Biocon Limited

BSE: 532523 │ NSE: BIOCON │ REUTERS: BION.NS │

BLOOMBERG: BIOS IN │ WWW.BIOCON.COM

Investor Presentation
May 2019
Safe Harbor

Certain statements in this release concerning our future growth prospects are forward-looking
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 currencies, 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 the company, nor its directors
and any of the 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.

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Agenda

Our Journey

Business & Financial Highlights

• Small Molecules
Our Business • Biologics
• Branded Formulations
• Research Services - Syngene

Five Year Financials

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Biocon: Asia’s Leading Biopharma Company

Our Vision
To enhance global healthcare through innovative and affordable
biopharmaceuticals for patients, partners and healthcare
systems across the globe

Our Mission
To be an integrated Biotech enterprise of global distinction

Our Values
Integrity & Ethical Behavior
Performance driven Work Culture
Value Creation through Innovation & Differentiation
Quality through Compliance & Best Practices
Collaboration, Team Work & Mutual Respect

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 Committed to
Affordable Access

Aiming to develop products that can

potentially benefit a billion patients

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The Biocon Journey: A Continuous Evolution

1978-1999 2000-2004 2005-2009 2010-2015 2016 and beyond

Focused on
Transforming Building the
global Poised for Global
An Enzymes into a Base Business
development and Impact with
Company Biopharma and Expertise in
strategic global Biosimilars
Company Biologics
alliances

Successful IPO, Enzymes Mylan Insulins Global Partnership

Biocon listed in Business collaboration with Sandoz for
India Divested signed Next-Gen Biosimilars

Global
Entered Developed
Collaboration
IPO of Syngene Markets of Japan, US,
for Biosimilars
EU with Biosimilars
with Mylan

Unwavering focus through the years on innovation & difficult to make, niche
products to create tangible differentiators for sustainable growth

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Key Innovations: Making a Difference Ogivri™, first biosimilar
Trastuzumab approved
by US FDA Launches
Second Novel Ogivri™,
Biologic (Insulin Glargine biosimilar
prefilled disposable
Launches KRABEVA®,
Trastuzumab
pen) biosimilar Bevacizumab
First Novel in EU
in India
Biologic
Launches
Launches Basalog One™
ALZUMAb™
Launches (Itolizumab)
BASALOG®
Launches
(Insulin Glargine)
BIOMAb EGFR®
(Nimotuzamab)

Approval of
Semglee,
biosimilar
Insulin Insulin
Glargine Glargine in
launched EU and
in Japan Australia.
Introduces Launch in EU
CANMAb™
Launches
(bisimilar
INSUPen®/ Trastuzumab) Approved
Launches INSUPen® EZ and launched
First US FDA INSUGEN® (German Technology Fulphila™,
approval for (rh- Insulin) Insulin Delivery Device) biosimilar
Lovastatin Pegfilgrastim
in US

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Business & Financial Highlights

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Business: Recent Highlights

On March 1, 2019, Dr. Christiane Hamacher was appointed the CEO of Biocon Biologics India
Limited, to lead Biocon’s Biosimilars business and transform it into a major global player in
biologics.

Ogivri®, biosimilar Trastuzumab was launched in Europe by our partner Mylan in the quarter
ended March 31, 2019

Health Canada approved Biocon and Mylan’s Ogivri™, the first Trastuzumab biosimilar, for the
Treatment of HER2-Positive Breast and Gastric Cancers

Following the successful approval and European launch of Hulio®, (biosimilar Adalimumab) in-
licensed by our partner Mylan from Fujifilm Kyowa Kirin Biologics, the commercialization rights
have been extended from Europe to Global Markets.

Syngene, our Research Services subsidiary, announced the opening of its Centre for Advanced
Protein Studies, set up in collaboration with the Biotechnology Industry Research Assistance
Council or BIRAC, at Syngene’s campus in Bengaluru.

To commemorate the 40th anniversary of Biocon the Board of Directors of the Company at the
meeting held on April 25, 2019 recommended the issue of 1 bonus share for every 1 share held in
Biocon.

The Board also recommended a Final Dividend of Re 1/- per share (pre-bonus) for FY19.

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Revenue Highlights

All Figures in ₹ Million except %

Particulars Q4 FY19 Q4 FY18 Growth FY19 FY18 Growth

- Small Molecules 4,719 4,255 11% 17,728 15,077 18%

- Biologics 4,511 2,408 87% 15,169 7,702 97%

- Branded Formulations 1,330 1,491 -11% 6,654 6,115 7%

- Syngene (Research Services) 5,338 4,091 30% 18,255 14,231 28%

- Inter-segment (610) (550) 11% (2,572) (1,828) 41%

Revenue from Operations 15,288 11,695 31% 55,144 41,297 34%

- Other Income 282 675 -58% 1,444 2,062 -30%

Total Revenue 15,570 12,370 26% 56,588 43,359 31%

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Financial Summary

All Figures in ₹ Million except %

Growth
Particulars Q4 FY19 Q4 FY18 Growth FY19 FY18
(%)

Revenue 15,570 12,370 26% 56,588 43,359 31%

EBITDA 4,312 3,005 43% 15,381 10,353 49%

Net Profit# 2,137 1,304 64% 7,291 3,724 96%

R&D Expenses in
921 508 81% 2,899 2,158 34%
P&L

Gross R&D Spends 1,659 975 70% 4,796 3,804 26%

EBITDA Margin 28% 24% 27% 24%

EPS# (Rs.) 3.6 2.2 12.2 6.2

# Adjusted for any exceptional items

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Our Business

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Business Segments

Branded Formulations

Finished Dosage Business in India &

Overseas

Small Molecules Research Services

Syngene
Differentiated APIs CRO offering integrated service platform
& Generic Formulations for novel molecule drug discovery &
development for small & large molecules

Biologics
Novel Biologics & Biosimilars
Innovation in biologics development including novel
molecules & biosimilars

Complex Small Comprehensive Presentation in Biologics

Molecule APIs to Drug Substance Drug Products Delivery Devices
Biologics
Vials, Cartridges & Reusable & Disposable
Novels & Biosimilars Prefilled Syringes Prefilled, Pens

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Small Molecule : APIs & Generic Formulations

Differentiated APIs Current Constituents

Portfolio
Product Portfolio leverages core
Simvastatin, Pravastatin, Atorvastatin,
fermentation technology strengths Statins
Rosuvastatin, & Fluvastatin.
Among world’s largest manufacturers of Tacrolimus, Sirolimus, Everolimus,
Immuno
statins & immunosupressant APIs Mycophenolate Mofetil & Mycophenolate
suppressants
Sodium
Early mover in niche products at
commercial scale Other Orlistat, Fidaxomicin, Glatiramer Acetate,
Biopharma other molecules

Generic Formulations
Niche pipeline; Solid oral & parenteral products in both potent & non-potent categories for emerging
and developed markets.

Focus therapeutic segments – Metabolics, Oncology, Immunology & Auto-immune indications

Generic Formulations strategy includes First-to-Files and Para IVs.

Launched generic Rosuvastatin, Simvastain & Atorvastatin tablets in US

Focus on vertically integrated development of molecules in chronic therapeutic areas

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Biologics: Biosimilars & Novel Biologics

Novel Biologics Biosimilars

Positioned among early
Creating market leadership wave of entrants with
in Innovation e.g., Insulin multiple biosimilars
Tregopil, Itolizumab commercialized globally.
15+ years of experience
is developing biologics.

Pipeline includes oral

Portfolio straddles
insulin; mAbs against
rh-insulin, insulin analogs,
targets like CD6, CD20
mAbs and other
& EGFR; bispecific NOVEL
BIOLOGICS BIOSIMILARS recombinant proteins.
fusion mAbs

Strong scientific and

Potential to change the technical capabilities. Over
treatment paradigm in 1500 people dedicated to
diabetes, immunology. support this business
across various functions

Biocon is a pioneer in bringing high quality, yet affordable, novel biologics & biosimilars to
patients globally

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Strategic Partnership with Mylan for Biosimilars: Insulins & mAbs

Partnership leverages Biocon’s Strong Development & Manufacturing Capability

and Mylan’s Regulatory & Commercial Excellence

BIOCON MYLAN
• Global-scale, complex biologics • Strength in Regulatory/ filings
manufacturing capabilities strategy

• Facilities accredited by • Strong commercialization

international regulatory agencies capability in US and EU.

• Decade-long experience & • Market agility and speed

demonstrated expertise in
developing MAbs and other
biologics

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

Generic Insulin Analogs Biosimilar MAbs & other Biologics

Mylan’s Exclusive
US, Canada, Europe,
Commercialization Developed markets
Australia & New Zealand
Regions
# In Developed Markets only

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Strategic Partnership with Sandoz for next generation Biosimilars

Broader Biocon participation in end to end development and commercialization with a

global leader in biosimilars

Portfolio addresses next wave of immunology and oncology biosimilars

Market opportunity to open up by middle of next decade

Both partners share responsibility for end-to-end development, manufacturing and global regulatory
approvals for a number of biosimilars

Costs & profits are shared equally

Commercialization Responsibilities

Sandoz Biocon
1. North America (US & Canada) 1. Japan, Australia, New Zealand
2. EU (European Free Trade Association (EFTA) 2. All Emerging Markets
and Balkan states)

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Status of Biocon’s Global Biosimilars Portfolio*
Therapeutic Area Molecule Status
Oncology TRASTUZUMAB Launched in EU & Emerging Markets. Approved in U.S., Canada &
Australia.
Oncology PEGFILGRASTIM Launched in the U.S. Approved in EU, Australia & Canada.
Oncology BEVACIZUMAB Launched in India. Global Phase III.
MYLAN & LOCAL PARTNERS

Oncology FILGRASTIM Preclinical

Oncology PERTUZUMAB Early Development
Diabetes INSULIN GLARGINE Launched in the EU, Japan# & Emerging Markets. Approved in
Australia & New Zealand. Under review in U.S.
Diabetes INSULIN GLARGINE 300 IU/ML Early Development

Diabetes INSULIN ASPART Global Phase III

Diabetes INSULIN LISPRO Preclinical
Diabetes RECOMBINANT HUMAN Launched in Emerging Markets. In active development for U.S.
INSULIN (partnered with Lab Pisa)
Autoimmune ADALIMUMAB Partner Mylan has launched in-licensed product Hulio® in EU.
Biocon benefits from economic interest
Autoimmune ETANERCEPT Partner Mylan’s in-licensed product filed for approval in EU. Biocon
retains economic interest
Oncology & VARIOUS ASSETS Early stage development
SANDOZ

Immunology

# Japan launch is outside of the Mylan partnership

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Biocon Well Placed in Competitive Global Landscape (1)
Molecule Biosimilar Development Pipeline$
Phase I Phase 3 Regulatory Submission Approved/ Marketed
EMA FDA EMA FDA
ADALIMUMAB DM Bio Coherus, Momenta, Samsung, Pfizer Amgen, Samsung, Amgen, BI,
Celltrion, Alvotech, Sandoz, Fresnius/ Sandoz
DRL, BI, Fuji Kirin/
Mylan/BIOCON
ETANERCEPT Coherus, Hanwha Lupin/Mylan/ Samsung, Sandoz Sandoz
BIOCON

TRASTUZUMAB DM Bio, United Hanwha/ Prestige, Amgen Amgen, Celltrion, BIOCON,

BioPharma, Tanvex, EirGenix, Pfizer Samsung, Celltrion,
Alteogen, Sino, Shanghai Henlius / BIOCON Samsung, Pfizer,
NeuClone Accord
BEVACIZUMAB Sandoz, Daiichi, BI, Samsung, BIOCON Pfizer Amgen, Pfizer Amgen
Fresnius/DRL, Fuji-Kirin/ Astra, Cipla,
Tanvex, Apobiologix, mAbxience/ Amneal,
Zhejiang Teruisi Centus, Hanwha/
Prestige, Bio-Thera,
Shanghai Henlius,
Luye, Celltrion, JHL
PEGFILGRASTIM Fresnius/DRL, Pfizer, USV Apotex/ Intas, BIOCON, Coherus, BIOCON,
Kashiv (Adello), Sandoz Apotex/ Intas, Coherus
Lupin, Zydus Sandoz,
Mundipharma (Cinfa)
FILGRASTIM Lupin Apotex, Kashiv Sandoz, Teva, Sandoz, Pfizer
(Adello), Tanvex Hospira, Stada,
Intas, Hexal
$ Based on publically available information

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Biocon Well Placed in Competitive Global Landscape (2)
Molecule Biosimilar Insulin Development Pipeline$
Phase I Phase 3 Regulatory Submission Approved/ Marketed
EMA FDA EMA FDA
INSULIN GLARGINE Gan & Lee/ Sandoz BIOCON BIOCON, Eli Lilly, Eli Lilly, Merck
Merck (TA)

INSULIN ASPART Sanofi, BIOCON

INSULIN LISPRO Sanofi Sanofi

RH-INSULIN Rechon (EU)

$ Based on publically available information

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Biosimilars Manufacturing: Building Global Scale
Global Scale Manufacturing Capabilities in India
State-of-the-art manufacturing facilities – mammalian &
microbial

Facilities conform to most stringent cGMP guidelines -

Inspected by EMA, USFDA, Health Canada, ANVISA,
COFEPRIS, PMDA, TGA etc.

Second fill-finish sterile injectable line in Bangalore has

been approved by the DCGI. Will support future growth of
biologics formulations

Construction of second antibody manufacturing facility in

Bangalore ongoing, expected commissioning in 2021. Biocon Malaysia: Asia’s largest integrated insulins
anufacturing facility
Biocon’s First Manufacturing expansion overseas in
Iskandar, Johor.

Investment of ~US$300 mn in the first phase.

Plant has received GMP certificate from EMA and NPRA,

Malaysia

Sales commenced in E.U. & Emerging Markets; include

Insulins Facility In Bangalore OTA award by Ministry of Health – Malaysia.

Biocon over the years have built global scale and cost competitive, complex manufacturing
capabilities to address global market opportunities

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Novel Molecules - Pipeline & Therapeutic Area Focus

Insulin Tregopil * India Phase II/III in T2D

DIABETES First-in-Class Oral, Prandial Insulin ongoing

Itolizumab* Clinical Trial initiated in

Novel, humanized CD6 Antibody aGVHD

BVX-20#
INFLAMMATION Novel, humanized CD20 Antibody
Path to IND mapped

QPI-1007$ Phase III in NAION

SiRNA for ophthalmic disease

IMMUNO- EGFR mAb + TGFβrII*

Preclinical
ONCOLOGY Tumor-Targeted Fusion mAb*

* Out licensed to Equillium for US & Canada; # BVX-20 with Vaccinex; $ QPI-1007 licensed from Quark Pharma.

Incorporated in Boston, U.S. as a wholly owned subsidiary of Biocon

to focus on developing Immuno-oncology assets

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Novel Molecules: Progressing to key milestones
Asset Details
Insulin Tregopil USP: Oral, Ultra Rapid-Acting
Post- prandial glycemic control; Liver specific- portal delivery, Weight neutral
Phase II/III Ongoing
 Safety & tolerability established in Phase 1 studies in US – DDI, Food Effect, PK/PD Data available
 Pivotal Phase II/III clinical study in T2DM patients in India initiated, patient dosing ongoing
 JDRF supported Phase I Multiple Ascending Dose study planned in T1DM patients

Itolizumab USP: Novel CD-6 Biology presenting durable immune-modulatory benefits and superior
clinical safety
IND Approved for orphan
indications  Marketed in India for Plaque Psoriasis, licensed to Equillium for US & Canada
 Phase 1b/2 clinical trial for the treatment of acute graft-versus-host disease or aGVHD initiated. Fast track
designation accorded by US FDA
 Phase 2 clinical trial for the treatment of chronic graft-versus-host disease, or cGVHD, planned in H1
2019
 Proof-of-concept clinical trial for the treatment of severe asthma planned in H1 2019

QPI-1007 Novel SiRNA for ophthalmic disease:

In Phase III  Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION) – Patients randomized for global study (incl. in
India)

BVX-20 2nd Generation humanized antibody targeting CD-20

IND ready  Path to IND mapped out, to advance program in neuro-inflammatory disorder

EGFR mAb + TGFβRII USP: Higher local tumor concentration of immuno-modulatory arm resulting in a better
(Fusion mAb) therapeutic window

IND Ready  Pharmacology & MOA established in in-vitro & in vivo tumour models
 Proof of Concept established in in-vivo model
 Opportunity to target multiple tumour types

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Branded Formulations: India & UAE

Specialty business with regional ambitions; strong value builder for Biocon.
Biologics-led specialty products focused on chronic therapy areas.
Comprehensive offering of products, patient and physician support programs

INDIA UAE
India’s largest Insulins & leading Oncology Company Ranked among Top 15 pharmaceutical
Presence across therapies: Metabolics, Oncotherapeutics, companies in UAE.
Immunotherapy, Nephrology and Comprehensive Care Most branded generic products in Top 2 in
Division. respective segments.
Several brands ranked amongst 'Top 3' brands in respective Glaricon (Biosimilar Insulin Glargine) and
segments. Canhera (Biosimilar Trastuzumab) launched in
UAE

Insugen® ranks among Top 3 human insulin brands in India

CANMAb™ is No. 1 brand of Trastuzumab in India
Basalog®, is No 2 brand of Insulin Glargine in India

Key Brands
Insugen®
Basalog®
BIOMAb EGFR®
CANMAb™
ALZUMAb™
KRABEVA®
TACROGRAF™

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Research Services Business: Syngene

One of leading India based CROs, a global high growth

CRO company

End-to-end discovery, development and manufacturing

capabilities with focus on novel molecular entities

Offers an integrated drug discovery, development and

manufacturing platform for both small and large
molecules, antibody-drug conjugates and
oligonucleotides backed by best-in-class bioinformatics
services

World class infrastructure audited successfully by US

FDA, EMA, AAALAC and major life sciences partners

331* global clients across multiple sectors

World-class R&D and manufacturing infrastructure

spread over 1.4 million sq. ft

~4,000* qualified scientists

Strong track record of top-line growth with best in class

EBITDA margins (30+%) and Net Profit margin (high
teens to low 20’s)

Listed in India on BSE and NSE in 2015 * For fiscal ended March 31, 2019

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Five Year Financials All Figures in ₹ Million except EPS
Partculars FY14# FY15# FY16# FY17$ FY18$
Biopharmaceuticals Revenue 21,382 22,367 23,908 28,912 28,894
- Biopharma 17,468 18,071 19,534 23,423 22,779
- Branded Formulations 3,914 4,296 4,374 5,489 6,115
Contract Research Revenue 7,146 8,225 10,599 11,925 14,231
Total 28,528 30,592 34,507 40,837 43,125
Less: Inter-segment revenue (1,621) (1,828)
Other Income 804 837 1,192 1,571 2,062
Total Revenue 29,332 31,429 35,699 40,787 43,359
EBITDA 7,429 7,489 9,045 11,366 10,353
EBITDA Margin (%) 25% 24% 25% 28% 24%
Net Profit* 4,137 4,022 4,365 6,199 3,724
Net Profit Margin 14% 13% 12% 15% 8.5%
EPS* 20.7 20.1 21.8 30.9 6.2@
R&D Spends (in P&L) 1,310 1,688 2,750 2,662 2,158
R&D (as % of Biopharmaceuticals Revenue) 6.1% 7.5% 11.5% 9.7% 7.9%
# Numbers as per old I-GAAP; * Pre-Exceptional items; $ FY17, FY18 numbers have not been restated for comparative purposes, hence not comparable. Effective Apr 1,
2016, the Company has moved to Ind-AS accounting framework, FY runs Apr to Mar; @ Adjusted for bonus issues of shared in FY18
In FY17, FY18 – Biopharma includes Small Molecules & Biologic segments as per Ins-AS framework

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 Investor Relations contact:

Saurabh Paliwal
Tel : +91 80 6775 2040
Email: investor.relations@biocon.com

For further information, please visit

www.biocon.com

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