QUVIVIQ

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Idorsia announces the appointment of Srishti Gupta, MD as CEO to ensure the long-term success of Idorsia
Globenewswire· 2025-06-10 05:00
Core Viewpoint - Idorsia Ltd announces the appointment of Dr. Srishti Gupta as the new CEO effective July 1, 2025, succeeding André C. Muller, who will transition to an advisory role to ensure a smooth leadership change [1][3][4]. Group 1: Leadership Transition - Dr. Srishti Gupta has been a board member since 2021 and is well-positioned to lead the company due to her deep understanding of Idorsia's operations and product portfolio [1][2]. - André C. Muller, the current CEO, will retire and take on an advisory role, having successfully led the company through financial restructuring and the commercial ramp-up of QUVIVIQ in the EUCAN region [3][4]. - The leadership transition aims to maintain stability and continuity as the company focuses on advancing its product portfolio and achieving profitability by the end of 2027 [4][5]. Group 2: Dr. Srishti Gupta's Background - Dr. Gupta has over 20 years of experience in global health and biopharmaceutical innovation, with a strong background in strategy and healthcare systems [2][8]. - She previously spent 18 years at McKinsey & Company, where she held senior leadership roles in the pharmaceutical and global health practices [2][9]. - Dr. Gupta holds an MD from Harvard Medical School and multiple degrees from Harvard University and the University of Cambridge, showcasing her strong academic credentials [8][9]. Group 3: Company Outlook - The company is optimistic about the commercial success of QUVIVIQ, which is gaining traction in Europe, and is reactivating collaboration discussions for TRYVIO [5][12]. - Dr. Gupta emphasizes the need for balancing ambition with financial discipline, indicating a focus on smart investments in promising assets [5][6]. - Idorsia aims to evolve into a leading biopharmaceutical company, committed to discovering and commercializing transformative medicines [11][12].
New funds secured – allowing the commercial ramp-up of QUVIVIQ to accelerate Idorsia’s path to profitability
Globenewswire· 2025-05-21 05:00
Core Viewpoint - Idorsia Ltd has secured a CHF 150 million new money facility to extend its cash runway to mid-2026 and has provided an update on the restructuring of its convertible bond debt, along with an upgraded financial outlook for 2025 and beyond [2][3][9]. Financial Update - The new money facility will be drawn down in the coming days and has a maturity of 24 months, fully backed by a bondholder group [3]. - The company expects net sales of around CHF 130 million for QUVIVIQ in 2025, with a projected non-GAAP operating loss of approximately CHF 175 million [16][19]. - Idorsia aims to achieve sustainable commercial profitability in 2026 and overall profitability by the end of 2027, with QUVIVIQ sales ramping up to around CHF 210 million in 2026 and CHF 270 million in 2027 [19][20]. Commercial Strategy - The company is focusing on the commercial ramp-up of QUVIVIQ, which has seen a 50% growth quarter on quarter in Q1 2025, with 10 million tablets prescribed compared to 15 million for the entire year of 2024 [6][8]. - Efforts are being made to secure reimbursement in various countries, including Spain and the Nordic region, and to expand co-promotion partnerships in the GP market [6][9]. Debt Restructuring - Approximately 90% of bondholders have agreed to amend terms and exchange bonds for newly created notes in Idorsia Investments SARL, which will help remove the convertible debt overhang [9][12]. - The restructuring will sequester rights to three of Idorsia's assets, allowing for the repayment of the newly created notes [11][13]. R&D and Pipeline - Idorsia has a strong track record in discovering first- or best-in-class drugs and is prioritizing assets in its pipeline that have the greatest potential for mid-term value creation [10]. - The company is actively working on several compounds, including QUVIVIQ, lucerastat, and others, with ongoing clinical trials and regulatory discussions [25][36][29]. Future Outlook - The company expects to achieve positive operating cash flow from 2028 onwards and plans to raise CHF 50 million via a new equity line to extend its cash runway [21]. - Idorsia is also exploring options to finance operations and repay the new money facility at maturity [21].
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]