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Biocon Ltd. Investor Presentation 2019

Sep 11, 2019

61176_rns_2019-09-11_a3abd6ba-8ae0-425b-9911-6c6d9c7e6783.pdf

Investor Presentation

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Bio .. un Limite-d

20th KM Hosur Road Electronics City Bangalore 560 100, India T 91 80 2808 2808 F 91 80 2852 3423 CIN: L24234KA1978PLC003417

www.biocon.com

September 11, 2019

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

Dear Sir/Madam,

Sub: Revised Investor Presentation for Quarter ended June 30, 2019. Ref: Regulation 30 ofthe SEBI Listing Obligations and Disclosure Requirements (LODR) Regulations, 2015.

With reference to the captioned subject, please find enclosed Revised Investor Presentation for Quarter ended June 30, 2019.

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

Thanking You,

Yours faithfully,

For BIOCON LIMITED

~

~ Mayank Verma Company Secretary & Compliance Officer

Encl: Investor Presentation

Biocon Limited

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

Investor Presentation

September 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.

Agenda

Our Journey

Our Business

Financial Highlights

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

Five Year Financials

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

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

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Key Innovations: Making a Difference

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Ogivri™, first biosimilar

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Financial Summary

All Figures in ₹ Million except %

Particulars Q1 FY20 Q1FY19 Growth FY19 FY18 Growth(%)
Revenue 14,900 11,926 25% 56,588 43,359 31%
EBITDA 4,616 3,066 51% 15,381 10,353 49%
Profit#Net 2,229 1,197 86% 7,291 3,724 96%
R&D Expenses inP&L 787 442 78% 2,899 2,158 34%
GrossR&D Spends 1,101 883 25% 4,796 3,804 26%
EBITDA Margin 31% 26% 27% 24%
EPS#(Rs.) 1.9 1.0 6.1 3.1

Adjusted for any exceptional items, EPS adjusted for bonus

All Figures in ₹ Million except %

Particulars by segment Q1 FY20 Q1FY19 Growth FY19 FY18 Growth
-Small Molecules 4,796 4,001 20% 17,728 15,077 18%
-Biologics 4,896 2,497 96% 15,169 7,702 97%
-Branded Formulations 1,334 1,473 -9% 6,654 6,115 7%
-Syngene(Research Services) 4,209 4,060 4% 18,255 14,231 28%
-Inter-segment (576) (793) -27% (2,572) (1,828) 41%
Revenue from Operations 14,659 11,238 30% 55,144 41,297 34%
-Other Income 241 688 -65% 1,444 2,062 -30%
Total Revenue 14,900 11,926 25% 56,588 43,359 31%

Key Financial Metrics – Evolution over last 5 quarters

All Figures in ₹ Million except %

FY 2020
Particulars Q1 Q2 Q3 Q4 FY19 Q1
SEGMENT REVENUE
a. Small Molecules 4,001 4,319 4,689 4,719 17,728 4,796
b. Biologics 2,497 3,675 4,486 4,511 15,169 4,896
c. Branded Formulations 1,473 1,639 2,122 1,330 6,564 1,334
d. Research Services 4,060 4,186 4,671 5,338 18,255 4,209
Total 12,031 13,819 15,968 15,898 57,716 15,235
Less: Inter-segment revenue (793) (609) (560) (610) (2,572) (576)
Net sales / Income from continuing operations 11,238 13,210 15,408 15,288 55,144 14,659
SEGMENT MARGINS* (PBIT/SegmentRevenue)
a. Small Molecules 18% 20% 21% 14% 18% 22%
b. Biologics 11% 25% 30% 33% 26% 38%
c. Branded Formulations 12% 7% 13% 4% 9% -2%
d. Research Services 20% 23% 23% 24% 23% 21%
Consolidated Margins 17% 20% 18% 19% 19% 21%
ROCE*(PBIT/CapitalEmployed)
a. Small Molecules 22% 22% 23% 22% 22% 27%
b. Biologics 4% 7% 9% 11% 11% 20%
c. Branded Formulations 74% 58% 79% 81% 81% -11%
d. Research Services 20% 23% 21% 21% 21% 17%
Consolidated ROCE (Annualized) 13% 15% 15% 15% 15% 18%

* Segment margins are before interest & other un-allocable expenditure / (income) and segment ROCE is before un-allocable assets/ liabilities.

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Business Segments

Novel Biologics & Biosimilars

Innovation in biologics development including novel molecules & biosimilars

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Small Molecule : APIs & Generic Formulations

Differentiated APIs CurrentPortfolio Constituents
ProductPortfolioleveragescorefermentationtechnologystrengths Statins Simvastatin, Pravastatin, Atorvastatin,Rosuvastatin, & Fluvastatin.
Amongworld'slargestmanufacturersofstatins&immunosupressantAPIs Immunosuppressants Tacrolimus, Sirolimus, Everolimus,Mycophenolate Mofetil& MycophenolateSodium
Earlymoverinnicheproductsatcommercialscale OtherBiopharma Orlistat,Fidaxomicin, GlatiramerAcetate,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

Biologics: Biosimilars & Novel Biologics

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

Potential to change the treatment paradigm in diabetes, immunology.

Biosimilars

Positioned among early wave of entrants with multiple biosimilars commercialized globally. 15+ years of experience is developing biologics.

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

Strong scientific and technical capabilities. Over 4000+ people dedicated to 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 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 Partnership with Sandoz for next generation Biosimilars

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

Status of Biocon Biologics Global Biosimilars Portfolio*

Therapeutic Area Molecule Status
Oncology TRASTUZUMAB Launched in EU, Australia & Emerging Markets. Approved in U.S.& Canada.
Oncology PEGFILGRASTIM Launched in the U.S. Approved in EU, Australia & Canada.
S Oncology BEVACIZUMAB Launched in India.Global Phase III.
RE Oncology FILGRASTIM Preclinical
NT Oncology PERTUZUMAB Early Development
RAPL Diabetes INSULINGLARGINE Launched in the EU, Japan#& Emerging Markets. Approved inAustralia & New Zealand. Under review in U.S.
AC Diabetes INSULIN GLARGINE 300 IU/ML Early Development
OL DiabetesINSULIN ASPART Global Phase III
&N Diabetes INSULIN LISPRO Preclinical
ALYM Diabetes RECOMBINANT HUMANINSULIN Launched in Emerging Markets. Phase I for U.S. (partnered withLab Pisa)
Autoimmune ADALIMUMAB product Hulio®Partner Mylan has launched in-licensedin EU.Bioconbenefits from economic interest
Autoimmune ETANERCEPT Partner Mylan's in-licensed product filed for approval in EU. Bioconretains economic interest
ZODNAS Oncology &Immunology VARIOUS ASSETS Early stage development

Japan launch is outside of the Mylan partnership

Biocon Biologics 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, Celltrion,Alvotech, Pfizer Pfizer Amgen, Samsung,Sandoz, Fresnius/DRL,Fuji Kirin/Mylan/BIOCON Amgen, BI,Sandoz, Samsung
ETANERCEPT Coherus, Hanwha Lupin/Mylan/BIOCON Samsung, Sandoz Samsung, Sandoz
TRASTUZUMAB DM Bio, UnitedBioPharma, Alteogen,NeuClone, Sino Tanvex,EirGenix/Sandoz, Hanwha/ Prestige,Shanghai Henlius/Accord Amgen, Celltrion,Pfizer, Samsung,BIOCON Amgen, BIOCON,Celltrion, Samsung,Pfizer
BEVACIZUMAB Sandoz, Daiichi,Fresnius/DRL, Tanvex,Apobiologix, ZhejiangTeruisi BI, Centus, Fuji-Kirin/Astra, BIOCON, Cipla,mAbxience/ Amneal,Hanwha/ Prestige, BioThera, Shanghai Henlius,Luye, Celltrion, JHL Samsung Amgen, Pfizer Amgen, Pfizer
PEGFILGRASTIM Fresnius/DRL, Pfizer,Kashiv(Adello), Lupin,Zydus Apotex/ Intas,Sandoz BIOCON, Coherus,Apotex/ Intas,Sandoz,USV/Juta,Mundipharma(Cinfa) BIOCON, Coherus
FILGRASTIM Lupin Apotex, Kashiv(Adello), Tanvex Sandoz,Teva,Hospira, Stada, Intas,Hexal Sandoz, Pfizer

$ Based on publically available information

Biocon Biologics Well Placed in Competitive Global Landscape (2)

Molecule Biosimilar Insulin Development Pipeline$
Phase I Phase 3 Regulatory SubmissionApproved/ Marketed
EMA FDA EMA FDA
INSULIN GLARGINE Lannett/ HEC Gan& Lee/ Sandoz BIOCON BIOCON,Eli Lilly,Merck Eli Lilly, Merck(TA)
INSULINASPART BIOCON Sanofi
INSULINLISPRO Sanofi Sanofi
RH-INSULIN BIOCON Rechon(EU)

$ Based on publically available information

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 EMA. To support future growth of biologics formulations and help expand access across global markets.
  • Construction of second antibody manufacturing facility in Bangalore ongoing, expected commissioning in FY20.

Insulins Facility In Bangalore

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, NPRA, Malaysia and other Emerging Market regulators.
  • Sales commenced in E.U. & Emerging Markets; include OTA award by Ministry of Health – Malaysia.

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

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Biocon Biologics: Transforming Healthcare, Transforming Lives

Vision: "Most Inspiring Global Leader in Biologics" delivering affordable access to innovative and inclusive healthcare solutions, transforming patient lives.

Implement strategic initiatives going beyond the product in our aspiration to reach dominant market share in key markets, unlock underserved markets, and differentiate us from competition

PATIENTS Patient-Centricity & Therapeutic Area Leadership•Leader with a vision that resonates strongly with global scientific communities
SRA PEOPLE Unique Culture with Talent Diversity•Unique culture of constant innovation•Inherent strengths in co-creation and leveraging diversity
LLPIR Disruptive &DifferentiatedPortfolio•Leader in a disruptive, differentiated portfolio offering•Achieve scientific excellence by leveraging cutting-edge technology
UOFEH PARTNERS Agile Delivery Capability•Global scale manufacturing with AI/ML equipped systems•Innovative delivery models that optimize number of intermediaries
T Innovative, Technology-Driven Operating Models•Archetype-based technology-driven operating model leveraging partnerships•Ability to serve patients at the centreof the income pyramid
BUSINESS Excellencein Market Shaping•Leader in creating sustainable market advantages and policy shaping
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Branded Formulations: Now aligned with Biologics Growth Strategy

  • 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.

UAE

  • Ranked among Top 15 pharmaceutical companies in UAE.
  • Most branded generic products in Top 2 in respective segments.
  • Glaricon (Biosimilar Insulin Glargine) and 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™

Novel Molecules - Pipeline & Therapeutic Area Focus

DIABETES Insulin Tregopil(In-house program)First-in-Class Oral, Prandial Insulin•Liver specific-portal delivery, Weight neutral•Pivotal Phase II/III clinical study in T2DM patients in India ongoing•JDRF supported Phase I Multiple Ascending Dose study planned in T1DM patients India Phase II/III inT2D ongoing
Itolizumab(Licensed to Equilliumfor US & Canada)Novel, humanized CD6 Antibody•Novel CD-6 Biology presenting durable immune-modulatory benefits and superior clinicalsafety•Marketed in India for plaque Psoriasis Clinical Trialinitiated in aGVHD,Severe Asthma
INFLAMMATION BVX-20# (Partnered with Vaccinex)Novel, 2ndGeneration humanized CD20 Antibody•Path to IND mapped out, to advance program in neuro-inflammatory disorder Path to INDmapped
QPI-1007(licensed from Quark Pharma)SiRNA for ophthalmic disease•Non-ArteriticAnterior Ischemic Optic Neuropathy (NAION)•Patients randomized for global study (incl. in India) Phase III in NAION
IMMUNOONCOLOGY EGFR mAb+ TGFβrII(In-house program)Tumor-Targeted Fusion mAb*•Higher local tumor concentration of immuno-modulatory arm resulting in a bettertherapeutic window•Opportunity to target multiple tumor types Pre-clinical

Incorporated in Boston, U.S. as a wholly owned subsidiary of Biocon to focus on developing Immuno-oncology assets

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 1.5 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

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* For fiscal ended March 31, 2019

Biocon: Group Structure

Legend: Ultimate Holding Company Joint Venture Direct Subsidiary Step-down subsidiary 2nd Step-down subsidiary % Depict voting power Details are as on July 31, 2019

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Saurabh Paliwal

Tel : +91 80 6775 2040

Email: [email protected]

For further information, please visit www.biocon.com