Transcript Ranbaxy Laboratories Limited

Ranbaxy Laboratories
Limited
To become a Research based International
Pharmaceutical Company
UBS Global Generic and Specialty Pharmaceuticals Conference
New York
May 8, 2007
Safe Harbor
Except for the historical information contained herein, statements in this presentation and the
subsequent discussions, which include words or phrases such as “will”, “aim”, “will likely result”,
“would”, “believe”,
“may”, “expect”, “will continue”, “anticipate”, “estimate”, “intend”, “plan”,
“contemplate”, “seek to”, “future”, “objective”, “goal”, “likely”, “project”, “should”, “potential”, “will pursue”
and similar expressions or variations of such expressions may constitute "forward-looking statements".
These forward-looking statements involve a number of risks, uncertainties and other factors that could
cause actual results to differ materially from those suggested by the forward-looking statements. These
risks and uncertainties include, but are not limited to our ability to successfully implement our strategy,
our growth and expansion plans, obtain regulatory approvals, our provisioning policies, technological
changes, investment and business income, cash flow projections, our exposure to market risks as well
as other risks. Ranbaxy does not undertake any obligation to update forward-looking statements to
reflect events or circumstances after the date thereof.
Key Drivers of Growth
Value of Drugs going off patent 2006 - 11
35
Significant patent expiries
through 2011
30
25
20
15
10
5
0
2006
2007
2008
2009
$ Bn
2010
2011
Source : IMS
Increasing genericisation
France
Spain
Italy
Accelerating branded generics
Russia
Rationalizing Healthcare costs
- key priority for Governments
South Africa
India
Key Issues
Increasing competition
Increasing focus on costs
Consolidation - Changing Landscape
Source: UBS, Business World, 30th October 2006
The India Pharma Story – Davos 2006
Source – Financial Times
Scientific Manpower Output
Number of Higher Education Institutions
Number of Students enrolled in
Higher Education Institutions
05/06
18,123
+59%
00/01
11,412
05/06
10,500
90/01
5,932
00/01
7,500
80/01
4,861
90/01
4,000
80/01
3,000
Source: Indian University Grants Commission
Number of Institutions courses
Source: Indian University Grants Commission
PhD Degree awarded in Science
05/06
99/00
Pharmacy
1478
669
+120%
03/04
5408
Medicine
229
174
+32%
00/01
3734
205
52
+294%
90/01
2950
Physiotherapy
(USA 03/04
Source: Pavan Agarwal (2006) based on data
from professional councils
+40%
+44%
25,000)
Source: Indian University Grants Committee
The Education Advantage
Engineers/Science graduates p.a. – India 0.7 mn, China 0.5 mn, EU 0.5 mn, USA 0.4 mn, Japan 0.3 mn
India in Global Generics
% Share of USA DMF filings
India
China
2004
27%
9%
2005
37%
10%
Highest No
2006
44%
14%
of DMF filings
Q4’06
47%
9%
Source: US FDA / J P Morgan Research
FDA Approved
Plants in India
India in Global Generics
ANDA Filings in USA by Indian Companies
160
144
120
80
64
46
40
24
0
2002
2003
2004
2005
One in every four ANDAs filed by Indian Companies in top US FDA filers
(Source: KPMG)
No Chinese generic company has yet filed a US FDA ANDA but expected
in 2008
Ranbaxy Today
Worldwide Presence
Amongst Top 10 Global Gx companies
Ground presence in 49 countries,
products sold in > 125
International business ~ 80% of sales
Manufacturing locations in 11 countries
Global Sales
$ 1339
> 11,000 employees, 51 nationalities
Strong Generics & Innovative research
$ 972
capabilities
$ 553
2001
2003
2006
Highlights - 2006
Financials
$ Mn
2006
2005^
%
Sales
1339
1145
+17%
EBIDTA*
16%
7%
-
PAT
114
60
+90%
Strong growth in USA
Markets
Leadership position in home market
Robust performance in Branded Gx
markets
Exclusivity in Simvastatin 80 mg tablets
Inorganic impetus
* % sales, ^ excludes sales from discontinued operations .i.e . Allied Businesses divested in 2005
Increasing Focus on Costs
Sales growth +17%
SGA growth - Nil
Optimizing SG&A cost structures
2006
Improving R&D cost efficiencies
% Bio-Studies (BA/BE^) conducted
2006
2005
In-House
71%
28%
Overseas CRO
8%
61%
Indian CRO
21%
11%
Advanced Markets
Increasing sourcing from low cost
countries .i.e. India & China
2005
35%
2005
Low Cost Countries
20%
65%
80%
2008*
* Estimate, ^ Bio-Analytical / Bio - Equivalence
Geographic Sales Split - 2006
Africa
$85, +24%
Europe
$332, +23%*
6%
25%
27%
Asia
$367, +19%
Global Sales – 2006 (US$ Mn)
33%
DF
1224
+20%
API
115
- 9%
1339
+ 17%
Total
Americas
$440, +18%
Sales 2006 – Dosage Forms US$ 1224 Mn
Key New Markets – Canada, Spain, Italy, Australia & Japan
* Including CIS, RoW – Rest of the World
Geographic Sales Split – Q1 2007
Africa
$85, +24%
Europe
$332, +23%*
7%
31%
Global Sales – Q1 2007 (US$ Mn)
27%
Asia
$367, +19%
29%
DF
332
+30%
API
23
- 25%
Total
355
+ 24%
Americas
$440, +18%
Sales Q1 2007 – Dosage Forms US$ 332 Mn
* Including CIS, RoW – Rest of the World
USA
Sales
Strong growth in USA, +15%
$ 380
$ 332
Simvastatin 80 mg 180 day exclusivity
- Market Share (MS) of 56%
Increasing No of Prescriptions
+15%
- Q1 2005 - 10.8 Mn
- Q1 2006 - 12.5 Mn
- Q1 2007 - 14.1 Mn
Cumulative chain store listings at 1057
(44 added in Q1 ’07)
2006
Branded business growth at 20%
OTC
2005
Brands
Generics
Source (Market Share) : IMS
USA Product Pipeline
Cumulative ANDA Filings
199 cumulative filings
Innovator Market Size
111 approvals
- 88 ANDAs – US$ 56 Bn
88 pending approval
- 20 FTF – US$ 26 Bn
~ 20 FTF ANDAs
2006 - 27 filings
- 10 approvals
Source (Market Size) : IMS
USA
Products pending approval
200
Second largest
pipeline
# of ANDAs
160
120
80
40
0
Teva
Ranbaxy
Sun
Mylan
Watson
DRL
Barr
Par
Source: Merrill Lynch Equity Research, February 2007
USA
Potential FTF Challenges
45
Second largest
FTF pipeline
27
18
9
n
Su
Pa
r
ar
r
B
so
n
at
W
yl
an
M
R
L
D
xy
an
ba
R
va
0
Te
# of FTFs
36
Source: Merrill Lynch Equity Research, February 2007
European Union
Sales
Presence in 23 of the 27 EU countries
300
$ 267
Regulatory changes & price impacted
250
Romania
Western European markets
Strong product flow in ’07 with
multiple Day 1’s
Major countries
$ 214
200
150
100
- Germany : AOK business
- France
: Supplies from India
- UK
: Gabapentin launch
50
0
RoE to maintain growth momentum
$ Mn
2006
2005
India
Fastest growing Company in India on MAT basis
Ranbaxy
(Source :ORG-IMS Mat Mar 2007)
GSK
65 new products introduced in 2006
5.0%
Cipla
5.1%
4.9%
First to market
10
NDDS
6
In-licensed
8
Source : ORG – IMS Audit Nov 2006, Moving Quarter Basis
No 1 NDDS Company with 8% MS. Contribution to total sales ~ 9%
Dedicated task forces for Specialized & Chronic therapies
Chronic share contribution at 21% (2005 : 20%)
21 brands in Top 300 of Industry ( 2005 :19)
Source : IMS - ORG
Research & Development
New R&D facility for Drug
Discovery Research (DDR)
R&D III
R&D I
R&D II
R&D IV
Research & Development
Dedicated Facilities for Innovative & Generics Research
> 1400 R&D Personnel ( ~ 250 PhD’s)
8 - 10 NCE molecules in pipeline
NDDS based products ( 4 platform technologies)
R&D collaborations
Alliance /
Collaboration in
DDR
Out-licensing
in DDR
Out-licensing
in NDDS
Ranbaxy – GSK Collaboration
Expansion of strategic alliance established in 2003
Take leads beyond candidate selection to POC* in man
Therapeutic area focus of AI, Metabolic, Anti-inflammatory
and Oncology
> US$ 100 mn in milestone payments and double digit
royalties on commercialization of a product
Co- marketing rights in India
First candidate identified for Respiratory Inflammation
Proof of Concept
Ranbaxy – NCE Pipeline
Molecule
Status
Remarks
RBx 11160
(Malaria)
Under Phase II B trials
Agreement for part
(with Piperaquine)
funding by DST*
RBx 10558
(Dyslipidemia)
IND approval received
RBx 9841
Phase I trials
Out-licensed to PPD Inc.
from DCGI* (India) in May ‘06
(Urinary Incontinence)
Out-licensing opportunity
being explored
Candidate Selection
GSK Program - COPD / Asthma
5 molecules under lead
RBx 10017876 - Inhalation PDE IV B, COPD/ Asthma
optimization including
RBx 10020025 - Tiotropium like , MRA inh., COPD / Asthma
1 with GSK
RBx 10014255 - Anti infective, Macrolide / Ketolide
RBx 10019821 - Diabetes, DPP IV
* Department of Science & Technology, Drug Controller General of India
Ranbaxy – NCE Progress
Department of Science & Technology (DST) part funding
on 3 molecules
Scientific Advisory Board comprising 6 globally
renowned scientists
GSK – 1 milestone triggered
Therapeutic Focus - Anti-infectives (Malaria)
- Anti-inflammatory (COPD/ Asthma)
- Metabolic diseases (Diabetes)
- Oncology
Unprecedented : Precedented targets ratio – 40:60
Generic Research & Development
27 ANDA filings in USA
33 Filings in the European Union
2006 Product Filings & Approvals
Dosage Forms
Key Country / Region
API
Filings
Approvals
Filings
Approvals
USA
27
10
15
5
European Union
33
32
100
117
BRICS
95
71
14
12
Rest of World
462
474
42
22
Total
617
587
171
156
Excludes India for API approvals, EU filings and approvals include Mutual Recognition Procedure (MRP) and
De-centralized Procedure (DCP) filings and approvals.
Recent Acquisitions & Alliances
Terapia (Romania)
Zenotech (India)
Be-Tabs (South Africa)
Krebs (India)
Allen (Italy)
Jupiter Biosciences*(Ind.)
Ethimed (Belgium)
Cardinal Drugs (India)
Mundogen (Spain)
Auto-injector Tech.(USA)
* Subject to due diligence
Niche Alliances
Increasing focus on chronic / lifestyle diseases segment
High entry barriers - technology & resource intensive
Zenotech
Jupiter*
Bio-similars &
Peptides
Oncologics
Krebs
Fermentation
based products
* Subject to due diligence
Enhancing In-house Technologies
Penems
Market size worldwide of ~ US$ 1.5 bn
Imipenem + Cilastatin launched in India, China, Africa,
APAC
Key US / EU launches beginning 2009
Limuses
Global market size in excess of US$ 1.5 bn
Ex - US / EU launches beginning 2008
Well placed for US / EU launches
Worldwide market in excess of US$ 5 bn
Oral High Potency
Non-cytotoxics
Patents expiring from 2008 onwards
Day 1 launches planned for US / EU
Financials
Figures in US$ Mn
Particulars
2006
%
Q1 2007
%
Sales
1339
17%
355
24%
EBITDA
207
% sales
16%
144%
43
12%
35%
OPBT*
131
481%
36
102%
PBT
144
226%
37
94%
PAT
114
90%
29
81%
* 2005 sales excludes sales from discontinued operations .i.e Allied Businesses. OPBT – Operating profit before tax
In Summary
A strong 2006 performance on all parameters
Buoyant performance across key geographies
Continuing focus on cost optimization
Robust product flow
Growth through organic & inorganic
Discovery pipeline progressing well
Global Generic rank – 9th / 10th
Thank You …
Ranbaxy at the UBS Global Generic and Specialty Pharmaceuticals Conference
New York
May 8, 2007