Integrum

CEO’s statement

What an incredible first few months as acting CEO of Integrum. I’m truly impressed by the team’s dedication to improving the lives of amputees with our groundbreaking OPRA® Implant System, a bone-anchored prosthetic.

Financial performance in the Quarter and for the period May-October 2024
Revenues amounted to 21,772 (27,558) KSEK during the quarter, a decrease of -21%. The decrease is related to strong comparison numbers in the previous year partly consisting of sales of a start-up set to a distributor in Turkey. The sequential growth was 18% vs the previous quarter. The growth was mainly driven by an increase in the number of stage one (S1) surgeries and Axor sales. For the period May-Oct the revenue amounted to 40,230 (47,952) KSEK. Operating profit EBIT amounted to -11,295 (6,454) MSEK in the quarter and to -23,280 (3,529) MSEK for the period May-Oct.

Sales Force Productivity
The U.S. market for S1 surgeries, the fixture of titanium with Biohelix surface, has experienced a strong growth in number of surgeries during the second quarter vs the first quarter 2024/2025. This success stems from focused pipeline management and effective execution. Our sales team has prioritized ecosystem training and education for Certified Prosthetists and Orthotists (CPOs), along with patient engagement and strong surgeon support. Our company-wide approach, from the CEO to the sales team, centers on carefully mapping the patient journey to ensure they advance seamlessly through each essential step toward surgery. Another priority is developing strategic roadmaps with two key U.S. and two European hospital partners to establish Integrum Centers of Excellence. Once this playbook is in place, it will enable us to launch additional centers with greater speed and precision. These efforts are driving wider adoption of our surgical solutions. Integrum has also expanded its team with a Sales Director who brings extensive experience in orthopedics and prosthetics, further strengthening our market presence.

On-Label Use in the U.S.
In the U.S. the OPRA® Implant System, intended for above-knee amputees, has the Premarket Approval (PMA) from the FDA, the most stringent approval pathway for U.S. medical devices. Our new U.S. marketing team is sharpening the product’s competitive edge over non-PMA-approved alternatives. We are educating healthcare professionals on the importance of on-label (PMA) product use for patient safety and regulatory compliance. Integrum has partnered with over 30 leading U.S. hospital systems, offering patients access to experienced clinical teams and numerous surgical centers.  In the US the next step is focused on market penetration of OPRA Femoral and in a parallel track continuing the PMA process for Humeral.  The ongoing efforts to communicate the OPRA® Implant System's economic value to U.S. payers and hospitals support our sustained long-term growth strategy.

Portfolio and Product Launch in the UK and the U.S.
The recent UK launch of the Femoral and Humeral Systems marks a significant milestone for our portfolio. Regulatory approval was achieved this quarter, with early cases focused on key hospitals. In the U.S., we launched the new AXOR for prosthetic fitting, which has been approved for reimbursement from the Centers for Medicare & Medicaid Services (CMS).

Additionally, Integrum participated in the Orthopedic Trauma Association’s first-ever symposium on osseointegration, reaffirming our commitment to advancing orthopedic trauma expertise.

Our R&D team has reviewed and prioritized projects based on market potential and revenue impact to align with strategic goals. Our prioritized markets are US, Germany, Austria and the UK.

Creating shareholder value
Our strategy focuses on the 'critical few' priorities essential for U.S. market success: driving sales productivity, strengthening leadership, and expanding our portfolio. We aim to strengthen our competitive edge and maintain our market leading position by growing in new customer segments and deepening our core market of medical specialists. We have launched an internal program to motivate and educate employees around finding and executing cost saving initiatives. To support this, we have established clear objectives for employees, prioritizing market penetration of the OPRA® Implant System. This targeted approach sets the foundation for long-term, sustainable success and lays the groundwork for the next CEO.

Mölndal, 4 December 2024

Scott Flora
Chief Executive Officer

The interim report can be found here:

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