Q3 2024 highlights

› Total net revenues of SEK 136.5 m (156.1)
› EBITDA of SEK -0.7 m (-9.5)
› Net earnings of SEK -41.9 m (-33.3)
› US Commercial segment net revenues of SEK 131.0 m (140.4), in local currency USD 12.6 m (13.0)
› Cash flow from operating activities of SEK -13.4 m (-21.9), cash and cash equivalents of SEK 114.9 m (184.2)
› Earnings per share before and after dilution amounted to SEK -1.21 (-0.97)
› Orexo AB´s sustainability work ranked among the top five percent of all 70,000 businesses
worldwide reviewed by EcoVadis
› For OX124, our 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 as well as further information from a new human factors study (HF study). A new HF study was successfully conducted in July.
› The financial guidance for 2024 reiterated.

Important events after the end of the period

› An exploratory phase 1 clinical study was initiated for OX640 in participants with allergic rhinitis.

A quarter of setbacks and achievements

CEO Comments in brief

The third quarter has been challenging, starting with the delay of OX124’s approval and, from a financial perspective, we had a marginally negative EBITDA. This negative EBITDA result was primarily due to higher legal costs, retrospective adjustments of the Abstral® royalties and lower Zubsolv® sales. The development was partly compensated by a 15 percent drop in expenses. Zubsolv prescription volumes in the US are stable, but sales were negatively impacted by a reduction in inventory levels at wholesalers and a weakening USD.

Looking beyond the third quarter, I am pleased to see Zubsolv sales continuing to show stable demand and growth in some segments. We remain optimistic that we can get OX124, our high dose rescue medication for opioid overdose, approved and expand treatment alternatives for patients suffering from opioid use disorder. In the quarter we made progress in our business development efforts, attracting new companies to leverage our AmorphOX® technology, and we continue to see interest in OX640. Also, there are signs that we are making some progress to resolve the legal disputes in the US.

Nikolaj Sørensen
President and CEO

For the full CEO comments view 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 October 24, 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=50048738
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-q3-report-2024

Prior to the call, presentation material will be available on the website under Investors/ Report Archive