Western market progress but developing markets difficult

Genedrive plc (GDR) is a commercial-stage biotech focused on point-of-care molecular diagnostics. Its Genedrive® molecular diagnostic platform offers low-cost, simple-to-use devices for highly sensitive and specific testing. The rapid analysis of samples aids real-time decision-making, whether in clinical, public health or biothreat applications. GDR is developing a portfolio of assays for the Genedrive device, with its hepatitis C virus (HCV) and biothreat assays already on the market. The HCV diagnostics market is proving challenging due to a lack of access to HCV drugs, but biothreat revenue should support GDR in fiscal 2020.

• Strategy: Now that the Genedrive technology platform has received CE marking, management has completely re-focused the company onto the commercialisation pathway for gene-based diagnostics in hepatitis C, TB, biothreat pathogen detection and Antibiotic-Induced Hearing Loss (AIHL).
• Interims: Ongoing challenges with commercialisation of the HCV-ID kit and delays in delivering orders to the Department of Defense (DoD) have combined with expiry of grant-funded programmes to deliver group sales of £0.6m (£1.5m) in 1H’20. Product sales were ca£0.33m (£0.78m), the majority from the DoD.
• Operational progress: Regulatory approval for HCV-ID was achieved in India at the end of 1H’20; however, although the WHO pre-qualification assessment is still ongoing, expected completion is now further delayed. Crucially, the DoD increased its framework contract for pathogen detection by $2.0m/£1.5m.
• Risks: The Genedrive platform has been validated by CE marking of the HCV-ID and RNR1 kits, repeat orders from the US DoD, and funding from Innovate UK and the NIHR. The key risks are commercialisation in undeveloped global health markets and funding for anti-viral or anti-microbial drugs.
• 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 large, global opportunity – should market factors improve, the HCV-ID test has excellent potential. The next 12 months will be indicative of GDR’s ability to deliver traction across two assays.