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Uni-Bio Science Group
Asia Biotech Invest 2016
May 2016
1
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
1st 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
Source: Thomson Reuters, graph not to scale
Growth
2
Full biotech value chain capability in China – ready to
capitalize on the lucrative Chinese healthcare space
Biotech Value Chain
HKSE:0690
Research
Preclinical
Phase 1-3
Manufacture
Market
Access
&
Sales &
marketing
Regulatory
Subsidiaries
Completed Phase III of pTh and E4
pTh dossier accepted by CFDA Apr 2015
E4 dossier expected in 2H2016
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
Uni-Bio Portfolio
4
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
Marketed
Product
Pipeline
GeneTime® (EGF)
Type
Biologic (External fluid)
Cat.*
Bio-1
Indication
Burns/Dermatology/
Wound Care
Corneal Ulcer
Launch Date
2000
GeneSoft® (EGF)
Biologic (Eye drop)
Bio-1
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
rhPTH 1-34 (recombinant parathyroid
hormone 1-34)
Biologic (Lyophilized powder)
Bio-7
Osteoporosis
2017
2004
New formulation development

pTh and E4: liquid formulations
Earlier products in development

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 exChina
5
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
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)
Insulinotropic agent for T2
Diabetes treatment
Number of
Competitor*
Exclusive
1
4
4
Reimbursement
NRDL
PRDL (3 provinces)
NRDL
PRDL (13 provinces)
1H2015
Sales
HKD28.1M
HKD11.9M
HKD19.2M
To be launched in 2016
Description
*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 2014
6
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)
• China accounts for
37% of global OP
population
(Over 150M)
• Increase BMD
• lower fracture rate
• Reduce Bone Pain
• No cost-effective
alternative in
China
• First or second
domestic launch
Uni-E4
(GLP-1 Agonist)
• China has four
times the T2D
patients of US
(Over 100M)
• Reduce body
weight
• Lower
hypoglycemia risk
• No cost-effective
alternative in
China
• First or second
domestic launch
*Best estimated based on past registration timeline data, launch times may be affected by various
uncontrollable factors
7
Numerous growth catalyst opportunities by indication
expansion and delivery system enhancement
Uni-PTH &
Uni-E4
Lyophilized powder + Innovative Delivery Device
Osteoporosis
Enhance Delivery System: to increase
patient comfort during use, improve
patient drug compliance
Expand indication: address
unmet needs
2nd Generation
Pre-filled Pen
(Liquid Cartridge)
3rd Generation
Long-acting
Version
Future
Innovative
Formulations
Diabetes
Uni-PTH
Fracture
HKD11B
Uni-E4
Antiobesity
HKD12B
8
Uni-Bio Execution
Capabilities
9
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 (1th*)
• Novartis (3rd*)
• Abbott (10th*)
• Lundbeck
Koh Phee Wah, CPA, MBA
CEO of Uni-Bio Science Healthcare
• Prior COO at UCB (12th**) China
• 15 years GM experience in life science MNC (BD,
Pharmacia - now Pfizer, Monsanto)
• Successfully launched Celebrex
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
*Global pharmaceutical ranking (2013) based on MCap
**Global biotech ranking (2013) based on MCap
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 (2nd*)
• 10 years doctor in Beijing
Tongren hospital
10
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
4. Financing to support near term growth
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



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
Summary
12
Uni-Bio: A quality Chinese biotech story quickly approaching
value inflection point
Growth Catalysts
•
2015 Highlights
• Sales growth outpaced industry*
• Uni-PTH dossier accepted by CFDA
and positive phase 3 results for UniE4
• Secured new diabetes product to
launch in 2016
•
•
•
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
Kingsley
Leung
Executive Director
[email protected]
Phee Wah Koh
Harvey Sun
CEO – China
Operations
[email protected]
Group IR and
Communications
[email protected]
14