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Understanding the
Strategy of M&A
in the
Pharmaceutical
Industry
By
Abhishek Ghosh
10 July, 2015
1© 2015 KPMG, an Indian Partnership and a member firm of the KPMG network of independent member firms affiliated with KPMG International Cooperative (“KPMG International”), a Swiss entity. All rights reserved.
Agenda
2
• Introduction: Pharmaceutical Industry Scenario
June 2015
3-18
• Introduction: Sun Pharmaceuticals
• Segmentation of the Business and Business Model
• Structure Pre and Post Transaction
• What Strategic Decision led to the Ranbaxy Acquisition?
19-22
• Competitors in India
• Customer Analysis
23-27
• Opportunities in Pharmerging Markets
• Strategy for Expanding in Pharmerging Markets
28-31
• SWOT Analysis
• Long-Term Strategy
• Synergies and Challenged Post the Ranbaxy Acquisition
• Capabilities Post Acquisition
2© 2015 KPMG, an Indian Partnership and a member firm of the KPMG network of independent member firms affiliated with KPMG International Cooperative (“KPMG International”), a Swiss entity. All rights reserved.
Introduction: Pharmaceutical Industry Scenario
June 2015
• Market Size: US$ 1.2 trillion by 2017 (CAGR: 3-6%)
• Key Growth Drivers: Emerging Markets
Source: pp. 11, “2013-14 SPIL-Director’s Report and Management Discussion and Analysis”, Sun Pharmaceutical Industries Limited, http://www.sunpharma.com/, Accessed on 30 June,
2015
* Detailed explanation in: Jackson Richard et. al, “Global Aging and Future of Emerging Markets” (2011: Centre for Strategic and International Studies and Everest Capital), pp. 2-4
Economic and
Healthcare
Austerity
Measures
* Unfavourable
Demographic Dividend
Lowering of Savings and
Investments due to
Greying Population
Budgetary Pressure due
to Rising Pension and
Healthcare Costs
Double-Digit Growth in Emerging MarketsSingle-Digit Growth in Developed Markets
Economic
Growth
* Favourable
Demographic
Dividend
Increased
Out-of-
Pocket
and
Private
Spending
Increased
Governmental
Healthcare
Funding
Savings
Realized from
the Growing
availability of
Generic Drugs
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• Outlook of the Indian Pharmaceutical Sector
• Projected to grow at a CAGR of 11-14% during 2013-17.
• One of the key exporters to the U.S.A and other markets-the highest number of US FDA approved
manufacturing facilities outside U.S.A.
• Indian Pharmaceutical companies received over 150 ANDA (Abbreviated New Drug Applications)
approvals from the U.S FDA during 2013, accounting for ~38% of the total approvals.
Outlook of the Indian Pharmaceutical Industry
Source: pp. 11, “2013-14 SPIL-Director’s Report and Management Discussion and Analysis”, Sun Pharmaceutical Industries Limited, http://www.sunpharma.com/, Accessed on 30 June,
2015
Market Position
13 11
Market Size
US$ 14 bn US$ 22-32 bn
Year
2012 2017
4© 2015 KPMG, an Indian Partnership and a member firm of the KPMG network of independent member firms affiliated with KPMG International Cooperative (“KPMG International”), a Swiss entity. All rights reserved.
Introduction: Sun Pharmaceuticals
• Sun Pharmaceuticals was started in 1983 in Vapi, India by Dilip Shanghvi with only five products to
treat psychiatric ailments.
• After its historic US$ 4 bn all-stock acquisition ( stock swap ratio : 0.8 : 1) of Ranbaxy in April 2014,
Sun has become, by 2015, the largest chronic prescription company in India and the fifth largest
specialty generic pharma company in the world.
• Market Leader in:
• By 2011, Ranbaxy’s global revenues crossed US$2 billion, the first Indian company to do so.
Psychiatry Neurology Cardiology
Orthopedics Ophthalmology Nephrology
Gastroenterology
5© 2015 KPMG, an Indian Partnership and a member firm of the KPMG network of independent member firms affiliated with KPMG International Cooperative (“KPMG International”), a Swiss entity. All rights reserved.
Major Acquisitions and Alliances – Sun Pharma and Ranbaxy
1992
Ranbaxy + Eli Lilly & Co.
Joint Venture (India)
1995
Sun Pharma + API Plant
from Knoll Pharma
Acquisition
(Ahmednagar, Maharashtra)
1997
Sun Pharma + Caraco
Pharmaceutical Laboratories,
Acquisition (U.S.A)
2006
Ranbaxy+Unbranded
Generics Business of GSK
Acquisition (Italy and Spain)
2006
Ranbaxy + Be Tabs
Pharmaceuticals, the 5th
largest generics company in
South Africa
Acquisition
2006
Ranbaxy + Terapia, the
largest generic pharma
company in Romania
Acquisition
2010
Sun Pharma Acquires
controlling stake in Taro
Pharmaceuticals
(U.S.A)
2012
Sun Pharma + Dusa and
Generics Segment of URL
Pharmaceuticals
Acquisition (U.S.A)
2015
Sun Pharma + Ranbaxy
Acquisition
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Segmentation of the Industry’s Business Lines
Industry Segments
Generics
Specialty
Complex
Branded
Consumer
Medicine
Protected Originals
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Segmentation of the Business at Sun
Major Business
Segments
(Sun Pharma)
U.S. Generics
Indian Branded
Generics
International
Branded Generics
(ROW except
U.S.A)
Active
Pharmaceutical
Ingredients (API)
Major Market Categories (By Geography):
• U.S Formulations: 5th largest generics company in US with one of the largest ANDA pipelines
(159 ANDA’s awaiting approval) with 50% contribution to revenue in June, 2015.
• Indian Generics: Leading position in high growth chronic therapies with Indian brand generics
contributing 24% of total sales revenue in June, 2015.
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Business Model
1. Plans to in-license products that are already marketed or are in late stage clinical development in key
therapy areas such as CNS disorders, Cardiology, Diabetes and Metabolic disorders, Gastroenterology,
Ophthalmology, Oncology, Pain, Allergy, Asthma, Inflammation and Gynaecology.
2. Strategic interest in in-licensing bio-similar products and new products based on
recombinant/humanized monoclonal antibody technology used in the above therapy areas.
3. Out-licensing product range includes dosage forms for oral, injectable, topical and transdermal
routes developed through non-infringing routes and/or patented routes.
4. Out-licensing sought for specialty generics, super generics, and bulk drugs in therapy areas such as
CVS, CNS, Pain, Cancer, Gynaecology, Allergy, Asthma other respiratory diseases.
5. Focused on expanding in key markets such as Russia and CIS countries, China and South East Asia,
Africa, Brazil and Mexico.
Identify
Promising
New
Molecules
Test them in
Large
Clinical
Trials
Build Strong
Product
Portfolio
Focus on
Niche and
Complex
Molecules to
Garner
Premium to
Peers
Promote
them with an
Extensive
Sales and
Marketing
Presence
9© 2015 KPMG, an Indian Partnership and a member firm of the KPMG network of independent member firms affiliated with KPMG International Cooperative (“KPMG International”), a Swiss entity. All rights reserved.
Sequence of Metrics Analyzed
Profits
Revenues
Revenue /
Unit
Customer
Analysis
Competitor
AnalysisNo. of
Units Sold
Expenses
Fixed
Variable
Metrics to be Determined
within the Company over
Time and Between
Competitors in the same time
period
10© 2015 KPMG, an Indian Partnership and a member firm of the KPMG network of independent member firms affiliated with KPMG International Cooperative (“KPMG International”), a Swiss entity. All rights reserved.
Structure Pre-Transaction
RANBAXY
PUBLIC
SHAREHOLDERS
+ CUSTODIANS
63.41%36.9%
SUN PHARMA
PUBLIC
SHAREHOLDERS
PROMOTERS AND
PROMOTER GROUP
36.35% 63.65%
DAIICHI
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Structure Post-Transaction
SUN PROMOTER AND
SUN PROMOTER GROUP
SUN PHARMA
(MERGED
ENTITY)
9% 36%55%
DAIICHI
PUBLIC
SHAREHOLDERS
(RANBAXY + SUN)
12© 2015 KPMG, an Indian Partnership and a member firm of the KPMG network of independent member firms affiliated with KPMG International Cooperative (“KPMG International”), a Swiss entity. All rights reserved.
What Strategic Decision Impacted the Ranbaxy Acquisition?
Problem Definition: What was the impact on-
a. Revenue
b. Costs
c. Operational Efficiencies and Synergies
PAT of Sun Pharma (Standalone) 2010-14
-3000
-2500
-2000
-1500
-1000
-500
0
500
1000
1500
2000
MAR '10 MAR '11 MAR '12 MAR '13 MAR '14
PAT (Rs. in Crore)
PAT
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Declining Revenues Post Dusa, URL Acquisitions in U.S.A in 2012
CAGR in Revenue [2012-14] = -(11.02)%
Sun Pharmaceuticals (Standalone)
Net Sales Revenue [2010-2014]
0.00
500.00
1,000.00
1,500.00
2,000.00
2,500.00
3,000.00
3,500.00
4,000.00
4,500.00
MAR '10 MAR '11 MAR '12 MAR '13 MAR '14
1,845.09
3,107.57
4,015.56
2,432.14
2,828.79
Net Sales (Rs. in Crore)
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Increasing Costs Since Acquisition in 2012
0.00
500.00
1,000.00
1,500.00
2,000.00
2,500.00
3,000.00
3,500.00
4,000.00
4,500.00
MAR '10 MAR '11 MAR '12 MAR '13 MAR '14
1,845.09
3,107.57
4,015.56
2,432.14
2,828.79
Total Expenses (Rs. in Crore)
Sun Pharmaceuticals (Standalone) Expenses
[2012-14]
CAGR in Expenses [2012-14] = 6.52%
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Pricing Pressures Uniform throughout the Pharma Industry
• Government-mandated price controls on 348 essential drugs in May, 2013 impacted prices of both
MNC’s and local firms producing essential drugs.
• A new Act, known as Drugs (Prices Regulation and Control) Act enacted to have effective control
on prices, production, distribution and supply of medicines in India.
• All customer segments are very sensitive to change in price of generics.
• Thus, growth will be fueled only by increasing volumes.
16© 2015 KPMG, an Indian Partnership and a member firm of the KPMG network of independent member firms affiliated with KPMG International Cooperative (“KPMG International”), a Swiss entity. All rights reserved.
• GlaxoSmithKline (GSK) and Sanofi Aventis were affected the most. Bottom lines of domestic drug
makers such as Cipla and Cadila would also take a hit.
• Least impacted were companies such as Sun Pharma and Lupin.
• Some companies like GSK have created a Developing Countries Unit that caps prices at no more than
25% of the UK price and reinvests 20% of any profits back in the country it covers.
GSK CFO Simon Dingemans says,
“Price reductions [in China] are in many ways very important in driving up the access and take-up of
healthcare coverage. We see very good volume response to that, which shows that the strategy is
working.”
(Bloomberg)
Pricing Pressures Uniform throughout the Pharma Industry
17© 2015 KPMG, an Indian Partnership and a member firm of the KPMG network of independent member firms affiliated with KPMG International Cooperative (“KPMG International”), a Swiss entity. All rights reserved.
Causes of Price Decline and Fall in PAT at Sun Pharma
• Sun Pharma and Ranbaxy to hive off certain products due to CCI regulation, for the merger to
become effective
• Sun Pharma sold products under the Tamlet brand name and Ranbaxy divested 6 brands, leading to
price erosion.
Ranbaxy Divestments
Eligard
Triolvance
Raciper L
Terlibax
Rosuvas
EZ
Olanex F
18© 2015 KPMG, an Indian Partnership and a member firm of the KPMG network of independent member firms affiliated with KPMG International Cooperative (“KPMG International”), a Swiss entity. All rights reserved.
• One-time merger expenditure and high cost of integration of Ranbaxy
• Debt reduction strategy to consolidate debt position
• US$ 800 mn debt obligation of Ranbaxy at the time of merger to be serviced by Sun Pharma,
reducing PAT
• Regulatory expenses in the U.S.
• Opportunity cost owing to new-product approval delays and clinical trial delays in the U.S leading
to subdued PAT
• US sales hit
• Pricing pressure from channel consolidation
• Customer Consolidation
• Recalls from the Halol facility, which contributes 25% of consolidated profits
• Currency Headwinds in Russia, Venezuela and other emerging markets
Causes of Price Decline and Fall in PAT at Sun Pharma
Source: Kanungo Soumanty, “Pharma firms to face US approval delays and currency headwinds this quarter too”, DNA, http://www.dnaindia.com/money/report-pharma-firms-to-face-us-
approval-delays-currency-headwinds-this-quarter-too-2092157, Accessed on 4 June, 2015
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Competitors in India – Consistently Growing Market Share of Sun
[2000-13]
Source: pp. 26, “Director’s Report”, Sun Pharmaceutical Industries Ltd., http://www.sunpharma.com/investors/annualreports, accessed on 2 July, 2015
Competitor Market Share Growth in India [2000-13]
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Customer Analysis: Segmentation of Sources of Revenue
Segmentation into Customer Segments by Geography
Source: IR Presentation June 2015, Sun Pharmaceutical Industries Limited, Accessed on 30 June, 2015
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Customer Segment in India: Falling Sales per Representative
• In the largest market (U.S.A), sales have experienced consistent growth of 40.66% CAGR between
2012 and 2015 (INR 137 bn in 2015 including the impact of the Ranbaxy merger, up from INR 98 bn
in 2014) and 438 ANDA’s have been approved in 2015, an increase of 15.05% from 2012.
• In India, sales have increased consistently to INR 67 bn in 2015 (including the effect of the Ranbaxy
merger), from INR 37 bn in 2014.
However, a realignment to the preferred distribution
channel preference of key customer segments may be
required since the Sales per Representative has seen a
sharp decline in 2015
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High Price Sensitivity, Opportunity to Differentiate Product
Price Sensitivity of Emerging Markets:
Challenges for Upward Price
Revision
Enablers for Upward Price
Revision
Essential Drug List Revision in
China; Government Cost
Containment Measures in Brazil
and Russia
Increased Healthcare Investment
by the Chinese, Brazilian, Russian
and Indian Governments
Slowdown in Economic Growth in
Brazil and Russia
Rising affluence of patients paying
out-of-pocket for premium
products in China
Attempts at Differentiation of Products:
Company Segment
Pfizer, Sanofi Generics
Novo Nordisk, Roche Specialty
Boehringer Ingelheim, Bayer,
GSK, Teva
Consumer Health
Product differentiation (except for brand equity) is not the most viable strategy in India, which follows process
patents that favour imitators and generics manufacturers, opportunities to increase revenues or introduce cost
competitiveness more viable
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Opportunities in Pharmerging Markets: China Leads Spending; Brazil,
India Follow
Source: pp. 8, “2013-14 SPIL-Director’s Report and Management Discussion and Analysis”, Sun Pharmaceutical Industries Limited, http://www.sunpharma.com/, Accessed on
30 June, 2015
Split-Up of Revenue Spending and Contribution to Sales Growth [2012-17] by Customer
Segments for the Pharma Industry
* EU5 countries include Germany, France, Italy, Spain and the U.K
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Rise of Generics in Pharmerging Markets (China, India, Brazil)
• As the Pharmerging markets emerge, a global spending shift towards generics is forecasted.
• Pharmaceutical Spending absolute growth in Pharmerging markets would increase from US$ 30 bn in
2012 to US$ 40 in 2017 (estimated) and spending on generics in these markets would increase from
58% in 2012 to 63% in 2017 (estimated).
Pharmerging Economies (Based on the IMS Health Global Market Prognosis)
Classification Based on Income Level, Growth Rate and Pharmaceutical Spend per Person
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Drivers for Growth in Generics in Emerging Markets:
Rise of Generics in Pharmerging Markets (China, India, Brazil)
Generics are
most affordable
for govt.
healthcare
programmes and
consumers
Increasing
Incidence of
Chronic
Diseases
Increasing Life
Expectancy and
an Ageing
Global
Population
Patent-
protected brand
volume growth
set to shrink
with patents
expiring
Weaker IP laws
in some
developing
countries
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Highest Growth in Generics in Pharmerging Economies
Product Mix in Pharmerging Economies
• Top 8 Mature Markets include U.K, France, Germany, Italy, Spain, Japan, U.S.A and Canada
• LIC : Low Income Countries
• LC $ : Constant Local Currency Dollars, used to smoothen out effects of exchange rate fluctuations
• Pharmerging Economies, based on minimum anticipated added value to the global pharmaceutical market, as enumerated by IMS Health Global Market Prognosis include: Brazil,
Turkey, Russia, China, India, Mexico, South Korea, Venezuela, Poland, Argentina, Vietnam, South Africa, Thailand, Indonesia, Egypt, Pakistan, Ukraine, Algeria, Colombia,
Saudi Arabia and Nigeria
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Strategy for Expansion in Generics in Pharmerging Economies
• Between January 2008 and February 2013, India has seen 226 M&A deals in the Pharma Sector, with
81.4% of the deals involving local companies
• Ranbaxy had a large product portfolio, established infrastructure linking its complex supply chain and
excellent stakeholder relationships to boost inorganic growth when acquired.
Integrated
Distributors
Large
Portfolios
Strong
Brand
Equity in
the Local
Market
Efficiencies
of Scale
Attractiveness of Investing in Local Companies in the Target Market
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SWOT Analysis of Sun Pharma
• Established brand Market
leader in dermatology
(U.S), specialty chronic
segment and branded
generics (India)
Strengths Weaknesses
ThreatsOpportunities
• Focus on access to generic
products, market presence and
technology
• Differentiation of products by
focusing on complex generics
• Increasing share of branded
specialty drugs
• Achieve critical mass in key
markets
• Branded generics growth will slow
down due to payer pressure to reduce
costs via commoditization
• Improved manufacturing standards
would reduce the brand proposition
of branded generics and unprotected
originals leading to large price cuts
• Consolidation would lead to low
margins and difficult cost structure
for sophisticated MNC’s to replicate
• Karkhadi facility faces restrictions
in approval of its Abbreviated New
Drug Applications [ANDA’s] by the
USFDA due to its non-compliance
with certain current Good
Manufacturing Practices (cGMP)
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Leveraging Opportunities and Strengths: Long-Term Strategy at Sun
• Sustainable Revenue and Cash Flow Stream:
• Targeting complex / differentiated products in key markets
• Focus on fast-growing chronic therapies and timely product launches
• Using Investments to Develop Complex Products and Turning Around Underperforming
Acquisitions
• Cost Leadership
• Vertical Integration
• Optimisation of Operational Expenses
• Closer links between the back-end and supply chain
30© 2015 KPMG, an Indian Partnership and a member firm of the KPMG network of independent member firms affiliated with KPMG International Cooperative (“KPMG International”), a Swiss entity. All rights reserved.
Synergies and Challenges Post the Ranbaxy Acquisition
Synergies
• All-Stock Deal used to leverage
Sun’s huge Market Cap, Cash
preserved for future deals,
CAPEX
• Sun will be in the top spot in 13
Therapy segments, up from 7 in
2014
• Better Over-the-Counter Portfolio
in India
• Better Dermatology Franchise in
India (55% of Ranbaxy Sales)
• Strong presence of Ranbaxy in
India and other Emerging Markets
Challenges
• Regulatory Turnaround needed to
access Ranbaxy’s Product Pipeline
• US$ 500 mn in payments to the US
Department of Justice for
manufacturing violations may
have affected brand equity of
Ranbaxy
• Increased competition in the
Generics Segment (high
dependence on Absorica of
Ranbaxy)
• Lower Sales Growth, Margin,
Returns, which means Pay Back
Period might exceed 6 Years
Source: “Finding a Cure”, Business Today, http://businesstoday.intoday.in/story/sun-pharma-buys-ranbaxy-implications-profits-debt-usfda/1/205241.html, accessed on 1 July, 2015
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Capabilities of the Company Post Acquisition
• The tax burden can be alleviated for 8 years following the transaction as the Income Tax Act allows for
the losses of Ranbaxy to be set off the profits of Sun Pharma for the aforementioned period.
• The merged entity will have a highly complementary portfolio of specialty and generics targeting
chronic and acute treatments globally.
• Presence in 55 markets and capabilities across specialty branded products and complex generics.
• In the U.S.A, no. 1 in generic dermatology and no. 3 in the branded dermatology market. Pro-forma
U.S. revenues to be about US$ 2.2 bn with a strong capability in developing complex products.
• In India, Sun Pharma will become the largest pharmaceutical company with over 9% market share.
No. 1 by prescriptions across 13 different classes of specialist doctors in India. Pro forma revenues in
India will be about US$ 1.1 bn.
• Ranbaxy will add to competitive edge in acute care, hospitals and OTC businesses with robust brands.
• 31 amongst top 300 brands and greater distribution reach.
• Foundation for OTC business in India.
• The target is to generate synergy benefits of about US$ 250 mn by the third year- driven by revenue,
procurement, supply chain and other cost synergies.
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• ANDA: An Abbreviated New Drug Application is an application that allows the applicant to
manufacture and market the generic drug product to provide a safe, effective, low cost alternative to
more expensive licensed medications.
• API: Active Pharmaceutical Ingredient refers to the active or central ingredient in the drug product
which causes the direct effect on the disease diagnosis, prevention, treatment or cure.
• Branded Generics: A branded generic is a drug that is bioequivalent to the original product, but is
now marketed under another company's brand name.
• Complex Drugs: Drugs with complex active ingredients, formulations routes of delivery or drug-
device combinations.
• Generics: A drug product that is comparable to a brand in dosage form, strength, quality, performance
characteristic and intended use. Instead of a brand name or registered trademark, they carry either the
name of the manufacturer or the nonproprietary name of the drug. Generic products are available once
the patent protections afforded to the original developer have expired. Market competition often leads
to substantially lower prices for both the original brand name product and the generic forms.
• In-Licensing: The business model of acquiring one or more products still in pre-clinical or clinical
development (fairly advanced stages of development) and focusing on its product development and
launch. The skills involved are therefore medical and clinical, rather than relating to discovery.
Glossary
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• Specialty Drugs: Drugs that are expensive, have limited access, complicated treatment regimens,
compliance issues, special storage requirements and manufacturer reporting requirements.
• Out-Licensing: The business model of a company that seeks a partner in the development and co-
marketing of its compound from the late-stage clinical trial phase to the product launch phase. This is a
strategic way to continue to generate value from pipeline assets, while sharing the risks and high costs
inherent in any R&D program.
• OTC Drugs: A drug for which prescription is not needed.
• US FDA: The Unites States Food and Drug Administration is responsible for protecting and promoting
public health through the regulation and supervision of food safety, prescription and over-the-counter
pharmaceutical drugs (medications), vaccines, biopharmaceuticals and other similar consumer
products.
Glossary
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External Sources
• “2013-14 SPIL-Director’s Report and Management Discussion and Analysis”, Sun Pharmaceutical
Industries Limited, http://www.sunpharma.com/investors/annualreports , Accessed on 30 June, 2015
• “IR Presentation, June 2015”, Sun Pharmaceutical Industries Limited,
http://www.sunpharma.com/investors/annualreports, Accessed on 30 June, 2015
• “Pharmerging Markets- Picking a Pathway to Success”, Q2 IMS Pharmerging white paper 06-2013
(2013), Accessed on 30 June, 2015
• Jackson Richard et. al, “Global Aging and Future of Emerging Markets” (2011: Centre for Strategic
and International Studies and Everest Capital), pp. 2-4
• “Govt. to regulate prices of 652 medicines, prices set to fall”, ET,
http://articles.economictimes.indiatimes.com/2013-05-17/news/39336744_1_essential-drugs-price-
control-indian-pharmaceutical-alliance, Accessed on 30 June, 2015
• Kanungo Soumanty, “Pharma firms to face US approval delays and currency headwinds this quarter
too”, DNA, http://www.dnaindia.com/money/report-pharma-firms-to-face-us-approval-delays-
currency-headwinds-this-quarter-too-2092157, Accessed on 4 June, 2015
• Sharma Kumar, “Finding a Cure”, Business Today, http://businesstoday.intoday.in/story/sun-pharma-
buys-ranbaxy-implications-profits-debt-usfda/1/205241.html, Accessed on 1 July, 2015
Thank you
Presentation by Abhishek Ghosh
Summer Trainee
KPMG, Lodha Excelus
Mumbai
The KPMG name, logo and “cutting through
complexity” are registered trademarks or trademarks
of KPMG International.
© 2015 KPMG, an Indian Partnership and a member
firm of the KPMG network of independent member
firms affiliated with KPMG International Cooperative
(“KPMG International”), a Swiss entity. All rights
reserved.

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M&A in Pharma

  • 1. Understanding the Strategy of M&A in the Pharmaceutical Industry By Abhishek Ghosh 10 July, 2015
  • 2. 1© 2015 KPMG, an Indian Partnership and a member firm of the KPMG network of independent member firms affiliated with KPMG International Cooperative (“KPMG International”), a Swiss entity. All rights reserved. Agenda 2 • Introduction: Pharmaceutical Industry Scenario June 2015 3-18 • Introduction: Sun Pharmaceuticals • Segmentation of the Business and Business Model • Structure Pre and Post Transaction • What Strategic Decision led to the Ranbaxy Acquisition? 19-22 • Competitors in India • Customer Analysis 23-27 • Opportunities in Pharmerging Markets • Strategy for Expanding in Pharmerging Markets 28-31 • SWOT Analysis • Long-Term Strategy • Synergies and Challenged Post the Ranbaxy Acquisition • Capabilities Post Acquisition
  • 3. 2© 2015 KPMG, an Indian Partnership and a member firm of the KPMG network of independent member firms affiliated with KPMG International Cooperative (“KPMG International”), a Swiss entity. All rights reserved. Introduction: Pharmaceutical Industry Scenario June 2015 • Market Size: US$ 1.2 trillion by 2017 (CAGR: 3-6%) • Key Growth Drivers: Emerging Markets Source: pp. 11, “2013-14 SPIL-Director’s Report and Management Discussion and Analysis”, Sun Pharmaceutical Industries Limited, http://www.sunpharma.com/, Accessed on 30 June, 2015 * Detailed explanation in: Jackson Richard et. al, “Global Aging and Future of Emerging Markets” (2011: Centre for Strategic and International Studies and Everest Capital), pp. 2-4 Economic and Healthcare Austerity Measures * Unfavourable Demographic Dividend Lowering of Savings and Investments due to Greying Population Budgetary Pressure due to Rising Pension and Healthcare Costs Double-Digit Growth in Emerging MarketsSingle-Digit Growth in Developed Markets Economic Growth * Favourable Demographic Dividend Increased Out-of- Pocket and Private Spending Increased Governmental Healthcare Funding Savings Realized from the Growing availability of Generic Drugs
  • 4. 3© 2015 KPMG, an Indian Partnership and a member firm of the KPMG network of independent member firms affiliated with KPMG International Cooperative (“KPMG International”), a Swiss entity. All rights reserved. • Outlook of the Indian Pharmaceutical Sector • Projected to grow at a CAGR of 11-14% during 2013-17. • One of the key exporters to the U.S.A and other markets-the highest number of US FDA approved manufacturing facilities outside U.S.A. • Indian Pharmaceutical companies received over 150 ANDA (Abbreviated New Drug Applications) approvals from the U.S FDA during 2013, accounting for ~38% of the total approvals. Outlook of the Indian Pharmaceutical Industry Source: pp. 11, “2013-14 SPIL-Director’s Report and Management Discussion and Analysis”, Sun Pharmaceutical Industries Limited, http://www.sunpharma.com/, Accessed on 30 June, 2015 Market Position 13 11 Market Size US$ 14 bn US$ 22-32 bn Year 2012 2017
  • 5. 4© 2015 KPMG, an Indian Partnership and a member firm of the KPMG network of independent member firms affiliated with KPMG International Cooperative (“KPMG International”), a Swiss entity. All rights reserved. Introduction: Sun Pharmaceuticals • Sun Pharmaceuticals was started in 1983 in Vapi, India by Dilip Shanghvi with only five products to treat psychiatric ailments. • After its historic US$ 4 bn all-stock acquisition ( stock swap ratio : 0.8 : 1) of Ranbaxy in April 2014, Sun has become, by 2015, the largest chronic prescription company in India and the fifth largest specialty generic pharma company in the world. • Market Leader in: • By 2011, Ranbaxy’s global revenues crossed US$2 billion, the first Indian company to do so. Psychiatry Neurology Cardiology Orthopedics Ophthalmology Nephrology Gastroenterology
  • 6. 5© 2015 KPMG, an Indian Partnership and a member firm of the KPMG network of independent member firms affiliated with KPMG International Cooperative (“KPMG International”), a Swiss entity. All rights reserved. Major Acquisitions and Alliances – Sun Pharma and Ranbaxy 1992 Ranbaxy + Eli Lilly & Co. Joint Venture (India) 1995 Sun Pharma + API Plant from Knoll Pharma Acquisition (Ahmednagar, Maharashtra) 1997 Sun Pharma + Caraco Pharmaceutical Laboratories, Acquisition (U.S.A) 2006 Ranbaxy+Unbranded Generics Business of GSK Acquisition (Italy and Spain) 2006 Ranbaxy + Be Tabs Pharmaceuticals, the 5th largest generics company in South Africa Acquisition 2006 Ranbaxy + Terapia, the largest generic pharma company in Romania Acquisition 2010 Sun Pharma Acquires controlling stake in Taro Pharmaceuticals (U.S.A) 2012 Sun Pharma + Dusa and Generics Segment of URL Pharmaceuticals Acquisition (U.S.A) 2015 Sun Pharma + Ranbaxy Acquisition
  • 7. 6© 2015 KPMG, an Indian Partnership and a member firm of the KPMG network of independent member firms affiliated with KPMG International Cooperative (“KPMG International”), a Swiss entity. All rights reserved. Segmentation of the Industry’s Business Lines Industry Segments Generics Specialty Complex Branded Consumer Medicine Protected Originals
  • 8. 7© 2015 KPMG, an Indian Partnership and a member firm of the KPMG network of independent member firms affiliated with KPMG International Cooperative (“KPMG International”), a Swiss entity. All rights reserved. Segmentation of the Business at Sun Major Business Segments (Sun Pharma) U.S. Generics Indian Branded Generics International Branded Generics (ROW except U.S.A) Active Pharmaceutical Ingredients (API) Major Market Categories (By Geography): • U.S Formulations: 5th largest generics company in US with one of the largest ANDA pipelines (159 ANDA’s awaiting approval) with 50% contribution to revenue in June, 2015. • Indian Generics: Leading position in high growth chronic therapies with Indian brand generics contributing 24% of total sales revenue in June, 2015.
  • 9. 8© 2015 KPMG, an Indian Partnership and a member firm of the KPMG network of independent member firms affiliated with KPMG International Cooperative (“KPMG International”), a Swiss entity. All rights reserved. Business Model 1. Plans to in-license products that are already marketed or are in late stage clinical development in key therapy areas such as CNS disorders, Cardiology, Diabetes and Metabolic disorders, Gastroenterology, Ophthalmology, Oncology, Pain, Allergy, Asthma, Inflammation and Gynaecology. 2. Strategic interest in in-licensing bio-similar products and new products based on recombinant/humanized monoclonal antibody technology used in the above therapy areas. 3. Out-licensing product range includes dosage forms for oral, injectable, topical and transdermal routes developed through non-infringing routes and/or patented routes. 4. Out-licensing sought for specialty generics, super generics, and bulk drugs in therapy areas such as CVS, CNS, Pain, Cancer, Gynaecology, Allergy, Asthma other respiratory diseases. 5. Focused on expanding in key markets such as Russia and CIS countries, China and South East Asia, Africa, Brazil and Mexico. Identify Promising New Molecules Test them in Large Clinical Trials Build Strong Product Portfolio Focus on Niche and Complex Molecules to Garner Premium to Peers Promote them with an Extensive Sales and Marketing Presence
  • 10. 9© 2015 KPMG, an Indian Partnership and a member firm of the KPMG network of independent member firms affiliated with KPMG International Cooperative (“KPMG International”), a Swiss entity. All rights reserved. Sequence of Metrics Analyzed Profits Revenues Revenue / Unit Customer Analysis Competitor AnalysisNo. of Units Sold Expenses Fixed Variable Metrics to be Determined within the Company over Time and Between Competitors in the same time period
  • 11. 10© 2015 KPMG, an Indian Partnership and a member firm of the KPMG network of independent member firms affiliated with KPMG International Cooperative (“KPMG International”), a Swiss entity. All rights reserved. Structure Pre-Transaction RANBAXY PUBLIC SHAREHOLDERS + CUSTODIANS 63.41%36.9% SUN PHARMA PUBLIC SHAREHOLDERS PROMOTERS AND PROMOTER GROUP 36.35% 63.65% DAIICHI
  • 12. 11© 2015 KPMG, an Indian Partnership and a member firm of the KPMG network of independent member firms affiliated with KPMG International Cooperative (“KPMG International”), a Swiss entity. All rights reserved. Structure Post-Transaction SUN PROMOTER AND SUN PROMOTER GROUP SUN PHARMA (MERGED ENTITY) 9% 36%55% DAIICHI PUBLIC SHAREHOLDERS (RANBAXY + SUN)
  • 13. 12© 2015 KPMG, an Indian Partnership and a member firm of the KPMG network of independent member firms affiliated with KPMG International Cooperative (“KPMG International”), a Swiss entity. All rights reserved. What Strategic Decision Impacted the Ranbaxy Acquisition? Problem Definition: What was the impact on- a. Revenue b. Costs c. Operational Efficiencies and Synergies PAT of Sun Pharma (Standalone) 2010-14 -3000 -2500 -2000 -1500 -1000 -500 0 500 1000 1500 2000 MAR '10 MAR '11 MAR '12 MAR '13 MAR '14 PAT (Rs. in Crore) PAT
  • 14. 13© 2015 KPMG, an Indian Partnership and a member firm of the KPMG network of independent member firms affiliated with KPMG International Cooperative (“KPMG International”), a Swiss entity. All rights reserved. Declining Revenues Post Dusa, URL Acquisitions in U.S.A in 2012 CAGR in Revenue [2012-14] = -(11.02)% Sun Pharmaceuticals (Standalone) Net Sales Revenue [2010-2014] 0.00 500.00 1,000.00 1,500.00 2,000.00 2,500.00 3,000.00 3,500.00 4,000.00 4,500.00 MAR '10 MAR '11 MAR '12 MAR '13 MAR '14 1,845.09 3,107.57 4,015.56 2,432.14 2,828.79 Net Sales (Rs. in Crore)
  • 15. 14© 2015 KPMG, an Indian Partnership and a member firm of the KPMG network of independent member firms affiliated with KPMG International Cooperative (“KPMG International”), a Swiss entity. All rights reserved. Increasing Costs Since Acquisition in 2012 0.00 500.00 1,000.00 1,500.00 2,000.00 2,500.00 3,000.00 3,500.00 4,000.00 4,500.00 MAR '10 MAR '11 MAR '12 MAR '13 MAR '14 1,845.09 3,107.57 4,015.56 2,432.14 2,828.79 Total Expenses (Rs. in Crore) Sun Pharmaceuticals (Standalone) Expenses [2012-14] CAGR in Expenses [2012-14] = 6.52%
  • 16. 15© 2015 KPMG, an Indian Partnership and a member firm of the KPMG network of independent member firms affiliated with KPMG International Cooperative (“KPMG International”), a Swiss entity. All rights reserved. Pricing Pressures Uniform throughout the Pharma Industry • Government-mandated price controls on 348 essential drugs in May, 2013 impacted prices of both MNC’s and local firms producing essential drugs. • A new Act, known as Drugs (Prices Regulation and Control) Act enacted to have effective control on prices, production, distribution and supply of medicines in India. • All customer segments are very sensitive to change in price of generics. • Thus, growth will be fueled only by increasing volumes.
  • 17. 16© 2015 KPMG, an Indian Partnership and a member firm of the KPMG network of independent member firms affiliated with KPMG International Cooperative (“KPMG International”), a Swiss entity. All rights reserved. • GlaxoSmithKline (GSK) and Sanofi Aventis were affected the most. Bottom lines of domestic drug makers such as Cipla and Cadila would also take a hit. • Least impacted were companies such as Sun Pharma and Lupin. • Some companies like GSK have created a Developing Countries Unit that caps prices at no more than 25% of the UK price and reinvests 20% of any profits back in the country it covers. GSK CFO Simon Dingemans says, “Price reductions [in China] are in many ways very important in driving up the access and take-up of healthcare coverage. We see very good volume response to that, which shows that the strategy is working.” (Bloomberg) Pricing Pressures Uniform throughout the Pharma Industry
  • 18. 17© 2015 KPMG, an Indian Partnership and a member firm of the KPMG network of independent member firms affiliated with KPMG International Cooperative (“KPMG International”), a Swiss entity. All rights reserved. Causes of Price Decline and Fall in PAT at Sun Pharma • Sun Pharma and Ranbaxy to hive off certain products due to CCI regulation, for the merger to become effective • Sun Pharma sold products under the Tamlet brand name and Ranbaxy divested 6 brands, leading to price erosion. Ranbaxy Divestments Eligard Triolvance Raciper L Terlibax Rosuvas EZ Olanex F
  • 19. 18© 2015 KPMG, an Indian Partnership and a member firm of the KPMG network of independent member firms affiliated with KPMG International Cooperative (“KPMG International”), a Swiss entity. All rights reserved. • One-time merger expenditure and high cost of integration of Ranbaxy • Debt reduction strategy to consolidate debt position • US$ 800 mn debt obligation of Ranbaxy at the time of merger to be serviced by Sun Pharma, reducing PAT • Regulatory expenses in the U.S. • Opportunity cost owing to new-product approval delays and clinical trial delays in the U.S leading to subdued PAT • US sales hit • Pricing pressure from channel consolidation • Customer Consolidation • Recalls from the Halol facility, which contributes 25% of consolidated profits • Currency Headwinds in Russia, Venezuela and other emerging markets Causes of Price Decline and Fall in PAT at Sun Pharma Source: Kanungo Soumanty, “Pharma firms to face US approval delays and currency headwinds this quarter too”, DNA, http://www.dnaindia.com/money/report-pharma-firms-to-face-us- approval-delays-currency-headwinds-this-quarter-too-2092157, Accessed on 4 June, 2015
  • 20. 19© 2015 KPMG, an Indian Partnership and a member firm of the KPMG network of independent member firms affiliated with KPMG International Cooperative (“KPMG International”), a Swiss entity. All rights reserved. Competitors in India – Consistently Growing Market Share of Sun [2000-13] Source: pp. 26, “Director’s Report”, Sun Pharmaceutical Industries Ltd., http://www.sunpharma.com/investors/annualreports, accessed on 2 July, 2015 Competitor Market Share Growth in India [2000-13]
  • 21. 20© 2015 KPMG, an Indian Partnership and a member firm of the KPMG network of independent member firms affiliated with KPMG International Cooperative (“KPMG International”), a Swiss entity. All rights reserved. Customer Analysis: Segmentation of Sources of Revenue Segmentation into Customer Segments by Geography Source: IR Presentation June 2015, Sun Pharmaceutical Industries Limited, Accessed on 30 June, 2015
  • 22. 21© 2015 KPMG, an Indian Partnership and a member firm of the KPMG network of independent member firms affiliated with KPMG International Cooperative (“KPMG International”), a Swiss entity. All rights reserved. Customer Segment in India: Falling Sales per Representative • In the largest market (U.S.A), sales have experienced consistent growth of 40.66% CAGR between 2012 and 2015 (INR 137 bn in 2015 including the impact of the Ranbaxy merger, up from INR 98 bn in 2014) and 438 ANDA’s have been approved in 2015, an increase of 15.05% from 2012. • In India, sales have increased consistently to INR 67 bn in 2015 (including the effect of the Ranbaxy merger), from INR 37 bn in 2014. However, a realignment to the preferred distribution channel preference of key customer segments may be required since the Sales per Representative has seen a sharp decline in 2015
  • 23. 22© 2015 KPMG, an Indian Partnership and a member firm of the KPMG network of independent member firms affiliated with KPMG International Cooperative (“KPMG International”), a Swiss entity. All rights reserved. High Price Sensitivity, Opportunity to Differentiate Product Price Sensitivity of Emerging Markets: Challenges for Upward Price Revision Enablers for Upward Price Revision Essential Drug List Revision in China; Government Cost Containment Measures in Brazil and Russia Increased Healthcare Investment by the Chinese, Brazilian, Russian and Indian Governments Slowdown in Economic Growth in Brazil and Russia Rising affluence of patients paying out-of-pocket for premium products in China Attempts at Differentiation of Products: Company Segment Pfizer, Sanofi Generics Novo Nordisk, Roche Specialty Boehringer Ingelheim, Bayer, GSK, Teva Consumer Health Product differentiation (except for brand equity) is not the most viable strategy in India, which follows process patents that favour imitators and generics manufacturers, opportunities to increase revenues or introduce cost competitiveness more viable
  • 24. 23© 2015 KPMG, an Indian Partnership and a member firm of the KPMG network of independent member firms affiliated with KPMG International Cooperative (“KPMG International”), a Swiss entity. All rights reserved. Opportunities in Pharmerging Markets: China Leads Spending; Brazil, India Follow Source: pp. 8, “2013-14 SPIL-Director’s Report and Management Discussion and Analysis”, Sun Pharmaceutical Industries Limited, http://www.sunpharma.com/, Accessed on 30 June, 2015 Split-Up of Revenue Spending and Contribution to Sales Growth [2012-17] by Customer Segments for the Pharma Industry * EU5 countries include Germany, France, Italy, Spain and the U.K
  • 25. 24© 2015 KPMG, an Indian Partnership and a member firm of the KPMG network of independent member firms affiliated with KPMG International Cooperative (“KPMG International”), a Swiss entity. All rights reserved. Rise of Generics in Pharmerging Markets (China, India, Brazil) • As the Pharmerging markets emerge, a global spending shift towards generics is forecasted. • Pharmaceutical Spending absolute growth in Pharmerging markets would increase from US$ 30 bn in 2012 to US$ 40 in 2017 (estimated) and spending on generics in these markets would increase from 58% in 2012 to 63% in 2017 (estimated). Pharmerging Economies (Based on the IMS Health Global Market Prognosis) Classification Based on Income Level, Growth Rate and Pharmaceutical Spend per Person
  • 26. 25© 2015 KPMG, an Indian Partnership and a member firm of the KPMG network of independent member firms affiliated with KPMG International Cooperative (“KPMG International”), a Swiss entity. All rights reserved. Drivers for Growth in Generics in Emerging Markets: Rise of Generics in Pharmerging Markets (China, India, Brazil) Generics are most affordable for govt. healthcare programmes and consumers Increasing Incidence of Chronic Diseases Increasing Life Expectancy and an Ageing Global Population Patent- protected brand volume growth set to shrink with patents expiring Weaker IP laws in some developing countries
  • 27. 26© 2015 KPMG, an Indian Partnership and a member firm of the KPMG network of independent member firms affiliated with KPMG International Cooperative (“KPMG International”), a Swiss entity. All rights reserved. Highest Growth in Generics in Pharmerging Economies Product Mix in Pharmerging Economies • Top 8 Mature Markets include U.K, France, Germany, Italy, Spain, Japan, U.S.A and Canada • LIC : Low Income Countries • LC $ : Constant Local Currency Dollars, used to smoothen out effects of exchange rate fluctuations • Pharmerging Economies, based on minimum anticipated added value to the global pharmaceutical market, as enumerated by IMS Health Global Market Prognosis include: Brazil, Turkey, Russia, China, India, Mexico, South Korea, Venezuela, Poland, Argentina, Vietnam, South Africa, Thailand, Indonesia, Egypt, Pakistan, Ukraine, Algeria, Colombia, Saudi Arabia and Nigeria
  • 28. 27© 2015 KPMG, an Indian Partnership and a member firm of the KPMG network of independent member firms affiliated with KPMG International Cooperative (“KPMG International”), a Swiss entity. All rights reserved. Strategy for Expansion in Generics in Pharmerging Economies • Between January 2008 and February 2013, India has seen 226 M&A deals in the Pharma Sector, with 81.4% of the deals involving local companies • Ranbaxy had a large product portfolio, established infrastructure linking its complex supply chain and excellent stakeholder relationships to boost inorganic growth when acquired. Integrated Distributors Large Portfolios Strong Brand Equity in the Local Market Efficiencies of Scale Attractiveness of Investing in Local Companies in the Target Market
  • 29. 28© 2015 KPMG, an Indian Partnership and a member firm of the KPMG network of independent member firms affiliated with KPMG International Cooperative (“KPMG International”), a Swiss entity. All rights reserved. SWOT Analysis of Sun Pharma • Established brand Market leader in dermatology (U.S), specialty chronic segment and branded generics (India) Strengths Weaknesses ThreatsOpportunities • Focus on access to generic products, market presence and technology • Differentiation of products by focusing on complex generics • Increasing share of branded specialty drugs • Achieve critical mass in key markets • Branded generics growth will slow down due to payer pressure to reduce costs via commoditization • Improved manufacturing standards would reduce the brand proposition of branded generics and unprotected originals leading to large price cuts • Consolidation would lead to low margins and difficult cost structure for sophisticated MNC’s to replicate • Karkhadi facility faces restrictions in approval of its Abbreviated New Drug Applications [ANDA’s] by the USFDA due to its non-compliance with certain current Good Manufacturing Practices (cGMP)
  • 30. 29© 2015 KPMG, an Indian Partnership and a member firm of the KPMG network of independent member firms affiliated with KPMG International Cooperative (“KPMG International”), a Swiss entity. All rights reserved. Leveraging Opportunities and Strengths: Long-Term Strategy at Sun • Sustainable Revenue and Cash Flow Stream: • Targeting complex / differentiated products in key markets • Focus on fast-growing chronic therapies and timely product launches • Using Investments to Develop Complex Products and Turning Around Underperforming Acquisitions • Cost Leadership • Vertical Integration • Optimisation of Operational Expenses • Closer links between the back-end and supply chain
  • 31. 30© 2015 KPMG, an Indian Partnership and a member firm of the KPMG network of independent member firms affiliated with KPMG International Cooperative (“KPMG International”), a Swiss entity. All rights reserved. Synergies and Challenges Post the Ranbaxy Acquisition Synergies • All-Stock Deal used to leverage Sun’s huge Market Cap, Cash preserved for future deals, CAPEX • Sun will be in the top spot in 13 Therapy segments, up from 7 in 2014 • Better Over-the-Counter Portfolio in India • Better Dermatology Franchise in India (55% of Ranbaxy Sales) • Strong presence of Ranbaxy in India and other Emerging Markets Challenges • Regulatory Turnaround needed to access Ranbaxy’s Product Pipeline • US$ 500 mn in payments to the US Department of Justice for manufacturing violations may have affected brand equity of Ranbaxy • Increased competition in the Generics Segment (high dependence on Absorica of Ranbaxy) • Lower Sales Growth, Margin, Returns, which means Pay Back Period might exceed 6 Years Source: “Finding a Cure”, Business Today, http://businesstoday.intoday.in/story/sun-pharma-buys-ranbaxy-implications-profits-debt-usfda/1/205241.html, accessed on 1 July, 2015
  • 32. 31© 2015 KPMG, an Indian Partnership and a member firm of the KPMG network of independent member firms affiliated with KPMG International Cooperative (“KPMG International”), a Swiss entity. All rights reserved. Capabilities of the Company Post Acquisition • The tax burden can be alleviated for 8 years following the transaction as the Income Tax Act allows for the losses of Ranbaxy to be set off the profits of Sun Pharma for the aforementioned period. • The merged entity will have a highly complementary portfolio of specialty and generics targeting chronic and acute treatments globally. • Presence in 55 markets and capabilities across specialty branded products and complex generics. • In the U.S.A, no. 1 in generic dermatology and no. 3 in the branded dermatology market. Pro-forma U.S. revenues to be about US$ 2.2 bn with a strong capability in developing complex products. • In India, Sun Pharma will become the largest pharmaceutical company with over 9% market share. No. 1 by prescriptions across 13 different classes of specialist doctors in India. Pro forma revenues in India will be about US$ 1.1 bn. • Ranbaxy will add to competitive edge in acute care, hospitals and OTC businesses with robust brands. • 31 amongst top 300 brands and greater distribution reach. • Foundation for OTC business in India. • The target is to generate synergy benefits of about US$ 250 mn by the third year- driven by revenue, procurement, supply chain and other cost synergies.
  • 33. 32© 2015 KPMG, an Indian Partnership and a member firm of the KPMG network of independent member firms affiliated with KPMG International Cooperative (“KPMG International”), a Swiss entity. All rights reserved. • ANDA: An Abbreviated New Drug Application is an application that allows the applicant to manufacture and market the generic drug product to provide a safe, effective, low cost alternative to more expensive licensed medications. • API: Active Pharmaceutical Ingredient refers to the active or central ingredient in the drug product which causes the direct effect on the disease diagnosis, prevention, treatment or cure. • Branded Generics: A branded generic is a drug that is bioequivalent to the original product, but is now marketed under another company's brand name. • Complex Drugs: Drugs with complex active ingredients, formulations routes of delivery or drug- device combinations. • Generics: A drug product that is comparable to a brand in dosage form, strength, quality, performance characteristic and intended use. Instead of a brand name or registered trademark, they carry either the name of the manufacturer or the nonproprietary name of the drug. Generic products are available once the patent protections afforded to the original developer have expired. Market competition often leads to substantially lower prices for both the original brand name product and the generic forms. • In-Licensing: The business model of acquiring one or more products still in pre-clinical or clinical development (fairly advanced stages of development) and focusing on its product development and launch. The skills involved are therefore medical and clinical, rather than relating to discovery. Glossary
  • 34. 33© 2015 KPMG, an Indian Partnership and a member firm of the KPMG network of independent member firms affiliated with KPMG International Cooperative (“KPMG International”), a Swiss entity. All rights reserved. • Specialty Drugs: Drugs that are expensive, have limited access, complicated treatment regimens, compliance issues, special storage requirements and manufacturer reporting requirements. • Out-Licensing: The business model of a company that seeks a partner in the development and co- marketing of its compound from the late-stage clinical trial phase to the product launch phase. This is a strategic way to continue to generate value from pipeline assets, while sharing the risks and high costs inherent in any R&D program. • OTC Drugs: A drug for which prescription is not needed. • US FDA: The Unites States Food and Drug Administration is responsible for protecting and promoting public health through the regulation and supervision of food safety, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals and other similar consumer products. Glossary
  • 35. 34© 2015 KPMG, an Indian Partnership and a member firm of the KPMG network of independent member firms affiliated with KPMG International Cooperative (“KPMG International”), a Swiss entity. All rights reserved. External Sources • “2013-14 SPIL-Director’s Report and Management Discussion and Analysis”, Sun Pharmaceutical Industries Limited, http://www.sunpharma.com/investors/annualreports , Accessed on 30 June, 2015 • “IR Presentation, June 2015”, Sun Pharmaceutical Industries Limited, http://www.sunpharma.com/investors/annualreports, Accessed on 30 June, 2015 • “Pharmerging Markets- Picking a Pathway to Success”, Q2 IMS Pharmerging white paper 06-2013 (2013), Accessed on 30 June, 2015 • Jackson Richard et. al, “Global Aging and Future of Emerging Markets” (2011: Centre for Strategic and International Studies and Everest Capital), pp. 2-4 • “Govt. to regulate prices of 652 medicines, prices set to fall”, ET, http://articles.economictimes.indiatimes.com/2013-05-17/news/39336744_1_essential-drugs-price- control-indian-pharmaceutical-alliance, Accessed on 30 June, 2015 • Kanungo Soumanty, “Pharma firms to face US approval delays and currency headwinds this quarter too”, DNA, http://www.dnaindia.com/money/report-pharma-firms-to-face-us-approval-delays- currency-headwinds-this-quarter-too-2092157, Accessed on 4 June, 2015 • Sharma Kumar, “Finding a Cure”, Business Today, http://businesstoday.intoday.in/story/sun-pharma- buys-ranbaxy-implications-profits-debt-usfda/1/205241.html, Accessed on 1 July, 2015
  • 36. Thank you Presentation by Abhishek Ghosh Summer Trainee KPMG, Lodha Excelus Mumbai
  • 37. The KPMG name, logo and “cutting through complexity” are registered trademarks or trademarks of KPMG International. © 2015 KPMG, an Indian Partnership and a member firm of the KPMG network of independent member firms affiliated with KPMG International Cooperative (“KPMG International”), a Swiss entity. All rights reserved.