Cenerimod

Ad hoc announcement pursuant to Art. 53 LR Allschwil, Switzerland – April 30, 2025Idorsia Ltd (SIX: IDIA) today announced its financial results for the first quarter of 2025. Business highlights Q1 2025 QUVIVIQ™ (daridorexant): Strong performance and accelerating sales in Q1 2025 with total Idorsia-led net sales of CHF 25 m.QUVIVIQ EUCAN: Demand grew by 50% from Q4 2024 to Q1 2025, strongly driven by reimbursed markets. Overall, more than 10 million nights of sleep prescribed in Q1 2025.Daridorexant: Positive data with daridorexant in patients with chronic insomnia and nocturia published in the Journal of Sleep Research and assessing the transition from night to day published in Sleep Medicine.TRYVIO™ (aprocitentan): REMS requirement removed by US FDA.Aprocitentan: Effect of reducing blood pressure and proteinuria in Black patients with resistant hypertension published in HypertensionRestructured convertible bond debt: Tailored approach to remove large debt overhang.New funding: Bondholders to provide CHF 150 m new money facility.Viatris collaboration: Updated agreement removed significant cash requirement for 2025. Financial highlights Net revenue Q1 2025 of CHF 59 m.US GAAP operating expenses Q1 2025 of CHF 5 m (income) were positively impacted by a one-off gain from the amendment of the Viatris deal with non-GAAP operating expenses Q1 2025 of CHF 78 m.US GAAP operating income Q1 2025 of CHF 67 m and non-GAAP operating loss of CHF 17 m. Guidance for 2025 – unforeseen events excluded QUVIVIQ net sales of around CHF 110 m.SG&A expenses of around CHF 210 m, R&D expenses of around CHF 100 m, leading to non-GAAP operating expenses of around CHF 325 m.US GAAP loss for global business of around CHF 125 m. André C. Muller, Chief Executive Officer of Idorsia, commented:“Beyond the transformation of Idorsia’s financial situation, we made significant progress on multiple fronts in the first quarter. QUVIVIQ is taking off in Europe with a particularly impressive performance in France following the commercial partnership to call on GPs initiated in October 2024; we hope Germany will follow suit, as a similar partnership will kick-in from April 2025. In the US, we have implemented a focused commercialization approach for QUVIVIQ to maintain sales until the potential descheduling of the dual orexin receptor antagonist (DORA) class can be achieved. We received great news from the FDA, with the removal of the REMS requirement for TRYVIO allowing a shift toward broad product availability in retail pharmacies. This, together with the early positive prescribing experience in leading US hypertension centers of excellence gives us confidence of the potential of our antihypertensive drug. Lastly, we streamlined the R&D organization to invest in our promising refocused pipeline. All these achievements put us on a solid path to reach our 2025 goals.” Financial results US GAAP results First Quarterin CHF millions, except EPS (CHF) and number of shares (millions) 20252024Net revenue 5910Operating expenses 520Operating income 6731Net income 6330Basic EPS 0.330.17Basic weighted average number of shares 188.9179.1Diluted EPS 0.230.13Diluted weighted average number of shares 270.8233.3 Net revenue of CHF 59 m in Q1 2025 resulted from QUVIVIQ product sales (CHF 25 m), product sales to partners (CHF 1 m), and contract revenues (CHF 32 m), comprising a one-off exclusivity fee of CHF 32 m paid by an undisclosed party in relation to a potential aprocitentan deal, and non-cash revenue related to the R-Bridge royalty monetization agreement of CHF 1 m. This compares to net revenue of CHF 10 m in Q1 2024 from QUVIVIQ product sales. US GAAP operating expenses of CHF 5 m (income) in Q1 2025 and CHF 20 m (income) in Q1 2024 were impacted by a one-off gain of CHF 90 m (Viatris deal amendment) in 2025 and CHF 125 m (Viatris deal) in 2024, respectively. Excluding these one-off gains, US GAAP operating expenses at Q1 2025 decreased by CHF 20 m, mainly driven by R&D expenses of CHF 27 m decreasing by CHF 6 m compared to Q1 2024 (CHF 33 m), and SG&A expenses of CHF 54 m decreasing by CHF 14 m compared to Q1 2024 (CHF 68 m). US GAAP net income in Q1 2025 of CHF 63 m (CHF 27 m net loss excluding Viatris deal amendment) and CHF 30 m in Q1 2024 (CHF 95 m net loss excluding Viatris deal). Excluding these one-offs, the reduced net loss in Q1 2025 was primarily due to lower operating expenses from cost savings through the effective restructuring efforts announced in November 2024 and higher revenue. The US GAAP net income resulted in a basic net income per share of CHF 0.33 (diluted net income per share of CHF 0.23) in Q1 2025, compared to a basic net income per share of CHF 0.17 (diluted net income per share of CHF 0.13) in Q1 2024. Non-GAAP* measures First Quarterin CHF millions, except EPS (CHF) and number of shares (millions) 20252024Net revenue 5810Operating expenses (78)(96)Operating loss (17)(85)Net loss (25)(86)Basic and diluted EPS (0.13)(0.48)Basic and diluted weighted average number of shares 188.9179.1 * 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 Q1 2025 amounted to CHF 25 m; the difference versus US GAAP net income was mainly driven by the one-off gain from the amendment of the Viatris Deal (CHF 90 m). The non-GAAP net loss resulted in a net loss per share of CHF 0.13 (basic and diluted) in Q1 2025, compared to a net loss per share of CHF 0.48 (basic and diluted) in Q1 2024. 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 were created out of capital band and were listed on 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 135 million – updated to reflect the positive impact of the one-off exclusivity fee paid by an undisclosed party in Q4 2024 but recognized in Q1 2025 – and mainly driven by the amended deal with Viatris. This would result in a US-GAAP loss for the global business of around CHF 125 million. All amounts exclude unforeseen events and potential revenue related to additional business development activities. Arno Groenewoud, Chief Financial Officer, commented:“The updated agreement with Viatris, and the convertible debt restructuring, together with the new money facility agreed with our bondholders, has significantly changed the financial situation of Idorsia. That said, there are still several steps to implement in order to realize what was agreed. The restructuring of the bonds is moving forward with the first step approved by the court, allowing us to proceed to the next bondholder meetings. We are also making progress with putting the new money facility in place. The excellent uplift with QUVIVIQ in Europe and the tight cost-control means we are well on track with our financial performance targets.” Liquidity and indebtednessAt the end of the first quarter of 2025, Idorsia’s liquidity amounted to CHF 51 million. (in CHF millions) Mar 31, 2025Dec 31, 2024Liquidity Cash and cash equivalents 51106Total liquidity* 51106 Indebtedness Convertible loan 335335Convertible bond 797797Other financial debt 190189Total indebtedness 1,3221,321 *rounding differences may occur Commercial operationsIn the first quarter of 2025, QUVIVIQ™ (daridorexant) in the US, Germany, Italy, Switzerland, Spain, UK, Canada, Austria, France, and Sweden generated total product sales of CHF 25 million. Europe and Canada ProductMechanism of actionIndicationCommercially availableDual orexin receptor antagonistTreatment of adult patients with insomnia characterised by symptoms present for at least three months and considerable impact on daytime functioningSweden: Sept. 2024France: Mar. 2024Austria: Feb. 2024UK: Oct. 2023Spain: Sept. 2023Switzerland: Jun. 2023Germany: Nov. 2022Italy: Nov. 2022 Management of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenanceCanada: Nov. 2023 QUVIVIQ (daridorexant) net sales in the first quarter of 2025 reached CHF 19.4 million in the Europe and Canada (EUCAN) region, a significant increase from CHF 3.5 million in the first quarter of 2024. In France, QUVIVIQ is reimbursed for moderate and severe chronic insomnia patients after, or as an alternative to, cognitive behavioral therapy for insomnia. The outstanding launch in France is driven by a combination of co-promotion with Menarini reflected by a new-to-brand share growing from 1.1% in September 2024 to 9.3% in January 2025 in the general practitioner (GP) segment, and a strong positioning to specialists in retail and hospital settings reflected by a solid new-to-brand share evolution from 9.7% in September 2024 to 14.4% in January 2025 in the psychiatrist segment. 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 demand increasing by 20% quarter on quarter. In February 2025, Idorsia successfully concluded negotiations for the reimbursement price in Germany. Idorsia is expanding its commercial reach from specialist prescribers to GPs through a commercial partnership with Berlin-Chemie (a wholly owned subsidiary of the Menarini Group), which started in 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 which grew by 48% from Q4 2024 to Q1 2025. 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. QUVIVIQ demand in Canada grew by 25% from Q4 2024 to Q1 2025. Austria will soon become the fourth EUCAN country to grant public reimbursement to QUVIVIQ, starting from June 1, 2025. This is a significant achievement in a country that has strict reimbursement rules and underpins the value QUVIVIQ brings to patients, physicians and the healthcare system. In Italy, QUVIVIQ is now officially available for all prescribers, following its publication in the Official Gazette in mid-March 2025, this includes GPs who represent nearly 80% of the total insomnia market. In Switzerland, Spain, 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. Benjamin Limal, President of Europe and Canada region, commented:“Demand has grown by an impressive 50% quarter on quarter, mainly driven by reimbursed markets. Across Europe and Canada, more than 10 million nights of sleep have been prescribed in the first quarter of 2025. Recent successes in access and pricing, notably in Austria and Germany, reinforce our confidence for continued growth moving forward. QUVIVIQ has been strongly adopted by specialists and more and more general practitioners start prescribing QUVIVIQ due to our increased efforts with recent partnerships for the GP market.” 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 ProductMechanism of actionIndicationCommercially available sinceDual orexin receptor antagonistTreatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenanceMay 2022 QUVIVIQ® (daridorexant) net sales in the first quarter of 2025 amounted to CHF 5.9 million in the US, compared to CHF 6.5 million in the first quarter of 2024. As of the end of the first quarter of 2025, more than 180,000 patients have been treated with QUVIVIQ since launch in the US, over 600,000 prescriptions have been dispensed, and the product has been prescribed by more than 50,000 healthcare professionals. Michael Moye, President and General Manager of Idorsia US, commented:“We have implemented a streamlined, focused, and more cost-efficient commercialization approach for QUVIVIQ to maintain sales until the potential descheduling of the dual orexin receptor antagonist (DORA) class can be achieved. Our commercialization partner, Syneos Health, is fully operational and executing a highly targeted digital marketing plan supporting 20 virtual sales reps. Syneos is now also executing educational programming and market access activities in support of the virtual representatives. We are seeing early, positive prescribing results in key customer areas.” For more information about QUVIVIQ in the US, see the Full Prescribing Information (PI and Medication Guide). ProductMechanism of actionIndicationCommercially available sinceDual endothelin receptor antagonistTreatment of hypertension in combination with other antihypertensive drugs, to lower blood pressure in adult patients who are not adequately controlled on other drugsOctober 2024 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 the 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 via Walgreens Specialty Pharmacy. 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. The US FDA has determined that a REMS is no longer necessary to ensure the benefits of TRYVIO outweigh the risk of embryo-fetal toxicity and that labeling is sufficient for conveying the safety information. 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. Michael concluded:“Early prescribing experience in leading US hypertension centers of excellence has been very positive, with prescribers confirming that they are seeing blood pressure reductions, safety and tolerability consistent with the Phase 3 study. The REMS removal and shift toward broad product availability in retail pharmacies has profoundly improved the potential of TRYVIO to reach millions of patients struggling with their hypertension on existing medication regimens.” 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. In March 2025, “A randomized cross-over trial of daridorexant for the treatment of chronic insomnia and nocturia” was published in the Journal of Sleep Research. The new data provides evidence of the benefit of daridorexant, at a daily dose of 50 mg, in patients aged >=55 years with chronic insomnia and comorbid nocturia, with efficacy data on symptoms of both conditions, improvement in daytime functioning, and a good safety and tolerability profile. In April 2025, the “Effect of daridorexant on nighttime wakefulness and next-morning sleepiness: assessing the transition from night to day in insomnia disorder” was published in Sleep Medicine. The analysis of the Phase 3 data provides evidence that daridorexant reduces wakefulness throughout the entire night, while decreasing morning sleepiness and improving daytime functioning and alertness in patients with chronic insomnia disorder. Idorsia-led portfolioThe company will develop each asset to the next inflection point or seek a partner. CompoundMechanism of actionTarget indicationStatusQUVIVIQ™ (daridorexant)Dual orexin receptor antagonistInsomniaCommercialized by Idorsia in the US, Germany, Italy, Switzerland, Spain, the UK, Canada, Austria, France, and Sweden; approved throughout the EU.LucerastatGlucosylceramide synthase inhibitorFabry diseasePhase 3 open-label extension study ongoing – kidney biopsy sub-study results expected in Q2 2025 – regulatory pathway to be further discussed with FDA.DaridorexantDual orexin receptor antagonistPediatric insomniaPhase 2 in pediatric insomnia is ongoing.ACT-777991CXCR3 receptor antagonistVitiligoProof-of-concept study in preparation for patients with vitiligo. Unique precision medicine with a dual targeting of CD8+ CXCR3+ T cells offers potential for a first-in-class targeted systemic therapy for effective and safer treatment of immuno-dermatology and autoimmune disorders.ACT-1004-1239ACKR3 (CXCR7) receptor antagonistProgressive multiple sclerosis Proof-of-concept study in preparation for patients with progressive MS. Unique combination of re-myelination and anti-inflammatory effect with decreased inflammatory cell infiltration.IDOR-1117-2520CCR6 receptor antagonistPsoriasisProof-of-concept study in preparation for patients with psoriasis. Unique potential as a first-in-class, oral, targeted systemic therapy for effective treatment of Th17-driven immuno-dermatology and autoimmune disorders.ACT-1016-0707LPA 1 receptor antagonistImmune-mediated and fibrosis related disordersEntry-into-human package complete. Potential best-in-class due to insurmountable binding mode – proven inhibitory activity in preclinical models of inflammation and fibrosis.IDOR-1134-9712CFTR Type-IV correctorCystic FibrosisEntry-into-human package in progress. A unique corrector targeting an Idorsia-identified binding site on the Cystic Fibrosis Transmembrane regulator (CFTR) protein. Potential synergy with other molecules.IDOR-1141-8472Orexin 2 receptor agonistOrexin-related CNS disordersEntry-into-human package ready to begin. Potential best-in-class – sustained chronic efficacy in a preclinical model of narcolepsy.IDOR-1126-6421Undisclosed mechanismOrgan injury / fibrosisEntry-into-human package in progress. Broad potential of undisclosed mechanism for inhibiting organ injury and fibrosis – proven effectiveness in several preclinical models of organ injury. Synthetic Glycan Vaccine PlatformIdorsia will seek a partner for the platform or individual vaccines.IDOR-1134-2831Synthetic glycan vaccineClostridium difficile infectionIdorsia is conducting a Phase 1 clinical pharmacology study which will test the immune response of the vaccine and evaluate its safety and tolerability. Results expected in Q2 2025.IDOR-1142-0810Synthetic glycan vaccineKlebsiella pneumonia infection Entry-into-human package in progress. 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, 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. 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. 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. In April 2025, "Aprocitentan for Blood Pressure Reduction in Black Patients” was published in Hypertension. The publication reports preplanned analyses of the efficacy, tolerability and safety of aprocitentan in the subgroup of African American patients enrolled in the Phase 3 PRECISION study in patients with confirmed resistant hypertension. Aprocitentan, when added to a combination of at least three antihypertensive drugs (four in more than 50% of patients), produced clinically meaningful and sustained blood pressure reductions. Aprocitentan also markedly decreased proteinuria in the patients with proteinuria at baseline. As reported by the authors, aprocitentan was safe and well tolerated, even in those Black patients with chronic kidney disease. CompoundMechanism of actionTarget indicationPartner/statusTRYVIO™ (aprocitentan) Dual endothelin receptor antagonistSystemic hypertension in combination with other antihypertensivesTo be defined: worldwide development and commercialization rightsCommercially available in the USJERAYGO™ (aprocitentan)Dual endothelin receptor antagonistResistant hypertension in combination with other antihypertensivesTo be defined: worldwide development and commercialization rights Approved in the EU and UK; Marketing authorization applications under review in Canada, and SwitzerlandQUVIVIQ™ (daridorexant)Dual orexin receptor antagonistInsomniaNxera Pharma: license to develop and commercialize for Asia-Pacific region (excluding China)Launched for the treatment of insomnia in Japan; Phase 3 ongoing in South KoreaDaridorexantDual orexin receptor antagonistInsomniaSimcere: license to develop and commercialize for Greater China regionNDA submitted in Greater China; approved for the treatment of insomnia in Hong-KongSelatogrelP2Y12 inhibitorAcute myocardial infarctionViatris: worldwide development and commercialization rightsPhase 3 “SOS-AMI” program ongoingCenerimodS1P1 receptor modulatorSystemic lupus erythematosusViatris: worldwide development and commercialization rightsPhase 3 “OPUS” program ongoingDaridorexantDual orexin receptor antagonistPosttraumatic stress disorder (PTSD)US Department of Defense (DOD): Idorsia is supporting a clinical study sponsored by the US DOD to develop new therapies to treat PTSDACT-1002-4391EP2/EP4 receptor antagonistImmuno-oncologyOwkin: global license to develop and commercializePhase 1 ongoing Further details including the current status of each project in our partner-led portfolio can be found in our innovation fact sheet. 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. In order to attend and vote at the AGM, shareholders must be registered in the company's shareholder register by May 19, 2025, 17:00 CEST, 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 Annual General Meeting of Shareholders on May 28, 2025Half-Year 2025 Financial Results reporting on July 30, 20259-Month 2025 Financial Results reporting on October 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 10 investor.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

In February 2025, the global biopharmaceutical industry remains active in clinical-stage drug financing and collaboration activities. For instance, XtalPi Holdings successfully raised over HKD 3.2 billion via two equity placements, which will be used to further develop its AI+CRO business model. Additionally, in the realm of innovative drug partnership deals, CSPC Group’s subsidiary signed an exclusive licensing agreement with Radiance Biopharma for the antibody-drug conjugate (ADC) SYS6005, which includes up to $150 million in potential development and regulatory milestone payments as well as up to $1.075 billion in potential sales milestone payments. Innovent Biologics outlined a global exclusive collaboration and licensing agreement with Roche for the next-generation ADC candidate IBI3009, with potential milestone payments reaching up to $1 billion. 1. Nxera Pharma and Viatris Collaborate to Advance the Development and Commercialization of an S1P1 Receptor Modulator in the Asia-Pacific Region On February 28, 2025, Nxera Pharma reached a significant agreement with Viatris Inc. and Idorsia Pharmaceuticals Ltd regarding the rights to develop and commercialize Cenerimod in Japan, South Korea, and other Asia-Pacific regions (excluding China). Cenerimod, a novel oral S1P1 receptor modulator, holds significant potential as a first-line or best-in-class therapy for various autoimmune diseases. Under the terms of the agreement, Nxera Pharma will receive an upfront payment of $10 million from Viatris and will be eligible for regulatory milestone payments upon Cenerimod's approval in Japan. Additionally, Nxera Pharma will collect royalties based on net sales within the designated territories. Cenerimod is a highly selective S1P1 receptor modulator that primarily works by controlling lymphocyte migration to reduce inflammation. Prior to this, Viatris had already secured exclusive global rights to develop and commercialize Cenerimod outside of Japan and the Asia-Pacific region (excluding China) through a 2024 research and development agreement with Idorsia. This new partnership with Nxera Pharma further reinforces Viatris's global positioning in drug development and provides robust support for Cenerimod's ongoing research and development. The mechanism of Cenerimod lies in its selective targeting of the S1P1 receptor. By inhibiting lymphocyte egress from peripheral lymphoid organs into systemic circulation, Cenerimod effectively suppresses inflammatory responses. This allows it to address the abnormally elevated levels of type I interferons (IFN-1) and other pro-inflammatory cytokines observed in autoimmune diseases such as systemic lupus erythematosus (SLE). This collaboration underscores the critical role of cross-company partnerships in accelerating the development of innovative medicines. It not only expedites market entry for novel drugs to meet unmet medical needs but also effectively distributes research and development risks, fostering sustainable growth within the pharmaceutical industry. For Cenerimod, this collaboration promises broader market access and technical support, paving the way for potential breakthroughs in the treatment of autoimmune diseases. 2. Shuangqi Pharmaceutical and Anaerobic Biotechnology Collaborate to Advance the Development and Commercialization of a Quadrivalent Lactobacillus Vaginal Live Biotherapeutic Capsule Inner Mongolia Shuangqi Pharmaceutical has entered into a significant agreement with Anaerobic Biotechnology concerning an innovative live biotherapeutic product, KAL-001, for vaginal use. This microecological therapy aims to restore a healthy vaginal environment by regulating its microbiota, specifically targeting vaginal inflammatory conditions in women of reproductive age. KAL-001 is composed of four specific strains of Lactobacillus, identified after a complex process of screening, isolation, preservation, and evaluation by Anaerobic Biotechnology. KAL-001 works by replenishing beneficial bacterial flora, i.e., Lactobacillus, in the vagina to restore and maintain a healthy microbial balance. This therapeutic approach differs from traditional antibiotic treatments. Instead of directly killing pathogens, it inhibits the growth of harmful microorganisms by increasing the population of beneficial microbes. Lactobacilli produce metabolic byproducts such as lactic acid, which lower vaginal pH and create an inhospitable environment for pathogenic organisms. Additionally, Lactobacillus may competitively exclude other potential pathogens and enhance the host’s local immune response through immunomodulatory mechanisms. The collaboration extends beyond product development and includes the transfer of commercialization rights. According to the licensing agreement, Shuangqi Pharmaceutical will pay Anaerobic Biotechnology an upfront fee of RMB 25 million and commit to milestone payments of up to RMB 170 million based on development progress and sales performance, along with royalties derived from net sales. This arrangement reflects the confidence both parties have in the market potential of KAL-001 and highlights their commitment to supporting R&D investments. 3. Sino Biopharmaceutical Collaborates with Sciwind Biosciences to Advance the IL-29 Project; CPX102 Expected to Become a Breakthrough Treatment for RSV Sino Biopharmaceutical has announced the signing of an exclusive strategic collaboration agreement with Sciwind Biosciences for the development and commercialization of the human interleukin-29 (IL-29, also known as interferon-λ1) project. The deal grants exclusive licensing and cooperation rights in 19 countries, including China (including Hong Kong, Macau, and Taiwan), Brazil, Saudi Arabia, Thailand, and Singapore. The partnership aims to expedite the development of CPX102 and expand its applications in the global market. CPX102 is an inhalable aerosol solution developed through protein engineering based on IL-29. As a type III interferon, it does not directly kill or inhibit viruses but induces antiviral protein production by activating cell surface receptors, thereby preventing viral replication. Additionally, it can activate immune cells, such as cytotoxic T lymphocytes (CTLs) and natural killer (NK) cells, thus enhancing the body's innate immune response against viral infections. This treatment is particularly effective for respiratory syncytial virus (RSV) infections in children, as it directly targets the epithelial cells in the lungs via inhalation, allowing for rapid onset of action and significantly improving the clearance of the virus. As the world's first aerosolized inhalation medication for RSV treatment, CPX102 offers high patient acceptability, particularly for children. Its local administration results in systemic exposure that is only about 1/100 of the injection dosage, drastically reducing the occurrence of systemic side effects. This not only helps avoid the discomfort associated with injections but also makes the treatment process safer and more comfortable, an especially critical factor for pediatric patients with pulmonary viral infections. As a broad-spectrum antiviral drug, CPX102 activates the host immune system to clear various respiratory viruses, including RSV, SARS-CoV-2, and influenza viruses, and is not affected by viral mutations. Given the current lack of effective treatments for RSV, particularly in high-incidence countries like China, CPX102 has vast market potential. It is estimated that RSV causes approximately 330 million respiratory infections globally each year, with China being one of the countries with the highest incidence rate. Currently, CPX102 is undergoing Phase IIb clinical trials in China and is expected to become the first Class 1 innovative drug in the country approved for the nebulized treatment of RSV infections in children. Considering the unmet demand for RSV therapies both in China and globally, along with the promising clinical results of CPX102, this drug has the potential to become a blockbuster product in the respiratory and anti-infective therapeutic area, bringing tremendous market value and social benefits. 4. Ligand Pharmaceuticals Invests $75 Million to Support Castle Creek Biosciences’ D-Fi Gene Therapy On February 25, Ligand Pharmaceuticals announced the completion of a $75 million royalty financing agreement with Castle Creek Biosciences to fund the Phase III clinical development of D-Fi (FCX-007), a gene therapy for dystrophic epidermolysis bullosa (DEB), through its initial data readouts. Of the $75 million investment, Ligand provided $50 million, while leading a consortium—including Paragon Biosciences, Valor Equity Partners, and new investor XOMA Royalty Corporation—that contributed the remaining $25 million. In return, the investors will receive single-digit percentage royalties on global sales of D-Fi. D-Fi is an autologous gene-modified cell therapy designed to treat DEB, a rare genetic skin disorder caused by mutations in the COL7A1 gene. This condition results in insufficient production of type VII collagen (COL7), which is critical for anchoring the dermis to the epidermis. To address this, D-Fi uses dermal fibroblasts harvested from the patient, modifies them ex vivo with a self-inactivating (SIN) lentiviral vector encoding the COL7A1 gene to produce COL7 protein, and locally injects the treated cells into chronic wounds. This promotes the formation of anchoring fibrils within the skin. Clinical studies have shown that D-Fi is well-tolerated, with the primary adverse reactions being localized injection site responses. This collaboration underscores Ligand's commitment to investing in breakthrough treatments that have the potential to transform patients’ lives while also diversifying its income-generating asset portfolio. Matthew Gantz, President and CEO of Castle Creek Biosciences, expressed support for the partnership, emphasizing its significance as a critical step towards addressing the unmet needs of patients with DEB. 5. Eli Lilly Acquires Organovo's FXR Program, Including Key Therapy FXR314 On February 25, 2025, Organovo Holdings announced that Eli Lilly and Company would acquire its FXR program, including its core asset FXR314. This transaction marks a significant milestone for Organovo in advancing drug development for inflammatory bowel disease (IBD) using their proprietary 3D human tissue models. FXR314 is a potentially "best-in-class" oral farnesoid X receptor (FXR) agonist, initially developed to target metabolic dysfunction-associated steatohepatitis (MASH). However, recognizing the immense market potential of inflammatory bowel disease and the limitations of existing therapeutic options, Organovo deemed FXR314 equally compelling for the IBD space. Preclinical studies have demonstrated that FXR314 improves key indicators of ulcerative colitis in a dose-dependent manner using an adoptive T-cell transfer model. Under the agreement terms, Organovo will receive an upfront payment from Eli Lilly, in addition to milestone payments as FXR314 progresses through critical regulatory and commercial achievements. Moreover, Eli Lilly will obtain worldwide rights to develop and commercialize Organovo’s FXR program, including all associated intellectual property. Organovo anticipates reporting results from the Phase IIa clinical trial of FXR314 for ulcerative colitis in the first half of 2026. Through this acquisition, Eli Lilly not only strengthens its portfolio in the inflammatory bowel disease field but also underscores its commitment to innovative therapies. Previously, Eli Lilly successfully launched the IL-23 monoclonal antibody Mirikizumab for treating ulcerative colitis and Crohn’s disease, achieving significant results. With the addition of FXR314 from Organovo, Eli Lilly is well-positioned to further expand its impact in IBD treatment, offering new hope to patients. 6. CARsgen Therapeutics Partners with SoftBank Xinchuang to Accelerate the Development of Off-the-Shelf CAR-T Cell Therapies in China On February 25, 2025, CARsgen Therapeutics announced a strategic partnership with SoftBank Xinchuang, jointly investing in Ukaize Biopharmaceuticals. This collaboration aims to accelerate the development and commercialization of CARsgen’s two off-the-shelf CAR-T cell therapy products in mainland China. These products include a BCMA CAR-T therapy targeting multiple myeloma and plasma cell leukemia, as well as a CD19/CD20 CAR-T therapy for B-cell malignancies. Through this partnership, CARsgen seeks to leverage external capital to expedite innovation in the CAR-T therapy field. As part of the agreement, a SoftBank Xinchuang-managed fund will subscribe to RMB 80,000,000 of newly issued registered capital in Ukaize Biopharmaceuticals, acquiring an 8% equity stake upon transaction completion. This financing not only provides essential funds for Ukaize but also reduces CARsgen’s ownership in Ukaize from 100% to 92%. The capital investment will be allocated to support Ukaize’s research, production, and commercialization efforts. For a rapidly evolving biotech company, such funding is vital to advancing clinical trials and shortening the time required to bring new products to market. CARsgen’s two CAR-T cell therapy products target key molecular markers: BCMA (B-cell maturation antigen) and CD19/CD20. The BCMA CAR-T therapy is primarily designed to treat multiple myeloma and plasma cell leukemia—both of which are challenging, refractory hematologic malignancies. Meanwhile, the CD19/CD20 CAR-T therapy is developed to combat B-cell-derived malignancies. These therapies work by genetically engineering patients' T cells to recognize and destroy cancer cells, offering a new form of personalized treatment. This approach represents a significant advancement in the field of cancer treatment by enabling precision-targeted therapy against cancer cells while minimizing damage to normal tissues. 7. CSPC Licenses ROR1-Targeting ADC to Radiance Biopharma On February 19, 2025, CSPC Pharmaceutical Group announced that it has granted Radiance Biopharma exclusive rights for the development and commercialization of its proprietary ROR1-targeting antibody-drug conjugate (ADC), SYS6005, in the United States and other major markets. Under the terms of the agreement, Radiance Biopharma will pay an upfront fee of $15 million, with additional development and regulatory milestone payments of up to $150 million, and sales milestone payments totaling up to $1.075 billion. Furthermore, Radiance Biopharma will pay tiered royalties based on the annual net sales of the product in the licensed territories. This collaboration marks another major milestone for CSPC in its global market expansion. SYS6005 is a monoclonal antibody-drug conjugate specifically designed to bind to the ROR1 receptor on the surface of tumor cells. Through endocytosis, the ADC delivers the potent mitotic inhibitor MMAE into cancer cells, where it releases its cytotoxic payload to effectively kill the cancer cells. This targeted design enhances therapeutic efficacy while minimizing damage to healthy tissues. SYS6005 received approval from the Chinese National Medical Products Administration (NMPA) to enter clinical trial stages by the end of 2024, with indications including hematological malignancies, ovarian cancer, non-small cell lung cancer, and other advanced malignancies. These developments highlight the broad potential application of SYS6005 in oncology. 8. Brexogen and BMI Korea Enter Technology Transfer Agreement for Exosome-Based Therapy On February 19, 2025, Brexogen, a biotechnology company specializing in exosome-based therapies, announced a technology transfer and licensing agreement with BMI Korea for its innovative injectable therapeutic, BxC-I17e. BxC-I17e, an exosome-based therapy currently undergoing clinical trials for the treatment of atopic dermatitis in the United States, is at the forefront of Brexogen’s pipeline. Under the terms of the agreement, BMI Korea gains rights to develop additional potential indications, excluding immune-related diseases, for domestic and major export markets. Financially, Brexogen will receive a non-refundable upfront payment of 30 billion KRW (approximately $23 million) and will be eligible for milestone payments tied to clinical, regulatory, and commercial achievements, alongside double-digit percentage royalties on net annual sales. Additionally, if BMI Korea enters sublicensing agreements with third parties, Brexogen will share in the resultant licensing revenues. BMI Korea, a company generating over 100 billion KRW in annual revenue, brings robust pharmaceutical manufacturing capabilities, ensuring high-quality and scalable production for BxC-I17e. BxC-I17e is a key asset in Brexogen's pipeline, leveraging the company’s proprietary exosome technology, which allows precise control over the therapeutic cargo carried by exosomes to enable targeted disease treatment. Currently undergoing Phase I clinical trials for atopic dermatitis, BxC-I17e demonstrates broad therapeutic potential. BMI Korea plans to explore its application in indications outside the immunology field, offering promising new therapeutic possibilities. At present, no exosome-based therapies have received commercial approval globally, making this collaboration a significant step forward in advancing innovation in exosome therapeutic development and setting new benchmarks within the industry. Brexogen is not only exploring dermatological treatments with BxC-I17e but has already successfully commercialized products like BREXTEM-S for skin regeneration and BREXTEM-H for hair restoration. Looking ahead, Brexogen is preparing for its anticipated 2026 IPO on KOSDAQ, which is expected to accelerate the clinical and commercial adoption of exosome-based therapies. 9. Biogen and Stoke Therapeutics Collaborate on Developing a Treatment for Dravet Syndrome On February 18, 2025, Biogen and Stoke Therapeutics announced a collaboration to develop and commercialize zorevunersen, a potentially first-in-class therapeutic for the treatment of Dravet syndrome. Dravet syndrome is a rare genetic epilepsy disorder characterized by treatment-resistant seizures and neurodevelopmental delays. Under the agreement, Stoke will continue to lead global development and retain exclusive development and commercialization rights in the U.S., Canada, and Mexico, while Biogen will have exclusive commercialization rights in other territories worldwide. The partnership leverages Biogen’s extensive expertise in neurological disorders and its global commercialization capabilities, aiming to bring new therapeutic hope to patients with Dravet syndrome. As part of this collaboration, Stoke will receive an upfront payment of $165 million, and both companies will share external clinical development costs, with Biogen contributing 30% and Stoke covering 70%. Additionally, Stoke is eligible for up to $385 million in development and commercial milestone payments. If zorevunersen achieves commercial success globally, Stoke will receive tiered royalties on net sales, ranging from low double digits to high teens. This financial structure not only provides Stoke with the necessary funding support but also lays the groundwork for subsequent research and development activities. Zorevunersen is an investigational antisense oligonucleotide (ASO) targeting the SCN1A gene, which is the root cause of most Dravet syndrome cases. The drug has been granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) based on preliminary clinical evidence suggesting it can provide significant improvements unmet by existing therapies. In Phase I/IIa and open-label extension (OLE) studies, patients treated with zorevunersen experienced a sustained reduction in the frequency of convulsive tonic-clonic seizures, as well as improvements across multiple cognitive and behavioral metrics. These findings support the potential for zorevunersen to progress to pivotal global Phase III trials, potentially becoming the first treatment to alter the course of Dravet syndrome. Currently, there are no approved disease-modifying therapies for Dravet syndrome, making the development of zorevunersen highly significant. The pivotal Phase III EMPEROR trial is expected to commence in the second quarter of 2025, with primary data readouts anticipated in the second half of 2027 to support global regulatory submissions. This progress is crucial for addressing the significant unmet medical needs of patients with Dravet syndrome and may herald a new era in the treatment of severe genetic disorders. 10. Foundation Medicine Partners with Sumitomo Pharma America to Advance Innovative Treatments for Acute Leukemia On February 18, 2025, Foundation Medicine, a genomics company dedicated to transforming cancer care, announced a collaboration with Sumitomo Pharma America (SMPA) to develop FoundationOne® Heme as a companion diagnostic tool to identify acute leukemia patients with KMT2A rearrangements or NPM1 mutations. These patients may be eligible for treatment with SMPA’s investigational menin inhibitor, enzomenib (DSP-5336). The collaboration aims to leverage advanced comprehensive genomic analysis to develop novel targeted therapies for hematologic malignancies. Acute leukemia is a condition requiring urgent intervention due to its rapid proliferation of blood cells, leading to the swift onset of symptoms. Approximately 30% of acute myeloid leukemia (AML) patients carry NPM1 mutations, while 5–10% of AML patients present with KMT2A (MLL) rearrangements. Menin inhibitors are gaining focus as a targeted therapeutic option for these specific genetic alterations. Menin plays a critical role in regulating hematopoiesis through its interaction with the KMT2A gene. The mechanism of action of menin inhibitors involves disrupting this protein-protein interaction, thereby inhibiting the proliferation of leukemia cells. Enzomenib (DSP-5336), developed by Sumitomo Pharma, is a menin inhibitor designed to treat patients with KMT2A rearrangements or NPM1 mutations in acute leukemia. The drug works by interrupting the interaction between menin and KMT2A, aiming to inhibit the growth of leukemia cells. Preclinical studies have shown promising results for this therapeutic approach in patients with the aforementioned genetic variants. This partnership is expected to drive the development of enzomenib and accelerate its clinical application. The FoundationOne® Heme platform combines DNA sequencing with RNA sequencing technologies, enabling the detection of all types of genomic alterations, including base substitutions, insertions and deletions, copy number variations, and gene fusions. This platform provides physicians with testing options for both blood and tissue samples, helping tailor personalized treatment plans based on a patient's specific genomic alterations. Read the Rest of the Series Highlights of February 2025: Biopharmaceutical Clinical-Stage Drug Investment, Financing, and Collaboration Deals (2) How to get the latest progress on drug deals? If you would like to access the latest transaction event information, you can click on the 'Deal' module from the homepage of the Synapse database. Within the Deal module, you can search for global pharmaceutical transaction information using labels such as Drugs, Organization, Target, Drug Type, Deal Date.  Furthermore, you can obtain the original link to the transaction coverage by clicking on the "Deal Name." In the analysis view, you can see the most active assignors, assignees, popular targets, and other dimensions of analysis, as well as the distribution of research and development statuses at the time of the transaction, to help you better understand the search results. The Synapse database also supports the ability to view current transactions from the dimension of "drugs" (by selecting "drugs" from the "Adjust Dimension" dropdown menu above). Targeting transactions involving renowned pharmaceutical companies that are of interest to the industry, such as Merck, Roche, etc., Synapse has identified a group of "leading companies" through drugs that have achieved global sales exceeding 1 billion US dollars in 2022. Transactions involving drugs from these leading companies can be filtered by clicking on the "Leading Company" tag on the left-hand side. In addition to the drug transaction module, you can also view related transaction history on the drug detail page and the institution detail page. Click on the image below to explore new pharmaceutical funding transactions!