Helsinki, 20 August 2015 at 8:00 AM
Company Highlights, January – June 201
- Phase III multi-centre trial in the US for stroke therapy is progressing according to plans; successfully enrolling patients on time with first milestone interim analysis expected in Q3 2015
- January – June 2015 revenue growth of 55.4 percent compared to first half of 2014
- Appointment of Olli Riikkala as Chairman of the Board of Directors, and Juliet Thompson as a new independent non-executive director
Status of clinical development
Nexstim's Navigated Brain Therapy (NBT®) System is currently in the development phase. The Company is currently building clinical evidence by conducting a clinical Phase III multi-centre clinical trial to demonstrate the effectiveness of the use of Nexstim’s NBT® System in post-acute stroke therapy. The clinical trial is progressing according to plans and the first interim analysis milestone is estimated to be reached in Q3 2015 with a second interim analysis in Q1 2016. The final analysis is expected to be ready by the end of 2016.
CEO Janne Huhtala’s review
he first half of 2015 contained several successes, including the positive progress made in the Phase III clinical trial using our NBT® System and traction of Navigated Brain Stimulation (NBS). We are also pleased with the momentum of continued interest from academics and clinicians in Nexstim’s technology and software.
Nexstim continued to progress its ongoing Phase III, two year, multi-centre clinical trial for the use of Nexstim’s NBT® System in post-acute stroke therapy in 12 different rehabilitation centres in the US. The trial is on track for completion by end 2016 and we estimate that we will announce the interim analysis in Q3 2015. The company has ongoing dialogue with FDA regarding the 510(k) De Novo submission.
Nexstim has been targeting NBS system sales to strategic customers such as teaching hospitals and universities with a strong KOL presence and supported by capital equipment investment sales models. Medical research from these important centres continues to be published internationally by Nexstim affiliates, extolling the benefits of NBS mapping in neurosurgery and neurosurgical planning, and demonstrating the value of NBS to neurosurgery outcomes and workflows, supporting the wider adoption of this technology and software.
Nexstim revenues EUR 643.2 thousand have increased by 55.4 percent compared to the equivalent period in 2014 (EUR 413.9 thousand) due to an increase in NBS system sales revenue in Europe and the Middle-East. Sales of NBS systems in US markets was disappointing, mainly due to customers postponing capital investment decisions, causing a consequential lumpiness in revenue expectations. We estimate that the sales pipeline for H2 2015 will continue to be strong, however, due to potential delays in the US market, the overall full year 2015 NBS sales growth rate may be affected.
Nexstim ended the first half of 2015 with a cash position of EUR 6.1 million. Due to the possible lower level of NBS sales in US and slightly higher than earlier estimated Phase III trial costs, the current cash and cash generated from sales is estimated to be sufficient to finance the company’s existing clinical development trials for the first two milestones (Q3 2015 and Q1 2016) and pre-commercialisation activities.
With the potential for successful Phase III trial milestones, Nexstim is preparing for the possibility of advancing the NBT® system commercialisation and, during 2015, Nexstim has actively engaged with the investment community and has received a lot of positive interest.
Nexstim also was very pleased to announce the appointment of Olli Riikkala as Chairman of the Board of Directors, and Juliet Thompson as a new Board member, at the Annual General Meeting, adding strength to the Board and aligning it to Nexstim’s international growth strategy.
Key performance indicators
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*The number of Shares and subscription price have been adjusted to take account the effect of the merging of the share classes and share split on 29 September 2014, where the number of Shares was increased 14-fold
Based on its business forecast and sensitivity analysis the company expects its net sales from the sale of NBS Systems (Pre-Surgical Mapping, PSM) to grow during financial year 2015 and operating profit to be positive during second half of the financial year 2017 at the earliest.
Helsinki 20 August 2015
Board of Directors
Janne Huhtala, Chief Executive Officer
+358 (0)40 8615046
UB Capital Oy (Certified Adviser)
+358 (0)9 2538 0225
Consilium Strategic Communications
Mary-Jane Elliott / Ivar Milligan / Laura Thornton
+44 (0)20 3709 5700
Publication of financial information
A conference call for media, investors and analysts will take place at 3.00 pm Finnish time on Thursday 20 August 2015. Janne Huhtala, Chief Executive Officer, and Mikko Karvinen, Chief Financial Officer, will present the financial and operational results followed by a Q&A session. The presentation material will be available on the Nexstim website shortly before the conference call begins.
The dial-in numbers for the conference call are:
Finland:+358 (0)9 231 95386
Sweden: +46 (0)8 566 19407
UK: +44 (0)1452 557 851
US: +1 86 66 65 40 42
The call ID number is: 35660312
Financial statements release for the year ending 31 December, 2015 will be published on or about 29 February 2016.
About Nexstim Plc
Nexstim, formed in 2000 and based in Finland, is a medical technology company aiming to improve rehabilitation for stroke patients. Nexstim has pioneered its technology in brain diagnostics with the Navigated Brain Stimulation (NBS) system as the first and only FDA-cleared and CE-marked navigated Transcranial Magnetic Stimulation (nTMS) device for pre-surgical mapping of the motor and speech cortices. Based on the same technology platform, the company has developed a device for stroke therapy called Navigated Brain Therapy (NBT®). In H1 2014, Nexstim initiated a two-year pivotal Phase III study at 12 sites in the US aiming to demonstrate the effectiveness of NBT® and gain FDA clearance for commercialisation in post-acute stroke therapy in the US. Nexstim's shares are listed on Nasdaq First North Finland and Nasdaq First North Sweden. For more information please visit www.nexstim.com.