Encouraging H1 sales indicate Mauna Kea ("MKEA") connues to enjoy the posive growth trend previously reported in Q1. With sales increased 58% YoY to €3.3m (H1/2020: €2.1m), driven by a 62% increase in consumables revenues and an 109% increase in system sales. Sales connued to grow across all regions including AsiaPacific (+71% to €0.9m) and EMEA & RoW (+198% to €0.8m). While overall H1 US growth was lower (+25% to €1.7m), a more than doubling of US sales in Q2 indicates a robust recovery driv
Companies: Mauna Kea Technologies SA Class O
In a year when elective procedure volumes fell 20% or more due to the COVID-19 pandemic, Mauna Kea (“MKEA”) reported FY2020 sales of €6.5m; down 12% YoY. Systems and services sales grew 12% and 16% YoY respectively, whilst consumables sales fell by 32%, reflecting the global drop in procedure volumes in 2020. A positive recovery was evident across all geographies in H2/2020 with Q4/2020 sales increasing 41% YoY to €2.4m, driven by contributions of €1.3m (+44%) from the US, €0.7m (+34%) in APAC a
Mauna Kea's ("MKEA") Q3/2020 sales exceeded management's expectations, growing 13% YoY to €2.0m (Q3/2019: €1.8m). Systems and services revenue grew 58% and 37% respectively compared to Q3/2019, largely reflecting a rebound in capital sales in all markets. The anticipated fall in consumable sales was also less than expected (16% vs. 23% - 27%);driven by better than expected performance from the US pay-per-use ("PPU") programme. We also note the narrowing YoY sales performance between H1/2020 (-47
In line with expectations, Mauna Kea's ("MKEA") reported a 30% YoY decrease in H1 revenues to €3.2m, reflecting the disruption from the ongoing COVID-19 pandemic. Consumables and system sales were most heavily impacted because of the significant drop in procedure volumes (see our note from July 2020) and reduction in demand for new systems which impacted both direct and distributor sales channels. However, MKEA reported that it expects a bounce back in sales for Q3 & Q4/2020E as a combination of
Mauna Kea announced plans to commence a first in human clinical trial in partnership with Johnson & Johnson's Lung Cancer Initiative to evaluate the feasibility and safety of J&J’s Monarch catheter-based robotics platform in combination with Cellvizio for the diagnosis of peripheral lung nodules. Mauna Kea has remained tight lipped with regards to the company's partnership with J&J since a strategic equity investment of €7.5m in December 2019. In our view, the initiation of the clinical trial re
Mauna Kea reported Q1/2020 sales of €1.5m (-14% YoY), with a strong start to the year offset by the impact of COVID-19. Cellvizio system and services sales for the quarter were flat at €0.6m (-1% YoY) and €0.3m (+0% YoY) respectively, however, sales of consumables decreased 27% YoY to €0.6m as a result of lower procedure related demand as resources for elective procedures are re-allocated to fighting the pandemic worldwide. The impact of COVID-19 on procedure volumes cannot be ignored moving for
Q4/2019 results revealed that Mauna Kea's top line grew 10% YoY to €7.4m for FY2019, despite weaker than expected Q4 sales of €1.7m (-20% YoY). Total FY2019 sales were largely driven by those to clinical customers, which represented 96% of total sales, and a 47% increase in consumable sales indicating high utilisation of the growing Cellvizio installed base. In-line with both ours and management's expectations, straight system sales decreased 14% YoY following the shift to a pay-per-use model wh
Mauna Kea announced a € 7.5m strategic investment from Johnson & Johnson Innovation - JJDC, Inc. ("JJDC" - part of Johnson & Johnson ("J&J")) which provides further funding for the development of the Cellvizio platform and will allow the company to execute its strategic growth initiatives as it expands into the interventional pulmonology ("IP") market. A subscription price of €1.40, represents a c.30% premium to the previous close. The agreement also provides J&J with a 24-month period in which
Mauna Kea reported 9M/2019 sales of €5.7m (+24% YoY) on track to reaching our FY2019 revenue estimate of €8.6m. Q3 sales decreased by 7% YoY to €1.8m, driven largely by an increased commercial focus on clinical over pre-clinical sales. As such, performance in Q3 is in line with the strategic priorities set out by management for 2019, with clinical sales accounting for 99% of Q3/2019 total sales vs. 75% in Q3/2018. As we expected, Q3 revenues from Cellvizio straight sales and services declined 32
Earlier this year, Mauna Kea announced successful FDA clearance for the use of the Cellvizio® system in the field of interventional pulmonology ("IP"). This paves the way for entry into the large lung cancer diagnostics market and would allow Mauna Kea to leverage its existing expertise in the field of gastroenterology to maximise adoption. In our view, IP represents a promising commercial opportunity based on (1) a large market with a vast clinical need, (2) Cellvizio's® unique ability to facil
Mauna Kea reported Q2/2019 sales of €2.2m, up 33% YoY. Sales growth was primarily driven by a 58% YoY increase in consumable sales (€1.2m), which accounted for 54% of total revenues and highlight the company's continued focus on maximising utilisation of Cellvizio, one of three key strategic targets set forth by management earlier this year. Sales growth was partly offset by a 21% decrease in service revenues associated with prioritisation of Cellvizio utilisation rather than installation as see
Mauna Kea announced successful reimbursement coverage for the use of confocal laser endomicroscopy ("CLE") for Barrett's Esophagus ("BE") in France. This further validates the clinical utility of Cellvizio and is testimony to Mauna Kea's ability to deliver on its strategic milestones for 2019, as set out in our recent report. With reimbursement in place in France, Mauna Kea is delivering on its promise to drive revenue generation outside the US by providing clinicians with a strong incentive for
Mauna Kea reported strong Q1/2019 sales of €1.7m (65% YoY) with consumables sales of €0.9m (96% YoY) representing 51% of total sales, thus highlighting continued progress toward maximising utilisation of Cellvizio, which represents one of three key strategic targets set out by management for 2019. While total sales growth was in part driven by softer sales in Q1/2018, total consumable sales grew 10% vs. Q4/2018, indicating Cellvizio's increasing utilisation, which we continue to consider a key p
Mauna Kea reported FY2018 total sales of €6.8m (1% YoY) with sales of €2.1m (37% YoY) in Q4 highlighting the increasing traction for Cellvizio and validating the transition to the new pay-per-use ("PPU") model in the US. Total sales growth was largely driven by a 17% increase in consumables sales, the key performance indicator for PPU, in our view. As we expected, FY2018 revenues from Cellvizio straight sales declined (-13% YoY) as a result of the move to the new sales model, but this decline wa
Mauna Kea reported Q4/2018 financial results slightly below our expectations, however, with sales of €2.1m (37% YoY), Q4 represents the strongest quarter for Mauna Kea in 2018, thus highlighting the increasing traction for Cellvizio and validating the transition to the new pay-per-use ("PPY") model in the US. Total sales were largely driven by consumables sales of €0.8m, of which €0.3m were associated with PPY (112% YoY). As we expected, FY2018 revenues from Cellvizio straight sales declined (-1
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Full-year results were in line with the trading update of 21 July, with revenues of £31m (-2%), reflecting the impact of COVID-19 on out-patient procedure rates, resulting in 14% and 24% declines in adjusted EBITDA and pre-tax profit, respectively. Lower than expected procedure growth rates and the decision to discontinue non-core (non-chlorine dioxide products) reduces forecast revenues by c.£3m to £33m in FY 2022. However, higher gross profit and tight control of costs (+6%) results in an unch
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IXICO has provided an upgraded trading statement for FY21E following its previous update in August 2021. Revenues are now expected to be £9.2m (vs £8.7m previously), broadly in line with FY20A, which we see as a strong result given the pandemic and Huntington's Disease (HD) trials de-scope. EBITDA is expected to be materially ahead of FY20A's £1.3m, supported by strong Q4/21 trading, cost control and positive one-offs. The company has ended FY21 with a strong order book (£18.8m) and cash positio
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Today’s prelims are in line with management’s expectations with losses before tax in the period of £30.3m (vs. £29.4m prior year). Post-merger, 4D pharma is clearly a different beast with access to the largest global capital market for Pharma/Biotech, and supported by £25.2m (net) proceeds from corporate activity. The company has cash runway until Q2 2022 and is well placed to successfully execute its clinical development strategy with multiple shots on goal. Primary focus is on MRx0518 with two
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Exactly one year ago, the FTSE 100 closed at 5,862, having fallen 100 points on the day, the lowest point since mid-May 2020, due in part, to the strength of sterling vs US$ at $1.34. One year on, the FTSE 100 has risen to 7,119, a rise of 21%, it remains 7% below the peak in January 2020. From an international viewpoint, US and European markets continue to trade at record highs. The US Federal Reserve is close to withdrawing some of its economic support this year as inflation picks up and the e
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SkinBioTherapeutics has announced it will launch its lead commercial product, AxisBiotix-Ps on World Psoriasis Day, 29 October 2021. To support the launch, the company has begun to receive, and store finished product in the Netherlands (close to its manufacturing partner) ahead of initial launches in the UK and US. Clearly the launch of its first product is a significant step for SkinBioTherapeutics, marking the transition from development company to commercial operation. We are encouraged by th
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Synairgen reported interim results to 30 June in which the adjusted net loss was £32.8m with period-end cash of £46.2m. Substantial pre-commercial progress and manufacturing activities have made in the half, although slower country approvals for trial sites will result in Phase III data readout slipping into Q1 2022. With increasing evidence of the need for a broad-spectrum antiviral delivered to the lungs and recognition that vaccines don’t provide complete protection against hospitalisations d
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ANGLE reported an adjusted net loss of £7.2m (+58% vs. -£3.2m), with establishment revenues increasing 26% to £0.3m and costs rising 48% to £8.9m, reflecting the costs of opening its pharma services business and clinical laboratories in the US and UK. Net cash at 30 June was £21.0m, with a further £18.9m (net) placing proceeds after period-end. Evidence of momentum building within pharma services, backed by confirmation of three contract wins and multiple ongoing discussions (some of which are w
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Softline the global solutions and services provider in digital transformation and cybersecurity, with its headquarters in London, is considering proceeding with a potential initial public offering of global depositary receipts representing its ordinary shares. The Company is considering applying for admission of the GDRs to the standard listing segm
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The current situation in the CDMO arena looks a bit like an arms race and Lonza seems to have firm plans to be part of it. The recently updated mid-term guidance is the explanation to do so, in our view. Management is strongly dedicated to staying with the extraordinary high EBITDA margin for the coming years.
Lonza’s hybrid investors day was well attended in Zurich, in which we participated.
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The positive market research results for Eroxon®, released this morning, provides further support for the company’s ongoing partnering efforts. We continue to believe that MED2002 is a differentiated product with significant potential in both prescription and OTC markets, and look forward to further PK data followed by Phase III start in H1 2018.
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The oncology consultancy using mathematical models to support the development of cancer treatment regimens and personalised medicine solutions yesterday announced it has entered into a partnership with Tabula Rasa HealthCare® (TRHC) (NASDAQ: TRHC), a healthcare technology Company advancing the field of medication safety. Through this initiative, Physiomics' personalised docetaxel model will be integrated into TRHC's market-leading precision dosing solution, DoseMeRx®. Both parties expect positiv
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Samarkand Group Limited, the cross-border eCommerce technology and retail group opening up the world's largest market for brands and retailers, intends to IPO on the Apex Segment Aquis Stock Exchange Growth Market. Admission is targeted for March 2021. Cellular Goods a UK-based provider of premium consumer products based on biosynthetic cannabinoids announced its intention to join the main market (standard) this spring. Target valuation £20m raising c. £8m “to finalise the development and launch
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