Orchid Pharma Investor Presentation

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Orchid Pharma Investor Presentation

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Title: Orchid Pharma Investor Presentation


1
CONFIDENTIAL
Orchid A new growth phase
A Presentation
March 2006
2
Disclaimer
  • This presentation includes forward-looking
    statements / projections, which are based on
    current expectations and forecast 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,
    the Companys ability to successfully implement
    strategies, the market acceptance and demand of
    the Companys products and services, the
    Companys growth rates, expansion, technological
    change and the Companys 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.

3
Key trends in global pharma
  • Global pharma offers a huge opportunity USD 518
    billion market (2004), growing at 7 to 9 during
    the last few years US, Europe and Japan
    constitute 87 of the global market
  • Generics are a fast growing segment of USD 68
    billion (2004) US, Europe and Japan constitute
    75 of global generics
  • Faced with patent expiries, and stagnant RD
    productivity, global pharmas RD budgets (USD 60
    billion plus) could benefit from significant
    off-shoring
  • Steady growth of generics on one hand and the
    increasing compulsions for new drugs on the other
    offer a major opportunity for India and Orchid
  • Orchids business model focuses on two key
    drivers generics and discovery outsourcing

4
Orchid a name in global pharma
  • Incorporated in July 1992 as a 100 EOU
    commenced operations in February 1994
  • Evolved rapidly into an integrated life sciences
    company with a strong presence across the pharma
    value chain Active pharmaceutical Ingredients
    (APIs), Formulations and Drug discovery
  • Leader in high technology life-saving antibiotics
    cephalosporins, betalactams and carbapenems
    with core competencies in sterile injectable
    products
  • Revenues of Rs 700 crore human resource base of
    2600 plus 5 manufacturing plants, 2 research
    centres and 2 overseas joint ventures an
    investment base of over Rs 1000 crore
  • 11th largest Indian pharmaco, a status achieved
    in just 11 years of operations
  • Amongst the Top 5 cephalosporin antibiotic
    producers of the world
  • Largest manufacturer-exporter of cephalosporin
    products in India
  • 6th largest exporter of pharmaceutical products
    in India
  • US FDA approved facilities, both API and
    formulations additional EDQM and TGA
    certifications GLP accredited RD Centre
  • ISO certified facilities
  • ISO 9001 2000 Quality
  • ISO 14001 Environmental Management
  • OHSAS 18001 Occupational Health Safety
  • Pioneer of zero discharge pharmaceutical
    manufacturing in India
  • Recipient 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
    awarded by Frost Sullivan

5
Orchids vision is to
become an integrated pharmaceutical corporation
of global scale and standing, with a
comprehensive coverage from Discovery to
Delivery
6
To fulfill the vision, Orchid has pursued a
strategy to grow the business in multiple horizons
Integrating investments by Schroders and IFC,
Orchid set up world-class research and
manufacturing facilities, US FDA compliant, to
implement the multi-horizon business strategy
7
Orchid achieved aggressive organic and inorganic
business development, value added by joint
ventures and strategic alliances
Horizon 3
NDD NDDS research Biotech Research
Horizon 2
Generics (US EU) Formulations
Horizon 1
Bulk - Unregulated Bulk - Regulated
8
State-of-the-art manufacturing facilities
API plant, Alathur
API plant, Aurangabad
Non-sterile API plant, Alathur
Sterile API plant, Alathur
9
State-of-the-art manufacturing facilities
Betalactam Formulations Plant, Irungattukottai
Ceph Formulations facility, Irungattukottai
Betalactam API Facility, Aurangabad
Non-antibiotic API Plant, Aurangabad
10
Orchids business model
  • Orchids business is global
  • API
  • Formulations
  • Orchid has strong growth drivers
  • Niche generics (cephs, betalactams penems)
  • Increasing presence in regulated markets (US
    Europe)
  • Drug discovery and drug delivery research
  • Orchid has end-to-end execution capability
  • API
  • Formulations
  • Research

11
Orchids niche generics model
2010-11
2005-06
2006-07
2007-08
2008-09
2009-10
Cephalosporins
Betalactams
Carbapenems
Non-antibiotics
A carefully developed niche therapeutic strategy
would drive growth, year over year, with
step-function increases in turnover and
profitability
12
Orchids generics market opportunity 2005-2010
based on current retail market sizes in USD
Million
  • Key success factors for Orchid
  • Broad-based presence in all key markets
  • Full-spectrum product coverage with blockbuster
    and niche products
  • Calibrated entry in line with patent expiries
  • Robust distribution arrangements with reputed
    partners
  • Proven technical, managerial capabilities

Relatively exclusive position in the antibiotic
space, with few competitors
13
Orchid has a unique position in the antibiotic
generics space
  • The cephalosporin,high-end betalactam and
    carbapenem generics space, where Orchid
    specializes, has less number of players and is
    relatively insulated from price pressures
  • Manufacture requires dedicated, non-switchable
    facilities
  • High technology and investment requirements
    present significant entry barriers
  • Orchid has the widest product range and the most
    comprehensive US FDA approved facilities and a
    core competence in sterile injectable products

14
Key products offer major opportunity in the US
during 2005-08
Veterinary product yet to be genericised
Orchid-Apotex partnership has secured the leading
position in Ceftriaxone generics market in the
US Cefprozil Cefoxitin with Par and Apotex have
been the recent launches
15
The positive impact of the various generics
initiatives has resulted in the superior
performance in FY 2006
Rs Mn
Net of ED
16
Highlights of FY06 performance
  • Impressive increases in turnover and
    profitability, compared to Q3 of FY05
  • Turnover up by 38 from Rs 1722.6 mn to Rs 2376.0
    mn
  • EBITDA up by 65 from Rs 422.4 mn to Rs 697.6 mn
  • PAT up by 403 from Rs 57.6 mn to Rs 289.6 mn
  • And in 9 months of FY06 too
  • Turnover up by 27 from Rs 5098.9 mn to Rs 6471.8
    mn
  • EBITDA up by 57 from Rs 1215.8 mn to Rs 1904.9
    mn
  • PAT up by 341 from Rs 144.1 mn to Rs 635.2 mn
  • EBITDA margin of 29 reflects an industry leading
    performance (25 in Q3 FY05 and 24 in first 9
    months)
  • Performance driven substantially by increases
    from regulated market business which stood at 40
    of Q3 turnover
  • Successful launch and quick ramp-up of generic
    Ceftriaxone injection and successful launch of
    Cefprozil Tablets and Suspension have been key
    growth drivers further increases in sales and
    additional launches should keep up the growth
    momentum

17
Orchid has also initiated correction of capital
structure with overseas GDR and bond programmes
  • Successfully closed in November 2005, a GDR cum
    FCCB issue for USD 75 million with green-shoe of
    USD 2.6 million GDRs and USD 5 million FCCBs
  • To retain promoter shareholding, warrants,
    convertible to shares, have been issued to
    promoters / promoter groups as per SEBI rules
  • GDR / Bond proceeds have been utilised to pare
    down debt (long term and short term) by USD 59
    million (from USD 282 million, pre-issue)
  • Companys debt-equity ratio has improved from 2.8
    (pre-issue) to 1.8 (post-issue) will improve
    further to 1.21 if FCCBs are converted later
  • Balance proceeds (less issue expenses) set apart
    for accelerating the NPNC ANDA programmes and
    value-adding formulations facilities in the
    futuristic carbapenems space, apart from normal
    capex

18
Shareholding Pattern
As of March 01, 2006
Shares listed on NSE, BSE and MSE
19
The Drug Discovery Opportunity
  • Global pharmaceutical players are keen on
    strengthening their NCE pipeline in alliance with
    niche drug discovery firms
  • high cost and long lead time of in-house MNC
    efforts
  • shrinking pipeline
  • growing pressure from generics, dictating need
    for more innovative drugs
  • Apart from new molecules, potential exists for
  • supply of pre-clinical and clinical quantities
  • pre-clinical evaluation of new leads
  • custom synthesis of select structures /
    processes, and
  • co-development
  • All this presents a major opportunity for Orchid

20
Orchids RD infrastructure
New Drug Discovery Centre, Sholinganallur
Pharma RD Centre, Irungattukottai
RD Centre (Process Biotech), Sholinganallur
Pre-clinical facility, Sholinganallur
21
Orchids RD Key Statistics
  • Engaged in complete spectrum of pharmaceutical
    RD from drug discovery to drug delivery
  • USD 35 million invested from inception on RD
  • Current spend at 6 to 7 of turnover, one of the
    highest in the industry
  • Over 100 molecules developed in-house for generic
    medicines
  • Over 330 patent applications filed with US PTO,
    PCT, European and Indian PTOs 116 published and
    38 granted 30 of the patent applications are
    for new drugs and new drug delivery systems
  • Over 300 scientific personnel, covering the
    entire spectrum of RD
  • 36 laboratories, over two campuses of 12 acres in
    Chennai

22
Drug discovery capabilities
23
Pharma research capabilities
  • Undertakes formulation development of all types
    of dosage forms for global markets
  • 24 ANDAs filed with US FDA 11 approved already
    several more in submission and approval
    pipelines
  • Platform technologies patented for novel drug
    delivery
  • Sustained / extended release and controlled
    release technologies deployed
  • Provides pre-formulation and formulation support
    to drug discovery

Pharma Research
24
Target and mechanism based discovery
  • Anti-cancer
  • Anti-inflammation
  • Anti-infective
  • Metabolic disorder therapies
  • Diabetes
  • Obesity
  • Auto-immune diseases

Clinical
Pre-clinical
Discovery
  • BLX-1002 in anti-diabetes area in Phase II trials
  • Eight leads in
  • anti-cancer area
  • Four leads in Arthritis, IBD Psoriasis
    therapies
  • Several leads in diabetes and other areas
  • Thousands of compounds designed
  • Hundreds synthesised
  • Several hits obtained

25
About BLX-1002, novel anti-diabetes molecule
  • Novel orally active small molecule, developed by
    our US drug discovery JV, Bexel Pharmaceuticals
    (now a 74 Orchid subsidiary)
  • Successfully completed human clinical (safety,
    tolerability proof of efficacy) studies in
    Europe
  • Distinctive mode of action, compared to the
    latest series of anti-diabetes drugs
  • Glucose reduction as well as lipid lowering and
    hypertension control
  • No change in liver enzymes and no weight gain,
    two critical issues with other anti-diabetes
    drugs
  • Current strategy is to out-license the molecule

26
Orchids Mission 2010 is to.
Become a USD 1 Billion Company by 2010-11
  • Mission 2010 is well supported by
  • Multiple business drivers
  • Specific product-market plans
  • Robust distribution arrangements
  • Infrastructural assets
  • Organisational competencies
  • Selective new initiatives
  • Clear regulatory road map, spanning all the above

Turnover in USD Mn
1000
160
2010-11 (E)
2007-08 (E)
2004-05 (A)
2005-06 (E)
Not to scale
A - Actuals E - Estimates
27
Overview of Orchids generics contracts
Additional individual filings for Mexico,
Canada and Europe (not quantified here) are
required,as the case may be
Not for distribution
28
Highlights of Orchids distribution contracts
  • All ANDAs are developed and owned by Orchid
  • Manufactured from Orchids state-of-the-art
    generics plant at Irungattukottai, with API from
    Orchids modern API plants at Alathur and
    Aurangabad
  • Supplies will be made by Orchid under a profit
    share arrangement, after netting-off transfer
    price and marketing costs
  • Exclusivity subject to mutual performance
  • Development plan and funding based on sign-up and
    achievement of certain regulatory / launch
    milestones
  • Long-term horizon of partnership, with provision
    for renewal and potential to add further products

29
New initiatives - NPNC regulated generics
strategy
  • Master list of over 87 NPNC molecules drawn up
    covering diverse therapeutic groups (CVS, CNS,
    ADD, Urology, Osteo etc)
  • The above molecules address a current and peak
    retail opportunity of US 85 billion and US 191
    billion in the US EU.
  • Supply agreements have been executed with 3
    prominent players viz Alpharma/Actavis, Stada
    Par in the US EU generic space
  • The agreements cover 20 molecules that address a
    current retail opportunity of USD 25 Billion.
  • Would diversify therapeutic portfolio and provide
    continuous product pipeline
  • Some of the molecules would provide Para-IV /
    first-to-file opportunities
  • New RD labs and API and Formulations
    manufacturing facilities for NPNC commissioned. 2
    DMFs 1 ANDA already filed in the NPNC space.
    Further filings underway with an aggressive
    target of 2 ANDAs per month

30
New initiatives - CRAMS
  • Leveraging world-class RD base, Custom Research
    and Manufacturing Services (CRAMS) taken up as a
    new initiative
  • GLP certification of Orchids RD Centre by
    National GLP Authority, aligned to OECD
    Principles, is expected to be a major facilitator
    for global tie-ups
  • First contract signed with a global pharmaco
    (Pfizer) for supporting NCE development for
    animal health application
  • Dialogue initiated with select MNCs for further
    initiatives

31
Orchids transition from un-regulated to
regulated markets FY 1995 to FY 2011
FY 1994-95
FY 2004-05
FY 2005-06 (E)
FY 2010-11 (E)
32
Orchid offers major competitive advantage for
global pharma through own development as well as
partnerships
  • Capabilities and strengths of an integrated
    pharmaceutical major
  • A complete in-house, end-to-end connected
    infrastructure, and a complete portfolio of
    products and services covering
  • Active pharmaceutical ingredients / Intermediates
  • Generic formulations
  • Drug discovery
  • In the niche, premium Cephs / Sterile Pen. /
    Penems / Oral NPNC space
  • Ability to offer the above products and services
    with world-class quality at a cost advantage
  • Adherence to principles of client confidentiality
    and intellectual property rights

33
Orchid Value Proposition (1/2)
  • Fully integrated pharmaceutical corporation, with
    proven technical and managerial capabilities
  • State-of-the-art infrastructure for APIs and
    formulations with global regulatory compliance,
    including US FDA
  • Multi-therapeutic product portfolio, with a
    unique core competence in niche antibiotics and
    sterile injectables
  • Robust business model with execution solidity and
    track record of successful US generics entry and
    ramp-up

34
Orchid Value Proposition (2/2)
  • Multiple business drivers and sequential product
    roll-outs of premium and niche generics, with
    step-function increases in performance
  • US cephalosporin generics from 2005-06
  • US betalactam generics from 2007-08
  • EU Ceph betalactam generics from 2007-08
  • US / EU NPNC generics from 2007-08
  • US/ EU penem generics from 2008-09
  • Promising drug discovery pipeline covering
    anti-diabetes, anti-obesity, anti-inflammation,
    anti-cancer and anti-infective therapeutic areas
    (not factored in the business projections)
  • Attractive PE multiples and low price / cash
    earnings multiples

35
THANK YOU
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