TAKE Solutions Limited Delivering Domain-intensive Services In Life - - PowerPoint PPT Presentation

TAKE Solutions Limited

Delivering Domain-intensive Services In Life Sciences And Supply Chain Management

www.takesolutions.com

2

At A Glance 17

Offices

1,500+

FTE

7

Countries

15,872

Revenue 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

www.takesolutions.com

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Life Sciences Drug Development Landscape

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

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 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

Manufacturing

Approved drugs are mass produced and sold to the public

Safety Monitoring

The 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! Patients Patients As long as the drug is in the market, the regulators require that its safety is monitored and reported regularly ~ 1 Year

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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 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

Manufacturing

Approved drugs are mass produced and sold to the public

Safety Monitoring

The 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 Company Sponsor Company

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Need for Outsourcing in Life Sciences

A 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 Market

Quicker Turn-around time

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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

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Life Sciences Outsourcing

An Attractive Growth Opportunity

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Types of Sponsors

Who 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

• utsourcing 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!

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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

www.takesolutions.com

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

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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

• ver 25

Countries

Majority of

• ur associates

are PhDs, Doctors, Statisticians, Scientists and MBAs

20%

• f associates

with over 10 years of Industry Experience

120+

Network Members

300+

Safety Consulting Engagements

100000+

Regulatory Submissions

80000+

Patients & Volunteers

4000+

Sites

330+

Clinical Trials

1000+

BABE & Lab Studies

www.takesolutions.com

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

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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

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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

• n 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

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Services

ICH E6 GCP Assessment Clinical Ops Transformation

Technology Solutions

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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

“ ”

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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 & LATAM

Regulatory Hubs

5+

Unique Technology Propositions

Submissions Across

130+

Countries

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with over 150 clients, is a fully integrated web-based eDMS and eCTD Submissions

Key Regulatory Offerings

Strategic Regulatory Consulting

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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

• f SOPs and audit readiness with accurate

data at all times Services

Technology 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

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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

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We help life sciences companies

Minimize Risks across the product lifecycle

30+

Years in PV

100+

Member Companies of

• ur PV Networks

We have successfully completed

300+ Safety Consulting Engagements

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Signal Management

Key Safety Offerings

Strategic Safety Consulting

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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

• n 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,

• versight and dashboarding tools

Services

Technology Solutions

PV Oversight / Readiness

E2E PV Optimization

Next Generation PV Safety Medical Governance

www.takesolutions.com

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-

• rganizations

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www.takesolutions.com

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Clientele

Large Innovators Small / Mid Innovators Generics Others

Proud Partners

across all Segments!

www.takesolutions.com

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Ram Yeleswarapu

President

A widely acknowledged industry thought leader, Ram Yeleswarapu co-founded the

• rganization’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 R

Vice Chairman & MD

Srinivasan HR, Founder of TAKE Solutions. He brings over 3 decades of leadership and has held significant leadership positions in

• rganizations including the Shriram Group,

Sembcorp Logistics and Temasek Capital.

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

• f

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

• ver

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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www.takesolutions.com

Technology

PIM, e-commerce, enterprise workflow & IT solutions for auto and engineering industries

Engineering

Design & build high quality products with continuous engagement and extended support

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Our Supply Chain Management Solutions

Supply Chain Collaboration Engineering Services

Sourcing

Smart global sourcing programs without the associated risks and hassles

Compliance

Compliance solutions for IMDS, Conflict Minerals, RoHS, REACh, Prop65 and more

Automate and streamline

• rder-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)

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Delivering Growth with Healthy Margins

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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%

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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%

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61% 71% 77% 82% 88% 39% 29% 23% 18% 12%

FY14 FY15 FY16 FY17 FY18 Life Sciences Supply Chain Management

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Capitalizing On The Potential For Life Sciences

Life Sciences Revenue Growing by

29.5%

(CAGR) every year!

91%

Revenue from Life Sciences

(Q4 FY18)

www.takesolutions.com

Delivering Consistent Returns

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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

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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

• n 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

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