Final Results
08 June 2026
Well positioned for accelerated commercial scale up with revenue growth and expanding US adoption
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 year ended 31 December 2025 (“FY25”). FY25 saw the Company strengthen its revenues in the US and Europe.
DownloadThese Results are available in PDF
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Operational highlights
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| University Clinic Dresden, Germany growth in primary care diagnosis and expansion of LIPID inCode and THROMBO inCode in Spain and Italy. |
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Post-period end
- Successful completion of a £4.7m secondary placing to support scale up and commercialisation.
- American College of Cardiology and American Heart Association (ACC/AHA) Dyslipidemia and Lipid Management guidelines updated including CAD PRS new ‘risk enhancer’ for prevention of heart disease.
- Progressing manufacturing and commercial preparations for CARDIO inCode (CAD PRS) launch with Thermo Fisher.
Current trading and Outlook
- First four months of the year to April 2026 consolidated revenues are broadly in line with the same period in 2025, despite lower revenues from NHS and Catalonia pilot study.
- Over 70 US Institutions and clinics now onboarded with ramp up in orders over the first four months of 2026 supported by new US ACC/AHA guidelines including CAD PRS for prevention of heart disease.
- Ongoing commercial discussions with Thermo Fisher regarding pricing and distribution of CARDIO inCode.
- Ongoing strategic discussions with NHS for prevention of heart disease and surveillance of ovarian cancer.
- During 2026, the Company expects to complete the following key deliverables:
- Increase in year-on-year revenues, improved margins with a reduction in EBITDA losses moving the Company towards breakeven
- Commercial expansion of LIPID inCode® and scale-up of CARDIO inCode® with Thermo Fisher
- Submit new FDA De Novo PMA for CARDIO inCode, targeting an approval end Q4.26.
- Expansion of the MVZ Uniklinikum, Germany collaborative programme to provide LIPID inCode® testing for patients
- Build on EU partnerships and finalise ongoing collaborative discussions
- Growth of ROCA® trust adoption across 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 continue to strengthen our commercial position supported by the progress of our Thermo Fisher collaboration in the US and EU and the recent US ACC/AHA guideline changes which have increased visibility of our testing and established Polygenic Risk Scores as a new ‘risk enhancer’ for the prevention of heart disease. Discussions have progressed with the FDA and we anticipate filing our updated De Novo PMA submission in Q3.2026. We have a busy period ahead and anticipate continued growth and commercial updates which we will advise in due course. With a strengthened balance sheet following our £4.7 million fundraise, growing commercial traction and continued progress towards our FDA submission, we believe we are well positioned to accelerate growth and deliver on our strategic objectives.”
Analyst briefing
A briefing open to equity research analysts will take place on Monday, 8 June 2026 at 09.30am BST. To register and for more details please contact Walbrook PR on genincode@walbrookpr.com.
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 Wednesday, 10 June at 11am 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.
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:
| GENinCode Plc | www.genincode.com or via Walbrook PR | ||
| Matthew Walls, CEO | |||
| Cavendish Capital Markets Limited | Tel: +44 (0)20 7397 8900 | ||
| Giles Balleny / Trisyia Jamaludin (Corporate Finance) | |||
| Nigel Birks (Life Sciences Specialist Sales)Harriet Ward (Corporate Broking) | |||
| Dale Bellis / Michael Johnson (Sales) | |||
| Walbrook PR Limited | |||
| Anna Dunphy | Tel: 020 7933 8780 or genincode@walbrookpr.com | ||
About GENinCode:
GENinCode Plc is a UK based company specialising in genetic risk assessment of cardiovascular disease. 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 preventative care and treatment strategies. GENinCode CE marked invitro-diagnostic molecular tests combine clinical algorithms and bioinformatics to provide advanced patient risk assessment to predict cardiovascular disease.
CHAIRMAN AND CHIEF EXECUTIVE OFFICER’S STATEMENT
On behalf of the Board, we are pleased to present the audited financial statements for the twelve-month period ended 31 December 2025 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.
2025 Business review
During the period, the Company saw a 14% increase in revenues to £3.1m (2023: £2.7m), driven by growth across its European and US 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 targeted test engagement of the top US physicians in preventive cardiology and lipidology. The Company continues to build partnerships with US key opinion leaders (KOLs) and major institutions, supported by education programmes using our ‘SITAB’ system (System of Integrated Traceability Analysis and Biology) to deliver polygenic risk scores and data registry capability. Our testing continues to expand across institutions, community clinics, and executive health settings.
The Company has now successfully onboarded over 45 top-tier institutional sites, mainly for the sale of LIPID inCode. Test volumes are anticipated to grow following the recent CARDIO inCode-Score Thermo Fisher collaboration and are expected to materially increase once FDA approval and expanded insurance coverage are received. 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 approximately 21 million patients, of whom around 8.5 million likely to be prescribed CARDIO inCode-Score once covered by insurance.
Following progressive and ongoing discussions with the FDA, the Company is now finalising its updated CARDIO inCode-Score Coronary Artery Disease Polygenic Risk Score (CAD PRS) De Novo Pre Market submission. Discussions with the FDA were primarily focused on provision of further data around multi-ethnic population groups, statistical and medical review analysis to confirm the accuracy of the new clinical data to be submitted to FDA. The agreed study requirements to resolve these remaining deficiencies have been included in the new Kaiser Permanente study protocols with the clinical studies now ongoing and expected to complete over the next quarter in preparation for the new Pre Market submission to be filed in Q3.26.
US FDA approval of CARDIO inCode-Score (CAD PRS) would allow the test to be marketed nationally as a Medical Device, substantially expanding the potential market opportunity in the US.
In January 2025 CARDIO inCode-Score was included in the US Centres for Medicare and Medicaid Services (CMS) 2025 Clinical Lab Fee Schedule with a median price of $500 per test. This development marks an important step in facilitating reimbursement from Medicare and Medicaid across the US. In addition, the Company is preparing its MolDx submission for US state-based reimbursement.
In December 2025, GENinCode and Thermo Fisher Scientific signed a collaboration covering manufacturing, distribution and sales of CARDIO inCode-Score to laboratories across the US and Europe, Middle East and Africa (EMEA) regions. Prior to US FDA approval, laboratories are being introduced to CARDIO in-Score as an ‘In House Assay’ for the prevention of heart disease. Once FDA Medical Device approval is received, the collaboration will extend to manufacturing and sale of the Medical Device to laboratories and test centres across the US. A similar approach will be adopted in the EMEA market.
Thermo Fisher Scientific has been chosen as the preferred partner based on the design and development of the CARDIO inCode-Score (CAD PRS) test on Thermo Fisher’s proprietary QuantStudio™ 5 Dx Real Time PCR System. The QuantStudio™ 5 Dx Real Time PCR System is globally available with significant installation coverage across the US and EMEA region. Increasing demand for CARDIO inCode-Score will be met by Thermo Fisher Scientific’s scale up of the test manufacturing. Thermo Fisher Scientific is a major global provider of genetic reagents to labs with an installed QuantStudio (QS Dx) platform user base.
The Thermo Fisher collaboration is non-exclusive for a 3 Year term that is extendable. Sales and distribution will be conducted through Thermo Fisher Scientific’s lab network with end pricing under discussion. GENinCode’s core US products, CARDIO inCode and LIPID inCode, are US CLIA and CAP approved.
GENinCode has built a significant body of clinical evidence around the clinical utility of the CARDIO inCode-Score (CAD PRS). In March 2026, post period end, the American College of Cardiology and American Heart Association announced an update to the Dyslipidemia and Lipid Management guidelines which now includes coronary artery disease polygenic risk scores (CAD PRS) as a new risk assessment tool for the prevention of heart disease. We are delighted to see CAD PRS included in the US guidelines to improve coronary heart disease risk Calculation, Personalisation and Reclassification (CPR) to prevent heart disease.
LIPID inCode is a 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 cardiovascular disease, in the form of atherosclerosis, angina or heart attack. 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, we continue to progress our NHS commercial collaboration to improve diagnosis and turnaround time for testing of Familial Hypercholesterolemia (FH) and for the prevention of heart disease using coronary artery disease (CAD) and cholesterol (LDL) polygenic risk scores at significantly reduced costs to the NHS. The LIPID inCode implementation in the North-East and North-Cumbria (Newcastle) has now resulted in GENinCode processing approximately 2,800 FH tests over the past 24 months enabling the region to meet the NHS 10 Year Plan. Importantly, the region is the only region in NHS England to meet the NHS 10 Year Plan for FH testing. FH genetic testing is critically important to diagnose patients in the population who are at high risk of heart disease and from these tests over 500 positive FH patients have been identified and diagnosed.
https://thehealthinnovationnetwork.co.uk/case_studies/genomic-testing-for-cardiovascular-conditions/
Whilst we have made great progress to support the NHS for FH diagnosis and cardiovascular disease prevention, future progress has been slowed by the major strategic, organisational and funding changes across the NHS.
There is continuing and growing demand for LIPID inCode in Spain and Italy and for the introduction of THROMBO inCode in public hospital labs.
We are progressing the CARDIO inCode-Score pilot studies in the Spanish regions of Catalonia and Extremadura. We tested approx. 900 individuals with the final results under review. The Catalonia region has a population of approx. 7.7 million, with an estimated 476,000 individuals at risk of a cardiovascular event e.g. heart attack.
The Extremadura region has a population of approx. one million, with an estimated 50,000 individuals at risk of a cardiovascular event. CARDIO inCode-Score is expected to change clinical practice by identifying those individuals at high genetic risk and improving preventive treatment.
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-Score for cardiovascular prevention in primary care has contributed to growth, with the 2025 announcement of the Catalonia regional pilot implementation providing successful preliminary clinical results. Other pilots are underway in the Extremadura region and negotiations are ongoing in further Spanish regions including Andalucía, Basque region, and Baleares.
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.
In December 2025, the Company entered into collaboration with Sohin Genetics, Mexico to distribute the CARDIO inCode-Score (CAD PRS) test for the prevention of coronary artery disease. Mexico has a population of over 130 million with an estimated cardiovascular disease market of USD$ 4.3 billion, with coronary artery disease the leading cause of death.
In October 2025, the Company 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 FY25, the Company saw year-on-year revenues increase 14% to £3.1m (2024: £2.7m), driven by growth across the UK, EU, and US businesses. The Company continues to scale its commercial programme across these core markets whilst maintaining tight control over its operational costs. Gross profit for the year was £1.8m (2024: £1.4m), with an improved margin of 59% (2024: 53%).
Administrative expenses increased to £6.7m (2024: £5.9m). The year-on-year increase in Administrative costs reflects the extended commercial costs of selling and scaling the business, together with reduced R&D tax credits, gave rise to an increase in total comprehensive loss for the year of (£5.5m) (2024: (£4.3m)). The cash position at the end of December 2025 was £0.8m (2024: £1.1m). At the beginning of 2026, the Company successfully completed a £4.7m secondary placing on AIM to support its commercialisation and scale-up.
Capital Structure
The number of shares in issue at 31 December 2025 was 286,882,042. The loss per share for the year ending 31 December 2025 was 2.08p/share. The Board of Directors will not be recommending a dividend payment for the year ended 31 December 2025. Following the recent secondary placing completed in February 2026, the total number of ordinary shares in issue is 753,041,137.
Outlook
We expect to see revenues grow across the business over the coming year based on increasing sales volumes initially through the Thermo Fisher collaboration and subsequently, through the FDA Pre Marketing approval of CARDIO inCode-Score once it receives FDA approval. We are focused on commercial opportunities with leading US and EU labs and hospital institutions whilst maintaining readiness to develop our UK NHS relationship. Following progressive discussions with the FDA regarding CARDIO inCode-Score, we expect to submit our updated ‘De Novo’ Pre Market submission over the coming months. CARDIO inCode-Score approval represents a significant milestone and 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 2026, the Company expects to complete the following key deliverables:
- Increased Year-on-Year revenues and improving margins with a reduction in EBITDA losses moving towards breakeven
- Commercial expansion of LIPID inCode and scale-up of CARDIO inCode
- Implementation of LIPID inCode and CARDIO inCode testing in leading US healthcare institutions and State-based healthcare systems
- Progress FDA De Novo Pre Market submission for approval of CARDIO inCode-Score
- Expansion of the MVZ Uniklinikum, Germany collaborative programme to provide LIPID inCode® testing for its patients
- 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
We have a strong and growing competitive clinical advantage to identify patients at high genetic risk of coronary heart disease and to improve preventive care.
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.
| Matthew Walls | William Rhodes |
| Chief Executive Officer | Chairman |
| 5rd June 2026 | 5rd June 2026 |
Consolidated Income Statement for the Year Ended 31 December 2025
| Notes | 2025 | 2024 | |||
| £’000 | £’000 | ||||
| CONTINUING OPERATIONS | |||||
| Revenue | 4 | 3,076 | 2,701 | ||
| Cost of sales | (1,272) | (1,275) | |||
| GROSS PROFIT | 1,804 | 1,426 | |||
| Administrative expenses | (6,670) | (5,873) | |||
| ADJUSTED EBITDA | (4,866) | (4,447) | |||
| Depreciation | (163) | (240) | |||
| Amortisation | (103) | (107) | |||
| Share based payment expense | (761) | (397) | |||
| Impairment loss | - | (149) | |||
| Reversal of contingent consideration provision | - | 206 | |||
| OPERATING LOSS | 5 | (5,893) | (5,134) | ||
| Other income | 7 | 43 | 99 | ||
| Finance charge | 7 | (13) | (48) | ||
| LOSS BEFORE INCOME TAX | 5 | (5,863) | (5,083) | ||
| Income tax | 8 | 158 | 649 | ||
| LOSS FOR THE YEAR | (5,705) | (4,434) | |||
| ATTRIBUTABLE TO: | |||||
| Equity holders of the parent company | (5,705) | (4,434) | |||
| LOSS PER SHARE | |||||
| Basic earnings per share (pence) | 10 | (2.08) | (2.53) | ||
| Diluted earnings per share (pence) | 10 | (2.08) | (2.53) | ||
Consolidated Statement of Comprehensive Income 31 December 2025
| 2025 | 2024 | ||||
| Notes | £’000 | £’000 | |||
| LOSS FOR THE FINANCIAL YEAR | (5,705) | (4,434) | |||
| Other comprehensive income | |||||
| Items that are or may be subsequently reclassified to the profit and loss: | |||||
| Exchange differences on translation of foreign operations | 198 | 132 | |||
| OTHER COMPREHENSIVE INCOME FOR THE YEAR | 198 | 132 | |||
| TOTAL COMPREHENSIVE LOSS FOR THE YEAR | (5,507) | (4,302) |
Consolidated Statement of Financial Position 31 December 2025
The financial statements were approved and authorised for issue by the Board of Directors on 5 June 2026 and were signed on its behalf by:
….......................................................
Paul Foulger
Director
Date: 5 June 2026
Company Statement of Financial Position 31 December 2025
As permitted by Section 408 of the Companies Act 2006 GENinCode Plc has taken the exemption from presenting its unconsolidated profit and loss account. The parent company's loss for the financial year was £4,639k (2024 – loss of £4,808k).
The financial statements were approved and authorised for issue by the Board of Directors on 5 June 2025 and were signed on its behalf by:
…...............................................
Paul Foulger
Director
5 June 2026
Consolidated Statement of Changes in Equity for the Year Ended 31 December 2025
| Foreign | Share | |||||
| Called up | Share | Currency | based | |||
| share | premium | Translation | payment | Retained | Total | |
| capital | account | Reserve | reserve | earnings | equity | |
| £’000 | £’000 | £’000 | £’000 | £’000 | £’000 | |
| Balance at 1 January 2024 | 958 | 15,551 | 45 | 246 | (15,511) | 1,289 |
| Changes in equity | ||||||
| Loss for the financial year | - | - | - | - | (4,434) | (4,434) |
| Other comprehensive income | - | - | 132 | - | - | 132 |
| Total comprehensive (expense)/income | - | - | 132 | - | (4,434) | (4,302) |
| Share based payments | - | - | - | 397 | - | 397 |
| Equity issue | 812 | 2,931 | - | - | - | 3,743 |
| Total transactions with owners, recorded directly in equity | 812 | 2,931 | - | 397 | - | 4,140 |
| Balance at 31 December 2024 | 1,770 | 18,482 | 177 | 643 | (19,945) | 1,127 |
| Changes in equity | ||||||
| Loss for the financial year | - | - | - | - | (5,705) | (5,705) |
| Other comprehensive income | - | - | 198 | - | - | 198 |
| Total comprehensive (expense)/income | - | - | 198 | - | (5,705) | (5,507) |
| Share based payments | - | - | - | 761 | - | 761 |
| Equity issue | 1,099 | 2,644 | - | - | - | 3,743 |
| Total transactions with owners, recorded directly in equity | 1,099 | 2,644 | - | 761 | - | 4,504 |
| Balance at 31 December 2025 | 2,869 | 21,126 | 375 | 1,404 | (25,650) | 124 |
Company Statement of Changes in Equity for the Year Ended 31 December 2025
| Called up | Share | ||||
| share | Premium | Share based payment | Retained | Total | |
| capital | account | reserve | earnings | equity | |
| £’000 | £’000 | £’000 | £’000 | £’000 | |
| Balance at 1 January 2024 | 958 | 15,551 | 246 | (15,255) | 1,500 |
| Changes in equity | |||||
| Loss for the financial year | - | - | - | (4,808) | (4,808) |
| Total comprehensive (expense)/income | - | - | - | (4,808) | (4,808) |
| Share based payments | - | - | 397 | - | 397 |
| Equity issue | 812 | 2,931 | - | - | 3,743 |
| Total transactions with owners, recorded directly in equity | 812 | 2,931 | 397 | - | 4,140 |
| Balance at 31 December 2024 | 1,770 | 18,482 | 643 | (20,063) | 832 |
| Changes in equity | |||||
| Loss for the financial year | - | - | - | (4,639) | (4,639) |
| Total comprehensive (expense)/income | - | - | - | (4,639) | (4,639) |
| Share based payments | - | - | 761 | - | 761 |
| Equity issue | 1,099 | 2,644 | - | - | 3,743 |
| Total transactions with owners, recorded directly in equity | 1,099 | 2,644 | 761 | - | 4,504 |
| Balance at 31 December 2025 | 2,869 | 21,126 | 1,404 | (24,702) | 697 |