Accelerating into fiscal 2019 with first sales

genedrive plc (GDR) is a commercial-stage company focused on point-of-care molecular diagnostics. Its Genedrive® molecular diagnostic testing platform is at the forefront of this technology, offering a rapid, low-cost, simple-to-use device with high sensitivity and specificity in the diagnosis of infectious diseases. Rapid analysis of patient samples greatly aids clinical and public health decision-making, with field testing particularly important in emerging markets. The 2018 fiscal year saw solid operational progress to generate first commercial sales. CE marking of the assay for hepatitis C virus (HCV) detection was awarded, and three commercial partnerships were agreed.

• Strategy: Now that the Genedrive technology platform has received CE marking, the new management team has completely re-focused the company onto the commercialisation pathway for gene-based diagnostics, signing three important commercial agreements, and divesting its Services Business unit.
• Full-year results: FY’18 was the first reporting period to include commercial product sales. Genedrive and HCV assay revenues contributed £0.13m to the £1.94m total for the Diagnostics Business (£2.62m). The Services Business was divested towards the end of the period, contributing £0.96m in net proceeds.
• Post-period fundraise: GDR has raised a total of £6.0m through a mix of debt and equity: a Placing of 15.2m shares @ 23p to raise £3.5m (gross), coupled with a loan note for £2.5m from the British Growth Fund. On completion (10 December), this boosted GDR’s cash position to an estimated £8.0m.
• Risks: The platform technology has been de-risked through the receipt of CE marking for its assay for detection of HCV infection. The main risk is commercial, given that it often takes time for new technologies to be adopted. However, partnering with major global and local experts reduces this risk.
• Investment summary: Genedrive technology ticks all the boxes of an ‘ideal’ in vitro diagnostic that satisfies the need for powerful molecular diagnostics at the point of care/need. The hepatitis C market is a very large global opportunity, and the HCV-ID test has excellent potential, even in developing countries. With strong partners being signed for different countries, such as the NHS in the UK, and evidence of early sales traction, GDR is at a very interesting inflection point.