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Research: Healthcare
Laboratorios Farmacéuticos ROVI (ROVI) has announced top-line data from the pivotal Phase III PRISMA-3 trial evaluating DORIA (ISM risperidone) in schizophrenia. DORIA achieved the primary endpoint of a statistically significant reduction (p<0.0001) in PANSS score at week 12 (both 75mg and 100mg doses once-monthly intra-muscular injection). These data not only validate DORIA but also the ISM technology platform developed by ROVI. ROVI plans to file the US NDA in H219. We forecast a potential launch in 2021 in both the US and EU and peak sales opportunities of US$411m (US and EU) in 2027. DORIA has the potential to be highly value enhancing to ROVI’s long-term profit growth. This is in line with our expectations and we leave our forecasts and valuation unchanged at €1.23bn or €21.9 per share.
Written by
Laboratorios Farmacéuticos ROVI |
DORIA Phase III trial hits primary endpoint |
DORIA update |
Pharma & biotech |
19 March 2019 |
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Business description
Analysts
Laboratorios Farmacéuticos ROVI is a research client of Edison Investment Research Limited |
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Laboratorios Farmacéuticos ROVI (ROVI) has announced top-line data from the pivotal Phase III PRISMA-3 trial evaluating DORIA (ISM risperidone) in schizophrenia. DORIA achieved the primary endpoint of a statistically significant reduction (p<0.0001) in PANSS score at week 12 (both 75mg and 100mg doses once-monthly intra-muscular injection). These data not only validate DORIA but also the ISM technology platform developed by ROVI. ROVI plans to file the US NDA in H219. We forecast a potential launch in 2021 in both the US and EU and peak sales opportunities of US$411m (US and EU) in 2027. DORIA has the potential to be highly value enhancing to ROVI’s long-term profit growth. This is in line with our expectations and we leave our forecasts and valuation unchanged at €1.23bn or €21.9 per share.
Year end |
Revenue* (€m) |
PBT** |
EPS** |
DPS |
P/E |
Yield |
12/17 |
277.4 |
20.3 |
0.40 |
0.12 |
43.1 |
0.7 |
12/18 |
304.8 |
19.3 |
0.39 |
0.08 |
44.2 |
0.5 |
12/19e |
335.4 |
26.9 |
0.49 |
0.10 |
35.2 |
0.6 |
12/20e |
363.2 |
46.5 |
0.83 |
0.19 |
20.8 |
1.1 |
Note: *Total revenue including government grants. **PBT and EPS are normalised, excluding amortisation of acquired intangibles, exceptional items and share-based payments.
ROVI’s R&D focus is on its proprietary ISM technology, which centres on developing novel, long-acting (once a month or once every three months) formulations of approved drugs. The PRISMA-3 Phase III study is a placebo-controlled trial designed to evaluate the efficacy and safety of monthly intramuscular injections of DORIA in patients with acute exacerbation of schizophrenia. PRISMA-3 is additionally assessing whether an improvement in PANSS from day four is achievable and statistically significant. If so, and if it is included in its label, DORIA would have a unique selling point versus its competitor long-acting injectable (LAIs). The trial is also looking at health economic-related outcomes, which could be relevant in pricing and reimbursement negotiations. We believe DORIA’s profile will enable it to take a 5% share of the LAI market. We retain our probability of success of 75% for the Phase III PRISMA-3 trial and await the full data (expected by end June 2019) to assess any additional implications to our model.
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Disclaimer
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