GENinCode shares plunge on wider annual loss

(Sharecast News) - GENinCode shares plunged on Thursday after the predictive genetics company reported wider annual losses and said revenue in the first four months of 2026 was broadly flat year on year, despite higher full-year revenue and a recently strengthened balance sheet.

The AIM-traded company, which focuses on cardiovascular disease prevention and ovarian cancer risk testing, said revenue for the year ended 31 December rose 14% to �3.1m from �2.7m, driven by volume growth in the US and Europe.

Gross profit increased to �1.8m from �1.4m, with gross margin improving to 59% from 53%.

However, adjusted EBITDA losses widened to �4.9m from �4.4m, reflecting increased commercial support and a reduced annual research and development tax credit.

The operating loss widened to �5.9m from �5.1m, while the loss for the year increased to �5.7m from �4.4m.

Cash reserves at year-end stood at �0.8m, compared with �1.1m a year earlier.

The market reaction suggested investors were focused on the cash position, widening losses and the pace of near-term revenue growth, even after GENinCode completed a �4.7m fundraise after the year end.

For the first four months of 2026, the company said consolidated revenue was broadly in line with the same period in 2025, despite lower revenue from the NHS and the Catalonia pilot study.

GENinCode said US commercial activity continued to expand, with more than 45 clinics and hospital institutions onboarded by the end of 2025 for LIPID inCode and CARDIO inCode.

Since the period ended, that had increased to more than 70 US institutions and clinics, with orders ramping up in the first four months of 2026.

The company said the American College of Cardiology and American Heart Association had updated dyslipidemia and lipid management guidelines after the year end to include coronary artery disease polygenic risk scores as a new risk enhancer for heart disease prevention.

Discussions with the US Food and Drug Administration over CARDIO inCode-Score had progressed, with a new De Novo pre-market submission expected in the third quarter of 2026 and approval targeted by the end of the fourth quarter.

GENinCode said discussions had been extended to agree the ongoing programme to resolve remaining deficiencies, including further data on multi-ethnic population groups and additional statistical and medical review analysis.

The company also highlighted its collaboration with Thermo Fisher Scientific to manufacture, distribute and sell the CARDIO inCode coronary artery disease polygenic risk score test through Thermo Fisher's laboratory network in the US and EMEA. Commercial discussions over pricing and distribution were continuing.

In the UK, GENinCode said expansion of LIPID inCode in the North of England had recently been offset by headwinds from major strategic, organisational and funding changes across the NHS.

Its North East and North Cumbria implementation had processed about 2,800 familial hypercholesterolemia tests over the past 24 months, identifying more than 500 positive patients.

In Europe, the company reported continued demand for LIPID inCode in Spain and Italy, as well as growth at University Clinic Dresden in Germany.

CARDIO inCode pilots were progressing in Spain's Extremadura and Catalonia regions, while GENinCode said it was building on partnerships across the EU.

For ROCA, its ovarian cancer risk algorithm, the company said its first NHS commercial contract with University College London Hospitals had been announced, with contractual discussions ongoing with other NHS trusts. It was also seeking further adoption across the NHS and expansion in Europe.

Chief executive Matthew Walls said GENinCode continued to strengthen its commercial position, supported by progress with Thermo Fisher in the US and EU and recent US guideline changes that had increased visibility of its testing.

"Discussions have progressed with the FDA and we anticipate filing our updated De Novo PMA submission in the third quarter of 2026," he said.

"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."

During 2026, GENinCode said it expected to deliver year-on-year revenue growth, improved margins and reduced EBITDA losses as it moved towards breakeven.

It said growth would be supported by commercial expansion of LIPID inCode, scale-up of CARDIO inCode with Thermo Fisher, further progress in Germany, increased ROCA adoption and continued strengthening of its commercial teams.

At 1205 BST, shares in GENinCode were down 18.26% at 0.94p.

Reporting by Josh White for Sharecast.com.

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