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Realheart Interim Report Q2 2024
Prenumeration
Beskrivning
| Land | Sverige |
|---|---|
| Lista | First North Stockholm |
| Sektor | Hälsovård |
| Industri | Medicinteknik |
Summary of Interim Report April – June 2024
| (SEK) | |||||
| Group Overview | 2024-04-01 | 2023-04-01 | 2024-01-01 | 2023-01-01 | |
| 2024-06-30 | 2023-06-30 | 2024-06-30 | 2023-06-30 | ||
| 3 mon | 3 mon | 6 mon | 6 mon | ||
| Operating income | 30 322 | 103 897 | 40 380 | 128 078 | |
| Earnings after financial items | -6 321 701 | -2 963 831 | -14 106 388 | -7 064 470 | |
| Balance Sheet total assets | 86 640 481 | 117 598 027 | 86 640 481 | 117 598 027 | |
| Equity / Assets ratio | 74% | 81% | 74% | 81% | |
| Earnings per share | -0,07 | -0,08 | -0,15 | -0.20 | |
| Number of shares | 96 994 446 | 34 979 248 | 96 994 446 | 34 979 248 | |
| Diluted earnings per share for the period* | -0.03 | -0.08 | -0.06 | -0.20 | |
| Parent Company Overview | 2024-04-01 | 2023-04-01 | 2024-01-01 | 2023-01-01 | |
| 2024-06-30 | 2023-06-30 | 2024-06-30 | 2023-06-30 | ||
| 3 mon | 3 mon | 6 mon | 6 mon | ||
| Operating income | 30 322 | 103 897 | 40 380 | 128 078 | |
| Earnings after financial items | -6 158 452 | -2 211 630 | -13 922 442 | -6 748 689 | |
| Balance Sheet total assets | 87 141 085 | 111 626 572 | 87 141 085 | 111 626 572 | |
| Equity / Assets ratio | 74% | 85% | 74% | 85% | |
| Earnings per share | -0,06 | -0,08 | -0,14 | -0.19 | |
| Number of shares | 96 994 445 | 33 183 461 | 96 994 445 | 34 979 248 | |
| Diluted earnings per share for the period* | -0.03 | -0.06 | -0.06 | -0.19 | |
*Rights issue July 2024, and Series TO02, at full exercise January 31, 2025.
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 Q4 with 4.9 MSEK. 1.9 MSEK for purchased services and other external costs and 3.0 MSEK for personnel.
Employees
The number of employees in the Group at the end of the quarter was 12 full-time employees and 3 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
At the end of the period the cash balance was 22.8 MSEK. In July the rights issues was finalized and the company will receive 24.3 MSEK before issue costs. This means that cash will last to Q4, 2025. In order to solve the Company's longer-term financing need, Realheart works continously to evaluate alternatives for further capitalization of the Company.
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
During the last quarter, we have noted several important events related to the pre-clinical development of our total artificial heart, Realheart® TAH, as well as to the company's financial status. In April, we announced excellent results, in several parameters, from a pre-clinical implantation test. Our ability to continue this important work has been strengthened by an injection of mixed funds. For the second time, we have been awarded a grant of SEK 4 million from Vinnova and a grant from Medtech4Health. Finally, in early July, we announced the outcome of our latest rights issue, which amounted to SEK 24.3 million. With this funding, we aim to complete our preclinical program.
Significant Events During the First Quarter of the Year
The period begins with a press release announcing that Realheart intends to present positive hematology data at the American Society for Artificial Internal Organs 70th Annual Conference in Baltimore. The new study data presented reinforces the company's previous results, which show that the company's artificial heart, Realheart® TAH, has a low harmful impact on red blood cells (hemolysis) compared to today's market-dominant heart pump systems. The new results are based on in-depth analyses including several blood components and further confirm that Realheart® TAH causes a significantly lower degree of blood damage.
In mid-April, Realheart reports results from another successful preclinical trial with Realheart® TAH, showing that Realheart® TAH results in good cardiac function and low levels of blood damage, while the survival time of the implanted animal exceeded previous trials. Overall, the results support that Realheart® TAH has good potential to replace the human heart in the future.
In early May, Realheart decides on a rights issue of SEK 48.5 million. The rights issue, which runs between June 12 and July 5, is approximately 50 percent covered by guarantee commitments and subscription commitments from existing shareholders and external investors.
In mid-May, the company announced that it had received a grant from Vinnova of approximately SEK 100,000 as part of a competence-enhancing grant. The grant, which will be used to develop production processes for Realheart® TAH, is funded by Medtech4Health, a strategic innovation program aimed at strengthening the medical device industry.
May ends with an announcement that the company has received SEK 4 million in a grant from Vinnova together with its partner at the Royal Institute of Technology (KTH) with the aim of further developing the company's transplantation system. The project runs for two years.
The last event of the period is that Realheart publishes a prospectus for a rights issue of units of approximately SEK 48.5 million.
Significant Events After the End of the Period
On July 9, Realheart announces the outcome of the completed rights issue, where the Company initially raises approximately SEK 24.3 million before issue costs.
In mid-July, it is announced that Realheart carries out a directed issue of units to guarantors in connection with the completed rights issue. In total, guarantors have chosen to receive the guarantee compensation paid in units. The company's board of directors has therefore decided, based on the authorization from the annual general meeting on June 7, 2024, to issue 6,300,000 units, corresponding to 12,600,000 new shares and 6,300,000 warrants of series TO3 as compensation to these guarantors, which will increase the company's share capital by approximately SEK 504,000.00.
In the beginning of August, the Company announces that Jimmy Nybom will succeed Andreas Hultdin as interim Chief Financial Officer (CFO) during the ongoing recruitment process of a permanent CFO. Jimmy Nybom will start his assignment on September 6.