NEXSTIM PLC HALF-YEAR REPORT JANUARY 1 – JUNE 30, 2022 (UNAUDITED)

NEXSTIM PLC HALF-YEAR REPORT JANUARY 1 – JUNE 30, 2022 (UNAUDITED)




NEXSTIM PLC HALF-YEAR REPORT JANUARY 1 – JUNE 30, 2022 (UNAUDITED)

Company announcement, Helsinki, August 12, 2022 at 9 am (EEST)

NEXSTIM PLC HALF-YEAR REPORT JANUARY 1 – JUNE 30, 2022 (UNAUDITED)

THE BEST HALF-YEAR IN NEXSTIM’S HISTORY IN TERMS OF NET SALES AND OPERATING RESULT

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

January–June 2022 in brief

  • The company’s net sales increased by 129.6%, to EUR 6.8 million (3.0).
  • Net sales growth adjusted for currency exchange rates was 110.3%.
  • Equipment sales were EUR 1.8 million (1.6), with an increase of 11.1%. Continuous net sales accounted for EUR 1.5 million (1.4), with an increase of 9.0%. The licensing business accounted for EUR 3.5 million (0.0).
  • The net sales of the diagnostics business (NBS) increased by 19.3% during the first half of the year, to EUR 2.1 million (1.8).
  • The net sales of the therapy business (NBT®) increased by 290.4% during the first half of the year, to EUR 4.7 million (1.2) including the license fee for the technology license agreement received during the review period.
  • The operating result was EUR 2.3 million (-0.9).
  • The result for the period was EUR 3.2 million (-0.9).

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

EUR 1,000   1–6/2022 6 months

1–6/2021 6 months

Change, %

1–12/2021 12 months

   
Net sales   6,793.0 2,958.6 129.6% 6,397.5
Gross margin   6,140.2 2,391.8 156.7% 5,262.0
Gross margin, %   90.4% 80.8% 82.3%
Adjusted comparable gross margin*   2,605.4 2,391.8 8.9% 5,262.0
Adjusted comparable gross margin-%*   80.0% 80.8% 82.3%
Personnel expenses   -2,495.4 -2,028.2 23.0% -4,347.8
Other operating expenses   -1,787.6 -1,555.0 15.0% -3,083.3
Operating result   2,333.4 -902.8 -1,452.2
Result for the period   3,209.4 -946.3 -832.1
           
Earnings per share   0.48 -0.17 -0.14
Diluted earnings per share (EUR)   0.44 -0.16 -0.13
Cash flow from operating activities   2,414.0 -1,918.7 -2,109.0
Cash in hand and at bank   6,580.3 6,690.8 -1.7% 5,194.7
Total equity   5,593.1 3,796.7 47.3% 3,202.7
Equity ratio (%)   54.1% 38.9% 34.7%

* Net sales for the review period have been adjusted for the license fee (EUR 3.5 million) for the technology license agreement with Magnus Medical.

Future outlook

Based on business forecasts, the company expects its net sales to continue to grow during 2022, and the operating result for the financial year will be positive.

Mikko Karvinen, CEO of Nexstim:

Nexstim continued its record high growth during the first half of 2022, achieving its all-time best performance in net sales, in the operating result, and in the result for the period. During the first half of 2022, our total net sales were EUR 6.8 million (3.0), and our growth rate was higher than ever before at 129.6%. The strong growth enabled us to achieve our first profitable operating result for the half-year period, with the operating profit being EUR 2.3 million (-0.9).
Our rapid growth rate was mainly due to the sale of a technology license related to the NBT® system to Magnus Medical and the agreement license fee of around EUR 3.5 million, which was recognized as revenue during the first half of 2022. In addition, in our diagnostics and therapy businesses, the deliveries of system orders received in 2021 totaled around EUR 1.0 million during the review period. I would like to thank Nexstim’s customers, employees, partners, and investors for helping us achieve our record strong performance. In line with our main strategic goal, we will continue our profitable net sales growth throughout 2022, with the aim of achieving our first profitable financial year and minimizing future equity needs.

Strong growth continued in the Diagnostics Business and the Therapy Business

The growth of our Diagnostics Business (NBS) and Therapy Business (NBT®) has continued through new system sales in our key markets in the United States and Europe. Thanks to this growth in our system base, our continuous revenue stream is growing steadily, which increases the stability and predictability of our operations. We want to develop and evolve.

The Diagnostics Business was a significant source of income for Nexstim during the review period, and its net sales increased by 19.3%, to EUR 2.1 million (1.8). We delivered seven new NBS systems during the review period. With these deliveries, by the end of the first half of 2022, we were able to fulfill all system orders that had remained undelivered on the date of the financial statements for 2021. In the Diagnostics Business, the NBS system has been sold to more than 210 research universities and leading hospitals across the world to date. We are happy to see that our customers are increasingly seeking to use the Nexstim system in both diagnostic and therapeutic applications. The new NBS System 5 configuration (NBS5+) is now also available in the United States, enabling the use of diagnostic and therapeutic applications in the same system. All the FDA 510(k) indications are now available in the same system in the US market, which is important. As an example of this progress, we are pleased to announce that all of the seven NBS systems delivered during the first half of 2022 had both diagnostics and therapy treatment applications. It is also our pleasure to announce that during the first half of the year, we delivered the second NBS5+ system to the first hospital chain in the United States. We see this combined system as a clear competitive advantage and look forward to expanding with this platform approach to other key markets globally.

The net sales of the Therapy Business increased by 290.4% during the first half of 2022, amounting to EUR 4.7 million (1.2). The growth was due to the sale of a license to Magnus Medical, Inc., totaling around EUR 3.5 million, which was recognized as revenue. During the review period, we sold three new NBT® systems: two to North America and one to Europe for the treatment of severe depression. In the Therapy Business, by the end of the first half of 2022, a total of 57 Nexstim systems with therapy capabilities had been installed worldwide (22 in the United States and 35 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 an additional NBT software option installed.

In addition to the deliveries mentioned above, we had an order backlog of around EUR 0.3 million EUR at the end of the first half of 2022.

Nexstim’s cash and cash equivalents totaled EUR 6.6 million on June 30, 2022. The company’s profitability continued to improve significantly during the first half of 2022, and our solvency has also improved accordingly. In addition to this favorable development, a license fee of around EUR 3.5 million from Magnus Medical in February 2022 has further improved the company’s solvency and cash adequacy. Through profitable growth, we are seeking to minimize any needs for new equity, and the company is not currently actively planning new financing rounds.

Our strategy focuses on creating growth and profitability

In February, we announced the sale of our technology license related to the NBT® system to Magnus Medical, Inc. The total value of the agreement is around EUR 17 million. We will continue our operations as normal and focus on implementing our strategy until the beginning of the five-year royalty period. The license agreement provides Nexstim with unique opportunities to gain financial benefits, expand the use of our technology in the treatment of patients, and allocate our resources to other business areas during the royalty period.

Our strategic main goals for 2022 also include expanding Nexstim’s network of exclusive partner clinics, especially in the United States. This involves the installation of 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 in the vast U.S. market, but partnerships are also possible for targeted investments in the European and Asian markets.

The agreement on strategic cooperation and a minority interest in PNC Management Services LLC signed at the end of 2021 is our first concrete 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. We are very pleased with our cooperation with Dr. Kuluva and his clinic, and we believe this cooperation will create excellent opportunities for us to continue our growth in the future. In May 2022, the parties signed an agreement that entitles Dr. Kuluva to a 10% minority interest in the private equity company established by Nexstim in the United States. The purpose of the private equity company is to further expand Nexstim’s network of partner clinics in the United States. We are looking forward to continuing our cooperation with Dr. Kuluva’s expert team. Through our cooperation, Nexstim’s TMS technology can be used to treat a growing number of patients in the United States.

Creating future growth paths

In February, we reported the clinical outcomes of the first 311 patients who had completed treatment with the Nexstim NBT® system for major depressive disorder (MDD). The 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. The treatment outcomes of these 311 patients were excellent: around 50% were in remission at the end of the treatment and 77% had obtained a clinical response. These outcomes are markedly 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 patient registry data during the second half of 2022.

The pilot study at Kuopio University Hospital continues. It examines the use of an accelerated iTBS protocol in the treatment of severe depression with the Nexstim NBT® system. Accelerated iTBS means transcranial magnetic stimulation (TMS) therapy where stimulation is given several times per day for one week, whereas in conventional TMS therapy, stimulation is given once a day during several weeks.
In the continuation of the previously reported pilot study, the effectiveness of the accelerated iTBS protocol will be tested in an additional 20 patients. The patient treatments in the continued pilot study were estimated to be completed in mid-2022, but the nurses’ strike in the spring temporarily discontinued the study, and our current estimate is that the treatments will continue until the end of 2022. Nexstim is actively monitoring the continuation of treatment, and the results will be announced as soon as possible after their completion.

Our system is clearly differentiated 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 emphasized 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. Getting more data on the patient treatment outcomes with the intensified accelerated treatment protocols is important for the strategic development path of our business.

Creating shareholder value in exceptional circumstances

While investing in growth, we are actively monitoring the global political situation, which has changed due to the war in Ukraine. We unequivocally condemn Russia’s military action in Ukraine and hope for a quick, peaceful resolution of the conflict. Despite the international tension, our outlook for 2022 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 both the situation in Ukraine and the coronavirus pandemic as we promote 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 210 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.
  • During the second half of 2022, we are planning to continue medical pilot trials.
  • We have an active commercial installed base of 57 NBT® systems across three continents.

Publication of financial information

The financial statements bulletin for the financial year that will end on December 31, 2022, will be published on or around February 27, 2023.

Results briefing on August 12, 2022

The company will hold two live webinars for the media, investors, and analysts on Friday, August 12, 2022. 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.

Finnish-language webinar on August 12, 2022 at 10.30 am (EEST): Sign up here >>>
English-language webinar on August 12, 2022 at 3 pm (EEST) Sign up here >>>

The half-year review and other financial reports are available on the website: https://www.nexstim.com/investors/financial-reports-and-presentations

Helsinki, August 12, 2022

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

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 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 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.

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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