Valneva: A Promising Future with VLA15 Vaccine and Strong Portfolio

Valneva (VALN) has been initiated with a Buy rating by Brandon Folkes of H.C. Wainwright due to its promising future prospects. The company's lead program, VLA15, a Lyme disease vaccine co-developed with Pfizer, is expected to provide pivotal data by 2025 and potential commercial launch in 2027. Valneva also has a robust portfolio of approved vaccines targeting travel and endemic diseases, which have generated substantial revenue and are projected to grow in 2025. The analyst expects Valneva to be profitable by 2027.

Valneva SE (VALN) has been initiated with a Buy rating by Brandon Folkes of H.C. Wainwright, highlighting the company's promising future prospects. The lead program, VLA15, a Lyme disease vaccine co-developed with Pfizer, is expected to provide pivotal data by 2025 and potential commercial launch in 2027. Valneva also boasts a robust portfolio of approved vaccines targeting travel and endemic diseases, which have generated substantial revenue and are projected to grow in 2025. The analyst expects Valneva to be profitable by 2027.

VLA15: A Pivotal Moment in Lyme Disease Vaccine Development

Valneva's VLA15, a multivalent recombinant protein vaccine targeting six serotypes of Borrelia, is currently in Phase 3 clinical trials. This vaccine candidate is the only Lyme disease program in late-stage clinical development. Pfizer Inc., Valneva's development partner, is executing a randomized, placebo-controlled Phase 3 field efficacy study, with topline data expected as soon as all Lyme disease cases are confirmed by the end of the 2025 Lyme disease season in the U.S. [1]

The incidence of Lyme disease is significant, with over 89,000 cases reported in the U.S. in 2023. The vaccine's success could provide a significant breakthrough in preventing this bacterial illness, which is transmitted through the bite of infected ticks. Pfizer aims to submit a Biologics License Application to the U.S. Food and Drug Administration and a Marketing Authorization Application to the European Medicines Agency in 2026, subject to positive Phase 3 data. [1]

Financial Performance and Outlook

Valneva reported total revenue of EUR97.6 million in the first half of 2025, a 37.8% increase from EUR70.8 million in the first half of 2024. Product sales reached EUR91 million, up 33.3% from EUR68.3 million in the same period last year. The company's IXIARO sales increased by 30.6% year-over-year to EUR54.7 million, while DUKORAL sales rose by 16.4% to EUR17.4 million. The IXIARO gross margin was 65.5%, compared to 57.5% in the first half of 2024. [2]

Despite the revenue growth, Valneva reported an operating loss of EUR16.8 million in the first half of 2025, compared to an operating profit of EUR46.7 million in the previous year. The company's cash position stood at EUR161.3 million as of June 30, 2025, indicating effective cash management and reduced operating cash burn. Valneva anticipates product sales of EUR170 million to EUR180 million and total revenues of EUR180 million to EUR190 million in 2025. [2]

IXCHIQ: Navigating Safety Concerns and Market Expansion

Valneva's IXCHIQ chikungunya vaccine achieved 650% sales growth in the first half of 2025, driven by R&D costs and reduced cash burn. The vaccine's approval in Brazil marked a significant milestone, opening access to a market where Brazil alone reported over 1 million cases since 2019. Valneva's collaboration with Instituto Butantan and Serum Institute of India further solidifies its footprint in Latin America and LMICs. [3]

Safety concerns over 17 SAEs (including 2 deaths) in elderly patients prompted regulatory pauses, but the FDA lifted restrictions for 60+ in August 2025. The vaccine's regulatory approvals in the U.S., EU, UK, and now Brazil have been bolstered by robust Phase 3 data showing a three-year immune response. [3]

Conclusion

Valneva's promising vaccine portfolio and financial outlook position the company as a leader in the high-growth, unmet medical need sector. With a strong cash position and a robust pipeline, Valneva is well-positioned to navigate the challenges of vaccine development and regulatory scrutiny. The company's strategic partnerships and market expansion efforts further enhance its prospects for success. The analyst's expectation of profitability by 2027, driven by the success of VLA15 and other vaccine programs, underscores Valneva's potential for long-term growth.

References

[1] https://www.vax-before-travel.com/2025/08/12/no-lyme-disease-vaccine-year
[2] https://finance.yahoo.com/news/valneva-se-inrlf-h1-2025-070905475.html
[3] https://www.ainvest.com/news/valneva-ixchiq-vaccine-navigating-safety-concerns-unlock-long-term-2508/