OREXO AB SP/ADR - ORXOY STOCK NEWS

Orexo AB (OTCQX: ORXOY) announced its participation in the Pareto Securities' 13th Annual Healthcare Conference on September 7-8, 2022, in Stockholm, Sweden. CEO Nikolaj Sørensen will present on September 7 at 2:30 pm CET, and he, along with new CFO Fredrik Järrsten, will be available for meetings. Orexo develops pharmaceuticals and digital therapies aimed at addressing substance use disorders, with its lead product ZUBSOLV® for opioid use disorder. The company reported total net sales of SEK 565 million in 2021.

Orexo's Q2 2022 report highlights significant financial improvement with total net revenues reaching SEK 147.8 million, up from SEK 142.8 million last year. The US Pharma segment, particularly ZUBSOLV®, generated net revenues of SEK 139.6 million. Despite net losses of SEK 35.8 million, earnings per share improved to -1.04 from -2.15. Cash flow from operations increased positively to SEK 14.5 million.

Orexo has secured a Veterans Affairs Federal Supply Schedule contract for its digital therapy deprexis®, effective late July 2022. This long-term contract expands access to nearly 15 million US citizens in federal healthcare systems, including the Veterans Affairs, Indian Health Service, and Department of Defense. Initial commercialization efforts are anticipated to begin late Q4 2022, with expanded usage expected throughout 2023. The contract will last until 2032.

Orexo AB (OTCQX: ORXOY) has initiated the first human clinical study (OX640-001) for OX640, a nasal adrenaline rescue medication aimed at improving emergency treatment for allergic reactions. The global market for adrenaline products exceeds USD 2 billion and is expected to grow. OX640 aims to offer enhanced stability and convenience over traditional intramuscular injectors, potentially making it a preferred option for patients. The company is exploring partnerships for development and commercialization, with study costs included in their 2022 OPEX guidance.

Orexo reported a strong start to 2022 with total net revenues of SEK 159.4 million, up from SEK 132.3 million in Q1 2021. The EBITDA turned positive at SEK 2.8 million, a significant improvement from -SEK 23.9 million last year. However, net earnings were SEK -23.6 million, an improvement over -SEK 31.5 million in Q1 2021. ZUBSOLV® generated SEK 139.1 million in US revenues. Operating cash flow was negative at SEK -61.6 million, and cash reserves decreased to SEK 437.8 million.

On April 27, 2022, Orexo AB (OTCQX: ORXOY) announced that its partner Gesynta Pharma received Orphan Drug Designation from the FDA for OX-MPI (GS-248), targeting systemic sclerosis, a rare autoimmune disease. This designation provides up to seven years of market exclusivity and financial advantages for drug development. OX-MPI (GS-248) is currently undergoing a Phase 2 clinical trial, with results expected later in 2022. Orexo is entitled to a tiered share of future revenues from the drug, enhancing its revenue potential.

The annual general meeting of Orexo AB on April 21, 2022, confirmed eight board members, re-elected James Noble as chairman, and Ernst & Young as auditor. Total board fees are SEK 3,550,000, with additional fees for independent members. Guidelines for management remuneration were approved, and there will be no dividend for 2021. The meeting authorized new share issues and share repurchases, aimed at enhancing capital efficiency. Two long-term incentive programs for employees were established, mirroring previous years' structures.

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.