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Beskrivning
| Land | Sverige |
|---|---|
| Lista | First North Stockholm |
| Sektor | Hälsovård |
| Industri | Medicinteknik |
Second quarter 2024/25 (August - October)
- Net sales amount to 21.8 (27.6) MSEK, which is a decrease of 21.0 % compared with the corresponding period last year. The growth in the US market and in Rest of the World is -23 % and -14 % compared with the corresponding period last year, respectively.
- Operating result amounts to -11.3 (6.5) MSEK. The operating result amounted to -10.5 MSEK excluding currency effects of -0.8 MSEK, most of which are unrealized internal accounts receivables.
- Profit/loss after tax amounted to -8.9 (3.9) MSEK, which resulted in earnings per share of SEK -0.46 (-0.22).
- Cash flow from operating activities amounts to -9.5 MSEK (6.8), change in working capital was 1.0 MSEK (-1.2) and investing activities -3.3 (-2.0). Total cash flow was -12.0 (3.4) MSEK. Liquid assets as of 2024-10-31 amount to 34.1 (33.3) MSEK, not including 31.6 MSEK in accounts receivables.
Significant events in the quarter
- The board announced that Scott Flora, board member since 2023, was appointed acting CEO of Integrum AB after Rickard Brånemark left the role and was appointed Chief Scientific Advisor.
- The first OPRA® Implant System procedure was done in the UK.
- Ty Hanners was appointed Director of Sales, US, focused on expanding the OPRA surgical system product offering to amputees.
1 May 2024 - 31 October 2024 (6 months)
- Net sales amounted to 40.2 (48.0) MSEK, a decrease of 16.1 % compared with the corresponding period in the previous year. The growth in the US market and in the Rest of the World is -11.4 % and -16.5 % compared with the corresponding period last year, respectively.
- Operating result amounted to -23.2 (3.5) MSEK. The operating result amounted to -21.1 MSEK excluding currency effects of -2.1 MSEK, most of which are unrealized internal accounts receivables.
- Profit after tax amounted to -18.4 (1.0) MSEK, which resulted in earnings per share of SEK -0.95 (0.06).
- Cash flow from operating activities amounts to -20.0 (4.2) MSEK. Total cash flow was 17.2 (-8.6) MSEK.
Significant events in the year
- Integrum carried out an issue of 961,539 new series B shares, at a subscription price of SEK 52 per share, raising proceeds of approximately SEK 50 million.
- The company has finalized a trade term loan facility agreement of about 24 MSEK as an option to finance its accounts receivables
- Integrum announced that the company has received market approval for the OPRA® Implant System in Israel.
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/
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 04-12-2024 07:00 CET.