ORTHOCELL LIMITED — Earnings Release 2026

Oct 1, 2025

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ASX Announcement

Orthocell Announces Record Revenue of $3m for September Quarter

• Record revenue of $3.0 million achieved for the quarter ended 30 September 2025, driven primarily by increasing market penetration of nerve repair product Remplir™ in Australia and Singapore.

• September quarter revenue represents a 9.1% increase over the previous quarterly record of $2.7 million for the June 2025 quarter.

• This result is the sixth consecutive quarter of record revenue, with a Compound Quarterly Growth Rate (“CQGR”) of 9.5% since product launches in Q2 FY23.

• Outstanding result does not yet include material revenue from Remplir sales in the US, which are expected to build during the December 2025 Quarter and grow into 2H FY26.

• Highlights of the US commercialisation of Remplir include:

• a distributor network that now covers 25+ States and 40% of the US population;

• first US surgeries completed across multiple hospitals, with over 100 surgeons now introduced to the product; and

• over 50+ VAC applications lodged with hospitals; 11 approvals in place and beginning to unlock scale adoption

• The first Canadian distributor was recently appointed, and initial sales from this region are targeted for the December quarter with market adoption expected to grow steadily into 2026.

• Orthocell maintains robust cash reserves of circa $27.0 million and is well-positioned for continued commercial expansion.

• Full Quarterly Activity Report and Appendix 4C to be released by in the next 1-2 weeks.

Perth, Australia; 2 October 2025: Regenerative medicine company Orthocell Limited (ASX:OCC, “Orthocell” or the “Company”) is pleased to announce a record quarterly revenue result of $3.0 million for the quarter ended 30 September 2025.

The September quarter's revenue represents a 9.1% increase over the previous quarter, marking the sixth consecutive quarter of record revenue. The Company has achieved a CQGR of 9.5% since product launches in Q2 FY23 (Figure 1).

Importantly, while the result includes a modest but strategically significant financial contribution from early Remplir surgical cases in the US, the record revenue performance was primarily driven by increased market penetration in existing markets, particularly Australia and Singapore. The anticipated growth in

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adoption of Remplir by surgeons in the US represents the potential for a material increase in revenue moving forward, expected to build in the December quarter and grow thereafter.

Growth in Remplir sales is expected to be further supplemented by market entry in Canada. With the recent appointment of the first Canadian distributor, initial sales are targeted for the December quarter with market adoption expected to grow steadily into 2026.

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Total revenue by quarter
CQGR 9.5%
3.00
2.75
2.21 2.22
2.03
1.88
1.77
1.68
1.61
1.51
1.35
1.10
1.02
Total revenue ($m)
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Figure1: Quarterly Revenue

Orthocell CEO and MD, Paul Anderson, said:

“The record revenue result for the September quarter is a particularly pleasing result, given it has largely been achieved from our existing markets in Australia and Singapore. It’s a tangible confirmation that surgeons are growing increasingly comfortable using Remplir in nerve repair procedures.

“Our US Remplir rollout remains on target with early surgical cases having been successfully undertaken during the quarter. As expected, these cases represented a modest financial contribution in the September quarter, but we see significant upside in our revenue growth potential as US momentum builds and Canada comes online. This is the market entry plan we followed in Australia and Singapore, and we hope to replicate it on a far larger scale in the US.”

With circa $27.0 million in cash and no debt, Orthocell is well-positioned to drive rapid product adoption to deliver a step change in revenue in FY26. Remplir rollout in the US$1.6 billion US market[1] continues to build momentum, with in-country representatives making significant progress working with distributors to gain hospital approvals, on-board surgeons and establish active accounts. Initial US surgical cases continue to build.

1 Nerve repair market sizes estimated using referenced papers from both US and OUS databases and studies.

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Orthocell expects to release its full Quarterly Activity Report and Appendix 4C by Friday, 10 October.

Release authorised by:

Paul Anderson

Orthocell Ltd CEO and MD

For more information, please contact:

General enquiries Media enquiries Investor enquiries Paul Anderson Haley Chartres Shaun Duffy Orthocell Limited H^CK Director VECTOR Advisors CEO and MD P: +61 8 9360 2888 P: +61 423 139 163 P: +61 404 094 384 E: paul.anderson@orthocell.com E: haley@hck.digital E: sduffy@vectoradvisors.au

About Orthocell Limited

ACN 118 897 135

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 the US, Australia, New Zealand, Singapore, UK, Europe, Canada and Brazil and is distributed globally by BioHorizons Implant Systems Inc. Remplir™, for peripheral nerve reconstruction, recently gained clearance for use in the US. The Company has appointed 14 US distributors and recorded initial sales. The Company’s flagship nerve repair product is also approved in Australia, New Zealand and Singapore where it is distributed by Device Technologies Group. Other Remplir approvals include Thailand and Canada. 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

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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.

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