Daridorexant hydrochloride

Tokyo, Japan and Cambridge, UK, 8 August 2025 – Nxera Pharma (“the Company” or “Nxera”; TSE: 4565) provides an update on operational activities and reports its consolidated results for the second quarter and first half ended 30 June 2025. The full report can be found here. Chris Cargill, President and CEO of Nxera, commented: “Nxera continued to make good progress in the first half of 2025. We are seeing increasing revenues from sales of PIVLAZ® and QUVIVIQ®, our marketed products in Japan, as well as notable progress across our partnered programs, with multiple programs advancing through clinical development and reaching important revenue-bearing milestones. This includes NBI-‘568 – being advanced by Neurocrine – which is the first candidate designed using Nxera technology to enter Phase 3 trials. Using our NxWave™ platform, these candidates are designed to address areas of significant and increasing medical need across our key therapeutic focus areas of obesity and metabolic disorders, neurology/neuropsychiatry, and immunology and inflammation. In addition, we continue to make progress advancing our inhouse pipeline of novel candidates. Moving into the second half of 2025, we anticipate further key data readouts from multiple clinical trials and with several new studies due to commence, we are well positioned to deliver significant value for patients and shareholders.” Operational Highlights for Q2 2025 Progress with marketed products in Japan The Group sells PIVLAZ® (clazosentan sodium 150mg) for the prevention of cerebral vasospasm in Japan using its in-house salesforce. PIVLAZ® revenue increased from JPY 5,393 million to JPY 5,805 million (up by 7.6% vs the prior corresponding period)The Group earns royalty revenue on sales of QUVIVIQ® (daridorexant 25 and 50 mg) by Shionogi & Co., Ltd. (“Shionogi”), as well as revenue on the supply of QUVIVIQ® to Shionogi. This amounted to JPY 1,586 million for the first half 2025. As sales of QUVIVIQ® began in the fourth quarter of the prior year, there were no sales for the prior corresponding period Progress with partnered programs Neurocrine Biosciences dosed the first patient in its Phase 3 registrational program of NBI-1117568 (NBI-‘568), resulting in a payment of US$15 million to the Company NBI-‘568 is an oral, selective muscarinic M4 receptor agonistThe Phase 3 study is a global double-blind, placebo-controlled trial evaluating NBI-’568 in adults with a primary diagnosis of schizophrenia who are experiencing an acute exacerbation or relapse of symptomsThe study is expected to enroll approximately 280 patients. The primary endpoint of the study is a reduction from baseline in the Positive and Negative Syndrome Scale (PANSS) The key secondary endpoint is improvement in the Clinical Global Impression of Severity (CGI-S) scale Development milestone achieved under the multi-target collaboration and license agreement with Eli Lilly and Company targeting diabetes and metabolic diseases, resulting in a payment to the Company US$4.8 million milestone payment received from Centessa Pharmaceuticals (UK) Limited (“Centessa”) as a result of Centessa initiating clinical development of ORX142 ORX142 is Centessa’s second investigational, novel, highly potent and selective OX2R agonist discovered using Nxera technology and being developed for the treatment of select neurological and neurodegenerative disordersThe milestones were achieved as Centessa first received clearance of an Investigational New Drug (IND) application by the US Food and Drug Administration (FDA) for a Phase 1 clinical study of ORX142 in healthy volunteers and second, with the initiation of the studyThe payment receipt was fully recognized as revenue in the second quarter of 2025 Post-period events Nxera launched a broad proprietary pipeline targeting obesity and chronic weight management Independent of our productive drug discovery collaborations with Pfizer and Eli Lilly, Nxera has established, expanded and accelerated drug discovery efforts of its own proprietary pipeline across a broad range of validated GPCR targets in obesity and associated metabolic disordersCentral to this pipeline is Nxera’s new, wholly-owned oral small molecule GLP-1 agonist program, focused on differentiated chemistry, which is distinct, independent and developed separately from Pfizer’s PF-06954522, allowing Nxera full control to drive rapid progressComplementing this program, Nxera is simultaneously accelerating the advancement of an additional six established GPCR-targeted programs focused on obesity and chronic weight managementPfizer discontinued development of its Phase 1 candidate PF-06954522 (a small molecule GLP-1 agonist, which was discovered under a strategic drug discovery collaboration with Nxera) due to a portfolio decision by Pfizer Financial Highlights for the Six-month Period ended 30 June 2025 Revenue totalled JPY 15,094 million (US$101.6 million*), an increase of JPY 2,374 million (US$18.0 million) vs. the prior corresponding period. This increase was primarily due to the inclusion of sales of QUVIVIQ® following its launch in the fourth quarter of 2024. R&D expenses totalled JPY 7,474 million (US$50.3 million), an increase of JPY 1,987 million (US$14.2 million) vs. the prior corresponding period. This increase primarily reflects an increased investment in R&D and the impact of the weaker Yen.SG&A expenses totalled JPY 7,566 million (US$51.0 million), a decrease of JPY 456 million (US$1.8 million) vs. the prior corresponding period. This decrease was primarily due to lower selling related costs as a result of targeted cost savings, partially offset by incremental spend on personnel to strengthen organizational capabilities.Operating loss totalled JPY 2,756 million (US$18.5 million) vs. an operating loss of JPY 3,654 million (US$24.0 million) in the prior corresponding period. This change in profitability reflects the combined effect of all movements explained above.Loss before income tax totalled JPY 3,722 million (US$25.1 million) vs. a loss before income tax of JPY 3,158 million (US$20.8 million) in the prior corresponding period.Net loss totalled JPY 3,137 million (US$21.1 million) vs. a net loss of JPY 4,703 million (US$30.9 million) in the prior corresponding period.Core operating profit** totalled JPY 364 million (US$2.5 million) vs. a core operating profit of JPY 1,176 million (US$7.7 million) in the prior corresponding period. Cash and cash equivalents as at 30 June 2025 amounted to JPY 32,997 million (US$228.1 million) having increased by JPY 729 million (US$22.3 million) from the beginning of the year. *Convenience conversion to US$ at the following rates: FY 2025: 1US$ =148.56 JPY; FY 2024: 1US$ =152.12 JPY; 30 Jun 2025: 1US$ = 144.66 JPY; 31 Dec 2024: 1US$ = 156.83 JPY ** Core operating profit / loss is an alternative performance measure which adjusts for material non-cash costs and one-off costs in order to provide insights into the recurring cash generation capability of the core business. –END– About Nxera PharmaNxera Pharma is a technology powered biopharma company, in pursuit of new specialty medicines to improve the lives of patients with unmet needs in Japan and globally. We have built an agile, new-generation commercial business in Japan to develop and commercialize innovative medicines, including several launched products, to address this high value, large and growing market and those in the broader APAC region. Behind that, and powered by our unique NxWave™ discovery platform, we are advancing an extensive pipeline of over 30 active programs from discovery through to late clinical stage internally and in partnership with leading pharma and biotech companies. This pipeline of potentially first- and best-in-class candidates is focused on addressing major unmet needs in some of the fastest-growing areas of medicine across obesity and metabolic disorders, neurology/neuropsychiatry and immunology and inflammation. Nxera employs approximately 400 talented people at key locations in Tokyo and Osaka (Japan), London and Cambridge (UK), Basel (Switzerland) and Seoul (South Korea) and is listed on the Tokyo Stock Exchange (ticker: 4565). For more information, please visit www.nxera.life LinkedIn: @NxeraPharma | X: @NxeraPharma | YouTube: @NxeraPharma Enquiries: Nxera – Media and Investor RelationsShinya Tsuzuki, VP, Head of Investor RelationsShinichiro Nishishita, VP Investor Relations, Head of Regulatory DisclosuresMaya Bennison, Communications Manager+81 (0)3 5210 3399 | +44 (0)1223 949390 |IR@Nxera.life MEDiSTRAVA (for International Media)Mark Swallow, Frazer Hall, Erica Hollingsworth+44 (0)203 928 6900 | Nxera@medistrava.com Forward-looking statementsThis press release contains forward-looking statements, including statements about the discovery, development, and commercialization of products. Various risks may cause Nxera Pharma Group’s actual results to differ materially from those expressed or implied by the forward looking statements, including: adverse results in clinical development programs; failure to obtain patent protection for inventions; commercial limitations imposed by patents owned or controlled by third parties; dependence upon strategic alliance partners to develop and commercialize products and services; difficulties or delays in obtaining regulatory approvals to market products and services resulting from development efforts; the requirement for substantial funding to conduct research and development and to expand commercialization activities; and product initiatives by competitors. As a result of these factors, prospective investors are cautioned not to rely on any forward-looking statements. We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. Attachment Nxera Pharma FY25Q2 E_Tanshin

Ad hoc announcement pursuant to Art. 53 LR QUVIVIQ™ (daridorexant): Strong performance and sales acceleration with total net sales of CHF 58 million in H1 2025 and increase of 145% compared to the same period in 2024, largely driven by sales in Europe. NDA approval with Simcere in China. Aprocitentan (TRYVIO/JERAYGO) commercial opportunity significantly improved with REMS removal and very positive real-world experience – engaging in partnership discussions. Net revenue H1 2025 of CHF 131 million – boosted by the CHF 32 million exclusivity fee and CHF 40 million milestone from Simcere recognized in H1 2025. US GAAP operating income H1 2025 of CHF 64 million and non-GAAP operating loss of CHF 15 m. Cash runway extended to the end of 2026 – on track to reach commercial profitability goal in 2026 and overall profitability starting from the end of 2027. Allschwil, Switzerland – July 30, 2025Idorsia Ltd (SIX: IDIA) today published its Financial Report for the first half of 2025. The results confirm that the commercial acceleration of QUVIVIQ coupled with the financial discipline implemented over the past 12 months have successfully delivered an operational turn-around. The company is on track to reach its target of overall profitability starting from the end of 2027. Srishti Gupta, MD, Chief Executive Officer of Idorsia, commented: “The commercial acceleration of QUVIVIQ, combined with our financial discipline, has put Idorsia on track to reach overall profitability starting from the end of 2027. We are advancing the assets in our pipeline that we believe will bring the greatest value to the company and patients. And by using ‘lead where we can and partner where we should’ as our guiding light, we intend to expand our strategic partnerships, starting with TRYVIO.” Srishti continued:“The removal of the REMS in the US, excellent feedback from early prescribers, and our market preparation work, have significantly improved the commercial opportunity and is making a great basis to engage in the partnership process. Hypertension experts at major centers of excellence confirm positive patient experiences and efficacy and safety consistent with our pivotal clinical trial. This includes the unique ability of TRYVIO to treat hypertensive patients with chronic kidney disease, a condition that is very common in millions of patients with difficult to control hypertension, and who are often underserved with the current guideline directed therapies.” Arno Groenewoud, Chief Financial Officer, commented: “The excellent performance from QUVIVIQ, particularly in Europe, puts us on-track to reach our improved financial guidance provided in May 2025 and overall profitability starting from the end of 2027. With the newly secured CHF 150 million facility and an updated collaboration with Simcere, bringing an additional CHF 40 million in milestone payments, we have significantly strengthened our financial position and extended our cash runway through the end of 2026. We are currently carefully looking at all options to fund Idorsia to overall profitability starting from the end of 2027.” Commercial operationsIn the first half of 2025, QUVIVIQ™ (daridorexant) in the US, Germany, Italy, Switzerland, Spain, UK, Canada, Austria, France, Sweden, and Finland generated total product sales of CHF 56 million, over 140% increase compared to the same period in 2024. Europe and CanadaQUVIVIQ (daridorexant) net sales in the first half of 2025 reached CHF 44 million in the Europe and Canada (EUCAN) region, an almost 4 times increase from CHF 9 million in the first half of 2024. QUVIVIQ is the only long-term pharmacological treatment for insomnia in Europe and is on-track to become the standard of care. This is reflected by the performance and the extremely positive feedback from both healthcare professionals and patients. The keys to success are to secure public reimbursement, focused promotional efforts to specialist prescribers, and expansion to primary care through co-promotion partnerships and omnichannel initiatives. 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 StatesQUVIVIQ® (daridorexant) net sales in the first half of 2025 amounted to CHF 11.9 million in the US, compared to CHF 14.2 million in the first half of 2024, with a meaningful improvement in gross margin, driven by greater proportion of payer-paid prescriptions. At the beginning of 2025, the company 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. 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. 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. 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 has completed a portfolio prioritization to advance four investigational clinical assets with the potential to transform treatment paradigms. Lucerastat: Idorsia has conducted a kidney biopsy sub-study belonging to the ongoing open-label extension (OLE) of the Phase 3 study. This sub-study enrolled male participants with classic Fabry disease who had been treated for more than 3 years with lucerastat monotherapy. The main objective of the sub-study was to evaluate the number of globotriaosylceramide (Gb3) inclusions in certain type of kidney cells using established methods of quantification. In parallel, a new interim analysis of the ongoing OLE of the Phase 3 study where ongoing participants had received lucerastat for at least 42 months was performed. The analysis corroborated the long-term effect on plasma Gb3 levels and a potential positive long-term effect on kidney function. It also confirmed the safety and tolerability profile observed during the 6-month randomized treatment period. The results of both the interim analysis and kidney biopsy sub-study are supportive of further investigation for patients with Fabry disease. The company is in ongoing discussions with the US FDA to agree on the optimal regulatory pathway to approval. Daridorexant: Idorsia is conducting a Phase 2 dose-finding study to assess the efficacy, safety, and pharmacokinetics of multiple-dose oral administration of daridorexant in pediatric patients aged 10 to <18 years with insomnia disorder (NCT05423717). The primary objective of the study is to characterize the dose-response relationship of daridorexant on objective total sleep time (TST), using polysomnography. Patients will be randomized in a 1:1:1:1 ratio to 10 mg, 25 mg, or 50 mg daridorexant, or placebo and treated for 2 weeks. The study is expected to complete enrollment by the end of 2025 with readout expected around mid-2026. The study is part of a US FDA-approved Pediatric Study Plan and an EU PDCO-approved Paediatric Investigation Plan. Idorsia will also advance three first-in-class chemokine receptor antagonists into studies which will each be proof-of-concept in the specific indication under investigation as well as proof-of-mechanism for a range of disorders where the pathways can be applied. Key development assets Further details including the current status of each project in our portfolio can be found in our innovation fact sheet. Vaccine platform: On June 30, 2025, Idorsia announced a milestone in the development of a bacterial vaccine based on the company’s synthetic glycan chemistry platform. Initial data from healthy participants showed that the vaccine, which has the potential to be the first-ever directed against Clostridioides difficile (C. difficile) bacteria and spores, is well-tolerated, and induces positive antigen titers in humans that recognize the bacteria. Idorsia will now activate partnering discussions to advance as fast as possible the development of the C. difficile vaccine and the advancement of the technology platform. Financial results Net revenue of CHF 131 million in H1 2025 resulted from QUVIVIQ product sales (CHF 56 million), product sales to partners (CHF 2 million), and contract revenues (CHF 73 million). This compares to net revenue of CHF 26 million in H1 2024 as a result of QUVIVIQ product sales (CHF 23) and contract revenue (CHF 3 million). US GAAP operating expenses of CHF 75 million in H1 2025 and CHF 94 million in H1 2024 were impacted by a one-off gain of CHF 90 million (Viatris deal amendment) in 2025 and CHF 125 million (Viatris deal) in 2024, respectively. Excluding these one-off gains, US GAAP operating expenses at H1 2025 decreased by CHF 54 million, mainly driven by R&D expenses of CHF 50 million decreasing by CHF 21 million compared to H1 2024 (CHF 71 million), and SG&A expenses of CHF 103 million decreasing by CHF 39 million compared to H1 2024 (CHF 142 million). US GAAP net income in H1 2025 amounted to CHF 52 million (CHF 38 million net loss excluding Viatris deal amendment) and CHF 79 million (net loss) in H1 2024 (CHF 204 million net loss excluding Viatris deal). Excluding these one-offs, the reduced net loss in H1 2025 was primarily driven by revenue growth and lower operating expenses resulting from rightsizing efforts initiated at the end of 2024. The US GAAP net income resulted in a basic net income per share of CHF 0.26 (diluted net income per share of CHF 0.26) in H1 2025, compared to a basic net loss per share of CHF 0.44 (diluted net loss per share of CHF 0.44) in H1 2024. * 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 H1 2025 amounted to CHF 25 million; the difference versus US GAAP net income was mainly driven by the one-off gain from the amendment of the Viatris Deal (CHF 90 million). The non-GAAP net loss resulted in a net loss per share of CHF 0.13 (basic and diluted) in H1 2025, compared to a net loss per share of CHF 1.02 (basic and diluted) in H1 2024. Repurchase OfferOn June 25, 2025, Idorsia announced the launch of the repurchase offer to the holders of its outstanding CHF 200 million convertible bonds maturing in 2025 (CB 2025; ISIN CH0426820350), and CHF 600 million convertible bonds maturing in 2028 (CB 2028; ISIN CH1128004079). The main offer period of the Repurchase Offer started on July 10, 2025, and is expected to end at 17:30 hrs CEST on August 7, 2025. More information can be found in the dedicated press release. New money facilityA new money facility for a net amount of CHF 150 million has been signed and the company drew down the first tranche of CHF 70 million on June 2, 2025. This new money facility has a maturity of 24 months and is fully backstopped by a bondholder group. More information can be found in the dedicated press release. Liquidity and indebtednessAt the end of the first half of 2025, Idorsia’s liquidity amounted to CHF 72 million. *rounding differences may occur Liquidity at the end of the first half of 2025 does not include the CHF 40 million milestone recognized in the second quarter from Simcere, following the amendment of the licensing agreement and the approval of QUVIVIQ in China, and the remaining CHF 80 million available under the new money facility. 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 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 165 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 55 million. All amounts exclude unforeseen events and potential revenue related to additional business development activities. 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 9-Month 2025 Financial Results reporting on October 30, 2025 Full-Year 2025 Financial Results reporting on February 26, 2026 Notes to the editor About IdorsiaThe 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 “intend”, "estimates", "believes", "expects", "may", "are expected to", "will", "will continue", "should", "would be", "seeks", "pending" or "anticipates" or similar expressions, or by discussions of strategy, plans or intentions. Such statements include descriptions of the company's investment and research and development programs, business development activities and anticipated expenditures in connection therewith, descriptions of new products expected to be introduced by the company and anticipated customer demand for such products and products in the company's existing portfolio. Such statements reflect the current views of the company with respect to future events and are subject to certain risks, uncertainties and assumptions. Many factors could cause the actual results, performance or achievements of the company to be materially different from any future results, performances or achievements that may be expressed or implied by such forward-looking statements. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or expected. Attachment Press Release PDF Press Release PDF