Cspc Pharmaceutical Group Limited · HKEX:1093
Cspc Pharmaceutical — Q1 2023 Earnings Presentation
35 slides from Cspc Pharmaceutical's earnings presentation, May 2023
Slide 1: 2023 1Q Results
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Slide 2: China's Leading Innovative Pharmaceutical Enterprise
China’s Leading Innovative Pharmaceutical Enterprise R&D Capability Manufacture Capability • 8 R&D platforms • 10+ production bases • 5 R&D centres located in China & U.S. • Nano formulation：27 production lines • ~ 2,000 R&D staff built with production capacity of 20M • ~300 R&D projects (~110 innov
Slide 3: 2023 1Q Highlights
2023 1Q Highlights R&D BD New drug approval: • Nectin-4ADC: licensed out the SYS6006 (Covid-19 mRNA vaccine) rights in the US, EU, UK, Canada, EUA Australia, Iceland, Liechtenstein, Norway and Switzerland to Corbus, 3 applications for marketing with US$7.5M upfront payment, approval: potentially US$
Slide 4: Financial Highlights, Business Review, R&D Capability, Pipeline, BD & ESG
b Financial Business R&D Pipeline BD & ESG Highlights Review Capability r |
Slide 5: Part 01 Financial Highlights
Part 01 Financial Highlights
Slide 6: Financial Highlights
Financial Highlights Unit: RMB ‘000 Revenue 1Q2023 1Q2022 Change 8.05bn Revenue +2.3% 2.3% 8,053,269 7,873,893 7.87bn Gross profit 5,518,599 5,810,962 -5.0% Gross profit margin 68.5% 73.8% -5.3pp R&D expenses 1,007,649 901,517 +11.8% 1Q2022 1Q2023 Underlying profit attributable to +0.1% shareholders
Slide 7: Revenue
Revenue Revenue by product category Finished drug revenue Unit: RMB MM Unit: RMB MM 1Q2023 1Q2022 Change 1Q2023 1Q2022 Change Finished drugs 6,422 6,302 +1.9% Nervous system disease 2,125 1,936 +9.8% products 551 700 -21.3% Oncology products 1,444 2,157 -33.1% Bulk vitamin C +27.3% Anti-infective pr
Slide 8: Operating Profit
Operating Profit Unit: RMB MM 1Q2023 1Q2022 1Q2023 1Q2022 Change Change OPM OPM Finished drug 1621 1578 +2.7% 25.2% 25.0% +0.2pp Bulk vitamin C 31 146 -78.6% 5.7% 20.9% -15.2pp Bulk antibiotics 26 31 -14.4% 5.7% 8.4% -2.7pp Functional Food and Other 144 119 +21.1% 23.4% 23.5% -0.1pp Business 8
Slide 9: Part 02 Business Review
Part 02 Business Review
Slide 10: Finished Drug Overview by Therapeutic Areas
Finished Drug Overview by Therapeutic Areas Nervous • Major products: NBP, Oulaining, Enxi, Shuanling system Digestion & Oncology • Major products: Duomeisu, Jinyouli, Keaili metabolism • Duoenda (Mitoxantrone Hydrochloride Liposome Injection) launched in January 3.1% Others 2022, injecting new vita
Slide 11: Key Products Overview
Key Products Overview NBP Mingfule Xuanning Anfulike Butylphthalide soft capsules and injections Recombinant human TNK tissue-type Levamlodipine maleate tablets Amphotericin B Cholesteryl Sulfate • 1st Class 1 new drug of cardio- plasminogen activator for injection and dispersible tablets Complex fo
Slide 12: Bulk Product Business, Functional Food and Other Business
Bulk Product Business, Functional Food and Other Business Bulk vitamin C Bulk antibiotics Functional food and others • Major products: vitamin C, • Major products: 7-ACA • Mainly driven by the growth vitamin C - sodium, vitamin C - (intermediate), penicillin of caffeine products, calcium and granula
Slide 13: Part 03 R&D Capability
Part 03 R&D Capability
Slide 14: R&D Overview
R&D Overview • 5 R&D centres • 8 national science & • Around 300 projects under • 87 national projects located in China & technology qualifications development (around 110 U.S. innovative drug projects) • RMB 860M national • 2 state key labs funding • R&D expenses in • 1647 IP applications 2023 1Q:
Slide 15: R&D Milestones
R&D Milestones 2019-2021 ✓ Xuanning obtained drug registration 2022 ✓Duoenda launched approval from US FDA. ✓Copiktra launched ✓ R&D centres established in SH & BJ; ✓Duentai EUA ✓ Jinyouli won the Second Prize of State Scientific and Technological Progress Award ✓ Established nucleic acid technology
Slide 16: Innovative R&D Platforms
Innovative R&D Platforms Nano- mRNA ADC formulation vaccine siRNA ➢ Mitoxantrone liposome ➢ Albumin-bound docetaxel ➢ Covid-19 mRNA ➢ PCSK9 siRNA ➢ DP303c （HER2 ADC） ➢ Paclitaxel nanoparticles vaccine ➢ SYSA1801 (CLDN18.2 (instant type) ➢ Rabies mRNA ➢ Cisplatin micelle ADC) vaccine BsAb mAb Small P
Slide 17: Nano-formulation Platform
Nano-formulation Platform Nano-formulation Novel Industrialized Novel drug carrier Novel drug delivery Novel preparation development and production technology design technology method manufacturing platform • Invented single-phase solution • Invented continuous flow • Invented Albumin • Invented amm
Slide 18: mRNA Vaccine platform
mRNA Vaccine platform 1 Advantages of antigen 2 mRNA vaccine design 3 Industrialization advantage design • Mutation prediction platform • Base modification, UTR screening, • Multiple nano-formulation codon optimization and structural products launched • The combination of bioinformatics elements inc
Slide 19: siRNA Platform
siRNA Platform 1 HTS screening platform 2 CMC platform 3 Industrializationn advantage • Rational sequence design based • Build strong oligonucleotides • Industrialization advantage of on bioinformatics and CMC platform based on QbD CSPC experienced scientists strategy • Pilot scale and commercial •
Slide 20: ADC Platform
ADC Platform ADC Design Characteristics Advantages Conjugation Engineering TGase The specific conjugation on the homogeneous Mode catalysis glutamine residue in the Fc region catalyzed by Conserved Q295 residue engineering modified Tgase can produce highly Conjugation purified ADC molecule with stab
Slide 21: Bispecific Antibody Platform
Bispecific Antibody Platform YBODY bispecific antibody platform ✓ Intact IgG：good PK/PD，convenient purification process • In-house developed, global leading asymmetrical bispecific ✓ Construction strategy for KIH and salt bridge：highly efficient antibody platform YBODY® for tumor treatment heterodi
Slide 22: Pipeline
Part 04 Pipeline 22
Slide 23: Candidates under Clinical Trial Stage
Candidates under Clinical Trial Stage （29） （5） (18) (8) PhI PhII (POC) Ph II / III pivotal trial NDA ALMB0166 ALMB0168 CLDN18.2 Alprostadil CM326 JMT101 CM310 JMT103 Cx43i mAb Cx43s mAb ADC liposome TSLP EGFR mAb IL4R RANKL NBL-015 NBL-012 NBL-020 SYHA1402 NBP Capsule rhTNK-tPA SKLB1028 CLDN18.2 mAb
Slide 24: Pipeline – Large Molecule
Pipeline – Large Molecule Over 40 new biologic drugs under development: 3 filed BLA, 18 under clinical trial stage(9 under pivotal trial stage) and over 20 under pre-clinical stage Ph II / III TA Major Candidates Target Indication (s) Pre-clinical Phase I Phase II NDA pivotal trial JMT103 RANKL Gian
Slide 25: Pipeline - Small Molecule
Pipeline - Small Molecule Over 40 small molecule new drugs under development: 3 filed NDA, 21 under clinical trial stage (4 under Phase III / pivotal trial stage) and over 20 under pre-clinical stage Ph II / III TA Major Candidates Target Indication (s) Pre-clinical Phase I Phase II NDA pivotal tria
Slide 26: Pipeline - Small Molecule
Pipeline - Small Molecule Ph II / III TA Major Candidates Target Indication (s) Pre-clinical Phase I Phase II NDA pivotal trial DBPR108 DPP-4 Diabetes Digestion & NDA accepted SYHA1402 ARI Diabetic neuropathy Metabolism SYHA1805 FXR Agonist NASH Desvenlafaxine ER tablets 5-HT, NE Antidepressant NDA
Slide 27: Pipeline - New Preparation
Pipeline - New Preparation Over 30 new preparations under development: 2 applied marketing approval, 11 under clinical trial, and over 20 under pre-clinical stage Phase III / TA Major Candidates Indication(s) Pre-clinical Phase I Phase II Pivotal Clinical NDA Trial Mitoxantrone hydrochloride liposom
Slide 28: Pipeline Products Launch Plan
Pipeline Products Launch Plan 13 12 Ulsinumab Plaque psoriasis mRNA vaccine Semaglutide 10 RSV 10 Diabetes mRNA vaccine Clevidipine injectable VZV Vaccine emulsion mRNA vaccine TG103 Hypertension Rabies Tramadol celecoxib Large molecule Obesity, Diabetes hydrochloride Paliperidone palmitate Small mo
Slide 29: Common Generics Launch Plan
Common Generics Launch Plan 13 candidates have filed applications for marketing approval，expecting the approval in 2023-2024； Over 20 candidates are under pharmaceutical research，expecting the approval in 2025-2026 No. Product Therapeutic Area Expected to be launched 1 Sacubitril Valsartan Sodium Ta
Slide 30: IND Approvals Obtained as of May 25
IND Approvals Obtained as of May 25 IND approval for the 1st indication (6+1) SYH2045 (Advanced malignant tumors) Meloxicam nanocrystal injection (moderate-to-severe pain for adults) Clevidipine injectable emulsion (hypertension) Octreotide long-acting injection (acromegaly) NBL-020 (advanced solid
Slide 31: BD&ESG
Part 05 BD&ESG
Slide 32: BD Global Strategy and Achievements
BD Global Strategy and Achievements Acceleration of business development, build up an international BD ecosystem TA Eco- Product positioning：to meet unmet clinical needs, focus on clinical benefits , follow up international cutting-edge technology and New system solutions drugs trends, explore new T
Slide 33: 2023 BD Strategy in Key Therapeutic Areas
2023 BD Strategy in Key Therapeutic Areas Strengthen the leading Expand to new TAs &novel position in existing TAs technology platforms • Focus on whole-process • Strengthen the differentiated • Focus on IgAN, early-stage • Pay attention to companies with management of stroke, especially planning fo
Slide 34: Aim to Become an ESG Leader in Pharmaceutical Industry
Aim to Become an ESG Leader in Pharmaceutical Industry • Awarded “AAA Enterprise with • Adhere to the procurement Continuous MSCI ESG Harmonious Labour Relations in principle of “fair, impartial, green Hebei Province” and “National and transparent” rating upgrade Advanced Enterprise in Employment” A
Slide 35: Thanks!
WeChat of CSPC IR Team： Thanks！
CSPC Pharmaceutical Group — Q1 2023 Earnings Presentation on 6ix