Slide 1: Full Year Results 2021 and Outlook 2022
SPECIALIST IN CNS DRUG DEVELOPMENT INNOVATIVE TREATMENTS TO IMPROVE QUALITY OF LIFE Full Year Results 2021 and Outlook 2022 Tuesday, March 15, 2022, 3:00 pm CET
Slide 2: Full Year Results 2021 and Outlook 2022 Telephone Conference
FULL YEAR RESULTS 2021 AND OUTLOOK 2022 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: 2021 - Back on track (1/2)
2021 - Back on track (1/2) Evenamide - schizophrenia • TQT-Study 010 and EEG Study 008 both met their primary objectives: absence of arrhythmia risk in healthy volunteers, and of EEG/neurological abnormalities in patients with schizophrenia • Newron initiated - open-label add-on study in patients wi
Slide 5: 2021 - Back on track (2/2)
2021 - Back on track (2/2) Xadago®/safinamide – Parkinson’s disease • Partnership agreement with Zambon on potentially pivotal study in patients with levodopa-induced dyskinesia (PD LID) • Newron, Zambon and Supernus acting to protect intellectual property rights in the US (Paragraph IV Notice Lette
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 16 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 in PD: Marketed compound with opportunity for second label
• FIRST APPROVED NCE IN >10 YRS (US, EU) • GLOBALLY LICENSED Xadago in PD • DOUBLE DIGIT/SINGLE DIGIT % ROYALTIES Marketed >€65M MILESTONES/ROYALTIES COLLECTED • TO REACH PEAK COMMERCIAL POTENTIAL, compound with GET SECOND LABEL FOR LID IN PD opportunity for • 40% OF PD PATIENTS • ONLY 1 APPROVED DR
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, Switzerland, UAE, Brazil and Colombia; Launched in Canada in 2019 Launched in Aust
Slide 12: Evenamide – The Commercial Opportunity
EVENAMIDE – THE COMMERCIAL OPPORTUNITY Addresses medical need in key sub-populations, COM: 2033 (WW), 10 yrs exclusivity post approval (EU) First add-on antipsychotic to be approved for inadequately responding or treatment resistant patients − Up to 70% of chronic schizophrenia population every (o
Slide 13: Evenamide – Target Product Profile
EVENAMIDE – TARGET PRODUCT PROFILE Formulation: Oral Dose: BID Dual Indications: 1) Add-on treatment Indication…patients with Inadequate Response on their current antipsychotic monotherapy 2) Add-on treatment Indication…patients diagnosed as TRS (treatment resistant schizophrenia) • TRS is a broad d
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 Schizophrenia and Psychiatric 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 Monotherapy Reverses PPI Deficit Induced by Ketamine
EVENAMIDE AS A MONOTHERAPY REVERSES THE PPI DEFICIT INDUCED BY GLUTAMATE DYSREGULATION DUE TO KETAMINE - COMBINATION OF INEFFECTIVE DOSES OF CLOZAPINE AND EVENAMIDE FULLY RESCUES PPI 80 combination EVE + CLO Impairment P<0.001 60 ### Minimal effective dose Plasma concentration *** monotherapy %PPI A
Slide 17: 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 18: Evenamide: Regulatory Interactions
EVENAMIDE: REGULATORY INTERACTIONS Health Authorities (Spain, Denmark, Sweden, Germany, UK, CHMP, US, Canada) in agreement with proposed Phase III plan Newron provided additional informative studies as requested by the FDA prior to allowing Newron to initiate its Phase III development program - Prec
Slide 19: Evenamide: Phase III Clinical Development Plan for Schizophrenia Indication
EVENAMIDE: PHASE III CLINICAL DEVELOPMENT PLAN FOR SCHIZOPHRENIA INDICATION Phase III program will cover specific populations: • Non-treatment resistant patients: chronic schizophrenics experiencing inadequate benefit for symptoms of their psychosis, on current atypical antipsychotic monotherapy (ri
Slide 20: Newron Listing Profile as of December 31, 2021
NEWRON LISTING PROFILE AS OF DECEMBER 31, 2021 Newron is listed at − SIX since December 2006 and − Since June 26, 2019, also at the Dusseldorf Stock Exchange (XETRA) Newron issues ordinary shares (nominal value 0.20€), only Number of outstanding shares as of Dec. 31, 2021: 17,845,345 • Senior
Slide 21: Analysts and Most Recent Info on Shareholdings
ANALYSTS AND MOST RECENT INFO ON SHAREHOLDINGS Sell-side analyst coverage: Peter Welford Disclosed* material shareholders (>3%) Zambon > 4% Leonildo Delgado Further coverage: RX Securities, ValueLab, Edison *: to the best of Newron’ knowledge https://www.six-exchange-regulation.com/en/home/publicati
Slide 22: Group Consolidated Financials (IFRS) FY 2021 – Income statement
Group Consolidated Financials (IFRS) FY 2021 – Income statement EUR/000 2021 2020 Licence income 34 23 Royalties 5.728 5.235 Research and development (10.725) (14.853) expenses Marketing and advertising (38) (331) expenses General and administrative (7.356) (8.140) expenses Operating loss (12.357) (
Slide 23: Group Consolidated Financials (IFRS) FY 2021 – Balance sheet and Cash flow
Group Consolidated Financials (IFRS) FY 2021 – Balance sheet and Cash flow statements EUR/000 2021 2020 Non-current assets 11.059 13.324 Current assets 4.833 6.624 Cash and other financial ass 34.594 31.250 Total shareholders' equity 3.107 17.246 Non-current liabilities 43.725 27.060 Current liabili
Slide 24: AGM Agenda
AGM April 5, 2022 – 10.00 am CET - Newron premises AGENDA 1. Approval of the balance sheet as at 31 December 2021. Connected and consequent resolutions 2. Redefinition of the number of the Board members. Related and consequent resolutions 3. Appointment of the statutory auditors for the three fiscal
Slide 25: 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 26: Q&A
Q&A
Slide 27: 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