Chemical Works Of Gedeon Richter Plc · BET:RICHTER
Chemical Works Of Gedeon Richter — Gedeon Richter — Investor Presentation (March 2024)
24 slides from Chemical Works Of Gedeon Richter's investor presentation, Mar 13, 2024
Slide 1: Gedeon Richter Biotechnology (BIO) Business
Gedeon Richter Biotechnology (BIO) Business 13 March 2024
Slide 2: Richter Biotechnology – Executive summary
Richter Biotechnology – Executive summary • The Biosimilar opportunity: the fastest growing subsegment in pharmaceuticals, as more than 40 biological blockbusters (USD 1bn+) with total global sales volumes of USD 200bn+ are expected to lose exclusivity in the next 10 years • Richter biosimilar strat
Slide 3: The Biosimilar opportunity
The Biosimilar opportunity 3
Slide 4: 15% CAGR of the biosimilar market mainly driven by 50+ blockbuster LOEs until 2031
15% CAGR of the biosimilar market mainly driven by 50+ blockbuster LOEs until 2031 Total Biosimilars net sales (in USD bn) Market concentration (% of total gross sales) USA EU51 RoW Other Biogen Lilly Sandoz Amgen Pfizer 22.6 19% p.a. 100 Beyond top 5, there are 94 34% additional players 74 15% p.a.
Slide 5: Biosimilar strategy and proprietary development assets
Biosimilar strategy and proprietary development assets 5
Slide 6: Gedeon Richter Biotechnology business unit focus
Gedeon Richter Biotechnology business unit focus Development and manufacturing of Biosimilars / Biologics Commercialization of Biosimilars / Specialty products for treatment of Rheumatology, other Auto-immune diseases and Osteoporosis (RIO) in Europe and Australia Psoriatic Rheumatoid Axial spondylo
Slide 7: Gedeon Richter Biosimilar portfolio and product pipeline
Gedeon Richter Biosimilar portfolio and product pipeline Early CMC Molecule Indication Originator Late CMC dev Clinical dev Submission Commercial dev BEMFOLA® * Infertility r-hFSH TERROSA® Osteoporosis Teriparatide RGB14 Osteoporosis Denosumab Oncology RGB19 RA Tocilizumab RGB17 Thrombocytopenia Rom
Slide 8: Richter BIO assets in Hungary
Richter BIO assets in Hungary 8
Slide 9: Biotechnology R&D – Budapest
Biotechnology R&D – Budapest ▪ R&D facilities cover process technology and analytical method development laboratories ▪ Full service portfolio to address small-scale and scale-up development requirements ▪ Small scale process development/clone selection capabilities (AMBR – 200 L) ▪ Formulation deve
Slide 10: Mammalian cell expressed DS and DP manufacturing facilities – Debrecen
Mammalian cell expressed Drug Substance (DS) and Drug Product (DP) manufacturing facilities – Debrecen DS DP ▪ 2 x 5000 L stainless steel ▪ Syringe, cartridge, vial filling fermentation capacity (RABS) ▪ 4 x 2000 L single use ▪ Automated freeze drying & 2 x 50 L pilot scale ▪ Variable batch sizes bi
Slide 11: Overview of the Debrecen manufacturing site
Overview of the Debrecen manufacturing site 11
Slide 12: BIO assets in Germany Richter-Helm transaction
BIO assets in Germany Richter-Helm transaction 12
Slide 13: Transaction overview
Transaction overview Highlights of the deal • Richter agreed to acquire its partner’s, HELM’s interest in all of its German biological assets, assuming 100% ownership of both RHB (Richter-Helm BioLogics) and RHT (Richter-Helm BioTec) • Total transaction value includes a cash payment of EUR 40.6mn fo
Slide 14: RHT - teriparatide biosimilar is partnered globally with overall sales of ~EUR 125mn in 2023
RHT - teriparatide biosimilar is partnered globally with overall sales of ~EUR 125mn in 2023 Europe: Gedeon Richter & Stada Canada: Avir Japan: Mochida South Korea: MENA: Tabuk Daewon Israel: Dexcel Taiwan, Thailand: Lotus Colombia: Gedeon Richter Malaysia, Singapore, Philippines: Mega Brazil: Gedeo
Slide 15: RHT – teriparatide biosimilar; Gedeon Richter brand - TERROSA
RHT – teriparatide biosimilar; Gedeon Richter brand - TERROSA® • PTH fragment for treatment of postmenopausal osteoporosis GR teriparatide sales in 2019-23 (EUR mn) • Total turnover of the molecule was close to EUR 125m in 2023… • …including EUR 56.8mn sales generated by Gedeon Richter 57 through di
Slide 16: Richter BIO facilities RHB facilities in Germany
Richter BIO facilities RHB facilities in Germany COMPANY PROFILE Bovenau up to 1500 liter Bovenau (RHB) (microbial, DS prod.) Hamburg (RHB) Hannover (microbial, R&D) Hannover (RHB) (microbial, DS up to pilot plant) Debrecen (GR) (mammalian, DS/DP prod.) 300 liter Budapest (GR) (mammalian, R&D) Hambu
Slide 17: Richter Biologics Germany (RHB) – microbially expressed biopharmaceuticals
Richter Biologics Germany (RHB) – focused on microbially expressed development & manufacture of biopharmaceuticals EXPANSION Production in Bacteria • Recombinant proteins e.g. secreted, periplasmic and insoluble proteins • Bacterial vaccines e.g. attenuated whole cell vaccines • Plasmid DNA propriet
Slide 18: Microbially expressed Biopharmaceuticals production value chain
Microbially expressed Biopharmaceuticals production value chain COMPANY PROFILE EXPANSION Complete Drug Substance Development & Manufacturing from one Source Strain Development Process Development / Process Transfer Clinical Trial Supply Commercial / Optimization Analytical Development / Scale-up Ph
Slide 19: Capacity expansion at the Bovenau site – to become operational in 2024
Capacity expansion at the Bovenau site – to become operational in 2024 EXPANSION ▪ New production building housing two additional production lines − (200L and 1000L working volume), focused on production of rec. proteins, Nanobodies, vaccines and pDNA − Space, connections and energies for an additio
Slide 20: RHB – audits and accreditations
RHB – audits and accreditations COMPANY PROFILE EXPANSION Health Regulatory Pharmaceutical and Medical Ministry of Health Agency - Brazil Devices Agency - Japan and Welfare - China Ministry of Food and Ministry of Health - Türkye Drug Safety – Republic of Korea ✓ Inspections by local German Federal
Slide 21: Formycon AG
Formycon AG @ Geveon RicuTER Heath is ourmission 21
Slide 22: Richter became a strategic partner of Formycon AG
Richter became a strategic partner of Formycon AG Highlights of the deal • Richter became a strategic investor of Formycon AG via equity investment on 29 January 2024, acquiring 9.08% of Formycon’s share capital in a cash capital increase • The placement price per new share was EUR 51.65, total proc
Slide 23: Contacts Financial calendar Investor relations manager
Contacts Financial calendar Company name: Gedeon Richter Plc. Sector: Pharmaceutical | 25 April 2024 – AGM Company address: 1103 Budapest, Gyömrői út 19-21., Hungary | 14 May 2024 – Q1 2024 results | 6 August 2024 – H1 2024 results Telephone: +36 1 431 5764 | 12 November 2024 – Q1-Q3 2024 results Fa
Slide 24: Disclaimer
Disclaimer This presentation and the associated slides and discussion contain forward-looking statements. These statements are naturally subject to uncertainty and changes in circumstances. Those forward-looking statements may include, but are not limited to, those regarding capital employed, capita