Latest news with #QUVIVIQ™
Yahoo
4 days ago
- Business
- Yahoo
Idorsia publishes invitations to bondholder meetings
Ad hoc announcement pursuant to Art. 53 LR Bondholder meetings will take place on Wednesday, June 25, 2025, to vote on proposals to amend the terms of the two outstanding convertible bonds CB 2025 and CB 2028 Allschwil, Switzerland – June 6, 2025Idorsia Ltd (SIX: IDIA) today announced that following the expiry of the appeal period for the amended terms approved at the CB 2025 bondholder meeting of February 25, 2025 – during which no appeal was filed – it has published invitations to the next bondholder meetings for 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). At the meetings, the company will propose changing the current terms of the CB 2025 and CB 2028 as part of the larger holistic restructuring, as announced in a press release on February 26, 2025, and an update published on May 21, 2025. To date, approximately 87% of the holders of the CB 2025 and 90% of holders of the CB 2028 have entered a legally binding lockup agreement in support of the holistic restructuring. Such bondholders have committed to vote in favour of the proposed amendments to the terms of the CB 2025 and CB 2028 at or before the meeting. The amendment of the terms of the CB 2025 and CB 2028 will be conditional on the consummation of the exchange offer, which is expected to be launched around or following the date of the bondholder meetings. Bondholders can access the invitations to the two bondholder meetings scheduled for Wednesday, June 25, 2025, including the terms of the resolution and additional information about the meeting, as well as a financial status report as of April 30, 2025, at the following links: and 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 contact:Investor & Media RelationsIdorsia Pharmaceuticals Ltd, Hegenheimermattweg 91, CH-4123 Allschwil+41 58 844 10 – – 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
Yahoo
04-03-2025
- Business
- Yahoo
Idorsia announces financial results for 2024
Ad hoc announcement pursuant to Art. 53 LR Allschwil, Switzerland – March 4, 2025Idorsia Ltd (SIX: IDIA) today announced its financial results for 2024. Business highlights 2024 Viatris collaboration: Global research and development collaboration, focused on the development and commercialization of selatogrel and cenerimod entered in March 2024. QUVIVIQ™ (daridorexant): Outstanding launch dynamic in France, and a strong performance in Germany accelerate sales in 2024 – Total Idorsia-led net sales of CHF 61 million in 2024. TRYVIO™ (aprocitentan): Commercially available in the US since October 2024. JERAYGO™ (aprocitentan): Approved in European Union in June 2024 and the UK in January 2025 – marketing authorization application under review in Switzerland and Canada. Subsequent events Restructured convertible bond debt: Tailored approach to remove large debt overhang. New funding: Bondholders to provide CHF 150 million new money facility. Viatris collaboration: Updated agreement removes significant cash requirement for 2025 Financial highlights Net revenue FY 2024 at CHF 113 million. US GAAP operating expenses FY 2024 at CHF 351 million – benefiting from one-off income of CHF 125 million from the Viatris deal – and non-GAAP operating expenses FY 2024 at CHF 427 million. US GAAP operating loss FY 2024 of CHF 232 million and non-GAAP operating loss of CHF 308 million. Guidance for 2025 unforeseen events excluded QUVIVIQ net sales of around CHF 110 million. SG&A expenses of around CHF 210 million, R&D expense of around CHF 100 million, leading to non-GAAP operating expenses of around CHF 325 million. US GAAP loss for global business of around CHF 155 million. André C. Muller, Chief Executive Officer of Idorsia, commented:'We were not able to close the envisaged out-licensing agreement for aprocitentan, but we will now pivot to potential alternative partners. Despite this unexpected setback, we were able to agree a holistic restructuring of our convertible bond debt and secure additional funding for future operations. With so much attention going to the financial situation of the company during the past six months, it's easy to lose sight of how well the company was performing in other areas. We exceeded our sales target for QUVIVIQ, with a particularly strong performance in France and Germany. Our next potential blockbuster, TRYVIO, was made available for prescription in the US, approved as JERAYGO in the EU and UK, and submitted for review in Switzerland and Canada. We closed a great deal with Viatris for our Phase 3 assets, selatogrel and cenerimod, and we have advanced our early-stage pipeline of potentially first- or best-in-class discoveries. With commercial profitability forecast in 2026, and overall profitability forecast for 2027, we have a lot to be excited about.'Financial results US GAAP results Full Year Fourth Quarter in CHF millions, except EPS (CHF) and number of shares (millions) 2024 2023 2024 2023 Net revenue 113 152 60 22 Operating expenses (351) (409) (140) (134) Operating loss (232) (255) (78) (111) Net loss (264) (298) (84) (117) Basic and diluted EPS (1.45) (1.67) (0.45) (0.65) Basic and diluted weighted average number of shares 182.4 178.2 188.3 178.6 Net revenue of CHF 113 million in 2024 is the result of QUVIVIQ product sales (CHF 61 million), product sales to partners (CHF 47 million), and contract revenues (CHF 5 million). This compares to net revenue of CHF 152 million in 2023, which included CHF 107 million one-off incomes (mainly PIVLAZ sales in Japan and the APAC (ex-China) Nxera deal). Other revenues in 2023 consisted of QUVIVIQ product sales (CHF 31 million), and other contract revenue of CHF 15 million. US GAAP operating expenses in 2024 (CHF 351 million) and 2023 (CHF 409 million) were impacted by one-off incomes of CHF 125 million (Viatris deal) and CHF 298 million (Nxera deal) respectively. Excluding these one-off incomes, US GAAP operating expenses in 2024 amounted to CHF 476 million, decreasing by CHF 231 million compared to 2023 (CHF 707 million), mainly driven by R&D expenses of CHF 144 million decreasing by CHF 150 million compared to 2023 (CHF 294 million), and SG&A expenses of CHF 273 million decreasing by CHF 120 million compared to 2023 (CHF 392 million). US GAAP net loss in 2024 amounted to CHF 264 million (CHF 298 million in 2023). The net loss was favorably impacted by the one-off income related to the Viatris deal (Nxera deal in 2023) and lower operating expenses throughout all functions. The reduction in operating expenses is mainly a result of the restructuring initiative from 2023 which became fully cost effective in 2024 and the Viatris Deal, which relieved the group from Phase 3 development costs related to selatogrel and cenerimod. The US GAAP net loss resulted in a basic net loss per share of CHF 1.45 (basic and diluted) in 2024, compared to a net loss per share of CHF 1.67 (basic and diluted) in 2023. Non-GAAP* measures Full Year Fourth Quarter in CHF millions, except EPS (CHF) and number of shares (millions) 2024 2023 2024 2023 Net revenues 113 152 60 22 Operating expenses (427) (654) (121) (137) Operating loss (308) (501) (60) (115) Net loss (330) (542) (73) (121) Basic and diluted EPS (1.81) (3.04) (0.39) (0.68) Basic and diluted weighted average number of shares 182.4 178.2 188.3 178.6 * Idorsia measures, reports, and issues guidance on non-GAAP operating performance. Idorsia believes that these non-GAAP financial measurements more accurately reflect the underlying business performance and therefore provide useful supplementary information to investors. These non-GAAP measures are reported in addition to, not as a substitute for, US GAAP financial performance. Non-GAAP net loss in 2024 amounted to CHF 330 million; the difference versus US GAAP net loss was mainly driven by a net gain from the Viatris Deal (CHF 125 million). The non-GAAP net loss resulted in a net loss per share of CHF 1.81 (basic and diluted) in 2024, compared to a net loss per share of CHF 3.04 (basic and diluted) in 2023. Viatris collaborationIn March 2024, Idorsia entered into a global research and development collaboration with Viatris, for the global development and commercialization rights to selatogrel and cenerimod. Idorsia received an upfront payment of USD 350 million (CHF 308 million) with Idorsia obligated to contribute USD 200 million for the development of selatogrel and cenerimod. Idorsia is entitled to potential development and regulatory milestone payments, and certain contingent payments of additional sales milestone payments and tiered royalties in the mid-single to low-double digit percentages on annual net sales. In February 2025, Idorsia reached an agreement with Viatris to update the terms of the collaboration. In exchange for a USD 100 million reduction to Idorsia's contribution to the development costs due in 2025, Idorsia has agreed to a USD 250 million reduction in future potential regulatory and sales milestone payments, and an expansion of territorial rights to Viatris for cenerimod. The agreed royalties on future sales remain unchanged. Under the updated terms, Idorsia's contribution for the development of selatogrel and cenerimod is reduced to USD 100 million with no commitment in 2025. Idorsia has contributed USD 73 million in 2024 for the performance of development services, and the remaining USD 27 million will be paid in 2026. Restructured convertible bond debt and new funding securedOn February 26, 2025, Idorsia announced that it has reached an agreement with more than two-thirds of the holders of its outstanding convertible bond debt on the main terms of a holistic restructuring of the bonds and a CHF 150 million new money facility, to alleviate the short- to mid-term debt overhang of CHF 800 million while retaining upside potential of key assets beyond the value of the debt. As part of the holistic restructuring Idorsia will issue up to 27.5 million shares and up to 25.5 million warrants. When complete, the tailored solution secures future operations of Idorsia into 2026. More information can be found in the dedicated press release. Capital increaseIn connection with the holistic restructuring of the convertible bond debt and raising of additional funds, 35 million registered shares with a nominal value of CHF 0.05 each have been created out of capital band and will be listed today, March 4, 2025. Financial guidance for 2025As previously announced, for the Idorsia-led portfolio in 2025, the company expects a continued acceleration of QUVIVIQ with net sales of around CHF 110 million, COGS of around CHF 15 million, SG&A expenses of around CHF 210 million, and R&D expense of around CHF 100 million, leading to non-GAAP operating expenses of around CHF 325 million. This performance would result in an Idorsia-led business non-GAAP operating loss of around CHF 215 million and US-GAAP operating loss of around CHF 260 million. The company expects US-GAAP EBIT for the partnered business of around CHF 105 million, mainly driven by the amended deal with Viatris. This would result in a US-GAAP loss for the global business of around CHF 155 million. All amounts exclude unforeseen events and potential revenue related to additional business development activities. Arno Groenewoud, Chief Financial Officer, commented:'I'm pleased that our performance in 2024 exceeded our expectations, with higher QUVIVIQ sales and lower OPEX. The series of initiatives that we announced last week totally changes the financial situation of Idorsia. By relieving the significant debt overhang, removing significant and immediate cash requirements, and securing new funding, Idorsia is able to continue to operate into 2026. We will continue our efforts to maximize QUVIVIQ sales and reduce costs moving forward in order to make the money last.' Liquidity and indebtednessAt the end of 2024, Idorsia's liquidity amounted to CHF 106 million. (in CHF millions) Dec 31, 2024 Sep 30, 2024 Dec 31, 2023 Liquidity Cash and cash equivalents 106 92 145 Total liquidity* 106 92 145 Indebtedness Convertible loan 335 335 335 Convertible bond 797 797 796 Other financial debt 189 162 162 Total indebtedness 1,321 1,294 1,293 *rounding differences may occur Commercial operationsIn 2024, QUVIVIQ™ (daridorexant) in the US, Germany, Italy, Switzerland, Spain, UK, Canada, Austria, France, and Sweden generated total product sales of CHF 61 million. Europe and Canada Product Mechanism of action Indication Commercially available Dual orexin receptor antagonist Treatment of adult patients with insomnia characterised by symptoms present for at least three months and considerable impact on daytime functioning Sweden: 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 maintenance Canada: Nov. 2023 QUVIVIQ (daridorexant) net sales in 2024 reached CHF 32 million in the EUCAN region, a significant increase from CHF 6.5 million in 2023. In France, QUVIVIQ is reimbursed for moderate and severe chronic insomnia patients after, or as an alternative to, cognitive behavioral therapy for insomnia (CBT-I) since January 2024, and was launched in March 2024 as the first and only pharmacotherapy recommended for the treatment of chronic insomnia. Through a commercial partnership with Menarini in France, Idorsia expanded its commercial reach from specialist prescribers to general practitioners (GPs) in October 2024, which has substantially increased sales quarter on quarter with France being one of the main drivers of sales growth in the EUCAN region. In Germany, QUVIVIQ was launched in November 2022 and is the only sleep medication in Germany that can be prescribed for long-term treatment of chronic insomnia. The progress made in Germany is reflected by the performance of QUVIVIQ on the market, with net sales increasing by 279% in 2024 compared to 2023. In February 2025, Idorsia successfully concluded negotiations for the reimbursement price in Germany. Idorsia is expanding its commercial reach from specialist prescribers to general practitioners (GPs) through a commercial partnership with Berlin-Chemie (a wholly owned subsidiary of the Menarini Group) beginning in early April 2025. In the UK, QUVIVIQ is recommended as first-line pharmaceutical treatment for patients with chronic insomnia, after, or as an alternative to, cognitive behavioral therapy for insomnia (CBT-I). QUVIVIQ was launched in October 2023 at NICE approval. The priority in the UK in 2024 was to secure regional access, and the team has achieved reimbursement throughout 85% of the UK, as well as raising awareness of QUVIVIQ among general practitioners. Increased access and awareness have started to translate into strong demand in the UK. In Canada, after being approved in April 2023, QUVIVIQ was launched in November 2023 to the private market, representing 55% of the Canadian insomnia market. To date, 85% of private Canadian lives are covered. The focus is now on public payers; the company submitted public reimbursement dossiers and expects decisions by the end of 2025. In Switzerland, Italy, Spain, Austria, and Sweden, where we are still negotiating for reimbursement, launches have been very successful despite the out-of-pocket costs for patients, particularly in Switzerland where we see a strong demand. In Italy, we have achieved an expansion of the prescriber base from specialists to now include general practitioners who represent nearly 80% of the total insomnia market. Benjamin Limal, President of Europe and Canada region, commented:'Commercial efforts with QUVIVIQ in the EUCAN region are beginning to translate into promising success. Sales have shown a steady increase since the first launch in November 2022, with a recent acceleration – particularly driven by an outstanding launch in France and a great performance in Germany. This dynamic is expected to continue in the coming months as access expands in key European markets. We are also expanding our commercial reach from specialist prescribers to general practitioners through commercial partnerships such as Menarini in France and Berlin-Chemie in Germany.' For more information about QUVIVIQ in the EU, see the Summary of Product Characteristics. For more information about QUVIVIQ in Switzerland, see the Patient Information and Information for Healthcare Professionals. For more information on the marketing authorization of QUVIVIQ in Canada, see the Product Monograph. United States Product Mechanism of action Indication Commercially available since Dual orexin receptor antagonist Treatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance May 2022 QUVIVIQ® (daridorexant) net sales in 2024 reached CHF 28.6 million in the US, an increase of 17% compared to 2023. As of the end of 2024, almost 175,000 patients have been treated with QUVIVIQ since launch in the US, over 550,000 prescriptions have been dispensed, and the product has been prescribed by more than 51,000 healthcare professionals. Michael Moye, President and General Manager of Idorsia US, commented:'In the US, we have implemented a change to the commercialization approach for QUVIVIQ with the objective to reduce operating costs while maintaining the sales. We are still hopeful that descheduling of the dual orexin receptor antagonist (DORA) class can be achieved and the real value of QUVIVIQ in the US market can be unlocked. Our commercialization partner, Syneos Health, has switched to 20 virtual sales reps, operating with a data driven, highly targeted call plan, instead of the around 100 field force sales reps we had before. Syneos is now also executing marketing, focused digital media, data analytics and market access activities in support of the virtual representatives.' For more information about QUVIVIQ in the US, see the Full Prescribing Information (PI and Medication Guide). Product Mechanism of action Indication Commercially available since Dual endothelin receptor antagonist Treatment of hypertension in combination with other antihypertensive drugs, to lower blood pressure in adult patients who are not adequately controlled on other drugs October 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 both the REMS program and specialty distribution channel, begun engaging with hypertension experts at major cardiovascular and nephrology congresses, and initiated encouraging discussions with payors, resulting in TRYVIO being made available for prescription in October 2024. Michael concluded:'TRYVIO has been available to prescribe to the millions of patients in the US whose high blood pressure is not adequately controlled by other drugs since October 2024. A detailed US market assessment, campaign and educational approach is now complete, although funding for a field sales force and promotional activities continues to be dependent on a partnership deal. However, we have started to execute a limited launch of TRYVIO in the US in order to maintain and increase the value of a potential out-licensing deal for aprocitentan.' For more information see the Full Prescribing Information including BOXED Warning (PI and Medication Guide). Research & DevelopmentOur drug discovery engine has produced innovative drugs with the potential to transform the treatment paradigm in multiple therapeutic areas, including CNS, cardiovascular, and immunological disorders, as well as orphan diseases. The company also has a vaccine platform for the discovery and development of glycoconjugate vaccines to prevent infection. The company has focused its drug discovery efforts, reducing the number of active projects in research and development and preparing some for out-licensing. The prioritization has resulted in a portfolio of assets where Idorsia intends to develop to the next inflection point before partnering, or when feasible and appropriate, developing further ourselves. The company expects new lucerastat data from a kidney biopsy sub-study (to the ongoing Phase 3 open-label extension study) in the second quarter of 2025, with further discussions on the regulatory pathway to follow. The results from a Phase 1 study of our Clostridium difficile infection vaccine are also expected in the coming months. The company will need to further prioritize activities in order to reduce costs and the decisions on which assets to advance will be taken based on the data when available and the results of ongoing out-licensing discussions for early-stage assets. Idorsia-led portfolioThe company will develop each asset to the next inflection point or seek a partner. CompoundMechanism of actionTarget indication Status QUVIVIQ™ (daridorexant)Dual orexin receptor antagonistInsomnia Commercialized by Idorsia in the US, Germany, Italy, Switzerland, Spain, the UK, Canada, Austria, France, and Sweden; approved throughout the EU. LucerastatGlucosylceramide synthase inhibitorFabry disease Phase 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 insomnia Phase 2 in pediatric insomnia is ongoing. ACT-777991CXCR3 receptor antagonistVitiligo Idorsia will conduct a proof-of-concept study 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 receptor antagonistProgressive multiple sclerosis Idorsia will conduct a proof-of-concept study for patients with progressive MS. Unique combination of re-myelination and anti-inflammatory effect with decreased inflammatory cell infiltration. IDOR-1117-2520CCR6 receptor antagonistImmune-mediated disorders Phase 1 program ongoing. 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 disorders Entry-into-human package complete. Potential best-in-class due to insurmountable binding mode – proven inhibitory activity in preclinical models of inflammation and fibrosis. IDOR-1141-8472Orexin 2 receptor agonistOrexin-related CNS disorders Entry-into-human package ready to begin. Potential best-in-class – sustained chronic efficacy in a preclinical model of narcolepsy. IDOR-1126-6421Undisclosed mechanismOrgan injury Entry-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 Platform Idorsia will seek a partner for the platform or individual vaccines. IDOR-1134-2831Synthetic glycan vaccineinfection Idorsia is conducting a Phase 1 clinical pharmacology study which has the potential to show whether the vaccine induces an immune response. Results expected in Q2 2025. IDOR-1142-0810Synthetic glycan vaccineinfection 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 partner-led portfolioFor Idorsia, sophisticated partnerships are a way of gaining strategic access to technologies or products and fully exploiting our discovery engine and clinical pipeline. We seek suitable external project partners to maximize the value of internal innovation. Aprocitentan is an innovative and highly differentiated drug, commercially available in the US and approved in Europe and UK for the millions of patients who are unable to bring their hypertension under control with existing medications. As the first drug to target the endothelin pathway in systemic hypertension, aprocitentan has blockbuster potential in uncontrolled hypertension, particularly for difficult to treat patients with chronic kidney disease and hypertension, and further potential beyond hypertension. The priority remains to partner aprocitentan, having been released from the exclusivity constraint with the undisclosed party, the company will resume discussions with alternative potential partners that recognize the value of aprocitentan. On March 19, 2024, the US Food and Drug Administration (FDA) approved TRYVIO™ (aprocitentan) for the treatment of hypertension in combination with other antihypertensive drugs, to lower blood pressure in adult patients who are not adequately controlled on other drugs. See the commercial operations section above. On June 27, 2024, the European Commission (EC) approved JERAYGO™ (aprocitentan) for the treatment of resistant hypertension in adult patients in combination with at least three antihypertensive medicinal products. The recommended dose is 12.5 mg orally once daily. The dose can be increased to 25 mg once daily for patients tolerating the 12.5 mg dose and in need of tighter blood pressure (BP) control. For more information about JERAYGO in the EU, see the Summary of Product Characteristics. CompoundMechanism of actionTarget indication Partner/status TRYVIO™ (aprocitentan) Dual endothelin receptor antagonistSystemic hypertension in combination with other antihypertensives To be defined: worldwide development and commercialization rightsCommercially available in the US JERAYGO™ (aprocitentan)Dual endothelin receptor antagonistResistant hypertension in combination with other antihypertensives To be defined: worldwide development and commercialization rights Approved in the EU and UK; Marketing authorization applications under review in Canada, and Switzerland QUVIVIQ™ (daridorexant)Dual orexin receptor antagonistInsomnia Nxera 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 Korea DaridorexantDual orexin receptor antagonistInsomnia Simcere: license to develop and commercialize for Greater China regionNDA submitted in Greater China; approved for the treatment of insomnia in Hong-Kong SelatogrelP2Y12 inhibitorAcute myocardial infarction Viatris: worldwide development and commercialization rightsPhase 3 'SOS-AMI' program ongoing CenerimodS1P1 receptor modulatorSystemic lupus erythematosus Viatris: worldwide development and commercialization rightsPhase 3 'OPUS' program ongoing DaridorexantDual 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 PTSD ACT-1002-4391EP2/EP4 receptor antagonistImmuno-oncology Owkin: global license to develop and commercializePhase 1 ongoing IDOR-1134-9712CFTR Type-IV correctorCystic Fibrosis Undisclosed: Option to license following the completion of ongoing entry-into-human package Further details including the current status of each project in our partner-led portfolio can be found in our innovation fact sheet. Human ResourcesIdorsia reduced 249 positions worldwide in 2024, bringing the total number of permanent employees to 689 (2023: 938). Following a consultation process with employee representatives at headquarters in December 2024, a further reduction of approximately 250 positions globally was anticipated. The company has already begun the implementation of the restructuring and expects the cost reduction to be largely effective by Q2 2025. The total number of permanent employees who are not on notice at the end of February 2025 is 552. Financial ReportThe Financial Report 2024 is available at Annual ReportIdorsia's Annual Report 2024 – consisting of the Business Report, Governance Report, Compensation Report, Sustainability Report, and Financial Report (already published today) – will be published on March 27, 2025. Note to ShareholdersThe Annual General Meeting (AGM) of Shareholders to approve the Annual Report of the year ending December 31, 2024, will be held on Wednesday, May 28, 2025. Registered shareholders with voting rights individually or jointly representing at least 0.5% of the share capital of the company, being entitled to add items to the agenda of the general meeting of shareholders, are invited to send in proposals, if any, to Idorsia Ltd, attention Corporate Secretary, Hegenheimermattweg 91, CH-4123 Allschwil, to arrive no later than April 11, 2025. Any proposal received after the deadline will be disregarded. In order to vote at the Annual General Meeting, shareholders must be registered in the company's shareholder register by May 19, 2025, at the latest. Results Day CenterInvestor community: To make your job easier, we provide all relevant documentation via the Results Day Center on our corporate website: Events Publication of the Annual Report 2024 on March 27, 2025 First Quarter 2025 Financial Results reporting on April 30, 2025 Annual General Meeting of Shareholders on May 28, 2025 Half-Year 2025 Financial Results reporting on July 30, 2025 Notes to the editor About IdorsiaIdorsia Ltd is reaching out for more – we have more passion for science, we see more opportunities, and we want to help more patients. The purpose of Idorsia is to challenge accepted medical paradigms, answering the questions that matter most. To achieve this, we will discover, develop, and commercialize transformative medicines – either with in-house capabilities or together with partners – and evolve Idorsia into a leading biopharmaceutical company, with a strong scientific core. Headquartered near Basel, Switzerland – a European biotech hub – Idorsia has a highly experienced team of dedicated professionals, covering all disciplines from bench to bedside; QUVIVIQ™ (daridorexant), a different kind of insomnia treatment with the potential to revolutionize this mounting public health concern; strong partners to maximize the value of our portfolio; a promising in-house development pipeline; and a specialized drug discovery engine focused on small-molecule drugs that can change the treatment paradigm for many patients. Idorsia is listed on the SIX Swiss Exchange (ticker symbol: IDIA). For further information, please contactInvestor & Media RelationsIdorsia Pharmaceuticals Ltd, Hegenheimermattweg 91, CH-4123 Allschwil+41 58 844 10 – – 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
Associated Press
28-02-2025
- Business
- Associated Press
Nxera Pharma Enters Agreement with Holling to Commercialize Daridorexant in Taiwan
Daridorexant is a potential best-in-class treatment in the high-growth, dual orexin antagonist class of medicines treating sleep disorders, such as insomnia Filing of daridorexant in Taiwan planned for 2025, and launch, if approved, is expected during 2026 Daridorexant is launched in Japan as QUVIVIQ™ and is in Phase 3 trials in South Korea Tokyo, Japan and Cambridge, UK, 28 February 2025 – Nxera Pharma Co., Ltd. ('Nxera' or 'the Company'; TSE 4565) announces that it has entered a license, supply and commercialization agreement with Holling Bio-Pharma Corp. ('Holling') for daridorexant in Taiwan. Daridorexant is an oral dual orexin receptor antagonist (DORA) for the treatment of insomnia that selectively binds to receptors of the wake-promoting neuropeptide orexin (OX1R and OX2R), inhibiting excessive wakefulness and facilitating the transition to sleep. According to Taiwan's National Health Research Institutes, sleep disorders such as insomnia affected 12-20% of the adult population in 2021, approximately 4-5 million people. Under the terms of the agreement, Nxera will be responsible for the supply of drug product and Holling will be responsible for regulatory, commercial and distribution activities and will hold all regulatory approvals. Holling expects to file a New Chemical Entity (NCE) to the Taiwan Food and Drug Administration (FDA) in mid-2025, which if approved would lead to an expected launch in mid-2026. Nxera will receive an upfront payment on signing and is eligible for near-term regulatory and sales milestones plus royalties on net sales from Holling, as well as revenue on the supply of drug product to Holling. Dr. Makoto Sugita, CMO and President of Nxera Pharma Japan, commented: 'This new partnership with Holling will enable us to bring daridorexant, a potential best-in-class treatment, to the growing population of patients suffering with insomnia in Taiwan. Holling's wealth of experience as a leading commercial distributor in Taiwan makes it the ideal partner and we look forward to working together to prepare daridorexant for filing and launch, if approved, in 2026. This latest agreement is part of our strategy to expand access to innovative medicines in Japan and throughout the APAC region, working with leading regional commercialization partners for products targeting larger patient populations while leveraging our internal capabilities in specialty medicine and rare diseases.' –END– About Daridorexant Daridorexant is a dual orexin receptor antagonist that blocks the binding and activity of the wake-promoting neuropeptides known as orexins. Daridorexant 25mg and 50mg was approved in Japan in September 2024 and launched under the brand name of QUVIVIQ™ by Nxera Pharma Japan ('NPJ') and Shionogi in December 2024. Nxera is also conducting a Phase 3 trial with daridorexant in adults with insomnia in South Korea. QUVIVIQ™ is approved in the US, Europe and certain other countries and marketed in these territories by Idorsia Pharmaceuticals Ltd. * QUVIVIQ™ is a trademark of Idorsia Ltd. About Insomnia Disorder Insomnia disorder is defined as difficulty initiating or maintaining sleep, causing clinically significant distress or impairment in important areas of daytime functioning. As defined this impact on sleep quantity or quality should be present for at least three nights per week, lasts for at least three months, and occurs despite an adequate opportunity to sleep. Insomnia is a condition of overactive wake signaling and studies have shown that areas of the brain associated with wakefulness remain more active during sleep in patients with insomnia. According to Taiwan's National Health Research Institutes, sleep disorders such as insomnia affected 12-20% of the adult population in 2021, approximately 4-5 million people. Insomnia as a disorder is quite different from a brief period of poor sleep, and it can take its toll on both physical and mental health. It is a persistent condition with a negative impact on daytime functioning. Research has shown that poor quality sleep can affect many aspects of daily life, including the ability to concentrate, mood, and energy levels. The goal of treatments for insomnia is to improve sleep quality and quantity, as well as daytime functioning, while avoiding adverse events and next-morning residual effects. Current recommended treatment of insomnia includes sleep hygiene therapy, cognitive behavioral therapy, and pharmacotherapy. About Holling Bio-Pharma Corp. Headquartered in Taipei, Taiwan, Holling Bio-Pharma has been established for nearly five decades and is now the largest pharmaceutical distributor in Taiwan. Over the years, Holling Bio-Pharma primarily work with companies with innovate products and has continuously introduced the latest therapeutic drugs ranging from small molecule drugs and biologics to vaccines to help patients in Taiwan combat various diseases. With a fully equipped and professional team, Holling Bio-Pharma offers comprehensive services including drug registration, market access, product promotion, warehousing, and logistics. Holling Bio-Pharma also has extensive experience and expertise in the CNS field, with successful launch of innovative CNS products from both EU and US. The company is committed to delivering high-quality services that meet international standards, ensuring the latest medical innovations reach patients efficiently and effectively. About Nxera Pharma Nxera 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. In addition to several products being commercialized in Japan, 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 is focused on addressing major unmet needs in some of the fastest-growing areas of medicine across neurology, GI and immunology, metabolic disorders and rare diseases, and leverages the power of our unique and industry leading GPCR-targeted structure-based drug discovery NxWave™ platform to provide a sustainable source of best- or first-in-class candidates. Nxera employs over 350 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). Enquiries: Nxera – Media and Investor Relations Kentaro Tahara, VP Investor Relations and Corporate Strategy Shinichiro Nishishita, VP Investor Relations, Head of Regulatory Disclosures Maya Bennison, Communications Manager +81 (0)3 5210 3399 | +44 (0)1223 949390 |[email protected] MEDiSTRAVA (for International Media) Mark Swallow, Frazer Hall, Erica Hollingsworth Forward-looking statements This 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.
