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.
UPPSALA, Sweden, Feb. 8, 2024 /PRNewswire/ -- Positive EBITDA in H2 setting the target for FY 2024
Q4 2023 highlights
- Total net revenues of SEK 166.0 m (156.1)
- EBITDA of SEK 12.4 m (-53.1), EBITDA excluding costs for legal processes and external non-repeating clinical trials, SEK 23.4 m (-0.1)
- Net earnings of SEK -18.6 m (-91.8)
- US Pharma segment (Zubsolv® US) net revenues of SEK 151.3 m (142.6), in local currency USD 14.2 m (13.3), US Pharma EBIT of SEK 75.4 m (77.0)
- Cash flow from operating activities of SEK -2.6 m (-48.9), cash and invested funds of SEK 171.0 m (351.9)
- Earnings per share before and after dilution amounted to SEK -0.54 (-2.67)
- 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
- Robin Evers elected as board member at the Extraordinary General Meeting. He replaces Henrik Kjaer Hansen who has resigned. Kjaer Hansen has instead been appointed chairman of the Nomination Committee, representing Novo Holdings A/S.
- FDA accepted the New Drug Application filing for review of OX124, a high-dose rescue medication for opioid overdose with naloxone
- Financial outlook provided for 2024 on page 15.
Important events after the end of the period
- MODIA and Vorvida® will be reimbursed within the US Veterans Affairs Federal Supply Schedule as of January 1, 2024.
| SEK m unless otherwise stated | 2023 | 2022 | 2023 | 2022 |
| Net revenues | 166.0 | 156.1 | 638.8 | 624.3 |
| Cost of goods sold | -20.1 | -25.9 | -88.9 | -102.6 |
| Operating expenses | -154.5 | -201.3 | -659.5 | -705.6 |
| EBIT | -8.6 | -71.1 | -109.5 | -183.9 |
| EBIT margin | -5.2 % | -45.6 % | -17.1 % | -29.5 % |
| EBITDA | 12.4 | -53.1 | -32.5 | -115.2 |
| Earnings per share. before dilution. SEK | -0.54 | -2.67 | -3.73 | -5.17 |
| Earnings per share. after dilution. SEK | -0.54 | -2.67 | -3.73 | -5.17 |
| Cash flow from operating activities | -2.6 | -48.9 | -95.0 | -156.6 |
| Cash and invested funds | 171.0 | 351.9 | 171.0 | 351.9 |
Financial outlook 2024
- The buprenorphine/naloxone market will grow 2-5 percent, based on current growth trajectory
- Zubsolv net sales in USD will be in line with 2023
- Cost control is a priority and OPEX excluding depreciation and amortization will decline from SEK 582 m in 2023 to
below SEK 530 m in 2024 - Positive EBITDA for the FY 2024.
The financial outlook 2024 is based on a forward looking assumption of a USD/SEK exchange rate of 10.28 calculated
as an average of December 2023 by the Riksbanken.
Strong recovery in financial results and FDA initiated the review of OX124
CEO Comments in brief
“I am pleased to report a Q4 result delivering a positive EBITDA and strong Zubsolv® net sales both compared to Q4 2022 and Q3 2023. Zubsolv net sales year over year grew more than 6 percent in both SEK and USD, and nearly 8 percent quarter over quarter. I am also delighted to share that we are continuing to drive efficiencies across the business and have reduced operating expenses by 23 percent from last year. This recovery in financial performance is not driven by exchange rates, on the contrary, our EBITDA in H2 would have been nearly SEK 8 million higher if we had applied the exchange rates from end of 2022.
I am also pleased to announce that we, despite currency headwinds, reached our financial guidance for 2023, and in particular the positive EBITDA for H2. With relatively stable exchange rates and no other extraordinary events in 2024, we are confident we can reach a positive EBITDA for the FY 2024.”
To read the full CEO Comments view attached PDF.
Contact persons quarterly report
Nikolaj Sørensen, President and CEO, Fredrik Järrsten, EVP and CFO, or Lena Wange, IR & Communications Director
Tel: +46 18 780 88 00, +1 855 982 7658, E-mail: ir@orexo.com.
Presentation
On Feb. 8, at 2 pm CET analysts, investors and media are invited to attend a presentation, incl. a Q&A.
To attend via teleconference where you can ask questions verbally:
https://conference.financialhearings.com/teleconference/?id=2001504
When registered you will be provided phone numbers and a conference ID to access the conference.
To attend via webcast:
https://ir.financialhearings.com/orexo-q4-2023
Prior to the call, presentation material will be available on the website under Investors/Reports/Audiocasts.
This information is information that Orexo AB (publ.) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication through the agency of the contact persons set out above at 8 am CET on February 8, 2024.
The following files are available for download:
| Orexo Interim Report Q4 2023, incl Full Year published February 8, 2024 |
View original content:https://www.prnewswire.com/news-releases/orexo-interim-report-q4-2023-incl-full-year-report-302057213.html
SOURCE Orexo
Company Codes: Bloomberg:ORX@SS, ISIN:SE0000736415, RICS:ORX.ST, Stockholm:ORX, OTC-PINK:ORXOY
