Formycon Ag · XETR:FYB
Formycon — Investor Presentation (December 2024)
25 slides from Formycon's investor presentation, December 2024
Slide 1: Formycon AG – The Biosimilar Experts
Formycon AG The Biosimilar Experts November / December 2024
Slide 2: Disclaimer
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 si
Slide 3: Skillset and mindset are our key ingredients
Skillset and mindset are our key ingredients Pure Play Biosimilar More than 240 employees Combining high professional Formycon's pipeline Company – established 2012 from 31 different countries. expertise in biopharma- includes three approved in Munich, Germany. ceutical development with biosimilars,
Slide 4: We are acting along a clear mission
We are acting along a clear 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: Huge Biosimilar target opportunities
Huge Biosimilar target 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 s
Slide 6: The Biosimilar market develops very dynamically
The Biosimilar market develops very dynamically 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 market ● US ● EUROPE
Slide 7: Biosimilar development with different risk profile – high probability of success
Biosimilar development with different risk profile – high probability of success 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 8: Full value chain covered in successful hybrid model
Full value chain covered 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 trusted long-term
Slide 9: Maximizing our assets along a clear pathway
Laser focus on pipeline execution and expansion Maximizing our assets along a clear pathway 2023 2024 Strong financial Important year Sustainable and operational to prepare the profitability with performance ground for the continuous pipeline next ignition growth stage 9 Formycon AG – The Biosimilar
Slide 10: Many important Milestones achieved in 2024
Many important Milestones achieved in 2024 – further exciting News expected in the upcoming Weeks Positive CHMP Opinion Approval of Approval of Approval of Positive CHMP Opinion for Stelara® Biosimilar- Stelara® Biosimilar- Stelara® Biosimilar- Eylea® Biosimilar-Candidate for Eylea® Biosimilar- Cand
Slide 11: Launched & late-stage Projects well on track – Strong Newsflow ahead
Launched & late-stage Projects well on track – Strong Newsflow ahead Lucentis® Biosimilar Stelara® Biosimilar Candidate Eylea® Biosimilar Candidate [Ranibizumab] [Ustekinumab] [Aflibercept] ● Launch in Canada and Switzerland ● Settlement for Launch in Europe ● FDA Approval for FYB203/ by Teva. and C
Slide 12: 2nd wave of Projects progressing well
2nd wave of Projects progressing well Keytruda® Biosimilar Candidate Undisclosed New undisclosed [Pembrolizumab] Biosimilar Candidates Biosimilar Candidate ● First patient entered Phase I ● Clones with superior stability, ● New Biosimilar Candidate in the clinical trial “Dahlia” to compare productiv
Slide 13: Strong maturing and growing pipeline
Strong maturing and growing pipeline Diversified portfolio of commercial, late and mid stage programs with multiple catalysts over the next 12 – 18 months Lucentis® 50% Further approvals Ophthalmology $2.0bn [US*] [ex-US] [MENA] (Genentech Inc.) owned and launches 2022 Stelara® Fully Launches in US,
Slide 14: FYB201 – Lucentis Biosimilar well positioned
FYB201 – Lucentis® Biosimilar well positioned IQVIA Monthly Data R3M (rolling 3-month) *Volume-based / Source: FYB201 well established Approved ● Launched in 20 countries. and launched ● CIMERLI® ramp-up in the US with > 40% market share in the ranibizumab market as of August 2024*. Indications ● Pi
Slide 15: Lucentis Biosimilar FYB201 (Ranibizumab)
Lucentis® Biosimilar FYB201 (Ranibizumab) 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 Approved in EU, UK, Xbrane STADA (EU) / US to be settled Comple
Slide 16: FYB202 – Stelara Biosimilar Candidate ready to launch
FYB202 – Stelara® Biosimilar Candidate ready to launch FYB202 Competitive Advantage Approved ● Submission according to initial schedule and settlement with J&J puts FYB202 in position for market entries in US, EU and Canada. ● Fresenius Kabi as strong partner with potential for commercial lead posit
Slide 17: Stelara Biosimilar Candidate FYB202 (Ustekinumab)
Stelara® Biosimilar Candidate FYB202 (Ustekinumab) Ustekinumab Competitive Landscape Development Company Commercialization Partner Status Phase III Submission / Approval Approved and Launched in EU / Approved in US Alvotech Teva (US) / Stada (EU) Completed Expected Launch in US: 21. Feb.2025 Amgen O
Slide 18: FYB203 – Eylea Biosimilar Candidate approved in US & recommended for EU
FYB203 – Eylea® Biosimilar Candidate approved in US & recommended for EU Formycon Income Position Approved ● Mid-single to low-double-digit-percentage participation in all Klinge income from commercialization partners across Targeted reference Indications all territories. Neovascular Age-Related Mac
Slide 19: Eylea Biosimilar Candidate FYB203 (Aflibercept)
Eylea® Biosimilar Candidate FYB203 (Aflibercept) Aflibercept Competitive Landscape Development Company Status Phase III Submission / Approval Alvotech Completed n/a Amgen Completed Approved in US & EU / Launch in US Biocon (Mylan / Momenta) Completed Approved in US & EU Celltrion Completed US-Filing
Slide 20: FYB206 – Keytruda Biosimilar Candidate in the leading group
FYB206 – Keytruda® Biosimilar Candidate in the leading group Targeted reference Indications Achievements and next important Milestones Immuno-oncology: Melanoma (black skin cancer), ● Important IP has been generated non-small cell Lung Cancer, classical Hodgkin’s Lymphoma ● Clinical Phase I trial “D
Slide 21: Keytruda Biosimilar Candidate FYB206 (Pembrolizumab)
Keytruda® Biosimilar Candidate FYB206 (Pembrolizumab) Pembrolizumab Competitive Landscape Development Company Status Submission / Approval Alvotech Pre-Clinical -- Amgen Phase I / III to be launched -- Bio-Thera Phase I / III to be launched -- Henlius Pre-Clinical -- mABxience Phase III launched --
Slide 22: 2024 Guidance confirmed
2024 Guidance confirmed 9M 2024 Revenue EBITDA Adjusted EBITDA* Working Capital ● Revenue: 4Q 2024 expected in the range of € 20m 41.1 -17.7 2.9 65.8 ● EBITDA: 4Q EBITDA expected to be € million € million € million € million “black zero” ● Adjusted EBITDA At equity result 4Q also expected Guidance R
Slide 23: Formycon – now uplisted to Prime Standard!
Formycon – now uplisted to Prime Standard! − Market Segment: Frankfurt Stock Exchange Shareholder Structure Regulated Market (Prime Standard) 24.04 % Santo Holding (Deutschland) GmbH − Uplisted to Prime Standard on Nov. 12, 2024 13.25 % Wpart GmbH, Wen.Co Invest GmbH, Peter Wendeln enables Formycon'
Slide 24: Fully focused pure-play Biosimilar Company
Fully focused pure-play Biosimilar Company WE HAVE all ingredients to WE ACT in a highly WE CREATED WE ARE entering the next successfully develop and attractive market a strong Platform with stage of the Formycon commercialize a growing track record Growth Story pipeline 24 Formycon AG – The Biosimi
Slide 25: Thank You!
Thank You! Formycon AG Version: November / December 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 25 Formycon AG – The Bios