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Acarix has announced that the FDA is reviewing a de novo 510(k) application for its innovative CADScor cardiac diagnostic device. This is important news as it could mean that Acarix might enter the US market by 2021 – although it will need marketing alliances and good reimbursement. Given weak European sales and no update on German reimbursement, accessing the large US market could radically transform the business. Acarix might need US clinical data to ensure that it gains Medicare and insurer r
Companies: Acarix AB
Acarix has competed a rights issue of 28.67m shares at SEK1.50/share to raise SEK43m before expenses. The proceeds will fund a programme of market development and clinical trials. The process for German public reimbursement is underway. In the UK, NICE has carried out a technical assessment enabling a dialogue to start. Acarix is now developing a US market entry strategy and assessing the likely FDA trial needs.
CADScor H1 unit sales were to Germany (six), Sweden (three) and Denmark (one). Interestingly, Q219 patch sales were very strong at 1,690 up from 640 in Q119. These 1000 ‘extra’ sales could be an indication that users are starting to run more tests from the installed CADScor base. The process for German public reimbursement is underway. In the UK, NICE has done a technical assessment enabling a dialogue to start. Acarix is now developing a US market entry strategy and the likely FDA trial needs.
Acarix has gained strong support from clinical users, one comments that CADScor will ‘shorten waiting lists and add value for both patients and healthcare system’. The CADScor medical device helps doctors rule out coronary artery disease, avoiding complex and costly further testing in 50% of cases. Q119 sales were SEK299k with a gross profit of SEK209k, a 70% margin. Acarix sells to the German and Austrian private markets (about 10% of the population) and the Scandinavian public sector. The proc
The CADScor medical device helps doctors rule out coronary artery disease and so avoids complex and costly further testing in 50% of cases. Acarix is in a market development phase; FY18 results show CADScor sales of SEK1m. The application for German public reimbursement is underway; more news is expected in mid-2019. Acarix is focused on the German private market (about 10% of the population) plus public sector sales in Scandinavia. The significant long-term sales potential remains unaltered, bu
Acarix’s Q3 results showed a marked upturn in the number of systems sold: seven in Q3 vs eight in H1. Disposable patch sales in Q3 were 680 vs 800 in H1. These sales generated Q3 revenues of SEK351k. We have adjusted our sales forecast upwards to SEK1.3m for the full year 2018. Feedback from German and Swedish customers has been very positive. German public reimbursement might occur in 2019. We do not expect a US launch before 2022 and we assume a US trial starts in 2019 to enable this. Per Pers
Acarix’s H1 results show steady sales with eight systems and 800 disposable patches sold to June. These generated H1 revenues of SEK465k with gross profit of SEK349k, a 75% average margin. We now expect sales of just over SEK1m for the full year 2018 before hoped-for German reimbursement in 2019. A new commercial officer, Per Persson, has joined. We do not expect a US launch before 2022 and we assume a US trial starts in 2019. The indicative value remains SEK448m (SEK19.46/share). Additional cli
Acarix’s Q1 update shows sales of four systems to March. Revenues were SEK230k with gross profit of SEK158k; a gross margin of 69%. We do not expect any major sales upturn in 2018, as the key factor is German government reimbursement, which is not expected before 2019. There is additional sales potential in other European territories. We do not expect a US launch before 2022, but we have assumed a US trial starts in 2019. The indicative value remains at SEK448m (SEK19.46/share). Additional clini
Acarix’s annual report confirms reported 2017 revenues of SEK638k. Gross profit was SEK430k, with a gross margin rise to 75% in Q4. We do not expect any major sales upturn in 2018, as the key factor is German government reimbursement – this is not expected before 2019. There is additional sales potential in other European territories. We do not expect a US launch before 2022, but we have assumed a US trial starts in 2019. The indicative value remains at SEK448m (SEK19.46/share). Mr Lindholm is t
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EKF has reported a strong H1, with revenues of £37.5m and double-digit growth in underlying non-Covid related business. Management reports it is trading in line with expectations for the full year and we make no change to our profit forecasts at this stage. New growth initiatives are proceeding to plan and should lead to accelerated core growth from FY23 onwards. We continue to see substantial upside on successful execution with the shares trading on an FY23 P/E of 13.1x and an EV/EBITDA of just
Companies: EKF Diagnostics Holdings plc
Singer Capital Markets
Kromek reported full-year results to 30 April that were in line with the trading update of 16 May. Record visibility over our FY 2023 revenue forecast of £18m (c.53% of which is already contracted and 37% “Awarded not Contracted”, with the balance from its normal monthly run rate) is a great start for FY 2023 on which the company can build further. We are leaving forecasts unchanged for the moment, despite additional contract wins, and expect to introduce FY 2024 forecasts at the time of its int
Companies: Kromek Group Plc
Kromek announced a £1.7m fundraise by way of the issue of convertible loan notes (8% coupon, 18-month conversion period at 15p per share), which will allow the company to minimise any potential supply-chain disruption to the delivery of contracts during the year. We make only minor changes to forecasts to reflect the additional interest (c.£0.1m) accrued, with adjusted pre-tax loss increasing to £5.0m. We leave our target valuation of £118m (27p) unchanged, with near-term catalysts (e.g. a secon
Companies: Omega Diagnostics Group PLC
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Unigel Group, intends to join the Aquis Growth Market. Unigel Group is a pioneer in the field of thixotropic gels for the fibre optic cable industry. The Company is also a supplier of laminated steel tapes to the fibre optic cable industry in the US. Thixotropic gels and laminated steel tapes are essential components to the rapidly growing global fibre optic cable market. The Group export
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Smith & Nephew reported mostly in-line Q2 22 numbers, missing the top-line estimates (-0.6%) but beating on the trading profit (+0.5%), albeit marginally.
The Q2 performance was overshadowed by a 100bp margin downgrade for FY22 (-50bps Y-o-Y vs +50bps previously), which sent the stock ~9% lower in the session following the update. The reiteration of the top-line growth outlook of 4-5% was no help either.
We will cut our estimates, largely to reflect the soft margin guidance.
Companies: Smith & Nephew PLC
In Q2, Astra sustained its solid top-line momentum. Like in the past few quarters, this outperformance was again driven by higher COVID-19 business sales and solid growth in Diabetes drug Farxiga. Moreover, the recovering Oncology and much-needed green shoots in Rare Diseases were the icing on the cake. Although, profitability again came under the scanner but should improve in the coming quarters/years as the company completes its ‘growth phase’. Overall, a decent set of results and our positive
Companies: AstraZeneca PLC
Companies: SourceBio International Plc
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Inteliqo Limited, intends to join the Aquis Growth Market. Inteliqo Limited provides sales, marketing and distribution services to technology product owners under long-term distribution agreements. The Company has agreed its first such agreement in respect of the Ipedia iQ product range. The iQ product is a smart translation earphone (earbuds) system which offers integrated real time speech
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Belluscura has announced that it has entered into a Group Purchasing Organisation Product Supply Agreement with VGM Group which further expands its distribution network across the US.
Companies: Belluscura PLC
Companies: Argo Blockchain Plc (ARB:LON)Kromek Group Plc (KMK:LON)
For the year to 30 April 2022 Kromek reported results in line with the Trading Update of 16 May: revenue of £12.1m, +16.5%YoY, and an EBITDA (adj.) loss of £1.2m. We estimate revenue in the Advanced Imaging division grew 28% YoY to £4.6m, whilst the CBRN segment grew 1.5x to £5.4m.
Kromek reports that it expects growth to accelerate in both its core segments – security-related CBRN and advanced imaging – with the prospect of “a substantial year-on-year increase in revenue”. The CBRN segment in
Smith & Nephew’s growth acceleration and margin expansion in Q2 should continue in H215, more reflecting internal changes than improvements in market fundamentals. Its c 13% premium on 2015 P/E to its global ortho peers is supported by its brisker growth and strategic value.
Feature article: Utility regulation – Changes afoot - Patching up a tainted model
While the gas supply crisis – and its price implications – have dominated the UK price regulated sectors in recent months, other issues have arisen that have seriously tainted the price regulation system itself. Indeed, it is fair to ask whether it is ‘’fit for purpose’’.
Back in 1984, price regulation, via an unsophisticated RPI-x formula, was introduced to prevent the privatised British Telecom (BT) from abusin
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Hardman & Co