EMD Serono Showcases Depth of MS Portfolio at ECTRIMS Supporting Commitment to Advancing MS Care

Company’s scientific leadership will be highlighted in 39 abstracts presented across its multiple sclerosis (MS) portfolio Data on investigational BTK inhibitor evobrutinib demonstrate long-term disease stability in people living with relapsing MS (RMS) Phase IV study highlights improvement in measures of Quality of Life in people living with RMS after two years of treatment with MAVENCLAD® (cladribine) tablets EMD Serono, the Healthcare business sector of Merck KGaA, Darmstadt, Germany, in the U.S. and Canada, today announced the company will present 39 abstracts at the 38th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), being held October 26-28, 2022 in Amsterdam, the Netherlands. The breadth of data highlights the Company’s scientific leadership in multiple sclerosis (MS) and includes a presentation on a clinical trial with long-term data on Expanded Disability Status Scale (EDSS) scores in people with relapsing MS (RMS) treated with evobrutinib, an investigational agent, as well as new data demonstrating MAVENCLAD® (cladribine) tablets improved Quality of Life (QoL) in people with highly active RMS over two years. Additionally, a two-year follow-up study showed the onset of action on the reduction of MRI lesions with MAVENCLAD being maintained from Month 2 through two years. “Multiple sclerosis has a profound impact on quality of life and improving this through therapy is often the most important outcome for people living with MS,” said Gavin Giovannoni, Professor of Neurology, Queen Mary University of London. “The data presented at ECTRIMS further substantiate the therapeutic benefit of MAVENCLAD by improving Quality of Life measures over two years, combined with new evidence that the early effect on MRI lesions is maintained over that period.” In the final analysis of the open-label, single-arm, multicenter, Phase IV CLARIFY-MS study, statistically significant (p≤0.0001) improvements from baseline were observed for Multiple Sclerosis Quality of Life-54 (MSQoL-54) physical and mental health composite scores (mean changes of 4.86 and 4.80, respectively; p<0.0001). Changes in MSQoL-54 composite scores were consistent across treatment naïve and prior disease-modifying treatment (DMT) subgroups. Annualized relapse rate was 0.13 in all patients (0.08 in patients who had not received DMT prior to receiving MAVENCLAD) and median EDSS was unchanged over two years. No new safety concerns emerged. Also to be presented are new MRI outcomes data from the Phase IV MAGNIFY-MS study, which demonstrated an onset of action from Month 2 with sustained reduction in MRI lesion counts maintained out to two years in people with highly active RMS treated with MAVENCLAD. The proportion of lesion-free patients increased from 47% at baseline to 86.2% at the end of the study (Month 18–24). In the study, MRI lesions at baseline were compared over multiple time periods, from initial screening to Month 24. Over the two years, the benefit:risk profile of MAVENCLAD remained unchanged and in line with observations made during the clinical trial program. Additionally, updated post-approval safety data will be presented based on an analysis of 56,300 patients who received MAVENCLAD post-approval, representing 95,664 patient-years of experience, as of July 2022. The study found the safety profile of MAVENCLAD is consistent with findings from the clinical development program and the CLARIFY-MS and MAGNIFY-MS studies. “The breadth of our data at ECTRIMS exemplifies our commitment to pushing forward scientific innovation with the development of evobrutinib, while generating new, meaningful data to demonstrate the safety profile and effectiveness of MAVENCLAD,” said Jan Klatt, Senior Vice President, Head of Development Unit Neurology & Immunology, Merck KGaA, Darmstadt, Germany. “Our goal is to ensure people living with MS, and those who treat them, have the information they need to manage their MS today and in the future.” Beyond the MAVENCLAD and evobrutinib data presented, EMD Serono will have several Company events, along with additional data from its MS portfolio at ECTRIMS 2022. Company activities at ECTRIMS 2022: “Connecting the dots: immune cells and CNS inflammation” co-chaired by Professor Gavin Giovannoni, MBBCh, PhD, FCP (Neurol., SA), FRCP, FRCPath, Blizard Institute, Barts and the London School of Medicine and Dentistry, UK, and Celia Oreja-Guevara, MD, PhD, Hospital Clínico San Carlos, Madrid, Spain (October 26, 2022, 13:15-14:15 CEST) “New tools for new challenges in multiple sclerosis” chaired by Stephen Krieger, MD, Mount Sinai Hospital, New York, NY, USA (October 28, 2022, 14:15-15:15 CEST) Product Theater: Early Experience with MAVENCLAD by Ravi Dukkipati, MD, WellSpan Neurology, York, PA, USA Below is the full list of company-related abstracts accepted for presentation at ECTRIMS 2022: MAVENCLAD Poster Presentations Abstract Name Authors ID Presentation Details Improvements in Quality of Life Over 2 Years in Patients Treated With Cladribine Tablets for Highly Active Relapsing Multiple Sclerosis: Final Analysis of CLARIFY-MS Solari A, Montalban X, Lechner-Scott J, Piehl F, Brochet B, Langdon D, Hupperts R, Selmaj K, Havrdova EK, Patti F, Brieva L, Maida EM, Alexandri N, Smyk A, Nolting A, Keller B, on behalf of the CLARIFY Investigators P108Session: 1 Date: October 26, 2022 Time: 16:30- 18:30 CEST Presenter: Jeannette Lechner-Scott Early Onset of Action and Sustained Efficacy of MRI Outcomes during Cladribine Tablets Treatment in Highly Active Relapsing Multiple Sclerosis: Results of the 2-year MAGNIFY-MS Study De Stefano N, Achiron A, Barkhof F, Chan A, Derfuss T, Hodgkinson S, Leocani L, Montalban X, Prat A, Schmierer K, Sellebjerg F, Vermersch P, Wiendl H, Keller B, Smyk A, Gardner L P717 Session: 2 Date: October 27, 2022 Time: 17:00- 19:00 CEST Presenter: Nicola De Stefano Updated Post-Approval Safety of Cladribine Tablets in the Treatment of Multiple Sclerosis, With Particular Reference to Liver SafetyGiovannoni G, Leist T, Jack D, Galazka A, Nolting AP341Session: 1 Date: October 26, 2022 Time: 16:30- 18:30 CEST Presenter: Gavin Giovannoni High Adherence and Minimal Delays of Year 2 Treatment in People with Multiple Sclerosis Treated with Cladribine Tablets: Results from Multi-Country Patient Support ProgrammesOh J, Ayer M, Alroughani R, Lemieux C, Morgan K, D’Eramo M, Vella T, Boshra A, de Souza S, Verdun di Cantogno E, Sabidó MP727Session: 2 Date: October 27, 2022 Time: 17:00 CEST Presenter: Jiwon Oh Treatment Emergent Adverse Events Experienced Early and Transiently in the Treatment Course with Cladribine Tablets: Data from the CLEVER Real-World StudyZiemssen T, Posevitz-Fejfar, Wagner T, Übler S, Richter J, Müller B, Penner I-KP772Session: 2 Date: October 27, 2022 Time: 17:00- 19:00 CEST Presenter: Talf Ziemssen Maven4: Phase IV Non-Interventional, Prospective, Spanish Multicenter Study to Evaluate Cladribine Tablets Long Term Effectiveness on Real-World Clinical PracticeSaiz A, Aladro Benito Y, Costa-Frossard F, Sánchez Magro I, Rodríguez Antigüedad AP774Session: 2 Date: October 27, 2022 Time: 17:00- 19:00 CEST Presenter: Albert Saiz Cladribine Protects SH-SY5Y Neuron-Like Cells from Oxidative Stress Conditions In VitroEixarch H, Calvo-Barreiro L, Fissolo N, Boschert U, Comabella M, Montalban X, Espejo CP784Session: 2 Date: October 27, 2022 Time: 17:00- 19:00 CEST Presenter: Herena Eixarch Real-World Use of Cladribine Tablets (Completion Rates and Treatment Persistence) in Patients With Multiple Sclerosis in England: The CLARENCE StudyBrownlee W, Amin A, Herbert A, Ashton LP762Session: 2 Date: October 27, 2022 Time: 17:00 CEST Presenter: Wallace Brownlee Decision-making Factors in Patient Choice to Initiate Treatment with Cladribine: A Preliminary Baseline Analysis From the STATURE StudyAllan M, Grech L, Cartwright A, Harding J, Mardan J, O’Maley J, Savickas S, Sharma M, Murambiwa P, Stockle P, Bardsley B, Butler EP304Session: 1 Date: October 26, 2022 Time: 16:30- 18:30 CEST Presenter: Michelle Allan Assessment of Treatment Satisfaction Across Oral DMTs for Multiple Sclerosis: a Preliminary Baseline Analysis from the STATURE Study.Grech L, Allan M, Cartwright A, Harding J, Mardan J, O’Maley T, Savickas S, Sharma M, Murambiwa P, Stockle P, Bardsley B, Butler EEP1086Session: ePoster Date: October 26-28, 2022 A Real-World Study of Four-Year Follow Up Study of Patients Treated with Oral Cladribine From 2018-2022O’Neill DTD, Sharma M, Dong G, Hodgkinson SJEP1132Session: ePoster Date: October 26-28, 2022 A Study of Activated and Naïve T Regs and B Cell Subsets For 30 Months After the Use of CladribineHodgkinson SJ, O’Neill DTD, Sharma M, Dong G, Verma ND, Al-atiyah R, Hall BMP704Session: 2 Date: October 27, 2022 Time: 17:00- 19:00 CEST Presenter: Suzanna Hodgkinson CLADCOMS - CLADribine Tablets Long-Term Control of MS – a Post-Marketing Investigator Driven StudyFink K, Nilsson P, Alonso L, Sveningsson A, Gunnarsson M, Lange N, Ayad A, Vrethem M, Burman J, Lycke J, Piehl FEP1060Session: ePoster Date: October 26-28, 2022 Clinical Effectiveness and Safety of Cladribine Tablets for Patients Treated at least 12 Months in the Swedish Post-Market Surveillance Study “Immunomodulation and Multiple Sclerosis Epidemiology 10” (IMSE 10)Rosengren V, Ekström E, Forsberg L, Hillert J, Nilsson P, Dahle C, Svenningsson A, Lycke J, Landtblom A-M, Burman J, Martin C, Sundström, Gunnarsson M, Piehl F, Olsson TP728Session: 2 Date: October 27, 2022 Time: 17:00- 19:00 CEST Presenter: Linda Forsberg SARS-CoV2 Exposure Rates and Serological Response of People Living With MSLonginetti E, Asplund K, Kockum I, Englund S, Burman J, Fink K, Fogdell-Hahn A, Gunnarsson M, Hillert J, Langer-Gould A, Lycke J, Nilsson P, Salzer J, Svenningsson A, Mellergård J, Frisell T, Olsson T, Piehl FP558Session: 2 Date: October 27, 2022 Time: 17:00- 19:00 CEST Presenter: Elisa Longinetti COVID-19 Humoral and T-cell Mediated Vaccination Responses in People with Multiple SclerosisVickaryous N, Rios F, Schalk L, Asardag AN, George K, Kang A, Baker D, Giovannoni G, Dobson RP781Session: 2 Date: October 27, 2022 Time: 17:00- 19:00 CEST Presenter: Nikki Vickaryous Differences Between Clinical Trials and “Real-World” Use of Disease Modifying Therapies: Insights from the UK OPTIMISE:MS Pharmacovigilance StudyDobson R, Matthews P, Miller A, Pindoria J, Waddingham EP763Session: 2 Date: October 27, 2022 Time: 17:00- 19:00 CEST Presenter: Ruth Dobson Cladribine Treatment Exerts Specific Effects on Memory B Cell Immunoglobulin Repertoires in Multiple Sclerosis PatientsRuschil C, Gabernet G, Kemmerer CL, Ziemann U, Nahnsen S, Kowarik MCEP1115Session: ePoster Date: October 26-28, 2022 Presenter: Christoph Ruschil Cladribine Effects on T and B Cell Subsets and T Cell Reactivity in Multiple SclerosisHansen RH, von Essen MR, Mahler MR, Cobanovic S, Binko TS, Sellebjerg FP697Session: 2 Date: October 27, 2022 Time: 17:00- 19:00 CEST Presenter: Rikke Holm Hansen Safety and Efficacy of Cladribine Therapy Following a Treatment with Anti-CD20 Compounds in Relapsing Multiple Sclerosis Patients: A Pilot StudySacco R, Disanto G, Pravatà E, Gobbi C, Zecca CEP1068Session: ePoster Date: October 26-28, 2022 Evobrutinib Poster Presentations Abstract Name Authors ID Presentation Details Evobrutinib, a Bruton’s Tyrosine Kinase Inhibitor, Maintains Lowered Serum Neurofilament Light Chain Levels Over 2.5 Years of Treatment, in Patients With Relapsing Multiple Sclerosis Kuhle J, Kappos L, Montalban X, Benkert P, Li Y, Thangavelu K, Hyvert Y, Tomic D EP1021Session: ePoster Date: October 26-28, 2022 Presenter: Jens Kuhle MRI and Clinical Outcomes 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 TrialVermersch P, Arnold D, Wolinsky JS, Havrdova E, Kinkolykh A, Hyvert Y, Tomic D, Montalban XP731Session: 2 Date: October 27, 2022 Time: 17:00- 19:00 CEST Presenter: Patrick Vermersch Evobrutinib Exert a Therapeutic Action on EAE by Increasing the Peripheral and Central Classical Dendritic Cell Number and MaturationSerrano-Regal MP, Calahorra L, Alonso-García I, Grenningloh R, Boschert U, Haselmayer P, Ortega MC, Machín-Díaz I, Camacho-Toledano C, García-Arocha J, Clemente DP307Session: 1 Date: October 26, 2022 Time: 16:30- 18:30 CEST Presenter: Mari Paz Serrano-Regal Evobrutinib, a Bruton’s Tyrosine Kinase Inhibitor, Acts on Microglia: Implications in the Treatment of Progressive Mechanisms in Multiple SclerosisGeladaris A, Torke S, Grenningloh R, Boschert U, Brück W, Weber MSP693Session: 2 Date: October 27, 2022 Time: 17:00- 19:00 CEST Presenter: Anastasia Geladaris B cells infiltrating the MS brain: from local maturation to targeting by evobrutinibBogers L, van Langelaar J, Rijvers L, Engelenburg HJ, Melief M-J, Wierenga-Wolf AF, Rip J, Blok KM, de Vries HE, Hendriks RW, Boschert U, Smolders J, van Luijn MMP147Session: 1 Date: October 26, 2022 Time: 16:30- 18:30 CEST Presenter: Laurens Bogers Immune response following mRNA COVID-19 vaccination in patients with multiple sclerosis treated with the Bruton’s tyrosine kinase inhibitor evobrutinibBar-Or A, Cross AH, Cunningham A, Hyvert Y, Seitzinger A, Drouin EE, Alexandri N, Tomic D, Montalban XP1188Session: 1 Date: October 26, 2022 Time: 16:30- 18:30 CEST Presenter: Amit Bar-Or Rebif® (interferon beta-1a) Subcutaneous Injection Poster Presentations Abstract Name Authors ID Presentation Details Exploring the Relationship Between Serum GDF-15 and Disease Stability in Patients with a First Clinical Demyelinating Event Treated with Subcutaneous Interferon β-1a or Placebo in the REFLEX Study Coray M, Freedman MS, Barkhof F, Comi G, De Stefano N, Kappos L, Enz L, Seitzinger A, Jack D, Kuhle J, Mehling MEP1027Session: ePoster Date: October 26-28, 2022 Presenter: Mali Coray Evolution of the RebiSmart® Autoinjector Device in Support of Adherence to Subcutaneous Interferon Beta-1a Therapy for Relapsing Multiple Sclerosis Arnaud L, Keiser M, Henninger E, Piras F, Seitzinger A, Jack D, Le Masne Q EP1079 Session: ePoster Date: October 26-28, 2022 Presenter: Dominic Jack Validation of a Semi-Automated Method to Quantify Lesion Volume Changes in Multiple Sclerosis on 2D Proton Density- Weighted Images Using Subtraction ImagingMattiesing RM, Stel S, Mangroe AS, Brouwer I, Versteeg A, van Schijndel RA, Uitdehaag BMJ, Barkhof F, Vrenken HP634Session: 2 Date: October 27, 2022 Time: 17:00- 19:00 CEST Presenter: Rozemarijn M Mattiesing Expression of peripheral blood IFN-inducible genes predicts treatment outcome in patients with secondary progressive multiple sclerosis treated with IFN-beta-1aGurevich M, Zilkha-Falb R, Menascu S, Magalashvili D, Dolev M, Sonis P, Mandel M, Achiron AP353Session: 1 Date: October 26, 2022 Time: 16:30- 18:30 CEST Presenter: Michael Gurevich Non-Product Specific Poster Presentations Abstract Name Authors ID Presentation Details DISCOntinuation of disease-modifying therapies in MS (DISCOMS) Extension – Study Design and Baseline Demographics to Date Engebretson E, Cutter G, Fox R, Kister I, Miller A, Morgan C, Seale R, Corboy JREP1089Session: ePoster Date: October 26-28, 2022 Expert Opinion on the Use of Contraception in People with Multiple Sclerosis Hillert J, Bove R, Haddad L, Hellwig K, Houtchens M, Magyari M, Mercki G, Montgomery S, Nappi R, Stenager E, Thompson H, Tulek Z, Verdun di Cantogno E, Simoni M P080 Session: 1 Date: October 26, 2022 Time: 16:30- 18:30 CEST Presenter: Jan Hillert Single-Cell RNA Sequencing of Peripheral CD8+ T Cells of MS-Discordant Monozygotic Twins Reveals Disease-Associated Alterations In Immune SignalingKavaka V, Mutschler L, Eglseer K, Flierl-Hecht A, Kümpfel T, Hohlfeld R, Kerschensteiner M, Gerdes L.A, Beltran E P159Session: 1 Date: October 26, 2022 Time: 16:30- 18:30 CEST Presenter: Vladyslav Kavaka Caregiver Burden and Associated Factors Among Caregivers of Persons with Multiple Sclerosis: Application of a Specific InstrumentVanotti S, Roman MS, Ferrandina F, Bauer J, Rosa R, Casas Parera I, Saladino ML, Caceres FEP0864Session: ePoster Date: October 26-28, 2022 Presenter: Sandra Vannoti Evolutionarily Conserved Signatures of Microglia in Health and DiseaseSalinas V, Manouchehri N, Hussain R, Stuve OP131Session: 1 Date: October 26, 2022 Time: 16:30- 18:30 CEST Presenter: Victor Salinas Peripheral Blood Immune Markers Associated With Immunosenescence in Multiple Sclerosis and Healthy ControlsCarpentier Solorio Y, Daigneault A, Tastet O, Clénet M-L, Farzam-kia N, Levert A, Da Cal S, Clément W, Jamann H, Laurent C, Mamane VH, Ouedraogo O, Moratalla AC, Balthazard R, Lahav B, Prat A, Girard J-M, Duquette P, Rousseau M-C, Arbour N, Larochelle CP545Session: 2 Date: October 27, 2022 Time: 17:00- 19:00 CEST Presenter: Catherine Larochelle Chemerin Correlates with MS Progression Parameters and Affects Intracellular Metabolism in Human Microglia and MacrophagesLoonstra FC, van der Pol SM, Falize KF, van Heertum T, de Ruiter LR, Schoonheim MM, Killestein J, Uitdehaag BMJ, Kooij G, de Vries HE, Rijnsburger MP551Session: 2 Date: October 27, 2022 Time: 17:00- 19:00 CEST Presenter: Merel Rijnsburger Amyloid and some tau Proteinopathy are Observed in a Subset of Individuals with Multiple Sclerosis Taga M, Duquesne L, Lee A, Sigalov A, Peralta Cruz F, De Jager PP1204Session: 2 Date: October 27, 2022 Time: 17:00- 19:00 CEST Non-Product Specific Oral Presentations Abstract Name Authors ID Presentation Details Biological Roles of Myeloid Cell Subsets During CNS Inflammation Manouchehri N, Victor, Hussain RZ, Stuve OO124Session: Young Scientific Investigators' Session 3: Long-term outcomes and safety Date: October 27, 2022 Time: 15:00- 16:00 CEST Presenter: Navid Manouchehri

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