It has been a long time since Valneva has seen such a surge. The group has announced several pieces of good news in just a few weeks.
In July, the European Medicines Agency (EMA) lifted the temporary restriction on the use of Ixchiq in people aged 65 and over, imposed in May after 17 cases of serious side effects, even including two deaths. Ixchiq is Valneva's vaccine against chikungunya virus, a disease transmitted by tiger mosquitoes. This treatment represents 8% of the company's H1 revenue.
However, the pharmacovigilance committee recommends that vaccination be reserved for high-risk situations and after an individual assessment of the benefit-risk ratio. The decision paves the way for a similar lifting of the suspension in the US in the coming months.
At the same time, the WHO has warned of a risk of a repeat of the 2005/2006 global epidemic that started in the Indian Ocean. Valneva and Bavarian Nordic are the only two companies with a commercial vaccine against chikungunya.
The recent news does not stop there. Investors are regaining their appetite for European biotech stocks: Sanofi has acquired Vicebio for $1.15bn, a British biotech company specializing in respiratory vaccines, including a combination candidate against respiratory syncytial virus and human metapneumovirus. Meanwhile, Nordic Capital and Permira have launched a takeover bid for Bavarian Nordic, the aforementioned Danish laboratory which specializes in vaccines and immunotherapies for infectious diseases and certain cancers. It is particularly well known for its vaccines against smallpox, monkeypox, and chikungunya. Finally, there has also been a surge in Abivax, which reported positive clinical results in two Phase 3 trials for the treatment of ulcerative colitis, a chronic inflammatory bowel disease. Against this backdrop, speculation about a takeover bid from Pfizer for Valneva, or its Lyme asset, has resurfaced.
These strong arguments are also reflected in the figures, as Valneva recorded revenue of €97.6m for H1, up 37.8% compared to last year. Performance of its three main vaccines is highly satisfactory, with:
- Ixiaro/Jespect (+30.6%, €54.7m), which are used to treat Japanese encephalitis, a serious viral disease transmitted by mosquitoes in certain regions of Asia and the Pacific. These treatments benefit from a favorable basis for comparison and deliveries to the US Department of Defense.
- Dukoral (+16.8%, €17.4m), an oral vaccine against cholera and certain types of diarrhea caused by enterotoxigenic Escherichia coli (ETEC), intended mainly for travelers in high-risk areas, benefited in particular from a government order for Mayotte.
- Ixchiq (€7.5m compared with €1m in H1 2024) is gaining momentum, thanks to intensified marketing and targeted deliveries in La Réunion.
The bottom line is still a loss of €20.8m, but cash flow has increased compared to last year thanks to lower cash consumption. This provides good visibility for the next quarterly deadlines.
For the current fiscal year, Valneva is maintaining its targets: revenue expected between €180m and €190m, R&D expenses of between €90m and €100m, and over a 50% reduction in operating cash burn to less than €30m.
Other catalysts could well follow and fuel speculation, as two major announcements are expected:
- Phase 3 results for the Lyme disease vaccine (VLA15), developed with Pfizer. If successful, Valneva could receive up to $143m in launch payments, royalties of 14-22% and up to $100m in commercial milestones.
- Phase 1 results for the Zika vaccine.
