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  • Orexo
    Box 303 751 05 Uppsala
    +46 (0)18 780 88 00
    +46 (0)18 780 88 88
    http://www.orexo.com

    • Quotes

    With the acquisition of the rights to two digital health products from GAIA and the appointment of Dennis, a thought leader in the digital health industry in the US, we are well positioned to lead this development within the complementary disease areas of our pharmaceutical business.
    Nikolaj Sørensen, President and CEO
    Our strategy is to focus on solutions with scientifically proven therapeutic effect which will benefit the healthcare system as a whole and more importantly patients.
    Nikolaj Sørensen, CEO, about Digital Therapies
    I am convinced that DTx will become an integral and natural part of addiction treatment in the future. This digital therapy for OUD patients is perfectly positioned with Orexo’s competences and commercial organization in the US.
    Nikolaj Sørensen, President and CEO
    Mundipharma Australia has been a good partner in the approval process and we are confident that their experience and infrastructure will create a strong foundation for a successful launch of Zubsolv®
    Nikolaj Sørensen, President and CEO
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    Orexo: Salem Tewolde, Head of Supply Chain, on solving real problems

    News Release  Salem shares her experiences of heading up the supply chain at Orexo, ensuring timely delivery of Zubsolv® and preparing to launch OX124. Furthermore, her passion for enabling sustainability. Hi Salem, how would you describe your role as Head of Supply Chain? I work with my team to make sure we have everything in place to maintain an uninterrupted supply of our commercial products to distribute. Right now, one of our primary focuses is on ensuring a sustainable supply chain for OX124, our high-dose rescue medication. A large part of my role is ensuring that the supply

    Orexo to participate in Pareto Securities´ 15th Annual Healthcare Conference 2024

    Uppsala, Sweden – September 3, 2024 – Orexo AB (Publ.), (STO:ORX) (OTCQX:ORXOY), today announces the company will participate in Pareto Securities´ 15th Annual Healthcare Conference, that takes place on September 19, at Downtown Camper by Scandic, Brunkebergstorg 9, Stockholm, Sweden.   On the day, between 2:25-2:45 CET (room Event Small), Robert Rönn, SVP and Head of R&D, will give a company presentation. Robert Rönn and Lena Wange, Investor Relations, will also be available for 1-1 meetings. For more information, please contact: Orexo AB (publ.) Lena Wange, IR &

    Orexo Q2 2024 Interim Report

    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

    Orexo: invitation to presentation of the Q2 2024 Interim Report

    Uppsala, Sweden – Juli 8, 2024 – As previously communicated Orexo will announce the Interim Report for the second quarter of 2024 on July 17 at 8 am CET. The same day at 2 pm, analysts, investors, and media are invited to attend a presentation where Nikolaj Sørensen, CEO, and Fredrik Järrsten, CFO, will present the latest development and host a Q&A. To attend via teleconference where you can ask questions verbally use this link:  https://conference.financialhearings.com/teleconference/?id=50048737 

    Orexo Q1 2024 Interim Report

    Starting 2024 with a positive EBITDAQ1 2024 highlights›     Total net revenues of SEK 139.3 m (158.8)›     EBITDA of SEK 15.9 m (-41.1) ›     Net earnings of SEK -8.9 m (-63.9)›     US Commercial segment net revenues of SEK 129.3 m (140.3), in local currency USD 12.4 m (13.5)›     Cash flow from operating activities of SEK -18.9 m (-61.6), cash and invested funds of SEK 198.0 m (278.9)›     Earnings per share before and after dilution amounted to SEK -0.26 (-1.86)›     MODIA® and Vorvida® were reimbursed within the US Veterans Affairs Federal Supply Schedule as of January 1,

    Orexo announces data from the MODIA® study evaluating impact on use of illicit opioids

    · The six-month randomized controlled trial (RCT) enrolled 437 participants at 36 sites across the US · The study demonstrated no statistically significant difference between treatment arms in any pre-specified endpoint · Both treatment arms had unexpectedly high rates of treatment response, with no adverse events associated with the use of MODIA  · A post hoc analysis found that patients completing all 24 modules of MODIA had a significantly higher treatment response than those who did not complete the entire program · Orexo will continue to commercialize MODIA as a mobile

    Orexo publishes the Annual and Sustainability Report for 2022

    Uppsala, Sweden - March 28, 2023 – Orexo’s Annual and Sustainability Report for 2022 has been published and can be downloaded at, www.orexo.com, where it is also available in Swedish in accordance with the European Single Electronic Format (ESEF). A PDF version of the report is attached to this press release.   Nikolaj Sørensen, President and CEO: “By finalizing the development of OX124, and launching MODIA®, we have improved Orexo’s offering for opioid dependent patients. Our strengthened position means that we are ready to benefit from the deregulation for physicians to treat

    Orexo submits New Drug Application to FDA for OX124, a high-dose rescue medication for opioid overdose

    · OX124 is designed to reverse the effects of the most powerful synthetic opioids, such as fentanyl · Nine out of ten fatal opioid overdoses in the US involve synthetic opioids · If approved, the US launch is expected to be initiated in H1 2024   Uppsala, Sweden – February 3, 2023 – Orexo AB (publ.), (STO:ORX) (OTCQX:ORXOY), today announces the submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for its lead pharmaceutical pipeline asset, OX124, a nasal rescue medication for opioid overdose. OX124, is based on Orexo´s drug delivery platform

    Orexo's lead product ZUBSOLV® added to NY State Medicaid MAT Preferred Drug List

    · ZUBSOLV® will be available to all patients with Medicaid insurance in NY state effective March 22, 2022 · ZUBSOLV® market access improves in the public segment to 48 percent unrestricted access from 42 percent currently · ZUBSOLV® maintains unrestricted access to over 98 percent of patients in commercial segment Uppsala, Sweden – February 24, 2022 – Orexo AB (publ.), (STO:ORX) (OTCQX:ORXOY), announced today information about improved market access position for ZUBSOLV® (buprenorphine and naloxone) sublingual tablet (CIII) for opioid dependence. This news follows the publication

    Invitation to presentation of the Q4 Interim Report, on January 27 at 2 pm CET

    Uppsala, Sweden – January 20, 2022 – As previously communicated Orexo will announce the Q4 Interim Report, which also includes the 2021 Full Year Report, on January 27 at 8 am CET. The same day at 2 pm CET analysts, investors and media are invited to attend a presentation where Nikolaj Sørensen, CEO, Joseph DeFeo, CFO and Robert Rönn, Head of R&D will present the latest development. After the presentation a Q&A will be held. Questions can also be sent in advance to ir@orexo.com, not later than 11 am CET.Please view the instructions below on how to participate. Link: https://tv.

    Orexo Q2 2021 Interim Report

    "First commercial DTx contract signed with a large healthcare provider"Summary · Total net revenues of SEK 142.8 m (179.1) · Net earnings of SEK -73.7 m (-32.5) · EBITDA of SEK -41.1 m (-9.0) · US Pharma segment (ZUBSOLV® US) net revenues of SEK 126.0 m (172.5), in local currency USD 15.0 m (17.8), EBIT of SEK 61.6 m (88.8) · Cash flow from operating activities of SEK -20.9 m (-7.2), cash balance of SEK 679.7 m (677.2) · Two patents for ZUBSOLV®, with protection until 2032, were issued by the US Patent and Trademark Office · First patient enrolled in pivotal study

    Orexo Q1 2021 Interim Report

    Investing in future growth driversQ1 2021 summary · Total net revenues of SEK 132.3 m (175.0) · Net earnings of SEK -31.5 m (82.6) · EBITDA of SEK -23.9 m (39.1) · US Pharma segment (ZUBSOLV® US) net revenues of SEK 126.8 m (163.9), EBIT of SEK 66.1 m (75.9) · Cash flow from operating activities of SEK -47.8 m (48.1), cash balance of SEK 725.5 m (861.4) · A new patent for OX124, overdose rescue medication, was issued by the US Patent and Trademark Office (USPTO), protecting the technology until 2039 · Issued a new corporate bond amounting to a nominal value of SEK

    Report from Orexo AB’s annual general meeting, 13 April 2021

    Election of the board of directors and auditor The annual general meeting in Orexo AB (publ) on 13 April 2021 resolved, in accordance with the nomination committee’s proposal, that the number of board members shall be eight with no deputy board members. James Noble, Staffan Lindstrand, David Colpman, Henrik Kjær Hansen, Kirsten Detrick, Fred Wilkinson, Mary Pat Christie and Charlotte Hansson were re-elected as ordinary board members. James Noble was re-elected as chairman of the board. Ernst & Young Aktiebolag was re-elected as auditor. Fees to the board of directors and the auditor

    Notice of Annual General Meeting of Orexo

    The shareholders of Orexo AB (publ), reg. no. 556500-0600, registered office Uppsala, are summoned to the annual general meeting, to be held on Tuesday 13 April 2021. In order to mitigate the spread of Covid-19, the board of directors has decided that the annual general meeting will be conducted by advance voting only, without physical presence of shareholders, proxies and third parties. Orexo welcomes all shareholders to exercise their voting rights at this annual general meeting through advance voting on the basis of temporary statutory rules, according to the procedure set out

    Orexo announces new US patent for ZUBSOLV®

    Uppsala, Sweden – December 30, 2020 – Orexo AB (publ.), (STO:ORX) (OTCQX:ORXOY) today announces that the US Patent and Trademark Office has issued an additional patent for ZUBSOLV®, Orexo’s sublingual buprenorphine and naloxone tablet (CII) for the treatment of opioid use disorder. The new patent, US Patent No. 10,874,661, expires in September 2032 and further strengthens the company´s intellectual property for ZUBSOLV® in the US. Orexo will now have six patents listed in the Orange Book for ZUBSOLV®. Nikolaj Sørensen, President and CEO, said: “I am pleased to announce that we have

    Interim Report Q1 2020

    A good start to the year despite COVID-19 Q1 2020 highlights · Total net revenues of SEK 175.0 m (174.3), up 0.4 percent · EBITDA of SEK 39.1 m (12.0), up 225.8 percent  · Net earnings of SEK 82.6 m (14.1), up 485.8 percent · US Pharma (Zubsolv® US) net revenues of SEK 163.9 m (161.7), up 1.3 percent in SEK and -4.0 percent in local currency. HQ & Pipeline net revenues of SEK 11.1 m (12.6). · US Pharma (Zubsolv US) EBIT of SEK 75.9 m (68.2), up 11.2 percent, Digital Therapeutics EBIT of SEK -12.0 m (-) and HQ & Pipeline EBIT of SEK -29.9 m (-67.1) · Cash flow from

    Orexo ends share buy-back program

    Uppsala, Sweden – April 6, 2020. Orexo AB (publ) has ended the program to repurchase its own ordinary shares that was announced on February 17, 2020. A total of 500,000 shares, equivalent to approximately 1.4 per cent of the issued ordinary shares in the company, have been repurchased as part of the buy-back program at a total purchase sum of SEK 27.2 million.The purpose of the buy-back program was to promote efficient capital usage in the company and to provide flexibility as regards the company’s possibilities to distribute capital to its shareholders. The maximum amount of repurchased

    Orexo publishes the Annual Report for 2019

    Uppsala, Sweden - March 26, 2020 – Orexo’s Annual Report, including the Sustainability Report, for the 2019 fiscal year has been published. The Annual Report can be downloaded on the company’s website, www.orexo.com (investors/reports, presentations and audiocasts), and a PDF is also attached to this press release.   In regards to ESMA´s recommendations the Report also includes the operational and financial impact the company sees due to COVID-19 (CEO Comments, Board of Directors Report and Note 34), which still is in line with earlier communicated information within this field. Orexo

    Orexo Interim Report Q3 2019

    Strong financials paving the way for broadening the business Q3 2019 highlights · Total net revenues of SEK 231.2 million (216.6), up 6.7 percent · Zubsolv® US net revenues of SEK 182.7 million (165.4), up 10.4 percent in SEK and 3.0 percent in local currency · EBITDA of SEK 114.1 million (39.8), up 186.7 percent. EBITDA ex Abstral® of SEK 71.7 million (-8.9). · US EBIT of SEK 93.4 million (55.6), up 68.0 percent · Cash flow from operating activities of SEK 135.7 million (24.5), building a cash balance of SEK 812.9 million (516.6) · Net earnings of SEK 111.7 million (

    Orexo´s Nomination Committee for the Annual General Meeting 2020

    Uppsala, Sweden – October 14, 2019 – Prior to the Annual General Meeting (AGM) in 2020, Orexo has appointed a Nomination Committee which represents approximately 44 percent of the number of votes in the company as of September 30, 2019. The Nomination Committee, comprises: · Christian Salling, Novo Holdings A/S, also Chairman of the Nomination Committee · Björn Odlander, HealthCap · Claus Berner Møller, Arbejdsmarkedets Tillaegspension (ATP) · Martin Nicklasson, Chairman of the Board of Orexo The Nomination Committee will prepare proposals to the AGM regarding Chairman

    Orexo signs partnership agreement with GAIA to develop and commercialize a new digital therapy for the treatment of Opioid Use Disorder

    Uppsala, Sweden – August 20, 2019. Orexo AB (publ), the fully integrated specialty pharmaceutical company addressing opioid addiction and pain, today announces it has entered into an exclusive agreement with GAIA AG (GAIA), a global leader in digital therapeutics that successfully launched its first digital health product in 2001, for a new digital therapy (DTx) for the treatment of Opioid Use Disorder (OUD). Orexo will have the exclusive global commercial rights to the product and intends to launch it in the US in 2022, subject to regulatory approval. The medically assisted treatment of

    Orexo Interim Report Q2 2019

    Improving all fundamentals Q2 2019 highlights · Total net revenues of SEK 201.2 million (199.7), up 0.8 percent and 19.1 percent when excluding ex-US milestone payment of SEK 30.8 million in Q2 2018 · Zubsolv® US net revenues of SEK 184.4 million (158.4), up 16.4 percent in SEK and 6.7 percent in local currency · EBITDA of SEK 60.4 million (50.6), up 19.4 percent · US EBIT of SEK 87.5 million (55.5), up 57.6 percent · Cash flow from operating activities of SEK 46.1 million (39.0), building a cash balance of · SEK 697.0 million (494.8) · Net earnings of SEK 54.6

    Orexo signs license and supply agreement with Mundipharma for Zubsolv® in Australia and New Zealand

    Uppsala, Sweden – July 10, 2019: Orexo AB (publ.), the fully integrated specialty pharmaceutical company addressing opioid addiction and pain, today announces the company has signed an agreement granting Mundipharma Pty Limited (Mundipharma Australia) the exclusive rights to commercialize Orexo’s lead product, Zubsolv®, for the treatment of opioid dependence, in Australia and New Zealand. As Mundipharma Australia has supported Orexo to obtain marketing authorization for Zubsolv in Australia it has been a natural step to continue the collaboration. Under the terms of the agreement, Orexo

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