Aprocitentan

Ad hoc announcement pursuant to Art. 53 LR Idorsia delivers on its upgraded 2025 guidance , with strong QUVIVIQ sales growth, disciplined investment, and a significantly improved bottom line. Focused investment in Idorsia’s pipeline of first-in-class medicines to drive future growth, with key readout for daridorexant in pediatric insomnia imminent and Lucerastat registration study advancing in Fabry’s disease. Allschwil, Switzerland – February 26, 2026 Idorsia Ltd (SIX: IDIA) announces strong financial and operational results for the full year 2025, setting a new base for further growth ahead and a catalyst rich 2026. Srishti Gupta, MD, Chief Executive Officer of Idorsia, commented: “2025 marked a year of disciplined execution and renewed momentum for Idorsia. We delivered on our upgraded guidance, more than doubled QUVIVIQ sales, and significantly strengthened our financial position – demonstrating that focused investment and commercial excellence can go hand in hand. At the same time, we continued the next phase of growth: positioning TRYVIO/JERAYGO as the first treatment to target a new pathway in hypertension in decades and progressing our pipeline, including the upcoming readout of the pediatric insomnia study and the registrational program for lucerastat in Fabry disease. With multiple catalysts ahead, we enter 2026 with clarity, confidence, and a clear path toward sustainable growth.” QUVIVIQ ® (daridorexant) Global 2025 net sales grow to CHF 134 million, reflecting outstanding year-over-year momentum – with continued strong growth ahead. QUVIVIQ continues to reshape the insomnia treatment landscape, and we are investing to accelerate its trajectory toward blockbuster status. Growth will be driven by expanded global reach through partnerships targeting general practitioners, strategic commercial alliances, additional public reimbursement wins, potential U.S. descheduling, adoption of innovative digital and distribution models, and the initiation of a U.S. label-enhancing study focused on daytime functioning. New opportunity to transform the treatment paradigm in pediatric insomnia with results expected in Q2 2026 from the Phase 2 study for daridorexant – the only dual orexin receptor antagonist in development for this population with high unmet need. TRYVIO™ / JERAYGO™ (aprocitentan) TRYVIO is available in the US and used in the top 25 hypertension centers. Robust on-market experience among leading experts indicates “PRECISION-like” double-digit blood pressure reductions and confirms the tolerability pro diverse patient groups. Regulatory success in 2025 – JERAYGO is approved in EU, UK, Switzerland, and Canada. Partnering discussions to maximize the global value of TRYVIO/JERAYGO are progressing. Research & Development Alignment with the FDA on the registrational program for lucerastat, positioning Idorsia to advance the first oral therapy intended for all patients with Fabry disease. Advancing Idorsia’s immunology portfolio of first-in-class compounds – starting with Idorsia’s CCR6 antagonist proof-of-concept in psoriasis (proof-of-mechanism for other CCR6- and Th17-associated autoimmune diseases). Clinical validation for Idorsia's revolutionary drug-like synthetic glycan vaccine technology. Financial highlights for full year 2025 QUVIVIQ sales: CHF 134 million Contract revenue (one-off): CHF 72 million contract revenue Non-GAAP operating expenses: CHF 328 million Non-GAAP operating loss: CHF 100 million including one-off contract revenue of CHF 72 million (US GAAP operating loss: CHF 33 million including CHF 90 million one-off income from Viatris agreement) Strengthened balance sheet through successful debt restructuring and new financing. Financial Guidance for 2026 QUVIVIQ sales: CHF 200 million Non-GAAP operating expenses: approx. CHF 330 million Non-GAAP operating loss: CHF 120 million (US GAAP operating loss: approx. CHF 160 million) Positive commercial contribution and focused investment in value-driving pipeline assets results in continued improvement of underlying business performance. 2026 guidance reflects continued growth of QUVIVIQ (approximately 50% increase in Idorsia-led sales), investment in the lucerastat registration program, and development of the company’s immunology portfolio. TRYVIO/JERAYGO revenues and investments are not included, as these will be considered in any potential partnership agreement. All amounts exclude unforeseen events and any potential upsides from new direct-to-patient distribution models currently being implemented in several geographies and revenue related to additional business development activities. Financial results US GAAP results Full Year Fourth Quarter in CHF millions, except EPS (CHF) and number of shares (millions) 2025 2024 2025 2024 Net revenue 221 113 48 60 Operating expenses (268) (351) (106) (140) Operating income (loss) (33) (232) (56) (78) Net income (loss) (112) (264) (78) (84) Basic & diluted EPS (0.52) (1.45) (0.31) (0.45) Basic & diluted weighted average number of shares 214.7 182.4 248.3 188.3 Net revenue of CHF 221 million in 2025 resulted from product sales (CHF 134 million), product sales to partners (CHF 7 million), and contract revenues (CHF 79 million). This compares to net revenue of CHF 113 million in 2024 as a result of QUVIVIQ product sales (CHF 61 million), product sales to partners (CHF 47 million), and contract revenue (CHF 5 million). US GAAP operating expenses of CHF 268 million in 2025 and CHF 351 million in 2024 were impacted by a one-off gain of CHF 90 million (Viatris deal amendment) in 2025 and CHF 125 million (Viatris deal) in 2024, respectively. Excluding these one-off gains, US GAAP operating expenses for 2025 decreased by CHF 83 million, mainly driven by R&D expenses of CHF 102 million decreasing by CHF 42 million compared to 2024 (CHF 144 million), and SG&A expenses of CHF 221 million decreasing by CHF 52 million compared to 2024 (CHF 273 million). US GAAP net loss in 2025 amounted to CHF 112 million compared to CHF 264 million (net loss) in 2024. The reduced net loss in 2025 was primarily driven by revenue growth and lower operating expenses as a result of an operational restructuring initiated in Q4 2024. The US GAAP net loss resulted in a net loss per share of CHF 0.52 (basic and diluted) in 2025, compared to a net loss per share of CHF 1.45 (basic and diluted) in 2024. Non-GAAP* measures Full Year Fourth Quarter in CHF millions, except EPS (CHF) and number of shares (millions) 2025 2024 2025 2024 Net revenue 214 113 47 60 Operating expenses (328) (427) (96) (121) Operating income (loss) (100) (308) (47) (60) Net income (loss) (118) (330) (54) (73) Basic and diluted EPS (0.55) (1.81) (0.22) (0.39) Basic and diluted weighted average number of shares 214.7 182.4 248.3 188.3 * Idorsia measures, reports, and issues guidance on non-GAAP operating performance. Idorsia believes that these non-GAAP financial measurements more accurately reflect the underlying business performance and therefore provide useful supplementary information to investors. These non-GAAP measures are reported in addition to, not as a substitute for, US GAAP financial performance. Non-GAAP net loss in 2025 amounted to CHF 118 million; the difference versus US GAAP net income was mainly driven by the one-off gain from the amendment of the Viatris deal (CHF 90 million), depreciation and amortization (CHF 17 million) , share-based compensation (CHF 6 m), impairment charges (CHF 3 m), restructuring charges (CHF 3 m), accretion and issuance cost amortization (CHF 16 m) and a debt extinguishment loss related to the debt restructuring (CHF 37 million). The non-GAAP net loss resulted in a net loss per share of CHF 0.55 (basic and diluted) in 2025, compared to a net loss per share of CHF 1.81 (basic and diluted) in 2024. Liquidity and indebtedness Liquidity on December 31, 2025, amounted to CHF 89 million. This amount does not include the remaining CHF 80 million available under the new money facility (term loan). (in CHF millions) Dec 31, 2025 Sep 30, 2025 Dec 31, 2024 Liquidity Cash and cash equivalents 89 64 106 Total liquidity* 89 64 106 Indebtedness Convertible loan 335 335 335 Convertible bonds 49 49 797 Debt notes** 753 753 - Term loan 18 13 - Other financial debt 187 186 189 Total indebtedness 1,342 1,336 1,321 *rounding differences may occur ** The debt notes issued by Idorsia Investments SARL in exchange for convertible bonds are senior secured with the shares in Idorsia Investments SARL. The A Notes only benefit from a limited and subordinated Swiss-law governed guarantee by Idorsia Ltd. Human Resources Idorsia reduced more than 200 positions worldwide in 2025, bringing the total number of permanent employees to 487 (2024: 689). Annual Report Idorsia's Annual Report 2025 – consisting of the Business Report, Governance Report, Compensation Report, Sustainability Report, and Financial Report, is available at . Note to Shareholders The Annual General Meeting (AGM) of Shareholders to approve the Annual Report of the year ending December 31, 2025, will be held on Wednesday, May 6, 2026. Registered shareholders with voting rights individually or jointly representing at least 0.5% of the share capital of the company, being entitled to add items to the agenda of the general meeting of shareholders, are invited to send in proposals, if any, to Idorsia Ltd, attention Corporate Secretary, Hegenheimermattweg 91, CH-4123 Allschwil, to arrive no later than March 22, 2026. Any proposal received after the deadline will be disregarded. In order to vote at the Annual General Meeting, shareholders must be registered in the company's shareholder register by April 27, 2026, 17:00 CEST, at the latest. Results Day Center Investor community: To make your job easier, we provide all relevant documentation via the Results Day Center on our corporate website: . Events First Quarter 2026 Financial Results reporting on April 28, 2026 Annual General Meeting of Shareholders on May 6, 2026 Half-Year 2026 Financial Results reporting on July 30, 2026 Notes to the editor About Idorsia The purpose of Idorsia is to challenge accepted medical paradigms, answering the questions that matter most. To achieve this, we will discover, develop, and commercialize transformative medicines – either with in-house capabilities or together with partners – and evolve Idorsia into a leading biopharmaceutical company, with a strong scientific core. Headquartered near Basel, Switzerland – a European biotech hub – Idorsia has a highly experienced team of dedicated professionals, covering all disciplines from bench to bedside; QUVIVIQ™ (daridorexant), a different kind of insomnia treatment with the potential to revolutionize this mounting public health concern; strong partners to maximize the value of our portfolio; a promising in-house development pipeline; and a specialized drug discovery engine focused on small-molecule drugs that can change the treatment paradigm for many patients. Idorsia is listed on the SIX Swiss Exchange (ticker symbol: IDIA). For further information, please contact George Thampy Senior Vice President, Head of Investor Relations Idorsia Pharmaceuticals Ltd, Hegenheimermattweg 91, CH-4123 Allschwil +41 58 844 10 10 investor.relations@idorsia.com – media.relations@idorsia.com – The above information contains certain "forward-looking statements", relating to the company's business, which can be identified by the use of forward-looking terminology such as “intend”, "estimates", "believes", "expects", "may", "are expected to", "will", "will continue", "should", "would be", "seeks", "pending" or "anticipates" or similar expressions, or by discussions of strategy, plans or intentions. Such statements include descriptions of the company's investment and research and development programs, business development activities and anticipated expenditures in connection therewith, descriptions of new products expected to be introduced by the company and anticipated customer demand for such products and products in the company's existing portfolio. Such statements reflect the current views of the company with respect to future events and are subject to certain risks, uncertainties and assumptions. Many factors could cause the actual results, performance or achievements of the company to be materially different from any future results, performances or achievements that may be expressed or implied by such forward-looking statements. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or expected. Attachment Press Release PDF

当我们谈到现代医学，不能不承认西医在急症抢救、外伤处理、感染控制和外科手术方面的卓越表现。 它们犹如“快刀斩乱麻”的武器，能在关乎生命的刹那间提供最精准、最快速的救援。 例如，一位车祸中的重伤者，依靠西医的快速止血和手术，可能就是在生死线上多撑几分钟甚至几小时。 而对感染的精准抗菌、更复杂外科手术技术，也让无数患者重获新生。 然而，面对慢性疾病，西医的核心策略则偏向“治标”。 它更像是对火苗的尝试灭火——控制血压、血糖、血脂等指标，稳定病情、延缓疾病的進展。 多数慢性病患者需终身服药，药物的目标是降低风险点，而未必能根本“治愈”。 这就像是为不断冒火的炉火安上了恒温器，控制火焰不让它烧得太旺，却未必消灭火源。 如此一来，虽然指标稳定，但部分患者仍常感不适、疲惫，甚至出现药物副作用。 而中医和自然疗法则强调“整体观”。 他们不仅关注某一症状，更关心人体的整体气血调和、脏腑平衡，以及内环境的健康。 比如一份中医调理方案，可能会通过调节脾胃气机、补气养血，增强体质，从源头上改善身体的内在免疫力。 这就像是在根上施肥修枝，而非只在火苗上浇水。 结合临床实践，它们实际上是互补的。 急性病发作时，快速、精准的西医治疗犹如救火队到场，而慢性病的管理则借助中医调理和自然疗法，帮人体恢复“健康基础”。 不要把二者看成对立，最科学的做法应是“标本兼治”，急重时依赖西医抢救，慢性时辅以调理，形成一条完整的健康防线。 从2025年至2026年的最新研究成果来看，西医在慢性疾病治疗上，也迎来了令人振奋的变革。 比如： - 高血压领域，国产的醛固酮合酶抑制剂如Lorundrostat和Baxdrostat在III期试验中显示出对难治性高血压的显著降压作用，一些患者甚至在停药后依然保持血压平稳。 RNA干扰药物Zilebesiran支持半年一次的皮下注射，大大提升了患者的依从性。 Aprocitentan，这个新型的内皮素受体拮抗剂，不仅降压效果突出，还显示出夜间血压控制更佳的潜力，为血管保护带来新希望。 研究还发现，TRPV4-RhoA轴相关药物如AH001在动物模型中可以快速持续降压，潜在减少传统药物的副作用，为差异化治疗提供新思路。 - 糖尿病方面，最新的口服GLP-1药物如orforglipron，在临床试验中超预期地降低A1C达2%以上，同时改善体重和血脂。 这意味着未来患者不再需要依赖多次注射，可以更便捷地控制血糖。 同时，脐带间充质干细胞治疗在中国得到批准，显示出对2型糖尿病的显著改善——部分患者血糖达标，胰岛素减量超50%。 一款创新的再生胰岛E-islet 01也在临床试验中取得突破，未来可能会给1型和严重2型糖尿病带来根本性改变。 更令人振奋的是，双靶或三靶的GLP-1激动剂不仅控糖，还兼具减重和护心肾的多重效果，医保报销后，大大改善了患者的治疗可及性和体验。 - 高血脂，特别在与高血压、糖尿病合并存在时，超长效PCSK9单抗药物如瑞卡西单抗已获批，结合他汀类药物，显著降低LDL-C，改善血脂异常。 针对高乳糜微粒血症的siRNA药物也在逐步推进，为超长期或个性化的降脂方案提供了新选择。 - 红斑狼疮方面，生物制剂如阿伏利尤单抗（anifrolumab）在亚洲人群的临床试验中，表现出降低疾病活度、减少激素需求的潜力。 采用新型免疫细胞疗法，比如CAR-NK细胞反应，深度清除异常B细胞，有望带来持久缓解和免疫耐受。 中国也在更新指南，强调“达标治疗”——即长期实现疾病的缓解，最大程度保护器官。 - 强直性脊柱炎（AS）最新的JAK抑制剂和IL-17A单抗药物，已通过临床试验，展现出快速缓解、改善功能的新途径。 医保的覆盖使得这些高端药物变得更易获取，为更多患者带来希望。 这些最新动向说明：西医并非“治不好”的代名词，而是在不断突破机制边界。 从长效药物、精准靶向到免疫细胞疗法，未来慢性病不再是“终身控制”的标签，而可能迎来“更深的改善甚至根治”。 当然，技术的突破也意味着更全面的治疗方案出现，这时中医和自然疗法的整合作用越发凸显。 社会认知应逐渐转变，不是“你得吃药一辈子”，而是“通过科学创新，疾病的管理方案在不断优化”，逐步让患者享有更高品质的生活。 总结起来，现代医学在抗击慢性病的“战场”上，正进行一场由“控制指标”向“恢复健康”的转变。 未来的疾病管理，绝非依赖药物与手术的“单打独斗”，而是结合“精准药物 + 体质调理 +生活方式”的“多维共治”。 这不仅是科技的进步，更是对“健康”更深层的定义。 你会发现，理解这些背后的新趋势，不仅帮你看清未来医疗方向，也让自己在面对疾病时，拥有更多理性的选择和信心。 毕竟，健康的真谛，既在科技创新，也在于我们每个人的科学生活习惯与积极调整。