Aprocitentan

Ad hoc announcement pursuant to Art. 53 LR CHF 150 million new money facility from bondholders now implemented and providing cash runway to mid-2026 Holistic convertible debt restructuring progressing with bondholder meeting to be held in the coming weeks – ~90% of bondholders have already agreed to amend the terms and to exchange bonds for newly created notes in Idorsia Investments SARL Idorsia re-activating collaboration discussions for aprocitentan following the removal of the TRYVIO REMS and positive prescriber experience Guidance for 2025 upgraded due to successful commercial ramp-up of QUVIVIQ Financial outlook – company continues to target commercial profitability in 2026 and overall profitability in 2027 Cash flow outlook – company targets positive operating cash flow in 2028 and will therefore need to raise funding for ongoing operations and to bridge to sustainable profitability Allschwil, Switzerland – May 21, 2025Idorsia Ltd (SIX: IDIA) today announced the implementation of the CHF 150 million new money facility previously agreed (press release) with holders of its convertible bond debt. In addition, the company provides an update on the holistic restructuring of the convertible bond debt and an overview of its plans for investment moving forward. The company also upgraded its guidance for 2025 and gave a positive financial outlook beyond. New money facilityA new money facility for a net amount of CHF 150 million to extend Idorsia’s cash runway to mid-2026 has now been signed and the company intends to draw down the first tranche of funds in the coming days. This new money facility has a maturity of 24 months and is fully backstopped by a bondholder group. André C. Muller, CEO of Idorsia, commented: “Securing both the new money facility and the restructuring of the convertible debt overhang allows us to fully concentrate on driving the commercial ramp-up of QUVIVIQ in Europe and Canada which will bring the company to profitability in the near-term, with an upside in the US should the DORA class be descheduled. We will also continue to invest in our R&D portfolio in an efficient and responsible manner to advance selected compounds from our very innovative pipeline to the next inflection points.” Commercial ramp-up of QUVIVIQThe company is working to elevate the conversation around chronic insomnia so that it is established as an independent medical disorder and that the short- and long-term burden of the condition is well understood. The medical, access and commercial teams are tackling long entrenched behaviors to ensure patient access to QUVIVIQ, to help healthcare professionals understand the broad patient population that can benefit from the product’s differentiated profile, and to support patients to get the best out of their QUVIVIQ treatment. As a result of these efforts, QUVIVIQ is taking off in Europe and Canada (EUCAN region) as shown in the first quarter of 2025 (press release) with a 50% growth quarter on quarter, translating into 10 million QUVIVIQ tablets being prescribed in the first quarter of 2025 compared to 15 million tablets in the whole of 2024. Growth is driven by countries where reimbursement has been secured: France, Germany, the UK, Canada (for the private market), and most recently Austria (from June 1, 2025). The company continues to work towards reimbursement in Spain, Canada, and the Nordic region. The successful commercial approach of implementing co-promotion partnerships for the GP market in France and Germany will also be taken in other markets, and the company will look for collaborations with potential partners to expand the European footprint and other geographies such as LATAM and Middle East. In the US, a streamlined, focused, and more cost-efficient commercialization approach for QUVIVIQ has been implemented to maintain sales until the potential descheduling of the dual orexin receptor antagonist (DORA) class can be achieved. Should this occur, a major barrier to prescription will be removed and there is every reason to believe that the true potential of QUVIVIQ can be unlocked. Based on the feedback at medical congress and symposia, the positive experience from prescribers and patients alike, and the commercial ramp-up across the EUCAN region, Idorsia is confident to reach commercial profitability in 2026. Activating the clinical development pipelineIdorsia has a very strong track-record in discovering first- or best-in-class drugs with significant potential to change the treatment paradigms in the target indications. This is matched by the design of efficient development programs that generate the safety and efficacy data that allow prescribers to practice evidence-based medicine. In the short history of the company, Idorsia has secured three product approvals in different geographies. Based on this outstanding success and expertise, the company has prioritized assets in the pipeline that have the greatest potential to create value in the mid-term. The result is a portfolio of potential blockbusters. Further details including the current status of each project in our portfolio can be found in our innovation fact sheet. Holistic convertible bond debt restructuringFollowing a successful completion of the ongoing restructuring, Idorsia will have removed its convertible debt overhang through the creation of an asset-backed new entity where the debt will be sequestered together with Idorsia’s rights for three of the company’s assets. The newly established Luxembourg entity, Idorsia Investments SARL (previously referred to as the “SPV”), will facilitate the holistic restructuring of Idorsia’s convertible bond debt. As of today, bondholders have committed to exchange at least CHF 710 million of the Idorsia convertible bond debt, for newly created notes expected to be issued by Idorsia Investments SARL in the coming weeks, in each case subject to the agreement with such bondholders, which would leave Idorsia Ltd with a maximum of CHF 90 million of convertible bond debt maturing in 2034/2038. Idorsia Pharmaceuticals Ltd will contribute its rights for aprocitentan, selatogrel, and cenerimod, to Idorsia Investments SARL to allow the repayment of the newly created notes. Once the notes have been fully repaid, rights to all three products sequestered to Idorsia Investments SARL will return to Idorsia, delivering long-term value creation to Idorsia shareholders. For more details see the press release issued in February 2025. André Muller concluded: “Following the removal of the TRYVIO REMS and positive prescriber experience in the US, we are excited to have the opportunity to strike a deal for aprocitentan that recognizes this new value proposition. Based on our forecasts for aprocitentan, and the forecasts of our partner Viatris for selatogrel and cenerimod, the three assets sequestered to Idorsia Investments SARL have the potential to not only allow the repayment of the newly created Notes in the short- to mid-term, but to also deliver significant long-term growth for Idorsia once the rights have been returned.” Financial guidance for 2025 For the Idorsia-led portfolio in 2025, the company expects a continued acceleration of QUVIVIQ with net sales of around CHF 130 million, COGS of around CHF 15 million, SG&A expenses of around CHF 200 million, and R&D expense of around CHF 90 million, leading to non-GAAP operating expenses of around CHF 305 million. This performance would result in an Idorsia-led business non-GAAP operating loss of around CHF 175 million and US-GAAP operating loss of around CHF 220 million. The company expects US-GAAP EBIT for the partnered business of around CHF 135 million and mainly driven by the amended deal with Viatris. This would result in a US-GAAP loss for the global business of around CHF 85 million. All amounts exclude unforeseen events and potential revenue related to additional business development activities. Arno Groenewoud, Chief Financial Officer, commented:“With 4 months of QUVIVIQ sales behind us, the new co-promotion collaboration in Germany reaching out to GPs, and the new commercial approach stabilizing in the US, we are clearly seeing the successful commercial ramp-up of QUVIVIQ in action. As a result, I am now confident that we will substantially exceed the sales target by around 20%, compared to our expectations at the beginning of 2025.” Financial outlookIdorsia aims to reach sustainable commercial profitability in 2026 and overall sustainable profitability by the end of 2027. Sustainable profitability only includes income generated from Idorsia’s portfolio of assets. This implies Idorsia-led QUVIVIQ sales ramp-up to around CHF 210 million in 2026 growing to around CHF 270 million in 2027, both at an approximate 80% gross margin. The ramp-up will be predominantly driven by the EUCAN region with a potential upside in the US (depending on DEA descheduling of the DORA class). During this period, non-GAAP OPEX (including marketing and selling, R&D and G&A) will remain stable with annual non-GAAP OPEX of around CHF 285 million. Beyond 2027, Idorsia aims to continue the sales trajectory of QUVIVIQ with a stable OPEX, leading to higher sustainable profitability. This could benefit from additional income from new collaborations from the existing pipeline assets and from the return of sequestered products following the repayment of Idorsia Investments SARL notes. Cash-flow outlookThe company expects to achieve a positive operating cash flow from 2028 onwards. To further extend the cash runway into early 2027, the company has committed to the new money facility lenders to raise CHF 50 million via a new equity line but may also look to other avenues to strengthen its balance sheet. The company will then explore all options to fully finance operations and repay the new money facility at maturity. Notes to the editor Idorsia’s portfolioIdorsia intends to develop certain assets to the next inflection point before partnering, or when feasible and appropriate, developing further with in-house expertise. Other assets are already being prepared for out-licensing. LucerastatLucerastat is an oral inhibitor of glucosylceramide synthase, offering a potential new treatment approach for all patients living with Fabry disease, irrespective of the mutation type of the GLA gene. During a Phase 3 open-label study, with patients treated for up to 6 years, lucerastat has shown a long-term effect on plasma Gb3 levels and improved kidney function compared to historical data. The effect of lucerastat on reducing the eGFR decline is seen across all subgroups of patients with a particularly large effect observed in patients with renal impairment at baseline, and in patients with anti-drug antibody to enzyme replacement therapy, two groups of patients with a high medical need. The analysis also showed a safety and tolerability profile consistent with that observed during the 6-month randomized treatment period. The company is conducting a pilot kidney biopsy sub-study within a subset of patients currently participating in the OLE study. The regulatory pathway will then be further discussed with the US FDA. ACKR3 (CXCR7) receptor antagonistIdorsia's ACKR3 (CXCR7) receptor antagonist, a first-in-class compound that offers a unique combination of re-myelination and anti-inflammatory effects A proof-of-concept study is in preparation for patients with progressive multiple sclerosis. CCR6 receptor antagonistIdorsia's selective CCR6 receptor antagonist is a first-in-class, oral therapy for the treatment of T helper 17 driven immuno-dermatology and autoimmune disorders. A proof-of-concept study is in preparation for patients with psoriasis. CXCR3 receptor antagonistIdorsia's first-in-class oral CXCR3 receptor antagonist allows dual targeting of CD8+ CXCR3+ T cells and melanocytes and offers potential as the first targeted systemic therapy for vitiligo and other immuno-dermatology and autoimmune disorders. There is currently no systemic treatment approved for the treatment of vitiligo. A proof-of-concept study is in preparation for patients with vitiligo. Other early-stage assetsIdorsia also has a synthetic glycan vaccine platform, with vaccines targeting Clostridium difficile, Klebsiella pneumonia, and Neisseria gonorrhea infections, as well as other undisclosed pathogens alone or combined. The results from the lead program, a Phase 1 study in Clostridium difficile infection which will test the immune response of the vaccine and evaluate its safety and tolerability, are expected in in Q2 2025. If positive, Idorsia will seek a partner for the platform or individual vaccines. Further details including the current status of each project in our portfolio can be found in our innovation fact sheet. Idorsia Investments SARL portfolio TRYVIO™/JERAYGO™ (aprocitentan)TRYVIO™ (aprocitentan) is approved in the US for the treatment of hypertension in combination with other antihypertensive drugs, to lower blood pressure in adult patients who are not adequately controlled on other drugs. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. TRYVIO is the first and only new treatment to decrease systemic blood pressure on top of existing therapies by blocking the endothelin pathway via both endothelin receptors and has the potential to preserve or improve renal function. TRYVIO is ready to launch with a comprehensive collection of FDA-approved product positioning, branding, websites, materials, training and educational platforms, and field sales force and MSL coverage plans. TRYVIO was made available for prescription in October 2024 and there is ongoing engagement with hypertension experts at major cardiovascular and nephrology congresses and encouraging discussions with payors. In March 2025, the US FDA fully released TRYVIO from its REMS (Risk Evaluation and Mitigation Strategy) requirement to minimize the burden on the healthcare delivery system of complying with the REMS. As a result, a rapid transition from specialty pharmacy to a wide retail pharmacy distribution model is underway. Funding for a field sales force and promotional activities continues to be dependent on a partnership deal. JERAYGO™ (aprocitentan) is approved in the EU and UK for the treatment of resistant hypertension in adult patients in combination with at least three antihypertensive medicinal products. Viatris DealIn 2024, Idorsia entered into a global research and development collaboration with Viatris, for the global development and commercialization rights to selatogrel and cenerimod. Idorsia is entitled to potential development and regulatory milestone payments, and certain contingent payments of additional sales milestone payments and tiered royalties in the mid-single to low-double digit percentages on annual net sales. SelatogrelAcute Myocardial Infarction (AMI) accounts for ~1/3 of all deaths in developed nations and there is a dire need for early intervention, as ~30% of deaths occur prior to hospital admission. Selatogrel has the potential to shift the treatment paradigm in AMI as a potent, reversible and highly selective P2Y12 receptor antagonist, with rapid uptake & fast onset of action and short duration. In the Phase 2 trial, > 90% of participants had > 80% inhibition of platelet aggregation within 15 minutes after dosing, there was reduced off-target interference of hemostasis compared to other P2Y12 inhibitors and no difference in major bleeds compared to placebo on top of standard of care of dual anti-platelet therapy. Comprehensive Phase 3 study design with Special Protocol Assessment was agreed to with FDA and includes a fast-track designation. Currently in Phase 3, on schedule for full enrollment / study expected to read out in 2026. (source: “Selatogrel (AMI) Overview & Market Opportunity” Viatris presentation provided in November 2024). CenerimodCenerimod is a first-in-class oral therapy with a novel mechanism of action and potential for highly differentiated benefit-risk profile in Systemic Lupus Erythematosus (SLE). During the Phase 2 CARE study with over 400 patients, cenerimod 4mg met its primary endpoint, demonstrating statistically significant and clinically meaningful reduction in mSLEDAI-2K1 with a differentiated safety profile vs. existing SLE treatments. FDA fast-track designation, two comprehensive Phase 3 studies ongoing which reflect the learnings from Phase 2, including higher enrollment of INF-1 High patients. Currently in Phase 3, on schedule for full enrollment in 2025 / study expected to readout in 2026. (source: “Cenerimod (SLE) Overview & Market Opportunity” Viatris presentation provided in November 2024). About IdorsiaIdorsia Ltd is reaching out for more – we have more passion for science, we see more opportunities, and we want to help more patients. 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:Investor & Media RelationsIdorsia Pharmaceuticals Ltd, Hegenheimermattweg 91, CH-4123 Allschwil+41 58 844 10 10investor.relations@idorsia.com – media.relations@idorsia.com – www.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 "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 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 Press Release PDF

注：本文不构成任何投资意见和建议，以官方/公司公告为准；本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及），不代表平台立场。任何文章转载需要得到授权。高血压是全球最常见的慢性病之一，严重威胁着心脑血管健康。随着疾病负担的增加，抗高血压药物的研发和应用成为了医学界的重点。近年来，抗高血压药物复方制剂逐渐被广泛应用。复方制剂通过结合多种药物成分，提供更强的降压效果，同时降低副作用，改善患者的依从性。本文基于摩熵咨询市场研究报告《利尿剂——市场研究专题报告》部分精华内容，探讨了抗高血压药物复方制剂的优势、市场现状以及发展前景，为读者提供对于该行业的深入洞察。 01抗高血压药物复方制剂概述  01五大类抗高血压药物抗高血压药物是用于降低血压、控制高血压的药物，主要包括五大类：钙通道阻滞剂、β受体阻滞剂、ACE抑制剂、ARBs（血管紧张素II受体拮抗剂）和利尿剂。五大类降压药各有优劣，钙通道阻滞剂降压效果强，β受体阻滞剂起效快、作用强，ACEI类降压药品种数量多，ARB类降压药半衰期最长，而利尿剂价格相对低廉。目前我国高血压仍以单药治疗为主，由五大类单药组成的复方制剂也逐渐被广泛应用，未来有望成为高血压市场的主导品类。图片来源：摩熵咨询《利尿剂——市场研究专题报告》02抗高血压药物复方制剂组方原则复方制剂组方原则为机制互补，一般具有相同作用机理及同类药物不予联合使用，具体来说，复方制剂组方原则包括以下几点：（1）不同作用机理降压药物联合，机制互补、增加疗效及减少不良反应；（2）兼顾控制高血压多重危险因素，降压药可以联合抗血小板、调脂等药物；（3）相同作用机理药物及同类药物不予联合：如β受体阻滞剂与非二氢吡啶类药物因都抑制房室传导就不予组合。复方制剂主要分为现代单片复方制剂（如尼群洛尔片）和传统复方制剂（如复方降压片、复方罗布麻片）。03抗高血压药物复方制剂优势复方制剂具备多重优势，包括降压效果更强、副作用更小、患者依从性更高及价格优势：（1）降压效果更强：通过不同作用机制的协同作用，复方制剂往往能提供更强的降压效果，适用于单药治疗效果不佳的患者。（2）副作用更小：由于多种药物成分的协同作用，复方制剂能够减少单一药物可能带来的副作用，提高患者的耐受性。（3）患者依从性更高：由于复方制剂服用方便且降压效果显著，患者更容易坚持治疗，从而提高用药的依从性。（4）价格优势：与单方制剂相比，复方制剂的日均费用最低，固定剂量组合的治疗方案可减少患者住院治疗几率，可节省医疗费用。02抗高血压药物复方制剂市场分析01抗高血压药物复方制剂整体市场分析近五年抗高血压复方制剂市场规模稳步增长，据摩熵医药销售数据统计，医院端销售额从2019年90.01亿元增长至2023年132.14亿元，与钙通道阻滞剂、ACEI降压药、ARB降压药等品类市场规模下滑形成明显对比，预计未来复方制剂市场规模将进一步扩大。五大类一线降压药份额分别为钙通道阻滞剂36.69%、ARB降压药13.23%、β受体阻滞剂11.94%、ACEI降压药5.87%、利尿剂5.80%。复方制剂目前已成为抗高血压药物第二大品类，2023年占比约26.47%。数据来源：摩熵医药数据库2023年企业竞争格局方面，诺华旗下抗高血压复方制剂产品合计销售额约39.95亿元，市场份额约42.65%，在我国市场上具备绝对优势。其次为正大天晴，2023年市场份额约9.84%。销售额排名前十的企业外资有4家，内资有6家。品种竞争格局方面，2023年最畅销产品为沙库巴曲缬沙坦钠片，医院端销售额达32.27亿元，份额占28.57%。其次为厄贝沙坦氢氯噻嗪片，销售额约16.41亿元，份额约14.53%。排名前十的品种年销售额均超过4亿元。数据来源：摩熵医药数据库02沙库巴曲缬沙坦钠片市场分析沙库巴曲缬沙坦钠片为诺华独家品种，于2015年获得美国FDA批准，并于2017年在中国上市，商品名为诺欣妥。近五年，诺欣妥在我国市场销售额呈现爆发式增长，从2019年4.81亿元显著增长至2023年39.92亿元。该产品吸引多家本土药企争相布局，2023年8月至2024年，国内相继有15家企业获得仿制药生产批文，目前暂未实现商业化，诺欣妥专利到期日为2026年11月，预计未来沙库巴曲缬沙坦钠片市场竞争将逐渐加剧。03厄贝沙坦氢氯噻嗪片市场分析厄贝沙坦氢氯噻嗪片原研企业为赛诺菲，1997年经美国FDA批准上市，2003年获准进口中国，商品名为安博诺。该品种于2018年纳入首批集采，销售额从2019年31.81亿元降至2020年22.11亿元，同比下滑30.49%。近两年销售额逐渐稳定，维持在24亿元左右。集采中选企业包括浙江华海药业、南京正大天晴以及原研企业赛诺菲三家，价格最高降幅达58.59%，最低中选单价为1.02元/片。03抗高血压药物市场趋势01未来新作用机制、新靶点降压药将逐渐涌入市场目前，高血压新药研发主要聚焦在新作用机制、新靶点方面，具体药物类型包括：双通道阻断型CCB、直接肾素抑制剂、ETA/ETB双重内皮素受体拮抗剂、氨基肽酶A抑制剂、钠钾离子通道转换酶抑制剂、利钠肽受体激动剂等。未来，这些新药将逐渐涌入市场，有望凭借创新机制、优异疗效、更小副作用等诸多优势脱颖而出。02全球多款新机制降压药获批上市/临床，明星药物Aprocitentan值得关注目前全球有多款新机制降压药获批上市或进入临床阶段，其中值得关注的有：（1）Aprocitentan，由Idorsia开发的一种双重内皮素A/B受体（ETA/ETB）拮抗剂，通过阻断内皮素扩张血管、抑制交感活性和减少醛固酮释放三重机制降低血压，是高血压领域近40年首款具有新机制的降压药，已在美国获批上市；（2）Baxdrostat，阿斯利康在研小分子降压药，通过抑制醛固酮合成酶来减少醛固酮的合成，有望成为难治性高血压有效药物，截至2024年11月，其全球最高研发阶段已进展至临床Ⅲ期。数据来源：摩熵医药全球药物研发数据库小结总结来说，抗高血压药物复方制剂不仅可以有效控制血压，还能降低副作用，改善患者依从性。随着科技的进步和研发的不断深入，抗高血压药物复方制剂有望为患者带来更多的治疗选择，并在全球范围内得到更广泛的应用。END本文为原创文章，转载请留言获取授权利尿剂市场研究专题报告完整报告领取方式近期热门资源获取数据透视：中药创新药、经典验方、改良型新药、同名同方的申报、获批、销售情况-2025042023H2-2024H1中国药品分析报告-2025042024年中国1类新药靶点白皮书-202503中国AI医疗健康企业创新发展百强榜单-202502解码护肤抗衰：消费偏好洞察与市场格局分析-2025022024年FDA批准上市的新药分析报告-2025012024年NMPA批准上市的新药分析报告-2025012024年医保谈判及市场分析报告-2025.012024年中国医疗健康投融资全景洞察报告-202501小分子化药白皮书（上）-2025012024医美注射材料市场发展分析报告-202412中国放射性药物产业白皮书-202410近期更多摩熵咨询热门报告，识别下方二维码领取联系我们，体验摩熵医药更多专业服务会议合作园区服务数据库咨询定制服务媒体合作👆👆👆点击上方图片，即可开启摩熵化学数据查询点击阅读原文，申请摩熵医药企业版免费试用！