REG - hVIVO PLC - H1 Trading update

hVIVOAnnouncement

Tue 07:00

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RNS Number : 9505R  hVIVO PLC  22 July 2025

hVIVO plc

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

 

H1 Trading update

 

hVIVO plc (AIM: HVO), a full-service Contract Research Organisation (CRO)
and the world leader in human challenge clinical trials, provides an unaudited
trading update for the six months ended 30 June 2025 (H1 2025).

 

Highlights

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

·    EBITDA margin (pre-exceptionals) of c.12% (H1 2024: 24.5%)

·    Cash of £23.3 million as at 30 June 2025 (30 June 2024: £37.1
million) reflecting purchase of CRS and Cryostore

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

·    Strong sales pipeline including large HCT opportunities in advanced
discussions

·    Good progress with clinical site and hLAB services

·    CRS and Cryostore acquisitions completed for £10.5 million net of
cash acquired and excluding transaction fees and contributed £5.5 million to
Group revenue in H1 2025

·    Integrations on track and sales synergies being realised from
cross-selling

·    Full year revenue guidance of £47 million and a low-single digit
EBITDA loss pre-exceptional items, an improvement on previous guidance
(mid-single digit)

 

hVIVO expects to report H1 2025 revenues of £24.2 million. CRS and Cryostore
delivered revenues of £5.2 million and £0.3 million respectively, broadening
the Group's services, therapeutic expertise, and customer base. The Company
expects to report EBITDA margins (pre-exceptionals) of c.12%, reflecting the
positive impact of operational efficiencies, cost management, and cancellation
fees during the period. hVIVO is debt-free with cash of £23.3 million as at
30 June 2025 and remains well-funded to continue to execute on its strategy of
building a business with diversified revenue streams, while maintaining tight
cost controls. Human challenge trials (HCTs) continue to be the Company's core
business, but the Group is now executing on a broader range of clinical
services for a larger number of clients.

 

Orderbook & Pipeline

The Company's sales pipeline remains strong, with substantial opportunities
across the Group. hVIVO is currently in advance discussions regarding a number
of major HCT projects across a variety of pathogens, some of which would
represent the Group's largest ever value contracts. In addition, hVIVO is
pursuing significant opportunities for its hLAB and clinical services
operations.

 

Some persistent macro and sector-specific headwinds remain however, including
a subdued biotech funding environment partly connected to uncertainties in the
US, which have impacted the broader CRO industry, resulting in delayed
contract conversion and a number of cancellations and postponements.

 

As at 30 June 2025 the Company's weighted contracted orderbook stood at £40
million and hVIVO continues to receive strong inbound interest across its
various business lines. The aggregate value of customer proposals submitted in
H1 2025 has already surpassed FY24 and there is a substantial pipeline of
opportunities in discussion which are not yet contracted.

 

The Board is confident that the issues affecting the sector are transitory
rather than fundamental. As the market normalises, and biotech funding
improves, hVIVO is strongly positioned to return to growth as the reputation
and quality of hVIVO's services remains unchanged and well recognised in the
industry.

 

Diversification of Revenue Streams

The Board is encouraged by the successful delivery and early performance of
the Group's newly launched and acquired service offerings, and believes that
there are excellent growth prospects for these services going forward. As
previously announced on 30 June 2025, hVIVO successfully completed its largest
field trial to date, demonstrating the Group's capability to execute
large-scale field trials. In addition, the Company also successfully delivered
key data on its largest laboratory contract to date. The Company also
continued to implement key automation projects during H1 2025 to drive
efficiencies across the Group.

 

The acquisition of CRS was completed at an attractive valuation multiple and
is already adding value to the Group. CRS enhances hVIVO's early-stage
clinical capabilities and expands the Company's revenue base through a broader
mix of service offerings. The integration of CRS is on track and the Company
expects CRS to be earnings accretive in 2026. The Board believes that hVIVO's
strategic positioning is stronger than ever following the acquisitions of CRS
and Cryostore. The Company is now more diversified and is serving a broader
client base, including those working in fast growing research areas such as
cardiometabolic (e.g. obesity) and respiratory diseases (e.g. asthma). The
Company is capitalising on these strengths through increased cross-selling
across the platform, with the first of these cross-selling opportunities
signed in H1 2025. In addition, the Group is encouraged that the aggregate
value of customer proposals submitted by CRS has also grown 60% in H1 2025
versus H1 2024 reflecting the Group's strong focus on business development.

 

Outlook

The Company expects to deliver revenues of £47 million and low-single digit
EBITDA loss (pre-exceptional items) for the full year, an improvement on
previous guidance (mid-single digit). The Company will update the market as
significant new contracts are signed.

 

The Board remains confident in the long-term growth potential of hVIVO, both
with the Company's world leading HCT business and the new diversified
offerings. hVIVO is now a unique provider in the European clinical services
sector and expects to achieve growth in 2026 and beyond as the macro and
sector-specific headwinds abate.

 

Chair Appointment

The Nominations Committee has identified a preferred candidate for the new
independent Non-Executive Chair who brings substantial sector-relevant
experience and expertise. The Board believes this appointment will add value
to the Company as it executes its growth strategy. Subject to successful
completion of customary due diligence procedures by the Company's Nominated
Adviser, an announcement will be made in due course.

 

Dr Yamin 'Mo' Khan, Chief Executive Officer of hVIVO, said: "The utility of
our services remains strong, as demonstrated by the recent success of our
client's Phase II candidate. Our diversification strategy is already
delivering results, and we expect continued momentum across all revenue
streams. While macroeconomic and sector-specific headwinds are still affecting
contract conversions, we remain confident in the long-term growth trajectory
of our services and the overall prospects for hVIVO. I'm encouraged by the
strength of our sales pipeline, with several major opportunities that could
enhance the growth of our services. We believe that we are well positioned to
deliver growth in FY26, and we look forward to keeping shareholders updated on
our progress."

 

Investor presentation

Yamin 'Mo' Khan, Chief Executive Officer, and Stephen Pinkerton, Chief
Financial Officer, will provide a live presentation relating to the trading
update via the Investor Meet Company platform today at 6:00pm 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 (https://www.investormeetcompany.com/hvivo-plc-1/register-investor) .
Investors who already follow hVIVO on the Investor Meet Company platform will
automatically be invited.

 

For further information please contact:

 

 hVIVO plc                                       +44 (0)20 7756 1300
 Yamin 'Mo' Khan, Chief Executive Officer

 Stephen Pinkerton, Chief Financial Officer

 Cavendish Capital Markets Limited (Nominated Adviser and Joint Broker)                  +44 (0)20 7220 0500
 Geoff Nash, Callum Davidson,

Trisyia Jamaludin, Harriet Ward

 Nigel Birks - Life Science Specialist Sales

 Louise Talbot - Sales

 Peel Hunt LLP (Joint Broker)                                        +44 (0)20 7418 8900
 James Steel, Dr Christopher Golden

 Davy (Joint Broker)                                                 +353 (0) 1 679 6363
 Anthony Farrell, Niall Gilchrist

 Walbrook PR (Financial PR & IR)                 +44 (0)20 7933 8780 or hvivo@walbrookpr.com

 Paul McManus / Alice Woodings /                 +44 (0)7980 541 893 / +44 (0)7407 804 654/

+44 (0)7584 391 303
 Lianne Applegarth

 

The information contained within this announcement is deemed by the Company to
constitute inside information as stipulated under the Market Abuse Regulation
("MAR") EU no.596/2014. Upon the publication of this announcement via
Regulatory Information Service ("RIS"), this inside information is now
considered to be in the public domain.

 

 

Notes to Editors

 

hVIVO plc (https://hvivo.com/)  (Ticker: HVO) is full-service 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 (https://hlabservices.com/)  brand.

 

Through its German subsidiary, CRS (https://crs-earlyphase.com/) , 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
(https://www.vennlifesciences.com/) , 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 (https://flucamp.com/) . 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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