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Realheart Interim Report Q1 240508
Prenumeration
Beskrivning
| Land | Sverige |
|---|---|
| Lista | First North Stockholm |
| Sektor | Hälsovård |
| Industri | Medicinteknik |
Summary of Interim Report January – March 2024
| (SEK) | ||||
| Group Overview | 2024-01-01 | 2023-01-01 | 2023-01-01 | |
| 2024-03-31 | 2023-03-31 | 2023-12-31 | ||
| 3 mon | 3 mon | 12 mon | ||
| Operating income | 10 058 | 24 181 | 902 882 | |
| Earnings after financial items | -7 784 687 | -4 100 639 | -67 977 292 | |
| Balance Sheet total | 93 733 581 | 119 484 206 | 102 638 279 | |
| Equity / Assets ratio | 79% | 82% | 80% | |
| Earnings per share | -0.08 | -0.12 | -0.70 | |
| Number of shares | 96 994 446 | 34 979 248 | 96 994 446 | |
| Parent Company Overview | 2024-01-01 | 2023-01-01 | 2023-01-01 | |
| 2024-03-31 | 2023-03-31 | 2023-12-31 | ||
| 3 mon | 3 mon | 12 mon | ||
| Operating income | 10 058 | 24 181 | 902 882 | |
| Earnings after financial items | -7 763 990 | -3 919 738 | -67 678 901 | |
| Balance Sheet total | 93 934 536 | 113 420 143 | 103 221 678 | |
| Equity / Assets ratio | 88% | 86% | 88% | |
| Earnings per share | -0.08 | -0.11 | -0.70 | |
| Number of shares | 96 994 446 | 34 979 248 | 96 994 446 |
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 Q1 with 4.7 MSEK. 1.7 for purchased services and other external costs and 3.0 for personnel. In line with the valuation model for impairment testing of intangible assets adopted at year and, the company has chosen to write down the asset capitalized in the period with 4.7 MSEK.
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.
Financial Position
With a cash balance of 34.3 MSEK at the end of the period the company has funding that will last until the first quarter of 2025.
In order to solve the Company's longer-term financing needs, Realheart works continuously to evaluate alternatives for further capitalization of the Company.
CEO Comment
The preclinical development of our artificial heart is progressing and we recently announced successful results from another implantation. Realheart® TAH produced good cardiac function and was gentle on the blood, while the survival time of the implanted animal exceeded previous trials. In March, Magnus Öhman took over as the new Chairman of the Board of Realheart. Magnus has extensive experience from leading positions in the medical device industry and will have an operational role in the development of Realheart® TAH. Earlier in the quarter, we were named Innovator of the Year in the Almi Guldstänk entrepreneurship competition - a definite confirmation of the increasing external interest in our unique concept.
Significant Events During the First Quarter of the Year
In the beginning of March, the Company announces that Magnus Öhman will take over as Executive Chairman of Realheart's Board of Directors. Magnus will thus take an active role in the company's operational work to develop and commercialise Realheart® TAH. Christer Norström, outgoing chairman, will remain on the board as a member.
In the middle of March, Realheart is awarded Almi Guldstänk as the innovator of the year 2023. Realheart was nominated based on the jury's motivation that highlights the company's development of the groundbreaking artificial heart Realheart® TAH.
During the first quarter, the Company announces the appointment of Andreas Hultdin as successor to Jonas Caspari Bark as Interim CFO. Andreas will act as interim CFO until a permanent successor has been appointed. Between 2019 and 2022, Andreas was CFO at Realheart where he among other things helped secure funding from the European Investment Council (EIC).
Significant Events After the End of the Period
In early April, the Company announces that positive haematological data will be presented at the American Society for Artificial Internal Organs 70th Annual Conference in Baltimore. During the conference, new study data will be presented that strengthens the company's previous results, which show that the company's artificial heart, Realheart® TAH, has a low damaging effect on red blood cells (hemolysis) compared to today's market-dominant heart pump system. The new results are based on in-depth analyses that include several blood components and further confirm that Realheart® TAH causes a significantly lower degree of blood damage.
In mid-April, more positive results from another successful preclinical trial with the Realheart® TAH artificial heart will be communicated. The implantation has been done within the framework of the preclinical programme that will form the basis for the first clinical study in humans. The results show that Realheart® TAH gives rise to good cardiac function and low levels of adverse blood effects, while the survival time of the implanted animal exceeded previous attempts. Overall, the results support that the Realheart® TAH has the potential to replace the human heart in the future.
On May 7, the board decided to propose a rights issue. The details and conditions are communicated on the company's website.