hVIVO plc (LON:HVO), a full-service Contract Research Organisation (CRO) and the world leader in human challenge clinical trials, has announced its audited results for the year ended 31 December 2024.
Financial highlights
| • | Revenue up 11.9% to £62.7 million (2023: £56.0 million) |
| • | EBITDA up 25.9% to £16.4 million (2023: £13.0 million) |
| • | EBITDA margin of 26.2% (2023: 23.3%) |
| • | Underlying EBITDA of £13.4 million (23.0%) excluding the Canary Wharf facility fee and overlapping facility costs |
| • | Basic adjusted earnings per share up 33.3% to 1.69p (2023: 1.27p) |
| • | Cash of £44.2 million as at 31 December 2024 (31 December 2023: £37.0 million) |
| • | Weighted contracted orderbook of £67 million as at 31 December 2024 (31 December 2023: £80 million) post-delivery of £62.7 million in the year |
| • | Dividend for the year of 0.2p per Ordinary Share (2023: 0.2p)* |
*Excludes special dividend of £3.1m (0.45p/share) paid in June 2023
Operational highlights
Key Contracts
| • | £6.3 million Human Rhinovirus (HRV – common cold virus) human challenge trial (“HCT”) contract signed with biotech client |
| • | £2.5 million Omicron characterisation study contract with mid-sized pharma client |
| • | £11.5 million Respiratory Syncytial Virus (“RSV”) HCT contact with existing top-tier global pharma client |
| • | Master Services Agreement (“MSA”) signed with mid-sized pharma client for HCT services |
| • | Five hLAB contracts signed post standalone services launch and a 99% growth in hLAB proposals within a 12-month period |
| • | Venn expanded its multi-year consultancy agreement with a major global pharma client |
Enhanced Operations
| • | Record number of participants inoculated in 2024 across nine challenge trials and seven challenge agents |
| • | Outstanding delivery of largest field trial to date with 817 participants recruited in just 43 days, following launch of clinical site services offering |
| • | Greater automation at FluCamp resulting in significant efficiency gains and reduced cost of volunteer/patient recruitment despite record number of trial participants |
| • | Flu B challenge model established and world’s first Flu B HCT completed |
| • | FluCamp volunteer and patient recruitment service offering launched with first contracts executed |
| • | Investment in new “off-the-shelf” models with new H1N1, H3N2, RSV A, and RSV B models |
Post-period end highlights
| • | Letter of Intent (LOI) signed with ILiAD Biotechnologies (“ILiAD”) for world’s first pivotal Phase III HCT to assess BPZE1, ILiAD’s whooping cough vaccine candidate – expected to be the Group’s largest HCT to date |
| • | Synergistic acquisition of two Clinical Research Units from CRS, a German-based full-service early-stage clinical development CRO, for €10.0 million in cash funded from hVIVO’s existing cash resources. Expected to be earnings enhancing following the first full year of ownership and adds a significant new revenue stream |
| • | Immediately earnings enhancing acquisition of Cryostore, a provider of temperature-controlled storage solutions for biological and clinical materials in London, for up to £3.2 million, bolstering hLAB offering |
| • | RSV HCT contract signed with new client, Inhalon Biopharma, to test an inhaled (mucosal) antiviral candidate |
| • | Successful pilot characterisation study for hVIVO’s human metapneumovirus (hMPV) challenge agent, validating the viability of the model |
| • | £2.0 million contract with a new biopharmaceutical client to complete the final stage of the hMPV characterisation study ahead of future HCTs |
| • | £3.2 million hLAB contract signed with US-based biotech for an international, multi-site Phase II field trial |
| • | Shionogi & Co., Ltd. (“Shionogi”), a major Japanese pharmaceutical company, reported positive results from a Phase IIa RSV HCT conducted by hVIVO |
| • | Memorandum of Understanding signed with the UK Heath Security Agency (UKHSA) with the aim of sharing preclinical insights, supporting vaccine innovation, working on human challenge trials, pandemic preparedness and promoting greater collaboration |
Annual dividend
As part of the Company’s annual dividend policy, a dividend of c.£1.4 million, being 0.2p per Ordinary Share will be payable on 11 June 2025 to shareholders on the register on 16 May 2025. The corresponding ex-dividend date is 15 May 2025.
Outlook
| • | Revenue guidance of £73 million for 2025 with H2 2025 weighting reflecting the scheduling of HCT contracts and the timing of the two acquisitions |
| • | EBITDA profit margins anticipated to be mid-high teens (excluding one-off costs), reflecting integration of CRS into the Group |
| • | Excluding potential ILiAD Phase III HCT, 70% of 2025 revenue guidance already contracted with good visibility into 2026 |
| • | The vast majority of the medium-term potential opportunities of c.£40 million announced in September 2024 have now been signed, with the exception of the final contract with ILiAD |
| • | In 2025, the Group is managing an increasingly active pipeline of opportunities which includes a number of hMPV HCTs |
| • | Integration of the acquisition of two Clinical Research Units from CRS underway, with the units expected to be earnings accretive in 2026 |
| • | Focus on integration and delivery against guidance |
| • | Reiterating medium-term target of growing Group revenue to £100 million by 2028 |
| • | Robust cash position with continued profitability and cash generation in 2025 and beyond |
Director Change
Since co-founding the business in 2017, and having been Chair for the past eight years, Cathal Friel has informed the Company that he does not intend to seek re-election to the Board of the Company at the Annual General Meeting in 2025. The Nominations Committee has already initiated a process to appoint a new Chair and the Company will announce the results of this process in due course.
Dr Yamin ‘Mo’ Khan, Chief Executive Officer of hVIVO, said: “2024 demonstrated further evidence of the strength of our long-term sustainable growth model, with record revenue and EBITDA coupled with strong cash generation. An increasing number of global biopharma companies have expressed their interest in our world-leading services, with additional models in various new indications underlining the value that HCTs can offer to the development of innovative new therapies.
“To meet this demand, we have built a world class organisation in personnel and infrastructure, with our new cutting-edge facility in Canary Wharf, which was largely funded by our clients, enabling the execution of larger more complex trials. The facility has also opened the door to new revenue streams such as laboratory, participant recruitment, and clinical site services. I would like to thank all of our employees across the Group who work diligently every day to efficiently deliver our services, to speed up drug development and bring important new therapies to patients in need. We look forward to delivering further progress in 2025 as we integrate our new revenue streams and build towards our £100 million revenue target in 2028.
“Finally, I would like to take this opportunity to thank our Chair, Cathal Friel. Cathal identified two loss making companies, Venn and hVIVO, and at personal risk, invested in the combined entity and transformed it into a long- term sustainable business model. He foresaw an opportunity and helped grow the business to where it stands today. It has been a pleasure to work with Cathal over the last three years and I would like to thank him, on behalf of everyone at the hVIVO Group, for his vision and leadership. We all wish him the best for the future.”
