VALNEVA Announces New $59 Million IXIARO® Supply Contract with US Government

 Valneva Announces New $59 Million IXIARO^® Supply Contract with US Government
  
Saint Herblain (France), January 16, 2019 - Valneva SE ("Valneva" or "the Company"), a biotech company developing and commercializing vaccines for infectious diseases with major unmet needs, announced today the signing of a new $59 million contract with the U.S. government Department of Defense for the supply of its Japanese encephalitis (JE) vaccine IXIARO^®.  

Under the terms of the agreement, Valneva will supply IXIARO^® doses to the Defense Logistics Agency of the U.S. Department of Defense, through 2019 and the beginning of 2020 with a value of $59 million guaranteed and potentially worth up to $70 million. A delivery schedule is being prepared and supply shipments will commence immediately. 

Franck Grimaud, Chief Business Officer of Valneva commented, "We are pleased to continue our important collaboration with the U.S. government to fight this deadly disease. The U.S. military has been using IXIARO^® since 2010 and we are excited to further support the expansion of its use and help protect military personnel and their families from Japanese encephalitis."  

IXIARO^® is the only JE vaccine approved by the U.S. Food and Drug Administration (FDA). It has been developed through a cooperative research and development agreement with the Walter Reed Army Institute of Research. Valneva markets and distributes IXIARO^® directly to the U.S. military and U.S. private market. In October 2018, the Company announced that the FDA approved an accelerated IXIARO^® vaccination schedule of two doses administered seven days apart, compared to the previous 28 day schedule. The accelerated schedule was approved for adult travelers aged 18-65 years in addition to the previously approved schedule. 

Following this contract award, the Company will provide initial financial guidance on the outlook for 2019.

About IXIARO^®/JESPECT^® 
Valneva's Japanese encephalitis vaccine is indicated for active immunization for the prevention of the disease for people who travel to, or live in, endemic areas. It has received marketing approval in the U.S., Europe, Canada, Hong Kong, Singapore, and Israel under the trade name IXIARO^® and in Australia and New Zealand where it is marketed as JESPECT^®. It is the only vaccine available to the U.S. military for Japanese Encephalitis. IXIARO^® is approved for use in individuals two months of age and older in the U.S. and EU member states, Canada, Norway, Liechtenstein, Iceland, Singapore, Hong Kong, and Israel. In all other licensed territories, IXIARO^®/JESPECT^® is indicated for use in persons aged 18 years or more.

About Japanese Encephalitis  
Japanese encephalitis is a deadly infectious disease found mainly in Asia. About 70,000 cases of JE are estimated to occur in Asia each year, although the actual number of cases is likely much higher due to underreporting in rural areas. JE is fatal in approximately 30 percent of those who show symptoms, and leaves half of survivors with permanent brain damage. The disease is endemic in Southeast Asia, India and China, a region with a population of more than three billion. In 2005, JE killed more than 1,200 children in only one month during an epidemic outbreak in Uttar Pradesh, India, and Nepal.

About Valneva SE 
Valneva is a biotech company developing and commercializing vaccines for infectious diseases with major unmet needs. Valneva's portfolio includes two commercial vaccines for travelers: IXIARO^®/JESPECT^® indicated for the prevention of Japanese encephalitis and DUKORAL^® indicated for the prevention of cholera and, in some countries, prevention of diarrhea caused by ETEC. The Company has various vaccines in development including a unique vaccine against Lyme disease. Valneva has operations in Austria, Sweden, the United Kingdom, France, Canada and the U.S. with over 450 employees. More information is available at www.valneva.com.

Valneva Investor and Media Contacts Laetitia Bachelot-Fontaine Global Head of Investor Relations & Corporate Communications M +33 (0)6 4516 7099 investors@valneva.com

Teresa Pinzolits Corporate Communications Specialist T +43 (0)1 20620 1116 communications@valneva.com

Forward-Looking Statements 
This press release contains certain forward-looking statements relating to the business of Valneva, including with respect to the progress, timing and completion of research, development and clinical trials for product candidates, the ability to manufacture, market, commercialize and achieve market acceptance for product candidates, the ability to protect intellectual property and operate the business without infringing on the intellectual property rights of others, estimates for future performance and estimates regarding anticipated operating losses, future revenues, capital requirements and needs for additional financing. In addition, even if the actual results or development of Valneva are consistent with the forward-looking statements contained in this press release, those results or developments of Valneva may not be indicative of their in the future. In some cases, you can identify forward-looking statements by words such as "could," "should," "may," "expects," "anticipates," "believes," "intends," "estimates," "aims," "targets," or similar words. These forward-looking statements are based largely on the current expectations of Valneva as of the date of this press release and are subject to a number of known and unknown risks and uncertainties and other factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievement expressed or implied by these forward-looking statements. In particular, the expectations of Valneva could be affected by, among other things, uncertainties involved in the development and manufacture of vaccines, unexpected clinical trial results, unexpected regulatory actions or delays, competition in general, currency fluctuations, the impact of the global and European credit crisis, and the ability to obtain or maintain patent or other proprietary intellectual property protection. In light of these risks and uncertainties, there can be no assurance that the forward-looking statements made during this presentation will in fact be realized. Valneva is providing the information in these materials as of this press release, and disclaim any intention or obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.

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• 2019_01_16_VLA_DoD_Contract_PR_EN.pdf