Year-end Report 2022 Redsense Medical AB (publ)

Back-to-back order records give tailwind for 2023

October – December 2022

• Net sales amounted to kSEK 8,027 (4,109), an increase of 95.3 percent.
• Operating profit, EBIT amounted to kSEK 555 (-2,582).
• Result after tax amounted to kSEK -2,297 (-1,421).
• Earnings per share was SEK -0.16 (-0.10) before and after dilution.

January – December 2022

• Net sales amounted to kSEK 14,340 (9,362), an increase of 53.2 percent.
• Operating loss, EBIT amounted to kSEK 10,208 (11,991).
• Result after tax amounted to kSEK -8,758 (-7,972).
• Earnings per share was SEK -0.62 (-0.57) before and after dilution.
• Net cash at December 31 was kSEK 10,581 (26,900).
• Cash and cash equivalents amounted to kSEK 3,672 (4,983).
• Cash flow from operating activities amounted to kSEK -9,488 (-12,221).

Significant events during the period

• On October 18, it was announced that Redsense had received its highest value order to date.
• On October 21, the appointed Nomination Committee for the 2023 Annual General Meeting was announced.
• On December 2, Redsense announced a new order valued at 15.2 MSEK from one of the company’s US distributors, smashing the company record once again.
• On December 8, member of the board Bo Unéus announced his decision to step down.

Significant events after the end of the period

• On January 3, Redsense announced that MSEK 4.75 of the previously disclosed record order had been delivered in December 2022, with the balance of the order planned for delivery in Q1.
• On January 20, Redsense announced that Jennie Kardell will join the company as new Chief Financial Officer as of March 2023.
• ECRI (Emergency Care Research Institute) included Venous Needle Dislodgement as number 4 on its 2023 list of Top 10 Technology Hazards.

Comment from the CEO

Excellent fourth quarter concludes 2022

Redsense’s fourth quarter marks a strong finish to an overall good year. With net sales that amounted to KSEK 8,027 for the quarter, we repeat the achievement of last year and record the company’s best fourth quarter to date. In addition, with net sales of KSEK 14,340 for the full year, we come very close to matching our annual sales record. The 53 percent of revenue growth year-on-year is a satisfying result and a sign of growing momentum.

Key to this outcome were two orders from our US distributors, one of MSEK 3.7 in October and one of MSEK 15.2 in December. Beyond their size, the orders are essential in that they indicate a clear turning point in the US home hemodialysis market and also give Redsense an excellent starting position for the new year. In conjunction with our distributors and supply chain partners, we are currently taking proactive measures to secure supply, coordinate deliveries, and manage inventory levels to ensure that the increased volumes are handled smoothly and without strain.

Active teamwork and interaction with stakeholders

Overall, it has been a busy and eventful year in both the United States and Europe. Customer training and support has been at the heart of our work, but much of the team’s efforts have also revolved around raising awareness in the US market, where we have attended a number of conferences to showcase our products and communicate with various stakeholders. During the quarter, we have also increased our interaction with dialysis providers and distributing partners to ensure that we stay on top of trends and sales developments.

Our participation at ASN Kidney Week in Orlando in November, the world’s premier nephrology meeting, merits a particular mention and resulted in fruitful meetings with customers, partners and other stakeholders. Home hemodialysis received a lot of focus, with several players making an appearance; considering our position in this segment, the attention it attracts is promising.

The need for blood leakage monitoring, especially in the context of home hemodialysis, is a matter fundamental to our growth and important for patient safety, and we are working alongside other organizations to increase awareness, lay a foundation for legislation and future Medicare reimbursement. The Congress briefing in March was one of the milestones in this process in 2022, and our effort is ongoing.

Finalizing the Clamp

The new Redsense Clamp, ensuring automatic shutdown of the dialysis machine’s pump, is nearing launch in 2023. We first showcased the product at the ERA Congress Paris in May

2022, where it was met with positive acclaim, and it is very exciting to soon be able to bring it to market. The final step before launch is a user study to complete the CE mark, which will be conducted in Toronto General Hospital in Canada, and we are currently engaged in finalizing the documentation to get the study running. For the launch of the Clamp, prioritized markets will be Canada and Australia, as well as selected countries in Europe. For the US market, additional regulatory steps will be required.

Europe remains an important market

In Europe, we decided to concentrate on the German market in 2022, which, among other things, resulted in a product validation carried out together with a large dialysis provider. The results were satisfactory, and there may be interest in testing the Clamp as well in the future. During the quarter, we also participated in a major Nephrology Conference in Berlin. This event was a good opportunity for us to interact with existing German customers and major dialysis providers. Germany will remain in focus in 2023, and when the Clamp is available, our effort in this market will be shaped around the new edge it provides.

Looking ahead

Strengthened by the fourth quarter, we are determined to follow up on the gains of 2022 and make 2023 yet another great year for Redsense. 2022 also included a CEO change and it has been a great privilege to take the helm of Redsense from my predecessor Patrik Byhmer who transitioned to Chairman of the Board. With a very competent and engaged team in place, we will continue to execute on our main strategic goals for 2023: growing within the US home hemodialysis segment and launching the Clamp across selected markets.

In the near term, a key priority is to secure the supply chain for increased demand and fulfil the order stock. I look forward to getting back to you on our progress.

Finally, I would like to take the opportunity to thank all our customers, employees, partners and shareholders for the past year. In 2023, we will continue our work to create value for patients and healthcare systems—and saving lives!

Pontus Nobréus
CEO, Redsense Medical

This information is information that Redsense Medical AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation and the Securities Markets Act. The information was submitted for publication, through the agency of the contact persons set out below, on February 27, 2023, at 08:30 CET.