Intervacc - Stable progress
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Intervacc - Stable progress

Progressing towards CVMP opinion in June 2021 Building awareness around Strangles Solid cash position ensures ample runway European approval process for Strangvac remains on track The European regulatory process for market approval of Strangvac remains on track. On 12 January, Intervacc replied to the EMA’s “day 120” questions, and the company now expects a positive opinion from the CVMP in June 2021. Intervacc also continues its preparations for marketing authorisation of Strangvac in the US. The company expects a few local studies on horses to be required in the US, and that local production of the drug product (“fill finish”) may help the process.

Aided by regulatory consultants, Intervacc estimates that the whole process will take ~18 months, implying potential US approval in late 2022. Partaking in initiatives such as Strangles Awareness Week As we covered in our previous research update, Intervacc entered into an exclusive distribution agreement with UK-based Dechra Pharmaceuticals to commercialise Strangvac in Europe ex-Nordics and Baltics, where Intervacc will market and sell Strangvac directly. Intervacc has now initiated awareness campaigns to educate horse owners about the disease, as well as spreading information about the Strangvac vaccine.

Strangles Awareness Week was initiated in early May, targeting the UK, Sweden and the Netherlands. Management indicates that Dechra has committed to running awareness campaigns across its focus markets ahead of the European sales start we expect in late Q3’21. Q1: an undramatic report with a solid cash position In line with our expectations, Intervacc reported Q1 revenues of SEK 1.

1m (+2%), and we believe the company should still be viewed as pre-commercial. With a quarterly burn rate of SEK 15m, Intervacc ended the quarter with a solid cash position of SEK 149m, which we believe will bridge the company to positive cash flow in late ‘22e.

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