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WKN: A3CMUG | ISIN: FI4000506811 | Ticker-Symbol: 5NX
Frankfurt
15.08.25 | 08:05
14,700 Euro
+0,68 % +0,100
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13,95014,20011:51
GlobeNewswire (Europe)
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Nexstim Oyj: Nexstim Plc Half-year Report January 1 - June 30, 2025 (unaudited)

NEXSTIM PLC HALF-YEAR REPORT JANUARY 1 - JUNE 30, 2025 (UNAUDITED)

Company announcement, Helsinki, August 15, 2025 at 9 am (EEST)

NEXSTIM ACCELERATED GROWTH AND IMPROVED PROFITABILITY IN THE FIRST HALF OF THE YEAR

The figures in parentheses refer to the previous year's comparative period, unless otherwise stated.

January-June 2025 in brief

  • The company's net sales were EUR 4.5 million (3.2), with an increase of 41.8 %
  • Net sales growth adjusted for currency exchange rates was 42.5 %
  • System sales were EUR 2.2 million (1.2), with an increase of 79.7 %. Recurring net sales accounted for EUR 2.1 million (1.9), with an increase of 7.7 %. Licensing accounted for EUR 0.2 million (0.0).
  • The net sales of the Diagnostics Business were EUR 2.5 million (1.5) with an increase of 65.3 %
  • The net sales of the Therapy Business were EUR 1.4 million (1.6) with a decrease of 8.4 %
  • The net sales of the Research and Neuroscience Business were EUR 0.6 million (0.1) with an increase of 565.7 %.
  • EBITDA was EUR 0.2 million (-0.5)
  • The operating result was EUR -0.2 million (-0.9)
  • The result for the period was EUR -0.3 million (-0.9)
  • The company signed an exclusivity agreement with Sinaptica Therapeutics, Inc. as part of a planned collaboration in the treatment of Alzheimer's disease. The agreed exclusive rights are conditional on payments totaling EUR 1.5 million to be made to Nexstim in multiple installments during 2025, of which EUR 0.2 million was recognized as revenue during the review period.

Business overview

Nexstim is a Finnish medical technology company operating in international markets. Its proprietary navigated Transcranial Magnetic Stimulation (nTMS) technology allows for personalized treatment and diagnostics for patients with challenging brain diseases and disorders. Nexstim provides solutions for non-invasive brain stimulation through diagnostic and therapy applications.

Key performance indicators

EUR thousand 1-6/2025 6 months1-6/2024 6 monthsChange, %1-12/2024 12 months
Net sales 4,506.23,176.941.8 %8,735.4
Gross margin 3,633.82,603.039.6 %6,901.4
Gross margin, % 80.6 %81.9 %-79.0 %
Adjusted comparable gross margin 3,433.82,603.031.9 %6,901.4
Adjusted comparable gross margin, % 79.7 %81.9 %-79.0 %
Personnel expenses -2,591.7-2,282.113.6 %-4,784.5
Other operating expenses -1,667.6-1,562.66.7 %-3,347.0
EBITDA 240.6-466.5-321.9
Operating result -246.4-864.2-71.5 %-535.4
Profit/loss for the period -338.8-948.1-64.3 %-892.3
Earnings per share -0.05-0.14-66.3 %-0.13
Diluted earnings per share (EUR) -0.04-0.12-69.6 %-0.11
Cash flow from operating activities 314.6699.6-55.0 %1,881.0
Cash in hand and at bank 2,662.73,032.1-12.2 %3,864.4
Total equity 3,179.31,867.770.2 %3,699.9
Equity ratio (%) 31.9 %28.7 %-31.2 %

Future outlook for year 2025

The company expects its net sales to grow and operating result to improve.

CEO Mikko Karvinen comments on the development during the period:

Nexstim continued its positive trend in terms of net sales growth and improved results during the first half of 2025. In H1 2025, we achieved total net sales of EUR 4.5 (3.2) million, representing growth of 41.8%. Gross margin increased by more than EUR 1 million from the comparable period last year to EUR 3.6 (2.6) million, which is a result of the favorable development of our sales volumes and prices. The increased customs duties in the United States did not have a significant impact on the results for the first half of 2025, and we have sought to minimize the potential impact of customs duties on future periods by taking them into account in new system sales offers. We were particularly pleased with the positive development of EBITDA during the first half of the year. EBITDA was EUR 0.2 (-0.5) million and was positively record-breaking for two consecutive half-years. The operating result for the first half of the year also showed improvement in the right direction, at EUR -0.2 (-0.9) million, with a result for the review period of EUR -0.3 (-0.9) million. The result was improved by a non-recurring item of EUR 0.2 million, which was the first installment of the license fee for the exclusivity agreement with Sinaptica. I thank Nexstim's customers, personnel, partners, and investors for the continuation of this positive development.

In line with the main objective of Nexstim's 2025-2028 strategy, we have focused on profitable net sales growth, and our sales forecast for full year 2025 looks promising. This growth is now supported by our global distributor partner network, which was strengthened at the end of last year by the Brainlab cooperation agreement. We are now looking to take immediate advantage of this, particularly in the marketing and sales of diagnostics systems in the United States and Europe. In early 2025, we developed and trained our partner network for the Diagnostics business in close cooperation with Brainlab. This will enable us to effectively and comprehensively deliver our sales and marketing message to as many markets as possible among Brainlab's thousands of existing customers. In addition to this collaboration, Nexstim's direct sales and marketing still have significant opportunities for developing the Therapy business, research and neuroscience customers, and the clinic partner network. We aim to continue leveraging our expert and efficient global teams to ensure positive profitability development. This was reflected in the moderate 11 percent growth in operating expenses in early 2025, enabling a simultaneous 40 percent increase in gross margin.

Business update

We have continued to grow our Diagnostics (NBS, Navigated Brain Stimulation) and Therapy (NBT®, Navigated Brain Therapy and NBS 6) businesses through the sale of new systems in our key markets in the US and Europe. Our growing installed base generates a steady stream of net sales which increases the stability and predictability of our operations.

The Diagnostics business grew by 65.3% during the first half of 2025, with net sales of EUR 2.5 (1.5) million. We delivered a total of seven new diagnostic systems during H1 2025. To date, we have sold more than 250 diagnostic systems to research universities and leading hospitals around the world. We are pleased that more of our customers want to use Nexstim system for both diagnostic and therapeutic purposes. The NBS System 5 configuration, NBS 5+, has enabled the use of diagnostic and therapeutic applications in the same system. This offering means that all FDA 510(k) indications are available in the same system on the US market. Most of the diagnostic systems delivered in early 2025 have both diagnostic and therapeutic applications. We consider combination systems to be a clear competitive advantage and aim to launch the latest generation of NBS 6 combination systems in key markets during the second half of 2025, following regulatory approvals.

Net sales from the therapy business decreased by 8.4% during the first half of 2025 and amounted to EUR 1.4 (1.6) million. The decline was mainly due to a decrease in system sales in the Therapy business, which fell by 37.0% compared to the same period last year. During H1 2025, we delivered one purely therapeutic system to Europe and the rest of the world. This development was mainly since most of the therapy applications were delivered in connection with Diagnostics and Research and Neuroscience system. At the end of June 2025, there were a total of 116 Nexstim systems with therapy applications installed worldwide (43 in the United States and 73 in Europe and the rest of the world) for the treatment of depression and chronic neuropathic pain. This number includes both NBT® and NBS 6 systems as well as NBS systems with optional NBT add-on software installed.

With the new strategy period, we now also report separately the net sales of the Research and Neuroscience business, which grew by as much as 565.7% during the first half of 2025, amounting to EUR 0.6 (0.1) million. This rapid growth was due to the sale of two research systems and a EUR 0.2 million license fee from Sinaptica's exclusive agreement.

In addition to the above-mentioned system already delivered, we had an open order backlog of eight systems at the end of June 2025.

In June 2024, we announced disagreements regarding the licensing of our technology to the US medical technology company Magnus Medical, Inc. Nexstim received additional information from them regarding the launch of their first commercial product, which, based on additional analysis conducted by the Company and an external party, led to a disagreement regarding the use of the licensed technology. Nexstim continues to gather additional information regarding Magnus Medical's commercial product and is planning further measures to defend its financial interests and intellectual property rights in accordance with the long-term agreement. The Company does not currently expect to receive any royalty income from Magnus Medical during 2025 in its business forecasts. Nexstim is not currently providing an estimate of the total value of the royalty period or financial expectations due to ongoing discussions regarding the disagreements.

Nexstim's cash reserves totaled EUR 2.7 (3.0) million on June 30, 2025, and cash flow from operations for the first half of the year was EUR 0.3 (0.7) million.

Strategic focus remains on growth and profitability

In line with our strategy for 2025-2028, Nexstim will continue to enable individualized and effective treatment and diagnostics for patients with severe brain diseases and disorders. The company's first strategic objective for 2025 is to continue profitable net sales growth and improve the operating result for the financial year. The growth and profitability of our Diagnostics and Therapy businesses play a key role in our efforts to minimize our future capital requirements on our journey towards sustained profitability. We also want to continue to highlight Research and Neuroscience as well as our clinic partners as special strategic customer groups as we progress with new features, business models, and indications for our future systems. The importance of partnerships is likely to increase in the future in the Therapy business as well, as we leverage our unique expertise and technology in emerging treatment areas.

Our second strategic objective for 2025 is to successfully support the long-term collaboration between Nexstim and Brainlab and to expand our network of other partners and clinics, primarily in the United States. I strongly believe that combining Nexstim's technological expertise and first-class services with Brainlab's innovative products, which have significant business growth potential and are well suited to Nexstim's offering and global customer base of leading hospitals, will create maximum value for patients, neurosurgeons, hospitals, and shareholders. Outside of Brainlab's exclusive rights, Nexstim will continue to independently develop, market, and sell its products and services in all markets for current and future neuroscience research solutions and therapeutic applications. This includes all neuromodulation treatments that are not administered in conjunction with neurosurgical intervention using non-invasive transcranial magnetic stimulation. Nexstim's own sales organization, in collaboration with other distributors and business partners, will continue to work in these areas. The parties have also agreed on certain gross margin targets for payments that Nexstim will receive from the sale of its products (including maintenance agreements) in Brainlab's business area. The gross margin target set for 2025 is EUR 4 million. The EUR 2 million portion of the gross margin target allocated to the first half of 2025 was not yet fully achieved, and a gross profit insurance payment of EUR 0.1 million was recognized as part of the Diagnostics business's net sales for the period.

With the expansion of the network of partner clinics, Nexstim's system will be installed in neuroscience clinics, and new investments may be made in clinic service companies in the large US market. Nexstim Investments, LLC, Nexstim's venture capital company, aims to expand Nexstim's network of partner clinics in the United States in collaboration with carefully selected leading experts in the field. We will continue to develop our cooperation model with experts, enabling the treatment of more patients in the United States with Nexstim's TMS technology. During the strategy period, we aim to increase the number of Nexstim systems and treatment sessions at our partner clinics.

Our third strategic objective for 2025 is to launch the new NBS 6 diagnostic system in our main markets, enabling ease of use and future add-on modules in the same system. The development and launch of a new product generation will continue to be an essential part of Nexstim's operations during the 2025-2028 strategy period. NBS 6 is a new combination system built on Nexstim's unique, clinically established technology, with a modular system concept that makes it easy to add new features to existing systems. Nexstim's NBS 6 system has FDA marketing and distribution approval for the treatment of major depression in the United States and is CE-approved in Europe for the treatment of major depression and chronic neuropathic pain. We will now continue to finalize the development of the system and progress regulatory approvals during 2025 so that, in line with our strategic objective, we will also have diagnostic applications launched in the key markets as part of the new NBS 6 system.

Building future growth paths

Our system clearly stands out from other TMS systems currently on the market, which do not have navigation features. In the future, the need for navigation functionality is likely to become even more important in technology, enabling more diverse treatment of brain disorders. This may open new markets for Nexstim in TMS treatments beyond severe depression and chronic neuropathic pain. The technological leadership, ease of use, and scalability of our product create an attractive foundation for growth through partnerships.

In January 2025, the company announced the start of joint development of the SinaptiStim® precision neuromodulation system for the treatment of Alzheimer's disease together with Sinaptica Therapeutics, Inc. ("Sinaptica"). The company announced that the planned delivery of the research system for the first validation testing, and future clinical trials was in March. Nexstim announced that it is developing the system according to Sinaptica's specifications, combining it with a high-resolution 64-channel electroencephalography (EEG) system from Bittium, which enables precision calibration of the therapy for each Alzheimer's patient. The new research system will be used in Sinaptica's upcoming clinical trials related to the treatment of Alzheimer's disease, with several studies planned to begin in 2025.

At the end of June 2025, the Company announced that it had signed an exclusivity agreement with Sinaptica Therapeutics, Inc. regarding the companies' planned collaboration in the field of Alzheimer's disease treatment. The signed agreement covers plans for 2025. The final agreement is expected to be drafted and signed before the end of the year. In June 2024, the Company announced that it had signed a letter of intent with Sinaptica regarding the development, manufacture, and supply of Sinaptica's patented precision neuromodulation system for the treatment of Alzheimer's disease and MCI (mild cognitive impairment). The system is based on Nexstim's NBS 6 medical TMS and neuronavigation systems and related software, including integrated EEG software. As part of the signed exclusive agreement, Sinaptica undertakes to order the research system it needs for clinical trials from Nexstim, and Nexstim will not commercialize its technology in the field of Alzheimer's disease independently or with partners other than Sinaptica. The agreed exclusivity is conditional upon payments of EUR 1.5 million in multiple installments to Nexstim during 2025. The planned partnership would be a global, 10-year exclusive arrangement. The financial structure of the partnership consists of a signing fee for the disclosed exclusivity rights, a milestone-based development project, and the sale of clinical and commercial system. The milestone-based project and purchases of clinical system are defined in more detail in the final agreements, which may be subject to change during negotiations. The long-term exclusive rights arrangement also depends on payments to be made by Sinaptica during 2025 and the signing of final agreements before the end of 2025.

Building shareholder value while taking exceptional circumstances into account

Despite the tense global political situation, our expectations for the rest of 2025 are positive in many ways. Our current business is heavily focused on the EU and the US, but with our new partners, we will continue to actively expand Nexstim's technology into the Asian market. Nexstim will continue its determined efforts to develop personalized and effective methods for the treatment and diagnosis of severe brain diseases and disorders. We strongly believe that our work will support long-term shareholder value growth in the form of increasingly strong competitive advantages, rapid growth, and improved financial results.

Nexstim's business areas

Diagnostics Business

  • Nexstim's NBS 5 system is the only CE-marked and FDA-cleared non-invasive solution for pre-surgical mapping of the motor cortex in brain cancer. Clinical data has been generated demonstrating the value of Nexstim's unique navigation system for pre-surgical mapping with regard to patient outcomes.
  • The system allows surgeons to be better prepared and more aggressive with tumor resection, due to their confidence in the location of the motor and speech cortex because of pre-surgical mapping.
  • More than 250 diagnostic systems have been sold to research universities and leading hospitals across the world.

Therapy Business

  • Nexstim's NBT® and NBS 6 systems are based on its unique navigated Transcranial Magnetic Stimulation (nTMS) technology, which allows for personalized, accurate, reproducible, and non-invasive brain stimulation.
  • In May 2018, Nexstim launched its Navigated Brain Therapy (NBT®) system in the United States for the treatment of MDD, following FDA clearance in November 2017.
  • Nexstim launched the NBS 6 system for therapy use in 2024. The NBS 6 is a new generation Nexstim system with a modular system concept that makes it easy to add new features to existing systems.
  • Both NBT® and NBS 6 systems are CE marked for the treatment of major depression and chronic pain, and have FDA approval for the treatment of major depressive disorder (MDD).
  • Active commercial installed base of 116 therapy systems across four continents (including both NBT® and NBS 6 systems and NBS systems with optional NBT® add-on software installed).

Research and Neuroscience Business

  • The core of the Research and Neuroscience business is the sale of Nexstim systems and support and development services to leading research hospitals and clinics, in order to support leading expert customers (key opinion leaders, KOLs) working in these institutions at the forefront of technological and clinical development.
  • The international research community is particularly interested in developing therapies based on the stimulation of connections/neural networks between different areas of the brain. Nexstim's unique electric field neuronavigation has proven to be particularly useful and necessary in this regard.
  • TMS-EEG diagnostics and treatment development based on this methodology are a growing area of interest in research. Here, too, neuronavigation and Nexstim's real-time EEG (electroencephalography) software are particularly useful and are attracting growing interest.

Publication of financial information

The financial statements bulletin for the financial year that will end on December 31, 2025, will be published approximately on February 26, 2026 and the annual review will be published approximately on March 5, 2026.

Results briefing on August 15, 2025

The company will hold two live webinars for the media, investors, and analysts on Friday, August 15, 2025. Mikko Karvinen, CEO, and Joonas Juokslahti, CFO, will present the company's financial and operational results, and will answer questions.

The first webinar will be held in Finnish at 10.30 am (EEST). The second webinar will be held in English at 3 pm (EEST).

Webinar details:

To attend the webinars, please register via the links below. Registered participants will receive more information via email.

Webinar in Finnish on August 15, 2025, at 10:30 am (EEST): Sign up here >>

Webinar in English on August 15, 2025, at 3 pm (EEST): Sign up here >>

Helsinki, August 15, 2025

Nexstim Plc

Board of Directors

Further information is available on the website www.nexstim.com or by contacting:

Mikko Karvinen, CEO

+358 50 326 4101

mikko.karvinen@nexstim.com

The Company's Certified Adviser is DNB Carnegie Investment Bank AB.

Distribution:
Nasdaq Helsinki
Key media outlets

About Nexstim Plc

Nexstim is a Finnish, globally operating growth-oriented medical technology company. Our mission is to enable personalized and effective diagnostics and therapies for challenging brain diseases and disorders.

Nexstim has developed a world-leading non-invasive brain stimulation technology for navigated transcranial magnetic stimulation (nTMS) with highly sophisticated 3D navigation providing accurate and personalized targeting of the TMS to the specific area of the brain.

Nexstim's Diagnostics Business focuses on commercialization of the Navigated Brain Stimulation (NBS) system. The NBS System 5 is the only FDA cleared and CE marked navigated TMS system for pre-surgical mapping of the speech and motor cortices of the brain.

Nexstim's Therapy Business markets and sells the NBS System 6 which is FDA cleared for marketing and commercial distribution for the treatment of major depressive disorder (MDD) in the United States. In Europe, the NBS 6 system is CE marked for the treatment of major depression and chronic neuropathic pain.

Nexstim shares are listed on Nasdaq First North Growth Market Finland.

For more information, please visit www.nexstim.com

© 2025 GlobeNewswire (Europe)
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