NEXSTIM PLC HALF-YEAR REPORT JANUARY 1 – JUNE 30, 2023 (UNAUDITED)

Company announcement, Helsinki, 18 August 2023, at 9 am (EEST)

IN THE FIRST HALF OF THE YEAR, THE COMPANY FOCUSED ON COST EFFICIENCY

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

January–June 2023 in brief

• The company’s net sales were EUR 2.5 million (6.8, comparative 3.3), with a decrease of 63.1 %. Net sales of the comparative period include the EUR 3.5 million technology license fee recognized during spring 2022. 
• Net sales decrease adjusted for currency exchange rates was 63.3 %. 
• System sales were EUR 1.1 million (1.8), with a decrease of 37.4 %. Recurring net sales accounted for EUR 1.4 million (1.5), with a decrease of 6.4 %. The licensing business accounted for EUR 0.0 million (3.5). 
• The net sales of the Diagnostics Business (NBS) were EUR 1.3 million (2.1) with a decrease of 36.0 %.
• The net sales of the Therapy Business (NBT®) were EUR 1.2 million (4.7) with a decrease of 75.2 %. Net sales of the comparative period include the EUR 3.5 million technology license fee recognized during spring 2022.
• The company achieved savings of approximately EUR 0.5 million in operating expenses compared to the comparison period 
• EBITDA was EUR -1.1 million (2.6).
• The operating result was EUR -1.4 million (2.3).
• The result for the period was EUR -1.4 million (3.2).

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 (NBS system) and therapy (NBT® system) applications. 

Key performance indicators

Future outlook

Based on business forecasts, the company expects that its comparable net sales will grow in 2023 and its EBITDA (operating result before depreciations) for the financial year will be positive.

CEO Mikko Karvinen comments on developments during the review period:

During the first half of 2023, we have especially focused on projects that are crucial for the company's strategic competitive advantage, such as improving the company's cost efficiency through our new global team structures and the launch of our new NBS 6 system in both the EU and US markets. In line with our main strategic objective, we have continued to focus on profitable net sales growth, still targeting a positive EBITDA for the full financial year 2023, while minimizing future capital needs. To ensure this positive profitability development, during January-February 2023 we conducted change negotiations within the company as part of the transition to a global process organization, which will enable us to continue to serve Nexstim's customers better and more efficiently and deliver growth in long-term shareholder value. The therapy application areas we have chosen (MDD, severe depression and chronic pain) are indications where our unique technology is already delivering clear clinical results and contributing to the profitability of our customers' operations. We are also continuing discussions on new strategic partnerships to further scale the use of our technology in care.

In H1 2023, we achieved total net sales of EUR 2.5 (6.8, comparative 3.3) million, a decrease of 63.1%. Most of the decline in net sales was due to a one-off license fee of EUR 3.5 million for a technology license agreement included in the net sales for the comparative period. In addition, net sales for the comparative period H1 2022 included backlog of orders for systems valued approx. EUR 1.0 million received for the Diagnostics and Therapy business during the previous year 2021. Despite the decline in net sales, we are pleased with the high level of our adjusted comparable gross margin, driven by the favorable development of our sales prices and the success of key hardware component purchases in the current inflationary environment. We can also be pleased with the decrease in both personnel and other operating expenses, achieving savings of approximately EUR 0.5 million compared to the comparative period. We believe these will help us achieve a positive EBITDA for the second half of the year and full year 2023 results.

Diagnostics and Therapy business update

We have continued to grow our Diagnostics (NBS) and Therapy (NBT®) businesses with new system sales in our key markets in the US and Europe. This installed base is generating a steady stream of revenue, adding stability and predictability to our operations. We want to develop and evolve.

Diagnostics net sales decreased by 36.0% to EUR 1.3 (2.1) million. We delivered a total of 6 new NBS systems during the review period. On the diagnostics business side, around 220 NBS systems have been sold to date to research universities and leading hospitals worldwide. We are pleased to see that more and more of our customers want to use Nexstim systems for both diagnostic and therapy purposes. The NBS System 5 configuration, NBS5+, enables diagnostic and therapy applications to be run on the same system. This offering allows the US market to have all FDA 510(k) indications available on the same system. Of the six NBS systems delivered in H1 2023, all have both diagnostic and therapy applications. We see this combined platform as a clear competitive advantage and are looking to expand this platform offering to other key markets globally.

Net sales in the Therapy business declined by 75.2% in H1 2023 to EUR 1.2 (4.7) million, due to the license sale of approximately EUR 3.5 million to Magnus Medical, Inc. which was recognized in the comparative period. We sold a total of 2 new NBT® systems during the period; 1 in North America and 1 in Europe and the rest of the world for use in the treatment of severe depression. On the Therapy business side, at the end of H1 2023, there were a total of 70 Nexstim systems with therapy software installed worldwide (26 in the US and 44 in Europe and the rest of the world) for the treatment of depression and chronic neuropathic pain. This number includes both NBT® systems and NBS systems with optional additional NBT software installed.

Nexstim's total cash and cash equivalents as of 30 June 2023 amounted to EUR 2.1 million. Through profitable growth, we are seeking to minimize any needs for new equity, and the company is not currently actively planning new financing rounds.

Strategic focus on creating growth and profitability

In February 2022, we announced the sale of our NBT® system technology license to Magnus Medical, Inc. The total value of the agreement is estimated at approximately EUR 17 million. We will continue with business as usual and focus on executing our strategy until the five-year royalty period of the license agreement begins. This spring, Magnus Medical has estimated their commercial product launch to take place in the second half of 2024 and we will follow this same public information in our own estimates for the start of the royalty period. This licensing agreement opens unique opportunities for Nexstim to achieve financial benefits, expand the use of our technology in patient care and allocate our own resources to other business areas during the royalty period.

Our second key strategic goal for 2023 is launching the new NBS 6 product, enabling easy-to-use systems and the use of future additional modules in the same system. The launch and development of the new product generation is an essential part of Nexstim’s operations during the 2020-2024 strategy period. The NBS 6 is a combined system that has been built on Nexstim’s unique, clinically established technology. The modular product design allows for an expansion of system capabilities over time. The new solution creates long-term value for Nexstim’s customers and investors. The first release in April-May concerns therapy applications. Nexstim's Therapy business markets and sells the NBS System 6 system, which has FDA marketing and distribution approval for the treatment of major depression in the United States. NBS System 6 is also CE-approved in Europe for use in the treatment of major depression and chronic neuropathic pain. Nexstim unveiled the NBS 6 system at the Clinical TMS Society 11th Annual Meeting, held in Colorado Springs, Unites States on May 4 – 6. and our sales opportunities for the product have developed favorably since then. We are prepared for the first customer orders and deliveries to happen during the second half of 2023.

Our third key strategic goal for 2023 is expanding the network of Nexstim exclusive collaboration clinics primarily in the USA and Europe. This would mean installing Nexstim systems in neuroscience centers, in line with our revised strategy, mainly in cooperation with our partners. Our new partnerships focus on strategic investments in service organizations, especially on the vast US market, but partnerships are also possible to make targeted investments in the European market.

We are very pleased with the beginning of our cooperation with Dr Kuluva and his clinic, and we believe that our cooperation creates excellent conditions for future growth. Our joint venture, PNC Management Services LLC, is our first agreement on a strategic partnership and the acquisition of a minority interest in the joint venture is our first step on this important strategic development path. This partnership allows us to work close to the patients and collect accurate information at the patient interface. In addition, the purpose of our private equity company is to further expand the network of Nexstim’s neuroscience centers in the United States. We are looking forward to continuing our cooperation with Dr Kuluva’s team of experts. Through our cooperation, Nexstim’s TMS technology can be used to treat a growing number of patients in the United States. We are currently involved in negotiations with several potential partner clinics in both the United States and Europe, and we are working hard to grow our network.

Creating future growth paths

In October last year, we reported clinical outcomes of the first 403 patients who had completed treatment with Nexstim NBT® system for major depressive disorder (MDD).  Nexstim NBT® system is indicated for the treatment of MDD in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode. Treatment outcomes of these 403 patients were excellent: approximately 50% were in remission at the end of the treatment and 76% had obtained a clinical response. These outcomes are clearly higher than what is usually reported for MDD with TMS-systems: In a well-conducted multisite study, remission rates were 26.5–28.7% and the patient-reported response rates were 41.5–56.4%¹. The patient-reported remission and response rates are also higher than those reported in a large sample of more than 3,800 patients who completed clinical rTMS treatment (remission 29.7–36.2%, response 62.7–70.4%)². We will continue to collect this invaluable data during the second half of the year 2023.

Nexstim published an overview of the results of the pilot study at Kuopio University Hospital in June 2023. This study investigated the use of an accelerated iTBS protocol for the treatment of severe depression using Nexstim's NBT® system. Accelerated iTBS is a treatment using transcranial magnetic stimulation (TMS), where stimulation is given several times a day for one week, as opposed to traditional TMS, where stimulation is given once a day for several weeks. All patients treated with the accelerated iTBS protocol completed their 5-day treatment, including a total of 20 patients who completed their planned 12-week follow-up. There were no system-related serious adverse events. All patients showed improvement in symptoms on the clinician-administered Hamilton Depression Rating Scale (HAMD-17) at the end of treatment, except for one patient who showed no change (mean score decrease from baseline of 27%, p < 0.001). At the end of 5 days of treatment, 15% of all 20 patients had achieved clinical remission and 30% clinical response, defined as >50% improvement from intervention. At the end of the 12-week follow-up period, 25% of patients were in clinical remission and 30% showed clinical response compared to baseline HAMD-17 scores.

We thank the Kuopio team for their valuable pilot study work done for this severe depression patient group under difficult extraordinary circumstances such as the COVID-19 pandemic. The 20 patient pilot study results do not seem to show any clear benefit for using the accelerated iTBS protocol, if compared to the conventional once a day TMS treatment of depression for up to 6 weeks, other than the smaller number of patient treatment days in total. Nexstim continues to develop the future use of accelerated iTBS protocols mainly through our strategic partnerships.

Shareholder value creation continues in exceptional circumstances

Despite the international tension, our outlook for the end of the year 2023 continues to be positive. At Nexstim, we purposefully continue our work to enable personalized and effective therapies and diagnostics for challenging brain diseases and disorders. We strongly believe that our work supports the growth of shareholder value over the long term, in the form of stronger competitive advantages, rapid growth, and better financial performance. While remaining optimistic about the future, we will continue to monitor closely the situation in Ukraine as we grow our business.

^{1)    Carpenter L. et al. Transcranial magnetic stimulation (TMS) for major depression: a multisite, naturalistic, observational study of acute treatment outcomes in clinical practice. Depress Anxiety. 2012 Jul;29(7):587–96. Epub 2012 Jun 11.}

^{2)    Sackheim, H. et al. Clinical outcomes in a large registry of patients with major depressive disorder treated with Transcranial Magnetic Stimulation. Journal of Affective Disorders 277 (2020) 65–74}

Nexstim’s business areas

Diagnostics Business (NBS)

• Nexstim’s NBS 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 NBS 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. The non-invasive device has demonstrated a 46% increase in progression-free survival in low grade gliomas versus the current gold standard.
• NBS systems have been sold to around 220 research universities and leading hospitals across the world.

Therapy Business (NBT®)

• Nexstim’s NBT® platform is 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.
• More than 300 million people worldwide are suffering from severe depression (MDD), with 20–40% of patients not responding to current treatment options. As a result, the treatment of MDD is the key focus for Nexstim’s sales and marketing activities for its NBT® system.
• The NBT® system is CE-marked for the treatment of depression and chronic pain.
• We have an active commercial installed base of 70 NBT® systems across four continents.

Publication of financial information

The financial statements bulletin for the financial year that will end on December 31, 2023, will be published on or around February 27, 2024.

Results briefing on August 18, 2023

The company will hold two live webinars for the media, investors, and analysts on Friday, August 18, 2023. 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 18, 2023, at 10:30 am (EEST): Sign up here >>
Webinar in English on August 18, 2023, at 3 pm (EEST): Sign up here >>

Helsinki, August 18, 2023

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 Advisor is Erik Penser Bank.

Distribution:
Nasdaq Helsinki
Key media outlets

See the full report:

Nexstim Plc_Half-Year Report H1 2023_EN

Nexstim Plc_Half-Year Report H1 2023_FI

Nexstim Plc_Half-Year Report H1 2023_SV

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