OREXO AB SP/ADR - ORXOY STOCK NEWS

Orexo AB (Publ.) will participate in Pareto Securities' 14th Annual Healthcare Conference on September 14 in Stockholm, Sweden. Robert Rönn, SVP and Head of R&D, will give a company presentation. Lena Wange, Investor Relations, will also be available for 1-1 meetings.

Orexo AB (publ.) announces the granting of a US patent for OX640, their nasal epinephrine powder product, providing protection until May 2041. The strong patent portfolio covering OX640 is a valuable asset to Orexo.

Orexo, a pharmaceutical company, has reported Q2 2023 financial highlights, including total net revenues of SEK 157.7m, EBITDA of SEK 5.6m, and net earnings of SEK -12.6m. The US Pharma segment saw net revenues of SEK 145.4m, and the company updated its financial outlook. Orexo also won a patent litigation against Sun Pharmaceutical and announced that ZUBSOLV® is now reimbursed by Medicaid in Indiana state.

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.

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.