Laboratorios Farmacéuticos ROVI - DORIA on target for US NDA in H219

ROVI has announced its pivotal Phase III PRISMA-3 trial continues on track and it expects to file an NDA with the FDA in the second half of 2019. The pre-specified DORIA interim analysis on the pivotal PRISMA-3 study has demonstrated that the study sample size (number of patients enrolled) does not need to be increased. We forecast efficacy data from the Phase III PRISMA-3 trial will be available in Q219 with a potential launch in 2021 in both the US and EU. We forecast peak sales opportunities of US$411m (US and EU) at a high gross margin, which has the potential to be highly value enhancing to ROVI’s long-term profit growth. We value ROVI at €1.16bn or €23.3/share.