Biocon Ltd. — Investor Presentation 2018

Nov 16, 2018

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

Biocon Limited

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

Investor Presentation

November 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.

Agenda

Our Journey

Business & Financial Highlights

Our Business

• Small Molecules
• Biologics
• Branded Formulations
• Research Services Syngene

Five Year Financials

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

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

Committed to Affordable Access

Aiming to develop products that can potentially benefit a billion patients

The Biocon Journey: A Continuous Evolution

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

E n d u r i n g E d g e

6

Key Innovations: Making a Difference

E d g e

Business & Financial Highlights

Business: Recent Highlights

• Our partner Mylan commenced commercial sales of Fulphila™ (biosimilar Pegfilgrastim) in the U.S. It is the first biosimilar Pegfilgrastim to be approved and commercialized in the U.S. and the first product from our joint portfolio to be launched there.
• Our partner, Equillium, filed an Investigative New Drug (IND) application and received go ahead from the US FDA to progress Itolizumab, our novel anti CD6 molecule, into clinical development in the United States in orphan indications.
• The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) issued positive opinions recommending approval of Fulphila™, biosimilar pegfilgrastim and approval of Ogivri®, biosimilar Trastuzumab. The decisions on approval of these two biosimilars by the European Commission are expected by November'18 and December'18, respectively.
• Our partner Mylan initiated the commercial launch of biosimilar Adalimumab (FKB product) across major markets in Europe, post Oct 16, 2018. Biocon will receive economic benefit for this product in line with our global collaboration with Mylan.
• Syngene, our Research Services subsidiary commissioned a new dedicated facility for Bristol-Myers Squibb (BMS) and renewed its collaboration with Baxter with a widened scope of engagement.

Revenue Highlights

All Figures in ₹ Million except %

Particulars	Q2 FY19	Q2FY18	Growth(%)	H1 FY19	H1 FY18	Growth(%)	FY18
-Small Molecules	4,319	3,505	23	8,320	7,134	17	15,077
-Biologics	3,675	1,557	136	6,172	3,396	82	7,702
-Branded Formulations	1,639	1,759	(7)	3,112	3,063	2	6,115
-Syngene(Research Services)	4,186	3,352	25	8,246	6,263	32	14,231
-Inter-segment	(609)	(487)		(1,402)	(833)		(1,828)
Revenue from Operations	13,210	9,686	36	24,448	19,023	29	41,297
-Other Income	544	508	7	1,232	1,048	18	2,062
Total Revenue	13,754	10,194	35	25,680	20,071	28	43,359

Financial Summary

All Figures in ₹ Million except %

Particulars	Q2 FY19	Q2FY18	Growth(%)	H1 FY19	H1 FY18	Growth(%)	FY18
Revenue	13,754	10,194	35	25,680	20,071	28	43,359
EBITDA	3,940	2,331	69	7,006	4,792	46	10,353
Profit#Net	1,840	688	167	3,037	1,501	102	3,724
R&D Expenses inP&L	769	539	43	1,211	1,121	8	2,158
GrossR&DSpends	1,196	956	25	2,079	1,887	10	3,804
EBITDA Margin	29%	23%		27%	24%		24%
EPS#@(Rs.)	3.1	1.1		5.1	2.5		6.2

Adjusted for any exceptional items, @ Adjusted for bonus

**~ Product Revenue Mix (FY18): Ex-India 70% : India 30%**

Business Segments

Small Molecule : APIs & Generic Formulations

Differentiated APIs

• Product Portfolio leverages core fermentation technology strengths
• Among world's largest manufacturers of statins & immunosupressant APIs
• Early mover in niche products at commercial scale

Generic Formulations

CurrentPortfolio	Constituents
Statins	Simvastatin, Pravastatin, Atorvastatin,Rosuvastatin, & Fluvastatin.
Immunosuppressants	Tacrolimus, Sirolimus, Everolimus, MMF& MPA
OtherBiopharma	Orlistat,Fidaxomicin, GlatiramerAcetate,other molecules

• 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

Biologics: Biosimilars & Novel Biologics

Biosimilars

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.

Novel Biologics

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

Strategic Partnership with Mylan for Biosimilars: Insulins & mAbs

BIOCON MYLAN

• Global-scale, complex biologics manufacturing capabilities

• Facilities accredited by international regulatory agencies

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

• Strength in Regulatory/ filings strategy

• Strong commercialization capability in US and EU.

• Market agility and speed

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

	Generic Insulin Analogs	Biosimilar MAbs & other Biologics
Mylan's ExclusiveCommercializationRegions	US, Canada,Europe,Australia & New Zealand	Developed markets

In Developed Markets only

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

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
1.2.	North America (US & Canada)EU (European Free Trade Association (EFTA)and Balkan states)	1.2.	Japan, Australia, New ZealandAllEmerging Markets

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

Partner	TherapeuticArea	Molecule	Status
MYLAN &LOCALPARTNERS	Oncology	Trastuzumab	Approved in U.S. Received positive opinion recommendingapproval from EMA's CHMP. Under review in Canada andAustralia. Launched in emerging markets
	Diabetes	InsulinGlargine	Approved in EU & Australia. Under review in U.S. and Canada.Launched in Japan through partner FUJIFILM Pharma. Launchedin emerging markets
	Oncology	Pegfilgrastim	Approved and launched in U.S. Received positive opinionrecommending approval from EMA's CHMP. Under review inCanada and Australia
	Diabetes	Insulin Aspart	Global Phase I completed
	Diabetes	Insulin Lispro	Preclinical
	Autoimmune	Adalimumab	Mylanhas launched Hulioin EU. Bioconbenefits from economicinterest.
	Oncology	Bevacizumab	Launched in India. Global Phase III ongoing
	Oncology	Filgrastim	Preclinical
	Autoimmune	Etanercept	Mylan'sin-licensed product filed for approval in Europe. Bioconretains economic interest
LOCALPARTNERS	Diabetes	Recombinant HumanInsulin	Launched in several emerging markets.In active development for U.S. (partnered with Lab Pisa)
SANDOZ	Oncology &Immunology	Various	Early stage development

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

@ In clinical development, excludes pre-clinical assets

Biosimilars Manufacturing: Building Global Scale

Biocon Malaysia: Asia's largest integrated insulins manufacturing facility

• Biocon's First Manufacturing expansion overseas in Iskandar, Johor.
• Investment of over US$275mn in the first phase.
• Sales commenced in Emerging Markets; include OTA award by Ministry of Health – Malaysia.
• Plant has received EMA GMP certificate for drug substance and drug product.
• 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. To be built in two phases over 3-4 years.

Insulins Facility In Bangalore

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

Novel Molecules - Pipeline & Therapeutic Area Focus

Insulin Tregopil*First-in-Class Oral, Prandial Insulin	India Phase II/III inT2D commenced
Itolizumab*Novel, humanized CD6 Antibody	IND Approved fororphan indications
BVX-20#Novel, humanized CD20 Antibody	Path to IND mapped
QPI-1007$SiRNA for ophthalmic disease	Phase III in NAION
EGFR mAb+ TGFβrII*Tumor-Targeted Fusion mAb*	Preclinical

Novel Molecules: Progressing to key milestones

Asset	Details
Insulin Tregopil	USP: Oral,Ultra Rapid-ActingPost-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
ItolizumabIND Approved for orphan	USP: Novel CD-6 Biology presenting durable immune-modulatory benefits and superiorclinical safety
indications	Marketed in India for Plaque Psoriasis, licensedto Equillium for US & CanadaPhase 1b/2 clinical trial for the treatment of acute graft-versus-host disease, or aGVHD, planned in early2019Phase 2 clinical trial for the treatment of chronic graft-versus-host disease, or cGVHD, planned in H12019
	Proof-of-concept clinical trial for the treatment of severe asthma planned inH1 2019
QPI-1007	Novel SiRNAfor ophthalmic disease:
In Phase III	Non-ArteriticAnterior Ischemic Optic Neuropathy (NAION)–Patients randomized for global study (incl. inIndia)
BVX-20	2ndGeneration humanized antibody targeting CD-20
IND ready	Path to IND mapped out, to advance program in neuro-inflammatory disorder
EGFR mAb+ TGFβRII(FusionmAb)	USP: Higher local tumorconcentration of immuno-modulatory arm resulting in a bettertherapeutic 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
E d g e	E n d u r i n g22

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

• 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.
• Insugen® ranks among Top 3 human insulin brands in India
• CANMAb™ is No. 1 brand of Trastuzumab in India

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

Key Brands

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

UAE

• 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.

Research Services Business: Syngene

• 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, antibodydrug conjugates and oligonucleotides backed by bestin-class bioinformatics services
• End-to-End discovery, development and manufacturing capabilities with focus on novel molecular entities
• World class infrastructure audited successfully by US FDA, EMA, AAALAC and major life sciences partners
• Over 316* global clients across multiple sectors

E n d u r i n g

E d g e

• 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)

* For fiscal ended March 31, 2018

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
OtherIncome	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
EBITDAMargin (%)	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 BiopharmaceuticalsSales)	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

Investor Relations contact:

Saurabh Paliwal

Tel : +91 80 6775 2040

Email: investor.relations@biocon.com

For further information, please visit www.biocon.com