Workflow
QUVIVIQ
icon
Search documents
Bondholders approve amended terms of the 2025 and 2028 convertible bonds
Globenewswire· 2025-06-25 17:15
Core Viewpoint - Idorsia Ltd. successfully held bondholder meetings to approve amendments to the terms of its convertible bonds, extending their maturity dates significantly [1][2][3]. Group 1: Bondholder Meetings - Two bondholder meetings were conducted for Idorsia's CHF 200 million convertible bonds maturing in 2025 and CHF 600 million convertible bonds maturing in 2028 [2]. - The amendments include extending the maturity date of the CB 2025 to July 17, 2034, and the CB 2028 to August 4, 2038 [2]. Group 2: Voting Outcomes - A significant majority of 89.5% of CB 2025 holders and 93.5% of CB 2028 holders voted in favor of the amendments, surpassing the required two-thirds majority [3]. - The amendments will become binding upon approval by the higher cantonal composition authority and are contingent on the completion of the repurchase offer for both bonds [3]. Group 3: Company Overview - Idorsia Ltd. aims to challenge medical paradigms and develop transformative medicines, positioning itself as a leading biopharmaceutical company [6]. - The company is headquartered near Basel, Switzerland, and has a strong focus on small-molecule drug discovery [7].
Idorsia launches repurchase offer for its 2025 and 2028 convertible bonds
Globenewswire· 2025-06-25 05:20
Core Viewpoint - Idorsia Ltd has announced a repurchase offer for its outstanding convertible bonds as part of a broader restructuring strategy aimed at enhancing its financial position and operational efficiency [1][2]. Group 1: Repurchase Offer Details - The repurchase offer targets CHF 200 million convertible bonds maturing in 2025 and CHF 600 million convertible bonds maturing in 2028 [1]. - Approximately 87.5% of the CB 2025 and 90.1% of the CB 2028 bondholders have entered into a lockup agreement to support the restructuring and participate in the repurchase offer [3]. - The main offer period for the repurchase is set to begin on July 10, 2025, and conclude on August 7, 2025, with a minimum acceptance condition of 85% of the total issued nominal value required for the offer to proceed [4]. Group 2: Participation and Documentation - Bondholders can access the repurchase offer documentation and participate through Kroll Issuer Services Ltd, which will also facilitate a new money facility for eligible bondholders [5]. - Detailed instructions and eligibility criteria for participation in both the repurchase offer and the new money facility are available in the repurchase offer documentation [5]. Group 3: Company Overview - Idorsia Ltd aims to challenge established medical paradigms by discovering, developing, and commercializing transformative medicines, positioning itself as a leading biopharmaceutical company [7]. - The company is headquartered near Basel, Switzerland, and has a strong focus on small-molecule drugs, with a promising development pipeline and partnerships to maximize portfolio value [8].
Idorsia’s QUVIVIQ expands into China as Simcere receives NDA approval – Idorsia and Simcere update their licensing agreement
Globenewswire· 2025-06-23 05:00
Ad hoc announcement pursuant to Art. 53 LR Idorsia to receive USD 50 million (an additional USD 30 million) approval milestone payment in return for a reduction in Simcere potential sales milestones and tiered royalty payments. Allschwil, Switzerland – June 23, 2025Idorsia Ltd. (SIX: IDIA) today announced that Simcere Pharmaceuticals Group Ltd (2096.HK, “Simcere”) has received approval for QUVIVIQ® (daridorexant) from the Chinese National Medical Products Administration for the treatment of adult patients w ...
Idorsia publishes invitations to bondholder meetings
Globenewswire· 2025-06-06 05:00
Core Viewpoint - Idorsia Ltd is conducting bondholder meetings on June 25, 2025, to vote on proposed amendments to the terms of its outstanding convertible bonds, CB 2025 and CB 2028, as part of a holistic restructuring plan [1][2][3]. Group 1: Bondholder Meetings - The bondholder meetings are scheduled for June 25, 2025, to discuss amendments to the terms of the CHF 200 million convertible bonds maturing in 2025 (CB 2025) and CHF 600 million convertible bonds maturing in 2028 (CB 2028) [2][3]. - Approximately 87% of CB 2025 holders and 90% of CB 2028 holders have entered legally binding lockup agreements in support of the restructuring, committing to vote in favor of the proposed amendments [4]. Group 2: Restructuring and Conditions - The proposed amendments to the terms of CB 2025 and CB 2028 are part of a larger holistic restructuring plan announced earlier in 2025 [3]. - The amendment of the terms will be contingent upon the successful completion of an exchange offer expected to be launched around the time of the bondholder meetings [5]. Group 3: Company Overview - Idorsia Ltd aims to challenge accepted medical paradigms and is focused on discovering, developing, and commercializing transformative medicines [8]. - The company is headquartered near Basel, Switzerland, and has a strong scientific core with a promising in-house development pipeline [9].
Nxera Pharma Operational Highlights and Consolidated Results for the First Quarter 2025
Globenewswire· 2025-05-02 06:30
Core Insights - Nxera Pharma has made significant progress since its transformation from Sosei Heptares, aiming to lead biopharmaceutical innovation in Japan and globally [2][3] - The company anticipates 2025 to be a pivotal year with key data readouts from multiple clinical trials and new studies commencing [3] Operational Highlights - Neurocrine initiated a Phase 3 program for NBI-1117568 targeting schizophrenia, supported by positive Phase 2 data [5] - Nxera assigned rights for cenerimod to Viatris, receiving an upfront payment of US$10 million, with additional milestone and royalty potential [6] - An agreement was signed with Holling Bio-Pharma for the commercialization of daridorexant in Taiwan, with a potential launch in 2026 [6] - Clinical development plans for partnered muscarinic agonists include multiple Phase 2 and Phase 3 studies scheduled for 2025 [6] Financial Highlights - Revenue for Q1 2025 totaled JPY 6,644 million (US$43.5 million), an increase of JPY 2,033 million (US$12.5 million) year-over-year, primarily due to the launch of QUVIVIQ® and an R&D milestone event [11] - R&D expenses rose to JPY 3,808 million (US$25.0 million), reflecting increased investment and the impact of a weaker Yen [11] - Operating loss improved to JPY 2,193 million (US$14.4 million) from JPY 3,076 million (US$20.7 million) in the prior year [11] - Net loss decreased to JPY 760 million (US$5.0 million) from JPY 3,281 million (US$22.1 million) in the previous year [11] - Cash and cash equivalents as of 31 March 2025 were JPY 34,465 million (US$230.0 million), an increase of JPY 2,197 million (US$24.3 million) since the beginning of the year [11] Corporate Developments - New appointments to the Board of Directors include Ms. Naoko Shimura and Ms. Nicola Rabson as External Directors [6] - Mr. Kiyoshi Kaneko was appointed Chief Commercial Officer, and Ms. Mariko Nakafuji was promoted to Chief Legal Officer [11] Pipeline and Strategy - Nxera is advancing over 30 active programs from discovery to late clinical stages, focusing on neurology, metabolic diseases, and immunology [10][12] - The company aims to address major unmet needs in rapidly growing medical areas, leveraging its NxWave™ discovery platform [10][12]
Idorsia issues invitation to the 2025 Annual General Meeting of Shareholders
Globenewswire· 2025-05-02 05:00
Core Points - Idorsia Ltd has announced the date for its Annual General Meeting (AGM) to be held on May 28, 2025, to approve the Annual Report for the year ending December 31, 2024 [1] - The Chairman of the Board, Jean-Paul Clozel, expressed gratitude towards the Board members and noted that Dr. Sophie Kornowski will not seek re-election, while all other members will stand for re-election [2] - The company aims to amend its Articles of Association regarding share capital to enhance financing flexibility [2] Company Overview - Idorsia Ltd is focused on discovering, developing, and commercializing transformative medicines, with a strong scientific core and a commitment to challenging accepted medical paradigms [6][8] - The company is headquartered near Basel, Switzerland, and is positioned within a European biotech hub, emphasizing its capabilities in drug discovery, particularly in small-molecule drugs [7][8] AGM Agenda Highlights - The AGM will include votes on the Annual Report 2024, Consolidated Financial Statements 2024, and Statutory Financial Statements 2024 [7] - Other key agenda items include the appropriation of available earnings, discharge of the Board of Directors, amendments to share capital, and re-elections of Board members and statutory auditors [7]
Idorsia announces financial results for the first quarter 2025 – QUVIVIQ taking off in Europe and TRYVIO REMS removal increases the value of this outstanding asset
Globenewswire· 2025-04-30 05:00
Core Insights - Idorsia Ltd reported significant financial improvements in Q1 2025, with net revenue reaching CHF 59 million, a substantial increase from CHF 10 million in Q1 2024, driven by strong sales of QUVIVIQ and a one-off exclusivity fee [4][6][11] - The company has streamlined its R&D organization and focused on its promising pipeline, which includes QUVIVIQ and TRYVIO, positioning itself for growth in 2025 [3][20] Financial Highlights - Q1 2025 net revenue was CHF 59 million, compared to CHF 10 million in Q1 2024, with QUVIVIQ product sales contributing CHF 25 million [4][6] - Operating income for Q1 2025 was CHF 67 million, up from CHF 31 million in Q1 2024, while net income increased to CHF 63 million from CHF 30 million [4][6][8] - Non-GAAP operating loss for Q1 2025 was CHF 17 million, a significant improvement from a loss of CHF 85 million in Q1 2024 [10][11] Product Performance - QUVIVIQ demonstrated strong performance with net sales of CHF 25 million in Q1 2025, and demand in Europe and Canada grew by 50% from Q4 2024 to Q1 2025 [5][31] - In France, QUVIVIQ's market share increased significantly, with a new-to-brand share growing from 1.1% in September 2024 to 9.3% in January 2025 [25] - TRYVIO received FDA approval and had its REMS requirement removed, allowing for broader distribution in retail pharmacies [3][38] Strategic Developments - Idorsia restructured its convertible bond debt and secured a CHF 150 million new money facility to alleviate short- to mid-term debt overhang [16][20] - The updated agreement with Viatris reduced Idorsia's development cost contributions and expanded territorial rights, enhancing financial flexibility [14][20] - The company aims for continued growth in 2025, projecting QUVIVIQ net sales of around CHF 110 million and a non-GAAP operating loss of approximately CHF 215 million [18][19] Research and Development - Idorsia is focusing its drug discovery efforts on fewer active projects, preparing some for out-licensing while developing others to the next inflection point [41][42] - Recent publications highlighted the efficacy of daridorexant in treating chronic insomnia and nocturia, supporting its market potential [44][45] Liquidity and Indebtedness - As of March 31, 2025, Idorsia's liquidity stood at CHF 51 million, down from CHF 106 million at the end of 2024 [21][22] - Total indebtedness remained stable at CHF 1.322 billion, with convertible loans and bonds unchanged [22][23]
New data with daridorexant assessing the transition from night to day in insomnia disorder published in Sleep Medicine
Globenewswire· 2025-04-29 05:00
Core Insights - Idorsia Ltd announced the publication of a study on daridorexant, highlighting its effectiveness in treating chronic insomnia by reducing nighttime wakefulness and improving next-morning sleepiness [1][2] Group 1: Study Findings - The Phase 3 study demonstrated that daridorexant significantly reduced wake after sleep onset (WASO) compared to placebo, with similar rates of daytime somnolence [4] - Data from 930 patients showed that both 25 mg and 50 mg doses of daridorexant significantly decreased WASO in the second, third, and fourth quarters of the night, with effects being dose-dependent [4] - Improvements in next-morning sleepiness, daytime alertness, and ability to function were observed from Day 1 and continued to improve over the 3-month treatment duration [7] Group 2: Mechanism of Action - Daridorexant is a dual orexin receptor antagonist that blocks wake-promoting orexin neuropeptides, providing a targeted approach to managing insomnia without broad inhibition of brain activity [6] - The drug's mechanism allows for restorative sleep while avoiding next-morning residual effects, a common issue with traditional sleep medications [5] Group 3: Market Context - Insomnia affects approximately 10% of the global population, translating to around 25 million adults in the US alone, indicating a significant market opportunity for effective treatments like daridorexant [9][10] - Current insomnia management strategies include sleep hygiene, cognitive behavioral therapy, and pharmacotherapy, with daridorexant offering a novel pharmacological option [11]