Innovative Science

Affordable Medicine

www.biocon.com

Corporate
Presentation
December 2013

Disclaimer
Certain statements in this release concerning our future growth prospects are forwardlooking statements, which are subject to a number of risks, uncertainties and
assumptions

that

could

cause

actual

results

to

differ

materially

from

those

contemplated in such forward-looking statements. Important factors that could cause

actual results to differ materially from our expectations include, amongst others
general economic and business conditions in India, our ability to successfully
implement our strategy, our research and development efforts, our growth and
expansion plans and technological changes, changes in the value of the Rupee and
other currency changes, changes in the Indian and international interest rates, change
in laws and regulations that apply to the Indian and global biotechnology and
pharmaceuticals industries, increasing competition in and the conditions of the Indian
biotechnology and pharmaceuticals industries, changes in political conditions in India
and changes in the foreign exchange control regulations in India. Neither our company,
nor our directors, nor any of their respective affiliates have any obligation to update or
otherwise revise any statements reflecting circumstances arising after this date or to
reflect the occurrence of underlying events, even if the underlying assumptions do not
come to fruition.

Biocon:
Overview

Established in 1978
Listed in India since 2004, over US$1 Bn market cap^
Consolidated revenues ~ US$ 467Mn ( FY13)
Over 6500 employees, with largest scientific pool of ~ 2000 at Asias
largest biotech hub
Global scale USFDA compliant bio-manufacturing base
Products available in over 75 countries
Well Balanced bio-pharma business model : Five Growth Accelerators
o
o
o
o
o

Small Molecules
Branded Formulations
Bio-similars
Novel Molecules
Integrated Research Services

3
^ as in November 2012

Biocon Well Aligned With The

Changing Trends
Biocon is an emerging, global Biopharmaceutical enterprise
focused on developing affordable products
and services
for
patients,
partners
Biocon
is committed
to: and healthcare systems
across the world
Reducing therapy costs of chronic diseases (Diabetes,
cancer and
immune-mediated diseases)

Research and marketing partnerships that provide global

access
Leveraging the India cost advantage to deliver high
value,
licensable R&D assets
4

Risk Balanced Business Model

Balanced
PortfolioProducts &
Services
PRODUCT
S

RESEARC
H
SERVICES

DEVELOP
ED
MARKETS

Self Financed
R&D
and
Manufacturing

EMERGIN
G
MARKETS

Strategic
Research &
Marketing
Partnerships
Risk Balanced

Global Scale Manufacturing Base

Amongst the worlds largest

producers of Statins & Immunosuppressants
Asias largest Insulin producer
USFDA approved API & Aseptic fillfinish facilities
Indias largest Biologics capacity
6

on Affordable Innovation: Biocon Research Centre

Innovation Strategy based on Collaborative R&D
using Shared Risk and Reward,
whilst delivering Affordable Innovation
First-of-its kind in South
East Asia
Venue for world-class
research on biologics
Spread across 200,000
sq. ft. with:
o Molecular Biology Lab
o Biologics Process Science

State-of-the-art Integrated Research

& Development Center (BRC)

Labs
o Formulations Development
Lab
7
o Molecular
Characterization

Research & Development

R&D Spend: About ~10 % of Biocon Revenue

Employee Strength: ~ 500 scientists , 20% PhDs / MDs & 50%
Masters
Five core functional areas
Large patent portfolio >1200
Over 25 publications in journals of international repute
Global leadership in pichia based fermentation
Process development and characterization of Biologics (MAbs &
Insulins)
8

Regulatory Inspections
USFDA

Other Health Authorities

Sl.
No.

Regulatory Authority
Year of Audit
/ Agency

Sl.
No.

Regulatory Authority / Agency

Year of Audit

USFDA

November 2000

Egyptian Health Authority

February 2006

USFDA

December 2003

Mexican Health Authority

October 2006

USFDA

December 2006

Cuban Health Authority

March 2007

USFDA

January 2009

ANVISA Brazil Health

Authority

February 2008

Jordan Health Authority

July 2008

Indonesian Health Authority

May 2009

EUGMP
Sl.
No.

Regulatory Authority
Year of Audit
/ Agency

Korean Health Authority

November 2009

Mexican Health Authority

April 2010

BfArM Germany

January 2005

Saudi FDA

September 2010

EUGMP - Hamburg

November 2005

10

Oman Health Authority

January 2011

EUGMP - Stuttgart

December 2006

EUGMP - Germany

August 2008

EUGMP - Hamburg

November 2009

Afsaaps - French

Nov-Dec -2010
9

Global Footprint: Expansion in

Malaysia

First overseas manufacturing facility is underway at BioXCell, Johor, Malaysia

Large scale, automated, fermentation based Drug
Substance facility
Drug Product facility for product presentations such as
vials, cartridges & devices

Asias largest Integrated Insulin facility to be

10
ready by end of 2014

Focus on Strategic Partnering

Presence Across the Value Chain

Discovery &
Development

Development
&
Commercializa
tion

BMS

Diabetes

Oral Insulin

Vaccin
ex

Oncology

BVx20

Insulin Analogs
Mylan

Commercializa Optime
r
tion

BMS

Oncology &
Auto Immune

First in Class
Anti Infective

Discovery to
Commercializatio

Biosimilars

Fidaxomicin

11

Our Business
12
Verticals

on: Unlocking Value : Key Growth Accelerators

ANDAs & 505 (b)(2)
filings

Small
Molecul
es
Integrat
ed
offerings

Researc
h
Services

Partnering
through
Licensing

Five
Key
Business
Verticals

Novel
Molecul
es

Biosimila
rs
(Insulins
and
MAbs)

Branded
Formulati
ons

EMERGING
MARKETS
EMERGING
MARKETS
FOCUS
FOCUS

Progressi
ng to
Devices

Rapidly growing,
India-centric
business

13

Diversified Offering
Small Molecules: Base
Business

Moving up the Value Chain

Portfolio

Constituents

Small Molecules:
Statins

Simvastatin, Atorvastatin, Lovastatin, Rosuvastatin,

Fluvastatin & Pravastatin

Immunosuppress
ants

Tacrolimus, MMF & MPA

Other Biopharma

Orlistat, Fidaxomicin, 50+ other molecules

Branded
Formulations

Diabetology, Cardiology, Nephrology, Oncology,

Immunotherapy, Comprehensive Care and Bioproducts

Biosimilars

Insulin & Analogs; Biosimilar MAbs

Novel Molecules

IN-105, Itolizumab, BVx20 and others

14

owth Segment: Small Molecules

Proprietary Technology & Forward
Integration

Robust portfolio of APIs, including

Statins, Immuno-suppressants and
Proprietary Products like
Fidaxomicin

Leveraging characterization
infrastructure to develop complex
APIs

Forward integration to develop and

market finished formulations
Move up the value chain through
ANDAs and 505 (b)(2) filings

15

Growth Segment: Biosimilars

Biosimilars Pipeline: Focus on Insulins & MAbs
Portfolio

Biosimilar
Insulins

Biosimilar
MAbs
and other
biologics

Biosimilar Molecule

Process
Development /
Scale-up /
Preclinical

Phas
e
1/II
b

rh- Insulin
Glargine
Lispro & Aspart

Trastuzumab
Bevacizumab,
Adalimumab
Etanercept, Pegfilgrastim

o Emerging Markets focus through Regional Partnerships

o Portfolio Opportunity Size*
Biosimilar Insulins: $ 17 Bn
Biosimilar MAbs & Other biologics: $ 33 Bn
16
*Market size of innovator products

Phas
e III

Mark
et

Growth Segment: Biosimilars: Co

Development

Co-Development & Commercialization Collaboration

Combines Biocon's R&D and manufacturing
expertise in
biologics with Mylans regulatory &
commercialization capabilities in the US and Europe
Biosimilar Insulin
Analogs

Biosimilar MAbs & other

Biologics

Global Market Size

of Portfolio*

~ USD 13 Bn

~ USD 34 Bn

Portfolio
Constituents

Glargine, Lispro &

Aspart

Trastuzumab, Peg-filgrastim,
Bevacizumab, Adalimumab,
Eternacept

Mylans Exclusive
Commercialization
Regions

US, Canada, Europe,

Australia & New
Zealand

All regulated markets

Structure: Upfront Payment + Cost Sharing + Supplies + Profit Sharing #

Mylan and Biocon to share development and capital costs
Profit Sharing Arrangement in regions where Mylan17
has exclusive
*Market Size of innovator products MAT Dec commercialization rights
#

Growth Segment: Biosimilars- Insulins

Biosimilar Insulin & Analogs- Clinical Update
Biosimilar rh-Insulin
o EU Phase III completed
o Results from Part 1 of the study
establishes the Efficacy end-point (non
inferiority to innovator product)

o Immunogenicity and safety at the 6 month

time interval also similar to innovator; 12
months data awaited
o Market Authorization for EU to be filed in
FY 14

Biosimilar Insulin Glargine

o Global Phase I (PK-PD) study successfully
completed
o Established equivalence between
biosimilar insulin glargine and the
innovator product
o Global Phase III to commence in 2013
o Market Authorization to be filed in 2015
18

wth Segment: Branded Formulations: India

80 brands across seven therapy segments
Several Biocon brands among Top 5
Focus on patient convenience, product
differentiation & personalized medical
support
Key Brands: Insugen, Basalog, Abraxane,
BioMAb EGFR, Statix and Erypro
INSUPen German technology based
Innovative reusable pen: value add to
Insulins portfolio

Fastest Growing Insulins

Company
Growth
Biocons Value Growth
Biocon: 33%
Sanofi Aventis: 20%
Novo Nordisk: 16%

YoY*

#4 in overall insulin
mkt
#3 in the 40 IU Insulin
mkt
#1 in the Glargine vial

Biocons Volume Market

share*

100 IU Insulin: 15%

Glargine vials: 87%
19
*ORG IMS MAT Aug 2012

Growth Segment: Research Services

Value Based Positioning

Business Model has evolved from fee for services to
integrated collaborative & strategic partner for
global bio-pharma customers
Integrated Model spanning discovery
& early development to late stage
clinical studies
Large Portfolio of Offerings
combining Chemistry & Biologics
expertise with cost advantage
Custom partnership models ranging
from FTE based to risk-reward
models
Clientele comprising of 100+ large
and mid-size pharma & biotech
companies
22

Financial Performance
FY13

FY12

Reven
ue

467

395

EBITD
A

110

106

%
Growth

USD Mn

18%
3%

FY13
94

62 FY12

Bio-Pharma

280

250

10%

Branded
Formulations

640

476

34%

Research Services

102

75

36%

PAT

FY09

FY10

FY11

50%% Growth

FY12

Revenue
219
274
342
395
467
EBITDA
68
84
105
106
110
Net profit*
44
50
63
23
62
94
* Net profit is pre-exceptional. No exceptional items in FY10, FY11 and FY12 ; Exchange rate

FY13

Corporate Social
Responsibility
VISION: To promote social and
economic inclusion by ensuring
that marginalized communities
have equal access to healthcare
services
educational
Focus onand
integrated
healthcare programs
opportunities.
and primary education
CSR initiatives aligned with the growing
health issues of the communities we
serve

FY12 Highlights:

80,000, Maths Work Books Chinnara

Ganitha distributed in primary
schools in eight districts of Karnataka
9 Arogya Raksha Primary Healthcare
Clinics, meted out medical
consultations to over 60,000 patients
1,00,000 people enrolled under
Arogya Raksha Yojana-Micro Health
Insurance Scheme, in Karnataka

Education

Sanitation

Chinnara Ganitha
program,
Scholarships,
Aata Pata Wadi

Community toilets,
Individual toilets,
Rain water
harvesting

Arogya
Raksha

Infrastructu
re

Micro Health
Insurance,
ARY Clinics,
Diabetic Foot
Clinic,
25
Preventive

Housing for Flood

Relief at Bagalkot:
411 houses built
Solar Lighting
Health Centre to
come up

Looking Ahead

Thrust on Increasing Market

Share of Biosimilar Insulins in
Emerging Markets
Move up the Value Chain:
DMFs to ANDAs in US
APIs to Finished Dosage in
EU/Japan

Focus on building brand value

and market share in Emerging
Markets

Expand customer base for

26

Innovative Science
Affordable Medicine

Thank You
www.biocon.com