NEXSTIM PLC HALF-YEARLY REPORT 1 JANUARY – 30 JUNE 2020 (UNAUDITED)

Company announcement, Inside Information, Helsinki, 14 August 2020 at 15:00 (EEST)

NEXSTIM PLC HALF-YEARLY REPORT 1 JANUARY – 30 JUNE 2020 (UNAUDITED

Highlights, January – June 2020

• Focused on minimizing the effect of COVID-19 pandemic as well as updating company strategy. Considering the difficult business environment, good progress with four new NBS systems sold, three in the US one in the EU and a total of five new NBT® systems installed to clinics in the US and Europe, across multiple sites, for the treatment of Major Depressive Disorder (MDD)
  
• January 1 – June 30, 2020 was historically the Company’s best first half to date when measured by net sales, operating result and result for the period. The total net sales in the first half was EUR 1.6 million (2019 H1: EUR 1.2 million), operating result EUR -1.8 million (2019 H1: -3.4 million) and result for the period EUR -1.2 million (2019 H1: EUR -3.7 million)
  
• NBS net sales grew by 47% in H1 to EUR 0.9 million (2019 H1: EUR 0.6 million) and the NBT net sales grew by 18% in H1 amounting to EUR 0.7 million (2019 H1: EUR 0.6 million)
  
• The successful rights issue executed in the spring was oversubscribed and raised a total of EUR 2.2 million of new equity
  
• Business Finland decided on a partial debt cancellation of three R&D loans granted for stroke rehabilitation including accrued interests. A total of EUR 0.9 million of loan capital will not be collected.
  
• Martin Jamieson decided to leave his positions as the CEO of the Company and as a member of the Board of Directors. Nexstim’s Board of Directors appointed Mikko Karvinen as the CEO and Joonas Juokslahti as the CFO of the company.

Business Overview

     Nexstim is a Finnish medical technology company operating in international markets developing and marketing pioneering navigated non-invasive brain stimulation systems for both therapeutic (NBT^® system) and diagnostic (NBS system) applications.

     The Company developed its NBT^® device based on its NBS technology platform; commercialisation of the NBT^® system for MDD is currently Nexstim’s key strategic focus. 

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® 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 2020 in the area of accelerated treatment protocols in both severe depression and chronic neuropathic pain
• A total of 28 NBT® systems installed globally for the treatment of depression

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 tumour 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 direct cortical stimulation (DCS).
  
• The NBS system has been sold to approximately 170 research universities and leading hospitals across the world

CEO Mikko Karvinen’s review

From March 2020, much of Nexstim's management and personnel time focused on minimizing the business impact of the COVID-19 pandemic in the form of executing necessary adjustments needed and quick implementation of a savings program. Thanks to these successful actions, we were able to ensure the continuity of both NBS and NBT^® customers and revenue growth for both businesses in a very difficult business environment. I am pleased about this positive development, and that we achieved the best H1 so far measured by several financial metrics. Fortunately, as we have improved the Company's financial performance, we have also safeguarded the well-being of our personnel, and no confirmed COVID-19 infections have been identified in the Nexstim Group companies so far.

I’m glad that during the spring and summer time in the turmoil of containing the COVID-19 health and financial crisis effects, we dedicated a substantial amount of Nexstim Board and management time to clarify our thoughts about our strategy for the years 2020-2024. Nexstim continues to enable personalised and effective therapies and diagnostics for challenging brain diseases and disorders. Our main strategic focus will stay in the therapeutic indications where we will bring the new accelerated therapy protocols to the core 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 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 and where maybe in more severe cases also more hospital inpatient treatments are required in the future. We will progress in our science-based development path so that Nexstim’s navigated TMS device will continue to be at the forefront of delivering new treatments for future indications.

The NBS business was a significant source of income for our Company in the first half of the year, with net sales growing by 51% to EUR 0.9 million (2019 H1: EUR 0.6 million). The system sold well in the United States, where, despite the COVID-19 environment, three new NBS Systems were successfully sold and delivered during the reporting period. As a result, the Company's total net sales increased by 33 percent during the first half of 2020 to EUR 1.6 million (2019 H1: EUR 1.2 million). We also ensured the continuity of the NBS service business despite the difficult customer environment and we did not lose any service contract customers as hospital neurosurgeries continued almost unchanged despite the health crisis. During the second half of 2020, we will continue to invest in the growth of the NBS business, for example, in establishing new U.S. reimbursement codes, while continuing to seek a long-term strategic partner for increasing the commercial exploitation of this diagnostic business.

During H1 2020, the NBT business suffered more from the effects of the COVID-19 pandemic. NBT client clinics and hospitals had to limit therapy treatments locally due to mobility restrictions, and this slowed down the number of systems and services sold as well as disposable parts, especially to U.S. therapy clinics. We also had to drastically reduce our commercial personnel in our subsidiaries due to the cost saving program, especially in NBT sales, as the short-term effects of the measures taken were necessary to secure our cash balance. Despite these negative effects, the net sales of the NBT business increased by 18 percent during H1 2020 and amounted to EUR 0.7 million (2019 H1: EUR 0.6 million). During the first half of 2020, we delivered and installed a total of 5 new NBT^® Systems - 4 in the U.S. and 1 in Europe (Italy) - for use in the treatment of MDD. As a result, there were at the end of H1 2020 a total of 28 NBT^® Systems installed worldwide for the treatment of depression and chronic neuropathic pain.

We are confident that by further emphasising the unique navigation 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 are launching new pilot trials during H2 2020 for both severe depression and chronic neuropathic pain. 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.

In addition to the commercial advancement of NBT^® Systems, we also saw continued development in sales, driven by high-margin aftersales products, including revenue from services, support functions, spare parts, and disposables. As the share of NBT^® business from the total revenue increases, the share of recurring revenue is likely to increase. Recurring revenue (total sales of the therapy business excluding NBT^® System sales) during H1 2020 covered 100 percent of the therapy business revenue. During the rolling 12 months, Nexstim achieved an average of EUR 70 thousand in therapy revenue per NBT^® System.

Nexstim's cash and cash equivalents on June 30, 2020 totalled EUR 4.8 million, including the Kreos loan. During H1 2020, we succeeded in reducing the negative cash flow from operating activities to EUR -1.6 million, compared to EUR -3.7 million in H1 2019, especially through austerity measures. The Company loans decreased in April 2020 as innovation funding agency Business Finland decided that a total of EUR 0.9 million from the capital and interest of three loans granted for Nexstim’s research and development projects has been settled by debt cancellation. To further finance our business and growth strategy, we raised a total of EUR 2.2 million in new capital in the spring 2020 rights issue. I would like to thank all the shareholders who subscribed for the Offer Shares. We are very pleased with the outcome of the share issue, with the overall investment environment in spring being particularly challenging due to the coronavirus COVID-19 pandemic. The support we received reflects investors’ faith and strong commitment to Nexstim’s future.

In terms of operational business, in H2 2020, we will continue to focus on securing the service business of our existing NBS and NBT customer base and increasing the utilisation rate of our existing installed base, taking into account the COVID-19 pandemic environment. We are also working 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 manor in the EU.

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 equipment to numerous depressed patients. This information is used to support our marketing and we believe it will increase the rollout of NBT^® Systems in key markets in the U.S. and the EU. There are also plans to continue to leverage our strong network of leading KOL’s and patient registry data. In April 2020 we reported the clinical outcomes of the first 55 patients who had completed NBT therapy for treatment of MDD at clinical sites in the U.S. About 40% of the patients completing the treatment achieved clinical remission and 71% 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 100 completed treatment sessions of depression patients. We then plan to use this patient registry data to publish a series of background papers highlighting the benefits of our NBT^® equipment in the treatment of major depression.

I am confident that the selected measures in accordance with the revised 2020-2024 strategy will increase shareholder value over the long-term in the form of stronger competitive advantages, faster growth, and better financial results. While being optimistic about the future, we will closely monitor the development of the COVID-19 pandemic as we continue to execute the selected strategy during the second half of 2020.

Key performance indicators

EUR in thousands	1-6/2020 6 months	1-6/2019 6 months	1-12/2019 12 months
Net sales	1,614.5	1,217.4	3,348.1
Personnel expenses	-1,597.3	-2,079.1	-4,713.0
Other operating expenses	-1,363.7	-1,968.2	-3,647.5
Depreciation and amortization	-189.2	-205.3	-524.6
Operating profit / -loss	-1,836.5	-3,362.0	-6,517.5
Profit/ -Loss for the period	-1,169.1	-3,664.9	-6,782.6
Earnings per share (EUR)	-0.01	-0.29	-0.25
Cash flows from operating activities	-1,560.6	-3,679.0	-6,681.5
Cash in hand and at banks	4,754.2	6,378.6	4,266.2
Total equity	288.2	-495.2	-740.1
Equity ratio (%)	4.65	-3.94	-8.49
Number of shares in the end of the period (pcs)	439,622,756	35,400,873	62,786,630
Average number of shares during the period (pcs)	93,873,959	12,835,277	27,611,274
Diluted number of shares in the end of the period (pcs)	479,636,776	52,450,118	64,080,578
Diluted average number of shares during the period (pcs)	99,280,934	17,817,551	36,392,323

Future Outlook

Based on its business forecast, the Company expects that the full year 2020 operating loss will decrease in comparison to year 2019

Helsinki 14 August 2020

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

Publication of financial information

A live webinar for media, investors and analysts will take place at 16:00 Finnish time on Friday 14 August 2020. Mikko Karvinen CEO, and Joonas Juokslahti CFO, will present the financial and operational results followed by a Q&A session. The webinar will be in English.

Webinar details:
To attend the live webinar, please register via the link below. Registered participants will receive more information to their e-mail.

Live Webinar in English on 14 August 2020 at 16:00 (EEST): Register here >>>

Financial statements release for the year ending 31 December 2020 will be published on or about 26 February 2021.

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

Attachment

• Nexstim Plc_Half-Yearly Report H1 2020_FINAL_EN