NEXSTIM PLC HALF-YEARLY REPORT 1 JANUARY – 30 JUNE 2021 (UNAUDITED)

NEXSTIM PLC HALF-YEARLY REPORT 1 JANUARY – 30 JUNE 2021 (UNAUDITED)




NEXSTIM PLC HALF-YEARLY REPORT 1 JANUARY – 30 JUNE 2021 (UNAUDITED)

Company announcement, Inside Information, Helsinki, 13 August 2021 at 09:00 am (EEST)

NEXSTIM PLC HALF-YEARLY REPORT 1 JANUARY – 30 JUNE 2021 (UNAUDITED)

NEXSTIM’S HISTORICALLY BEST FIRST HALF MEASURED BY NET SALES, OPERATING RESULT AND RESULT FOR THE PERIOD

Figures in parentheses refer to the corresponding period of the previous year unless otherwise stated.

Summary of January – June 2021

• The company’s net sales increased by 83.3% to EUR 3.0 million (1.6)
• Exchange rate-adjusted growth in net sales was 89.5% and 6.2 percentage points stronger than the reported net sales growth
• System sales were EUR 1.6 million (0.6), an increase of 186.6%. Recurring revenue accounted for EUR 1.4 million (1.1), an increase of 29.3%.
• Operating result was EUR -0.9 million (-1.8) with a loss decrease of 50.8%
• The result for the review period was EUR -0.9 million (-1.2)
• Net sales of the Diagnostics business (NBS) increased by 96.1% in the first half of the year to EUR 1.8 million (0.9)
• Net sales of the Therapy Business (NBT®) increased by 67.3% to EUR 1.2 million (0.7) in the first half of the year
• During the spring, a successful rights issue was arranged, which was oversubscribed and a total of EUR 6.6 million in new capital was raised. Funds raised from the rights issue significantly increased the company’s equity ratio to 38.9% (4.7%)
• The strategy updated by Nexstim during the review period for 2021-2024 focuses on profitable growth in the Diagnostics and Therapy business

Business Overview

Nexstim is a Finnish medical technology company operating in the international market, whose neuronavigation TMS technology platform (transcranial magnetic stimulation, TMS) enables individual treatment and diagnosis of patients with severe brain diseases and disorders. Nexstim offers solutions for noninvasive brain stimulation in diagnostic (NBS system) and therapy applications (NBT® system).

Key performance indicators
                                                

EUR in thousands 1-6/2021

6 months

1-6/2020

6 months

Change

%

1-12/2020

12 months

Net sales 2,958.6 1,614.5 83.3 4,114.0
Personnel expenses -2,028.2 -1,597.3 27.0 -3,731.5
Other operating expenses -1,555.0 -1,363.7 14.0 -2,429.3
Depreciation and amortization -172.7 -189.2 -8.7 -366.9
Operating result -902.8 -1,836.5 -50.8 -3,332.7
Result for the review period -946.3 -1,169.1 -19.1 -4,121.6
Earnings per share (EUR) -0.17 -1.25   -1.54
Cash flows from operating activities -1.918.7 -1,560.6 22.9 -2,724.7
Cash in hand and at banks 6,690.8 4,754.2 40.7 3,455.8
Total equity 3,796.7 288.2 1,217.4 -1,469.1
Equity ratio (%) 38.94 4.65 34.3 -28.25
Number of shares in the end of the period (pcs) 6,686,673 4,396,228   4,396,228
Average number of shares during the period (pcs) 5,440,004 938,740   2,676,931
Diluted number of shares in the end of the period (pcs) 7,273,773 4,796,368   4,788,348
Diluted average number of shares during the period (pcs) 5,922,617 992,810   2,904,203

* The number of shares in the table has been adjusted by the reduction of shares on May 17, 2021, where the number of shares was divided by 100.

Future Outlook

Based on its business forecast, the Company expects its revenue to continue to grow during year 2021 and a loss for the period is expected for the financial year.

CEO Mikko Karvinen comments on developments during the review period:

The first half of 2021 was a time of record growth for Nexstim. Our business has adapted very well to the changes in the operating environment caused by the COVID-19 pandemic, and during H1 2021 we achieved a total turnover of EUR 3.0 (1.6) million and a record growth rate of 83.3%. The growth rate was particularly fast, partly due to system deliveries made during the review period of orders received during 2020. System sales accounted for EUR 1.6 (0.6) million of total net sales, an increase of 186.6%. A warm thank you to Nexstim’s customers, personnel, partners and investors for enabling this record-breaking strong development.

The year 2021 began with investments focused on accelerating sales growth, while continuing to focus on securing the service business for our existing NBS and NBT® system customer base and increasing the utilization rate of installed systems. I am extremely pleased that the growth rate has been made possible by strong new system sales in the Diagnostics business (NBS) in pre-surgical brain mapping and well-developed recurring revenue growth in the Therapy business (NBT®). Alongside all growth efforts, we will continue to actively monitor the COVID-19 pandemic environment and its potential impact on our business during the remainder of the year.

Strong growth in both Diagnostics and Therapy businesses

The Diagnostics business (NBS) was a significant source of revenue for Nexstim during the review period, and its net sales increased by 96% to EUR 1.8 (0.9) million. Despite the COVID-19 pandemic, we sold and delivered 7 new NBS systems during the review period. We also ensured the continuity of the NBS service business despite the difficult customer environment, and we did not lose service contract customers as hospital neurosurgery procedures remained almost unchanged. We continued to invest in the growth of the Diagnostics business by, among other things, recruiting new sales team members to our U.S. organization during early 2021.

During the first half of 2021, the Therapy business (NBT®) suffered slightly more from the effects of the COVID-19 pandemic, mainly as local mobility restrictions reduced patients’ willingness and access to treatment. Despite these negative effects, the Therapy business’s net sales increased by 67% during the first half of 2021 and amounted to EUR 1.2 (0.7) million. We sold a total of 5 new NBT® systems during the review period; 4 to North America and 1 to Europe for use in the treatment of major depressive disorder (MDD). At the end of the review period, our global installed base had a total of 33 NBT® systems (18 in North America and 15 in Europe and the rest of the world) for use in the treatment of depression and chronic neuropathic pain.

On 30 June 2021, Nexstim’s cash in hands and at banks totalled EUR 6.7 million. During the first half of 2021, cash flows from operating activities was EUR -1.9 million, compared to EUR -1.6 million in the corresponding period of the previous year. The change was mainly due to large one-off austerity measures related to the COVID-19 pandemic in the first half of 2020. To finance the progress of our business and growth strategy, we raised a total of EUR 6.6 million in new capital in the spring 2021 rights issue. This oversubscribed issue reflects the confidence and strong commitment of our investors to the future of Nexstim.

Recurring revenue supports growth

We recognized positive development in sales, driven by high-margin aftersales products, including services, support functions, spare parts, and disposable trackers. Recurring revenue accounted for 46% of total net sales during the review period. As the Therapy business (NBT®) grows, the share of recurring revenue in total net sales is likely to increase. Recurring revenue (total sales of the Therapy business excluding NBT® system sales) during H1 2021 covered 78 percent of the Therapy business revenue. During the rolling 12 months, Nexstim achieved an average of EUR 77 thousand in Therapy revenue per NBT® system.

Focus of the strategy is on growth and profitability

During the spring and summer, we continued to update our strategy for 2021-2024. Nexstim continues to enable personalized and effective therapies and diagnostics for challenging brain diseases and disorders. Our updated strategy will rely on strong growth in both diagnostics and therapy in the coming years. The growth and profitability of both our Diagnostics and Therapy businesses play a key role in our efforts to minimize our future capital needs on our journey to profitability. New accelerated treatment protocols remain at the core of the long-term development path of our business. We see that this is possibly a game changer in the field of TMS treatments as we will seek for validation of higher efficacy rates and to show the benefits of a faster treatment process through our pilot studies. The selected therapeutic applications (MDD, severe depression and chronic pain) represent indications where our unique technology already demonstrates recognisable clinical outcome and customer profitability.

Execution of the strategy is progressing

In terms of operational business, 2021 will be our first full year of executing our renewed strategy. We will continue with focused investment into sales growth in both the Diagnostics and Therapy businesses. We also focus strongly on developing the service business and increasing the utilization rate of the installed base. In the Diagnostics business, commercial development takes place both through our own direct sales (USA and Germany) and globally through distributor partnerships. We also continue our work to increase the number of NBT® systems installed for use in the treatment of MDD, and we are doing this in line with our renewed strategy, primarily together with valued partners. The focus is particularly on the large U.S. market, but also in a targeted manner in the EU and in Asia markets.

At the same time, our goal is to continue to raise awareness of our NBT® system in the market. We aim to do this by increasing the number of patients with MDD treated with NBT® systems. As the number of patients increases and research data on pilot trials of new accelerated treatment protocols accumulate, we will be able to gather more clinical data to demonstrate the usefulness of our unique systems to numerous depressed patients. This information is used to support our marketing and we believe it will increase the rollout of NBT® systems. We also aim to continue to leverage our strong network of leading KOL’s and patient registry treatment data. In June 2021 we reported the clinical outcomes of the first 187 patients who had completed NBT therapy for treatment of MDD at clinical sites in the U.S. About 50% of the patients completing the treatment achieved clinical remission and 77% obtained a clinical response at the end of treatment. We will continue to collect this valuable patient registry data aiming to collect a patient data registry of over 200 completed treatment sessions of depression patients during year 2021.

Building the growth paths of the future

We are confident that by further emphasising the unique capabilities of the NBT® system, we can increase our market share. This is accomplished by clearly differentiating our system from the TMS systems currently on the market that do not have navigation capabilities. In the future, the need for a navigation function is likely to be further emphasised in technology that could treat patients in hospital for severe, treatment-resistant depression (TRD) and possible suicidal ideation. This could potentially open a new TMS treatment market for Nexstim that is separate from the current treatment of patients with MDD.

To better understand the ability of Nexstim’s NBT® system to treat patients with accelerated treatment protocols, we launched two new pilot trials in Finland during autumn 2020. In March 2021, we published encouraging initial results from a pilot study of 10 patients with severe depression at Kuopio University Hospital. No study discontinuations or serious adverse events issues had occurred. All ten patients showed improvement of symptoms on the clinician administered Hamilton Depression Rating Scale (HAMD-17) outcome measure at the end of treatment (mean decrease in score from baseline 37%, p<0.001). We plan to continue the pilot study of the treatment of severe depression at Kuopio University Hospital during the second half of 2021. In addition, we await initial results from a pilot study at Helsinki University Hospital on the treatment of therapy resistant chronic neuropathic pain. We estimate that the treatment of patients will continue during Q3 2021, and the results will be made public once available. As a company, Nexstim wants to be a pioneer in researching and commercialising this new treatment method that could potentially shake the whole TMS industry.

Building shareholder value

Unfortunately, we are still living in the prolonged COVID-19 pandemic, but we still feel positive about the whole of 2021, the first full year of implementing our new strategy. 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 will support long-term growth in shareholder value in the form of stronger competitive advantages, rapid growth, and better financial results. While again being optimistic about the future, we will closely continue to monitor the development of the COVID-19 pandemic as we operate our business.

Nexstim Business Areas

Diagnostics Business (NBS)

  • Nexstim’s Navigated Brain Stimulation (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 as a result of pre-surgical mapping. The non-invasive device has demonstrated a 46% increase in progression free survival in patients with low grade gliomas versus only using the current gold standard
  • The NBS system has been sold to approximately 190 research universities and leading hospitals across the world

Therapy Business (NBT®)

  • Nexstim’s Navigated Brain Therapy (NBT®) system is based on its unique navigated Transcranial Magnetic Stimulation (nTMS) technology which allows for personalised, accurate, reproducible and non-invasive brain stimulation
  • In May 2018, Nexstim launched its NBT® (Navigated Brain Therapy) system in the US for the treatment of MDD following FDA clearance in November 2017
  • MDD affects more than 300 million people worldwide with 20-40% of patients not responding to current treatment options. As a result, MDD is the 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
  • The Company has planned to start new pilot clinical trial during the second half of 2021 in the area of accelerated treatment protocols in both severe depression and chronic neuropathic pain
  • Active installment base of 33 NBT® systems spanning three continents

Financial information

The financial statements bulletin for the financial year ending 31 December 2021 will be published on or about 28 February 2021.

Results announcement on 13 August 2021

The company will hold two webinars for investors, analysts and the media on Friday, August 13, 2021. CEO Mikko Karvinen and CFO Joonas Juokslahti will present the financial and operational results, after which participants can ask questions.

The first webinar is in Finnish at 11:00 AM (EEST). The second webinar will be held in English at 03:00 PM (EEST).

Instructions for participating in the webinar:

Please register for the webinar via the link below. Additional information will be sent to those who have registered by e-mail.

Live webinar in Finnish on August 13, 2021 at 11:00 AM (EEST): Register here >>>
Live webinar in English on August 13, 2021 at 03:00 PM (EEST): Register here >>>

Helsinki 13 August 2021

Nexstim Plc

Board of Directors

For further information please visit www.nexstim.com or contact:

Mikko Karvinen, CEO
+358 50 326 4101
mikko.karvinen@nexstim.com

Erik Penser Bank AB (Certified Adviser)
+46 8 463 83 00
certifiedadviser@penser.se

About Nexstim Plc

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

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

SmartFocus® technology is used in Nexstim’s proprietary Navigated Brain Therapy (NBT®) system, which is FDA cleared for marketing and commercial distribution for the treatment of major depressive disorder (MDD) in the United States. In Europe, the NBT® system is CE marked for the treatment of major depression and chronic neuropathic pain.

In addition, Nexstim is commercializing its SmartFocus® based Navigated Brain Stimulation (NBS) system for diagnostic applications. The NBS system 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 shares are listed on the Nasdaq First North Growth Market Finland and Nasdaq First North Growth Market Sweden.

For more information please visit www.nexstim.com.

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