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Sequana Medical provided an update following encouraging data from its Phase IIa SAHARA Direct Sodium Removal (DSR) study in patients with persistent congestion despite maximal loop diuretic therapy. The DSR approach continues to demonstrate its potential in reducing persistent congestion, an area of unmet need given that c 90% of the more than one million US hospitalisations for heart failure (HF) are due to fluid overload. All 10 evaluable SAHARA patients enrolled in the original cohort design
Companies: Sequana Medical N.V
Sequana reported its FY21 results on 12 April and confirmed its operating guidance for the coming months. The company continues to expect to report top-line data for its North American POSEIDON study of alfapump in recurrent and refractory ascites (RRA) in Q422 and submit a US premarket approval (PMA) application in mid-2023. It plans to report top-line data for its SAHARA DESERT alfapump DSR study in patients with decompensated heart failure (HF) in H222. The company plans to begin its first hu
On 5 April, Sequana announced that it has completed all implantations required for the North American POSEIDON pivotal study assessing the alfapump device for the treatment of recurrent or refractory ascites (RRA) due to liver cirrhosis. Of the 71 patients enrolled in the study’s pivotal cohort, 40 have been implanted with the device. Top-line data are expected in Q422, and the company expects to submit a US pre-market approval (PMA) application in mid-2023, which we believe could lead to a US l
Sequana Medical recently announced positive interim data on six patients in its two-phase SAHARA DESERT study in decompensated heart failure (HF) patients with persistent congestion despite maximal diuretic therapy. While the sample size is small, alfapump DSR was shown to eliminate persistent congestion, restore normal bodily fluid volume and improve diuretic response. The market need for improved HF congestion control is significant, given that there are over one million hospitalisations in th
Meeting its recent Q421 guidance, Sequana has completed patient enrolment for the POSEIDON North American pivotal study assessing the alfapump system for the treatment of recurrent or refractory ascites (RRA) due to liver cirrhosis. 70 patients have been enrolled in the pivotal cohort, with Sequana expecting to implant 50 of these with the alfapump by the end of Q122. This should allow Sequana to meet its pre-defined target of having 40 evaluable patients for the primary efficacy analysis at six
Sequana Medical announced on 4 October that it had received approval from the US FDA to expand patient recruitment in the pivotal cohort of its POSEIDON pivotal study to 70 (an increase of 10 patients). This decision should allow Sequana to meet its pre-defined target of having 40 evaluable patients for the primary efficacy analysis, and thus provide it with the desired statistical power to potentially meet the primary endpoint. In our view, the positive FDA decision reduces a degree of uncertai
Sequana Medical indicated that due to a worldwide shortage of electronic components, it now anticipates its US premarket approval (PMA) application for the alfapump will now be submitted in mid-2023, compared to prior guidance of Q422. We have pushed back our potential North American alfapump launch estimate in recurrent and refractory ascites (RRA) to mid-2024 (from H223 previously), while our projections for the Direct Sodium Removal (DSR) programmes in heart failure are unchanged. We now obta
Sequana has reported positive data from the second interim analysis in roll-in cohort patients from the POSEIDON pivotal study. Results from 26 subjects confirmed the efficacy trends from the initial analysis in Q420 (which only reflected the first 13 patients in the cohort). As in that analysis, the subjects had a greater than 90% reduction in mean frequency of therapeutic paracentesis (TP) versus baseline, and all patients experienced at least 50% reduction in mean TP frequency per month versu
Sequana’s proprietary alfapump and Direct Sodium Removal (DSR) platforms are being advanced as long-term treatments for diuretic-resistant fluid overload related to liver disease, malignant ascites and heart failure (HF). The alfapump is commercialised in parts of Europe for liver disease and is undergoing a pivotal North American registration study (POSEIDON), with primary endpoint data expected in Q222. This device removes localised excess fluid build-up in the peritoneal cavity, and aims to p
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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