P2Y12 receptor

Ad hoc announcement pursuant to Art. 53 LR Allschwil, Switzerland – May 21, 2024 Idorsia Ltd (SIX: IDIA) today announced its financial results for the first quarter of 2024. Business highlights Viatris collaboration: Global research and development collaboration, focused on the development and commercialization of two innovative compounds, selatogrel and cenerimod. Commercial highlights QUVIVIQ™ (daridorexant): Total net sales of CHF 10 million in Q1 2024.QUVIVIQ in the US: Citizens petition to deschedule the DORA class progressing.QUVIVIQ in Europe: Further launches, including France, provide a solid base to increase European sales in 2024. Pipeline highlights TRYVIO™ (aprocitentan): Approved by the US FDA in March 2024.JERAYGO™ (aprocitentan): Recommended for approval in Europe.Daridorexant: Phase 3 study conducted by Simcere in Chinese patients fully recruited. Financial highlights Net revenue Q1 2024 at CHF 10 million.US GAAP operating expenses Q1 2024 benefiting from extraordinary income from Viatris deal with non-GAAP operating expenses Q1 2024 at CHF 96 million.US GAAP operating income Q1 2024 of CHF 31 million and non-GAAP operating loss of CHF 85 million.The Viatris deal: The upfront consideration of USD 350 million (CHF 308 million) was fully paid by Viatris to Idorsia in Q1 2024.Convertible bond 2024: Bondholders approve an extension of maturity by six months. Guidance for 2024 QUVIVIQ net sales of around CHF 55 million.US GAAP operating loss to reach CHF 340 million (which includes a one-off benefit of CHF 125 million from the Viatris deal), non-GAAP operating loss of around CHF 420 million (excluding contract revenues and the one-off benefit from the Viatris deal) – unforeseen events excluded. Jean-Paul Clozel, MD and Chief Executive Officer, commented:“We have already reached significant milestones in 2024. The deal with Viatris to accelerate the development of selatogrel and cenerimod brought cash and security for these assets, while retaining shareholder value. We came to an arrangement with holders of the convertible bond 2024 due for repayment in July, giving us the time we need to secure additional funding and avoid liquidity constraints. Also, the quality of our research and development engine was once again confirmed by the FDA’s approval of TRYVIO (aprocitentan) and the CHMP positive opinion received for JERAYGO (the trade name of aprocitentan in Europe). This will now unlock value for Idorsia as we evaluate possible launch strategies – including potential partnership – for the first antihypertensive working on a new pathway seen in almost 40 years.” Jean-Paul continued: “Since the first launch of QUVIVIQ, more than 14 million tablets have been dispensed worldwide, with well over 150,000 patients benefiting from QUVIVIQ. We continue to believe in the huge potential offered by this product and – thanks to a long patent life – there is plenty of time for this potential to be realized. Continued innovation is essential to securing the company’s future. Despite the reduction of the workforce, we continue to discover and develop new drugs with great potential in many areas of medicine. I am very confident that our vision to create an innovative, profitable, and sustainable science-based company will become a reality in the coming years.” Financial results US GAAP results First Quarterin CHF millions, except EPS (CHF) and number of shares (millions) 20242023Net revenues 1021Operating expenses 20(219)Operating income (loss) 31(198)Net income (loss) 30(212)Basic EPS 0.17(1.19)Basic weighted average number of shares 179.1178.0Diluted EPS 0.13(1.19)Diluted weighted average number of shares 233.3178.0 Net revenue of CHF 10 million in the first quarter of 2024 is the result of QUVIVIQ product sales. This compares to CHF 21 million in the first quarter of 2023, which included CHF 13.5 million sales of PIVLAZ in Japan (now assigned to Nxera Pharma as part of a transaction, more details can be found in the dedicated press release) and CHF 1 million revenue share from Johnson & Johnson related to ponesimod sales (revenue-sharing agreement now eliminated as part of the reacquisition of aprocitentan, more details can be found in the dedicated press release). US GAAP operating expenses in the first quarter of 2024 benefitted from extraordinary income of CHF 125 million from the Viatris deal resulting in a negative expense of CHF 20 million (CHF 219 million in the first quarter of 2023), of which CHF 4 million related to cost of sales (CHF 1 million in the first quarter of 2023), CHF 33 million to R&D expenses (CHF 93 million in the first quarter of 2023), and CHF 68 million to SG&A expenses (CHF 125 million in the first quarter of 2023). US GAAP net income in the first quarter of 2024 amounted to CHF 30 million (CHF 212 million net loss in the first quarter of 2023). The decrease of the net loss is mainly attributable to the one-off income related to the Viatris Deal but was also driven by lower operating expenses throughout all functions. The US GAAP net income resulted in a basic net income per share of CHF 0.17 (diluted net income per share of CHF 0.13) in the first quarter of 2024, compared to a net loss per share of CHF 1.19 (basic and diluted) in the first quarter of 2023. Non-GAAP* measures First Quarterin CHF millions, except EPS (CHF) and number of shares (millions) 20242023Net revenues 1021Operating expenses (96)(202)Operating income (loss) (85)(181)Net income (loss) (86)(189)Basic EPS (0.48)(1.06)Basic weighted average number of shares 179.1178.0Diluted EPS (0.48)(1.06)Diluted weighted average number of shares 179.1178.0 * 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 quarter of 2024 amounted to CHF 86 million: the CHF 116 million difference versus US GAAP net income was mainly due to the one-off effect of the Viatris Deal (CHF 125 million income), depreciation and amortization (CHF 4 million), and share-based compensation (CHF 4 million). The non-GAAP net loss resulted in a net loss per share of CHF 0.48 (basic and diluted) in the first quarter of 2024, compared to a net loss per share of CHF 1.06 (basic and diluted) in the first quarter of 2023. Viatris collaborationIn March 2024, Idorsia closed agreements with Viatris Inc. (NASDAQ: VTRS), a global healthcare company, for collaboration on the global development and commercialization of two Phase 3 assets – selatogrel and cenerimod – with Idorsia receiving an upfront payment of USD 350 million, and the right to potential development and regulatory milestone payments of up to USD 300 million, potential sales milestone payments of up to USD 2.1 billion, and potential contingent tiered royalties from mid-single- to low-double-digit percentage on annual net sales. A joint development committee is overseeing the development of the ongoing Phase 3 programs for selatogrel and cenerimod up to regulatory approval. Idorsia will contribute up to USD 200 million in the next 3 years and transferred the dedicated personnel for both programs to Viatris. Viatris has worldwide commercialization rights for both selatogrel and cenerimod (excluding, for cenerimod only, Japan, South Korea, and certain countries in the Asia-Pacific region). Idorsia has also granted Viatris a right of first refusal and first negotiation for certain other pipeline assets. Convertible bonds 2024In July 2018, the Group issued CHF 200 million of senior unsecured convertible bonds (ISIN: CH0426820350), which were due to mature on July 17, 2024. On May 6, 2024, a bondholder meeting was held, where 83.5% of the total outstanding bondholders voted in favor of amendments to the terms of the bonds. The approved bond terms include an amended conversion price of CHF 6.00, extended maturity date of January 17, 2025, and the option to call the bonds at par, in full or in part, at any time upon giving ten trading days' notice. The company has applied to the higher cantonal composition authority and upon approval the amendments to the bond terms will become binding and effective. A consent fee of 8,000,000 Idorsia shares will be delivered through SIX SIS once the amendment of the bond terms is effective. Financial outlook 2024For 2024 – excluding unforeseen events – the company expects QUVIVIQ net sales of around CHF 55 million; SG&A expenses of around CHF 300 million; R&D expense of around CHF 165 million for Idorsia-led pipeline assets; non-GAAP operating expenses of up to CHF 470 million. This performance would result in a non-GAAP operating loss of around CHF 420 million (excluding contract revenues and the one-off benefit from the Viatris deal). The company expects US GAAP operating loss for 2024 to reach CHF 340 million which includes a one-off benefit of CHF 125 million from the Viatris deal. André C. Muller, Chief Financial Officer, commented:“In addition to the funds already raised from our business development activities, I am confident in our ability to raise additional funding this year. We will continue to evaluate and prepare possible launch strategies – including potential partnership – for TRYVIO. The significant progress with access and availability of QUVIVIQ has started to gain traction, particularly in Europe, this will translate into higher sales in 2024. At the same time, the cost reduction initiative that took place in the latter part of 2023 is fully effective and reflected in our 2024 guidance, with significantly lower expenses. We must continue to control our costs and explore all avenues to extend our cash runway, but I see many reasons to be optimistic for the future of Idorsia.” Liquidity and indebtednessAt the end of the first quarter of 2024, Idorsia’s liquidity amounted to CHF 335 million. (in CHF millions) March 31, 2024Dec 31, 2023Liquidity Cash and cash equivalents 335145Short-term deposits --Total liquidity* 335145 Indebtedness Convertible loan 335335Convertible bond 797796Other financial debt 162162Total indebtedness 1,2931,293 *rounding differences may occur Commercial operationsIn the first quarter of 2024, QUVIVIQ™ (daridorexant) in the US, Germany, Italy, Switzerland, Spain, UK, Canada, Austria, and France generated total product sales of CHF 10 million. United States ProductMechanism of actionIndicationCommercially available sinceDual orexin receptor antagonistTreatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenanceMay 2022 In the US, net sales of QUVIVIQ® (daridorexant) in the first quarter of 2024 reached CHF 6.5 million. This net sales number includes the QUVIVIQ copay program aimed at driving demand and product uptake, and thus does not reflect the actual number of prescriptions dispensed. As of the end of the first quarter of 2024, more than 140,000 patients have been treated with QUVIVIQ, almost 400,000 prescriptions have been dispensed, and the product has been prescribed by more than 42,000 healthcare professionals. To begin with, the company ran a direct-to-consumer (DTC) television and digital campaign and offered a copay program. The strategy was to create a recognizable brand, enabling market access discussions. During 2023, the company made significant progress, reaching over 65% reimbursement in the commercial sector. As access increased, the commercial approach was adjusted, with the aim being to switch from a consignment model (providing substantially reduced or free prescriptions) to a payer paid model. In the first quarter of 2024, paid prescriptions accounted for 68% of the total – an increase of 36 percentage points from the same period in 2023 and of 7 percentage points from the previous quarter. The first Medicare Part D coverage – reaching 27% of covered lives – began in January 2024, opening an entirely new channel which has the potential to substantially improve product access and paid prescriptions. In February, there was a cyberattack on Change Healthcare (UnitedHealth Group), the largest adjudicator/processor of copay cards in the US, causing major disruption across the pharmaceutical industry, including the QUVIVIQ copay cards, with a negative impact on prescription dispensing levels. In March, the Idorsia US Market Access team put a solution in place to remedy the disruption, though the impact was still appreciable through to the end of March. In April 2023, Idorsia filed a citizen petition (CP), urging the Drug Enforcement Administration (DEA) to deschedule the DORA class of chronic insomnia medications, based on a review of evidence from available data, including post-marketing surveillance data. Starting in 2015, the independent FDA approvals of other DORAs included a recommendation that these drug products be scheduled based on preclinical data. The CP to deschedule the DORA class outlines current scientific and medical evidence demonstrating that the DORA class has a negligible abuse profile and potential for abuse, lacks non-medical use in the community, lacks physical and psychological dependence, and therefore, should not be a scheduled class under the Controlled Substances Act. The DEA and FDA acknowledged the CP, and the process to analyze and examine the request is moving forward. Notably, a report accompanying the FDA appropriations bill that was finalized in March 2024 informed the FDA that the process for descheduling the DORA class is a priority for Congress. Tausif ‘Tosh’ Butt, President, and General Manager of Idorsia US, commented:“I believe one of the biggest barriers to prescribing QUVIVIQ is the fact it is currently a scheduled drug. Apart from the obstacles to prescribing scheduled drugs, some payers require patients to be treated with low-cost drugs not indicated for insomnia, and others that carry black box warnings before covering QUVIVIQ. The US Congress has long supported the efforts of the FDA to address the opioid and addiction crisis, and this year it encouraged the FDA to also consider the impact of treatments for insomnia as a part of that larger public health mission. I am very hopeful for our citizen petition requesting a review of the evidence can lead to the descheduling of the DORA class of chronic insomnia medications.” For more information about QUVIVIQ in the US, see the Full Prescribing Information (PI and Medication Guide). ProductMechanism of actionIndicationCommercially available sinceDual endothelin receptor antagonistTreatment of hypertension in combination with other antihypertensive drugs, to lower blood pressure in adult patients who are not adequately controlled on other drugsApproved Mar. 2024Planned availability: H2 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. Idorsia plans to make TRYVIO available in the second half of 2024 to the millions of patients in the US whose high blood pressure is not adequately controlled by other drugs. Further details on the approval, together with commentary from company management can be found in the dedicated press release and investor webcast available from the company corporate website. For more information see the Full Prescribing Information including BOXED Warning (PI and Medication Guide). Europe and Canada ProductMechanism of actionIndicationCommercially availableDual orexin receptor antagonistTreatment of adult patients with insomnia characterised by symptoms present for at least three months and considerable impact on daytime functioningFrance: Mar. 2024Austria: Feb. 2024UK: Oct. 2023Spain: Sep. 2023Switzerland: Jun. 2023Germany: Nov. 2022Italy: Nov. 2022 Management of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenanceCanada: Nov. 2023 QUVIVIQ (daridorexant) net sales in the first quarter of 2024 reached CHF 3.5 million in the EUCAN region. In November 2023, treatment with daridorexant was added to the insomnia treatment guidelines for Europe. In “The European Insomnia Guideline: An update on the diagnosis and treatment of insomnia 2023”, published in the Journal of Sleep Research, the authors note that “The introduction of DORAs has probably been the most significant recent development in the pharmacological treatment of insomnia.” In Germany, QUVIVIQ was launched in November 2022. By law, sleep medications were then subject to a 4-week prescribing limitation (Anlage III BtMG). Following a review by the Federal Joint Committee (G-BA) – the highest decision-making body of the joint self-government of physicians, dentists, hospitals, and health insurance funds in Germany – this limitation was lifted for QUVIVIQ in November 2023. This makes it the only sleep medication in Germany that can be prescribed for long-term treatment of chronic insomnia. In December 2023, the price negotiated for QUVIVIQ under the AMNOG process became effective. Following the lifting of the prescribing limitation, the company submitted a second AMNOG dossier for the long-term treatment of chronic insomnia disorder (beyond 4 weeks), reflecting the indication approved by the EMA in 2022. The progress made in Germany is reflected by the performance of QUVIVIQ on the market, with a 63% increase in demand seen in Q4 2023 (compared to Q3 2023), followed by a strong start to 2024 (February +41% compared to December 2023). In Italy, QUVIVIQ was launched in November 2022. Currently, QUVIVIQ can only be prescribed by neurologists, psychiatrists, and specialists from sleep centers, and no sleep therapy is reimbursed. The company submitted a reimbursement dossier in June 2023 and requested the expansion of the prescriber base. The submission – detailing the efficacy and safety profile of QUVIVIQ and its estimated budget impact and cost-effectiveness in Italy – is under review, with the final outcome expected in the second half of 2024. In Switzerland, QUVIVIQ was launched to the self-pay market in June 2023. Following the launch of QUVIVIQ, awareness has increased among all specialties, and demand has increased solidly (+32% in Q4 2023 compared to Q3 2023) ahead of reimbursement, which is expected in the summer of 2024. In Spain, QUVIVIQ was launched to the self-pay market in September 2023. Spain represents the largest insomnia market in Europe, as was apparent in the first months of this product’s availability, despite it only being launched to the self-pay market. The company is assessing the opportunity to submit a reimbursement dossier to the Spanish authorities, in order to allow equal access for all patients with chronic insomnia. In the UK, QUVIVIQ was launched in October 2023. At the same time, technology appraisal guidance was published by the National Institute for Health and Care Excellence (NICE), allowing the transition to local access discussions and listing by healthcare boards for England, Wales, and Northern Ireland. In April 2024, the Scottish Medicines Consortium (SMC) also accepted QUVIVIQ for use within NHS Scotland. This means that the company has achieved full reimbursement throughout the UK, where QUVIVIQ is now recommended as first-line pharmaceutical treatment for patients with chronic insomnia, after, or as an alternative to, cognitive behavioral therapy for insomnia (CBT-I). The priority in the UK now, is to secure regional access. In France, QUVIVIQ was launched in March 2024 as the first and only pharmacotherapy recommended for the treatment of chronic insomnia disorder. In January 2024, the inclusion of QUVIVIQ in both the hospital and the retail formulary list of reimbursed pharmaceutical specialties was announced in the French Official Gazette, together with the French public price. This official publication means that, with a prescription from their doctor, patients with chronic insomnia in France have access to the treatment if they meet the requirements of the EU prescribing label for QUVIVIQ. The publication follows the positive recommendation by the Transparency Committee in May 2023, recognizing QUVIVIQ as providing clinical added value. 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. The reimbursement dossier was submitted to private market payers in the third quarter of 2023, and just a few months after the submission the team had secured reimbursement for more than 60% of private market patients. The focus is now on public payers with the submission to INESSS (Institut national d’excellence en santé et en services sociaux) finalized in March 2024 and the submission to CADTH (Canada’s Drug and Health Technology Agency) expected in the second quarter of 2024. Jean-Yves Chatelan, President of Europe and Canada region, commented:“The launch of Europe’s first and only dual orexin receptor antagonist is progressing well across all markets where we have made QUVIVIQ available. Including Canada, we have expanded availability into more markets and improved the reimbursement environment beyond many expectations. With continued positive feedback from physicians and patients on the differentiated profile of QUVIVIQ, I am very optimistic that the progress we have made will now translate into many more patients benefiting from QUVIVIQ and increasing volumes advancing the region towards profitability.” 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. Research & DevelopmentIdorsia has a diversified and balanced portfolio, comprising assets developed and/or marketed by Idorsia and assets that are partner-led to maximize the value we have created. Our 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 containing synthetic antigenic glycan molecules, with or without a carrier protein, to prevent infection. Alberto Gimona, MD and Head of Global Clinical Development of Idorsia, commented:“Despite a difficult period for our organization, the team has shown extraordinary commitment and made great progress with our portfolio. This is particularly evident in the successful registration of aprocitentan in the US and the positive opinion from the European Union’s CHMP, with labels that reflect the value of the compound. I was also very pleased to have found a way for both selatogrel and cenerimod programs to be fully supported through the collaboration with Viatris, while maintaining our involvement in their development. I look forward to advancing the portfolio and bringing benefits to patients in many areas of medical need.” Idorsia-led portfolio CompoundMechanism of actionTarget indicationStatusQUVIVIQ™ (daridorexant)Dual orexin receptor antagonistInsomniaCommercially available as QUVIVIQ in the US, Germany, Italy, Switzerland, Spain, the UK, Canada, Austria, and France; approved throughout the EUTRYVIO™ (aprocitentan) Dual endothelin receptor antagonistSystemic hypertension in combination with other antihypertensivesApproved as TRYVIO in the US, launch planned for H2 2024JERAYGO™ (aprocitentan)Dual endothelin receptor antagonistResistant hypertension in combination with other antihypertensivesPositive opinion from the European Committee for Medicinal Products for Human Use (CHMP) received in April 2024 – European Commission decision expected in approx. 2 monthsLucerastatGlucosylceramide synthase inhibitorFabry diseasePhase 3 primary endpoint not met; open-label extension study ongoingPhase 3 focused on renal function in preparationDaridorexantDual orexin receptor antagonistPediatric insomniaPhase 2 in pediatric insomnia ongoingACT-1004-1239ACKR3/CXCR7 antagonistDemyelinating diseases including multiple sclerosis Phase 2 in preparationSinbaglustatGBA2/GCS inhibitorRare lysosomal storage disordersPhase 1 completeACT-777991CXCR3 antagonistRecent-onset Type 1 diabetesPhase 1 completeIDOR-1117-2520UndisclosedImmune-mediated disordersPhase 1 ongoingIDOR-1134-2831Synthetic glycan vaccineClostridium difficile infectionPhase 1 initiating DaridorexantDaridorexant is a dual orexin receptor antagonist (DORA) which blocks the binding of the wake-promoting orexin neuropeptides. Rather than inducing sleep through broad inhibition of brain activity, daridorexant only blocks the activation of orexin receptors. Daridorexant is commercially available as QUVIVIQ in the US, Germany, Italy, Switzerland, Spain, the UK, Canada, Austria, and France, and is approved throughout the EU (see “Commercial operations” above). A post-approval study to investigate the efficacy of daridorexant in patients with insomnia and comorbid nocturia has completed recruitment and is expected to report results in mid-2024 (NCT05597020). Idorsia has initiated 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. The study is expected to enroll around 150 patients, who will be randomized in a 1:1:1:1 ratio to 10 mg, 25 mg, or 50 mg daridorexant, or placebo. The study is part of a US FDA-approved Pediatric Study Plan and an EU PDCO-approved Paediatric Investigation Plan. Aprocitentan Aprocitentan is a once-daily, orally active, dual endothelin receptor antagonist, which inhibits the binding of ET-1 to ETA and ETB receptors. Aprocitentan has a low potential for drug-drug interaction and a mechanism of action suited for lowering blood pressure in adult patients whose hypertension is not adequately controlled by other drugs. On March 19, 2024, aprocitentan was approved as TRYVIO in the US, with availability planned for H2 2024. On April 25, 2024, Idorsia received a positive opinion for aprocitentan (as JERAYGO™) from the Committee for Medicinal Products for Human Use (CHMP) as a treatment of resistant hypertension. A CHMP positive opinion is one of the final steps before marketing authorization can be granted by the European Commission; a final decision is expected approximately two months after publication of the CHMP opinion. Lucerastat Lucerastat is an oral inhibitor of glucosylceramide synthase, offering a potential new treatment approach for all patients living with Fabry disease, irrespective of the mutation type of the GLA gene. In October 2021, the company reported that lucerastat 1000 mg b.i.d. did not meet the primary endpoint of reducing neuropathic pain during 6 months of treatment versus placebo. However, Lucerastat demonstrated a substantial reduction in levels of the Fabry disease biomarker plasma Gb3 during the treatment period, with a decrease of approximately 50% observed in plasma Gb3 in the lucerastat treatment group compared to an increase of 12% in the placebo group. Furthermore, results suggested a treatment effect on kidney function. Lucerastat was well tolerated. Analysis of the ongoing open-label extension (OLE) of the Phase 3 study corroborated the long-term effect on plasma Gb3 levels and a potential positive long-term effect on kidney function. The analysis also showed a safety and tolerability profile consistent with that observed during the 6-month randomized treatment period. The company is conducting a kidney biopsy substudy within a subset of patients currently participating in the OLE study in order to steer further development in Fabry disease. Further details including the current status of each project in our portfolio can be found in our innovation fact sheet. Idorsia partner-led portfolioFor Idorsia, sophisticated partnerships are a way of gaining strategic access to technologies or products and fully exploiting our discovery engine and clinical pipeline. We seek suitable external project partners to maximize the value of internal innovation. CompoundMechanism of actionTarget indicationPartner/statusDaridorexantDual orexin receptor antagonistInsomniaNxera Pharma: license to develop and commercialize for Asia-Pacific region (excluding China)NDA submitted in JapanDaridorexantDual orexin receptor antagonistInsomniaSimcere: license to develop and commercialize for Greater China regionPhase 3 ongoingSelatogrelP2Y12 inhibitorAcute myocardial infarctionViatris: worldwide development and commercialization rightsPhase 3 “SOS-AMI” program ongoingCenerimodS1P1 receptor modulatorSystemic lupus erythematosusViatris: worldwide development and commercialization rights (excluding Japan, South Korea, and certain countries in the Asia-Pacific region)Phase 3 “OPUS” program ongoingDaridorexantDual orexin receptor antagonistPosttraumatic stress disorder (PTSD)US Department of Defense (DOD): Idorsia is supporting a clinical study sponsored by the US DOD to develop new therapies to treat PTSDACT-709478 (NBI-827104)T-type calcium channel blockerEpileptic encephalopathy with continuous spike-and-wave during sleep (CSCW)Neurocrine Biosciences: global license to develop and commercializePhase 2 OLE study ongoingACT-1002-4391EP2/EP4 receptor antagonistImmuno-oncologyOwkin: global license to develop and commercializePhase 1 in preparation Daridorexant (Nxera Pharma)Daridorexant is licensed to Nxera Pharma (previously known as Sosei Heptares) in the Asia-Pacific region (excluding China), and a New Drug Application (NDA) is under review with the Japanese Ministry of Health, Labor, and Welfare (MHLW). In Japan, Idorsia has a license agreement with Mochida Pharmaceutical for the supply, co-development and co-marketing of daridorexant. All potential milestones have been assigned to Nxera. Asia-Pacific region (excluding China): Australia, Brunei, Cambodia, Indonesia, Japan, Laos, Malaysia, Myanmar, New Zealand, Philippines, Singapore, South Korea, Thailand, Taiwan, and Vietnam. Daridorexant (Simcere)Daridorexant is licensed to Simcere in the Greater China region (Mainland China, Hong Kong, and Macau), and a Phase 3 study with daridorexant in Chinese patients has completed recruitment. Results are expected in June 2024 and, if the study is successful, an NDA in Mainland China is planned for the second half of 2024. An NDA is already under review with the Hong Kong Department of Health. Selatogrel and cenerimod (Viatris)A joint development committee from Idorsia and Viatris is overseeing the development of two ongoing Phase 3 programs up to regulatory approval. Selatogrel is a potent, fast-acting, reversible, and highly selective P2Y12 inhibitor being developed in a Phase 3 study (NCT04957719) for the treatment of acute myocardial infarction (“SOS-AMI”) in patients with a recent history of AMI. It is intended to be self-administered subcutaneously via a drug delivery system (autoinjector). Cenerimod is a highly selective S1P1 receptor modulator, given as an oral once-daily tablet, which is being developed in a Phase 3 program known as “OPUS” (NCT05648500, NCT05672576) for the treatment of systemic lupus erythematosus (SLE). Viatris has worldwide commercialization rights for both selatogrel and cenerimod (excluding, for cenerimod only, Japan, South Korea, and certain countries in the Asia-Pacific region). Daridorexant (US Department of Defense)Idorsia is supporting a clinical study sponsored by the US Department of Defense (DOD) to develop new therapies for posttraumatic stress disorder (PTSD). The Phase 2 study will evaluate the safety, tolerability, and efficacy of potential therapeutic interventions, including daridorexant, in active-duty US service members and veterans with PTSD (NCT05422612). ACT-709478 Neurocrine Biosciences has a global license to develop and commercialize ACT-709478 (NBI-827104), Idorsia’s novel T-type calcium channel blocker. ACT-709478 is being investigated in a Phase 2 open-label extension (OLE) study for the treatment of pediatric patients with epileptic encephalopathy with continuous spike-and-wave during sleep (CSCW), a rare form of pediatric epilepsy. While the blinded study did not meet the primary endpoint, ACT-709478 was generally well tolerated and Neurocrine continues to analyze the totality of data coming from the OLE study to determine the next steps. ACT-1002-4391Owkin has a global license to develop and commercialize ACT-1002-4391, Idorsia’s novel, potent EP2/EP4 receptor antagonist with antitumor efficacy, to be used both as monotherapy and in combination with other oncology agents. The compound is in preparation for Phase 1 clinical pharmacology studies. Owkin will use its proprietary AI-based data-mining platform to generate clinical trial designs and to identify patients who may benefit from, and potential targets for, the compound. Martine Clozel, MD and Chief Scientific Officer, commented:“The way we work in research is focused on and built around innovation and our core competencies. While we had to cut back on the number of people conducting research in 2023, we have maintained this fundamental approach to our drug discovery efforts. We have taken the restructuring as an opportunity to focus on fewer key areas of research and will advance our discoveries either through our own clinical development expertise, or with the right partner, aiming to maximize the benefit for patients and Idorsia.” 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. Upcoming Financial Updates Annual General Meeting of Shareholders on June 13, 2024Half-Year 2024 Financial Results reporting on July 25, 2024Nine-Months 2024 Financial Results reporting on October 29, 2024 Notes to the editor About IdorsiaIdorsia Ltd is reaching out for more – We have more ideas, we see more opportunities and we want to help more patients. In order to achieve this, we will develop Idorsia into a leading biopharmaceutical company, with a strong scientific core. Headquartered near Basel, Switzerland – a European biotech-hub – Idorsia is specialized in the discovery, development, and commercialization of small molecules to transform the horizon of therapeutic options. Idorsia has a 25-year heritage of drug discovery, a broad portfolio of innovative drugs in the pipeline, an experienced team of professionals covering all disciplines from bench to bedside, and commercial operations in Europe and North America – the ideal constellation for bringing innovative medicines to patients. Idorsia was listed on the SIX Swiss Exchange (ticker symbol: IDIA) in June 2017 and has over 750 highly qualified specialists dedicated to realizing our ambitious targets. For further information, please contactAndrew C. WeissSenior Vice President, Head of Investor Relations & Corporate CommunicationsIdorsia Pharmaceuticals Ltd, Hegenheimermattweg 91, CH-4123 Allschwil+41 58 844 10 10investor.relations@idorsia.com media.relations@idorsia.com www.idorsia.com The above information contains certain "forward-looking statements", relating to the company's business, which can be identified by the use of forward-looking terminology such as "estimates", "believes", "expects", "may", "are expected to", "will", "will continue", "should", "would be", "seeks", "pending" or "anticipates" or similar expressions, or by discussions of strategy, plans or intentions. Such statements include descriptions of the company's investment and research and development programs and anticipated expenditures in connection therewith, descriptions of new products expected to be introduced by the company and anticipated customer demand for such products and products in the company's existing portfolio. Such statements reflect the current views of the company with respect to future events and are subject to certain risks, uncertainties and assumptions. Many factors could cause the actual results, performance or achievements of the company to be materially different from any future results, performances or achievements that may be expressed or implied by such forward-looking statements. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or expected. Attachment Press Release PDF

New exploratory analysis demonstrates consistent results of XARELTO® in treating elderly and non-elderly patients with nonvalvular atrial fibrillation undergoing percutaneous coronary intervention XARELTO® is one of the most studied oral anticoagulants, and has been prescribed to more than 10 million patients in the United States NEW BRUNSWICK, N.J., April 8, 2024 /PRNewswire/ -- Johnson & Johnson announced today a new analysis of data from the PIONEER AF-PCI clinical trial demonstrating that XARELTO® (rivaroxaban) was associated with a reduced risk of clinically significant bleeding (CSB), and net adverse clinical events (NACE; a composite of clinically significant bleeding [CSB] or major adverse cardiovascular event [MACE]) or rehospitalization compared to warfarin among both elderly and non-elderly patients with nonvalvular atrial fibrillation (AF) undergoing percutaneous coronary intervention (PCI), a nonsurgical procedure designed to relieve narrowing or occlusion of the coronary artery.1,2 These data were featured in an oral presentation today at the American College of Cardiology 73rd Annual Scientific Session & Expo (ACC.24) in Atlanta, Georgia (Abstract #906-04). "Despite advances in cardiovascular care, patients with nonvalvular AF continue to be at risk of potentially life-threatening cardiovascular events, especially older patients considered difficult to treat due to multiple factors, including age and co-morbidities," said C. Michael Gibson*, M.D., CEO, of the nonprofit Baim Institute and professor of Medicine, Harvard Medical School. "A significant challenge in managing nonvalvular AF in older individuals undergoing PCI is determining a treatment that balances the prevention of stroke with the risk for bleeding. Results from the PIONEER AF-PCI trial reinforce the need to continue to research this complex and fragile elderly patient population." The PIONEER AF-PCI exploratory trial enrolled 2,124 patients with nonvalvular AF undergoing PCI, of whom 729 (34.3%) were elderly.1,3 Patients were randomized to either rivaroxaban- or warfarin-based antithrombotic regimens.1,3 The data analysis demonstrated a reduced rate of CSB among both elderly (≥75 years) and non-elderly (<75) patients with nonvalvular AF undergoing PCI treated with XARELTO® compared to warfarin.1 Elderly patients treated with XARELTO® had a lower rate of CSB at 12 months compared to those treated with warfarin (21.3% vs 31.4%; hazard ratio [HR], 0.64; 95% confidence interval [CI], 0.46-0.88; P=0.005; number needed to treat [NNT]=10).1 The reduction in CSB was consistent among non-elderly patients treated with XARELTO® compared to warfarin (15.3% vs 24.6%; HR, 0.58; 95% CI, 0.45-0.75; P<0.001; NNT=11; interaction P=0.676).1 The analysis also showed XARELTO® treatment was associated with a lower risk of NACE or rehospitalization in both elderly (HR, 0.77; 95% CI, 0.62-0.96) and non-elderly patients (HR, 0.69; 95% CI, 0.58-0.82; interaction P=0.435), primarily driven by a lower risk of CSB.1 In addition, the rates of major bleeding were lower in patients treated with XARELTO® compared to warfarin in both elderly (3.7% vs 5.2%; HR, 0.71; 95% CI, 0.33-1.55) and non-elderly (1.1% vs 2.5%; HR, 0.45; 95% CI, 0.18-1.10) patients.1 Patients treated with XARELTO® also experienced lower rates of minor bleeding compared to warfarin in both elderly (1.4% vs 3.8%; HR, 0.36; 95% CI, 0.12-1.07) and non-elderly (1.0% vs 1.4%; HR, 0.67; 95% CI, 0.23-1.92) patients.1 "At Johnson & Johnson, we are committed to driving innovation that can improve outcomes for all patients," said Avery Ince, M.D., Ph.D., Vice President, Medical Affairs, Cardiovascular & Metabolism, Johnson & Johnson. "With this new exploratory analysis at ACC.24, we're pleased to bring the latest research to healthcare providers that adds to the growing body of clinical evidence in older adults." About PIONEER AF-PCI PIONEER AF-PCI was an international, multi-center, randomized, open-label clinical trial evaluating the safety of rivaroxaban compared to warfarin for the treatment of patients at least 18 years of age with paroxysmal, persistent, or permanent nonvalvular AF who had undergone PCI with stent placement. In the trial, 2,124 participants with nonvalvular atrial fibrillation who had undergone PCI with stenting received, in a 1:1:1 ratio, low-dose rivaroxaban (15 mg once daily) plus a P2Y12 inhibitor for 12 months (group 1), low-dose rivaroxaban (2.5 mg twice daily) plus DAPT for 1, 6, or 12 months (group 2), or standard therapy with a dose-adjusted vitamin K antagonist (once daily) plus DAPT for 1, 6, or 12 months (group 3). The primary safety endpoint was the occurrence of clinically significant bleeding, a composite of major bleeding or minor bleeding according to Thrombolysis in Myocardial Infarction (TIMI) criteria or bleeding requiring medical attention during the treatment period (which was defined as the time from the first administration of a trial drug to 2 days after the trial drugs were discontinued, through 12 months of therapy). Secondary endpoints included the incidence of each component of the primary safety endpoint, as well as the following efficacy endpoints: the occurrence of a major adverse cardiovascular event (a composite of death from cardiovascular causes, myocardial infarction, or stroke), each component of the major adverse cardiovascular event endpoint, and stent thrombosis.3 About XARELTO ® (rivaroxaban) XARELTO® is a prescription medicine used to: reduce the risk of stroke and blood clots in adults who have a medical condition called atrial fibrillation that is not caused by a heart valve problem. With atrial fibrillation, part of the heart does not beat the way it should. This can lead to the formation of blood clots, which can travel to the brain, causing a stroke, or to other parts of the body FDA approved dosing for patients with nonvalvular AF is 20 mg once daily with an evening meal in patients with CrCl >50 mL/min. For patients with moderate to severe renal impairment (CrCl ≤50 mL/min), the FDA approved dosing is 15 mg once daily with an evening meal. IMPORTANT SAFETY INFORMATION WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT XARELTO ® ? XARELTO ® may cause serious side effects, including: Increased risk of blood clots if you stop taking XARELTO ® . People with atrial fibrillation (an irregular heart beat) that is not caused by a heart valve problem (nonvalvular) are at an increased risk of forming a blood clot in the heart, which can travel to the brain, causing a stroke, or to other parts of the body. XARELTO® lowers your chance of having a stroke by helping to prevent clots from forming. If you stop taking XARELTO®, you may have increased risk of forming a clot in your blood. Do not stop taking XARELTO ® without talking to the doctor who prescribes it for you. Stopping XARELTO ® increases your risk of having a stroke. If you have to stop taking XARELTO®, your doctor may prescribe another blood thinner medicine to prevent a blood clot from forming. Increased risk of bleeding. XARELTO® can cause bleeding which can be serious and may lead to death. This is because XARELTO® is a blood thinner medicine (anticoagulant) that lowers blood clotting. During treatment with XARELTO® you are likely to bruise more easily, and it may take longer for bleeding to stop. You may be at higher risk of bleeding if you take XARELTO® and have certain other medical problems. You may have a higher risk of bleeding if you take XARELTO ® and take other medicines that increase your risk of bleeding, including: Aspirin or aspirin-containing products Long-term (chronic) use of non-steroidal anti-inflammatory drugs (NSAIDs) Warfarin sodium (Coumadin®, Jantoven®) Any medicine that contains heparin Clopidogrel (Plavix®) Selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs) Other medicines to prevent or treat blood clots Tell your doctor if you take any of these medicines. Ask your doctor or pharmacist if you are not sure if your medicine is one listed above. Call your doctor or get medical help right away if you or your child develop any of these signs or symptoms of bleeding: Unexpected bleeding or bleeding that lasts a long time, such as: Nosebleeds that happen often Unusual bleeding from gums Menstrual bleeding that is heavier than normal, or vaginal bleeding Bleeding that is severe or you cannot control Red, pink, or brown urine Bright red or black stools (looks like tar) Cough up blood or blood clots Vomit blood or your vomit looks like "coffee grounds" Headaches, feeling dizzy or weak Pain, swelling, or new drainage at wound sites Spinal or epidural blood clots (hematoma). People who take a blood thinner medicine (anticoagulant) like XARELTO®, and have medicine injected into their spinal and epidural area, or have a spinal puncture, have a risk of forming a blood clot that can cause long-term or permanent loss of the ability to move (paralysis). Your risk of developing a spinal or epidural blood clot is higher if: A thin tube called an epidural catheter is placed in your back to give you certain medicine You take NSAIDs or a medicine to prevent blood from clotting You have a history of difficult or repeated epidural or spinal punctures You have a history of problems with your spine or have had surgery on your spine If you take XARELTO® and receive spinal anesthesia or have a spinal puncture, your doctor should watch you closely for symptoms of spinal or epidural blood clots. Tell your doctor right away if you have: back pain tingling numbness muscle weakness (especially in your legs and feet) or loss of control of the bowels or bladder (incontinence) XARELTO® is not for use in people with artificial heart valves. XARELTO® is not for use in people with antiphospholipid syndrome (APS), especially with positive triple antibody testing. Do not take XARELTO ® if you or your child: Currently have certain types of abnormal bleeding. Talk to your doctor before taking XARELTO® if you currently have unusual bleeding. Are allergic to rivaroxaban or any of the ingredients of XARELTO®. Before taking XARELTO ® , tell your doctor about all your medical conditions, including if you or your child: Have ever had bleeding problems Have liver or kidney problems Have antiphospholipid syndrome (APS) Are pregnant or plan to become pregnant. It is not known if XARELTO® will harm your unborn baby. Tell your doctor right away if you become pregnant during treatment with XARELTO®. Taking XARELTO® while you are pregnant may increase the risk of bleeding in you or in your unborn baby. Females who are able to become pregnant: Talk with your doctor about pregnancy planning during treatment with XARELTO®. Talk with your doctor about your risk for severe uterine bleeding if you are treated with blood thinner medicines, including XARELTO®. If you take XARELTO® during pregnancy, tell your doctor right away if you have any signs or symptoms of bleeding or blood loss. See "What is the most important information I should know about XARELTO ® ?" for signs and symptoms of bleeding. Are breastfeeding or plan to breastfeed. XARELTO® may pass into your breast milk. Talk to your doctor about the best way to feed your baby during treatment with XARELTO®. Tell all of your doctors and dentists that you or your child are taking XARELTO®. They should talk to the doctor who prescribed XARELTO® for you before you have any surgery, medical or dental procedure. Tell your doctor about all the medicines you or your child take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Some of your other medicines may affect the way XARELTO® works, causing side effects. Certain medicines may increase your risk of bleeding. See "What is the most important information I should know about XARELTO ® ?" HOW SHOULD I TAKE XARELTO ® ? Take XARELTO® exactly as prescribed by your doctor. Do not change your dose or stop taking XARELTO ® unless your doctor tells you to. Your doctor may change your dose if needed. Your doctor will decide how long you should take XARELTO®. XARELTO® may need to be stopped for one or more days before any surgery or medical or dental procedure. Your doctor will tell you when to stop taking XARELTO® and when to start taking XARELTO® again after your surgery or procedure. If you need to stop taking XARELTO® for any reason, talk to the doctor who prescribed XARELTO® to you to find out when you should stop taking it. Do not stop taking XARELTO® without first talking to the doctor who prescribes it to you. If you have difficulty swallowing XARELTO® tablets whole, talk to your doctor about other ways to take XARELTO®. Do not run out of XARELTO®. Refill your prescription of XARELTO® before you run out. When leaving the hospital following a hip or knee replacement, be sure that you will have XARELTO® available to avoid missing any doses. If you take too much XARELTO®, go to the nearest hospital emergency room or call your doctor right away. If you take XARELTO® for: Atrial Fibrillation that is not caused by a heart valve problem: Take XARELTO® 1 time a day with your evening meal. If you miss a dose of XARELTO®, take it as soon as you remember on the same day. Take your next dose at your regularly scheduled time. Blood clots in the veins of your legs or lungs: Take XARELTO® 1 or 2 times a day as prescribed by your doctor. For the 10-mg dose, XARELTO® may be taken with or without food. For the 15-mg and 20-mg doses, take XARELTO® with food at the same time each day. If you miss a dose: If you take the 15-mg dose of XARELTO ® 2 times a day (a total of 30 mg of XARELTO ® in 1 day): Take XARELTO® as soon as you remember on the same day. You may take 2 doses at the same time to make up for the missed dose. Take your next dose at your regularly scheduled time. If you take XARELTO ® 1 time a day: Take XARELTO® as soon as you remember on the same day. Take your next dose at your regularly scheduled time. Hip or knee replacement surgery: Take XARELTO® 1 time a day with or without food. If you miss a dose of XARELTO®, take it as soon as you remember on the same day. Take your next dose at your regularly scheduled time. Blood clots in people hospitalized for an acute illness: Take XARELTO® 1 time a day, with or without food, while you are in the hospital and after you are discharged as prescribed by your doctor. If you miss a dose of XARELTO®, take it as soon as you remember on the same day. Take your next dose at your regularly scheduled time. Reducing the risk of serious heart problems, heart attack and stroke in coronary artery disease: Take XARELTO® 2.5 mg 2 times a day with or without food. If you miss a dose of XARELTO®, take your next dose at your regularly scheduled time. Take aspirin 75 to 100 mg once daily as instructed by your doctor. Reducing the risk of a sudden decrease in blood flow to the legs, major amputation, serious heart problems or stroke in people with peripheral artery disease, including those who have recently had a procedure to improve blood flow to the legs: Take XARELTO® 2.5 mg 2 times a day with or without food. If you miss a dose of XARELTO®, take your next dose at your regularly scheduled time. Take aspirin 75 to 100 mg once daily as instructed by your doctor. For children who take XARELTO ® : The dose of XARELTO® depends on your child's body weight and will be calculated by your child's doctor. Your child's doctor will tell you if XARELTO® can be given to your child with or without food. The adult caregiver should give the dose. If your child is taking the tablet, the tablet should be taken whole and should not be split in an attempt to provide a lower dose of XARELTO®. If your child is taking the oral suspension, use the syringes provided in the original carton. The suspension will be prepared by the pharmacy. See the Instructions for Use included in the carton on how to properly give a dose of XARELTO® oral suspension to your child. Do not switch between the XARELTO® oral suspension or tablet without first talking to your doctor. If your child vomits or spits up: right after or within 30 minutes of taking the oral suspension, give a new full dose. more than 30 minutes after taking the oral suspension, do not give the dose again. Give the next dose at the regularly scheduled time. if vomiting or spitting up persists, contact your child's doctor right away. If your child misses a dose: If your child is taking XARELTO® 1 time a day, give the dose as soon as you remember on the same day. If this is not possible, skip this dose and give the next dose at the regularly scheduled time. If your child is taking XARELTO® 2 times a day, give the missed morning dose as soon as you remember. You may give the missed morning dose together with the evening dose. However, a missed evening dose can only be taken in the same evening. If your child is taking XARELTO® 3 times a day, skip the missed dose and give the next dose at the regularly scheduled time. WHAT ARE THE POSSIBLE SIDE EFFECTS OF XARELTO ® ? XARELTO ® may cause serious side effects: See "What is the most important information I should know about XARELTO ® ?" The most common side effect of XARELTO ® in adults was bleeding. The most common side effects of XARELTO ® in children include: bleeding vomiting cough inflamed stomach and gut Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects to Janssen Pharmaceuticals, Inc., at 1-800-JANSSEN (1-800-526-7736). Please read full Prescribing Information , including Boxed Warnings, and Medication Guide for XARELTO ® . Trademarks are those of their respective owners. Janssen and Bayer together are developing rivaroxaban. About Johnson & Johnson At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at or at . Follow us at @JanssenUS and @JNJInnovMed. Janssen Research & Development, LLC, Janssen Biotech, Inc. and Janssen Pharmaceuticals, Inc. are Johnson & Johnson companies. Cautions Concerning Forward-Looking Statements This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of rivaroxaban. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Research & Development, LLC, Janssen Biotech, Inc., Janssen Pharmaceuticals, Inc. and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 31, 2023, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at , or on request from Johnson & Johnson. None of Janssen Research & Development, LLC, Janssen Biotech, Inc., Janssen Pharmaceuticals, Inc. nor Johnson & Johnson undertake to update any forward-looking statement as a result of new information or future events or developments. *Dr. C. Michael Gibson is author of the PIONEER AF-PCI analysis titled, "Effect of Rivaroxaban on Bleeding or Ischemic Event and Rehospitalization Among Elderly or Non-Elderly Patients with Atrial Fibrillation Undergoing Percutaneous Coronary Intervention: Insights from the PIONEER AF-PCI Trial," and was provided payment for his participation in the study; he has not been compensated for contributing to this press release. SOURCE Johnson & Johnson

PITTSBURGH, March 27, 2024 /PRNewswire/ -- At a meeting with the investment community today, Viatris Inc. (NASDAQ: VTRS), a global healthcare company, will outline how it is continuing to evolve its R&D strategy to deliver on its goal of building a more durable, higher-margin portfolio of patented innovation on the foundation of its strong base business. The focus of the event will be a discussion of its collaboration with Idorsia, Phase 3 assets selatogrel and cenerimod and key elements of the Company's pipeline. Viatris CEO Scott A. Smith said: "Our confidence in our ability to continue to drive future growth and unlock shareholder value comes from our strong base business, well-established global infrastructure, and significant financial flexibility all of which give us the opportunity to continue to evolve our pipeline with the addition of potential blockbuster assets like selatogrel and cenerimod. The addition of high-science programs that deliver novel, meaningful patient impact and address significant unmet patient need will also give us the opportunity to accelerate long-term growth." Event highlights will include: Overview of global collaboration with Idorsia. The collaboration with Idorsia is a great example of Viatris' strategy in action—adding two late-stage potential blockbuster assets, selatogrel and cenerimod—and connecting Idorsia's highly productive drug development team and innovation engine with Viatris' existing infrastructure and experience. The Company will review key elements of the collaboration including how Viatris can make a difference in the delivery of these assets. The Company's history of development success. Viatris' confidence is rooted in the strength of its base business, its deep in-house development capabilities, the diversity of its pipeline and its proven track record of scientific success, including a remarkable list of firsts that have enabled the Company to address some of the world's most enduring health challenges. The Company will review key highlights from its high-margin organic pipeline, which it expects will deliver $450 million to $550 million in revenue in 2024. Overview of selatogrel. Selatogrel, a potentially life-saving medicine, aims to become the first and only self-administered treatment for Acute Myocardial Infarction (AMI), or heart attack, by filling the medical gap between the onset of symptoms and hospitalization when early intervention is critical. The Company will review the pharmacological pro selatogrel and the currently enrolling Selatogrel Outcome Study in suspected Acute Myocardial Infarction (SOS-AMI) global Phase 3 multi-center trial. This cardiovascular outcomes-based trial has received Special Protocol Assessment (SPA) agreement from the U.S. Food and Drug Administration (FDA) and selatogrel has received Fast-Track designation from the FDA. Overview of cenerimod. Cenerimod's novel mechanism of action has the potential to be a differentiated therapy for the treatment of Systemic Lupus Erythematosus (SLE), a chronic and progressive autoimmune disease in constant need of new treatment options that are safe and tolerable. The Company will review key learnings from the comprehensive Phase 2 program that has already been conducted and will review Oral S1P1 Receptor ModUlation in SLE (OPUS), the two ongoing Phase 3 multicenter, randomized, double-blind, placebo-controlled, parallel-group studies designed to evaluate cenerimod's efficacy, safety and tolerability in adult patients with moderate-to-severe SLE in addition to standard background therapy. Cenerimod has also received Fast-Track designation from the FDA. 2024 R&D Event Presenters The event will feature presentations from the following Viatris executives: Scott A. Smith, Chief Executive Officer Rajiv Malik, President Philippe Martin, Chief R&D Officer Doretta Mistras, Chief Financial Officer Expert thought leaders presenting at the event are: Dr. Deepak L. Bhatt, MD, MPH, MBA, FACC, FAHA, FESC, MSCAI, a top expert in cardiovascular medicine and interventional cardiology, is the Director of Mount Sinai Fuster Heart Hospital. Dr. Bhatt is highly recognized for his significant breakthroughs in the field of cardiology, including interventional cardiology, heart disease prevention, vascular medicine and heart failure. Dr. Anca Askanase, MD, founder and clinical director of Columbia University's new Lupus Center and the Director of Rheumatology Clinical Trials. Dr. Askanase is an internationally renowned clinician, diagnostician and researcher with more than 15 years specializing in complex SLE. Dr. Askanase trained as a rheumatologist at New York University (NYU) where she remained for more than 15 years on faculty, directing clinical trials, training fellows and residents and treating challenging cases of SLE at NYU's prestigious hospitals. Webcast Details Interested parties will be able to access a live webcast of the event at investor.viatris.com. An archived version also will be available following the live event and can be accessed at the same location for a limited time. About selatogrel Selatogrel is a potent, fast-acting, reversible and highly selective P2Y12 inhibitor, being developed for the treatment of Acute Myocardial Infarction (AMI), in patients with a history of AMI. It is intended to be self-administered subcutaneously via a drug delivery system (autoinjector). This novel, self-administered emergency agent has the potential to protect heart muscle in the very early phase of an AMI – in the crucial time between symptom onset and first medical attention – so as to treat the ongoing AMI and prevent early death. Viatris is enrolling patients into a large international, double-blind, randomized, placebo-controlled Phase 3 study – Selatogrel Outcome Study in suspected Acute Myocardial Infarction (SOS-AMI) – to assess the clinical efficacy and safety of selatogrel 16 mg when self-administered (on top of standard of care) upon the occurrence of symptoms suggestive of AMI. The primary efficacy endpoint is the occurrence of death from any cause, or non-fatal AMI, after self-administration of the study treatment. A Special Protocol Assessment has been agreed with the FDA, indicating its concurrence with the adequacy and acceptability of critical elements of overall protocol design for a study intended to support a future marketing application. Selatogrel has received Fast-Track designation from the FDA. This designation is intended to promote communication and collaboration between the FDA and pharmaceutical companies for drugs that treat serious conditions and fill an unmet medical need. About cenerimod Cenerimod is a highly-selective S1P1 receptor modulator given as an oral once-daily tablet. Cenerimod potentially offers a novel approach for the treatment of SLE, a disease with a significant impact on patients and limited treatment options. In December 2022, the Oral S1P1 receptor ModUlation in SLE (OPUS) program was initiated, which consists of two multicenter, randomized, double-blind, placebo-controlled, parallel-group Phase 3 studies to evaluate the efficacy, safety and tolerability of cenerimod in adult patients with moderate-to-severe SLE on top of background therapy. The main objectives of the program are to evaluate the effectiveness of cenerimod 4 mg in reducing disease activity, as well as controlling the disease, compared to placebo. The primary endpoint is response on SRI-4 at month 12 compared to baseline. Secondary endpoints include response on BICLA at month 12 compared to baseline and – for the first time in a lupus registration study – measures of sustained disease control: time to first confirmed 4-month sustained mSLEDAI-2K response and time to first confirmed 4-month sustained response in mucocutaneous manifestations (i.e. rash, alopecia, mucosal ulcers). The investigation of cenerimod for the treatment of SLE has received Fast-Track designation from the FDA. This designation is intended to promote communication and collaboration between the FDA and pharmaceutical companies for drugs that treat serious conditions and fill an unmet medical need. About Viatris Viatris Inc. (NASDAQ: VTRS) is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs globally. With a mission to empower people worldwide to live healthier at every stage of life, we provide access at scale, currently supplying high-quality medicines to approximately 1 billion patients around the world annually and touching all of life's moments, from birth to the end of life, acute conditions to chronic diseases. With our exceptionally extensive and diverse portfolio of medicines, a one-of-a-kind global supply chain designed to reach more people when and where they need them, and the scientific expertise to address some of the world's most enduring health challenges, access takes on deep meaning at Viatris. We are headquartered in the U.S., with global centers in Pittsburgh, Shanghai and Hyderabad, India. Learn more at viatris.com and investor.viatris.com, and connect with us on LinkedIn, Instagram, YouTube and X (formerly Twitter). Forward-Looking Statements This press release includes statements that constitute "forward-looking statements." These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward looking statements may include statements regarding how it is continuing to evolve its R&D strategy to deliver on its goal of building a more durable, higher margin portfolio of patented innovation on the foundation of its strong base business; its collaboration with Idorsia, Phase 3 assets selatogrel and cenerimod and key elements of the Company's pipeline; our confidence in our ability to continue to drive future growth and unlock shareholder value comes from our strong base business, well-established global infrastructure, and significant financial flexibility all of which give us the opportunity to continue to evolve our pipeline with the addition of potential blockbuster assets like selatogrel and cenerimod; the addition of high-science programs that deliver novel, meaningful patient impact and address significant unmet patient need will also give us the opportunity to accelerate long-term growth; the collaboration with Idorsia is a great example of Viatris' strategy in action—adding two late-stage potential blockbuster assets, selatogrel and cenerimod—and connecting Idorsia's highly productive drug development team and innovation engine with Viatris' existing infrastructure and experience; the Company's high-margin organic pipeline, which it expects will deliver $450 million to $550 million in revenue in 2024; information about selatogrel and cenerimod, information about clinical trials and studies; that a special protocol assessment has been agreed with the FDA, indicating its concurrence with the adequacy and acceptability of critical elements of overall protocol design for a study intended to support a future marketing application; selatogrel has received fast-track designation from the FDA; the investigation of cenerimod for the treatment of SLE has received fast-track designation from the FDA. Because forward-looking statements inherently involve risks and uncertainties, actual future results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to: actions and decisions of healthcare and pharmaceutical regulators; changes in healthcare and pharmaceutical laws and regulations in the U.S. and abroad; any regulatory, legal or other impediments to Viatris' ability to bring new products to market, including but not limited to "at-risk" launches; Viatris' or its partners' ability to develop, manufacture, and commercialize products; the outcome of clinical trials and studies; the scope, timing and outcome of any ongoing legal proceedings, and the impact of any such proceedings; the possibility that Viatris may be unable to realize the intended benefits of, or achieve the intended goals or outlooks with respect to, its strategic initiatives; the possibility that Viatris may be unable to achieve intended or expected benefits, goals, outlooks, synergies, growth opportunities and operating efficiencies in connection with divestitures, acquisitions, other transactions or restructuring programs, within the expected timeframes or at all; goodwill or impairment charges or other losses related to the divestiture or sale of businesses or assets; Viatris' failure to achieve expected or targeted future financial and operating performance and results; the potential impact of public health outbreaks, epidemics and pandemics; any significant breach of data security or data privacy or disruptions to our information technology systems; risks associated with international operations; the ability to protect intellectual property and preserve intellectual property rights; changes in third-party relationships; the effect of any changes in Viatris' or its partners' customer and supplier relationships and customer purchasing patterns; the impacts of competition; changes in the economic and financial conditions of Viatris or its partners; uncertainties and matters beyond the control of management, including general economic conditions, inflation and exchange rates; failure to execute stock repurchases consistent with current expectations; stock price volatility; and the other risks described in Viatris' filings with the Securities and Exchange Commission (SEC). Viatris routinely uses its website as a means of disclosing material information to the public in a broad, non-exclusionary manner for purposes of the SEC's Regulation Fair Disclosure (Reg FD). Viatris undertakes no obligation to update these statements for revisions or changes after the date of this press release other than as required by law. Company Codes: NASDAQ-NMS:VTRS