hVIVO plc – Unaudited Interim Results for Six Months Ended 30 June 2025

Interim results

Trading in line with expectations for full year

Returning to growth in 2026 

hVIVO plc (AIM: HVO), a full-service early phase Contract Research Organisation (CRO) and the world leader in human challenge clinical trials, announces its unaudited interim results for the six months ended 30 June 2025 (“H1 2025”). 

Financial summary

Revenue of £24.2 million (H1 2024: £35.6 million), in line with expectations of £47 million for the full year

·    Includes £5.2 million and £0.3 million revenue contribution from CRS and Cryostore respectively

EBITDA (pre-exceptionals*) of £3.0 million (H1 2024: £8.7 million)

·    EBITDA margin of 12.5% (H1 2024: 24.5%)

·    Net EBITDA loss from acquisitions of £0.5 million

Basic adjusted earnings per share of 0.29p (H1 2024: 0.81p)

Cash of £23.3 million as at 30 June 2025 (30 June 2024: £37.1 million) reflecting acquisition purchases

Weighted contracted orderbook of £40 million as at 30 June 2025 (30 June 2024: £71 million)

*exceptional items comprise acquisition related and restructuring costs of £1.4 million Operational highlights

Synergistic acquisitions of two Clinical Research Units from CRS and Cryostore completed for £10.5 million net of cash acquired

Integration near completion and sales synergies being realised

Strong progress with Clinical Services and hLAB services – completed delivery of 817 participant Phase II influenza trial

£3.2 million hLAB contract signed for an international, multi-site Phase II field trial

£5.5 million CRS contracts signed in the period, the majority of which will be recognised in 2025

Letter of Intent (“LOI”) signed with ILiAD Biotechnologies (“ILiAD”) for world’s first pivotal Phase III human challenge trial (“HCT”) which is expected to be the Group’s largest HCT to date

Bacterial lab fit-out completed ahead of future bacterial HCTs and hLAB contracts

 Post-period end highlights

Strong sales in new diversified service lines with c.£2 million and c.£5 million of new awards for Clinical Services and hLAB respectively

New Phase III clinical site study and awarded, expected to commence Q4 2025 with the majority of revenue expected to be recognised in 2026

Positive data generated from the final stage of the hMPV (human metapneumovirus) characterisation study, the world’s only contemporary-strain hMPV human challenge model is now available for vaccine and antiviral trials

Appointment of Shaun Chilton as independent Non-Executive Chair

 

Outlook

Trading remains in line with market expectations for the full year with the Company expecting to deliver revenues of £47 million and low-single digit EBITDA loss (pre-exceptional items) for the full year. The Company’s weighted contracted orderbook stood at £40 million as at 30 June 2025 with a strong pipeline of opportunities across the Group’s service lines with major opportunities in advanced discussion.

The aggregate value of customer proposals submitted in H1 2025 surpassed FY24 which bodes well for the medium-term growth of the Group, as does the increased conversion rate of proposals to contracts by CRS year-to-date versus 2024. A greater number of cross-selling opportunities between CRS and Venn Life Sciences are also being realised, with a further £2.1 million of Venn connected opportunities now in the CRS sales pipeline.

The Board remains confident in the long-term growth potential of hVIVO, both with the Company’s world leading HCT business and its new diversified service lines. Macroeconomic and sector specific headwinds continue to impact the HCT opportunity conversion rate which the Board expects to be transitory. hVIVO expects to achieve high-single digit revenue growth in 2026 on the back of anticipated growth in its newly diversified services and moving towards a normalisation of HCT activity.

Dr Yamin ‘Mo’ Khan, Chief Executive Officer of hVIVO, said: “The broader CRO industry has been impacted by macroeconomic and sector-specific headwinds, and hVIVO is no exception. However, we are greatly encouraged by the early success of our diversification strategy and by the strength of our pipeline, with the aggregate value of customer proposals submitted in H1 2025 exceeding FY24. Looking ahead we are focused on finalising the integration of CRS and Cryostore into the Group, realising further synergies presented by these bolt-ons, converting our pipeline into revenue, and positioning the business to return to sustainable growth in 2026 and beyond.”

Investor presentation

Yamin ‘Mo’ Khan, Chief Executive Officer, and Stephen Pinkerton, Chief Financial Officer, will provide a live presentation via the Investor Meet Company platform today at 18:00 BST.

The presentation is open to all existing and potential shareholders. Questions can be submitted at any time during the live presentation. Shareholders should be aware that the Company may not be in a position to provide answers to all questions, particularly in relation to forward-looking information beyond that disclosed in the trading update.

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

A copy of the investor presentation will be made available on the Company’s website here.

hVIVO plc

+44 (0)20 7756 1300

Yamin ‘Mo’ Khan, Chief Executive Officer

Stephen Pinkerton, Chief Financial Officer

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 Notes to Editors

hVIVO plc (Ticker: HVO) is full-service early phase Contract Research Organisation (CRO) and the global leader in human challenge trials. The company delivers end-to-end clinical development services to a diverse and expanding client base, including seven of the world’s ten largest biopharma companies.

hVIVO specialises in conducting human challenge trials across multiple infectious and respiratory indications, leveraging its state-of-the-art quarantine facility in London-the largest of its kind worldwide. The Company also offers comprehensive virology and immunology laboratory services under the hLAB brand.

Through its German subsidiary, CRS, hVIVO operates a 120-bed capacity across Mannheim and Kiel, providing early-phase clinical trial services, including first-in-human and proof-of-concept studies. Its second subsidiary, Venn Life Sciences, offers Early Drug Development Consulting and Biometry services to the biopharma sector.

The Group provides fully integrated drug development solutions from preclinical stages through Phase II trials, alongside patient recruitment via FluCamp. Additionally, its five clinical sites support outpatient Phase II and III trials, ensuring a seamless and efficient pathway from discovery to late-stage development.


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