Orexo Q2 2024 Interim Report
Orexo AB (ORXOY) released its Q2 2024 interim report, showing total net revenues of SEK 154.0 million, slightly down from SEK 157.7 million in Q2 2023. The company reported an EBITDA of SEK 5.0 million and net earnings of SEK -35.9 million. US Commercial segment net revenues increased to SEK 147.9 million. Notably, Orexo received a complete response letter from the FDA for OX124, its high-dose naloxone rescue medication for opioid overdose, requesting additional data. The company successfully conducted a new human factor study in early July. Orexo's CEO highlighted a strong recovery in Zubsolv sales and the company's focus on bringing OX124 to the US market, despite the delay in FDA approval.
- Third consecutive quarter with positive EBITDA at SEK 5.0 million
- US Commercial segment net revenues increased to SEK 147.9 million
- Strong recovery in Zubsolv sales, growing slightly year-on-year
- Second patent granted in the US for OX640, a nasal epinephrine powder product
- Sustainability work ranked among top five percent of 70,000 businesses worldwide by EcoVadis
- Total net revenues decreased to SEK 154.0 million from SEK 157.7 million in Q2 2023
- Net earnings declined to SEK -35.9 million from SEK -12.6 million in Q2 2023
- Cash and cash equivalents decreased to SEK 139.7 million from SEK 251.1 million in Q2 2023
- FDA requested additional data for OX124, delaying its approval and launch
- Increased legal expenses and retrospective adjustment of Abstral royalties impacted financial performance
UPPSALA,
Making progress, while the OX124 review time extended
Q2 2024 highlights
- Total net revenues of
SEK 154.0 m (157.7) - EBITDA of
SEK 5.0 m (5.6) - Net earnings of SEK -35.9 m (-12.6)
- US Commercial segment net revenues of SEK 147.9 m (145.4), in local currency
USD 13.9 m (13.8) - Cash flow from operating activities of SEK -6.5 m (-12.7), cash and cash equivalents of
SEK 139.7 m (251.1) - Earnings per share before and after dilution amounted to SEK -1.04 (-0.37)
- Second patent in the US granted for OX640, a nasal epinephrine powder product
- The financial guidance for 2024 reiterated
Important events after the end of the period
- Orexo AB´s sustainability work ranked among the top five percent of all 70,000 businesses worldwide reviewed by EcoVadis
- For OX124, a high dose naloxone rescue medication for opioid overdose, a complete response letter was received from the FDA, requesting additional technical data on the final commercial product and additional data from a new human factor (HF) study. A new HF study was successfully conducted in early July.
SEK m unless otherwise stated | 2024 | 2023 | 2024 | 2023 | 2023 |
Net revenues | 154.0 | 157.7 | 293.2 | 316.8 | 638.8 |
Cost of goods sold | -16.3 | -17.2 | -29.6 | -46.0 | -88.9 |
Operating expenses | -153.5 | -153.4 | -284.2 | -343.0 | -659.5 |
EBIT | -15.8 | -12.9 | -20.5 | -72.3 | -109.5 |
EBIT margin | -10.3 % | -8.2 % | -7.0 % | -22.8 % | -17.1 % |
EBITDA | 5.0 | 5.6 | 20.9 | -35.4 | -32.5 |
Earnings per share, before dilution, SEK | -1.04 | -0.37 | -1.30 | -2.22 | -3.73 |
Earnings per share, after dilution, SEK | -1.04 | -0.37 | -1.30 | -2.22 | -3.73 |
Cash flow from operating activities | -6.5 | -12.7 | -25.4 | -70.5 | -95.0 |
Cash and cash equivalents | 139.7 | 251.1 | 139.7 | 251.1 | 171.0 |
CEO comments in brief: Strong Zubsolv® recovery and focus on getting OX124 to the US market
"I am pleased to report our Zubsolv sales grew slightly year on year, with a strong improvement from the first quarter. This is the third consecutive quarter that we have achieved a positive EBITDA, despite additional costs for a new human factor study (HF study) for OX124, increased legal expenses and a retrospective adjustment of Abstral® royalties. The improvement in Zubsolv sales was expected following the inventory adjustments at the beginning of the year and sales in the quarter to wholesalers and pharmacies have become more aligned. Both also grew slightly compared to last year. We have made good progress in preparing for the launch of our second medication on the US market, OX124, but close to the publication of this Interim Report we received feedback from the FDA with a request to complement the application with additional technical data from the final commercial product. In the quarter we addressed the initial concerns raised by the FDA in April and have recently successfully conducted a new HF study. We are investigating the implications of the new request, but we are optimistic we can address these new concerns expeditiously, but there will be a delay in the original time guidance."
For the full CEO comments view attached PDF.
Contact persons quarterly report:
Nikolaj Sørensen, President and CEO
Fredrik Järrsten, EVP and CFO
Lena Wange, IR & Communications Director
Tel: +46 18 780 88 00, +1 855 982 7658,
E-mail: ir@orexo.com.
Presentation:
On July 17, 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=50048737
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-q2-report-2024/register
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 July 17, 2024.
This information was brought to you by Cision http://news.cision.com
https://news.cision.com/orexo/r/orexo-q2-2024-interim-report,c4015814
The following files are available for download:
Orexo Interim Report Q2 2024 published July 17 |
View original content:https://www.prnewswire.com/news-releases/orexo-q2-2024-interim-report-302199079.html
SOURCE Orexo
FAQ
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