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NEXSTIM PLC HALF-YEARLY REPORT 1 JANUARY - 30 JUNE 2018 (UNAUDITED)
Company announcement, Helsinki, 16 August 2018 at 9:00 am
NEXSTIM PLC HALF-YEARLY REPORT 1 JANUARY - 30 JUNE 2018 (UNAUDITED)
Highlights, January - June 2018
- Nexstim delivered its first Navigated Brain Therapy (NBT®) system in the US for the treatment of Major Depressive Disorder (MDD) following Nexstim's successful launch of the SmartFocusTM TMS technology at the Clinical TMS (transcranial magnetic stimulation) Society Annual Meeting in New York in May 2018
- 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 results are expected within three weeks from publishing this H1 2018 report
- Cash balance of EUR 10.3 million at end of June 2018, including new equity financing of EUR 1 million via a directed issue of new shares to Capricorn Health-tech Fund and EUR 4 million loan drawn from Kreos Capital V (UK) Limited
- Revenues amounted to EUR 1.1 million (2017: EUR 1.1 million)
Nexstim is a personalised neuromodulation company developing and marketing pioneering precisely navigated non-invasive brain stimulation systems for both therapeutic (NBT® system) and diagnostic (NBS system) applications.
Commercialisation of the NBT® system for therapeutic applications such as stroke rehabilitation, depression and pain is the key strategic focus for Nexstim.
The Company developed its NBT® system based on its NBS technology platform which has demonstrated a 46% increase in progression free survival in patients undergoing surgery for low grade gliomas versus the current gold standard used to map the brain.
- Nexstim's NBT® platform is based on its unique SmartFocusTM navigated Transcranial Magnetic Stimulation (nTMS) technology which allows for personalised, accurate, reproducible and non-invasive brain stimulation to treat a range of indications with significant unmet clinical need
- In November 2017, Nexstim received FDA clearance for the commercialisation of its NBT® system in the US for the treatment of MDD. The NBT® system was launched in the US in May 2018 and the first systems have been delivered to the first clinics. Currently only an estimated c.30 thousand patients receive TMS depression treatment in the US p.a. (c.2% penetration), but there is c.1.9 million addressable MDD patients in the US representing a total treatment value of addressable market of USD 17 billion
- In January 2018, Nexstim announced that patient enrolment had been completed in the supplementary 60 patient Phase III E-FIT trial. This ongoing US trial is assessing the use of the NBT® system in the rehabilitation of upper limb mobility following stroke. Trial completion is expected within three weeks from publishing this H1 2018 report. Positive results, when the data from the E-FIT trial are combined with data from the earlier Phase III NICHE study, will allow Nexstim to file for FDA clearance to market the device for this indication in the US. Estimated EU and US total annual volume of addressable patients for upper limb mobility rehabilitation post-stroke is about 0.8 million patients
- The NBS system continues to grow sales and it is now used in approximately 150 research universities and leading hospitals around the world
CEO Martin Jamieson's review
I am happy to report the important progress that Nexstim has made during the first half of 2018.
The Company began the US commercialisation of its NBT® system for the treatment of MDD, with the first deliveries of the device already being made following its launch in May 2018. The FDA cleared Nexstim's 510(k) for its NBT system to be used for MDD in November 2017. MDD is a recurrent and frequently chronic disorder with significant unmet clinical need that 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 personalised treatment that the unique navigational capabilities of our SmartFocusTM NBT® system delivers, we will be able to differentiate it from the non-navigational TMS devices currently on the market. The US sales pipeline for the depression indication is progressing well and we are accelerating our efforts to drive revenues by continuing to strengthen our US commercial organization.
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 the clinical development of NBT system 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, an approach which is in line with a recommendation from FDA. The earlier NICHE study demonstrated positive results in the active group, treated with the NBT system, with 2/3 patients showing a clinically meaningful response. However, the control group, treated using a sham coil also demonstrated a positive treatment effect which the Company believes was due to the sham coil providing therapy. The new sham coil that is being used in the E-FIT trial was deemed appropriate for use by the FDA.
Nexstim is in the process of formally closing the trial sites and expects to announce data from the E-FIT trial within three weeks from publishing this H1 2018 report. Positive data, based on combining the results from the E-FIT and NICHE studies, would support Nexstim's planned novo 510(k) filing for stroke rehabilitation. FDA clearance of this de novo 510(k) would allow Nexstim to market and sell its NBT system for stroke rehabilitation in the US, the largest and most lucrative market for this device.
Net sales grew by 2.0% in H1 2018 and amounted to EUR 1.1 million, compared to EUR 1.1 million in H1 2017. The growth was driven by NBS system sales in the US which had its strongest start to the year in the Company's history.
We have been 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. Operating cash burn amounted to EUR -3.1 million in H1 2018 compared to EUR -2.8 million in H1 2017 as we have continued to build our commercial sales, marketing and clinical organization.
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.
We still feel that the revenue potential of NBS system, for brain mapping, both growth in the US and other geographical market areas has not yet been achieved. We continue to search for a strong long-term partner to support our commercialisation efforts in this area.
We were very pleased to receive EUR 1.0 million in new funds from our long-term investor Capricorn Health-tech Fund via a directed share issue in June 2018. This financing was followed by drawing a EUR 4 million senior secured term loan from Kreos Capital. We believe that this is the right time to draw down our loan from Kreos, as we focus on commercialisation of our NBT® system in the US and Europe.
As of 30 June 2018, Nexstim had a cash position of EUR 10.3 million, which compares favourably to the cash position of EUR 9.2 million at the end of June 2017. The current cash balance and cash generated from sales will finance the Company until the end of Q2 2019.
The Company is actively evaluating the possibility for a 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 and to fund an expanded therapy clinical trial programme and the development of a patient treatment data registry.
Key performance indicators
|EUR in thousands|| 1-6/2018|
|Depreciation and amortisation||-154.4||-165.1||-341.3|
|Other operating expenses||-1,801.3||-1,759.0||-4,118.1|
|Profit/ -Loss for the period||-2,440.6||-3,433.9||-7,327.9|
|Earnings per share (EUR)||-0.03||-0.05||-0.09|
|Cash flows from operating activities||-3,123.0||-2,791.2||-5,402.9|
|Cash in hand and at banks||10,305.6||9,239.3||8,473.6|
|Equity ratio (%)||31.23||65.19||52.77|
|Number of shares in the end of the period (pcs)||97,531,529||86,053,694||93,173,604|
|Average number of shares during the period (pcs)||93,661,249||70,330,185||79,476,965|
|Diluted number of shares in the end of the period (pcs)||141,024,519||118,903,768||132,947,261|
|Diluted average number of shares during the period (pcs)||133,547,163||105,089,658||114,676,433|
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.
Helsinki 16 August 2018
Board of Directors
For further information please visit www.nexstim.com or contact:
Nexstim +44 771 516 3942
Martin Jamieson, Chairman and CEO firstname.lastname@example.org
Sisu Partners Oy (Certified Adviser) +358 (0)10 231 4560
Citigate Dewe Rogerson +44 (0)207 2822949
David Dible/Shabnam Bashir email@example.com
Publication of financial information
A conference call for media, investors and analysts will take place at 4:00 pm Finnish time on Wednesday 16 August 2018. Martin Jamieson, Chairman and CEO, and Mikko Karvinen, CFO, 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.
Financial statements release for the year ending 31 December 2018 will be published on or about 28 February 2019.
About Nexstim Plc
Nexstim is a targeted neuromodulation company focused on developing and commercializing its world-leading navigated non-invasive brain stimulation technology, known as SmartFocusTM TMS (transcranial magnetic stimulation), for therapeutic applications, namely stroke, depression and chronic pain via its Navigated Brain Therapy (NBT®) system.
Nexstim has launched its NBT® system in the US for the treatment of Major Depressive Disorder (MDD) following clearance from the FDA for marketing and commercial distribution for this indication. The NBT® system is CE marked in Europe for the treatment of stroke, major depression and chronic neuropathic pain.
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 within three weeks from publishing this H1 2018 report, 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 US.
In addition, Nexstim is commercialising its Navigated Brain Stimulation (NBS) system for diagnostic applications, based on the same technology. 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 Finland and Nasdaq First North Sweden. For more information please visit www.nexstim.com.