Orexo Ab Stock Price, News & Analysis

Orexo has released its Annual Report for 2021, highlighting significant operational advancements. The report indicates that the company is on track with its rescue medication OX124, expected to launch in late 2023 if approved. Despite challenges in reimbursement for digital therapies, Orexo established important collaborations with healthcare providers. Total net sales for 2021 reached SEK 565 million, and the company employs 121 people. Orexo is listed on Nasdaq Stockholm Mid Cap (ORX) and OTCQX (ORXOY) in the US.

Orexo AB has convened its annual general meeting on April 21, 2022, at its Uppsala facility. Shareholders must register by April 11, 2022, to attend. The agenda includes the election of board members, presentation of annual reports, and resolutions on management remuneration guidelines. The board proposes no dividend for 2021, with profits carried forward. Key proposals involve board fees totaling SEK 3,550,000 and an additional fee for independent members linked to share acquisition. James Noble is proposed for re-election as chairman, with Ernst & Young as auditor.

Orexo AB announces the appointment of Fredrik Järrsten as the new Chief Financial Officer (CFO), effective by early September 2022. He succeeds Joseph DeFeo, who has served for four years and will assist during the transition. Järrsten brings extensive experience from several life science companies, enhancing Orexo's capabilities for further development and expansion, particularly in digital therapeutics. The company reported total net sales of SEK 565 million in 2021, focusing on improving pharmaceuticals for substance use disorders.

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.