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Realheart Interim Report Q1 2025
Prenumeration
Beskrivning
| Land | Sverige |
|---|---|
| Lista | First North Stockholm |
| Sektor | Hälsovård |
| Industri | Medicinteknik |
Summary of Interim Report January – March 2025
| Group Overview | 2025-01-01 | 2024-01-01 | 2024-01-01 |
| 2025-03-31 | 2024-03-31 | 2024-12-31 | |
| 3 mon | 3 mon | 12 mon | |
| Operating income | 69 994 | 10 058 | 50 054 |
| Earnings after financial items | -9 898 370 | -7 784 687 | -34 350 238 |
| Balance sheet total | 71 568 884 | 93 733 581 | 83 279 673 |
| Equity / assets ratio | 81% | 79% | 81% |
| Earnings per share | -4.60 | -0.08 | -16.61 |
| Number of shares* | 2 153 330 | 96 994 446 | 2 068 152 |
| Parent Company Overview | 2025-01-01 | 2024-01-01 | 2024-01-01 |
| 2025-03-31 | 2024-03-31 | 2024-12-31 | |
| 3 mon | 3 mon | 12 mon | |
| Operating income | 69 994 | 10 058 | 50 054 |
| Earnings after financial items | -9 839 844 | -7 763 990 | -32 409 725 |
| Balance sheet total | 74 151 494 | 93 934 536 | 85 837 128 |
| Equity / assets ratio | 82% | 88% | 82% |
| Earnings per share | -4.57 | -0.08 | -15.67 |
| Number of shares* | 2 153 330 | 96 994 446 | 2 068 152 |
* In November 2024, a reverse share split was carried out whereby 100 shares were combined 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. Research and development costs incurred for Realheart® TAH were capitalized during the period January 1 - March 31, 2025, in the amount of SEK 7 million.
Employees
The number of employees in the Group at the end of the quarter was 12 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 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 11.5 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
Realheart develops Realheart® TAH, the world’s first completely artificial heart that mimics the structure and physiology of the natural human heart. Through the Company’s pioneering engineering, we have led the product through extensive preclinical evaluations, and recently the product was awarded HUD status by the FDA. This progress is made possible by great engineers and medical professionals, and individuals who see the potential in Realheart’s technology and support our vision. In the past quarter we were happy to have welcomed new, experienced long-term investors, providing further support toward entering our first-in-human clinical trial.
Significant Events During the First Quarter 2025
On January 29, Realheart announced via a press release that Realheart® TAH has received Humanitarian Use Device (HUD) designation from the U.S. 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.
On January 30, Realheart issues a press release announcing successful results from a preclinical implantation of the Realheart® TAH total artificial heart. The successful results are from a 7-day animal study of the Realheart® TAH and show that the device provides adequate cardiac function, automatically adapts to rest and exercise, and maintains good blood biochemistry.
On February 4, Realheart announces the outcome of the exercise of warrants of series TO 2 issued in connection with the rights issue of units carried out by the Company during the period June 20, 2023 - July 7, 2023. In total, 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.
On March 3, the Company communicates via a press release that the subscription price for warrants of series TO3 (the “warrants”) has been set at SEK 12.98. The exercise period for the warrants begins on March 3, 2025 and runs until March 31, 2025. The last day of trading in the warrants is March 27, 2025.
On March 27, the Company publishes two press releases, one with the intention to carry out a directed share issue and one with the decision on a directed share issue of a maximum of 2,881,115 shares, which at full subscription will provide the Company with approximately SEK 32.6 million. The investors in the Directed Share Issue consist of a limited number of qualified and other professional investors, including both new and existing shareholders, including Claes Mellgren and Per Olof Andersson. The Company has received subscriptions for 2,085,382 shares, which means that the Company will receive approximately SEK 23.6 million before deduction of transaction costs. In addition, the existing shareholder European Investment Council (“EIC”) has, in accordance with the Board of Directors’ issue resolution, the opportunity to decide on participation in the Directed New Share Issue with subscription of a maximum of 795,733 shares which, upon full subscription, will provide the Company with approximately SEK 9.0 million.
Significant Events After the End of the First Quarter
On April 2, Realheart announces, via a press release, the outcome of the exercise of warrants of series TO 3. The exercise period for the Warrants ran during the period March 3 through March 31, 2025. The final outcome shows that 159,992 shares were subscribed for through the exercise of Warrants, which corresponds to a utilization rate of approximately 58 percent. The subscription price for one share subscribed for through the exercise of the Warrants was SEK 12.98 and the Company received SEK 2.1 million before issue costs.
On April 29, it was announced via a press release that the Company has been granted a patent approval by the Japan Patent Office (JPO) for a pressure sensor for artificial hearts and circulatory support systems such as Realheart® TAH. The patent is a support measure to ensure market protection for the Company’s device in the Japanese market and is valid until 2041.
On May 2, the Company communicates via a press release that EIC has subscribed for 600,000 shares in the directed share issue decided by the Board of Directors of Realheart on April 27, 2025. The subscription price in the directed share issue amounts to SEK 11.13 per share. The Company thereby receives SEK 6,678,000 and its share capital increases by SEK 3,006,000, from SEK 22,037,507.04 to SEK 25,043,507.04. The total number of shares increases from 4,398,704 to 4,998,704. EIC’s subscription of shares entails a dilution of approximately 12.0 percent of the capital and votes for existing shareholders, based on the total number of shares and votes in the Company after the Directed New Share Issue.