Novacyt Regulatory News (NCYT)

Novacyt S.A.

("Novacyt", the "Company" or the "Group")

Half Year Trading update

Paris, France, and Eastleigh and Manchester, UK - 25 July 2024 - Novacyt S.A. (EURONEXT GROWTH: ALNOV; AIM: NCYT), an international molecular diagnostics company with a broad portfolio of integrated technologies and services, announces an unaudited trading update for the six months ended 30 June 2024.

Financial Highlights

· Unaudited Group statutory revenue for H1 2024 expected to be circa £10.3 million (H1 2023*: £3.3 million), of which c.£7.8 million relates to Yourgene Health ("Yourgene").

o  H1 2023 proforma revenue excluding COVID-19 sales was £11.4 million

· Encouraging growth in Reproductive Health (34% YoY increase on a proforma basis) and Non-invasive prenatal testing ("NIPT") (5% YoY increase on a proforma basis).

· Cash position at 30 June 2024 was £32.9 million (31 December 2023: £44.1 million), and the Group remains debt free.

· The Group is on track to deliver its target acquisition synergies by the end of 2024, reducing the annual cost base by £5.0 million following the acquisition of Yourgene, with the Directors believing further savings can also be made. 

· £5.0 million settlement fee was paid to the Department of Health and Social Care ("DHSC") in early July (post-period-end).

· Following the settlement with the DHSC as announced on 11 June 2024, the Group has submitted a request to reclaim circa £12.2 million VAT paid to HMRC relating to DHSC invoices that will now not be paid. The Company believes it is entitled to have all VAT refunded, however there is no guarantee that the claim will be successful and the timing of the refund is currently unknown. 

*excludes any Yourgene revenue as pre-acquisition

Commercial progress

Clinical

During the period the Company saw 34% growth on a proforma basis in its Reproductive Health business, due to the continued strong uptake of its cystic fibrosis portfolio in Australia, following a nationwide reimbursement pathway by the Australian government. The Company also saw 5% growth in its NIPT technology portfolio, as a number of former Genomic Services NIPT customers established in house laboratories and transitioned to higher margin technology customers for whom the Group now supplies its range of NIPT in vitro diagnostic ("IVD") workflows and tests.

The Group remains focused on building brand awareness and continues to have a significant presence at key international trade events, which has increased lead generation across the clinical portfolio. The team also hosted an educational summit for 20 distributors at the Company's Manchester facility to educate them on the expanded portfolio and discuss tactical commercial growth strategy across the regions.

Instrumentation

Ranger® Technology ("Ranger") remains an important part of the business and the Company continues to evaluate new opportunities across new human and non-human applications. Some instrumentation purchases in Ranger have been moved from H1 to H2, and the Group expects to see further evaluation and demonstration projects to mature throughout 2024. In May 2024, Yourgene signed a co-marketing agreement with Pacific Biosciences of California, Inc ("PacBio"), a leading developer of high-quality, highly accurate sequencing solutions with a global customer base, and the Company's global teams have sponsored a series of PacBio user meetings in the US and Thailand, enabling the business to demonstrate Ranger to and build relationships with PacBio's customer base, which has expanded the Ranger sales pipeline.

RUO

In June, Primer Design launched a real-time PCR workflow for rapid onsite detection of norovirus in oysters, a serious and growing threat to oyster farmers for which there are no other commercially available tests. The workflow was developed through customer feedback, and provides a user-friendly, cost-effective solution to identify contamination.

Regulatory/ R&D updates

In June 2024, the Company submitted its Yourgene Cystic Fibrosis Base for In Vitro Diagnostic Regulation ("IVDR") review and remains on track to submit future clinical products for IVDR approval.

In May 2024, Yourgene was granted a Human Tissue Authority ("HTA") Licence, enabling its Genomic Services division to test a wider range of tissue samples further broadening its service offering.

The Group has also begun to roll out onsite upgrades to existing customers for its IONA Nx NIPT workflow, with a number of enhancements including the capability to run 96 samples in one run rather than 48, giving IONA Nx a further competitive edge in the NIPT marketplace.

Taiwan update

The Group is in advanced stages of disposing of its Taiwanese laboratory business. The deal has been approved by the Taiwanese government and is expected to conclude shortly.

Commenting Lyn Rees, Chief Executive Officer, said: "The first half of 2024 has shown continued progress for us, with our efforts focused towards working as a single business, reducing our cost base and delivering growth following the acquisition of Yourgene. The settlement with the DHSC has allowed for complete focus on the integration and business growth.

"Despite some challenging trading conditions in H1, we have seen encouraging growth in Reproductive Health and in NIPT Technologies. Whilst we are concentrated on lowering our cost base, our R&D team is also developing an exciting pipeline of new products, which we expect to bring to market over the next 36 months. With strategic investment, this pipeline will ensure we have a balanced and exciting product portfolio that meets the specialist needs of our global customer base and allows us to expand into new technologies and applications."

 This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014.

Contacts

About Novacyt Group (www.novacyt.com)

Novacyt is an international molecular diagnostics company providing a broad portfolio of integrated technologies and services, primarily focused on the delivery of genomic medicine. The Company develops, manufactures, and commercialises a range of molecular assays and instrumentation to deliver workflows and services that enable seamless end-to-end solutions from sample to result across multiple sectors including human health, animal health and environmental.

The Company is divided into three business segments:

Novacyt is headquartered in Vélizy-Villacoublay in France with offices in the UK (in Stokesley, Eastleigh and Manchester), Taipei, Singapore, the US and Canada and has a commercial presence in over 65 countries. The Company is listed on the London Stock Exchange's AIM market ("NCYT") and on the Paris Stock Exchange Euronext Growth ("ALNOV").

For more information, please refer to the website: www.novacyt.com