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.Laboratorios Farmaceuticos Rovi is engaged in the sale of its own pharmaceutical products and the distribution of other products for which it holds licenses granted by other laboratories for specific periods, in accordance with the terms and conditions contained in the agreements entered into with said laboratories.
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