Newron Pharmaceuticals is focused on the central nervous system. Xadago for Parkinson’s disease (PD) is sold in Europe, Japan, the United States and other regions. Evenamide, a novel schizophrenia add-on therapy, is involved in a Phase II/III trial programme targeting schizophrenia.
Xadago is marketed as an add-on to levodopa therapy in PD. It is currently sold in Europe, Japan, the United States and other territories. Generic manufacturers have notified the FDA of their intention to file generic Xadago products. Newron is contesting these filings. Xadago is currently patent protected until at least 2027.
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Marco Caremi
Executive VP of Business Development
Stefan Weber
CEO
Forecast net cash (€m)
21.8
Forecast gearing ratio (%)
N/A
% | 1M | 3M | 12M |
---|---|---|---|
Actual | (8.1) | (15.5) | 244.4 |
Relative | (11.7) | (16.0) | 247.8 |
52 week high/low | CHF8.0/CHF1.3 |
Newron is developing evenamide as an add-on therapy for poorly managed and treatment-resistant schizophrenia (TRS). A potentially pivotal Phase III trial (study 008A) in patients with schizophrenia who are taking antipsychotics but not classified as having TRS is underway; readouts are expected in Q423 or Q124. In the Phase II trial (study 014/015) for patients with TRS, evenamide has demonstrated both safety and efficacy in readouts to date. In October 2023, encouraging interim readouts were reported corresponding to the six-month timepoint for the full 161-patient cohort in extension study 015; full one-year data are expected in Q124. Newron intends to begin an additional, potentially pivotal, multinational Phase III study (study 003) in TRS patients (expected to start in Q124). In its H123 results, Newron recorded total revenue of €5.5m for the period, nearly double H122’s revenue of €2.8m, primarily driven by higher royalty income for Xadago.
Y/E Dec | Revenue (€m) | EBITDA (€m) | PBT (€m) | EPS (c) | P/E (x) | P/CF (x) |
---|---|---|---|---|---|---|
2021A | 5.8 | (11.4) | (14.1) | (79.23) | N/A | N/A |
2022A | 6.1 | (12.6) | (17.0) | (95.34) | N/A | N/A |
2023E | 8.9 | (11.7) | (14.6) | (81.90) | N/A | N/A |
2024E | 6.8 | (19.1) | (22.3) | (124.77) | N/A | N/A |