Valneva SE (Euronext Paris:VLA) is a French-based pharmaceutical company focused on various infectious disease vaccines.
The company’s vaccine product portfolio includes, among others:
Ixiaro (Japanese encephalitis)
Dukoral (cholera)
Ixchiq* (chikungunya, a mosquito-borne fever disease).
VLA2001 (a coronavirus vaccine that did not succeed in an already saturated market)
VLA1601 (Zika virus vaccine)
As an investment case, however, I am most interested in the company’s work with the Lyme disease vaccine. Regarding this, in 2020, a collaboration agreement was signed with pharmaceutical company Pfizer for the development of the VLA15 vaccine, and additionally, Pfizer is a significant shareholder in Valneva, having invested €95M in the summer of 2022, acquiring an 8.1% ownership stake in the shares at that time. The vaccine program is currently in Phase 3 clinical trials (VALOR). If successful, it would be a significant event. In such a scenario, marketing authorization would be sought in 2026. Currently, there are no vaccines on the market for Lyme disease (which is an infection caused by the Borrelia burgdorferi bacterium), unlike for viral tick-borne encephalitis. Lyme disease vaccines using Moderna and Biontech’s mRNA technology are still in early research stages.
Recently, the stock has felt volatile, and it would be interesting to hear if forum members have been following the company?
The situation with this Lyme disease vaccine is indeed interesting.
The LYMErix vaccine received marketing authorization from the FDA for Lyme disease in 1998. Phase III results were positive for another vaccine as well, but the manufacturer did not proceed with seeking marketing authorization. LYMErix was withdrawn from the market by the manufacturer after only four years. The manufacturer noted a decline in sales due to low demand, which was partly fueled by justified and less justified side effects that became public. This also led to legal disputes at the time. I am under the impression that no strong evidence was ultimately found between such harms and the vaccine.
Now, more than 20 years later, the problem is being approached with a non-live recombinant vaccine, which is in Phase III and is also being studied in Finland. There has been interest in the vaccine. The vaccine’s mechanism of action is otherwise very interesting – when a tick bites a person who has developed a vaccine response, antibodies travel into the tick and neutralize the Borrelia bacteria it contains, which causes the infection.
Despite this, open questions remain. Since there is no long-term evidence of immune response, even for LYMErix, it is unknown how long the vaccine might protect against infection. The current vaccine was studied with a series of three injections, and if I recall correctly, a booster dose was given after one year. While frequently repeated booster doses might be good from a business perspective, not everyone necessarily desires them. The vaccine covers six common serotypes in North America and Europe, but not necessarily potential future, mutated strains of the evolving Borrelia bacteria. Additionally, competing, newer mRNA-technology vaccines may also enter human trials later.
The story of LYMErix shows that even a vaccine proven to be effective and safe can later fail for various reasons. Perhaps the world is now more ready for a Lyme disease vaccine than it was 20 years ago? If successful, a safe vaccine demonstrating long-term efficacy would indeed be a commercial success, as has been observed with, for example, the HPV vaccine, the Shingrix vaccine, and even the COVID-19 vaccine.
The mosquito-borne chikungunya virus disease is feared to spread into an epidemic, which WHO has recently warned about. Restrictions were placed this year on the Ixchiq vaccine developed by Valneva for those over 65 years old due to adverse events it caused. EMA’s safety committee removed the restriction on July 11. This has, to my understanding, been a catalyst for the increase in trading volume.
Over 7,000 cases of Chikungunya have been reported in Guangdong province in China since the beginning of July. Heavy rainfall and floods create ideal breeding conditions for mosquitoes.
Valneva julkaisi tänään puolivuosiraporttinsa H1 2025 (linkki)
Total revenues were €97.6 million compared to €70.8 million for the first half of 2024, an increase of 37.8%
Product sales reached €91.0 million compared to €68.3 million in the first half of 2024, an increase of 33.3%
Net loss of €20.8 million compared to a net profit of €34.0 million in the first half of 2024, which included one-time net proceeds of €90.8 million from the sale of a Priority Review Voucher (PRV)1
Significant reduction in operating cash burn (€10.9 million in the first half of 2025 compared to €66.3 million in the first half of 2024)
Cash and cash equivalents were €161.3 million as at June 30, 2025, compared to
€168.3 million as at December 31, 2024
Cash at June 30, 2025 included €20.1 million of net proceeds from two At The Market (ATM) transactions with leading U.S. institutional healthcare investors Novo Holdings A/S and Frazier Life Sciences in Q2 20252
Financial Outlook
The Company confirms the following guidance for fiscal year 2025:
Product sales expected to grow to €170-180 million, driving positive cash flow for the commercial business
Total revenues expected to reach €180-190 million
Total R&D investments expected between €90-100 million, partially offset by grant funding and anticipated R&D tax credits
Continued stringent focus on cash management supporting sufficient cash runway to reach key inflection points; targeting more than 50% lower operating cash burn compared to the prior year
Yhtiön tappiollisesta toiminnasta huolimatta kassa tuntuu olevan hallinnassa ja markkinat tuntuivat ottaneen tulokset positiivisesti vastaan. Vaikka Chikungunya-epidemia onkin eittämättä ollut lyhyen ajan positiivinen ajuri, kaikki katseet ovat lopulta suunnattu Pfizerin kanssa yhteistyössä kehitettyyn borrelioosirokotekandidaattiin VLA15 ja sen odotettuihin kolmosfaasin tuloksiin.
The US FDA suspended the marketing authorization for the Ixchiq vaccine, effective immediately, due to observed side effects. In early August, the vaccine’s usage restrictions were recently lifted, and now it’s a complete halt. The stock listed on Euronext Paris is down approximately 25% at the time of writing. However, the company did not directly change its guidance due to the incident.1
Could look like a buying opportunity, but I’ll pass myself. The safety looks poor. Considering that chikungunya is apparently usually a self-limiting disease. It feels like after COVID, speculators are looking for the next major epidemic and companies benefiting from it. It wasn’