Mabion Sa · GPW:MAB
Mabion Sa — Investor Presentation (March 2021)
38 slides from Mabion Sa's investor presentation, March 2021
Slide 1: Management Presentation
Management Presentation March 2021
Slide 2: Important
Important ▪ This presentation (the “Presentation”) has been prepared by Mabion S.A. (the “Company”), exclusively for the benefit and internal use of a recipient of this Presentation (the “Recipient”). Neither this Presentation (references to which shall be deemed to include any information which has
Slide 3: Important
Important ▪ While it is believed that such estimates, assessments, adjustments and judgments are reasonable and that the market information which has been prepared is appropriately reflective of the sector and the markets in which the Company operates, there can be no assurance that such estimates,
Slide 4: Management team
Management team Dirk Kreder, PhD, MBA Grzegorz Grabowicz, MBA Sławomir Jaros, PhD, MBA Adam Pietruszkiewicz Introduction CEO, President of the MB CFO, Member of the MB CSO, COO, Member of the MB Member of the Supervisory Board delegated as Member of the MB University of Stuttgart and University of K
Slide 5: Mabion - an integrated biopharmaceutical company
Mabion - an integrated biopharmaceutical company with a growing and diversified portfolio and strong competencies in the development of biologics Research & Development Clinical Development (up & downstream, up-scale & characteristics, analytics, (analytics, sample logistics, immunometric assays) va
Slide 6: Mabion excels in analytical, clinical, and regulatory know-how
Mabion excels in analytical, clinical, and regulatory know-how and possesses strong manufacturing capabilities through a lean and efficient organisation Strategy focused on developing proprietary products, with spare Integrated Biotech specialised in the capacity used to generate revenue from CDMO/C
Slide 7: Recent events – Novavax agreement, looking for strategic investor/partner
Section Page Recent events – Novavax agreement, looking for strategic investor/partner Financials – key performance information Business model - highly integrated biosimilar development company Products - attractive diversified portfolio of biologics Markets - large and growing biosimilar market App
Slide 8: Possible extending of collaboration into vaccines development and manufacturing
Possible extending of collaboration into vaccines development and manufacturing - another great opportunity for Mabion in the market with room for multiple winners selected developing entities vaccines’ availability being the issue COVID-19 vaccine types (approved, Ph3 or Ph2) of strategic importanc
Slide 9: Mabion entered into the agreement with Novavax
Mabion entered into the agreement with global player Novavax with intention to build a strategic drug manufacturing asset located in Poland … and Mabion is well-positioned What Novavax needs … to respond as a flexible and integrated CDMO Recent events a partner with know-how in biological drugs deve
Slide 10: Implementation works and technical batch manufacturing
Implementation works as well as technical batch manufacturing and release paving the way to the full-scale commercial production Mabion and Novavax entered into a framework agreement settling terms of cooperation for contract manufacturing of Novavax’ COVID-19 vaccine (NVX-CoV2373) component in Mabi
Slide 11: Novavax is a late-stage biotechnology company
Novavax is a late-stage biotechnology company with more than a decade of experience contending with most devastating diseases e.g.: COVID-19, seasonal influenza, RSV, Ebola, MERS, and SARS Business profile Drugs in development Listed on the New York Stock Exchange Trials Trials Trials Market Drug Pr
Slide 12: Why we want to invest long-term in COVID-19 vaccine manufacturing?
Why we want to invest long-term in COVID-19 vaccine manufacturing ? According to Coherent Market Insights, the global corona virus vaccine market is estimated to be valued at US$ 14.5 billion in 2021, and is expected to exhibit a CAGR of 30.9% Recent events during the forecast period (2021-2027) htt
Slide 13: Why we look for a strategic investor / partner
Why we look for a strategic investor / partner New foreseen dynamics in Mabion might be supported by strategic investor / partner Strategic investor – equity financing Strategic Partner – business co-operation technology transfer to Mabion Recent events Distribution capability Financing through prep
Slide 14: Financials – key performance information
Section Page Recent events – Novavax agreement, looking for strategic investor/partner Financials – key performance information Business model - highly integrated biosimilar development company Products - attractive diversified portfolio of biologics Markets - large and growing biosimilar market App
Slide 15: Estimations of financial needs and funding 2021-2023
Estimations of financial needs and funding 2021-2023 Total value Estimated allocation Planned expenses Financing (PLN mn) 2021 2022-2023 R&D (70% of amount, including PLN 25 mn on clinical trial) „U” shares issue TBU Maintenance & manufacturing 75-85 60-65% 35-40% „V” shares issue ~PLN 100-200 mn* Q
Slide 16: Planned capital increases: series U and V
Planned capital increases: series „U” and „V” Series „U” shares Series „V” shares ▪ Timing: ▪ Timing: ▪ To be announced ▪ Shareholders` Meeting 22 March ▪ Use of proceeds: ▪ Intended subscription period 1H 2021 ▪ Short term financing MabionCD20 development ▪ Use of proceeds: ▪ Funding co-operation w
Slide 17: Business model - highly integrated biosimilar development company
Section Page Recent events – Novavax agreement, looking for strategic investor/partner Financials – key performance information Business model - highly integrated biosimilar development company Products - attractive diversified portfolio of biologics Markets - large and growing biosimilar market App
Slide 18: Mabion operates in the high-growth biosimilars market
Mabion operates in the high-growth biosimilars market with a de-risked model, robust development/manufacturing capabilities and lean, integrated structure Active in biosimilars, a fast growing market segment and built on solid fundamentals ▪ Large underlying global market size of ca. EUR 1.2 bn with
Slide 19: Mabion specialises in complex antibody development and manufacturing
Mabion specialises in complex antibody development and manufacturing Mabion overview Core business focus ▪ Established in Łódź, Poland, in March 2007 by four Develop Manufacture Market Polish pharmaceutical companies with the aim of developing and manufacturing biological drugs Small Molecules ▪ Ass
Slide 20: Strong research, development, manufacturing and regulatory capabilities
Mabion has strong research, development, manufacturing and regulatory capabilities and expertise In vitro In vitro / animals Human Human Regulatory Sales and Analytical Preclinical Phase I / II Phase III filing / approval marketing ▪ Structural and ▪ Pharmacokinetics ▪ Safety ▪ Efficacy ▪ Submission
Slide 21: Unique scientific competences of Mabion's multi skilled team
Unique scientific competences of Mabion’s multi skilled team anitcoagulants vaccines monoclonal fusion antibodies Therapies and medicines based on proteins proteins proteins 240 Dedicated team of employees with Business model enzymatic or regulatory interleukins activity Ph.D.s R&D and Doctoral stud
Slide 22: EU-based state-of-the-art laboratory and manufacturing facility
EU-based state-of-the-art laboratory and manufacturing facility giving competitive edge Laboratory Productivity and cost-effectiveness ▪ Total MabionCD20 R&D cost to remain below USD 75m vs indicative development cost of a biosimilar ranging approx. USD 250m Costs substantially below the market aver
Slide 23: Highest quality standards in compliance with international regulations
Highest quality standards achieved in compliance witch international regulations ▪ GLP defines a set of rules and criteria for a quality system of management of research laboratories in order to ensure the trustworthiness of laboratory data Good Laboratory ▪ GLP applies to non-clinical studies condu
Slide 24: Products - attractive diversified portfolio of biologics
Section Page Recent events – Novavax agreement, looking for strategic investor/partner Financials – key performance information Business model - highly integrated biosimilar development company Products - attractive diversified portfolio of biologics Markets - large and growing biosimilar market App
Slide 25: Mabion's diversified portfolio of assets
Mabion’s diversified portfolio with a broad range of assets ready for commercialization Mabion’s commercialization molecule/drug clinical indication characteristics status partner focus approach pre-registration phase integrated asset in the EU partnered for the EU rituximab oncology (NHL) and biosi
Slide 26: MabionCD20 – lead biosimilar asset on the home-stretch to market launch
MabionCD20 – a lead biosimilar asset on the home-stretch to the market launch small-scale (clinical) process development full-scale (commercial) process development analytical and preclinical development technology outline, basic research generating stable cell lines, engineering implementation, ani
Slide 27: MabionCD20: likelihood of success increasing as data is generated
MabionCD20: as data is generated, the likelihood of success is increasing Amount Risk of Data Generated Products Establishment Submission Additional Resubmission, Cell line Clone Initial of in-vitro Phase I BE and Preclinical Phase III study data Review and development selection char
Slide 28: Summary
Summary: Mabion transforming into a fully-fledged integrated biopharmaceutical company unleashing additional growth potential Mabion is transforming from a one-product biotech company into a fully integrated biopharmaceutical company with an expanding portfolio MabionCD20 project is on track for sub
Slide 29: Markets - large and growing biosimilar market
Section Page Recent events – Novavax agreement, looking for strategic investor/partner Financials – key performance information Business model - highly integrated biosimilar development company Products - attractive diversified portfolio of biologics Markets - large and growing biosimilar market App
Slide 30: Biosimilar drugs being the answer to healthcare market issues
Biosimilar drugs being the answer to the burning issues of the healthcare market Biosimilars’ market expected to expand rapidly over the next few years, faster than off-patent bio drugs Need for ▪ Providing treatment options in the most severe With a increasing demand for biologics and costs savings
Slide 31: Biosimilar market gains on momentum
Biosimilar market gains on momentum Humira (adalimumab), patent cliff 2018 EU, 2022 US biosimilar product authorization in EU and US 3,4 biosimilars already approved 16 16 Keytruda (pembrolizumab), patent cliff 2028 EU, 2036 US EU US World’s top Opdivo (nivolumab), patent cliff 2026 EU, 2027 US 10 s
Slide 32: Aspiring to the top league players in the large rituximab markets
Aspiring to the top league players in the large rituximab markets Mabion intends to introduce MabionCD20 to the most attractive markets: the EU and the US Novartis (Sandoz) Another top player (Amgen/Allergan) market EU only launch 2017 files for the market approval in the US positively verifying mar
Slide 33: Challengers building up solid market shares
Challengers building up solid market shares Historical sales volume of rituximab in EU Volume forecast: UE and US Rituximab biosimilars in NHL and RA (% share) Truxima launched in Ruxience launched Q1, Rixathon in Q3 in Q1 28% 19% Overall sales volume 41% of rituximab in the 16% 59% 88% 51% EU has r
Slide 34: Appendix
Section Page Recent events – Novavax agreement, looking for strategic investor/partner Financials – key performance information Business model - highly integrated biosimilar development company Products - attractive diversified portfolio of biologics Markets - large and growing biosimilar market App
Slide 35: Decomposition of operating expenses and capex
Decomposition of operating expenses and capex PLN mn 1-3Q’20 1-3Q’19 r/r OPEX without D&A -33.0 -40.1 -18% Financials Operating cash flow -26.0 -24.8 +5% CAPEX -3.3 -7.9 -58% average quarterly cash OPEX (OCF) ~ PLN 8.7 mn average quarterly cash OPEX (OCF) ~ PLN 8.3 mn average quarterly CAPEX ~ PLN 1
Slide 36: Mabion's selected financials
MABION’s selected financials P&L (m PLN) 1-3Q 2020 1-3Q 2019 G&A cost limited R&D -26.2 -30.2 by 3.4 m PLN y/y G&A -14.2 -17.6 loss on operating activities -39.2 -46.7 net loss -39.9 -48.4 main G&A items: m PLN 1-3Q’20 1-3Q’19 savings Cash flow (m PLN) 1-3Q 2020 1-3Q 2019 office lease and office exp
Slide 37: Core competences replicated to advance other internal projects
Mabion’s core competences and development capabilities can be successfully replicated to advance other internal projects and tap into large markets Submission of Designing the Developing Implementa- an application Determination Obtaining Drug Starting the molecule and the basics of Pre-clinical tion
Slide 38: Thank you!
Thank you ! ul. gen. Mariana Langiewicza 60 95-050 Konstantynów Łódzki tel.: +48 42 29 08 210 email: info@mabion.eu 38