RE: RNS25 Sep 2024 07:48
“FDA 'De Novo' completion of substantive review. Ongoing FDA discussions regarding additional information“
The US Food and Drug Administration (FDA) De-Novo submission for CARDIO inCode-Score was filed in November 2023 and the FDA has recently completed its substantive review. Whilst the FDA submission and review process has been protracted and longer than expected, discussions remain progressive and constructive. The FDA have requested additional information as part of their review of the CARDIO inCode-Score medical device and we anticipate this should finalise the review process. We expect to provide this information over the coming months and give a further update towards the end of this year. Approval of CARDIO inCode-Score will extend our US commercial offering enabling laboratory testing across the US.
Financial review
Revenue for the period was £1.39m (H1 2023: £0.95m), a year-on-year increase of 46%, with a reduced Adjusted EBITDA loss of (£2.16m) (H1 2023: (£3.37m)), the decreased loss resulting from improving revenues and profit margins coupled with lower operational costs across the Group.
Revenue
Spain continues to be the largest region for sales and enjoyed a year-on-year growth of 21%. Sales in the UK increased to £328k (H1 2023: £131k), reflecting the full six-month revenue benefit of LIPID inCode® sales to the NHS effective from May 2023.
The Group enjoyed its first revenues in the US and recognised £71k of LIPID inCode® sales in the period. LIPID inCode® continues to be the leading revenue generating product in the Company, representing over 60% of the sales, boosted by the significant increase in UK sales to the NHS as highlighted above.
Gross profit
Gross profit was £730k (H1 2023: £467k). The gross profit margin increased to 52.6% (H1 2023: 49.2%). Geographically, the gross profit margins generated from Spain remained the same at the sub 50% level, however the Group benefitted from 55%+ margins from the UK sales and 70%+ margins from the US sales.
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