Sihuan Pharmaceutical Holdings Group Ltd. · HKEX:460
Sihuan Pharmaceutical — H1 2022 Earnings Presentation
48 slides from Sihuan Pharmaceutical's earnings presentation, August 2022
Slide 1: 2022 Interim Results Presentation
Building China’s Leading Medical Aesthetic and Biopharmaceutcial Company with Rigor and Innovation of a Pharmaceutical Company 2022 Interim Results Presentation August 2022
Slide 2: Disclaimer
The sole purpose of this Presentation (the “Presentation”) is to assist the recipient in deciding whether it wishes to proceed with a further investigation of Sihuan Pharmaceutical Holdings Group Ltd. (the “Company”) and it is not intended to form the basis of any decision to purchase securities, in
Slide 3: Category
Promoting Sihuan Pharmaceutical’s 2.0 version in full speed, Becoming a leading medical aesthetic and innovative pharmaceutical company with industrial upgrading and development Category 01 Company Overview and Results Highlights 02 Medical Aesthetic Business Review 03 Pharmaceutical Business Review
Slide 4: Group overview and key figures
China's leading independent R&D The Group's robust 'cash cow' platform for innovative drugs with the business keeps the Group most comprehensive pipeline in the financially sound domestic breast cancer track Building China’s leading integrated 25+ ~RMB 1.57 bil. ~RMB 7 bil. ~RMB1,233.0 mil. ~RMB683.
Slide 5: 2022H1 results highlights by segment
2022H1, total revenue achieved ~RMB1,464.2 mil. affected by epidemic and policy changes, decreased by 23.2% yoy MeiYan KongJian: Building China’s leading integrated medical aesthetic Medical Aesthetic platform with full product coverage Segment § Product introduction: Exclusive distributor of VIOL’s
Slide 6: Segment strategy and 2022 targets
MeiYan KongJian | “Star” business of the Group, building China’s leading integrated R&D, production and Medical Aesthetic Generic/MCM/Industrial Hemp sales platform of medical aesthetic with full product matrix Segment API/CDMO 2022 Target Accelerate the upgrading of version 2.0, successfully launch
Slide 7: Medical aesthetic product pipeline
Segment Subsidiary Business Category Product name Pre-clinical Clinical Registration Launch Collegen complex filler（Class III） Filler PLLA filler（Class III） PCL filler（Class III） Independtly Volumization,Support 10+ Class III independently R&D products* R&D PLLA gel（Class II） Skin care 20 skin care
Slide 8: Registration, production and sales capacity
Registration Production Sales Strong product registration Professional and efficient academic High-efficiency, low-cost full-dose and government marketing and sales platform with production platform affairs capabilities nationwide coverage The team has years of experience in drug registration, and i
Slide 9: MeiYan KongJian
Sihuan Medical Aesthetic MeiYan KongJian Building China’s leading medical aesthetic company 9
Slide 10: Rich product pipeline and strong R&D team
Rich product pipepline covering lifecycle needs Strong R&D team in China and overseas • Owns 40+ medical aesthetic products, covering all basic categories, • Owns strong capabilites and platform in R&D providing integrated solutions • 10+ class III and 20+ class II self-developed products: PCL fille
Slide 11: Medical aesthetic products by stage
Business Category Product Name Pre-clinical Clinical Registration Market Launch Collegen complex filler (class III） Filler PLLA filler（class II） PCL filler（class III） Independtly R&D Volumization, Support 10+ self-developed type III products* PLLA gel（class II） Skin care 20 skin care dressing produc
Slide 12: R&D Center in China and MEIYEN LAB in the U.S.
R&D Center in China MEIYEN LAB in the U.S. The company will improve existing medical aesthetic products and explore located in Los Angeles, California, USA, mainly to introduce innovative new applications, and industrialise the cutting-edge technologies developed technology, independent R&D of a new
Slide 13: Sales Team
Branding Dept 2,920+ medical aesthetic institution coverage Marketing Dept Marketing Dept 100% Sales Dept I New Media Dept top 500 institution coverage Sales center Sales Dept II 280+ city coverage as of 30 July 2022 Medical Dept Sales Team • The marketing and sales team are mainly from MNCs such as
Slide 14: Pharmaceutical Business
Pharmaceutical Business Successfully transformed from a generic to a biopharmaceutical company to upgrade and develop into a leading biopharmaceutical company in China at full speed 14
Slide 15: Pharmaceutical business overview
China's leading independent R&D platform for One of the few leading biopharmaceutical company innovative drugs with the most comprehensive with a full product coverage in the area of diabetes pipeline in the domestic breast cancer track and complications 25+ large and small molecule products under d
Slide 16: Xuanzhu Biopharm
Pharmaceutical Segment Xuanzhu Biopharm China's leading innovative biological drug R&D platform 16
Slide 17: R&D capability and product pipeline
Rich R&D product pipeline focusing on therapeutic areas with significant clinical needs R&D Capability § Over 25 products under research, committed to the development of Class 1.1 innovative drugs 2 products 10 products § 1-2 product INDs per year NDA accepted in phase I-III clinical trials The most
Slide 18: Xuanzhu Biopharm 2022 milestones
2022 Mar 2022 May 2022 June 2022 July HKEX approved to spin off The highly active and selective AXL- Xuanzhu Biopharm entered into an Anaprazole sodium obtained Xuanzhu Biopharm and to targeted inhibitor capsule XZB- exclusive licensing agreement with approval from NMPA on list on the STAR Market of
Slide 19: Xuanzhu Biopharm pipeline by therapeutic area
Drug Pre- Clinical Therapeutic Area Target Indications IND NDA Name clinical Phase I Phase II Phase III Breaset cancer (HR+/HER2-/End-line) Breast cancer (HR+/HER2-/second-line treatment with CDK4/6 inhibitor Birociclib fulvestrant) Breast cancer (HR+/HER2-/first-line treatment with AI) Breast Cance
Slide 20: Huisheng Pharm
Pharmaceutical Segment Huisheng Pharm Leading biopharmaceutical company with full product coverage in diabetes and complications 20
Slide 21: Diabetes product portfolio and market potential
1 Huge market potential in China Key Target Drugs GLP-1 DPP-4 inhibitor 2 • Liraglutide Injection • Sitagliptin Tablet Rich product pipeline • Semaglutide Injection • Linagliptin Tablet • Semaglutide Tablet • Vildagliptin Tablet • Alogliptin Tablet A number of blockbuster SGLT-2 inhibitor GLP-1 inno
Slide 22: Janagliflozin, insulin progress and Round A financing
Insulin Degludec and Insulin Aspart, a blockbuster Janagliflozin, class 1.1 innovative drug of SGLT-2 product, had last patient out for phase III clinical trials, inhibitor, NDA accepted and is in data cleaning stage has finished API on-site checking The first and only domestic company to obtain app
Slide 23: Huisheng diabetes pipeline by stage
R&D Stage Category Category Products Pre-clinical IND Phase I Phase II Phase III NDA Janagliflozin Oral Class 1.1 new drug Janagliflozin and Metformin tablets Insulin Degludec Injection Insulin Degludec and Insulin Aspart Injection New Insulin Insulin Degludec and Liraglutide Injection Faster-Acting
Slide 24: Biological base production capacity
2 Fermentation tanks of 12 tons 20 mil. units Phase II biological Designed capacity base capacity RMB2 bil. 6 Fermentation tanks Annual output value add of 12 tons Phase I biological 100 mil. units add Factory front door base capacity Designed capacity Support nearly RMB10 bil. add Annual output val
Slide 25: Sihuan CDMO
Pharmaceutical Segment Sihuan CDMO APIs+Formulation integrated CDMO strategy 25
Slide 26: Sihuan CDMO positioning
Sihuan CDMO § Leveraging on rich experiences in the devleopment and industrialzation of high-end APIs and high-standard production Positioning anagment system, committed to providing global customers with a leading integrated solution with specialty APIs as the core + undertaking high-end CDMO busin
Slide 27: Generic/MCM/Industrial Hemp
Pharmaceutical Segment Generic/MCM/Industrial Hemp Dozens of high-end generic drug and hundreds of approved MCM, solid “cash cow” 27
Slide 28: Generics and MCM pipeline and sales platform
Rich pipeline of high-end generics and modern Chinese Professional and efficient acadeic marketing and sales platform medicine products with nationwide coverage 4 products approved 25+ products ticarelor tablet、Tenofovir filed for application of registration alafenamide fumarate tablet,etc. to CDE a
Slide 29: 2022 Interim Financial Review
2022 Interim Financial Review 29
Slide 30: 2022H1 financial highlights
Continued large R&D investment to further focus on the innovative drug segment and promote the development of two innovative biologics platforms。 Revenue of Innovative Revenue of Medical Revenue of Generic and other medicine Total Revenue R&D Expenses Aesthetic Medicine (CDMO） ~RMB ~RMB ~RMB ~RMB ~R
Slide 31: Generic medicine revenue and R&D expenses
1,800 1,622 Ø Generic medicine 1,600 1,510 1,340 Ø R&D expenses in 2022H1 revenue in 2022H1 1,400 1,267 1,252 1,236 1,200 was RMB457.3 mil.， was RMB1,233.0 1,017 1,000 899 914 increased 37.1% yoy mil.，decreased 708 800 18.3% yoy 600 457 Ø The Group continues to 301 334 400 250 180 invest heavily in
Slide 32: 1H2022 Segment Information
Innovative 1H2022 Segment Information Medical Cash and cash Drugs & Others Generic Drugs Total （RMB’000） Aesthetic equivalents (API & CDMO) Revenue 98,612 132,598 1,232,987 1,464,197 Cash and cash equivalents Segment Results（before tax） 41,586 (498,070) 683,114 226,630 5,096,645 + Financial products
Slide 33: Appendix
& Pb NEE 25) SihuanPharm Appendix
Slide 34: Company development milestones
• Established JV with CROMA-Pharma to • Letybo was launched to market • Signed exclusive distribution expand into China’s medical aesthetic agreement with South Korean • The first independent R&D medical aesthetic product PLLA gel was approved market Hugel Inc. on botulinum toxin • Acquired American
Slide 35: Letybo botulinum toxin
Anti-aging product: short course of treatment, quick effect, short repair period for minimally invasive wound, the fourth Botunlinum toxin type A launched in China Letybo is positioned as cost-effective and high-quality, which is much higher than the industry requirements, to open up the market spac
Slide 36: Hyaluronate gel filler
TM Hyaluronate gel: good support, non-spreading displacement, uniform metabolism, long-lasting shaping, high viscosity value, high cross-linking degree and high shaping capacity One of the most popular hyaluronic acid filler brands in South Korea, can be used with Letybo® from the same company to ac
Slide 37: LipiVage fat harvesting system
Innovative fat harvesting system, with independent and ready-to-use two-step fat harvesting, cleaning and transferal system Innovative technology improves the survival rate of fat transplantation to 80%-90% China’s body contouring market is Highly innovative fat harvesting system Simple, fast and sa
Slide 38: PHA joint venture with Bluepha
PHA is a natural polyester, can be used in regenerative injection products, is a good choice for light medical aesthetics as a new material Sihuan Pharmaceutical’s MeiYan KongJian and Bluepha to establish JV, to enter the huge blue ocean of synthetic biology, and is a significant step forward into t
Slide 39: Birociclib CDK4/6 inhibitor
• A blockbuster product for HR+/HER2- advanced breast cancer (ABC）patients, an innovative drug of CDK4/6 inhibitor was developed by the company independently, with patents in China, the United States, Europe, Japan and Korea • First and fastest follower of the best-in-class product abemaciclib. Firs
Slide 40: KM257 HER2 bispecific antibody
• KM257 is a HER2 bispecific antibody(BsAb), independently developed by Xuanzhu Biopharm technology platform with independent intellectual property rights, with better molecular design, better stability and stronger anti-tumor efficacy, for HER2+ patients with high expression (such as breast cancer,
Slide 41: KM501 HER2 bispecific antibody ADC
• KM501-ADC is a HER2 bispecific antibody ADC, which is a modification of the bispecific antibody(BsAb) KM-257, therefore, it has many advantages of KM- 257 (such as better molecular design, better stability, stronger anti-tumor efficacy), and is used for patients with HER2+ medium and low expressio
Slide 42: Anaprazole sodium PPI
• The first and the only innovative PPI independently developed in China, with independent intellectual property rights, a new generation, with large market scale, the PPIs sale was nearly RMB 20 billion in 2021 in China • Has the clinical advantage of low risk of drug-drug interactions and the pric
Slide 43: XZB-0004 AXL inhibitor
• Authorized cooperation with SignalChem, to introduce the exclusive development and commercialization rights of the drug in Greater China • An oral small molecule AXL inhibitor with high selectivity, high efficacy and low side effects, a new target for cancer therapy • Compared with bemcentinib (Ph
Slide 44: Molecular glue degrader drugs
• Three targeted protein molecular glue degrader (MGD) drugs, are developed in cooperation with HB Therapeutics of the United States, with the potential of first in class • It has the characteristics of small weight, easy optimization of physical and chemical properties, easier to follow the "Lipins
Slide 45: Janagliflozin SGLT-2 inhibitor
• An innovative drug of SGLT-2 inhibitor, independently developed by the company, with patents in China, the United States, Europe, Japan and Korea • Compared the phase III clinical data results with the similar products that have been marketed, Janagliflozin shows similar or even better results • A
Slide 46: Insulin Degludec series
• A new generation of long-acting insulin analogs with unique long-acting mechanism, excellent hypoglycemic effect and low risk of hypoglycemia. Combination of Insulin Degludec series, to seize the high ground in the field of insulin • Insulin Degludec, Insulin Degludec/Aspart: the R&D progress ahea
Slide 47: Liraglutide and Semaglutide
• Liraglutide is a once-daily GLP-1 receptor agonist (GLP-1RA) for the treatment of type 2 diabetes (T2DM) and obesity. It forms a compound with insulin degludec in the pipeline • Semaglutide is a once-week GLP-1RA for the treatment of T2DM, and semaglutide tablet is the only oral formulation of GLP
Slide 48: Thank you!
Thank you！ Sihuan Pharm IR Department ir.sihuanpharm.com E: ir@sihuanpharm.com
Sihuan Pharmaceutical Holdings Group — H1 2022 Earnings Presentation on 6ix