A strategic shift to accelerate the commercialization of OPRA® Implant System

REG

CEO’s statement

Drawing on more than 40 years of experience in the MedTech sector, I am truly excited to help drive momentum at Integrum. OPRA® Implant System demonstrates groundbreaking potential and following this quarter's comprehensive business assessment and the Board's decision on a strategic shift, I am more confident than ever that we are entering a transformative period at Integrum.

Recovery in US market sales
Net sales in Q3 came in at SEK 23.7 million, marking a decline of 21 percent compared to the corresponding period last year – a quarter impacted by exceptional inventory buildup at distributors in EMEA/APAC. US sales remained stable at SEK 20.1 million compared to SEK 20.3 million in Q3 2023/24. Compared to previous quarters, we see a recovery in US sales (SEK 16.5 million in Q2), instilling confidence that our focused efforts on sales force productivity are paying off.

An eventful quarter
In November we launched a service initiative to enhance support of our AxorTM II devices in the US. This will strengthen our U.S presence, improve customer satisfaction and help providers maximize the value of our solutions.

During the quarter we announced that, in collaboration with Southern Prosthetic Supply (SPS), we will co-host seven regional educational events across the United States in the coming months. This aligns well with Integrum’s broader education strategy for 2025, which includes a goal to train more than 200 Certified Prosthetists and Orthotists (CPOs) throughout the year.

The company also welcomed the new board members Kristofer Westergren and Anette Lindqvist. I am certain their extensive experience will contribute to the OPRA® Implant System reaching patients in need as well as increasing shareholder value.

A strategic shift for accelerated commercialization and improved cost efficiency
On February 18, we announced a strategic shift to accelerate the market penetration of OPRA® Implant System. The strategy includes focusing on selected centers of excellence, strengthening the aftermarket business, and introducing a new Key Performance Indicator (the number of S1 surgical procedures) to enhance transparency. The new strategic plan is based on a comprehensive business analysis carried out by the Board of Directors and management. This analysis confirms the underlying demand for OPRA® Implant System and uncovers compelling opportunities to accelerate market uptake by establishing a limited number of centers of excellence across the U.S. and prioritized markets in Europe while strengthening the aftermarket business through enhanced CPO engagement and increased sales of Axor II. This focused approach builds on the conclusion that clinics where the OPRA® Implant System has already gained a foothold are generating healthy, recurring revenue streams with robust gross margins.

Separation of long-term R&D investments

While our R&D pipeline holds significant promise, the OPRA® Implant System deserves our full attention to maximize value creation for both amputees and shareholders. As part of the strategic shift, the Board of Directors is therefore evaluating strategic alternatives for Integrum’s long-term R&D pipeline, including a potential separation in whole or in parts. This would enable a more distinct valuation of Integrum’s different business components while separating long-term R&D investments from commercial operations. The evaluation aims to optimize resource allocation and create the best conditions for both the commercial and research operations to reach their full potential.

Successful share issue enhances financial stability

The directed share issue conducted alongside the announcement of the strategic shift strongly affirms the attractiveness of the new roadmap to investors. With proceeds of SEK 31 million before transaction costs and expected annual cost efficiencies of up to SEK 20 million once all strategic measures are implemented, along with the utilization of a trade term financing agreement already in early Q4, we have secured financial strength to implement our revised plan to enhance value creation for our shareholders.

Moving forward
This intense quarter has reinforced my strong belief in the positive outlook for Integrum, and we have set the stage for a more focused strategy and clear priorities. We are now well positioned to create the right conditions to unlock the full commercial potential of the OPRA® Implant System with the dual aims of providing amputees with a better quality of life and building shareholder value. While the road ahead will require patience and persistent effort, I am convinced that we have laid the foundation for sustainable success.

Mölndal, March 3rd, 2025

Scott Flora
Chief Executive Officer

The interim report can be found here:

https://integrum.se/investor-relations/financial-reports-calendar/

This disclosure contains information that Integrum AB is obliged to make public pursuant to the EU Market Abuse Regulation (EU nr 596/2014). The information was submitted for publication, through the agency of the contact person, on 03-03-2025 07:00 CET.

Datum 2025-03-03, kl 07:00
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