Valneva has adjusted its financial guidance for the 2023 calendar year, after the French vaccine specialist said it had not yet sold a priority review voucher.
The voucher’s sale would have brought in proceeds of €90m-€110m ($70.6m-$86.3m). As such, Valneva said it is now expecting total product sales revenues for the year of €130m-€150m, according to a 29 December press release.
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Valneva had originally updated its guidance in November 2023, expecting total revenues and other income between €220m-€260m, assuming sale of its priority review voucher before year-end.
Valneva secured the voucher upon approval from the US Food and Drug Administration (FDA) of its chikungunya vaccine Ixchiq. As per the Tropical Disease Priority Review voucher programme, the voucher – which cuts four months off FDA review time for any drug application it is redeemed for – can be sold to other companies.
Valneva’s chief financial officer Peter Bühler said: “We remain confident in our ability to sell our priority review voucher successfully at a price within the previously suggested range. As we continue to work actively toward a potential sale agreement, we look forward to providing an update in the new year.”
Currently, the secondary market for priority review vouchers has stabilised around the $100m mark. Sarepta, bluebird bio, Pharming, and Krystal Biotech all sold vouchers in 2023.
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By GlobalDataValneva is not the only company with an adjustment to a voucher sale. bluebird bio, which had originally agreed to sell its voucher to Novartis for $103m upon approval of its sickle cell disease gene therapy Lyfgenia (lovo-cel), did not end up receiving a voucher from the FDA.
As per its November guidance, Valneva expects a 42.6% increase in product sales during the first nine months of 2023 compared to the same period in 2022. The biotech pointed towards improved sales of its Japanese encephalitis vaccine Ixiaro and cholera vaccine Dukoral due to the continued recovery of the travel industry.
According to GlobalData’s Pharma Intelligence Centre, Ixchiq is forecast to have sales of $73m this year.
GlobalData is the parent company of Pharmaceutical Technology.
