Post on 25-Dec-2015
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DSP MERILL LYNCH INDIA ROADSHOWNovember 2007
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FINANCIALS
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9 Months Review
• Revenue 30%
• EBITDA 15%
• PAT 58%
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Head Line Revenue Statement
9 Months 2006 12 Months 2006 9 Months 2007 Change %
Revenue 108.86 170.83 142.10 31%
COGS 44.77 75.85 57.76 29%
GM 64.09 94.98 84.34 32%
Net Operating Expenses 44.59 63.30 61.85 39%
EBITDA 19.50 31.68 22.50 15%
Amortization 5.52 7.55 7.55 37%
Net Interest Cost 5.95 9.17 11.43 92%
Profit Before Tax 8.03 14.95 3.52 -56%
Tax 1.51 3.91 1.31 -13%
Profit After Tax 6.52 11.05 2.20 -66%
LESS: Minority Int. 0.75 2.01 -0.24 -132%
Profit After Min. Int. 5.78 9.03 2.44 -58%
US$ Mn
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Factors for Consideration
• US operations due to regulatory changes - ‘bleeding’ at approx US$ 8 mn / year
• Board Committee will announce its decision in Q4 - a permanent solution is expected.
• Sharp Rupee appreciation of 11% in 6 months has affected profitability significantly - all contracts for 2008 are being corrected to incorporate exchange fluctuation clauses.
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• Sterile injectable investments of US$110 mn (commenced in 2006) will start yielding revenue in 2008 with full effect in 2009 – investments in Steriles prior to 2006, US$ 30 mn
• Acquisition costs in 2006 & 2007 will partially yield results in 2008 and will have effect in 2009.
• Human Resources costs have gone up 24 % this include investing in an organization that is ready to execute for an upswing of growth opportunities.
Contd,,,,
Factors for Consideration
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Consolidated Abridged Balance SheetUS$ Mn Year ended Dec 2006
(12 months)Period ended Sept 2007
(9 months)
Assets
Non-current assets
Tangible fixed assets 139.05 186.29
Goodwill 42.58 126.69
Intangible fixed assets 7.27 6.95
Financial assets 0.38 0.53
Deferred tax assets - -
Current assets 109.51 136.72
Cash 9.42 40.31
308.21 497.49
Equity & Liabilities
Shareholders’ equity 73.72 70.94
Preference shares – liability 12.35 12.35
Long term interest bearing debt 106.61 174.89
Other non-current liabilities 22.14 104.98
Short term interest bearing debt 32.02 48.20
Deferred tax liabilities 4.93 5.22
Current liabilities 56.44 80.91
308.21 497.49
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Stake Holders Distribution
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DOMAIN - STERILES
STRATEGY
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Strides has the largest steriles business in India which has witnessed strong growth over the last couple of years
Segment delivers 35% EBITDA
The business has a global manufacturing footprint Three facilities in India: Catering to the US, LATAM, Australia,
South Africa & Europe One in Poland : (acquired last year facility to build additional
capacities) and one in Brazil (Plant recently completed) Also building additional capacities in Brazil and India over the next
2 years..
The business manufactures entire range of Steriles Dry Powder / Freeze Dried Vials (separate facility for
Cephalosporins, Penems, non-Penicillin and Non-Cephalosporins) Ampoules Liquid Vials Pre-filled syringes
The business is strongly positioned in Anti-biotic, Anti-bacterial, Cephalosporins, Steroids and Penem segments
Over the next two years it would create a presence in the Oncology segment
The business has a strong product pipeline with growing ANDA filings – 22 filings in 2006, 10 filings & 25 exhibit batches in 2007
in 2007 Strides has entered into Joint Ventures and has exclusive product partnerships in US, Spain, Portugal, Turkey and Norway
First proprietary product licensed to Big Pharma One NDDS drug filing expected in 2009 – post clinicals
OverviewOverview
To become among the largest manufacturers of Steriles globally in the next two years with over 1.5 million sterile units capacity per day.
Consolidate manufacturing capacity and capability across the globe
Manufacturing presence already in key markets Europe (Poland), Asia (India) and LATAM (Brazil)
Grow market reach across geographies Roll out value – partnerships
Consolidate presence across therapeutic areas Penicillins, Cephalosporins, Antibiotics,
Oncology & Steroids
StrategyStrategy
Steriles - Overview
Total Capex USD 110 mio in 2006/2007/mid 2008
Steriles10
Market Strategy
Grow presence across markets i.e. US, European Union, Australia and South Africa through key accounts and Joint Ventures.
Market strategy includes
Expand product portfolio Strides has a strong sterile portfolio for the Global Markets Sterile products are under development to keep ready a portfolio of its own or to license
at a later stage (mainly Onco) Mainly Niche products (lyophilized) - few players
Build value partnerships Strides has built partnerships through joint ventures, bringing products into the markets
with funding from the joint venture Also entered into an agreement with Big Pharma for a new Multivitamin – lyophilized
vial to be distributed in hospitals worldwide Strides retains rights for US – first proprietary product
Acquired a Marketing Authorization for Vancomycin in Europe (Italy & Netherlands) Filed Piptaz dossier in Europe, Canada, Australia, S. Africa (Latin America) & USA
Steriles11
Global Sales – Steriles
2005 2006 2007 (9 months)
SALES EBITDA SALES EBITDA SALES EBITDA
Steriles 19.29 38% 44.07 35% 31.73 35%
US$ Mn
Steriles12
DOMAIN – SGC’S
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Soft gel industry has application in the following areas:1. Health Food & Nutritionals 2. OTC3. Rx & 4. Paint ball business
The entire industry works on the Contract Manufacturing model including the Rx products. However, except for the Rx products intense competition prevails in all other segments due to lack of regulatory requirements in most of the countries to sell OTC’s & Nutraceuticals including the US
There are under 30 prescription drugs commercialized as softgel for a global value of about US$ 3 bio (not including branded OTC). Contract Manufacturing services for this sector is mainly controlled by Cardinal through their PCS division (recently acquired by Blackstone for US$ 3.2 bio)
Cardinal used to leverage its strong connectivity with brand Companies due to its strong distribution arrangement with these Companies. As a consequence, new soft gel introduction and Contract Manufacturing predominantly stays with Cardinal. This business although not reported separately has sales of US$ 385 mio with the EBITDA in excess of US$ 150 mio.
Focusing on the Nutritionals and simultaneously focusing on Rx products has resulted in serious FDA issues including warning letters for all key players in USA
Scenario is slightly different in other countries with more and more countries including Australia, Germany & Scandinavian Countries seeking regulatory approvals for Nutritional products. We see this as an emerging opportunity and we also expect the US to follow these guidelines.
As there are very few players in this business this is a significant opportunity for an established player to offer full services
SGC’s Overview
SGC14
Overview
To become a full service provider for the Rx Niche business. Have all Rx products generics equivalent
Grow market reach in Niche Nutritionals & OTCs
Create a strong product portfolio of Patent drugs & Off Patent drugs
Strides is the 5th largest SGC player by capacity
Strong manufacturing footprint
Full service provider including strong R&D
Very few players
Alternative Gelatin (plant based)being tested
Has a strong product pipeline (mostproducts do not have a generic equivalent)
Has many capabilities in softgels in nicheareas including Onco & Hormones.
Strategy
SGC15
Market Strategya. Competitive offering of Nutraceuticals Ex India
Range of value added Nutraceuticals including plant extract based products that require high degree of control on species input materials and finished product
Eg: Saw Palmetto; Plant Phospholipid & Vitamin; Gingko Biloba; Glucosamine’s & Chondroitin; Garcinia; CO-Q-10;Omega 3-6-9
Complex multi ingredient products such as MVT capsules for various medications
Offers full service (including shelf-ready packing) to store brands
Competitive and stable pricing capability through
a. Long term purchase contracts of key materials
b. Backward integration farm to pharmacy
SGC16
Category Products
Cough / cold & flu relief Day time & Night time soft gels with Phenylephrine Pseudoephedrine
Inflammation / pain relief Ibuprofen, Paracetamol, Naproxen Sodium
Sleep Aid Diphenhydramine
GI Simethicone; Docusate Sodium
Allergy Loratadine, Cetrizine, Fexafenadine
b. Expand OTCs Pipeline Dose conversion opportunity of tablets to softgels to
a. circumvent process patent on tablets b. offer convenience c. Rx to OTC switches
Use proprietary low extraction technology in soft gels to prevent misuse of products like Pseudoephedrine, Temazepam, etc.
National Brand Equivalence (NBE!) of key branded OTC’s in US especially products already developed and under licensing to partners
Partnering with innovator companies on line extension and lifestyle extension opportunities through conversion to softgels
Partnered with a top five pharma companies in life cycle extension project
Market Strategy
SGC17
2005 2006 2007 (Est.)
SALES EBITDA SALES EBITDA SALES EBITDA
India 4.75 13% 8.60 21% 9.50 18%
USA 16.25 4% 10.52 -37% 4.77 -105%
Total SGC
21.00 6% 19.00 -9% 14.00 -27%
US$ Mn
Global Sales – SGC
SGC18
Domain – ODF (other than SGC)
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ODF
Strides Overview of the ODF Business
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This business could be broadly divided into the following segments:
• Regulated Markets (ANZ, RSA, Japan, EU, N. America)• Strong Presence in ANZ• New Opportunities in RSA• Early foray into Japan has brought in learnings• Growing presence in EU can enlarge with Co-pharma partnership• Transnational outsourcing deals in negotiation will see huge growth
• Semi Regulated Markets (Latin America)• Presence largely through local manufacturing supported by high end product
pipeline from India• Local facilities running out of capacities
• ROW (Africa, Russia, ATM, Asia Pacific)• Current presence in Africa will get a boost with local manufacturing to
commence in Lagos in Q4 2007 – for validation. • Russia – we are focused on minimal opportunities. We are in discussions with a
local partner to enhance this relationship.
ODF
ODF Business Strategy
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• ATM • An excellent partnership in Anti TB with Sandoz• Strong growth experienced in TB product lines. With our own dossiers
getting ready, 2008 should see improved margins• Increased growth is expected in HIV as global purchasing picks up• Anti Malaria initiatives will see results in 2008. Strides is strategically
positioned with back end tie ups upto contract farming stage.
• Summary • ODF’s, Semisolids contribute about 50% of revenue.• Plants in India, Italy, Mexico, Nigeria gearing up to expand and handle the
increasing opportunities
ODF
ODF Business Strategy
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2005 2006 2007 (Est.)
SALES EBITDA SALES EBITDA SALES EBITDA
Regulated Markets
12 24% 15 26% 25 23%
ATM 11 26% 19 13% 17 6%
Others 48 23% 62 15% 59 9%
TOTAL 71 24% 96 17% 101 12%
US$ MnGlobal Sales – ODF
ODF
• Regulated Markets 2008 60% growth
• Exiting / Downsizing ATM / others to improve Margin Businesses
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Building Brands
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• Strides through acquisitions in 2006 commenced branded operations in India and Asia Region.
• Strides acquired a leading branded Company - Drug Houses of
Australia (Asia) Private Limited (DHA) in Singapore and also acquired Grandix Laboratories in India to commence an Indian branded operation.
• These two acquisitions enabled the Company to leverage its branded strategy.
• The branded business now constitutes over 10% of the Company’s sale and is expected to grow rapidly in the coming years.
Emerging Domain LeadershipBuilding Brands
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2006 2007
Sales EBITDA Sales EBITDA
Grandix --- --- 8.49* 25%
DHA 2.39** 25% 10.79 28%
Total 2.39 25% 19.28 27%
* 7 months ** 3 months
US$ Mn
Branded Sales
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• Strides has a differentiated Regional Leadership strategy focusing on the southern hemisphere (including Latin Africa, Asia & Australia) & Europe. The company believes in building regional leaderships organically and inorganically. The principle objective is to maximize front-end operations for its domains in Steriles and Softgels and the emerging domains of brands to grow the business.
• The company also believes in working with local partners, local management and building plans to leverage regional opportunities.
• It further believes in partnering with Companies that are strong, capable of brand building through financial partners or in licensing agreements in these regions.
Regional Leadership - Philosophy
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Latin America
• Strides is India’s largest Latin American player having its presence in the hospital and social security business mainly in Brazil, Mexico and Venezuela, with 2 manufacturing plants in Brazil and one in Mexico city.
• Strides is an integrated regional player in the market with a solid product pipeline. Strides has achieved significant success in these markets.
Regional Leadership
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Latin America - Highlights
No.2 hospital player in Brazil
Over 100 product registrations
Over 100 sales representatives in the field, in sales & marketing
Strong OTC presence in Brazil - Alcachofra is a No.1 OTC brand in segment.
Will launch Brand Business in 2008 H2.
Regional Leadership
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Africa
• A traditional market for Strides. The Strides operation has strong presence in West and French Africa with strong OTC & branded business
• A new manufacturing facility in Lagos, Nigeria has recently been validated and will commence production in Q1 2008, to meet local opportunities.
Regional Leadership
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Asia
• A new initiative in Asia is to build a Branded Generic Business in key Asian Markets, where growth is double the Industry’s growth.
• The acquisition of DHA & significant relationships in Malaysia and Hong Kong makes Asia a key future market for Strides..
Regional Leadership
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Europe & Middle East (EME)
• Strides operates the European territory with a mix of Regional and Corporate strategy.
• The 2 manufacturing plants located in Italy and Poland offer significant manufacturing capability for the group in sterile injectables in Poland and Fermentation & Semi-solids in Italy.
• Strides has entered into supply agreements with large EU players for some key markets of Europe – Spain, Portugal & Nordic
• Strides operates through its JV’s with Invent Pharma in Spain, and Abdi Ibrahim for the Turkish and Middle East markets
Regional Leadership
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2005 2006 2007 (Est.)
Latam 54 80 71
Africa 12 14 17
Europe 2 11 19
N. America (US & Canada)
21 18 8
Asia 2 4 14
India 2 2 10
ROW & Others 26 40 54
Total 119 171 193
US$ Mn
Regional Landscape
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Segmental EBITDA Margins
2006 (A)2007 (B)
9 Months
Steriles 35 % 35 %
SGC - Including USA
-9 % -27 %
SGC - Excluding USA
21 % 18 %
ODF & Others 17 % 12 %
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MANUFACTURING INFRASTRUCTURE
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Non Penicillin / Non Cephalosporins Cephalosporins Beta lactam Penems Oncology
Location Bangalore, India Bangalore, India Poland Bangalore, India Brazil (New) Bangalore, India Brazil Bangalore, India
Products • Sterile Liquid Vials• Sterile Dry Powder
Vials• Lyophilisation• Pre-filled Syringes• Ampoules
• Sterile Liquid Vials• Sterile Dry Powder
Vials• Lyophilisation• Pre-Filled Syringes• Ampoules
• Ampoules• Lyophilisation• Liquid Vials
• Dry Powder Vials • Dry Powder Vials • Dry Powder Vials • Dry Powder Vials • Sterile Liquid Vials• Sterile Dry Powder
vials - Lyophilisation
• Pre-filled syringes
Status • Set up in 1996• Refurbished 2004
• Commissioning in Q4 2008
• Acquired in 2006• Expansion into
Lyophilised Vials• Liquid vials in
2008
• Setup in 2006 • Ready Dec 2007 • Setup in 1999 • Ready Dec 2007 • Commissioning Q1 2008
Capacity • 170,000 units/day • 400,000 units/day • 200,000 units per day (two shifts)
• 170,000 units/day • 140,000 units/day (Single Shift)
• 125,000 units/day • 70,000 units/day (Single shift)
• 25000 units/day
Reg. Status • PIC, TGA, Health Canada, ANVISA, MHRA approved, USFDA (expected to inspect in Q1 2007)
• GSK, Novartis, Wyeth have inspected the facilities
• USFDA/EU approvable facility
• EU approved• USFDA to be
invited for inspection
• PIC, TGA &, ANVISA)
• ANVISA in Q1 2008 and TGA / MCC after that
• PIC, TGA, Health Canada, ANVISA, UNICEF, EU
• ANVISA in Q1 2008 including USFDA and TGA / MCC after that
• USFDA / EU approvable facility
FACILITIES
Diverse range including Penicillin, Cephalosporin, Penems, Hormones and Oncology
(1) New Site (2) Lyo site will be ready end 2007 with 4 mio
annual capacity
Manufacturing – Global Scale
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LocationJigni,
Bangalore, India
Bilekahalli, Bangalore,
India
Bangalore, India (New)
Hosur, India
Jurong, Singapore
MilanItaly
TolucaMexico
Vittoria Brazil
Lagos Nigeria
Campos Brazil
Products• Rx• OTCs
• Rx • Rx• OTC
• Rx• OTC• Nutraceuticals
• Rx • OTC• Nutraceuticals
• Rx • OTC
• Rx • OTC
• Rx • OTC
• Rx • OTC
• Rx
Dosages
• Tablets• Capsules
Powders• Dedicated
Anti TB facility
• Dedicated Betalactum capsules
• Dedicated Oncology Capsules & Tablets
• Tablets • Tablets• Capsules• Creams• Liquids
• Creams• Ointments• Liquids
• Tablets• Capsules
• Tablets• Ointments
• Tablets• Capsules• Ointments
• Tablets• Capsules• Oral drug
Status
• Set up in 1998
• Expanded 2006
• Set up in 2000 • Commissioning in Q4 2008
• Acquired in 2000
• Acquired in October 2006
• Acquired in July 2005
• Set up in 2000
• Acquired in 2002
• Commissioning in H2 2007
• Commissioning of HGC in Dec 2008 & other by mid 2008
Capacity Per Annum
•Tablets • 2200 mio - • 210 mio • 1500 mio • 300 mio - • 165 mio • 120 mio • 720 mio -
• Capsules
• SGC 2300 mio
• HGC 450 mio
• HGC 350 mio • 200 mio - • 300 mio - • HGC 44 mio
- • 180 mio • 120 mio
• Powders• 26.0 mio
sachets- - - - - - - - -
• Liquids - - - - • 1.2 mio liters • 3.45 mio - - - -
• Creams & Ointments
- - - - • 1.2 mio liters • 24.37 mio - • 5 mio • 0.45 mio -
Reg. Status
• EU• TGA• MCC• ANVISA
approved
• TGA• UK MHRA• WHO GMP• MCC,
ANVISA approved
• USFDA approvable facility Expected readiness H2 2008
• WHO GMP• Being upgraded
for MCC & RSA
• PIC approved • EU approved • MOH, Mexico approved
• ANVISA approved
• NAFDAC• WHO
approved
• ANVISA approved
Manufacturing Global Scale (ODF’s & Semisolids)
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Location
Vittoria Brazil
(Penems & Penicillins)
PolandIndia
(Oncology)India
(SPD– II)
Total Capex 15.5 16.5 40.0 38.0
Formats
• Penems, Injectibles
• Penicillins (Orals & injections)
• Dedicated Anti TB facility
• Liquid Vials• Lyophilisation• Pre filled
Syringes
• Liquid Vials• Lyophilised
Injections• Orals• Pre filled
Syringes
• Liquid Injections
• Dry Powder fills
• Lyophilised Injections
Commercial Mfg. date
• Dec 2007 • Phase I – Apr 2008• Phase II – Sept 2008
• March 2008 • October 2008
CAPEX
• USD 110 mio capex for new Sterile facilities nearing completion
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TECHNICAL INFRASTRUCTURE
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R & D
• Strides Technology & Research: Central HUB
• Based in Bangalore & products Tech. Transferred to regions
• Infrastructure for Clinical supplies, Process Development & Scale-up activities
• Analytical Services Labs
• HVAC systems & containment stations available for handling high potency compounds.
• Scientific pool of over 300 Scientists
• Retention programs
• Training for skills upgradation
• Regulatory Affairs Management aligned to target market needs
• Key Enablers:
• Strategic Sourcing, Quality Management System (design), IP Cell & Clinical Affairs Management
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Pipeline
• Steriles• A Strong pipeline of Sterile products over 100 – with 12
pending filings expected by end 2007 from FDA & 30 submissions in 2008.
• Niche products in Lyo Injectables
• Niche oral products like Vancomycin capsules and a whole range of Immunosuppressants
• Softgels• Alternative gelatin – differentiation to OTC strategy
• Non Extraction technologies – Drugs of Abuse
• Hormonal range (First generic)
• Sustained Release (NDA)
• Key generic products filed as ANDA’s
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Market StrategyCreate a complete range of Rx SGCs
Pipeline Current Market Size
Exp. To Mkt
Patent - US
PlayersUS
ANDA Readines
s
Development Strategy
Licensing Status
Benzonatate 100mg, 200mg
US-$45 MEU-$ 0.0 MROW-$14 M
2008 None 20 ANDA Filed US-AA Filing Under discussion
Calcitriol 0.25mcg;0.5mcg
US-$56.2M;EU-$31.4M;ROW-$114.9M
2008 None 7 Q-4’07 US-AA Filing Under discussion
Ergocalciferol 50,000IU
US- $ 99.7MEU-$102.8MROW-$ 356.5M
2008 None 10 Q-1 ‘09 US-AA Filing; Licensed in US
Progesterone 100mg;200mg
US = $110.4 M, EU= $ 45.7 M ROW = $69.2 M
Q3 2009 None 1 Q-2’08 ANDA filing-US Licensed in US
Paricalcitol US=$ 34.8 M EU= $ 0.0 M; ROW $ 0.0 M
2014 2014 1 Q-4’08 Filing - US Under discussion
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Focusing on 800 mio USD Rx opportunityContd……..
Market StrategyCreate a complete range of Rx SGCs
Pipeline Current Market
Size
Exp. To
Mkt
Patent-US PlayersUS
ANDA Readiness
Development Strategy
Licensing status
Methoxsalen 10mg;20mg
US - $13.1 MEU - $0.7 MROW- $2.6 M
2009 None 1 Q-4’07 ANDA Under discussions
Doxercalciferol - 0.5UGM & 2.5 UGM
US-$38.6 MEU-$0.0 MROW-$0.1 M
2010 Jul’2021. 1 Q-1’09 Para-IV Challenge Under discussions
Nimodipine 10mg;30mg
US- $28 MEU-$34.1 MROW-$55.6 M
Q-2’09 None 3 Q-1’08 ANDA Under discussions
Vinorelbine 10mg;20mg;30mg
US- $0.0 MEU-$48.9 MROW- $2.3 M
2010 None None Q-4’08 EU filing Onco Portfolio
Bexarotene 75 mg
US- $17.4 MEU- $14.9 MROW- $0.0 M
2016 05 Oct 2016 1 Q-4’08 Global filing- Para- III
Onco Portfolio
Etoposide 50mg
US-$16 MEU-$9.6 M ROW-11.2 M
2010 None 2 Q-4’08 Global Filing Onco Portfolio
Dutasteride0.5mg
US- $266 MEU- $136.9 MROW- 33.4 M
2015 20 Nov 2015 1 Q2-09 Filing – US Under discussion
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Product Dossier Submission (Regulated Markets)
Submitted
2006 / 07
Approvals Received
To Date
ODF 21
21*INJECTIONS 71
NDA’S 7
TOTAL 99
* Includes 16 ARV’s
1st Sterile product approved by USFDA / HPB
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• Strides is amongst India’s leading exporter of pharmaceuticalso Growth investments nearing completion
• Strides is India’s leading Steriles manufacturer and has the strongest pipeline in the industry.
• Partnership and regional strategy in global markets will ensureo Significant revenue growths with high marginso Acquisitions nearing course correction will deliver results going forward.
• The focus of the company would be execution and improving its product pipeline and focusing on customer service.
Strides - Summary
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Thank You