Glenmark Pharmaceuticals Limited · NSE:GLENMARK
Glenmark Pharmaceuticals — Investor Presentation (November 2008)
60 slides from Glenmark Pharmaceuticals's investor presentation, November 2008
Slide 1: November '08
NOVEMBER ‘08 1
Slide 2: Safe Harbour Statement
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 Regu
Slide 3: Content
Content Glenmark – A Snapshot The Evolving Pharma Value Chain Re‐organisation of Glenmark Glenmark Pharmaceuticals Ltd. (GPL) R& D ‐ H1 Highlights & Program Details SBU ‐ H1 Highlights & Road Map Operations – H1 Highlights & Near Future Plans Financials & Projections Glenmark Generics Ltd. (GGL) SBU
Slide 4: Glenmark - A Snapshot
G Glenmark Glenmark -A Snapshot
Slide 5: Glenmark - A Snapshot
Year 2000 Turnover ‐ USD 38 Mn 2 Formulations Manufacturing Facilities Operations in 27 countries Sales from International operations – 8% Initiation into NCE research Year 2008 Research Based Glenmark Global •One of the leaders in Integrated drug discovery amongst Indian companies •Operations in ov
Slide 6: The evolving Pharma Value Chain
Rapid Changes in Global Scenario – The evolving Pharma Value Chain Proprietary/ Branded Business Key Requisites‐ V Innovation A Brand Building L “Pull” for products Branded Generic Companies will either U Marketing front ends transition up the value chain towards E Proprietary business Branded Gener
Slide 7: The Re-organisation of Glenmark
The Re‐organisation of Glenmark Separate focus on both business domains: Proprietary & Generics GLENMARK GLENMARK Effective April 2008 GLENMARK GLENMARK PHARMACEUTICALS PHARMACEUTICALS LTD LTD (GPL) (GPL) GLENMARK GLENMARK GENERICS GENERICS LTD LTD (GGL) (GGL) (A (A subsidiary subsidiary of of the t
Slide 8: GPL & GGL: Current Infrastructural Support
GPL & GGL: Current Infrastructural Support – In line with Business Requirements 1 dosage plant Biologics R&D ‐ –Czech Switzerland Republic Clinical R&D – Oxford UK 1 API plant ‐ 1 dosage plant Gujrat, India ‐HP, India 1 dosage plant ‐ Formulations Generics R&D ‐ Maharashtra, India R&D‐India India NC
Slide 9: GPL & GGL: Clearly Demarcated Focus Areas & Business Imperatives
GPL & GGL: Clearly Demarcated Focus Areas & Business Imperatives Business Imperatives ‐ GPL Business Imperatives ‐ GGL •Brand Building •Low cost manufacturing •Prescription Generation •Maintaining supply of low‐cost API •Create ‘pull’ for brands •Efficient spread of distribution •Market Novel Drugs
Slide 10: GPL – Span of Operations
GPL – Span of Operations GPL R&D Finished Dose Formulations New Chemical New Biological Rest of the European Union United States Entities (NCE) Entities (NBE) World (RoW) (EU) (US) 10
Slide 11: GPL: Pioneering Transformation to Innovation-led Proprietary Business
GPL : Pioneering Transformation by Transitioning from Branded Generics domain to Innovation‐led proprietary biz. domain Clinical R&D – Oxford UK Biologics R&D ‐ IPM, Regulatory, Switzerland Global BD‐ USA NCE R&D‐ Establishing Global Centers of Excellence: India •Small Molecule Research in India •Bi
Slide 12: R&D: H1 Highlights
R&D : H1 Highlights •Clinical Research Centre established in Oxford, UK. Aims to be the best‐in‐class set‐up in Clinical Operations, Biometrics and Pharmacovigilance •Initiated Phase IIb Asthma and COPD studies on Oglemilast (GRC 3886) •Melogliptin (GRC 8200), a treatment for type II diabetes, compl
Slide 13: Progress on pipeline: A Snapshot
Progress on pipeline: A Snapshot New Chemical Entities & New Biological Entities Compound Primary Indication Target Target Pre‐ Ph I Ph II Ph III Approval Launch clinicals GRC 3886 Asthma, COPD PDE IV Inhibitor 2012 (Oglemilast) GRC 8200 Diabetes Mellitus (Type II) DPP IV 2012 (Melogliptin) Inhibito
Slide 14: Program: Oglemilast (GRC 3886)
Program : Oglemilast (GRC 3886 ) Target PhosphoDiesterase (PDE) IV Inhibitor Indication Asthma, COPD (Chronic Obstructive Pulmonary Disease) Status • Out‐licensed North American rights to Forest Labs. Total deal size is $ 190 mn. Already received total $ 35 mn as upfront and milestones. Glenmark wil
Slide 15: Oglemilast (GRC 3886) – Strengths of the Program
Oglemilast (GRC 3886 )– Strengths of the Program Strengths of the program‐ •Potential first‐in‐class opportunity •Disease modifying properties of PDEIV inhibitors •Validated pathway in respiratory disease •No emesis is seen, unlike other compounds of its class. Hence larger therapeutic window •Oral,
Slide 16: Oglemilast – Key Differentiator: Lack of Emesis
Oglemilast (GRC 3886 ) Key Differentiator from other compounds in class – Lack of Emesis Previous PDE4i which went through late stage development suffered from low efficacy and side effects related to emesis •Oglemilast designed for lack of emesis as a side effect •Possibility to escalate doses and
Slide 17: Oglemilast (GRC 3886): Clinical Development Update
Oglemilast (GRC 3886 ) : Clinical Development Update Clinical Development Ongoing Multi‐center Phase IIb study in Ongoing Multi‐center Phase IIb study in COPD Asthma Study Design – Treatment, Study Design ‐ Multicenter, Randomized, Double Blind, Placebo randomized, double‐blind, placebo‐ Control, Pa
Slide 18: Program: Melogliptin (GRC 8200)
Program : Melogliptin (GRC 8200) Target Dipeptidyl Peptidase (DPP) IV Inhibitor Indication Diabetes Mellitus (Type II) Status • Ph IIb ongoing; expected to enter Ph III by Oct 2009 • Expected to be 4th or 5th in the market with differentiating features • Had out‐licensed molecule to Merck KGaA for a
Slide 19: Melogliptin (GRC 8200) – Strengths of the Program
Melogliptin (GRC 8200)– Strengths of the Program Strengths of the program‐ •DPP IV is one of the most promising treatment pathway to come up in the large and growing diabetes market ‐ Current analyst estimated market size is over USD 35 Bn by 2015 •GRC 8200 has the potential to be best –in‐ class in
Slide 20: Melogliptin – Potential to be best-in-class
Melogliptin (GRC 8200) – Potential to be best‐in‐class Amongst the most potent molecules in DPP‐IV class IC50 nM (reported / In-house generated) Molecule Recombinant DPP4 Human Plasma DPP4 Rat Plasma DPP4 Melogliptin 1.61 2.92 2.76 Sitagliptin 18 / 26.7 NA / 45.79 NA / 107.4 Vildagliptin NA / 16.57
Slide 21: Melogliptin (GRC 8200) – Clinical Development Update
Melogliptin (GRC 8200) – Clinical Development Update Clinical Development Ongoing Multi‐center Phase IIb study ‐ Glenmark, India (Total required ~ 500 randomised patients) Study Design : Phase IIb, 12‐Week Randomized, Double‐Blind, Parallel Group, Placebo‐Controlled Study Latest update: 1145 Patient
Slide 22: Program: GRC 6211
Program :GRC 6211 Target Transient Receptor Potential Vanilloid (TRPV)1 Antagonist Indication Osteoarthritic pain, Neuropathic Pain, Urinary Incontinence. Osteoarthritic pain was taken as the lead indication with Eli Lilly Status TRPV1 – GRC6211 •Eli Lilly suspended further clinical development for
Slide 23: Program: GRC 4039
Program : GRC 4039 Target (a) PhosphoDiesterase (PDE) IV Inhibitor (b) TNF – Alpha Inhibitor (c) T‐Cell Cytokine Inhibitor Indication Rheumatoid Arthritis (RA), Multiple Sclerosis & other inflammatory disorders Status Completion of Phase I Trials, Phase II to be initiated for RA Good safety , tolera
Slide 24: GRC 4039 – Clinical Development Update
GRC 4039 – Clinical Development Update Clinical Development Completion of Phase I Trials, Phase II to be initiated for RA •56 subjects completed Single Dose study and 32 subjects completed Multiple Dose study •Good safety and tolerability •No serious adverse effects were noted during the study •Favo
Slide 25: Program: GRC 10693
Program : GRC 10693 Target Cannabinoid‐2 (CB‐2) Receptor Agonist Indication Neuropathic Pain, Osteoarthritis and other Inflammatory Pain Status Entered Phase I trials and is progressing well. Expected to enter Phase II before the end of Strengths of the program‐ FY’09. Ongoing discussions with sever
Slide 26: GRC 10693 – Highly specific for CB2 over CB1
GRC 10693 – Highly specific for CB2 over CB1 & High efficacy in pain models CB1 vs CB2 – CB1 agonists (Narcotics such as Morphine, Codeine) are well established analgesics but are plagued by psychoactive side effects while CB2 may be devoid of this side effect In‐Vivo Efficacy Model – GRC 10693 – Hi
Slide 27: GRC 10693 – Clinical Development Update
GRC 10693 – Clinical Development Update Clinical Development Glenmark is currently conducting a Phase I clinical study in healthy volunteers in Europe. This study is designed to investigate the safety, tolerability and pharmacokinetics of single and multiple doses of GRC 10693. The study will be c
Slide 28: Program: GBR 500 - Monoclonal Antibody
Program :GBR 500 ‐ Monoclonal Antibody [mAb] Target Antagonist of the VLA‐2 (Alpha2 βeta1) integrin Indication MS (Multiple Sclerosis) , inflammatory diseases like IBD (Inflammatory Bowel Disease) Status Filed an IND application with the US FDA for initiation of Phase I trials. Phase I will be immed
Slide 29: GBR 500 – Broad Anti-inflammatory Potential
GBR 500 – Broad Anti‐inflammatory Potential Broad Anti‐inflammatory Potential‐ GBR 500 •Integrins regulate movement of leukocytes and cytokine release •Alpha2Beta1 integrin antagonist (GBR 500) targets integrin receptors and is an effective therapy for various inflammatory disorders •These disease m
Slide 30: Program: GRC 15300
Program: GRC 15300 Target Transient Receptor Potential Vanilloid (TRPV)3 Antagonist Indication Osteoarthritic pain, Neuropathic Pain, Urinary Incontinence. Status TRPV3 – GRC 15300 (Formerly GRC 17173) •Glenmark decided to pursue a better candidate ‐ GRC 15300 than GRC 17173. •Change will not signif
Slide 31: GRC 15300 – Strengths of the Program
GRC 15300 – Strengths of the Program Strengths of the program‐ •Glenmark has one of the most in‐depth research programs in TRP channels globally •Potential first‐in‐class for TRPV3 •TRPV3 target acts in different temperature range devoid of hyperthermia issues. This is contrary to some of the TRPV1
Slide 32: GRC 15300: first-in-class opportunity in various pain conditions
GRC 15300: first‐in‐class opportunity in various pain conditions First‐in‐class Opportunity Some TRPV3 Ligands Patented: But None in Clinical Development High Efficacy observed in Animal Models of Neuropathic Pain Company Mechanism Effect of GRC 15300 on CCI - induced mechanical hyperalgesia in male
Slide 33: Program: GBR 600 - Monoclonal Antibody
Program :GBR 600 ‐ Monoclonal Antibody [mAb] Target Von Willebrand Factor Indication Thrombotic Stroke /Acute Coronary Syndromes; Cardiovascular Disorders Status Currently in pre‐clinical development, showing good progress Strengths of the program‐ Glenmark expects to file for Phase 1 by March ‘09.
Slide 34: GBR 600: Potentially high efficacy & safety
GBR 600 : Potentially high efficacy & safety Blood Loss Liability minimised with GBR 600 in non‐human primate model 18 16 16 Efficacy & Safety of GBR 600 – 14 Average of relative blood loss •Bleeding was self limiting and not severe 12 10 •GBR 600 shows high potency and 8 8 insignificant bleeding in
Slide 35: Program: GRC 9332
Program: GRC 9332 Target Stearoyl CoA Desaturase‐1(SCD1) Inhibitor Indication Obesity; Dyslipidemia; NAFLD; Metabolic Syndrome Status Currently in IND enabling studies Plans to file a Phase 1 application by the end of this financial year or early next year. Key Differentiators • Potential first in c
Slide 36: GPL – Specialty Business
G Glenmark GPL -— Specialty Business Rest Of The World (RoW) Finished Dose Formulations as European Union (EU) United Sates (US) 36
Slide 37: Rest Of The World (RoW) – The Year Till Date
Rest Of The World (RoW) – The Year Till Date Russia CIS: Building on stronghold in Russia while increasing focus on 3 major CIS countries LatAm -Continuing intense Russia & activity in the sphere of new CIS India : Sharpening focus market entry through divisional Lat Am approach India Africa-ME: Mak
Slide 38: India Formulations – The year till date & going forward
India Formulations – The year till date & going forward: H1 Highlights •Revenue increase of 16.8% over H1 FY 2008 •Steady growth driven by new brand introductions and successful strategy of divisionalisation •According to ORG Sep 2008, Glenmark registered a value growth of 17.7% in the Indian pharma
Slide 39: India Formulations – Revenues and Growth Drivers
India Formulations – Revenues and Growth Drivers India : Growth Drivers Revenues in USD Mn 175 •FY09‐ Increasing share of Dermatology market 152 through multiple divisions 135 •Innovative product launches (Novel combinations, NDDS) •Critical Care segment entry through new division ‘Critica’ •FY10‐ D
Slide 40: Russia-CIS, Africa-Middle East & Asia-Pacific – The year till date
Russia‐CIS, Africa‐Middle East & Asia‐Pacific (Semi Regulated Markets) – The year till date & going forward: H1 Highlights •H1 revenues from Asia, Africa and CIS region were USD 25.72 Mn registering growth of 10.8% over H1 2008 •The company filed 17 products and received 84 product approvals in SRM
Slide 41: Semi Regulated Markets Revenues and Growth Drivers
Asia‐Pacific , Africa‐Middle East & Russia‐CIS (Semi Regulated Markets) Revenues and Growth Drivers : Revenues in USD Mn Asia Pacific: Growth Drivers •FY09‐ Healthy growth numbers from subsidiaries in Malaysia, Philippines ; •Entry into large hospital segments in mkts. Including Vietnam, Malaysia •F
Slide 42: Latin America – The year till date & going forward
Latin America ‐ The year till date & going forward: H1 Highlights •Glenmark’s revenues from Latin American operations registered an overall decline of 9.4% over H1 2008. Mainly attributed to tender orders that were executed in 1st qtr of last financial year. •As reported by IMS Sept. ’08 , the Brazi
Slide 43: Latin America – Revenues and Growth Drivers
Latin America ‐ Revenues and Growth Drivers : Revenues in USD Mn 80 LatAm : Growth Drivers 60 •FY09‐ Organic growth in Brazil and 48 initial contribution from Peru, Venezuela •FY10‐ Niche product launches in Brazil & New Market growth in Peru, Venezuela & Mexico FY 2008 FY 2009 * FY 2010 * *Projecte
Slide 44: European Union (EU) - United States (US)
The year till date and going forward – European Union (EU) ‐ United States (US) H1 Highlights •Glenmark’s EU operations registered growth of 160.3% over H1 •Glenmark is actively looking at inorganic entry 2008 (mainly attributed to brand acquisitions in Poland) options into the US Specialty market •
Slide 45: GPL – Operations: H1 Highlights
GPL – Operations: H1 Highlights H1 Highlights •Completed capacity expansion at formulations plant at Nashik ,India •Commenced site activities at •Biologics API plant at Aurangabad, India •New formulation plant at Brazil •Acquired land from SEZ at Indore, India: Basic engineering for building over te
Slide 46: GPL – Operations: Near Future Expansion Plans
GPL – Operations: Near Future Expansion Plans Facility Timelines for Projected Capex Projected Capex commissioning Spend 0809 (USD Mn) Spend 0910 (USD Mn) Biologics Biologics API Plant Q1 2010 14 2.7 API Pilot Plant & Q3 2010 0.3 5.6 Clinical Module for NCEs Formulations Czech Plant – Q4 2009 2.2 2.
Slide 47: GPL - Financials & Projections
GPL ‐ Financials & Projections *Projected Gr. : 25% Profits In $ mn 93 123* 157* 47
Slide 48: GGL – Span of Operations
GGL – Span of Operations GGL API Finished Dose Formulations Argentina Global US EU (Oncology) 48
Slide 49: GGL: Progression towards Global Integrated Generic & API Leader
GGL : Rapid progression towards attaining its vision of becoming a Global Integrated Generic & API Leader Active Pharmaceutical Ingredients: •Continued expansion of API capabilities to support both internal and 3rd party dosage forms European Union: •Focus on difficult to develop molecules •In proce
Slide 50: US Formulations – The year till date and going forward
US Formulations – The year till date and going forward H1 Highlights •Continued excellent performance by Glenmark Generics Inc. USA. The subsidiary posted H1 revenues of over USD 85.90 Mn registering a growth of 124.2% over H12008 •Filed 10 ANDA’s with the US FDA and received 5 approvals during H1 2
Slide 51: GGL: Expanding Presence in the US Generics Market
GGL : Expanding Presence in the US Generics Market Plans to participate in > 50% of market ,in focus therapy areas, by 2014 Market covered by projected GGL Therapeutic Category Total US Market (USD Bn) portfolio ‐ FY 2014 (USD Bn) Dermatology 4.3 2.5 Controlled Substances 12 4 Modified Release 22 12
Slide 52: GGL: Stepping-up ANDA filings in focus therapy areas
GGL : Stepping‐up ANDA filings in focus therapy areas Till FY2008 H1 2009 Projected H2 2009 Projected 2010 Dermatology 10 2 7 8 Controlled Substance 4 ‐ 3 4 ANDA Filings Update Modified Release 6 2 4 10 Hormones 3 ‐ 4 5 Oncology ‐ ‐ ‐ 5 First‐to‐file (P IVs) 6 1 2 3 Immediate Release 32 5 4 4 Total
Slide 53: EU Formulations – The year till date and going forward
EU Formulations ‐ The year till date and going forward H1 Highlights •Glenmark Generics Europe Ltd (GGEL) achieved a major milestone by launching its first product in Western Europe via initiation of sales of Perindopril tablets in the UK. •Filed 8 Marketing Authorization Applications (MAA’s) till d
Slide 54: Oncology (Argentina) – The year till date and going forward
Oncology (Argentina)‐ The year till date and going forward H1 Highlights •Oncology business posted growth of over 35.9% with revenues of USD 5 Mn, as against H1 2008 •Glenmark Generics SA filed 4 dossiers & 31 Extra company* dossiers •Launched products in Ecuador, Venezuela, Yemen, Paraguay *Extra-c
Slide 55: Active Pharmaceutical Ingredients (API) – The year till date
Active Pharmaceutical Ingredients (API) – The year till date and going forward H1 Highlights •Global API business posted growth of over 14.5% with revenues of USD 22 Mn, compared to H1 2008 •Initiated business in South Africa & Egypt •Company has filed 32 DMFs till date. Additionally 4 European DMFs
Slide 56: GGL Operations – H1 Highlights
GGL Operations – H1 Highlights H1 Highlights Goa plant (India) increased capacity by 33% . Added 4th oral solids line ANVISA audit and approval in Goa Formulations Facility, India Successful US FDA audit – Goa Formulations Facility, India Successful US FDA audit ‐ Ankleshwar API facility, India Succ
Slide 57: GGL Operations – Near Future Expansion Plans
GGL Operations – Near Future Expansion Plans Facility Timelines for Projected Capex Projected Capex commissioning Spend 0809 Spend 0910 (USD Mn) (USD Mn) R&D Phase II (Expansion) at Q2 2010 4.4 4.4 Taloja, India API Expansion At Ankleshwar, Q2 2010 2.7 2.7 India New API Facility At Q1 2011 0.1 11.1
Slide 58: GGL - Financials & Projections
GGL ‐ Financials & Projections 429* 297* 10 196 4 Gr. : 44% Gr. : 52% Profits In $ mn 64 87* 125* 58
Slide 59: Glenmark – Consolidated Financials
Glenmark – Consolidated Financials 932* *Projected Revenues In USD Mn 673* 499 Gr.: 38% Gr.: 35% In USD Mn FY 2008 FY2009 FY2010 PAT (USD Mn) 157 210 282 Basic EPS (INR) 25.81 34.52 46.36 P/E 18.98 8.78 6.54 •Basic EPS: Doesn’t consider impact of dilution on account of ESOps and convertible bonds •I
Slide 60: Thank You
THANK YOU For queries on Glenmark Pharmaceuticals Ltd, please contact: media@glenmarkpharma.com For queries on Glenmark Generics Ltd, please contact: connect@glenmark-generics.com 60
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