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 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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Update
Marco Caremi
Executive VP of Business Development
Stefan Weber
CEO
Forecast net cash (€m)
29.1
Forecast gearing ratio (%)
N/A
% | 1M | 3M | 12M |
---|---|---|---|
Actual | 4.3 | (19.8) | 45.5 |
Relative | 0.8 | (17.6) | 33.4 |
52 week high/low | CHF11.0/CHF4.2 |
Newron is developing evenamide as an add-on therapy for poorly managed and treatment-resistant schizophrenia (TRS). In April/May 2024, Newron shared positive results from a Phase II/III trial (study 008A) in patients with schizophrenia who are taking antipsychotics but not classified as having TRS (primary and key secondary endpoints met). In January 2024, positive final results (12-month data for the full patient cohort) were announced for a Phase II trial (study 014/015) in TRS patients. Over 70% of patients experienced a clinically meaningful reduction in disease severity and 25% achieved remission. With these encouraging results in hand, Newron now intends to begin a potentially pivotal, multinational Phase III TRS programme (which could commence by end-2024). In its FY23 results, Newron recorded total revenue of €9.1m (up 48.6% y-o-y) for the period, primarily derived from Xadago-related royalty income.
Y/E Dec | Revenue (€m) | EBITDA (€m) | PBT (€m) | EPS (c) | P/E (x) | P/CF (x) |
---|---|---|---|---|---|---|
2022A | 6.1 | (12.6) | (17.0) | (95.34) | N/A | N/A |
2023A | 9.1 | (11.2) | (16.0) | (89.81) | N/A | N/A |
2024E | 24.3 | 2.1 | (2.6) | (14.12) | N/A | N/A |
2025E | 27.1 | 3.3 | (0.8) | (4.31) | N/A | N/A |