Interim Report Q2 – April – June, 2023 Redsense Medical AB (publ)

APRIL – JUNE 2023

• Net sales amounted to kSEK 4,831 (1,927), an increase of 151%.
• Operating loss, EBIT amounted to kSEK 3,045 (2,428).
• Result after tax amounted to kSEK -2,966 (-2,137).
• Earnings per share were SEK -0.21 (-0.15).

SIGNIFICANT EVENTS DURING THE PERIOD

• On April 28, Redsense announced that Redsense and FDA held a Pre-Submission Meeting in preparation for the 510(k) Premarket Submission of the Redsense Clamp.
• On May 8, Redsense announced that the Home Dialysis Risk Prevention Act was introduced by the US House of Representatives.
• On June 30, Redsense announced that Redsense has submitted an application for cross-trading on OTCQX Best Market in the US.

SIGNIFICANT EVENTS AFTER THE REPORTED PERIOD

• On July 7, Redsense announced that the Redsense Alarm system was featured in KFF Health News.
• On August 15, Redsense announced that Redsense received a new order valued at mSEK 11.2 from one of our US distributors.

CONTINUED STRONG TOPLINE GROWTH

We are pleased to report another quarter with strong sales growth. Net sales increased by 151 percent to kSEK 4,831 (1,927). Adding to the strong sales in the previous quarter, the continued growth is a sign that our business is establishing a solid momentum. Net sales for the first half year 2023 was kSEK 11,655, providing a growth of 131 percent.

The foundation and current growth driver for our business is the US market. During the quarter, we have continued to make deliveries relating to the record-breaking order of mSEK 15.2 from December 2022. Most of this order has now been delivered, but there is still a delivery to be made to the distributor in the fall of 2023. Furthermore, we also received and delivered an order from our other US distributor during the quarter.

In addition, the sales to our European distributors during the quarter is encouraging, and I would like to highlight orders from our UK distributors. The UK has recommendations in place to use blood leakage monitors for venous needle dislodgement, and the UK was an early adopter of the Redsense technology.

Growth initiatives in the US

Redsense has a unique position of being the only blood leakage system having FDA clearance, and the sales growth for Redsense is driven by the development of the home hemodialysis market. Home treatment is gaining popularity thanks to improved clinical outcome, lower cost, increased convenience, and quality of life for the patient. This is supported by both political initiatives and promotions from the major dialysis providers in the US in order to increase the number of patients being treated in home settings.

One important initiative is the Home Dialysis Risk Prevention Act (H.R.3118), which was introduced in the US House of Representative in May 2023. This bipartisan legislation aims to provide Medicare coverage of monitoring devices to detect and alarm when a venous needle dislodgement (VND) occurs during home hemodialysis. Some of these home hemodialysis patients, especially those dialyzing solo or during the night, are already benefiting from using a Redsense Alarm system. However, monitoring devices are not currently included in Medicare coverage.

An implementation of the proposed bill will pave the way for a substantial opportunity for Redsense. The exact potential depends on the final wording of the bill, but regardless, it will represent a sales growth possibility.

The Clamp is another growth opportunity, and during the quarter we held a 510(k) Pre-Submission meeting with the United States Food and Drug Administration (FDA). Based on the feedback from the FDA, will we work on all activities needed to complete the submission application during the fall.

OTC markets

During the second quarter, we have taken steps to increase further shareholder value by applying for cross-trading on OTCQX. Given that most of our revenue is in the US, and with our biggest growth opportunities in this market, it comes naturally to initiate a process to facilitate for North American investors, to trade the Redsense share. The US stock market is one of the largest marketplaces for investors and we believe that OTCQX is a cost-effective way to allow US investors and individual stock buyers to trade the Redsense share.

Looking forward

We have a busy agenda during the rest of the year, and one important task is to finalize the CE mark for the Redsense Clamp. The remaining activity is the usability study, to be performed by Toronto General Hospital. As soon as the CE mark has been concluded, primary launch markets will be Canada, Australia, and selected countries in Europe.

Our focus in the US excels the momentum within home hemodialysis, and we aim to leverage the positive sales trend to the dialysis providers and maintain a close dialogue with our distributors to ensure adequate stock levels. To promote the advancement of the Home Dialysis Risk Prevention Act, as well as the regulatory process for the 501(k) submission for the Clamp, will also be high on the agenda.

As announced on August 15, 2023, we received an order valued at mSEK 11.2 from one of our US distributors. We are pleased with the continued strong sales development in the US and this order means that we can secure a strong performance for 2023.

It has been a pleasure to welcome the new members of the Board of Directors, and I look forward to continuing the work with the Board to expand our business and reach new heights. The diverse skills and experience of the Board of Directors will be useful when we scale up our business going forward.

Half-way into this year, I am pleased to see such strong sales growth, and I am looking forward to keeping you updated on our further progress, with several important milestones to be achieved.  I am proud to lead a successful team, and we are continuing our efforts to increase safety for dialysis patients!

Pontus Nobréus
CEO Redsense Medical AB

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 August 29, 2023, at 08:30 CET.