Intervacc - More progress than meets the eye
Progressing according to plan after an eventful year We expect a positive CVMP opinion in Q2’21 European distribution agreement around the corner Q4: an undramatic report with an optimistic outlook In line with our expectations, Intervacc reported Q4 revenues of SEK 0.9m (-13%) as it continued to renew the product portfolio of Nordvacc’s distribution business. The company is on track to show solid cost control, with EBIT of SEK -7.2m followed by operating cash flow (inc. capitalised R&D) of SEK -4.4m. We believe the end-Q4’20 cash position of SEK 164m will bridge Intervacc into positive cash flow in late 2022e.
While the recent news flow has been relatively sparse, we note that Intervacc continues to execute on its plan, especially focusing on securing the infrastructure needed for the launch of Strangvac. We also note that both preclinical projects (piglets & dairy cows) are now testing vaccine candidates in the target animals, with results pointing in the right direction. No timeline or detailed development plan was provided.
Solid regulatory development On the regulatory side, a key focus has been to strengthen the application dossier to the EMA, where we note that Intervacc sent in its “day 120 replies” on January 12, 2021. The next regulatory landmark for EU approval will be day 180, where the company expects a shorter list of follow-up questions. Intervacc remains on track for a positive CVMP opinion in Q2’21.
After a positive opinion it usually takes ~30 days to get final approval (max 67 days). We assume a 90% likelihood of approval, and a European commercial launch in H2’21e. In parallel, Intervacc are working to establish a path forward towards approval in the US by the USDA.
The incoming dialogue with the CVB (part of USDA) will decide whether local US safety studies will be required in the approval process. We expect an European distribution agreement in H1’21 We trim our estimates to reflect a more gradual sales ramp-up in 2021. Intervacc ha....