PDF
Beskrivning
| Land | Sverige |
|---|---|
| Lista | First North Stockholm |
| Sektor | Hälsovård |
| Industri | Medicinteknik |
Summary of the year-end report (relates to the Group)
Full year (01/01/2024-12/31/2024)
- Net sales totaled SEK 18,783,000 (SEK 8,273,000).
- Operating profit/loss totaled SEK -54,254,000 (SEK -65,933,000)
- Profit/loss after financial items totaled SEK -47,860,000 (SEK -80,875,000).
- Basic and diluted earnings per share totaled SEK -4,3 (SEK -24,1).
- The equity ratio on December 31, 2024, was 84% (75%).
The fourth quarter (10/01/2024 - 12/31/2024)
- Net sales totaled SEK 4,612,000 (SEK 4,456,000).
- Operating profit/loss totaled SEK -14,705,000 (SEK -20,408,000)
- Profit/loss after financial items totaled SEK -8,730,000 (SEK -25,648,000).
- Basic and diluted earnings per share totaled SEK -0,6 (SEK -3,8).
- The equity ratio on December 31, 2024, was 84% (75%).
Significant events in the fourth quarter of 2024
- CLS announced it will focus on its successful neurosurgery business to drive sustainable high-margin growth with a streamlined operation, positioning the company for long-term success. The company's direction was refined in consideration of current market conditions and opportunities
- An Extraordinary General Meeting was held in October during which it was decided to re-elect Lars-Erik Eriksson, Marika Crohns, and Sandra Brandmeier as board members. Peter Mantas and Peter Max were elected as board members. Immediately after the general meeting the newly appointed board elected Peter Max to be the chairman of the board.
- The follow-up of patients in the CLS-sponsored clinical study at Skåne University Hospital (SUS) was completed. The clinical team at SUS carried out the treatments with the complete solution for MRI-guided laser ablation in neurosurgery co-developed by CLS and ClearPoint Neuro Inc. which is already successfully marketed and sold in the US by ClearPoint Neuro Inc. under the brands ClearPoint Prism® Neuro Laser Therapy System and ClearPoint® Neuro Navigation System.
- CLS received ISO certificate in accordance with the new Medical Device Regulation (MDR) which places increased and clearer demands on manufacturers of medical devices. This is fundamental for CLS to continue to be able to apply for CE marking of new products and indications, such as a market approval of the ClearPoint Prism® Neuro Laser Therapy System in Europe.
- The exercise period for Clinical Laserthermia Systems AB ("CLS" or the "Company") warrants of series TO 7 B took place during the period from and including November 11, 2024 to and including November 22, 2024. A total of 4 512 532 warrants were exercised for the subscription of 4 512 532 new shares, corresponding to approximately SEK 16,6 million and a subscription rate of approximately 74 percent. In order to ensure that the proceeds amounted to 100%, the Company also decided on a directed issue to a consortium of new and existing investors of approximately SEK 5,8 million (the "Directed Issue"). The Company thus received a total of approximately SEK 22.4 million before deductions for transaction costs
Significant events after the end of the period
- Data from the clinical trial using MRI-guided FLA with TRANBERG® Thermal Therapy System in patients with prostate cancer at Radboud University Medical Center (Nijmegen, NL) was published in Journal of Vascular and Interventional Radiology.
- Lars-Erik Eriksson, co-founder, long-time board member and former CEO, left the board of directors at his own request.
Comments from CEO Dan J. Mogren
Dear Shareholders,
2024 has been a transformative year for CLS, marked by strong revenue growth, strategic realignment, and important clinical and regulatory milestones. As we refine our focus on neurosurgery, we are positioning the company for long-term success with a more streamlined and high-margin business model.
A Year of Continued Growth and Improved Financials
We more than doubled our net sales in 2024, reaching SEK 18.8 million compared to SEK 8.3 million in 2023 with significantly improved gross margin to 52% for 2024 and well in line with the long-term target of reaching 60%. Our loss after financial items narrowed from SEK -80.9 million to SEK -47.9 million. This reflects our progress in driving revenue growth while improving cost efficiency.
Focus on Neurosurgery
A key decision in 2024 was to concentrate our business on the neurosurgery segment, where we see the greatest potential for sustainable, high-margin growth. Our partnership with ClearPoint Neuro Inc. continues to thrive, with our ClearPoint Prism® portfolio for MRI-guided laser ablation already being marketed and sold successfully in the U.S. The completion of patient follow-ups in our Skåne University Hospital clinical study further reinforces the strength of our technology in real-world settings.
Reaching Regulatory and Clinical Milestones
In 2024, we made important progress in clinical validation and regulatory compliance:
- Our ISO certification under the new Medical Device Regulation (MDR) ensures we can continue seeking CE marking for new products and indications, including market approval of the ClearPoint Prism® Neuro Laser Therapy System in Europe.
- We saw significant progress in finalization of our clinical study program within urology, with data from our prostate cancer study at Radboud University Medical Center being published in a leading medical journal.
Further Strengthening Our Financial Base
We successfully raised approximately SEK 22.4 million through the exercise of TO 7 B warrants and a directed share issue to both new and existing investors. This capital injection provides the resources needed to support our strategic transition and continued development into 2025.
Governance and Leadership
In October, we welcomed new board members, including Chairman Peter Max, alongside the re-election of experienced leadership. Their expertise will be instrumental as we execute our growth strategy.
Looking Ahead with Confidence
As we enter 2025 with a proven track record and a clear focus on neurosurgery, improved financials, and a solid regulatory foundation, we are well-prepared to scale our business and are continuously working on attracting strategic long-term investors to support our goal to become cash positive in 2026.
I want to thank our team, partners, and investors for their continued trust and commitment. The future of CLS is bright, and I look forward to the opportunities ahead.
Sincerely,
Dan J. Mogren
CEO, Clinical Laserthermia Systems
This disclosure contains information that CLS is obliged to make public pursuant to the EU Market Abuse Regulation (EU nr 596/2014). The information was submitted for publication, through the agency of the contact person set out below, on February 21, 2025 at 08:30 CET.
Contact information:
Dan J. Mogren, CEO Clinical Laserthermia Systems AB (publ)
Tel: +46 - (0)705 - 90 11 40
E-mail: dan.mogren@clinicallaser.com
About CLS
Clinical Laserthermia Systems AB (publ), develops and sells TRANBERG® Thermal Therapy System and ClearPoint Prism® Neuro Laser Therapy System with sterile disposables, for minimally invasive treatment of cancer tumors and drug-resistant epilepsy. The products are marketed and sold through partners for image-guided laser ablation and are used in studies for treatment with imILT®, the company's interstitial laser thermotherapy for immune stimulating ablation with potential abscopal treatment effect. CLS is headquartered in Lund, Sweden, with subsidiaries in Germany, the United States and a marketing company in Singapore. CLS is listed on Nasdaq First North Growth Market under the symbol CLS B. Certified adviser (CA) is FNCA Sweden AB.
For more information about CLS, please visit the Company's website: www.clinicallaser.se
This disclosure contains information that CLS is obliged to make public pursuant to the EU Market Abuse Regulation (EU nr 596/2014). The information was submitted for publication, through the agency of the contact person, on 21-02-2025 08:30 CET.