hVIVO (HVO) investor relations material

Strategic evolution and business transformation

• Transitioned from a niche human challenge trial CRO to a fully integrated, end-to-end clinical drug development platform, now offering four standalone or integrated service lines across preclinical to phase III stages, including consulting, clinical trials, laboratory, and challenge studies.

• Revenue mix is shifting, with HCT declining from 81% in 2024 to a projected 35–40% in 2026, while clinical trials, laboratory, and consulting services expand, supported by significant investments in infrastructure, technology, and acquisitions.

• Disciplined capital allocation focuses on organic growth, targeted bolt-on acquisitions, and shareholder returns, avoiding transformational or non-adjacent deals.

• Medium-term targets include 10–15% revenue CAGR, EBITDA margin expansion to 15–20%, improved cash conversion, and a book-to-bill ratio above 1.2x, assuming continued HCT market normalization and no transformational M&A.

• Expanded patient and volunteer databases, integrated IT and quality systems, and broadened geographic reach, especially in the UK and Germany.

Integrated service model and operational capabilities

• Four integrated service lines—consultancy, clinical trials, HCT, and laboratories—provide end-to-end support from preclinical strategy through Phase III, with multiple entry points for clients.

• Consultancy drives early engagement, influencing program strategy and regulatory planning, and supports long-term partnerships and revenue expansion across service lines.

• Clinical trial operations span four specialized sites in the UK and Germany, supporting Phase I–III studies, with a combined participant database and integrated systems for recruitment and quality management.

• Laboratory services relaunched as a standalone offering, with investments in automation, next-generation sequencing, and bioinformatics to support all service lines and diversify the project portfolio.

• Human challenge trials remain a core differentiator, with a world-leading platform, proprietary challenge models, and rapid proof-of-concept data generation, now expanding into new infectious and respiratory disease models.

Market positioning, trends, and growth drivers

• Positioned as a differentiated provider with unique assets: genetic screening, large participant databases, owned labs and clinical sites, and advanced laboratory capabilities.

• Industry trends favor specialist early clinical development partners, with growing demand for integrated CRO services, faster proof-of-concept, and recruitment capabilities.

• Expansion into high-growth therapeutic areas such as respiratory, cardiometabolic, and metabolic diseases, leveraging partnerships with leading academic and clinical centers.

• The global obesity therapeutics market is projected to exceed $111.7bn by 2035, with a surge in pipeline innovation and clinical trial activity, particularly in Europe.

• Six key investment drivers include scientific leadership, diversification, unique full-service offering, loyal customer base, attractive valuation, and favorable market outlook.