(AOF) – Valneva is in advanced talks with Scotland’s economic development agency “Scottish Enterprise” for a multi-million pound grant to complete construction and operationalization of its site of Livingston’s strategic production facility in Scotland. Following the termination of the agreement with the British government (HMG) for the supply of Valneva’s inactivated vaccine candidate against Covid-19, VLA2001, Valneva has suspended plans to expand its Scottish site.
Valneva and Scottish Enterprise have since engaged in a very constructive dialogue aimed, through this grant, to make the Livingston site a key site for vaccine production from a long-term perspective.
Thus, Valneva and Scottish Enterprise would jointly invest in the new plant. Scottish Enterprise’s contribution is expected to come through a series of grants totaling £ 10-20million to enable Valneva to start production at the plant.
Discussions between Valneva and the Scottish Government also include the possible supply to Scotland of doses of VLA2001, subject to obtaining a marketing authorization.
Valneva has also offered to offer 25,000 doses of VLA2001 for the primary vaccination of employees of the Scottish National Health Service and front-line people, subject to obtaining marketing authorization.
The grant agreement should also include employment commitments, and the grant is subject to the signing of the contract and a final audit.
Valneva continues to try to reach an out-of-court settlement with HMG regarding the termination of the supply agreement and the execution of the ongoing clinical trial funding agreement. Valneva continues to reserve all its rights of legal action in the event that an amicable solution is not found.
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= / Key points / =
– Specialist in the development of prophylactic vaccines against infectious diseases with limited therapeutic options;
– Revenue of € 110m € bn drawn from Europe for 56%, ahead of America (27%), then Asia-Oceania (9%) and Africa-Middle East (8%) ;
– Business model: portfolio of diversified vaccines for the general public, financing of clinical developments through a specialized infrastructure, 2 commercial vaccines (Ixiaro and Dukoral against Japanese encephalitis and cholera) and vaccine distribution rights for third parties;
– Capital 15.07% owned by the Grimaud la Corbière group, 8.78% by the British MVM Life Science and 8.20% by BPI France, Frédéric Grimaud chairing the 5-member supervisory board and Thamas Lingelbach chairing the management board ;
– Solid balance sheet with € 449m in equity against € 196m in debt, reinforced by net cash of € 330m in cash at the end of June, and then by listing on the Nasdaq and the 1
er
s payments from Pfizer (€ 140 million) and the British government.
= / Issues / =
– Medium-term strategy for further development of the Ixiaro and Dukoral vaccines to finance its R&D, expansion of the manufacturing network (3 sites, in Scotland, Sweden and Austria) and partnerships to enhance the group’s assets;
– Innovation strategy inherent to the business model, supported by € 85 million in R&D investments, with 3 main assets and 3 preclinical programs:
– the only vaccine in clinical development against Lyme disease,
– the only single injection vaccine against chikungunya,
– the only inactivated and adjuvanted whole virus COVID-19 vaccine currently in clinical trial in Europe,
– candidate vaccines against human metapneumovirus, parvovirus and norovirus;
– Environmental strategy for the regular reduction of environmental impacts;
– Good visibility of the activity thanks to agreements with:
– the British government (orders for 100 million doses of anti-Covid vaccines by 2022 and options on 190 million by 2025, i.e. € 1.4 billion in total),
– with Pfizer to co-develop and market a vaccine against Lyme disease for $ 308 million,
– with the American authorities for the Ixiario vaccine against Japanese encephalitis ($ 70 million),
– with Bavarian Nordic for the marketing and distribution of specialized vaccines,
– with Batavia Biosciences for the development of an inexpensive vaccine against polio,
– with the Butantan institute for a vaccine against chikingunya for low-income countries.
= / Challenges / =
– Sensitivity to the results of studies of vaccines against Lyme disease (phase 2) in particular (marketing request for 2024) and against chikingunya and Covid 19 (phase 3);
– Outcome of discussions with the European Commission on the supply of 60 million doses of anti -Covid vaccine and marketing of this vaccine by the end of the year;
– Impact of the pandemic: stable turnover at € 47.5 million and widening of the net loss to € 86.4 million due to R&D expenditure on the Covid 19;
– 2021 objectives: excluding Covid vaccine, turnover between € 80 and 105 million and R&D expenses between € 65 and 75 million.
Boost for French pharmacy
At the end of a recent CSIS, the French authorities announced an unprecedented amount of credits (7 billion euros): 1.5 billion for university hospital research, 2 billion for investment in health via bpi France , 1.5 billion in aid for the relocation of industrial projects, and 2 billion to strengthen investment in three sectors of the future (bioproduction, digital medicine, and pandemic preparedness). In addition, the annual growth in drug expenses reimbursed by Medicare will be 2.4%, which should generate at least 0.5% growth in laboratory turnover,
Above all, the normal drug marketing procedure will be accelerated (up to 500 days saved) if the actual benefit is sufficient.