Helsinki, 26 February 2015 at 8:00 AM
Nexstim listed to Nasdaq First North Helsinki & Stockholm and continued Phase III multi-centre trial in the US
Company Highlights, July – December 2014
- Phase III multi-centre trial in the US for stroke therapy is progressing according to plans, first milestone interim analysis from the Phase III stroke therapy trial expected in Q3 2015
- Successful listing of the company’s shares to Nasdaq First North Finland and Nasdaq First North Sweden raising new equity of EUR 15.3 million
- July – December 2014 revenue growth of 31.0 percent compared to second half of 2013
- First successful reimbursements for Navigated Brain Stimulation (NBS) in Germany
Status of clinical development
Nexstim's NBT System is in the development phase. The Company is currently building clinical evidence by conducting a clinical Phase III multi-centre trial to demonstrate the effectiveness of the therapy treatment using NBT System. The clinical trial is progressing according to plans. The next interim analysis milestones are estimated to be reached Q3 2015 and Q1 2016 and the clinical evidence is assumed to be ready by the end of 2016. Chronic neuropathic pain trial in co-operation with The Walton Centre is progressing according to plans.
CEO Janne Huhtala’s review
I am delighted to present to you Nexstim’s first financial statement release as a publicly listed company. 2014 has been a transformational year for the Company, both operationally and financially. I am pleased to report to you that the 2014 full year results show that Nexstim is firmly set on a good course and that both our product portfolio as our finances are in good health.
In November 2014 we successfully listed the company’s shares on Nasdaq First North Finland and Nasdaq First North Sweden, securing funds for the ongoing Phase III trial in the US for stroke therapy and for pre-commercialisation activities.
In early 2014, we saw encouraging results (over 80 percent response rate in active therapy group) from the Phase II trial for the use of Nexstim’s NBT® System in post-acute stroke therapy and subsequently initiated our Phase III, two year, multi-centre trial in April, in 12 different rehabilitation centres in the US. We closed 2014 with a strong cash position of EUR 11.5 million which is estimated to be sufficient to finance the company’s existing clinical development trials and pre-commercialisation activities. In 2015, we will continue to build on the substantial achievements of 2014 and, although not expected due to complete before end of 2016, we expect to see the first milestone interim analysis from the Phase III stroke therapy trial in Q3 2015.
Operationally, we have managed sales growth for our lead Navigated Brain Stimulation (NBS) product to strategic customers with capital equipment investment sales model. The new NBS 5 System for non-invasive pre-surgical mapping in clinical neurosurgery was launched in October and our efforts have been primarily targeting universities and teaching hospitals with strong key opinion leaders (KOL) presence. During second half of 2014 Nexstim revenue increased by 31.0 percent compared to second half of 2013 due to more successful closing of sales cases. On an annual level 2014 revenue increased by 18.1 percent compared to 2013. Furthermore, the first successful reimbursements for NBS in Germany marks an important step in the extension of our reimbursement coverage.
Today, with both its NBS and NBT® Systems, based on our core e-Field mapping software, Nexstim remains a world leader in navigated Transcranial Magnetic Stimulation (nTMS). The Nexstim team and clinical centres are committed to bringing innovative and ground-breaking solutions for the many patients suffering from strokes. With our strong product portfolio, strict financial management and the continued passion and commitment of all our staff, who deserve our deepest appreciation and gratitude, we are looking towards a very promising future.
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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.
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. Further, the Company has reduced its share capital for loss coverage on 29 September 2014. Therefore, pursuant to the Finnish Companies Act, all distributions of unrestricted equity to the shareholders by the Company are subject to a three months' public summons to the creditors until 3 October 2017. In the event dividends are distributed, all Shares entitle to equal dividends.
At the end of the financial period of 2014, the distributable assets of the group’s parent company were EUR 13,115,638.68. The Board of Directors proposes that Nexstim Plc should not pay any dividend for the financial period of 2014.
Helsinki 26 February 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
+44 (0)20 3709 5700
Publication of financial information during year 2015
A conference call for analysts will take place at 15:00 EET on Thursday 26 February 2015 which will be hosted by Janne Huhtala, Chief Executive Officer, and Mikko Karvinen, Chief Financial Officer, who will present the financial and operational results followed by a Q&A session.
The dial-in numbers for the conference call are:
Helsinki: +358 923195187
Stockholm: +46 850336434
London: +44 1452555566
US: +1 6315107498
The call ID number is 80666514
Half-Yearly Report January-June 2015 (H1) will be published on Thursday, August 20, 2015.
Nexstim Annual Report 2014 will be published on company web pages on Monday, March 9, 2015.
The Annual General Meeting will be held on Tuesday, March 31, 2015 beginning at 10:00 a.m.
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.