Valneva Reports Strong Q1 Revenue Growth and Positive EBITDA Reaffirms Financial Guidance and Pipeline Outlook for 2017 Robust Q1 financial results - confirming financial self-sustainability strategy
  • Total revenues and grants of €29.1 million in Q1 2017 (vs €24.7 million in Q1 2016) driven by a strong increase in vaccine sales;

  • Q1 product sales performance up 26.7% compared to Q1 2016, mainly driven by IXIARO®sales to the US military and strong sales in the travel market;

  • EBITDA of €3.4 million and operating profit of €0.5 million in Q1 2017 compared to an operating loss of €2.7 million in Q1 2016;

  • Net loss reduced to €1.7 million in Q1 2017 compared to a net loss of €5.0 million in Q1 2016;

  • Cash position at €45.2 million at end of March 2017.

    2017 outlook confirmed
  • Valneva confirms it expects 2017 overall IFRS revenues to reach €105 to €115 million, reflecting up to 17% total revenue growth compared to 2016, driven mainly by IXIARO®/JESPECT®and DUKORAL®sales;

  • The Company confirms it intends to invest between €21 million and €23 million in R&D in 2017, corresponding to approximately 20% of annual revenues;

  • Valneva confirms it expects an EBITDA of €5 to €10 million in 2017.

    R&D Highlights
  • Patient recruitment for the Phase I trials of Valneva's Lyme vaccine candidate in the US and EU is advancing in accordance with the study protocol and the Company intends to accelerate the program´s progression towards Phase II;

  • Valneva plans to advance its Chikungunya vaccine candidate into Phase I in the second half of 2017;

  • Valneva also seeks to partner its Phase III-ready Clostridium difficile vaccine candidate in 2017.

Thomas Lingelbach, President and CEO and Franck Grimaud, Deputy CEO of Valneva, commented, "We are very pleased with our first-quarter operational performance which validates our financial guidance for the full year. We will continue to focus on commercial execution while at the same time allocating our capital to promising R&D projects that we believe will create substantial value and patient benefit, such as our Lyme disease vaccine candidate". Key Financial Information

€ in thousand

3 months ending March 31 (unaudited)

2017

2016

Revenues & grants

29,122

24,687

Net profit/(loss)

(1,657)

(5,037)

EBITDA1

3,359

14

Net operating cash flow

12,131

(6,602)

Cash, short-term deposits and marketable securities, end of period

45,208

33,408

Lyon (France), May 11, 2017 - Valneva SE ("Valneva" or "the Company"), a fully integrated, commercial stage biotech company focused on developing innovative lifesaving vaccines, reported today its consolidated financial results for the first quarter ended March 31, 2017. The condensed consolidated interim financial report is available on the Company's website at www.valneva.com.

A webcast for financial analysts, fund managers, investors and journalists will be held today at 2:00 pm (CET). A replay will be available on the Company's website. Please refer to this link: http://edge.media-server.com/m/p/axsxyw36.

Commercialized vaccines

JAPANESE ENCEPHALITIS VACCINE (IXIARO®/JESPECT®) Strong sales growth driven by US military supply

In the first quarter of 2017, IXIARO®/JESPECT®revenues increased to €15.6 million compared to

€14.6 million in the first quarter of 2016, mainly driven by strong sales to the US military. This sales increase follows an update in the US Navy medical guidance at the end of 2016, stating that Japanese Encephalitis vaccination is now required for all Navy personnel and DoD employees assigned to Japan or the Korean peninsula for over 30 days. At the time of this update, vaccination against Japanese encephalitis was already required for U.S Air Force personnel and the Marine Corps so assigned. Based on first quarter revenues, Valneva confirms it expects IXIARO®/JESPECT®revenues to reach between €58 and €62 million in 2017, through continued marketing and sales activities and an increase in product adoption by travelers.

1 EBITDA (Earnings before interest, taxes, depreciation and amortization) was calculated by excluding depreciation, amortization and impairment of tangible and intangible assets from the operating loss.

CHOLERA / ETEC- DIARRHEA VACCINE (DUKORAL®2) Strong sales performance in Canada, the UK and the Nordics

DUKORAL®revenues grew to €9.8 million in the first quarter of 2017 compared to €5.4 million in the first quarter of 2016, primarily due to increased sales in Canada (which accounts for more than 50% of global revenue for this product), the United Kingdom and the Nordics. Valneva will continue to invest in growing the DUKORAL®vaccine through promotional activities and geographic expansion and expects DUKORAL®sales to grow by approximately 10% in 2017 to

€27 million.

Technologies and services

EB66®CELL LINE

In the first quarter of 2017, Valneva signed 5 new EB66®agreements including a research license with MSD Animal Health for the development of new EB66®-based veterinary vaccines and a commercial license with Bavarian Nordic.

Under the terms of the commercial agreement signed with Bavarian Nordic, the Danish biotech company has the rights to develop and commercialize multiple poxvirus-based vaccines on the EB66®cell-line. The deal also includes the possibility for Bavarian Nordic to transfer, upon regulatory approvals, some of its existing product candidates produced on chicken embryonic fibroblast (CEF) onto Valneva's EB66®technology.

Valneva expects to sign additional agreements for the licensing of its EB66®vaccine platform in the coming quarters.

Vaccine Candidates

CLOSTRIDIUM DIFFICILE VACCINE CANDIDATE- VLA 84 Partnering agreement sought in 2017

Clostridium difficile (C. difficile) is the most common infectious cause for nosocomial diarrhea in Europe and the US. There are an estimated 450,000 cases of C. difficile in the US annually3and no vaccine against the disease is commercially available.

Valneva seeks to partner its Clostridium difficile vaccine candidate and has ongoing discussions with interested parties. Published Phase II data4from the most advanced vaccine program targeting primary prevention of Clostridium Difficile Infections (CDI) indicates that Valneva´s VLA84 provides an immunological profile comparable to that other product.

  1. Indications differ by country - Please refer to Product / Prescribing Information (PI) / Medication Guide approved in your respective countries for complete information, including dosing, safety and age groups in which this vaccine is licensed. ETEC: Enterotoxigenic Escherichia coli (E. Coli) bacterium

  2. Lessa et al, Burden of Clostridium difficile Infection in the United States. N Engl J Med 2015;372:825-34

4

G. de Bruyn et al. Vaccine 34 (2016) 2170-2178

LYME BORRELIOSIS VACCINE CANDIDATE - VLA 15 Patient recruitment progressing in the US & EU

Following clearance from the Food & Drug Administration (FDA) and the Belgian authorities at the end of 2016, Valneva has initiated Phase I clinical trials in the US and Europe, and vaccinated the first subject at the end of January 2017.

Patient recruitment for the Phase I trials is advancing in accordance with the study protocol and the Company intends to accelerate the program´s progression with a view to starting Phase II in early 2018.

Currently, there is no licensed vaccine available to protect humans against Lyme disease, a multi systemic tick-transmitted infection affecting more than 300,000 Americans each year. The global market for a vaccine against Lyme disease is estimated at approximately €700 - €800 million annually5.

CHIKUNGUNYA VACCINE CANDIDATE - VLA 1553 Expected to enter Phase I in the second half of 2017

Valneva is also working actively on the development of a Chikungunya vaccine and expects to enter Phase I clinical development in the second part of 2017. Pre-clinical data has shown that Valneva's live attenuated vaccine candidate has a good safety profile and the potential to provide long term protection against Chikungunya after a single immunization. The Chikungunya virus (CHIKV) re-emerged from East Africa in 2014, causing devastating epidemics of debilitating and often chronic arthralgia, and is now considered as a major health threat with 180,000 reported cases in the Americas in 20166. There is currently no antiviral treatment for CHIKV infection and no licensed vaccine to prevent the disease. The global market for a Chikungunya vaccine is estimated at approximately €500 million annually7.

Other Business Update

VALNEVA SHARES NOW TRADABLE ON DEUTSCHE BÖRSE XETRA®PLATFORM

Valneva's common shares have recently been accepted for continuous trading on the electronic trading platform Xetra®under the symbol VLA FP.

Xetra®, one of the biggest electronic and global trading systems, is a leading European trading venue operated by Deutsche Börse which handles over 90% of all of the stock trades for the

Frankfurt Stock Exchange.

Valneva SE common shares will continue to trade in Segment B of Euronext Paris (ticker: VLA.PA) and on the Prime Market of the Vienna stock exchange (ticker: VALNEVA SE ST).

5 Company estimate supported by independent market studies

6

PAHA/WHO data: Number of reported cases of Chikungunya Fever in the Americas - EW 33 (August 19, 2016)

7 Company estimate supported by independent market studies

Valneva SE published this content on 11 May 2017 and is solely responsible for the information contained herein.
Distributed by Public, unedited and unaltered, on 11 May 2017 07:21:13 UTC.

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