Orexo AB

Orexo Q2 2026 Interim Report

Källa: MFN
Negativ

Sammanfattning

Orexo redovisar en minskning av nettoomsättningen till 3,5 MSEK (4,8 MSEK) för andra kvartalet 2026. Periodens resultat uppgick till -102,5 MSEK (-97,5 MSEK) och kassaflödet var -109,3 MSEK (2,2 MSEK). Bolaget fortsätter att arbeta med sina läkemedelsprojekt och har initierat en process för att utvärdera möjligheter till ytterligare finansiering.

Analys

Orexos andra kvartal präglas av minskad omsättning och ett ökat negativt resultat jämfört med föregående år. De operativa framstegen inom läkemedelsprojekten Izipry, OX640 och OX390 fortskrider enligt plan, med förväntad FDA-godkännande för Izipry under Q1 2027. Bolaget har även inlett ett vetenskapligt samarbete för att expandera sin AmorphOX-teknologi. Med tanke på det negativa kassaflödet och det pågående arbetet med att säkra ytterligare finansiering, samt den pågående utredningen från DOJ, är situationen komplex.

Nyckeltal

Net revenues
3.5 (4.8) MSEK
Net earnings
-102.5 (-97.5) MSEK
Cash flow from operating activities
-93.3 (-53.4) MSEK
Earnings per share before dilution
-2.92 (-2.81) SEK

Insikter

  • • Bolaget initierar en process för att utvärdera ytterligare finansiering, vilket indikerar ett kapitalbehov.
  • • Planerad NDA-resubmission för Izipry i Q3 2026 och potentiellt FDA-godkännande i Q1 2027 är viktiga milstolpar.
  • • Fortsatt fokus på utveckling av AmorphOX-teknologin med växande externt intresse.

Vad har förändrats sedan förra rapporten?

Orexo Q1 2026 Interim Report

  • • Net revenues ändrades med -1.5 (-30.0%).
  • • Net earnings ändrades med +2.7 (+2.6%).
  • • Cash flow from operating activities ändrades med -60.0 (-180.2%).

Building momentum for the next chapter

Financial summary April – June

  • Total net revenues of SEK 3.5 m (4.8)
  • Net earnings for the period is SEK -102.5 m (-97.5)
  • Cash flow for the period is SEK -109.3 m (2.2)
  • Earnings per share before and after dilution SEK -2.92 (-2.81)
  • Net earnings for the period for discontinued operations is SEK 2.1 m (57.8).

Operational highlights April – June

  • Izipry: Supportive stability and reliability data for the final commercial product were generated, supporting the planned NDA resubmission in Q3 2026. Potential FDA approval expected in Q1 2027
  • OX640 advanced toward pivotal development, with commercial-scale manufacturing and study preparations progressing according to plan ahead of Q4 2026
  • OX390 delivered positive proof-of-concept in vivo data and achieved further regulatory alignment with the FDA, supporting continued advancement of the program
  • A scientific collaboration with a pharmaceutical organization was initiated to support the expansion of AmorphOX® into GLP‑1 agonists and other large molecule applications
  • Growing external interest in AmorphOX generated multiple partnering discussions across small molecules, peptides and vaccines.

Significant events after the end of the period

  • No significant events after the end of the period.
SEK m unless otherwise stated2026Apr-Jun2025Apr-Jun2026Jan-Jun2025Jan-Jun2025Jan-DecNet revenues3.54.88.517.926.0Cost of goods sold-0.1-0.1-0.6-4.8-14.5Operating expenses-106.7-89.9-186.2-174.6-364.3Of which research and development expenses/operating expenses, %4659495764EBIT-103.3-85.3-178.2-161.5-352.7EBIT margin %neg.neg.neg.neg.neg.EBITDA-95.1-73.8-161.1-139.0-285.7Earnings per share before dilution, SEK-2.92-2.81-5.95-5.44-11.65Earnings per share after dilution, SEK-2.92-2.81-5.95-5.44-11.65Cash flow from operating activities-93.3-53.4-126.8-95.0-195.4Cash and cash equivalents Orexo232.8121.3232.8121.3912.4Cash and cash equivalents payable to Dexcel44.1—44.1——Total Cash and cash equivalents276.9121.3276.9121.3912.4Unless otherwise stated, all data refers to continued operations post Zubsolv US divestment as of Dec. 31 2025. Discontinued operations are presented in Note 10.

CEO comments in briefDuring the quarter, we made good progress across our portfolio of rescue medications, including OX640 for the treatment of anaphylaxis, Izipry™ for synthetic opioid overdose and OX390 for adulterated opioid overdose. We remain on track to reach important value inflection points, including the start of the pivotal trial for OX640 in fourth quarter of 2026 with read-out in the first quarter of 2027, and a potential FDA approval of Izipry in the first quarter of 2027 following the planned resubmission in the third quarter of this year.

For OX390, which is being developed in collaboration with BARDA, operating under the US Department of Health and Human Services, we reported successful in vivo study results during the quarter. At the same time, our strengthened business development team is seeing growing interest in the AmorphOX technology from external parties.

Following the divestment of Zubsolv® US, we continue to adapt and optimize the organization to support our new growth strategy. We are also intensifying our efforts to resolve the Department of Justice (DOJ) investigation.

To fully realize the value of our technology platform and development pipeline, while also removing the unresolved DOJ-related legal matters, we have initiated a process to evaluate opportunities for securing additional financing together with our financial advisor, DNB Carnegie.

Uppsala, Sweden, July 16, 2026

Nikolaj SørensenPresident and CEO

For full CEO Comments see PDF

Contact personsNikolaj Sørensen, President and CEOFredrik Järrsten, EVP and CFO+46 18 780 88 00ir@orexo.com

PresentationJuly 16, at 2 pm CEST analysts, investors and media are invited to attend a presentation, incl. a Q&A. Participants may access the event via live webcast or teleconference through the following link:https://investorcaller.com/events/orexo/orexo-q2-report-2026Prior to the call, presentation material will be available on the website under Investors/Rapport archive.

This information is information that Orexo AB is obliged to make public pursuant to the EU Market Abuse Regulation and the Securities Markets Act. The information was submitted for publication, through the agency of the contact persons set out above, at 2026-07-16 07:00 CEST.

AttachmentsOrexo Interim Report Q2 2026 Published July 16

Öppna PDF

Fler nyheter från Orexo AB

Relaterade pressmeddelanden och bolagshändelser från samma bolag.

Se bolagssidan