investor and analyst meet presentation 11feb13
TRANSCRIPT
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Shasun Pharmaceuticals Limited
Analyst meeting Presentation
11th February 13
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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. TheCompany 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.
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3
Business Outlook
SHASUN
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Shasun Growth Strategy
Shasun is working towards growth strategy Rs 2000 Crs by FY 15
Fo
rmulations
CRAMS
Biotech
NewMarkets
APIs
APIs growth
Capacity increase for Ibuprofen
and derivates
Increase in API capacity -
Focusing on new products
development
New market growth
Formulations growth
Capacity expansion and new
contracts
Own ANDA filings
Co Development
CRAMS growth
New customers/ new products
acquisition in US, EU and Japan
New facility in Vizag
Exploit technology differentiation
Biotech/Nanotech growth
Exploring biosimilars
R&D in cutting edge technologies
with collaborative efforts
Nano technology development
Technology tie-ups New productsCapacity expansion Cost optimization
Growth Drivers
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Business Verticals
API &Intermediates
Matured and NewAPIs
FORMULATIONS
Oral Solid Dosage(Tablets & Hard Gel
Capsules)
Developmentcapabilities ranges
from OSD to TopicalGel; Oral Dry Powder
Suspension and OralSolution
CRAMS
Contract Researchfacility in India & UK
ContractManufacturing
facility in India & UK
BIOTECH &NANOTECH
Biosimilars
Radioactive GoldNanoparticles
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API Strategy
Product Growth drivers
Ibuprofen and
Derivates
Shasun is one of the largest manufacturers of Ibuprofen in the world.
Ibuprofen Derivatives growth in Europe and South Asia with improved margins
Gabapentin Capacity expansion and process improvement will help the growth
Market growth in India, S Asia , EU and Africa
Nizatidine Nizatidine is an anti-ulcerant drug and reentry in to Japan market
Cycloserine Used for Multi drug resistant TB. Tender based market , one of the 2 suppliers
approved by WHO
Tenofovir DMF filed in 2012 and product sales in 13-14
Sevelamer HCl Shasun filed DMF in 2009. Growth driver-Patent Expiry Aug 13
Sevelamer
Carbonate
Shasun filed DMF in 2009. Growth driver -Patent Expiry Aug 14
Colesevelam Shasun filed DMF in 2009. Growth driver -Patent Expiry Apr 15
New products 5 DMF filled in FY 13 and 11 Products under development to support growth
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API Products DMF filings FY 13
S No Product DMF Category DMF filed
1 Pitavastatin calcium US DMF 11thApril 2012
2 Tenofovir US DMF 24th May 2012
3 Levetiracetam US DMFCEP
27th September 201228th September 2012
4 Milnacipran HCl US DMF 26th November 2012
5 Dextromethorphan US DMF 26th December 2012
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API New products pipeline
Product pipeline to support growth
APIs under dev Therapeutic Area Product Peak Sales US Patent Expiry
Product - 1 Anti-viral -WHO $4 Bn Jul '17
Product - 2 Anti-inflammatory $800 M Open
Product - 3 Anti-ulcerant $3.4 Bn Open
Product-4 Metabolic disorder $750 M Sep '18
Product - 5 Anti-emetic $500 M Jul '18,
Product - 6 Anti-convulsant $4.3 Bn Dec '16
Product - 7 Anti-ulcerant $610 M Jun '20
Product - 8 Lipid lowering agent $6 Bn Dec '16
Product - 9 Metabolic disorder $600 M Nov '25,
Product - 10 Respiratory Disease $1 Bn Jan '20
Product-11 Anti-coagulant $4 Bn Feb '22
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Formulation - Strategy
Technology ValueCreation
India : Generic In-
House & Out Licensing
CDAMS
NDA 505 (b) (2) Complex Formulations
Products in Development Team India
In Progress
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CDAMS Formulations product pipeline
Strong growth product pipeline
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Own ANDA development -Products under development launch in phased
manner FY 15 to FY 17
Long term contracts with large generic players
Big Pharma partnership for contract manufacturing
Profit sharing agreements to provide benefit by FY 15
Domestic formulation entry
Formulation move up in value chain
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Formation of Team India Formulations as per plan with 138 adequately trainedand purpose oriented employees.
Successful launch of Siren a cause based campaign towards Eradication of
Childhood anemia.
3000 Plus doctors 2000 plus retailers and several other caregivers are made to
experience the unique strengths, approach and value proposition of Brand
Shasun
10 products with 16 SKUs to reach market by March 13.
India - Formulation marketing
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CRAMS API Pipeline SPL
5
12
5
3
8
0
2
4
6
8
10
12
14
Preclinical Phase I Phase II Phase III Launch
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SHASUN-NBI LLC S-NBI-29
Clinical trial study in patient dogs with prostate cancer 12th dog in progress and
results consistent with respect to tumour regression. Total of 20 dogs to be done.
Biodistribution study in healthy dogs 2 more dogs being done and positive
indication of being selectively retained only in tumour cells and leaking out of
normal cells
Preparatory steps underway for IND submission for Phase-1 trials:
Additional preclinical studies (toxicity) being undertaken
Compiling Investigators Brochure & setting up Advisory Board
Pre-IND meeting being setup with US FDA in June 13
IND submission targeted by Sep13
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Shasun India Review of YTD Dec 12
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Shasun India Business Update
Formulation
1. Profit sharing agreement signed with a US based customer for 4 products andfirst launch expected in 2015
2. WHO-Geneva has approved the facility
3. NCE Molecule development contract for 3 major customers
Pondy Ibu Plant
1. Ibu Derivatives capacity expanded2. Long term supply contracts for supply of Ibuprofen
3. Backward integration of raw material project
Cuddalore
1. Reduction realisation in one of the API
2. Process improvement projects to improve the margin
3. Facility inspected by WHO Geneva and approval awaited
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Shasun India Business Update
Bio Tech
1. Gold Nano particle project IND application with US FDA by Sep13
2 Tapping into the opportunity of Tender businesses
3. Dossiers being submitted for export marekts
CRAMS API
1. Japan focus area for growth and secured two new projects
2. NCE Molecule development contract for 2 customers
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Major Strategy Projects
New Plant for API in Cuddalore plant
Creation of new production block for New Products in Cuddalore
Green field project in Vizag Phase I
Formulation capacity expansion Phase II
Existing products capacity expansion in line with sales
Backward Integration of key raw material
Sh h S l i i i d
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Business Review
Shasun Pharma Solutions Limited, UK
12 13 S SL U d
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12-13 SPSL Update
People
Stable UK Management Team has an average of 20 years
of service at the Dudley site
Expanded Business Development Team working well
and delivering increased number of RFPs
Staff transfer program continues with Shasun, India to
share best practice and enhance level of integration
Profitability
YTD EBITDA of 6.0M vs 5.2M last year
EBITDA/Sales margin of 23% vs 17% last year
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12-13 SPSL Update
Sales Activities
Client visits to site up 50% on 11-12
Request for Proposal (RFP) count up 35% on 11-12
Proposal performance up 11% on 11-12
Compliance (Quality, Safety, Environmental)
Successful completion of several major HSE regulatory inspections
Record waste treatment & bioplant performance
Continued strong performance on Process Right First Time
Over 80 customer visits & 10 successful customer Quality Audits
during 2012-13
In estment Update 12 13
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Investment Update 12-13
Over the last 12 months we have invested around 2.5M at Dudley
Investment in general infrastructure upgrades of around 1M
New capability investment of around 1.5M
New cGMP Scale Up Lab Hydrogenation Suite
Successful validation of new 20L high pressure, high
containment API suite
Established facility for production of Controlled Substances
Enhanced capabilities for Bio treatment plant
R&D Capabilities
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Part of Shasun Global R&D Organisation
Strong IP portfolio of more than 40 patents
Over 40 Scientists based in UK (60% PhDs)
World Class Hazard Evaluation Lab
UK Process Industry Innovation Award Winner in
2011 and 2012
Strong reputation for high levels of technical and
service excellence
UK Development Resources (Chemistry, Scale Up
Labs and Pilot Plant) currently running at capacity
R&D Capabilities
Strategy for growth
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PROTECT and extract maximum value from established businesses
NURTURE new growth opportunities
SECURE and deliver new business
Strategy for growth
CRAMS SPSL UK Pipeline
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CRAMS SPSL UK Pipeline
12 new products introduced in last 12 months
7
10 10
25
Phase I Phase II Phase III Launch
K G th D i E i ti P d t P t SPSL UK
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Key Growth Drivers Existing Product Prospects SPSL UK
Phase &
Application
Status Annual Potential
API for European
Biotech
Phase III; Alzheimers Phase III initiated; Validation ProposalAgreed; Supply Agreement discussions in
progress
15-35M
Technology Product for
European Big Pharma
Launched; anticoagulant
Over 30% growth achieved in 2012-13;progressing demand for 2013-14
1.5-2.5M
Registered Intermediatefor European Big
Pharma
Phase III; RespiratoryDisease Good Phase III data; launch in 2013-14;SPSL to be only validated source 1-2M
API for European
Biotech
Phase II for Psoriasis, Piloting, scale up and validation proposalsin progress; client looking for a supply
agreement
5-8M
Technology
Intermediate for
Generic Product
Generic Launch forVentricular failure
Working with client to supply keyintermediate using HKR technology; 2013order finalised, looking at back integration
4-6M plus back integration
Key New Business Opportunities SPSL UK
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Key New Business Opportunities SPSL UK
Database of Open Proposals Value at 20M
Phase &
Application
Status Annual Potential
Technology
Intermediate for US
Biotech
Phase III for Psoriasis Technology application to target key chiralintermediate for Phase III API; MSA signed
and POC work in progress in lab
5-10M
API fro European Big
Pharma
Launched; HIV Bid submitted to re-enter supply chain as2nd source;
3M
API for US Biotech Phase III; Oncology Bid will be accepted and supply agreement
granted subject to positive Phase III interimresults in Q1 2013
3-5M
Hazardous
Intermediate European
Pharma
Launched; ImagingAgent
Client interested in SPSL option due topast experience with this hazardous
process
5-7M
Fine Chemical
Intermediate
Fine chemical Evaluating Dudley options for supply of keyfine chemical intermediate based on scale
and hazard
2.5M
Shasun
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Financial Review
Shasun
Shasun Sales
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Shasun Sales
Sales Product (Rs laks) YTD Dec 12 YTD Dec 11 Growth % of Business
API 39,319 38,956 1% 51.4%
Ibuprofen & derivatives 22,982 18,475 24% 30.0%
Other APIs 16,338 20,481 -20% 21.3%
CRAMS India 13,595 10,792 26% 17.8%
CRAMS - API 3,048 5,211 -42% 4.0%
CRAMS - Formulation 10,547 5,581 89% 13.8%
Bio Tech 423 122 246% 0.6%
SPL India - TOTAL 53,336 49,871 7% 69.7%
SPSL UK -CRAMS 23,209 22,750 2% 30.3%
TOTAL 76,545 72,621 5% 100.0%
SPL India Forex position YTD Dec 12
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SPL India Forex position YTD Dec 12
All pending contracts closed
Forex details Rs laks Q1 FY13 Q2 FY13 Q3 FY13 YTD Dec-12
Cash Loss Forward Contract 980 1,025 180 2,185
MTM and Reinstaement (12) (2,045) (350) (2,407)
Total Loss / (Profit) 968 (1,020) (170) (222)
SPL India Financial YTD Dec 12
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SPL India Financial YTD Dec 12
SPL Standalone (Rs. Lakh) Q3 FY13 Q3 FY12 9M FY13 9M FY12
Sales & operating revenue 19,915 21,284 57,761 53,323
Rawmaterial cost 12,634 12,438 35,416 33,548
Operations cost 6,066 5,389 17,040 14,073
Total operating cost 18,700 17,827 52,455 47,621
EBITDA 1,216 3,457 5,306 5,702
EBITDA % 6.10% 16.24% 9.19% 10.69%
PBT - after forex loss (69) 1,402 1,600 (233)
Profit on sale of Asset 181 - 181
Tax (177) 134 180 (1875)
Profit After Tax 289 1,268 1,600 1,642
SPSL UK Financial YTD Dec 12
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SPSL UK Financial YTD Dec 12
SPSL UK Standalone (GBP 000) Q3 FY13 Q3 FY12 9M FY13 9M FY12
Sales & operating revenue 8,343 12,023 26,731 30,090
Rawmaterial cost 1,507 4,057 5,465 9,198
Operations cost 5,121 5,437 15,138 15,680
Total operating cost 6,628 9,495 20,603 24,879
EBITDA 1,715 2,528 6,128 5,211
EBITDA % 20.56% 21.03% 22.93% 17.32%
PBT - after forex loss 769 1,593 3,180 2,556
Tax - - - (667)
Profit After Tax 769 1,593 3,180 3,223
Consolidated Financial YTD Dec 12
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Consolidated Financial YTD Dec 12
Consolidated (Rs. Lakh) Q3 FY13 Q3 FY12 9M FY13 9M FY12
Sales & operating revenue 27,362 31,108 81,556 76,699
Rawmaterial cost 14,049 15,682 39,842 40,469
Operations cost 10,829 9,824 31,498 26,374
Total operating cost 24,877 25,506 71,340 66,843
EBITDA 2,484 5,602 10,216 9,856
EBITDA % 9.08% 18.01% 12.53% 12.85%
PBT - after forex loss 463 2,591 3,978 1,787
Profit on sale of Asset 181 - 181 -
Tax (177) 131 180 (2,373)
Profit After Tax 821 2,460 3,979 4,160
Consolidated Funding Dec 12
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Consolidated Funding Dec 12
Funding as on 31.12.2012 Rs laks SPL India SPSL UK TotalTerm loan 12,361 5,362 17,723
Working capital 26,128 4,781 30,910
Cash in hand (847) (1,931) (2,778)Total Borrowings 37,643 8,212 45,855
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Thank You