harsh bal - mdi gurgaon invited seminar - 17 dec 2012

www.promedgroup.com

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Challenging Healthcare Barriers Globally

Growing Successful Companies – A Pharma PerspectiveHarshawardhan (Harsh) Bal, M.Pharm., PhD

SVP - Business Development & Strategy

Promed Group

17th Dec 2012

Management Development Institute (MDI), Gurgaon

1

Agenda

• Brief intro

• Enterprise maturation & evolution – A Pharma perspective

• Promed Group

• Business overview

• Mission and vision

• Product categories

• Differentiated strategy to build a global pharma co

• Global strategy - US entry

• Growth strategy - Russia & India

• Corporate Social Responsibility

• Value proposition & summary

• Contact info

• Q&A

www.promedgroup.com 2

Brief bioFrom science to the business of science

About me• M.Pharm. in Pharm Tech, Dept of Pharmacy, Nagpur U• Work-ex (NPIL, USV, Mumbai; formulation R&D)• PhD. Molecular Biology (National Inst. of Immunology/JNU)

• Targeted therapies for cancer using Ab-toxin conjugates• Post-doctoral fellowship

• Univ of Rochester Medical Center, NY (Gene therapy)• Cold Spring Harbor Lab, NY (Genomics & Bioinformatics)

• Dana-Farber/Harvard Cancer Center, Boston – Signalingpathways + target discovery in HIV/AIDS & HTLV/Leukemia

• OSI Pharma (now Astellas Pharma), NY - Novel protein family target discovery based on human genome sequencing

• Millennium Pharma (Takeda Oncology), Cambridge, MA• KM (managing org. memory on proprietary genes, drugs)

• Booz & Co. (NY & Rockville, MD) – Strategy + mge consulting• Pharma/Biotech + federal consulting (BMS, NIH, USFDA)

• Avendus; MAPE Advisory, Mumbai – I-banking (M&A, PE)• Stem Cell Capital, US - Cross-border i-banking; BD+consulting• Piramal Healthcare, US – Head of Global API business• Promed Group, Gurgaon – Head of Global BD & strategy


To do• Know what you want early• Build industry connections• Network aggressively (LinkedIn,

local events, etc.)• Research industry trends• Invest in companies • ...

Review questions• What are your near/LT goals?• What are your core

competencies? • What is your ideal company?• What is your ideal role?• Do you want to gain experience

first or be an entrepreneur?• …

Cross-cutting skills, cross-domain experience

Drug discovery R&D

Strategy consulting I-banking

BD&L (Corp Dev.)

Entrepreneur/VC?

Enterprise maturation & evolution curve


Single therapy focus- Specialty pharma cos- Core expertise- E.g., Promed

Multiple therapy focus- Full product portfolio- Diversification - E.g., Piramal

To do• Identify industries of interest to

you – Pharma, IT, infra, ...• Research start-ups, growth

phase & mature cos• Trace their growth and

evolution over last 5-10 yrs• Identify incremental and

disruptive trends/innovations• Correlate stock trends with

events wherever possible

Review questions• What were their growth

strategies?• What were the trends/

innovations that shaped their evolution?

• How did they differentiate?• Are they competitive today?• What should they do in next 5

and 10 yrs?

Global diversified fully integrated enterprise

5

• Ophthalmology focused specialty pharmaceutical company established in 1990 and headquartered in Gurgaon

• Fully integrated pharma co with full formulation R&D, manufacturing and marketing capabilities

• Global presence with established footprint –• Russia, Kazakhstan, Ukraine and India• #2 position in the ethical ophthalmology segment after Alcon• Four brands amongst top 15 ophthalmic brands in Russia• Deep market penetration and directly cover ~100 biggest cities in Russia• Provis India (wholly owned sub) fastest growing ophtha co in India• Strong presence in >45 cities and expanding in South and West India• Strong focus and developing business in US, EU and Australia

• Develops, manufactures and markets a wide range of products –• Ophthalmic, respiratory, otic, and wound care solutions

• Regulatory approvals from EU-GMP, TGA-Aus; USFDA audit expected Q12013

• Current revenues at USD 45 Mn and growing at ~20-25% yoy

About Promed

www.promedgroup.com

Corporate goals

• To be recognized as a research-basedglobal company offering a completerange of ophthalmology and ENTproducts

VisionVision

• To provide innovative products throughpersistent research and development

• To become a leading pharma companyknown for manufacturing 'difficult tomake' products by continuallyintroducing advanced technologies

• To create mutually exciting strategicalliances and opportunities for ourstakeholders

• To become a preferred employer in thepharma sector

MissionMission

www.promedgroup.com6

Promed Business Overview

Generic & differentiated products

Promed Group

Provis (India)Russia & CIS

Regulated Markets

(US/CAN, UK/EU)

Contract manufacturing (Nalagarh, HP)

CMO Services

Promed Research Centre, Gurgaon

Promed Research Centre, Gurgaon

www.promedgroup.com7

Product Categories

Ophthalmic Formulations- Multi dose solutions & suspensions

- Specialized capabilities (preservative free UDs)

Respiratory Care (for nebulization)- Inhalation solutions

- Inhalation suspensions

Wound Care- Sodium chloride irrigation solution

ENT Care- Nasal drops

- Ear drops


Indications/uses• Anti-inflamm/NSAIDs• Anaesthetic• Artificial tears/dry eye• Anti-glaucoma• Anti-infective+anti-

inflamm combos• Mydriasis (for myopia)• Nutrition

Differentiated strategy to build global pharma companyPhase 1 – Achieving ophthalmology segment leadership

UK/EU• Licensing (Big 5)• CMO contracts

India• Inorganic growth• Licensing/M&A

• Brands• Cos with FF

Russia • New product development• In-licensing of products• New TAs (ENT)

US/Canada• Pharmacy chains• Distribution partners• R&D partnerships (P4, 505b2)• Acquisitions

• Cos with products/ANDAs• Formulation development

ROW• Partner with local

companies

www.promedgroup.com

Differentiated strategy to build global pharma companyPhase 2 – Achieving multi-specialty depth; focus on India, Russia & US

India• New TAs• New segments • Licensing/M&A

• Brands• Cos with FF

Russia • New therapy areas• New segments • Licensing/M&A

• Brands, companies

US/Canada• New therapeutic areas• New segments • Licensing/M&A

• Cos with products/ANDAs• Formulation development

www.promedgroup.com

Building a global companyUS/CAN strategy

11www.promedgroup.com

Entry strategy for US• Partnership with pharmacy chains• S&M agreements with distribution partners• JV with generics and branded pharma cos• Co-development deals with innovator pharma• In-licensing of marketed products/ANDAs• Acquisition of companies/products• Establish label and front-end

To do• Identify homegrown Indian

companies in specific sectors that have become global

• Review their competitive positioning, product and service offerings

• Compare their financials and valuations

Review questions• Which global markets did they

target? Why?• Which inorganic strategies did they

pursue? • What products did they introduce in

domestic and global markets?• What regulatory issues did they

face?• How did they build brand presence?• How much market share do they

have?

Questions on US strategy • How much revenues should co target in next 5

and 10 yrs from US? • Should we partner with a third party or set up

our own office? • What type of JV deals should we get into?• What new business areas should we target?

• New products • New product categories• New therapeutic areas• New segments

• Is the contract manufacturing business (as a service to big pharma companies) sustainable?

12

JV model for partnering with US based companies

Company Y + Company X retain US rights;

Company Y provides full S&M

Company Y + Company X retain US rights;

Company Y provides full S&M

Exit through IPO/buyout

Exit through IPO/buyout

Company X markets products in home

territories

Company X markets products in home

territories

Company X partners with Company Y

Branded JV(50:50)

- Commercialize NDAs

- Acquire NDAs/brands/ branded cos

- Commercialize Company X’s innovator

products

- Company X provides R&D + manufacturing

Generics majority JV (80 Company X:20 Company Y)

- Commercialize ANDAs

- Acquire ANDAs/generics cos

- Commercialize Company X’s ANDAs

- Company X provides R&D + manufacturing

3-4 years 3-4 years

www.promedgroup.com

Building a global company Russia strategy


Russia strategy • New product development

• UD for existing products• Improved formulations

• Once daily regimen• Better patient experience

• Preservative-free products• Inorganic opportunities

• In-licensing of products/companies • Manufacturing setup • New TAs/Segments

To do• Identify Indian companies that have

entered Russian market• Review their competitive positioning,

product and service offerings • Compare their financials and

valuations

Review questions• Why did they target Russia?• What regulatory issues did they

face?• How did they build brand presence?• What are the fastest growing product

segments in Russia? • How many new products did they

introduce over last few years?• How much market share do they

have?

Questions on Russia strategy • How much revenues should company

target in next 5 and 10 yrs from Russia? • What new business areas should we

target?• New products, product categories• New therapeutic areas/segments

• How many new products should we introduce every year?

Building a global companyIndia strategy


India strategy • Inorganic opportunities

• Acquisition of brands/companies • New therapeutic areas/segments

Strategic partnerships • Partnership with specialty hospitals• Institutional sales

Questions on India strategy• How much revenues should co target in

next 5 and 10 yrs from India?

• What new business areas should we target?

• New products • New product categories• New therapeutic areas• New segments

To do• Identify specialty “pure play” and

diversified Indian (Pharma and other) companies

• Review their product and service offerings

• Compare them against peers – product mix, product ratings (IMS data), markets, financials, valuations

• Review recent deals in the Pharma space (M&A, PE funding, etc.)

Review questions• What does it take to become a successful

generic co in India?• What product mix and pricing strategy

should one employ? • How are Indian generic companies

valued against their peers in US? • Is this a good market for an IPO?• How should a co choose a PE firm?• What exit options should be considered?

CSR - Seva in our Hearts

CSR initiatives

• Promed contributes 2% of net profit to CSR activities

• Every employee puts 2 work days per year into Seva activities

• Integrated health check-up camps -specialized eye camps, dental checkups, blood donation camps for the community at regular intervals

• Support NGOs - Deepalya Foundation, Aarushi - Shelter for female child; sponsorship for education

• Plantation drives and green manufacturing practices to help protect the environment


CSR – Seva in our Hearts


Summary


Promed value proposition –• Innovation driven co with sharp focus on

execution and delivery• Fully integrated with strong product R&D and

GMP manufacturing • Cost-competitive and high-speed development

and manufacturing • Adherence to stringent quality controls and

processes per global standards• Fundamentally partnership-driven model with

clients and builds LT relationships • Strong global regulatory expertise

• #2 position in Russian ethical ophthalmology market

• Robust ANDA pipeline for US and regulated markets

• Established products in EU • EU-GMP and TGA-Aus approved• USFDA audit Q1 2013

Promed is extremely well-positioned to emerge as a global diversified pharma co

Harsh Bal, M.Pharm., PhDSr. VP – Business Development & Strategy

E: [email protected]: +91 813 015 8883

LinkedIn: in.linkedin.com/in/harshbal

PROMED Exports Pvt. Ltd.

261, Udyog Vihar, Phase- IV, GurgaonHaryana - 122001, India

T: +91(124) 495 1100F: +91(124) 430 1263

W: www.promedgroup.com

Contact

We are hiring – please send your resumes to us!

We need your creative out-of-the-box thinking & bold new ideas.



We need change agents and entrepreneurial minds with a can-

do attitude.


do attitude.


do attitude.

harsh bal - mdi gurgaon invited seminar - 17 dec 2012

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