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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 announced the issuance of two new patents by the US Patent and Trademark Office for ZUBSOLV®, a sublingual tablet for opioid use disorder. These patents, expiring in September 2032, enhance Orexo's patent portfolio to nine patents listed in the Orange Book for ZUBSOLV®. CEO Nikolaj Sørensen emphasized the importance of these patents in maintaining the product's profitability and supporting long-term growth objectives.
Orexo reported Q1 2021 net revenues of SEK 132.3 million, down 24% compared to the same period in 2020. Net earnings were SEK -31.5 million and EBITDA was SEK -23.9 million. The US Pharma segment generated SEK 126.8 million in revenues. Cash flow from operations decreased to SEK -47.8 million, with a cash balance of SEK 725.5 million. Orexo secured new patents for OX124 and ZUBSOLV®. A partnership with Magellan Rx was established to test modia™.
Orexo AB (OTCQX: ORXOY) announced a collaboration with ApexB.io and Magellan Rx Management to research its digital therapeutic modia™, aimed at treating opioid use disorder (OUD). The partnership seeks to gather real-world evidence supporting the digital treatment's accessibility. This initiative aligns with CDC calls to combat rising overdose deaths, which surged by 21% to over 83,000 in the U.S. in the past year. Orexo is also advancing other digital therapeutics, deprexis® and vorvida®, in response to growing mental health challenges.
Orexo announces the early redemption of its SEK 500 million senior unsecured callable floating rate bonds originally due in 2021. The bonds will be redeemed in full on March 3, 2021, at a price of 101.50% of the nominal amount plus accrued interest. The record date for this redemption is set for February 24, 2021. To facilitate this process without default, Orexo has received a temporary waiver from the bond agent. Following the redemption, the bonds will be delisted from Nasdaq Stockholm.
Orexo AB has successfully issued senior unsecured callable floating rate bonds worth SEK 500 million, oversubscribed under a SEK 1,000 million framework, maturing in February 2025. These bonds carry a floating interest rate of 3-month Stibor + 375bps per annum and received strong interest from institutional investors. The funds will facilitate the repurchase of existing bonds totaling SEK 77.4 million and early redemption of SEK 148.5 million. This signals investor confidence in Orexo's growth strategy in developing its pipeline and digital therapeutics.
On February 1, 2021, Orexo AB announced its plans to issue senior unsecured callable floating rate bonds worth up to SEK 500 million under a total framework of SEK 1,000 million with a four-year tenor. The proceeds will be used to repay existing bonds and support general corporate purposes. Existing bondholders may subscribe to the new bonds or opt for a premium repurchase of their current holdings. The company aims to enhance its financial flexibility for future investments.
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Orexo has established a Nomination Committee ahead of the 2021 Annual General Meeting (AGM), representing approximately 44% of the company's voting power as of September 30, 2020. The committee includes notable members such as Christian Salling (Novo Holdings A/S), Björn Odlander (HealthCap), and James Noble (Chairman of the Board). Proposals for the AGM include appointments and fees for board members and auditors. Shareholders can submit their proposals by February 12, 2021. The AGM is set for April 13, 2021, amid ongoing monitoring of COVID-19 guidelines.
Orexo AB (OTCQX: ORXOY) invites investors and analysts to a teleconference on October 1, 2020, at 3 pm CET, to discuss updates on its Digital Therapeutics business, focusing on the efficacy of deprexis® and vorvida® therapies. The company will outline commercialization strategies, market access initiatives, and technical platform offerings.
The event will feature CEO Nikolaj Sørensen and key executives, concluding with a Q&A session. Orexo aims to redefine addiction treatment through clinically validated digital solutions.
Orexo AB (OTCQX: ORXOY) has initiated patent infringement litigation against Sun Pharmaceutical Industries in the U.S. District Court for New Jersey. The lawsuit responds to Sun's Abbreviated New Drug Application (ANDA) seeking to market generic versions of Orexo's ZUBSOLV® (buprenorphine and naloxone). Orexo claims that multiple patents protecting ZUBSOLV® are being infringed, with expiration dates from December 2027 to September 2032. This legal action will delay FDA approval of Sun's ANDA for 30 months while the case proceeds. Orexo anticipates increased legal costs primarily in 2021 and 2022.