investor and analyst meet presentation 11feb13

7/29/2019 Investor and Analyst Meet Presentation 11Feb13

1/35

Shasun Pharmaceuticals Limited

Analyst meeting Presentation

11th February 13


2/35

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.


3/35

3

Business Outlook

SHASUN


4/35

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


5/35

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


6/35

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


7/35

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


8/35

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


9/35

Formulation - Strategy

Technology ValueCreation

India : Generic In-

House & Out Licensing

CDAMS

NDA 505 (b) (2) Complex Formulations

Products in Development Team India

In Progress


10/35

CDAMS Formulations product pipeline

Strong growth product pipeline


11/35

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


12/35

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


13/35

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


14/35

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


15/35

Shasun India Review of YTD Dec 12


16/35

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


17/35

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


18/35

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


19/35

19

Business Review

Shasun Pharma Solutions Limited, UK

12 13 S SL U d


20/35

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


21/35

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


22/35

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


23/35

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


24/35

PROTECT and extract maximum value from established businesses

NURTURE new growth opportunities

SECURE and deliver new business

Strategy for growth

CRAMS SPSL UK Pipeline


25/35

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


26/35

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


27/35

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


28/35

28

Financial Review

Shasun

Shasun Sales


29/35

29

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


30/35

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


31/35

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


32/35

SPSL UK Financial YTD Dec 12

SPSL UK Standalone (GBP 000) Q3 FY13 Q3 FY12 9M FY13 9M FY12



Operations cost 5,121 5,437 15,138 15,680


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


33/35

Consolidated Financial YTD Dec 12

Consolidated (Rs. Lakh) Q3 FY13 Q3 FY12 9M FY13 9M FY12



Operations cost 10,829 9,824 31,498 26,374


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


34/35

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


35/35

Thank You

investor and analyst meet presentation 11feb13

Documents