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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.
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Orexo reported its Q1 2023 financial results, with net revenues of SEK 158.8 million, slightly down from SEK 159.4 million in Q1 2022. The company experienced a significant EBITDA decline, reporting SEK -41.1 million compared to SEK 2.8 million last year. Net earnings also saw a loss of SEK -63.9 million, worse than the previous SEK -23.6 million. Despite stable ZUBSOLV® sales in both SEK and USD, operating expenses surged by 30.6%, totaling SEK 189.4 million. A New Drug Application for OX124 has been submitted to the FDA, but challenges in the packaging line require a resubmission planned for Q3 2023. Cash flow from operations stood at SEK -61.6 million, with cash reserves down to SEK 278.9 million.
On April 18, 2023, Orexo AB held its annual general meeting, confirming the board of directors with eight members, including James Noble as chairman. The board received a fee of SEK 3,550,000, and an additional SEK 1,050,000 for independent members, contingent upon acquiring shares in Orexo. The meeting approved the financial statement for 2022, with no dividends declared. Authorization was granted for share issuances and repurchases up to 20% and 10% of shares, respectively. Two new long-term incentive programs (LTIP 2023 and LTIP Stay-on 2023) were adopted for selected employees. Orexo reported total net sales of SEK 624 million for 2022, primarily from its product ZUBSOLV® for opioid use disorder.
Orexo AB announces a delay in the US launch of OX124, a high-dose rescue medication for opioid overdose, pushing the anticipated date to late 2024 from early 2024. This shift is attributed to unforeseen technical issues with the secondary packaging process, requiring a resubmission of the New Drug Application (NDA) to the FDA. Despite the delay, the FDA has indicated that the request for resubmission is solely due to the packaging issues and not other concerns. Orexo aims to resubmit the NDA by Q3 2023, with hopes for approval in the latter half of 2024.
Nikolaj Sørensen, CEO, expressed disappointment over the delay but emphasized confidence in resolving the packaging issues.
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Orexo AB has announced a postponement of the publication date for its 2022 Annual Report from March 24, 2023, to March 28, 2023. This change is attributed to extended auditing processes related to the European Single Electronic Format (ESEF). In 2022, Orexo reported total net sales of SEK 624 million and had 126 employees. The company is actively involved in the development of pharmaceuticals and digital therapies addressing substance use disorders and mental health, with its leading product ZUBSOLV® marketed mainly in the U.S.
Orexo AB has scheduled its annual general meeting for April 18, 2023, at its Uppsala, Sweden facility. Shareholders must be registered by April 6, 2023, to attend and must notify the company by April 12, 2023. The meeting's agenda includes the election of board members, approval of financial statements, and key resolutions regarding share issuances and incentive programs. Notably, the board proposes no dividend for 2022 and aims to implement two performance-based incentive programs: LTIP 2023 and LTIP Stay-on 2023, aimed at retaining and motivating employees while aligning their interests with shareholders. The company holds a total of 34,710,639 shares, with 343,023 being its own shares.
Orexo AB has submitted a New Drug Application (NDA) to the FDA for OX124, a nasal rescue medication aimed at reversing opioid overdoses, particularly from synthetic opioids like fentanyl. With opioid overdoses surpassing 81,000 annually in the U.S., the high-dose naloxone formulation of OX124 promises faster and more effective treatment, as demonstrated in pivotal studies. The product is expected to launch in H1 2024, potentially expanding the naloxone market significantly, which is currently valued at USD 300-500 million. OX124 is protected by patents until 2039.
Orexo announced its Q4 2022 results with total net revenues of SEK 156.1 million, up from SEK 144.0 million in Q4 2021, showing a positive 8.4% increase. The U.S. Pharma segment contributed significantly, with net revenues of SEK 142.6 million. However, EBITDA was SEK -53.1 million, and net earnings were SEK -91.8 million, reflecting substantial operational costs. Cash flow from operations was negative at SEK -48.9 million, with total cash and investments decreasing to SEK 351.9 million. Positive advancements include the first clinical study results for OX640 and the last patient enrolled in the MODIA trial. Financial outlook for 2023 was also provided.
Orexo announced the initiation of two exploratory feasibility studies utilizing its proprietary drug delivery platform, amorphOX®, in collaboration with leading biopharmaceutical and vaccine companies. The studies follow the successful formulation of the Covid-19 spike protein, which exhibited excellent protein stability. amorphOX® has shown significant improvements in stability and bioavailability compared to other technologies. The company aims to advance these projects into revenue-generating partnerships if feasibility is confirmed.