Slide 1: Company Presentation
Company Presentation April 2025 AIM: HVO
Slide 2: Disclaimer
Disclaimer The contents of this presentation and the information which you are given at the time of the presentation have not been approved by an authorised person within the meaning of the Financial Services and Markets Act 2000 (the “Act”). Reliance on this presentation for the purpose of engaging
Slide 3: Introduction
Dr. Yamin ‘Mo’ Khan Chief Executive Officer Introduction
Slide 4: A Full-Service CRO
A Full-Service CRO Record Results £62.7m £16.4m Revenue EBITDA Dublin Corporate Office Manchester +11.9% 2023: £56.0m +25.9% 2023: £13.0m Screening Site CRS Kiel Clinical Research Unit Ely 26.2% 1.69p Biobank EBITDA Margin EPS Whitechapel Screening & Clinic 2023: 23.3% +33.1% 2023: 1.27p Leiden |Con
Slide 5: Delivering on our Growth Strategy
Delivering on our Growth Strategy Optimise Scale • Purpose built facility • 50-bed quarantine unit • Individually zoned rooms • 32-bed outpatient units in London • Call-bell system • 120-bed units in Germany • Pneumatic chute delivery • Doubled lab capacity • Automation • 32 freezer storage for bios
Slide 6: Strategic Acquisition of CRS Mannheim & Kiel
Strategic Acquisition of CRS Mannheim & Kiel 45+ Years of experience Long-term track record as early-phase specialist 120 Expanding hVIVO’s Expanding hVIVO’s Expanded European Beds (78 long-term) Site Services Therapeutic Expertise Footprint Phase I-II Cardiometabolic 94 Beds Mannheim +1,850 Trials
Slide 7: Cryostore Acquisition - Strengthening hLAB Offering
Cryostore Acquisition - Strengthening hLAB Offering 1999 Established A specialist provider of biological and clinical materials storage 32 Freezers Home office- GMP & GDP HTA GMO CL-3 compliant license controlled drugs licence approved approved c.2,800 sqft Scope for future expansion 37 Clients 2024
Slide 8: A record year
Stephen Pinkerton Chief Financial Officer A record year
Slide 9: Record Revenue & Expanding Services
Record Revenue & Expanding Services Revenue Revenue by Service Revenue CAGR of 13.7% 2024 2023 £62.7m £56.0m 2022 £48.5m 2022 2023 2024 HCT Site Services Consulting hLAB Virus Manufacture • Field trial revenue - contributed 6% • hLAB revenue • Challenge revenue grew 13% o £3.2m hLAB project signed,
Slide 10: Record EBITDA
Record EBITDA EBITDA Margin EBITDA 25% EBITDA CAGR of 34.5% 24% 26.2% £16.4m 23% 23.3% Underlying 23.0% 22% £13.0m £13.4m 21% Underlying 20% £9.1m 19% 18% 18.7% 17% 16% 2022 2023 2024 2022 2023 2024 • Excluding the impact of the facility funding & overlapping • 2024 reflects recruitment & clinic ope
Slide 11: Strong Cash Generation
Strong Cash Generation £44.2m £13.1m £13.1m Cash £37.0m Upfront Upfront Payments £15.8m £15.8m Payments • Strong cash position with £44.2m as at Upfront £28.4m Upfront Payments 31 Dec 2024 Payments £29.1m £12.5m £12.5m £29.1m HVO Cash • £29.1m hVIVO cash Upfront HVO Cash Upfront Payments Payments •
Slide 12: A Sustainably Cash Generative Business
A Sustainably Cash Generative Business 60.0 £12.8m 50.0 £1.6m £44.2m -£3.4m 40.0 £37.0m -£2.5m -£1.4m 30.0 20.0 10.0 - Opening balance Cash generated from Working capital Fixed asset purchases Dividend Net interest received Closing balance operations movement • Strong cash generated from operations
Slide 13: Driving Growth
Driving Growth Basic Adjusted EPS Annual Dividend EPS CAGR of 32.7% Reflecting sustainable cash generation and a 1.69p robust balance sheet 1.27p 10 April 15 May c.£1.4m Final Results Ex-dividend date 0.96p 0.2 pence 16 May 11 June per Ordinary Share Record date Payment date 2022 2023 2024 Well-posi
Slide 14: Strong delivery in 2024 and beyond
Dr. Yamin ‘Mo’ Khan Chief Executive Officer Strong delivery in 2024 and beyond
Slide 15: A Full-Service CRO
A Full-Service CRO Expanding our European footprint, expertise, and recruitment potential CMC Preclinical Phase I Phase Phase Ib & IIa Phase II & III Phase III Data Regulatory Consulting Consulting Consulting I HCT Site Services HCT Mgmt. Specialist virology & Immunology laboratory services Biobank
Slide 16: Integration of CRS
Integration of CRS Completed In progress Planned • Integration plan finalised • IT integration mapping • 2025 adjusted loss in line with 2024 • Initial audit completed • BD CRM & VMS • Earnings accretive 2026 • No surprises • Vendor consolidation • Single IT infrastructure • New reporting structure
Slide 17: Our Core Business: Human Challenge Trials
Our Core Business: Human Challenge Trials Q125 Key Highlights Average #Volunteers per HCT • LOI with ILiAD Biotechnologies 2x Growth • hMPV challenge agent manufactured & successful pilot characterisation trial completed • hMPV characterisation trial contract signed • RSV mucosal antiviral HCT contr
Slide 18: Strong Delivery of New Service Lines
Strong Delivery of New Service Lines Largest Field Trial to Date Launch of hLAB Standalone Services Multinational Trial FluCamp Multinational Trial £3.2 million US & UK sites Enrolled 817 volunteers in Phase 2 field trial Project value to date hVIVO sole UK site just over 6 weeks I'm in awe of your
Slide 19: Market
Market Worlds First Pivotal Phase III HCT – Regulatory Milestone Phase I & Phase I/II Trials by Country (2021-2024)* 700 • LOI signed with ILiAD Biotechnology 600 • Data to support a marketing authorisation application 500 400 • Following consultation with the FDA 300 200 • Potential pivotal develop
Slide 20: Orderbook & Pipeline – 31 Dec 2024
Orderbook & Pipeline – 31 Dec 2024 £67m Weighted Pipeline Distribution HCT Pipeline Distribution Contracted Orderbook* by Service by Disease H3N2 H1N1;H3N2 Pertussis Challenge Challenge H5N1 Coronavirus Site Services Site Services H3N2; RSV; HRV hLAB hLAB Norovirus RSV Venn Life Venn Life PIV CRS CR
Slide 21: Track Record of Delivery - Strategy for Future Growth
Track Record of Delivery - Strategy for Future Growth Expansion of HCT Models Outlook 13 characterised models 2025 revenue guidance of £73m (H2 weighting) Responding to client demand / market trends Development of Stand-Alone 2025 adj EBITDA guidance mid-high teens, reflecting integration of CRS int
Slide 22: Questions
Avivo Questions
Slide 23: Appendix
Avivo Clinical Trials Recruitment Appendix
Slide 24: Experienced Board of Directors
Experienced Board of Directors Cathal Friel Dr Yamin ‘Mo’ Khan Stepen Pinkerton Chair CEO CFO Not seeking re-election Elaine Sullivan Prof Brendan Buckley Martin Gouldstone Senior Independent NED NED Independent NED 24
Slide 25: What is a Human Challenge Trial?
What is a Human Challenge Trial? A clinical trial where healthy volunteers are exposed to a pathogen to test the effectiveness of vaccine and treatments Stage 3 Volunteers undergo full disease trajectory of infection and recovery Stage 1 Stage 2 Stage 4 Inoculation with Volunteers discharged from Vo
Slide 26: Benefits of Human Challenge Trials
Benefits of Human Challenge Trials Scientific Clinical Development • Generates invaluable dosing, safety and • Requires fewer subjects efficacy data • Significant time savings • Helps optimise for larger field trials • No seasonal dependence • De-risks Phase III programs Benefits of Human Challenge
Slide 27: hVIVO's Expanding Challenge Agent Portfolio
hVIVO’s Expanding Challenge Agent Portfolio 10 challenge agents manufactured in the past three years – investing in sustainable growth New to hVIVO in the past 2 years * In development In planning for the future: Bacterial challenge, Norovirus, Dengue 27
Slide 28: Challenge Trial Revenue Recognition Profile
Challenge Trial Revenue Recognition Profile £6m Stage 1: Stage 2: Stage 3: Stage 4: Pre-study preparation FluCamp Quarantine Phase Trial completion activities Reservation fee recruitment £5m • hVIVO receives an upfront, non- refundable booking of c.10-20% of £4m total trial value to reserve quaranti
Slide 29: HCT Services: Significant Barriers to Entry
HCT Services: Significant Barriers to Entry USP CUSTOMERS RECRUITMENT FACILITY • Precedent EXPERTISE • Established • Challenge data relations EXPERIENCE • 50-bed CL-3 • Flucamp • Sample PRODUCTS quarantine • Sole provide to • Generic calculations big pharma • Scientific Team • Virology/ Screening Im
Slide 30: The World's Largest Human Challenge Unit
The World’s Largest Human Challenge Unit Staff Space Kitchen Changing IMP Area Outpatient Unit Quarantine Beds Kitchen Airlock IMP Storage 30
Slide 31: CRS & Cryostore Financial Highlights
CRS & Cryostore Financial Highlights CRS Acquisition Trading History (unaudited) Cryostore Acquisition Trading History (unaudited) • Revenue FY24 €19.9m (FY23 €18.6m) • Revenue FY24 £0.89m (FY23 £0.81m) • Adjusted EBITDA FY24 -ve€1.8m (FY23-ve€1.6m ) • EBITDA FY24 -£0.52m (FY23 £0.54m) • Contracted
Slide 32: Expanded Expertise & Global Market Reach – Unlocking New Growth
Expanded Expertise & Global Market Reach – Unlocking New Growth Worldwide BD Team with No Additional Resources Cross-Selling Specialist Therapeutic Areas • Infectious disease • Dermatology • Respiratory • Renal / Hepatic Impairment • Cardiometabolic • Immunology / Inflammation CRS, Head of BD Locati
Slide 33: CRS: Long History & Recognised Quality
CRS: Long History & Recognised Quality C RS 1977 1992 2006 2013 2017 2025 Prof. Dr. Lücker Pharm PlanNet CRS Clinical CRS Clinical Management Acquired by GmbH Research Services Research Services buy-out hVIVO Institut für klinische Contract Kiel, Mannheim, Berlin, Wuppertal Acquisition of LTS Pharma
Slide 34: CRS Experience (5 Years)
CRS Experience (5 Years) Studies performed – Healthy Volunteers First-in-Human (2018 - YTD 2024) Top 5 CRO in Europe for FIH SAD/MAD, Biosimilars , 6 #1 in the DACH region. Bioequivalence, 9 FIH & ascending dose, 27 FIH & ascending dose BA / PK / PD , 15 DDI Clinical Pharmacology during Renal Hepati
Slide 35: Venn Life Sciences Service Offering
Venn Life Sciences Service Offering Discovery/Lead Drug Development NDA, BLA, MAA Lifecycle Management Optimization Gap Analysis, Due diligence Quality (Chemistry, Manufacturing, and Controls) Variations/ Changes Quality development (CMC): process development, analytical development, product Quality
Slide 36: Focus on ESG
Focus on ESG ESG Highlights • Sustainability is integral to our corporate ethos & ISO 14001 accreditation achieved at Canary operational framework Wharf site 2024 • ESG Group reports to the Audit & Risk Committee Expanded facilities & services support the • We play a pivotal role in expediting the d
Slide 37: hVIVO's State-of-the-Art Facilities
hVIVO’s State-of-the-Art Facilities Canary Wharf Quarantine Unit hLAB Virology & Immunology Laboratories Plumbers’ Row Screening Facility Manchester Screening Centre Biobank Watch the walk-through tour of Canary Wharf here 37
Slide 38: Stay in touch
Avivo Stay in touch AIM: HVO