take solutions limited · phase ii: 100s phase iii: 1000s roughly for every 10,000 compounds...

TAKE Solutions LimitedDelivering Domain-intensive Services In

Life Sciences And Supply Chain Management

www.takesolutions.com2

At A Glance 17 Offices

1,500+ FTE

7Countries

15,872Revenue FY18

(INR Mn)

USA HQ: Princeton, NJ

Clinical, Regulatory &

Safety consulting and

technology centers.

Trial operations through

strategic partnerships

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 operations hub in

Chennai

>91% Revenue from

Life Sciences(Q4 FY18)

Moving Towards

100%from Life Sciences

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

Bringing a drug to the

market is a complex

process involving many

time consuming and

expensive stagesDrug 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


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


Clinical$27.6 Bn (2017) to $32.9 Bn (2020)

6%CAGR

Regulatory$2.6 Bn (2017) to $3.7 Bn (2020)

11.5%CAGR

Safety

$1.8 Bn (2017) to $2.5 Bn (2020)

10.5%CAGR

Life Sciences

Outsourcing

USD 32 Bn(2017)

Life Sciences

Outsourcing

USD 39.1 Bn(2020)

The USD 32 Bn Life Sciences

Outsourcing Industry will

reach USD 39 Bn by 2020

8

Life Sciences OutsourcingAn Attractive Growth Opportunity


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


2017 – Leader in IDC MarketScape: Worldwide Life Science Drug

Safety Services

2013 – Leader in IDC MarketScape on Drug Safety Services

Worldwide Life Science Drug Safety Services

2011 – Leader in IDC MarketScape: Worldwide Life Sciences R&D

IT Outsourcing

11

We Deliver Results

Consistently Recognized as a Leader in Life Sciences

The only company to host

7 unique proprietary

Life Sciences industry network forums!

Multicultural

Talent from

over 25

Countries

Majority of

our associates

are PhDs,

Doctors,

Statisticians,

Scientists and

MBAs

20%of associates

with over 10

years of

Industry

Experience

120+ Network

Members

300+ Safety

Consulting

Engagements

100000+ Regulatory

Submissions

80000+ Patients &

Volunteers

4000+ Sites330+

Clinical

Trials 1000+ BABE & Lab

Studies


Our Life Sciences Journey

12

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

2007 2011

WCI Consulting,

UK

Ecron Acunova,

India

2016… and have strategically added to our

competencies through acquisitions

Services

Technology

Regulatory

Safety

Today TAKE is a Single Global Life Sciences Brand with capabilities across Clinical, Regulatory and Safety

Services

Technology

Nets

Consulting

Regulatory

Safety

Services

Technology

Nets

Consulting

Clinical Regulatory

Safety

Capabilities

across

Markets

Capabilities

across

Markets

Capabilities

across

Markets


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

7% of All Biosimilars Trials in

India in 2017

100+ Innovator and Generics

Sponsors

1000+BA/BE & Lab Studies

330+ Clinal Trials


Key Clinical Offerings

Non-

Interventional

Studies

Bioavailability &

Bioequivalence

Studies

Medical

Imaging

Services

Clinical Data

Services

Full Service

Clinical

Trials

Biologics &

Biosimilars

Studies

For Heads of Clinical Operations, focused

on sharing best practice to define

excellence in delivery of clinical trials

OneClinical

Our Optimized eClinical and Analytics

Clinical Trials Management Platform

Offers Comprehensive Trial Oversight and

Enables Faster Decisions

Strategic Clinical

Consulting

14

Services

ICH E6 GCP

Assessment

Clinical Ops

Transformation

Technology

Solutions


How Do We Help Our Clients?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

biological product

approved by DCGI

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

”


We help life sciences

companies Stay Compliant

*including life cycle management of approved products

Submitted

8% of Total Regulatory

Submissions to USFDA 2012-2017

100,000+ Global Regulatory

Submissions*

46,000+ eCTD

15,000+ Nees

10,000+ Paper

Submissions

USA, APAC &

LATAMRegulatory Hubs

5+ Unique Technology

Propositions

Submissions

Across

130+Countries


with over 150 clients, is a

fully integrated web-based eDMS and

eCTD Submissions

Key Regulatory Offerings

Strategic Regulatory

Consulting

17

Labeling &

Artworks

Submissions

& Report

Publishing

Regulatory

Information

Management

Labeling

Assessment

Express

License

Maintenance

For Labeling Professionals; focused on the full

lifecycle of labeling

For Regulatory Information Management

(RIM) professionals to develop best practices

and leading edge solutions for RIM

traceREADY is a next generation mobility

platform that enables easy implementation

of SOPs and audit readiness with accurate

data at all timesServicesTechnology

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


How Do We Help Our Clients?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 15-18k

submissions per annum

• ~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


Signal

Management

Key Safety Offerings

Strategic Safety

Consulting

20

End-to-End

PV Services

Safety Risk

Management

Adverse

Event

Reporting

Benefit Risk

Governance

For Heads of Safety of Top 30 Life Sciences companies;

invests in thought leadership to help shape future practices

For Heads of Information Technology for PV departments, focused

on increasing business value from technology investments

For Heads of Safety of mid-sized Life Sciences

companies with a range of product portfolios

including one or more of Pharma, Biologicals,

Consumer, and Medical Devices

For PV leads of Life Sciences companies in

the APAC region with Pharma, Consumer,

Generics, or mixed portfolios

For Chief Medical Officers; addressing

strategic and governance topics within the

remit of the CMO

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?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

21


Clientele

Large Innovators

Small / Mid

Innovators

Generics

Others

Proud Partnersacross all Segments!


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.


TechnologyPIM, e-commerce,

enterprise

workflow & IT

solutions for auto

and engineering

industries

EngineeringDesign & build high

quality products

with continuous

engagement and

extended support

25

Our Supply Chain Management Solutions

Supply Chain Collaboration Engineering Services

SourcingSmart global

sourcing programs

without the

associated risks

and hassles

ComplianceCompliance

solutions for IMDS,

Conflict Minerals,

RoHS, REACh,

Prop65 and more

Automate and streamline

order-to-cash and procure-

to-pay processes through a

central, easy to use

dashboard

Solutions:

• Procure-to-pay

(backward supply chain)

• Order-to-cash (forward

supply chain)


Delivering Growth with Healthy Margins

27

7,304

10,301

13,446

15,872

1,494 2,133

2,622 3,065

3%

5%

7%

9%

11%

13%

15%

17%

19%

21%

23%

-

2,000

4,000

6,000

8,000

10,000

12,000

14,000

16,000

18,000

FY15 FY16 FY17 FY18

Operating Revenue and EBITDA in INR Millions

18.1%

19.3%

20.5% 20.7%

Operating

Revenue

EBITDA

EBITDA

Margins 29.5%

CAGR

27.1%

CAGR

19.5%


Region Wise Breakup

28

Americas

FY17

79.3%FY16

74.0%

APAC

FY17

13.3%FY16

17.0%

Europe

FY17

7.4%FY16

9.0%

% - Revenue Contribution

FY18

80.1%

FY18

6.5%

FY18

13.4%


61%71%

77%82%

88%

39%29%

23%18%

12%

FY14 FY15 FY16 FY17 FY18

Life Sciences Supply Chain Management

29

Capitalizing On The Potential For Life Sciences

Life Sciences

Revenue

Growing by

29.5%(CAGR) every year!

91% Revenue from

Life Sciences(Q4 FY18)


Delivering Consistent Returns

30

11.8%

12.7%

19.1%

17.6%

14.0%

10.9%

12.2%

15.3% 15.2%

12.5%

RoNW(Return on

Net worth)

ROCE(Return on

Capital Employed)

FY14 FY15 FY16 FY17* FY18**

* - QIP dilution in FY17

** - Preferential share allotment in FY18


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


take solutions limited · phase ii: 100s phase iii: 1000s roughly for every 10,000 compounds...

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