Title: CONFIDENTIAL
1CONFIDENTIAL
A presentation on
August 9, 2005
2Disclaimer
- 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.
3Contents
Pharmaceutical Industry Orchid - An
introduction Initiatives Undertaken Growth
drivers Generics Drug Discovery Financials Miss
ion 2010 Value Proposition
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4Pharmaceutical Industry
5Global 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
6Global 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
7Trends 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
8Orchid - An introduction
9Orchid
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
10Orchid - 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
11Orchid - Capital Structure
FCCB subscribed in May 2001, converted in
November 2002
12Shareholding Pattern
As on July 18, 2005
Shares listed on NSE, BSE and MSE
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14Orchid - 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
15Orchid - 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
16A skilled employee base supports competencies
across all locations
17Initiatives Undertaken
18Our 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
19Orchids select facilities (1/2)
API plant - Alathur
API plant - Aurangabad
Orchid Towers
Non-sterile API plant
Sterile API plant
20Orchids select facilities (2/2)
Generics facility- Rear view
Generics facility Front view
Non-ceph formulations facility
Ceph formulations facility
21Organic and inorganic growth
22Growth Drivers Generics Drug Discovery
23Business 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
24Orchid 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
25For Orchid, the chosen core antibiotic generics
field offers significant advantages in the
immediate and near term
26Orchids 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
27Orchid 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
28Key Products offer major opportunity in the US
Veterinary product yet to be genericised
29Potential 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
30Track 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
31The 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
32Orchids Process and Discovery infrastructure
New Drug Discovery Complex
RD Centre at Sholinganallur, Chennai
Pre-clinical facility
33Orchids 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
34Orchid-Bexel drug discovery pipeline
35About 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
36In 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
37Financials
38Orchid FY 2004-05 vs FY 2003-04
Rs Mn
39Orchids Q1 performance 2005-06 vs 2004-05
Rs Mn
40Orchids 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
41Orchids penetration into the regulated markets
of US and EU has been notable
42Key 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
43Orchid is also diversifying the product portfolio
Rs Mn
44Mission 2010
45Mission 2010
Become a USD 1 Billion Company by 2010-11
46Nine 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
47Integrating multiple initiatives, Orchid plans
achieve a turnover of USD 1.0 Bn by 2010-11
All figures within the boxes are in USD Mn
48A snap-shot of the key product and business
growth drivers (2005-10)
49NPNC 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
50New facilities
Non-antibiotic API Plant - Aurangabad
Non-antibiotic Formulations Plant - Chennai
Betalactum Plant - Chennai
Pharma RD complex - Chennai
51Orchids 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
52Overview of Orchids generics contracts
Additional individual filings for Mexico,
Canada and Europe (not quantified here) are
required,as the case may be
53Highlights 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
54Orchids transition from un-regulated to
regulated markets FY 1995 to FY 2011
55The 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
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58Orchids 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
59Some 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
60Some 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
61THANK YOU