Company announcement, Helsinki, 16 August 2019 at 9:00 am
Highlights, January - June 2019
- Focused on executing our depression-led therapy strategy. Good progress with a total of eight new NBT systems installed in clinics in the US and Europe, across multiple sites, for the treatment of Major Depressive Disorder (MDD)
- Therapy business net sales grew strongly (170%) in H1 amounting to EUR 0.6 million (2018 H1: EUR 0.2 million)
- In April 2019, Nexstim arranged a share offering, which was supported by new major anchor investors, that raised EUR 3.5 million of new capital
- H1 net sales total amounted to EUR 1.2 million (2018 H1: EUR 1.1 million)
Nexstim is a personalised 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 for MDD is currently Nexstim's key strategic focus.
- Nexstim's Navigated Brain Therapy (NBT) system is based on its unique navigated Transcranial Magnetic Stimulation (nTMS) technology which allows for personalised, accurate, reproducible and non-invasive brain stimulation
- In May 2018, Nexstim launched its NBT system in the US for the treatment of MDD following FDA clearance in November 2017
- MDD affects more than 300 million people worldwide with 20-40% of patients not responding to current treatment options. As a result, MDD is the focus for Nexstim's sales and marketing activities for its NBT system
- The NBT system is CE marked for the treatment of depression and chronic pain
- A total of 18 NBT systems installed globally for the treatment of depression
- Nexstim's Navigated Brain Stimulation (NBS) system is the only CE-marked and FDA-cleared non-invasive solution for pre-surgical mapping of the motor cortex in brain cancer. Clinical data has been generated demonstrating the value of Nexstim's unique navigation system for pre-surgical mapping with regard to patient outcomes
- 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 as a result 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 160 research universities and leading hospitals across the world
CEO Martin Jamieson's review
I am happy to report the important progress that Nexstim has made in the first half of 2019 executing its strategy, which is focused on driving the sales of its NBT system for the treatment of MDD.
During the period, we have delivered and installed a total of eight new NBT systems - four in the US and four in Europe (Germany, Austria, Sweden and Finland) - for the treatment of MDD. As a result, there are now a total of eighteen NBT Systems installed for the treatment of depression, globally.
We are confident that by continuing to highlight the NBT system's unique navigational capabilities, we will be able to gain further market share, by clearly differentiating it from the non-navigational TMS devices currently on the market. We now have a promising NBT system sales pipeline in both the US and EU and will focus our efforts into converting these into orders during the second half of 2019.
The therapy business net sales for H1 2019 grew strongly by 170 percent to EUR 0.6 million, compared to EUR 0.2 million in H1 2018. Sales of the NBS system were lower during the first half of 2019 due to some system sales being postponed into H2 2019. This led to the Company's net sales total increasing 13 percent from EUR 1.2 million in H1 2019, compared to EUR 1.1 million in H1 2018. In addition to the progress with our NBT system, we are continuing to see an improvement in our sales mix with a growing contribution from high margin after sales, including revenue from services, support, spare parts and consumable head trackers.
H1 2019 has been a time of investment to support our growth, particularly in our US commercial team as well as in Europe. As a result of this investment, operating cash burn amounted to EUR -3.7 million in H1 2019 compared to EUR -3.1 million in H1 2018.
In order to finance our growth strategy, we raised a total of EUR 3.5 million of new capital in a share offering which closed in April 2019.
I wish to thank our investors for supporting our share offer and I am delighted that we were able to attract new major anchor investors. This support reflects their confidence and strong commitment to Nexstim's success.
With these new funds and potential further investments based on the offer warrants and cost saving efforts, Nexstim is now focused on continuing to drive the sales of its NBT systems globally. This clear therapy focused strategy means that we continue seeking a partner for our pre-surgical mapping business.
During H2 2019, we will focus on growing the active installed base of NBT Systems used for treatment of MDD with the emphasis on the large US market. It is our priority to raise market awareness of our NBT System. We are looking to achieve this by increasing the number of MDD patients treated with our NBT System which will allow us to collect more clinical data showing the benefits that our unique system is able to deliver to the large number of patients with depression. This data will be used to support our marketing efforts which we are confident will increase the adoption of our NBT system across the US.
We also plan to leverage our strong Key Opinion Leader network in the US and to utilize the patient registry data we are generating to publish a series of White Papers highlighting the advantages that our NBT System delivers when used to treat MDD. We believe that these efforts will allow us to generate higher therapy sales as we leverage our continuing investments in commercial sales, marketing, and clinical resources.
As of 30 June 2019, Nexstim had a cash position of EUR 6.4 million, which includes the Kreos loan.
We are continuing to evaluate a number of different funding options and strategic alternatives for our businesses. A key potential source of funding during October-November 2019 is via the exercise of a large number of the warrants that were issued as part of the April 2019 share offering.
Key performance indicators
|EUR in thousands||1-6/2019|
|Depreciation and amortization||-205.3||-154.4||-424.0|
|Other operating expenses||-1,968.2||-1,801.3||-3,985.9|
|Profit/ -Loss for the period||-3,664.9||-2,440.6||-6,154.3|
|Earnings per share (EUR)*||-0.29||-0.78||-1,93|
|Cash flows from operating activities||-3,679.0||-3,123.0||-6,192.5|
|Cash in hand and at banks||6,378.6||10,305.6||7,175.2|
|Equity ratio (%)||-3.94||31.23||-0.98|
|Number of shares in the end of the period (pcs)*||35,400,873||3,251,050||3,253,751|
|Average number of shares during the period (pcs)*||12,835,277||3,122,041||3,187,487|
|Diluted number of shares in the end of the period (pcs)*||52,450,118||4,700,817||4,703,495|
|Diluted average number of shares during the period (pcs)*||17,817,551||4,451,572||4,577,627|
*The number of shares has been adjusted to take account the effect of the reverse share split on 26 November 2018, where the number of shares was decreased 30-fold.
Based on its business forecast, the Company expects therapy business revenue to grow during year 2019 and a loss for the period is expected for the financial year 2019.
Helsinki 16 August 2019
Board of Directors
For further information please visit www.nexstim.com or contact:
Martin Jamieson, Chairman and CEO
+44 771 516 3942
Sisu Partners Oy (Certified Adviser)
+ 358 40 842 4479
Publication of financial information
A conference call for media, investors and analysts will take place at 4:00 pm Finnish time on Friday 16 August 2019. 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) 808 109 0700
US: + 1 866 966 5335
The call Password is Nexstim.
Financial statements release for the year ending 31 December 2019 will be published on or about 28 February 2020.
About Nexstim Plc
Nexstim is a medical technology company focused on the development and commercialization of its world-leading SmartFocus TMS technology, a non-invasive brain stimulation system for the treatment of Major Depressive Disorder (MDD). The Company's proprietary Navigated Brain Therapy (NBT) system, a highly sophisticated 3D navigation, is the only personalised, navigated transcranial magnetic stimulation (TMS) approach providing accurate targeting of the TMS to the specific area of the brain associated with MDD.
Nexstim's NBT system has been launched in the US for the treatment of 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 major depression and chronic neuropathic pain.
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.
- Nexstim Half-Yearly Report H1 2019 ENG - FINAL 20190816 (https://ml-eu.globenewswire.com/Resource/Download/51fe6bc3-b752-41c7-af97-877ce8b4874c)