Valneva with updates on ongoing UK and Canadian processes

27.10.2021

Valneva submitted changes to the French Financial Market Authority on October 26, 2021. These concern the ongoing incidents, for example around the Covid vaccine candidate VLA2001 and the British government, but also at Dukoral and the Canadian health authority. The change at the French authority includes an explanation of changes to the company’s segment reporting structure effective January 1, 2021 and events after the reporting period that affected the circumstances of the termination of the agreement to supply VLA2001, the Covid19 vaccine candidate, to the UK and the possible effects of this termination. The change states that the UK government announced its decision to terminate the UK supply contract on September 10, 2021. This included the allegation that Valneva would in future violate the UK supply contract, which could give rise to a liability for damages (the contractual limit would not exceed the amounts received). As stated in the amendment, Valneva strongly denies any claims related to the breach of the UK supply contract and it claims that it is very unlikely that such a UK authority claim would ultimately be successful. However, the termination of the British supply contract was recognized. Valneva has no obligation to reimburse or repay any amounts paid by the UK authorities in the event of termination.

Valneva continues to discuss the terms of the termination of the UK supply contract with the UK authority. These final terms, as well as other commercial opportunities and receipt of regulatory approval from VLA2001, may affect the company’s financial condition. The potential impact of the termination of the UK supply agreement on the company’s financial position is set out in the note on post-period events in the change with the authorities. The notice discusses the potential impact on the Company’s inventories and prepayments for inventories, property, plant and equipment, reimbursement liabilities, and contract liabilities.

In addition, the company has received a request for information from a directorate of Health Canada, the agency that oversees pharmaceutical products in Canada, regarding the data supporting the indication and labeling of the company’s Dukoral® product. This remains an ongoing issue and should the indication or labeling of Dukoral® in Canada change significantly, this could have a significant negative impact on the company’s sales, which in turn could result in the product no longer being economically viable.

Finally, the company had planned to announce the third quarter results on November 18, 2021. Because it is currently difficult to assess the impact of a number of post-closing events, on November 18, 2021, the company will only change its cash position for the quarter ended September 30, 2021 and revenue for the nine months ended September 30 2021. The annual financial statements on December 31, 2021 enable all necessary elements to be integrated.

Here are some updates on the current candidates: In October 2021, the company announced positive first phase 3 results for VLA2001. In anticipation of these results, the company initiated its rolling filing and review process with the UK Medicines & Healthcare Products Regulatory Agency (“MHRA”) in August 2021. The company expects to feed its positive first phase 3 results into this application in November 2021. MHRA approval could take place by the end of 2021. Further filings with other supervisory authorities can be made in 2022.

In September 2021, Valneva and Pfizer Inc. announced positive new Phase 2 results, including data after a booster dose, for Valneva’s Lyme disease vaccine candidate VLA15. The two companies are working closely together on the next development steps and are planning a placebo-controlled approval-relevant phase 3 study for 2022. Dosing of the first subject in the Phase 3 clinical trial will trigger a milestone payment from Pfizer of $ 25 mo.

With respect to VLA1553, the company’s Chikungunya vaccine candidate, the company has received confirmation from the EMA that it has accepted the protection substitute that Valneva previously agreed with the US Food & Drug Administration (FDA) as the basis for approval. The company announced in August 2021 that the seroprotection rate observed in the pivotal Phase 3 study of VLA1553 was 98.5%, exceeding the FDA-agreed threshold of 70% for protection.

Photo credit

1. Valneva, Vienna, Credit: Valneva, (© Aussender) >> Open on photaq.com

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