Our Vision “To emerge as a leading, research-based, global, integrated pharmaceutical company ” Our Values Safe Harbour Statement This presentation has been prepared by Glenmark. The information, statements and analysis made in this presentation describing company’s objectives, projections and estimates are forward looking statements and progressive within the meaning of applicable security Laws and Regulations. The analysis contained herein is based on numerous assumptions. Actual result may vary from those expressed or implied depending upon economic conditions, government policies and other incidental factors. No representation or warranty, either expressed or implied, is provided in relation to this presentation. This presentation should not be regarded by recipients as a substitute for the exercise of their own judgment. 2 Agenda Glenmark Glenmark Pharmaceuticals Limited (GPL) – Specialty Business Glenmark Generics Limited (GGL- wholly owned sub. of GPL) – Generics Business Glenmark – Consolidated Financials and Projections Glenmark Glenmark has made rapid strides towards achievement of vision • Research efforts in Small molecules, Biologics and Generics Research based • 13 new molecules under development • Over $ 110 mn of cash received from out-licensing partners; Further milestones worth over $ 600 mn Pre 2000 Glenmark Sales< $ 20 mn Domestic focus <5% of exports • Over 5000 employees across 5 continents • Mfg facilities in 4 countries Global • Operates in over 85 countries Glenmark today Revenues : $ 499 mn India based MNC >60% of exports • Front ends in US, India, Brazil and other markets worldwide • 3 API plants Integrated • 8 finished dosage plants • 3 research facilities 4 Glenmark - Global Footprint Glenmark Generics Europe Limited, London, UK Medicamenta, Czech Republic 1 Dosage Plant, HP, India 1 API Plant, Gujarat, India 1 Dosage Plant – Czech Republic 1 Dosage Plant, Maharashtra, India Glenmark Generics Ltd., US Glenmark India 1 Dosage Plant - Brazil Glenmark Pharma Europe Limited, London, UK Glenmark Generics SA, Argentina 3 Dosage Plants, Goa, India Bowter Bartlett South Arica R&D for NCEs, India R&D for Generics, India 1 Dosage Plant - Argentina Glenmark Farmacetica Ltda., Brazil R&D for Biologics, Switzerland 2 API Plants, Maharashtra,India Several other subsidiaries and representative offices exist across the world 5 Glenmark - Financials Change (ending Mar’07) FY 20082 (ending Mar’08) Audited Un-audited (in %) Operating income (A) 283.54 499.18 76% Expenditure (B) 186.96 299.80 60% % EBITDA (Operations) [C =(A-B)/A] 34% 40% EBT (Operations) (D) 78.30 165.79 112% Other Income (E) 3.56 11.06 211% PBT (F=D+E) 81.86 176.85 116% PAT (G) 70.25 156.72 123% Basic Earnings per share (in rupees) 12.99 25.81 FY 20071 In $ mn Note : 1. Average conversion rate for FY 2006-07 of Rs. 44.14 / USD 1.00 2. Average conversion rate for FY 2007-08 of Rs. 40.28 / USD 1.00 6 Glenmark Glenmark has shown consistent robust growth across businesses 600 70% 499 60% 500 50% 400 40% 300 283 171 30% Revenues Growth 200 20% 100 10% 0 0% FY 06 1 ending Mar’06 FY 07 2 ending Mar’07 3 FY 08 ending Mar’08 Revenues in $ mn Note : 1. 2. 3. Average conversion rate for FY 2005-06 of Rs. 44.28 / USD 1.00 Average conversion rate for FY 2006-07 of Rs. 44.14 / USD 1.00 Average conversion rate for FY 2007-08 of Rs. 40.28 / USD 1.00 7 Glenmark Glenmark is divided into two main businesses with different business focus Specialty/Proprietary Glenmark Pharmaceuticals Ltd (GPL) Generics Wholly owned subsidiary Glenn Saldanha Chairman: Glenn Saldanha CEO: Terry Coughlin Global end to end Specialty Company Global integrated Generic & API leader MD and CEO: Leadership Vision Glenmark Generics Ltd (GGL) *To be listed in India during FY 2009 8 Agenda Glenmark Glenmark Pharmaceuticals Limited (GPL) – Specialty Business Glenmark Generics Limited (GGL- wholly owned sub. of GPL) – Generics Business Glenmark – Consolidated Financials and Projections Vision for Glenmark Pharmaceuticals Limited “Global end-to-end Specialty Company” Product Portfolio Launch two proprietary drugs Build late stage pipeline Market Presence Target 2015 Proprietary product front ends in US, key ROW & European markets Market Positioning Innovation led company Differentiated branded generic company Licensing Build differentiated product franchise Invest in building brands Expand into new territories Transition into a proprietary product marketing company 10 Glenmark Pharmaceuticals Limited: Specialty Business Global Therapeutic Focus Inflammation Innovative R&D Therapeutic Focus Pain, Respiratory (Asthma/COPD), Rheumatoid Arthritis Metabolic Disorders Diabetes (Type II), Obesity Dermatology Psoriasis, Pruritus, Atopic Dermatitis 11 Glenmark Pharmaceuticals Limited: Specialty Business Business Unit Structure Glenmark Pharmaceuticals Ltd. (GPL) R&D NCE Finished Dosage Formulations Biologics (Swiss) ROW (Rest of the World) Europe US (Inorganic entry) 12 Research and Development (R&D) Glenmark Pharmaceuticals Limited: Specialty Business Glenmark’s R&D Efforts – both small molecules and biologics New Chemical Entity (NCE) Research New Biological Entity (NBE) Research Over 300 scientists Over 55 scientists Based in Mumbai, India Based in Switzerland Pipeline of 13 molecules 8 NCEs and 5 NBEs 14 Glenmark Pharmaceuticals Limited: Specialty Business Research Pipeline: 13 molecules at various stages of development Screening World class targets DPP-IV, PDE IV, CB2, TRPV1, SCD1, VLA2, TRPV3 etc. Discovery 13 research molecules One undisclosed NCE Pre-clinical GRC 10693 Phase I GRC 4039 GRC 9332 Three undisclosed NBEs Phase IIb Oglemilast (1) Melogliptin (2) GBR 500 * GRC 6211 (3) GBR 600 * GRC 17173 * NBE (1) Out-licensed to Forest Labs and Tejin Pharma (2) Out-licensed to Merck KGaA – All rights received back (3) Out-licensed to Eli Lilly & Co. 15 Glenmark Pharmaceuticals Limited: Specialty Business Progress on Research Pipeline Compound Primary Indications Target Target Launch GRC 3886 (Oglemilast) Asthma, COPD PDE IV 2011 GRC 6211 Osteoarthritis, Neuropathic Pain, Dental Pain, Incontinence TRPV1 2012 GRC 8200 (Melogliptin) Diabetes (Type II) DPP IV 2012 GRC 4039 Rheumatoid Arthritis, Inflammation, Multiple Sclerosis PDE IV + TNF-ά + T-cell 2012 GRC 10693 Neuropathic Pain, Osteoarthritis and other Inflammatory Pain CB 2 2013 GRC 9332 Obesity, Dyslipidemia, Metabolic Disorders SCD 1 2013 GRC 17173 Osteoarthritis, Neuropathic Pain, Dental Pain TRPV3 2013 GBR 500 Acute Multiple Sclerosis, Inflammatory Disorders VLA2 2013 GBR 600 Acute Stroke/ Coronary Syndrome, Thrombosis Cardiovascular Disorders undiscl osed 2014 Preclinicals Phase I Phase II Phase III Approva l One NCE and three biologics are at the discovery stage and are expected to enter the clinics during FY 2010/2011 16 Glenmark Pharmaceuticals Limited: Specialty Business Oglemilast [Target: PhosphoDiesterase (PDE) IV Inhibitor] Indications Asthma, COPD (Chronic Obstructive Pulmonary Disease) Opportunity • High level of unmet need • Lack of novel validated targets: Dominated by reformulations and “me-too” products Competing Compounds • Compound under development following same mechanism is Roflumilast (Altana - Ph III) Status • Ph IIb for COPD initiated in US; Ph IIb for asthma will be initiated by Sep 2008 • Out-licensed North American rights to Forest Labs. Total deal size is $ 190 mn. Already received total $ 35 mn as upfront and milestones. Glenmark will also receive royalties upon launch • Out-licensed Japanese rights to Teijin Pharma. Total deal size is $ 53 mn. Received $ 6 mn as upfront payment. Glenmark will also receive royalties upon launch Key Differentiators • Oral, once daily regimen • No emesis and nausea observed in the clinics • Large therapeutic window to escalate doses (as compared to other PDE IVs) Targeted population/Market Size • Asthma patients: 45 mn worldwide • COPD patients: 30 mn worldwide (with only 6 mn receiving treatment) • COPD/Asthma market : $ 28.7 bn worldwide Potential Peak Sales >$ 3 bn worldwide Target Launch 2011 17 Glenmark Pharmaceuticals Limited: Specialty Business GRC 6211 [Target: Transient Receptor Potential Vanilloid (TRPV)1 Antagonist] Indication Osteoarthritis, Neuropathic Pain, Dental Pain, Incontinence Opportunity • Large unmet medical need • Recent concerns around safety of Cox-2 inhibitors will propel sales of safer products Competing Compounds MK-2295 (Merck & Co. - Ph II) and SB 705498 (GSK - Ph II) are two competing compounds under development following same mechanism Status • Ph IIb ongoing • Out-licensed to Eli Lilly & Co. for developing and marketing for North America, Europe and Japan for various pain indications, including osteoarthritis. Total deal size is $ 350 mn. Received upfront payment of $ 45 mn. Glenmark has rights for co-promotion in the US and will also receive royalties upon launch Key Differentiators • Potential first in class opportunity Targeted population/Market Size • Osteoarthritis Market: $ 4 bn; >20 mn patients • Neuropathic Pain Market: $ 5 bn; >40 mn patients Potential Peak Sales >$ 3 bn worldwide Target Launch 2012 18 Glenmark Pharmaceuticals Limited: Specialty Business Melogliptin [Target: Dipeptidyl Peptidase (DPP) IV Inhibitor] Indications Diabetes (Type II) Opportunity • Large, undiagnosed and increasing patient population • Less than 50% of diabetics treated successfully, therefore excellent prospects for products with a strong safety and efficacy profile • Recently observed safety issues related to Glitazones Competing Compounds • Januvia (Merck & co. - Sitagliptin), the first in class compound was launched in Oct’06; JanuMet (Sitagliptin + Metformin) launched in Apr 07. Sales tracking of Januvia franchise > $ 1bn • Galvus (Novartis - vildagliptin) launched in Brazil & Mexico. Galvus & Eucreas (vildagliptin + metformin) approved in EU Status • Ph IIb ongoing; expected to enter Ph III by Oct 2009 • Expect to be 4th or 5th in the market with differentiating features • Out-licensed molecule to Merck KGaA for a total deal size of $ 250 mn. Due to portfolio restructuring at Merck KGaA, Glenmark received all rights back for further development and commercialization. Glenmark had received $ 31 mn as upfront payment from Merck KGaA earlier • Currently under discussions for licensing with potential partners Key Differentiators • Good specificity over DPP VIII and DPP IX • Better side effect profile as compared to similar compounds Targeted population/Market Size • 125 mn patients worldwide • Market Size: $ 13 bn worldwide Potential Peak Sales >$1 bn worldwide Target Launch 2012 19 Glenmark Pharmaceuticals Limited: Specialty Business GRC 4039 Target: (a) PhosphoDiesterase (PDE) IV Inhibitor (b) TNF – Alpha Inhibitor (c) T-Cell Cytokine Inhibitor Indication Rheumatoid Arthritis (RA), Inflammation, Multiple Sclerosis Opportunity • Void exists in RA therapy for orally available potent small molecules • 35% of RA patients remain untreated • Biological treatments currently available are expensive Competing Compounds • Biological (e.g. anti-TNFa) and small molecules Status • Ph I ongoing; Key Differentiators • Excellent efficacy in animal models in RA • Good safety profile to achieve higher exposure levels in humans • Good bioavailability across species and a long half-life indicating the potential for a once-daily dosing regimen Targeted population/Market Size • Rheumatoid Arthritis Market: $16 bn; > 20 mn patients Potential Peak Sales >$3 bn worldwide Target Launch 2012 20 Glenmark Pharmaceuticals Limited: Specialty Business GRC 10693 [Target: Cannabinoid-2 (CB-2) Receptor Agonist] Indication Neuropathic Pain, Osteoarthritis and other Inflammatory Pain Opportunity • Large unmet medical need • Recent concerns around safety of Cox-2 inhibitors will propel sales of safer products Competing Compounds GW-842166X (GSK - Ph II) & A-796260 (Abbott – Discovery) follow similar mechanism Status • Pre-clinical development; expected to enter the clinics in Q1 FY 2009 Key Differentiators • Potential early launcher in this class Targeted population/Market Size • Neuropathic Pain Market: $ 5 bn; >40mn patients • Osteoarthritis Market: $ 4 bn; >20 mn patients Potential Peak Sales >$2 bn worldwide Target Launch 2013 21 Glenmark Pharmaceuticals Limited: Specialty Business GRC 9332 [Target: Stearoyl CoA Desaturase-1(SCD1) Inhibitor] Indication Obesity; Dyslipidemia; Metabolic Disorders Opportunity • Current approved products characterized by modest efficacies and problematic safety and tolerability profiles • Large unmet medical need with growing patient population globally on account of changing lifestyles Competing Compounds • Ph-I program at Isis/Merck & Co.; Discovery program at Xenon/ Novartis Status • Pre-clinical development; expected to enter clinics by Q3 FY09 Key Differentiators • Potential first in class; early mover advantage Targeted population/Market Size • More than 160 mn people estimated to be Obese in major markets worldwide – only 6 mn are treated therapeutically • Current Market : $ 2 bn Potential Peak Sales >$1bn worldwide Target Launch 2013 22 Glenmark Pharmaceuticals Limited: Specialty Business GRC 17173 [Target: Transient Receptor Potential Vanilloid (TRPV)3 Antagonist] Indications • Neuropathic Pain, Osteoarthritis, Dental Pain Opportunity • Recent concerns around safety of Cox-2 inhibitors will propel sales of safer products • Large unmet medical need Competing Compounds • In July 2007, Pfizer acquired a series of TRPV3 antagonists for pain from Hydra Biosciences for total milestone payments of $ 190 mn and royalties on launch Status • Pre-clinical development; expected to enter clinics by Q3 FY 09 Key Differentiators • Potential first in class opportunity Targeted population/Market Size • Osteoarthritis Market: $ 4 bn; >20 mn patients • Neuropathic Pain Market: $ 5 bn; >40mn patients Potential Peak Sales >$ 3 bn Worldwide Target Launch 2013 23 Glenmark Pharmaceuticals Limited: Specialty Business GBR 500 Target: (a) Alpha2 βeta1 Integrin Antagonist (b) Very Late Antigen (VLA2)2 Indication MS (Multiple Sclerosis), IBD (Inflammatory Bowel Disease) Opportunity • Inhibits a variety of cell types (neutrophils, etc) associated with different forms of inflammation hence should work in a variety of inflammatory diseases Competing Compounds • Novel in class with same indications Status • IND preparation; expected to enter clinics by Q2 FY 09 Key Differentiators • Potential first in class with the target • Offers significant differentiation potential with potentially superior efficacy to competing products Targeted population/Market Size • MS Market : $ 3 bn; • IBD biologics Market: $ 5 bn; > 4 mn patients Potential Peak Sales > $ 1 bn Target Launch 2013 24 Glenmark Pharmaceuticals Limited: Specialty Business GBR 600 [Target: Undisclosed] Indication Acute stroke / Coronary Syndrome; Thrombosis Cardiovascular Disorders Opportunity • The high incidence of bleeding with the marketed products remains the greatest challenge in disease treatment • Clinical efficacy has been modest with current agents Competing Compounds • Marketed drugs for PCI (Percutaneous Coronary Indications) indications include Plavix(Sanofi-Aventis), ReoPro (Eli Lilly) and Integrilin (Schering Plough) Status • Pre-clinical development; expected to enter the clinics by Q4 FY 09 Key Differentiators • Low incidence of bleeding, thus allowing wider use of GBR-600 • Large therapeutic window between efficacy dose and bleeding dose • Novel mechanism for current targeted indications Targeted population / Market Size • Current Market : $2 bn • GBR-600 has the potential to significantly expand the current market by offering improved efficacy with favorable adverse event profile Potential Peak Sales > $ 1 bn Target Launch 2014 25 GPL- Specialty Business RoW, Europe and US Europe (80*) ROW India (2000*) Latin America (200*) Asia (200*) US (inorganic route) Africa (160*) CIS (300*) *Sales force strength Glenmark Pharmaceuticals Limited: Specialty Business Glenmark’s strategy for future growth in RoW markets • Focus on Top-15 markets • High thrust on building ‘branded business’ which currently accounts for over 85% • Launch of novel ‘differentiated’ branded generics for getting a significant competitive edge Asia India Africa Latin America Australia Strategy CIS • Capitalize on ‘local know-how’ (country heads in over 20 markets) • Driving the business through qualified, experienced and dedicated ‘field force’ • Focus on sustainable doctor centric ‘prescription’ based model for building brands • Leverage on efficient and quality ‘distribution’ network for better market penetration 27 RoW Markets India Glenmark Pharmaceuticals Limited: Specialty Business India – Performance FY 2008 175 Revenues in $ mn 152 135 97 FY 2007 ending Mar’07 FY 2008 ending Mar’08 FY 2009 * ending Mar’09 FY 2010 * ending Mar’10 Highlights ¤ Glenmark registered a growth of 21% higher than the Indian pharma market growth at 15% (ORG Feb 2008) ¤ Currently commands 1.36% market share – up from 1.29% in FY 2007 (ORG Feb 2008) ¤ Currently ranked 24th in the highly fragmented Indian pharma market ¤ Top-10 brands contribute over 60% of India business * Projected 29 Glenmark Pharmaceuticals Limited: Specialty Business India – Action Plan Glenmark’s presence ¤ Operates through 9 divisions ¤ Sales force > 2000 medical representatives ¤ Markets over 250 products in India Action Plan FY 2009 ¤ Register growth of over 10 % ¤ Launch > 20 new products ¤ Maintain leadership in dermatology and consolidate position in other therapies RoW Markets Latin America (LatAm) Brazil Venezuela Mexico Peru Chile Bolivia Columbia Ecuador Caribbean countries Glenmark Pharmaceuticals Limited: Specialty Business LatAm – Performance FY 2008 80 Revenues in $ mn 60 48 26 FY 2007 ending Mar’07 FY 2008 ending Mar’08 FY 2009 * ending Mar’09 FY 2010 * ending Mar’10 Highlights ¤ ¤ Registered growth of over 65% ¤ ¤ Filed for over 100 product approvals in FY 2008 Launched 25 products across LatAm Top-10 brands contribute over 75% of LatAm business * Projected 32 Glenmark Pharmaceuticals Limited: Specialty Business LatAm – Action Plan ¤ LatAm Pharma Market : >$ 35 bn ¤ Brazil, Mexico, Argentina, Venezuela are the key markets Glenmark’s Presence ¤ Registered over 250 products in the LatAm markets ¤ Strong sales force setup of 200 medical representatives ¤ Register growth of over 25 % Action Plan FY 2009 ¤ File for 80 product approvals and launch 60 products ¤ Plans to enter Mexico during FY 2009 Revenue contribution * Carribea Venezuel n a 5% 3% FY 2009 (ending Mar’09) Others 9% FY 2010 (ending Mar’10) Others Mexico 7% 6% Carribea n 5% Venezuel a 4% Peru 3% Peru 3% * Projected Brazil 80% Brazil 75% 33 RoW Markets Australasia (excluding India, CIS & Japan) Malaysia Philippines Indonesia China South Korea Myanmar Vietnam Sri Lanka Cambodia Australia Glenmark Pharmaceuticals Limited: Specialty Business Australasia– Performance FY 2008 32 Revenues in $ mn 11 FY 2008 ending Mar’08 13 FY 2009 * FY 2010 * ending Mar’09 ending Mar’10 Highlights ¤ ¤ ¤ * Projected Launched over 60 products Filed for over 100 product approvals Top-10 brands contribute over 65% of the business 35 Glenmark Pharmaceuticals Limited: Specialty Business Australasia – Action Plan ¤ Australasia Pharma Market (excluding India, Japan, CIS) : >$ 55 bn Glenmark’s Presence ¤ China, Philippines, Malaysia, Indonesia, Australia are the key markets ¤ Registered over 400 branded generic products across Asian markets ¤ Recently entered Australia, China and Indonesia ¤ Strong sales force setup of 200 medical representatives Action Plan FY 2009 ¤ Register growth of over 20 % ¤ File for 100 product approvals and launch 30 products Revenue contribution * Malaysia 24% Indonesia 15% FY 2009 (ending Mar’09) Malaysia 19% FY 2010 (ending Mar’10) Australia 15% Phillipines 21% Phillipines 18% Others 55% Others 18% China 15% * Projected 36 RoW Markets Africa South Africa Nigeria Kenya Sudan Egypt Tanzania Yemen Ivory Coast Zambia Mauritius Uganda Cameroon Ghana Includes middle east countries Glenmark Pharmaceuticals Limited: Specialty Business Africa– Performance FY 2008 42 Revenues in $ mn 25 18 FY 2008 ending Mar’08 FY 2009 * ending Mar’09 FY 2010 * ending Mar’10 Highlights ¤ ¤ ¤ ¤ * Projected Launched 80 products across Africa Filed for over 150 product approvals across Africa Top-10 brands contribute over 85% of Africa business Glenmark marked its entry into Egypt by establishing an office 38 Glenmark Pharmaceuticals Limited: Specialty Business Africa – Action Plan ¤ Africa Pharma Market : >$ 10 bn ¤ South Africa, Nigeria, Sudan, Kenya, Egypt are key markets Glenmark’s Presence ¤ Register over 600 branded generic products ¤ Marketing products in over 30 countries; Direct presence in 10 countries ¤ 160 sales representatives across Africa ¤ Register growth of over 35 % ¤ File for 75 products and launch 45 products Action Plan FY 2009 ¤ Plans to enter Algeria, UAE ¤ Look for brand acquisition opportunities for entry/growth Sudan 14% Nigeria 11% * Projected Revenue contribution * South Africa 20% FY 2009 (ending Mar’09) Kenya 14% Others 41% Sudan 12% Egypt 12% South Africa 25% FY 2010 (ending Mar’10) Kenya 12% Nigeria 15% Others 24% 39 RoW Markets CIS Russia Ukraine Uzbekistan Kazakhstan Glenmark Pharmaceuticals Limited: Specialty Business CIS – Performance FY 2008 66 Revenues in $ mn 38 22 FY 2008 FY 2009 * FY 2010 * ending Mar’08 ending Mar’09 ending Mar’10 Highlights ¤ Company launched 40 products ¤ Filed for over 30 product approvals across CIS ¤ Top-5 brands contribute over 90% of CIS business ¤ Glenmark’s brand Ascoril is the no 1 brand in the cough expectorant market in Russia * Projected 41 Glenmark Pharmaceuticals Limited: Specialty Business CIS – Action Plan ¤ CIS Pharma Market : >$ 15 bn Glenmark’s Presence ¤ Russia, Ukraine, Uzbekistan & Kazakhstan are the key markets ¤ Registered over 70 branded generic products ¤ 300 medical representatives cover entire CIS ¤ Register growth of over 70 % Action Plan FY 2009 Ukraine 4% Uzbekist an 4% ¤ File for 25 product approvals ¤ Launch 25 products Revenue contribution * Kazakhs tan 1% Russia 91% * Projected FY 2009 (ending Mar’09) Uzbekist an 3% Ukraine 4% Kazakhs tan 1% FY 2010 (ending Mar’10) Russia 92% 42 Europe Glenmark Pharmaceuticals Limited: Specialty Business Europe – Performance FY 2008 ¤ Glenmark established its first commercial foothold in Europe by acquiring Medicamenta a.s, Czech Republic in 2007 ¤ Glenmark also established its presence in Romania & Bulgaria in 2008 40 Revenues in $ mn 20 9 FY 2008 ending Mar’08 FY 2009 * ending Mar’09 FY 2010 * ending Mar’10 * Projected 44 Glenmark Pharmaceuticals Limited: Specialty Business Europe: Strategy for the future ¤ Focus on CEE (Central Eastern European) markets which are primarily branded in nature ¤ Build/acquire front end infrastructure in CEE markets through sales force over the next 5 years ¤ Transition front-ends to selling/co-promoting Glenmark’s proprietary medications that would reach the market in the next 3-5 years 45 Glenmark Pharmaceuticals Limited: Specialty Business Europe Branded Generics Market – Key characteristics ¤ The opportunity in the branded generics market lies mostly in the Central Eastern European (CEE) countries and some new member states of the EU like Romania & Bulgaria ¤ Glenmark’s focus is on the six largest brand markets of Europe Market size 2008(in $ bn) Per Capita GDP spend (in $) Branded Generic Penetration by Value Poland 6.4 867 50% Czech Republic 3.7 1479 45% Hungary >3.0 1337 35% Romania 2.2 NA NA Bulgaria > 1.0 NA NA Turkey > 6.0 586 NA EU 15 > 150 3100 - US > 250 6401 46 Glenmark Pharmaceuticals Limited: Specialty Business Europe: Plans for FY 2009 ¤ Double revenues each year for the next 3-4 years ¤ Enter Poland, Hungary and Turkey through organic/inorganic means ¤ Plan to launch at least 5 products New 14% Revenue contribution * Bulgaria 3% Bulgaria 12% Czech 50% Romania 28% Czech 69% Romania 24% FY 2009 ending Mar’09 * Projected FY 2010 ending Mar’10 47 Glenmark Pharmaceuticals Limited: Specialty Business US: plans to enter the specialty segment in the near future ¤ Initiate operations in the US during FY 2009 ¤ Evaluate acquisition of a specialty company/brands with a primary care sales force ¤ Glenmark intends to conclude this acquisition over the next 12-18 months 48 Glenmark Pharmaceuticals Limited: Specialty Business Infrastructure and facilities Location Production Lines R&D Facility, Navi Mumbai NCE Research and Process Development Regulatory Approvals NA R&D Facility, Switzerland Biologics Research NA Nasik, Maharashtra, India Solid orals, liquid orals, & external creams, powders and capsules for regulated markets Brazil (ANVISA), Ethiopia, Zimbabwe, Uganda, Nigeria; Tanzania, Ghana, R.D. Congo, Sudan, South Africa (MCC ) Baddi, Himachal Pradesh, India Solid orals, semi-solid and liquid orals as well as external preparations like lotions, creams, capsules, etc. for India and semiregulated markets US FDA, MHRA, TPD Canada, Nepal Sao Paulo, Brazil Solid orals, semi-solid & liquid orals for Latin America ANVISA Vysoke Myto, Czech Republic Solid and semi-solid orals SUKL, Czech Republic Expansion Plans New formulation plant in India to be commissioned in FY 09 NCE API facility in India to be commissioned in FY 09 49 Glenmark Pharmaceuticals Limited: Specialty Business Financials and Projections – Organic growth only Revenues In $ mn* 303 377 504 CAGR ~29 % 69 69 Business Mix 60 9 22 11 18 48 * NCE 66 Europe CIS 32 42 80 152 175 FY 2008 FY 2009 FY 2010 93 (ending Mar 09) 123 In $ mn (Assumed exchange rate of ~40.28 INR/USD for FY08 and ~ 40 INR/USD for FY09 and FY10) Australasia Africa LatAm India 60 135 (ending Mar 08) Profits In $ mn 20 38 13 25 40 (ending Mar 10) 157 CAGR ~ 30% 50 Glenmark Pharmaceuticals Limited: Specialty Business Summary of key objectives – FY 2009 ¤ Ensure at least eight molecules are in the clinical stages ¤ Ensure at least five molecules are in the Ph II clinical trial stage ¤ Ensure four molecules are partnered out by FY 09 (including Oglemilast & GRC 6211) ¤ Initiate acquisition of specialty front end in the US ¤ Enter 7-8 new markets in Europe and RoW markets ¤ Launch over 100 products and file for over 300 products approvals across geographies 51 Glenmark Generics Ltd. (GGL) Generics Business Agenda Glenmark Glenmark Pharmaceuticals Limited (GPL) – Specialty Business Glenmark Generics Limited (GGL- wholly owned sub. of GPL) – Generics Business Glenmark – Consolidated Financials and Projections Safe Harbour Statement This presentation has been prepared by Glenmark. The information, statements and analysis made in this presentation describing company’s objectives, projections and estimates are forward looking statements and progressive within the meaning of applicable security Laws and Regulations. The analysis contained herein is based on numerous assumptions. Actual result may vary from those expressed or implied depending upon economic conditions, government policies and other incidental factors. No representation or warranty, either expressed or implied, is provided in relation to this presentation. This presentation should not be regarded by recipients as a substitute for the exercise of their own judgment. 54 Vision for Glenmark Generics Limited (GGL) “Global Integrated Generic & API leader” Product Portfolio 170 generics on the US market 70 generic dossiers for EU markets Over 50 % of revenues from niches Target 2015 Market Presence Presence in Japan, South Africa & other generic markets Front ends in Japan and key EU markets along with NA Market Positioning Key Generic Player Preferred supplier of APIs Expand Niche Product Portfolio Increase Geographical Reach Vertical Integration 55 Glenmark Generics Ltd. - Business Unit Structure Glenmark Generics Ltd. (GGL) Finished Dosage Formulations North America Europe API Argentina (Oncology) API 56 North America Glenmark Generics Limited: Generics Business North America – Performance FY 2008 303 Revenues in $ mn 207 140 50 FY 2007 ending Mar’07 FY 2008 ending Mar’08 FY 2009 * ending Mar’09 FY 2010 * ending Mar’10 Highlights ¤ ¤ ¤ ¤ * Projected Doubling of portfolio: 28 products on the market Entry into dermatology with launch of five Clobetasol products First semi-exclusive product : First 180 day shared exclusivity for Glenmark - Oxcarbazepine Garnered over 20-25% market share in most products 58 Glenmark Generics Limited: Generics Business North America: The US Market The Market ¤ $ 286 bn ¤ 65% generics by volume represent 20% of the market by value ¤ Political climate increasingly supportive of generics to lower healthcare costs Market Characteristics ¤ Increasing competition in “me-too” generics ¤ Authorized generics and shared exclusivities reducing upsides from 180-day exclusivities ¤ Customers prefer vertically integrated companies Opportunities with long term plan ¤ In the next 3-5 years, drugs worth $ 60-70 30 Bn are going off-patent 20 2009 22 2010 2011 Values in $ Bn 59 Glenmark Generics Limited: Generics Business North America – Glenmark’s rise as a generic player ¤ GGI, USA (Glenmark Generics Inc.) launched the first product in Jan 2005 Background ¤ Registered net revenues of $ 140 mn in FY 2008 Product Portfolio 28 ¤ 28 products on the market ¤ > 30 products filed with USFDA ¤ Presence in controlled substances, hormones, oncology, modified release and dermatology ¤ Portfolio of marketed products has doubled each year during the last three years 13 6 FY 2006 ending Mar’06 FY 2007 FY 2008 ending Mar’07 ending Mar’08 Highlights ¤ Revenues crossed $ 100 mn in first three years of operations ¤ Received 180 day exclusivity for Oxcarbazepine ¤ Filed PIVs (FTF opportunities) for Zetia®, Tarka®, Strattera® & Crestor® 60 Glenmark Generics Limited: Generics Business US: Plan for ANDA Filings ANDAs filed / marketed Till FY FY FY Total Filings (Includes partner filings) 2008 2009 2010 Dermatology 10 8 8 26 Controlled Substance 4 4 4 12 Modified Release 6 10 10 26 Hormones 3 4 5 12 Oncology - 4 5 9 First to File (P-IVs) 6 3 3 12 Immediate Release 32 4 4 40 Total 61 37 39 137 61 Glenmark Generics Limited: Generics Business US Product Portfolio: Dermatology ¤ Total Topical Derma Market is $4.3 bn of which over The Market 50% of sales are generic ¤ Higher barriers to entry due to development costs ¤ Higher margins based on fewer competitors ¤ Key generic players include: Fougera, Perrigo, Taro ¤ Partnership with Paul Capital for clinical development of 16 dermatology products GGL’s Portfolio ¤ Only Indian Company with India based dermatology portfolio [1 already launched; 18 products anticipated (current market size $390 mn) to be launched within next 3 years] Fillings (Cumulative) 26 18 10 Till FY 2008 FY 2009 ending Mar’08 ending Mar’09 FY 2010 ending Mar’10 62 Glenmark Generics Limited: Generics Business US Product Portfolio: Controlled Substances (CS) ¤ Total CS Market is valued over $12 bn ¤ Key generic players include: Mallinckrodt, Watson, Endo ¤ High barriers to entry: The Market ¤ DEA licensures required ¤ Limitations on importing controlled substances from foreign countries ¤ Higher margins on controlled substance products due to limited players ¤ Controlled substance portfolio (current market GGL’s Portfolio size $ 200 mn) ¤ 3 controlled substances already launched ¤ 7 additional products anticipated to be launched within next 3 years 12 Fillings (Cumulative) 8 4 Till FY 2008 FY 2009 FY 2010 ending Mar’08 ending Mar’09 ending Mar’10 63 Glenmark Generics Limited: Generics Business US Product Portfolio: Modified Release ¤ Total sales revenue for Modified Release oral solids is over $22 bn The Market ¤ Higher barriers to entry ¤ Difficult to develop ¤ Unique technologies ¤ Higher margins on modified release products due to limited players. GGL’s Portfolio ¤ Several modified released products in pipeline and already filed [14 products anticipated (current market size $1.6 bn) to be launched within next 3 years] 26 Fillings (Cumulative) 16 6 Till FY 2008 FY 2009 ending Mar’08 ending Mar’09 FY 2010 ending Mar’10 64 Glenmark Generics Limited: Generics Business US Product Portfolio: Hormones ¤ Total Solid oral dosage Hormones Market is approximately $5 bn The Market ¤ Key generic players include: Barr & Watson ¤ Higher margins on Hormones Products ¤ Limited players ¤ Dedicated facility required ¤ Higher cost of bio-studies ¤ Only Indian Company with India based hormones GGL’s portfolio portfolio [10 products anticipated (current market size $1 bn) to be launched within next 3 years] 12 Fillings (Cumulative) 7 2 Till FY 2008 FY 2009 FY 2010 ending Mar’08 ending Mar’09 ending Mar’10 65 Glenmark Generics Limited: Generics Business US Product Portfolio: Oncology ¤ Total Oncology Market in the United States is over $10 bn ¤ Key generic players include: Teva Sicor, Ben-Venue & The Market Barr ¤ Higher margins on Oncology Products ¤ Limited players ¤ Dedicated facility required ¤ Portfolio includes a mix of 14 solid oral dosage and 13 GGL’s portfolio injectable products (Total market size: >$ 7.5 bn) 9 Fillings (Cumulative) 4 0 Till FY 2008 ending Mar’08 FY 2009 FY 2010 ending Mar’09 ending Mar’10 66 Glenmark Generics Limited: Generics Business US Product Portfolio: FTF ANDA Ongoing Litigation Product Brand Name Plaintiff IMS Sales Ezetimibe Zetia® Schering Plough $ 1.8 bn Atomoxetine Strattera® Eli Lilly $ 526 mn Rosuvastatin Ca (no litigation) Crestor® -- $ 1.7 bn Trandopril/ Verapimil Tarka® Sanofi-Aventis $ 95 mn Fillings (Cumulative) 6 Till FY 2008 9 FY 2009 ending Mar’08 ending Mar’09 12 FY 2010 ending Mar’10 67 Glenmark Generics Limited: Generics Business North America: Strategy for future ¤ Continue to focus on niche categories; expand presence into other niche categories ¤ Set Glenmark Generics apart as a preferred supplier to the industry ¤ Manage product portfolio to include a judicious mix of PI, PII, PIII and PIV filings ¤ Strive for vertical integration for most of our products in all categories (including niche categories) 68 Glenmark Generics Limited: Generics Business North America: Plans for FY 2009 ¤ Register growth of 45 % ¤ Launch over 20 products and file over 35 products ¤ Including dermatology, controlled substances, hormones and other niche categories ¤ Leverage partnerships with other generic players ¤ Evaluate entry into 1 or 2 additional niche categories 69 Europe Glenmark Generics Limited: Generics Business The European Market ¤ $ 182 bn ¤ Generic penetration is low as compared to the Market Size North America in many of the countries ¤ Market is broken down into several countries with different requirements ¤ To bring down the cost of publicly funded Market Characteristics healthcare is the main driver in promoting generics ¤ Europe is characterized with each country having different regulatory authorities and distinct pricing/reimbursement policies ¤ Key markets with high generic penetration: UK, Germany, Netherlands Opportunities ¤ Key markets with low generic penetration: France, Italy, Spain, Belgium ¤ Large no of products set to go off-patent in the next 3-5 years 71 Glenmark Generics Limited: Generics Business Europe generics business is gearing up for future ¤ GGEL (Glenmark Generics Europe Ltd.) was established in 2004 Background ¤ Majority of current revenues are as licensing income from dossier customers ¤ Already filed for five MAAs which have been outlicensed to several Europen generic companies Product Portfolio ¤ Portfolio of more than 30 EU CTD solid and semisolids dossiers at various stages of development ¤ Several supply deals are in place with leading European generic players 10 Revenues in $ mn 4 0.2 FY 2008 * Projected ending Mar’08 FY 2009 * ending Mar’09 FY 2010 * ending Mar’10 72 Glenmark Generics Limited: Generics Business Europe: Strategy for future growth ¤ Establishing Glenmark 4-5 distribution front ends in Western European markets in the next 3-5 years through organic/inorganic means in order to market own products directly ¤ Developing niche generic products, and partnering & creating alliances with EU companies ¤ Building up the infrastructure to support growth objectives and create a significant presence in the EU markets ¤ Licensing and distribution partnerships with strong local / Pan-EU partners with a view to maximize the product portfolio and market opportunities ¤ Continue to support finished dosage pipeline with backward integration into APIs 73 Glenmark Generics Limited: Generics Business Europe: Plans for FY 2009 ¤ Acquire 1-2 generic distribution front ends in EU ¤ Launch 3 products into several countries ¤ File for at least 10 MAAs Total MAA Filings (cumulative) 25 15 5 Till FY 2008 ending Mar’08 FY 2009 ending Mar’09 FY 2010 ending Mar’10 74 Oncology Business Glenmark Generics Limited: Generics Business Oncology market Market Size ¤ Total Market Size >$ 30 bn ¤ Generic market worldwide > $ 8 bn ¤ Lesser competition because of entry barriers ¤ Difficult to develop molecules ¤ Specially designed/dedicated manufacturing Market Characteristics facilities ¤ Better operating margins due to lower price erosion ¤ Longer product life cycle as older therapies continue to co-exist with newer ones ¤ 95 % of classic chemotherapy products are not Opportunities protected by patent which will ensure high profitability in regulated markets (less competition) ¤ Large no of products set to go off-patent in the next 3-5 years 76 Glenmark Generics Limited: Generics Business Oncology generics business ¤ Glenmark acquired the Argentinean marketing company Background Glenmark Generics S.A. (erstwhile Servycal S.A.) with a focused oncology portfolio Product Portfolio ¤ Presence in oncology in over 23 countries ¤ Caters to 75% of cancer therapy products ¤ Robust product pipeline for the near future ¤ Presence in cytotoxics, anti-hormonals & supportive therapies ¤ Plans to upgrade own dedicated manufacturing facility 25 15 Revenues in $ mn 8 6 * Projected FY 2007 FY 2008 ending Mar’07 ending Mar’08 FY 2009 * ending Mar’09 FY 2010 * ending Mar’10 77 Glenmark Generics Limited: Generics Business Oncology Business: Strategy for future growth ¤ Use Argentina as a hub to spread the oncology business Use Argentina as a hub for spreading the oncology business ¤ Continue to file dossiers and expand presence in other Latin American and ROW markets ¤ Develop product portfolio for regulated markets and initiate oncology filings in regulated markets ¤ First filing in the US and EU by FY 09/FY10 Increase coverage for cancer therapy products ¤ Expansion of product portfolio to cater to 95% Cancer therapy products 78 Glenmark Generics Limited: Generics Business Oncology Business : Plans for FY 2009 ¤ Register growth of over 80 % ¤ Enter 3-4 new countries including regulated markets ¤ File over 90 products for approval across various countries Total Dossier Fillings (Cumulative) 515 405 310 Till FY 2008 ending Mar’08 FY 2009 ending Mar’09 FY 2010 ending Mar’10 79 Active Pharmaceutical Ingredients (API) Business Glenmark Generics Limited: Generics Business The Global API Market Market Size ¤ >$ 75 bn ¤ Growth >10% (2005) ¤ Increased consolidation in generic pharmaceutical industry ¤ More focus on higher value creating opportunities Market Characteristics driven by intellectual property ¤ Stringent regulatory approval process in US/EU leads to high switching costs ¤ Increase in competition from Indian and Chinese API suppliers ¤ Large no of products set to go off-patent in the next 3-5 years Opportunities ¤ Many of the other historical less-regulated markets are quickly shifting towards stricter regulations limiting competition and opportunities for established players like Glenmark 81 Glenmark Generics Limited: Generics Business API Business Background ¤ API business spans across 80 countries including regulated markets like US and Europe ¤ > 50% of the revenues is from exports Product Portfolio ¤ Filed over 30 USDMFs till date ¤ Filed several Canadian DMFs, EDMFs and CEPs/CoSs 90 70 48 Sales in $ mn 30 * Projected FY 2007 FY 2008 FY 2009 * FY 2010 * ending Mar’07 ending Mar’08 ending Mar’09 ending Mar’10 Highlights ¤ Registered growth of over 45% ¤ Exports contribute over 50% of the revenues ¤ Initiated commercial supplies to various customers 82 Glenmark Generics Limited: Generics Business API Business: Drivers for future growth Continue to be a preferred 3rd party API supplier Expand product portfolio and market presence ¤ Partner with generic companies to capture first and alternate source opportunities ¤ Establish close relationship with major generic players globally to capture high end opportunities ¤ Continue to file DMFs across geographies ¤ Increase focus on entry into new markets ¤ Expand API capabilities to support dosage in niche areas (hormones, dermatology, controlled substances etc.) ¤ Focus on difficult to develop molecules Focus on IP Investments to ramp up infrastructure and generating IP around molecules ¤ Invest in building infrastructure in order to cater to increased demand and growth 83 Glenmark Generics Limited: Generics Business API Business: Plans for FY 2009 ¤ Register growth of over 40 % ¤ File over 15 USDMFs ¤ Ramp-up commercial supplies to regulated markets on upcoming approvals of ANDAs/Dossiers filed and pending at 3rd party customers ¤ Focus on development of over 15 APIs annually to provide cost and timing advantage to complement US and Europe generic filings ¤ Enter 5-6 new markets Till FY 2008 US DMF Fillings ending Mar’08 31 FY 2009 FY 2010 ending Mar’09 ending Mar’10 18 18 Total Filings 67 84 Glenmark Generics Limited: Generics Business Plants and Infrastructure Location Production Lines Regulatory Approvals R&D Facility, Navi Mumbai Formulation/API development facility, Bio-analytical and clinical R&D NA Goa, India • Oral solids, semi-solids for regulated markets – Colvale • Hormones for regulated markets – Colvale • Oral solids - Kundiam US FDA, Canada (TPD), South Africa (MCC), Brazil (ANVISA), Quintiles (a CRO; for EU-GMP), Ethiopia Health Authority, Brecon (a CRO) & Tunisia , UAE, UK (MHRA); Botswana Oncology plant, Argentina Oncology products for regulated markets Local FDA GMP approved Ankleshwar, India Manufacturing blocks for regulated markets US FDA; UK (MHRA) Kurkumbh, India Manufacture of intermediates & APIs for India and semi-regulated markets Mohol, India Local FDA GMP approved Expansion Plans New Formulation plant at Jambusar SEZ New API Facility at Jambusar SEZ New R&D Centre at Taloja (India) to be commissioned by FY 09 Upgradation of Argentina plant for Onco products 85 Glenmark Generics Limited: Generics Business Financials and Projections – Organic growth only Revenues In $ mn* 196 296 428 CAGR ~48 % 25 90 15 Argentina 70 API Business Mix 8 48 US and EU generics 313 211 140 FY 2008 (ending Mar 08) Profits In $ mn * 64 FY 2009 (ending Mar 09) 87 In $ mn (Assumed exchange rate of ~40.28 INR/USD for FY08 and ~ 40 INR/USD for FY09 and FY10) FY 2010 (ending Mar 10) 125 CAGR ~ 39% 86 Glenmark Generics Limited: Generics Business Summary of key objectives for FY 09 ¤ Launch at least 5 products every quarter in the US generic market ¤ Launch at least 3 products in EU across several markets; File at least 10 MAAs with focus on niche areas ¤ File over 30 ANDAs in the US generic market with focus on niche categories ¤ File at least 15 USDMFs ¤ Acquire 1-2 front ends in WE territory ¤ Commissioning of new R&D facility at Taloja 87 Agenda Glenmark Glenmark Pharmaceuticals Limited (GPL) – Specialty Business Glenmark Generics Limited (GGL- wholly owned sub. of GPL) – Generics Business Glenmark – Consolidated Financials and Projections Glenmark Consolidated Financials and Projections 504 Specialty 377 Generics 303 196 FY 2008 (ending Mar 08) 296 FY 2009 (ending Mar 09) 428 FY 2010 (ending Mar 10) Consolidated Revenues ($ mn) 499 673 932 PAT ($ mn) 157 210 282 Basic EPS (INR) 25.81 34.52 46.36 P/E (Based on Rs. 600 Share Price as at 25 Apr, 2008) 23.25 17.38 12.94 * In $ mn (Assumed exchange rate of ~40.28 INR/USD for FY08 and ~ 40 INR/USD for FY09 and FY10) 89 Thank you 90