Biocon Ltd. — Investor Presentation 2020

Jun 11, 2020

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

Biocon Biologics Investor Presentation

Transforming Healthcare. Transforming Lives June 2020

Safe Harbour

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, 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 biotechnology and pharmaceuticals industries, changes in political conditions and changes in the foreign exchange control regulations. 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

Biocon Biologics

Uniquely positioned as fully integrated player for biosimilars

Development Partnerships (Mylan, Sandoz) 2

Products in pipeline 28

Products taken from Lab to Market 5

Patents granted (Biologics)* ~860

Countries where our ~120

products are available

R&D sites (Bangalore, Chennai) 2

cGMP approvals from International regulatory agencies** 25+

Office locations around the globe 4

*Status Jun 2019 **Key regulatory approvals from US, EU, Japan, Canada, Australia, Brazil, Mexico, Turkey, GCC etc*.*

Our Vision

Biocon Biologics

'Transforming Healthcare, Transforming Lives.'

Most inspiring global leader in Biologics delivering affordable access to innovative and inclusive healthcare solutions, transforming patient lives.

We transform healthcare

Example: Diabetes – a global epidemic

Biocon Biologics

Committed to make a difference to patients' lives

served 2.1 million patients* in FY 20 touch over 5 million patient lives* by FY 22

We are serving global patient needs with high quality, affordable Biosimilars

Biocon Biologics - Set Up For Success

Well positioned in therapeutic areas like diabetes and oncology and inflammatory diseases Business & commercial strategy tailored to market archetypes, aim to be disruptive

• As a committed stakeholder of the United Nation's Sustainable Development Goals* (SDG) framework, Biocon Biologics is committed to UNIVERSAL healthcare both for diabetes and cancer treatments
• Business and commercial strategy will be aligned to address needs of patients and healthcare systems based on specific market archetypes
• Most innovative and disruptive healthcare company; aspires to transform patient lives through innovative and inclusive healthcare solutions
• Be a leader in MoW markets by delivering high quality and low cost medicines
• *https://sustainabledevelopment.un.org/

Competitive Cost

Fully integrated from Lab to market and focused on biosimilars

Capacity enhancement aligned with expanding global demand

Next wave of biosimilars through direct commercialization

Investing in digital marketing and new technologies across the value chain

Biocon Biologics

Foundation based on over 40 years of experience in science and manufacturing

Biocon Biologics Holding Structure

Independent and international management team with top talents

Market overview

Nature of Biosimilars

High investments, quality focus and scale needed to deliver biosimilars across the world

Biologics Market

Significant opportunity for biosimilars

1. Excludes vaccines; 2. As of 2019

Note: size of market is indicative

Source: IMS, FDA, gabionline, Worldometers, press search, BCG analysis

Biocon Biologics – Biosimilars is our only focus

Major player with 28 molecules in pipeline

	PRODUCT	BIOCON BIOLOGICS	PFIZER	AMGEN	SAMSUNG	SANDOZ	CELLTRION	COHERUS	LILLY	SANOFI
GNDRILIEOFSFEORUQUNIOMU	Pegfilgrastim
	Trastuzumab
	Bevacizumab
	Adalimumab
UTSNELIUSSHINCG INANROFRTS	Etanercept
	Glargine
	Aspart
	Lispro
	Infliximab
	Rituximab				*
	Filgrastim

Note: Phase 3 or later assets displayed only as check marks; *Samsung admits it failed to develop Rituxan biosimilar (http://www.koreabiomed.com/news/articleView.html?idxno=6608)

Biocon Biologics Pipeline

Steady stream of launches every year^ in developed markets

Undisclosed: US Undisclosed: US

Business

Biocon Biologics footprint across the world

Serving patient needs in emerging & developed markets

Biocon Biologics footprint across the world

~2M patients reached in FY20

Product	FY20PlannedReach	FY20EstimatedReach*
RHI	2.0M	1.7M
Glargine	479k	283k
Pegfilgrastim	26k	20k
Adalimumab	24k	24k
Trastuzumab	20k	18k
Total	2.6M	2.0M

Number of patients = (Volume supplied in FY20) / (Dose per patient per year - PPPY ) | Assume 70kg Trastuzumab (eBC/mBC) ~17x 440mg per year (Ogivri FDA label dosage) | Pegfilgrastim – Assume 6 cycles of treatment per year (Fulphila FDA label dosage) RHI ~50 units per day (Humulin FDA label dosage ) | Glargine ~40 units per day (Basaglar FDA label dosage )

Biocon Biologics

Global Product Portfolio

BIOCON BIOLOGICS is independently developing many biosimilar assets

With MYLAN, 11 biosimilars being co-developed for global markets

With SANDOZ, set of next-gen immunology, oncology biosimilars being co-developed for global markets

Biocon – Mylan Partnered Product Pipeline

Early mover in first wave of biosimilar launches in the next 3–5 years

		THERAPEUTIC		STATUS
		AREA	MOLECULE	US	EU	RoW
Biocon's strong		Oncology	Trastuzumab	$ 2.8 B	$ 1.5 B	Launched in Australia Canada &Emerging Markets.
development and			Pegfilgrastim	$3.4B	$ 0.4 B	Launched in Canada and Australia
manufacturing capabilities			Bevacizumab	$ 3.1 B	$ 1.8 B	Launched in India
+			Filgrastim			-
			Pertuzumab			-
		Diabetes	Glargine 100 IU/ml	$ 2.2 B	$ 0.8 B	Launched in Australia, Japan* &EmergingMarkets. Approved in New Zealand.
Mylan's regulatory and			Glargine 300 IU/ml			-
commercial excellence			Aspart	$ 1.3 B	$ 0.85 B	-
			Lispro			-
Cost and profit		Autoimmune	Adalimumab**	-	$ 3.9^ B	-
share model			Etanercept**	-	$ 1.8 B	-
		Early Development/ Preclinical			Planned Submission/ Filed	ApprovedMarketed

*Japan is outside of Mylan partnership; **Partner Mylan has in-licensed product (Biocon benefits from economic interest); ^assuming 2/3 of Humira reported international sales & Biosimilars IQVIA sales; "$ numbers indicate market size of innovator reported sales + Biosimilars IQVIA sales in CY 2019

Pegfilgrastim - Fulphila

Pegfilgrastim biosimilars at 28%1 of total US market; with the additional approval of a new manufacturing facility, Fulphila is well-positioned to grow rapidly in the US and expand in other markets

• Fulphila® was one of the most successful biosimilar launches in the U.S.
• Biosimilars to Pegfilgrastim captured a volume market share of 28%1 in Mar'20.
• This growth reflects the increase in penetration and ease of adoption of biosimilars by prescribers, payers and patients

Biocon/ Mylan first to launch in US Expanded capacity to drive U.S. growth, enter new markets

• Biocon and Mylan's sBLA for Pegfilgrastim Drug Substance to be manufactured at Biocon's new Biologics manufacturing facility, approved by the U.S. FDA in Nov'19.
• This facility will enable Biocon Biologics to scale up capacity multi-fold.
• This capacity expansion will help address growing patient needs in EU, Australia and Canada, where Fulphila® is approved.

Trastuzumab

First biosimilar trastuzumab approval globally with CANMAb™ in India; OgivriTM launched in the US, EU and Australia; Biocon Biologics has sufficient manufacturing capacity to fulfil demand for global markets

• Regulatory approval in more than 80 countries worldwide including India, Brazil, Algeria, Turkey and UAE
• CANMAb™, the world's first trastuzumab biosimilar, launched in India in 2014.
• In Brazil, Biocon's biosimilar trastuzumab, ZEDORA enjoys a 41% share of the non-tender market2 .

Emerging Markets Developed Markets

• First biosimilar trastuzumab approved by the U.S. Food and Drug Administration (FDA) in Dec 2017
  • Launched in US in Dec 2019, Ogivri unit share ~2%1 in Mar'20
• Unanimously recommended by the FDA Oncologic Drugs Advisory Committee (ODAC)
• Launched in the competitive, but sizable EU markets in Mar'19.
• In Aug'19, the first biosimilar trastuzumab approved and launched in Australia; available on the Pharmaceutical Benefits Scheme (PBS).

BBL's Biosimilar Trastuzumab aims to address the huge unmet need for patients and for healthcare savings, and is well positioned to succeed as a global leader in a competitive market

23 1 Company Reported Data 2 IQVIA Data

Insulins Portfolio

Equitable access to more affordable insulins is critical to address the growing incidence of diabetes globally Biocon Biologics is among the Top 5 insulins players globally, vertically integrated and cost competitive

Recombinant Human Insulin (rh-insulin)

• Currently registered in ~45 countries and commercialized in many emerging markets.
• BBL is committed to universal access to rhinsulin by reducing prices for low and middleincome countries (LMIC) to less than 10 US cents/day
• Independent development program for the US market, completed Phase-1 studies.
• Acceleration impact on US launch timing, linked to recent positive FDA guidance for insulin biosimilars, is under review

Insulin Glargine

• Approved in ~70 countries and commercialized in key emerging markets such as Brazil, Mexico, Malaysia, South Korea, UAE
• Launched in Japan, EU and Australia,
• Confident of securing approval from US FDA in Jun'20
• Huge opportunity in a limited competition market

Insulin Aspart

• Under review in the EU, expected to launch in FY21E.
  • EU net sales of ~$0.85B1 (2019),
• On track for US filing in mid-CY'20.
  • US net sales of ~$1.3B1 (2019),

Bevacizumab

Launched in India in Nov 2017; global trial complete, US filing done in Dec'19

• US - 2 players approved by FDA, biosimilar share ~28%1
  • Amgen was first to launch, Amgen launched in Jul'19, captured ~28%1 by March 2020
  • Pfizer launched in Jan'202
  • Samsung filed in US in Nov'19, 5 more late stage players
• EU – 2 players approved by EMA, no launches so far
  • Amgen approved in Jan'18;
  • Pfizer approved in Feb'19
  • Samsung filed in EU in Jul'19

Market Dynamics BBL's Bevacizumab

• Krabeva launched in India in Nov 2017
• Filed in US and EU in Dec'19 and Feb'20 respectively
• US launch planned in FY21 and EU launch in FY 22
• Filing in other markets in early FY21

Biocon – Sandoz exclusive partnership

Co-development of next-generation biosimilars

Shared responsibility for…

Manufacturing

Global regulatory approvals

Costs & Profits are shared equally

Broader Biocon participation in end-to-end development and commercialization

Various assets are in early stage development stage for global markets

R&D and manufacturing

Research & Development

World class research talents and infrastructure

• 85,000 sq. ft. state of the art research facility in BLR
• 8,000 sq. ft. microbial and cell culture pilot plants
• 60,000 sq. ft research center in Chennai
• 45,000 sq. ft. pilot plan in Malaysia

Biocon Research Centre, Bangalore

• 450+ employees
• 20% with MDs or PhD's
• 60% with Masters Degrees
• Alumni from leading Indian & International Universities

Research & Development

Capabilities and Structure

C A P A B I L I T I E S

• Drug Discovery

• Process Development

• Scale Up & TT to manufacturing

• Analytical Sciences

• Bioanalytical Sciences

• Intellectual Property Rights

P L A T F O R M E X P E R T I S E

• Pichia pastoris

• E. Coli

• CHO

• NS0

• Fusion Proteins

• Drug Substance: Upstream

• Drug Substance: Downstream

• Formulation & Drug Product

Process sciences Analytical & bioanalytical sciences Intellectual property rights

• Analytical Method Development

• Physico-chemical characterization

• Functional characterization

• PK & Immunogenicity

• Toxicology

• Patents

• Trademarks

• Litigation support

Global Scale Manufacturing Expertise

Largest Biologics manufacturing capacity in India

State-of-the-art manufacturing facilities – mammalian & microbial

Facilities conform to most stringent cGMP guidelines

Regulatory approvals - EMA, US FDA, Health Canada, ANVISA, COFEPRIS, PMDA, TGA, MCC etc.

Second fill-finish sterile injectable line in Bangalore has been approved by key regulators including EMA and US FDA. It will support future growth of biologics formulations

Construction of second antibody manufacturing facility in Bangalore ongoing. First phase to be operationally qualified in FY20

Manufacturing Sites

Largest Biotech Hub in India

Capabilities To Address Global Market Opportunities: Global Scale - Cost Competitive - Complex Manufacturing

Unlocking Market Opportunity

The opportunity expected to increase ~2.5x as new products are commercialized

Context of global leadership Biosimilar penetration

80%+ total biosimilar market shares open the door to leadership-level shares

Encouraging trend of significant biosimilar adoption in both Europe and US provides an opportunity for Biocon Biologics to capture a dominant share of the market

FY22 Aspiration of $1Bn

Multiple levers to further accelerate growth in the next 2 years

• Ramp up of pegfilgrastim and trastuzumab and glargine
• Launch of insulin glargine in US
• • Continued growth in existing developed and emerging markets
  • Launches of insulin aspart and bevacizumab in various markets
    • Launch of recombinant insulin in US
    • Enhance market share

Diversified mix across developed and emerging markets

• While US is biggest growth driver, MOW growth is also significant
• Continued performance in key Markets: Algeria and Brazil for trastuzumab, Malaysia and Mexico for insulins
• Early entry into China as potential upside

What to Expect In The Next Decade?

Only a few players will succeed in the BS market and we will be one of them!

Accelerating the growth path

Ability to further differentiate and disrupt healthcare

Leveraging our affordable innovation model & global scale R&D

Further strengthening the broad pipeline

Competitive Cost Fully integrated from Lab to market and focused on biosimilars

O U R A D V A N T A G E

Capacity enhancement aligned with expanding global demand

Next wave of biosimilars through direct commercialization

Investing in digital marketing and new technologies across the value chain

Conclusion

Key Investment Highlights

Highest quality, differentiated, transformative, pure play, scaled biosimilars company

• Global biosimilar market presents a large and attractive opportunity; Biocon Biologics is the best suited to tap into this opportunity
• Best-in-class platform with a de-risked first wave pipeline of 8 advanced products and deep pipeline of second wave products, supported by an efficient R&D engine
• Commercial partnerships with two of the largest pharma companies in the world; significantly reducing commercialization risk
• High quality, low cost, commercial scale manufacturing capabilities
• Vision to provide technology driven, personalized care to transform the Healthcare ecosystem
• Strong corporate governance, sponsorship and highly experienced management team

* Includes molecules in clinical development or which has been filed/ approved/ launched in developed markets - Pegfilgrastim, Trastuzumab, Insulin Glargine, Bevacizumab, Insulin Aspart along with molecules in-licensed by Mylan where Biocon benefits from economic interest - Adalimumab and Etanercept

Questions