Year End Report May 2022 – April 2023: CONTINUING TO BUILD THE COMPANY

FOURTH QUARTER 2022/23 (FEBRUARY – APRIL)

• Net sales amounted to SEK 18.1 (18.3) million, which is a decrease of 1.1% compared with the corresponding period last year.
• Operating profit amounted to SEK -7.2 (-0.5) million.
• Profit/loss after tax amounted to SEK 6.4 (3.3) million, which resulted in earnings per share of SEK 0.35 (0.18).
• Cash flow from operating activities before changes in working capital amounted to SEK -6.4 (-0.0) million. Liquid assets as of 30 April 2023 amounted to SEK 41.9 (75.3) million

Significant events in the quarter

• The company is continuing to expand and develop the   organisation. During the period, the company welcomed four new employees: three at Integrum AB and one at Integrum Inc.
• Work on the transition to certification according to MDR continued, albeit at a lower intensity and with reduced expenses, as the certification was granted in the period. During the quarter, costs of SEK 1.4 million were capitalized as intangible assets. The costs refer to external costs as well as time spent internally.
• Shirley Ryan AbilityLab received a USD 1.5 million grant from the US Department of Defense. The grant will finance a clinical trial to examine the benefits of Integrum’s e-OPRA^TM Implant System compared to a traditional socket prosthesis system.

1 MAY 2022 – 30 APRIL 2023 (12 MONTHS)

• Net sales amounted to SEK 74.3 (55.7) million, an increase of 33.3% compared with the corresponding
  period in the previous year.
• Operating profit amounted to SEK -19.7 (1.0) million.
• Profit after tax amounted to SEK -3.7 (21.3) million,
  which resulted in earnings per share of SEK -0.2 (1.19).
• Cash flow for the period from operating activities before changes in working capital amounted to SEK -26.2 (2.5) million.

Significant events in the year

• 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.
• During the period Integrum received the MDR certificate for its OPRA^tm Implant System.
• United States Patent and Trademark Office approved patent for the OPRA^TM Implant System. The system is now patent protected until 2044 in the US.
• The company received ISO 13485 certification during the year. This is a part of the investments done in the MDR project.  Is it now verified that Integrum’s QMS system is appropriate and meet regulatory medical device requirements. 

CEO’s statement

Continuing to build the company. Integrum’s revenues amounted to SEK 18.1 million during the fourth quarter (February-April), similar to Q4 last year and Q3 this year. We are confident that the  growth decline is temporary, and the building blocks we are putting in place will deliver continued long-term growth. These building blocks include, regulatory approvals, a strengthened IP portfolio, key recruitments, awareness campaigns, and research grants. Over the year, we have continued to see strong growth in our sales of 33 %, and we remain committed to building a global orthopaedic company.

Awareness campaigns drive future growth
During recent months we have invested in raising awareness about our implant systems in social media campaigns in the U.S., on platforms like Instagram, Facebook, and LinkedIn. The goal is to build awareness amongst prospective patient groups – like veterans, trauma, and bone cancer patients – and educate them about our superior alternative to sockets. Also, we have turned to professionals to build awareness amongst orthopaedic surgeons, trauma surgeons, rehabilitation specialists, and prosthetists about Integrum and OPRA^TM Implant System.  The campaigns have already been shown to significantly increase the number of followers on social media and generate an increased reach measured in impressions and engagement. From now on, we plan to maintain a strong social presence on both patient and professional channels, and the increased interest is expected to generate a growing patient pipeline. We have over 50 hospitals using our implants, and we can now focus on increasing the number of patients treated at these hospitals.

MDR certificate facilitates future scale-up in Europe
We finally received the EU Medical Device Regulation (MDR) certificate for our OPRA^TM Implant System in the beginning of March. The certification reflects that our product and Quality Management System meet all the requirements of the new EU regulations for medical devices. It also shows that we are at the forefront in terms of quality assurance and regulatory affairs and gives us an edge over competitors in the osseointegration area. The certificate also marks the end of an intense, resource- and cash-demanding process, and we can now fully focus on our scale-up in Europe.

e-OPRA attracts prestigious research grants
In March, Shirley Ryan AbilityLab – a top-ranked physical medicine and rehabilitation hospital based in Chicago – received a USD 1.5 million grant from the US Department of Defense. The grant will finance a clinical trial to examine the benefits of Integrum’s e-OPRA^TM Implant System compared to a traditional socket prosthesis system in above knee amputees

Strengthening our board with strategic know-how
In May, the board announced the appointment of Scott Flora as an adjunct board member. Scott Flora has vast experience from strategic and leadership roles in the healthcare sector and a great understanding of how the orthopaedic industry works, especially in the U.S. He has previously contributed to Integrum’s business development in the role of Strategic Advisor, and we are now very excited that he has chosen to expand his commitment to the company. We have strengthened the management team with a Chief Operating Officer, a new Head of QARA, and a new Supply Chain Manager, and we have recently moved to a new office at the GoCo House. We are well prepared for the continued expansion of our business.

Summarizing the quarter, we are further strengthening our business in several areas. Key recruitments, a strong IP and regulatory platform, the MDR certification give us a great opportunity to scale up our business in Europe, the awareness campaigns in the US will drive continued growth, not only in the US but over time also in Europe and our own investment in R&D will, together with grants, support the further development of our next-generation implant system e-OPRA^TM. I am convinced we remain on track to become a global leader in our field.

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 08-06-2023 08:30 CET.