Daridorexant hydrochloride

Tokyo, Japan and Cambridge, UK, 31 October 2025 – Nxera Pharma (“the Company” or “Nxera”; TSE: 4565) provides an update on operational activities and reports its consolidated results for the third quarter and nine months ended 30 September 2025. The full report can be found here. Chris Cargill, President and CEO of Nxera, commented: “During the third quarter of 2025, we made strong progress in advancing our plans for obesity and metabolic diseases, an area of strategic focus where we see exceptional opportunity and have observed significant patient need. Our newly launched proprietary pipeline, led by our differentiated oral GLP-1 agonist and including multiple complementary GPCR-targeted programs, positions Nxera to play a leading role in shaping the next generation of metabolic therapies. “Meanwhile, our partnered programs continue to advance successfully with multiple milestones achieved across ongoing collaborations, notably with Centessa and its portfolio of orexin agonists, where there is growing industry interest in the orexin mechanism as a promising basis for novel therapies for sleep-wake disorders and other neurological conditions. These candidates were discovered using NxWave™ technology, reflecting the strength and versatility of our platform to generate novel molecules with potential to make meaningful therapeutic advances for patients. We also achieved a second important R&D milestone under our multi-target discovery collaboration with AbbVie focused on neurological diseases, resulting in a payment of US$10 million to Nxera. With this progress and a robust pipeline of data and milestones ahead, we are well positioned to close the year with strong momentum.” Operational Highlights for Q3 2025 Launch of proprietary pipeline targeting obesity and chronic weight management, led by an oral small molecule GLP-1 agonist and six additional GPCR-targeted programs Programs leverage Nxera’s NxWave™ structure-based design platform to advance differentiated small molecules aimed at optimizing metabolic efficacy, sustaining weight reduction, and preserving lean mass. First patient dosed in Phase 2a trial of investigational cancer immunotherapy HTL0039732 HTL0039732 (also known as NXE0039732) is Nxera’s novel oral EP4 antagonist being investigated to treat a wide range of solid cancers in combination with other immunotherapiesCancer Research UK’s Centre for Drug Development is sponsoring and managing the ongoing trial Second R&D milestone reached under Nxera’s multi-target discovery collaboration with AbbVie, resulting in a payment of US$10 million to the Company Collaboration aims to leverage Nxera’s NxWave™ platform to discover, develop and commercialize new medicines targeting novel GPCR targets associated with neurological disease Post-period events Nxera’s partner Cancer Research UK presented data from the successfully completed Phase 1 clinical trial of HTL’732 at the European Society for Medical Oncology Congress (ESMO) 2025 HTL’732 was well-tolerated, confirmed target engagement and demonstrated encouraging early efficacy in two distinct tumor types when administered in combination with atezolizumabThe Phase 1 trial met the key objectives and identified a dose for the Phase 2 expansion trial which is now underway Manufacturing approval partial amendment from Japan’s Ministry of Health, Labour and Welfare for an additional manufacturing site in Asia for QUVIVIQ 25 and 50mg Expected to improve profitability through manufacturing cost reductions to advance toward 2030 vision Financial Highlights for the Nine-month Period ended 30 September 2025 Revenue totalled JPY 21,848 million (US$147.4 million*), a decrease of JPY 135 million (an increase of US$2.0 million) vs. the prior corresponding period. The decrease was due to the smaller size of individual milestone receipts compared to the prior corresponding period, despite there being more milestone events: there were six milestone events in the period under review vs. five milestone events in the prior corresponding period. This reduction is partially offset by the inclusion of sales of QUVIVIQ® following its launch in the fourth quarter of 2024. R&D expenses totalled JPY 11,200 million (US$75.6 million), an increase of JPY 2,683 million (US$19.2 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 11,410 million (US$77.0 million), a decrease of JPY 307 million (US$0.5 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 5,907 million (US$39.9 million) vs. an operating loss of JPY 2,846 million (US$18.8 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 6,838 million (US$46.1 million) vs. a loss before income tax of JPY 2,293 million (US$15.2 million) in the prior corresponding period.Net loss totalled JPY 4,809 million (US$32.5 million) vs. a net loss of JPY 3,503 million (US$23.2 million) in the prior corresponding period.Core operating loss** totalled JPY 986 million (US$6.6 million) vs. a core operating profit of JPY 4,425 million (US$29.3 million) in the prior corresponding period. Cash and cash equivalents as at 30 September 2025 amounted to JPY 28,461 million (US$191.5 million) having decreased by JPY 3,807 million (US$14.3 million) from the beginning of the year. *Convenience conversion to US$ at the following rates: FY 2025: 1US$ =148.18 JPY; FY 2024: 1US$ =151.14 JPY; 30 Sep 2025: 1US$ = 148.60 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 _ FY25Q3_Tanshin

Ad hoc announcement pursuant to Art. 53 LR QUVIVIQ (daridorexant) global net sales (excluding sales to partners) increased by >130% year-on-year to CHF 91 million in 9M 2025 – continuing Idorsia’s trajectory towards profitabilityAprocitentan (TRYVIO/JERAYGO) the first and only dual ERA indicated for systemic hypertension and the only new medicine to be included in the ACC/AHA Hypertension Management guidelinesOperating cash runway extended beyond profitability into 2028 following CHF 65.6 million financing with oversubscribed demand from top-tier US and European institutional investors Allschwil, Switzerland – October 30, 2025Idorsia Ltd (SIX: IDIA), announces 9-month 2025 financial results. Outstanding sales performance of QUVIVIQ coupled with significantly lower operating expenses keeps Idorsia on-track to achieve overall profitability by the end of 2027. Srishti Gupta, MD, Chief Executive Officer of Idorsia, commented: “I focused my first 100+ days on supporting the commercial teams to drive QUVIVIQ’s growth, progressing discussions to bring TRYVIO to market, prioritizing and advancing our pipeline assets in a financially disciplined manner, and securing our financial situation. I’m very happy to report that we progressed on all fronts. Increased QUVIVIQ sales, coupled with the decrease in OPEX, are keeping us on track to profitability. The team has done an outstanding job, successfully delivering a financial turnaround in a very short time span. I want to extend my gratitude to the investors who participated in our financing round; we have been very encouraged by the strong support of our long-term shareholders.” Recent Business HighlightsCommercial portfolio QUVIVIQ® (daridorexant) Idorsia reaffirms its QUVIVIQ 2025 sales guidance of around CHF 130 million in net sales.Global net sales – excluding sales to partners (CHF 3 million) – for 9M 2025 of CHF 91 million, reflecting outstanding year-over-year performance. In Europe, where QUVIVIQ is the only long-term pharmacological treatment for insomnia and on-track to become the standard of care, 9M sales reached CHF 73 million thanks to strong performance, particularly in France, the United Kingdom, Germany and Switzerland.Global expansion of QUVIVIQ continues as Simcere launches in China opening a royalty stream to Idorsia. QUVIVIQ is now available in 13 countries across Europe, North America and Japan.New real-world evidence presented at World Sleep 2025 underscores QUVIVIQ’s sustained safety and efficacy, and use in the treatment of insomnia for patients with neurological and psychiatric comorbidities. TRYVIO™ / JERAYGO™ (aprocitentan) TRYVIO is the first systemic hypertension therapy to target a new pathway in over 30 years and is the only new medicine featured in the ACC/AHA Guidelines for Hypertension Management in the United States. Real-world prescriber feedback confirms PRECISION-like double-digit BP reductions and good tolerability across patient groups.Clinicians are particularly embracing TRYVIO for patients with uncontrolled hypertension and comorbid chronic kidney disease (CKD), where data suggest the potential for renal protective benefit in addition to blood pressure lowering – without risk of hyperkalemia or aggravation of renal function.Active partnership discussions are ongoing to maximize the therapeutic and commercial impact of aprocitentan. Research & Development Daridorexant: Pediatric study, including patients with autism and/or attention-deficit hyperactivity disorder (ADHD), is on track to complete recruitment by year-end, with results expected in Q2 2026.Lucerastat: Data from the Phase 3 open-label extension study in Fabry disease, where patients have been treated for at least 42 months, corroborated the positive long-term effects on plasma Gb3 levels and potentially on kidney function, as well as the safety and tolerability profile observed in MODIFY. These findings together with a kidney biopsy substudy are informing the design of a new Phase 3 program being reviewed with authorities.Chemokine programs: Three first-in-class chemokine receptor antagonists are progressing to proof-of-concept studies in the specific indication under investigation as well as proof-of-mechanism for a range of disorders where the pathways can be applied. IDOR-1117-2520 is an oral first-in-class, selective CCR6 antagonist being investigated for the treatment of Th17-driven immuno-dermatology and autoimmune disorders. A study in patients with psoriasis will begin in Q4 2025.ACT-1004-1239 is a first-in-class, oral, brain-penetrating drug with potential to transform the treatment paradigm in MS by inducing remyelination and reducing neuroinflammation. A study in patients with progressive MS is expected to begin in Q1 2026.ACT-777991 is a first-in-class, oral antagonist of the chemokine receptor CXCR3. CXCR3 is primarily implicated in the migration of CD8+ T cells, responsible for targeting and destroying melanocytes. A study in patients with vitiligo is expected to begin in 2026. Synthetic glycan vaccine platform: Initial data showed that the C. difficile vaccine is well-tolerated and showed immunogenicity in a Phase 1 study. The vaccine has advanced to a higher-dose cohort, with top-line results anticipated in mid-2026. Partnership discussions have been activated to accelerate the development of this vaccine. Financial results Idorsia reiterates its 2025 full-year financial guidance and remains focused on reaching profitability by the end of 2027.October 2025 CHF 65.6M financing extends cash runway into 2028, subject to refinancing of the new money facility.9-month financials reflect continued improvement in sales performance and disciplined control of R&D and SG&A expenses. US GAAP resultsNine MonthsThird Quarterin CHF millions, except EPS (CHF) and number of shares (millions)2025202420252024Net revenue173534126Operating expenses(162)(211)(87)(118)Operating income (loss)23(154)(41)(90)Net income (loss)(34)(180)(86)(101)Basic EPS(0.17)(1.00)(0.40)(0.55)Basic weighted average number of shares203.4180.5214.5182.4Diluted EPS(0.17)(1.00)(0.40)(0.55)Diluted weighted average number of shares203.4180.5214.5182.4 Net revenue of CHF 173 million in the first nine months of 2025 resulted from product sales (CHF 92 million), product sales to partners (CHF 3 million), and contract revenues (CHF 78 million). This compares to net revenue of CHF 53 million in the first nine months of 2024 as a result of QUVIVIQ product sales (CHF 49 million) and contract revenue (CHF 4 million). US GAAP operating expenses of CHF 162 million in the first nine months of 2025 and CHF 211 million in the first nine months of 2024 were impacted by a one-off gain of CHF 90 million (Viatris deal amendment) in 2025 and CHF 125 million (Viatris deal) in 2024, respectively. Excluding these one-off gains, US GAAP operating expenses for the first nine months of 2025 decreased by CHF 84 million, mainly driven by R&D expenses of CHF 75 million decreasing by CHF 36 million compared to the first nine months of 2024 (CHF 111 million), and SG&A expenses of CHF 163 million decreasing by CHF 46 million compared to the first nine months of 2024 (CHF 209 million). US GAAP net loss in the first nine months of 2025 amounted to CHF 34 million (CHF 124 million net loss excluding Viatris deal amendment) and CHF 79 million (net loss) in the first nine months of 2024 (CHF 204 million net loss excluding Viatris deal). Excluding these one-offs, the reduced net loss in the first nine months of 2025 was primarily driven by revenue growth and lower operating expenses as a result of an operational restructuring initiated in Q4 2024. The US GAAP net loss resulted in a net loss per share of CHF 0.17 (basic and diluted) in the first nine months of 2025, compared to a net loss per share of CHF 1.00 (basic and diluted) in the first nine months of 2024. Non-GAAP* measuresNine MonthsThird Quarterin CHF millions, except EPS (CHF) and number of shares (millions)2025202420252024Net revenue167533726Operating expenses(232)(305)(80)(106)Operating income (loss)(53)(248)(38)(78)Net income (loss)(65)(258)(40)(75)Basic and diluted EPS(0.32)(1.43)(0.19)(0.41)Basic and diluted weighted average number of shares203.4180.5214.5182.4 * 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 the first nine months of 2025 amounted to CHF 65 million; the difference versus US GAAP net income was mainly driven by the one-off gain from the amendment of the Viatris deal (CHF 90 million), depreciation and amortization (CHF 13 million), accretion expenses (CHF 10 million) and a debt extinguishment loss related to the debt restructuring (CHF 37 million). The non-GAAP net loss resulted in a net loss per share of CHF 0.29 (basic and diluted) in the first nine months of 2025, compared to a net loss per share of CHF 1.43 (basic and diluted) in the first nine months of 2024. Liquidity and indebtednessLiquidity on September 30, 2025, amounted to CHF 64 million. This amount does not include the remaining CHF 80 million available under the new money facility (term loan) and the net proceeds of CHF 63 million from the offering of new shares successfully completed on October 10, 2025. (in CHF millions)Sep 30, 2025Jun 30, 2025Dec 31, 2024Liquidity Cash and cash equivalents6472106Total liquidity*6472106 Indebtedness Convertible loan335335335Convertible bond49798797Debt notes**753--Term loan1349-Other financial debt186189189Total indebtedness1,3361,3701,321 *rounding differences may occur ** The debt notes issued by Idorsia Investments SARL in exchange for convertible bonds are senior secured with the shares in Idorsia Investments SARL. The A Notes only benefit from a limited and subordinated Swiss-law governed guarantee by Idorsia Ltd. Financial guidance for 2025As previously announced, for the Idorsia-led portfolio in 2025, the company expects a continued growth 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 operating 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 Jefferies Global Healthcare Conference in London on November 17-20, 2025Evercore Annual Healthcare Conference in Miami on December 2, 2025 Follow the fireside chat with CEO, Srishti Gupta, at 3pm ET on Dec 2 here Citi's Global Healthcare Conference in Miami on December 3, 2025J.P. Morgan Annual Healthcare Conference in San Francisco, January 12-15, 2026Full-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 contactGeorge ThampySenior Vice President, Head of Investor 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 “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. 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