Slide 1: Investors meeting
MABION S.A. Investors meeting 9th May 2018 Warsaw
Slide 2: Safe Harbor Statement
Safe Harbor Statement IMPORTANT: You must read the following before continuing. The following applies to this document, the oral presentation of the information in this document by Mabion S.A. (the “Company”) or any person on behalf of the Company, and any question-and-answer session that follows th
Slide 3: Agenda
Agenda 1. Summary 2017 2. Financial Results - 2017 3. Private Placement & Financing 4. MabionCD20 & Pipeline 5. MabionCD20 in MS 6. Expansion of production and R&D capacity 7. Highlights 2018
Slide 4: 1. Summary 2017
MABION S.A. 1. Summary 2017
Slide 5: Summary 2017
Summary 2017 ▪ Mabion - first biotechnology company that successfully completed clinical programme and confirmed bioequivalence its MabionCD20 to Mabthera: ▪ Positive results from Phase 3 trial in rheumatoid arthritis (RA) ▪ Supportive PK trial in non-Hodgkin lymphoma (NHL) completed with positive r
Slide 6: 2. Financial Results - 2017
MABION S.A. 2. Financial Results - 2017
Slide 7: Main factors influencing Company's financial results in 2017
Main factors influencing Company’s financial results in 2017 ▪ Lack of sales ▪ Continued R&D works on MabionCD20 (completion of clinical trials, preparing Marketing Authorisation Application for EMA, scaling-up production process of MabionCD20 to 2500 L) ▪ Pre-clinical stage R&D works on MabionEGFR
Slide 8: The Company's financial results for 2017
2017 2016 The Company’s Sales of research and development services 0 0 Cost of services sold 0 0 financial results for Research and development costs -43,257 -44,219 2017 General and administrative expenses Other operating income and expenses, net -21,322 2,203 -13,938 2,626 [PLN thousands] Operatin
Slide 9: Sources of financing during next 12 months
Sources of financing during next 12 months Management assumes that the Company’s activities will be financed during next 12 months from the following funds: ▪ Own funds from sale of P- series shares ▪ Subsidies from EU-financed projects (Szybka ścieżka, InnoNeuroPharm, CBR) ▪ Milestone payments from
Slide 10: 3. Private Placement & Financing
MABION S.A. 3. Private Placement & Financing
Slide 11: Pricing of a private placement of 1,920,772 existing shares
Pricing of a private placement of 1,920,772 existing shares, with gross proceeds of PLN 174.8 million Share price of PLN 91.00 per share MABION S.A. Iinstitutional investors specialized in healthcare and life sciences including from the United States → Reinforce and diversify Mabion’s shareholder ba
Slide 12: Uses of funds from sale of P-series shares
Uses of funds from sale of P-series shares – Capacity & Mabion MS Funds from the P-series share issue will be used for: ▪ Repayment of existing bank loan and other borrowings incl. interest (ca. PLN 78 million) – 50% extended ▪ R&D costs, incl. own share in EU-financed projects (ca. PLN 28.5 million
Slide 13: 4. MabionCD20 & Pipeline
MABION S.A. 4. MabionCD20 & Pipeline
Slide 14: Product pipeline by therapeutic area
2017 WW Rev Commercial Product Therapeutic Area Brand Name Region Preclinical Clinical Note (US$B)(1) Rights Late-Stage Assets MAA submission 2018 Europe Autoimmunology; Rituxan/MabThera BPD Type 2 meeting with FDA MabionCD20 US$ 7.7 US Oncology (rituximab) Pending FDA feedback scheduled for 2018 (2
Slide 15: MabionCD20
MabionCD20 ▪ Clinical trials results confirmed and published, the remaining secondary endpoint result expected before MAA submission ▪ Extensive analytical work related to technology transfer to Konstantynów Łódzki facility ▪ Dossier almost completed ▪ Dossier preparation proces – multilayer project
Slide 16: Examples of dossier preparation timing
Examples of dossier preparation timing Drug/ Company Last patient visit: Submission date: Positive opinion of the Date of issue of marketing CHMP authorisation valid throughout the European Union: Mvasi (bevacizumab)/ Amgen Europe 23/09/2015 1/12/2016 9/11/2017 15/01/2018 B.V. (15 months after the e
Slide 17: Current Rituxan/MabThera Market
Current Rituxan/MabThera Market ▪ Global sales of Rituxan/MabThera were ~US$ 7.7B globally in 2017 (up 1% overall)(1) ▪ US: US$ 4.3B up 6% (patent expiry in US expected June 2018) Roche regional ▪ Europe: US$ 1.8B down 10% due to market entry of Truxima and Rixathon (~US$ 200M) sales ▪ ROW: US$ 1.6B
Slide 18: MabionCD20: Clinical Data Package
▪ Mabion’s completed studies are comparable (or larger) in size than many peers ▪ Precedent exists for companies submitting a BLA without clinical trials conducted in the US(1) MabionCD20: Clinical Data Package Company Biosimilar Name Major Study 1 (Indication / Patients) Major Study 2 (Indication /
Slide 19: MabionEGFR Biosimilar to Erbitux
MabionEGFR Biosimilar to Erbitux Current Erbitux (cetuximab) Market(1) ▪ Global sales of Erbitux were ~US$ 1.6B globally in 2017 (Lilly in US and Merck KGaA ex-US) ▪ Cetuximab is a chimeric antibody with a high barrier due to glycosylation site characteristics ▪ Despite the loss of patent protection
Slide 20: 5. Mabion MS
MABION S.A. 5. Mabion MS
Slide 21: Clinical Validation of Rituximab in Multiple Sclerosis
Clinical Validation of Rituximab in Multiple Sclerosis ▪ Roche tested rituximab in controlled Phase 2 studies ▪ An analysis of 882 rituximab-treated MS patients in the Swedish MS register demonstrated improved ▪ Roche statement:(1) symptoms for MS patients (published in Neurology) “Our early studies
Slide 22: Roche's CD20 in MS Ocrevus (ocrelizumab)
Roche’s CD20 in MS Ocrevus (ocrelizumab) ▪ Like rituximab, Ocrevus selectively targets CD20-positive B-cells ▪ Ocrevus is a monoclonal human antibody and rituximab is chimeric ▪ Ocrevus is the first and only medication for both relapsing and primary progressive MS ▪ Only approved treatment for prima
Slide 23: Mabion CD20 in MS: Thesis & Approach for Innovative Product
Mabion CD20 in MS: Thesis & Approach for Innovative Product ▪ Existing body of evidence around CD20 suggests MabionCD20 could be a safe and effective treatment for MS, like Ocrevus ▪ MabThera not approved for MS but has successfully been used as off-label treatment ▪ Roche tested MabThera for MS, bu
Slide 24: MabionCD20 in MS - innovative therapy for multiple sclerosis treatment
MabionCD20 in MS - innovative therapy for multiple sclerosis treatment ▪ Patent application filed ▪ Second patent application in preparation ▪ Draft of clinical development strategy completed ▪ Preparation for regulatory authorities meetings in progress ▪ We have product for the trial ▪ We have safe
Slide 25: Total reported sales for MS drugs till 2016 & consensus forecast sales
Total reported sales for MS drugs till 2016 & consensus forecast sales MABION S.A.
Slide 26: 6. Expansion of production and R&D capacity - structure and plans
MABION S.A. 6. Expansion of production and R&D capacity - structure and plans
Slide 27: Planned Expansion - Stage 1
Planned Expansion - Stage 1 General ▪ Mabion is planning a significant increase of manufacturing capacity in the EU GMP certified production plant in Konstantynów Łódzki ▪ Current capacity (2x2,500L) is expected to be sufficient for near-term demand of MabionCD20 in Europe Stage 1: Expand existing m
Slide 28: Planned Expansion - Stage 2
Planned Expansion - Stage 2 Stage 2: Investing in new manufacturing building ▪ Purpose: Fully support US commercialization of MabionCD20 as a biosimilar, potential MabionCD20 MS commercialization and commercialization of future biosimilar assets ▪ Facility to house up to 12 2,500L bioreactors ▪ Init
Slide 29: Mabion II Expansion Project
Mabion II Expansion Project Mabion II 2018 2019 2020 2021 Expansion Project Q1 02:03:04] Q1: 02: 3:04) Q1: 02:03:04] 01: 02:03:04 Technological Project GMP Certification
Slide 30: 7. Highlights 2018
MABION S.A. 7. Highlights 2018
Slide 31: Highlights 2018
Highlights 2018 ▪ Lead asset, MabionCD20, is a biosimilar to Roche’s Rituxan/MabThera (rituximab) ▪ Completed a large Phase 3 trial in RA and PK trial in NHL ▪ Partnered with Mylan for EU commercial distribution ▪ Preparing regulatory submission in EU 2018; discussions with US FDA ongoing ▪ MabionCD
Slide 32: Thank You
Thank You