REG - hVIVO PLC - Trading Update

hVIVOAnnouncement

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RNS Number : 8041Q  hVIVO PLC  29 January 2026

hVIVO plc

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

 

Trading update

FY25 revenue in line and positive adjusted EBITDA

Positioned to return to growth in 2026

 

London, UK - 29 January 2026, hVIVO plc (AIM: HVO), a full-service early
phase Contract Research Organisation (CRO) and the world leader in human
challenge clinical trials, provides a trading update for the year ended 31
December 2025 (FY25). The FY25 financials in this statement remain subject to
audit.

 

Highlights

 •    Revenue is expected to be c.£46.7 million (2024: £62.7 million), in line
      with expectations
 •    Adjusted EBITDA margin is expected to be positive low single-digit* (2024:
      26.2%), above expectations
 •    Cash of c.£14.3 million as at 31 December 2025 (31 December 2024: £44.2
      million), no debt and ahead of expectations
 •    Completed strategic acquisitions and integration of CRS Mannheim & Kiel
      and Cryostore, creating an integrated end-to-end early clinical development
      offering, from preclinical to Phase III
 •    Four integrated specialist service lines (Consulting, Clinical Trials, Human
      Challenge Trials ("HCTs"), and Laboratories) now fully operational
 •    Guidance reiterated for high single digit revenue growth in 2026

 

* Adjusted EBITDA is stated before one off exceptional items related to
acquisitions.

 

Yamin 'Mo' Khan, Chief Executive Officer of hVIVO, said: "I am pleased to
update the market that we expect to report positive (adjusted) EBITDA ahead of
guidance for FY25. This was driven by stronger than expected operational
delivery in Q4 2025, and the contractual protections embedded within our
model.

 

"Following the acquisition of CRS and Cryostore we now offer a full
end‑to‑end service platform from preclinical through to Phase III across
multiple therapeutic areas. The integration of CRS and Cryostore is complete,
and we are realising synergies across our four specialist service lines. Our
purpose-built full-service early phase capabilities clearly differentiate us
within the market and together with our strong and diverse pipeline, we
reiterate our guidance for high single digit revenue growth in 2026."

 

Revenue in line, EBITDA and cash ahead of expectations

hVIVO expects to report revenues of c.£46.7 million for FY25 (2024: £62.7
million), in line with expectations. It also expects to report a low positive
single-digit adjusted EBITDA margin (2024: 26.2%), ahead of previous guidance
of an adjusted EBITDA loss. This improvement was driven by a better than
expected Q4 performance, implementation of cost control measures, and the
recognition of cancellation fees with no associated variable costs.

 

The Group's cash position of c.£14.3 million as at 31 December 2025 (31
December 2024: £44.2 million) reflects the purchase of, and strategic
investment in the acquisitions completed during the year, with CRS generating
cash in Q4 2025. The Company's balance sheet remains debt free and provides
hVIVO with sufficient funds to continue investing in growth initiatives across
the Group.

 

Full-service early phase CRO

hVIVO completed the acquisitions of CRS Mannheim & Kiel and Cryostore in
2025. As a result, hVIVO can now provide seamless pre-clinical to Phase III
drug development services. In addition, hVIVO has diversified its service
lines to expand its therapeutic expertise beyond infectious diseases,
including cardiometabolic, respiratory and immunology. The acquisitions have
now been fully integrated, with multiple cross-selling opportunities being
realised across the Group.

 

The hVIVO business is being progressively reorganised into the following four
specialist services lines working together to accelerate drug development for
clients:

 

·    Consulting (incorporating Non-Clinical, Clinical, CMC, PK, Data
Management, Biostatistics, Regulatory);

·    Clinical Trials (incorporating Phase I / II CRO services, Phase II /
III site services, recruitment services);

·    Human Challenge Trials (challenge model development and execution);
and

·    Laboratories (incorporating standalone laboratory services, including
biobank and storage services).

 

Market conditions and pipeline

FY25 was a challenging year with macroeconomic and sector-specific headwinds
affecting the vaccine industry and the broader CRO industry, resulting in
several programme deferrals and cancellations in HCTs. There is, however,
evidence of a return in the infectious disease market, marked by increased
M&A in the space in 2025.

 

Consequently, hVIVO enters FY26 with increasing momentum in its sales pipeline
across all four of the Group's service lines, including a number of HCT
opportunities such as the potential ILiAD Phase III trial. The aggregate
value of customer proposals submitted in FY25 exceeded FY24, providing a
positive indicator for the Group's medium-term revenue growth. The Company
will provide an update on its orderbook at both full year and half-year
results going forward.

 

Outlook

hVIVO's service capability is now beyond just human challenge trials. Although
the Company expects modest improvements in the HCT market, hVIVO now has a
well diversified offering beyond HCTs, allowing the business to broaden its
target clients and contributing substantially to the sales pipeline.

 

The Group has identified four key growth initiatives that will drive revenue
expansion over time: 1) expand therapeutic specialism in cardiometabolic
diseases (including obesity and diabetes trials), 2) an expanded respiratory
offering alongside traditional challenge models, 3) enhanced laboratory
services, and 4) patient recruitment services.

 

With its infrastructure in place, and revenue expansion and diversification
opportunities attainable, the newly strengthened Board is confident that
hVIVO's full-service platform will support near and longer-term growth. hVIVO
maintains its guidance for high-single digit revenue growth in 2026.

 

Investor meeting

Yamin 'Mo' Khan, Chief Executive Officer, and Stephen Pinkerton, Chief
Financial Officer, will provide a brief presentation with Q&A via the
Investor Meet Company platform today at 18:00 GMT.

 

The meeting is open to all existing and potential shareholders. Questions can
be submitted at any time during the meeting. 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.

 

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.

 

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

 ICR Healthcare (Financial PR & IR)                                                  hVIVO@icrhealthcare.com

 Mary-Jane Elliott / Stephanie Cuthbert / Phillip Marriage / Louis Ashe-Jepson

 

 

 

Notes to Editors

 

hVIVO plc (https://hvivo.com/) (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 (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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