EMD Serono Shares Advances in MS Portfolio with Key Efficacy and Safety Data at AAN 2022

New Phase II data show evobrutinib sustained low annualized relapse rates (ARRs) and had no new safety signals at 2.5 years – the longest follow-up of any Bruton’s tyrosine kinase inhibitor in multiple sclerosis (MS) Updated safety data continue to demonstrate patients treated with MAVENCLAD® (cladribine) tablets for their MS who have confirmed or suspected COVID-19 had mild to moderate disease symptoms and no increased risk of serious outcomes A retrospective analysis of real-world data from the GLIMPSE study shows MAVENCLAD had lower ARRs and lower risk of relapse than fingolimod, dimethyl fumarate and teriflunomide in relapsing MS patients EMD Serono, the Healthcare business sector of Merck KGaA, Darmstadt, Germany, in the U.S. and Canada, today announced 13 abstracts from the Company’s multiple sclerosis (MS) portfolio will be presented at the 2022 American Academy of Neurology (AAN) Annual Meeting, being held April 2-7. Data being presented include presentations on investigational Bruton’s tyrosine kinase (BTK) inhibitor evobrutinib, including new 2.5-year efficacy and safety data in patients with relapsing multiple sclerosis (RMS) from a Phase II open-label extension study and a Phase II post-hoc analysis demonstrating that treatment with evobrutinib led to a reduction in slowly expanding lesions (SEL), which may be associated with chronic inflammation in the central nervous system (CNS). Additionally, retrospective real-world efficacy and safety data on MAVENCLAD® (cladribine) tablets will be presented, including relapse data compared to other oral disease modifying therapies (DMTs) as well as COVID-19 outcomes. “Focusing on the needs of people with MS is at the heart of everything we do. This includes innovative research with real-world data to better understand the effectiveness of MAVENCLAD in clinical practice to help inform treatment decisions,” said Jan Klatt, Senior Vice President, Head of Development Unit Neurology & Immunology, Merck KGaA, Darmstadt, Germany. “Additionally, we are working tirelessly on the future of MS treatments with evobrutinib, which targets both acute and potentially also chronic inflammation to prevent disease progression and achieve better outcomes for patients. With new evobrutinib data at AAN, we now have two and a half years of efficacy and safety data in patients with relapsing MS from the largest Phase II BTK inhibitor clinical trial.” Key evobrutinib data include: Safety and efficacy results from the evobrutinib Phase II open-label extension, finding no new safety signals and maintained efficacy (annualized relapse rate of 0.12 for patients receiving evobrutinib 75mg twice-daily in the 48-week double-blind period) over 2.5 years in patients with RMS Data from a post-hoc analysis in the Phase II trial with evobrutinib demonstrating a reduction in volume of SELs, an in-vivo magnetic resonance imaging (MRI) correlate with chronic active inflammation and axonal loss within the CNS, which may be predictive of subsequent clinical disease progression in MS Key MAVENCLAD® (cladribine) tablets data include: Data from the Phase IV CLARIFY-MS and MAGNIFY-MS studies demonstrating MS patients treated with MAVENCLAD who acquired COVID-19 typically experienced mild to moderate disease symptoms/effects with no increased risk of serious outcomes from COVID-19 infection Data from the GLIMPSE study*, a longitudinal, retrospective analysis of adult patients identified with RMS from the MSBase Registry, showing MAVENCLAD had lower annualized relapse rates and lower risk of relapse than fingolimod, dimethyl fumarate and teriflunomide in RMS patients Additional Company activities at AAN 2022: Industry Therapeutic Update 1: “Early DMT Switch Considerations in MS and Discussing the Capacity to Mount an Immune Response” chaired by Ann Bass, MD, Medical Director of the comprehensive MS clinic at the Neurology Center of San Antonio (April 2, 7-8:30 p.m. PDT, Grand Ballroom, Sheraton Grand, Seattle) Industry Therapeutic Update 2: “Seeing What’s Unseen in MS” chaired by Jiwon Oh, MD, PhD, Medical Director, BARLO MS Centre, St. Michael’s Hospital, Toronto (April 4, 7-10 p.m. PDT, Grand Ballroom, Sheraton Grand, Seattle) In addition to the data being presented at AAN, EMD Serono launched a new educational initiative for neurologists on the potential role of BTK in MS. The initiative “BTK and MS” focuses on three key areas: the lack of control over chronic neuroinflammation for those living with MS, the challenges healthcare providers face in measuring disease progression, and the potential role of BTK in MS pathology. To keep up to date with our activities at AAN along with future data and information, follow us on Twitter @EMDSerono and LinkedIn: EMD Serono, Inc. #AANAM #MSInsideOut Below is the full list of EMD Serono-related abstracts accepted for presentation at AAN 2022: Evobrutinib Oral Presentations: Abstract Name Authors Presentation Details Effects of Evobrutinib, a Bruton's Tyrosine Kinase Inhibitor, on Slowly Expanding Lesions, an Emerging Imaging Marker of Chronic Tissue Loss in Multiple Sclerosis Arnold D, Elliott C, Montalban X et al. Program ID: 009 Session: S24 - MS Therapeutics Date: April 4, 2022 Time: 5:06 pm PDT/8:06 pm EDT Presenter: Arnold D Safety Profile Characterization of Evobrutinib in Over 1000 Patients from Phase II Clinical Trials in Multiple Sclerosis, Rheumatoid Arthritis and Systemic Lupus Erythematosus Montalban X, Wallace D, Genovese MC et al. Program ID: 007 Session: S14 - MS Therapeutics Date: April 4, 2022 Time: 4:42 pm PDT/7:42 pm EDT Presenter: Montalban X Evobrutinib Poster Presentations: Abstract Name Authors Presentation Details Safety and Efficacy of Evobrutinib, a Bruton’s Tyrosine Kinase Inhibitor in Relapsing Multiple Sclerosis Over 2.5 Years of the Open-label Extension to a Phase II Trial Montalban X, Wolinsky JS, Arnold DL et al. Program ID: 001 Neighborhood: 4 Session: P5 - MS Clinical Trials and Therapeutics 1 Date: April 3, 2022 Time: 11:45 am-12:45 pm PDT/2:45 pm-3:45 pm EDT Presenter: Montalban X The Role of Human and Mouse BTK in Myeloid Cells Bassani C, Molinari M, Martinielli V et al. Program ID: 006 Session: P3 - MS Immunology and Basic Science 1 Date: April 2, 2022 Time: 5:30 pm-6:30 pm PDT/8:30 pm-9:30 pm EDT Presenter: Muzio L MAVENCLAD® (cladribine) tablets Poster Presentations: Abstract Name Authors Presentation Details Clinical Outcomes in Patients With COVID-19 During Two Phase IV Studies of Cladribine Tablets for Treatment of Multiple Sclerosis: An Update Yavorskaya V, Karan R, Borsi L et al. Program ID: 005 Neighborhood: 4 Session: P11 - MS COVID 2 Date: April 5, 2022 Time: 11:45 am-12:45 pm PDT/2:45 pm-3:45 pm EDT Presenter: Salloukh H Real-world Comparative Effectiveness and Persistence of Cladribine Tablets and Other Oral Disease-modifying Treatments for Multiple Sclerosis from GLIMPSE: Results from the MSBase Registry Butzkueven H, Spelman T, Ozakbas S et al. Program ID: 003 Neighborhood: 4 Session: P12 - MS Clinical Practice & Decision Making 4 Date: April 5, 2022 Time: 5:30 pm-6:30 pm PDT/8:30 pm-9:30 pm EDT Presenter: Verdun Di Cantogno E Comparative Effectiveness of Cladribine versus Fingolimod in the Treatment of Highly Active Relapsing Multiple Sclerosis: The MERLYN (MavEnclad Real worLd comparative efficacy Non-iNterventional) Study Brownlee W, Haghikia A, Hayward B et al. Program ID: 005 Neighborhood: 4 Session: P7 - MS Clinical Trials & Therapeutics 3 Date: April 4, 2022 Time: 8:00 am-9:00 am PDT/11:00 am-12:00 pm EDT Presenter: Brownlee W Cladribine Tablets In Patients With Relapsing Remitting Multiple Sclerosis Or Active Secondary Progressive Multiple Sclerosis After Suboptimal Response To A Disease Modifying Therapy (CLICK-MS and MASTER-2): Interim Baseline And Safety Review Aldridge J, Bass A, Evans E et al. Date: April 24-27, 2022 Virtual e-Poster Presenting: Miravalle A Rebif® (interferon beta-1a) subcutaneous injection Poster Presentations: Abstract Name Authors Presentation Details Exploratory Analysis of Serum GDF-15 Levels in Patients Receiving Subcutaneous Interferon β-1a in the REFLEX Trial Coray M, Seitzinger A, Roy S et al. Program ID: 007 Neighborhood: 4 Session: P2 - MS Biomarkers Date: April 2, 2022 Time: 11:45 am-12:45 pm PDT/2:45 pm-3:45 pm EDT Presenter: Verdun di Cantogno E Post-approval Safety of Subcutaneous Interferon Β-1a in the Treatment of Multiple Sclerosis, With Particular Reference to Respiratory Viral Infections Freedman MS, Todorović M, Murgašová Z et al. Program ID: 005 Neighborhood: 4 Session: P8 - MS Therapeutics MOA and Safety 3 Date: April 4, 2022 Time: 11:45 am-12:45 pm PDT/2:45 pm-3:45 pm EDT Presenter: Korick J INFORM - Interferon beta Exposure in the 2nd and 3rd Trimester of Pregnancy a – Register-Based Drug Utilisation Study in Finland and Sweden Sabidó M, Suzart Woischnik K, Grimes N et al.Program ID: 009 Neighborhood: 4 Session: P8 - MS Special Populations 2 Date: April 4, 2022 Time: 11:45 am-12:45 pm PDT/2:45 pm-3:45 pm EDT Presenter: Verdun de Cantogno E Non-Product Specific Poster Presentations: Abstract Name Authors Presentation Details Patient Practices and Experiences During COVID-19 Among Individuals Enrolled in MS LifeLines Patient Support Program Costantino H, Lebson L, Mackie dMS et al. Date: April 24-27, 2022 Virtual e-Poster Presenting: Nicholas J A Cross-Sectional Survey Evaluating Cladribine Tablets Treatment Patterns Among Patients with Multiple Sclerosis Enrolled in the MS LifeLines Patient Support Program Nicholas J, Mackie dMS, Castantino H et al. Date: April 24-27, 2022 Virtual e-Poster Presenting: Nicholas J *Previously presented at ACTRIMS 2022

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