Corporate News

Oxford, UK. GENinCode Plc (AIM: GENI), the predictive genetics company focused on the prevention of cardiovascular disease (“CVD”) and risk of ovarian cancer announces its audited final results for the twelve months ended 31 December 2024 (“FY24”). FY24 saw the Company introduce its novel polygenic tests to the US market and strengthen its commercial programme in the UK and Europe.    

Financial and Operational highlights

• Year on Year revenues increased 25% to £2.7m (2023: £2.2m), driven by volume growth in the UK and Europe
• First US test revenues received for LIPID inCode^® for the diagnosis of familial hypercholesterolemia (“FH”) and CARDIO inCode^® for the genetic risk of coronary artery disease (“CAD”)
• US Notice of Allowance (granted patent status) received for CARDIO inCode^®
• NHS expansion of LIPID inCode^® for FH diagnosis in North of England
• Growth of LIPID inCode^® in University Clinic Dresden, Germany for primary care diagnosis of FH
• CARDIO inCode^® pilot launched in Extremadura, Spain
• NICE recommendation for ROCA as preferred test for ovarian cancer surveillance
• Reduced Year on Year Adjusted EBITDA loss of (£4.4m) (2023: loss of (£6.7m)) reflecting increased revenues and strengthening margins
• Cash reserves of £1.1m at 31 December 2024 (2023: £2.5m)

Post-period end

• Successful completion of a £4.1m secondary placing to support scale up and commercialisation
• CARDIO inCode^® pilot launched in Catalunya region, Spain
• CARDIO inCode^® ‘De Novo’ progressive discussions to resolve deficiencies ongoing with Food and Drug Administration (FDA) for approval of CARDIO inCode^® for prevention of coronary heart disease in the US
• Inclusion of CARDIO inCode^® in the 2025 Centers for Medicare and Medicaid Services (CMS) Clinical Lab Fee Schedule 
• NHS (UCL) adoption of Risk of Ovarian Cancer Algorithm (ROCA®) test for women at high risk of ovarian cancer 

Current trading and Outlook

• For the first four months of FY25 consolidated revenues were 20% higher than same period in 2024
• During 2025, the Company expects to complete the following key deliverables:
  • Significant increase in year-on-year revenues, improving margins with a substantive reduction in EBITDA losses continuing to move the Company towards breakeven
  • Commercial expansion of LIPID inCode^® and scale-up of CARDIO inCode^® across the US market
  • Implementation of LIPID inCode^® and CARDIO inCode^® testing in leading US healthcare institutions and State-based healthcare systems 
  • Finalise discussions with FDA and agree De Novo approval pathway for CARDIO inCode^®
  • Expansion of the NHS programme for LIPID inCode^® and introduction of CARDIO inCode^®
  • Expansion of the MVZ Uniklinikum, Germany collaborative programme to provide LIPID inCode^® testing for its patients
  • Build on EU partnerships and finalise ongoing collaborative discussions
  • Growth of ROCA^® trust adoption in the NHS and expansion in EU
  • Continued strengthening of the commercial, marketing and selling teams to support revenue growth

Matthew Walls, Chief Executive Officer of GENinCode Plc said: “We have continued to grow and strengthen the business over the past year and are now beginning to advance US business revenues alongside the roll-out of our NHS test programme and expanding European business. We are holding ongoing and progressive discussions with the FDA for US regulatory approval of CARDIO inCode^® to significantly accelerate growth. Commensurate with the revenue growth and ongoing operational efficiencies, we are now moving the business towards breakeven. On behalf of the Board, I would like to thank our valued shareholders for their support, and we look forward to a positive remainder of 2025.”

Analyst briefing

A briefing open to equity research analysts will take place on Wednesday 4 June 2025 at 09.30am BST. To register and for more details please contact Walbrook PR on [email protected].

Investor presentation

Matthew Walls, Chief Executive Officer, and Paul Foulger, Chief Financial Officer, will provide a live presentation relating to the results via the Investor Meet Company platform on Thursday, 5 June at 2pm BST. The presentation is open to all existing and potential shareholders. Questions can be submitted pre-event via the Investor Meet Company dashboard until 9am the day before the meeting or at any time during the live presentation. To register, please use the following link: https://www.investormeetcompany.com/genincode-plc/register-investor

Investors can sign up to Investor Meet Company for free and add to meet GENinCode here. Investors who already follow GENinCode on the Investor Meet Company platform will automatically be invited.

For more information visit www.genincode.com

Enquiries:

About GENinCode:

GENinCode Plc is a UK based company specialising in genetic risk assessment of cardiovascular disease and ovarian cancer. Cardiovascular disease is the leading cause of death and disability worldwide.

GENinCode operates business units in the UK, Europe through GENinCode S.L.U., and in the United States through GENinCode U.S. Inc. 

GENinCode predictive technology provides patients and physicians with globally leading preventive care and treatment strategies. GENinCode invitro-diagnostic molecular tests combine clinical algorithms and AI bioinformatics to advance patient risk assessment to prevent the onset of cardiovascular disease and ovarian cancer.

CHAIRMAN AND CHIEF EXECUTIVE OFFICER’S STATEMENT

On behalf of the Board, we are delighted to present the audited financial statements for the twelve-month period ended 31 December 2024 for GENinCode Plc. 

This statement provides a summary of progress over the past year for the Group, recent developments, and an outlook for the year ahead.    

2024 Business review

During the period, the Company saw a 25% increase in revenues to £2.7m (2023: £2.2m), driven by growth across its UK and European businesses.  

GENinCode is a genetics company focused on the prevention of cardiovascular disease (“CVD”) and the early detection of ovarian cancer. The Group’s test portfolio includes: 

CARDIO inCode^® - Polygenic risk assessment of coronary heart disease

LIPID inCode^® - Prevention of heart disease, genetic diagnosis and risk assessment of familial (inherited) hypercholesterolemia

THROMBO inCode^® - Genetic diagnosis and risk assessment of thrombophilia and thrombotic risk

SUDD inCode^® - Genetic diagnosis and cause of sudden cardiac death and familial heart disease

ROCA^® - Risk of Ovarian Cancer Algorithm (“ROCA”) 

The Group is scaling its commercial programmes across the US, UK and Europe. 

US Business

GENinCode’s US strategy includes a targeted engagement plan focused on the top 250 US physicians in preventive cardiology and lipidology. The Company has built partnerships with US key opinion leaders (KOLs) and major institutions, supported by education programmes and our ‘SITAB’ portal (System of Integrated Traceability Analysis and Biology) to delivering polygenic risk scores and data registry capability. Our service-based testing is now seeking to expand across institutions, community clinics, and executive health settings. In addition, commercial payer discussions are progressing, focused on benefit investigation and securing payer coverage.

The Company has successfully onboarded over 20 top-tier institutional sites, mainly for the use of LIPID inCode with adoption expected to grow significantly, following CARDIO inCode-Score FDA approval and expanded insurance coverage. The Total Addressable Market for CARDIO inCode is estimated at $10.5 billion, with a Serviceable Available Market of $4.5 billion. Initial market scoping indicates an addressable patient pool of 21 million patients, with 8.5 million likely to be prescribed CARDIO inCode-Score once covered by insurance.

GENinCode’s core US products, CARDIO inCode and LIPID inCode, are US CLIA and CAP approved. Following the FDA notice of deficiencies received in April, the Company continues to hold ongoing and progressive discussions with the FDA regarding its ‘De Novo’ submission for CARDIO inCode-Score. US FDA approval of CARDIO inCode-Score would allow the test to be marketed nationally as a medical device in a ‘kit’ format, substantially expanding the US market.

In January 2025, the Company announced that its CARDIO inCode-Score test had been included in the U.S. Centres for Medicare and Medicaid Services (CMS) 2025 Clinical Lab Fee Schedule with a median price of approximately $500 per test. This is an important step in facilitating reimbursement from Medicare and Medicaid across the United States. In addition, the Company is preparing a MolDx submission for US state-based reimbursement once FDA approval is received.

The US clinical environment for genetic risk assessment of CVD continues to strengthen with statements from the US American College of Cardiologists/American Heart Association (ACC/AHA), recognising polygenic risk scores (PRS) as an important new risk parameter for comprehensive risk assessment of coronary artery disease.  

LIPID inCode^® is a globally leading test for Familial Hypercholesterolemia (FH) with increasing recognition by the US Centres for Disease Control (CDC) of the public health importance of testing to identify individuals suffering with FH as these individuals are at high risk of ‘earlier in-life’ onset of CVD, in the form of atherosclerosis, angina, heart attack or ischemic stroke. LIPID inCode^® has received reimbursement coding and medical classification coding (ICD-10) coverage in the US with an average insurance reimbursement of $1,229, reflecting the Clinical Laboratory Fee Schedule for the test and the broad Familial Hypercholesterolemia Panel of tests to identify FH genetic variants. 

UK and Europe Business

In the UK, our commercialisation strategy is focused on delivering prevention of heart disease and Familial Hypercholesterolemia (FH) testing within the NHS. The Company is building relationships with leading medical institutions and Health Innovation Networks (HINs) to enhance the detection and management of FH. FH affects approximately 1 in 250 individuals in the UK, equating to between 230,000 and 260,000 people.

The North East and North Cumbria NHS has now processed over 2,300 FH tests, helping the NHS Genetic Lab Hub meet its targets for FH detection, a critical element of the NHS Long Term Plan to prevent CVD. The NHS Long Term Plan focuses on preventing CVD and improving outcomes and is the single largest medical condition for NHS England where lives can be saved.

Additionally, the Company is introducing CARDIO inCode to the NHS, to prevent coronary heart disease (CHD). The Company continues to advance discussions with other NHS England trusts to broaden the implementation of both LIPID inCode and CARDIO inCode nationwide. We anticipate further expansion in LIPID inCode testing across other NHS regions and genetic lab hubs in 2025. 

In the EU our commercial products are CE-Marked, with CARDIO inCode, THROMBO inCode, and LIPID inCode generating revenues, primarily in Spain. Year-on-year revenue growth in Spain was driven by THROMBO inCode and LIPID inCode, supported by Spanish regions’ Familial Hypercholesterolemia (FH) detection plans. The regional roll-out of CARDIO inCode for cardiovascular prevention in primary care is contributing to growth with the recent announcement of the Catalonia roll-out, with other pilots underway in the Extremadura region and negotiations ongoing in Andalucía, Madrid and the Basque region.

The Catalonia region in Spain has adopted CARDIO inCode for primary care cardiovascular risk assessment, targeting a CVD addressable market of approximately 476,000 patients aged 45 to 64. Catalonia regional test volumes are expected to escalate to approximately 1,000 patient tests through 2025 as increasing numbers of physicians, community practices and regions are educated and onboarded for testing.

In Italy, direct business operations are expanding with partnerships such as Fondazione SISA supporting LIPID inCode. In Germany, LIPID inCode sales are strengthening through collaboration with Uniklinikum, leveraging the NHS model for implementation.

The Company has recently entered into an agreement with University College London (UCL) to be the first trust to adopt the Risk of Ovarian Cancer Algorithm (ROCA) Test within the NHS. NICE draft guidelines recommend ROCA testing every four months for women at risk of ovarian cancer. Final NICE guidance was released in March 2024 officially recommending the test. Efforts are underway to roll out the ROCA test across several NHS regions with support from Cancer Alliances and Specialised Services. The test has gained strong backing from gynaecological oncologists, geneticists, and genetic counsellors.

International expansion of ROCA is progressing, with agreements signed in Switzerland and Austria in 2024, with plans to expand into Germany and Spain. The US market remains under evaluation, with ongoing considerations based on progress in the UK and Europe.

Intellectual Property

We maintain an ongoing intellectual property programme to strengthen our existing patent portfolio and advance our family of patents for both CARDIO inCode^® and THROMBO inCode^®. We will continue to build our intellectual property portfolio and actively evaluate in-licensing and acquisition opportunities as appropriate to enhance our competitive product positioning. 

Financial review

In FY24, the Company saw year-on-year revenues increase 25% to £2.7m (2023: £2.2m), driven by growth across our UK and European businesses, as well as our first US revenues. The Company continues to scale its commercial programme across the US, UK and EU markets whilst maintaining tight control over its operational costs. At the beginning of 2025, the Company successfully completed a £4.1m secondary placing on AIM to support its commercialisation, scale-up and launch of new tests in the US and UK. Gross profit for the year was £1.4m (2023: £1.0m) with a margin of 53% (2023: 47%).  

Administrative expenses decreased to £5.9m (2023: £7.8m). The year-on-year Administrative cost reduction reflecting reduced investment in launch preparations, laboratory development costs, clinical studies and external advisory support costs.  The reduced Administrative costs gave rise to a reduced adjusted EBITDA loss for the year of (£4.4m) (2023: (£6.7m)), with the cash position at the end of December 2024 being £1.1m (2023: £2.5m). 

Capital Structure

The number of shares in issue at December 2024 was 176,964,424. The loss per share for the year ending 31 December 2024 was 2.53p/share. The Board of Directors will not be recommending a dividend payment for the year ended 31 December 2024. Following the recent secondary placing completed in March 2025, the total number of ordinary shares in issue is 286,882,042. 

Outlook

We expect to grow revenues across the business over the coming year based on increasing sales volumes and collaborations. We are focused on commercial programmes with leading EU and US hospital institutions whilst developing our UK NHS relationships and expanding our EU business. Following the FDA notice of deficiencies received in April, the Company has held positive discussions with the US FDA regarding its CARDIO inCode ‘De Novo’ submission. CARDIO inCode approval would represent a significant milestone and further growth accelerator for the Company as a ‘first in class’ low cost, commercially available genetic test to prevent heart disease, the leading cause of death globally. Given the challenging markets, we will grow revenues whilst maintaining a tight control over operational costs to target a breakeven/profit position over the medium term. We expect to de-risk our business model whilst delivering strong growth across our core markets. 

During 2025, the Company expects to complete the following key trading deliverables:

• Significant increase in year-on-year revenues, improving margins and ongoing reduction in EBITDA losses moving the Company towards breakeven 
• Commercial expansion of LIPID inCode^® and scale-up of CARDIO inCode^® across the US market
• Implementation of LIPID inCode^® and CARDIO inCode^® testing in leading US healthcare institutions and State-based healthcare systems 
• Finalise discussions with FDA and agree De Novo approval pathway for CARDIO inCode^®
• Expansion of the NHS programme for LIPID inCode^® and introduction of CARDIO inCode^®
• Expansion of the MVZ Uniklinikum, Germany collaborative programme
• Build on EU partnerships and finalise ongoing collaborative discussions
• Following ROCA UCL collaboration in the NHS, commence first surveillance tests in the NHS and expand EU.
• Continued strengthening of the commercial, marketing and selling teams to support revenue growth.               

We have a strong and growing competitive clinical advantage to identify patients at high genetic risk of coronary heart disease and improve preventive care for cardiovascular disease. 

Commensurate with this growth we will build investment in our international manpower resources and expertise. 

We continue to build our business and believe our tests are industry leading and will deliver significant investor returns. We would like to thank our investors, Board, management and employees for their strength and determination in helping support and drive our business growth. 

We look forward to updating our investors on our forthcoming progress.

Consolidated Income Statement
for the Year Ended 31 December 2024

Consolidated Statement of Comprehensive Income
for the Year Ended 31 December 2024

Consolidated Statement of Financial Position
31 December 2024

Company Statement of Financial Position
31 December 2024

Consolidated Statement of Changes in Equity
for the Year Ended 31 December 2024

Company Statement of Changes in Equity
for the Year Ended 31 December 2024

Consolidated Statement of Cash Flows
for the Year Ended 31 December 2024