Redsense Medical

April – June 2024

• Net sales amounted to kSEK 8,749 (4,831)

• Operating profit, EBIT amounted to kSEK 613 (-3,045).

• Result after tax amounted to kSEK 625 (2,966).

• Earnings per share were SEK 0.04 (0.21).

Significant events during the period

• On April 24, The Board of Directors in Redsense resolved to carry out a directed share issue of approximately MSEK 9.8.

• On May 22, Redsense announced that Discover Capital GmbH has sold all their shares in Redsense Medical AB (publ.)

• On May 23, Redsense announced that ShapeQ GmbH has bought 750,000 shares and passed the 10% threshold.

• On May 27, Redsense announced that former CEO Pontus Nobréus has left Redsense and that CFO Jennie Kardell is now appointed acting CEO.

• On May 31, The Board of Directors in Redsense resolved to carry out a directed share issue of MSEK 7.5.

• On May 25, Redsense announced that ShapeQ GmbH after the first directed issue has passed the 20% threshold.

Significant events after the period

• On July 15, Redsense announced that ShapeQ GmbH after the second directed issue has passed the 25% threshold.

Comment from the CEO

The wind of change has blown over Redsense

This quarter has involved a change of CEO and I now have the opportunity to lead the company as acting CEO. Redsense Medical is going through an exciting chapter. We are about to introduce a unique offering to the market with Redsense Clamp, a device that automatically stops the blood flow. With the help of the entire team we introduce the clamp, which works in tandem with the Redsense Alarm, in new markets and expand our presence in markets where we have already established a solid foundation.

Uneven sales to distributors but a steady increase to end-customers

Net sales for Q2 2024, our strongest quarter ever, amounted to kSEK 8,749 (4,831), with the US market driving this performance. The US continues to be the foundation of our business, contributing 99% of our net sales in Q2 2024. Given the positive developments in the home hemodialysis segment and the growing demand for Redsense products, we remain confident that this trend will be reflected in our sales to US distributors throughout the year. The home hemodialysis segment in the US remains our primary market, where the Redsense alarm system holds a unique position as the only FDA-cleared blood leakage system for hemodialysis. This treatment method is rapidly growing due to its improved clinical outcomes, convenience, quality of life for patients, and cost-effectiveness.

Our US business model and value chain, involving two distributors supplying dialysis providers, result in variations in order size and frequency, causing fluctuations in quarterly sales. Sales data clearly indicates the expansion of the home hemodialysis market, the tailwind that we have is evident in the increased sales from our distributors to end-users. During the second quarter of 2024, we observed a solid increase in sales compared to the same period last year and compared to the last quarter.

Almost there with the Redsense Clamp

The Redsense Clamp usability study in Canada is progressing well, with all patients now recruited. This study is crucial for finalizing the CE-mark for the Redsense Clamp. While the study is still accumulating the required number of treatments, we are planning and preparing for its launch later this year. With the Redsense Clamp, we have excellent opportunities to attract new customers and enter new markets, thereby increasing our sales outside the US. Combined with the Redsense alarm, we offer an attractive package, especially for home hemodialysis settings, enhancing patient safety. Our initial focus markets for the launch include Canada, Australia, and selected European countries.

At the largest annual nephrology conference in Europe, the European Renal Association Congress (ERA), Dr. Chan, who is responsible for the Clamp usability study, presented at a seminar about how the Clamp can give the patients extra security and that this security can increase the patient’s confidence to move from in-center hemodialysis to home hemodialysis.

Major investment from ShapeQ

As we have announced, one of our key owners, ShapeQ, has significantly increased its ownership stake from 6.5% to 20.9% this quarter through a combination of purchases and directed issues. This substantial increase in investment is a clear testament to ShapeQ’s confidence in our strategic direction, business model, and long-term growth potential. Their enhanced commitment is not just a vote of confidence, but also a vital catalyst that will provide us with the necessary support and resources as we execute our initiatives and strive to achieve our ambitious goals.

With ShapeQ’s backing, we are more confident than ever in our ability to achieve our strategic objectives and drive sustained growth and success in the future.

Looking ahead

As we look forward to the remainder of the year, we are committed to executing our goals for 2024. This includes leveraging our strong position in the US home hemodialysis segment for further growth, obtaining the CE mark for the Redsense Clamp, and releasing it to the market. We are also focused on submitting the 510(k) application to the FDA and hoping for the Home Dialysis Risk Prevention Act is successful.

Finally, I would like to extend my gratitude to the Redsense team for their trust and dedication during this windy quarter and to our shareholders for their unwavering support. As long as the winds remains this warm and positive we are happy to have them fill our sails.

Jennie Kardell

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 Market Act. The information was submitted for publication, through the agency of the contact person specified above, on August 29, 2024, at 08:30 CET.