Earnings release
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Ph: +61 8 9360 2888 Fax: +61 8 9360 2899 www.orthocell.com Quarterly Report –March 2025 Perth, Australia; 14 April 2025: Regenerative medicine company Orthocell Limited (ASX: OCC, “Orthocell” or the “Company”) is pleased to release its Quarterly Report for the quarter ended 31 March 2025. Key highlights for the quarter: 1. Orthocell’s primary focus for the quarter was commercial preparation for US FDA 510(k) clearance for Remplir™, its flagship nerve repair product. Clearance was received shortly after the end of the quarter on 03 April 2025. • The Company is now cleared to commence commercial distribution into the globally significant US$1.6 billion1 nerve repair market which is expected to provide a step change in revenue. • Orthocell is well placed to generate first US sales this financial year with logistics and sales pathways already established, including the November 2024 appointments of experienced US- based marketing, sales and medical education executives who have been in place for the quarter and focused on pre-launch activities. • Key pre-launch event successfully completed at the 2025 IFSSH and IFSHT Triennial Congress in the US. Attended by leading peripheral nerve surgeons from the US and other countries. • The Company is prepared for the expected step change in revenue from the US, with annual medical device manufacturing capacity for 100,000 units in place, and capability for further modularised low capital manufacturing expansion. • Significant Remplir™ inventory built up during the quarter. 2. Fourth consecutive quarter of strong revenue with $2.22 million reported for the March 25 Quarter. • Revenue consistent with the previous quarter result of $2.21 million after strong growth over the previous 4 quarters. 38% increase over the previous corresponding March quarter in FY24. • Quarterly revenue has now grown by an average of 8%, compounded for the last ten quarters, following Striate+™ USA and Remplir™ AUS product launches in November 2022. • Demonstrates clear traction with new and existing surgeons, underpinned by the excellent performance of Striate+ and Remplir™ in clinical practice • For clarity, revenue does not yet reflect any US Remplir™ sales 3. Strong cash position retained with A$31.7m cash at bank (no debt). • Orthocell remains well capitalised to continue the global commercialisation roll out of Remplir™ and Striate+. • No material capital expenditure required from Orthocell to support the initial US roll out of Remplir™. • Cost effective sales model adopted with a focus on external distributors throughout global markets and targeted internal on-the-ground staff in the US. 4. Further regulatory applications lodged to open up additional markets for Remplir™. • Regulatory application lodged with Health Canada for approval to sell Remplir™ into the US$75 million1 Canadian market. Approval is expected during the second half of CY2025. • Regulatory application to the FDA of Thailand for the sale of Remplir™ in the growing US$84million1 market. Approval is expected in Q3 CY2025.
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Ph: +61 8 9360 2888 Fax: +61 8 9360 2899 www.orthocell.com 5. Continued rollout of Striate via Orthocell’s global distribution partner BioHorizons. • First Striate+ sales recorded into Germany, Austria and Switzerland (DACH Region). • Regulatory approval received from Singapore’s Health Sciences Authority, allowing the Company to commence sales of its market leading dental guided bone regeneration product, Striate™, in the key market of Singapore 6. Orthocell added to the S&P/ASX All Ordinaries Index. • The S&P Dow Jones Indices announced March 2025 quarterly rebalance of the S&P/ASX Indices. Orthocell was added to the All Ordinaries – Effective prior to the Open on March 24, 2025 Orthocell CEO and MD, Paul Anderson, said: “Our primary focus this quarter has been to ensure we were ready to deliver Remplir sales into the US as soon as practical following receipt of FDA clearance. We’ve been working on the basis we would be successful with the FDA and it was extremely gratifying to see approval come through immediately after the end of the quarter.” “We expect this to be a significant revenue inflection point for us, so a major component of our activities over this quarter has been on-the-ground in the US with a focus on pre-launch sales activities and ensuring logistics are in place. I’m pleased to say we’re ready to go.” “We have also maintained the strong sales levels from the previous quarter and continue to receive excellent feedback from surgeons, which in turns gives us confidence as we enter the US market with Remplir.” Corporate and financial commentary Orthocell reported quarterly revenue to $2.22 million in the March 25 Quarter, consistent with the previous quarter re sult of $2.21 million after strong growth over the previous 4 quarters, and up 38% from $1.61 million for the same period last year (March 24 Quarter, Figure 1). Consistently growing revenue shows clear traction with new and existing surgeons, translating to growing sales of the Company’s market-leading products Striate+ and Remplir. Figure 1 – Quarterly Revenue Quarterly revenue has grown by 8% compounded for the last ten quarters following the product launches in Q2 FY23. Revenue is up 38% from $ 1.61 million in March 24 Quarter to $2.22 million in March 25 Quarter. *CQGR = Compound Quarterly Growth Rate Cash receipts received from customers, inclusive of GST, for quarter ended 31 March 2025 totalled $1,359k, consistent with the Company’s expectations. Following receipt of a $3.18 million refund from the Australian 1.02 1.10 1.35 1.68 1.77 1.51 1.61 1.88 2.03 2.21 2.22 - 0.50 1.00 1.50 2.00 2.50 FY23Q1A FY23Q2A FY23Q3A FY23Q4A FY24Q1A FY24Q2A FY24Q3A FY24Q4A FY25Q1A FY25Q2A FY25Q3A TOTAL REVENUE BY QUARTER Total revenues ($millions) CQGR 8%
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Ph: +61 8 9360 2888 Fax: +61 8 9360 2899 www.orthocell.com Government’s Research and Development (R&D) Tax Incentive program, Net cash inflows from operating activities for the quarter were $605k. Expenditure was focused on commercial and R&D activities. At the end of the quarter, Orthocell held a cash balance of ~A$31.7 million. Orthocell’s cash balance places the Company in a strong position to continue its strategy to expand into the USA in 2025 and continue lodgement of international regulatory applications. Continued revenue growth from the Australian market with Remplir highlights the best-in-class product dynamic and the significant revenue potential of global markets. As detailed in Section 6.1 of Appendix 4C, payments to related parties include salaries, fees and superannuation contributions. Collagen Medical Devices Orthocell’s collagen medical devices are manufactured using a proprietary SMRT™ manufacturing process, which is designed to remove all cellular and genetic material while preserving the natural collagen structure. The purified collagen scaffold provides the ideal environment for cellular attachment and proliferation. The devices are completely absorbed by the body, integrating and resorbing into the tissue as it heals with no immunogenic reactions. Consequently, this medical device has a wide and growing range of uses in orthopaedics and other surgical specialities. We call this our collagen medical device platform - a family of products with wide potential for future development. A facility upgrade to increase manufacturing capacity to >100,000 units per year was completed in December 2022. Striate+™ for dental bone and tissue repair Striate+ is a market-leading resorbable collagen membrane used in guided bone and tissue regeneration procedures. Clinical studies have shown Striate+ supported transition from a two-stage to a single-stage dental procedure, reducing the procedure time and recovery periods by several months. This is of significant interest to patients and clinicians, due to potential improvements in efficiency and efficacy of dental procedures. In July 2022, the Company executed a global exclusive licence and distribution agreement with BioHorizons Implant Systems Inc (BioHorizons), one of the largest dental implant companies, for its Striate+ premium dental membrane. BioHorizon’s USA update Striate+™ continues to impress with momentum building and global market expansion underway BioHorizons completed a US product launch of Striate+ in November 2022, with a focus on supplying existing Key Opinion Leader (KOL) accounts and other major customers. Since market launch, the BioHorizons marketing and sales team has actively promoted Striate+ at key industry conferences and various educational meetings and workshops. These activities have resulted in a ramp up of product sales and growing revenue in US, Europe, UK and Australia. Orthocell continues to work with BioHorizons to gain market access in additional large or strategic markets where they have established accounts and/or distribution networks. During the quarter: 1. BioHorizons officially launched and completed first sales of Striate+™, in the significant markets of Germany, Austria and Switzerland; 2. BioHorizons continued to roll out their education and promotional activities including attendance at the strategic Association for Osseointegration's 2025 annual congress in Seattle; 3. Orthocell’s regulatory team progressed its global market expansion program with approval in the strategic markets of Singapore and Brazil and remains on track to submit an application for approval in Columbia in Q4 2025.
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Ph: +61 8 9360 2888 Fax: +61 8 9360 2899 www.orthocell.com Remplir™ for nerve regeneration Remplir is a collagen nerve wrap used in the repair of peripheral nerve injuries. It provides compression-free protection to the nerve, generating an ideal microenvironment to aid nerve healing. Remplir has proven to be an important step forward in the improvement of nerve repair surgery. Its ease of use, consistent and predictable high-quality outcomes will empower surgeons to improve the lives of people navigating these complex injuries. The Company appointed Device Technologies (DVT) as the exclusive distributor of Remplir across Australia and New Zealand in September 2022 and DVT Asia as exclusive distributor in Singapore in November 2024. Remplir is now being sold in Singapore, Australia and New Zealand, where sales continue to grow with an increasing number of surgeons using and endorsing its unique repair qualities. Device Technologies – Australia and New Zealand update Remplir™ accounts expanding and momentum building DVT officially launched Remplir in Australia in November 2022, with a focus on supplying existing orthopaedic and plastic reconstructive KOL accounts. The ramp up of product sold since market launch is gaining traction with ~200 orthopaedic and plastic surgeons now using Remplir in peripheral nerve repair surgeries, from facial nerves to upper and lower limb nerves, across Australia and New Zealand. Feedback from the clinicians and DVT salesforce continues to be excellent, with adoption driven by Remplir’s unique qualities that enable less suturing, creation of the optimal healing microenvironment and facilitation of free gliding within the repair site during the critical healing period. During the quarter, Orthocell assisted DVT with a series of targeted Remplir education and marketing events, including product roadshows and surgeon workshops in Adelaide, Sydney and Melbourne. Device Technologies Asia - Singapore update Key account expansion continues Orthocell is working with DVT Asia to establish key accounts with leading plastic, reconstructive and orthopaedic specialists. During the quarter, the Company completed numerous product presentations and the Nerve Cadaveric Course titled, “Peripheral Nerve Transfer and Forearm Fractures”. The course was very well received and attended by PRN surgeons from Singapore, Malaysia and Indonesia. Remplir US pre-launch activities Well placed to generate first sales with pre-launch complete The Company is now cleared to commence commercial distribution into the globally significant US$1.6 billion1 nerve repair market. Orthocell is well placed to generate first US sales with a US logistics and customer service partner engaged, sales pathways already established and significant Remplir™ inventory built up. During the quarter the US based sales, education and marketing team actively prepared for product launch. Activities included: 1. Clinical presentations, Key Opinion Leader engagements and potential distributor meetings at the 2025 AAHS, ASPN, ASRM Annual Meeting and the 2025 American Academy of Orthopaedic Surgeons Annual Meeting. Each strategic event was attended by globally leading PRN surgeons meeting to share advances in the field of peripheral nerve repair. 2. Successful pre-launch completed at the 2025 IFSSH and IFSHT Triennial Congress. Attended by leading peripheral nerve surgeons from the US and other countries. 3. Product roadshows in San Diego, Nashville Tennessee, North Carolina, and Tampa Florida. Orthocell team met with potential distributors and leading PNR’s in plastics, orthopaediacs, urology and neurosurgery.
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Ph: +61 8 9360 2888 Fax: +61 8 9360 2899 www.orthocell.com Advanced Cellular Therapies Orthocell’s cell therapies aim to treat diseased or damaged tissue by local implantation or injection of healthy cells where tissue repair is needed. The process involves harvesting a piece of healthy tissue (tendon or cartilage) from the patient. The tissue sample is sent to Orthocell’s manufacturing facility where the cells are extracted and grown in culture over a few weeks until there are sufficient cell numbers to implant. Characterisation of the final product is performed to assess the cell’s purity, potency and identity before implantation, ensuring high quality tissue repair. The use of a patient’s own cells to repair tissue damage reduces the risk of rejection or transmission of infectious diseases. Orthocell is licensed by the TGA to manufacture autologous chondrocytes (OrthoACI™) and tenocytes (OrthoATI™) for cartilage and tendon repair. OrthoATI™ OrthoATI™ is a world-leading cell therapy in development for the treatment of chronic degenerative tendon injuries. OrthoATI can be used in both surgical and non-surgical applications and is at the forefront of a large and increasing market opportunity, estimated to be worth >US$7.7bn1 and growing. During the quarter, the Company attended the 2025 American Academy of Orthopaedic Surgeons Annual Meeting. The meeting was attended by orthopaedic surgeons and sports physicians from across USA. Dr Jason Harvey, a respected Australian upper limb specialist surgeon, presented data from the Orthocell-sponsored clinical study comparing OrthoATI to surgery for the treatment of severe, chronic, treatment-resistant lateral epicondylitis (‘LE Study’). Orthocell is well-positioned to explore the next stage of development of OrthoATI, targeting US FDA registration, and is working with its US-based corporate adviser to identify potential strategic partners to progress OrthoATI without the need for significant investment in the near term. Release authorised by: Paul Anderson Orthocell Ltd CEO and MD For more information, please contact: General & Investor enquiries Paul Anderson Orthocell Limited CEO & MD P: +61 8 9360 2888 Media enquiries Haley Chartres H^CK Director P: +61 423 139 163 1 Addressable market estimate was developed by the Company using reports from US healthcare databases and referenced papers of studies conducted both within and outside the US.
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Ph: +61 8 9360 2888 Fax: +61 8 9360 2899 www.orthocell.com E: paulanderson@orthocell.com.au E: haley@hck.digital About Orthocell Limited ACN 118 897 135 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 CelGro ™ platform of collagen medical device s 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), Canada (MDL), Australia (ARTG), New Zealand (WAND), the UK (UKCA Mark) and Europe (CE Mark) and is distributed globally by BioHorizons Implant Systems Inc. Remplir™, for peripheral nerve reconstruction, recently received approval in Australia, New Zealand and Singapore and is distributed exclusively by Device Technologies. 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.
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Appendix 4C Quarterly Report for entities subject to Listing Rule 4.7B ____________________________________________________________________________________________ Name of entity Orthocell limited ABN Quarter ended ("current quarter") 57 118 897 135 31 March 2025 Current quarter $A'000s Year to date (9 months) $A'000s 1. Cash flows from operating activities 1.1 Receipts from customers 1,359 3,811 1.2 Payments for: (a) (964) (4,015) (b) (925) (2,650) (c) (940) (1,948) (d) (1) (2) (e) (871) (2,585) (f) (587) (1,777) 1.3 Dividends received (see note 3) - - 1.4 Interest received 349 952 1.5 Interest & other costs of finance paid - (5) 1.6 Income taxes paid - - 1.7 Government grants & tax incentives received 3,185 3,215 1.8 Other - - 1.9 Net cash from / (used in) operating activities 605 (5,004) 2. Cash flows from investing activities 2.1 Payments to acquire: (a) - - (b) - - (c) (90) (298) (d) - - (e) intellectual property (42) (49) (f) other non-current assets - - Proceeds from disposal of: (a) - - (b) - - (c) - - (d) investments - - (e) intellectual property - - (f) other non-current assets - - 2.3 Cash flows from loans to other entities - - 2.4 Dividends received (see note 3) - - 2.5 Other (provide details if material) - - 2.6 Net cash from (used in) investing activities (132) (347) Appendix 4C Quarterly report for entities subject to Listing Rule 4.7B entities businesses research & development (including allocated staff costs) product manufacturing and operating overheads leased assets administration & corporate costs staff costs (other than R&D staff) marketing, business development & investor relations Consolidated statement of cash flows businesses property, plant & equipment property, plant & equipment investments entities __________________________________________________________________________________________________________________ + See chapter 19 for defined terms Page 1 of 4
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Appendix 4C Quarterly Report for entities subject to Listing Rule 4.7B ____________________________________________________________________________________________ Current quarter $A'000s Year to date (9 months) $A'000s 3. Cash flows from financing activities 3.1 - 17,000 3.2 Proceeds from issue of convertible debt securities - - 3.3 Proceeds from exercise of share options 461 497 3.4 - (850) 3.5 Proceeds from borrowings - - 3.6 Repayment of borrowings - - 3.7 Transaction costs related to loans & borrowings - - 3.8 Dividends paid - - 3.9 Other (lease payments) (58) (191) 3.10 Net cash from / (used in) financing activities 403 16,456 4. Net increase / (decrease) in cash & cash equivalents for the period 4.1 30,843 20,614 4.2 605 (5,004) 4.3 (132) (347) 4.4 403 16,456 4.5 - - 4.6 Cash & cash equivalents at end of period 31,719 31,719 5. Reconciliation of cash & cash equivalents Current quarter Previous quarter $A'000s $A'000s 5.1 Bank balances 3,719 3,843 5.2 Term deposits 28,000 27,000 5.3 Bank overdrafts - - 5.4 Other (provide details) - - 5.5 6. Payments to related parties of the entity & their associates Current quarter $A'000s 6.1 Aggregate amount of payments to these parties included in item 1 308 6.2 - 7 Financing facilities available Total facility amount Amount drawn at quarter end at quarter end $A'000s $A'000s 7.1 Loan facilities - - 7.2 Credit standby arrangements - - 7.3 Other (please specify) - - 7.4 Total financing facilities - - 7.5 Unused financing facilites available at quarter end - Note: the term 'facilty' includes all forms of financing arrangements available to the entity. Add notes as necessary for an understanding of the position. Proceeds from issues of equity securities (excluding convertible debt securities) Net cash from / (used in) operating activities (item 1.9 above) at the end of the quarter (as shown in the consolidated statement of cash flows) to the related items in the accounts Net cash from / (used in) investing activities (item 2.6 above) Cash & cash equivalents at beginning of period Net cash from / (used in) financing activities (item 3.10 above) Effect of movement in exchange rates on cash held Cash & cash equivalents at the end of the quarter (should equal item 4.6 above) 31,719 30,843 Aggregate amount of payments to these parties included in item 2 Note: if any amounts are shown in items 6.1 or 6.2, your quarterly activity report must include a description of, and an explanation for, such payments Transaction costs related to issues of equity securities, or convertible notes Consolidated statement of cash flows __________________________________________________________________________________________________________________ + See chapter 19 for defined terms Page 2 of 4
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Appendix 4C Quarterly Report for entities subject to Listing Rule 4.7B ____________________________________________________________________________________________ 7.6 8. Estimated cash available for future operating activities $A'000s 8.1 605 8.2 Cash and cash equivalents at quarter end (item 4.6) 31,719 8.3 Unused finance facilities available at quarter end (item 7.5) - 8.4 Total available funding (item 8.2 + item 8.3) 31,719 8.5 Estimated quarters of funding available (item 8.4 divided by item 8.1) N/A 8.6 If item 8.5 is less than 2 quarters, please provide answers to the following questions: 1. Answer: N/A 2. Answer: N/A 3. Answer: N/A Has the entity taken any steps, or does it propose to take any steps, to raise further cash to fund its operations and, if so, what are those steps and how likely does it believe that they will be successful. Does the entity expect to be able to continue its operations and to meet its business objectives and, if so, on what basis? Net cash from / (used in) operating activities (item 1.9) Note: if the entity has reported positive net operating cash flows in item 1.9 answer item 8.5 as "N/A". Otherwise, a figure for the estimated quarters of funding available must be included in item 8.5 Include in the box below a description of each facility above, including the lender, interest rate and whether it is secured or unsecured. If any additional facilities have been entered into or are proposed to be entered into after quarter end, include a note providing details of those facilities as well. Does the entity expect that it will continue to have the current level of net operating cash flows for the time being __________________________________________________________________________________________________________________ + See chapter 19 for defined terms Page 3 of 4
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Appendix 4C Quarterly Report for entities subject to Listing Rule 4.7B ____________________________________________________________________________________________ Compliance statement 1 2 This statement gives a true and fair view of the matters disclosed. Date: Authorised by: Paul Anderson - Managing Director (Name of body or officer authorising release - see note 4) Notes 1 2 3 4 5 If this report has been authorised for release to the market by your board of directors and you wish to hold yourself out as complying with recommendation 4.2 of the ASX Corporate Governance Council’s Corporate Governance Principles and Recommendations, the board should have received a declaration from its CEO and CFO that, in their opinion, the financial records of the entity have been properly maintained, that this report complies with the appropriate accounting standards and gives a true and fair view of the cash flows of the entity, and that their opinion has been formed on the basis of a sound system of risk management and internal control which is operating effectively. If this report has been authorised for release to the market by your board of directors, you can insert here: “By the board”. If it has been authorised for release to the market by a committee of your board of directors, you can insert here: “By the [name of board committee – eg Audit and Risk Committee]”. If it has been authorised for release to the market by a disclosure committee, you can insert here: “By the Disclosure Committee”. This quarterly cash flow report and the accompanying activity report provide a basis for informing the market about the entity’s activities for the past quarter, how they have been financed and the effect this has had on its cash position. An entity that wishes to disclose additional information over and above the minimum required under the Listing Rules is encouraged to do so. If this quarterly cash flow report has been prepared in accordance with Australian Accounting Standards, the definitions in, and provisions of, AASB 107: Statement of Cash Flows apply to this report. If this quarterly cash flow report has been prepared in accordance with other accounting standards agreed by ASX pursuant to Listing Rule 19.11A, the corresponding equivalent standard applies to this report. Dividends received may be classified either as cash flows from operating activities or cash flows from investing activities, depending on the accounting policy of the entity. This statement has been prepared in accordance with accounting standards and policies which comply with Listing Rule 19.11A. __________________________________________________________________________________________________________________ + See chapter 19 for defined terms Page 4 of 4 14 April 2025