Uni-Bio Science Group Asia Biotech Invest May 2016

Transcription

1 Uni-Bio Science Group Asia Biotech Invest 2016 May

2 Uni-Bio is at the critical value inflection point, ready to evolve BIIB First monoclonal antibody for cancer developed by IDEC Key clinical milestones delivered, Uni-Bio may follow the footstep of the greats 1 st major product launch announcement CELG Launch of Thalomid for erythema nodosum leprosum GILD Launch of Vistide for CMS in HIV patients Uni-Bio Science Uni-PTH NDA submitted to CFDA Uni-E4 completed phase 3 R&D Growth Source: Thomson Reuters, graph not to scale 2

3 Full biotech value chain capability in China ready to capitalize on the lucrative Chinese healthcare space HKSE:0690 Research Preclinical Biotech Value Chain Phase 1-3 Manufacture Market Access & Regulatory Sales & marketing Completed Phase III of pth and E4 pth dossier accepted by CFDA Apr 2015 E4 dossier expected in 2H2016 Subsidiaries Latest GMP standards, Pinapu Site for pth and E4 (stability tests being conducted now) Latest GMP for EGF products (both biologics: GeneTime + GeneSoft) Medical (RA, Medical Affairs) GA (reimbursement, pricing) BD (expand portfolio) S&M (in-house and partner) 3

4 Uni-Bio Portfolio 4

5 Well-balanced proprietary biologics franchise Uni-bio is one of the very few regional biotech players that successfully developed new drugs through the full clinical development pathway Product Type Cat.* Indication Launch Date Marketed GeneTime (EGF) Biologic (External fluid) Bio-1 Burns/Dermatology/ 2000 Wound Care GeneSoft (EGF) Biologic (Eye drop) Bio-1 Corneal Ulcer 2004 Pinapu (Voriconazole) Chemical (Tablet) Chem-6 Fungal infections 2005 Mitiglinide Chemical (Tablet) Chem-3 Type II diabetes 2016 rexendin-4 (recombinant Exendin-4) Biologic (Lyophilized powder) Bio-1 Type II Diabetes 2018 Pipeline rhpth 1-34 (recombinant parathyroid hormone 1-34) New formulation development pth and E4: liquid formulations Earlier products in development Biologic (Lyophilized powder) Bio-7 Osteoporosis 2017 EPO-FC: long-acting (1-2 weekly EPO) E4-FC: long-acting (1-2 weekly E4) *Chem-3: New chemical drug not marketed in China but marketed WW, Chem-6: Chemical drug substance or preparation in compliance with national standards. Bio-1: Biologic not yet marketed WW; Bio-7: Biologic marketed ex- China 5

6 Sales portfolio with strong market access position Limited number of competitors (mature generics have >200 competitors*) and wide reimbursement coverage ensure strong volume growth and limited pricing pressure Description Number of Competitor* Reimbursement 1H2015 Sales GeneTime GeneSoft Pinapu Mitiglinide rhegf for wound healing and surgical scars rhegf derivative for corneal epithelia healing Voriconazole for fungal treatment (inc. candidiasis and aspergillus) Exclusive Insulinotropic agent for T2 Diabetes treatment NRDL PRDL (3 provinces) NRDL PRDL (13 provinces) HKD28.1M HKD11.9M HKD19.2M To be launched in 2016 *Same formulation competitors, calculated by averaging data from basket of 24 molecules under 8 major therapeutic areas (e.g. cardiovascular, oncology, infectious disease) Source: IMS 2014, GBI Source, ** Ex-307, *** IMS

7 Imminent launch of two potential blockbusters in China Both products are ph3 complete and expected launch within next 2 years* Large market potential Clinical advantages Solution to an unmet need First-tomarket advantage Uni-PTH (Parathyroid hormone) Uni-E4 (GLP-1 Agonist) China accounts for 37% of global OP population (Over 150M) China has four times the T2D patients of US (Over 100M) Increase BMD lower fracture rate Reduce Bone Pain Reduce body weight Lower hypoglycemia risk No cost-effective alternative in China No cost-effective alternative in China First or second domestic launch First or second domestic launch *Best estimated based on past registration timeline data, launch times may be affected by various uncontrollable factors 7

8 Numerous growth catalyst opportunities by indication expansion and delivery system enhancement Uni-PTH & Uni-E4 Lyophilized powder + Innovative Delivery Device Osteoporosis Diabetes Enhance Delivery System: to increase patient comfort during use, improve patient drug compliance 2 nd Generation Pre-filled Pen (Liquid Cartridge) 3 rd Generation Long-acting Version Uni-PTH Fracture HKD11B Expand indication: address unmet needs Uni-E4 Antiobesity HKD12B Future Innovative Formulations 8

9 Uni-Bio Execution Capabilities 9

10 Commercially driven execution team with strong international and local experience Edward Chan, MSc VP of Business Development Uni-Bio Science Healthcare 25 years of sales & marketing and BD exp. in MNC, including J&J (1 th* ) Novartis (3 rd *) Abbott (10 th* ) Lundbeck Matthew Kong, BSc VP of Sales and Marketing Uni-Bio Science Healthcare Over 20 yrs of sales and marketing exp. in China pharmaceutical industry. Prior senior position at Servier New Additions - GA (Market Access) - BP&A Koh Phee Wah, CPA, MBA CEO of Uni-Bio Science Healthcare Prior COO at UCB (12 th **) China 15 years GM experience in life science MNC (BD, Pharmacia - now Pfizer, Monsanto) Successfully launched Celebrex Weiyue Han, BSc GM of Dongguan Taili 20 years developing biotech drug experience Sichuan Science and Technology Progress Award Jacky Wen, Ph.D. GM of Beijing Genetech Over 30 years building GMP and GLP facilities, as well as in developing new drugs Emily Liu, MD VP of Medical and Regulatory affairs Uni-Bio Science Healthcare Ex-medical GM in GE Heathcare 7 years in Pfizer (2 nd *) 10 years doctor in Beijing Tongren hospital *Global pharmaceutical ranking (2013) based on MCap **Global biotech ranking (2013) based on MCap 10

11 Other essential pieces in place to support successful drug launches 1. High quality GMP manufacturing For current portfolio, our products are made to latest GMP standards For Uni-PTH and Uni-E4, all facilities are in place No more significant expenditure expected 3. Increasing capability of support functions Tigermed appointed to support RA for new products Strengthened our Medical team New GA Manager: former GA Lead (Celgene), Novartis New enterprise level IT system 2. Strengthening sales and marketing network Increased in-house sales force by 40%+ and regional distributor network by 20%+ in 2015 Negotiating partnerships to expand sales coverage 4. Financing to support near term growth Multiple fundraising & PRC government grant experience Healthy balance sheet (1H2015) HKD133.5M net cash (USD 17M) Strong IR and investor network: winner of HKIRA Award Best Small-cap IR (2015) 11

12 Summary 12

13 Uni-Bio: A quality Chinese biotech story quickly approaching value inflection point 2015 Highlights Sales growth outpaced industry* Uni-PTH dossier accepted by CFDA and positive phase 3 results for Uni- E4 Secured new diabetes product to launch in 2016 Growth Catalysts Launch of Uni-E4 and Uni-PTH (core & G2 formulations, delivery system) Expand sales reach (SF + collaboration) Launch of new diabetes product in 2016 (New products from BD) Strong IR (e.g. HKIRA award) Operational Excellence International Management with extensive local experience Proven clinical team Facilities compliant to latest GMP standards (working process for pth & E4) Current portfolio well placed, profitable and self-sustaining. Uni-Bio s main objectives at Asia Biotech Invest: Search for strategic investors to support Uni-Bio long-term growth Business development collaboration opportunities *2015 MAT IMS hospital sales growth ~5-6% 13

14 Kingsley Leung Executive Director Phee Wah Koh CEO China Operations Harvey Sun Group IR and Communications 14