Interim report May – Jan 2022/23: Solid growth and stronger market presence

The period Nov 1st 2022 – Jan 31st 2023

▪    Net sales amounted TSEK 18 680 (12 636), which is an increase of 48% compared with the corresponding period last year. The growth in the US market is 40% compared with the corresponding period last year.

▪    Operating loss amounted to TSEK -13 773 (503)

▪    Net profit amounted to TSEK -14 176 (541)

▪    Cashflow from operating activities amounted to TSEK -14 083 (863)

▪    Earnings per share amounted to -0,74 SEK (0,03)

Significant events in the quarter

▪    Continue to add well renowned hospitals, where NYU Langone, ranked among the top 5 orthopaedic surgery hospitals, is now offering the treatment. In Europe the University Hospital of Regensburg in (DE) started to treat patients.

▪    The Yang Center for Bionics at MIT was reported to explore future possibilities with our mind-controlled prosthesis e-OPRA in their clinical research.

▪    Pending an EU Medical Device Regulation (MDR) certificate for the OPRA Implant System, we have strengthened our management team and started preparation for scale-up. In January Annika Fahlén was appointed as Director of Quality Assurance and Regulatory Affairs, QARA. And in February, we welcomed Mats Dotevall as our new Chief Operating Officer and site manager. With these additions, our management team has the expertise needed to leverage our innovative products and succeed in the market.

FIRST NINE MONTHS May 1st 2022 – JAN 31st 2023

▪    Net sales amounted TSEK 56 141 (37 401), which is an increase of 50% compared with the corresponding period last year. The growth in the US market is 54% compared with the corresponding period last year

▪    Operating profit amounted to TSEK -12 533 (1 486)

▪    Net profit amounted to TSEK -10 111 (1 482)

▪    Cashflow from operating activities amounted to TSEK -17 116 (2 261)

▪    Earnings per share amounted to - 0,55 SEK (0.97)

Significant events in the period

▪    The board appointed Rickard Brånemark as the company’s new CEO. In connection with this, Rickard Brånemark resigned as Chair of the Board, and Bengt Sjöholm was appointed Chair of the Board.

 

CEO comment

With continued growth, strong health economic data, new high-profile hospitals in the client base, and extensive research programs launched for e-OPRATM, Integrum reinforces its position as a leader of osseointegrated implant systems.

Continued growth and stable financial position
Revenues amounted to SEK 18,7 million during the third quarter (November-January), which corresponds to 48 percent growth compared to the corresponding quarter last year (30 percent in local currency). The continued year-on-year growth is encouraging, especially since late autumn and Christmas is a challenging time for planned surgeries in the U.S. The many holidays create fewer surgery slots and for a company like Integrum, which is still in the early days of commercialization, every day and procedure makes a difference.

At the end of the quarter, liquid assets amounted to SEK 46,3 million. Together with SEK 21 million in secure accounts receivables, we have a stable financial position and the means in place to drive further growth.

Adding new high-profile hospitals in both Europe and the U.S.
When high-profile hospitals start to perform surgeries with our OPRATM Implant System, we know the benefit exceeds the order value. Surgeons interact and learn from each other, and so do patients. Good clinical experiences spread, especially from clinics known to lead the development. In November, the University Hospital of Regensburg in Germany performed its first implant surgery with OPRATM Implant System. The university hospital specializes primarily in restoring body shape and function in complex cases following tumors, accidents, burns, wounds, injuries, and diseases of the hand and wrist.

In December, NYU Langone in New York City, which is ranked among the top five hospitals in the US for orthopaedic surgery, initiated an osseointegration program based on the OPRATM Implant System. The new program follows two successful initial procedures performed at the hospital and is proof that NYU Langone values the paradigm shift in treatments that OPRATM Implant System offers for patients. We see this repeatedly – when clinics want to offer the best technology available to their patients, they start to ask about Integrum’s OPRATM Implant System.

In November, we were able to deepen our dialogue with key players in the market and further increase the interest in our implant systems at the Global Collaborative Conference on Osseointegration in Charlotte, North Carolina, U.S. – a three-day event that brought together surgeons, researchers, prosthetists, patient navigators, rehabilitation teams and others engaged in the field of osseointegration.

Competent team in place to scale up
Pending an EU Medical Device Regulation (MDR) certificate for the OPRA Implant System, we have strengthened our management team and started preparation for scale-up. In January, we appointed Annika Fahlén as Director of Quality Assurance and Regulatory Affairs, QARA. Annika Fahlén is an accomplished leader with vast experience in the field, acknowledged for her business acumen and track record in implementing organizational process improvements. In February, we welcomed Mats Dotevall as our new Chief Operating Officer and site manager. Mats Dotevall is an experienced and strategic leader with excellent management skills who knows the global implant business very well. With these additions, our management team has the expertise needed to leverage our innovative products and succeed in the market.

Extensive research programs for e-OPRA
The research initiative by the Yang Center for Bionics at MIT, which was launched in the fall of 2022, will explore future possibilities with our mind-controlled prosthesis
e-OPRA. Integrum will provide osseointegrated implant technology and the company’s OPRATM Implant System and e-OPRA will play a key role in the center’s research
activities. The Yang Center for Bionics will unite experts from three MIT schools, and researchers at the center will collaborate with clinical and surgical collaborators at
Harvard Medical School. Together with the ongoing clinical programs for e-OPRA, the research collaboration will help take e-OPRA closer to a potential marketing approval.

As the OPRA Implant System now becomes more established in both the European and the U.S. markets, it is deeply satisfying to see how our next-generation e-OPRA Implant System attracts more interest. With our proven technology and unique value proposition, we are building a global leader in our field, and we are proud to extend a message of hope to all those persons who have lost an arm or a leg.

This information is such that Integrum AB (publ) is required to publish in accordance with the EU Market Abuse Regulation and the Swedish Security Markets Act. The information was submitted for publication, through the agency by the contact persons set out below on March 1, 2023, at 8:30 am (CET).