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.
Key performance indicators
EUR in thousands 7-12/2014 7-12/2013 1-12/2014 1-12/2013
6 months 6 months 12 months 12 months
Net sales 1,796.5 1,371.7 2,210.4 1,871.0
Personnel expenses -2,018.3 -1,492.5 -3,660.2 -3,043.4
Depreciation and amortisation -252.1 -96.0 -377.4 -237.7
Other operating expenses -3,826.2 -1,403.8 -5,498.5 -2,472.0
Profit/ -Loss for the period -5,318.1 -1,966.7 -10,445.4 -4,514.9
Earnings per share (EUR)* -1.02 -0.68 -2.37 -1.63
Diluted earnings per share (EUR)* -0.92 -0.64 -2.16 -1.51
Cash flows from operating activities -5,277.1 -2,124.5 -7,785.2 -3,983.7
Cash in hand and at banks 11,483.7 1,010.0 11,483.7 1,010.0
Total equity 8,589.9 -2,382.1 8,589.9 -2,382.1
Equity ratio (%) 65.29 -30.23 65.29 -30.23
Number of shares in the end of the
period (pcs)* 7,130,758 3,189,004 7,130,758 3,189,004
Average number of shares during the
period (pcs)* 5,237,468 2,880,550 4,406,572 2,767,995
Diluted number of shares in the end of
the period (pcs)* 7,917,698 3,401,454 7,917,698 3,401,454
Diluted average number of shares
during the period (pcs)* 5,799,236 3,093,000 4,826,140 2,980,445
*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
Future Outlook
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
Nexstim Plc
Board of Directors
For further information please visit www.nexstim.com or contact:
Nexstim +358 40 8615046
Janne Huhtala, Chief Executive Officer janne.huhtala@nexstim.com
UB Capital Oy (Certified Adviser) +358 9 2538 0225
Consilium Strategic Communications +44 (0)20 3709 5700
Mary-Jane Elliott nexstim@consilium-comms.com
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.
[HUG#1897383]
