Valneva (VLA) TD Cowen 45th Annual Health Care Conference summary

Strategic focus and business model

• Specializes in developing, manufacturing, and commercializing prophylactic vaccines for infectious diseases with high unmet medical need, leveraging a fully integrated model from R&D to sales.

• Commercial business centers on travel vaccines, with a portfolio including IXIARO (Japanese encephalitis), DUKORAL (cholera/ETEC), and IXCHIQ (chikungunya).

• Technology-agnostic approach enables flexibility across vaccine modalities and partnerships.

• Shifting commercial focus back to proprietary vaccines to improve gross margins and profitability.

• Investments in cost-efficient manufacturing and infrastructure support future growth.

Pipeline highlights and R&D progress

• Lead program is a Lyme disease vaccine, partnered with Pfizer, in phase III with first data readout expected by end of 2024 and regulatory filings anticipated in 2026.

• Chikungunya vaccine is licensed in major markets, with label extensions and LMIC approvals pending; phase IV studies and long-term antibody persistence monitoring ongoing.

• Shigella vaccine candidate in phase II, targeting children and travelers, with positive early data and FDA Fast Track designation.

• Zika vaccine candidate in phase I, leveraging COVID-era platform, with results expected late 2024 and further development contingent on data and regulatory discussions.

• Preclinical pipeline includes EBV and broad enteric disease programs, with a focus on high-risk, high-reward opportunities.

Market opportunity and financial outlook

• Lyme disease and chikungunya represent significant market opportunities, with Lyme's addressable market estimated above $1 billion and chikungunya at $500 million.

• Commercial sales exceeded €160 million in 2023, with 2024 guidance of €170–180 million and total revenues projected at €180–190 million.

• R&D investments of €90–100 million in 2025, partially offset by grants and tax credits; cash burn expected to drop by over 50% to below €30 million.

• Continued travel vaccine sales growth expected for IXIARO and DUKORAL, with IXCHIQ as the main growth driver.

• Anticipates sustained profitability following successful Lyme vaccine launch, supported by milestone payments, royalties, and improved gross margins.