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 2023 (“FY23”). FY23 saw the Company strengthen its commercial programme in the UK and Europe and prepare its novel genetic tests for introduction to the US market.

Financial and Operational highlights

• Year on Year revenues increased 51% to £2.2m (2022: £1.4m), driven by core test growth in the UK and Europe
• Approval of California state license, CLIA certification and CAP accreditation, opening the US market
• Launch of US Early Access Programs for LIPID inCode^® test for the diagnosis of familial hypercholesterolemia (“FH”) and CARDIO inCode^® test for the genetic risk of coronary artery disease (“CAD”)
• FDA ‘De Novo’ submission (transition from 510K) in November 2023 for CARDIO inCode®
• NHS clinical adoption of LIPID inCode^® for FH diagnosis and expansion in North of England
• Implementation of LIPID inCode^® in University Clinic Dresden, Germany for primary care diagnosis of FH
• CARDIO inCode^® pilot launched in Extremadura, Spain
• Adjusted EBITDA loss of (£6.7m) (2022: loss of (£5.6m) reflecting increased investment in the international commercialisation programme with
• Cash reserves of £2.5m at 31 December 2023 (2022: £9.7m)

Post-period end

• Successful completion of a £4.0m secondary placing to support scale up and commercialisation
• First revenues in US market and completion of commercial agreements with Wake Forest University Baptist Medical Center/Atrium Health, University of California - Irvine (UCI) and Indiana University (IU Health) - Executive Health and Concierge  
• Publication of data on CARDIO inCode^® in American Journal of Preventive Cardiology and Kaiser Permanente presentation of CARDIO inCode^® data at European Society of Cardiology preventive cardiology meeting in April 2024, showing that CARDIO inCode identifies individuals at the highest risk of CHD
• US Notice of Allowance (granted patent status) received for CARDiO inCode^®
• National Institute for Health and Care Excellence (NICE) approval of Risk of Ovarian Cancer Algorithm (ROCA®) test for women at high risk of ovarian cancer
• ROCA® license agreements recently completed with Genesupport.ch in Switzerland and Ordensklinikum in Austria 

Current trading and Outlook

• US commercial operations now started to complement growing UK and EU revenues and expect strengthening revenues across the business over the coming year
• April 2024 YTD consolidated revenues 37% higher than same period in 2023
• During 2024, the Company expects to complete the following key deliverables:
  • Significant increase in year-on-year revenue growth  
  • Commercial expansion of LIPID inCode^® and CARDIO inCode^® across the US market
  • Implementation of LIPID inCode^® and CARDIO inCode^® testing in leading US healthcare institutions and State-based healthcare systems 
  • Finalisation of De Novo FDA regulatory substantive review for the approval of the CARDIO inCode^® medical device to accelerate US sales
  • 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 develop ongoing collaborative discussions with pharmaceutical companies.
  • Following NICE guideline approval for ROCA test, commence first commercial programs in the NHS and EU.
  • Continued strengthening of the commercial, marketing and selling teams to support revenue growth.

Matthew Walls, Chief Executive Officer of GENinCode Plc said: “We are scaling up our business and increasing test revenues in the US, UK and Europe. Notably, we have commenced initial US payor claims and revenues and are broadening our NHS commercial relationships whilst continuing to expand our European business. We will maintain tight operational cost control to target breakeven over the medium term whilst offering significant business growth and opportunity. 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 2024.”

Investor meeting

The Company will host a presentation for investors via the IMC platform at 2pm BST on Tuesday, 4 June. The presentation is open to all existing and potential shareholders. Questions can be submitted pre-event via your Investor Meet Company dashboard up 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

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 2023 for GENinCode Plc. 

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

2023 Business review

In the preliminary results for the twelve months ending 31 December 2023, the Company saw a 51% increase in revenues to £2.2m (2022: £1.4m) driven by growth across its UK and European businesses.

The Group’s key products include:

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

LIPID inCode^® - 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

The Group is now starting its first commercial programmes in the US to complement its UK and European revenue growth.

US Business

The US clinical environment for genetic risk assessment continues to see positive developments including advancing statements from the US American College of Cardiologists/American Heart Association (ACC/AHA), for increasing recognition of polygenic risk scores (PRS) in the risk assessment of coronary artery disease.

Following the commissioning of our US CLIA (Clinical Laboratory Improvement Amendments) and College of American Pathologists (CAP) accredited diagnostic lab in California, the past year has focused on the set-up and completion of our Early Access Programmes (EAPs) for the soft launch of LIPID inCode^® and CARDIO inCode^® in the US market. The EAPs are a forerunner to full commercialisation with the programmes commissioning our cloud-based system (SITAB^®) for ordering, processing, algorithmic risk scoring and reporting to a select group of leading healthcare institutions and key opinion leaders in preventive cardiology. On completion of the EAPs, physicians were surveyed to gather feedback in preparation for the commercial introduction of PRS testing. The EAPs have now largely been completed and are transitioning into commercial programmes which will be the main focus of growth in 2024.

LIPID inCode^® is a globally leading test for Familial Hypercholesterolemia (FH) with increasing recognition by the US Centres for Disease Control (CDC) of the 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 and 2024 will see the first revenues for LIPID inCode^® emerging from its commercial adoption.     

Following the CARDIO inCode^® 510(k) medical device submission in August 2023, the Food and Drug Administration (FDA) reviewed the submission and noted CARDIO inCode^®‘s ‘first in class’ position and the deep clinical evidence for polygenic risk assessment of CHD. Based on these factors and the novel position of CARDIO inCode^®, the FDA requested the Company to transition to a De Novo pathway for market approval. The crossover to a De Novo pathway enables the Company to work with the FDA to establish a new polygenic regulatory class for the CARDIO inCode^® medical device based on its favourable benefit-risk profile and associated special controls thereby establishing a new regulatory standard for future polygenic tests in this class. Following the FDA request, the Group submitted its De Novo submission in November 2023 for market clearance and expects further updates from the FDA over the coming months. 

During the year we continued our collaboration with Indiana University (IU) School of Medicine, the largest US medical school, in preparation for the introduction of CARDIO inCode^® to the US market and expanded our collaboration with Kaiser Permanente, California, to assess CARDIO inCode^® for the polygenic risk assessment of coronary heart disease. In August 2023, Kaiser Permanente presented an abstract of their ongoing study programme with CARDIO inCode^® at the European Society of Cardiologists in Amsterdam, showing polygenic risk assessment in over 63,000 patients and the incidence of coronary heart disease over a 14 year follow up period. More recently the American Journal of Preventive Cardiology published the milestone Kaiser Permanente paper on ‘Polygenic risk and incident coronary heart disease in a large multiethnic cohort’ providing strong and growing clinical evidence for the inclusion of polygenic ‘lifetime’ risk assessment for prevention of coronary heart disease in national guidelines. We continue to work closely with Kaiser Permanente and IU and expect further instrumental clinical publications and results.

We also announced our first CARDIO inCode^® collaboration with MedStar Health, covering the states of Washington D.C. and Maryland to support our clinical utility programmes for CMS/payer reimbursement filings. The MedStar programme uses CARDIO inCode^® in a primary preventive care setting to advise physicians of the polygenic ‘lifetime’ risk of patients for coronary heart disease. The patient risk scores are then used in conjunction with traditional clinical risk assessment to personalise treatment including lifestyle change and therapeutic intervention. 

UK and Europe Business

In May 2023 the UK NHS announced the successful implementation of our first LIPID inCode^® NHS clinical programmes to improve diagnosis and turnaround time for the testing of Familial Hypercholesterolemia (FH). The implementation of this programme in the North of England supports the NHS 10-Year plan to identify 25% of individuals in the UK suffering with FH. LIPID inCode^® is being delivered at a reduced cost to the NHS, with rapid turnaround times for testing and an improved comprehensive diagnostic and risk assessment panel. Since the implementation we have processed over 1,000 FH tests in the North of England enabling the NHS Genetic Lab Hub to begin meeting their NHS long term targets. Resulting from this improved performance, the NHS North of England is the only region now meeting its FH test targets set out in the NHS 10 Year Plan. We anticipate an expansion in LIPID inCode^® testing across other NHS regions and genetic lab hubs in 2024.

Following the announcement of MVZ Uniklinikum, Germany collaboration in May 2023, sales of LIPID inCode^® have now commenced. Uniklinikum represents the largest treatment centre in Germany for patients suffering with FH and the German team is following a similar pathway to the NHS with state-based reimbursement for our initial LIPID inCode^® test.

The Spanish market saw a strengthening in revenue through 2023 with its core tests all seeing growing demand. The CARDIO inCode^® pilot implementation study in the Spanish region of Extremadura also continued to make good progress. The Extremadura region has a population of more than one million, with an estimated 50,000 individuals at risk of a cardiovascular event, e.g. heart attack. CARDIO inCode^® is expected to change clinical practice by identifying those individuals at high genetic risk and improve preventive treatment. Successful completion of the pilot in over 500 individuals will lead to the extension of the programme across the Extremadura region. 

In March 2024, the Risk of Ovarian Cancer Algorithm (“ROCA”) test received NICE recommendation as the preferred test for ovarian cancer surveillance in individuals at high risk of ovarian cancer who do not undertake risk reducing surgery. The new NICE guidance is focused on identifying and managing familial and genetic risk of ovarian cancer.

Publication of NICE guidance is an important milestone for the ROCA test. After many years of academic and corporate investment, the ROCA test has been comprehensively assessed by NICE as the surveillance technology of choice where patients at high risk of familial ovarian cancer decide to defer preventative surgery. Surveillance using the ROCA test will help individuals feel more supported while they start or grow their families or until they reach menopause, whilst also providing a cost-saving benefit for the NHS. We are now assisting the NHS to establish appropriate call and recall systems that will enable the ROCA test to be offered by the NHS to all eligible individuals.

Intellectual Property

We maintain an ongoing intellectual property programme to strengthen our existing patent portfolio and are advancing 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 FY23, the Company saw Year-on-Year revenues increase 51% to £2.2m (2022: £1.4m), driven by growth across our UK and European businesses. 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 2024, the Company successfully completed a £4.0m 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 £1.0m (2022: £0.6m) with a margin of 47% (2022: 44%).

Administrative expenses increased to £7.8m (2022: £6.3m). The year-on-year cost increase reflected growth in staffing and professional costs with the ramp up in US and UK investment in preparation for the US and UK laboratory commissioning and test service delivery, increased sales and marketing resources, and spending on market access and launch preparations. 

This increased commercial investment gave rise to an adjusted EBITDA loss for the year of (£6.7m) (2022: (£5.6m)), with the cash position at the end of December 2023 being £2.5m (2022: £9.7m).

Capital Structure

The total number of ordinary shares in issue was 95,816,866. The loss per share for the year ending 31 December 2023 was 7.0p/share. The Board of Directors will not be recommending a dividend payment for the year ended 31 December 2023. 

Outlook

With US commercial operations now starting to complement our growing UK and EU revenues, we anticipate strengthening revenues across the business over the coming year as we scale up testing to prevent cardiovascular disease. We are focused on commercial programmes with leading US hospital institutions whilst developing our UK NHS relationship and the expansion of our EU business. 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 in our core markets.

During 2024, we expect to complete the following key deliverables:

• Significant increase in year-on-year revenue growth  
• Commercial expansion of LIPID inCode^® and CARDIO inCode^® across the US market
• Implementation of LIPID inCode^® and CARDIO inCode^® testing in leading US healthcare institutions and State-based healthcare systems 
• Progression of our De Novo FDA regulatory submission for the approval of the CARDIO inCode^® medical device to accelerate US sales
• Expansion of the NHS programme for LIPID inCode^® and introduction of CARDIO inCode^®
• Expansion of the MVZ Uniklinikum, Germany collaborative programme
• Build on our EU partnerships and develop our ongoing collaborative discussions with pharmaceutical companies.
• Following NICE guideline approval for The ROCA test, commence first commercial programs in the NHS and 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 as well as explore acquisition opportunities to take advantage of the opportunities opening to us.

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 Statement of Comprehensive Income
for the Year Ended 31 December 2023

The notes form part of these financial statements

Consolidated Statement of Financial Position
31 December 2023

The notes form part of these financial statements

Consolidated Statement of Financial Position (Cont.)
31 December 2023

The financial statements were approved by the Board of Directors on 31 May 2024 and were signed on its behalf by:

….......................................................

Paul Foulger
Director
Date: 31 May 2024

Company Statement of Financial Position
31 December 2023

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 £13,842k (2022 – loss of £1,907k).

The financial statements were approved by the Board of Directors on 31 May 2024 and were signed on its behalf by:

…...............................................

Paul Foulger
Director
31 May 2024

Consolidated Statement of Changes in Equity
for the Year Ended 31 December 2023

Company Statement of Changes in Equity
for the Year Ended 31 December 2023

Consolidated Statement of Cash Flows
for the Year Ended 31 December 2023