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Realheart Year End Report Q4 2023
Prenumeration
Beskrivning
| Land | Sverige |
|---|---|
| Lista | First North Stockholm |
| Sektor | Hälsovård |
| Industri | Medicinteknik |
Summary of Year-End Report 2023
| (SEK) | ||||
| Group Overview | 2023-10-01 | 2022-10-01 | 2023-01-01 | 2022-01-01 |
| 2023-12-31 | 2022-12-31 | 2023-12-31 | 2022-12-31 | |
| 3 mon | 3 mon | 12 mon | 12 mon | |
| Operating income | 798 047 | 31 468 | 902 882 | 667 589 |
| Earnings after financial items | -52 895 973 | -2 914 829 | -67 977 292 | -13 987 911 |
| Balance sheet total | 119 816 255 | 102 638 279 | 119 816 255 | 102 638 279 |
| Equity/Assets ratio | 80% | 81% | 80% | 81% |
| Earnings per share | -0.55 | -0.09 | -0.70 | -0.42 |
| Number of shares | 96 994 446 | 33 183 461 | 96 994 446 | 33 183 461 |
| Parent Company Overview | 2023-10-01 | 2022-10-01 | 2023-01-01 | 2022-01-01 |
| 2023-12-31 | 2022-12-31 | 2023-12-31 | 2022-12-31 | |
| 3 mon | 3 mon | 12 mon | 12 mon | |
| Operating income | 798 047 | 31 468 | 902 882 | 667 589 |
| Earnings after financial items | -52 865 323 | -2 824 786 | -67 678 901 | -13 810 029 |
| Balance sheet total | 103 221 678 | 111 229 225 | 103 221 678 | 111 229 225 |
| Equity/Assets ratio | 80% | 88% | 80% | 88% |
| Earnings per share | -0.55 | -0.09 | -0.70 | -0.42 |
| Number of shares | 96 994 446 | 33 183 461 | 96 994 446 | 33 183 461 |
Revenue and Result
Scandinavian Real Heart is working with research and development and currently has no sales of any products. The income reported for the period consists mainly of received de minimis grants. Research and development costs of Realheart® TAH were capitalized during Q3 with 5.4 MSEK. 2.8 MSEK for purchased services and other external costs and 2.6 MSEK for personnel. During the period, write-downs of capitalized costs for research and development for the years 2016-2020 were made by 50,1 MSEK.
Financial Position
During the period, the company has received Grant payments from EIC, Vinnova and Eurostars of 10.3 MSEK, and interest income of 0.5 MSEK. With a cash balance of 43.3 MSEK at the end of the period the company has funding that will last to the and of 2024. In order to solve the Company's longer-term financing needs, Realheart works continuously to evaluate alternatives for further capitalization of the Company.
Employees
The number of employees in the Group at the end of the quarter was 11 full-time employees and 4 hourly employees.
Related party transactions
No significant related party transactions have taken place during the period.
Significant risks and uncertainties
Realheart's focus is on getting through the pre-clinical phase (Hemolysis, GLP studies on animals and endurance tests) to be able to start clinical studies. This means that the company must finalize the version of both the controller and the heart pump that will be included in these tests. Realheart must also conduct parallel discussions with the Notified Body in the EU and with the FDA in the US to ensure the fastest and safest route to market for the product.
The company is continuously working on measures to minimize delays. Furthermore, the continued product development requires that the company can solve its financing. The board is continuously working with different scenarios to ensure the company's future operations.
CEO Comment
In the autumn, we presented a clarified strategy that initially focuses the commercialisation of Realheart TAH on patients on the waiting list for a heart transplant - a well-defined sub-market with high potential to generate significant revenues and lay the foundation for our long-term value creation. Shortly after Christmas, the European Innovation Council (EIC) announced its decision to pay the second part of its development grant to Realheart under its accelerator programme. During the spring, a number of important milestones are expected in the preclinical development of Realheart TAH - with the goal of reaching the clinical development phase in 2025.
Significant Events During the Fourth Quarter of the Year
In October, Realheart communicates that Giovanni Lauricella has been adjuncted to the board of directors. Giovanni Lauricella is a managing partner at Lifeblood Inc., specializing in recruitment and fund raising for medtech companies.
The very first day in November, The Company announces Its successfully establishment a novel test system to evaluate hemolysis of its total artificial heart. The preclinical test system replicates the body's circulatory system and enables more precise evaluations of hemolytic events.
In the middle of November, Realheart provides a strategy update on the development and commercialization of its artificial heart, the Realheart® TAH, which in initial testing has been shown to induce 80% lower levels of hemolysis compared to today's market-dominant artificial heart.
The last event of the year is a press release about Realheart has received its second payment from the European Innovation Council (EIC) grant that was awarded in December 2021, aimed at supporting the development of the artificial heart Realheart TAH. The payment of 750,000 EUR equals 30% of the total grant sum of 2.5 MEUR.
Significant Events After the End of the Period
WRITE-DOWN OF INTANGIBLE ASSETS
The Board of Directors of Scandinavian Real Heart AB decided February 12 on a write-down of the book value of intangible fixed assets in the parent company of a total of -50.1 MSEK, mainly due to increased WACC and current market conditions. The write-down has no impact on Cash-Flow but will impact net income in the fourth quarter of 2023.
The value of the Group's intangible assets is tested annually or when indications of significant changes in assumptions are identified. In connection with the work on the 2023 financial statements, a thorough analysis of the book values of the Group's intangible assets has been carried out in relation to current WACC requirements.
Due to the sharply increased interest rate level in 2023, which increases WACC requirements, and previously communicated delays in the commercialization process, the Board of Directors has decided to write down the value of intangible assets by -50.1 MSEK. The write-down does not impact cash flows.
A write-down of the value of intangible assets means that the requirement for future amortization decreases, which gives a better future result.