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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
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
E n d u r i n g E d g e
Key Innovations: Making a Difference
E d g e

Ogivri™, first biosimilar
7


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.


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

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

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 | |
| E n d u r i n gE d g e |
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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
E d g e
E n d u r i n g
* 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

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

Saurabh Paliwal
Tel : +91 80 6775 2040
Email: [email protected]
For further information, please visit www.biocon.com