Orexo Ab Stock Price, News & Analysis

Orexo AB (OTCQX: ORXOY) announced on July 16, 2021, the initiation of the pivotal trial (OX124-002) for its naloxone rescue medication, OX124, designed to reverse opioid overdoses. The first cohort was dosed on July 15, 2021. This study compares OX124 to an injection reference product and is crucial for the New Drug Application in the US, with initial results expected in Q4 2021. The potential market for OX124 could grow from USD 300-500 million to USD 1.5-2 billion, with estimated sales potential of USD 70-110 million upon FDA approval.

Orexo's Q2 2021 results show net revenues of SEK 142.8 million, down from SEK 179.1 million year-over-year. Net earnings hit SEK -73.7 million, a decrease from SEK -32.5 million. The company reported an EBITDA of SEK -41.1 million, significantly lower than SEK -9.0 million in the previous year. However, ZUBSOLV® achieved net revenues of SEK 126.0 million in the US market. Key developments include new commercial agreements and the enrollment of the first patient in a pivotal study for modia™.

Sober Grid, a leading social media platform for addiction recovery, has partnered with Orexo to provide its users access to clinically validated digital therapeutics, vorvida® and deprexis®, starting August 2021. Vorvida® targets problematic alcohol use, while deprexis® addresses depression symptoms. These digital therapies utilize cognitive behavioral therapy and AI-driven personalization to enhance user experience. The collaboration aims to expand mental health accessibility, particularly for those hesitant to seek in-person treatment.

Orexo AB (OTCQX: ORXOY) has partnered with Sober Grid, enhancing access to its digital therapies vorvida® and deprexis® for over 300,000 users. The partnership aims to provide effective support for problematic alcohol use and depression. Available initially through Sober Grid's peer coaches in August 2021, the therapies will later be accessible to all users via the app, demonstrating Orexo's commitment to mental health support through innovative digital solutions.

Orexo AB (OTCQX: ORXOY) has enrolled the first participant in a pivotal study evaluating modia™, a digital therapeutic for opioid use disorder (OUD). This randomized study will assess modia™ combined with sublingual buprenorphine/naloxone for its effectiveness in reducing illicit opioid use, enrolling around 400 participants across the US. The opioid epidemic worsened during the COVID-19 pandemic, with over 67,500 fatalities linked to opioid overdoses. Orexo aims to address this gap in treatment options as part of their mission to improve substance use disorder responses.

Orexo AB announced the issuance of two new patents by the US Patent and Trademark Office for ZUBSOLV®, a sublingual tablet for opioid use disorder. These patents, expiring in September 2032, enhance Orexo's patent portfolio to nine patents listed in the Orange Book for ZUBSOLV®. CEO Nikolaj Sørensen emphasized the importance of these patents in maintaining the product's profitability and supporting long-term growth objectives.

Orexo reported Q1 2021 net revenues of SEK 132.3 million, down 24% compared to the same period in 2020. Net earnings were SEK -31.5 million and EBITDA was SEK -23.9 million. The US Pharma segment generated SEK 126.8 million in revenues. Cash flow from operations decreased to SEK -47.8 million, with a cash balance of SEK 725.5 million. Orexo secured new patents for OX124 and ZUBSOLV®. A partnership with Magellan Rx was established to test modia™.

Orexo AB (OTCQX: ORXOY) announced a collaboration with ApexB.io and Magellan Rx Management to research its digital therapeutic modia™, aimed at treating opioid use disorder (OUD). The partnership seeks to gather real-world evidence supporting the digital treatment's accessibility. This initiative aligns with CDC calls to combat rising overdose deaths, which surged by 21% to over 83,000 in the U.S. in the past year. Orexo is also advancing other digital therapeutics, deprexis® and vorvida®, in response to growing mental health challenges.

Orexo announces the early redemption of its SEK 500 million senior unsecured callable floating rate bonds originally due in 2021. The bonds will be redeemed in full on March 3, 2021, at a price of 101.50% of the nominal amount plus accrued interest. The record date for this redemption is set for February 24, 2021. To facilitate this process without default, Orexo has received a temporary waiver from the bond agent. Following the redemption, the bonds will be delisted from Nasdaq Stockholm.