Industry 

Profile
Biocon Limited is the largest biopharmaceutical company of India. It was
incorporated in 1978 as a joint venture between Biocon Biochemicals Limited and an Indian
entrepreneur, Kiran Mazumdar Shah. The company started as an enzyme manufacturer and
was soon exporting to US and Europe.

The pharma sector is well poised to take an important position in the world markets.
India being the largest generic medicines provider, supplies over 50% of the world demand
for various vaccines and over 40% of generic demand in the US. This basically points to a
simple conclusion, that India has an enormous advantage or conducive environment to
produce generic medicines because India being one of the largest producers of STEM
graduates.

Indian pharma sector is expected to be a $100 Billion opportunity by 2025. The

export pharma sector is expected to be $25 Billion opportunity, with the main export of bulk
drugs, intermediates, drug formulations, biologicals, Ayush and herbal products and surgical
devices.

Now, we will go deeper and talk about the biotechnology space in India. The sector
mainly comprises of biopharmaceuticals, bio-services, bio-agriculture, bio-industry and bio-
informatics. The majority of revenue is generated in biopharma.

India is among the fastest-growing markets for the biotech sector, having the second-
highest USFDA approvals. India is also a favoured destination for clinical research, clinical
trials and contracts research services due to the growing bio-services sector.

Global Trends
i. Growing and ageing population: The population is still rising with most of the world
population becoming ‘older’. The spread of non-communicable diseases commonly found in
the elderly, like cancer and other cardiovascular diseases opens up opportunities for novel
healthcare products and therapies.

ii. Pricing Pressure: With the rising population and increased life expectancy, the demand for
novel and complex healthcare products is going to rise and hence consumers will have to pay
more ‘out of the pocket expenses’ (exceeding health insurance claims), resulting in pressure
from governments to fix prices for some products

iii. Technological Advancements: With the expanding scope of AI and data analytics in

healthcare, there is a big scope for companies in this space to use more of the digital
platforms to build on their increased efficiencies. This will translate into more research and
development expenses, but over long term, it may pan out to be a competitive advantage.

iv. More Collaboration: Increasing scope for strategic partnerships is another definitive trend.
This will be more advantageous for well-established firms working in emerging countries,
who now want to geographically diversify. They will move toward global players and might
indulge in joint ventures to enable a win-win situation.

v. More resilient healthcare systems: This is a crucial point that we see emerging post the
COVID scenario. The lack of consensus, political mismanagement, inadequate health
infrastructure to tackle the virus, has led to growing dissent among the public and a question
mark on the pharma and healthcare sector as a whole discounting the political clout. This also
gives an opportunity for key infrastructure and organizational/ strategic players to create a
functioning & efficient healthcare system.
The Indian pharmaceutical sector has been growing at 15% CAGR since 2015. There is a big
overhang, which is the COVID outbreak (PwC). It is also estimated that the sector will
register a 10-13% growth in FY21 (ICRA)

The major issue going forward is pricing pressure. The growth of both the US GDP
and the pharma sector (being a major importer from India) manufacturing issues, US-FDA
drug approvals and the vaccines developed for COVID will increase competition causing a
downward pressure on pricing

The Indian biotech sector has been growing at ~ 10-12% annually. The main regulator
in India for this sector is Department of Biotechnology (DBT). Moreover, the medical
devices and diagnostics sector is seen as a growing area for the industry. Another special
trend seen in India is that lot of startups (2700+) are in the biotech space and it is expected
that there will be 10000+ biotech sectors by 2024.

Additionally, due to 100% FDI allowed under automatic route for greenfield pharma
and manufacturing of medical devices, there is a big possibility of increase in competitive
intensity in the sector
Company Profile

The company is led by Siddharth Mittal, CEO and Joint MD along with Kiran Shaw,
the chairperson and the MD of the company. Recently, Dr. Arun Chadavarkar retired as CEO
& Joint MD of Biocon on 30th November 2019 after spending 29 years at the company.
Here, we will be only talking about Kiran Mazumdar Shaw, as she is the majority shareholder
in Biocon, close to ~ 40% and is the chairperson of the board. She also became the executive
chairperson of the company. She started this company as a joint venture with Biocon
Biochemicals Limited with a startup capital of Rs. 10,000 as an enzyme’s manufacturer.

She was born on 23rd March 1953 in Bangalore, became the India’s richest self-made
woman billionaire with a net-worth of around $4.1 Billion according to Forbes. Under her
leadership, Biocon became the first company to receive US FDA approvals for its two
biosimilar products for the treatment of cancer. She was the one responsible for making
Biocon taking a different approach from the copy-cat generic business to a high-end R&D
company. Back when she was a young student, she wanted to become a doctor but couldn’t
and when such an opportunity arose, she jumped to it and became an entrepreneur, which was
not at all a famous career option for a woman back in the Indian society of 1970s. She
completed her Bachelor’s in science degree from Bangalore University and did her Masters
from Melbourne University. She has received accolades from the GoI such as Padma
Bhushan in 2005 and Padma Shri in 1989. She holds a lot of international awards and
honorary degrees from international universities. She also holds board memberships in
Infosys and Narayan Health.
Biocon’s Business:

Source: FY19-20 Annual Report

Biocon is India’s largest integrated biopharmaceutical pure play company listed both
on NSE and BSE. Since its operational inception back in 1978, Biocon had been engaged in
the manufacturing of enzymes. In 1999, Biocon leveraging on its fermentation technology
derived from 21 years of experience in enzymes business, forayed into the pharmaceutical
business. The pharmaceutical companies have been engaged in the generic formulation
business, due to cheap imports of APIs (the core raw material) from China and lower cost due
to the ‘generic’ nature of the medicines, which translated to low R&D expenses.

Biocon started its pharma business not in ‘generic’ space but started targeting
manufacturing of APIs, biosimilars, novel biologics etc. The company also started tackling
diabetes by venturing into therapeutic business. This is important because it showed a
differentiated approach adopted by the company. This approach also brought in considerable
advantages like high barriers to entry, first mover advantage, high cost of R&D expenses and
setting up of clinical trials and research.
The company also believes bi-specific antibodies to be the next major opportunity.
These antibodies offer an advanced therapy treatment against cancer.
The company also recently stated that they have reached an inflection point in their
biosimilar business and have consolidated the whole value-chain into a wholly owned
subsidiary, Biocon Biologics headed by Dr. Christiane Hamacher.
Biocon also holds more than 50% market share as the leading producer of Olistat API.
Biocon entered back in 2003, being one of the first movers, in the mammalian cell culture
technology. They are used in developing complex molecules which helps in repressing tumor.
The company also believes that oncology market to be the major dominant market in
the therapies industry, projected sales to be ~US $129 billion over 2017 to 2024. The
company’s partnership with Volantis in digital therapies is a step in this direction.
Corporate Governance

The corporate governance of Biocon has been quite robust in its 40+ years of
existence. Led by good management and dedicated policies of related party transactions, the
company has always been following the adhered policies and guidelines of SEBI. At times,
when lot of well reputed corporate houses are being questioned for their corporate
governance standards, Biocon hasn’t shown any glimpse of ‘a miss’. There are lot of RPAs as
studied from the annual reports by the author between the company and its subsidiaries, but
no red flag has been observed. Going ahead, the situation should be monitored.

Vision, Mission& Values

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

Mission
To be an integrated biotechnology enterprise of global distinction.

Essential to this mission is excellence in:

- Intellectual asset creation through discovery, research and   development

- State-of-the-art manufacturing capabilities

- Internationally benchmarked quality and regulatory systems

- New medical insight through disease specific

  clinical research

- Customer relationship through outstanding products

  and services

- Human resource development through training,

  mentoring and empowering

- Management of research and business partnerships

Values
- Integrity and Ethical Behaviour

- Performance driven work culture

- Value Creation through Innovation & Differentiation

- Quality through Compliance & Best Practices

- Collaboration, Team Work & Mutual Respect

PRODUCTS PROFILE

Biocon is an innovation-led global biopharmaceutical enterprise that aims to

transform scientific discoveries into medical advances that can impact human health. We
have built differentiated capabilities based on a deep insight into Life Sciences. We have
acquired the knowledge, expertise and skills essential for developing and manufacturing
‘best-in-class’ small and large molecule therapies. We invested ahead of the curve in the
promising future of Targeted Biologics that are revolutionizing the treatment of chronic
diseases. We have consciously chosen to focus on segments that require intensive R&D
efforts and long gestation periods.

OUR GROWTH VERTICALS

Biocon's four key growth verticals aim to deliver sustainable, long term value for
patients, partners and healthcare systems across the globe. The fully integrated business
model spans the complete drug value chain, from pre-clinical discovery to clinical
development and to commercialisation of small molecule APIs, generic formulations,
branded formulations and biologics including both novels & biosimilars.
Biocon Biologics

Biocon Biologics is a subsidiary of Biocon Ltd, an innovation led global

biopharmaceuticals company and India's first publicly listed biotech enterprise.

An independent entity, with its own dedicated management, Biocon Biologics

consolidates the development, manufacturing and commercialization operations of Biocon’s
biosimilars business.
The Company has over the years benefited the lives of millions of patients and built
credibility globally as a strong biosimilars player. Its scientific know-how, technological
expertise and global scale manufacturing capabilities have positioned it ahead of the curve in
the realm of biosimilars. Today, it has a large portfolio of biosimilars under global clinical
development with three of these commercialized in at least one of the developed markets of
EU, U.S. and Japan.

Novel Biologics
Biocon has puhed scientific boundaries and created new knowledge that is
breakthrough in its impact to human existence through novel biologics and novel targets in
the area of large molecules.

The Novel Biologics portfolio has both in-house as well as partnered and in-licensed
products targeting diabetes, oncology and immunology. Biocon’s focus on innovation for
global markets continues to be strengthened by directing efforts at increasing depth and
emphasis on our in-house research capabilities – including access to novel IP, therapeutic
modalities, in-vivo and in-vitro models, toxicology studies, early regulatory filings, academic
collaborations etc.

BIOCON'S JOURNEY IN NOVEL DRUGS

We have a strong process to progress these discovery programs through stage gates by
rigorous evaluation of their ‘functional activities’ and ‘mechanism of action’ to differentiate
from competition. Our skills in manufacturing processes, analytical development as well as
cutting-edge translational and clinical sciences enable us to maximize the overall probability
of success in the clinic.

Success of Biocon Novel Portfolio

Novels In Pipeline
At Biocon, we are developing novel biologics aimed at addressing local as well as
global unmet medical needs in the areas of diabetes, autoimmune/ inflammation and
oncology. The basket of novel assets under clinical development represents a combination of
early and advanced stage assets.

Small Molecule APIs

Biocon is one of the leading global suppliers of complex small molecule APIs
spanning statins, anti-obesity agents, anti-diabetics, immunosuppressants, peptides, oncology
products and anti-fungals. Our products are sold to third party customers who in turn
formulate and sell the finished dosages in global markets including the U.S., Europe and
large emerging markets.

We have built one of the largest fermentation based bulk drug capacities for statins
and immunosuppressants globally. We are now one of the largest statins manufacturers in the
world supplying our drug substances to over 60 countries.

Key API Portfolio:

Cardiology
 Simvastatin
 Pravastatin
 Atorvastatin
 Rosuvastatin
 Fluvastatin
 Dabigatran
 Sacubitril/Valsartan
  Apixaban
 Rivaroxaban

Immunosuppressants Basket
 Tacrolimus
 Sirolimus
 Everolimus
 Mycophenolate Mofetil (MMF)
 Mycophenolate Sodium (MPA)

Anti-Diabetics
 Vildagliptin
 Linagliptin
 Sitagliptin
 Dapagliflozin
 Pioglitazone
 Repaglinide & peptides (Liraglutide/Semaglutide)

Multiple Sclerosis
 Glatiramer Acetate
 Fingolimod
 Teriflunomide

Other Key Products

 Orlistat
 Fidaxomicin
 Mirabegron

Research Services

Our publicly listed subsidiary, Syngene International Limited, is an innovation

focused global discovery, development and manufacturing organisation providing integrated
scientific services to the pharmaceutical, biotechnology, nutrition, animal health, consumer
goods and specialty chemical industries around the world.
The innovative culture of Syngene is driven by the passion of its 3,500-strong team of
scientists who work with clients from around the world to solve their scientific problems,
improve R&D productivity, speed time to market and lower the cost of innovation.

Its clientele include world leaders such as Bristol-Myers Squibb, Baxter, Amgen,
GSK, Merck KGaA and Herbalife.
 Syngene has its Registered Office in Bengaluru, Karnataka, India. The Company’s
shares are listed on the Bombay Stock Exchange (BSE) and the National Stock Exchange
(NSE) in India.

Manufacturing structure

Biocon’s unique technological strengths across large scale world-class manufacturing

facilities supported by a strong quality culture and a consistent track record of regulatory
compliance have enabled us to efficiently manufacture and supply differentiated and complex
products and emerge as a strong global player. Our API and formulation manufacturing
facilities together enable our vertical integration strategy and ensure supply reliability.
Biocon currently has 5 state-of-the-art facilities across Bangalore, Hyderabad and
Visakhapatnam in India that manufacture high quality products with reliability and
efficiency. In addition to our in-house manufacturing sites, strategic partnerships with global
CMOs are leveraged to add value to our partners.

API manufacturing

Our API manufacturing facilities leverage complex technology platforms that range

from microbial fermentation, chromatographic purification, chemical synthesis, peptide
synthesis and HPAPIs.

Our API facilities are equipped with a wide range of equipment, to handle

fermentation and chemical processes, including but not limited to fermenters (upto 100 KL
scale), high-pressure liquid chromatography columns (upto 1200 mm), extractors, decanters,
filtration units (microfiltration/ultrafiltration/nano-filtration), cryogenic reactors,
hydrogenators, centrifuges, crystallizers, lyophilizers and dryers.
Manufacturing Infrastructure 
Our formulation manufacturing infrastructure helps us manufacture potent and non-
potent oral solid dosage forms as well as parenteral dosage forms such as lyophilized
powders, liquid vials, cartridges, devices and pre-filled syringes.

Our state-of-the-art oral solid facility is equipped with similar unit operations like the
R&D facility; including but not limited to wet/dry granulators, fluidised bed dryer, blender,
compressors, capsule and blister packing machines; which ensures seamless scale-up from
R&D to cGMP facility.

BIOCON CAMPUS, BANGALORE

• USFDA, EMA, COFEPRIS, KFDA approved facility spread over 25

acres
• APIs based out of fermentation and synthetic chemistry
BIOCON PARK, BANGALORE

• USFDA, EMA, COFEPRIS, KFDA approved facility spread over 90

acres
• APIs based out of fermentation, synthetic chemistry, peptides, HPAPIs
and Oral solid formulations

BIOCON LIMITED, HYDERABAD

• USFDA, EMA, COFEPRIS, TGA approved facility spread over 12 acres

• APIs based out of synthetic chemistry and peptides

BIOCON LIMITED, VISHAKHAPATNAM

• USFDA approved facility spread over 7 acres

• High-potent APIs and advanced intermediates
BIOCON LIMITED, VISHAKHAPATNAM

• Upcoming greenfield facility spread over 50 acres

• APIs based out of fermentation and synthetic chemistry
Facilities Approved By Key International Regulatory Agencies
Quality & Compliance

At Biocon, excellence is our hallmark and a value and Quality and Compliance enable
us to consistently achieve this across all functions of Research & Development,
Manufacturing, Testing, Release and Distribution of our differentiated products. We follow
Good Manufacturing Practice (GMP), Good Storage Practice (GSP) and Good Distribution
Practice (GDP)) throughout our operations to assure high standards of quality.

MAINTAINING COMPLIANCE

Our manufacturing sites have undergone several regulatory inspections by

health authorities across the world as a part of new product approval, and/or verification
of compliance. This ensures continued global acceptance of our complex small
molecule Active Pharmaceutical Ingredients, Biosimilars and Oral solid dosage formulations.
Proactive investments in infrastructure, training and certifications have helped us maintain a
strong compliance track record in regulatory inspections.

MEETING QUALITY STANDARDS

 Our best-in-class technology and processes meet the demanding benchmarks of
global regulatory agencies. Our manufacturing facilities across Bengaluru, Telangana
and Visakhapatnam in India and Johor in Malaysia, have received over 50 cGMP
approvals from international regulatory agencies.