Clazosentan sodium

Ad hoc announcement pursuant to Art. 53 LR Allschwil, Switzerland – March 4, 2025Idorsia Ltd (SIX: IDIA) today announced its financial results for 2024. Business highlights 2024 Viatris collaboration: Global research and development collaboration, focused on the development and commercialization of selatogrel and cenerimod entered in March 2024. QUVIVIQ™ (daridorexant): Outstanding launch dynamic in France, and a strong performance in Germany accelerate sales in 2024 – Total Idorsia-led net sales of CHF 61 million in 2024. TRYVIO™ (aprocitentan): Commercially available in the US since October 2024. JERAYGO™ (aprocitentan): Approved in European Union in June 2024 and the UK in January 2025 – marketing authorization application under review in Switzerland and Canada. Subsequent events Restructured convertible bond debt: Tailored approach to remove large debt overhang. New funding: Bondholders to provide CHF 150 million new money facility. Viatris collaboration: Updated agreement removes significant cash requirement for 2025 Financial highlights Net revenue FY 2024 at CHF 113 million. US GAAP operating expenses FY 2024 at CHF 351 million – benefiting from one-off income of CHF 125 million from the Viatris deal – and non-GAAP operating expenses FY 2024 at CHF 427 million. US GAAP operating loss FY 2024 of CHF 232 million and non-GAAP operating loss of CHF 308 million. Guidance for 2025 unforeseen events excluded QUVIVIQ net sales of around CHF 110 million. SG&A expenses of around CHF 210 million, R&D expense of around CHF 100 million, leading to non-GAAP operating expenses of around CHF 325 million. US GAAP loss for global business of around CHF 155 million. André C. Muller, Chief Executive Officer of Idorsia, commented:“We were not able to close the envisaged out-licensing agreement for aprocitentan, but we will now pivot to potential alternative partners. Despite this unexpected setback, we were able to agree a holistic restructuring of our convertible bond debt and secure additional funding for future operations. With so much attention going to the financial situation of the company during the past six months, it’s easy to lose sight of how well the company was performing in other areas. We exceeded our sales target for QUVIVIQ, with a particularly strong performance in France and Germany. Our next potential blockbuster, TRYVIO, was made available for prescription in the US, approved as JERAYGO in the EU and UK, and submitted for review in Switzerland and Canada. We closed a great deal with Viatris for our Phase 3 assets, selatogrel and cenerimod, and we have advanced our early-stage pipeline of potentially first- or best-in-class discoveries. With commercial profitability forecast in 2026, and overall profitability forecast for 2027, we have a lot to be excited about.”Financial results Net revenue of CHF 113 million in 2024 is the result of QUVIVIQ product sales (CHF 61 million), product sales to partners (CHF 47 million), and contract revenues (CHF 5 million). This compares to net revenue of CHF 152 million in 2023, which included CHF 107 million one-off incomes (mainly PIVLAZ sales in Japan and the APAC (ex-China) Nxera deal). Other revenues in 2023 consisted of QUVIVIQ product sales (CHF 31 million), and other contract revenue of CHF 15 million. US GAAP operating expenses in 2024 (CHF 351 million) and 2023 (CHF 409 million) were impacted by one-off incomes of CHF 125 million (Viatris deal) and CHF 298 million (Nxera deal) respectively. Excluding these one-off incomes, US GAAP operating expenses in 2024 amounted to CHF 476 million, decreasing by CHF 231 million compared to 2023 (CHF 707 million), mainly driven by R&D expenses of CHF 144 million decreasing by CHF 150 million compared to 2023 (CHF 294 million), and SG&A expenses of CHF 273 million decreasing by CHF 120 million compared to 2023 (CHF 392 million). US GAAP net loss in 2024 amounted to CHF 264 million (CHF 298 million in 2023). The net loss was favorably impacted by the one-off income related to the Viatris deal (Nxera deal in 2023) and lower operating expenses throughout all functions. The reduction in operating expenses is mainly a result of the restructuring initiative from 2023 which became fully cost effective in 2024 and the Viatris Deal, which relieved the group from Phase 3 development costs related to selatogrel and cenerimod. The US GAAP net loss resulted in a basic net loss per share of CHF 1.45 (basic and diluted) in 2024, compared to a net loss per share of CHF 1.67 (basic and diluted) in 2023. * 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 2024 amounted to CHF 330 million; the difference versus US GAAP net loss was mainly driven by a net gain from the Viatris Deal (CHF 125 million). The non-GAAP net loss resulted in a net loss per share of CHF 1.81 (basic and diluted) in 2024, compared to a net loss per share of CHF 3.04 (basic and diluted) in 2023. Viatris collaborationIn March 2024, Idorsia entered into a global research and development collaboration with Viatris, for the global development and commercialization rights to selatogrel and cenerimod. Idorsia received an upfront payment of USD 350 million (CHF 308 million) with Idorsia obligated to contribute USD 200 million for the development of 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. In February 2025, Idorsia reached an agreement with Viatris to update the terms of the collaboration. In exchange for a USD 100 million reduction to Idorsia’s contribution to the development costs due in 2025, Idorsia has agreed to a USD 250 million reduction in future potential regulatory and sales milestone payments, and an expansion of territorial rights to Viatris for cenerimod. The agreed royalties on future sales remain unchanged. Under the updated terms, Idorsia's contribution for the development of selatogrel and cenerimod is reduced to USD 100 million with no commitment in 2025. Idorsia has contributed USD 73 million in 2024 for the performance of development services, and the remaining USD 27 million will be paid in 2026. Restructured convertible bond debt and new funding securedOn February 26, 2025, Idorsia announced that it has reached an agreement with more than two-thirds of the holders of its outstanding convertible bond debt on the main terms of a holistic restructuring of the bonds and a CHF 150 million new money facility, to alleviate the short- to mid-term debt overhang of CHF 800 million while retaining upside potential of key assets beyond the value of the debt. As part of the holistic restructuring Idorsia will issue up to 27.5 million shares and up to 25.5 million warrants. When complete, the tailored solution secures future operations of Idorsia into 2026. More information can be found in the dedicated press release. Capital increaseIn connection with the holistic restructuring of the convertible bond debt and raising of additional funds, 35 million registered shares with a nominal value of CHF 0.05 each have been created out of capital band and will be listed today, March 4, 2025. Financial guidance for 2025As previously announced, for the Idorsia-led portfolio in 2025, the company expects a continued acceleration of QUVIVIQ with net sales of around CHF 110 million, COGS of around CHF 15 million, SG&A expenses of around CHF 210 million, and R&D expense of around CHF 100 million, leading to non-GAAP operating expenses of around CHF 325 million. This performance would result in an Idorsia-led business non-GAAP operating loss of around CHF 215 million and US-GAAP operating loss of around CHF 260 million. The company expects US-GAAP EBIT for the partnered business of around CHF 105 million, mainly driven by the amended deal with Viatris. This would result in a US-GAAP loss for the global business of around CHF 155 million. All amounts exclude unforeseen events and potential revenue related to additional business development activities. Arno Groenewoud, Chief Financial Officer, commented:“I’m pleased that our performance in 2024 exceeded our expectations, with higher QUVIVIQ sales and lower OPEX. The series of initiatives that we announced last week totally changes the financial situation of Idorsia. By relieving the significant debt overhang, removing significant and immediate cash requirements, and securing new funding, Idorsia is able to continue to operate into 2026. We will continue our efforts to maximize QUVIVIQ sales and reduce costs moving forward in order to make the money last.” Liquidity and indebtednessAt the end of 2024, Idorsia’s liquidity amounted to CHF 106 million. *rounding differences may occur Commercial operationsIn 2024, QUVIVIQ™ (daridorexant) in the US, Germany, Italy, Switzerland, Spain, UK, Canada, Austria, France, and Sweden generated total product sales of CHF 61 million. Europe and Canada QUVIVIQ (daridorexant) net sales in 2024 reached CHF 32 million in the EUCAN region, a significant increase from CHF 6.5 million in 2023. In France, QUVIVIQ is reimbursed for moderate and severe chronic insomnia patients after, or as an alternative to, cognitive behavioral therapy for insomnia (CBT-I) since January 2024, and was launched in March 2024 as the first and only pharmacotherapy recommended for the treatment of chronic insomnia. Through a commercial partnership with Menarini in France, Idorsia expanded its commercial reach from specialist prescribers to general practitioners (GPs) in October 2024, which has substantially increased sales quarter on quarter with France being one of the main drivers of sales growth in the EUCAN region. In Germany, QUVIVIQ was launched in November 2022 and is the only sleep medication in Germany that can be prescribed for long-term treatment of chronic insomnia. The progress made in Germany is reflected by the performance of QUVIVIQ on the market, with net sales increasing by 279% in 2024 compared to 2023. In February 2025, Idorsia successfully concluded negotiations for the reimbursement price in Germany. Idorsia is expanding its commercial reach from specialist prescribers to general practitioners (GPs) through a commercial partnership with Berlin-Chemie (a wholly owned subsidiary of the Menarini Group) beginning in early April 2025. In the UK, QUVIVIQ is recommended as first-line pharmaceutical treatment for patients with chronic insomnia, after, or as an alternative to, cognitive behavioral therapy for insomnia (CBT-I). QUVIVIQ was launched in October 2023 at NICE approval. The priority in the UK in 2024 was to secure regional access, and the team has achieved reimbursement throughout 85% of the UK, as well as raising awareness of QUVIVIQ among general practitioners. Increased access and awareness have started to translate into strong demand in the UK. In Canada, after being approved in April 2023, QUVIVIQ was launched in November 2023 to the private market, representing 55% of the Canadian insomnia market. To date, 85% of private Canadian lives are covered. The focus is now on public payers; the company submitted public reimbursement dossiers and expects decisions by the end of 2025. In Switzerland, Italy, Spain, Austria, and Sweden, where we are still negotiating for reimbursement, launches have been very successful despite the out-of-pocket costs for patients, particularly in Switzerland where we see a strong demand. In Italy, we have achieved an expansion of the prescriber base from specialists to now include general practitioners who represent nearly 80% of the total insomnia market. Benjamin Limal, President of Europe and Canada region, commented:“Commercial efforts with QUVIVIQ in the EUCAN region are beginning to translate into promising success. Sales have shown a steady increase since the first launch in November 2022, with a recent acceleration – particularly driven by an outstanding launch in France and a great performance in Germany. This dynamic is expected to continue in the coming months as access expands in key European markets. We are also expanding our commercial reach from specialist prescribers to general practitioners through commercial partnerships such as Menarini in France and Berlin-Chemie in Germany.” For more information about QUVIVIQ in the EU, see the Summary of Product Characteristics. For more information about QUVIVIQ in Switzerland, see the Patient Information and Information for Healthcare Professionals. For more information on the marketing authorization of QUVIVIQ in Canada, see the Product Monograph. United States QUVIVIQ® (daridorexant) net sales in 2024 reached CHF 28.6 million in the US, an increase of 17% compared to 2023. As of the end of 2024, almost 175,000 patients have been treated with QUVIVIQ since launch in the US, over 550,000 prescriptions have been dispensed, and the product has been prescribed by more than 51,000 healthcare professionals. Michael Moye, President and General Manager of Idorsia US, commented:“In the US, we have implemented a change to the commercialization approach for QUVIVIQ with the objective to reduce operating costs while maintaining the sales. We are still hopeful that descheduling of the dual orexin receptor antagonist (DORA) class can be achieved and the real value of QUVIVIQ in the US market can be unlocked. Our commercialization partner, Syneos Health, has switched to 20 virtual sales reps, operating with a data driven, highly targeted call plan, instead of the around 100 field force sales reps we had before. Syneos is now also executing marketing, focused digital media, data analytics and market access activities in support of the virtual representatives.” For more information about QUVIVIQ in the US, see the Full Prescribing Information (PI and Medication Guide). On March 19, 2024, the US Food and Drug Administration (FDA) approved TRYVIO™ (aprocitentan) 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. The recommended dosage of TRYVIO is 12.5 mg orally once daily, with or without food. Following the approval, the US team rapidly established both the REMS program and specialty distribution channel, begun engaging with hypertension experts at major cardiovascular and nephrology congresses, and initiated encouraging discussions with payors, resulting in TRYVIO being made available for prescription in October 2024. Michael concluded:“TRYVIO has been available to prescribe to the millions of patients in the US whose high blood pressure is not adequately controlled by other drugs since October 2024. A detailed US market assessment, campaign and educational approach is now complete, although funding for a field sales force and promotional activities continues to be dependent on a partnership deal. However, we have started to execute a limited launch of TRYVIO in the US in order to maintain and increase the value of a potential out-licensing deal for aprocitentan.” For more information see the Full Prescribing Information including BOXED Warning (PI and Medication Guide). Research & DevelopmentOur drug discovery engine has produced innovative drugs with the potential to transform the treatment paradigm in multiple therapeutic areas, including CNS, cardiovascular, and immunological disorders, as well as orphan diseases. The company also has a vaccine platform for the discovery and development of glycoconjugate vaccines to prevent infection. The company has focused its drug discovery efforts, reducing the number of active projects in research and development and preparing some for out-licensing. The prioritization has resulted in a portfolio of assets where Idorsia intends to develop to the next inflection point before partnering, or when feasible and appropriate, developing further ourselves. The company expects new lucerastat data from a kidney biopsy sub-study (to the ongoing Phase 3 open-label extension study) in the second quarter of 2025, with further discussions on the regulatory pathway to follow. The results from a Phase 1 study of our Clostridium difficile infection vaccine are also expected in the coming months. The company will need to further prioritize activities in order to reduce costs and the decisions on which assets to advance will be taken based on the data when available and the results of ongoing out-licensing discussions for early-stage assets. Idorsia-led portfolioThe company will develop each asset to the next inflection point or seek a partner. Further details including the current status of each project in our portfolio can be found in our innovation fact sheet.Idorsia partner-led portfolioFor Idorsia, sophisticated partnerships are a way of gaining strategic access to technologies or products and fully exploiting our discovery engine and clinical pipeline. We seek suitable external project partners to maximize the value of internal innovation. Aprocitentan is an innovative and highly differentiated drug, commercially available in the US and approved in Europe and UK for the millions of patients who are unable to bring their hypertension under control with existing medications. As the first drug to target the endothelin pathway in systemic hypertension, aprocitentan has blockbuster potential in uncontrolled hypertension, particularly for difficult to treat patients with chronic kidney disease and hypertension, and further potential beyond hypertension. The priority remains to partner aprocitentan, having been released from the exclusivity constraint with the undisclosed party, the company will resume discussions with alternative potential partners that recognize the value of aprocitentan. On March 19, 2024, the US Food and Drug Administration (FDA) approved TRYVIO™ (aprocitentan) 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. See the commercial operations section above. On June 27, 2024, the European Commission (EC) approved JERAYGO™ (aprocitentan) for the treatment of resistant hypertension in adult patients in combination with at least three antihypertensive medicinal products. The recommended dose is 12.5 mg orally once daily. The dose can be increased to 25 mg once daily for patients tolerating the 12.5 mg dose and in need of tighter blood pressure (BP) control. For more information about JERAYGO in the EU, see the Summary of Product Characteristics. Further details including the current status of each project in our partner-led portfolio can be found in our innovation fact sheet. Human ResourcesIdorsia reduced 249 positions worldwide in 2024, bringing the total number of permanent employees to 689 (2023: 938). Following a consultation process with employee representatives at headquarters in December 2024, a further reduction of approximately 250 positions globally was anticipated. The company has already begun the implementation of the restructuring and expects the cost reduction to be largely effective by Q2 2025. The total number of permanent employees who are not on notice at the end of February 2025 is 552. Financial ReportThe Financial Report 2024 is available at www.idorsia.com/annual-report. Annual ReportIdorsia's Annual Report 2024 – consisting of the Business Report, Governance Report, Compensation Report, Sustainability Report, and Financial Report (already published today) – will be published on March 27, 2025. Note to ShareholdersThe Annual General Meeting (AGM) of Shareholders to approve the Annual Report of the year ending December 31, 2024, will be held on Wednesday, May 28, 2025. 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 April 11, 2025. 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 May 19, 2025, at the latest. Results Day CenterInvestor community: To make your job easier, we provide all relevant documentation via the Results Day Center on our corporate website: www.idorsia.com/results-day-center. Events Publication of the Annual Report 2024 on March 27, 2025 First Quarter 2025 Financial Results reporting on April 30, 2025 Annual General Meeting of Shareholders on May 28, 2025 Half-Year 2025 Financial Results reporting on July 30, 2025 Notes to the editor 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 contactInvestor & 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