OREXO AB SP/ADR - ORXOY STOCK NEWS

Orexo AB announced that its product ZUBSOLV® (buprenorphine and naloxone) will be added to the New York Medicaid MAT formulary as a preferred product effective March 22, 2022. This change increases ZUBSOLV®'s unrestricted access in the public segment by 6 percentage points to 48% in the U.S., up from 34% at the end of 2020. ZUBSOLV® has historically had a minimal presence in New York's Medicaid segment, which has a gross sales value of nearly USD 180 million. The improved access is expected to boost Orexo's growth opportunities and strengthen its market position amongst Medicaid patients.

Orexo reported Q4 2021 net revenues of SEK 144.0 m, down from SEK 159.2 m in Q4 2020. The company faced net earnings of SEK -66.0 m and EBITDA of SEK -48.5 m. The US Pharma segment (ZUBSOLV®) generated SEK 133.6 m in net revenues, showing a decline from last year. Operating cash flow was SEK -80.6 m, while cash reserves remained stable at SEK 504.1 m. Positive developments included a favorable outcome for the OX124 pivotal trial and the initiation of a new project, OX640, for a nasal adrenaline rescue medication.

Orexo AB (OTCQX: ORXOY) has announced the initiation of OX640, a nasal adrenaline product aimed at emergency treatment of allergic reactions, a market valued over USD 2 billion. This product leverages Orexo's proprietary amorphOX platform, promising stability and convenience compared to current auto-injectors. The FDA has been consulted regarding the development plan, with an exploratory clinical study expected in late 2022 to finalize timelines. Orexo aims to explore partnerships in development and commercialization to bring OX640 to market.

Orexo AB (publ.) has unveiled its novel drug delivery platform, amorphOX^TM, which enhances the stability of amorphous drug compositions. This innovative powder technology allows for rapid drug dissolution and is suitable for various administration routes, such as nasal and sublingual. The platform has demonstrated effectiveness in in vivo studies and offers a competitive advantage for Orexo's first product, OX124, an overdose rescue medication. Several new patent applications have been filed to protect amorphOX^TM until 2042.

Orexo AB (OTCQX:ORXOY) has successfully completed the pivotal trial for its lead drug candidate OX124, demonstrating faster absorption of naloxone compared to traditional methods. The trial met its primary endpoints, allowing the company to anticipate filing a New Drug Application (NDA) with the FDA in H2 2022, followed by a potential US launch in H2 2023. OX124 aims to address the rising opioid overdose crisis, which has seen over 96,000 overdose deaths in the US, predominantly from synthetic opioids. Orexo's innovative formulation positions it well in a growing market.

Orexo AB reported a challenging Q3 2021 with total net revenues of SEK 145.9 m, slightly down from SEK 150.3 m in Q3 2020. Net earnings were SEK -52.0 m, an improvement over SEK -84.9 m last year. The US Pharma segment generated net revenues of SEK 136.4 m (USD 15.8 m), while EBITDA remained negative at SEK -47.4 m. Operating cash flow also reported a decline of SEK -79.7 m. Positive highlights included a signed partnership with Sober Grid and the initiation of a pivotal trial for lead asset OX124. A commercial agreement was also established with Benefis Health System.

Orexo has established a Nomination Committee ahead of its 2022 Annual General Meeting (AGM), representing about 38% of the voting rights as of September 30, 2021. The committee includes members from Novo Holdings, ATP, and Orexo's Chairman, James Noble. It will propose key roles and remuneration for the upcoming AGM scheduled for April 21, 2022. Shareholders can submit proposals until February 18, 2022, for the Nomination Committee and until March 10, 2022, to address matters at the AGM. More details are available on Orexo's website.

Orexo announced the publication of a manuscript detailing the MODIA™ digital therapeutic for Opioid Use Disorder (OUD). Developed with GAIA Therapeutics, MODIA™ combines cognitive behavioral therapy with artificial intelligence to enhance treatment accessibility. Currently in a clinical evaluation phase, the study aims to assess MODIA™'s effectiveness alongside traditional medication-assisted treatment (MAT). The pivotal study will involve 400 participants across the U.S., focusing on reducing opioid use over 24 weeks. MODIA™ has not yet received FDA evaluation and may present unknown risks.

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.