Genedrive (GDR) H2 2024 earnings summary

Executive summary

• Two flagship point-of-care pharmacogenetic tests, MT-RNR1 and CYP2C19, address neonatal antibiotic-induced hearing loss and stroke management, are recommended by NICE, and have strong clinical and economic value with no direct competitors.

• Achieved significant operational milestones, including initial UK and international sales, regulatory progress, and positive health technology assessments.

• The company is focused on growing adoption in the UK and internationally, using direct sales domestically and distributor networks abroad.

• Positioned in a global market estimated at over £320M annually, with significant opportunities in the US, UK, Europe, and Middle East.

Financial highlights

• Revenue and other income rose to GBP 500,000 (FY24: £0.5M) from GBP 55,000 (FY23: £0.06M), driven by increased adoption and grant income.

• R&D costs increased to GBP 4.2 million (FY23: £3.9M), reflecting product development and clinical study expenses.

• Loss after tax was GBP 7.1 million (FY23: £5.2M), with a year-end cash position of GBP 5.2 million (FY24: £4.6M) and monthly cash consumption reduced to GBP 330,000.

• Successful equity fundraising of GBP 6 million gross in June 2024 supported commercial growth initiatives.

• Net cash inflow was GBP 2.6 million, with unaudited cash at Nov 21 of GBP 3 million.

Outlook and guidance

• Anticipated FDA approval for MT-RNR1 in the US by late 2026, with ongoing efforts to expedite the process.

• On track with regulatory and registration processes for target regions, including US FDA submissions for both products.

• Expectation of increased commercial traction and revenue growth in 2025 as more live sites are established and pilots continue in the UK and Scotland.

• Updates expected on Scottish implementation, CYP2C19 CE-IVD certification by end of Q1 2025, and further international expansion.

• Focused on expanding into regions recognizing UKCA, CE-IVD, and US FDA approvals.