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  • Writer's pictureMark Watson-Mitchell

hVIVO - Human Challenge Clinical Trials market leader

 

 

Key facts

                                         hVIVO – LON: HVO

Market capitalisation

£200m

Price

29.25p

52-week high/low

31.45p / 12.50p

Analyst Valuations per share

29p - 38p

 

The Mission Statement for this group is -


“Delivering today’s healthcare by empowering tomorrow’s innovation.”


While its Vision Statement is -


“To transform global healthcare by revolutionising the drug development process through scientific ingenuity.”


The Business


hVIVO is a rapidly growing specialist contract research organisation and the world leader in testing infectious and respiratory disease vaccines and therapeutics using human challenge clinical trials.


The group provides end-to-end early clinical development services to its large, established and growing repeat client base, which includes four of the top 10 largest global biopharma companies.


The group's fast-growing services business includes a unique portfolio of 11 human challenge models, with a number of new models under development, to test a broad range of infectious and respiratory disease products.


The company has world-class challenge agent manufacturing, specialist drug development and clinical consultancy services via its Venn Life Sciences brand, and a lab offering via its hLAB brand, which includes virology, immunology biomarker and molecular testing.


The group offers additional clinical field trial services such as patient recruitment and clinical trial site services.


hVIVO runs challenge studies in London from its Whitechapel quarantine clinic, its state-of-the-art Queen Mary BioEnterprises 24-bedroom quarantine clinic with its highly specialised on-site virology and immunology laboratory, and its clinic in Plumbers Row, in Whitechapel.


To recruit volunteers / patients for its studies, the company leverages its unique clinical trial recruitment capability via its FluCamp volunteer screening facilities that are situated in London and Manchester.


The company is currently underway with the construction of a new larger state-of-the-art facility in Canary Wharf, which will serve as a comprehensive site, housing quarantine bedrooms, advanced laboratories, an outpatient unit, and corporate offices.


This will be all conveniently spread across two floors, while the facility will contain 50 quarantine beds, with the potential expansion capabilities to accommodate up to 70 quarantine beds in the future.


The move to this facility is scheduled to complete in H1 2024.


What is a Human Challenge Study


The Imperial College in London describes a human challenge study as a carefully managed medical research study, during which volunteers are intentionally given an infection in a safe way with healthcare support.


Human challenge studies have a unique ability to investigate and understand the onset and development of disease in a controlled environment.


They allow researchers to tease out complicated interactions and point out potential targets for prevention, vaccines or treatment that cannot be seen in patients who are infected naturally. 


A Human Challenge Trial is outlined by hVIVO as a clinical trial where healthy volunteers are exposed to a pathogen to test the effectiveness of vaccine and treatments in a faster and more efficient setting.


The Benefits of a Human Challenge Trial


Scientific – they generate invaluable dosing, safety and efficacy data, while helping to optimise for larger field trials.


Clinical Development – they require fewer subjects, they make significant time savings and de-risk Phase III program.


Regulatory – they offer the potential for Fast-Track or Break-Through designation, while offering for potential approval and Emergency Use Authorisation.


Financial – the trials offer significant valuation uplift for Biotech sponsors, while allowing products to ‘Succeed Fast’ or ‘Fail Fast’.


The World Leader


Building on decades of unrivalled experience, hVIVO is currently the only Contract Research Organisation focused on challenge studies, providing world-class expertise and capabilities in challenge agent manufacture, a unique portfolio of established human challenge models to test a broad range of infectious and respiratory disease products, and specialist drug development and clinical consultancy services.


The group, which is the World Leader in testing infectious and respiratory disease products using human challenge clinical trials, is currently conducting studies on RSV, Influenza, COVID-19, hMPV, HRV, Malaria, Asthma & COPD.


Its lab services include assay development, transfer and optimization across the immunological, molecular and cell-based assay platforms, including offering options in sample matrix testing and specialty biomarker assays.


2023 Trading Update – 30th January 2024


As at the end of last year the group had a contracted Order Book of £80m, with 90% of revenue guidance of £62m for this year already covered 90%, while showing a good visibility for next year.


The group has a medium-term target of £100m by 2028.


The highly cash-generative ability of the group was identified by end-2023 cash at bank of £37.0m (£28.4m).


CEO Dr Yamin ‘Mo’ Khan stated that:


"In 2023, hVIVO demonstrated strong financial and operational performance, delivering record-breaking results across all key parameters.


The sustained success of the Group, coupled with a growing orderbook, reinforces the resilience of our business model and reaffirms the stability of the market.


The infectious disease market has witnessed increased interest from both commercial and non-profit entities, as well as a notable uptick in M&A activity.


A significant highlight of the year was the market authorisation of the first-ever vaccine incorporating human challenge trial data as part of its submission package.


I am excited about 2024 as we look forward to our move to a larger facility and the further diversification of our services including the addition of new challenge agents.


The new facility will substantially boost our revenue potential and should lead to improved operational efficiencies and enhanced margins.


We are pleased to share a new target of growing the Group's revenue to £100m by 2028.

This growth will be primarily achieved through strong organic growth complemented by small strategic bolt-on acquisitions that adhere to our disciplined criteria, ensuring our long-term success."


Shareholders


JP Morgan Asset Management holds 47.06m (6.92%) of the group’s 679m issued shares, other holders include Canaccord Genuity Wealth (3.19%), Octopus Investments (2.08%), Gresham House Asset Management (1.87%), Thornbridge Investment Management (1.47%), Mandarine Gestion SA (1.03%) and Livingbridge EP (0.50%), while private holdings include Cathal Friel (3.11%), Allan Rankin (3.04%) and Brendan Buckley (0.59%).


Analyst’s View


Seb Jantet at Liberum Capital, with a Target Price of 29p, rates the group’s shares as a Buy.


He was impressed at the award of the recent £16.8m RSV contract with one of the company’s existing large pharma clients.


His estimates for the year to end December 2023 were for an increase in sales to £56m (£48m) while pre-tax profits could increase to £9.3m (£6.7m), lifting earnings up to 1.3p (0.9p) enabling the dividend payment of 0.6p (nil) per share.


For the current year he was going for £61m sales, £8.6m profits, 1.2p earnings and a 0.2p per share dividend.


At the recently appointed NOMAD and Joint Broker Cavendish Capital Markets, their analysts Stuart Harris and Chris Donnellan fixed a 38p Target Price on the shares.


Following the end January Trading Update for the Final Results for 2023 they suggest that £56m sales produced £10.5m in adjusted pre-tax profits, worth 1.5p in earnings and looking to pay a dividend of 0.2p per share.



The current year they estimate could see £62m sales, £10.9m profits, 1.5p earnings and paying out a 0.2p dividend.

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