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Disclaimer
This presentation may include certain forward looking statements , based on current expectations, within the meaning of applicable laws and regulations. Actual results may differ and the company does not guarantee realization of these statements. The Company also disclaims any obligation to revise any forward-looking statements. The readers may use their own judgment and are advised to make their own calculations before deciding on any matter based on the information given herein. No part of this presentation may be reproduced, quoted or circulated without prior written approval from Shasun Pharmaceuticals Limited.
SHASUN
Business Outlook
Mission
Shasun people, facilities and capabilities are among the best in the industry. Shasun cover the entire life cycle of a product at all scales, from pre-clinical and clinical phases to validation and commercial supply, while fully complying with HSE and cGMP regulations and standards within FDA and MHRA approved facilities.
Global Footprint
V iza g-India
Shasun has developed its presence in some of the major countries in the world. We continue to expand our base and globalize further.
BUSINESS MODEL
Pre-Launch
FTE Low Cost Intermediates Tactical Kg (Big Pharma) Total Service Offering Hazard / Complexity / API Strategic Supply Options Project Management Geographic Preferences Post-Launch Cost Effective API & Formulation Total / High Service Hazard / Complexity / API Assurance of Supply Flexible Asset Base
PI
PII
PIII
Technology (F, HKR) Application of NOPPs Highly Experienced and Customer Focused People
Business overview
Shasun Business Segments Active Pharmaceutical Ingredients: Shasun is the largest manufacturer of Ibuprofen in the world. Its current API portfolio includes Ibuprofen, Nizatidine, Ranitidine , Gabapentin , Olanzapine and Cycloserine amongst others Active New API product development pipeline API Contract Research & Manufacturing (CRAMS): Shasuns CRAMS business spans India and UK SPSL Dudley, UK facility has over 40 years of expertise in working with top pharma companies for custom services and manufacturing. It has a very healthy mix of emerging and big pharma clients Finished Dosages Formulation CRAMS Provides oral solid dosage development and manufacturing services at its Formulations facility in Pondicherry This facility has undergone successful inspections by US FDA, MHRA (UK) and TPD Health Canada Recently expanded the formulations capacity from 1.4 billion tablets per annum to 5 billion tablets per annum Biotech: This unit launched Streptokinase, a fibrinolytic drug used for the treatment of heart attacks
API facility in Cuddalore Multi-product API facility 4 Production Blocks, cGMP operation US FDA / MHRA approved Formulations - Pondicherry Commissioned in Dec 2005 ,cGMP operation Formulation development capabilities Current capacity to manufacture 5 billion units of OSD US FDA / MHRA approved Contract Formulations to US / EU
Cuddalore
Pondicherry
Shasun Research Centre (SRC) Chennai Contract research and custom synthesis services 12 synthetic labs, 6 kilo Labs and 1 scale up facility Key customers in Japan, USA and EU which include large MNC Pharma Biotech Facility Pondicherry Production of recombinant streptokinase Facility approved for COPP /WHO
Shasun UK facility
42 Acre Site Process Research &Development Laboratories Scale Up Laboratory Facilities Highly flexible Pilot Plant 3 Large Scale Production Facilities D1, D1.5 & D2 450 m cGMP reactor capacity Commercial Biological Waste Water Treatment Facility Top Tier COMAH site Successful MHRA audit November 2010 Successful FDA PAI May 2011 Successful PMDA PAI in July 2011
Pondy Ibu Plant 1. New alternative Fuel Boiler installed, resulting in reduced steam cost 2. Signed long term contracts with big pharma for supply of Ibuprofen 3. Completed capacity expansion Cuddalore 1. 2. 3. Process optimization for a major API Capacity expansion for API Plant commissioned within 5 days of cyclone
CRAMS API 1. 2. 3. Integration of UK and Indian CRAMS to create a global CRAMS organization Emerging Pharma customer acquisitions-current year 11 new customers Break through with one Big pharma involving 10 FTE contract
Vizag new facility 1. Phase I construction started and expected to be completed by Dec 12 Corporate 1. 2. Opened China sourcing office Capex committed spend for 9 months Rs 50 Cr to support growth
Formulations
Technology tie-ups
APIs growth Grow Ibuprofen derivates Increase in API capacity Focusing on new products development New market growth
Capacity expansion
Formulations growth Capacity expansion and new contracts Own ANDA filings Shasun branded formulations, investment for future
Cost optimization
CRAMS growth New customers/ new products acquisition in US, EU and Japan New facility in Vizag
Biotech
CRAMS
APIs
API -Portfolio
Product Ibuprofen and Derivates Gabapentin Growth drivers Shasun is one of the largest manufacturers of Ibuprofen in the world. Ibuprofen and its derivatives offer new growth opportunities with improved margins The product went generic in US in 2005 and has since then been a significant growth driver for Shasun Capacity expansion will help the growth Nizatidine is an anti-ulcerant drug. It is used for the treatment of multi drug resistant TB. The Company commercialized the product in EU and North American market in FY 11. Shasun filed DMF in 2009. The drug is going generic in 2013. Shasun filed DMF in 2009, The drug is going generic in 2013. Shasun filed DMF in 2009, The drug is going generic in 2014.
Manufacturing capacities for Key products in most licences in US / EU & SEA incl India
Approved as suppliers
Gaba )
No. of DMFs
US DMF Filings
3 2 1 0
FY 11-12 1 0 1
FY 12-13 E 6 4 6
FY 13-14 E 7 5 7
Nano technology
SHASUN-NBI has developed a radioactive gold nano construct
based therapeutic agent, NBI-29 (GA-198AuNP) for treating solid tumor
NBI-29
NBI-29
efficacy and is considered to be a significant oncological breakthrough as it will realistically alleviate pain and suffering of cancer patients
Tumor
Preclinical
Treated Group
toxicity study in swine. Efficacy study in dogs being carried out and additional tox study planned in rodents & rabbits
Further scale-up of OSD revenues through contractual agreements While the service oriented model remains the key pillar of the business, Shasun is also investing in building its own ANDA. Near term focus on site transfer business and build client relationships Product development services emerging pharma customers on NCE to
Scale up OSD revenue Capacity expansion Site transfer business Product development services
Plans to tie-up with Pharma Companies for launch of Patented Products in India
CRAMS API
Partnering with innovators in the early phase Seeking Timely opportunities and building success Stories= Able Management. Sustaining Growth through in house talent- experienced motivated team, IP assets, State of Art regulatory compliant facilities. World Leaders in supplying some of the APIs. Global foot Print offerings Pipeline of Mega blockbusters
CRAMS API
Shasun portfolio has grown to 37 launched products. The pre launch pipeline remains strong with 28 projects in the clinical phase 2 & 3 API CRAMS UK Pipeline
30 25 20 15 10 5 0 Phase I Phase II Phase III Launch 9 11 8 28
Shasuns focus is on its core strengths of safety & quality compliance, continuous improvement and innovation, which has continued to attract new clients.
The Shasun CRAMS business unit has focused on several markets for growth and built many key relationship with innovator companies
Phase II
Phase III
Launch
Product A, API Launch, Antidepressant Product B, interm.Launch,Antidepressant Product C, interm Launch, Anti gout Product D, API Product E, API Product F, interm Product G, API Prelaunch, ED Prelaunch, Diabetic Phase 3, Asthma Phase 2,
Business Review
26
Proof of concept to commercial supply - a full range of services across all phases of the product lifecycle on one site
Investment Update
Over the last 12 months we have invested around 2.8M at Dudley Investment in general infrastructure upgrades of around 1M New capability investment of around 1M Upgrades to enhance pilot plant capabilities, replacing last remaining older technology isolation units Investment to enhance drying capacity on Dudley 2 in order to increase utilisation New expansion to Purified Water System Capacity enhancements on D1 and D2 for key product production expansions .. With customer support of 1.4M
Pilot Plant Upgrades New High Pressure Lab Suite
Maintaining and nurturing our key growth driver products Prospecting for new business Technology promotion and targeted offers
CRAMS -Pipeline
28
10
12 8
Phase I
Phase II
Phase III
Launch
100-300MT; 25-50M Potential for 20MT per annum ; 3-4M Future : 1MT for 2M
10-20MT; 1.5-2.5M
14% 6% 40%
7% 23%
11%
40%
59%
Big Pharma Biotech Mid Size / Emerging Non Pharma
2009-10
2011-12
R&D Capabilities
Part of Shasun Global R&D Organisation CTO Michel Spagnol UK Head of Technical Services Paul Quigley Strong IP portfolio of more than 40 patents 41 Scientists based in UK (60% PhDs) cGMP Kilo Lab facilities from 10 to 50L High Potency Capability at 10 and 20L World Class Hazard Evaluation Lab Special capabilities: Chiral Synthesis, Azides, Thiophosgene, Diphosgene, HF, TMS Cyanide, diazomethane North East Process Industry Cluster (NEPIC) Innovation Award Winner Winner in 2011 for 4th Generation HKR Catalyst Winner in 2012 for Novel Synthesis to Huperazine A
Shasun
Financial Review
39
Shasun Sales
Sales Product (Rs laks) Q3 FY12 Q3 FY11 Growth 9M FY12 API 16,625 11,846 40% 41,907 Ibuprofen & derivatives 7,156 6,112 17% 18,360 Other APIs 9,469 5,734 65% 23,547 CRAMS CRAMS - API CRAMS - Formulation Bio Tech SPL - TOTAL SPSL UK -CRAMS TOTAL 4,465 2,637 1,828 66 21,156 9,724 30,880 2,652 68% 1,174 125% 1,478 24% 59 14,557 5,279 19,836 12% 45% 84% 56% 10,785 5,205 5,580 122 52,814 23,024 75,838 9M FY11 Growth 35,095 19% 17,339 6% 17,756 33% 7,563 3,405 4,158 105 42,763 18,375 61,138 43% 53% 34% 16% 24% 25% 24%
40
Closing Closing Closing (31.12.2011) (30.09.2011) (30.06.2011) Total Borrowings 25,831 24,292 22,395 Net Worth 18,479 17,523 17,274 Debt /Equity 1.40 1.39 1.30 Shasun Pharmaceuticals Limited - Consolidated Closing Closing Closing Closing Funding Details (31.12.2011) (30.09.2011) (30.06.2011) (31.03.2011) Total Borrowings 38,739 36,579 33,037 32,954 Net Worth 11,998 9,971 9,025 8,392 Debt /Equity 3.23 3.67 3.66 3.93
Financial Update
Sales growth of 22% EBITDA 93% growth and current year 9 months FY 12 EBITDA exceeded full year FY 11 EBITDA EBITDA /Sales current year 13% vs 8% last year PAT Current year 9 months FY 12 PAT Rs 41.59 exceeded full year FY11 PAT Rs 26.62 crs Re-structuring of portfolio more added value business Good growth in newer products Continued success in new product capture providing a healthy pipeline of new business
Create differentiated product / service offerings Improving operating margins Expansion of API /Formulation capacity Enhanced focus on New Business Development Expansion into new products/ geographies Focus on achieving sustainable growth Enhance shareholder returns
Achieving sustainable growth and enhancing shareholder wealth remains our key objective.
Thank You