China Pharma Holdings, Inc. PPT 2012.pdfChina Pharma Holdings, Inc. CPHI ( NYSE/Amex ) INVESTOR...
Transcript of China Pharma Holdings, Inc. PPT 2012.pdfChina Pharma Holdings, Inc. CPHI ( NYSE/Amex ) INVESTOR...
China Pharma Holdings, Inc.
CPHI( NYSE/Amex )
INVESTORPRESENTATION
CPHI( NYSE/Amex )
INVESTORPRESENTATION
www.chinapharmaholdings.com
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Safe Harbor Statement
Safe Harbor Statement Under the Private Securities Litigation Reform Act of1995: Any statements set forth in this presentation that are not historicalfacts are forward-looking statements that involve risks and uncertainties thatcould cause actual results to differ materially from those in the forward-looking statements, which may include, but are not limited to, such factorsas unanticipated changes in product demand, increased competition, failureto obtain or maintain intellectual property protection, downturns in theChinese economy, uncompetitive levels of research and development,failure to obtain regulatory approvals, and other information detailed fromtime to time in China Pharma Holdings, Inc.’s filings and future filings withthe United States Securities and Exchange Commission.
The forward-looking statements contained in this presentation are madeonly of this date, and China Pharma Holdings, Inc. is under no obligation torevise or update these forward-looking statements.
China Pharma - Helpson
Strong contender in new drugs as well as generics and First-to-Market generics. Highly profitable operation with robust new product pipeline.
Long History: wholly owned subsidiary Helpson was founded in 1993 with research focus
Production: 8 GMP-certified production lines with multiple formulation capabilities
Distribution: Strong track record of selling to public hospitals with national distribution network covering 30 municipalities and provinces
Diversified product portfolio composed of 20 branded and generic drugs
Future: New drugs and “Super” generic drugs in R&D Pipeline
China Pharma is a fully integrated pharmaceutical company with a focus on medicines for high incidence and high mortality diseases in China.
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20
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60
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2005 2007 2009 2011
Revenue in USD Mln$ Mln
China Market Place for Generics
Basic Generics: 1) Common drug2) Low demand on research and production capabilities3) Strong competition, often with hundreds of manufactures4) Lower gross margins5) Very large market, especially after Healthcare Reform
First-to-Market generics:1) Generics to the western world but new to China2) High demand on R&D and production capabilities3) Less competition4) High gross margins5) Selling mostly to hospitals in large cities6) Regulatory exclusivity 3yr- 5yrs (monitoring period)
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The two “Generic” markets in China:
Company Overview – Product Focus
Main therapeutic areas: 1) CNS, Cardio-cerebral vascular2) Infectious and Respiratory Diseases 3) Digestive Diseases
Products:1) Newly Developed Drugs 2) Generics of Off-Patent Branded Drugs3) Modern Traditional Chinese Medicines
(TCMs)4) New formulations
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Low-risk development based on market demand. Diverse portfolio of 20 products on the market.
Modern, Scalable Manufacturing Facilities
Eight Scalable, Modern, GMP-certified Production Lines
Located in Hainan, China; built in 2002
Approximately 8,000 m2 manufacturing facility
Ongoing Upgrades & Expansion to Meet Increasing Demand
$3 M investment in 2008 increased freeze dry powder injectable capacity
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Production Line
1. Tablet 2. Capsule 3. Granule 4. Injectable 5. Dry Powder 6. Cefaclor Only 7. Biological API 8. Chemical API
China’s Healthcare Reform
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Chinese government are investing billions of RMB to implement a universal health-care system.
Medical insurance coverage massively expanded. Pharmaceutical industry will be realigned by new policies on quality and
pricing control (Essential Drug List, “EDL” & National Insurance Catalog, “NIC”).
Overall industry volume to expand strongly but margins will be under pressure for a period of time.
Opportunities for CPHI:1) Opportunity to expand distribution network into rural areas with very large
markets. Two (2) of the Company’s drugs are listed as on the National EDL and a few drugs are on provincial EDL.
Overall, reform is positive for CPHI and the Chinese Pharma industry.
Our Business Model: Commercialization
Secure, established networksSales infrastructure expansion
Distribution Increasing Market Share
We favor drugs with >$1 B global sales
High-incidence, high-mortality diseases
Drug Selection
New drugs
Reformulated drugs
Off-patent branded drugs
Experience with SFDA process
Development
8 GMP - Certified manufacturingproduction lines capable of multiple formulations
Expertise in new drug marketing and launching process
Commercialization
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Revenues by Therapeutic Category
2011 Revenue by Product Type
Other14% - $11 mil
CNS Cardio-Cerebrovascular32% - $25.8 mil
Respiratory, Anti-Viro/ Infection
39% - $32 milDigestive
15% - $12.4 mil
Diversified Product Portfolio
CNS & Cerebral-Cardiovascular
Diseases
Ograzel/Alginic Sodium Diester/Propylgallate:Stroke (cerebral thrombosis / embolism), coronary heart disease; hyperlipidemia. Propylgallate dry powder format more stable than other forms
Buflomedil: Peripheral blood vessel diseases, e.g. intermittent claudication; Raynaud’s disease. National Key New Product Award; 4 dosage forms on market.
Gastrodin: Brain trauma, neurasthenia, headache, anxiety, vertigo
Bumetanide: Diuretic used in edema caused by heart failure, hypertension, renal failure or acute poisoning
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Anti-infection
Roxithromycin/Clarithromycin: Macrolide antibiotics: respiratory tract, urinary, soft-tissue infections. Clarithromycin: granules and capsule formats for easy administration to elderly and pediatric patients
Cefaclor/Cefalexin: Cephalosporin antibiotics: respiratory, urinary, soft tissue infections
Andrographolide: Anti-bacterial, anti-inflammatory, detoxifier: upper respiratory infection, bacilliary diarrhoea
Gall Wood Syrup Extract: Anti-bacterial, anti-inflammatory.
Cold - Flu
Digestive Disease
PuSenOK: Cold-flu symptoms: sinus and nasal congestion, pain, myalgia, fever, sore throat
Vitamin Supplements Vitamin B6: Vitamin B6 deficiency
Hepatocyte growth-promoting factor: Auxiliary treatment in acute and chronic hepatitis. Bioengineered medicine.Tiopronin: Treats acute Hepatitis B and drug-induced liver injury
Omeprazole Injections: is widely utilized to treat gastroesophageal reflux disease (GERD), and is highly effective in other conditions caused by excess acidic formulations in the stomach
Compound Ammonium Glycyrrhetate S for Injection: is used to treat abnormal functionality of the liver from liver disease.
Wound Recovery rhaFGF: Reparation of skin injuries
Diversified Product Portfolio (cont.)
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Tumor DiseaseGranisetron: Cancer chemotherapy induced, and post operative nausea and vomiting
Research & Development (cont.)
Concentrating on therapies for key disease areas, among leading causes of death in PRC.
Expected Medical
Expenditures on key D
isease Categories
Sources: 1:Freedonia/Roth; 2: N E J M, 353(11):1124-1134, 2005 “Major Causes of Death Among Men and Women in China”
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20 products commercialized prior to Jan 1, 2010;
1 (Tiopronin) Launched in May of 2009;
1 (Omeprazole ) Launched in 4th
quarter of 2009;
Strong Commercialization Track Record
Leveraging R&D efforts by
Collaborating
with Elite Academic
Institutions
Chinese Academy of Sciences
China University of Pharmaceuticals
Sichuan University
Chongqing Medical Industry Institute
Military Medical Academy Basic Medical Science Institute
China Pharma Holdings,
Inc.Joint R&D
China PharmaRetains
Ownership Rights from
resulting Intellectual Property
Compelling Product Pipeline
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Project Name Indication R&D Discovery
R&D Optimization
SFDA Tecnhical Analysis
SFDA Approved
Central Nervous System
CNS1 Alzheimer Disease
CNS2
Cardio Vascular
Rosuvastatin (Crestor Generic) Cholestero Control
Candesarten Hypertension
Heart Disease Drug Coronary Heart Disease
Infectious Diseases
Ceftriaxone and Tazobactam sodium Drug-Resistent AntiBiotic
Digestive
Hepatitis Drug Liver Protection
Pain & Wound Recover
PAIN-1 Pain Management
Clinical Trials (if Necessary)
Currently in Phase 2 Clinical Trial
Awatiting Final SFDA Production Approval
Awatiting Final SFDA Production Approval
Currently in Phase 3 Clinical Trial
Novel Antibiotic Combination in Clinical Trials
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Antibiotic Blockbuster:
Third Generation Cephalosporin + Bacterial Enzyme Inhibitor 3rd generation Cephalosporin antibiotic Bacterial enzyme inhibitor Formulated to improve drug-resistance profile
3rd generation Cephalosporin alone encounters resistance 20%-70% of certain target pathogen strains may be resistant 2
Broad spectrum
$5.8 B Estimated Cephalosporin Antibiotic Market in China 3Company Expects Significant Revenue Contribution from drug after Launch.
Clinical Trials Addressing Antibiotic Resistance Clinical program initiated (November 2008) Phase II of the clinical trial commenced in early 2011 Potential approval in 2013 with a 3 to 5 year regulatory exclusivity (monitoring period)
Source: 1: Centers for Disease Control and Prevention, 2003; 2:Chinese Ministry of Health National Antimicrobial Resistance Investigation Net (MOHnarin); 3: SFDA Information Center
“Antibiotic resistance has been called one of the world’s most pressing public health concerns.”1
Cholesterol-lowering blockbuster statin product Worldwide sales for 2010 exceeded $5.5 billion The use of Crestor® has translated into a 60% decrease in the number of cardiac events (heart
attack, sudden cardiac death) and a 17% reduction in the risk of stroke. Has shown favorable results in international clinical comparisons with other leading statins, such
as Atorvastatin (Lipitor®), Pravastatin and Simvastatin.
Hyperlipidemia in China Prevalence rates estimated at 7% to 8%, which translates to approximately 100 million people
suffering from high cholesterol in China. With 30% penetration rate at 1/10 of US price for Crestor,
the Chinese market size would be $3.2 bln. A 2% market share would imply $64 mln per year in revenue for CPHI.
Clinical Trials Clinical Trials completed in December of 2010.
Currently awaiting SFDA production approval..
Pipeline Drug Highlight: RosuvastatinGeneric Form of Crestor®
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1000
2500
4000
5500
2006 2007 2008 2009 2010
Global Crestor Sales$ Mln
Source: 2010 Astra Zeneca Annual Report
$ Mln$ Mln$ Mln
Generic form of Candesartan: 2007 worldwide sales over $2.5 billion1
Front-line therapy for Hypertension Well-tolerated, high safety record On China’s National Basic Medical Insurance Drug List
Sales of Sartan drugs in China2
2007 sales approached $190 million (RMB 1.3 billion) -- YoY increase of 56%
Hypertension in China3
60% of all urban adults aged 65+ years suffer hypertension Urban prevalence predicted to be 100 million by 2011
Clinical Trials Completed all review testing procedures Pending final SFDA production approval
Sources 1: Takeda Pharmaceutical Company Ltd., Annual Report 2008; 2: Medical Economic News 2008, Sept. 03; 3: Nature Reviews, Drug Discovery: 2008 May; 7 383-384.
Pipeline Drug Highlight: Candesartan.
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Generic Form of Candesartan: anti-hypertension drug
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Sales & Marketing Network
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Prescription-based sales and marketing network covering major hospitals across China
Well-experienced sales team: 16 sales offices, 30 provinces, ~1,250 distributors
Close relationship with hospitals and municipal pharma distributors allows rapid roll out of new products
Fewer intermediaries between end user (hospital pharmacies) and China Pharma enables CPHI to obtain higher profit margins
Extensive marketing network built over a decade represent a barrier-to-entry advantage for CPHI
Significant Market Share in Public Hospitals with National Distribution Network
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Extensive Distribution Network
Distribution System
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Covering 30 provinces and municipalities
16 sales offices
Experienced Marketing Team
New Product Launch & Marketing Experience
Financial Highlights
Equity Snapshot Income Statement
Balance Sheet Cash Flow and Other
(In US$ millions) 12/31/2011Cash and equivalents $ 4.1 Accounts receivable 69.7Working capital 96.8Total assets 156.4Total long term debt 0.0Total shareholders’ equity 142.5
(in US $ millions, except EPS) FY’11 FY’10
Revenue $ 81.2 $ 74.4
Gross profit 29.0 30.3Gross margin % 36% 41%Op Income 22.0 24.7Net Income 19.3 23.4GAAP EPS $0.44 $0.54
(in US $ millions) FY’ 11 FY’ 10
Cash flow from operations $ 5.24 $ 7.79
Cash flow from investing -5.6 -10.5
Cash flow from financing 0.6 2.7
Ticker symbol (NYSE Amex): CPHI
Share price (3/31/12): $0.68
52-week price range: $0.62 - $2.75
Shares outstanding (3/31/12): 43.5 M
Market cap (3/31/12): $29.6 M
P/E (FY’11 EPS of $0.44): 1.55 X
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Investment Highlights
Proven record in commercializing new and generic drugs
Pipeline of new products with potential blockbuster drugs
Diversified product portfolio with 20 products
Highly profitable with >20% net income margin
Experienced nationwide distribution network mainly targeting hospitals;
Management Team
Ms. Zhilin LiPresident and CEO
Helpson founder (wholly-owned China Pharma subsidiary) Chairman and CEO of Helpson since 1993 Former President of Haikou Bio-Engineering Institute, President of Sichuan Institute of Biology Biology degree from Sichuan University
Ms. Yao HuangCTO
Began career at Helpson in 1994 Certified Senior Engineer and Registered Pharmacist Graduated from Chengdu Chinese Medicine and Pharmaceutics University >25 years professional experience in pharmaceutical manufacturing.
Mr. Yingwen ZhangIndependent Director
Independent director since January 2008. Commercial Counselor of the China Embassy in Malaysia from 2000 through 2005. Member of the BOD at Chongqing Wanli Holdings (Group) LLC (SHA:600847)
Mr. Michael BennettIndependent Director
Independent director since February 2008. Serves as Independent Director for various Chinese companies listed in the US. Graduated from Michigan State University with an MBA in Finance and BA in Accounting.
Mr. Baowen DongIndependent Director
Independent director since March 2008. Engineering and Medical Science faculty at the Sichuan University from 2003 to 2008,
assessed and evaluated faculty teaching. Concentration in biomedical and medical information research. Graduated from Xi’an University of Science and Technology in 1966
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Contact Information
China Pharma Holdings, Inc.Diana Huang & Sam HsingPhone: +86-898-6681-1730E-mail: [email protected] Site: www.chinapharmaholdings.com
Corporate Headquarters: Haikou City, Hainan, P.R.China