Formycon Ag · XETR:FYB
Formycon — Investor Presentation (September 2023)
28 slides from Formycon's investor presentation, September 2023
Slide 1: Formycon AG – The Biosimilar Experts
Formycon AG The Biosimilar Experts
Slide 2: Vision & Mission: Contributing to ease financial strains on healthcare systems
VISION & MISSION Pioneering Work in Biosimilar Development Contributing to ease the financial strains on the world’s healthcare systems Formycon AG The Biosimilar Experts 2 Formycon AG – The Biosimilar Experts
Slide 3: Vision & Mission: Improving Patient Access to Vital Medicines
VISION & MISSION Pioneering Work in Biosimilar Development Improving Patient Access to Vital Medicines Formycon AG The Biosimilar Experts 3 Formycon AG – The Biosimilar Experts
Slide 4: About Formycon
A B O U T F O R M YC O N Key Data Core Competences Strong Pipeline ● Commercial Stage Biosimilar ● Exceptional Pool of ● Three late-stage focused Biotechnology Biosimilar Experts with Biosimilars – one approved Company – established 2012 extensive Experience in and launched, two heading in Munich, G
Slide 5: Highlights H1/2023
HIGHLIGHTS H1/2023 JANUARY 2023 FEBRUARY 2023 APRIL 2023 JUNE 2023 ● Coherus ● Fresenius Kabi ● Stelara Biosimilar ® ● Biologics License BioSciences, Inc. becomes commer- Candidate FYB202 Application for becomes comer- cialization partner shows positive Eylea® Biosimilar cialization partner for Stel
Slide 6: Highlights H2/2023 – To Be Continued
HIGHLIGHTS H2/2023 – TO BE CONTINUED … AUGUST 2023 TO BE CONTINUED … ● Formycon and ● EU-regulatory Fresenius Kabi submission for entered into a FYB203 settlement ● Regulatory agreement with J&J submission for and secured US FYB202 in the license date for US & EU Stelara® Biosimilar Candidate FYB202
Slide 7: About Biosimilars
G LO B A L Q U A L I T Y B I O S I M I L A R S ABOUT BIOSIMILARS 7 Formycon AG – The Biosimilar Experts
Slide 8: Differences Between Generics and Biosimilars
DIFFERENCES BETWEEN GENERICS AND BIOSIMILARS New Chemical New Biological Development and Entity (NCE) Entity (NBE) Risk-Profile – / + Innovative Innovative – Clinical + Small Molecule Drug Biopharmaceutical Drug Technical Manu- Development: 10–14 years Development 10–14 years Development facturing S
Slide 9: The Biosimilar Market Is Highly Dynamic
T H E B I O S I M I L A R M A R K E T I S H I G H LY DY N A M I C Global Biosimilar Sales 2016 – 2030 USD Billion* 74.0 2015 – 2021 2021 – 2025 RoW CAGR 39% RoW CAGR 16% US CAGR 97% US CAGR 26% Europe CAGR 48% Europe CAGR 8% Biosimilars is the fastest growing segment ● ROW 32.9 in Pharma. The US mar
Slide 10: Recent US Launches Show Accelerated Uptake
R E C E N T U S B I O S I M I L A R L AU N C H E S S H O W AC C E L E R AT E D U P TA K E EU US ● EU Biosimilars have taken above 60 % of ● For therapeutic areas with US biosimilars launched prior reference market volume to 2019, the average share after two years was 13 % ● Timing for market adoptio
Slide 11: Biosimilars Generate Significant Savings
B I O S I M I L A R S G E N E R AT E S I G N I F I C A N T S AV I N G S Global savings from Biosimilars ● Annual savings could exceed $ 100Bn in 2026 and 2027 as some of the largest spending biologic molecules will have well developed biosimilar competition by this time ● This level of savings will
Slide 12: Pipeline
G E A R E D T O WA R D S G R O W T H PIPELINE 12 Formycon AG – The Biosimilar Experts
Slide 13: Strong Pipeline
STRONG PIPELINE Diversified portfolio of commercial, late and mid stage programs with multiple catalysts over the next 12 – 18 months Lucentis® Approvals Expired Ophthalmology 50% owned CA, AUS, +++ $2.9bn (Genentech Inc.) US: 06/2020, EU: 07/2022 2022 [US] [ex-US] [MENA] Stelara® Submission Patent
Slide 14: FYB201 – Lucentis Biosimilar
FYB201 – LUCENTIS® BIOSIMILAR Approved and launched Indication Neovascular Age-Related Macular Degeneration (nAMD), DME1, CNV2, PDR3, RVO4 Target Market 2022 Approved USD 2.9 billion Further Potential Project Rights 50% Ownership in Joint Venture (Bioeq AG) which holds project and commercialization
Slide 15: Lucentis Biosimilar FYB201 (Ranibizumab) Well Positioned
LUCENTIS® BIOSIMILAR FYB201 (RANIBIZUMAB) WELL POSITIONED Ranibizumab Competitive Landscape Development Company Commercialization Partner Status Phase III Submission / Approval Samsung Biologics Biogen Completed (End of 2019) Approved in US, EU, UK, CA STADA (EU) / Commercialization in Approved in E
Slide 16: FYB202 – Stelara Biosimilar Candidate
F Y B 2 0 2 – S T E L A R A® B I O S I M I L A R C A N D I DAT E Indication Achievements and next important Milestones Psoriasis (Arthritis), Crohn’s Disease, Ulcerative Colitis ● Clinical development with extended pharmacokinetics study successfully completed Target Market 2022 USD 9.7 billion ● Se
Slide 17: Stelara Biosimilar FYB202 (Ustekinumab)
S T E L A R A® B I O S I M I L A R F Y B 2 0 2 (USTEKINUMAB) Ustekinumab Competitive Landscape Development Company Commercialization Partner Status Phase III Submission Alvotech Teva (US) / Stada (EU) Primary endpoint met US-/EU-Filing (Q1 2023) Amgen Primary endpoint met US-Filing (11/2022) Celltri
Slide 18: FYB203 – Eylea Biosimilar Candidate
F Y B 2 0 3 – E Y L E A® B I O S I M I L A R C A N D I DAT E Indication Achievements and next important Milestones Neovascular Age-Related Macular Degeneration (nAMD), ● Biologics Licence Application submitted to the FDA DME1, mCNV2, DR3, RVO4 in June 2023. FDA file acceptance on August 28, 2023 Tar
Slide 19: Eylea Biosimilar FYB203 (Aflibercept)
E Y L E A® B I O S I M I L A R F Y B 2 0 3 (AFLIBERCEPT) Aflibercept Competitive Landscape Development Company Status Phase III Submission / Approval Alvotech Start (07/2022) — Amgen Primary endpoint met (Q3/2022) — Biocon (Mylan / Momenta) Completed US-Filing (10/2021) Celltrion Positive 24-week re
Slide 20: FYB206 – Keytruda Biosimilar Candidate
F Y B 2 0 6 – K E Y T R U DA® B I O S I M I L A R C A N D I DAT E Indication Achievements and next important Milestones Immuno-oncology: Melanoma (black skin cancer), ● Process Development and Development of the non-small cell Lung Cancer, classical Hodgkin’s Lymphoma Manufacturing Process at commer
Slide 21: Financials and Stock Market
C R E AT I N G VA L U E W I T H B I O S I M I L A R S FINANCIALS AND STOCK MARKET 21 Formycon AG – The Biosimilar Experts
Slide 22: Financial Performance (IFRS) – Accelerating Business
F I N A N C I A L P E R F O R M A N C E ( I F R S ) – AC C E L E R AT I N G B U S I N E S S Fiscal R EV ENU E WOR KING NET INCOME ● Guidance: year 2023 EBITDA CA PITA L + Concretized in figures (corridors) current forecast + Slightly increased 75 to 85 -15 to -5 15 to 25 -20 to -30 ● Revenue increas
Slide 23: Formycon on the Stock Market
F O R M YC O N O N T H E S T O C K M A R K E T ● Listed on Frankfurt Stock Exchange since June 2012 / Shareholder Structure SME segment “Scale” (Open Market) ● ~54 % Anchor Investors incl. Athos KG, Active ● Registered capital: € 16,038,775 Ownership Capital, Wendeln & Cie. KG, DSP Shares outstandin
Slide 24: Management Team & Board Members
F O R M YC O N M A N AG E M E N T T E A M & B OA R D M E M B E R S 24 Formycon AG – The Biosimilar Experts
Slide 25: Management Team
M A N AG E M E N T T E A M Complementary Skills and Experience Dr. Stefan Glombitza, Nicola Mikulcik Dr. Andreas Seidl, Enno Spillner, CEO of Formycon CBO of Formycon CSO of Formycon CFO of Formycon ● More than 20 years of ● 12 years Global Head of ● More than 20 years of ● More than 24 years of exp
Slide 26: Highly Experienced Supervisory Board
H I G H LY E X P E R I E N C E D S U P E R V I S O R Y B OA R D Strategic advice with a broad corporate perspective Dr. Olaf Stiller Peter Wendeln Klaus Röhrig Wolfgang Essler Chairman Deputy Chairman Member Member ● CEO of Paedi Protect AG ● Managing partner of ● Founding partner of Active ● Chief
Slide 27: Key Investment Highlights
KEY INVESTMENT HIGHLIGHTS Commercial-stage Potential to address a large and Proof of capabilities with recent biosimilar-focused biotechnology growing market with constantly Lucentis® biosimilar approvals and company expanding product pipeline successful launches Remarkable pipeline including Effici
Slide 28: Disclaimer
DISCLAIMER Formycon AG This presentation may contain forward-looking statements and information which are based on Version: August 2023 Photos: Hagen Brede, Adobe Stock, Formycon AG Fraunhoferstraße 15 our current expectations and certain assumptions. Various known and unknown risks, 82152 Martinsri