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DSP MERILL LYNCH INDIA ROADSHOW November 2007 1
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FINANCIALS 2
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9 Months Review Revenue 30% EBITDA 15% PAT 58% 3
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Head Line Revenue Statement 9 Months 200612 Months 2006 9 Months 2007 Change % Revenue108.86170.83142.1031% COGS44.7775.8557.7629% GM64.0994.9884.3432% Net Operating Expenses44.5963.3061.8539% EBITDA19.5031.6822.5015% Amortization5.527.55 37% Net Interest Cost5.959.1711.4392% Profit Before Tax8.0314.953.52-56% Tax1.513.911.31-13% Profit After Tax6.5211.052.20-66% LESS: Minority Int.0.752.01-0.24-132% Profit After Min. Int.5.789.032.44-58% US$ Mn 4
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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. 5
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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 6
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Consolidated Abridged Balance Sheet US$ Mn Year ended Dec 2006 (12 months) Period ended Sept 2007 (9 months) Assets Non-current assets Tangible fixed assets139.05186.29 Goodwill42.58126.69 Intangible fixed assets7.276.95 Financial assets0.380.53 Deferred tax assets-- Current assets109.51136.72 Cash9.4240.31 308.21497.49 Equity & Liabilities Shareholders’ equity73.7270.94 Preference shares – liability12.35 Long term interest bearing debt106.61174.89 Other non-current liabilities22.14104.98 Short term interest bearing debt32.0248.20 Deferred tax liabilities4.935.22 Current liabilities56.4480.91 308.21497.49 7
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Stake Holders Distribution 8
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DOMAIN - STERILES STRATEGY 9
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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 Overview 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 Strategy Steriles - Overview Total Capex USD 110 mio in 2006/2007/mid 2008 Steriles 10
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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 Steriles 11
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Global Sales – Steriles 200520062007 (9 months) SALESEBITDASALESEBITDASALESEBITDA Steriles19.2938%44.0735%31.7335% US$ Mn Steriles 12
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DOMAIN – SGC’S 13
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Soft gel industry has application in the following areas: 1. Health Food & Nutritionals 2. OTC 3. 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 SGC 14
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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 5 th 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 (most products do not have a generic equivalent) Has many capabilities in softgels in niche areas including Onco & Hormones. Strategy SGC 15
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Market Strategy a. 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 SGC 16
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CategoryProducts Cough / cold & flu reliefDay time & Night time soft gels with Phenylephrine Pseudoephedrine Inflammation / pain reliefIbuprofen, Paracetamol, Naproxen Sodium Sleep AidDiphenhydramine GISimethicone; Docusate Sodium AllergyLoratadine, 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 SGC 17
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200520062007 (Est.) SALESEBITDASALESEBITDASALESEBITDA India4.7513%8.6021%9.5018% USA16.254%10.52-37%4.77-105% Total SGC 21.006%19.00-9%14.00-27% US$ Mn Global Sales – SGC SGC 18
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Domain – ODF (other than SGC) 19
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ODF Strides Overview of the ODF Business 20
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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 21
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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 22
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200520062007 (Est.) SALESEBITDASALESEBITDASALESEBITDA Regulated Markets 1224%1526%2523% ATM1126%1913%176% Others4823%6215%599% TOTAL7124%9617%10112% US$ Mn Global Sales – ODF ODF Regulated Markets 2008 60% growth Exiting / Downsizing ATM / others to improve Margin Businesses 23
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Building Brands 24
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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 Leadership Building Brands 25
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20062007 SalesEBITDASalesEBITDA Grandix--- 8.49*25% DHA2.39**25%10.7928% Total2.3925%19.2827% * 7 months ** 3 months US$ Mn Branded Sales 26
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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 27
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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 28
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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 29
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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 30
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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 31
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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 32
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200520062007 (Est.) Latam548071 Africa121417 Europe21119 N. America (US & Canada) 21188 Asia2414 India2210 ROW & Others264054 Total119171193 US$ Mn Regional Landscape 33
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Segmental EBITDA Margins 2006 (A) 2007 (B) 9 Months Steriles35 % SGC - Including USA -9 %-27 % SGC - Excluding USA 21 %18 % ODF & Others17 %12 % 34
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MANUFACTURING INFRASTRUCTURE 35
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Non Penicillin / Non CephalosporinsCephalosporinsBeta lactamPenemsOncology LocationBangalore, India PolandBangalore, IndiaBrazil (New)Bangalore, IndiaBrazilBangalore, 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 Lyophilisation Liquid 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 36
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Location Jigni, Bangalore, India Bilekahalli, Bangalore, India Bangalore, India (New) Hosur, India Jurong, Singapore Milan Italy Toluca Mexico Vittoria Brazil Lagos Nigeria Campos Brazil Products Rx OTCs 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 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 Commissionin g in Q4 2008 Acquired in 2000 Acquired in October 2006 Acquired in July 2005 Set up in 2000 Acquired in 2002 Commissi oning in H2 2007 Commissi oning 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) 37
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Location Vittoria Brazil (Penems & Penicillins) Poland India (Oncology) India (SPD– II) Total Capex 15.516.540.038.0 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 38
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TECHNICAL INFRASTRUCTURE 39
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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 40
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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 41
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Market Strategy Create a complete range of Rx SGCs PipelineCurrent Market Size Exp. To Mkt Patent - US Players US ANDA Readines s Development Strategy Licensing Status Benzonatate 100mg, 200mg US-$45 M EU-$ 0.0 M ROW-$14 M 2008None20ANDA FiledUS-AA FilingUnder discussion Calcitriol 0.25mcg; 0.5mcg US-$56.2M; EU-$31.4M; ROW-$114.9M 2008None7Q-4’07US-AA FilingUnder discussion Ergocalciferol 50,000IU US- $ 99.7M EU-$102.8M ROW-$ 356.5M 2008None10Q-1 ‘09US-AA Filing;Licensed in US Progesterone 100mg; 200mg US = $110.4 M, EU= $ 45.7 M ROW = $69.2 M Q3 2009None1Q-2’08 ANDA filing-US Licensed in US ParicalcitolUS=$ 34.8 M EU= $ 0.0 M; ROW $ 0.0 M 2014 1Q-4’08 Filing - USUnder discussion 42
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Focusing on 800 mio USD Rx opportunity Contd…….. Market Strategy Create a complete range of Rx SGCs PipelineCurrent Market Size Exp. To Mkt Patent-USPlayers US ANDA Readiness Development Strategy Licensing status Methoxsalen 10mg;20mg US - $13.1 M EU - $0.7 M ROW- $2.6 M 2009None1Q-4’07ANDAUnder discussions Doxercalciferol - 0.5UGM & 2.5 UGM US-$38.6 M EU-$0.0 M ROW-$0.1 M 2010Jul’2021.1Q-1’09Para-IV ChallengeUnder discussions Nimodipine 10mg;30mg US- $28 M EU-$34.1 M ROW-$55.6 M Q-2’09None3Q-1’08ANDAUnder discussions Vinorelbine 10mg; 20mg; 30mg US- $0.0 M EU-$48.9 M ROW- $2.3 M 2010None Q-4’08EU filingOnco Portfolio Bexarotene 75 mg US- $17.4 M EU- $14.9 M ROW- $0.0 M 201605 Oct 20161Q-4’08Global filing- Para- III Onco Portfolio Etoposide 50mg US-$16 M EU-$9.6 M ROW-11.2 M 2010None2Q-4’08Global FilingOnco Portfolio Dutasteride 0.5mg US- $266 M EU- $136.9 M ROW- 33.4 M 201520 Nov 20151Q2-09Filing – USUnder discussion 43
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Product Dossier Submission (Regulated Markets) Submitted 2006 / 07 Approvals Received To Date ODF21 21* INJECTIONS71 NDA’S7 TOTAL99 * Includes 16 ARV’s 1 st Sterile product approved by USFDA / HPB 44
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Strides is amongst India’s leading exporter of pharmaceuticals o 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 ensure o Significant revenue growths with high margins o 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. Our significant achievement is that we are a niche player with a rich pipeline that get sustained and vigorous inspite of price erosion of generic business, by focusing on difficult to manufacture products. We strongly believe that we are in the cusp of leadership in the segments we have chosen to export. Strides - Summary 45
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Thank You
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