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Novacyt Initiation of Coverage: Through the rapid commercialisation of a COVID-19 test, Novacyt has transformed its financial position. Demand for the Group's COVID-19 test and other COVID-19 reagents are expected to make up the majority of revenue generated until FY22E, whereupon the Group is looking to drive long-term growth across its business via the development of high-margin clinical diagnostics and establish itself as a leader in infectious disease testing.
Companies: Novacyt SAS
Despite challenges in the early part of the period, Yourgene has delivered a robust H1 performance and enters H2 with strong momentum on a number of fronts. Key strategic milestones were achieved in the period, including the launch of the flagship IONA Nx NIPT product on the Illumina platform in September and the acquisition of Coastal Genomics and associated fundraise in August. Both are supportive of FY estimates, as are the launch of Yourgene's Covid services and products such as DPYD, which are generating strong momentum. We make no change to our forecasts at this stage.
Companies: Yourgene Health Plc
Futura Medical has reported details of its third meeting with the FDA that firmed up the format of the six-month confirmatory study. The new trial, known as FM71, will involve c 100 patients with erectile dysfunction (ED). Around c 20 will be in the US and the balance will be similar to those who took part in the FM57 Phase III trial. The primary endpoint is efficacy against baseline assessment. The important secondary endpoints relate to speed of onset of effect and adverse events. There is no placebo and a comparison arm, using 5mg tadalafil (Cialis), will employ the same endpoints and provide an appropriate reference frame for an overall MED3000 risk/benefit analysis.
Companies: Futura Medical plc
ANGLE raised £19.6m (gross) to capitalise on the first-mover advantage that the FDA clearance for Parsortix will create, catalysing ANGLE’s ability to exploit the emerging multi-billion dollar liquid biopsy market. It will enable ANGLE to pursue multiple parallel revenue streams: (i) as a service provider to the pharma industry particularly looking to improve on immunotherapy patient outcomes (companion diagnostics) and (ii) to develop a number of specific clinical applications. Not only does it strengthen the balance sheet ahead of partner discussions but it provides the resources to develop in parallel relevant laboratory developed tests and fund the necessary clinical utility studies that will accelerate clinical adoption. We re-introduce forecasts and raise our target price to 150p (c.£310m EV), which is supported by risk-adjusted DCF and peer group analyses.
Companies: ANGLE plc
A positive trading update from SDI Group justifies upgrading FY 2021 sales and adjusted EPS forecasts by 10% and 15%, respectively, broadly to the levels we were forecasting before the COVID-19 pandemic struck in early 2020. Contract wins for MPB Industries (flowmeters for ventilators) and Atik Cameras (supplying cameras for PCR DNA amplifiers) are expected to be fulfilled within FY 2021 and consequently we leave FY 2022 forecasts unchanged. We are encouraged by the news that the other businesses within the group are seeing order patterns returning towards normality. We upgrade our target price to 110p, at which level the stock trades on multiples that compare favourably to both the market and peer comparators. Our forecasts exclude the potential for further acquisitions as the company continues to execute on its buy and build strategy.
Companies: SDI Group plc
The slow recovery in vaccination rates and lower patient visits to physicians weighed on the top-line, although prudent cost management ensured margin expansion in Q3. While rising COVID cases could postpone the recovery in the vaccines segment, sturdy demand for the newer class of respiratory and HIV drugs should make up for the shortfall. A strengthening presence in the oncology and lupus space is also a positive. Favourable results from COVID-related trials could be a needle-mover in Q4.
Companies: GlaxoSmithKline plc
Scancell has announced a proposed raise of up to £33m in additional funding at a price of 13p a share. Redmile Group will invest c £30m through an immediate £12.1m subscription in 93.1m new shares, with a further £17.9m as a convertible loan note (CLN) subject to shareholder approval. There is also an Open Offer of up to £3m (23.3m shares).
Companies: Scancell Holdings Plc
Allergy Therapeutics has announced the screening of the first patient in the G309 exploratory field study of Grass MATA MPL, a short course, aluminium-free, allergen-specific, subcutaneous immunotherapy (SCIT), in seasonal allergic rhinitis and/or rhinoconjunctivitis induced by grass pollen. G309 is a double-blind, placebo controlled, randomised study designed to evaluate the efficacy and safety of an optimized Phase III dose of 27,600 SU Grass MATA MPL. The trial will run for one year, capturing the 2020/21 allergy season, and recruit c 150 patients over 12 sites in Germany and the US. The primary endpoint is the combined symptom medication score (CSMS) averaged over the peak grass pollen season.
Companies: Allergy Therapeutics plc
Allergy Therapeutics (AGY.L): Initiation of field trial | Sensyne Health (SENS.L): Research agreement with Milton Keynes University Hospital
Companies: Allergy Therapeutics plc (AGY:LON)Sensyne Health Plc (SENS:LON)
The formal launch of DXRX - The Diagnostics Network marks a definitive step forward for Diaceutics. The development of an automated data platform brings a host of benefits to stakeholders and a meaningful number of collaborations are now live. With the share price now trading at a level more than 30% below that prior to September's interim results, we are upgrading our recommendation to Buy.
Companies: Diaceutics Plc
Aided by a strong improvement in trading in the core business and ongoing demand for the Primestore MTM device, EKF has indicated it is on track for a record monthly performance in October. In addition, Primestore MTM has recently been successfully evaluated by Public Health England in a peer-reviewed comparative study, which concluded it was the only commercially available sample collection device where no residual virus was detectable out of 23 tested. We believe this may bode well for wider UK market adoption in future. Having upgraded several times already this year, we make no further changes to our estimates, but continue to see sensitivity to the upside.
Companies: EKF Diagnostics Holdings plc
Venture Life aims to become a global leader in the self-care branded product market, where there are a number of structural growth drivers. It has a unique and scalable platform to develop, manufacture and distribute products, including its own brands and international customers’ brands. What is already a high margin business is poised to deliver a compelling mixture of top line growth with significant operating leverage. Performance in H1 (EBITDA +347%) highlights the potency of VLG’s model. Acquisitions can also leverage the platform to drive growth, and management has a very strong track record here. On top of this exciting growth play, there is also a chance that its Dentyl dual-action mouthwash could have applications to slow/reduce CV19 transmission, adding to the upside potential.
Companies: Venture Life Group Plc
ANGLE plc (AGL.L): Acceptance of FDA submission | Feedback plc (FDBK.L*): Partnership agreement | Open Orphan (ORPH.L): Human Challenge Study Model contract with UK Government
Companies: AGL FDBK ORPH
FY 2020 was the first full year of delivery under Oncimmune’s three-year plan of operational, technical and commercial targets for products and services, accomplishing major milestones to support their commercialisation, accelerating post period. Significantly, since year end, there has been a step-change in the performance of Oncimmune’s ImmunoINSIGHTS services business attracting new contracts with world leading biopharma companies and recently a high profile Government funded project to address COVID-19.
Companies: Oncimmune Holdings Plc
Synairgen has raised £80m to fund a Phase III trial for SNG001 in COVID-19 disease, which is due to commence in Q4 2020 and will be run globally by Parexel, with results expected in Q2 2021, and scale up manufacturing. This follows a successful pre-IND meeting with the FDA, which provided the guidance to commence such a study. Assuming that this trial replicates the results seen in the 100-patient Phase II trial, we would expect Emergency Use Approval (EUA) to follow shortly thereafter. Meanwhile, the Managed Access Programme (MAP) in the UK and Europe, run by Clinigen, could generate early commercial revenues. We have made adjustments to forecasts to reflect these costs and raise our SOTP rNPV target price to 420p, which could rise further should stockpiling orders be received.
Companies: Synairgen plc