Syngene International Limited has informed the Exchange about Investor Presentation
Ref: Syn/CS/SE/IP/2023-24/Apr/12
April 26, 2023
To, The Manager, BSE Limited Corporate Relationship Department Dalal Street, Mumbai – 400 001 Scrip Code: 539268
Dear Sir/Madam,
Syngene International Limited Biocon SEZ, Biocon Park, Plot No. 2 & 3, Bommasandra Industrial Area, IV Phase, Jigani Link Road, Bengaluru 560099, Karnataka, India. T +91 80 6891 8000 F +91 80 6891 8808 CIN: L85110KA1993PLC014937 www.syngeneintl.com
To, The Manager, National Stock Exchange of India Limited Corporate Communication Department Bandra (EAST), Mumbai – 400 051 Scrip Symbol: SYNGENE
Sub: Investor Presentation under Regulation 30 of SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015.
With reference to Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015, please find enclosed the Investor Presentation for the quarter and year ended March 31, 2023. The Company will use this presentation for any meeting scheduled with analysts or institutional investors up to June 30, 2023.
The above-mentioned Investor Presentation will also be available on website of the Company www.syngeneintl.com.
This is for your information and records.
Thanking You, Yours faithfully, For SYNGENE INTERNATIONAL LIMITED
___________________ Priyadarshini Mahapatra Company Secretary and Compliance Officer
Enclosed: Investor Presentation.
Investor Presentation
April 2023
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 in India, business outlook of our clientele and their research and development efforts, our ability to successfully implement our strategy, 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, 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.
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2
Contents
1
2
3
4
5
Operating Highlights
Syngene – Putting Science to Work
Syngene strengths
Financials
Shareholding and Share Information
Appendix
Putting Science to Work
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1
Operating Highlights
Q4 FY23 performance
Operating Highlights
Q4 Financial Highlights
•
•
•
Strong growth in the fourth quarter, added to a positive performance over the course of the year
The growth of Discovery Services and Dedicated Centers remained steady. The research facility in Hyderabad, which is a vital part of our Discovery Services, continued to expand and now houses approximately 900 scientists.
Growth in Development Services was driven predominantly by further orders from existing clients, which reflects the high service levels and sustained on- time delivery
Total Revenue Rs.10,172 Mn
Reported EBITDA Rs. 3,369 Mn
• Manufacturing Services continued to support the long-term partnership with Zoetis, following the successful regulatory inspections by the US, European and UK regulatory authorities.
Profit After Tax Rs. 1,787 Mn
EBITDA Margin at 33.1% PAT Margin at 17.6%
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Full Year FY23 performance
Operating Highlights
FY23 Financial Highlights
•
•
•
•
•
•
•
•
Delivered full-year results ahead of our upgraded guidance
FY23 delivered the highest absolute year-on-year increase in revenue and EBITDA in the last 5 years
All four divisions of the Company delivered sustained growth through the year.
The biologics manufacturing partnership with Zoetis signed in the first quarter, is expected to be worth US$ 500 Mn over 10 years, subject to regulatory approvals and market demand
Our partnership with BMS marked 25 years of collaboration in March 2023. It is BMS' biggest R&D facility outside the US
Commissioned a state-of-the-art sterile fill-finish facility and a kilo lab for polymers and specialty materials
Dedicated PROTACs (proteolysis-targeting chimeras) facility for clients involved in researching treatments for cancer and other therapy areas was opened at Hyderabad
In addition to successful regulatory audits of its biologics facilities, Syngene successfully nearly eighty audits from regulators and clients in the past year endorsing the quality standards
Total Revenue Rs.32,638 Mn
Reported EBITDA Rs. 10,053 Mn
Profit After Tax Rs. 4,644 Mn
EBITDA Margin at 30.8% PAT Margin at 14.2%
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6
2
Syngene – Putting Science to Work
Partner in innovation: #Puttingsciencetowork
Who we are and what we do We aim to be a world class partner delivering innovative scientific solutions for clients
We offer integrated solutions across research, development and manufacturing
Sector expertise include pharmaceuticals, biotech, nutrition, animal health, consumer goods and specialty chemicals
Our team includes more than ~5,000 scientists out of total ~6,000+ headcount, operating across 3 state-of- the-art campuses located in India’s leading life science hubs: Bangalore, Mangalore and Hyderabad
Established track record in discovery research and development for small and large molecules. Emerging presence in commercial manufacturing
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Key facts and figures
400+ active clients
15 collaborations with top 20 pharmaceutical companies
400+ patents held with clients
World class infrastructure of 2 Mn+ sq. ft. qualified to meet international standards
Rs. 45,587 Mn (US$563Mn*) Gross Block of Investments ^
Rs. 32,638 Mn (US$403Mn*) FY23 Revenue
Rs. 4,644 Mn (US$57Mn*) FY23 PAT before exceptional item
~6,000+ headcount including ~5,000+ talented scientists
All figures are as on March 31, 2023, unless otherwise specified. *At Rs81/US$
^Tangible and Intangible Assets
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International accreditations
• USFDA,OHSAS 18001
• GLP, cGMP, AAALAC & CPCSEA Certified facilities
•
•
•
CAP accreditation, ISO/IEC 27001:2013 accreditation
EMA and PMDA approved, AAALAC accredited facility
The safety assessment laboratories and large molecule bioanalytical lab are ISO IEC 17025:2017 certified by the National Accreditation Board for Testing and Calibration Laboratories (NABL)
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Our experience spans multiple industry segments and partnerships with global leaders across the world
Large & mid-sized biopharma
Emerging biopharma
Universities
Animal health
Agrochem
Consumer products
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Our journey so far
Globalization and strategic collaboration • Expanded into formulations development • Contract with Endo Pharmaceuticals to develop novel anti cancer
biological therapeutic molecules • Extension of collaboration with BMS; • Merger of Clinigene • Crossed annual turnover of Rs. 5 Billion
Foundation • Operations started • Expansion of R&D Lab • Granted 100% EOU status by the Government of India
1993 – 2000
2010 – 2014
2001 – 2009
Expansion • Expanded service offerings to
include chemical development, safety assessment, biologics development
• Collaboration with BMS to set
up BBRC, Syngene’s first dedicated R&D Center
2015 – 2018
IPO and further collaborations • IPO and listing • Collaboration with Amgen to set up a dedicated R&D center
2019 – 2023
Continued investments and growth • Expanded collaboration with BMS,
Amgen and Zoetis
• Expansion of IDD platform •
Laboratory capacity expansion in Bangalore, Hyderabad
• Expansion in Mangalore for
commercial API manufacturing • Capacity and capability addition in
Biologics manufacturing
• Entered in long-term partnership
with Zoetis for Biologics commercial-scale manufacturing • Commissioned sterile fill-finish
facility in Bangalore
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Our broad capabilities, spanning the value chain, facilitates integration and captures additional benefits for clients Research business
Development and Manufacturing business
Discovery Services
Dedicated R&D Centers
Development Services
Manufacturing Services
Flexible Platform with capability across multiple modalities including small molecule, large molecule, peptides, oligonucleotides, antibody drug conjugates, PROTACs
SynVent - our proprietary platform for Integrated Drug Discovery
SARchitect- our proprietary platform for data visualization and analysis, including features specifically designed to foster collaboration between scientific experts across geographies
Ring-fenced infrastructure for exclusive operations for an individual client
Pre-clinical to clinical trials
Manufacturing of small and large molecules for commercial supplies
Dedicated, multi-disciplinary team of scientists
Access to entire Syngene ecosystem for specialist research and development operations
Drug substance and drug product development
cGMP-compliant facilities
Associated services to demonstrate the safety, tolerability and efficacy of the selected drug candidate
State-of-the art API manufacturing and Biologics manufacturing facilities
cGMP-compliant manufacturing of clinical supplies, and registration batches for small molecules
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A 'one-stop-shop' for discovery research, development and manufacturing services (small and large molecules)
Small Molecules
Large Molecules
Antibody-Drug Conjugates
PROTACs
Discovery
Development
Manufacturing
Chemistry
Biology
Drug Substance Development
Drug Product Development
Clinical Supplies
Integrated Drug Substance – Drug Product
HPAPI
Safety Assessment
Specialty Molecules
Oligonucleotides
Integrated Drug Discovery
Therapeutic Antibody Discovery & Engineering; Cell Line Development
HPU* (Phase 1)
Bio Analytical Lab (Large Molecules)
Stability & Analytical Services
Commercial Supplies
Bioprocess Development, Process Characterisation, Clinical Manufacturing (Microbial & Mammalian)
Research Informatics: Bioinformatics, integrative analysis, target dossiers, systems modeling, cheminformatics and AI
* Human Pharmacology Unit
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Flexible collaboration models
1
2
3
4
5
6
Dedicated R&D centers
Full time equivalent (FTE)
Fee for service
Productivity-based model
Risk-reward
• Dedicated scientific and support teams work exclusively on the client’s projects
• Clients are provided with customized and ringfenced infrastructure
• Long-term strategic alliances that last usually five years or more
• Pre-defined numbers of scientific personnel from pre-determined disciplines work full- time on client projects
• Deliverables and team composition evolve as the project advances
• Client contracts for
agreed services within a defined scope
• Flexible, ‘on demand’
personnel and research infrastructure deployed to achieve the project objectives
• Agreements are
typically renewed annually
• Engagements may be short-term or long- term
• Resources and services are directly linked to productivity generated by our team
• Relationship spans a
portfolio of milestone- driven research projects
• Client benefits from reduced upfront payments in exchange for significant success- based milestone payments against pre- agreed criteria
Delivery-based contract for CDMO business
•
Per kg or per batch model with built-in milestones progressing towards achievement of outcome and delivery of drug substance, drug product
… we are open to any single or combination of above
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Our state-of-the-art infrastructure
Bangalore campus 90 acres housing most of Syngene’s capabilities
Discovery Services Hyderabad campus commenced operation in Aug 2019
Biologics Bangalore campus Manufacturing plant scale: Mammalian- ~100-2000L Microbial - ~200-500L
API Manufacturing Mangalore campus Commissioned March 2020 Capacity: 70KL Reactor size: 2-12KL
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Experienced workforce: building capabilities and careers
~6,000+ total headcount
5000+ scientists delivering high quality solutions – create a competitive edge
Inspiring technical excellence and providing opportunities to grow
Nurturing young talent and enhancing science skills
• Syngene Training Academy offers new graduate recruits a six-month extended induction to help them
understand the Company’s vision and values while acquiring the skills to be an industrial scientist
• Science Certification Program is open to all employees to enhance their capabilities keep their skills up to
date and provide opportunities for continuous learning
PhDs Master's Degree
Others
Developing leaders and managers
• Emerging Leaders Development Program is designed to help strong managers transition from managerial
to leadership roles
10%
28%
62%
• Manager Development Program is designed for first- and second-line managers to develop basic management skills and performance management to help them manage their teams and ensure that they are making a positive contribution to the organizational goals
Promoting workplace diversity
• The Company has strong equal opportunity policies to protect against all forms of discrimination and
provide a workplace where all employees can deliver their best work
• Support provided to parents of young families. 27% of employees are female and 14% of management
positions are held by females
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Operational robustness driving strategy execution
Continuous improvement embedded in operations driven by certified operational leaders Six Sigma Black Belt certified staff in each service line and support function Green belt certified staff across operations All employees white belt certified
Quality management system: digitized and audit-ready 80 customer and regulator audits in the last financial year 8 successful USFDA audits in the last 4 years
Focused execution through strong Project Management Structured program management for executing client projects enabled by SynPro platform and SynPro Academy ensuring delivery of client projects
Digital as a differentiator AI capability in all research teams IoT for maintenance and infrastructure reliability Data Management, IT infrastructure and security systems to strengthen our proposition as a strategic partner to clients
Client-focused commercial organization Leaders based in the US, Europe, UK and Asia Close to client locations
Strategic Sourcing that makes a difference Strategic supplier management to avoid supply chain disruption Supply distributed across the world to ensure business continuity
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3
Syngene strengths
Syngene strengths
A global scale CRO/CDMO •
Integrated Drug Discovery, Development and Manufacturing service provider
• Small and large molecules, ADCs, oligonucleotides • Listed on Indian Stock Exchanges (NSE and BSE)
Solutions through innovation • IP fully assigned to clients • Track record of data management and
security
• Over 400+ patent filings by clients recognizing Syngene scientists
Quality matters • Fully digitized quality organization • Strong compliance track record with global regulators • US FDA, EMA and PMDA approved, GLP certified, AAALAC
accredited facilities
• 80 client and regulator audits in the last financial year
Science in our DNA •
Located in 3 top India life science hubs: Bangalore, Mangalore and Hyderabad
• ~5000+ qualified scientists including ~500 PhDs (~6,000+
total headcount) Resilient supply chain management
• • 2 Mn+ sq. ft. world-class R&D and manufacturing
infrastructure
Blue chip client list + 400+ active clients • Partnering with large / mid-size / emerging
biopharma and other industries
• Clients concentrated in US, Europe & Japan • Track record of working with diverse industry
sectors
Making a difference • Partnerships have delivered numerous clinical candidates • Delivery history for integrated CMC programs up to clinical trials and beyond
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Strong track record of growth and profitability
Total Revenue (Rs. Mn)
FY19 to FY23 - CAGR 14%
EBITDA (Rs. Mn)
FY19 to FY23 - CAGR 13%
Profit Before Tax * (Rs. Mn)
FY19 to FY23 - CAGR 9% FY18 to FY22 - CAGR 8%
32,638
26,570
20,935
22,489
19,007
6,995
7,364
6,119
10,053
8,489
4,154
4,456
4,342
5,936
5,151
FY19
FY20
FY21
FY22
FY23
FY19
FY20
FY21
FY22
FY23
FY19
FY20
FY21
FY22
FY23
Gross Block^ (Rs Mn)
EBITDA margins
Profit After Tax * (Rs. Mn)
FY19 to FY23 - CAGR 9%
45,587
39,435
34,599
30,171
21,612
32%
33%
33%
32%
31%
3,662
3,821
3,316
4,211
4,644
FY19
FY20
FY21
FY22
FY23
FY19
FY20
FY21
FY22
FY23
FY19
FY20
FY21
FY22
FY23
*Before exceptional items
^Tangible and Intangible Assets
Putting Science to Work
21
Levers for future growth
Expand/extend existing clients • •
Service integration Flexible business models including dedicated centers
Engage New Clients •
Tailored service offerings, high quality infrastructure and access to qualified personnel
Offtake in commercial manufacturing in both biologics and small molecule API
Integrated Drug Discovery •
Proprietary model leveraging breadth of capabilities to deliver end-to-end project requirements
Capacity expansion • •
Continuous investment FTE services, manufacturing, formulation, biologics, stability
Client engagement
Capacity
Forward Integration
Capability
Capability additions •
New capabilities across multiple domains including adjacent sectors Stability, analytical and bio-analytical services, viral testing, clinical scale injectable fill finish New platforms: antibody drug conjugates, CAR- T, PROTACs
•
•
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22
Committed to safety and sustainability
Safety is our first priority
Committed to environmental protection
•
•
•
•
Accredited with ISO 45001:2018 for Occupational Health and Safety (OH&S) measures
Risk assessments are an integral part of our operation: a proactive approach in incident prevention
Kavach, our flagship safety program, has delivered improvement in safety metrics and drives focus on industrial safety for all employees
13.7 million manhours without Lost Time Incident (LTI) on rolling 12-month basis for FY22
•
•
•
•
•
•
•
Accredited with ISO 14001:2015 for our Environment Management System
20% reduction in freshwater usage; 152KL rainwater harvested
92% of the total waste generated is recycled in an environment-friendly manner for FY22
3R’s operations constantly monitored to identify opportunities to reduce, reuse, and recycle waste
59,700 tCO2 emissions avoided in FY22 through efficiency measures
74 Mn KWH of electricity usage from green energy sources - up 18% from FY21
86% of total energy consumption from green energy sources in FY22
• Member of the United Nations Global Compact
Refer to the CSR link on our website to know about our corporate social responsibility pursuits on healthcare, education, environment, rural development Refer to the ESG Report on our website to know more
All figures are as on March 31, 2022, unless otherwise specified
Putting Science to Work
23
Industry recognition for our scientific capability and best practices
• Bio-Excellence Award 2018: At Bengaluru
Tech Summit, Bengaluru
• Best Bioprocessing Excellence Award 2018 -
At 5th Biologics Manufacturing Asia, Singapore • Healthcare Company of the Year 2018: At the 7th Annual VC Circle Awards 2018, Mumbai • HR Excellence Award 2018 'For Best Talent
Management Strategy’: World HRD Congress, Mumbai
• CMO Leadership Award Winner 2020 - under
• CMO Leadership Awards 2022 Received 6 awards for all
Categories: Capabilities, Compatibility, Expertise and Service
• Bioprocessing Excellence Awards 2020 in the category 'Bioprocessing Excellence in South Asia—Viral Clearance and Safety Testing’ • Great Place to Work Certified™ Company •
(ASSOCHAM) CSR & NGO Awards 2020 for our contribution to COVID-19 relief work in Karnataka.
categories, including Capabilities, Compatibility, Expertise, Quality, Reliability and Service
• CMO Leadership Award Champion 2022 Additional
•
Recognition received in CMO Leadership Awards 2022 for top performance in all categories 'Most Preferred Workplaces of 2022' by Team Marksmen Daily in association with India Today Recognized for its holistic reorientation of the business landscape in the context of the pandemic, and for creating a collaborative and empowering culture for its employees.
2017 2018
2019
2020
2021
2022
• Ranked as one of the 25 fastest growing companies in India
• Dream Companies to Work Award at the 29th Edition of the World HRD
by Outlook Business
• CMO Leadership Awards 2019 - Presented by Life Science
•
•
Leader Magazine FICCI CSR Award for Environmental Sustainability -At the 17th Edition of the awards in New Delhi Safe Workplace Champion Award - At the 8th Manufacturing Supply Chain Summit and Awards
• Best Leadership Development Program for Middle
•
Management Award - At the 6th Global Training and Development Leadership Awards India Pharma Award 2019 - For “Excellence in Contract Research and Manufacturing Services” at CPhI & P-MEC India Expo.
• Utthama Suraksha Puraskar 2019 - (Pharma and Chemical
Manufacturing Category) by National Safety Council of India (NSCI). Leadership Awards
Congress Awards.
• Asian Leadership Award for Excellence in Branding and Marketing in the
Contract Research Development and Manufacturing category
• CRISIL awards Syngene Top score among Indian Pharma: for Environment
•
•
Safety Governance (ESG) Syngene ranked #69 in Fortune India magazine's list of 'Top 100 Indian wealth creators 2021’ India Pharma Awards 2021 for Operational Excellence: Manufacturing organized by Informa Markets, India
• Best Governed Company in the Listed Segment: Medium Category at the 21st National Awards for Excellence in Corporate Governance by The Institute of Company Secretaries of India (ICSI)
• Most Innovative New Learning Programme at the L&D Vision & Innovation
Award organized by Transformance Forums
• Mahatma Award 2021 Under Health & Wellbeing Category • Best Corporate Foundation Award at the World CSR Congress
Putting Science to Work
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Robust risk management framework
Syngene has a risk management framework to identify, monitor, report and manage risk Every risk owner monitors and manages risks relevant to their area of responsibility
Executive Committee (EC)
Board of Directors(BOD)
•
Identify and mitigate risk in respective business areas
•
Sign-off on Enterprise Risk Framework annually
• Review and approve the key
updates to enterprise risks and deep-dive into few risk areas every quarter
•
Sign-off on Enterprise Risk Framework annually
• Ensure that appropriate measures are in place to mitigate the risks • Review updates to enterprise risks and deep dive into few risk areas every quarter
• Provide strategic direction on
mitigation of risks
• Ensure principal risks are properly
managed
Risk Owner
Board Risk Committee
Risk identification
Risk assessment
Risk analysis and rating
Risk mitigation
Monitoring and reporting
Refer Annual report for complete risk profile and risk mitigation strategy
Putting Science to Work
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4
Financials
Q4FY23 financial highlights
Particulars
Q4 FY23
Q4 FY22
YoY change
Q3 FY23
QoQ change
Revenue from operations
9,944
7,581
Other income
Reported revenue
Material costs
Staff costs
Other direct costs
Other expenses
Foreign exchange (gain)/loss, net
EBITDA
EBITDA Margin
Depreciation and Finance Cost
PBT
Tax
PAT
PAT Margin
228
10,172
2,938
2,528
273
1,022
42
147
7,728
2,149
1,797
238
985
-91
3,369
2,650
33.1%
34.3%
1,060
2,309
522
859
1,791
313
1,787
1,478
17.6%
19.1%
31%
56%
32%
37%
41%
15%
4%
-146%
27%
23%
29%
67%
21%
7,859
172
8,031
2,061
2,192
264
876
156
2,482
30.9%
1,083
1,399
302
1,097
13.7%
27%
32%
27%
43%
15%
3%
17%
-73%
36%
-2%
65%
73%
63%
All figures in Rs. Mn unless otherwise specified
Putting Science to Work
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FY23 financial highlights
Particulars
FY23
FY22
YoY Change
Revenue from operations
Other income
Reported revenue
Material costs
Staff costs
Other direct costs
Other expenses
Foreign exchange (gain)/loss, net
EBITDA
EBITDA Margin
Depreciation and Finance Cost
PBT
Tax
PAT before exceptional item
PAT Margin
PAT after exceptional item
PAT Margin after exceptional item
31,929
26,042
710
528
32,639
26,570
8,602
8,876
1,109
3,580
418
10,054
30.8%
4,118
5,936
1,292
4,644
14.2%
4,644
14.2%
7,490
7,408
872
2,859
-548
8,489
32.0%
3,338
5,151
940
4,211
15.8%
3,958
14.9%
23%
34%
23%
15%
20%
27%
25%
-176%
18%
23%
15%
37%
10%
17%
Balance Sheet Highlights
As on 31st March 2023
Shareholders’ funds
Net Fixed assets
Other net assets (1)
Net cash/(debt) (2)
Total Use of Funds
36,180
28,437
(1,818)
9,561
36,180
(1) Other Assets calculated as (Inventories + Trade Receivables + Unbilled Revenues + Advance Tax + FX premium less ( Trade payables + Others current liabilities) at the end of the year (2) Net cash / (Net debt) calculated as the Cash & cash equivalents (Cash and bank balances + Current investments+ Fixed deposits) less Total debt (Short-term borrowings + Long-term borrowings) at the end of the year
All figures in Rs. Mn unless otherwise specified
Putting Science to Work
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5
Shareholding and Share Information
Syngene and Biocon Group
Syngene is an operationally independent publicly listed subsidiary of Biocon Limited, established in 1993 as India’s first Contract Research Organization. Company has 25+ years of experience in novel molecule discovery, development and manufacturing services
Biocon Limited, founded in 1978, is an innovation-led global biopharmaceuticals company and has majority holding in key operating entities including Syngene
Integrated services: • Discovery research • Development • Manufacturing
small/large molecules
• • •
•
Product Based Biosimilars Formulations and Compounds Alternative Therapeutic Drugs
*
*including operating subsidiaries other than Syngene
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Shareholding and Share Information
Syngene’s Shareholding Pattern*
1.0%
44.1%
54.9%
Promoter & Promoter Group
Public
ESOP Trust
Syngene’s Share Information*
NSE Ticker
BSE Ticker
Market Cap (Rs. Mn)
% free-float
Free-float market cap (Rs. Mn)
Share Outstanding (Mn)
SYNGENE
539268
2,38,653
44%
1,05,290
401
*As on 31st March 2023
Putting Science to Work
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For more details
Visit our website www.syngeneintl.com
https://twitter.com/SyngeneIntl
https://www.linkedin.com/company/syngene-international-limited
https://www.facebook.com/syngeneintl/
https://www.youtube.com/channel/UCIC4WSA1k5YAC531gMLkbIQ
IR Contact: Krishnan G/ Suruchi Daga + 91 9819992927/+91 8800176009 investor@syngeneintl.com krishnan.g@syngeneintl.com suruchi.daga@syngeneintl.com
Media Contact: Shotorupa Ghosh +91 8450977080 shotorupa.ghosh@syngeneintl.com
Putting Science to Work
32
Appendix
Discovery Services
Target Identification and Target Identification and Validation Validation
Hit Hit Identification Identification
Hit to Lead Hit to Lead
Target ID Target ID 1. Pathway analysis 1. Pathway analysis 2. Omics 2. Omics 3. Knock-in / knock-out 3. Knock-in / knock-out
In vitro assays: In vitro assays: 1. Biochemical 1. Biochemical 2. Orthogonal 2. Orthogonal 3. HTS Formats 3. HTS Formats
Hypotheses: Hypotheses: 1. Therapeutic 1. Therapeutic 2. Mechanistic 2. Mechanistic 3. Target Engagement 3. Target Engagement
HTS/DEL/Fragments/Virtual HTS/DEL/Fragments/Virtual Screening Screening 1. Library Design/Synthesis/ 1. Library Design/Synthesis/ Maintenance Maintenance 2. Hit validation, Resynthesis 2. Hit validation, Resynthesis 3. Series Qualification, 3. Series Qualification, Prioritization Prioritization
In vitro assays: In vitro assays: 1. Cellular Mechanistic 1. Cellular Mechanistic 2. Cellular Functional 2. Cellular Functional 3. Relevant Off-Target(s) 3. Relevant Off-Target(s) In vitro ADME assays: In vitro ADME assays: 1. Protein Binding 1. Protein Binding 2. Metabolism 2. Metabolism 3. CYP Inhib/Induct 3. CYP Inhib/Induct Research Operating Plan: Research Operating Plan: 1. Assay Priority 1. Assay Priority 2. Key Studies 2. Key Studies 3. Critical Path 3. Critical Path
IND / Ph1 DE IND / Ph1 DE
Ph1-HV or Patient (as appropriate): 1. Exposure 2. PD
Lead Optimization Lead Optimization
In vivo assays/studies: In vivo assays/studies: 1. PK (R/NR) 1. PK (R/NR) 2. PD, PK/PD 2. PD, PK/PD 3. Efficacy 3. Efficacy
Hypothesis: Hypothesis: 1. Patient Selection 1. Patient Selection
IND Enabling IND Enabling
Later Translational: 1. PK/PD/Efficacy 2. Refinement of patient selection hypothesis 3. Biomarkers
Human Dose Projection 1. h-PK Projection 2. PK/PD/Efficacy data 3. Safety/Tox data
Optimization: 1. Biochem/Cell Potency 2. Selectivity 3. Phys/Chem Properties 4. In Vitro/Vivo Tool Cmpds
Optimization: 1. Biochem/Cell Potency 2. Selectivity 3. Phys/Chem Properties 4. In Vitro/Vivo Tool Cmpds
Optimization: Optimization: 1. Tgt Optimal h-Profile 1. Tgt Optimal h-Profile 2. Candidate Selection 2. Candidate Selection 3. Backup Strategy 3. Backup Strategy
Drug Substance (DS, aka API) 1. Route Scouting (define specs) 2. Scale Up 3. Manufacture/Stability
In vitro Safety: In vitro Safety: 1. hERG 1. hERG 2. 2.
Ion Channels
Ion Channels
Tox-Suitable Tox-Suitable Formulation Formulation (maximize exposure) (maximize exposure)
DRF Tox (R/NR) DRF Tox (R/NR) Bioanalysis Bioanalysis
GLP Tox (R/NR) GLP Bioanalysis
Iterative Data Analysis and Interpretation, Models, Hypothesis Generation
Biology Biology Translation Translation
Chemistry Chemistry Development Development Formulation Formulation Clinical Clinical Development Development
Safety Safety Assessment Assessment
Informatics Informatics
Drug Product (DP) 1. Pre-Formulation Studies 2. Ph1 Suitable Formulation 3. Prototype/Stability 4. Manufacture/Stability 5. IND, BA/BE, DDI and Phase 1 clinical trials 6. GCP Bioanalysis
MTD or RP2D MTD or RP2D (as appropriate) (as appropriate)
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Development Services and Manufacturing Services
Developability Assessment
Development phase
Clinical Phase
Phase I
Phase II
Phase III
Registration/process validation
Commercial batches
Safety Assessment
Early PK, MTD/DRF studies, Exploratory Tox
• IND enabling GLP Tox studies: Ames, Chromosomal aberration, Micronucleus tests, Pivotal repeat dose (Rodent and Non- rodent)
• NDA enabling studies: Sub- chronic and
Repro-tox studies
• Local Tolerance
• Safety Pharmacology: CNS, Respiratory, CV Telemetry, hERG
study
Chemical Dev and Manuf.
• Route scouting • Process safety evaluation • Scalability
Formulation Dev and Manuf.
• Pre-formulation • Salt polymorph screening • Excipient compatibility
Analytical Services
Methods for Pre-formulation and Bio-analytical
• Fit to purpose Process dev • Material supply • Impurity identification • Enable and scale • Tox material delivery
• Solid Oral & Injectable
dosage forms
• Enabling formulation
technologies
• Methods for Intermediate,
Final DS, DP
• Forced degradation studies • Solid state characterisation
• Process dev , robustness and safety study • Unit operation studies • Impurity synthesis & characterization • DS clinical batch supply
Clinical Supplies for all phases • FIH formulation for Phase 1/2A • Final dosage form for Phase 2B/3
and onwards
Chronic and Carcinogenicity study
• Process DOE, QBD and scale
up studies
• Process Risk assessment • FMEA analysis • Registration and process validation batches manuf.
Commercial batches manuf. and packaging
• Phase appropriate method validation for DS & DP (microbial methods) • Specifications for DS & DP • In process and Finished product analysis • Final batch release with COA • Reference standard , Impurities, Isolation and characterisation
Robustness of Analytical methods and full validation as per ICH
Analysis of commercial batches
Stability Services
Selection of suitable container closure system & packaging
• Development stability studies
• ICH stability for all phases • Shelf life Estimation • Re-test extension
Stability study of registration/ process validation batch
Stability study of commercial batches
Clinical Development
• Human Pharmacology Unit (Phase I/BE studies) • Clinical Trial Services – full solution provider for conducting trials in India • Central Lab Services including regulated bioanalytical lab • Clinical data management, biostatistics and medical writing
Regulatory Support
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Biologics Development and Manufacturing services
Developability Assessment
Development phase
Clinical Phase
Phase I
Phase II
Phase III
Registration/process validation
Commercial batches
Process & analytical development
• Cell line development /
selection
• Process screening • Process characterization
• Clone to GMP • Upstream process Optimization • Viral clearance studies
• Process DOE, robustness and safety study • Unit operation studies • Impurity synthesis & characterization • DS clinical batch supply (non-GMP clinical & GMP) • CMC & regulatory support • Method development & testing
• Process risk assessment • FMEA analysis • Tech transfer package
• Commercial batches • manufacturing and
packaging
• technical support
Scale-up & QC/QA
• Methods for pre-formulation
and bio-analytical
• Methods for intermediate,
final DS, DP
• Critical to quality parameter
identification
• Forced degradation studies
• Clinical phase process development & supply • Specifications for DS & DP • In process and finished product analysis • Viral clearance studies • Packaging and ICH storage stability and shelf-life estimation
• 3-Lot testing & equipment
validation
• Cleaning validation studies • Pre-audit preparation
• QC/QA analysis & release of commercial product w/ COA
• Stability analysis • Root cause Investigation &
CAPA management
Commercial production & supply chain
• Early screening of asset capability and capacity
• Capacity utilization
planning
• Late phase clinical supply using manufacturing scale
equipment
• Supplier identification • Waste management plan • CAPEX requirement identification
• Supplier qualification • Pre-audit preparation • Protocol documentation • Master batch record
development
• Operation training
• Sales and operations
planning
• Delivery / logistics • Customer & regulatory
audits
• Process improvement & Regulatory filing updates
Regulatory Support
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Thank you
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