2025-02-26
Year-End Report Q4, 2024
Summary of Year-End Report October – December 2024
| Group Overview | 2024-10-01 | 2023-10-01 | 2024-01-01 | 2023-01-01 |
| 2024-12-31 | 2023-12-31 | 2024-12-31 | 2023-12-31 | |
| 3 mon | 3 mon | 12 mon | 12 mon | |
| Operating income | 5 024 | 798 047 | 50 054 | 902 882 |
| Earnings after financial items | -10 329 017 | -52 895 973 | -34 350 238 | -67 977 292 |
| Balance sheet total | 83 279 673 | 102 638 279 | 83 279 673 | 102 638 279 |
| Equity / assets ratio | 81% | 80% | 81% | 80% |
| Earnings per share | -4,99 | -0,55 | -16,61 | -0,70 |
| Earnings per share after dilution | -4,24 | -0,39 | -14,08 | -0,51 |
| Number of shares* | 2 068 152 | 96 994 446 | 2 068 152 | 96 994 446 |
| Number of shares after full exercise of warrents | 2 438 927 | 134 071 898 | 2 438 927 | 134 071 898 |
| Parent Company Overview | 2024-10-01 | 2023-10-01 | 2024-01-01 | 2023-01-01 |
| 2024-12-31 | 2023-12-31 | 2024-12-31 | 2023-12-31 | |
| 3 mon | 3 mon | 12 mon | 12 mon | |
| Operating income | 5 024 | 798 047 | 50 054 | 902 882 |
| Earnings after financial items | -12 583 526 | -52 865 323 | -32 409 725 | -67 678 901 |
| Balance sheet total | 85 837 128 | 103 221 678 | 85 837 128 | 103 221 678 |
| Equity / assets ratio | 82% | 80% | 82% | 80% |
| Earnings per share | -6,08 | -0,55 | -15,67 | -0,70 |
| Earnings per share after dilution | -5,16 | -0,39 | -13,29 | -0,50 |
| Number of shares* | 2 068 152 | 96 994 446 | 2 068 152 | 96 994 446 |
| Number of shares after full exercise of warrants | 2 438 927 | 134 071 898 | 2 438 927 | 134 071 898 |
* In November 2024, a share reverse split was carried out, which meant that 100 shares were merged into 1 share.
Revenue and Result
Scandinavian Real Heart AB is currently engaged in research and development and currently has no sales of its own products. The revenue recognized for the period consists mainly of grants received for research and development. Research and development costs incurred for Realheart® TAH were capitalized during the period October 1 – December 31, 2024, in the amount of SEK 10 million.
Employees
The number of employees in the Group at the end of the quarter was 11 full-time employees and 2 hourly employees.
Transactions With Related Parties
No significant transactions with related parties have taken place during the period.
Significant Risks and Uncertainties
Realheart’s focus is on getting through the preclinical phase (hemolysis, GLP studies in 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 to be included in these tests. Realheart must also hold parallel discussions with the Notified Body in the EU and with the FDA in the US to ensure the fastest and safest route for the product to market.
The company is continuously working on measures to minimize delays. Furthermore, the continued product development requires that the company can can secure funding in both the short and long term. The board is continuously working on different scenarios to ensure the company’s future operations.
Financial Position
At the end of the period, the Group’s cash and cash equivalents amounted to SEK 23.7 million. At present, the Group does not generate its own positive cash flow and is thus dependent on external financing. In order to solve the longer-term financing needs, the Board of Directors is continuously evaluating options for further capitalization of the company.
CEO Comment
The last three months have seen important progress in the development of our artificial heart, Realheart® TAH. At the end of January, we were pleased to announce new successes in the ongoing preclinical safety studies evaluating the treatment safety and function of our artificial heart. Shortly before this, we received the news that the U.S. Food and Drug Administration (FDA) approved the company’s application for Humanitarian Use Device (HUD) status for Realheart® TAH, which could potentially have a positive impact on the future clinical development of our technology.
Significant Events During the Fourth Quarter 2024
On the first day of the period, the Company announced the publication of a preclinical study describing a new method to simulate hemolysis in artificial hearts using pumping mechanisms. This unique method will be important in the further development of Realheart® TAH. Based on its innovative approach, the study was awarded the ESAO-SAGE research prize at the 50th Congress of the European Society for Artificial Organs 2024.
Ten days into the period, Realheart announces that it has initiated a collaboration with Professors Arjang Ruhparwar and Jan Schmitto, at the Department of Cardiothoracic, Transplant and Vascular Surgery at Hannover Medical School, Hannover, Germany. The collaboration aims to familiarize leading transplant surgeons with Realheart® TAH and gain valuable professional input for the clinical trials. Realheart® TAH is intended for use in patients awaiting heart transplantation or as an alternative to transplantation.
A few days into November, a decision was taken on a 1:100 reverse share split, whereby one hundred (100) existing shares were consolidated into one (1) share. The reverse share split was registered with the Swedish Companies Registration Office in November.
Halfway through the period, the Company communicates that it has been granted an approval by the Patent Office of India for its patent application (no. 202117045813) for a technical application related to the clinical use of Realheart® TAH.
Midway through the period, updated safety data from a preclinical study with Realheart® TAH is also presented at the 30th Annual Meeting of ISMCS 2024. At the meeting, the company’s R&D engineer Faisal Zaman was nominated for the Helmut Reul Young Investigator Award, a prestigious award that rewards groundbreaking innovation.
On the very last day of the period, Realheart announces that the subscription price for warrants series TO 2 (the “Warrants”) has been set to SEK 8.47. The exercise period for the warrants commences on January 2, 2025 and runs until January 31, 2025. The last day of trading in the warrants is January 29, 2025.
Significant Events After the End of the Fourth Quarter
The first event after the end of the period is that the Company’s total artificial heart, Realheart® TAH, has been granted Humanitarian Use Device (HUD) designation by the US Food and Drug Administration (FDA). The HUD designation makes Realheart® TAH eligible to apply for Humanitarian Device Exemption (HDE), an expedited regulatory pathway that can grant the product special market rights.
January concludes with successful results from a 7-day animal study of Realheart® TAH, showing that the device provides adequate cardiac function, automatically adjusts to rest and exercise, and maintains good blood biochemistry.
A few days into February, the outcome of the subscription period for the warrants of series TO 2 (“Warrants”) issued in connection with the rights issue of units carried out by the Company during the period June 20, 2023 – July 7, 2023 is announced. A total of 17,035,600 Warrants were exercised for subscription of 85,178 shares, corresponding to a subscription rate of approximately 51 percent of the total 33,495,885 issued Warrants. Through the exercise, Realheart will receive approximately SEK 721 thousand before issue costs.