Gedeon Richter

Biotechnology (BIO)

Business

13 March 2024

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 strategy: carefully selected proprietary biosimilar development projects combined with strong biological manufacturing capability and a growing complementary CDMO business
  • Richter biosimilars today: a balanced pipeline with two commercial products (teriparatide & FSH); one with successfully completed clinical phase ahead of filing for registration (denosumab); one in phase-3 (tocilizumab) and several pre-clinical candidates
  • BIO assets in Hungary: state-of-the-art mammalian cell expression based DS (Drug Substance) R&D and manufacturing capability; fill & finish DP (Drug Product) capability in addition to medical device assembly
  • BIO assets in Germany: high quality microbial R&D and manufacturing CDMO capabilities; three sites, one undergoing a major capacity expansion; teriparatide biosimilar DS manufacture
  • BIO assets in Germany: HELM transaction allows the exit of the long-time partner and raises Richter's ownership to 100%
  • Formycon deal: a new partner with an equity link to jointly explore development, manufacturing and commercial opportunities along the whole biosimilar value chain

2

The Biosimilar opportunity

3

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

22

6

5 11

2022

15% p.a.

28

39

15

10

16

12

8

6

2024

2026

49

18

20

11

2028

19% p.a. 100

  1. 46
  1. 32
  1. 22

2030 2032

34%

10%

7%

15%

16%

19%

Beyond top 5, there are 94 additional players

Top 5 account for 66% of the market

Biologics LOEs 2022-2031

50+

Assets with >1bn LOE sales over next 10 years

$210+bn

Cumulative peak sales for products going off-patent between 2022-31

Source: McKinsey BiosimCast 2022, IQVIA Analytics Link 2017-22, PHAST, EVALUATE, Press search

4

Biosimilar strategy and proprietary development assets

5

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

Psoriasis

Psoriatic

Rheumatoid

Axial spondylo-

Osteoporosis

arthritis

arthritis

arthritis

Skin affected

Joints affected

Bone/skeleton affected

Biologics CDMO services (microbial & mammalian)

6

Gedeon Richter Biosimilar portfolio and product pipeline

Molecule

Indication

Originator

Early CMC

Late CMC dev Clinical dev

Submission

Commercial

dev

BEMFOLA® *

Infertility

r-hFSH

TERROSA®

Osteoporosis

Teriparatide

RGB14

Osteoporosis

Denosumab

Oncology

RGB19

RA

Tocilizumab

RGB17

Thrombocytopenia

Romiplostim

RGB20

Autoimmune

RGB24

Autoimmune

* Bemfola is a biosimilar product manufactured by the BIO business unit, but is marketed by and its sales are reported under the WHC business unit. Bemfola was

acquired by Richter in 2016.

7

Richter BIO assets in

Hungary

8

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 development capabilities
  • Broad range of analytical method development capabilities (including MS & wide array of bioassays)
  • Pilot plants for both drug substance and drug product development and scale down activities
  • Packaging development services
  • Dedicated clinical team
  • Strong regulatory affairs capabilities

Established in 2007

Mammalian cell expression based R&D projects

9

Mammalian cell expressed Drug Substance (DS)

and Drug Product (DP) manufacturing facilities - Debrecen

DSDP

  • 2 x 5000 L stainless steel fermentation capacity
  • 4 x 2000 L single use & 2 x 50 L pilot scale bioreactors added in 2019
  • Analytical services support
  • Scale down development capabilities available
  • Syringe, cartridge, vial filling (RABS)
  • Automated freeze drying
  • Variable batch sizes
  • Stainless steel / single use available
  • Label / blister technology
  • QC & QA services

Opened in 2012 Greenfield investment Expansion finished 2019

Mammalian cell fermentation & downstream processing

Fill and Finish capabilities

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Gedeon Richter plc published this content on 13 March 2024 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 13 March 2024 07:13:06 UTC.