Big step forward in launching OX124 in the US
Q3 2023 highlights
› Total net revenues of
› EBITDA of
› Net earnings of
› US Pharma segment (ZUBSOLV® US) net revenues of
› Cash flow from operating activities of
› Earnings per share before and after dilution amounted to -0.97 (-0.77)
› ZUBSOLV reimbursed by Medicaid in
› The patent win announced in the end of Q2 was appealed by
› The first patent issued in the US for OX640, epinephrine rescue medication for allergic reactions
› OX124, high-dose rescue medication for opioid overdose, refiled with the FDA
Important events after the end of the period
› The MODIA® study didn't meet the primary end-points, but showed high rates of treatment response in both study arms, with no adverse events associated with the use of MODIA
›
SEK m unless otherwise stated |
2023 Jul-Sep |
2022 Jul-Sep |
2023 Jan-Sep |
2022 Jan-Sep |
2022 Jan-Dec |
Net revenues | 156.1 | 161.0 | 472.8 | 468.3 | 624.3 |
Cost of goods sold | -22.8 | -28.0 | -68.8 | -76.7 | -102.6 |
Operating expenses | -161.9 | -182.8 | -505.0 | -504.3 | -705.6 |
EBIT | -28.6 | -49.8 | -100.9 | -112.8 | -183.9 |
EBIT margin | -18.4% | -31.0% | -21.3% | -24.1% | -29.5% |
EBITDA | -9.5 | -32.4 | -44.8 | -62.1 | -115.2 |
Earnings per share. before dilution. SEK | -0.97 | -0.77 | -3.19 | -2.50 | -5.17 |
Earnings per share. after dilution. SEK | -0.97 | -0.77 | -3.19 | -2.50 | -5.17 |
Cash flow from operating activities | -21.9 | -60.7 | -92.4 | -107.8 | -156.6 |
Cash and invested funds | 184.2 | 443.9 | 184.2 | 443.9 | 351.9 |
Comments by the CEO, Nikolaj Sørensen :
Approaching EBITDA in balance H2
"Prevailing in the patent litigation against Sun Pharmaceutical was a positive start to the quarter and strengthened our long-term ability to expand our US Commercial presence and product portfolio. The next product for commercialization in the US, the high-dose rescue medication for opioid overdose, OX124, was filed again with the FDA in September. With approval, we will launch our second pharmaceutical product in the US late 2024 or early 2025.
To read the full CEO Comments, view attached PDF.
Contact persons quarterly report
Tel: +46 18 780 88 00, +1 855 982 7658, E-mail: ir@orexo.com.
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This information is information that
https://news.cision.com/orexo/r/orexo-q3-2023-interim-report,c3867716
https://mb.cision.com/Main/694/3867716/2402320.pdf
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