Genedrive (GDR) H1 2025 earnings summary

Executive summary

• Achieved first UK commercial sales of Genedrive® CYP2C19-ID Kit, with implementation at major NHS stroke centers and positive value assessments from NICE and SHTG.

• Scottish Government announced £800k investment for national rollout of MT-RNR1 testing in newborns; 11 babies identified as positive since test introduction, preventing lifelong hearing loss.

• Expanded operational capabilities, increased headcount, and strengthened international distribution, with installations in Italy and Saudi Arabia.

• NICE and FDA Breakthrough Device Designation support for both flagship products, with regulatory progress in the UK, EU, and US.

Financial highlights

• Revenue and other income for H1 2024/25 was £0.35m, up from £0.24m in H1 2023/24.

• R&D spend increased to £2.1m (H1 2023/24: £1.9m); operating loss widened to £2.6m (H1 2023/24: £2.4m).

• Loss after taxation was £2.3m (H1 2023/24: £2.0m); basic loss per share was 0.4p (H1 2023/24: 2.0p).

• Cash at 31 December 2024 was £2.1m, declining to £1m by 20 March 2025; equity fundraise of up to £1.25m announced.

• Net assets at 31 December 2024 were £3.1m (30 June 2024: £5.4m).

Outlook and guidance

• Anticipates growing commercial opportunities in the UK and internationally, with focus on both sales and non-dilutive grant income.

• CE-IVD certification for CYP2C19 test expected April 2025, enabling broader international sales.

• U.S. market entry progressing for both products, with regulatory engagement ongoing and FDA Breakthrough Device Designation in place.

• Additional funding extends cash runway to pursue commercial opportunities; Board continues to assess longer-term financing options.