Formycon Ag · XETR:FYB
Formycon — Investor Presentation (January 2024)
32 slides from Formycon's investor presentation, January 2024
Slide 1: Formycon AG – The Biosimilar Experts
Formycon AG The Biosimilar Experts
Slide 2: Forward-looking statements disclaimer
This presentation may contain forward-looking statements and information which are based on our current expectations and certain assumptions. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, pe
Slide 3: Biosimilar Market
F O R M YC O N AG BIOSIMILAR MARKET 3 Formycon AG – The Biosimilar Experts
Slide 4: Vision & Mission
VISION & MISSION Biosimilars open up enormous opportunities Contributing to ease Improving the financial strains on the patient access to vital world’s healthcare systems medicines 4 Formycon AG – The Biosimilar Experts
Slide 5: Biosimilar Opportunities
BIOSIMILAR OPPORTUNITIES 45 Blockbuster drugs with an expected global sales volume of more than 200 USD billion will lose their exclusivity in the coming years, creating huge opportunities for Biosimilars Year Number of blockbuster drugs losing exclusivity Cumulative global annual peak sales in USD
Slide 6: 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 7: US Biosimilar Launches in the Medical Benefit Channel Show Accelerated Uptake
U S B I O S I M I L A R L AU N C H E S I N T H E M E D I C A L B E N E F I T C H A N N E L S H O W AC C E L E R AT E D U P TA K E ● For US Biosimilars launched prior to 2019, the average share after two years was 13 % ● For US Biosimilars launched in the last two years, the average share was 65 %! S
Slide 8: 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 USD 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 wil
Slide 9: Biosimilar Development
F O R M YC O N AG BIOSIMILAR DEVELOPMENT 9 Formycon AG – The Biosimilar Experts
Slide 10: Differences Between Generics and Biosimilars
DIFFERENCES BETWEEN GENERICS AND BIOSIMILARS New Chemical New Biological Entity (NCE) Entity (NBE) Innovative Innovative Small Molecule Drug Biopharmaceutical Drug Development: 10–14 years Development 10–14 years Budget: $ 1–2bn Budget $ 1–2bn Biological active Patent protection 20 – 25 years ingred
Slide 11: Biosimilar Development Probability of Success
B I O S I M I L A R D E V E LO P M E N T P R O B A B I L I T Y O F S U C C E S S The probability of success for a Biosimilar is continuously high over the course of development1. This is different for innovative drug developments: Here, on average, only one in twelve innovative drugs makes it from t
Slide 12: Full Value Chain Covered in Successful Hybrid Model
F U L L VA L U E C H A I N C O V E R E D IN SUCCESSFUL HYBRID MODEL With our team of highly experienced scientists and regulatory affairs experts, Formycon covers a large part of the Biosimilar development value chain in-house. For the areas of manufacturing and commercialization, we rely on well tr
Slide 13: Formycon AG – R&D Powerhouse & Pipeline
G E A R E D T O WA R D S G R O W T H F O R M YC O N A G – R&D POWERHOUSE & PIPELINE 13 Formycon AG – The Biosimilar Experts
Slide 14: About Formycon
A B O U T F O R M YC O N Pure Play Biosimilar More than 230 employees Combining high professional Formycon’s Pipeline Company – established 2012 from 31 different countries. expertise in biopharma- consists of one approved in Munich, Germany. ceutical development with and launched Biosimilar More th
Slide 15: Highlights 2023
HIGHLIGHTS 2023 Formycon reached all key milestones in 2023 RESEARCH & DEVELOPMENT BUSINESS OPERATIONS FINANCE & IR FYB202 (Stelara® Biosimilar Candidate) FYB201 (Lucentis® Biosimilar) gained strong Successful capital increase submission to FDA and EMA market share in US, ramping up in EU. of approx
Slide 16: Outlook for 2024
O U T LO O K F O R 2 0 2 4 2024 is expected to bring some further important milestone achievements RESEARCH & DEVELOPMENT BUSINESS OPERATIONS FDA approvals for FYB202 (Stelara® Commercialization partnerships for Biosimilar Candidate) and FYB203 FYB203 (Eylea® Biosimilar Candidate) FYB201 (Lucentis®
Slide 17: Strong Pipeline
STRONG PIPELINE Diversified portfolio of commercial, late and mid stage programs with multiple catalysts over the next 12 – 18 months Lucentis® 50% Approvals and Ophthalmology $2.9bn (Genentech Inc.) owned launches, e.g. CA 2022 [US] [ex-US] [MENA] Stelara® Fully Approvals in US Immunology $9.7bn 20
Slide 18: FYB201 – Lucentis Biosimilar
FYB201 – LUCENTIS® BIOSIMILAR Approved and launched Indications 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 19: Lucentis Biosimilar FYB201 (Ranibizumab) Well Positioned
LUCENTIS® BIOSIMILAR FYB201 (RANIBIZUMAB) WELL POSITIONED FYB201 / Ranivisio® / Ongavia® / Cimerli™ Formycon Competitive Advantage Income Position ● Unique position in the US due to availability in both ● Low teens % from Cimerli® (US), Ranivisio® (EU) dosages and exclusive "interchangeability" stat
Slide 20: 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 Targeted Reference Indications Achievements Psoriasis (Arthritis), Crohn’s Disease, ● Clinical development successfully completed Ulcerative Colitis ● Settlement with J&J for US license date no later than Target Market 2022 April 15, 2
Slide 21: Stelara Biosimilar Candidate FYB202 (Ustekinumab)
S T E L A R A® B I O S I M I L A R C A N D I DAT E F Y B 2 0 2 (USTEKINUMAB) FYB202 Formycon Competitive Advantage Income Position ● Submission according to initial schedule and ● Milestone payments related to the completion of settlement with J&J puts FYB202 in good position clinical phases of abou
Slide 22: 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 Targeted reference Indications Achievements and next important Milestones Neovascular Age-Related Macular Degeneration (nAMD), ● Biologics License Application submitted to the FDA DME1, mCNV2, DR3, RVO4 in June 2023. FDA file acceptance on
Slide 23: Eylea Biosimilar Candidate FYB203 (Aflibercept)
E Y L E A® B I O S I M I L A R C A N D I DAT E F Y B 2 0 3 (AFLIBERCEPT) FYB203 Formycon Competitive Advantage Income Position ● Commercialization experiences and lead position ● Mid-single to low-double-digit-percentage from FYB201 in the ophthalmology/AMD space will participation in all Klinge inc
Slide 24: 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 Targeted reference Indications 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 manufacturi
Slide 25: 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 25 Formycon AG – The Biosimilar Experts
Slide 26: Financial Performance (IFRS)
FINANCIAL PERFORMANCE (IFRS) 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 + Topline and EBITDA unchanged current forecast + Significant increase in net income due to one-off 75 to 85 -15 to -5 15 to 25 50 to 60 and non-cash effect
Slide 27: 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: € 16,053,025 Ownership Capital, Wendeln & Cie. KG, DSP Shares outstandin
Slide 28: Management Team & Board Members
F O R M YC O N AG M A N AG E M E N T T E A M & B OA R D M E M B E R S 28 Formycon AG – The Biosimilar Experts
Slide 29: 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 27 years of ● More than 20 years of ● More than 20 years of ● More than 24 years of exper
Slide 30: 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 31: Formycon Is a Fully Focused Pure-Play Biosimilar Company
F O R M YC O N I S A F U L LY F O C U S E D P U R E - P L AY B I O S I M I L A R C O M PA N Y Proof of capabilities with recent Lucentis® Efficient hybrid business model taking biosimilar approvals and successful advantage of in-house expertise and selected launches external partnerships Remarkable
Slide 32: Formycon AG contact details
F O R M YC O N AG Formycon AG Version: January 2024 Photos: Hagen Brede, Adobe Stock, Formycon AG Fraunhoferstraße 15 82152 Martinsried / Planegg Germany T + 49 89 864 667 100 F + 49 89 864 667 110 E ir@formycon.com I www.formycon.com Formycon AG The Biosimilar Experts 32 Formycon AG – The Biosimila