Biotalys EPA issues proposed registration decision for Evoca

We increased our Target Price for Biotalys to € 7.5 (was €6.1) while maintaining our Buy rating after Biotalys announced that the US EPA (Environmental Protection Agency) has issued its proposed registration decision to approve its first biofungicide, Evoca. The EPA will now initiate the final phase in its regulatory review, allowing stakeholders such as growers and industry associations 15 days to provide feedback before finalizing its regulatory decision. The EPA has also posted a final rule exempting Evoca's active ingredient residues on treated crops from tolerance requirements, indicating that no maximum residue limits will apply and highlighting the product candidate's exemplary safety profile. We increased our probability of success for Evoca from 85% to 95% (together with the associated higher validation of the platform) resulting in a higher SOTP based Target Price of € 7.5 (was € 6.1).


We welcome that the US Environmental Protection Agency initiates the public participation procedure but Evoca is just the beginning for Biotalys as they intend to bring a pipeline of fungicides and insecticides to the market in the coming years.

An approval of Evoca paves the way for the regulatory submission of Evoca NG, the next-generation version of the product candidate, and Biotalys' anticipated first commercial launch. Recall that Biotalys expects the review process for Evoca NG to be significantly shorter as the product contains the same active ingredient as Evoca and features enhanced formulation and production methods.