Nexstim Plc (NXTMH:HEX, NXTMS:STO) ("Nexstim" or "Company"), a neuromodulation company developing and marketing pioneering navigated non-invasive brain stimulation systems for both therapeutic and diagnostic applications, today provides its financial statements for the full year 2017 (1 January–31 December 2017) and H2 2017 (1 July-31 December 2017). 

Highlights, July – December 2017

• The US Food and Drug Administration (FDA) cleared Nexstim's Navigated Brain Therapy (NBT^®) system for marketing and commercial distribution in the US for the treatment of Major Depressive Disorder (MDD) in November 2017 – launch expected Q2 2018
• Appointment of Steve Beller as Vice President and General Manager, North America, to lead commercialisation efforts for NBT^® in the US
• New equity financing of EUR 1.75 million via a directed issue of new shares to City Financial Investment Company Limited in October 2017
• Loan agreement with Kreos Capital V (UK) Limited agreed in December 2017 that provides Nexstim with access to a senior secured term loan facility of up to EUR 4 million
• Revenues amounted to EUR 1.6 million (2016: EUR 1.6 million)

Post-period Highlights

• In January 2018, Nexstim completed patient recruitment in the Phase III E-FIT trial (Electric Field Navigated 1Hz rTMS for Post-Stroke Motor Recovery Trial). The trial, which recruited a total of 60 patients, will provide additional data to support a de novo 510k filing with FDA to gain approval to market the NBT system for stroke rehabilitation in the US

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 the key strategic focus for Nexstim.

NBT®

• Nexstim’s NBT^® platform is based on unique navigated Transcranial Magnetic Stimulation (nTMS) technology which allows for accurate, reproducible and non-invasive brain stimulation in therapy with the aim of targeting indications with significant unmet clinical need

• Initial applications of focus are for the treatment of stroke, depression and chronic pain

• In November 2017, Nexstim received FDA clearance for commercialization of its NBT^® system in the US for the treatment of MDD and will launch the device in the US in Q2 2018. MDD affects more than 300 million people worldwide and 20-40% of patients gain insufficient benefit from current treatment options

• In January 2018, Nexstim announced completed enrolment in a supplementary 60 patient Phase III E-FIT trial that is ongoing in the US for use of the NBT^® system in rehabilitation of upper limb mobility following stroke. Trial completion is expected in mid-2018, allowing Nexstim to file for FDA clearance to market the device for this indication in the US. Estimated EU and US annual market size for upper limb mobility rehabilitation post-stroke is about USD 1.8 billion

• The NBT^® system is CE marked for stroke rehabilitation and the treatment of depression and chronic pain

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 and demonstrates the value of Nexstim’s unique navigation system

• 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 150 research universities and leading hospitals across the world

CEO Martin Jamieson’s review

I am delighted to report the important progress made by Nexstim in 2017, which has continued into 2018.

In January 2018, Nexstim announced completion of patient enrolment in its E-FIT trial (Electric Field Navigated 1Hz rTMS for Post-Stroke Motor Recovery Trial) for stroke rehabilitation, an important milestone in clinical development for this indication. The trial recruited its planned total of 60 patients. The E-FIT trial uses a new sham comparator and has been designed to provide data to supplement the completed Phase III NICHE trial, in line with FDA recommendation. The NICHE study demonstrated positive results in the active group, with 2/3 patients showing a clinically meaningful response, but also demonstrated a positive treatment effect in the control group, treated using a sham coil. The new sham coil in the E-FIT trial was deemed appropriate for use by the FDA.

Nexstim expects the E-FIT trial to be completed in mid-2018, generating data which we anticipate will support our de novo 510(k) filing. De novo 510(k) clearance would allow Nexstim to market and sell the NBT system for stroke rehabilitation in the US, the largest and most lucrative market for this device.

The company is preparing to advance commercialisation efforts for Nexstim’s NBT^®system in the US, starting with MDD, following FDA 510(k) clearance for this indication in November 2017. MDD is a recurrent and frequently chronic disorder with significant unmet clinical need and affects 2-5% of the population in developed countries. Stimulation of the brain through repetitive Transcranial Magnetic Stimulation (TMS) has been demonstrated to be effective in the treatment of MDD in patients who have failed pharmacologic treatment.

We are confident that by highlighting the NBT^® system's unique navigational capabilities, we will be able to differentiate it from the non-navigational TMS devices currently on the market. We look forward to launching the NBT^® system for this important indication during Q2 2018.

Turning to our NBS system, net sales grew by 6.6% in 2017 to EUR 2.6 million, compared to EUR 2.5 million in 2016.

During 2017, we worked to shift to a distributor model for US sales to drive use of the system in pre-surgical mapping. This required large changes to our US business organisation and NBS system sales growth in the US has not yet been achieved. We continue to train distributor representatives and provide them with the latest knowledge and skills to sell the NBS system.

We are pleased that in this context, operating cash burn only amounted to EUR -5.4 million in 2017 compared to EUR -7.2 million in 2016, mainly as a result of the organizational changes implemented.

During 2018, we will focus on building sales of the NBT^® system in larger EU markets and launching the device for depression in the US, as well as working towards FDA de novo 510(k) filing for stroke. This will involve investments in commercial sales, marketing, and clinical resources.

I am very pleased to welcome Steve Beller, Vice President and General Manager, North America, who will lead commercialisation efforts for Nexstim’s NBT^® system in the US across indications. He has extensive experience in the US neuromodulation market, most recently as Area Vice-President at Abbott Neuromodulation.

Going forward, we believe that there is significant global potential for our NBT^®systems, not only across the US and Europe, but also in the untapped and extensive Asian market, where negotiations for an assembly and distribution arrangement continue.

To support our growth plans, we announced new equity financing of the gross amount EUR 1.75 million via a directed issue of new shares to a London-based fund managed by City Financial Investment Company Limited in October 2017. This financing was followed by a new loan agreement with Kreos Capital in December 2017 for a senior secured term loan facility of up to EUR 4 million.

As of 31 December 2017, Nexstim had a cash position of EUR 8.5 million, which compares favourably to the cash position of EUR 8.2 million at the end of 2016. The current cash balance, cash generated from sales, and, if required, draw down of the loan facility with Kreos, will finance the Company until the end of Q1 2019.

The Company is actively evaluating the possibility for new fund raising during H2 2018 to prepare for the potential commercial launch of its NBT^® system for use in stroke rehabilitation in the US in H1 2019.

Key performance indicators

Future Outlook

Based on its business forecast, the Company expects financial year 2018 to be a year of multiple investments and a larger loss than in financial year 2017 is expected for the period.

Board of Directors’ Proposal on the Dividend

During its existence, 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 entitle to equal dividends.

At the end of the financial period of 2017, the distributable assets of the group’s parent company were EUR 18,526,651.59. The Board of Directors proposes that Nexstim Plc should not pay any dividend for the financial period of 2017.

Helsinki 28 February 2018

Nexstim Plc

Board of Directors

Publication of financial information during year 2018

A conference call for analysts, investors and media will take place at 15:00 Finnish time (EET) on Wednesday 28 February 2018, hosted by Martin Jamieson, Chairman of the Board and CEO, and Mikko Karvinen, CFO, who will present the financial and operational results followed by a Q&A session.

The dial-in numbers for the conference call are:
Finland: +358 (0) 800 914672
Sweden: +46 (0) 20 089 6377
UK: +44 (0) 20 3003 2666
US: + 1 866 966 5335
Standard International: +44 (0) 20 3003 2666

The call password is Nexstim

Half-Yearly Report January-June 2018 (H1) will be published on Thursday, August 16, 2018

Nexstim Annual Report 2017 (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 Wednesday, March 7, 2018.

The Annual General Meeting will be held on Wednesday, March 28, 2018 beginning at 10:00 am. 

About Nexstim Plc

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. Nexstim's NBS system is the only FDA cleared and CE marked system based on navigated Transcranial Magnetic Stimulation (nTMS) for the pre-surgical mapping of the speech and motor cortices of the brain. Based on the same technology platform, the Company has developed the Navigated Brain Therapy (NBT^®) which is CE marked in Europe for the treatment of stroke, major depression and chronic neuropathic pain.

Nexstim has received clearance from the FDA for marketing and commercial distribution of its NBT^® system for the treatment of Major Depressive Disorder (MDD) and looks forward to introducing the NBT^® system for this important indication during Q2 2018.

The NBT^® system is currently in a 60 patient, supplemental Phase III study, E-FIT trial, for its use in stroke rehabilitation. The trial is expected to complete in mid-2018, allowing Nexstim to file for FDA clearance. FDA clearance would allow Nexstim to start marketing and selling its NBT^® system for stroke rehabilitation in the USA.

Nexstim shares are listed on the Nasdaq First North Finland and Nasdaq First North Sweden. 

Nexstim financial statement release 2017