Celon Pharma Sa · GPW:CLN
Celon Pharma Sa — Investor Day (April 2021)
47 slides from Celon Pharma Sa's investor day presentation, Apr 21, 2021
Slide 1: Capital Markets Day
CAPITAL MARKETS DAY A P R I L 2 1 , 2 0 2 1 1
Slide 2: Agenda
Agenda 1. Introduction 2. Corporate Session: Business & Finance Update - Management Team Strategy For Future Growth Branded Generics – Solid Foundation Supporting Investment in Innovation Innovative Business Financial Highlights 3. Interactive KOL Session Neuropsychiatry Oncology Inflammatory Diseas
Slide 3: Introduction - Our Presenters
Introduction - Our Presenters Celon Pharma Maciej Wieczorek, PhD Iwona Giedronowicz Jacek Glinka Chief Executive Officer Chief Financial Officer Chief Commercial Officer Key Opinion Leaders Prof. Eduard Vieta Jair C. Soares Prof. Joanna Piotr Wierzbiński, PhD University of Barcelona McGovern Medical
Slide 4: Disclaimer
Disclaimer Neither this presentation (the “Presentation”, references to which shall be deemed to include any information which has been or may be supplied in writing or orally in connection herewith or in connection with any further enquiries) nor any copy of it nor the information contained herein
Slide 5: Corporate Session: Business & Finance Update – Management Team
Corporate Session: Business & Finance Update – Management Team 5
Slide 6: Strategy For Future Growth
Strategy For Future Growth 6
Slide 7: Evolution
Evolution rom branded generics to innovations INNOVATIVE DRUG DEVELOPMENT COMPLEX GENERICS 2. 2 2 2 2 2 2 ry ' Py ' : First ‘Opening First Upscaling Salmex i Contract with H | PDE10 in clinical Falkieri 3D ri R&D European manufacturing (salmeterol | Simcere for China | development Phase Il Qn Depart
Slide 8: Strategy evolution & our vision
Strategy evolution & our vision EXPLORING HIGH GROWTH POTENTIAL SHAREHOLDER VALUE CREATION INNOVATIVE DRUGS PRODUCT FOCUS Future pharmacological technologies (recombinat proteins, bispecifics, mRNA) PHARMACEUTICAL TECHNOLOGY Technology/early product supplier + selected product/indications marketer C
Slide 9: On a verge of accelerated growth
On a verge of accelerated growth Breakthrough clinical Targeted innovation results translating into strategy real clinical benefits Proven • unmet medical needs Broad late stage clinical track-record • blockbuster potential program readouts in the Evolutionary next couple of years competency in glob
Slide 10: Key goals 2021 - 2025
Key goals 2021 - 2025 COMMITMENT TO INNOVATION LEGACY BUSINESS PROFITABLE GROWTH 1. Increase R&D pipeline by doubling R&D investments with 1. Continued geo-expansion of commercial presence with focus on late stage developments Salmex (generic Advair/Seretide) 2. Advance 2 new preclinical projects ea
Slide 11: Branded Generics – Solid Foundation Supporting Investment in Innovation
Branded Generics – Solid Foundation Supporting Investment in Innovation 11
Slide 12: Branded generics sales in 2020
Branded generics sales in 2020 Sales in total 74%
Slide 13: Volume market share for Celon's actively promoted generics in Poland
Volume market share for Celon's actively promoted generics in Poland 64% 30 tabletek powlekanych & = me 39° Ketrel EES % Quetiapinum Tiny. i a tebe powlekane Rte — y Salmex | \ ; \ Leena wl \ Ze Salmex _Ketrel
Slide 14: Generic business - strong and growing source of cash flows
Generic business - incubation ete oeges and capabilities and strong and growing source of cash flows 2018 21.6% 2019 8.8 iN 2020 *35.0 PLN MLN Global Regulatory © viatris PRI : Aldo-Unién ~ SALVUS and Partnering Experience:
Slide 15: Manufacturing capabilities
Manufacturing capabilities Maximum Annual Available Capacity TABLETTING: O6 3 bn tablets PACKAGING LINES: 28 min packs (2020 production volume: >5 min packs) INHALERS: >8 min currently, mln available from Q4 2021 (2020 production volume: >2 mln)
Slide 16: Key strategic competences
Key strategic competences Various Intellectual pharmaceutical Property forms development Management Full size commercial infrastructure in Poland and global network of partnerships outside Poland GMP Manufacturing - dry forms and dry powder inhalers Global Regulatory & Supply Chain
Slide 17: Innovative Business
Innovative Business 17
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Slide 19: Broad clinical stage pipeline
Broad clinical stage pipeline MOLECULAR TARGET INDICATION RESEARCH PRE-CLINICAL DEVELOPMENT Pease | (unknown) Treatment-resistance Esketamine depression Schizophrenia (raise) ACT / psychomotor disorders Diabetes Ginab Spon: / diabetic neuropathy Solid tumors EGER inhibitors (bladder, lung, gastric)
Slide 20: Falkieri - esketamine Dry Powder Inhaler
Falkieri - esketamine Dry Powder Inhaler DESIGNED TO IMPROVE ON SPRAVATO SHORTCOMINGS PHASE OF INDICATION(S) ADMINISTRATION SAFETY DOSING DEVELOPMENT REMS (misuse and Spravato abuse risk, Treatment-Resistant In the clinic (esketamine Approved potential Intranasal Unipolar Depression (TRUD); both acu
Slide 21: Falkieri - developed leveraging experience in respiratory technologies
Falkieri - esketamine Dry Powder Inhaler DEVELOPED LEVERAGING OUR EXPERIENCE IN RESPIRATORY TECHNOLOGIES CMC Phase 1 Phase 2 (chemistry, manufacturing, (healthy volunteers) (treatment resistant control) and product depression) development Spravato Falkieri (Esketamine intransal) (Esketamine DPI) 2 P
Slide 22: Falkieri targets markets with high unmet needs
Falkieri - esketamine Dry Powder Inhaler TARGETS MARKETS WITH HIGH UNMET NEEDS INDICATION EPIDEMIOLOGY APPROVED TREATMENTS* FALKIERI MARKET POTENTIAL 30% of patients with None in the treatment resistant setting bipolar depression Treatment Resistant Bipolar Depression 4 antipsychotics in bipolar dep
Slide 23: CPL'36 PDE10a inhibitor
CPL’36 PDE10a inhibitor - ovel agent across two neuropsychiatric conditions TARGETED INDICATIONS: • Acute schizophrenia Levodopa is the mainstay • Levodopa-induced dyskinesia (movement therapy for Parkinson’s disease unfortunately after disorder) in Parkinson’s disease many years of therapy it can i
Slide 24: CPL'36 best-in-class second generation molecule
CPL’36 PDE10a inhibitor - best-in-class second generation molecule CPL500036 MP10 TAK063 PDE10A19 kon (1/Ms) koff (1/s) t1/2 (s) • Structurally different to MP-10 and Tak-063 CPL500036 TAK063 5.63E+06 2.31E+06 3.18E-02 6.93E-03 22.00 100.00 • Superior pharmacodynamic profile. Fast PDE10a enzyme MP10
Slide 25: CPL'36 Phase 1 readouts compare favorably
CPL’36 Phase 1 readouts compare favorably to other compounds AUC(0-24h) in subjects with stable schizophrenia increased in dose-proportional manner on Day 1 at doses between 3 to 30 mg, and slightly less than dose proportional on Day 7 (Based on Goldsmith et al., 2017) • ~60 healthy volunteers, sing
Slide 26: First-ever PDE10a study in that indication
Phase 2 - PoC Studies Underway 20 mg 55 pts Primary objective: Change from Dosing Arms baseline in positive Patients 40 mg Schizophrenia 1:1:1 symptoms of (n=165) Randomization (once daily, 55 pts 28 days) schizophrenia placebo (PANSS - positive 55 pts subscale) at Week 4 20 mg Primary objective: st
Slide 27: CPL'36 - PDE10a inhibitor
CPL’36 - PDE10a inhibitor TARGETED INDICATIONS: SCHIZOPHRENIA • Multiple antipsychotic agents approved with atypicals most widely used • All atypical antypsychotics carry tolerability risks such as weight gain, metabolic impairements or movement disorders • Negative and cognitive symptoms of disease
Slide 28: CPL'280 GPR40 agonist
CPL’280 GPR40 agonist - novel oral antidiabetic agent designed to be non-hepatotoxic TARGETED INDICATIONS: Lower risk of • Type 2 diabetes hypoglycemia unlike with the • Diabetic neuropathy sulfonylureas still used by ca. 20% of pts UNIQUE MECHANISM OF ACTION: glucose dependent release of insulin HY
Slide 29: CPL'280 clean safety profile with no evidence of liver injury
CPL’280 GPR40 agonist - clean safety profile with no evidence of liver injury High expectations for fasiglifam (Takeda) not delivered • Phase 3 terminated due to liver toxicity risk, Merck & Co and Eli Lilly's structurally similar molecules were also halted • Increased ALT/AST > 3 ULN in 4-5% of pat
Slide 30: CPL'280 designed to improve on sulfonylureas limitations
CPL’280 GPR40 agonist - designed to improve on sulfonylureas limitations DIABETES TYPE 2 - WHERE WE ARE AIMING • Metformin is the first line oral treatment, new agents (GLP1, SGLT2) shown slow uptake in first-line • Sulfonylureas still used by 20-40% of patients in second or third line when there is
Slide 31: CPL'110 FGFR inhibitor
CPL’110 FGFR inhibitor - established targeted cancer therapy in solid tumors TARGETED INDICATIONS: Validated approach with 2 FGFR inhibitors already approved by the • Gastric cancer FDA pemigatinib (Incyte) in cholangiocarcinoma and erdafitinib • Bladder cancer (J&J) in bladder cancer with • NSCLC (
Slide 32: CPL'110 - attractive markets for effective targeted agents
CPL’110 - attractive markets for effective targeted agents GASTRIC CANCER • Estimated new cases in US (2020) – 27.600, 5 yr survival 37% • FGFR aberrations in 4-60%, predominantly FGFR2 • Anti FGFR2 mAb effective in Phase 2 with more benefit seen in patients with higher FGFR overexpression • Market
Slide 33: CPL'116 JAK/ROCK inhibitor
CPL’116 JAK/ROCK inhibitor - dual anti-inflammatory & anti-fibrotic activity TARGETED INDICATIONS: Robust anti- inflammatory activity • CS – cytokine release storm (COVID-19) with additional • PsO – plaque psoriasis cardiovascular protection and ant-- • ILD – interstitial lung disease in RA fibrotic
Slide 34: CPL'116 dual JAK/ROCK inhibitor - multiple market opportunities
CPL’116 dual JAK/ROCK inhibitor - multiply market opportunities TARGETED INDICATIONS: CS – cytokine release storm in Covid-19 • Dexametahsone (generic) and Olumiant (baricitinib), JAK inhibitor effective and approved in emergency setting • Market size dependent on COVID-19 or other potential viral e
Slide 35: 2021/2022 Clinical trials news flow
2021/2022 Clinical trials news flow FALKIERI treatment resistant bipolar depression – final Phase 2 results 2Q 2021 CPL’280 (GPR40) – multiple administrations – Phase 2 in diabetes starts FALKIERI – Phase 3 regulatory feedback applications CPL’116 (JAK/ROCK) – final phase 2 results CPL’116 (JAK/ROCK
Slide 36: On a verge of accelerated growth
On a verge of accelerated growth Breakthrough clinical Targeted innovation results translating into strategy real clinical benefits Proven • unmet medical needs Broad late stage clinical track-record • blockbuster potential program readouts in the Evolutionary next couple of years competency in glob
Slide 37: Financial Highlights
Financial Highlights 37
Slide 38: Key facts & figures
Key facts & figures CASH INFLOWS CASH OUTFLOWS 1. Growing branded generics business: 1. Currently funding 15 R&D projects with 5 in the clinical stage of development • In 2020: • Investments of PLN 52.8 mln Revenues PLN 138.1 mln (USD 36.3 mln) (USD 13.7 mln) in 2020 +37% compared to 2019 (+10% comp
Slide 39: Segment dynamics - well balanced business model with growing R&D costs
Segment dynamics - well balanced business model with growing R&D costs BRANDED GENERICS INNOVATIVE PRODUCTS (R&D) TOTAL Revenues Revenues Revenues 138.1 21.5 21.9 123.8 20.7 160.0 100.8 144.8 121.4 2018 2019 2020 2018 2019 2020 2018 2019 2020 Expenses Expenses Expenses 52.8 163.9 111.1 47.8 143.5 88
Slide 40: Group and Segment P&L Details
Group and Segment P&L Details PLN MLN BRANDED GENERICS SEGMENT INNOVATION SEGMENT (R&D) TOTAL 2018 2019 2020 2020/2019 (%) 2018 2019 2020 2020/2019 (%) 2018 2019 2020 Sales of medicines 114.9 98.9 129.1 30.5% 0.0 0.0 0.0 114.9 98.9 129.1 Other income 3.8 1.8 2.6 0.0 0.0 0.0 3.8 1.8 2.6 Government gr
Slide 41: Balance sheet
Balance sheet A. Increase in tangible assets by PLN 192.7 mln (U$ 50 mln) over last 3 years, mostly due to our new, state-of-the-art PLN mln 01.01.2018 31.12.2018 31.12.2019 31.12.2020 ASSETS R&D Center with integrated clinical supplies and upgraded Non-current assets 213.1 261.3 316.3 412.6 manufac
Slide 42: Interactive KOL Session
Interactive KOL Session 43
Slide 43: Neuropsychiatry
Neuropsychiatry 44
Slide 44: Oncology
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Slide 45: Inflammatory Diseases
Inflammatory Diseases 46
Slide 46: Interactive Q&A Session with Management Team and KOL
Interactive Q&A Session with Management Team and KOL 47
Slide 47: Conclusions
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