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NEXSTIM PLC FINANCIAL STATEMENTS RELEASE 2020

Nexstim Oyj
·15-min read

Company announcement, Helsinki, 26 February 2021 at 9:00 am (EET)

NEXSTIM PLC FINANCIAL STATEMENTS RELEASE 2020

Nexstim Plc (NXTMH:HEX, NXTMS:STO) ("Nexstim" or "Company"), today provides its financial statements for the full year 2020 (1 January–31 December 2020) and H2 2020 (1 July-31 December 2020).

Highlights, July – December 2020

  • Continued to minimize the effect of COVID-19 pandemic as well as focusing on generating profitable revenue growth. Considering the difficult business environment, excellent progress with 9 new NBS systems sold, 3 in the US 6 in the EU and rest of the world. Total of 3 new NBT® systems installed to clinics in the US and Europe, across multiple sites, for the treatment of Major Depressive Disorder (MDD)

  • July 1 – December 31, 2020 was the Company’s best reported second half to date when measured by net sales and operating result. The total net sales in the second half was EUR 2.5 million (2019 H2: EUR 2.1 million) and operating result EUR -1.5 million (2019 H2: -3.2 million)

  • NBS net sales grew by 4% in H2 to EUR 1.3 million (2019 H2: EUR 1.2 million) and the NBT net sales grew by 35% in H2 amounting to EUR 1.2 million (2019 H2: EUR 0.9 million)

  • Started two new pilot studies in treating severe depression (Kuopio University Hospital) and therapy resistant, chronic neuropathic pain patients (Helsinki University Hospital) with accelerated iTBS therapy treatment protocols using NBT system.

Post-period Highlights

  • Shareholders were invited to the Extraordinary General Meeting (EGM) of the Company to decide on authorizations for the Board of Directors to decide on share issues and issuances of option rights and special rights to shares. The EGM will be held on Monday, March 1, 2021

Business Overview

Nexstim is a neuromodulation company 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 is currently Nexstim’s key strategic focus.

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 US for the treatment of MDD following FDA clearance in November 201

  • 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 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

  • Two ongoing pilot studies in treating severe depression and therapy resistant, chronic neuropathic pain patients with accelerated iTBS therapy treatment protocols

  • Active commercial installed base of 31 therapy treatment systems across three continents


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

  • The NBS system has been sold to approximately 180 research universities and leading hospitals across the world


CEO Mikko Karvinen’s review

Year 2020 has been a time for Nexstim to adjust and learn a new way of doing business under the global health and financial crisis caused by the COVID-19 pandemic. At first, we faced the crisis by safeguarding our valuable cash resources in the form of executing necessary adjustments needed and quick implementation of a savings program. We continued by ensuring that the vast number of both NBS and NBT® customers could continue to operate their systems in a very difficult business environment. Also new ways of digital sales and marketing were successfully implemented to continue our growth path for the full year 2020. I am proud of our Nexstim teamwork under these extreme conditions, and as a sign of our success we achieved the best year so far measured by several financial metrics, including record revenue level. Fortunately, as we have significantly improved the Company's financial performance, we have also continued to safeguard the well-being of our personnel and doing our best in ensuring that our personnel and family members stay as safe as possible.

This has been the first year of implementing our newly renewed 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 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 and where possibly 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 full year 2020, with net sales growing by 19% to EUR 2.2 million (2019: EUR 1.8 million). The systems were sold especially well in the United States, where, despite the COVID-19 environment, 6 new NBS Systems were successfully sold and delivered during the year 2020. As a result, the Company's total net sales increased by 23 percent during the full year of 2020 to new record level of EUR 4.1 million (2019: EUR 3.3 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 2021, we will continue to invest in the growth of the NBS business, for example, with recruitment of new sales team members to our US organization.

During full year 2020, the NBT business suffered a bit more from the effects of the COVID-19 pandemic. NBT client clinics and hospitals had to somewhat limit therapy treatments locally due to lockdown measures and mobility restrictions, and this slowed down the number of systems and services sold as well as disposable parts delivered, 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 28 percent during full year 2020 and amounted to EUR 2.0 million (2019: EUR 1.5 million). During full year 2020, we delivered and installed a total of 8 new NBT® Systems - 6 to the U.S. and 2 to Europe and the rest of the world for use in the treatment of MDD. As a result, there were at the end of 2020 a total of 31 NBT® Systems installed worldwide (16 in the U.S. and 15 in Europe and the rest of the world) 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 launched two new pilot trials in Finland during H2 2020, one for severe depression at Kuopio University Hospital and another for therapy resistant chronic neuropathic pain at Helsinki University Hospital. We are awaiting first results from the severe depression pilot trial soon. 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 full year 2020 covered 86 percent of the therapy business revenue. During the full year 2020, Nexstim achieved an average of EUR 71 thousand in therapy revenue per NBT® System.

Nexstim's cash and cash equivalents on December 30, 2020 totalled EUR 3.5 million, including the Kreos loan. During full year 2020, we succeeded in reducing the negative cash flow from operating activities to EUR -2.7 million, compared to EUR -6.7 million in 2019, especially through austerity measures and increased gross margin. 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.

In terms of operational business, 2021 will be our first full year of executing our renewed strategy. This is a year of focused investments into accelerating our sales growth while continuing to focus on securing the service business of our existing NBS and NBT customer base and increasing the utilisation rate of our current installed base. Parallel to all growth measures we will actively keep monitoring the COVID-19 pandemic environment. 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 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 treatment data. In October 2020 we reported the clinical outcomes of the first 108 patients who had completed NBT therapy for treatment of MDD at clinical sites in the U.S. About 42% of the patients completing the treatment achieved clinical remission and 74% 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. We also plan to use this patient registry data to publish a series of background papers highlighting the benefits of our NBT® system in the treatment of major depression.

Despite we still live in the prolonged COVID-19 pandemic, we eagerly look forward to the year 2021 as the first full year of executing our new strategy. I know that our Nexstim team will work hard to increase shareholder value over the long-term in the form of stronger competitive advantages, faster 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.


Key performance indicators

EUR in thousands

7-12/2020
6 months

7-12/2019
6 months

1-12/2020
12 months

1-12/2019
12 months

Net sales

2,499.5

2,130.7

4,114.0

3,348.1

Personnel expenses

-2,134.2

-2,634.0

-3,731.5

-4,713.0

Other operating expenses

-1,065.6

-1,679.3

-2,429.3

-3,647.5

Depreciation and amortisation

-177.7

-319.3

-366.9

-524.6

Operating profit (loss)

-1,496.2

-3,155.5

-3,332.7

-6,517.5

Profit/ -Loss for the period

-2,952.5

-3,117.8

-4,121.6

-6,782.6

Earnings per share (EUR)

-0.01

-0.07

-0.02

-0.25

Cash flows from operating activities

-1,164.1

-3,002.5

-2,724.7

-6,681.5

Cash in hand and at banks

3,455.8

4,266.2

3,455.8

4,266.2

Total equity

-1,469.1

-740.1

-1,469.1

-740.1

Equity ratio (%)

-28.25

-8.49

-28.25

-8.49

Number of shares in the end of the period (pcs)

436,622,756



62,789,630

436,622,756

62,786,630

Average number of shares during the period (pcs)

439,622,756

42,146,358

267,693,026

27,611,274

Diluted number of shares in the end of the period (pcs)

478,834,792

64,080,578

478,834,792

64,080,578

Diluted average number of shares during the period (pcs)

479,482,049

54,664,246

290,420,292

36,392,323


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.

Board of Directors’ Proposal on the Dividend

Since it was founded, the Company's operations have been unprofitable, and no dividend has been distributed. In the forthcoming years, the Company will focus on financing the growth and the development of its business and the Company will adhere to a very stringent dividend policy, tied to the Company's results and financial standing. The Company does not expect to be able to distribute dividends in the near future. In the event dividends are distributed, all Shares will be entitled to equal dividends.
At the end of the financial period of 2020, the distributable assets of the group’s parent company were EUR 12,353,405.03. The Board of Directors proposes that Nexstim Plc should not pay any dividend for the financial period of 2020.

Helsinki 26 February 2021

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

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


Publication of financial information during year 2021

The company will hold two live webinars for media, investors and analysts on Friday 26 February 2021. Mikko Karvinen CEO, and Joonas Juokslahti CFO, will present the financial and operational results followed by a Q&A session.

The first live webinar will be in Finnish and it takes place at 1 pm EET. The second live webinar will be in English at 3 pm EET.

Webinar details:

To attend the webinars, please register via the links below. Registered participants will receive more information to their e-mail.

Live Webinar in Finnish on 26 February 2021 at 1 pm (EET): Register here >>>

Live Webinar in English on 26 February 2021 at 3 pm (EET): Register here >>>

Half-Yearly Report January-June 2021 (H1) will be published on Friday, August 13, 2021 Nexstim Annual Report 2020 (Report of the Board of Directors, the Financial Statements and Consolidated Financial Statements and the Auditor's Report) will be published on company web pages on Friday, March 5, 2020. The Annual General Meeting is tentatively scheduled to be held on Tuesday, April 29, 2020.


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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