Summary of the interim report (relates to the Group)
Full year (
- Net sales totaled
SEK 8,273,000 (SEK 6,268,000 ). - Operating profit/loss totaled
SEK -65,933,000 (SEK -67,442,000 ) - Profit/loss after financial items totaled
SEK -80,875,000 (SEK -71,265,000 ). - Basic and diluted earnings per share totaled
SEK -0.12 (SEK -0.85 ). - The equity ratio at
December 31, 2023 , was 75,4% (18,6%).
The fourth quarter (
- Net sales totaled
SEK 4,456,000 (SEK 4,295,000 ). - Operating profit/loss totaled
SEK -20,408,000 (SEK -18,226,000 ) - Profit/loss after financial items totaled
SEK -25,648,000 (SEK -19,618,000 ). - Basic and diluted earnings per share totaled
SEK -0.02 (SEK -0.15 ). - The equity ratio at
December 31, 2023 , was 75,4% (18,6%).
Significant events in the fourth quarter of 2023
- CLS signed Mobile Service Provider (MSP) Agreements with Kearney Urology Center PC of Kearny,
Nebraska, USA , and KASRAEIAN Urology ofJacksonville, FL , USA, for image guided focal laser ablation (FLA) of localized prostate cancer. CLS will provide the TRANBERG® Thermal Therapy System, including sterile disposables, training, and on-site clinical and technical support on a pay-per-procedure basis. -
CLS selected
Quest International , a global aftermarket technical service provider to OEMs, to provide service and logistics operations for the US market. Under the agreement, Quest will provide end-to-end white glove service management, including field services, depot repair, and warehousing and logistics support for CLS's TRANBERG Thermal Therapy System. -
CLS and US based
HALO Diagnostics , a leader in precision diagnostics and image-guided therapies (HALO Dx), entered an agreement to initiate a clinical study using the TRANBERG Thermal Therapy System to perform image-guided FLA of low-to-intermediate risk prostate cancer in 25 patients. According to the agreement,HALO Diagnostics will purchase the TRANBERG sterile disposables required for the study. -
CLS entered into an exclusive distribution agreement with
Avanco Advanced Medical Solutions to market and sell CLS's TRANBERG product portfolio for image-guided FLA of localized prostate cancer inPortugal . - CLS announced its participation in a national French study together with Urolib (urological team of the Medical Center Chateau Galland (MCCG)) in Besançon, and that the first patient was safely treated with CLS TRANBERG Thermal Therapy system for laser ablation of prostate cancer. Disposables and accessories will be purchased from CLS during the study.
Kristian Waldeck was appointed VP Medical Affairs and member of the company's management team.
Significant events after the end of the period
- CLS received an order for ClearPoint Prism(TM) Neuro Laser Therapy System products from
ClearPoint Neuro, Inc (Nasdaq:CLPT). The order has a value of approximatelySEK 8.1 million . -
CLS obtained market approval for its portfolio of TRANBERG Thermal Therapy Systems from the
Singapore Health Science Authority and initiated the process of commercialization in theAsia Pacific region. - CLS hosted a business update, including presentations of the company´s strategic and commercial roll-out as well as an updated sales ambition to achieve a positive operating profit (EBITDA) during the 2026 financial year.
-
CLS signed a new agreement with
Image Guided Therapy SA (IGT) under which CLS will acquire all rights to IGT's technology for MRI-based temperature measurement and control of laser-based tissue ablation.
Comments from CEO
2023 was an exciting year for CLS. Revenues grew by 32% driven foremost by the urology segment and the recently implemented Mobile Service Provider model. During the fourth quarter we announced that two additional clinics signed Mobile Service Provider agreements in the US. In December we received a new order for products from our US neurosurgery partner,
Strong revenue growth with continued focus on costs
CLS revenues grew strongly in 2023 with our urology market segment leading the way and our neurosurgery market segment revenues maintaining their 2022 level. While the US continued to be the main source of sales, the signing of a new distribution agreement in
During the quarter we saw the benefits of the cost efficiency projects we have implemented. Costs were in line with our expectations and by reducing other external costs, we have been able to invest for growth in the US business. With the boost in sales and improved margins, our operating profit has improved against the previous year.
Investment in MSP model delivers results
During the fourth quarter we finalized two agreements in the US for our Mobile Service Provider model. The first was with the Kearney Urology Center PC, and the second with the
In addition to these two agreements, we have several potential MSP agreements in the pipeline. The fact that we have been able to reach these agreements within less than a year of launching the MSP model validates the investments we have made. It is clear our customers appreciate and value our MSP services.
New orders and positive feedback for our US neurosurgery business
In
Together with
Continued expansion in
In November, we announced an agreement with
In an important development for CLS following the end of the quarter, the
Safeguarding our core technology and IP
Following the end of the quarter, CLS filed a patent application to expand and extend protection for the company's technology. This application includes protections for critical improvements to the CLS non-cooled laser applicator that CLS believes are patentable. If the patent application is approved, protection is provided for the improvements until 2044. In addition, we are currently working on transitioning to the EU MDR certification and anticipate that this will be in place no later than 2025. This is an important milestone for CLS that adds significant value to the company as it reduces the overall regulatory risk.
New clinical studies for treatment of prostate cancer
The fourth quarter saw a number of new clinical studies announced involving the TRANBERG Thermal Therapy System for the treatment of prostate cancer. In November we announced an agreement with
We reported in December that first patient was treated with the CLS TRANBERG Thermal Therapy system as part of the nation-wide IRMPROFT study in
During the quarter two additional patients were treated as part of the Skåne
Strengthening the CLS Team
In December we welcomed
Looking forward to an exciting 2024
During 2023, we identified several ways to expand our addressable markets and optimize reimbursement potential. To unlock these opportunities in 2024, strategic investments are necessary during the coming year, especially within the neuro business segment. These investments, in combination with the delay in obtaining the Singaporean market approval, means our goal to achieve a positive operating profit (EBITDA) has been pushed forward into 2026.
We are excited about the opportunities that lie ahead in 2024. With regulatory approval in
After an exciting end to 2023, we look forward to you being part of an even more exciting 2024.
CEO,
Contact information:
Tel: +46 - (0)705 - 90 11 40
E-mail: dan.mogren@clinicallaser.com
About CLS
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
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