Interim report May – Oct 2022: Continued steady growth shows that we are on track to establish OPRA[TM] in the US

The period AUG 1st 2022 – Oct 31st 2022

▪    Net sales amountedTSEK 20 226 (11 883), which is an increase of 70% compared with the corresponding period last year. The growth in the US market is 78% compared with the corresponding period last year.

▪    Operating profit amounted to TSEK 873 (-243)

▪    Net profit amounted to TSEK 2 320 (16 186)

▪    Cashflow from operating activities amounted to TSEK -1 032 (1 238)

▪    Earnings per share amounted to 0,13 SEK (0.90)

Significant events in the quarter

▪    The number of hospitals offering the treatment continue to increase. In the period 6 new hospitals approved the treatment in the US. In Europe, Oslo University Hospital and the Karolinska University Hospital in Stockholm are expanding the treatment with additional amputation levels on both upper and lower limb. University Hospital of Regensburg in Germany recently started a treatment program.

▪    Researchers at Massachusetts Institute of Technology (MIT) have decided to use OPRATM and e-OPRATM in its research. This is a great recognition of the unique capabilities that our research and implant systems bring to patients, both today with OPRATM and tomorrow with e-OPRATM. 

▪    United States Patent and Trademark Office approved patent for the OPRATM Implant System. The system is now patent protected until 2044 in the US.

▪    The company received ISO 13485 certification in the quarter. 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. 

▪    A scientific paper on sensory feedback using the OPRATM Implant System together with e-OPRATM is under academic evaluation regarding potential research misconduct. 

FIRST SIX MONTHS May 1st 2022 – Oct 31st 2022

▪    Net sales amountedTSEK 37 461 (24 765), which is an increase of 51% compared with the corresponding period last year. The growth in the US market is 62% compared with the corresponding period last year

▪    Operating profit amounted to TSEK 1 239 (1 003)

▪    Net profit amounted to TSEK 1 770 (17 468)

▪    Cashflow from operating activities amounted to TSEK -13 957 (-5 274)

▪    Earnings per share amounted to 0,10 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

In our second quarter, revenues amounted to SEK 20,2 million, representing a growth of 70 percent compared to the corresponding quarter last year. Growth in local currency was 42 percent for the total group as well as in the US compared to the same period last year. The numbers show that we are on track to establish the OPRATM Implant System in the US market and that our focused strategy pays off. We are at the same time determined to accelerate our efforts in both the US and Europe to speed up market penetration, and to offer an even larger group of persons with mobility challenges a normalized and active life.

Continued focus to enable long-term growth in the US
One of our focus areas in the US is to increase the number of hospitals that approve treatments with the OPRATM Implant System. The process to receive a new hospital approval can be demanding, due to administrative processes and extensive evaluations pertaining to performance and pricing. We are learning by doing. During the second quarter we received six new hospital approvals, and in total we have now signed agreements with 35 hospitals in the US. Another focus area is to increase the number of treatments per hospital. There are several steps involved and increasing the awareness among all stakeholders is crucial. One part of the significant marketing effort is the recently launched social media campaign primarily increasing awareness among persons living with mobility challenges. We have also launched the OPRATM Ambassador program which, together with a PR campaign and the social media program, will generate broad attention to the treatment benefits with our bone-anchored implant system.

The US reimbursement system is complex, and for longer term growth we are establishing a comprehensive plan for gaining wider-spread reimbursement, including MediCare During the quarter we have developed and started to implement such a plan together with leading strategists in the area. The goal is to create a new standard of care.

In discussions with payers, health economics is key, and we have already collected a first set of data showing convincing evidence for the economic benefits of using OPRATM Implant System in the US market.

In October we received approval in the US for a patent covering not only important design features of the OPRATM Implant System, but also design features that are of vital importance to e-OPRATM and other future versions of the implant system. The patent grants Integrum exclusivity to these design features until 2044 and provides a good foundation for our long-term growth in the US.

Delayed scaling up in Europe
In Europe we continue to see a delayed pandemic effect on elective surgeries. Still, we are delighted to welcome the scale-up of the use of OPRATM Implant System at the Oslo University Hospital. The hospital has expanded its patient offering to include artificial thumb replacement surgery, while the number of above-knee patients is also expected to increase. We see the same interest at the Karolinska University Hospital in Sweden, and at the University Hospital of Regensburg in Germany surgeons have performed the first thumb replacement using OPRATM Implant System, a procedure which now will be offered to additional patients.

ISO 13485 certification confirms our quality work
Being a growing MedTech company with global ambitions, we need a best-in-class quality management system (QMS). In October we received the ISO 13485 certification for medical devices, confirming that our QMS is appropriate and meet regulatory requirements.

Transparency and quality are core values both for Integrum as a company and for me personally as a scientist and clinician.  I, therefore, welcome the recent correction of the Brief Report originally published in the New England Journal of Medicine (NEJM) in April 2020, and the assessment that has been initiated by an academic external ethics committee of me personally, in my role as a researcher affiliated with Gothenburg University.

MIT using e-OPRATM underpins future possibilities
The development of e-OPRATM – the world's first mind-controlled prosthesis – is continuing and new pathways are being explored together with MIT. At the Center for Bionics the lower limb is at focus and e-OPRATM will, in combination with novel reconstructive procedures drive restoration possibilities after amputation to the unimaginable

This is not only a great recognition of the unique capabilities that Integrum’s research brings to patients, but also a cost-effective way to explore future research possibilities.

Based on the current macro-economic situation we consider growth with cost awareness to be the prevailing strategy. This is not stopping us from aggressively pursue R&D with soft money from international research programs collaborations

We are here for those that can benefit from our achievements, and I know I speak for all my fantastic co-workers at Integrum, we are proud to be able to help other humans to live better lives. We can do more, and we will do more.

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 December 1, 2022, at 8:30 am (CET).