CORRECTION A new record revenue quarter with 61% growth

The figures for Rights of Use assets (6,620 KSEK) were missing in the previous report and have now been added. The total sums for Fixed Assets and the Balance Sheet remain the same.

THIRD QUARTER 2023/24 (NOV – JAN)

• Net sales amounts to 30.1 (18.7) MSEK, which is an increase of 61% compared with the corresponding period last year. The growth in the US market is 43% compared with the corresponding period last year.
• Operating profit amounts to 0.3 (-13.8) MSEK (EBIT 1.1%). The operating profit amounted to 6.1 MSEK (EBIT 20.2%) excluding currency effects of -5.7 MSEK, most of which are unrealized internal accounts receivables.
• Profit/loss after tax amounts to 0.8 (-13.6) MSEK, which resulted in profit per share of SEK 0.05 (-0.74).
• Cash flow from operating activities amounts to 2.0 MSEK (-14.1), change in working capital was -2.9 MSEK (8.2) and investing activities -4.0 (-1.2). Total cash flow for the period was -5.0 (-7.1) MSEK. Liquid assets as of 2024-01-31 amount to 28.4 (46.3) MSEK, not including 29.2 MSEK in accounts receivables.

Significant events in the third quarter

• The US Department of Defense decided to fully fund a clinical study of OPRA™ Implant System on up to 30 patients with transtibial (below-knee) amputations. The study will be performed by the Walter Reed National Military Medical Center. Integrum will supply OPRA™ Implant Systems on commercial terms.
• The company held a pre-submission meeting with the US Food and Drug Administration (FDA). Based on the conclusions from the meeting, Integrum plans to submit a Pre-Market Approval (PMA) application for Integrum’s OPRA™ Implant System in transhumeral amputations based on existing clinical data.
• Integrum received its final MDR certification. The company’s OPRATM Implant System product portfolio has thereby been granted MDR certification and may be freely distributed within the EU for treatment in individuals living with disabilities because of limb loss.
• The company established a Center of Excellence at the Center for Complex Endoprosthetics, Osseointegration and Bionics in Kyiv, with the intention to spearhead orthopedic treatment using OPRA™ Implant System in individuals who have suffered limb loss.

• 1 MAY – 31 JANUARY 2022/23 (9 MONTHS)
• Net sales amounts to 78.1 (56.1) MSEK, which is an increase of 39% compared with the corresponding period last year. The growth in the US market is 29% compared with the corresponding period last year
• Operating profit amounts to 3.9 (-12.5) MSEK (EBIT 5.0%). The operating profit amounted to 2.5 MSEK (EBIT 3.2%), excluding currency effects of 1.4 MSEK, most of which are unrealized internal accounts receivables.
• Profit/loss after tax amounts to 1.9 (-10.1) MSEK, which resulted in earnings per share of SEK
  0.1 (-0.55).
• Cash flow from operating activities amounts to 2.6 (-17.1) MSEK. Total cash flow was -13.6 (-29.0) MSEK. 
• During the year, The Centers for Medicare and Medicaid Services (CMS) granted the osseointegrated external prosthetic connection device Axor II™ a new reimbursement code. The new code is connected to a set reimbursement that will help to drive growth in the US.

CEO’s statement

The third quarter has been characterized by record sales figures, mainly driven by our continued expansion in the US and a recent accelerating growth in emerging markets.

Yet another quarter with record sales and profit

Revenues amounted to 30.1 MSEK in the third quarter, corresponding to an increase of 61.2 percent compared to the same period last year. Excluding direct currency effects, operating profit amounted to 6.1 MSEK leading to an EBIT margin of 20.2%.

Enhanced collaborations in the US

In the US, which is our prioritized market, we have worked to deepen existing collaborations with hospitals offering treatment with our innovative products. The work is based on Integrum's network model to collect and connect healthcare professionals that surround the patient undergoing treatment with the OPRA™ Implant system. By building an ecosystem with all key players, we lessen hospitals’ administrative burden and help them funnel patients through the treatment process. Ultimately, we believe this will increase patient turnover and, most importantly, improve the individual patient’s healthcare experience.

In November, we announced our plans to apply for pre-market approval (PMA) for the use of the OPRA™ Implant System in above-elbow treatment. Following a successful meeting with the FDA, we are working with high focus to compile the necessary regulatory documentation needed for a formal application.

Expansion into new markets

Integrum's innovative and bone-anchored OPRA™ Implant System restores mobility in a completely different way than traditional socket prostheses. To this end, our ambition is to treat as many amputees as possible, as quickly as possible, with the OPRA™ Implant System to improve their quality of life. Hence, during the fall, alongside our US operations, we have focused on making the OPRA™ Implant System available in Ukraine and Turkey – two countries that, for various reasons, have seen rapidly growing groups of amputees.

In December, we announced the establishment of a clinical center of excellence in Kyiv – aimed at training Ukrainian surgeons in using the OPRA™ Implant System. During the fall, I visited the center three times to perform surgeries, initially pro bono to swiftly get the center into operations. In January, the center independently performed seven surgeries, and is now conducting self-sufficient clinical activities offering the OPRA™ Implant System. The collaboration has generated orders already in the short term; at the end of January, Integrum sold and delivered OPRA^TM Implant Systems to a value of SEK 3.5 million.

The need for Integrum's bone-anchored prosthetic treatments in Ukraine is partly driven by an increased incidence of the tourniquet syndrome, which primarily affects soldiers at the front. The syndrome occurs when treatment of extensive injuries to limbs is delayed. Due to the restricted blood flow during acute treatment with torniquets, the affected individual is usually left with a short stump. In these cases, socket prostheses use is almost impossible, unlike the  OPRA™ Implant System which can restore full mobility.

During my last visit in Kyiv, I met with Ukraine's Minister of Health, Viktor Liashko, who expressed the country's extensive need for high-standard prosthetic treatments and its willingness to invest in restoring the population's health. According to the Ukrainian Ministry of Health, nearly 100,000 people are expected to have an amputation at the end of 2024.

In Turkey, since the end of October, we have been working with our partner Medikon to establish a business solution to offer treatments for people injured in the country's extensive earthquake in early 2023.

A skilful organization to achieve high growth

We have, time and again, shown the overturning potential in our innovative bone-anchored solutions – based both on a large body of scientific and clinical evidence, as well as important public recognition. As the organization has grown with skilled experts in key positions, we now see an important shift in our regulatory and commercial activities laying the foundation for meaningful growth. Integrum is the world’s foremost company in in advanced amputation treatment, and we look forward to leading the way in restoring mobility globally.

Mölndal, 29 February 2024

Rickard Brånemark

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 29-02-2024 09:39 CET.