Orion Oyj Class A · OMXHEX:ORNAV
Orion Oyj Class A — Investor Day (May 2023)
17 slides from Orion Oyj Class A's investor day presentation, May 25, 2023
Slide 1: Innovative Medicines Research & Development
Innovative Medicines Research & Development Outi Vaarala, Senior Vice President
Slide 2: Disclaimer
Disclaimer This presentation contains forward-looking statements which involve risks and uncertainty factors. These statements are not based on historical facts but relate to the Company’s future activities and performance. They include statements about future strategies and anticipated benefits of
Slide 3: Innovative Medicines
GRION Innovative Medicines
Slide 4: Overview of Innovative Medicines
Overview of Innovative Medicines 120 101 Innovative Medicines launch and 100 Q1'22 +89% business model is very different EUR million 80 60 Q1'23 from that of branded generics or 42 40 generics 22 20 2022 (w/o EUR 228 0 milestone) Net sales R&D of Innovative Medicines Sales split in Q1'23 requires di
Slide 5: Darolutamide (Nubeqa) – lifecycle so far
Darolutamide (Nubeqa®) – lifecycle so far IDEA PRE-CLINICAL RESEARCH PHASE I / PHASE II ARAMIS PHASE III ARANOTE PHASE III Research & Development ARASTEP ARASENS PHASE III PH III Partnering Endo Pharmaceuticals BAYER MA in nmCRPC MA in mHSPC Milestones 7 50 8+20 30 45 received by MEUR MEUR MEUR MEUR
Slide 6: Building blocks for growth – Innovative Medicines
Building blocks for growth – Innovative Medicines Short term Mid-term Long-term NUBEQA ODM-2081 ganaxolone ODM-1051 NUBEQA ODM-2081 ODM-1051 ODM-1111 ODM-2121 ODM-1111 ganaxolone Other R&D pipeline ODM-2121 Expanding product portfolio and/or development pipeline through in-licensing and M&As Nubeqa
Slide 7: Research & Development
GRION Research & Development
Slide 8: Overview of Orion's Research & Development
Overview of Orion’s Research & Development RE-FOCUSING OF R&D IN 2022 Number of R&D personnel ~400 Why pain and oncology? • Orion R&D has a proven track record of success R&D expenses in 2022: EUR 133 million on discovery and development of innovative medicines • ~10% of Group net sales for cancer p
Slide 9: Research aims to deliver new projects to clinical phase
Research aims to deliver new projects to clinical phase ONGOING 8 RESEARCH PROJECTS ONCOLOGY PAIN Research areas Research areas Immuno-oncology Cancer genomics and Ion channels Neuro-immune interaction • FiCAR T-cell therapy cell signalling • 2nd generation immune- checkpoint inhibitors Antibody dru
Slide 10: Key clinical development pipeline
Key clinical development pipeline Project/compound Indication PHASE I PHASE II PHASE III REGISTRATION ARASENS / darolutamide 1 Prostate cancer (mHSPC) ARANOTE / darolutamide 1 Prostate cancer (mHSPC) ARASTEP / darolutamide 1 Prostate cancer (BCR) ODM-208 2 Prostate cancer (mCRPC) ODM-105 / tasipimid
Slide 11: Darolutamide (Nubeqa)
Darolutamide (Nubeqa®) Clinical trial and treatment Indication Primary endpoint and results Key secondary endpoints ARAMIS Metastasis free survival darolutamide + ADT nmCRPC Overall survival prolongation by 22.0 months, 31% risk reduction (HR=0.69, p=0.003) 59% risk reduction (HR=0.41, p<0.001) ARAS
Slide 12: ODM-208
ODM-208 • ODM-208 is a CYP11A inhibitor blocking synthesis of • Partnering with Merck / MSD in 2022 steroids and thus ligands for androgen receptor • CYPIDES Ph II trial is on-going activation • Plan to proceed to Ph III studies by the end of 2023 Preliminary Phase II results – published at ESMO 202
Slide 13: ODM-208 suppressed steroid hormone biosynthesis and led to frequent PSA declines
ODM-208 suppressed steroid hormone biosynthesis and led to frequent PSA declines in men with extensively pre-treated mCRPC with AR-LBD mutations 53% (24/45) of patients achieved a serum PSA reduction Unmeasurable steroid hormone levels were achieved in of at least 50% from the baseline concentration
Slide 14: ODM-212 – about to enter the clinical phase
ODM-212 – about to enter the clinical phase Role of YAP/TEAD activation in cancer • ODM-212 is an oral small molecule blocking TEAD YAP1Amp MDSCs activity NF2LoF TREGs LATS1/2LoF PD-L1 Stroma • Targeted indication(s): solid tumors with YAP/TEAD Tumor- TME and activation intrinsic antitumor oncogene
Slide 15: ODM-111
ODM-111 Unmet clinical need for pain treatments Orion’s solution • Almost one fifth of the adult • ODM-111 is a non-opioid oral small population suffer from pain molecule blocking Nav1.8 ion channel that mediates pain signalling • Novel, non-addictive analgesics with improved efficacy and safety pro
Slide 16: Key takeaways
Key takeaways 1. Nubeqa® is the growth driver in short & mid-term 2. Research focus in oncology and pain 3. Orion’s development pipeline more robust than earlier with ODM-212 entering clinical phase I and ODM-208, ODM-105, and ODM-111 proceeding to next phases 16 CMD 25 May 2023 © Orion Corporation
Slide 17: CMD 25 May 2023 © Orion Corporation
17 CMD 25 May 2023 © Orion Corporation