STRIDES PHARMA SCIENCE LIMITED — Investor Presentation 2021

Aug 6, 2021

August 6, 2021

BSE Limited Phiroze Jeejeebhoy Towers, Dalal Street, Mumbai – 400 001 Scrip code: 532531

The National Stock Exchange of India Limited Exchange Plaza, Bandra-Kurla Complex Bandra (E) Mumbai - 400 051 Scrip code: STAR

Dear Madam/ Sir,

Sub: Stelis Biopharma - Q1 FY22 Investor Update

Please find attached Q1 FY22 Investor Update issued by Stelis Biopharma Ltd., the biopharmaceutical division of Strides.

Thanks & Regards, For Strides Pharma Science Limited,

Manjula Ramamurthy Company Secretary

Encl. As above

An integrated biologics and vaccine player in the making

Stelis Biopharma Limited , Q1FY22 Investor Update | August 06, 2021

Introduction to Stelis:

A vertically integrated company with capabilities to take molecules from lab to market

z Stelis is a vertically integrated biopharma and vaccine company ready to expand horizons

• ▸ Sterile injectable fill/finish for complex small molecules

• ▸ Flexible model for partner engagement

• ▸ One-stop shop solution from cell line and process development to commercial manufacturing in biopharma

• ▸ End-to-end development & manufacturing of Drug Substance(DS) & Drug Product(DP)

▸ Talented scientific and technical teams with experience from companies such as Merck, AGC, Amgen, Patheon, Fuji Diosynth, Selexis, P&G, Mallinckrodt, Pfizer, Lonza, Allergan amongst others

▸ Separated from other two facilities eliminates any cross contamination

• ▸ Quality and regulatory expertise with demonstrated experience in global compliance
• ▸ Operations designed, built and validated to meet regulatory market standard

30,000 sq.ft. state-of-the-art process development; pilot/scale-up and small-scale biopharma CGMP facility

Core Capabilities:

• ▸ Cell line and strain development, selection & characterization
• ▸ Upstream and downstream process development – Viral, Mammalian & Microbial
• ▸ Analytical development physicochemical, microbiology, bioassay & characterization methods
• ▸ Formulation development
• ▸ Regulatory, device and clinical strategy consulting

Dedicated R&D Setup Large Commercial Capability Standalone Vaccine facility

300,000 sq. ft. integrated commercial biopharma manufacturing facility catering to biologics DS and aseptic DP fill finish in different formats

Core Capabilities:

• ▸ Cell banking MCBs and WCBs (including secure storage)
• ▸ Drug Substance manufacture Microbial and Mammalian – clinical and commercial (2000KL by Dec'21 and 8000KL by Mar'22)
• ▸ Drug Product manufacture (Vials – 10 million or 4 million lyophilized vials, Cartridges – 40 million and Prefilled syringes – 28 million)
• ▸ Pen Device Assembly and release as per ISO standards
• ▸ Validation services, stability studies & misc. support services

250,000 sq. ft. dedicated DS and DP manufacturing facility for vaccines with ability to cater to multiple vaccine types including viral vector, protein subunit

Core Capabilities:

DS manufacturing

• ▸ Manufacturing Science and Technology (MSAT)– 8 X 200 L
• ▸ Commercial Facility 20 X 2000L (12 x2000L by Oct'21 and additional 8 x 2000L by Dec'21)

DP Manufacturing

• ▸ Formulation development
• ▸ Secondary and tertiary packaging
• ▸ Cold chain inventory management
• ▸ Drug Product manufacture (operational by Oct'21)

Strategic oversight by Board of Directors with rich experience across diverse industries

z

Aditya Puri

Non-Executive Director & Chairperson

Vineeta Rai Independent Director & Chairperson of Audit Committee

Former IAS officer and the first woman to hold the post of Revenue Secretary in the Ministry of Finance. She has held posts in the Ministry of Urban Development, Ministry of Health & Family Welfare and Ministry of Home Affairs in the Union Government. She was voted one of 25 Most Powerful women in Business in India in 2004

Arun Kumar Founder

A first-generation entrepreneur with an intellect of picking "difficult to operate" domains with high scarcity value. Recipient of the E&Y Entrepreneur of the year award in the Healthcare sector in 2000, Business Today "India Best CEO Award (Mid-Sized Companies Category)," and the "Best CEO in the Pharma & Healthcare Industry" in 2014.

Ankur Thadani Non-Executive Director

Partner at TPG Growth. He has worked on investments in multiple sectors, including healthcare, Energy, and Consumer sectors across India and the broader South-Asia region. He also serves on the Boards of Cancer Treatment Services International, Rhea Healthcare, and Sutures India.

Mahadevan N Non-Executive Director

Senior Advisor, TPG Capital, Former Advisory Leader, Grant Thornton. He has significant experience in private equity, mergers and acquisitions, valuations, healthcare, medical devices, life sciences, business improvement, and capital markets

PR Kannan Executive Director and CFO

20+ years of experience in the finance, strategy, taxation and M&A. He has been with the Group for over a decade and was earlier the CFO for SeQuent Scientific Limited. He is credited to have led SeQuent towards sustainable growth and delivered significant stakeholder value.

• ▸ The Board of Stelis is delighted to appoint Mark as the CEO and MD designate of Stelis. He assumes the role with immediate effect and will be stationed at Stelis HQ in Bengaluru, India
• ▸ Mark will drive the growth strategy around the three business divisions and will provide strong leadership to the Company as Stelis continues to build itself for the next phase of growth and profitability.
• ▸ Mark is an organization builder with a track record of delivering unprecedented performance and growth in his previous roles.
• ▸ Before joining Stelis, Mark was the Chief Business Officer (CBO) for AGC Biologics (AGC), one of the world's leading global biopharmaceutical CDMOs. In his role at AGC, Mark led the organization to nearly a 3x increase in new sales in just two years and drove the acquisition of most of the world's top large pharma companies into their portfolio.
• ▸ Before AGC, leveraging his management consulting background, Mark led the global integration of three former CDMOs that were merged to create AGC Biologics.
• ▸ Mark has served over 25 years as a management consulting industry leader and C-level client advisor, leading large-scale business transformations and guiding many of the world's renowned companies to achieve record highs in revenue and profit. During this time, he served as the Chief Operating Officer (COO) for two international management consulting companies.
• ▸ Before joining the management consulting industry, Mark led a succession of US Navy units to unprecedented results, including serving as a combat center leader on a destroyer class ship.

Operating three differentiated domains in the global market covering the entire value chain

Global CDMO Services Vaccines Own Products

End to end service provider including process development, scale up and manufacturing services for biologics

A full services vaccines CDMO player with dedicated and integrated facility to cater to multiple vaccine types

Building a portfolio of advanced biosimilars, peptides, and other leading products with our in-house development capabilities.

Global CDMO Services:

Deep expertise and high speed of execution in product development and large-scale manufacturing

INDUSTRY DYNAMICS

Leveraging our scientific capabilities with World Class infrastructure having large scale capacities

Driven by growth in biologics and strong value proposition of outsourcing

Sticky business with high switching costs leading to better sustainability

Strong Operating margins driving better financial outcomes for global Biologic CDMO players

High barriers to entry driven by higher capex requirement and longer gestation period

Our Vision

To be the fully integrated global CDMO partner of choice for the global biopharma industry

STELIS STRATEGY

Our Mission Enable global partners to accelerate the development and commercialization of biological and pharmaceutical products for unmet patient needs

Our Business Focus

• End-to-end service provider to global players leveraging our deep expertise and high speed of execution in product development and manufacturing.
• Comprehensive capabilities from cell line and process development through to scale up, cGMP manufacturing and fill/finish of proteins and peptides
• Core services include process development, scale-up, and manufacturing services for biologicals and sterile injectables.

Fermentation

• ▸ Stainless steel fermenters (Sartorius) of capacity 50L, 300L & 1000L
• ▸ Homogenizer (GEA) and centrifuge (GEA) integrated with fermenters for efficient harvest operations
• ▸ Dedicated pre-culture area
• ▸ Dedicated autoclaves for sterilization and decontamination

Purification

• ▸ Flame proof area with high pressure chromatography system (Hanbon)
• ▸ Mix of single-use and conventional chromatography systems (Merck Millipore)
• ▸ High pressure chromatograph systems
• ▸ Filtration: viral filtration, ultrafiltration and dia-filtration
• ▸ Dedicated area for conjugation, bulk filtration & lyophilization

Hybrid model with stainless steel fermenter for upstream and single-use and conventional systems for downstream processing

Microbial Capabilities Mammalian capabilities

Cell Culture

• ▸ 4 single-use trains up to 2000L
• ▸ Line-up: 50L→200L→2000L
• ▸ Capability of handling batch, fed batch and perfusion cell culture process
• ▸ Production, testing and storage of master and working cell banks
• ▸ Dedicated pre-culture suites, media & buffer preparation rooms

Purification

• ▸ Pre and post viral segregation
• ▸ Single use flow path chromatography systems
• ▸ Filtration: viral filtration, ultrafiltration and dia-filtration
• ▸ Dedicated autoclaves for sterilization and decontamination
• ▸ Controlled freeze and thaw system

End-to-end disposable systems offer better regulatory compliance, no product carry over, less turn around time between batches and operational efficiency

Aseptic liquid fillingin all formats	Fully automaticpackaging line	Presentation	Equipment	Working Range	Annual Capacity(2 shift basis)	Status
High capacitywarehouse	100% visualinspection	Cartridge Filling with penassembly for pharma andbiopharma products	Bausch Strobelfillingline integrated withSteriline isolator	Diameter 7mm to14mm Height 40mmto 90mm	40 million	Validated andavailable for
		Pre-Filled Syringe Fillingfor pharma and biopharmaproducts	BauschStrobel fillingline integrated withSteriline isolator	0.5ml to 10ml	28 million
Cold rooms forstorage of productat various stages	Tertiary packagingarea	Vials and lyophilised vialsfor pharma and biopharmaproducts	Tofflon filling lineintegratedwithisolator andLyophilizer	1ml to 100mlLyophilization -Commercial: 9.2 sq. mand Clinical: 5.11 sq.m	10 million vialsand 4 millionLyophilised vials	commercialproduction
Track and tracesystems	Pen device assemblycapabilities	Additional Vial Line(Available for non-viralVaccines)	Attached to vial fillingmachine for bothclinical andcommercial use	1ml to 30ml	60 million

Q1FY22 Updates on global CDMO services business

Drug Product block commercialized with healthy order book for the next 18-24 months

• Drug product block running on high-capacity with healthy orderbook visibility over 18-24 months
• Filing on behalf of partners ongoing for several markets including the US, and Europe
• The target to achieve operational break even in FY22 is tracking as per expectations

On track to receive all major regulatory approvals in FY22*

• Partnered product filings have triggered inspections from global regulatory authorities including the EU/EMA and USFDA*
• Inspections expected at the site , post the Covid related travel restrictions are eased

Microbial drug substance block already validated and attracting commercial traction

• Microbial drug substance fully validated and under partner inspections for new business
• A funnel of partnered products to be manufactured as exhibit batches and to initiate regulatory approvals for the site
• Pending installation*(impacted due to Covid restrictions)* on mammalian block initiated, block to be mechanically completed by end FY22

Dedicated Suite for Vaccines :

New suite developed as per BSL 2 requirements with integrated capabilities

INDUSTRY DYNAMICS

Building an integrated global vaccine CDMO business with large capacity and diverse capability

14

Current Capabilities	DS	DP	Design and Unique features
			between the batches.
Viral vector	Yes	Yes	▸Nanoparticle fill finish capability
Protein subunit	Yes	Yes	Antigen6 million doses/month
m-RNA	Yes(Planned)	Yes	2021
DNA	Yes(Planned)	Yes	over the next 12-15 months

Design and Unique features

• ▸ Use of single use manifold systems to reduce the cross contamination
• ▸ Nanoparticle fill finish capability
• ▸ Manufacturing of Drug Substance and Drug Product for recombinant
• ▸ Phase 1 of the facility compliant to BSL 2 requirements designed to produce
• ▸ Facility built with modularly, phase 2 capacity to go on-stream from October
  • ▸ Targeted Phase 2 Capacity of 60 million doses/month
• ▸ Plans to produce over 1 billion doses from this capacity
• ▸ Facility designed to commercialize DS and DP for RNA and DNA vaccines over the next 12-15 months

Update on Sputnik V

• rAD5 and rAD26 components of the vaccine have been validated on the small scale
• Scale up of the vaccine on track to achieve commercial production
• Expected to launch Sputnik V(both components) in Q3FY22

Evaluating new vaccine partnerships

• Significant ongoing interest and discussions to partner with other global players for vaccines manufacturing
• Advanced discussions ongoing to In-license new vaccine technologies
• Plans to on-board at least one CDMO Contract on vaccines by Q4FY22

Own Products:

Commercially attractive products with leading assets nearing approval stage

Scaling a compelling biopharma franchisee built on global scale and a niche product portfolio

65b+ Addressable Opportunity for Stelis

With $60 billion worth of brands losing exclusivity, biosimilars presents a large opportunity

Due to complexity, Biosimilars have limited competition offering attractive and sustained pricing for a longer period of time

Limited pure play biosimilar companies with margin accretive business and future opportunities

Recent guideline changes indicate better prospects for late entrants and the market are seeing high penetration

Our Vision

To become a globally recognized biosimilar business delivering efficient solutions to patients for improving lives.

STELIS STRATEGY

Our Mission

To develop and manufacture compliant and affordable biotherapeutics to address unmet global needs

Our Business Focus

• Building a portfolio of advanced biosimilars, peptides, and other leading products with our development capabilities.
• While exploring opportunities in different categories, our core focus is on building a strong diabetic portfolio to target an exponentially growing world problem
• Attaining leadership in commercializing high-quality, affordable products with deep technical expertise

Molecule	Market Size ($b)	Indication	DevelopmentStage	Latest Update
STLP001Rh-Teriparatide	~2	Osteoporosis	Filed in EU/Phase 1 ready forUS	•EU file for MAA under review cycle, expected closure by Q4FY22•More than 20 companies are under discussion to license the productto commercialize in different geographies.
STLI001(Glargine)	~13	Diabetes	Clinical	•Phase-1 clinical trial for India dosing completed, initial results areencouraging. Global filings for several markets starting FY23
STLI002(Aspart)	~9	Diabetes	Pre-clinical	Program initiated and on track for late FY24 filing•
STLI003(Lispro)	`7	Diabetes	Pre-clinical	•Program initiation and scale-up planned in Q2/Q3FY22
STLG001	~6	Diabetes	Scale-up	•On track for Q3/Q4FY22 filing via ANDA path
STLG002	~7	Diabetes	Scale-up	•Development initiated, on track for filing in FY23 via ANDA path
STLS001	~5	Anti-hemorrhoid	Pre-clinical	•Pre-clinical stage , post FY24 opportunities

Thank you

For details, please visit www.stelisbiosource.com

Stelis Biopharma Limited

(Formerly Stelis Biopharma Private Limited) tar 1 Building, Opp. IIM Bangalore, Bilekahalli, Banngerghatta Road, Bangalore – 560 076, India Tel: +91 80 6784 0738 CIN: U74140KA2007PLC043095

For business and investor queries, please write to ankit@stelis.com