Slide 1: Developing Uniquely Differentiated Drugs for CNS Targets
DEVELOPING UNIQUELY DIFFERENTIATED DRUGS FOR CNS TARGETS Full Year Results 2020 and Outlook 2021 Tuesday, March 16, 2021, 3:00 pm CET
Slide 2: Full Year Results 2020 and Outlook 2021 Telephone Conference
FULL YEAR RESULTS 2020 AND OUTLOOK 2021 TELEPHONE CONFERENCE Please dial in five to ten minutes prior to the beginning of the call using one of the following telephone numbers: Switzerland/Europe: +41 (0)58 310 50 00 United Kingdom: +44 (0)207 107 0613 United States: +1 (1)631 570 56 13 Speakers: St
Slide 3: Disclaimer
Disclaimer RESTRICTED SCOPE; EXCLUSION OF LIABILITY; CONFIDENTIALITY This document has been prepared by Newron Pharmaceuticals S.p.A. ("Newron") solely for your information. The information contained herein has not been independently verified. No representation or warranty, express or implied, is ma
Slide 4: 2020 - Execution on strategy (1/2)
2020 - Execution on strategy (1/2) Evenamide - schizophrenia • All evenamide pre-clinical studies requested by the US Food and Drug Administration (FDA) have been completed with no toxicity concerns identified • Despite the COVID-19 pandemic, Newron successfully completed enrolment for explanatory s
Slide 5: 2020 - Execution on strategy (1/2)
2020 - Execution on strategy (1/2) Xadago®/safinamide – Parkinson’s disease • Newron notes that Supernus Pharmaceuticals acquired US rights to Xadago®/safinamide, effective June 2020 • Agreement signed with Zambon for potentially pivotal study with safinamide in patients suffering from Levodopa-indu
Slide 6: Company Highlights
Company Highlights Unique portfolio of innovative CNS product candidates • Xadago® for Parkinson’s disease – Global approvals validate Newron’s development capabilities from research to market • Evenamide – New concept in treating inadequate/non-response in schizophrenia • Ongoing search for strateg
Slide 7: Developing Uniquely Differentiated Drugs for CNS Targets
DEVELOPING UNIQUELY DIFFERENTIATED DRUGS FOR CNS TARGETS Xadago® (safinamide) Evenamide (NW-3509) Commercialized by partners in 15 European markets, the US, Phase IIa trial demonstrated efficacy; potential first mechanistically Canada and other markets for Parkinson’s disease (“PD”) validated treatm
Slide 8: Innovative Clinical Pipeline with Near-Term Catalysts
Innovative Clinical Pipeline with Near-Term Catalysts PRODUCTS Phase I Phase II Phase III Market Commercial Rights Adjunctive therapy in PD Zambon Adjunctive therapy in PD Zambon/Supernus Xadago® (safinamide)1 Adjunctive therapy in PD Meiji Seika/Eisai Levodopa Induced Dyskinesia (PD LID) Zambon/Sup
Slide 9: Xadago: 1st New Chemical Entity Approved in a Decade for Parkinson's Disease
Xadago®: 1st New Chemical Entity Approved in a Decade for Parkinson's Disease Fast and sustained efficacy, well tolerated Parkinson’s disease affects 7 to 10 million MID- TO LATE-STAGE PD PATIENTS – worldwide add-on to L-Dopa dopamine replacement Significant improvement of A progressive disorder,
Slide 10: Xadago: New Label Study in Patients with Levodopa Induced Dyskinesia
Xadago®: New Label Study in Patients with Levodopa Induced Dyskinesia • Zambon previously discussed with the US Food and Drug Administration (FDA) the design of a potentially pivotal efficacy study to evaluate the effects of Xadago®/safinamide in patients with PD LID • Intention is to perform the st
Slide 11: Significant Commercial Opportunity in Xadago (Safinamide)
Significant Commercial Opportunity in Xadago® (Safinamide) US / Canada EU Latin America Israel Japan / Asia Australia /New Zealand Launched in Germany, UK, Italy, Spain and other EU Launched in US in 2017 territories, and Switzerland; regulatory approval for Launched in Canada in 2019 Launched in 20
Slide 12: Schizophrenia: No Effective Treatment for the Last 20 Years
Schizophrenia: No Effective Treatment for the Last 20 Years to Reduce Burden of Disease Efficacy of current treatment options is insufficient VAST MARKET Onset of disease occurs in early adulthood affecting 1% of the population worldwide OPPORTUNITY (anti-psychotics Most patients with schizophreni
Slide 13: Evenamide Novel MoA: Synergistic with Marketed Antipsychotics
Evenamide Novel MoA: Synergistic with Marketed Antipsychotics Evenamide, a Voltage-Gated Sodium Channels (VGSC) Voltage-Gated Sodium Channels (VGSC) blockers may act blocker has the potential to target the abnormal synergistically with antipsychotics in schizophrenia therapy neuronal activity and
Slide 14: Evenamide's Unique MOA Demonstrated
Evenamide’s Unique MOA Demonstrated Selectively blocks native sodium channels, showing no off-target effect on >130 CNS receptors, enzymes, transporters, etc. Modulates sustained repetitive firing Selectively blocks VGSCs in a Inhibits without inducing impairment of voltage-and use-dependent manner
Slide 15: Evenamide Active in Wide Range of Schizophrenia Animal Models
Evenamide is Active in a Wide Range of Schizophrenia and Psychiatric Animal Models as a Monotherapy and as an Add-on to Existing Antipsychotics Monotherapy Add-on Pre-pulse inhibition (PPI) disrupted by dopamine activation (amphetamine -rat) Pre-pulse inhibition (PPI) disrupted by NMDA antag
Slide 16: Evenamide: Proof of Concept in Patients with Schizophrenia Demonstrated
Evenamide: Proof of Concept in Patients with Schizophrenia Demonstrated 4-week, placebo-controlled, add-on study of evenamide (15-25mg BID/day) in 89 patients on stable doses of aripiprazole or risperidone showing signs of worsening when compared to standard of care, at every assessment during the
Slide 17: Evenamide: Regulatory Interactions and Phase III Clinical Development Plan
Evenamide: Regulatory Interactions and Phase III Clinical Development Plan Health Authorities (Spain, Denmark, Sweden, Germany, UK, CHMP, US, Canada) in agreement with proposed Phase III plan Newron aims to complete additional informative studies, requested by the FDA, to allow for its Phase III to
Slide 18: Evenamide: Regulatory Interactions and Phase III Clinical Development Plan
Evenamide: Regulatory Interactions and Phase III Clinical Development Plan Phase III program will be comprised of two pivotal studies in specific populations: Non-treatment resistant patients: chronic schizophrenics experiencing inadequate benefit for symptoms of their psychosis, on current atypic
Slide 19: Newron Listing Profile as of December 31, 2020
NEWRON LISTING PROFILE AS OF DECEMBER 31, 2020 Newron is listed at − SIX since December 2006 and − Dusseldorf Stock Exchange (XETRA) since June 2019 Newron issues ordinary shares (nominal value 0.20€), only Number of outstanding shares as of Dec. 31, 2020: 17,845,345 • Senior managers and Dire
Slide 20: Analysts and Most Recent Info on Shareholdings
ANALYSTS AND MOST RECENT INFO ON SHAREHOLDINGS Sell-side analyst coverage: Lucy Codrington/Peter Welford Disclosed* material shareholders (>3%) René Wouters Zambon > 4% Bruno Bulic Further coverage: RX Securities, valuationLab, Edison *: to the best of Newron’ knowledge https://www.six-exchange-regu
Slide 21: Group Consolidated Financials (IFRS) FY 2020 – Income Statement
GROUP CONSOLIDATED FINANCIALS (IFRS) FY 2020 – INCOME STATEMENT EUR/000 2020 2019 Licence income 23 2,284 Royalties 5,235 4,754 Research and development (14,853) (17,440) expenses Marketing and advertising (331) (634) expenses General and administrative (8,140) (9,865) expenses Operating loss (18,06
Slide 22: Group Consolidated Financials (IFRS) FY 2020 – Balance Sheet and Cash Flow
GROUP CONSOLIDATED FINANCIALS (IFRS) FY 2020 – BALANCE SHEET AND CASH FLOW STATEMENTS EUR/000 2020 2019 Non-current assets 13,324 14,797 Current assets 6,624 6,328 Cash and other financial ass. 31,250 39,163 Total shareholders' equity 17,246 36,798 Non-current liabilities 27,060 17,895 Current liabi
Slide 23: Agenda – AGM April 13, 2021
AGM APRIL 13, 2021 – 10.30 AM CET - NEWRON PREMISES AGENDA 1. Approval of the financial statements as at December 31st, 2020. Related and consequent resolutions. 23
Slide 24: Company Highlights
Company Highlights Unique portfolio of innovative CNS product candidates • Xadago® for Parkinson’s disease – Global approvals validate Newron’s development capabilities from research to market • Evenamide – New concept in treating inadequate/non-response in schizophrenia • Ongoing search for strateg
Slide 25: Q&A
Q&A
Slide 26: Contact Details
CONTACT DETAILS NEWRON STEFAN WEBER – CEO +39 02 6103 46 26 pr@newron.com UK/EUROPE JULIA PHILLIPS / NATALIE GARLAND-COLLINS, FTI CONSULTING +44 20 3727 1000 SCnewron@fticonsulting.com SWITZERLAND VALENTIN HANDSCHIN +41 43 244 81 54 handschin@irf-reputation.ch GERMANY/EUROPE ANNE HENNECKE/CAROLINE B