Genedrive (GDR) H1 2024 earnings summary

Executive summary

• Focus on advancing point-of-care pharmacogenetic testing with two main products: MT-RNR1 ID Kit and CYP2C19 ID Kit, both progressing through regulatory approvals including NICE recommendations and UKCA marking.

• Achieved initial international sales of MT-RNR1 ID Kit, expanded distributor network including a key US partnership for FDA trials, and shifted to direct sales in UK/Ireland.

• Ongoing evidence generation supported by NICE, NIHR/OLS funding applications, and DEVOTE grant for CYP2C19 clinical validation.

• Addressable markets estimated at £100M for MT-RNR1 and £220M for CYP2C19 globally, with growing NHS and professional body support.

• CEO and CSO appointments in September 2023 brought extensive diagnostics and genomics experience.

Financial highlights

• Revenue and other income for H1 FY24 increased to £238k from £21k year-over-year, driven by new product launches and international expansion.

• R&D spend reduced slightly to £1.88m as focus shifted to near-commercialisation product development.

• Operating loss narrowed to £2.36m from £2.68m year-over-year; loss after tax improved to £2.04m; basic loss per share improved to 2.0p.

• Net cash outflow for H1 FY24 was £1.38m, with cash at bank of £1.23m at period end; post-period R&D tax credit of £0.8m received.

• Underlying monthly cash burn rate remains at approximately £0.4m; weighted average shares in issue increased to 103.9m.

Outlook and guidance

• Revenue expected from additional UK and international go-live sites for MT-RNR1; final NICE recommendations for CYP2C19 expected July 2024.

• Completion of DEVOTE clinical study for CYP2C19 to support CE-IVDR accreditation and UK sales launch; IVDR approval anticipated by end 2024/early 2025.

• FDA registration for MT-RNR1 and IVDR registration for CYP2C19 targeted for 2024-2025; plans to raise further equity funding to support US clinical trials and regulatory approvals.

• Board remains optimistic but acknowledges material uncertainty over going concern due to limited cash runway through May 2024 and need for additional funding.