Syngene International Limited has informed the Exchange about Investor Presentation
Ref: Syn/CS/SE/IP/2022-23/April/10
April 27, 2022
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, 2022. The Company will use this presentation for any meeting scheduled with analysts or institutional investors up to June 30, 2022.
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 2022
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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Contents
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Operating Highlights
Syngene – Putting Science to Work
Strategic Advantages
Financials
Shareholding and Share Information
Putting Science to Work
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1
Operating Highlights
Q4 FY22 performance
Operating Highlights
Q4
Q4 Financial Highlights
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was
driven
Growth all divisions.Development Services had a particularly strong quarter as it caught up on projects postponed due to supply chain and other Covid-related disruption, in addition to planned work.
delivery
across
solid
by
Phase three of the expansion plan at the Hyderabad research facility was completed
Company won two prestigious industry awards
o At the CMO Leadership Awards 2022 we ranked top in all the six core award categories - quality, expertise, compatibility, capabilities, reliability, and service.
o Golden Peacock Award for Excellence in Corporate Governance for the year 2021, awarded by the Institute of Directors.
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Revenue from operations increased by 15% year-on-year
EBITDA growth of 13% year-on-year
Total Revenue Rs. 7,728 Mn
EBITDA Rs. 2,650 Mn
Profit After Tax Rs. 1,478 Mn
EBITDA Margin at 34% PAT Margin at 19%
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Full year performance FY22
Operating Highlights
FY22 Financial Highlights
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Syngene’s Integrated Drug Discovery (IDD) platform, made a positive contribution to Discovery Services during the year as the number of IDD projects increased by 40% compared to the previous year.
Extended and expanded research collaboration with Amgen. Syngene will also build and operate a dedicated laboratory to accelerate the scale-up of small molecule projects.
Development and Manufacturing businesses included expanding the biopharma manufacturing capacity by commissioning a cGMP microbial facility and expanding of the mammalian cell manufacturing facility.
In small molecule development services, the oligonucleotide and highly potent API capabilities were both extended and plans are on track for the Mangalore manufacturing plant to achieve a major regulatory approval thus opening it up to a broader scope of projects.
• Worked with clients on diagnostics, treatments and vaccines related to the coronavirus. The Company also manufactured remdesivir under a voluntary licence from Gilead. This manufacturing will continue for as long as the pandemic persists.
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Revenue from operations increased by 19% year-on-year
EBITDA growth of 15% year-on-year
Total Revenue Rs. 26,570 Mn
EBITDA Rs. 8,489 Mn
Profit After Tax* Rs. 4,211 Mn
EBITDA Margin at 32% PAT Margin* at 16%
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*Note :Net profit for FY22 was Rs. 3,958 Mn inclusive of exceptional item of Rs. 253 Mn.| PAT and PAT margins without accounting for exceptional item
FY23 guidance
Parameter
FY23 Guidance
Revenue from operations
Expected to grow at least in the mid-teens
EBITDA Margin
PAT Margins and Growth (before exceptional items)
In light of positive demand environment for CRO and CDMO services, expect to step up investments in new scientific capabilities, IT, digitisation and commercial activities.
This step up in investment, along with resumption of travel and other business activities post-pandemic in an inflationary environment, is likely to put pressure on margins during the course of the year. In aggregate, expect to deliver an EBITDA margin around 30%.
With this step up in operating investment, the Company expects to be well positioned and anticipates seeing improved growth and operating leverage from FY24.
With the SEZ tax benefit for key operating units reducing this year and in coming years, the Company expects the effective tax rate to increase by 200 to 300 basis points in FY23, creating some dilution in the PAT margin.
PAT growth rate for the full year expected to be in single digits.
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2
Syngene – Putting Science to Work
Putting science to work
Who we are and what we do
Integrated solution provider across research, development manufacturing covering pharma, biotech, nutrition, animal health, consumer goods and specialty chemical.
Working with clients from around the world to find solutions to their scientific challenges for small and large molecules while improving productivity, speeding up time to market and lowering cost of innovation.
Innovative culture driven by the expertise of a highly qualified team of 6,000+ employees and supported by state-of-the-art infrastructure and market- leading technology
Well established in scientific research and development, emerging presence in commercial manufacturing of small molecules and large molecules
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Syngene key facts and figures
420+ active clients
15 collaborations with top 20 pharmaceutical companies
400+ Patents held with clients
2 Mn sq. ft. of World class infrastructure, qualified to meet international standards
Rs. 40,381 Mn Cum. Investment
Rs. 26,570 Mn FY22 Revenue
Rs. 4,211 Mn FY22 PAT before exceptional item
~5300 talented team of scientists Including ~500 PhDs
All figures are as on March 31, 2022, unless otherwise specified
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International accreditations
• USFDA,OHSAS 18001,
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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 (EBP)
Animal Health
AgroChem
Consumer products
Clinical-stage company creating novel medicines targeting
G protein-coupled receptors (GPCRs)
European clinical-stage biopharmaceutical focused on Oncology
Leading China based crop protection company
Large Japanese chemical company
Large MNC focussed on Agriculture & Nutrition segments
Global food and beverage company
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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
• Collaboration with Baxter to set up a dedicated R&D center • 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 set up a dedicated R&D center
2019 – 2022
Continued investments and growth • Expanded collaboration with BMS; Baxter and Amgen • Expansion of IDD platform •
Laboratory capacity expansion in Bangalore, Hyderabad • Expansion in Mangalore for
commercial API mfg. • Capacity and capability addition in Biologics manufacturing
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Our divisions
Research business
Development and Manufacturing business
Discovery Services
Dedicated R&D Centers
Development Services
Manufacturing Services
Engaged in early-stage research, from target identification to delivery of drug candidates for further development
Capabilities include Chemistry, Biology, Safety Assessment, and Research Informatics for small molecules; recombinant DNA engineering, cell line development, Next Generation Sequencing, and protein sciences for large molecules
Dedicated R&D facilities for strategic clients providing exclusive access to research teams, infrastructure, and project management to support the client’s R&D requirements.
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Engaged in activities from pre-clinical to clinical trials, including drug substance and drug product development, and associated services to demonstrate the safety, tolerability, and efficacy of the selected drug candidate, cGMP compliant manufacturing of clinical supplies, and registration batches for small molecules
Engaged in the manufacturing of small and large molecules for commercial supplies through cGMP- compliant facilities, a state-of-the art API manufacturing campus and a biologics manufacturing facility
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Our collaboration models
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Dedicated R&D Labs • Dedicated scientific and support teams work exclusively on the client’s project • Clients are provided with customized and ringfenced infrastructure
• Long-term strategic alliances that last usually five years or more
FTE • 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 • Agreements are
typically renewed annually
FFS • Client collaboration to deliver agreed services within a defined scope.
• Flexible, on demand
personnel and research infrastructure deployed to achieve the project objectives
• Engagements may be short or long- term
Productivity based model • Offer the services directly linked to productivity generated by our team
Risk-reward • Across a portfolio of stage gate-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 Per Batch model with built in milestones progressing towards achievement of outcome and delivery of drug substance, drug product
… and are open to any single or combination of above
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Our dedicated R&D centers exemplify the success of our long-term strategic alliances
• 600+ scientists • 300,000+ sq. ft. laboratory space • •
Largest R&D Center in Asia for BMS (est.d 2009). Integrated drug discovery and development in multiple therapeutic areas, including cardiovascular, fibrosis, immunology, oncology, translational medicine and pharmaceutical development
• Produced >10 drug candidates for further study and advanced new compounds for
first-in-human studies
• ca.200 scientists • 70,000 sq. ft. laboratory space • Dedicated R&D Center in India for Baxter (est.d 2013). • R&D activities centered on product and analytical development, preclinical evaluation in parenteral nutrition and renal therapy • Collaboration expanded to include microbiology research and preclinical assessment projects for medical devices • Delivered four new product development projects for registration in the US and European Union markets.
• ca.170 Scientists • 60,000 sq. ft. laboratory space • Exclusive R&D Center for Amgen Inc. in India (est.d 2016) •
Focus on medicinal & process chemistry, biologics, bioprocess, drug metabolism, pharmacokinetics, bioanalytical research and pharmaceutical development
• Operational excellence initiatives were introduced to improve productivity across functional areas.
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Backed by world class state of the art infrastructure
HQ Campus 90 acres in Bangalore where most of Syngene’s capabilities are housed today
R&D Expansion Genome Valley, Hyderabad, India commenced operation in Aug 2019
Biologics Expansion HQ Campus Biologics Manufacturing plant scale: Mammalian- ~100-2000L Microbial - ~200-500L
API Mfg Expansion Commercial Manufacturing to support product launch in Mangalore, India - Commenced operation in March 2020; Capacity: 70KL; Reactor size: 2-12KL
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Agile and experienced workforce supported by our commitment to continuous learning
~6000 strong pool of employees
Environment that engages our employees and enables them to grow
27% female employees vs 16% in FY16
Enriching talent pool
Encouraging development of life skills and technical expertise
~5300 scientists delivering quality output and creating competitive edge
• Started Syngene Training
Academy (STA) to make the transition smoother for new campus hires and equip them with essential skills
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Internally developed training modules tailored to our business and the specific needs of our employees
Fostering inclusion and diversity
• Equal opportunity employer,
proactively promoting inclusion and diversity across our workforce to get the best talent mix
Celebrating leaders and leadership • Bringing out leadership qualities in people and
celebrating leaders is one of the key focus areas.
• Key leadership and development interventions include Emerging Leaders Development Program (ELDP), People Managers Forum and Leadership
• Excellence and webinar series.
PhDs Master's Degree
Others
10% ~500
28% ~1480
62% ~3360
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Harnessing digitization and automation
Generating reliable and retrievable data by using advanced technology platforms.
Online management of specifications, procedures, policies, checklist, manuals, BMR, SMF, TTD, protocol, reports
Online document storage and issuance
Document Management Systems (DMS)
Learning Management Systems (LMS)
Online training platform which tracks learner progress and performance
Manage QC workflow, integrates instrument and manage samples and associated information
Laboratory Information Management Systems (LabWare LIMS)
Radio Frequency Identification System(RFID)
7 successful USFDA audits in past 4 years
TrackWise
Synpliance
Digitize all paperwork related to Quality Management system with no manual Intervention and automated notifications
Certification as per ISO 13485:2016, ISO/IEC 27001 and ISO 9001:2015 requirements
Online platform for tracking regulatory compliances enabling comprehensive compliance management
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Strategic Sourcing – agility and resilience that makes a difference
Our dedicated Strategic Sourcing professionals have the expertise and experience to work closely with our global supplier base to ensure timely delivery of supplies for smooth operations of the company, while ensuring strict adherence to quality and regulatory compliances.
e-procurement: Select, monitor and manage suppliers through the Vendor Evaluation System & the other digital tools
Logistics: Provide customized solutions for time-sensitive shipments and ensure product delivery at the fastest possible time while meeting local and international regulations
Commercial: Work as per the rules of the various governmental departments to ensure timely approvals, and to maintain requisite business licenses
Inventory management: Manage receipts, issues, handling and accounting of the materials and identify trends and adjust plans to optimize the supply chain
Procurement transformation • Optimized demand forecasting, ordering and delivery on a just-in-
time basis
• Building deep understanding of products markets and suppliers to
obtain optimum pricing Improving speed of order processing and turnaround times
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Digitalization Increased transparency, efficiency, and traceability in the procurement lifecycle with process automation
AI based automation Implementation of AI-enabled robotic process automation (RPA), covering both GMP and non-GMP materials and services
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Operational excellence is a way of life
Building Right Philosophy
Building Robust Process
Building Sustenance
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LEAN & SIX SIGMA is a belt certification program wherein black belt training is done by ASQ South Asia. 5s is an initiative scaled up to cover functional units GEMBA WALK was established and integrated with EHSS and Quality parameters. KAIZEN was launched as a part of SQDECC, a central repository to review and implement using cross-function team
• WHY CULTURE,
problem-solving culture
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Simplification of order- delivery processes. LEAN LABORATORY improving Lab productivity. QUALITY BY DESIGN identifies the risk while executing critical steps
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Right culture with high focus on safety, quality and customer service. SQDECC - New initiatives - Introduced quarterly audits ‘’SynZero’’ new platform to report unsafe conditions. Anytime Audit Readiness
Kaizen
Daily Visual Board
Syngene SQDECC
Problem Solving using Why Why
5S Implementation
GEMBA Walk
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3
Strategic Advantages
Syngene’s Strength
A Global CRO/CDMO •
Integrated Drug Discovery, Development and Manufacturing service provider
• Small and Large Molecules, ADCs, Oligonucleotides • Listed on Indian Stock Exchanges (NSE and BSE)
IP Position • IP can be fully assigned to clients • Strong track record of Data Integrity
and Security
• Over 400+ patent assignments by
clients recognizing Syngene
Quality Focus • Quality driven organization • Excellent track record of compliance with
global regulators
• US FDA, EMA and PMDA approved, GLP Certified, AAALAC Accredited facility
• 15+ regulatory and ~250 client audits in the last
3 years
Scientific Ecosystem • 2 Mn sq. ft.world-class R&D and Manufacturing
infrastructure
• Sites in Bangalore, Mangalore, and Hyderabad • ~5300 qualified scientists including ~500 PhDs • Highly effective supply chain practices •
Large molecule capacity of 10,000 L and small molecule capacity of 70,000 L
Marquee + ~ 420 active clients • Partnering with large / mid-size / emerging
BioPharma (EBP) and other industries • Clients concentrated in US, Europe & Japan • Track record of working with diverse industry
sectors
Track Record • Collaborations and partnerships to deliver numerous clinical candidates
• Delivery history for integrated
CMC programs towards FIH and beyond
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Strong track record of growth and profitability
Total Revenue (Rs. Mn)
EBITDA (Rs. Mn)
Profit After Tax * (Rs. Mn)
20,935
22,489
19,007
6,119
5,266
26,570
14,849
8,489
6,995
7,364
3,662
3,821
4,211
3,054
3,316
FY18
FY19
FY20
FY21
FY22
FY18
FY19
FY20
FY21
FY22
FY18
FY19
FY20
FY21
FY22
FY18 to FY22 - CAGR 16%
FY18 to FY22 - CAGR 13%
FY18 to FY22 - CAGR 8%
*PAT is before exceptional items
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Multiple levers for growth going ahead
Expand/Extend Existing Clients • High service integration • Dedicated centers model
Engage New Clients •
Tailored service offerings and dedicated personnel
Offtake in commercial manufacturing in both biologics and small molecule API
Integrated Drug Discovery •
Go to model, with an integrated scientific solution provider, delivering end to end client’s requirements
Client Engagement
Capacity
Forward Integration
Capability
Capacity Expansion • •
Consistent investment FTE services, manufacturing, formulation, biologics, stability
Capability Additions •
New capabilities across multiple domains incl. the allied sectors Stability, analytical and bio-analytical services, viral testing, Oligonucleotide bioinformatics New platforms: ADC,CAR-T,PROTACs
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Our end-to-end platform enables us to be a 'one-stop-shop' for discovery, development and manufacturing (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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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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Led by a globally experienced management team
Jonathan Hunt Managing Director and Chief Executive officer
Dr. Mahesh Bhalgat Chief Operating Officer
Sibaji Biswas Chief Financial Officer
Ashu Tandon Chief Commercial Officer
Sanjeev Sukumaran Chief Human Resources Officer
Experience
AstraZeneca
Sanofi, Amgen, Monsanto
Vodafone, Hutchison Telecomm
IQVIA Accenture
Thomson Reuters
Experience
Alok Mehrotra Chief Quality Officer
Reckitt Benckiser, PepsiCo, Godrej, DRL
Dr. Kenneth Barr SVP Discovery Services
Dr. Jan-Olav Henck SVP Development Services
FORMA Merck
Bayer AG, SSCI, Aptuit
Alex Del Priore SVP Manufacturing
Johnson Matthey
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Advised by Our Board of Directors
Kiran Mazumdar Shaw Non-Executive Chairperson
Chairperson of Biocon Limited, ~45 years of experience in the field of biotechnology
Jonathan Hunt Managing Director and Chief Executive officer
~30 years of experience in the global biopharmaceuticals industry
Dr. Carl Dcicco Independent Director
Professor Catherine Rosenberg Non-Executive Director
Vinita Bali Independent Director
Chief Scientific Officer in Foghorn Therapeutics
Professor in electrical and computer engineering at the University of Waterloo, Canada
Chief Executive Officer & MD of Britannia Industries from 2005 to 2014
Experience
Paul Blackburn Independent Director
Experience
40 years+ experience in the field of finance
Sharmila Abhay Karve Independent Director
Retired as audit partner from Price Waterhouse
Dr Vijay Kuchroo Independent Director
Founded five biotech companies including CoStim Pharmaceuticals and Tempero Pharmaceuticals
Kush Parmar Independent Director
Managing Partner at 5AM Ventures, a life sciences venture capital firm
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Committed to sustainability
Safety is at the heart of everything we do
Committed to environmental protection
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Accredited with ISO 45001:2018 for its Occupational Health and Safety (OH&S) measures
Risk assessments are the integral part of our operation - a proactive approach in incident prevention
21,761 man hrs of regular safety training under Kavach, our flagship safety program considerable improvement across several safety metrics
13.7 million manhours without Lost Time Incident (LTI) on rolling 12-month basis for FY22
Increased incident reporting
Reduction of incidents
Improved risk control measures
Improved general safety perception
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Accredited with ISO 14001:2015 for its effective Environment Management System (EMS)
34,000 KL of water conserved through effective rainwater harvesting as well as recycling of used water; up 61% from FY21
92% of the total waste generated are recycled in an environment-friendly manner for FY22
3-R’s Operations constantly monitored to identify opportunities to reduce, reuse, and recycle waste
67,000 tons of carbon dioxide emissions reduced in FY22,up 26% from FY21
74 Mn KWH of electricity usage through Green energy sources; up 18% from FY21
85% of Energy consumption is through green energy sources in FY22
Refer to the CSR link on our website to know about our corporate social responsibility pursuits on healthcare, education, environment, rural development
All figures are as on March 31, 2022, unless otherwise specified
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ESG report -a step towards delivering a transparent account of our progress on financial and non-financial parameters
ENVIRONMENTAL
SOCIAL
GOVERNANCE
• • • • •
Quality assurance Continuous improvement Responsible procurement Supplier code of conduct Supply chain sustainability
•
•
•
Environmental Governance through three areas energy use, Water conservation, and waste management. Energy maximizing the use of renewable resources and reducing the use of energy in offices, laboratories, and manufacturing units. 85% of electricity was procured from renewable sources delivering a reduction in greenhouse gas emissions of approximately 67013 tCO 2
• Water focusing on conserving and
promoting responsible use of water is a high priority and a zero discharge policy governs the management of wastewater and effluent
• Waste proactive approach to sorting and
facilitating appropriate recycling, reuse and disposal of waste is critical.
• •
•
• •
• •
• • •
•
Safety Centralized team of EHSS professionals embedded in every operational division. Kavach safety program with specialized stream Employees Equal opportunity with 27% female employees. Varied range of employee benefits Zero tolerance to child labor, forced labor, discrimination or violation of human rights Large learning & development platform Diversified leadership and employee base Healthcare service to the underprivileged section Best corporate foundation award.
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We have consistently received 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 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.
•
•
CMO Leadership Awards 2022 Received 6 awards for all 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
2017 2018
2019
2020
2021
2022
•
•
•
•
Ranked as one of the 25 fastest growing companies in India 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
• Dream Companies to Work Award at the 29th Edition of the World HRD
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
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Proactively managing risks through robust risk management framework
Syngene has a risk management framework to identify, monitor, report and manage risk across the business. 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 key 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
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
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4
Financials
Q4 financial highlights
Particulars
Revenue from Operations
Other Income
Total Revenue
Material and Power Costs
Employee Costs
Foreign exchange (gain)/loss, net
Other Expenses
EBITDA
EBITDA Margin
Depreciation and finance cost
PBT
Tax on above
PAT before exceptional item
PAT Margin
Exceptional item, net of taxes*
PAT after exceptional item
Q4 FY22
Q4 FY21
YoY Change
Q3 FY22
QoQ change
7,581
147
7,728 2,325
1,736
(91)
1,108
2,650
34%
859
1,791
313
1,478
19%
-
1,478
6,586
184
6,770
1,762
1,826
(47)
891
2,338
35%
766
1,572
194
1,378
20%
228
1,606
15%
(20%)
14%
32%
(5%)
94%
24%
13%
12%
14%
61%
7%
(8%)
6,414
129
6,543
1,898
1,888
(199)
793
2,163
33%
879
1,284
244
1,040
16%
-
1,040
18%
14%
18%
22%
(8%)
(54%)
40%
23%
(2%)
39%
28%
42%
42%
*Exceptional item is in relation to receipt of insurance claim in Q4FY21
All figures in Rs. Mn unless otherwise specified
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FY22 financial highlights
Particulars
Revenue from operations (excl export incentives)
Other Income
Total Revenue
Material and power costs
Employee costs
Foreign exchange (gain)/loss, net
Other Expenses
EBITDA
EBITDA Margin (%)
Depreciation, Interest and tax
Profit After Tax before exceptional item
PAT Margin (%)
Exceptional Items, net of taxes (3)
Profit After Tax after exceptional item
FY22
26,042
528
26,570
8,138
7,181
(548)
3,310
8,489
32%
4,278
4,211
16%
(253)
3,958
FY21
21,843
646
22,489
5,839
6,602
(171)
2,855
7,364
33%
3,543
3,821
17%
228
4,049
YoY Change
19%
(18%)
18%
39%
9%
220%
16%
15%
21%
10%
(2%)
Balance Sheet Highlights
As on 31st March 2022
Shareholders’ funds
Net Fixed assets
Other net assets (1)
Net cash/(debt) (2)
Total Use of Funds
32,976
27,392
(1,741)
7,325
32,976
(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 (3) Exceptional item in FY22 is in relation to reversal of services export incentive related to FY20 in line with Government notification. In FY21 relates to receipt from insurance claim
All figures in Rs. Mn unless otherwise specified
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5
Shareholding and Share Information
Biocon Group and Syngene
Biocon Limited, founded in 1978, is an innovation-led global biopharmaceuticals company
Syngene, a subsidiary of Biocon Limited, was established in 1993 as India’s first Contract Research Organization - Company has 25 years plus of unparalleled experience in novel molecule discovery, development and manufacturing services
Biocon Biologics, another subsidiary of Biocon Limited, consolidates the development, manufacturing and commercialization operations of Biocon’s biosimilars business
Integrated services: • Discovery • Development • Manufacturing
small/large molecules
• • •
•
Product Based Biosimilars Formulations and Compounds Alternative Therapeutic Drugs
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40
Shareholding and Share Information
Syngene’s Shareholding Pattern*
Syngene’s Share Information*
1%
29%
Promoter & Promoter Group
NSE Ticker
BSE Ticker
Market Cap (Rs. Mn)
Public
% free-float
ESOP Trust
Free-float market cap (Rs. Mn)
70%
Share Outstanding (Mn)
3M ADTV ^ (Shares)
3M ADTV ^ (Rs. Mn)
SYNGENE
539268
2,39,516
29%
69,268
401
4,45,313
261
*As on 31st March 2022
^ NSE Average Daily Traded Volume / Value
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41
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 + 91 806 891 9807 investor@syngeneintl.com
Media Contact: Shotorupa Ghosh +91 8450977080 Shotorupa.ghosh@syngeneintl.com
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42
Thank you
© 2022 Syngene International Limited, Bengaluru, India. All Rights Reserved. Syngene believes the information in this document is accurate as of its publication date; such information is subject to change without notice. Syngene acknowledges the proprietary rights of other companies to the trademarks, product names and such other intellectual property rights mentioned in this document. Except as expressly permitted, neither this documentation nor any part of it may be reproduced, stored in a retrieval system, or transmitted in any form or by any means, electronic, mechanical, printing, photocopying, recording or otherwise, without the prior permission of Syngene International Limited and/ or any named intellectual property rights holders under this document.
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