On track to deliver on multiple key business and R&D milestones
- €50 million raised in oversubscribed placement led by blue-chip US healthcare investors.
- Alignment obtained with FDA and EMA on Lyme vaccine development strategy; Phase 2 initiation on track to commence at the end of the 2018.
- Phase 1 study of Chikungunya vaccine transitioned into re-vaccination phase. Primary endpoint data expected by the end of the year.
- Data analysis for Phase 1 study of Zika vaccine candidate initiated. Primary endpoint data expected within the next few weeks.
- New IXIARO® supply contract with US Department of Defense expected before the end of 2018.
On track to deliver against full year revenues and EBITDA guidance
- FY product sales revenues to exceed €100 million, nine-month product sales revenues of €71.1 million (10% year on year growth at CER , 5% AER growth).
- FY revenues and grants of €110 million - €120 million confirmed.
- FY EBITDA expected in the range of €5 million - €10 million. Nine-month EBITDA at €6.1 million.
- FY R&D investment now estimated to be at €25 million - €30 million. Nine-month R&D investments at €18.2 million
David Lawrence, Valneva’s Chief Financial Officer, commented, “The important milestones that we have achieved during the year reflect the continued execution against our business and R&D objectives. The €50 million financing is a notable achievement to strengthen our shareholder base as we plan our capital needs for future R&D investments, notably the upcoming Lyme Phase 3. Our achievements in the year to date also give us confidence to confirm that we will meet both our business and R&D objectives for the year.”
About Valneva SE
Valneva is a fully integrated, commercial stage biotech company focused on developing innovative life-saving vaccines. Valneva’s portfolio includes two commercial vaccines for travelers: IXIARO®/JESPECT® indicated for the prevention of Japanese encephalitis and DUKORAL® indicated for the prevention of cholera and, in some countries, prevention of diarrhea caused by ETEC. The Company has various vaccines in development including a unique vaccine against Lyme disease. Valneva has operations in Austria, Sweden, the United Kingdom, France, Canada and the US with over 450 employees. More information is available at www.valneva.com.