INDIAN PHARMA 10X

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Pharma | Life science | Biotechnology PLB TRENDS & OPPORTUNITIES Assessment of HIGH GROWTH , HIGH MARGIN SPACE AJAY GOHIL CHALLENGE SEEKING FROM HARVARD & MCKINSEY In the Quest for 10X …… STRATEGIC OPTIONS Assessment for INDIA PHARMA cos. EVERY THING YOU WANT TO ABOUT INDIAN PHARMA A STORY OF INDIAN GENERICS PHARMA CO INGNX 10 X

Transcript of INDIAN PHARMA 10X

Page 1: INDIAN PHARMA 10X

Pharma | Life science | Biotechnology PLB

TRENDS & OPPORTUNITIES Assessment of HIGH GROWTH , HIGH MARGIN SPACE

AJAY GOHIL CHALLENGE SEEKING FROM HARVARD & MCKINSEY

In the Quest for 10X …… STRATEGIC OPTIONS Assessment for

INDIA PHARMA cos.

EVERY THING YOU WANT TO ABOUT INDIAN PHARMA

A STORY OF INDIAN GENERICS PHARMA CO – INGNX

10 X

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Strategic Options Assessment

Value Addition Specialty Inputs

Program Manager Across value chain

Platform as a service CRO/CMO as a service

Leverage the SMAC+ BIG DATA + e-commerce

M&A

Divestment

Strategic Alliances / JVs

CAPACITY Expansion

Biologics | Biosimilars | Bio enzymes

Ultra Advanced GENETICS research

Unmet medical needs | Rare diseases

Consumer sectors AN/HC/Chemicals

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Anatomy of the presentation

SECTION 1 MOLE size on big canvass A mediocre performance of INGNX

PERFORMANCE ANALYSIS

SECTION 2 Why INGNX should consider

SECTION 1 seriously ?

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SECTION 1

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MOLE Size in a big strategic canvass….

$ 900 Bn

Global Rx Pharma Size

0.0005% INGNX market share

IF INGNX just have to play in RED SMALL ZONE…Just

operational thinking..then the fault is NOT in

EMPLOYEES but ..with SNR MNGT

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Why INGNX should see this presentation?

INGNX should have been $ 10 Bn organization by now What is the problem with INGNX ?

Mole size , Mediocrity , Questionn of survival, Bullet point culture

Bullet point

Culture

INGNX can grow “10-X” How INGNX can grow 10 times … Strategic Thinking – Smart , Practical , Innovative

10 x

How to grow 10x Complete Strategic road map

How

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First lets see what is wrong with INGNX

INGNX should have been $ 10 Bn organization by now What is the problem with INGNX ?

Mole size , Mediocrity , Questionn of survival, Bullet point culture

Bullet point

Culture

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FIRST THING FIRST – Lets Clear some MYTHS TEMASEK …

Strategic MYTH TRUTH

Off patent means BIG opportunity for INDIAN GENERICS …

WRONG ..boss the days are gone..where the RANBAXY uses the reactors in small part of LUDHIANA and earned hefty premium on DRUGS to US Now there is very stringent FDA…mistakes and u r gone…and then there is ACCEPTABILITY

Again,… are the INDIANs the only guys who know the generics game,.. Remember not even the SUN + DRL + CIPLA is equal to MYLAN or TEVA or SANDOZ or HOSPIRA… globally + CHINESE Companies are now a FORCE to reckon with .. IN GENERICS the price erosion is so high… look what has happened to

LIPITOR…PLAVIX Furthermore ..the Global MNCs ..despite the patent loss ..have managed to stop the PLUMMET …and they have tactically used good marketing to arrest the FREE FALL…which indian Pharmas lack..

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FIRST THING FIRST – Lets Clear some MYTHS TEMASEK …

Strategic MYTH TRUTH

EV/EBIDTA for INDIAN PHARMA Cos will always increase – there is cool 5-6 Exit multiples

Long term outlook depends on the Cos future s – strategic plans – the sensitivity of the capital is very high wrt the Indian stocks..INDIAN cos are highly COUPLED with GLOBAL FINANCIAL

MARKETS ..the biggest fear is QE TAPER ..if the QE shrinks

..there could be capital withdrawal..thus Investment by TEMASEK in Indian firms ..all firms..is more to do with CAPITAL GLUT than

the real bright chances …and performance – TEMASEK WOULD AGREE SHEEPISHLY

Global MNCs will be weaken by off patents…

PARTIALLY TRUE – for ex . ASTRA ZENECA ..since it is unable to replace the off patent NEXIUM ( Aripiprazole ) or SYMBICORT or TEVA worried about COPAXONE – with next phase of the Molecules ( PIPELINE DRYNESS) ..but these guys have big pockets and they can simply buy the competition …

THE GLOBAL M&As like PFIZER bought HOSPIRA , TEVA intends to buy MYLAN ( 70% market ins specialty injectiables) etc ..would imply a Lot to be done for INGNX

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FIRST THING FIRST – Lets Clear some MYTHS TEMASEK …

Strategic MYTH TRUTH

Biologics means heavy investments …India Pharmas cant afford

If a WUXI APPTECH (A $ 700 MM Size small Chinese co have ambition to acquire and participate across the VALUE CHAIN ( drug

discovery to drug delivery ) … we talk about non being able to create value ..is not A TENABLE ARGUMENT …

Biologics have RAPIDLY GROWN and become BLOCKBUSTER drugs..if we analyze the PIPELINE of BIG PHARMA it is 90% MABs+ proteins + ANTIBODY DRUG CONJUGATES ( paclitexil + adalimumab) Also ..See how RITUXIMAB , AVASTIN ( bevacizumab) , HERCEPTIN ( trustuzumab) have quickly become BLOCK BUSTER ..leaving behind the small molecules XTANDI ( enzalutamide) , REVLIMID , GLEEVEC , KYPROLYS ( carflozumab etc ) … thus the BIOLOGICS are really the future …because it is based on the body's internal mechanism + IMMUNE SYSTEM and CELLS …

CAN TEMASEK DIFFER from this ?

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Analysis of VARIANCE – INGNX vs. PFIZER BULLET POINT CULTURE ….JUST BULLETED the company

Lack of Meta Systemic Strategic planning ..no

HGHMLC sectors , No BIG THINKING, No strategic

real investments No strategic partnership

$ 56 Bn

PFIZER

$ 1 Bn INGNX

Lack of Eco system synergies , No High

quality R&D , No undisputed leadership in

a single area …

Lack of Excellence in Operational aspects

No MaSE , No OE, no People excellence , No real

desire to excel…

JUST BULLET POINTS CULTURE .. NEVER REALLY UNDERSTOOD THE MIND OF PEOPLE , CUSTOMER What is the MS% of INGNX amongst the key strategic

therapeutics areas ? What is the KOL brand equity ? What about advocacy ? What is the marketing strength ? What is INGNX relative performance in terms of ROCE /

ROA / ROE ?

COMPLETELY OPERATIONAL MINDSET Why INGNX has not participated in HGHMLC

..who has stopped the company ? Why INGNX is not striving for the best

benchmark..in terms of best people . Best processes ..?

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Global Pharma Dynamics • Big Pharma- Consolidation

underway M&A , High performance pharma manufacturing (* Molecular biology products , Genes derived ..) ( Pfizer + Sandoz , Mylan + Teva , Actavis + B&L , Elan + Perrigo , Az + Kythera , Bayer CH + Merck CH )

• Key emerging areas – Immuno oncology

, lifestyle diseases , unmet medical needs, rare diseases…Orphan drugs can surprises too

• Key emerging markets – Low value – MENA,SEA

• High focus on R&D – pivotal around

Advanced Genomics , RNA intervention, CRSPR, Cell , Molecular biology

• Consumer / Animal HC & Nutrition , Enzymes , Anti oxidants ,

prebiotics, probiotics – High growth emerging areas – but highly competitive

• Off patent is necessary but not sufficient – has hurt Big

pharma..to extract the benefits the generics cos have to do much more ..that too in price erosion envt.

• Game is quickly shifting towards Biologics , Biosimilars can

be opportunity but requires High quality processes , unlike chemical molecules

• Compliance has become stringent - product registration

• China has massive cost advantages

Means INGNX has to really think strategically . Non linear and out of the comfort zone ….need to consider the following..

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Global Value chains in PLB Opportunities are DYNAMICALLY EVOLVING

Novel MAB

discovery

Discovery Biology +

Drug screening

Cell Line Engineering + vector

constrn

Toxicology + ADME + DM PK

BioAnalytical services Mfg

Process research

Assay formulation + Process

dev

Cell banking + viral

clearance validation

Clinical Testings

Phase 1 to Phase 4

C GMP mfg

Lot release stability testing

BIOLOGICS

Synthetic Chemistry

Discovery Biology

Medicinal Chemistry

ADME + DM PK

Formulation BA/BE

Mfg Process research

Stability Toxicity

Clinical Testings Phase 1 to

Phase 4

BioAnalytical services +

Commercial Mfg

SMALL CHEMICAL MOLECULES

Animal Models

Cell source characteriz

ation

Assay develop

ment

Safety + toxicology

Process Development

+ Bioanalytical

services

Kilo lab

Scale up +

process optimiza

tion

Technology transfer + Ascetic

process validation

C GMP mfg

Lot release stability testing

CELLS

The Mergers amongst the BIG PHARMA – verticals + Cloud technology will eliminate the need for spending on CRO /CMO infrastructures + Biologics as a

Service could alleviate problems for the pharma

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GENERICS ..can not save the day –cant be

sustainable game

Key Universal Truths , Observations , Prediction

Off patents are necessary

..but not sufficient for the

success in generics

Generics – needs much more than

being a generic..

Specialty pharma

can set in Biologics can grow like

INTERNET / Adv

technology platforms are must

Consumer healthcare & nutrition

+ Enzymes + Emerging Markets + AFRICA ….good but over crowded

IND Pharma would

require MUCH

SMARTER GAME PLAY

..not just GENERICS

PHARMA + BIOTECH + STEM CELLS + M&A + BIG DATA +

SMAC – can change the game on

its head

This means INGNX has to carefully select the strategic options

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CRITICAL QUESTIONS for INGNX.. This will establish the

importance of STRATEGIC THINKING

US$ 900 Bn : Total Rx market

Off patent market

US$ 150 Bn

What MONEY INGNX made from the OFF PATENT molecules since 2004 ?

Off patent is necessary but not sufficient –Means INGNX failed to identify the HGHM sectors , therapeutics to

differentiate Branded GENERICS

: US$ 100 Bn

How many brands of INGNX is UNDISPUTED MARKET LEADER ?

Branding & Marketing , Differentiation is must - company has lots ANDAs/DMFs /NDDS Approved generics ..what about

liberating potential Generics

$ 50 Bn

What is the EVA for Generics per site ? Cost advantages / manufacturing excellence / OE/ EOS /

Strategic Manufacturing / DMF advantages/ M&A is must

Formulation

$ 35 Bn

Is GENERIX leader in Innovative Drug Delivery platform, ANDA ?

Now lets analyze situation for INGNX

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why INGNX needs to look at the BIGGER picture at al ? Why INGNX can not have 10% growth forever ..why break heads

High Globalization – more opportunity for BIG

PHARMA than Generics

• EM –APAC –BRIC /CIVET are coupled to the growth of Adv economies and trade dependency

• Big Pharmas deep pockets can simply acquire the co..

• Strong adv of PFIZER / SANOFI / BMS / can really stop the plans for Indian comps..even MYLAN / TEVA/ SANDOZ are at risk..of losing grounds ..

GENERICS (0) vs R&D (5)

• The BIG pharmas have already started extending the life of their off patent molecules .through multiple GTM , MaSE Brand price points ..it will be big affairs for GENERICS to match the efforts

• GENERICS will always be subjected to competition..even if WINNING a SMALL BATTLE in generics..does not protect agains the big WAR …the ultimate investments need to be in R&D or CAPACITY building

Indian Investments is nothing if the globalization effects

are ignored

• The trends of SMAC / ecommerce has virtually made it possible to AIRDROP the FACILITIES

• The GTM has changed significantly – the consumers are bestowed with choices – the quality provider even a start up can compete with the BIG GUY ..as long as he provides the quality

• INGNX – has to compete in GENERICS market – the profits are low and GENERICS will not be a guarantee of success

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Why INGNX need to be concerned about STRATEGIC CANVASS

Pfizer – Spent $

250 Bn on Wyeth+ Pharmacia + Warner

Lambert

Adv R&D – Genomics + Molecular Bio + Specialty Sectors High Margin | High Barriers | Strategic

Consumer + Animal HC & Nut Mid margins + Low barriers + crowded

Plain JANE ..Generics

HOSPIRA

Bayer – Xarelto + CH

Actavis + Watson

$ 50 Bn spent

B&L + Forest

Merck Consumer

Merck kGA BMS +

Keytruda + Yervoy

SIGMA Aldrich

Sun + Ranbaxy

Mylan + TEVA

Novartis Eli Lilly

Glaxo

Danone

Nestle Zoetis

Mead Johnson

Saputo

CHINESE Cos can be every where

SABIC DUPONT

BASF

Fertilizers +

Micronutrients cos

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$ 1000 Bn Global opportunity Pharma

$ 500 Bn

Global opportunity

Biologics

$ 500 Bn Global opportunity Animal Health

FOR INGNX .. The presence across the HGHMLC sectors ..need LIBERATING POTENTIAL .. Simply operating in the INDIAN context

or relying on GENERICS can shut the doors…

INGNX must DIVERSIFY into HGHMLC strategic sectors …MUST ENRICH PORTFOLIO ..create differentiation – connect to consumer -

Big opportunities requires competitive

differentiation. GENERICS too big a

risk

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200 Bn$

API + HP API + formulation

Specialty APIs – High performance APIs – controlled substances – cytotoxic Target differentiated SMS – emerging therapeutics in Generics ANDAs / NDDS / Para 4 - widen the reach , Multiple mode of deliveries – FASTER Advanced FORMULATION technology ( Specialty Injectibles , Lyophilization , Liposomal ,)

Biologics + Biosimilar+

mab + genes

High margins / High process complexity / requires significant investments but competitive landscape is emerging

Strategic Alliances with Big pharma / Invest into R&Ds of selected genes – BRAF/ HLA/ cells / genes / vector – Invest into ADV GENOMICS ..cut the deals with ILLUMINA / BIORAD / CRSPR / RNA intervention technology

250 Bn$

CRO/CMO/ Custom

synthesis / Analytical chemistry

Develop expertise in specialty pharma molecules , High purity , high quality – analytic / molecular biology / HPLC/ Micro reactors / filters / high container manufacturing suites / lyophilization / Liposomal / micro/nano sphere technologies

Adv Analytical chemistry & Custom synthesis – sp chemical reactions , process development , route synthesis , label compounding

150 Bn$

Proteins / peptides / Vitamins Hormone

Invest in to PYRIDINE/ basic chemicals / vitamins/ high purity proteins / COSMETIC PEPTIDES / Collagen /FSH/ MSH / Insulin / Adrenalin / testosterone/ estrogen . M&A ( femicare ) , Opthalmic compounds – STRATEGIC ALLIANCES / LICENSING ( with Japanese companies)

Huge Market – High margins ..can be used in connecting with the CONSUMERS . Strategic synergies can be availed to consumer sector

500 Bn$

+

+

+

Consumer / Animal

Nutrition

Preferred brands in Animal / Consumer sectors – cosmetics , personal care, skin care , healthcare , nutrition drinks ., adult & child nutrition

Best benchmark with ABBOTT, MEAD JOHNSON , DANONE … or may have alliances / contract manufacture and later connect to CONSUMER

600 Bn$

+

Key strategic market sector evaluation

10x Total

addressable markets in Bn$

Why INGNX can not afford to remain in the STATUS QUO zone .,..it has to liberate potential.. IT HAS TO BE PROFESSIONAL and ULTRA HIGH PERFORMANCE COMPANY ….which is GLOBALLY COMPETITIVE

LIBERATE POTENTIAL

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WHY INGNX has shrunken to a MOLE size on big canvass ? case study on lack of Strategic Planning

2 - Low Executional Rigor in HG HM LC strategic market sectors

High end strategic market sectors are ignored – INGNX has been the follower..never really strive to create SPECIALTY SEGMENT ..long term vision .. Lack of executional rigors in the strategic market sectors to really create the

market presence

1 – Lack of strategic planning – Strategic options analytics

Why INGNX did not benchmark with the GLOBAL giants – like Unilever , P&G , L'Oreal , BASF , DANONE , Nestle – why INGNX never tried to best benchmark..where is the COM VISION ..what is holding INGNX back ..…this is called STRATEGIC PLANNING ..

No JVs/ No alliances / No Big M&As due to excessive profit seeking attitude

3 – PIRAHNAs in the RED OCEAN

INGNX – Even as a completely OPERATIONAL FOCUSED co..could not become the Market leader amongst the selected categories , KOLs, no

CRM / No motivated employees , No big quality quest ..and drives… MAY I KNOW WHY ???

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High Importance , Low Differentiation

Low Importance, Low differentiation

High Differentiation High Importance

High Differentiation, Low Importance

Calcium Tablets

Filgrastim

CONSUMER – Healthcare+ Nutrition +

Animal HC & N

Simple APIs

INGNX has good platforms like Marketing and Sales

distribution / brand equity –It can MAKE a GOOD strategic partner for

Advanced Products ..can make it big in CONSUMER

SECTOR too

Biotech R&D

CAR-T| RNA i| Biologics| Adv Genomics Mab| proteins & peptides |

CS+CT| HP API

INGNX never tried to create the space into High importance High diff SMS – it went after Low margin products and –

The opportunity cost of MISSING BUS is $ 10 Bn…which INGNX could have been by NOW

Can I know ? How

many products of INGNX ..have >50% MS and earns >50% gross

margin

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INGNX must identify the variance of HIGH PERFORMANCE vs MEDIOCRE PERFORMANCE

HGHMLC strategic markets sectors – not present

Not having portfolio of products across the SMS – presence in low value product categories

Lack of strategic planning Lack of VISION

Marketing / Sales / CRM gaps Product Portfolio gaps Customer Mix ( Missed positioning products Channel mix – Omni channel presence ( P&G deliver +connect) Total Awareness across customer segments – conversion achieved / A&P

budget Marketing campaign ROI Strategic Markets covered Value Pricing opportunities New customer segments - No CRM New Channel penetration – No SMAC / No Big data use

$

20

Bn INGNX Could have been

$ 0.8 Bn

Strategic GAP

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Big INDIAN Pharma comparison

2164 2060

1885 1830

1395

940

723

194 185

535 584

864

349 283

111 133

16 33

Rev Mn $

NI Mn $

EBIDTA Mn$

Indian Total Pharma size

50% revenue from US/EU thru GENERICS

INDIAN Cos have to be GLOBALLY competitive …china can easily crush them

INDIAN PHARMA is totally dependent on US/EU markets ..and

regulations will become stringent and there will

be 0% UNETHICS

..ever tolerated by FDA

$ 12 bn

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26

4

1

11

26

13

21

19

9

14

28

30

22

11

30

15

19

30

11

14

25

28

46

19 20

DRL Lupin Sun Cipla Cadila HC

Debt/Asset RoA%

RoE% NPM %

EBIDTA %

Lets compare Margins ….Big 5 EXCEPT SUN pharma..which has a

RECORD of meaningful ( so far) M&A , strategic partnership could manage above 40%

EBIDTA …without raising any DEBT ….

NO OTHER …company has EBIDTA above

30%

Indian companies …can never be compared with each other… but rather they need comparison with the GLOBAL PLAYERS

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Global Big Pharma vs. Big Generics Margins Comparison 2014

22 22 22

46

23

19

45

16 15

34

14

30

42

26

5 7

12

7 6

2

8 9

5

14 12

-4

6 5

18

12

28

12 13

5

26

20

13

20 22

-12

12

7

41

24

53

29

25

30

43

31 30

40

35

14

29

18

Debt/Asset RoA

NPM EBIDTA

The global generics are

finding tough to compete ..

While it is true that the OFF PATENT molecules have made BIG DENT into ASTRAZENECA margins – Nexium , SYMBICORT ..but Az has the problem of failure

of PIPELINE ..which can be corrected ..

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So we have seen Something is WRONG with INGNX

We have seen – HOW INGNX has failed in… Liberating potential - due to lack of strategic planning – never participating in real

HIGH GROWTH HIGH MARGIN LESS CYCLICAL STRATEGIC MARKETS

Operations excellence - Godrej never fully exerted the EXECUTIONAL RIGOUR necessary

to bring potential to life … failures of so many JOINT VENTURES

failed to avail SYNERGIES across meta systems , Eco systems ( Pls ask Mckinsey or Wharton ) …remained only mired in ACCOUNTING …and

PROFITS – now is 15% a good profits earned – it is a LESS THAN MEDIOCRE performance

Delivering the HIGH PERFORMANCE – people have no fear – because even 1%

growth bringers are rewarded instead of criticized … is this a right culture … need redefinition,

reimagination , redeployment of the strategic progress – while the NEAREST PEERS like ZYDUS , CADILA PHARMA , TORRENT , CLARIS .all have done something…

Energizing the right spirit - For example taking only 5 Minutes of interviews

for the SENIOR ROLES – Is not this a big CORPORATE GOVERNANCE issue? - what kind of Snr management is this who spends only 5minutes for high strategic roles..

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INGNX can not afford to remain in

status quo INGNX has to WORRY about the

GLOBAL PHARMA DYNAMICS

INGNX also need to relook into the strategic AGENDA ..

INGNX needs to read between the LINEs ..not just bullet point culture … DEVIL LIES IN

DETAIL..not in BULLET POINT SIR ..

So far we have seen

So What should INGNX do Now ?

Take Deep breath ..1

DHARMA YOG

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Now Lets see the How INGNX can grow 10X …..

INGNX can grow “10-X” How INGNX can grow 10 times … Strategic Thinking – Smart , Practical , Innovative

10 x

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As we have the GLOBAL MASSIVE OPPORTUNITIES and RISKS … INGNX has following choices …

INGNX $ 1 Bn

$ 10 Bn

10X Asset lite

Smart

Liberating $ 1.1 Bn

Profits can be at risk , Big capex

$ 50 Bn

-10%

CHOICE 3 : STATUS QUO

CHOICE 2 : 10% mindset Operations only ultra

paralytic Conservative thinking

CHOICE 1 :

Liberate Potential Global presence

Globally competitive Mega trends

This would require HIGH CALIBRE STRATEGIC PLANNING

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So lets answer …

Can INGNX become $ 10 bn by 2020 ? My Answer is YES HOW ?

$ 10 bn

Ultra High Quality Strategic planning -Key strategic therapeutic areas

-Differentiation , Excellence - Big consumerism MEGA trend

SMART PLAY -Strategic options / alliances / meta

system cross sectoral synergies -- Smarter Business Development

High Performance Environment

- Faster , Smarter , Better -Passion , CAN DO approach

BY Liberating the Potential

Requires A VISION DRIVEN PROFESSIONAL HIGH PERFORMANCE APPROACH

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DHARMA YOG

Achieving 10 X through RIGHT DHARMA

RIGHT VISION

Presence in High Growth High

Margin sectors

RIGHT STRATEGY

Smart , Advanced , practical resources

, systems , Ultra high performance

RIGHT CULTURE

Motivated Passionate Co

owner of vision Fearless

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Portfolio Enrichment

So lets start with the RIGHT VISION …. INGNX should be recognized as FIRST CHOICE ..amongst all HIGH VALUE SEGMENTS ..

Consumer First Marketing & Sales

Excellence Transformation

GTM Operational Excellence

Smart & Specialist Sp chemicals, Pref partner,

CRAMs Strengthen position across

Specialty Consumer Sectors like HC| Nutrition/ Sp pharma

Significant Globally competitive PLAYER

Recognized for Ultra advanced high value adding products

Connect to Consumers

Ultra advanced

Example – THINK FRESH , think Godfrey Philips FRESH –

Freedom, Rejuvenation,

Energy , Smartness < Health

Portfolio Enrichment

Smart & Specialist

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ECO SYSTEMS – Highest capital efficiency

Achieve the Highest ROI / RoA/ROCE / RoNW/ EVA across all HGHMLC sectors – through Strategic Portfolio management ( requires competitive differentiation, asset allocation , M&A ,

strategic vision- game shaping attitude )

RIGHT Framework for Liberating potential

Diagnostics 10 X treatment Implementation

META SYSTEMS- strategic Sustainable futuristic advantages

SYSTEMS- Highest Process People Product efficiency

Identification of HG HM LC sectors across all relevant industries ..stress test the growth assumptions ( in terms of impact

assessment of TRENDS + Risks – to evolve with robust strategic sectors for LIBERATING POTENTIAL

Excellence across Marketing & Sales , Supply chain, Production, Operations , Process , People …to liberate the

potential

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10%

SYSTEMS – CENTER OF EXCELLENCE

Marketing & Sales Excellence Value pricing

Brand Repositioning KOL /CRM/ B2B/B2C /

Operations Excellence -Forecast accuracy

-BPI/Cloud migration -OneINGNX

-Supply chain distribution

People Excellence Leadership

Process Information Performance

Eco systems – Strategic MAP

30% Competitive Differentiation Strategic Alliances with Eco

system partners

Robust Strategic Planning for

Assets , ROIs for SBUs , Market intelligence ,

Capacity Planning

EVA for Each SBUs – High ROCE | Smart

Analytics Eco system

partnerships Collaborative

Planning

10 x – FRAME WORK – INGNX

Meta systems – Strategic MAP

Entry into new HGHMLC strategic sectors Strategic alliances Licensing / M&A Availing MEGA TRENDS – Synergies Risks Mitigation

API + HP API + CS + CT

Biologics + Biosimilars

HG HM LC strategic clusters

Protein / peptides / Hormones

Consumer / Animal HC &

Nutrition

CMO / CRO / Cus synthesis

R&D/ CoEs

60%

Scope of Value

addition

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RIGHT performance themes

Liberate potential

MaSE – GTM, product enrichment, Key accounts , Cross sectoral synergies

Strategic Markets entry , CASPI, WIMO, PLASMET ,

High Growth , High margin, Less cyclical Auto/HA/OA OEMs,

Chemicals to Consumers

Futuristic step out

Strategic Adjacent Diversification (

Sustainable competitive advantages)

Ultra Advanced Technologies –High

performance advanced materials , Li, RE , Algae

,Fertilizers, PET/N, Sp chemicals, Oil n Gas N

Energy

Smart Play

Strategic Joint ventures, Alliances,

Asset light ( Smart & safe)

Cross Sectoral, Cross Functional , Cross SBUs synergies , cost savings, Optimal REACH OUT , CONVERGENCE GTM

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RIGHT STRATEGIC THEMES Key Strategic theme

Rationale What should be done

Entry into HGHMLC strategic markets Connect

to the consumer Leverage

Market expertise

Capacity building in API /HP( High

Performance) API ( OEL Level5) /CS/CT ) - $ 500 Bn

Lucrative markets – can be leveraged in phase with the current SBUs

M&A or Seek partnership or Strategic alliances with SABIC ,

BASF, DuPont , Dow on API

Marketing expertise leverage to set up GTM / establish the direct to

consumer partnership ..

SABIC for ex can provide PYRIDINE ..create the Anti infective.

Consumer chemicals ..market it ..explore SMS in Consumer Healthcare , Nutrition,..

Explore Strategic alliances with ABBOTT + NESTLE + MEAD JOHNSON..or

new entrants

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RIGHT STRATEGIC THEMES Key Strategic theme Rationale What should be done

Entry into HGHMLC strategic markets Connect to the

consumer Leverage

Market expertise

Animal & Consumer Care , Healthcare & Nutrition – Highly lucrative markets ( 30-45% margins)

Strategic partnership with Spe chemicals firms like SABIC , BASF, MOMENTIVE,

LONZA , LAND O LAKES, DUPONT , DANONE , SAPUTO ..etc to create the specialty nutrition business across CONSUMER / ANIMAL ( Cattle & Companion) sector value propositions

ENTRY into BIO ENZYMES / Specialty

Food ingredients – BIG $ 150 Bn Opportunity by 2025 ( Biofuel/ Bioplastics/ Food & beverages

Avail synergies from PEPTIDES / VITAMINS SBUs.

Advanced Processes / Tech/ products

Capacity building in Biologics , Adv genetics , proteins , peptides ,

US/EU / Japan – Otsuka , Lonza , Lanzatech , Genencor , illumina , Biorad. – Strategic

alliances with LOREAL , UNILEVER , NESTLE ..to capture entry into personal care, cosmetics, hormones market ..

Page 38: INDIAN PHARMA 10X

RIGHT Strategic Resource Allocation

INGNX

40% Biotech The Savior

20% CMO / CRO

20% GENERICS API – HP-API – Sp Injectables – NDDS

BIOSIMIALRS + Biologics + Adv Genomics + Stem cells + Adv proteins & peptides +

HP+HCMS

Capacity building – Samsung/ Lanza strategic alliances – To be recognized as HIGH QUALITY HIGH

PURITY Biologics+ P&P+ Biosimilar + Controlled substances or cytokines etc

Specialty generics areas – micro segments – KOL + ethical marketing + SMAC + customer satisfaction

20% CONSUMER

The DARK HORSE

INGNX must aim to become the UNILEVER of Consumer healthcare., nutrition, start B2B , E

commerce , Think Consumer Healthcare, Think INGNX ..use of SMAC – Compete with

ABBOTT , JOHNSHON

Page 39: INDIAN PHARMA 10X

RIGHT CULTURAL THEMES REIMAGINE , REDEFINE, REVITALISE

Customer Delight & inspiration

Smart & Innovative Makes Life easy & comfortable

Brings best of ..everything Fresh and Salubrious Energy & health

CONNECT TO CONSUMER in every

possible manner

Creating the Platform for the next growth stage –

Globally recognized brand

Specialty chemicals

/ Agri business

Page 40: INDIAN PHARMA 10X

INGNX has very high scope for 10x

10 X requires RIGHT VISION, RIGHT STRATEGIC PLANNING, RIGHT CULTURE

Having these RIGHT ELEMENTS ..still it needs to be implemented

So Lets look into the KARMA YOG to achieve the results..

So far we have seen

Take Deep breath ..2

NOW LETS LOOK INTO KARMA YOG

Page 41: INDIAN PHARMA 10X

KARMA YOG

How to Achieve 10X through Right KARMA

RIGHT GTM

Right Business models (

innovative + consumer centric)

RIGHT PROCESSES

Excellence in Marketing & Sales

Operations + Supply chain

People

RIGHT IMPLEMENTATION

Advanced Projects management +

EXECUTIONAL RIGOUR ..

Page 42: INDIAN PHARMA 10X

Now Lets see the IMPLEMENTATION PRACTICAL consideration to realize the

dream ..10x

How to grow 10x – KARMA YOG Complete Strategic road map

How

10%

SYSTEMS – CENTER OF EXCELLENCE

Marketing & Sales Excellence Value pricing

Brand Repositioning KOL /CRM/ B2B/B2C /

Operations Excellence -Forecast accuracy

-BPI/Cloud migration -OneINGNX

-Supply chain distribution

People Excellence Leadership

Process Information Performance

Page 43: INDIAN PHARMA 10X

CONSUMERISM –convergence GTM + connect to consumer, How to leverage the cross functional , cross eco system synergies How to derisk the portfolio and achieve the Highest ROCE

INGNX GROUP 10 Bn$ 2020

Focus on core – Mfg excellence , strategic partnership , alliances + licensing API / HP API + CS+ CT

Capacity building CMO + CRO + Custom

synthesis + High Purity Mnfg + HCMS

Connecting with consumers directly

Patients Comfort +

Ecosystem Care

Consumer Healthcare Nutrition

Focus on BIOLOGICS / BIOSIMILARS Key Mab / oncology / Lifestyle genes Diabetes - Adv genetics | GCSF) / IF/

TNFa/ EGVF/PD1/CAR –T / RNA I / CRISPR – strategic Licensing/

alliances / partnership

partner ship BIOLOGICS –

Advanced GENETICS labs + Molecular Biology +

Analytic Labs + Bio fuels

Bio chemicals Bio enzymes

Specialty Therapeutics Area Strategic importance

Animal Health & Nutrients

Proteins + Peptides + Hormones + Vit +

Sp Chemicals

Specialty chemicals

RIGHT GTM

Page 44: INDIAN PHARMA 10X

Innovative & Smart Business Models in Pharma

1 E-commerce Sell all under one roof

2 X V C Across the Value chain

3 D2D aaS

Drug Discovery to Delivery as a SERVICE

4 ADV GENOMICS

high end genomic research

Specialist input provider

Across the value chain – Program

manager

Consumer centric marketer

RIGHT GTM

The strategic options would requires strong

commitment and capability building

attitude – Pharma is now NO MORE

GENERICS …

PHARM-Emerging Markets

Page 45: INDIAN PHARMA 10X

Case study – How BIG DATA helps Healthcare industry – Opportunity to exploit

• The system, which was developed using design thinking and agile application development, is being implemented on the SAP HANA cloud platform. Incoming patient data is analyzed in real time and predictive tools help project where the disease is likely to spread. SAP Lumira infographics are used to inform the public, and last but not least, the Ariba network is used to quickly mobilize medical suppliers in the region.

Fighting disease with data SAP has joined forces with a number of institutions including the Hasso Plattner Institute and the Helmholtz Center for Infection Research to develop SORMAS, the Surveillance and Outbreak Response Management and Analysis System to help fight the spread of diseases like Ebola. How does it work?

Page 46: INDIAN PHARMA 10X

Risk ROI Assessment for INGNX of each model

Specialist Input Program manager Consumer centric

-High specialty business INGNX can leverage the expertise in one of the core areas – Manufacturing , CMO , Custom synthesis – - Strategic Therapeutics like ONCOLOGY , HIV , Biologics , Life style diseases can be thought of

-Strategic Alliances or own integrated services based - May risks so many business integration - very high returns - Emergence of the CLOUD platform would force the organization to comply with the new mode of business …like data migration. Data safety protocols. Accessibility to data to various regulatory offices … - Drug Discovery to Delivery as a service ..model like WUXI Apptech

-Consumer sectors such as Nutrition , healthcare , animal products are going to be ultra competitive . -Marketing warfare game - Overcrowded -Requires strong marketing brand A&P … but competition may not allow to get the desired premium

Innovative & Smart Business Models in Pharma RIGHT GTM

Page 47: INDIAN PHARMA 10X

Competition benchmarking … Explore few established models

The competition benchmarking… would require

very high bandwidth …to

manage the ultra large scale

projects…competitive

differentiation, high projects

management , financial updates

- would really mean HIGH CAPACITY

PERFORMANCE PLANNING

Page 48: INDIAN PHARMA 10X

CHINA – PHARMA EMERGING OPPORTUNITY FOR INGNX …please see the APPENDIX

Key opportunities Key proposal

JVs/ Strategic Alliances SINOPHARM / NEPSTAR /MINDRAY / WUXI APPTECH

Partnership with the BIG Chinese Distribution com can provide access to the $ 180 Bn market by 2020 ( CAGR 13%) + JVs with these cos may able to create the low cost strategic advantages… WuXi AppTec Partners with Fudan University and the Collaborative Innovation Center of Genetics and Development WuXi NextCODE Wins Genomics England Clinical Interpretation Tender in Both Rare Disease and Cancer

Bring Eco system together – to create

solid advantages

INGNX can play a role of managing the CRO or advanced R&D by participating with TSINGHUA Uni + ILLUMINA + WUXI APPTECH + SABIC + SINOPHARM etc Fosun Pharma, HOPU Investments, CEL Healthcare Fund, and WuXi PharmaTech to Jointly Acquire U.S. Innovative Biotechnology Company Ambrx

M&A in china INGNX can look forward to acquire small mid size coms in specialty chemicals, CRO , Consumer healthcare – Chinese cos have severe cost advantages + credibility in international markets

Launch of e-commerce / B2B /

B2C projects

Alibaba model – INGNX can be a great influencer – like WUXI APPTECH .

Page 49: INDIAN PHARMA 10X

RIGHT PROCESSES Key process Relevance

Strategic planning process

Entry into HG HMLC strategic markets

Market Planning Process Effective GTM + Market share capture

Risk Assessment Process Avoid the BLACK SWANs , Avoidables

QPR process Ensure the strategic direction

Performance Planning & Monitoring process

No last minute surprise or unpleasant mishap or intentional failures or sabotages

Collaborative networking process

To ensure smooth redressal , no hold backs in performance ..ease of doing business and work - every body must co-own the vision of org.and feel the need for helping every person in need.

Customer centric processes Every process must kept in mind the final outcome to customer value creation .

Sharp Analytics Processes Smooth & easy flow of critical intelligence , whoever need it . Whenever need it …and strong ACTION ORIENTED INSIGHTS

Page 50: INDIAN PHARMA 10X

Marketing & Sales Excellence – Energetic, Smart, Valued reach out , Most preferred to do

business with , Ethics

Users Customization Digital MaSE Influencers High standards of

Performance Ethics Hassle free Customer club Customer loyalty

schemes Customer Net

promotion KAM/ OEM/ CRM Most preferred

business partner

Marketing Strategies

Non users - Aware Part of the Elite list Regular reach out Trade fair, sponsorships Elite membership Demonstration of superior product

performance Active FEEDBACK system

Non users - Non Aware A&P , Good media presence , Smart image Helping hand, one ZYDEX image Instant customer responsiveness

Faster, Smarter , Better ways

Superior products

Smart REACH

OUT

Preferred Partner

CoE

Page 51: INDIAN PHARMA 10X

Operational Excellence

KPI 1 What is the depth of Therapeutic areas ?

KPI 2 How many ANDAs | DMFs filed for each therapeutic areas ?

KPI 3 - Does INGNX have the widest range of PORTFOLIO like sun or Zydus ?

KPI 4 If INGNX has focused on specialty what is the market share

KPI 5 How many products of INGNX has > 50% Market share and > 50% profits ?

Ultra high performance across the key KPIs – increase the executional rigor, robust operations planning , minimize slack ,

systematic & smart processes

CoE

Page 52: INDIAN PHARMA 10X

Processes excellence KPIs CoE

Participation across the HG HM LC sectors – has INGNX participated in all these sectors ….if not why .and how it can expand

KPI 1

REACH OUT penetration - FILGRASTIM – does INGNX has 50% above penetration in all key target audience and routes for FILGRASTIM

KPI 2

INFLUENCERS role – KOL recommendation / NPS – Net promoter of advocacy score – what is the Brand recall or equity for key products

KPI 3

Inventory + Distribution + Production planning + Forecasting – does INGNX have significant advantages in these processes

KPI 4

High Quality Market Intelligence – Does INGNX has all the mission critical information available within 3 clicks away from the beneficiary?

KPI 5

Page 53: INDIAN PHARMA 10X

• Performance is not well articulated and has not been defined properly , lacks the various end points considerations ( eg – Boss says tense, employee says tenacious)

• Performance lacks PLANNING in terms of various scenarios – Plan B , Plan C , effective outcomes ( U cant touch by climbing Mt everest)

• Performance does not incentivized the “tacit extra mile efforts “ but just enslaved by the results delivery ( employees feel uncared for)

• Performance is not properly segregated, the credits and blames must be fixed rather than applied homogeneously across the units ( somebody's non performance affect the entire chain)

• Lack of quality interaction and engagement of the senior leaders in achieving the success ( Non verbal behaviours- do u go to boss who does not even say good morning)

• Lack of REAL Strategic elements – like Quality products, effective value propositions , effective energy , enthusiasm

You cant MEASURE success, unless you able to DEFINE it … and You cant DEFINE it , unless you able to DESCRIBE it …

ROBERT KAPLAN – Strategy guru This necessitates the description of the performance in real sense ..

PEOPLE Excellence CoE

Page 54: INDIAN PHARMA 10X

Case : Product journey from Factory to Market- Where is the PERFORMANCE BOTTLENECK and which are the mission critical elements

Strategy Marketing Sales Customer

Supply chain Production Process

Legal / Registration

HR Quality /

R&D

Performance Bottleneck occurs ,…if

everything else functions as per the

plan ..except this one

If the High Growth, High Margin sectors

not identified 3 years in advance

If the product has not created awareness

and product features are not digested by

customers

If the product are not made available to the

customers through channel and distribution

If the product are not produced OTIF – on

time, in full as per the Quality

If the cost effective RM/PM not procured

at right time

If the Processes ( Accounting, controls , risk mngt ) are not in

place

If the product registration is not obtained in time

If the PEOPLE are not fully committed to the

JOB

Page 55: INDIAN PHARMA 10X

WHY PEOPLE excellence is Relevant to INGNX

Business drivers Potential Problems Potential Solutions My work

Growth Opportunities

What is the right vision 10X vs 10% ( Can there be full potential realization possible) – best strategic planning

10X possible – liberate potential tools, performance definition

ETHOS, SMILE, SHINE , GEM,

Performance Delivery

Are the best efforts applied in all the process, people ? – customer calls ( half hearted / has proper feedback taken/ has proper interview taken?)

Best benchmarks Talent METABOLISM High Performance environment culture

COE , Competency attached to values

Sustainability Is the performance delivery sustainable or just short term ,..is it creating long term value for the org

Strategic horizon wise competency profiling

Smart KPIs introduced .

Required TRANSFORMATION

Page 56: INDIAN PHARMA 10X

Global Strategic canvass – WHY Transformation is MUST for INGNX

RED OCEAN PHASE OUT

BLUE OCEAN opportunities

Long range New Strategic markets – Biopharma,

API/generics , Biologics Biosimilars , animal, poultry , Household disinfectant tissue papers, hygiene, oral , vitamin, consumer healthcare line for urban customers

New Business models – online presence, digital B2C , new territories, new markets

Strategic alliances and M&A – to fill the product gaps or geographic expansion

Capacity expansion across different countries

New ways of working

TRANSFORMATION PHASE

Improved Strategic planning – vision based transformation

Improved processes and systems

Improved culture – High performance and Business focused strategic HR partnership

Page 57: INDIAN PHARMA 10X

Center of Excellence – Pathway

Performance Excellence

Leadership Excellence

Process Excellence

Information Excellence

Business Excellence

CENTER OF EXCELLENCE

Actionable , valuable intelligence , insights

,Analytics competitive information

4

Strategic Business partnership Proactive,

Compelling values

5 Talent entry into org,

best benchmarks High Performance

genomics

1

Liberating Potential Effective

engagement Strategic vision achievement

2

0% HOLD BACKS Smooth Processes Highest quality of

results delivery

3

Page 58: INDIAN PHARMA 10X

The Evolving Role of Strategic HR in creating High performance Environment

BEST STRATEGY AND

PLANNING

INTELLIGENCE TO ADVANTAGE

EXTERNAL RELATIONSHIP

LIBERATE POTENTIAL

HIGH PERFORMANCE SALES & PROFITS

Performance

Excellence

Leadership

Excellence

Process Excellence

Information Excellence

Business Excellenc

e

For High Sales and profits, Global

Competitiveness is MUST

Which requires value creation in terms of ….

Competency Framework

Which requires practical and relvant tools and processes

Competency

Competency Framework

Center of Excellence

Page 59: INDIAN PHARMA 10X

EXECUTIONAL RIGOUR A Very IMPORTANT Aspect… THE LAST MILESTONE ..if u fail

here..u fail everything

Page 60: INDIAN PHARMA 10X

HOW to PACK – The 10x into org…

Business transformation cell

Corporate Strategy Business Development

Business Leadership

Corporate Advisory & Consulting

Corporate Affairs

M&A Vision 2030 Global

expansion New entries GTM

Capital structure Market/ PE /

Existing Products /services

ECO SYSTEM Alliances Customer

acquisitions Capturing all

trends / drivers

Best benchmark Operational

Excellence

Marketing & Sales Excellence Robust Business

Planning

Mckinsey ++ advisory Highest level of

intelligence Corporate talent

management BASE CAMPING

&

CORPORATE ARBORITUM

Corporate Social responsibilities Corporate

communication Govt Relations Investor

Relations Image

management

Page 61: INDIAN PHARMA 10X

Business As Usual

Operational Excellence

Robust Business Planning

Risks Assessed High ROI

Market intelligence

Business Transformation

Attitudinal change

Create Edge Drive results to

highest standards

Overall Strategic Campaigning Avail MACRO

drivers BIG THINKING

M&A Convergence

GTM Strategic Alliances

X>2

Operations Transformations Strategic

Consultants

AJAY GOHIL

Set ambitious Targets

Best benchmark

Create Edge Can Do attitude

Passion , Energy , Enthusiasm

Drive Performance to

the highest quality , ETHICs

Liberate Potential coaching,

Developing others

Balanced Approach STRATEGY = OPERATIONS

Page 62: INDIAN PHARMA 10X

SYSTEMS Operations

Markets Supply chain

META SYSTEMS

Consumer Healthcare

$ 500 Bn Sp chemicals, AI

AGRI business $ 250 Bn

Sp chemicals, AI

Vitamins, Nutrition, Animal Feed, healthcare

$ 250 Bn

API / HPAI $ 150 Bn

Biologics/ Biosimilars/

rDNA $ 150 Bn

Cell culture MCC

$ 35 Bn

Formulation Specialty

Injectables

Formulation Oral , Control

release

CPFaR /OE / TQM/6

sigma/ QC

ECO SYSTEMS INGNX requires translating the bigger

mega trends of meta systems ( ie entry into HGHM markets) ….

INGNX can have strategic joint venture with SABIC , BASF , DOW to offer highest value propositions

INGNX can avail the best processes , technologies .. Quicken the entries into HGHM markets

ALL THESE REQUIRES HIGH BAND WIDTH PLAYER

HGHM requires HIGH BANDWIDTH PLAYER

with SNAPDRAGON processors … NOT JUST DO

AS DIRECTED.. “ MANUFACTURING ONLY

GUY “

Page 63: INDIAN PHARMA 10X

SUMMARY – The REAL BULLET POINTS INGNX needs people Who

Have Ultra High bandwidth ..not just OPERATIONAL King

Can see the COMET coming light years away

Have ability to identify the HIGH PERFORMANCE GENE

Page 64: INDIAN PHARMA 10X

SECTION 2

Page 65: INDIAN PHARMA 10X

APPENDIX… Now this is not just for FUN …

Please GO through it to know why whatever is written earlier is

relevant

Page 66: INDIAN PHARMA 10X

INGNX can look forward to incorporate..in strategic planning

Pharma-emerging Opportunities

China pharma

Biologics global business dynamics

M&A global dynamics

Key Emerging areas across each Pharma / Bio tech Line of business and therapeutics

Page 67: INDIAN PHARMA 10X

Why GENERIX needs FASTER ,SMARTER, BETTER assets

READING BETWEEN THE LINE…. Something is WRONG

Page 68: INDIAN PHARMA 10X

Biologics Growing demand for biologics The imperative to find cost-effective alternatives to biologics reflects the growing demand for these specialty drugs. Since their origins in the 1980s, biologics have prospered into a US$150 billion market (2014), fuelled by such key launches as recombinant insulins, human growth hormone (HGH), alteplase, erythropoietin's (EPOs),granulocyte colony stimulating factors (G-CSFs) and then monoclonal antibodies (MAbs), among others. Currently accounting for 16% of global pharmaceutical expenditure and significantly outpacing total branded sales, biologics will continue to out-perform the global market as more

Page 69: INDIAN PHARMA 10X

Biosimilars – the paradigm shift in generics

Innovative products deliver new treatment options for a growing range of indications. Patent expiries driving new potential number of top-selling biologic brands, including Herceptin, Enbrel, Humalog, MabThera, Remicade and Aranesp, are due to lose product patent protection over the next five years, opening up a wealth of new possibilities for biosimilars players.

Key therapy areas such as cancer, diabetes and rheumatoid arthritis (RA) will spearhead this new wave of biosimilars, with attention focused on the real prizes of anti-TNF MAbs, MAbs for oncology, and insulins Diverse competitive landscape A diversified competitive arena for biosimilars is already emerging, with generics manufacturers, R&D-based pharma, and biotech companies

Page 70: INDIAN PHARMA 10X
Page 71: INDIAN PHARMA 10X

Biosimilars How fast they can be part of the mainstream uptake ..

Page 72: INDIAN PHARMA 10X

Biosimilar snapshot

Page 73: INDIAN PHARMA 10X

Now Lets us look at the BIG therapeutic category …where GENERIX stands ?

Oncology 2014 : 75 Bn$

2018 : 108 Bn$

Brand Molecule Company Class 2018 sales Mylan MS%

Avastin Bevacizumab Roche Anti VEGF Mab 7.5 Bn$

Revlimid Lenalidomide Celgene Immuno modulator 6.7 Bn$

Rituxan Rituximab Roche+BI Amti CD 20 Mab 6.3 Bn$

Herceptin Trastuzumab Roceh Anti HER2 Erb2 mab 5.3 Bn$

Brand Molecule Company Class 2018 sales Mylan MS%

Januvia Sitagliptin Merck DPP I 9.7 Bn$

Lantus Insulin Sanofi Insulin 5.9 Bn$

Novo Rapid Insulin Aspart NOVO Nordisk Insulin 4.9 Bn$

Victoza Liraglutide Novo nordisk GLP 1 3.6 Bn$

Anti Diabetic 2014 : 45 Bn$ 2018 : 65 Bn$

Anti Rheumatic

2014 : 40 Bn$ 2018 :50Bn$

Brand Molecule Company Class 2018 sales Mylan MS%

Humira Adalimumab Abbott / EL Anti TNF a mab 8.1 Bn$

Enbrel Etanercept Amgeni TNF a inhibitor 7.1 Bn$

Remicade Infliximab J&J Anti TNF a mab 4.9 Bn$ Is GENERIX in position to capture 30-40% market share in the off patent categories from 2014 – 2020 : Total size $ 200 Bn

What role Strategic Planner can play?

Page 74: INDIAN PHARMA 10X

Off patent is necessary condition – but not sufficient for GENERIX , again the question is what is the MS% of GENERIX

Trilipix (fenofibric acid) Cholesterol/Triglycerides AbbVie Global Sales 2012: $1.098 billion U.S. Sales 2012: $1.098 billion Expiration Date: January 2014, but generics launched July 2013

Evista (raloxifene HCI) Osteoporosis, breast cancer prevention Eli Lilly Global Sales 2012: $1.01 billion U.S. Sales 2012: $699 million Expiration Date: March 2014

Renagel/Renvela (sevelamer hydrochloride and sevelamer carbonate) Chronic Kidney Disease Sanofi Global Sales 2012: $861 million U.S. Sales 2012: $595 million Expiration Date: September 2014, March 2014 generic launch under license

Restasis (cyclosporine ophthalmic emulsion) Chronic dry eye Allergan Global Sales 2012: $792 million U.S. Sales 2012: Not reported, but ex-U.S. sales are "modest," company says Expiration Date: May 2014

Nasonex (mometasone furoate monohydrate) Respiratory Allergies Merck Global Sales 2012: $1.268 billion U.S. Sales 2012: $597 million Expiration Date: January 2014 (pediatric exclusivity)

Exforge/Exforge HCT (amlodipine/valsartan) Hypertension Novartis Global Sales 2012: $1.352 billion U.S. Sales 2012: $358 million Expiration Date: October 2014

Sandostatin LAR (octreotide acetate) Cancer Novartis Global Sales 2012: $1.512 billion U.S. Sales 2012: $649 million Expiration Date: June 2014

Micardis/Micardis HCT (telmisartan) Hypertension Boehringer Ingelheim Global Sales 2012: $2.217 billion U.S. Sales 2012: (not reported) Expiration Date: January 2014

Nexium (esomeprazole magnesium) Heartburn, Gastroesophageal Reflux Disease (GERD) AstraZeneca Global Sales 2012: $3.994 billion U.S. Sales 2012: $2,272 billion Expiration Date: May 2014

Copaxone (glatiramer acetate) Multiple Sclerosis Teva Pharmaceutical Industries Global Sales 2012: $3.996 billion U.S. Sales 2012: $2.9 billion Expiration Date: May 2014

What is the MS% of GENERIXC across the off patent

molecules in last 5 years - IS NOT IT a STRATEGIC

PLANNING ROLE.. Now this is where the META SYSTEMIC SYNERGIES of information

comes into play

Page 75: INDIAN PHARMA 10X

Financial leverages are stressful… requires very high level of strategic planning… it is not the work of JUST DO AS DIRECTED manufacturing guy

21.2

15.19

24.74

39.98

43.98

62.14

23.3

29.79

22.12

11.53

6.37

-8.66

9.07

-14.97

5.06

-0.62

45.8

36.87

27.58

29.12

26.89

51.28

24.11

10.59

Pfizer Inc.

Sanofi SA (ADR)

Teva Pharmaceutic...

Actavis PLC

Mylan Inc

Valeant Pharmaceu...

Perrigo Company PLC

Hospira, Inc.

EBITD margin

Net profit margin

Total debt to assets

The financial stress would mean the APIs and manufacturing would require to bear the brunt of cost cutting ..this would mean MYLAN like cos. With too much risk of generics …need high QUALITY strategic planning

Page 76: INDIAN PHARMA 10X

SNAPSHOT OF

PHARM-EMERGING MARKETS

CHINA centric strategy …a

great opportunity for INGNX ..

INGNX must grab with both hands..

Page 77: INDIAN PHARMA 10X

INGNX also can look up to CHINA – China Pharma Snapshot

Page 78: INDIAN PHARMA 10X

INGNX also can look up to CHINA – China Pharma Snapshot

2nd China’s Rank in Global Rx pharma market

120 China Rx Pharma Market size in Bn $ - 20% biologics + 80%

generics

400 $ Bn to be spent by CHINESE

Private and Govt on healthcare between 2015 – 2020

5 Chinese Total M&As – Inbound + Outbound

Page 79: INDIAN PHARMA 10X

CHINA – A constantly emerging landscape ..capable to change the game

The M&A has remained one of the strong activities amongst the 7 “strategic emerging industries “- SEI ( Pharma is one of the 7s) for china

Big Pharmas like SHANGHAI pharma , Sinopharma , Harbin – the front runner in M&A deals – have significant investments in pharma R&D

Major Inbound M&A deals – such as

SCICLONE – NOVAMED , GSK – Nanjing Mei Rei Hologic – TCT Medical products Biosensor – 50% of JW Med from shandong Weigao Novartis - 85% of Zhejiang Tianjin Biopharma Wuxi – Apptech have been the key M&A deals implying strong trend in consolidation, new capacity acquisition, R&D driven deals …

Page 80: INDIAN PHARMA 10X

China is very much into the game …

• All key emerging areas – RARE DISEASE , Orphan drugs developments, HIV /HCV/HPV , Immuno-ONCOGENES , CAR –T , TCR , Check point entry antigen binding, VIRUS LIKE PARTICLE , Gene identification for the disease , RNA intervention CRISPR etc…china is catching up much faster ..

• WUXI APPTECH , SINOPHARM , CRSG are the groups to watch out for …

• The global dynamics are changing fast..the trends are strongly in favour of BIOTECHNOLOGY and ADVANCED GENETICS …and the cell science..

Page 81: INDIAN PHARMA 10X

Different Emerging Pharma models for value creation

cell therapy manufacturing 45,000 square-foot facility under construction in Philadelphia Collaborations on breakthrough technologies and

products such as CAR-T and cancer immunotherapy's

Page 82: INDIAN PHARMA 10X

How Wuxi Apptech is taking the pharma world head on

.offers the compelling COLLOBORATION need.

Page 83: INDIAN PHARMA 10X

Chemistry & Discovery includes Synthetic Chemistry, Medicinal Chemistry, Radio Chemistry, Peptide Synthesis, and others.

Laboratory Testing includes Core Analytical Services, Biology, DMPK/ADME, Bioanalytical Services, Core Analytical Development, Toxicology, and Genomics.

Biologics includes Biologics Discovery, Development, and Manufacturing.

Small-Molecule Manufacturing includes Small-Molecule Manufacturing and Formulation. • Other includes Clinical Site Management Services and Biologic Reagents.

Innovative Business Model – Participating Across the value chain , across the globe

2015 HIGHLIGHT NextCODE Health Acquisition WuXi acquired NextCODE Health for $65 million • A leading genomics and bioinformatics company • Operations in Cambridge, Massachusetts, and Reykjavik, Iceland Gene sequencing and genetic-based diagnostics are advancing rapidly The next major challenge: speed and effectiveness of medical analysis and interpretation NextCODE provides the leading gene sequence analysis platform and the most efficient database architecture Platform provides the ability to store, visualize, and analyze genetic data at base-by-base resolution, in real time, from any browser NextCODE Exchange facilitates collaboration among clinicians and researchers INGNX can significantly acquire

competitive advantages being part of the large pharma mission

Page 84: INDIAN PHARMA 10X

If Wuxi a simple Chinese $ 800 Mn company can does ..so much so much..why cant INGNX …. This is called Strategic vision

Expansion of the Suzhou toxicology facility is underway, adding 49 animal rooms to the current 71 by the end of 2Q15 Ten Illumina HiSeq X sequencing machines are operational Collaborating with Foundation Medicine to bring best-in-class genomic testing to China to support clinical R&D and development of targeted therapies Launched Boshi360, the first online professional platform in China dedicated to rare diseases Acquired XenoBiotic Laboratories at end of third quarter

$ 38 MM …the Acquisition

made …and its well on its way to make 10x..

Page 85: INDIAN PHARMA 10X

Assessment and Identification of

HGHMLC strategic sectors

Page 86: INDIAN PHARMA 10X

The shifts in Pharma markets Generics / Off patent Rx drugs

Consumer Healthcare / Nutrition

Biosimilars / Biologics / Estb Mabs / CGV products

Generics Off patent Chemical molecules DMFs Easy to copy Less Process sensitive

The competitive landscape is getting over crowded Entry by GENERICS ( sun / zydus cadila/ Sandoz / teva/ mylan ) + entry by biotech ( skincare /peptides) – this guys need to be more vigilant…the entry of SOPHISTICATED PHARMA may make life miserable for Simple Consumer Marketers ..Product registration ( J&J /Unilever) – Oral care

High performance / HQHP processes, requires great preparation , BLA not yet defined High entry

barriers…Rich dividends $ 200 Bn market by 2020

Biosimilars Biologics Advanced Rare diseases Advanced Genetics , Proteins & peptides , Custom synthesis , Vitamins , Consumer healthcare, cosmetics , personal care Consumer Pharma / Biotech – skin care , SPF , collagen fibroblast builder , muscle builder , health drinks , energy drinks , nutrition The consumer

Healthcare / Nutrition advantage is with NESTLE , DANONE , MEAD JOHNSON ,ABBOTT ..can quick

Page 87: INDIAN PHARMA 10X

Key Latest developments

M&A IPO PE Innovative Cos

GSK – Glycovaxyn Voyager – Genzyme Valeant – Dendreon Acadia – CRC Shire – Salix

SteadMED Bivarus Cidara INVITAE NEXVET

Aptalis - TPG VAXXAS PRACTO Digisight Imagine health WaVe LS Lysosomal Thera AuraSense – spherical NA – gene regulation Orig3n – Pluripotent Stem cell storage

Example only – there are so many PHARMA / BIO TECH opportunities which can be kept in mind …to incorporate into

strategic planning

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Key Pharma M&As take away

RAISING THE BAR ON PERFORMANCE… Activist investors use shareholder arbitrage to force companies to “get lean.” Partnering and licensing opportunities are increasingly selective, with less margin

for error. One-time market authorization yields to periodic reevaluation through the product

life cycle. Relentless compliance scrutiny, expanding globally beyond illegal US off-label

marketing toward multibillion $ penalties for foreign corrupt practices. Pressure on industry to respond to a more diverse customer base, with multiple

engagement points beyond the physician. Operational challenges in high-potential emerging country markets: how to turn

strong revenues into sustainable profits? A bump up in patent expirations for big selling drugs in 2015, although the worst of

the “patent cliff” is over. China growth engine slows – GDP 14.2% in 2007 vs. 7.5% this year – while public

debt burden rises amidst more bias toward foreign multinationals. Greater pricing pressures in Europe amid generalized budget austerity. Pricing’s bottom line: future global profits depend on maintaining price freedom in

the US.

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Key Pharma M&As take away

RAISING THE BAR ON PERFORMANCE… Growing complexity in clinical trial requirements, including big

Phase IV population studies extending beyond the patent term.

New competitive threats from generics, CROs and adjacent industries – Google, Nestle – outside health care.

Crowding in key therapeutic categories - “counter launch” campaigns hype the marketing bill.

Social media’s disruptive effect on the patient/physician relationship and the accuracy of clinical trials – an alternative, open source information stream.

Formal patient group engagement in drug development, regulatory approval, market access.

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What BIG PHARMAs up to ?

• INVESTMENT DYNAMICS NO LONGER FAVOR ORGANIC GROWTH

• Big Pharma is cash rich and asset poor.

• Productivity crisis in in-house R&D: is the model broken?

• High drug candidate failure rate, especially in costly Phase III studies.

• 60 billion+ R&D spend in 2013 for 29 FDA approved drugs, mostly for small-population biologics. •

• M&A activity is reaching all-time high, with 2014 deal volume to date at more than $250 billion.

• Big Pharma’s in-house corporate venture funds are back and in a buying mood.

• Smaller biotechs with unique, clinically differentiated assets are driving innovation.

• Big Pharma puts its stable of older off-patent medicines on the block for potential buyers outside the industry.

• Collectively, the changes promise a more diverse industry, particularly with the entry of buyers from adjacent sectors – adding many potential new customers for the B2B advertising vertical.

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Pharmemerging markets India aims to introduce universal health coverage during the 12th five year plan (2012-2017), but the public health system faces massive problems with inadequate infrastructure, poor funding and inefficiency − Public health experts have recommended that the government move from 'insuring' to 'assuring' health by investing in primary care

Brazil −Plans for expansion and improvement of the public health infrastructure and more widespread provision of subsidised medicines −National List of Essential Drugs and Popular Pharmacy Programme increased the number of drugs covered under the scheme and will see further improvements over the next years

Vietnam −Plans to increase universal health insurance coverage to 75-80% population by 2015; 90% by 2020 −National Target Program for Health 2015 −Programme includes diabetes focus, increasing early diabetes detection by providing screening programmes and a nation-wide disease treatment network by 2015

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Key HGHMLC strategic market sectors

Cardiovascular & Metabolic Diseases

Immuno-Oncology Immunoscience Inflammation &

Remodeling Neuroscience Oncology Pain & Sensory

Disorders Rare Disease Vaccines.

Biotechnology Platforms Biologics Product & Process

Development Biotherapeutics Discovery Clinical Innovation Drug Safety Pharmacokinetics, Dynamics &

Metabolism Precision Medicine Small Molecule Product &

Process Development Small Molecule Therapeutics

Discovery.

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Key Developments Big pharmas not too shy on spending big dollars TAX savings - Redomiciling $ 385 BN deals in Life science sector Big Pharma Portfolio rationalization

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Off patent molecules – have average performance

BLAs are not clearly defined

Peptides / proteins /Small molecules – emerging sector

HIGH GROWTH HIGH MARGIN opportunities – Immuno-oncology , precision medicines , gene pills, formulation tech

OTC/CH/ AN – emerging markets

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• ƒVaccines for the prevention and/or treatment of infectious diseases

• ƒ Vaccines for the prevention and/or treatment

• of non-infectious diseases through the

• active elicitation of disease-modifying immune responses Adjuvant

• ƒNovel in vitro systems for assessment of vaccine immunogenicity

• ƒ Novel animal models for assessment of vaccine effectiveness

• ƒ Novel immunomodulators of the adaptive immune response

• Novel vaccine target antigen

• identification systems

• ƒ Novel vaccine delivery platforms

• ƒNovel vaccine administration systems

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Licensing & JVs

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ITS ALL BIOTECH High Number of deals in

Biotechnology – driven by genomics , Antibody –Protein interaction

Advanced Protein delivery technology

Precision Antigen binding

Mab+Mab | Mab+ Small molecules – Immuno-onclogy

RNA intervention , CRISPER , PTGS , siRNA

Next gen-sequencing

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Potential Licensing Deals strategic areas

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Cardiovascular &Metabolic Diseases • ƒ CVD (Acute Coronary Syndrome, heart

failure,

• peripheral arterial disease and atherosclerosis)

• ƒ Diabetes and related co-morbidities

• ƒ Obesity and related co-morbidities

• ƒ Renal diseases and related co-morbidities

• ƒ Prevention of cardiac remodeling

• ƒ Prevention of MACE via anti-inflammatory

• pathways

• ƒ Improvement in cardiac performance via

• protection or repair or improved vascular function

• ƒ Solute transporters and their role in metabolic

• and renal diseases

• ƒ Kidney podocyte architecture

• ƒ Insulin sensitization

Beta-cell function and survival in obesity and Diabetes ƒDysregulation of alpha-cell function ƒMetabolic adaptations to exercise which protect against or reverse diabetes Mechanisms which protect mitochondria under conditions of chronic caloric excess ƒGut and brain signals that regulate energy homeostasis and metabolism ƒThe role of sleep and circadian rhythm in regulating endocrine function and metabolism ƒCentrally-acting anorectics ƒBariatric surgery mimetics ƒModulators of beige and brown fat metabolism ƒLipid content and the development of liver fibrosis in patients with NASH / NAFLD ƒDysregulation of liver metabolism

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Immuno-Oncology – Key Potential Licensing deals areas

Novel Targets for Overcoming Tumor induced Immune Resistance

Targets that promote immune response

Targets that provide Innate immune support

Targets that reduce immune suppression

ƒPlatform Technologies

Mechanisms, biomarkers, and screening approaches to identify and accelerate the most promising combination therapies

New modalities to induce immune responses:

Bi-specific mAbs, nanoparticles, oncolytic

viruses, tumor vaccines For Identification of new immunemodulating targets

Robust monitoring of anti-tumor

immune responses

Monitoring of immune-supporting andimmune-suppressing biomarkers in the tumor o Novel animal models that accurately recapitulate human tumor-immune system interactions

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Immuno science ƒ Rheumatoid Arthritis ƒ Systemic Lupus Erythematosus ƒ Inflammatory GI disorders (i.e., Inflammatory Bowel Disease) ƒ Psoriasis ƒ Multiple Sclerosis

ƒ Other indications with high unmet need that are mechanistically related to those above Specific areas of interest include: ƒ Cytokines and their signaling pathways ƒ Adaptive Immunity, Lymphocyte biology including Th17 lymphocytes ƒ Regulatory cells and Tolerance induction ƒ Host-microbial interactions and micro biome

Technology platforms and products to

help understand patient segmentation in the disease

areas of interest and develop precision medicine strategies for innovative portfolio products ƒTechnology platforms and products that allow for greater tissue and cell specific delivery

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Inflammation & Remodeling

ƒ Diabetic nephropathy ƒ IgA nephropathy, Lupus nephritis and membranous nephropathy ƒAutosomal dominant polycystic kidney disease ƒ Acute kidney injury (prevention and treatment) ƒ COPD ƒ Severe asthma ƒ Pulmonary hypertension and Idiopathic Pulmonary Fibrosis ƒ Other pulmonary, liver and skin fibrotic diseases

ƒ Innate immune suppressors ƒ Oxidative stress modulators ƒ Anti-fibrotics ƒ

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Neuroscience Biomarkers for ƒ Alzheimer's Disease (AD) ƒ Parkinson's Disease (PD) ƒ Huntington's Disease ƒ Vascular Dementia (Cerebelar Amyloid Angiopathy) ƒ Multiple Sclerosis (MS) ƒ Cerebrovascular disease ƒ Hearing Loss ƒ Schizophrenia: positive, negative and cognitive deficits ƒ Bipolar Disorder ƒ Adjunctive treatment of Depression ƒ Addiction (opiate and alcohol) ƒ Autism spectrum disorders

Key Development Areas : Neurodegeneration / Neurological Disease: ƒNovel symptomatic agents for AD or PD (could include L-DOPA-induced dyskinesias) ƒ Agents affecting micro vascular circulation and brain metabolism with validated link to AD ƒImaging agents (e.g., tau, synuclein neurotransmitters, neuroinflammation and gliosis) ƒTranslational biomarkers – preclinical to clinical ƒBiological samples ( induced pluripotent stem cells) from well defined AD or PD patient populations ƒ Agents impacting neuroinflammation ƒConformational antibody that has cross reactivity to all “amyloids” (e.g., tau, Aß, huntingtin, δ-synuclein) ƒ Novel delivery of growth factors and other biotherapeutics (e.g., viral delivery or implanted device)

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Pain & Sensory Disorders Chronic pain

Neuropathic pain

Nociceptive pain

ƒ Acute pain

Perisurgical pain management, prevention of chronic post-operative pain

ƒEpigenetic pathways

ƒ Sensory disorders Disorders involving abnormal sensations of clinical relevance (e.g., visual, auditory, vestibular, somatosensory systems) ƒ Ion channels, notably targets where there is strong human genetic evidence for a role in pain or in mechanistically-related sensory disorders (e.g., epilepsy, channelopathies) ƒ Novel targets on pathways with known relevance to pain (e.g., neurotrophins) Highly differentiated opiates with fewer side effects, including novel abuse-resistant formulations and approaches to address over-consumption ƒ Nociceptor-specific drug delivery ƒTechnology platforms and products to help understand and segment patients in pain and develop Precision Medicine strategies innovative portfolio ƒ Novel approaches to demonstrate cross-species target engagement of an ion channel-excluding fMRI, microneuography, threshold tracking, capsaicin / cinnmaldehyde flare, UVB, etc.

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Rare Disease • ƒHematology (non-

malignant) • Hemophilia • Coagulation factors

with extended duration of activity and/or improved delivery

• Oral agents to treat hemophilia

• Immune tolerance • Novel approaches

(including gene therapy)to treat hemophilia patients

Other rare hematologic (non-malignant)

Indications Sickle cell anemia, & beta-Thalassemia Hemostasis (systemic and topical) ƒ

Neuromuscular Diseases Duchenne / Becker muscular dystrophy and other muscular dystrophies, disease modifying therapies Spinal Muscular Atrophy Friedreich’s ataxia: Upregulate frataxiexpression, inhibition of degradation or frataxin pathway bypass Amyotrophic lateral sclerosis: Proteinmisfolding approaches FABRY – LYSOZOMAL SUBSTRATE DISEASE – LSD / can think of M&A

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Biologics Product & Process Development

KEY EMERGING AREAS • ƒNext generation of microbial

and mammalian cell protein production systems

• ƒ Next generation process and manufacturing technologies

• ƒSystems and Synthetic Biology

• Technologies to design and influence host cell performance and product quality

• Novel expression systems with alternative post-translational modifications(e.g., glycosylation)

• Automated methods for mammalian cell line for biotherapeutics

Tissue specific delivery ƒ Alternative routes of delivery (transdermal, transmucosal) ƒAnalytics (biophysics) to predict stability ƒ Advanced formulations (improved stability, high dose delivery)

screening, selection and scale up Next generation cell culture process technologies Next generation purification process technologies – Harvesting technologies (e.g., smart polymer, automation)

High throughput analytics for product quality attributes

Advanced analytics for glycoconjugates and antibody drug conjugates Flexible and adaptive manufacturing technologies

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Biotherapeutics Discovery Transformational technologies to design, construct, and optimize biotherapeutics o Informed protein design optimizes molecular properties resulting in superior efficacy, pharmacokinetics, pharmacodynamics, safety, manufacturability and differentions ƒ

Antibody drug conjugate technologies

Novel ADC platforms, novel payloads, linkers, conjugation sites Bioconjugation technologies Combinatorial biologics such as bi-specific and multi-functional platforms with promising biophysical and manufacturing properties ƒ Structure-based and computational design of Therapeutics Novel technologies to rationally design antibody, protein and peptide therapeutics that display superior pharmaceutical properties (including selectivity, half-life extension, stability, formulatability) ƒ Technologies that enhance multi-transmembrane protein target expression / presentation for antibody generation and screening

Technologies and patient sample access for

antibody discovery from human

antibody responses Targeted delivery technologies that address /overcome cell membrane penetration, cross blood brain barrier ƒ Technologies that can significantly enhance general protein expression, purification, stability for discovery ƒ Integrated service providers to support early discovery activities for development of therapeutics Broadly applicable platforms to enhance speed / quality of antibody generation Novel biologics, combination

therapies, an "biobetters"

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Clinical Innovation

ƒPatient Engagement – Raising awareness

and supporting patient recruitment & retention for clinical trials, enhancing patient participation, improving generation of patient insights into study design, sharing data & information with trial participants

Real World Data – Leveraging diverse data sources and analytics tools to enhance study design and protocol optimization, capture clinical trial data more efficiently

Mobile & Digital Tools – Supporting the

informed and engaged patient during studies, improving study access and convenience, and enabling robust data capture whether reported

by the patient or leveraging novel sensors

ƒBiospecimen Management –

Enabling robust acquisition, innovative consent approaches, and advanced tracking and storage capabilities to enable ready access to human clinical specimens

to advance both traditional and precision medicine R&D ƒ

Innovative Partnerships –

Partnerships spanning other biopharma companies, others in healthcare, technology partners and beyond to stimulate new approaches to rapidly understanding the efficacy and safety of medicines in development

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Drug Safety – Key emerging areas • Mechanisms,

biomarkers, and screening

• approaches related to target organ toxicity

• Cardiovascular safety

• Liver injury

• Hypersensitivity

• Nephrotoxicity – esp., glomerular

• Skeletal and cardiac muscle toxicity Ocular safety

• Screening for abuse potential

Bio therapeutics-related analytical technologies Immunogenicity and other safety-relevant assays Deeper knowledge of targets and pathways

Knock-in, knock-out technologies Novel technologies and increased throughput for target localization studies Safety biomarker technologies Platforms

multiplex; analytical approaches; validated reagents

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Pharmacokinetics, Dynamics & Metabolism (PKDM)

Translational research o Translational modeling

and simulation approaches, systems pharmacology / PK-PD, integrated with quantitative biomeasures; deepen knowledge of targets and pathways;

Systems models of specific areas of toxicity, e.g., cardiovascular toxicity and application of PKPD to safety biomarker technologies to increase confidence in safety

Understand and de-risk the influence of hepatic and renal uptake and clearance on

toxicology in these organs – focus on disorders of bile production and bile acid transport ƒ

Quantitative Bioanalytics, Biomarkers, Biomeasures, and Immunogenicity (ADA) Assays – large and small molecule efforts Novel LC-MS/MS large molecule bioanalysis and automation techniques

Flow cytometry, cellular imaging techniques (Amnis) for biomarkers and biomeasures , and

highly multiparametric single cell analysis using mass cytometry (CyTOF) Development of a universal platform for Cell-based neutralizing antibody assays Biosimilars / Biocomparability: identification of critical attributes influencing PK and disposition Key vendor development for biotherapeutics bioanalytical capabilities PLATFORMS - mass spectrometry-based,ligand-binding assays, flow cytometry) cross various modalities, Quantitative biomarker capabilities in support of biomarker/ biome sure studies, •Regulated toxicology and clinical sample analyses • Next-generation of advanced intelligent •high-throughput automation platforms •for bioanalysis

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Precision Medicine

ƒPatient cohorts with high quality longitudinal molecular and phenotypic data and/or DNA and appropriately-consented, IRB-approved tissue samples o clinical trials o data mining o biomarker studies o genetic and pharmaco-genomic studies ƒ Systems Biology/Pharmacology o Databases with high quality treatment and disease outcomes associated with genetic, as well as molecular (metabolomic, proteomic, transcriptomic, epigenetic, clinical chemistry markers) or functional measures in particular imaging data

o Databases of searchable eQTLs, pQTLs across tissues o Disease biology guided combination therapy design platforms o Systems biology approaches and proven in silico tools to evaluate pharmacological perturbation and elucidate mechanisms of in vivo toxicity

o Mining of data for correlation and understanding of causality ƒ Breakthrough diagnostic technologies that also are highly quantitative, require minimal specimen/ tissue, offer quick turnaround time and can be multiplexed. This will include but not limited to: o Near-patient Point-of-Care technologies o Next Generation Sequencing technologies o Circulating cells o Circulating and urinary cell-free nucleic acids o Antigen receptor sequencing o Microbiome, including virome characterization ƒ In vivo imaging technologies (including MRI, PET, CT, optical imaging technologies, imaging agents, genetically encoded tags,

Imaging agents for small and large molecule compound distribution studies o Imaging agents monitoring physiology mechanisms and disease o Analytical tools and technologies ƒ Biospecimen Analysis o Circulating tumor cell and Nucleic Acid quantification and analysis o Multiplexed flow cytometry for leukocyte analysis o Automated IHC for tissue analysis (cancer, safety) o Advanced ADME – related genotyping o 3D cell models for safety and efficacy assessment that ideally incorporate genetic diversity ƒ Physiological Biomarkers o Technologies adding precision to pain management and treatment in pre-clinical and clinical studies o EEG-based biomarker for assessment of central pharmacology ƒ iPS cell resources and technologies to generate iPS cells that may be used to enable Precision Medicine strategies o Validated cell differentiation protocols o iPS cells derived from sub populations with specific genotypic / phenotypic data

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Cell therapies Imaging agents for small and large molecule compound distribution studies Imaging agents monitoring physiology mechanisms and disease Analytical tools and technologies Biospecimen Analysis Circulating tumor cell and Nucleic Acid quantification and analysis Multiplexed flow cytometry for leukocyte analysis Automated IHC for tissue analysis (cancer, safety) Advanced ADME – related genotyping 3D cell models for safety and efficacy assessment that ideally incorporate genetic

diversity Physiological Biomarkers Technologies adding precision to pain management and treatment in pre-clinical and

clinical studies EEG-based biomarker for assessment of central pharmacology ƒ iPS cell resources and technologies to generate iPS cells that may be used to enable

Precision Medicine strategies Validated cell differentiation protocols iPS cells derived from sub populations with specific genotypic / phenotypic data Technology to create iPS cells in a rapid and reproducible fashion without

insertional approaches