under the Company’s control

==> picture [60 x 39] intentionally omitted <==

Pipeline Advanced product portfolio with near term milestones and emerging pipeline. Orthocell is working with a US adviser to secure a partner to accelerate the commercialisation of the tendon cell therapy

Product	Status	Next Steps	Multi-Billion US Markets
Medical Devices
Ligament replacement	Successful pilot study completed	Pre-clinical and clinical study in development	>200,000 procedures per year
Tendon Cell Therapy
Rotatorcuff	RCT shows significantly more effective than steroid injection	US partnering strategyin	>1,000,000
Lateral	RCT shows as effective, and potentially	development	procedures per year
epicondyle	better than surgery

32

==> picture [60 x 39] intentionally omitted <==

Key Investment Highlights

Commercial-stage Best in class Strengthened medical device products for Bone, board with the company at revenue Nerve and Tendon appointments of inflection point repair highly experienced executives John Van Der Wielen, Professor Fiona Wood and Kim Beazley

$32.8M cash at Near term value bank, strengthened drivers including register, no royalty Remplir 510k study liabilities and results Q4 CY24 and funded to US market clearance approval of 1Q CY25 breakthrough nerve repair device

33

==> picture [255 x 97] intentionally omitted <==

Authorised for release by:

Co-Founder and Managing Director, Paul Anderson Orthocell Limited P: +61 8 9360 2888 E: paul.anderson@orthocell.com.au

orthocell.com

34