2023 Annual Business Report

Outlook

Valneva provides an updated 2024 financial guidance and its mid-term outlook.

Outlook

Financials & Outlook

2024 Financial Guidance

  • Expected total revenues between €170 million and €190 million
    • Including €160 million to €180 million of product sales
  • Other income expected between €100 million and €110 million, including proceeds of €95 million from the Priority Review Voucher (PRV) sale in early 2024
  • R&D expenses expected between €60 million and €75 million

Mid-term Outlook

Product sales

  • In the mid-term, Valneva expects continued sales growth for its travel vaccines IXIARO® and DUKORAL®, and with the current launch of IXCHIQ®, the Company anticipates annual product sales to approximately double by the end of 2026. This will be driven by IXIARO®, for which continued double-digit annual growth is expected for at least the next three years, and by ramping IXCHIQ® sales, which are expected to exceed €100 million in year three after initial launch, subject to anticipated regulatory approvals and even assuming potential competitive product entry. There may also be upside from potential IXCHIQ® stockpiling opportunities. Regulatory reviews are ongoing in Europe, Canada and Brazil, and decisions for these submissions are expected in 2024. The Company currently estimates that the travel market opportunity for chikungunya vaccines could be valued between €300 million to €400 million based on the number of travelers to endemic regions and their anticipated adoption of the vaccine. Additionally, considering the high unmet medical need that chikungunya represents in Low- and Middle-Income Countries (LMICs), Valneva expects strong adoption of its chikungunya vaccine in these countries.
  • The third-party product business supported Valneva’s revenues as a complement to its existing travel vaccine portfolio, especially during the COVID-19 pandemic. However, 2023 third-party sales of more than €35 million yielded only 36% gross margin, diluting Valneva’s overall margins, and the Company has therefore decided to focus resources on direct sales of its proprietary products. Valneva expects that third-party sales will gradually wind down to less than 5% of product sales by 2026/2027 considering the anticipated end to its collaboration with Bavarian Nordic by the end of 2025. This is expected to bring the gross margin back to pre-COVID levels or better, with additional margin improvements expected from the cost-efficient manufacturing process of IXCHIQ® and scaling effects from leveraging the Company’s new manufacturing facilities in Livingston (Scotland) and Solna (Sweden).

R&D

  • Valneva will continue leveraging its proven capabilities to develop differentiated first-, best- or only-in-class vaccine solutions in areas of high unmet medical need. As in previous years, the Company will focus on advancing a limited number of promising product candidates with the aim to have an additional clinical program entering Phase 3 upon completion of the Phase 3 program for Lyme. Valneva may reach its pipeline development objective organically and/or via strategic transactions.
  • Over the next three years, the Company expects approximately 40% of its R&D expenses to be linked to chikungunya development activities, including ongoing and anticipated clinical studies. These chikungunya expenses are expected to be supported at a sizable level by non-dilutive contributions from several institutions.

Cash management

  • In the mid-term, Valneva will continue focusing on stringent cost management with a particular focus on marketing and distribution as well as general and administrative costs. In parallel, IXCHIQ® sales ramp-up and anticipated gross margin improvements will further reduce the Company’s cash burn. The Company reduced its loss by more than €40 million in 2023 and expects to further reduce it in the coming years, anticipating that Valneva may achieve sustained profitability with potential commercial revenues from a successful development, approval and launch of its Lyme disease vaccine candidate partnered with Pfizer.
  • With the eighteen-month extension of the interest-only period of its Deerfield and OrbiMed loan, and based on 2023 year-end cash as augmented by the proceeds from the PRV sale, Valneva believes that it is sufficiently financed for its operational business, excluding debt repayment, until potential commercial revenues from its Lyme program enable the Company to operate in a sustained profitable way.