(BFM Bourse) – This setback on its vaccine against Lyme disease is more bad news for Valneva, which announced the day before that it was expecting a drop in sales in 2023.
Difficulties are mounting for Valneva. Its partner Pfizer decided to exclude a significant percentage of participants who had been recruited in the United States for the Phase III clinical study (last step before the potential marketing of a treatment) Valor, evaluating the effectiveness, the Safety and immunogenicity of a Lyme disease vaccine candidate, VLA15.
Lyme disease is a systemic infection caused by bacteria transmitted to humans by ticks. It is now considered the most common vector-borne disease in the northern hemisphere.
“The vaccination of these participants, representing approximately half of all study participants, will be discontinued following violations of Good Clinical Practice (GCP) at certain clinical trial centers operated by a trial company. third-party clinics” explains Valneva.
Difficult to assess the financial impact for an analyst
According to the biotechnology company, the exclusion of these participants is not linked to problems of safety of the candidate vaccine and is not motivated by adverse effects that would be reported by participants.
Valneva also indicates that the clinical trial is continuing on other sites not managed by the operator in question. Its partner Pfizer is still targeting a submission in 2025 of a biological license application to the US Food and Drug Administration and a marketing authorization application to the European Medicines Agency.
According to Portzamparc analysts quoted by Reuters, it is difficult at this stage to assess the financial impact of these disruptions on Valneva. “The question that remains is whether the regulators will be able to accept a dossier that only includes data from half of the participants initially planned,” they say.
For the market, this is a new disappointment. Down nearly 8% around 2:50 p.m., Valneva suffered the largest drop in the SBF 120 this Friday, back below 6 euros.
A recovery in sales of vaccines for travelers
The day before, the company had published a turnover in 2022 up slightly by 3.8% to 361.3 million euros. Valneva thus exceeds its sales target, which was set in a range of between 340 and 360 million euros, lowered last August. The laboratory had to lower its sights in particular because of the multiple disappointments on its vaccine against Covid-19. Valneva has experienced many difficulties in commercializing this vaccine.
On other vaccines, Valneva is doing well. In 2022, the group almost doubled its turnover from its “products” activity to reach 114.8 million euros against 63.0 million in 2021. Valneva explains this increase in sales by a faster than expected recovery. travel market but also sales of the COVID-19 vaccine in Europe and the Kingdom of Bahrain.
On the cash side, it stood at 289.4 million euros, against 346.7 million euros a year earlier. This amount includes a capital contribution of 90 million euros from Pfizer, which had acquired 8.1% of the French biotech through a call to the market in June 2022.
“With nearly 290 million euros in cash, we entered 2023 in a good position to support the commercial growth we expect as well as our R&D programs,” said Valneva’s chief financial officer.
A sharp slowdown in sales expected in 2023
For the current year, Valneva will no longer benefit from the Covid-19 effect. The Valneva group expects 130 million to 150 million euros in product sales in 2023, including marginal sales of vaccines against Covid-19 in Bahrain, the first country in the world to have authorized Valneva’s product.
The company is counting on its vaccine against chikungunya – this viral disease transmitted by certain mosquitoes, resulting in particular in acute fevers and joint pain – to revive itself. The company expects to file a marketing authorization application for VLA1553, its chikungunya drug candidate in Europe in the second half of 2023. In the United States, the procedure is at a more advanced stage. At the end of December, the company requested the green light from health authorities to sell its chikungunya vaccine in the country.
Sabrina Sadgui – ©2023 BFM Bourse
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