Post on 22-Dec-2015
1www.orchidpharma.com
Orchid Chemicals & Pharmaceuticals Ltd.
Creating Sustainable Value
November 2010
BSE: 524372 NSE: ORCHIDCHEM Bloomberg: OCP@IN Reuters: ORCD.BO
2www.orchidpharma.com
Disclaimer
This presentation includes forward-looking statements / projections, which are based on current expectations
and forecasts about future events. Such statements involve known / unknown risks, uncertainties and other
factors and may cause and defer the actual results materially. Such factors include, but are not limited to,
changes in local and global economic conditions, Orchid Chemicals & Pharmaceuticals Ltd. (‘Orchid’ or the
‘Company’) ability to successfully implement its strategies, the market acceptance and demand of the
Company’s products and services, the Company’s growth rates, expansion, technological change and the
Company’s exposure to market risks. By this nature, these indications and projections are only estimates and
actual results could differ from these in the future.
These materials are not an offer for sale of securities in the United States or in any other jurisdiction. No
securities of the Company may be offered or sold in the United States absent registration or an exemption from
registration under the U.S. Securities Act of 1933, as amended. The Company does not intend to register any
of its securities for offer or sale in the United States or elsewhere, or to conduct a public offering of securities in
the United States or elsewhere. No money or other consideration is being solicited pursuant to these materials.
3www.orchidpharma.com
Orchid Chemicals & Pharmaceuticals
Business
Vertically integrated global pharmaceutical company Established research, manufacturing and marketing capabilities Multi-therapeutic, multi-product global business Active Pharmaceutical Ingredients (API), finished dosage forms and drug discovery
Key Product Offerings
Fully integrated API and Finished Dosage Form product offerings Oral Antibiotics Diverse (oral) multi-category non-antibiotic product range (Non-Penicillin/Non-Cephalosporin)
Facilities
2 API manufacturing sites in India and 1 API manufacturing site in China 3 formulations manufacturing sites in India, and 3 research campuses in India Manufacturing facilities approved by US FDA, UK MHRA, EDQM, DMA, MCC and TGA R&D facility accredited by National GLP Authority of India (aligned to OECD principles of GLP)
Employees Human resource base of 4000 plus – includes over 700 scientific & technical manpower in R&D
and manufacturing, and around 1000 field personnel in domestic formulations
Financials*
Financials are on consolidated basis
Q2 FY11 Turnover: Rs 4,024 mn (US$ 91 mn) / H1 FY11 Turnover: Rs 7,670 mn (US$ 173 mn) FY10 Turnover: Rs 13,435 mn (US$ 298 mn)
* USD figures based on exchange rate of Rs 44 = 1$ (Q2FY11 & H1 FY11) / Rs 45 = 1$ (FY10)
4www.orchidpharma.com
Amongst the Top-15 Indian pharma companies, a status achieved in just 13 years of operationsAmongst the Top-15 Indian pharma companies, a status achieved in just 13 years of operations
Largest manufacturer-exporter of cephalosporin products in India; Amongst the top exporters of all pharmaceutical products in IndiaLargest manufacturer-exporter of cephalosporin products in India; Amongst the top exporters of all pharmaceutical products in India
Recipient of several awards from Government of India, Confederation of Indian Industry, Madras Management Association and other national and international agenciesRecipient of several awards from Government of India, Confederation of Indian Industry, Madras Management Association and other national and international agencies
Partner of Choice for ‘Competitive Excellence’ & ‘Contract Research - Collaborative Drug Discovery’ awarded by Frost & SullivanPartner of Choice for ‘Competitive Excellence’ & ‘Contract Research - Collaborative Drug Discovery’ awarded by Frost & Sullivan
Amongst the Top-5 cephalosporin antibiotic producers of the worldAmongst the Top-5 cephalosporin antibiotic producers of the world
Orchid’s Domain Leadership
Leader in high technology life-saving antibiotics ; cephalosporins, penicillins / betalactams and carbapenems
Complex non-penicillin, non-cephalosporin products
PresencePresence
Committed to a culture of high standards in safety, health and environmentCommitted to a culture of high standards in safety, health and environment
5www.orchidpharma.com
Become an Integrated Pharmaceutical
Corporation of Global Scale and Standing,
with a Comprehensive Coverage from
Discovery to Delivery
Key Differentiators
Orchid’s Vision is to…
• API to FDF
• Discovery to Delivery
• Global SCM
• US FDA• UK MHRA• EDQM• SA MCC• TGA• DMA
• Joint Ventures
• Collaborations
• License Agreements
• cGMP
• cGLP
• ISO
• OHSHAS
State-of-the-art R&D and
Manufacturing Facilities
End-to-end connectivity
Stringent quality,
regulatory compliance
Global alliances
and partnerships
6www.orchidpharma.com
Orchid Chemicals & Pharmaceuticals Ltd.
Orchid Research Laboratories Ltd., Chennai
NCPC Orchid Pharmaceuticals Company Ltd. China
Orchid Pharma Japan K K, Tokyo
Orchid Pharmaceuticals, Inc., Delaware, USA
Orchid Pharmaceuticals SA (Pty) Ltd. South Africa
Bexel Pharmaceuticals Inc., Union City, CA, USA
Diakron Pharmaceuticals Inc. San Diego, USA
Orchid Europe Ltd. London, UK
Orgenus Pharma Inc., Princeton, NJ, USA
Wholly owned subsidiary for drug discovery and development
Wholly owned subsidiary for business development (generics and CRAMS) in Japan
50:50 joint venture for manufacture of sterile cephalosporin APIs in China
Wholly owned subsidiary for rendering select services in US
Wholly owned subsidiary for undertaking South African generics foray
Wholly owned subsidiary for drug discovery and development in US
Affiliate (planned to be a subsidiary) for discovery and development of new cardiovascular drugs
Wholly owned subsidiary for generics foray in Europe
Wholly owned subsidiary
Orchid Group Corporate Structure
7www.orchidpharma.com
API facilities (Alathur, Chennai)
Largest cephalosporin API manufacturing complex
Approved by US FDA, UK MHRA and other international regulatory agencies
Variety of non-sterile and sterile (crystalline & lyophilised) APIs
High levels of throughput and manufacturing integration (980 MT of capacity per annum)
State-of-the-art infrastructure designed for highest levels of process efficiencies and environmental friendliness
GMP - Approved (WHO)
US-FDA – Approved (Nov’02, Sep’03 & Dec’06)
EDQM – Approved (Sep’03)
MHRA – Approved (Jan’06)
Hamburg Health Authority – Approved (Jan’06)
Australian-TGA - Approved (Feb’03)
ISO 9001:2000-certified Quality Management System (Re-certified in May’08)
ISO 14001-certified Environment Management System (Re-certified in May’08)
Danish Medicines Agency (EU-GMP) – Approval (Jan’09)
Pharmaceuticals & Medical Devices Agency (PMDA, Japan) – Oct’09)
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API facilities (Aurangabad) Multi-site API complex with dedicated facilities for
Penicillins Sterile Carbapenems Non-penicillin, Non-cephalosporins (NPNC)
Facilities designed for automated production
Manufacturing capacities : 48 MT for Penicillins, 12 MT for Sterile Carbapenems and 120 MT for NPNC
Approvals: UK MHRA (Approved - Jan ’07) US FDA (Approved - Feb ’07) OHSAS 18001:1999 Danish Medicines Agency [EU-GMP] (Approved - Jan ’09) WHO GMP Audit (Approved - Apr ‘10)
ISPE, INTERPHEX and Pharmaceutical Processing
Facility Awards 2009
Sterile Carbapenem Facility
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Formulation Facilities – Advanced Markets (Irungattukottai, Chennai)
Large state-of-the-art oral dosage form complex with multi-therapeutic facilities
World-class facilities with US FDA & UK MHRA and other international regulatory approvals
High throughput Oral cephalosporin formulations facility
Pilot and commercial scale NPNC (non-antibiotic) dosage forms plant
Global scale capacities
10www.orchidpharma.com
Highlights of Orchid’s Generics Contracts – US, EU model
Orchid has long term partnerships with leading global generic players in US and Europe to distribute its products in the respective markets.
Orchid licenses the generic products in return for development cum licensing fees received from the partners.
Orchid manufactures and supplies the products from its US FDA, UK MHRA approved facilities based on pre-agreed costs of goods and also receives share of revenues or net profits as per agreements.
The arrangements incorporate mutual performance parameters in terms of market and supply performance.
The typical initial term ranges upwards of five years from product launch, with the agreements providing for renewal.
The partnerships have been expanded in terms of product range and extended in terms of geographic coverage reflecting Orchid’s performance and partnership equity
Orchid is currently working on creating front-end marketing organisations of its own in the advanced markets
11www.orchidpharma.com
Novel Drug Delivery Systems (NDDS)
A new initiative to support product life cycle management of established drugs
Undertakes development of new dosage forms and strengths to enhance the efficacy and safety of existing drugs
Develops novel combinations of existing drugs for better compliance and / or synergistic effect
Platform technologies deployed to undertake NDDS developments
Strategy focuses on developing NDDS on bench scale and establishing limited proof-of-concept
Business strategy envisages collaborative approaches with MNCs and specialist delivery companies for further studies and eventual commercialization
Also provides support to development of conventional and novel formulations for New Chemical Entities
12www.orchidpharma.com
Orchid Research Laboratories Limited (ORLL)
BusinessBusiness
A wholly owned subsidiary of Orchid Chemicals & Pharmaceuticals for undertaking drug discovery and development
An integrated research company with end-to-end capabilities in drug discovery and development
Among the top ranked pharmaceutical discovery entities in India, with global standing
Objectives Discovery and development of New Chemical Entities (NCEs) Custom Research and Manufacturing Services (CRAMS)
FacilitiesFacilities
Drug Discovery Centre, Biology Centre, Animal House cum Pre-clinical Facility, CMC Facility, Analytical Centre, Formulation Facility in Chennai, India
R&D Facilities GLP accredited by National GLP Authority of India, aligned with OECD Principles
Employees Scientific base of 130 plus with several doctoral and post-doctoral scientists Access to 200 plus scientists in other R&D and technical domains of the Parent organization
RecognitionRecognition Partner of choice in ‘Contract Research – Collaborative Drug Discovery’ awarded by Frost &
Sullivan
13www.orchidpharma.com
Orchid Research Laboratories Ltd (ORLL) Animal House facility
Microbiology Facility
Microbiology Capabilities: MRO
Process Research & Development
Molecular modeling
IPM
Medicinal Chemistry
Analytical Chemistry
Assay Development
Microbiology in vitro functional capabilities
Microbiology in vitro hit profiling capabilities
Microbiology in vivo capabilities
Pre-Form/Formulation and DMPK
Toxicology Capabilities
Access to Parent’s Process Research and Pharma Research infrastructure
Special competencies
High quality infrastructure
130 plus scientists exclusively for drug discovery and drug biology. Supported by access to the parent’s process research and pharmaceutical capabilities, as needed
Has the capability to link up with clinical research organizations for human clinicals
Orchid’s integrated drug discovery and development infrastructure helps simultaneous, fast-track pursuit of multiple therapeutic programs
GLP Certified
14www.orchidpharma.com
ORLL’s product and services strategy
Project based services
Collaborative Drug Discovery
Proprietary Drug Discovery
Pfizer Biovitrum Dermact etc. FTE or Fee for Service models
MNC oriented Therapeutic area based Risk-reward shared models
Multiple TAs PCC in animals POC in humans Out-licensing
15www.orchidpharma.com
IPM
Patent Applications Filed : Total - 64414
2816
187399
NCE Process Biotech NDDS Generics
Patents Published : 226
13
86
136
NCE Process Biotech NDDS
Draft, file and prosecute high quality patent applications
644 patent applications filed in various national and international patent offices
Includes 187 patent applications for NCEs, 28 for NDDS and 14 for biotech
Several patent and search data bases
Prepare novelty / infringement reports
Monitor competitors’ patent portfolio
Coordinate with foreign patent attorneys
Prepare patent evaluation reports
Support Business Development & clarify portfolio related queries
Robust IPM systems to protect inventions, secure intellectual property and assure client confidentiality
16www.orchidpharma.com
ORLL’s multi-therapeutic, multi-lead discovery programNCE Development Status
1
2
1
3
1
1
Discovery Early Pre-clinical
Late Pre-Clinical
Regulatory Toxicology
Phase 1 Clinical
Phase II Clinical
3
2
2
2
NCE
Tyrosine-TZD, Non-PPAR molecule
3
DPP IV Inhibitor
Novel
Th1 / Th2 Cytokine Synthase Inhibitor
Diabetes
Therapeutic Segment
Inflammation
Oncology
(Non-Cytotoxic)
PDE IV Inhibitor
TNF Inhibitor
STAT 3 / IL-6 Inhibitor
HDAC Inhibitor
Anti-Infectives
Oxazolidinone
Cephalosporin
Betalactamase Inhibitor
1
CNS
Obesity
1
Novel
Novel
1 Oral Direct Thrombin InhibitorClotting Disorders
17www.orchidpharma.com
Orchid’s multi-horizon strategy would focus on a larger basket of oral products and new value adding niche opportunities
New Drug Discovery
Novel Drug Delivery
CRAMS
Generics for regulated markets
Branded for emerging markets
Branded for India
for in-house generics
for regulated markets
for emerging markets
Horizon 1 - API
Horizon 2 - Formulations
Horizon 3 – Innovation
18www.orchidpharma.com
Growth strategy
Orchid
Existing Business
API / Oral FDF / CRAMS / NDDS
Inorganic Strategies
(Front-end Mktg / in-licensing of products)
New niche Initiatives
(New product segments)
Target to grow topline by 15-20% y-o-y
Strong operational cash flow going forward based on niche product opportunities
Orchid recently acquired US-based marketing company Karalex Pharma, LLC.
19www.orchidpharma.com
Orchid’s Value Proposition
DOMESTICFORMULATIONS CRAMS
GLOBALGENERICS
(ORAL)
NDDS NCEsGLOBAL
APIs
Formulations InnovationAPI
State-of-the-art manufacturing infrastructure; two API sites, one oral generic formulations facility for advanced markets, two formulations facilities for certain emerging markets and R&D and drug discovery facilities
Global regulatory compliance, including US FDA, UK MHRA and DMA
Multi-therapeutic product portfolio, with an increased focus on oral cephalosporin and non-penicillin, non-cephalosporin (NPNC) products
Long term contracts with Hospira / other innovators for supply of APIs with assured capacity utilization
Integrated drug discovery capabilities with proprietary NCE pipeline as well as custom research and collaborative drug discovery
Financial flexibility to identify growth opportunities across the value chain
20www.orchidpharma.com
THANK YOUFor any information or clarifications, please visit www.orchidpharma.com
or call
Ch Ram, Head - Communications & Investor Relations
on +91 98400 11626 / ram@orchidpharma.com
© 2010 Orchid Chemicals & Pharmaceuticals Ltd., All Rights Reserved.
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