TAKE Solutions Limited

Delivering Domain-intensive Services In Life Sciences

March, 2018
 At A Glance
Leader in IDC
Europe HQ: Frankfurt, MarketScape:
15,872
Germany Worldwide Life
Major trial operations
center in Germany and Science Drug
USA HQ: Princeton, NJ sites through Europe Revenue FY18 Safety Services
Clinical, Regulatory & Specialists in UK, (INR Mn)
Safety consulting and Sweden, Germany,
technology centers. Poland, Denmark, Russia
Trial operations through and other locations
strategic partnerships
>91%
Revenue from
Life Sciences
(Q4 FY18)

APAC HQ: Chennai, India

Clinical Operations (Incl.
Generics) in Bangalore,
Chennai, Mangalore and
Manipal Regulatory &
LATAM Delivery Centre: Safety operations hub in Moving Towards

100%
Bogota, Columbia Chennai
Regulatory & Safety
support across 9+
countries in region from Life Sciences

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 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 stages
US $1 – 1.5 Billion per Drug!

Drug Discovery Pre-clinical Trials Clinical Trials (Phase I to III) Regulatory Approval Post-approval
~ 5 Years ~ 1 Year ~ 7 Years ~ 1.5 Years On Going
Basic Research (R&D) Human Trials
Molecule formulation (compound) Phase I: 10s Volunteers Roughly for every As long as the drug is
is identified to combat a disease Animal Trials Phase II: 100s Patients 10,000 compounds in the market, the
Phase III: 1000s Patients regulators require
Clinical Trials identified only 1 is
The molecule is tested for it’s approved for sale that its safety is
safety and efficacy by the regulator monitored and
reported regularly
Regulatory Submissions
The findings are submitted to the
regulator for approval at each stage

Safety Monitoring
The molecule is monitored and adverse
events are reported at each stage

Manufacturing
Approved drugs are mass produced
and sold to the public

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 Where Do We Come In?
US $1 – 1.5 Billion per Drug!

Drug Discovery Pre-clinical Trials Clinical Trials (Phase I to III) Regulatory Approval Post-approval
~ 5 Years ~ 1 Year ~ 7 Years ~ 1.5 Years On Going
Basic Research (R&D)
Molecule formulation (compound)
is identified to combat a disease
Clinical Trials
The molecule is tested for it’s
safety and efficacy

Regulatory Submissions
The findings are submitted to the
regulator for approval at each stage

Safety Monitoring
The molecule is monitored and adverse
events are reported at each stage

Manufacturing
Approved drugs are mass produced
and sold to the public

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As a strategic partner, TAKE Solutions delivers full-service

Clinical, Regulatory and Safety

services and solutions to the Life Sciences Industry

LIFE SCIENCES
 Need for Outsourcing in Life Sciences
A paradigm shift is taking place in Life Sciences

R&D R&D

Marketing & Clinical Marketing & Clinical

Branding Research Branding Research

Sponsor Sponsor
Company Company

Regulatory Regulatory
Manufacturing Manufacturing
Affairs Outsourced Affairs

Safety (PV) Inhouse Safety (PV)

Increased Management Reduced Cost of Reduced Time

Outsourcing has three Bandwidth Drug Development to Market
distinct advantages Focus on core activities Remain competitive in Quicker Turn-around
(R&D and Marketing) the market time
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 Life Sciences Outsourcing
An Attractive Growth Opportunity

Clinical 6%
$27.6 Bn (2017) to $32.9 Bn (2020) CAGR

Regulatory 11.5%
$2.6 Bn (2017) to $3.7 Bn (2020) CAGR

Safety 10.5%
$1.8 Bn (2017) to $2.5 Bn (2020) CAGR Life Sciences
Outsourcing
USD 39.1 Bn
(2020)
Life Sciences The USD 32 Bn Life Sciences
Outsourcing Outsourcing Industry will
USD 32 Bn reach USD 39 Bn by 2020
(2017)

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 Types of Sponsors
Who is Outsourcing?
Although Large Innovators
account for the majority,
Mid / Small Innovators
are an equally attractive
segment in this space!

Generics accounts for 10%

The Mid/Small Innovators Large Innovators (Turnover >US$ 5Bn)

(Turnover US$ 1-5 Bn) account are responsible for half of the
for 25% of the market outsourcing market

Innovators are bio-pharma Generics are bio-pharma companies that Others include medical devices
Companies that discover new drugs produce existing drugs after patent expires companies, academia, & CROs
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 Why Do Sponsors Choose Us?
Our Unique Formula = Technology Platform Based Services + Knowledge Partner

Clinical Regulatory

Capabilities
Services across
Full Operational Capabilities Markets Nets
Industry Forums

Technology Consulting
Experts Across The Globe
Innovative Platforms Safety

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

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 We Deliver Results
120+
Network
Members The only company to host
330+ 4,000+ 100,000+ 7 unique proprietary
Clinical Sites Regulatory
Trials
1,000+
Submissions
Life Sciences industry network forums!
BABE & Lab
Studies
80,000+
Patients & 300+
1,500+ Volunteers Safety Majority of
FTE Consulting
Engagements
our associates
are PhDs,
Doctors,
20% Statisticians,
of associates
Scientists and
with over 10
Consistently Recognized as a Leader in Life Sciences years of MBAs Multicultural
Industry Talent from
2017 – Leader in IDC MarketScape: Worldwide Life Science Drug Safety over 25
Experience
Services Countries
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

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 Our Life Sciences Journey
We have built our Clinical, Regulatory and Safety offerings organically …

Regulatory Regulatory Clinical Regulatory

Capabilities Capabilities Capabilities

across across
Services Services Markets Services across
Markets
Nets Markets
Nets

Consulting Consulting
Technology Safety Technology Safety Technology Safety

2007 2011 2016

… and have strategically added to our
competencies through acquisitions WCI Consulting, Ecron Acunova,
UK India

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 Our Global Life Sciences Brand
Today Navitas Life Sciences is TAKE’s Global Go-to-market Brand, with
capabilities across Clinical, Regulatory and Safety

Clinical Regulatory

Services
Full Operational Capabilities Nets
Industry Forums

Technology Consulting
Experts Across The Globe
Innovative Platforms Safety

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 100+
Innovator and Generics
Sponsors

We deliver High-quality, global trials

330+
Clinal Trials enabled by our proprietary eClinical
platform
1,000+
BA/BE & Lab Studies

Conducted Clinical Trials for the Conducted USPTO Patent for “Method for
1st Stem Cell Product in the 7% of All Biosimilars Trials in Optimizing Clinical Data
Indian Market India in 2017 Standardization”
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 Key Clinical Offerings

For Heads of Clinical Operations, focused

Medical on sharing best practice to define
Bioavailability & Imaging excellence in delivery of clinical trials
Bioequivalence Services
Studies
Biologics &
Biosimilars OneClinical
Studies Full Service Our Optimized eClinical and Analytics
Clinical Clinical Trials Management Platform
Trials Offers Comprehensive Trial Oversight and
Non- Services Technology Enables Faster Decisions
Interventional Solutions
Studies

Clinical Data ICH E6 GCP Clinical Ops

Services Assessment Transformation

Strategic Clinical
Consulting

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

Business Need
Results
Sponsor required a full-
service phase II stem cell 1st stem cell-based
study in a rare patient pool biological product
with high screen fail rate 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

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 Submissions
Across

130+
Countries
10,000+
Paper
Submissions
46,000+ We help life sciences
eCTD
companies Stay Compliant
100,000+
Global Regulatory 15,000+
Submissions* Nees

5+
USA, APAC & Unique Technology Submitted
Propositions
LATAM 8% of Total Regulatory
Regulatory Hubs Submissions to USFDA 2012-2017

*including life cycle management of approved products

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 Key Regulatory Offerings
For Labeling Professionals; focused on the full
lifecycle of labeling

For Regulatory Information Management

(RIM) professionals to develop best practices
Regulatory and leading edge solutions for RIM
Information
Submissions Management
& Report with over 150 clients, is a
Publishing fully integrated web-based eDMS and
eCTD Submissions

traceREADY is a next generation

License mobility platform that enables easy
Maintenance Technology implementation of SOPs and audit
Labeling & Services Solutions readiness with accurate data at all times
Artworks

Regulatory Data and Regulatory RA Systems

Labeling Information Management Intelligence
Assessment E2E Labelling
Regulatory Strategy and Consulting
Express Artwork
Product Lifecycle Management
Strategic Regulatory Submission Management & CMC Management
Consulting Regulatory Operations Strategy

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

Results
Business Need
• Successful delivery of 30% of
• Make 45k submissions annually
the Client’s global requirement
across multiple health
• ~30% efficiency gain over
authorities
baseline
• Maintain quality and timelines
• 98% accuracy in documentation
while accommodating growth
• 100% adherence to submission
in a cost-effective way
timelines

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 We help life sciences companies
Minimize Risks across the product lifecycle

30+ 100+
Years in PV* Member Companies of
our PV Networks We have successfully completed
300+ Safety Consulting
Engagements

*through acquisition of WCI Consulting

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 Key Safety Offerings
For Heads of Safety of Top 30 Life Sciences companies;
invests in thought leadership to help shape future practices
Adverse
Event For Heads of Information Technology for PV departments, focused
Reporting on increasing business value from technology investments
Safety Risk For Heads of Safety of mid-sized Life Sciences
Management Signal companies with a range of product portfolios
Management including one or more of Pharma, Biologicals,
Consumer, and Medical Devices

For PV leads of Life Sciences companies in

Benefit Risk the APAC region with Pharma, Consumer,
Governance Generics, or mixed portfolios
End-to-End
For Chief Medical Officers; addressing
PV Services
strategic and governance topics within the
remit of the CMO
Services

safetyREADY™ An accelerated
solution for implementation, upgrade and
migration for Oracle’s Argus Safety suite

E2E PV Optimization Safety Medical

Governance
Technology affiliateREADY Affiliate compliance,
Solutions oversight and dashboarding tools
PV Oversight / Readiness Next Generation PV
Strategic Safety
Consulting
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 How Do We Help Our Clients?
Case Study: Making a mid-size biotech compliant with latest EU regulation changes

Results
Business Need
• The baseline benefit-risk
profile of 200+ products was
Upcoming regulatory changes
established and is actively
necessitated an overhaul of the
monitored
Safety systems to enable cross-
• PV processes and benefit-risk
functional benefit-risk
governance that have been in
management throughout the
place for 5 years and survived
product lifecycle
3 major corporate re-
organizations

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 Small / Mid
Clientele Innovators

Generics

Large Innovators

Others
Proud Partners
across all Segments!

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 Leadership & Experts
Srinivasan H R
Vice 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.
Ram Yeleswarapu
President
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.
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D V Ravi
Director
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 Sriram
Executive 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.
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 Our Supply Chain Management Solutions

Engineering
Sourcing Design & build high
Smart global quality products with
sourcing programs continuous
without the engagement and
associated risks and extended support
hassles

Engineering Services Compliance Technology

Compliance solutions PIM, e-commerce,
for IMDS, Conflict enterprise workflow
Minerals, RoHS, & IT solutions for
REACh, Prop65 and auto and engineering
more industries

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 Delivering Growth with Healthy Margins
18,000 23%

15,872 21%
16,000 20.5% 20.7%
19.5%
19.3% 19%
14,000 18.1% 13,446
EBITDA 17%
Margins
12,000 29.5%
10,301 CAGR 15%
10,000
13%
8,000 7,304
Operating 11%
Revenue
6,000
9%

4,000
3,065 7%
2,622
2,133 27.1%
2,000 1,494 CAGR
EBITDA 5%

- 3%
FY15 FY16 FY17 FY18

Operating Revenue and EBITDA in INR Millions

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 Region Wise Breakup Europe

FY18 FY17 FY16

6.5% 7.4% 9.0%

APAC

FY18 FY17 FY16

Americas
13.4% 13.3% 17.0%
FY18 FY17 FY16
80.1% 79.3% 74.0%

% - Revenue Contribution 29
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 Capitalizing On The Potential For Life Sciences

12%
18%
23%
29%
39%
Life Sciences
Revenue
Growing by

88%
29.5%
77%
82% (CAGR) every year!
71%
61%

91%
Revenue from
Life Sciences
FY14 FY15 FY16 FY17 FY18 (Q4 FY18)

Life Sciences Supply Chain Management

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 Delivering Consistent Returns

19.1%

17.6%

15.3% 15.2%
14.0%
RoNW 12.7%
(Return on
Net worth) 11.8% 12.5%
12.2%

ROCE 10.9%
(Return on
Capital Employed)

FY14 FY15 FY16 FY17* FY18**

* - QIP dilution in FY17

** - Preferential share allotment in FY18

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 TAKE 360 Degree Coverage of
uses platform-based services to provide
the life sciences domain, Increasing Speed To Market and Reducing
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Cost of drug development 32
 Disclaimer

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.
THANK YOU
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