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.  

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.