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Orexo AB (ORXOY) reports developments for a Swedish pharmaceutical company whose U.S. security trades as ADRs on the OTCQX market. News centers on the company’s AmorphOX powder-based drug delivery technology, which is used to improve bioavailability and stability for small molecules, peptides and larger biomolecules, and on a diversified pipeline in clinical and preclinical development.
Recurring updates include R&D priorities following the U.S. Zubsolv divestment, organizational changes tied to product development, OX640 nasal epinephrine data for severe allergic reactions including anaphylaxis, intranasal formulation work with semaglutide, and collaborations for nasal powder vaccines. Company announcements also cover partner research, conference presentations and the parent company’s Nasdaq Stockholm listing alongside the ORXOY ADR program.
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.
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.