TAKE Solutions Limited · APAC HQ: Chennai, India Clinical Operations (Incl. ... Outsourcing USD...

TAKE Solutions LimitedThe Only Listed Full-service CRO In India

March 2019

www.takesolutions.com2

At A Glance

20,390Revenue FY19

(INR Mn)USA HQ: Princeton, NJ

Clinical, Regulatory & Safety

consulting and technology centers.

Clinical data sciences center in

Philadelphia. Clinical trials

operations across multiple sites

LATAM Delivery Centre:

Bogota, Columbia

Regulatory & Safety

support across 9+

countries in region

Europe HQ: Frankfurt,

Germany

Major trial operations

center in Germany and

sites through Europe

Specialists in UK,

Sweden, Germany,

Poland, Denmark, Russia

and other locations

APAC HQ: Chennai, India

Clinical Operations (Incl.

Generics) in Bangalore,

Chennai, Mangalore and

Manipal Regulatory &

Safety/PV operations hub

in Chennai

5 Successful

Global Life

Sciences

Acquisitions

20 offices

across

12 countries

Multi-country

Multi-site Clinical

Trial Capability

7500+ sites

120000+ patients

25,000 volunteers

20+ therapeutic areas

Copyright TAKE Solutions Limited 2019

TAKE is a preferred partner for Life Sciences Companies,

Improving Efficiency And Driving Better Outcomes Across The Drug Development Value Chain



Life Sciences Drug Development Landscape

Drug Discovery Pre-clinical Trials Clinical Trials (Phase I to III) Post-approval

Basic Research (R&D)Molecule formulation (compound)

is identified to combat a disease

Clinical TrialsThe molecule is tested for it’s

safety and efficacy

Regulatory SubmissionsThe findings are submitted to the

regulator for approval at each stage

ManufacturingApproved drugs are mass produced

and sold to the public

Safety MonitoringThe molecule is monitored and adverse

events are reported at each stage

~ 5 Years ~ 7 Years ~ 1.5 Years On Going

Regulatory Approval

Animal Trials

Human Trials

Phase I: 10s

Phase II: 100s

Phase III: 1000s

Roughly for every

10,000 compounds

identified only 1 is

approved for sale

by the regulator

Volunteers

US $1 – 1.5 Billion per Drug!

PatientsPatients

As long as the drug is

in the market, the

regulators require

that its safety is

monitored and

reported regularly

~ 1 Year

Bringing a drug to the market is a complex process involving many time consuming and expensive stages



Where Do We Come In?

Drug Discovery Pre-clinical Trials Clinical Trials (Phase I to III) Regulatory Approval

~ 7 Years ~ 1.5 Years On Going

US $1 – 1.5 Billion per Drug!

Basic Research (R&D)Molecule formulation (compound)

is identified to combat a disease

Clinical TrialsThe molecule is tested for it’s

safety and efficacy

Regulatory SubmissionsThe findings are submitted to the

regulator for approval at each stage

ManufacturingApproved drugs are mass produced

and sold to the public

Safety MonitoringThe molecule is monitored and adverse

events are reported at each stage

Post-approval

~ 5 Years ~ 1 Year


As a strategic partner, TAKE Solutions delivers full-service

Clinical, Regulatory and Safety

services and solutions to the Life Sciences Industry

LIFE SCIENCES


www.takesolutions.com

Sponsor

CompanySponsor

Company

7

Need for Outsourcing in Life SciencesA paradigm shift is taking place in Life Sciences

R&D

Clinical Research

Regulatory Affairs

Manufacturing

Marketing & Branding

Safety (PV)

Clinical Research

Regulatory Affairs

Safety (PV)

Manufacturing

Marketing & Branding

R&D

Outsourced

Inhouse

Outsourcing has three

distinct advantages

Increased Management

Bandwidth Focus on core activities

(R&D and Marketing)

Reduced Cost of

Drug Development Remain competitive in

the market

Reduced Time

to MarketQuicker Turn-around

time



Life Sciences OutsourcingAn Attractive Growth Opportunity

Life Sciences

Outsourcing

USD 36.8 Bn(2018)

Life Sciences

Outsourcing

USD 43.9 Bn(2021)

Life Sciences

Outsourcing

USD 41.1 Bn(2020)

Life Sciences

Outsourcing

USD 38.8 Bn(2019)

Clinical

84%

The USD 36.8 Bn Life Sciences Outsourcing Industry is expected to reach USD 43.9 Bn by 2021



Life Sciences OutsourcingWhat Proportion of Development Cost is being Outsourced?

Large Innovator

SME Innovator

Generics

Government

Others

2017 2021

Innovators are bio-pharma

Companies that discover new drugs(Large = Turnover > US$ 1 Bn)

(SME = Turnover < US$ 1 Bn)

Generics are bio-pharma companies that

produce existing drugs after patent expiresOthers include Association/Non-Profit,

Academic, CROs, etc.

39%

50%

43%

26%

19%

45%

57%

52%

30%

21%

Outsourcing trend is Picking Up Across All Segments, And there is

still Significant Headroom left for growth



Types of SponsorsWho is Outsourcing?

Innovators are bio-pharma

Companies that discover new drugs

Generics are bio-pharma companies that

produce existing drugs after patent expires

Others include medical devices

companies, academia, & CROs

Large Innovators (Turnover >US$ 5Bn)

are responsible for half of the

outsourcing market

The Mid/Small Innovators

(Turnover US$ 1-5 Bn) account

for 25% of the market

Generics accounts for 10%

Although Large Innovators

account for the majority,

Mid / Small Innovators are an equally attractive

segment in this space!



Why Do Sponsors Choose Us?

Offering both end-to-end services and bespoke functional services

Our Unique Formula Technology Platform Based Services += Knowledge Partner

Full Operational Capabilities

Innovative Platforms

Services

Technology

Nets

Consulting

Clinical Regulatory

Safety

Industry Forums

Experts Across The Globe

Capabilities

across

Markets



We Deliver Results

ISO 9001:2015: Quality Management System

ISO 27001:2013: Information Security

Management System

NABL (ISO 15189:2012): Clinical Laboratories

Multiple Accreditations/certifications

1,500+ FTE

120+ Network

Members

300+ Safety

Consulting

Engagements

150,000+ Regulatory

Submissions

120,000+ Patients &

Volunteers

7,500+ Sites400+

Clinical Trials

1,000+ BABE Studies

The only company to host

10 unique proprietary

Life Sciences industry network forums!



Our Life Sciences Journey

13

We have built our Clinical, Regulatory and Safety offerings organically…

2007 2011

WCI Consulting,

UKEcron Acunova,

India

2016

…and have strategically added to

our Competencies through

Acquisitions

Services

Technology

Regulatory

Safet

y

Services

Technology

Nets

Consulting

Regulatory

Safety

Services

Technology

Nets

Consulting

Clinical Regulatory

Safety

Capabiliti

es across

Markets

Capabiliti

es across

Markets

Capabiliti

es across

Markets

2019

DataCeutics,

USA

Onsphere

Corporation,

USA

KAI Research,

USA



Our Global Life Sciences Brand

14

Over the years, we have built/acquired

many life sciences brands…

Now, we unified them all to form our

Global Go-to-Market Brand

A Unified Global Brand Has

Three Key AdvantagesImproved Brand

Awareness / Recall

Uniform Product

Offerings & Delivery

Experience

Consistent

Messaging



Our People Strength Across the Globe

15

FY 19 470 employees

FY 18 345 employees

AMERICAS

FY 19 134 employees

FY 18 195 employees

EUROPE

FY 19 991 employees

FY 18 960 employees

APAC

We are dependent on highly skilled

manpower and with a global

presence. The availability of the right

resources has not been a challenge

26%LS & Technology

Domain Experts

27%Engineering and

Management

Professionals

47%Other

CompetenciesMulticultural

Talent from

over 25

Countries

50%of associates

with over 10

years of

Industry

Experience



We deliver High-quality, global trials

enabled by our proprietary eClinical

platform

Conducted Clinical Trials for the

1st Stem Cell Product in the

Indian Market

USPTO Patent for “Method for

Optimizing Clinical Data

Standardization”

Conducted

8% of All Biosimilars Trials in

India in 2018

100+ Innovator and Generics

Sponsors

1,000+BA/BE Studies

400+ Clinal Trials



Investigator

Payment

Key Clinical Offerings

RBM /

Central &

Remote

Monitoring

Full-service

Clinical Trials

(P1-4)

Biosimilars

Clinical Data

Services

BA/ BE

Studies

Non-

intervention

al Studies

OneClinical

Our Optimized eClinical and Analytics

Clinical Trials Management Platform

Offers Comprehensive Trial Oversight and

Enables Faster Decisions

Strategic Clinical

Consulting

17

Services

ICH E6 GCP

Assessment

Clinical Ops

Transformation

Technology

Solutions

CDM,

Biostatistics &

Programing,

Data

Standardization,

MW



How Do We Help Our Clients?Case Study: Full-service phase II stem cell therapy study

Business Need

Sponsor required a full-

service phase II stem cell

study in a rare patient pool

with high screen fail rate

Results

1st stem cell-based

product approved by DCGI

We Greatly Appreciate the valued contribution of TAKE Solutions towards our success in our endeavour to bring ‘Stem cell Product’ to the world market. - Sponsor“

”Copyright TAKE Solutions Limited 2019


We help life sciences

companies Stay Compliant

*including life cycle management of approved products

Submitted

6% of Total Regulatory

Submissions to USFDA 2012-2018

150,000+ Global Regulatory

Submissions*

95,000+ eCTD

20,000+ NeeS

35,000+ Paper

Submissions

USA, APAC &

LATAMRegulatory Hubs

5+ Unique Technology

Propositions

Submissions

Across

130+Countries



Product

Lifecycle

ManagementChemistry,

Manufacturing

and Controls

Management

Key Regulatory Offerings

20

Strategic Regulatory

Consulting

Submissions

& Report

Publishing

End To End

Labelling

And Artwork

Management

Services

with over 175 clients,

is a fully integrated web-based eDMS and

eCTD Submissions

traceREADY is a next generation mobility

platform

ServicesTechnology

Solutions

Regulatory Strategy and Consulting

Product Lifecycle Management

CMC Management

RA Systems Regulatory

Intelligence Regulatory Data and

Information Management E2E Labelling

Artwork

Submission Management &

Regulatory Operations Strategy

labelREADY is a end-to-end label

management platform

rimREADY is a state-of-the-art submission

planning platform

idmpREADY is our IDMP implementation

platform



How Do We Help Our Clients?Case Study: Global publishing and submission management for top 5 pharma

Business Need

• Make 45k submissions annually

across multiple health

authorities

• Maintain quality and timelines

while accommodating growth

in a cost-effective way

Results

• Successful delivery of 30% of

the Client’s global requirement

• ~30% efficiency gain over

baseline

• 98% accuracy in documentation

• 100% adherence to submission

timelines



We help life sciences companies

Minimize Risks across the product lifecycle

30+ Years in PV*

100+ Member Companies of

our PV Networks We have successfully completed

300+ Safety Consulting

Engagements

*through acquisition of WCI Consulting Copyright TAKE Solutions Limited 2019


Signal

Management

Key Safety Offerings

Strategic Safety

Consulting

23

End-to-End

PV Services

Safety Risk

Management

Adverse

Event

Reporting

Benefit Risk

Governance

safetyREADY™ An accelerated

solution for implementation, upgrade and

migration for Oracle’s Argus Safety suite

affiliateREADY Affiliate compliance,

oversight and dashboarding tools

Services

Technology

SolutionsPV Oversight / Readiness

E2E PV OptimizationNext Generation PV

Safety Medical

Governance



How Do We Help Our Clients?Case Study: Making a mid-size biotech compliant with latest EU regulation changes

Business Need

Upcoming regulatory changes

necessitated an overhaul of the

Safety systems to enable cross-

functional benefit-risk

management throughout the

product lifecycle

Results

• The baseline benefit-risk

profile of 200+ products was

established and is actively

monitored

• PV processes and benefit-risk

governance that have been in

place for 5 years and survived

3 major corporate re-

organizations

24Copyright TAKE Solutions Limited 2019


Clientele

Proud Partnersacross all Segments!



Governance Practices

26

6 Independent Directors 4 Executive Directors 2 Non-Executive

TAKE’s Board comprises of 12 Directors Who Are Experts In Their Fields

Including an Independent Chairman

5 Board

Meetings

in FY19

May 17th 2018

August 10th 2018

October 30th 2018

February 13th 2019

March 28th 2019

Audit Committee

Stakeholder’s Relationship Committee

Nomination & Remuneration

Committee

CSR Committee

Risk Management Committee 5

Board

Committees

We have gender inclusive

board consisting of 3

Women DirectorsA relatively Young Board



Ram YeleswarapuPresident

A widely acknowledged industry thought

leader, Ram Yeleswarapu co-founded the

organization’s Life Sciences business and has

been a key contributor to its growth. He

leverages deep domain expertise from over

25 years of industry experience with large

global pharmaceutical organizations including

Merck, Parke Davis and Amgen.

Leadership & Experts

Srinivasan H RVice Chairman & MD

Srinivasan HR, Founder of TAKE Solutions. He

brings over 3 decades of leadership and has

held significant leadership positions in

organizations including the Shriram Group,

Sembcorp Logistics and Temasek Capital.

D V RaviDirector

D.V. Ravi, Co-founder of TAKE Solutions. He is also the

Managing Director of Shriram Capital, a financial services

conglomerate with USD 15 Billion AUM. His portfolio of

expertise includes key areas of Corporate Strategy,

Finance and Leadership Development. He has an

exemplary track record of value creation across several

enterprises.

Subhasri SriramExecutive Director & Chief Financial Officer

Subhasri Sriram has over 25 years of experience in

Financial Services and has served in key leadership

positions in the Shriram Group. She was the CFO of the

USD 2.4 Billion Shriram City Union Finance. She has

expertise in setting up strong governance systems and

transparent processes. She was recognized as one of the

most influential CFOs in India by Chartered Institute of

Management Accountants in 2016.



Group Structure

28

3 Entities in India

2 Entities in Singapore

5 Entities in US

4 Entities in UK

One holding company and two

other operational entities.

While Ecron Acunova has a

clinical license and hence

needs to continue as a

separate legal entity, the

other operational entity

Navitas is operated from a

Special Economic Zone, to

avail tax and other export

related benefits.

One holding company and

one operational companyAll acquired through M&A

and need to be retained

for tax and other benefits.

We are looking to optimize

on the number of entities

in the long run.

All acquired through M&A

and need to be retained

for tax and other benefits.

We are looking to

optimize on the number of

entities in the long run.

In addition to the above, there are 11 entities in unique geographies, that are statutorily required for

doing business in those countries.

Our SCM vertical APA Engineering consists of a holding company and 2 other subsidiaries.


29Copyright TAKE Solutions Limited 2019


Our Supply Chain Management Solutions

Engineering Services TechnologyPIM, e-commerce,

enterprise

workflow & IT

solutions for auto

and engineering

industries

EngineeringDesign & build high

quality products

with continuous

engagement and

extended support

SourcingSmart global

sourcing programs

without the

associated risks

and hassles

ComplianceCompliance

solutions for IMDS,

Conflict Minerals,

RoHS, REACh,

Prop65 and more



To be a USD $500 Million

Life Sciences R&D SpecialistVision 2021

$200 Mn$246 Mn

$292 Mn

$400 Mn

$500 Mn

2017 2018 2019 2020 2021

We are on track to achieve our 5 Year Vision



20.46% 20.70%

19.50% 19.31%

20.46%

21.34%

22.27%

20.27%19.63%

20.88%

Delivering Growth with Healthy Margins

33

All figures in INR Millions

7,304

10,301

13,446

15,872

20,390

1,577 2,340 2,751 3,129

4,280

1,494 2,133

2,622 3,065

4,172

FY15 FY16 FY17 FY18 FY19

Operating

Revenue

Adjusted

Operating EBITDA

Adjusted

EBITDA

FY19 Reported Operating EBITDA

INR 3,834.61 Mn (18.81%)

FY19 Reported EBITDA

INR 3,942.10 Mn (19.23%)

Adjusted

Operating EBITDA

Margins

Adjusted EBITDA

Margins



TAKE Solutions’

Growth Journey

FY 2008 FY 2009 FY 2010 FY 2011 FY 2012 FY 2013 FY 2014 FY 2015 FY 2016 FY 2017 FY 2018 FY 2019

Technology Company Technology-Enabled Services Organization Platform-driven CRO

Revenue EBITDA

11%CAGR

19%CAGR

10%CAGR

10%CAGR

23%CAGR

23%CAGR

Steadily shifted focus to Life Sciences to Drive Growth



Significantly Ramped Up Our Global Clinical Trials Capabilities

Legend:

FY16 FY17 FY18 FY19

Clinical

Regulatory&

Safety/PV

Consulting

& Nets

Limited offerings + Extended

Geographical Presence

Extended offerings + Extended


Limited offerings + Limited


Full-service offerings

+ Global Presence



Region Wise Breakup

36

Americas

FY18

80.1%FY17

79.3%

APAC

FY18

13.4%FY17

13.3%

Europe

FY18

6.5%FY17

7.4%

% - Revenue Contribution

FY19

83.6%

FY19

4.1%

FY19

12.3%



71%77%

82%88% 92%

29%23%

18%12% 8%

FY15 FY16 FY17 FY18 FY19

Life Sciences Supply Chain Management

37

Capitalizing On The Potential For Life Sciences

Life Sciences

Revenue

Has Grown by

38% (CAGR)

over 5 years!

92% Revenue from

Life Sciences(FY19)



Snapshot of Year-on-Year Returns

38

14.5%

19.9%

18.0%

14.0%12.5%

13.6%

17.2%17.4%

14.6%

13.3%

RoNW(Return on

Net worth)

ROCE(Return on

Capital Employed)

FY15 FY16 FY17* FY18** FY19

* - QIP dilution in FY17

** - Preferential share allotment in FY18



Peer Comparison

39

Asset Turnover

EBITDA Margins

Average

Receivable Days

1.1

0.5 0.7

1.2

0.6 0.5

20%

30%

20% 17%13%

19%

A Large CRO

(Balance

Sheet Size

$532 Mn)

A Large CRO

(Balance

Sheet Size

$968 Mn)

A Large CRO

(Balance

Sheet Size

$2354 Mn)

A Large CRO

(Balance

Sheet Size

$7255 Mn)

A Large

Biologics

Co.

(Balance

Sheet Size

$22549 Mn)

9474

56

10995

81



A Change in Trajectory

40

The acquisition of WCI Consulting changed the focus of our Business

Our thought leadership forums,

developed by WCI is Our Key Differentiator in the industry today

Pre-Acquisition Post-Acquisition

We Rapidly grew the membership base of existing forums, and

Launched 6 New Forums. We are on track to launch our 7th Forum This Year

Launching in

2019

We have 120+ members across the

globe including 14 top tier companies

We have 16+ years of

benchmarking insights

The acquisition of WCI gave us the unique advantage of being the Only Company With Access to this

Benchmarking Data. WCI also helped us strengthen our foot-hold in Europe and accelerate our life sciences business.



A Successful Acquisition

41

The acquisition of Ecron Acunova fast-tracked our growth in the

Clinical Outsourcing Space

29%

% of Revenue from

Clinical Business

35%

% of Revenue

from Clinical

Business

FY18

FY19

27%

% of Revenue

from Clinical

Business

FY17



TAKE uses platform-based services to provide 360 Degree Coverage of

the life sciences domain, Increasing Speed To Market and Reducing

Cost of drug development


This presentation contains certain “forward-looking statements” concerning our future operations, prospects,

strategies, financial condition, future economic performance (including growth and earnings), demand for our

products and services and other statements of our plan, beliefs, expectations etc. These forwards looking

statements generally can be identified by words or phrases such as “aim”, “anticipate”, ”believe” ,”target”,

”expect”, ”estimate”, ”intend”, “objective”, “plan”, “project”, “shall”, “will”, “will continue”, “will pursue”,

”can”, “could”, “may” ,”should”,” would” or other words or phrases of similar import. Similarly, statements that

describe our objectives, plans or goals are also forward looking. These forwards looking statements we make are

not guarantees of future performance and are subject to various assumptions, risks and other factors that could

cause actual results to differ materially from those suggested by these forward looking statements. These factors

include among others, those set forth below. Forward looking statements that we make or that are made by others

on our behalf are based on knowledge of our business and the environment in which we operate. We cannot assure

you that the results or developments anticipated by us will be realized or, even if substantially realized, that they

would have the expected consequences to or effects on us or on our business operations.

Disclaimer


THANK YOU


http://www.takesolutions.com/

TAKE Solutions Limited · APAC HQ: Chennai, India Clinical Operations (Incl. ... Outsourcing USD...

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Transcript of TAKE Solutions Limited · APAC HQ: Chennai, India Clinical Operations (Incl. ... Outsourcing USD...