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Page 1: Hikal revenue ($ mn) - PharmaCompass · Hikal is a flexible, execution focussed customer oriented company Continued focus on Quality & Regulatory Governance We utilise technology
Page 2: Hikal revenue ($ mn) - PharmaCompass · Hikal is a flexible, execution focussed customer oriented company Continued focus on Quality & Regulatory Governance We utilise technology

Company Overview

• Established in 1988

Listed on the Bombay Stock Exchange

• Equity structure

– Principal shareholders (69%)

• Hiremath and Kalyani families

– World Bank, Washington D.C. (IFC) 9%

– Global Institutional Investors - 11%

– Public – > 8000 shareholders

• Investment Grade Credit Rating – Moody’s

• Business Focus:

• Pharmaceuticals

• Crop Protection

• Specialty Chemicals

2/25/2016

40 4152

8089 82

116 110

138 145

0

20

40

60

80

100

120

140

160

2006 2007 2008 2009 2010 2011 2012 2013 2014 2015

Hikal revenue ($ mn)

© Hikal Limited 2

Page 3: Hikal revenue ($ mn) - PharmaCompass · Hikal is a flexible, execution focussed customer oriented company Continued focus on Quality & Regulatory Governance We utilise technology

Locations

2/25/2016

Head Quarters

Chemicals

Pharma

Research & Development

U.S. Presence, New Jersey Japan Office, Tokyo

© Hikal Limited 3

Page 4: Hikal revenue ($ mn) - PharmaCompass · Hikal is a flexible, execution focussed customer oriented company Continued focus on Quality & Regulatory Governance We utilise technology

Board of Directors

2/25/2016

Baba Kalyani

Jai Hiremath

Chairman & MD

Sameer Hiremath

President & Joint MD

Prakash Mehta Sugandha Hiremath Kannan Unni Dr. Axel Kleemann

Amit Kalyani

Shivkumar Kheny

Dr. Wolfgang Welter

© Hikal Limited 4

Page 5: Hikal revenue ($ mn) - PharmaCompass · Hikal is a flexible, execution focussed customer oriented company Continued focus on Quality & Regulatory Governance We utilise technology

Leadership Team

Jai Hiremath

Chairman & MD

Sameer Hiremath

President & Joint MD

Kumar Inamdar

Crop Protection

Sham Wahalekar

Finance Anish Swadi

Strategy

Kumaar Priyaranjan

HR

Manoj Mehrotra

Pharmaceuticals

© Hikal Limited 5 2/25/2016

Page 6: Hikal revenue ($ mn) - PharmaCompass · Hikal is a flexible, execution focussed customer oriented company Continued focus on Quality & Regulatory Governance We utilise technology

Global Sales Distribution

2/25/2016 6 © Hikal Limited

Page 7: Hikal revenue ($ mn) - PharmaCompass · Hikal is a flexible, execution focussed customer oriented company Continued focus on Quality & Regulatory Governance We utilise technology

Human Resources – Our Intellectual Capital

Experienced workforce working with global innovator and speciality chemical companies

Employees continuously trained through in-house workshops and external programs

Total workforce – 1,163

Production, 347

Engineering, 135

Quality, 133

R&D, 206

Scale-Up, 107

EHS, 40

Support Functions, 195

PhDs, 23

MSc, 261

Engineers, 134Graduates and

Others, 745

© Hikal Limited 7 2/25/2016

Page 8: Hikal revenue ($ mn) - PharmaCompass · Hikal is a flexible, execution focussed customer oriented company Continued focus on Quality & Regulatory Governance We utilise technology

First Indian Company to become a Member of Rx 360

Been an active Rx 360 member since 2010

Rx 360 Facility Audit Report on file

Hikal - Head of Strategy - Member of the Board of Rx 360 (November 2014)

Formed the India Working group in January 2015 ; Co-Head of the India Working Group

Leading the initiative to educate companies and attract more membership and participants

Working with the trade organizations in India (Supply Chain Security initiatives)

Serve on the “Data Integrity Working Group”

Focusing on the security challenges in the local Supply Chain

2/25/2016 © Hikal Limited 8

"At Hikal, we are an integral part of the global supply chain for medicines. Protecting the integrity of

this supply chain is our obligation and responsibility.”

Page 9: Hikal revenue ($ mn) - PharmaCompass · Hikal is a flexible, execution focussed customer oriented company Continued focus on Quality & Regulatory Governance We utilise technology

Regulatory Approvals

• USFDA : Last inspection in April 2014

5th inspection after September 2012, August 2011, June 2008 & June 2004

• EDQM : June 2014

• WHO : Last inspection in December 2015

• KFDA : February 2011

• TGA : March 2006 (certification extended up to 2015)

• PMDA (Japan) : November 2012

• FSSC 22000 : December 2013

2/25/2016 9 © Hikal Limited

QA and QC personnel regularly trained to comply with all recent changes

Sites are audited frequently by multinational innovator companies from the US, Europe & Japan

Integrated Management System

ISO 9001 : February 2014

ISO 14001 : February 2014

OHSAS 18001 : February 2014

Page 10: Hikal revenue ($ mn) - PharmaCompass · Hikal is a flexible, execution focussed customer oriented company Continued focus on Quality & Regulatory Governance We utilise technology

2/25/2016 10

Antidepressant

Anticonvulsant Antiemetic

Antihistamine Antipsychotic

Antialzheimers

Antihypertensive

Antilipemic Hemorheologic

Antidiabetic Antithrombotic

Antiviral

Therapeutic Categories – Hikal Product List

Page 11: Hikal revenue ($ mn) - PharmaCompass · Hikal is a flexible, execution focussed customer oriented company Continued focus on Quality & Regulatory Governance We utilise technology

Regulatory Filings – DMF & CEP

11

Total 18 USDMF filed in various therapeutic categories

9 CEP to Hikal’s credit USDMF CEP

Gabapentin

Gabapentin Process 2

Ondansetron

Ondansetron HCl

Gemfibrozil

Triprolidine HCl

Venlafaxine HCl

Venlafaxine Base

Bupropion HCl

Bupropion Process 2

Cinnarizine

Memantine HCl

Quetiapine Fumarate

Donepezil HCl

Pregabalin

Pregabalin Process 2

Pentoxifylline

Vildagliptin

Decoquinate

Acebutalol HCl

Lacosamide

Olmesartan Medoxomil

Quetiapine Fumarate

EUGMP

Page 12: Hikal revenue ($ mn) - PharmaCompass · Hikal is a flexible, execution focussed customer oriented company Continued focus on Quality & Regulatory Governance We utilise technology

2/25/2016

Intellectual Property – Patent Strength at Hikal

© Hikal Limited 12

Total 67 Patents/ Patent Applications

22 Patents are granted in various countries / jurisdictions

Granted Patents - Pharmaceuticals

Gabapentin

Pregabalin

Vildagliptin

Venlafaxine

Ondansetron

Triprolidine

Valproic acid

Memantine

Donepezil

Quetiapine

Halo-dialkoxybenzene

Prasugrel

Page 13: Hikal revenue ($ mn) - PharmaCompass · Hikal is a flexible, execution focussed customer oriented company Continued focus on Quality & Regulatory Governance We utilise technology

2/25/2016 13

API Development Pipeline at Hikal

Apixaban

Dabigatran Etexilate Mesylate

Darunavir Ethanolate

Rivaroxaban

Sitagliptin HCl/Phosphate Monohydrate

Flurbiprofen

Duloxetine

Valacyclovir HCl

Cobicistat

Dapagliflozin

Canagliflozin / Hemihydrate

Butorphanol

We also offer Intermediates of API from our Product List

Page 14: Hikal revenue ($ mn) - PharmaCompass · Hikal is a flexible, execution focussed customer oriented company Continued focus on Quality & Regulatory Governance We utilise technology

2/25/2016

Solid State (Particle size)

Polymorph

Intellectual property

Regulatory support

Non-infringing routes, Novel routes

Customer Support

© Hikal Limited 14

Page 15: Hikal revenue ($ mn) - PharmaCompass · Hikal is a flexible, execution focussed customer oriented company Continued focus on Quality & Regulatory Governance We utilise technology

Manufacturing Plants – Pharmaceuticals

2/25/2016 © Hikal Limited 15

Page 16: Hikal revenue ($ mn) - PharmaCompass · Hikal is a flexible, execution focussed customer oriented company Continued focus on Quality & Regulatory Governance We utilise technology

Commercial Facilities

2/25/2016 © Hikal Limited 16

• US FDA : September 2012

• EU GMP : January 2014

Panoli – US FDA approved site for manufacturing cGMP Intermediates

Bangalore – US FDA approved site for manufacturing cGMP Intermediates & API’s

• ISO 9001

• ISO 14001

• OHSAS 18001

• USFDA : April 2014, August 2011, June 2004 & June 2008

• EU GMP : January 2014

• WHO GMP

• KFDA

• TGA

• PMDA (Japan)

• ISO 9001

• ISO 14001

• OHSAS 18001

Page 17: Hikal revenue ($ mn) - PharmaCompass · Hikal is a flexible, execution focussed customer oriented company Continued focus on Quality & Regulatory Governance We utilise technology

Research & Development Facility - Pune

2/25/2016 © Hikal Limited 17

Page 18: Hikal revenue ($ mn) - PharmaCompass · Hikal is a flexible, execution focussed customer oriented company Continued focus on Quality & Regulatory Governance We utilise technology

3 Pharma manufacturing facilities with potential for expansion

New multi-purpose plant being constructed

• Total reactor volume 205 m3

– Glass lined 46 m3

– Stainless steel 159 m3

• Number of reactors 45

• Reactor size 450 - 10,000 L

• Agitated Nutsche filters 6,500 L

• Rotary vacuum driers 2000 L

• Fluidized bed drier 100 kg/hour

• AHU system for powder processing area

• High capacity bromination facility

• High temperature reaction facility (+2400c)

• High vacuum distillation facility

2/25/2016

Panoli – US FDA Approved site for RSM’s & Advanced Intermediates

© Hikal Limited 18

Page 19: Hikal revenue ($ mn) - PharmaCompass · Hikal is a flexible, execution focussed customer oriented company Continued focus on Quality & Regulatory Governance We utilise technology

2/25/2016

Panoli – US FDA Approved site for RSM’s & Advanced Intermediates

© Hikal Limited 19

Page 20: Hikal revenue ($ mn) - PharmaCompass · Hikal is a flexible, execution focussed customer oriented company Continued focus on Quality & Regulatory Governance We utilise technology

2/25/2016

cGMP multipurpose API facilities

• Inspected and recertified by USFDA 4th time (April 2014)

• OHSAS 18001, ISO 14001

• Responsible Care certified

• 9 API production lines with finishing areas

• PLC controlled plants

• Total reactor volume 294 m3

– Glass lined 119 m3

– Stainless steel 175 m3

• Number of reactors 94

• Solvent recovery plant: 140 m3/day

• Zero discharge waste water treatment facility 450 m3/day

• Employees 347

Bangalore - USFDA Approved site for APIs & Intermediates

External View Multipurpose Plant , Bangalore

© Hikal Limited 20

Page 21: Hikal revenue ($ mn) - PharmaCompass · Hikal is a flexible, execution focussed customer oriented company Continued focus on Quality & Regulatory Governance We utilise technology

2/25/2016

Bangalore - USFDA Approved site for APIs & Intermediates

© Hikal Limited 21

Page 22: Hikal revenue ($ mn) - PharmaCompass · Hikal is a flexible, execution focussed customer oriented company Continued focus on Quality & Regulatory Governance We utilise technology

2/25/2016 22

Multipurpose and multi-product facility – API’s & Intermediates

• Area : 8,114 m2

• Plant has Two Sections

– Section – 1 , Pilot Plant

• 2 production trains with 6-reactors

• Can make two Products simultaneously

• Total reactor volume ~ 10.85 m3

• Batch size 5 – 60 Kg

– Section – 2 , Scale Up Plant

• Up to 8- reactors

• Total reactor volume ~ 21.8m3

• Batch size 50 - 300 Kg

Bangalore - Scale-Up & Launch Plant

© Hikal Limited

Page 23: Hikal revenue ($ mn) - PharmaCompass · Hikal is a flexible, execution focussed customer oriented company Continued focus on Quality & Regulatory Governance We utilise technology

Why we would be a potential partner

Hikal is a flexible, execution focussed customer oriented company

Continued focus on Quality & Regulatory Governance

We utilise technology to address our customer’s challenges

We execute our projects with disciplined processes

We deliver on our commitments

Collaborative approach to working with our partners for mutual benefit

We provide our partners with a distinct sustainable solution and advantage

2/25/2016 23

Page 24: Hikal revenue ($ mn) - PharmaCompass · Hikal is a flexible, execution focussed customer oriented company Continued focus on Quality & Regulatory Governance We utilise technology

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