Valneva SE (VALN:NASDAQ; VLA:FRA) dosed the first participant in a Phase 2 pediatric trial evaluating its chikungunya vaccine candidate, Ixchiq, on January 10, 2024, according to Edward White, analyst at HC Wainwright & Co.
The trial aims to support potential approval in children aged 1-11 years old.
Ixchiq recently received accelerated FDA approval in adults amid filings in Europe, Canada, and Brazil. Valneva sees over US$500 million in peak annual sales potential.
Trial Design and Commercial Outlook
The new randomized study will enroll 300 healthy children across sites in Honduras and the Dominican Republic. Participants will receive either a full dose, half dose, or placebo.
According to White, the data could back a future Phase 3 study to extend Ixchiq's initial labels. The vaccine is currently under regulatory review in several regions with potential 2024 approvals. Positive Phase 3 results were recently demonstrated in adolescents to support U.S. and Brazilian filings.
"The company anticipates a commercial launch for Ixchiq in the U.S. early this year. We project Ixchiq sales
of €40 million in 2024, growing to €310 million in 2028," White wrote. €310 million exchanges to around US$327 million.
Valuation View
HC Wainwright maintains a Buy rating and US$26 price target on Valneva. The valuation bakes in risks-adjusted net present value forecasts for near-term Ixchiq sales and long-term Lyme disease royalties.
Upside drivers include the execution of the pediatric development program and commercial launch over the next two years. According to White, successful pivotal results would support label expansion to tap into broader market potential.
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Disclosures for H.C. Wainwright & Co., Valneva SE, January 10, 2024
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H.C. WAINWRIGHT & CO, LLC RATING SYSTEM: H.C. Wainwright employs a three tier rating system for evaluating both the potential return and risk associated with owning common equity shares of rated firms. The expected return of any given equity is measured on a RELATIVE basis of other companies in the same sector. The price objective is calculated to estimate the potential movements in price that a given equity could reach provided certain targets are met over a defined time horizon. Price objectives are subject to external factors including industry events and market volatility.
H.C. Wainwright & Co, LLC (the “Firm”) is a member of FINRA and SIPC and a registered U.S. Broker-Dealer. I, Edward White , certify that 1) all of the views expressed in this report accurately reflect my personal views about any and all subject securities or issuers discussed; and 2) no part of my compensation was, is, or will be directly or indirectly related to the specific recommendation or views expressed in this research report; and 3) neither myself nor any members of my household is an officer, director or advisory board member of these companies. None of the research analysts or the research analyst’s household has a financial interest in the securities of Valneva SE (including, without limitation, any option, right, warrant, future, long or short position). As of December 31, 2023 neither the Firm nor its affiliates beneficially own 1% or more of any class of common equity securities of Valneva SE. Neither the research analyst nor the Firm knows or has reason to know of any other material conflict of interest at the time of publication of this research report.
The research analyst principally responsible for preparation of the report does not receive compensation that is based upon any specific investment banking services or transaction but is compensated based on factors including total revenue and profitability of the Firm, a substantial portion of which is derived from investment banking services. The Firm or its affiliates did not receive compensation from Valneva SE for investment banking services within twelve months before, but will seek compensation from the companies mentioned in this report for investment banking services within three months following publication of the research report. The Firm does not make a market in Valneva SE as of the date of this research report.
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