Research, Charts & Company Announcements
Research Tree provides access to ongoing research coverage, media content and regulatory news on NEXSTIM OYJ. We currently have 6 research reports from 1 professional analysts.
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Funded and back on stroke trial track
07 Mar 17
A key uncertainty for Nexstim was removed in December as the FDA confirmed that only one additional stroke rehabilitation trial in 60 patients will be required to seek de novo 510(k) regulatory approval for the NBT system. US approval might be obtained during Q418. Nexstim has used €8.8m from the Bracknor/Sitra funding arrangement and had €8.2m in cash in December. A further €3.2m can be raised from the arrangement. Excluding 30m issued warrants, this could fund Nexstim until late 2018. The NBS system achieved €2.5m in sales in 2016, with modest increases anticipated by Nexstim for 2017; new US distributors have been appointed.
More data please
29 Sep 16
The FDA has told Nexstim it may accept a “limited-sized” further trial plus additional analysis of the Phase III (NICHE) study. While this is positive for Nexstim – the FDA did not reject the application – it delays any approval to at least 2019. The new design is unlikely to be confirmed before H117. In our view, the uncertainty decreases the probability of success from 55% to 50%. Including the likely 2016 dilution, this decreases the indicative value from €0.96/share to €0.58/share. Nexstim should be funded until early 2018 on the current arrangements with Bracknor, but will then require further capital.
Sham surprise shows stroke success
25 Apr 16
The partly unblinded Phase III data, stopped after a futility analysis, show that two-thirds of treated patients showed meaningful clinical improvements, but also that the ‘active’ sham patients had similar responses. Nexstim will unblind the study, giving 138+ patients worth of data in Q2. The company aims to file an FDA de novo 510(k) application in Q316, which might give some US sales from mid-2017 if the FDA agrees. The system can already be sold in the EU. Extra trials to secure reimbursement are likely to be needed and indications such as depression could be developed. Nexstim has cash to last until Q316. The CEO left on 20 April; the chairman is acting as CEO.
NICHE stroke rehab trial fails its primary endpoint
01 Mar 16
The pivotal trial of Nexstim’s Navigated Brain Therapy (NBT) System in treating stroke patients has failed to meet its primary endpoint. We suspend our financial forecasts and valuation while Nexstim reviews its next strategic steps. It estimates its cash reach until Q316.
First hurdle cleared in pivotal trial
01 Oct 15
An independent committee’s interim analysis of the pivotal trial using Nexstim’s Navigated Brain Therapy System in the treatment of hemiplegic stroke patients recommended that it continue. A positive readout of the full trial in Q316 may enable a US launch in late 2017. We expect the NBT System to gradually capture a third of the €1.6bn market opportunity and we continue to value Nexstim at €112m based on a 70% probability of success.
Game-changing stroke treatment
10 Sep 15
Nexstim’s Navigated Brain Therapy System could transform the rehabilitation of hemiplegic stroke patients. Success in the ongoing Phase III trial may enable a US launch in late 2017. We expect the NBT system to gradually capture a third of the €1.6bn market opportunity and value Nexstim at €112m based on a 70% probability of success.
N+1 Singer - Morning Song 21-03-2017
21 Mar 17
accesso Technology (ACSO LN) Full year results in line, but key trading months still ahead | Augean (AUG LN) Double digit growth in ’16, good start to ‘17 | Earthport (EPO LN) Interims show continued top line strength | Goals Soccer Centres (GOAL LN) Good momentum under new team. It’s now all about delivery | IQE (IQE LN) FY’16 results prompt further upgrades | Microsaic Systems (MSYS LN) Challenges in 2016, strategy remains in place | mporium Group (MPM LN) Funds raised to help execute strategy | RhythmOne (RTHM LN) Dawn of the independents | ScS Group (SCS LN) Strong progress on key growth initiatives albeit comps now toughen | Sinclair Pharma (SPH LN) FY results: EBITDA ahead, Instalift™ gaining pace | Vectura Group (VEC LN) FY (9-month) results
Interim results lead to upgrades
27 Mar 17
Bioventix reported a strong set of interim results with revenues increasing by 32% (c.12-17% at constant exchange rates (CER)), driven largely by the continued roll-out of its customers’ Vitamin D assay products. This, in turn, led to a 41% increase in pre-tax profits and a 40% increase in adjusted EPS; which is reflective of the operational gearing of the business. We are upgrading our adjusted EPS to 78.7p (+5%) and, consequently, are raising our target price to 1750p. At this price level, the shares would trade on a 22.4x FY 2018 P/E and an EV/EBITDA of 17x. We await confirmation of Siemen’s high sensitivity troponin assay launch, expected in FY 2018.
27 Mar 17
Elecosoft* (ELCO): Steadily building profits (CORP) | Bioventix* (BVXP): Interim results lead to upgrades (CORP) | Hurricane Energy (HUR): Halifax discovery (BUY) | KBT Business Technology* (KBT): interims and contract win (CORP) | Independent Oil & Gas* (IOG): Licence updates (CORP)
N+1 Singer - Morning Song 22-03-2017
22 Mar 17
Carador Income Fund (CIFU LN) Premium rating restored, high levels of refinancing activity | Cello Group (CLL LN) Outlook getting brighter – watch Pulsar | Eckoh (ECK LN) Largest ever US secure payments win | eg solutions (EGS LN) Full year results in line | Futura Medical (FUM LN) Licensing deal for CSD500 in Portugal | Verona Pharma (VRP LN) Global agreement with QuintilesIMS to support development of RPL554 | Xaar (XAR LN) 2016 results slightly ahead, reduced visibility in 2017
Sinclair Pharma - Aesthetically Positioned to Continue Double-Digit Growth
23 Mar 17
With an innovative and differentiated product portfolio of injectable devices addressing the fast-growing aesthetics market, Sinclair is best positioned to continue to achieve double-digit revenue growth in the medium term.
N+1 Singer - Futura Medical - Licensing deal for CSD500 in Portugal
22 Mar 17
The agreement with F Lima further extends the market reach of CSD500, Futura’s erectogenic condom, and brings the total number of distribution partners to eight. The deal is in line with the company’s stated strategy of partnering with leading regional players in the consumer products space. We expect the condom to be launched in Portugal later this year. We retain a positive stance.