NEXSTIM PLC’S FINANCIAL STATEMENTS BULLETIN 2022

Company announcement, Helsinki 27 February 2023 at 9 am (EET)

NEXSTIM PLC’S FINANCIAL STATEMENTS BULLETIN 2022

NEXSTIM’S FIRST PROFITABLE FINANCIAL YEAR

January–December 2022

• The company’s net sales increased by 48.9%, to EUR 9.5 million (6.4).
• The company’s comparable net sales increased by 9.2%, to EUR 6.0 million (5.5).
• With an operating profit of EUR 0.8 million (-1.5), this was the company’s first profitable financial year.
• The profit for the period was EUR 1.3 million (-0.8)
• Cash flow from operating activities was EUR 1.0 million (-2.1)
• System sales were EUR 3.1 million (3.7), with a decrease of 17.4%. Recurring net sales were EUR 2.9 million (2.7), with an increase of 9.1%
• The net sales of the Therapy Business (NBT^®) increased by 126.8%, to EUR 6.1 million (2.7).
• The net sales of the Diagnostics Business (NBS) decreased by 7.7%, to EUR 3.4 million (3.7).

July–December 2022

• The company’s net sales were EUR 2.7 million (3.4), with a decrease of 20.5%
• Its comparable net sales increased by 8.0%, to EUR 2.7 million (2.5).
• Cash flow from operating activities was EUR -1.4 million (-0.2)
• System sales were EUR 1.3 million (2.0), with a decrease of 33.4%. Recurring net sales were EUR 1.4 million (1.5), with a decrease of 3.4%
• The operating result was EUR -1.5 million (-0.5). The operating loss increased by 171.8%.
• The profit for the period was EUR -1.9 million (0.1).

Key events after the 2022 financial year

On January 9, 2023, the company announced that the beginning of change negotiations when moving to a global process organization. The change negotiations were completed on February 8, 2023, and the outcome of the negotiations enables the transition to a global process organization, which will serve Nexstim's customers better and more efficiently in the future, and generate long-term shareholder value growth for shareholders. Temporary layoffs were avoided.

On February 8, 2023, the company announced that it would apply to remove the parallel listing of its shares from the Nasdaq First North Growth Market Sweden marketplace. Nasdaq Stockholm AB accepted the application on February 9, 2023. The last day of trading on the Nasdaq FN GM Sweden marketplace is April 14, 2023.

Business overview

Nexstim is a Finnish medical technology company operating in international markets. Its proprietary navigated Transcranial Magnetic Stimulation (nTMS) technology allows for personalised 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 thousand)	7–12/2022 6 months	7–12/2021 6 months	Change, %	1–12/2022 12 months	1–12/2021 12 months	Change, %
Net sales	2,733.7	3,438.9	-20.5 %	9,526.7	6,397.5	48.9 %
Gross margin	2,145.7	2,870.2	-25.2 %	8,285.9	5,262.0	57.5 %
Gross margin, %	78.5 %	83.5 %		87.0 %	82.3%
Adjusted comparable gross margin*	2,145.7	2,038.2	5.3 %	4,751.1	4,430.0	7.2 %
Adjusted comparable gross margin, %	78.5 %	80.5%		79.3 %	80.7%
Personnel expenses	- 2,333.4	- 2,319.6	0.6 %	-4,828.8	-4,347.8	11.1%
Other operating expenses	- 1,601.4	- 1,528.3	4.8 %	-3,389.0	-3,083.3	9.9%
Operating result	- 1,493.1	- 549.4	-171.8 %	840.3	-1,452.2
Profit for the period	- 1,902.6	114.2		1,306.8	-832.1
Earnings per share**	- 0.28	0.02		0.20	-0.14
Diluted earnings per share (EUR)**	- 0.26	0.02		0.18	-0.13
Cash flow from operating activities	- 1,411.9	- 190.3	-641.9%	1,002.2	-2,109.0
Cash in hand and at bank	4,441.3	5,194.7	-14.5%	4,441.3	5,194.7	-14.5%
Total equity	4,068.9	3,202.7	27.0%	4,068.9	3,202.7	27.0%
Equity ratio (%)	45.4%	34.7%		45.4%	34.7%

^{* The gross margin for the period 2022 has been adjusted for the license fee (EUR 3.5 million) for the technology license agreement with Magnus Medical. The gross margin for the previous period 2021 has been adjusted for the margin (EUR 0.8 million) from the development of two prototype systems.}

^{** 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 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.

Mikko Karvinen, CEO of Nexstim:

The year 2022 was record-breaking for Nexstim in terms of net sales, the operating profit and the profit for the period. Our total net sales in 2022 were EUR 9.5 (6.4) million, with an increase of 48.9%. Thanks to the strong growth, we recorded our first profitable financial year. Our operating profit was EUR 0.8 (-1.5) million, and our profit for the period was EUR 1.3 (-0.8) million.

The year was marked by rapid growth following the sale of a licence for technology related to our NBT^® system to Magnus Medical, Inc. Under this agreement, a licence fee of around EUR 3.5 million was recognised during the first half of 2022. During the second half of 2022, our system sales decreased from 2021, mainly because of the delivery of prototype systems (around EUR 0.9 million) during the second half of 2021. Such deliveries of prototype systems were not made during 2022. I would like to thank Nexstim’s customers, employees, partners and investors for helping us make a record-breaking year.

Development of operating activities in the Diagnostics and Therapy Businesses

We have continued to grow our Diagnostics Business (NBS) and Therapy Business (NBT^®) with new system sales in our key markets in the United States and Europe. The growth of our system base has led into steadily growing recurring net sales levels, which creates more stability and predictability for us. We want to develop and evolve.

The Diagnostics Business was a significant source of income for Nexstim during 2022, with EUR 3.4 (3.7) million in net sales. We delivered a total of 14 new NBS systems during 2022. In the Diagnostics Business, more than 210 NBS systems have been sold to 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. As an example of this progress, all of the 14 NBS systems delivered during 2022 had both diagnostics and therapy treatment applications. 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 126.8% during 2022, amounting to EUR 6.1 (2.7) million. The increase was due to the recognition of EUR 3.5 million in licence sales to Magnus Medical, Inc. During the financial year, we sold eight new NBT^® systems – five to North America and three to Europe – for the treatment of severe depression. In the Therapy Business, at the end of 2022, there were a total of 62 Nexstim systems with therapy capabilities installed worldwide (21 in the United States and 41 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.

Nexstim’s cash and cash equivalents totalled EUR 4.4 million on 31/12/2022. The company’s profitability continued to improve significantly during 2022, and its solvency has also improved accordingly. In addition to this favourable development, a licence fee of around EUR 3.5 million from Magnus Medical in February 2022 improved the company’s solvency and cash adequacy. Through profitable growth, we are seeking to minimise any needs for new equity, and the company is not currently actively planning new financing rounds.

Our strategy focuses on growth and profitability

In line with our strategy until 2024, Nexstim continues to enable personalised and effective therapies and diagnostics for challenging brain diseases and disorders. Our strategy relies on strong growth in diagnostics and therapy. Growth and profitability development in our Diagnostics and Therapy Business play a key role in our efforts to minimise future equity needs on our journey towards sustained profitability. To ensure this positive profitability development, we carried out change negotiations in the company during January and February 2023 as part of our adoption of a global process organisation, which will serve our customers better and more efficiently and generate long-term growth in shareholder value. Our selected therapeutic applications (MDD, severe depression and chronic pain) represent indications where our unique technology is already delivering recognisable clinical outcomes and customer profitability, but we are also continuing discussions concerning new strategic partnerships to further scale the use of our technology in health care.

In 2022, our most significant product development project was the development of a new generation of equipment. To be launched in 2023, NBS 6 is Nexstim’s newest generation of equipment. It makes Nexstim’s leading e-field-navigated TMS technology more user-friendly than ever before. This new generation of products includes a workflow-driven user interface and modular product configuration, which enables the features of the equipment to be tailored to the customer’s needs, and additional features can be included in response to future research and healthcare needs.

As an indication of the successful start of a partnership, we announced in early 2022 that we had sold a licence to our technology 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 under the licence agreement. Magnus estimates that the royalty period will start during 2023. The licence agreement places Nexstim in a unique place to gain financial benefits, extend the use of our technology in patient care and allocate our resources to other business areas during the royalty period.

Our strategic priorities for 2022 also included the expansion of Nexstim’s network of exclusive partner clinics, especially in the United States. This would mean installing more NBT^® systems in neuroscience clinics, in line with our revised strategy, mainly in cooperation with our partners. Our new partnerships focus on strategic investments in service organisations, especially on the vast US market, but partnerships are also possible to make targeted investments in European and Asian markets.

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 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 the network of Nexstim’s neuroscience centres 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 the United States and Europe, and we are working hard to be able to grow our network.

Creating future growth paths

In October 2022, we reported the clinical outcomes of the first 403 patients who had completed treatment with Nexstim’s NBT^® system for major depressive disorder (MDD). Nexstim’s 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 403 patients were excellent: around 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 2023.

The pilot study at Kuopio University Hospital continues. It examines the use of accelerated iTBS protocol in the treatment of severe depression with Nexstim’s 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 treatment of patients in the continuation study was completed at the end of 2022, and the study has progressed to the follow-up phase. Nexstim is actively monitoring the situation, and the results will be announced as soon as possible after their completion.

Our system clearly differentiates 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. 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 business growth, we actively monitor the global political situation, which has changed because of the war in Ukraine. We continue to unequivocally condemn Russia’s military action in Ukraine and hope for a quick, peaceful resolution to the conflict. Despite the international tension, we continue to have positive outlook for 2023. 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 being optimistic about the future, we will continue to monitor the situation in Ukraine closely as we grow our business.

<sup>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</sup>


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 tumour 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 more than 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 personalised, 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 62 NBT^® systems across four continents.
  
  

Publication of financial information

The annual report for the financial year that ended on 31 December 2022 will be published on 6 March (estimate). Contrary to what has been previously announced, the company's half-yearly report January-June 2023 (H1) will be published on Friday August 18, 2023. 

Results briefing on 27 February 2023

The company will hold two webinars for the media, analysts and investors on Monday 27 February 2023. Mikko Karvinen, CEO, and Joonas Juokslahti, CFO, will present the company’s financial and operational results, and will answer questions.

The first live webinar will be in Finnish, starting at 10.30 am EET. The second webinar will be held in English at 3 pm (EET).

Webinar details:

To attend the webinars, please register via the links below. Registered participants will receive more information via email.

Webinar in Finnish on Monday February 27, 2023 at 10:30 am (EET): Sign up here >>
Webinar in English on Monday February 27, 2023 at 3:00 pm (EET): Sign up here >>

Helsinki 27/02/2023

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

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

Attachment

• 2.2_Nexstim Plc_Tilinpäätöstiedote FY2022_EN_27022023_FINAL

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