CONFIDENTIAL - PowerPoint PPT Presentation

1 / 61
About This Presentation
Title:

CONFIDENTIAL

Description:

... received from US FDA for Cephalexin API and Cefazolin sterile API; Australian ... Cephalexin capsules and Ceftriaxone Inj. ; more expected ... – PowerPoint PPT presentation

Number of Views:602
Avg rating:3.0/5.0
Slides: 62
Provided by: ram59
Category:

less

Transcript and Presenter's Notes

Title: CONFIDENTIAL


1
CONFIDENTIAL
A presentation on
August 9, 2005
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.

3
Contents
Pharmaceutical Industry Orchid - An
introduction Initiatives Undertaken Growth
drivers Generics Drug Discovery Financials Miss
ion 2010 Value Proposition
?
?
?
?
?
?
?
4
Pharmaceutical Industry
5
Global Pharmaceutical Market
  • Size of global pharmaceutical industry is
    estimated to be USD 518 billion (2004) and is
    expected to grow significantly by 2005
  • Industry growth rate 7 to 9 during the last
    five years.
  • North America is the largest and the fastest
    growing market in the world (USD 248 billion in
    size and has grown by 7.8 during 2004)

Source IMS Global Health
6
Global Anti-infectives Market
  • Global anti-infectives constitute a large market
    in terms of both revenue and prescription volume
    - USD 30 bio
  • The anti-infectives market is poised to grow to
    USD 38 billion by 2006 at a CAGR of 3-5
  • Cephalosporins and combinations represent the
    largest segment (USD 9.65 billion) of the
    anti-infectives market
  • Cephalosporins are effective against both gram
    positive and gram negative bacteria with a wide
    spectrum of activity
  • There are over 60 Cephalosporins, spanning first
    to fourth generation, with diversified
    therapeutic activity newer cephalosporins are
    under pre-clinical and clinical trials
  • Regulated markets constitute 66 of the retail
    cephalosporin demand, which offers a major
    opportunity for Orchid

Global anti-infectives market
Global Cephalosporins market
7
Trends in Global Pharmaceutical Industry
  • Growing importance of generics
  • Generics will be a fast-growing segment in
    regulated markets
  • With USD 10 billion (retail) worth of drugs going
    off-patent each year on average, generics
    represent a major opportunity for India
  • High quality, cost-competitive API and
    formulations are vital for growth of generics
    industry
  • Managed healthcare driving down healthcare costs,
    boosting generics
  • Increasing need for new drug pipeline
  • Big pharma companies under great pressure to
    enhance NCE pipeline
  • Focus on extending patent life through novel drug
    delivery systems and therapeutic switch
  • Major potential to select Indian firms to support
    drug discovery
  • Consequent structural changes
  • Generics outsourcing
  • RD outsourcing

8
Orchid - An introduction
9
Orchid
Is a first generation enterprise which has carved
out for itself a niche in global anti-infectives
markets in a short span of time and... Is
evolving rapidly into a composite pharmaceutical
major with presence in bulk drugs, formulations
and drug discovery
10
Orchid - An Introduction
  • Orchid was incorporated in 1992 as a 100 Export
    Oriented Unit (EOU)
  • Promoted by Mr. K Raghavendra Rao, (Founder-
    MD), a first generation entrepreneur with
    hands-on experience in conceptualising and
    commercialising large pharmaceutical and other
    projects.
  • Commenced operations in February 1994 with
    manufacture of bulk cephalosporins (Cephs) range
    of antibiotics from its manufacturing facility at
    Alathur, near Chennai, Tamil Nadu.
  • Evolved rapidly into an integrated life sciences
    company with a strong presence in
  • Active Pharmaceutical Ingredients (APIs)
  • Formulations
  • New Drug Discovery (NDD)
  • Novel Drug Delivery Systems (NDDS)
  • Company employs over 2600 people across plants,
    research centre, field and offices.
  • Revenues of USD 160 million

API facilities at Alathur and Aurangabad
Formulations facilities at Alathur and
Irungattukottai RD Centre at Sholinganallur Pharm
a Research Centre at Irungattukottai
Joint ventures in China and US
11
Orchid - Capital Structure
FCCB subscribed in May 2001, converted in
November 2002
12
Shareholding Pattern
As on July 18, 2005
Shares listed on NSE, BSE and MSE
13
(No Transcript)
14
Orchid - An established name in the Indian
pharmaceutical industry
  • USD 160 million, Chennai-based pharma major in
    India
  • Leader in the global cephalosporins segment
  • Largest manufacturer-exporter of Ceph APIs in
    India
  • Among the Top Five Ceph manufacturers in the
    world
  • Fifth largest exporter of pharmaceutical products
    in India
  • Ranks among the Top 10 Indian pharma companies
    and Top 11 pharma companies (Indian and MNC) in
    terms of Sales

15
Orchid - Regulatory Approvals / Certifications
  • Approval received from US FDA for Cephalexin API
    and Cefazolin sterile API Australian TGA
    approval for entire range of Cephs (APIs) and
    Nutraceuticals (APIs and Formulations)
  • Orchids Generic facility has undergone
    successful inspection by US FDA without any 483
    observations. 9 ANDAs were taken for inspection
    Approvals received for Cefazolin Na Inj.,
    Cephalexin capsules and Ceftriaxone Inj. more
    expected
  • Certificates for Suitability (CoS) from EDQM for
    select products (9 so far)
  • Certifications ISO 9001 2000
  • ISO 14001
  • ISO 14001 and OHSAS 18001 for
    Aurangabad
  • Orchid pioneered zero discharge pharmaceutical
    manufacturing in India Invested over Rs 500
    million in effluent treatment plant at Alathur,
    National show-case in environment friendliness

16
A skilled employee base supports competencies
across all locations
17
Initiatives Undertaken
18
Our strategy, developed in consultation with
McKinsey, is to grow the business in multiple
horizons
In each of the Horizons, Orchid has taken
specific growth initiatives, both organic and
inorganic, under a major investment plan which
integrated Schroders and IFC investments,
internal generations and borrowings
19
Orchids select facilities (1/2)
API plant - Alathur
API plant - Aurangabad
Orchid Towers
Non-sterile API plant
Sterile API plant
20
Orchids select facilities (2/2)
Generics facility- Rear view
Generics facility Front view
Non-ceph formulations facility
Ceph formulations facility
21
Organic and inorganic growth
22
Growth Drivers Generics Drug Discovery
23
Business Model
  • Orchid business covers (domestic exports)
  • API
  • Formulations
  • Orchid has strong growth drivers
  • Generics (Cephs, betalactums and others US
    Europe)
  • New Drug Discovery (NDD)
  • Novel Drug Delivery Systems (NDDS)
  • Orchid has end-to-end execution capability
  • API
  • Formulations
  • Research

24
Orchid has a unique position in the antibiotic
generics space
  • The cephalosporin and high-end betalactum
    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

25
For Orchid, the chosen core antibiotic generics
field offers significant advantages in the
immediate and near term
26
Orchids near term generics opportunity 2005-2008
  • The generics market space (including US, Europe,
    Canada and Japan) for Cephalosporins and high-end
    betalactums is estimated at USD 7 billion
  • Of this, the US constitutes the single largest
    market (USD 3.2 billion)
  • Orchid is tapping this huge US anti-infectives
    generics market space on priority, followed by
    the European opportunity
  • Orchid will achieve a broad-based presence in
    this market with a significant share in this
    space, with specific block-buster and niche
    products

27
Orchid has several USPs in its core antibiotic
generics field, over and above the inherent
advantages of the field enumerated earlier
  • Comprehensive range of 16 oral and sterile
    cephalosporins, in 33 dosage forms and 85 dosage
    strengths, unmatched by any other player in the
    US generics space
  • Complete therapeutic range covering first to
    fourth generation cephalosporins and life-saving
    betalactums
  • Maximum number of 19 ANDA (and 18 DMFs) filings
    already made, coverage of the balance ANDAs (and
    DMFs) this fiscal
  • Three ANDA approvals (Cefazolin and Ceftriaxone
    injections and Cephalexin capsules) received,
    several others in pipeline
  • End-to-end product development, manufacturing and
    regulatory capabilities, covering both API and
    dosage forms
  • State-of-the-art, US FDA approved generics dosage
    form plants and API facilities
  • Distribution partnerships with top ranking
    generics companies, Apotex and Par

28
Key Products offer major opportunity in the US
Veterinary product yet to be genericised
29
Potential revenues from US antibiotics generics
  • Orchid expects a turnover of USD 20 million from
    the US foray in 2005-06 from H2
  • A doubling of regulated generics turnover is
    anticipated from 2006-07 onwards
  • Regulated generics would offer robust
    profitability of at least 50 as trended from key
    launches and current indications

30
Track record of rapid regulatory filings in the
cephalosporin space
  • US Generics entry is supported by 18 US DMFs and
    19 ANDAs, already filed with the USFDA
  • Plans for 2005 target a further increase in DMF /
    ANDA filings
  • EU DMFs including 10 CoS applications filed few
    more in the pipeline
  • MA dossier activity for EU generics gathering
    momentum in parallel

31
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

32
Orchids Process and Discovery infrastructure
New Drug Discovery Complex
RD Centre at Sholinganallur, Chennai
Pre-clinical facility
33
Orchids end-to-end business model for drug
discovery
Orchid has complete in-house capabilities for
drug discovery and development from structure
design to drug screening in animal models human
clinicals are outsourced to CROs
34
Orchid-Bexel drug discovery pipeline
35
About BLX-1002
  • Novel orally active small molecule, developed by
    our US drug discovery JV, Bexel Pharmaceuticals
    (now a 74 Orchid subsidiary)
  • 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
  • Successfully completed human clinical (safety,
    tolerability proof of efficacy) studies in
    Europe
  • Outlicensing deals being discussed with MNCs

36
In research and other knowledge intensive areas,
long term IPR value is built
Orchids cumulative patent filing count is 255
Patent filings as of June 2005
37
Financials
38
Orchid FY 2004-05 vs FY 2003-04
Rs Mn
39
Orchids Q1 performance 2005-06 vs 2004-05
Rs Mn
40
Orchids recent performance 2004-05 vs 2003-04
and Q1 of 2005-06 vs Q1 of 2004-05
  • Orchids revenues were maintained with higher
    profitability, despite continued competitive
    conditions in the unregulated markets
  • Profitability has been robust in FY 05 and in Q1
    of FY 06 as summarised below (on a respective
    basis)
  • EBIDTA has grown by 8.4 and 23.1
  • EBIDTA margin is higher at 24.1 and 26.9
  • Cash profit margins were higher at 13.1 and
    14.2
  • Improved profitability has been achieved through
  • higher proportion of sale to regulated markets
  • a higher value added product mix
  • plant related process efficiencies/yield
    improvements
  • RM price reduction of key inputs Pen-G 7-ADCA
  • Entry into regulated generics from Q2 of FY 06
    will have a major positive impact on future
    financials

41
Orchids penetration into the regulated markets
of US and EU has been notable
42
Key highlights of regulated markets
  • Orchids revenues from the regulated markets has
    grown by 29.3 to Rs 1638.9 Mn, mainly due to
    higher revenues from the US EU markets
  • N.American market revenues had grown by 147 to
    Rs 595.9 Mn, driven by Cephalexin and Cefazolin
    API sales
  • EU market revenues had grown by 16 to Rs 1022.1
    Mn, based on a large product portfolio
  • Orchids regulated market share on total revenues
    has gone up to 24.2 in FY 04-05 from 18.3 in FY
    03-04

43
Orchid is also diversifying the product portfolio
Rs Mn
44
Mission 2010
45
Mission 2010
Become a USD 1 Billion Company by 2010-11
46
Nine business drivers to achieve Mission 2010
  • Consolidate base business model
    (APIFormulations)
  • Fulfill North American CefTazo-Pip generics
    opportunity
  • Extend into EU with CefTazo-Pip generics
  • Enter Japan with CefTazo-Pip API
  • Implement NPNC regulated market business model
  • Expand formulations business in Less Regulated
    Markets
  • Consolidate miscellaneous initiatives (NPNC
    non-reg. etc)
  • Diversify anti-infectives business with penems
    and penicillins
  • Capture out-licensing value from NDD and NDDS

47
Integrating multiple initiatives, Orchid plans
achieve a turnover of USD 1.0 Bn by 2010-11
All figures within the boxes are in USD Mn
48
A snap-shot of the key product and business
growth drivers (2005-10)
49
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 92 Bio and US 191 Bio
    in the US EU.
  • As of date supply agreements have been executed
    with 3 prominent players viz Alpharma, Stada
    Par in the US EU generic space
  • The agreements cover 20 molecules that address a
    current retail opportunity of USD 25 Bio.
  • Would diversify therapeutic portfolio and provide
    continuous product pipe-line
  • Some of the molecules would provide Para-IV /
    first-to-file opportunities
  • New RD labs and API facility for NPNC
    commissioned. Formulations facility under
    advanced execution

50
New facilities
Non-antibiotic API Plant - Aurangabad
Non-antibiotic Formulations Plant - Chennai
Betalactum Plant - Chennai
Pharma RD complex - Chennai
51
Orchids distribution strategy for regulated
markets (ceph and non-ceph)
  • Unique in Indian pharma for its broad-spectrum
    product coverage and beneficial terms
  • Covers 36 products in 76 dosage forms and 178
    dosage strengths
  • Alliances with top-ranking generic-players, known
    for robust market presence more selective
    alliances likely
  • Enables Orchid focus investments and attention on
    technology and product development
    manufacture

52
Overview of Orchids generics contracts
Additional individual filings for Mexico,
Canada and Europe (not quantified here) are
required,as the case may be
53
Highlights of Orchids distribution contracts
  • All ANDAs will be developed and owned by Orchid
  • Manufacture would be 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
    favourable profit share arrangement
  • Exclusivity subject to performance
  • In addition, the partners would pay Orchid for
    ANDA related developmental costs - part upfront
    and the balance based on achievement of certain
    regulatory / launch milestones
  • Flexibility to supply API to third parties

54
Orchids transition from un-regulated to
regulated markets FY 1995 to FY 2011
55
The Mission 2010 business model is reinforced by
several positives
  • The model is robust with success and the right
    traction in all key components
  • Track record of performance in the regulated
    cephalosporins arena 18 US DMFs and 19 ANDAs in
    a short time and several more in clear visibility
  • Complete gamut of API, formulations and drug
    discovery facilities, with requisite
    certifications and approvals
  • A comprehensive list of NPNC generic products
    which has met the due diligence of established
    generic players
  • Notable successes in firming up three major NPNC
    development and marketing arrangements for the US
    and EU.
  • Fast progress in NPNC API and formulation
    development
  • A high level of organizational awareness on the
    path forward, activities and milestones

56

Value Proposition
57
(No Transcript)
58
Orchids business model offers major partnership
benefits to a global pharmaco
  • Capabilities and strengths of an integrated
    pharmaceutical major
  • A complete in-house, end-to-end connected
    infrastructure, and a complete portfolio of
    services covering
  • Active pharmaceutical ingredients / Intermediates
  • Generic formulations
  • Drug discovery
  • In the 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

59
Some key positives (1/2)
  • Orchid is well positioned as a fully integrated
    life sciences company
  • Orchid operates in the global pharmaceutical
    industry and has the necessary world-class
    infrastructure that meets the global regulatory
    requirements, including US FDA
  • Global pharma provides Orchid an opportunity
    (generics and outsourcing of manufacturing and
    basic research), which will substantially boost
    the revenue and profit performance of the Company

60
Some key positives (2/2)
  • Combined with Orchids proven management
    capabilities, the Company is well poised to
    become a significant player in the global
    markets
  • Orchids business model is robust and is set to
    achieve quantum increases in performance with US
    ceph generics entry from 2005-06, and with US/EU
    NPNC generics entry from 2007-08
  • Amongst the lowest price / cash earnings
    multiples among comparables in the industry,
    providing high potential

61
THANK YOU
Write a Comment
User Comments (0)
About PowerShow.com