S1PR1

Sustained efficacy was confirmed with an annualized relapse rate of 0.098 and 67% of patients were relapse-free at six years Safety was consistent with prior findings and the established safety pro Zeposia with nearly 10 years of clinical experience In a separate DAYBREAK analysis, nearly 97% of followed patients were relapse-free at 90 days post Zeposia discontinuation; patients that did relapse showed no evidence of rebound effect PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol Myers Squibb Company (NYSE: BMY) today announced new results from the Phase 3 DAYBREAK open-label extension trial, demonstrating the long-term efficacy and safety pro Zeposia (ozanimod) in patients with relapsing forms of multiple sclerosis (MS). These data (Poster #P090) and nine additional abstracts will be presented at the 9th annual Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum 2024 in West Palm Beach, Florida taking place February 29 to March 2. In the DAYBREAK long-term extension study, treatment with Zeposia demonstrated a low annualized relapse rate of 0.098. Three- and six-month confirmed disability progression was absent in 82.8% and 84.8% of participants in the trial respectively. At Month 60, the adjusted mean number of new/enlarging T2 lesions per scan (range: 0.79–0.93) and the adjusted mean number of gadolinium-enhancing lesions (0.06–0.08) were similar across patient cohorts. “These DAYBREAK data continue to validate the role of Zeposia in the long-term management of relapsing forms of multiple sclerosis, with two-thirds of patients relapse-free at six years of treatment,” said Bruce Cree, MD, PhD, MAS, study investigator and professor of Clinical Neurology, University of California San Francisco (UCSF) Weill Institute for Neurosciences and Clinical Research Director, UCSF MS Center. “These findings add to our confidence in Zeposia as an important treatment option for people living with the disease, highlighting its efficacy and safety over time.” In the DAYBREAK trial, 2,494 participants were exposed to Zeposia for an average of 60.9 months (12,664.7 person-years); 2,219 participants (89.0%) had any treatment-emergent adverse event (TEAE), 381 (15.3%) had a serious TEAE and 98 (3.9%) discontinued the study due to a TEAE. The most common TEAEs were nasopharyngitis (21.3%), headache (17.1%), COVID-19 infection (16.5%) and upper respiratory tract infection (12.4%). No new safety signals emerged; data from this long-term observational study of patients treated for up to 81.5 months were consistent with the established safety pro Zeposia. Additionally, a separate analysis (Poster #P097) was conducted to assess the risk of rebound after Zeposia discontinuation in the DAYBREAK trial. Five hundred forty-four participants (21.8%) discontinued the study early, while 1,950 participants (78.2%) remained on treatment until the end of the trial. Approximately 2.2% were known to have relapsed after permanently discontinuing Zeposia, with 87.3% of relapses occurring between 29 and 90 days (median time to onset: 61 days) after discontinuation. Nearly all patients were not taking any disease modifying therapy for MS at the time of relapse. Most relapses were mild (n=20 [36.4%]) or moderate (n=34 [61.8%]) and most patients made a complete recovery. No post-treatment relapse was associated with rebound effect, characterized by severe exacerbation of disease or severe persistent increase in disability. “Currently no cure exists for multiple sclerosis, but effective strategies and treatments can help slow disease progression and alleviate symptoms,” said Jonathan Sadeh, MD, MSc, senior vice president and head of global program leaders, Immunology, Cardiovascular and Neuroscience development, Bristol Myers Squibb. “These DAYBREAK efficacy, safety and rebound data underscore a consistent and sustained safety and efficacy pro add to the body of evidence supporting Zeposia’s role in the treatment armamentarium. We remain focused on advancing care and delivering meaningful innovations in neuroscience, including for the millions of people impacted by relapsing forms of multiple sclerosis.” At the ACTRIMS Forum 2024, Bristol Myers Squibb and collaborators will present multiple abstracts that reinforce the company’s growing body of research on Zeposia as a treatment for relapsing forms of MS and unwavering commitment to people living with the disease. Summary of Presentations: Bristol Myers Squibb presentations featured at the ACTRIMS Forum 2024 include: Zeposia clinical abstracts Long-term safety and efficacy of ozanimod in relapsing multiple sclerosis: Final analysis of the DAYBREAK open-label extension study Author: Krzysztof Selmaj Presentation Number: P090 Session Number: Poster session 1 Absence of rebound effect following ozanimod discontinuation among participants in the DAYBREAK open-label extension study Author: Ralf Gold Presentation Number: P097 Session: Poster session 1 Patient-reported outcomes after 1 year of ozanimod use for early relapsing multiple sclerosis: An interim analysis of the ENLIGHTEN study Author: Sarah Morrow Presentation Number: P433 Session: Poster session 2 Baseline predictors of long-term disability progression in ozanimod-treated participants with relapsing multiple sclerosis from the SUNBEAM, RADIANCE, and DAYBREAK trials Author: Hans-Peter Hartung Presentation Number: P096 Session: Poster session 1 Changes in cognitive functioning over 1 year in ozanimod-treated patients with early relapsing multiple sclerosis: An interim analysis of the ENLIGHTEN study Author: John DeLuca Presentation Number: P354 Session: Poster session 2 Long-term efficacy of ozanimod in disease-modifying treatment–naive vs experienced patients with relapsing multiple sclerosis Author: Diego Centonze Presentation Number: P092 Session: Poster session 1 Long-term efficacy of the sphingosine 1-phosphate receptor modulator ozanimod by age category in patients with relapsing multiple sclerosis: Final results from two Phase 3 trials and an open-label extension trial Author: Bruce Cree Presentation Number: P091 Session: Poster session 1 Effects of ozanimod on cognitive processing speed: Updated findings from the Phase 3 SUNBEAM and DAYBREAK extension trials Author: John DeLuca Presentation Number: P353 Session: Poster session 2 Zeposia MS health economics outcomes research abstracts Real-world clinical outcomes for disease-modifying therapy–naïve and experienced patients with multiple sclerosis treated with ozanimod: A U.S. retrospective medical chart review Author: Damemarie Paul Presentation Number: P477 Session: Poster session 2 Ozanimod use in patients with multiple sclerosis treated in a large U.S. healthcare system: A retrospective case series Author: Jennifer Hadlock Presentation Number: P478 Session: Poster session 2 Bristol Myers Squibb thanks the patients and investigators who have participated in Zeposia clinical trials. About DAYBREAK DAYBREAK was a Phase 3, multi-center, long-term open-label extension study to evaluate the safety and efficacy of Zeposia (ozanimod) administered orally to patients with relapsing forms of multiple sclerosis (RMS). Eligible patients from the RADIANCE, SUNBEAM and RPC01-1001 trials diagnosed with RMS were enrolled to receive treatment until the end of the DAYBREAK. Patients in the trial received Zeposia 0.92 mg (equivalent to 1 mg). About Multiple Sclerosis Multiple sclerosis (MS) is a disabling, unpredictable disease in which the immune system attacks the protective myelin sheath that covers the nerves. The myelin damage disrupts communication between the brain and the rest of the body. Ultimately, the nerves themselves may deteriorate—a process that's currently irreversible. MS affects 700,000 people in Europe and approximately 2.9 million people worldwide. Relapsing forms of MS (RMS), including clinically isolated syndrome, relapsing remitting disease and active secondary progressive disease, is characterized by clearly defined attacks of worsening neurologic function. These attacks—often called relapses, flare-ups or exacerbations—are followed by partial or complete recovery periods. During these recovery periods, also called remissions, symptoms improve partially or completely with no apparent progression of disease. However, smoldering neuroinflammation can be present from the earliest stages of MS, which is underlying and continuous disease activity occurring simultaneously in different areas of the brain that contributes to disability accumulation. Since MS relapses are unpredictable, patients can feel frustrated, stressed or scared when they occur. RMS is the most common disease course at the time of diagnosis. Approximately 85% of patients are initially diagnosed with RMS, compared with 10%-15% diagnosed with progressive forms of the disease. Bristol Myers Squibb: Delivering Breakthrough Science for Meaningful Interventions in Neuroscience Neurological conditions represent some of the greatest challenges of our time because of their impact on society, including patients, caregivers, families and healthcare systems. At Bristol Myers Squibb, we are committed to advancing our robust pipeline of potential medicines for neurological disorders with the goal of modifying disease and improving quality of life. Leveraging genetics, biomarkers and predictive sciences, we target key pathways involved in the initiation and progression of neurological diseases to develop therapies with the potential to optimize patient outcomes. About Zeposia (ozanimod) Zeposia (ozanimod) is an oral, sphingosine 1-phosphate (S1P) receptor modulator that binds with high affinity to S1P receptors 1 and 5. Zeposia blocks the capacity of lymphocytes to egress from lymph nodes, reducing the number of lymphocytes in peripheral blood. The mechanism by which Zeposia exerts therapeutic effects in multiple sclerosis (MS) is unknown but may involve the reduction of lymphocyte migration into the central nervous system. Zeposia is approved in numerous countries around the world for the treatment of adults with relapsing forms of MS and adults with moderately to severely active ulcerative colitis. U.S. FDA APPROVED INDICATIONS ZEPOSIA® (ozanimod) is indicated for the treatment of: Relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. Moderately to severely active ulcerative colitis (UC) in adults. IMPORTANT SAFETY INFORMATION Contraindications: Patients who in the last 6 months, experienced myocardial infarction, unstable angina, stroke, transient ischemic attack (TIA), decompensated heart failure requiring hospitalization, or Class III/IV heart failure or have a presence of Mobitz type II second-degree or third-degree atrioventricular (AV) block, sick sinus syndrome, or sino-atrial block, unless the patient has a functioning pacemaker Patients with severe untreated sleep apnea Patients taking a monoamine oxidase (MAO) inhibitor Infections: ZEPOSIA may increase the susceptibility to infections. Life-threatening and rare fatal infections have occurred in patients receiving ZEPOSIA. Obtain a recent (i.e., within 6 months or after discontinuation of prior MS or UC therapy) complete blood count (CBC) including lymphocyte count before initiation of ZEPOSIA. Delay initiation of ZEPOSIA in patients with an active infection until the infection is resolved. Consider interruption of treatment with ZEPOSIA if a patient develops a serious infection. Continue monitoring for infections up to 3 months after discontinuing ZEPOSIA. Herpes zoster was reported as an adverse reaction in ZEPOSIA-treated patients. Herpes simplex encephalitis and varicella zoster meningitis have been reported with sphingosine 1-phosphate (S1P) receptor modulators. Patients without a healthcare professional-confirmed history of varicella (chickenpox), or without documentation of a full course of vaccination against varicella zoster virus (VZV), should be tested for antibodies to VZV before initiating ZEPOSIA. A full course of vaccination for antibody-negative patients with varicella vaccine is recommended prior to commencing treatment with ZEPOSIA. Cases of fatal cryptococcal meningitis (CM) were reported in patients treated with another S1P receptor modulator. If CM is suspected, ZEPOSIA should be suspended until cryptococcal infection has been excluded. If CM is diagnosed, appropriate treatment should be initiated. In the MS and UC clinical studies, patients who received ZEPOSIA were not to receive concomitant treatment with antineoplastic, non-corticosteroid immunosuppressive, or immune-modulating therapies used for treatment of MS and UC. Concomitant use of ZEPOSIA with any of these therapies would be expected to increase the risk of immunosuppression. When switching to ZEPOSIA from immunosuppressive medications, consider the duration of their effects and their mode of action to avoid unintended additive immunosuppressive effects. Use of live attenuated vaccines should be avoided during and for 3 months after treatment with ZEPOSIA. If live attenuated vaccine immunizations are required, administer at least 1 month prior to initiation of ZEPOSIA. Progressive Multifocal Leukoencephalopathy (PML): PML is an opportunistic viral infection of the brain that typically occurs in patients who are immunocompromised, and that usually leads to death or severe disability. PML has been reported in patients treated with S1P receptor modulators, including ZEPOSIA, and other MS and UC therapies and has been associated with some risk factors. If PML is suspected, withhold ZEPOSIA and perform an appropriate diagnostic evaluation. If confirmed, treatment with ZEPOSIA should be discontinued. Immune reconstitution inflammatory syndrome (IRIS) has been reported in MS patients treated with S1P receptor modulators who developed PML and subsequently discontinued treatment. IRIS presents as a clinical decline in the patient’s condition that may be rapid, can lead to serious neurological complications or death, and is often associated with characteristic changes on MRI. The time to onset of IRIS in patients with PML was generally within a few months after S1P receptor modulator discontinuation. Monitoring for development of IRIS and appropriate treatment of the associated inflammation should be undertaken. Bradyarrhythmia and Atrioventricular Conduction Delays: Since initiation of ZEPOSIA may result in a transient decrease in heart rate and atrioventricular conduction delays, dose titration is recommended to help reduce cardiac effects. Initiation of ZEPOSIA without dose escalation may result in greater decreases in heart rate. If treatment with ZEPOSIA is considered, advice from a cardiologist should be sought for those individuals: with significant QT prolongation with arrhythmias requiring treatment with Class 1a or III anti-arrhythmic drugs with ischemic heart disease, heart failure, history of cardiac arrest or myocardial infarction, cerebrovascular disease, and uncontrolled hypertension with a history of Mobitz type II second-degree or higher AV block, sick sinus syndrome, or sino-atrial heart block Liver Injury: Elevations of aminotransferases may occur in patients receiving ZEPOSIA. Obtain liver function tests, if not recently available (i.e., within 6 months), before initiation of ZEPOSIA. Patients who develop symptoms suggestive of hepatic dysfunction should have hepatic enzymes checked and ZEPOSIA should be discontinued if significant liver injury is confirmed. Fetal Risk: There are no adequate and well-controlled studies in pregnant women. Based on animal studies, ZEPOSIA may cause fetal harm. Women of childbearing potential should use effective contraception to avoid pregnancy during treatment and for 3 months after stopping ZEPOSIA. Women who become pregnant while taking ZEPOSIA for MS may enroll in the ZEPOSIA pregnancy registry by calling 1-877-301-9314 or visiting . Increased Blood Pressure: Increase in systolic pressure was observed after about 3 months of treatment and persisted throughout treatment. Blood pressure should be monitored during treatment and managed appropriately. Certain foods that may contain very high amounts of tyramine could cause severe hypertension in patients taking ZEPOSIA. Patients should be advised to avoid foods containing a very large amount of tyramine while taking ZEPOSIA. Respiratory Effects: ZEPOSIA may cause a decline in pulmonary function. Spirometric evaluation of respiratory function should be performed during therapy, if clinically indicated. Macular Edema: S1P modulators have been associated with an increased risk of macular edema. Patients with a history of uveitis or diabetes mellitus are at increased risk. Patients with a history of these conditions should have an ophthalmic evaluation of the fundus, including the macula, prior to treatment initiation and regular follow-up examinations. An ophthalmic evaluation is recommended in all patients at any time if there is a change in vision. Continued use of ZEPOSIA in patients with macular edema has not been evaluated; potential benefits and risks for the individual patient should be considered if deciding whether ZEPOSIA should be discontinued. Posterior Reversible Encephalopathy Syndrome (PRES): Rare cases of PRES have been reported in patients receiving a S1P receptor modulator. If a ZEPOSIA-treated patient develops unexpected neurological or psychiatric symptoms or any symptom/sign suggestive of an increase in intracranial pressure, a complete physical and neurological examination should be conducted. Symptoms of PRES are usually reversible but may evolve into ischemic stroke or cerebral hemorrhage. Delay in diagnosis and treatment may lead to permanent neurological sequelae. If PRES is suspected, treatment with ZEPOSIA should be discontinued. Unintended Additive Immunosuppressive Effects From Prior Immunosuppressive or Immune-Modulating Drugs: When switching from drugs with prolonged immune effects, the half-life and mode of action of these drugs must be considered to avoid unintended additive immunosuppressive effects while at the same time minimizing risk of disease reactivation. Initiating treatment with ZEPOSIA after treatment with alemtuzumab is not recommended. Severe Increase in Multiple Sclerosis (MS) Disability After Stopping ZEPOSIA: In MS, severe exacerbation of disease, including disease rebound, has been rarely reported after discontinuation of a S1P receptor modulator. The possibility of severe exacerbation of disease should be considered after stopping ZEPOSIA treatment so patients should be monitored upon discontinuation. After stopping ZEPOSIA in the setting of PML, monitor for development of immune reconstitution inflammatory syndrome (PML-IRIS). Immune System Effects After Stopping ZEPOSIA: After discontinuing ZEPOSIA, the median time for lymphocyte counts to return to the normal range was 30 days with approximately 90% of patients in the normal range within 3 months. Use of immunosuppressants within this period may lead to an additive effect on the immune system, therefore caution should be applied when initiating other drugs 4 weeks after the last dose of ZEPOSIA. Most Common Adverse Reactions that occurred in the MS clinical trials of ZEPOSIA-treated patients (≥4%): upper respiratory infection, hepatic transaminase elevation, orthostatic hypotension, urinary tract infection, back pain, and hypertension. In the UC clinical trials, the most common adverse reactions that occurred in ≥4% of ZEPOSIA-treated patients and greater than in patients who received placebo were upper respiratory infection, liver test increased, and headache. Use in Specific Populations: Hepatic Impairment: Dosage adjustment in patients with mild or moderate hepatic impairment (Child-Pugh class A or B) is required, and use of ZEPOSIA in patients with severe hepatic impairment (Child-Pugh class C) is not recommended. For additional safety information, please see the full Prescribing Information and Medication Guide. About Bristol Myers Squibb Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube, Facebook and Instagram. Cautionary Statement Regarding Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, the research, development and commercialization of pharmaceutical products. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements. Such forward-looking statements are based on current expectations and projections about our future financial results, goals, plans and objectives and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years, that are difficult to predict, may be beyond our control and could cause our future financial results, goals, plans and objectives to differ materially from those expressed in, or implied by, the statements. These risks, assumptions, uncertainties and other factors include, among others, that results of future post-marketing studies will be consistent with the results of this study, that Zeposia (ozanimod) for the additional indication described in this release may not be commercially successful, any marketing approvals, if granted, may have significant limitations on their use, and that continued approval of such treatment for such additional indication may be contingent upon verification and description of clinical benefit in additional confirmatory trials. No forward-looking statement can be guaranteed. Forward-looking statements in this press release should be evaluated together with the many risks and uncertainties that affect Bristol Myers Squibb’s business and market, particularly those identified in the cautionary statement and risk factors discussion in Bristol Myers Squibb’s Annual Report on Form 10-K for the year ended December 31, 2023, as updated by our subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the Securities and Exchange Commission. The forward-looking statements included in this document are made only as of the date of this document and except as otherwise required by applicable law, Bristol Myers Squibb undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise. corporatefinancial-news

Expands Viatris' Portfolio of Innovative Assets by Immediately Adding Two Phase 3 Assets, Selatogrel and Cenerimod, Both With Blockbuster Revenue Potential Includes Future Optionality to Expand Collaboration With Additional Innovative Assets Combines Viatris' Financial Strength and Worldwide Operational Infrastructure With Idorsia's Proven, Highly Productive Drug Development Team and Innovation Engine Deal Structure Reinforces Viatris' Disciplined Approach to Capital Allocation Viatris Announces R&D Event to be Held March 27, 2024 PITTSBURGH, Feb. 28, 2024 /PRNewswire/ -- Viatris Inc. (NASDAQ: VTRS), a global healthcare company, and Idorsia Ltd (SIX: IDIA) today announced they have entered into agreements for a significant global research and development collaboration under which Viatris will receive exclusive global development and commercialization rights to two Phase 3 assets as well as the potential to add additional innovative assets in the future. The collaboration includes selatogrel, a potential life-saving self-administered medicine for patients with a history of acute myocardial infarction (AMI), or heart attack, and builds on Viatris' existing global cardiovascular franchise and specialty infrastructure, as well as its knowledge, leadership, and distribution capabilities for self-administered medication for acute life-threatening conditions. The collaboration also includes cenerimod, a novel immunology asset that has the potential to be a first-in-class oral therapy for the treatment of systemic lupus erythematosus (SLE), the most common form of lupus. Through lifecycle management, this asset also has the potential for broad application across multiple autoimmune diseases in a specialist-driven category with attractive market dynamics for oral therapies and could be a cornerstone asset in Viatris' immunology platform. Viatris CEO Scott A. Smith said: "I am extremely pleased with our global research and development collaboration with Idorsia. We are connecting Idorsia's proven, highly productive drug development team and innovation engine with Viatris' strong global infrastructure and experience to focus on two late-stage potential blockbuster assets with long-dated patent protection. I believe that together we will be able to execute on the potential of these global assets, and any future assets, as we work to deliver on our goal of building a more durable, predictable portfolio on the foundation of our strong base business, and that selatogrel and cenerimod can become meaningful components of Viatris' business over the long term. Smith continued: "As I have said previously, in addition to continuing to develop the three core therapeutic areas that we identified—ophthalmology, dermatology and GI—we are also going to be opportunistic in seeking out assets that we believe fit our company well and have the potential to contribute significantly to our future revenue growth. Entering into this type of global research and development partnership structure with Idorsia is a great example of our disciplined approach to capital allocation." Viatris Chief R&D Officer Philippe Martin said: "I am excited to have the opportunity to work with Idorsia's talented drug development team who are essential to the execution of these clinical programs. Both selatogrel and cenerimod have the potential to be important medicines by providing significant advances for patients suffering with life-altering disease. Selatogrel has the potential to become the first self-administered treatment for recurring AMI that fills the medical gap during the pre-hospital phase of a life-threatening condition. Cenerimod has the potential to fill the need for a more tolerable and effective treatment for SLE, in combination with standard therapy, earlier in disease progression." Idorsia CEO Jean-Paul Clozel, MD, said: "I'm delighted that with Viatris we have found a strong partner to secure and accelerate the development programs for both selatogrel and cenerimod by leveraging the strength of Viatris' global infrastructure. From the first meeting, it was clear that the team at Viatris shares the same excitement and engagement for our innovations. This global collaboration allows us to share the costs of the ongoing Phase 3 programs whilst retaining long-term shareholder value, by sharing the rewards for success through the milestones and royalties." Terms of the Transaction Under the terms of the agreements, the development programs and certain personnel for selatogrel and cenerimod will be transferred to Viatris in exchange for an upfront payment to Idorsia of $350 million, 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. Viatris and Idorsia will both contribute to the development costs for both programs. Viatris will have worldwide commercialization rights for both selatogrel and cenerimod (excluding, for cenerimod only, Japan, South Korea and certain countries in the Asia-Pacific region) and intends to utilize its Global Healthcare Gateway® infrastructure to bring access to patients worldwide. A joint development committee will oversee the development of the ongoing Phase 3 programs through regulatory approval. The agreements also provide Viatris a right of first refusal and a right of first negotiation for certain other assets in Idorsia's pipeline. The closing of the transaction is subject to certain limited closing conditions, but no additional regulatory or shareholder approvals are required. The transaction is expected to close at the end of March. Citi is acting as financial advisor to Viatris. R&D Event Viatris will hold an R&D Event on March 27, 2024, from 10 a.m. to noon ET, in New York City. The event will include presentations from Viatris executives discussing the global research and development collaboration with Idorsia and other elements of the Company's pipeline, as well as presentations from two expert thought leaders. The presenters will be available to answer questions at the end of the presentations. Expert thought leaders presenting at the event are: Dr. Deepak L. Bhatt, MD, MPH, a top expert in cardiovascular medicine and interventional cardiology, Director of Mount Sinai Heart. 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 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. Interested parties will be able to access a live webcast of the event at investor.viatris.com. An archived version 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. Idorsia 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. In addition, the FDA designated the investigation of selatogrel for the treatment of suspected AMI as a "fast-track" development program. 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, the result of 20 years of research in Idorsia's labs, is a highly selective S1P1 receptor modulator, given as an oral once-daily tablet. Cenerimod potentially offers a novel approach for the treatment of systemic lupus erythematosus (SLE), a disease with a significant impact on patients and limited treatment options. In December 2022, Idorsia initiated the OPUS program (Oral S1P1 Receptor ModUlation in SLE), 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 been designated as a "fast-track" development program by 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 Idorsia Idorsia 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 20-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 800 highly qualified specialists dedicated to realizing our ambitious targets. 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 Viatris and Idorsia entering into a significant global research and development collaboration; expanding Viatris' portfolio of innovative assets by immediately adding two Phase 3 assets, selatogrel and cenerimod, both with blockbuster revenue potential; includes future optionality to expand collaboration with additional innovative assets; combines Viatris' financial strength and worldwide operational infrastructure with Idorsia's proven, highly productive drug development team and innovation engine; deal structure reinforces Viatris' disciplined approach to capital allocation; R&D investor event to be held March 27, 2024; information about selatogrel and cenerimod; cenerimod could be a cornerstone asset in Viatris' immunology platform; we are connecting Idorsia's proven, highly productive drug development team and innovation engine with Viatris' strong global infrastructure and experience to focus on two late-stage potential blockbuster assets with long-dated patent protection; believe that together we will be able to execute on the potential of these global assets, and any future assets, as we work to deliver on our goal of building a more durable, predictable portfolio on the foundation of our strong base business, and that selatogrel and cenerimod can become meaningful components of Viatris' business over the long term; in addition to continuing to develop the three core therapeutic areas that we identified—ophthalmology, dermatology and GI—we are also going to be opportunistic in seeking out assets that we believe fit our company well and have the potential to contribute significantly to our future revenue growth; entering into this type of global research and development partnership structure with Idorsia is a great example of our disciplined approach to capital allocation; both selatogrel and cenerimod have the potential to be important medicines by providing significant advances for patients suffering with life-altering disease; selatogrel has the potential to become the first self-administered treatment for recurring AMI that fills the medical gap during the pre-hospital phase of a life-threatening condition; cenerimod has the potential to fill the need for a more tolerable and effective treatment for SLE, in combination with standard therapy, earlier in disease progression; the development programs and certain personnel for selatogrel and cenerimod will be transferred to Viatris in exchange for an upfront payment to Idorsia of $350 million, 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; Viatris and Idorsia will both contribute to the development costs for both programs; Viatris will have worldwide commercialization rights for both selatogrel and cenerimod (excluding, for cenerimod only, Japan, South Korea and certain countries in the Asia-Pacific region) and intends to utilize its Global Healthcare Gateway® infrastructure to bring access to patients worldwide; a joint development committee will oversee the development of the ongoing Phase 3 programs through regulatory approval; the agreements also provide Viatris a right of first refusal and a right of first negotiation for certain other assets in Idorsia's pipeline; the closing of the transaction is subject to certain limited closing conditions, but no additional regulatory or shareholder approvals are required the transaction is expected to close at the end of March. 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: 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; 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 scope, timing and outcome of any ongoing legal proceedings, and the impact of any such proceedings; 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 release other than as required by law. SOURCE Viatris Inc.

Ad hoc announcement pursuant to Art. 53 LR Viatris and Idorsia will collaborate on the global development and commercialization of two Phase 3 assets, selatogrel and cenerimod. Idorsia to receive an upfront payment of USD 350 million, potential development and regulatory milestone payments, additional sales milestone payments and tiered royalties on annual net sales. Viatris and Idorsia will both contribute to the development costs for both programs. Includes future optionality to expand collaboration with additional pipeline assets. Combines Viatris’ financial strength and worldwide operational infrastructure with Idorsia’s proven, highly productive drug development team and innovative engine. Allschwil, Switzerland – February 28, 2024 Idorsia Ltd (SIX: IDIA) today announced that it has entered into agreements for a significant global research and development collaboration with Viatris Inc. (NASDAQ: VTRS), a global healthcare company, for the global development and commercialization of two Phase 3 assets – selatogrel and cenerimod – for an upfront payment of USD 350 million, potential development and regulatory milestone payments, and certain contingent payments of additional sales milestone payments and tiered royalties from mid-single- to low double-digit percentage on annual net sales. A joint development committee will oversee the development of the ongoing Phase 3 programs for selatogrel and cenerimod through regulatory approval. Idorsia will contribute up to USD 200 million in the next 3 years and will transfer to Viatris at closing the dedicated personnel to both programs. Viatris will have 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. The company expects to close the transaction by the end of March, subject to customary closing conditions, but no additional regulatory or shareholder approvals are required. Jean-Paul Clozel, MD and Chief Executive Officer of Idorsia, commented: “I’m delighted that with Viatris we have found a strong partner to secure and accelerate the development programs for both selatogrel and cenerimod by leveraging the strength of Viatris’ global infrastructure. From the first meeting, it was clear that the team at Viatris shares the same excitement and engagement for our innovations. This global collaboration allows us to share the costs of the ongoing Phase 3 programs whilst retaining long-term shareholder value, by sharing the rewards for success through the milestones and royalties.” Scott A. Smith, Chief Executive Officer of Viatris, commented: “I am extremely pleased with our global research and development collaboration with Idorsia. We are connecting Idorsia’s proven, highly productive drug development team and innovation engine with Viatris’ strong global infrastructure and experience to focus on two late-stage potential blockbuster assets with long-dated patent protection. I believe that together we will be able to execute on the potential of these global assets and any future assets as we work to deliver on our goal of building a more durable, predictable portfolio on the foundation of our strong base business, and that selatogrel and cenerimod can become meaningful components of Viatris’ business over the long term.” André C. Muller, Chief Financial Officer of Idorsia, commented: “In the coming weeks and months, we have many inflection points ahead, namely the FDA and CHMP decisions for aprocitentan, as well as expanded access and availability of QUVIVIQ (daridorexant) in the US, Canada and across Europe.” André continued: “The upfront payment of USD 350 million gives us much needed liquidity. We’ve repeatedly explained that we have many balls in the air, we’ve now caught the first one and continue to work on others to secure Idorsia’s future. We are working on several funding options, including business development opportunities, equity, and equity-linked deals to significantly extend our cash runway.” Notes to the editor 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. Idorsia 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. In addition, the FDA designated the investigation of selatogrel for the treatment of suspected AMI as a “fast-track” development program. 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, the result of 20 years of research in Idorsia’s labs, is a highly selective S1P1 receptor modulator, given as an oral once-daily tablet. Cenerimod potentially offers a novel approach for the treatment of systemic lupus erythematosus (SLE), a disease with a significant impact on patients and limited treatment options. In December 2022, Idorsia initiated the OPUS program (Oral S1P1 Receptor ModUlation in SLE), 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 compard 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 been designated as a “fast-track” development program by 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). About Idorsia Idorsia 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 20-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 800 highly qualified specialists dedicated to realizing our ambitious targets. 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