Biocon Ltd. — Investor Presentation 2018

Sep 2, 2018

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Date of Submission: September 02, 2018

To The Secretary Listing Department BSE Limited Department of Corporate Services Phiroze Jeejeebhoy Towers, Dalal Street, Mumbai – 400 001 Scrip Code - 532523	To The Secretary Listing Department National Stock Exchange of India Limited Exchange Plaza, Bandra Kurla Complex Mumbai – 400 050 Stock Code- Biocon

Dear Sir/Madam,

Sub: Investor Presentation for Quarter ended June 30, 2018

Ref: Regulation 30 of the SEBI Listing Obligations and Disclosure Requirements (LODR) Regulations, 2015

With reference to the captioned subject, please find enclosed Investor Presentation for Quarter ended June 30, 2018.

Kindly take the above said information on record as per the requirement of Listing Regulations.

Thanking You, Yours faithfully For BIOCON LIMITED

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Akhilesh Nand Compliance Officer Encl: A/A

Biocon Limited

BSE: 532523 │ NSE: BIOCON │ REUTERS: BION.NS │ BLOOMBERG: BIOS IN │ WWW.BIOCON.COM

Investor Presentation September 2018

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

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Our Journey

Business & Financial Highlights

• Small Molecules

• Biologics

Our Business

• Branded Formulations

• Research Services - Syngene

Business Holding Structure & Five Year Financials

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Biocon: Asia’s Leading Biopharma Company

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Our Vision

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

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Our Mission

To be an integrated Biotech enterprise of global distinction

Our Values

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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

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1978-1999 2000-2004 2005-2009 2010-2015 2016 and beyond
Biosimilar
Focused on
Transforming Building the Trastuzumab
global
An Enzymes into a Base Business approved by US FDA;
development and
Company Biopharma and expertise in Biosimilar PEG-GCSF
strategic global
company biologics alliances approved & launched
in US
Successful IPO, Enzymes Mylan Insulins
Sandoz Biosimilars
Biocon listed in business collaboration
collaboration signed
India divested signed
Mylan Insulin Glargine
Antibodies launched in Japan;
IPO of Syngene
collaboration Approved in EU,
signed Australia
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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

Second Novel Biologic

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First Novel Biologic

Launches ALZUMAb™ Launches (Itolizumab) BASALOG® Launches (Insulin Glargine) BIOMAb EGFR® (Nimotuzamab)

Launches INSUPen®/ INSUPen® EZ

Launches

INSUGEN[®] (rh- Insulin)

First US FDA approval for Lovastatin

(German Technology Insulin Delivery Device)

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Ogivri™, first biosimilar Launches Trastuzumab KRABEVA[®] approved by US in India FDA

(Insulin Glargine prefilled disposable pen)

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Launches Basalog One™

Approval of Semglee™ in EU and Australia Approved and launched Fulphila™ in US

Insulin Glargine launched in Japan

Introduces CANMAb™ (Trastuzumab)

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Business & Financial Highlights

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Business: Recent Highlights

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Fulphila™, co-developed by Biocon and Mylan, becomes the first biosimilar Pegfilgrastim to be approved and launched in the U.S. Biocon is the first Company from India to have two biosimilars approved by the U.S. FDA.

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• Biocon’s sterile Drug Product manufacturing facility in Bengaluru received EIR from U.S. FDA and EU GMP certification.

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• Presentations made at American Society of Clinical Oncology (ASCO) annual meeting in June 2018 for novel biologic Nimotuzumab (BIOMAb EGFR[®] ) and biosimilar Trastuzumab (Ogivri™).

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• PK-PD data on novel Insulin Tregopil presented at American Diabetes Association Scientific Sessions in June 2018.

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Syngene extends its collaboration with Baxter up to 2024 and strengthens its growing client base.

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Revenue Highlights

All Figures in ₹ Million except %

Particulars	Q1 FY19	Q1 FY18	Growth (%)	FY18	FY17	Growth (%)
- Small Molecules	4,001	3,629	10	15,077	16,405	(8)
- Biologics	2,497	1,839	36	7,702	7,018	10
- Branded Formulations	1,473	1,304	13	6,115	5,489	11
- Syngene (Research Services)	4,060	2,911	39	14,231	11,925	19
- Inter-segment	(793)	(346)	129	(1,828)	(1,621)	13
Revenue from Operations	11,238	9,337	20	41,297	39,216	5
- Other Income	688	540	27	2,062	1,571	31
Total Revenue	11,926	9,877	21	43,359	40,787	6

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Financial Summary

					All Figures in ₹ Million except %	All Figures in ₹ Million except %
Particulars	Q1 FY19	Q1 FY18	Growth (%)	FY18	FY17	Growth (%)
Revenue	11,926	9,877	21	43,359	40,787	6
EBITDA	3,066	2,461	25	10,353	11,366	(9)
Net Profit	1,197	813	47	3,724	6,121	(39)
R&D Expenses in P&L	442	582	(24)	2,158	2,662	(19)
Gross R&D Spends	883	956	(8)	3,804	4,019	(5)
EBITDA Margin	26%	25%		24%	28%
EPS@ (Rs.)	2.0	1.4		6.2	10.2
@Adjusted for bonus
~	Product Revenue Mix (FY18): Ex-India			70% :	India 30%

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Our Business

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Business Segments

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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
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	Complex Small Molecule APIs to Biologics Novels & Biosimilars	Comprehensive Presentation in Biologics	Comprehensive Presentation in Biologics	Comprehensive Presentation in Biologics
		Drug Substance	Drug Products Vials, Cartridges & Prefilled Syringes	Delivery Devices Reusable & Disposable Prefilled, Pens
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Small Molecule : APIs & Generic Formulations

Differentiated APIs

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Product Portfolio leverages core fermentation technology strengths

Among world’s largest manufacturers of statins & immunosupressant APIs

Early mover in niche products at commercial scale

Current Constituents Portfolio Simvastatin, Pravastatin, Atorvastatin, Statins Rosuvastatin, & Fluvastatin. Immuno Tacrolimus, Sirolimus, Everolimus, MMF suppressants & MPA Other Orlistat, Fidaxomicin, Glatiramer Acetate, Biopharma other molecules

Generic Formulations

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

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

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

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Launched generic Rosuvastatin and Simvastain tablets in US

Focus on vertically integrated development of molecules in chronic therapeutic areas

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Biologics: Biosimilars & Novel Biologics

Biosimilars

Novel Biologics

15+ years of experience is developing biologics with multiple biosimilars commercialized globally

Strong scientific and technical capabilities. Over 1500 people dedicated to support this business across various functions

Portfolio straddles rh-insulin, insulin analogs, mAbs and other recombinant proteins.

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NOVEL
BIOSIMILARS
BIOLOGICS
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Creating market leadership in Innovation e.g., Insulin Tregopil, Itolizumab

Pipeline includes oral insulin; mAbs against targets like CD6, CD20 & EGFR; bispecific fusion mAbs; siRNA.

Potential to change the treatment paradigm in diabetes, immunology.

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

BIOCON

MYLAN

• Global-scale, complex biologics manufacturing capabilities

• Strength in Regulatory/ filings strategy

• Facilities accredited by international regulatory agencies

• Strong commercialization capability in US and EU.

• Decade-long experience & demonstrated expertise in developing MAbs and other biologics

• Market agility and speed

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

Strategic collaboration leverages Biocon’s strong development & manufacturing capability and Mylan’s regulatory & commercial excellence

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Strategic Partnership with Sandoz for next generation Biosimilars

Deal Structure

Portfolio addresses next wave of immunology and oncology biosimilars

Both companies 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. Japan, Australia, New Zealand 2. All Emerging Markets

• North America (US & Canada) 2. EU (European Free Trade Association (EFTA) and Balkan states)

Broader Biocon participation in end to end development and commercialization with a global leader in biosimilars

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Status of Biocon’s Global Biosimilars Portfolio

Partner	Therapeutic Area	Molecule	Status
MYLAN	Oncology	Trastuzumab	Approved in U.S. Under review in EU, Canada and Australia. Launched in emerging markets
	Diabetes	Insulin Glargine	Approved in EU & Australia. Under review in U.S. and Canada. Launched in Japan* through partner FUJIFILM Pharma. Launched in emerging markets
	Oncology	Pegfilgrastim	Approved and launched in U.S. Under review in EU, Canada and Australia
	Diabetes	Insulin Aspart	Global Phase I study completed
	Diabetes	Insulin Lispro	Preclinical
	Autoimmune	Adalimumab	Global Phase III completed
	Oncology	Bevacizumab	Global Phase III ongoing. Launched in India
	Oncology	Filgrastim	Preclinical
	Autoimmune	Etanercept	Preclinical
LAB PISA	Diabetes	Recombinant Human Insulin	Preclinical
SANDOZ	Oncology & Immunology	Various	Early/ Preclinical

* Japan launch is outside of Mylan partnership

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Biocon Well Placed in Competitive Global Landscape

Molecule	Biosimilar Development Pipeline@	Biosimilar Development Pipeline@	Biosimilar Development Pipeline@	Biosimilar Development Pipeline@	Biosimilar Development Pipeline@	Biosimilar Development Pipeline@
	Phase I	Phase 3	Regulatory Submission		Approved/ Marketed
			EMA	FDA	EMA	FDA
pegfilgrastim	DRL, Pfizer, Adello, Lupin, Zydus		Biocon, Apotex, Richter, Sandoz, Cinfa, USV	Coherus, Apotex, Sandoz	Coherus (+CHMP)	Biocon
trastuzumab	DM Bio, United BioPharma, Alteogen	Hanwha, Tanvex, EirGen, Shanghai Henlius / Accord	Biocon	Amgen, Celltrion, Pfizer, Samsung	Samsung, Celltrion, Amgen, Pfizer (+CHMP)	Biocon
insulin glargine		Biocon, Gan & Lee		Biocon	Biocon, Eli Lilly, Merck	Eli Lilly, Merck (TA)
adalimumab	Oncobiologics, DM Bio, Alvotech	Coherus, Biocon, Momenta, Pfizer	Mylan-Fuji-Kirin, Fresnius	Samsung, Sandoz	Amgen, Samsung, BI, Sandoz (+ CHMP)	Amgen, BI
bevacizumab	Sandoz, Daiichi, Oncobiologics, Cipla, DRL, Tanvex, Apobiologix, Celltrion	Biocon, BI, Pfizer, Samsung, Fuji-Kirin/ Astra Zeneca, Hanwha, Bio-Thera, mAbxience, Centus, Luye, Shanghai Henlius	Pfizer		Amgen	Amgen
insulin aspart	Biocon	Sanofi

@ In clinical development, excludes pre-clinical assets

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Biosimilars Manufacturing: Building Global Scale

Biocon Malaysia: Asia’s largest integrated insulins manufacturing facility

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Biocon’s First Manufacturing expansion overseas in Iskandar, Johor.

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Investment of over US$275mn in the first phase.

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Sales commenced in Emerging Markets; include OTA award by Ministry of Health – Malaysia.

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Plant has received EMA GMP certificate for drug substance and drug product.

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Insulins Facility In Bangalore
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• Second fill-finish sterile injectable line in Bangalore has been approved by the DCGI. Will support future growth of biologics formulations

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• Construction of second antibody manufacturing facility in Bangalore ongoing. To be built in two phases over 3-4 years.

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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

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Insulin Tregopil * India Phase II/III in
DIABETES
First-in-Class Oral, Prandial Insulin T2D commenced
Itolizumab
IND Ready
Novel, humanized CD6 Antibody
BVX-20 [#]
INFLAMMATION Path to IND mapped
Novel, humanized CD20 Antibody
QPI-1007 [$]
Phase III in NAION
SiRNA for ophthalmic disease
IMMUNO- EGFR mAb + TGFβrII
Preclinical
ONCOLOGY Tumor-Targeted Fusion mAb
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• • In-House program

• BVX-20 with Vaccinex

• $ QPI-1007 licensed from Quark Pharma.

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Novel Molecules: Progressing to key milestones

Asset	Details
Insulin Tregopil	USP: Oral, Ultra Rapid-Acting
Phase II/III Ongoing	Post- prandial glycemic control; Liver specific- portal delivery, Weight neutral
	 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
IND ready	clinical safety
	 Successful PoC data: Phase 3 in psoriasis, Phase 2 in rheumatoid arthritis, preclinical in
	multiple sclerosis. Marketed in India for Plaque Psoriasis
	 Preparations for IND commenced
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

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• Specialty business with regional ambitions; strong value builder for Biocon.

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• Biologics-led specialty products focused on chronic therapy areas.

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• Comprehensive offering of products, patient and physician support programs

INDIA

UAE

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• India’s largest Insulins & leading Oncology Company

• Presence across therapies: Metabolics, Oncotherapeutics, Immunotherapy, Nephrology and Comprehensive Care Division.

• Several brands ranked amongst 'Top 3' brands in respective segments.

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• Ranked among Top 15 pharmaceutical companies in UAE.

• Most branded generic products in Top 2 in respective segments.

• Ranked at No 4 in the cardiovascular segment.

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• Insugen® ranks among Top 3 human insulin brands in India

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• CANMAb™ is No. 1 brand of Trastuzumab in India

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• KRABEVA® , biosimilar Bevacizumab, benefiting large number of patients in India

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

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Research Services Business: Syngene

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• One of leading India based CROs, a global high growth CRO company

• Offers an integrated drug discovery and development platform for both small and large molecules backed by best-in-class bioinformatics services

• Focus on novel molecular entities

• Wide spectrum of services across a range of molecules including antibody-drug conjugates and oligonucleotides

• World class infrastructure audited successfully by US FDA, EMA, AAALAC and major life sciences partners

• Over 316* global clients across multiple sectors

• World-class R&D and manufacturing infrastructure spread over 1.3 million sq. ft

• 3,500* 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)

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• For fiscal ended March 31, 2018

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Business Holdings Structure[$]

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Biocon Limited,
India
Biocon SA,
Switzerland (100%) Small Molecules &
ANDA, Novels,
Biocon FZ LLC Branded
Biocon Pharma,
(100%)/ Formulations
India (100%)
NeoBiocon, UAE
(49%)
Biocon Healthcare
Biocon Pharma,
Sdn Bhd (100%)
USA (100%)
Syngene, India Biocon Biologics, UK
(70.74%) (100%)
Biosimilar mAbs
Biocon Sdn Bhd, Biocon Biologics & Insulins
Research Malaysia (100%) India (100%)
Services
Biocon Research,
India (100%)
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• Includes 0.09% held by Biocon Research Limited.

• $ Business holding structure shown includes certain work in progress corporate restructuring

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Five Year Financials

Five Year Financials
			All Figures in ₹ Million except EPS
Business Segment	FY13	FY14	FY15	FY16	FY17$
Biopharmaceuticals	18,705	21,382	22,367	23,908	26,259
- Biopharma	15,231	17,468	18,071	19,534	20,764
- Branded Formulations	3,474	3,914	4,296	4,374	5,495
Contract Research	5,572	7,146	8,225	10,599	11,382
Total Sales	24,227	28,528	30,592	34,507	37,641
Other Income	1,103	804	837	1,192	1,913
Total Revenue	25,380	29,332	31,429	35,699	39,554
EBITDA	5,957	7,429	7,489	9,045	10,656
EBITDA Margin (%)	23%	25%	24%	25%	27%
Net Profit*	3,241	4,137	4,022	4,365	5,879
Net Profit Margin	13%	14%	13%	12%	15%
EPS*	16.2	20.7	20.1	21.8	29.4
R&D Spends (in P&L)	1,640	1,310	1,688	2,750	2,665
R&D (as % of Biopharmaceuticals Sales)	8.8%	6.1%	7.5%	11.5%	10.1%

• # Numbers as per old I-GAAP.

• Pre-Exceptional items

• $ FY17 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

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Investor Relations contact:

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

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For further information, please visit www.biocon.com