Orexo Ab Stock Price, News & Analysis

Orexo AB has announced a postponement of the publication date for its 2022 Annual Report from March 24, 2023, to March 28, 2023. This change is attributed to extended auditing processes related to the European Single Electronic Format (ESEF). In 2022, Orexo reported total net sales of SEK 624 million and had 126 employees. The company is actively involved in the development of pharmaceuticals and digital therapies addressing substance use disorders and mental health, with its leading product ZUBSOLV® marketed mainly in the U.S.

Orexo AB has scheduled its annual general meeting for April 18, 2023, at its Uppsala, Sweden facility. Shareholders must be registered by April 6, 2023, to attend and must notify the company by April 12, 2023. The meeting's agenda includes the election of board members, approval of financial statements, and key resolutions regarding share issuances and incentive programs. Notably, the board proposes no dividend for 2022 and aims to implement two performance-based incentive programs: LTIP 2023 and LTIP Stay-on 2023, aimed at retaining and motivating employees while aligning their interests with shareholders. The company holds a total of 34,710,639 shares, with 343,023 being its own shares.

Orexo AB has submitted a New Drug Application (NDA) to the FDA for OX124, a nasal rescue medication aimed at reversing opioid overdoses, particularly from synthetic opioids like fentanyl. With opioid overdoses surpassing 81,000 annually in the U.S., the high-dose naloxone formulation of OX124 promises faster and more effective treatment, as demonstrated in pivotal studies. The product is expected to launch in H1 2024, potentially expanding the naloxone market significantly, which is currently valued at USD 300-500 million. OX124 is protected by patents until 2039.

Orexo announced its Q4 2022 results with total net revenues of SEK 156.1 million, up from SEK 144.0 million in Q4 2021, showing a positive 8.4% increase. The U.S. Pharma segment contributed significantly, with net revenues of SEK 142.6 million. However, EBITDA was SEK -53.1 million, and net earnings were SEK -91.8 million, reflecting substantial operational costs. Cash flow from operations was negative at SEK -48.9 million, with total cash and investments decreasing to SEK 351.9 million. Positive advancements include the first clinical study results for OX640 and the last patient enrolled in the MODIA trial. Financial outlook for 2023 was also provided.

Orexo announced the initiation of two exploratory feasibility studies utilizing its proprietary drug delivery platform, amorphOX^®, in collaboration with leading biopharmaceutical and vaccine companies. The studies follow the successful formulation of the Covid-19 spike protein, which exhibited excellent protein stability. amorphOX^® has shown significant improvements in stability and bioavailability compared to other technologies. The company aims to advance these projects into revenue-generating partnerships if feasibility is confirmed.

Orexo has released its Q3 2022 financial highlights, reporting total net revenues of SEK 161.0 million, up from SEK 145.9 million year-over-year. EBITDA improved to SEK -32.4 million compared to SEK -47.4 million previously. The US Pharma segment saw revenues of SEK 150.1 million. Cash flow from operations was SEK -60.7 million, with total cash and invested funds at SEK 443.9 million, down from SEK 588.1 million. A clinical study for OX640 was initiated, and positive data was announced thereafter.

Orexo AB (OTCQX: ORXOY) has announced the completion of participant enrollment in a pivotal study of its digital therapeutic, MODIA®, intended for treating opioid use disorder (OUD). This study involves 437 participants across 35 sites in the US and aims to evaluate MODIA® in combination with sublingual buprenorphine/naloxone against buprenorphine/naloxone alone. Orexo emphasizes its deep expertise in the OUD market, having worked extensively with their product, ZUBSOLV®, over the past nine years. The study's results are expected to support FDA clearance.

Orexo AB (OTCQX: ORXOY) has appointed Dr. Edward (Ed) Kim as the new Chief Medical Officer, succeeding Dr. Michael Sumner. Ed Kim, who has a strong background in psychiatry and over 16 years in the pharmaceutical industry, will lead US Medical Affairs and enhance collaboration with Orexo’s Swedish team. His focus will be on innovative treatments for substance use disorders and mental health. This leadership change highlights Orexo’s commitment to developing effective solutions in a critical therapeutic area.

Orexo has appointed a Nomination Committee ahead of its Annual General Meeting (AGM) scheduled for April 18, 2023. The committee includes Christian Salling, Claus Berner Møller, Patrik Walldov, and James Noble, representing approximately 38% of voting rights as of September 30, 2022. The committee will propose key governance decisions, including the Chairman of the Meeting and Board members' remuneration. Shareholders can submit proposals to the Nomination Committee until February 17, 2023. Orexo specializes in pharmaceuticals for substance use disorders, with notable sales of SEK 565 million in 2021.