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50 Leading Companies of the Year 2018

The Fully Integrated, Commercial Stage Biotech Company Focused On Developing Innovative Lifesaving Vaccines: Valneva

thesiliconreview-thomas-lingelbach-president-ceo-valneva-2018“Our mission is to help protect the lives of people around the world through the discovery, development, and commercialization of innovative vaccines against infectious diseases.”

Valneva is a commercial stage biotech company focused on developing innovative lifesaving vaccines. Valneva is listed on Euronext-Paris and the Vienna stock exchange and has operations in Austria, Sweden, the United Kingdom, France, Canada, and the US with over 450 employees.

Valneva's vision is to contribute to a world where no one dies or suffers from a vaccine-preventable disease. Valneva aims to become the leading vaccine biotech company by complementing product sales growth with the development of high-value R&D assets. Valneva invests proceeds from its commercial business in R&D. The Company's clinical pipeline includes a unique vaccine candidate against Lyme disease. 

Valneva’s Strategy

Valneva's strategy stems from its vision to contribute to a world in which no one dies or suffers from a vaccine-preventable disease.

Product Sales Growth

Valneva aims to increase its product sales from € 92.6 million in 2017 to approximately € 150 million by 2022 - representing an ongoing double-digit year on year growth. Where possible, to augment organic product sales growth and to leverage its infrastructure, its ambition is to add products to its commercial portfolio. The firm’s ambition is therefore to achieve overall product sales of over € 200 million by 2022.

Research and Development

Valneva's Research and Development (R&D) organization is committed to deliver vaccine candidates in areas of growing medical need and present innovative solutions to the benefit of individuals and society.

The firm’s current R&D pipeline is mainly focused on vector-transmitted diseases and the Company is concentrating its R&D expertise and resources, to a large extent, on the development of a much-needed vaccine against Lyme disease, the most common and one of the fastest growing vector-borne illnesses in the Northern Hemisphere for which there is no other clinical vaccine candidate in development worldwide.

In order to execute on its R&D pipeline progression through future value inflection points, Valneva has expected to increase R&D investments significantly in the coming years.Its R&D approach is to develop products through approval and commercial launch, alone, in co-development, or through partnership agreements that will generate revenues in the form of milestone payments as well as royalties on future product sales.

Financials

One of Valneva's key strategic objectives is to be financially self-sustainable in its operations. Valneva generated € 10.8 million positive EBITDA in 2017, marking the second consecutive year of positive operating results. Going forward, the company aims to maintain positive EBITDA for its business whilst continuing to invest in promising product candidates.

Products Portfolio

Valneva's commercial portfolio includes two 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 Enterotoxigenicn escherichia coli. 

Japanese encephalitis vaccine

Valneva’s Japanese encephalitis vaccine is licensed in more than thirty-five countries. It is marketed under the trade names IXIARO® in North America, Europe, Hong Kong, Singapore,and Israel and under the trade name JESPECT® in Australia and New Zealand where it is distributed by Seqirus.

Valneva manufactures the IXIARO®/JESPECT® vaccine at its fully-owned cGMP facilities in Livingston, Scotland. The site is licensed and operates under a Manufacturing Authorisation granted by the Medicines and Healthcare products Regulatory Agency (“MHRA”) and is also registered by the US FDA.

Since the approval of IXIARO®/JESPECT® in 2009, Valneva has been focusing on increasing penetration through its sales and marketing activities and global expansion strategy.

Vaccine against cholera and/or ETEC

Valneva acquired the DUKORAL® vaccine in February 2015 to complement the Company’s vaccine portfolio of travelers’ vaccines.

DUKORAL® was first licensed in Sweden in 1991 and was granted a marketing authorization in Europe in 2004. Today, DUKORAL® is registered in numerous countries across the globe.

In support of the Company’s objective to directly control the commercialization of its products in key markets, Valneva created a subsidiary in Canada, DUKORAL®’s largest market, at the end of January 2015.

Valneva manufactures the vaccine at its fully owned site in Solna, Sweden. Valneva’s subsidiary, Valneva Sweden AB, is approved by EMA (centralized procedure), WHO and Canadian authorities. Valneva Sweden has extensive experience in vaccine production and other processes requiring Biosafety level 2. Valneva Sweden holds manufacturing licenses to produce medicinal drugs and to manufacture clinical trial material.

Greet the Leader

Thomas Lingelbach, President, and Chief Executive Officer: Following the Intercell-Vivalis merger, Thomas Lingelbach was appointed President and CEO of Valneva. He has been with Intercell since 2006, serving as COO until 2011 and since then as CEO. He has held a variety of positions of increasing international responsibility in his more than 25 years in the pharma and vaccine industry. He joined Intercell from Novartis Vaccine & Diagnostics as Managing Director Germany focusing on the integration with Chiron Vaccine where he served as Vice President Global Industrial Operations and Managing Director Chiron-Behring. Thomas Lingelbach holds a Master's degree in Engineering and complemented his education with a Business Administration program.

“We aim to become the leading fully integrated, commercial-stage vaccine company by complementing organic growth with opportunistic M&A while investing into the development of promising vaccine candidates.”