Big step forward in launching OX124 in the US

Q3 2023 highlights
›     Total net revenues of SEK 156.1 m (161.0)
›     EBITDA of SEK -9.5 m (-32.4), EBITDA excluding costs for legal processes and external non-­repeating ­­clinical trials, SEK 13.3 m (14.3) 
›     Net earnings of SEK -33.3 m (-26.5)
›     US Pharma segment (ZUBSOLV® US) net revenues of SEK 140.4 m (150.1), in local currency USD 13.0 m (14.2), US Pharma EBIT of SEK 62.3 m (70.2)
›     Cash flow from operating activities of SEK -21.9 m (-60.7), cash and invested funds of SEK 184.2 m (443.9)
›     Earnings per share before and after dilution amounted to -0.97 (-0.77)
›     ZUBSOLV reimbursed by Medicaid in Indiana state as of July 1
›     The patent win announced in the end of Q2 was appealed by Sun Pharmaceuticals
›     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 
 ›     Robin Evers elected as board member at the Extraordinary General Meeting. He replaces ­Henrik ­Kjaer ­Hansen who has announced he will resign. Kjaer Hansen, has instead been appointed ­c­­hairman of the Nomination Committee, representing Novo Holdings A/S

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. Orexo’s treatments of opioid use disorder (OUD) range from maintenance treatment with ­ZUBSOLV®, digital psychosocial support through MODIA® and soon, the rescue medication with OX124. I am pleased to ­announce we reiterate our guidance to reach EBITDA in ­balance for H2 2023, despite the EBITDA for Q3 coming in at SEK -10 million. The negative result is explained by the SEK 18 million fee paid to the FDA for filing of OX124. In the current financial environment, improving financial results is important, and I am pleased to see we ­continue to reduce expenses."

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 Nov. 2, 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=2001503
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-q3-2023/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 November 2, 2023.