Ideas and opportunities for entering new markets in the generic pharmaceutical industry

1. International Market Entry
Analysis - Planning - Engagement - Operations
Prepared by:
Asa Cox
Founder

2. About Generic Pharma 2.0
Founded in 2008 as Genericlicensing Ltd, the business launched the first searchable database of dossiers
available for licensing. Swelled from 500 products to 9000 products in 2012. 3000 licensing teams worldwide
access the data from 150 developers.
In 2011 the company became Generic Pharma 2.0; branching into the OTC & Biosimilar sectors.
In 2012 a publishing division was created with the launch of New Pharma Thinkers in; followed by a Digital
Engagement business, connecting multiple industry websites to generate leads worldwide.
These innovative communication and data businesses have helped create an unparalleled industry network;
creating a unique channel for new opportunities and a platform to offer growth consulting services.
For a more detailed background view this presentation

3. Growth Consulting Services
Generic Pharma 2.0 is unique its in position as the only industry specialist with a global footprint.
We cover all of the major regions with on-the-ground experts.
Offices in London (UK) and Toronto (Canada)
Exclusive consulting associates in:
Asia Western Europe MENA
- Tokyo (Japan) - Hamburg (Germany) - Damascus (Syria)
- Singapore - Madrid & Barcelona (Spain) - Algiers (Algeria)
- Shanghai (China)
- Dhaka (Bangladesh) Eastern Europe Central Asia
- Warsaw (Poland) - via Athens (Greece)
Latin America - Sofia (Bulgaria)
- Buenos Aires (Argentina) Baltics
- Sao Paulo (Brazil) Russia and CIS - Vilnius (Lithuania)
- via Switzerland
All of our team has deep experience in the pharmaceutical industry. Many have been senior managers in
global generic companies; responsible for significant growth and strategic projects.

4. Step 1 - Analysis
Analysis of market entry portfolio Competitor analysis
Qualitative analysis Direct competitors in segment
- Validation of IMS data by in-market expert - Market share
Segment characteristics - Tactics and stated plans
- Trends and changes - Strengths & Weaknesses
- MOH plans Opportunities & Threats
Priorities & Pricing Expectations
- Sequence of introduction - Market penetration scenarios
- Optimal price level - Initial sales projections
Market Entry Options Overview Review of findings
- Regulatory & legal requirements - Select market entry option to investigate
- Likely investment requirement
- Challenges Deliverable
- Probability of success - Written report with data, analysis & recommendations
Cost: $5,000-10,000 per country

5. Step 2 - Planning
SWOT Analysis
- Extensive, in-depth evaluation of chosen market entry strategy
- Select primary research with market 'players' to validate assumptions
Infrastructure & know-how requirements
Regulatory - submissions, updates, PV, reporting
Sales - number of reps, experience, geographical spread, knowledge
Marketing - design, implementation, management
Finance - government filing, processing, management, reporting, tax
Legal - trading entity, management, reporting, timetables
Supply Chain - purchasing, logistics, importation, documentation
Review of findings
- Investment requirements
- Timelines
- Business challenges
Deliverable
- Written report with data, analysis & recommendations
Cost: $5,000-7,500 per country

6. Step 3 - Engagement
Business Model & Product Validation
- Preliminary discussions with 'friendly' contacts to confirm likely success
- Obtain initial feedback on proposed portfolio by long term contacts
- Report competitor intelligence and deal valuations for business case validation
Partners & Customers
- Engage partners with presentation and specific product opportunities
- Build partnership or product business case
- Present rationale and recommendations before next steps
Arrange Meetings
- Set up week long meeting trip with all selected companies
Follow Up
- Work through business evaluation, contract negotiation and relationship building
- Can act as local representative or only provide support when required (ie, face-to-face meetings)
Cost: $10,000-15,000 per 10 qualified meetings with follow up
$5,000-10,000 success fee per agreement signed

7. Step 4 - Operations
Business Set Up Recruitment
Introduction to : - Recommend and engage key operational team
- Lawyers & accountants - Provide cross references and industry reputation checks
- Recommend office space
- Regulatory consultants Cost: $250/hour or $1000/day + expenses
- Ministry of Health agents
- Pharmacovigilance partner
- Importation & logistics partners etc
- Contract sales
Marketing launch
- Improve profile to establish credibility and invite inquiries
- Build trade and channel relationships
- Local language website and marketing materials
Cost: $1500-$5000/month + $2500-5000 for design
Note: We have a dedicated marketing division - DigitalGiants

8. Market Details
Generic Pharma 2.0 can offer market entry services on a per country basis or across a whole region.
The follow pages contact some specific markets believed to be of interest

9. Latin America
Top Level Information
$70bn regional pharma market. 119% growth forecast to 2021.
7 of top 10 highest GDP growth countries are in Latin America.
Considered commercially High Risk by PhRMA, worry of anti-American sentiment.
50/50 in BMI Risk/Reward index. Brazil, Argentina & Mexico above 60% positive.
Strong socialist governments spend big on healthcare but protect domestic industry.
Recommended Strategy
JV/Partner with local company with strong local position and own manufacturing (esp. Brazil).
Set up regional hub in smaller market (e.g Columbia or Chile) where approval times are quicker.
Success Criteria
Value added products; standard generics are all made locally.
Finding the right partner for sales and marketing to compete with major domestic players
Local Expert
Former LATAM Head for leading global generic player
Case Study
Established local business unit for international pharma company; created from ground up to multi-million
revenue operation. Devised strategy, portfolio and oversaw all business operations.

10. Brazil
Top Level Information
203million population. $3.8trillion GDP, growing 7.5% p/a. $12,000 per capita. 21% still below poverty line.
$25billion drug market. Growing middle class provides strong growth (doubled in 10 years!)
Foreign market entrants grew 40% in 3 years to 2011. $2billion of deals with domestic players closed.
Major companies have sales force of 2000; middle management often have $200,000 salaries.
Recommended Strategy
JV/Partner with local company with strong local position and own manufacturing.
Distribution evolving to tech transfer and supply of supply elements (e.g API)
Success Criteria
Value added products; standard generics are all made locally.
Finding the right partner.
Local Experts
Former Director of Brazil subsidiary for major international generic company.
Case Study
Established local business unit for international pharma company; created from ground up to multi-million
revenue operation. Devised strategy, portfolio and oversaw all business operations.

11. Argentina
Top Level Information
42m people, concentrated in the Buenos Aires state, the largest state of the country (25%).
27% GDP growth forecast for 5 years. Current GDP $500 billion
$5.7bn Pharma market. 44% of total sales belong to local companies; the generic sector is 20%.
40-50% reimbursed to the patients: 15% by Pharma Co's, 15% Medical Insurance..
Local industry is very strong. Imports replacement enforced by government where available.
Recommended Strategy
JV/Partner with local company (who must own majority). Local manufacturing highly suggested.
Generics pharma to be sold directly to public and private hospitals and also directly to health insurance.
Success Criteria
Value added products; standard generics are mostly made by local branded generics producers.
Finding the right partner who has connections with major public buyers.
Local Expert
Former International Business Manager for LATAM Spanish region of an Argentinean company. Broad
knowledge and expertise in commercial, regulatory and operations.
Case Study
Design, development and management of two companies, one in Brazil and the other in Mexico as well as
licensing management all over LATAM. National responsibility for all Argentina.

12. USA
Top Level Information
'Pure' generic market dominated by major players and multinational Indian companies; especially for simple
formulations. 505b2 sector increasingly saturated, but still opportunities for complex products. Paragraph IV
/ first-to-file projects still provides greatest return but are highly competitive and litigation is expensive ($3-
5m). Many mid-size companies seeking to grow portfolio quickly. Number of small development companies
seeking partners. Few competitive manufacturing sites except for niche formulations or special handling.
Recommended Strategy
Progressive approach; licensing to strategic partnership to JV/acquisition or greenfield set up.
Model depends on investment capital, risk tolerance, portfolio and long term intent.
Success Criteria
Sales are controlled by a small number of large wholesalers/distributors; it is imperative to have a partner or
sales team with deep relationships. Differentiated portfolio will get most interest, although flexible business
models on holder products are attractive (if reasonable competition).
Local Experts
- CEO Asa Cox is highly connected in the US industry
- 2 Former VP's Business Development for leading global player
Case Study
Engaged all major marketing players and select upcoming speciality companies to license niche European
generic product. Competitive bid scenario resulted in multi-million licensing fee and option for future
products.

13. China
Top Level Information
1.4billion population. 20% of world population. By 2040 China will have a $124trillion economy.
Non-state companies produced 70% of GDP. 20% of luxury good are bought in China.
Chinese hospitals spent $3.5bn; revenue from pharmacies is nearly $7bn.
350m have state pension. 10% personal budget spent on healthcare. Trading up is a mega-trend.
China dominates the API industry, 3000-4000 domestic finished dose manufacturers. 95% generics.
Recommended Strategy
Partner/JV with local manufacturer who owns product approvals; build relationships with key distributors
over time and with strong management team.
Success Criteria
Connections at highest levels of corporations and government. Long term view.
Local Expert
Established international business development business in 1987; connected at all levels and across broad
spectrum of health care industry. Local team on hand to run projects.
Case Study
Evaluated international portfolio for market potential in China; identified suitable partners and engaged.
Build business case, business model and managed all transactional requirements.

14. Algeria
Top Level Information
36m people (80m including neighbouring Morocco & Tunisia), concentrate in north of country.
10% GDP growth forecast for 5 years. $190bn positive trade balance; 99% oil.
$3bn Pharma market. 86% public funded. 79% generic market. 80-100% reimbursed. Strong Gx incentives.
Industry focused internally, many imports banned. Value still 64% on imports.
Recommended Strategy
JV/Partner with local company (who must own majority).
Distribution evolving to tech transfer and supply of supply elements (e.g API)
Success Criteria
Value added products; standard generics are all made locally.
Finding the right partner.
Local Expert
Established local businesses for European clients. Founder of only pharmaceutical exhibition in country.
Business background with best network of decision makers available.
Case Study
Evaluated portfolio for major international generic company. Provided 5-year forecasts based on tiered
partnership recommendation. Engaged local companies and established local JV.

15. Baltics
Top Level Information
6.5 million population (3m-LIT, 2.2-LV, 1.3-EE), $138 million GDP, growing 3% p/a.
$20,000 per capita, all 3 countries are European Union members. 800 million Euro
drug market, growing 3% p/a; 90%-retail, 10%-hospital; 70%-Rx, 30%-OTC
generics by value (38%-LIT; 34%-LV; 28%-EE), generics by units (53%-LIT, 58%-LV, 49%-EE)
Reimbursement budgets for pharmaceuticals are flat; 0.5 million Euro - average sales.
Recommended major companies have sales force of 30 to target pharmacy chains.
Recommended Strategy
1) Licensing to one or several partners 2) JV/acquisition 3) Representative office.
Model depends on investment capital, risk tolerance, portfolio and long term intent.
Success Criteria
Sales are controlled by a small number of large pharmacy chains; it is imperative to have a partner or sales
team with deep relationships. Differentiated portfolio will get most interest, although flexible business
models on holder products are attractive (if reasonable competition).
Local Expert
Former Lithuania country manager and regional head for leading ethical and generic manufacturing
companies. Former member of the board of the pharma industry association. Strong relationships
throughout region since launching independent consulting business for licensing in/out
Case Study
Established local business unit for several international pharma companies; created from ground up to a
several million revenue operation. Devised strategy, portfolio and oversaw all business operations.

16. Russia & CIS
Top Level Information
The CIS market in 2011 was $25.5bn of which Russia was $18.8bn where the growth rate in 2012
and 2012 will be ±10%. In Russia there is the so-called “2020 Vision” where the declared aim of the
Russian government is to have 50% (by value) of all medicines sold in Russian to be made locally.
Corruption is an issue with most CIS countries at position 130 or below; the exceptions are Moldova
(36) and Georgia (51). (Canada has position 9).
Recommended Strategy
In view of the current long registration time in Russia (>2.5 years), it is best to start in in parallel to
Russia with some of the smaller markets where sales can be achieved faster. Choose a local distributor
with adequate promotional capabilities; representative office in larger markets.
Success Criteria
Value added products: standard generics are either made locally or imported from India, sometimes
China; finding the right partners; long term view.
Local Expert
Former Export Director of Middle sized companies active in the CIS, Balkans and Baltic States with
>20 years’ experience; contacts at all levels throughout the CIS.
Case Study
Established business from scratch in all the CIS markets for ethical and generic manufacturers.
Devised strategy, portfolio and oversaw all business activities.

17. Generic Pharma 2.0 Inc
www.genericpharma20.com
Canada: +1 705 615 1500
UK: +44 (0)845 453 1376
asa.cox@genericpharma20.com