E - Glenmark
E - Glenmark
E - Glenmark
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Disclaimer<br />
This presentation has been prepared by <strong>Glenmark</strong><br />
Pharmaceuticals Ltd. All information, statements and analysis<br />
made in this presentation describing company’s objectives,<br />
projections and estimates are forward looking statements and<br />
progressive within the meaning of applicable security Laws<br />
and Regulations. The analysis contained herein is based on<br />
numerous assumptions. Actual result may vary from those<br />
expressed or implied depending upon economic conditions,<br />
government policies and other incidental factors. No<br />
representation or warranty, either express or implied, is<br />
provided in relation to this presentation. This presentation<br />
should not be regarded by recipients as a substitute for the<br />
exercise of their own judgment.
Contents<br />
Background<br />
Strategy and Business Units<br />
Business Unit Overview<br />
Financials and Projections<br />
Summary
Background<br />
History<br />
Identity / Scope<br />
Global Footprint<br />
Financial<br />
Performance<br />
Market<br />
Capitalisation<br />
29-year old company<br />
Went public on Indian bourses in 1999<br />
Integrated, operating in Research,<br />
Manufacturing & Marketing of Pharmaceuticals<br />
Business interests span formulations and bulk<br />
activities<br />
Headquartered in Mumbai, India<br />
Operates in over 80 countries<br />
About 42% of revenues in FY 2006 from outside<br />
India<br />
Results in FY 2006 [ending March 31, 2006]:<br />
• Consolidated revenues of ~ $171 Mn<br />
• Consolidated Profit after Tax of ~ $20.5 Mn<br />
~USD 888 Mn [as at May 3, 2006]
Strategy and Business<br />
Units
Strategic roadmap: Transform into a specialty company<br />
through research<br />
Learning from Trends The transformation plan<br />
• Growing through generics alone is not a<br />
long-term value creator<br />
• Differentiation is key – but close to<br />
impossible in the generic space<br />
• Niche therapy segments offer good<br />
opportunity for value growth in generics<br />
space<br />
• Ownership of IP is critical to<br />
differentiation and value growth<br />
• NCE research is a large opportunity; but<br />
success in biologics can help leap-frog<br />
industry evolution<br />
• Taking proprietary molecules through all<br />
development phases is beyond our<br />
current skill-set and risk-appetite<br />
• Several markets are below the radar<br />
screen for bigger branded pharma<br />
players<br />
• Focus on building IP assets today, the key<br />
engine for this transformation<br />
• Out-license IP to drive/fund drug<br />
development<br />
• Retain/acquire IP rights for markets under<br />
the “radar” screen<br />
• In parallel, seek out such markets with<br />
growth potential and build a branded generic<br />
marketing foot-print in areas of dermatology,<br />
respiratory and oncology<br />
• Build and launch portfolios of generic<br />
products in the US niche segments like<br />
Dermatology and Controlled Substances<br />
• Subsequently, transform branded generics<br />
to specialty businesses: launch <strong>Glenmark</strong>brand<br />
novel drugs
Execute through Business Units aligned to Strategy<br />
Organized by Business Units<br />
CEO<br />
R&D<br />
Generic Formulations API<br />
Biologics<br />
(Swiss)<br />
India<br />
Formulati<br />
ons<br />
Less<br />
Regulated<br />
Markets<br />
Latin<br />
America<br />
NCE USA EU API
Build proprietary pipeline of NCEs/Biologics in high<br />
growth areas with good licensing potential<br />
RESEARCH FOCUS<br />
NCE RESEARCH BIOLOGICS<br />
Metabolic Disorders<br />
• Diabetes (Type II)<br />
• Obesity<br />
Inflammation<br />
• Asthma/COPD<br />
•Pain<br />
UNDISCLOSED THERAPIES AND<br />
TARGETS<br />
NCE Research – In Mumbai, India<br />
• Focused capability building over 5 years –<br />
170 scientists, spend ~5% of revenues<br />
• Eminent scientific advisory board<br />
• Five validated targets; 3 more planned<br />
• 6 leads – 2 in Ph II, 2 entering Ph I shortly<br />
and 2 in Pre-clinical<br />
• Target: One NCE into clinics every year<br />
Biologics Research – In Switzerland<br />
• Lab commissioned –15+ researchers<br />
by 2006<br />
• Invest to build capability until 2009-10<br />
• Start with bio-improvics; new drugs by<br />
2008<br />
• Target : Ph 1 on first lead by 2009<br />
License out the leads to partners for the markets of North America, Europe and Japan;<br />
retain marketing rights for rest of the world
Research and Development
NCE Research & Development<br />
Plan to progress 6 compounds in clinical trials in FY 2007<br />
Compound Target Primary Indications Status Target<br />
Launch<br />
GRC 3886<br />
(Oglemilast)<br />
PDE 4<br />
Asthma, COPD<br />
Ph II 2009/10<br />
GRC 8200 DPP IV Diabetes (Type II) Ph II 2010<br />
GRC 6211 VR 1 Osteoarthritis, Migraine,<br />
Incontinence, Asthma<br />
GRC 10622 CB 2 Neuropathic and<br />
inflammatory pain<br />
Ph I in<br />
Sept,06<br />
GRC 10389 CB 1 Obesity Ph I in Q4,<br />
FY07<br />
GRC 4039 PDE 4 Rheumatoid Arthritis,<br />
Inflammation<br />
2011<br />
Ph I in Nov,06 2012<br />
Ph I in<br />
Q1,FY08<br />
2011<br />
2012<br />
<strong>Glenmark</strong> will target concluding 2 licensing collaborations in FY 2007
NCE Pipeline<br />
Lead Target Indication Stage Status<br />
GRC 3886<br />
(Oglemilast)<br />
GRC 8200<br />
PDE 4<br />
DPP IV<br />
Asthma,<br />
COPD<br />
Diabetes<br />
(Type II)<br />
Ph II • Currently 2 Ph II trials underway for “exercise induced<br />
asthma” and “antigen challenge”; enrollment complete<br />
for the first study, top line results likely by Nov FY07<br />
• Phase II B for Asthma, COPD likely to begin Jan FY07<br />
• $ 30 Mn expected from Forest Inc. this year<br />
• In discussions with potential European Partners<br />
Ph II • Currently 2 Ph II trials underway in South Africa and<br />
India<br />
• Plan to file IND with USFDA in Feb/March FY07<br />
• Currently in advanced discussions with big pharma<br />
company for licensing for US, Europe, Japan and cocommercialization<br />
in RoW with <strong>Glenmark</strong> having<br />
exclusive rights for India.<br />
• Expect to conclude a deal in FY07
NCE Pipeline<br />
Lead Target Indication Stage Status<br />
GRC 6211 VR 1 Osteoarthriti<br />
s, Migraine,<br />
Incontinenc<br />
e, Asthma<br />
GRC 10622 CB 2 Neuropathic<br />
and<br />
inflammator<br />
y pain<br />
Ph I in<br />
Sept,06<br />
Ph I in<br />
Nov,06<br />
• Exciting target – after Merck licensed compound from<br />
Neurogen (currently in Ph I) and Pfizer licensed<br />
compound from Renovis (currently in pre-clinicals)<br />
• <strong>Glenmark</strong> currently in discussions for potential<br />
licensing. Timing of licensing would depend on the deal<br />
terms and ability to get co-promotion rights in some of<br />
the regulated markets. Expect to finalize partner by<br />
end-FY 07<br />
• <strong>Glenmark</strong> could be 2 nd in class with this compound<br />
• Likely to be first/second in class with an oral CB2<br />
Agonist. Currently Pharmos has an IV compound in Ph<br />
II and GSK has an oral compound in Ph I<br />
• Very exciting target as non-narcotic, peripherally acting,<br />
excellent pain-control and without addiction potential<br />
associated with Opoids. Potential applications in<br />
Rheumatoid Arthritis.<br />
• Currently in discussion with several big-pharma<br />
companies for potential licensing – expect to finalize<br />
partner by end FY07
NCE Pipeline<br />
Lead Target Indication Stage Status<br />
GRC 10389 CB 1 Obesity Ph I in<br />
Q4,<br />
FY07<br />
GRC 4039 PDE 4 Rheumatoi<br />
d Arthritis,<br />
Inflammatio<br />
n<br />
Ph I in<br />
Q1 FY08<br />
• Timelines delayed by 3-6 months for lead-optimization<br />
to differentiate us from existing drugs in development<br />
• Though Rimonabant (Sanofi-Aventis) is approved in<br />
EU, not an ideal candidate due to safety aspects<br />
• <strong>Glenmark</strong>’s lead target profile with clearly differentiate<br />
us on aspects of safety and drug metabolism<br />
• Though lead will enter Ph I in end-FY07, we expect to<br />
be third/fourth in class with a clear differential over<br />
existing compounds<br />
• After the withdrawal/setback of COX-2’s and the void<br />
that exists in RA therapy, we believe this could be a<br />
potential block-buster opportunity<br />
• The lead is also showing promise in Animal models in<br />
RA and other inflammatory conditions
Biologics research in Switzerland in early phase<br />
Swiss Presence<br />
• Diversifying research activities<br />
to cover biologics<br />
• Bioimprovics and New biologics<br />
in the future – biosimilars to<br />
build skill-sets in the near term<br />
• Biologics Research Centre<br />
established<br />
• Employed scientists with<br />
Biologics Research experience<br />
from Switzerland and Europe
Generic Formulations
Overview: Build/consolidate “branded generic” marketing<br />
footprint: Emphasis on the top 15 RoW countries<br />
RoW accounts ~12% of Global Pharma<br />
Market…<br />
…but 15 country markets contribute ~ 90%<br />
of ROW Market<br />
(2005 sales in $ Bn)<br />
265<br />
$ 21 bn<br />
Acquire<br />
• Africa: Egypt<br />
• AsiaPac/ME: China,<br />
Indonesia<br />
170<br />
6<br />
60 64<br />
90%<br />
$ 16 bn<br />
$ 27 bn<br />
Enter<br />
or<br />
Ally<br />
Grow<br />
• AsiaPac/ME: Australia,<br />
Saudi Arabia, S Korea<br />
• Africa: SA, Nigeria<br />
• Lat Am: Brazil, Argentina<br />
• AsiaPac/ME: Philippines,<br />
India, S Lanka, Malaysia,<br />
Russia<br />
US EU Japan ROW<br />
These 15 country markets are jointly growing at an annual rate of over 15% that will put<br />
them at 20% of the Global Pharma market by 2012
Overview: Acquire branded generic footprint in EU;<br />
market generics in the US market through own front-end<br />
EU Market<br />
US Market<br />
• Focus on select branded generic markets:<br />
Spain, Italy, Central and Eastern European<br />
Countries<br />
• Acquire privately held front ends<br />
– Euro 8-12 Mn Sales, cash generating<br />
– Pipeline in place for next 2-3 years<br />
– Good local brand equity<br />
– High overlap in prescriber base with<br />
our research focus<br />
• File and launch branded generics through<br />
own front-ends; also provide dossiers to<br />
partners for non-core markets<br />
• Partner with players to fund high cost<br />
developments – share marketing rights<br />
• Remain focused on generics<br />
• Market products to distributors, chains,<br />
wholesalers through own front-end<br />
• Combination of Make/Partner/Buy to build<br />
depth of portfolio rapidly<br />
– Own development<br />
– Product development alliances<br />
– Acquire registrations<br />
– Licensing marketing rights<br />
• Focus own development on specific niches<br />
with greater margins/sustainability:<br />
Dermatology and controlled substances<br />
• Use own API for cost advantage
India Formulations<br />
Current Status: FY 2006<br />
Revenue growth of 30% over FY 2005, 39% growth in March 2006 [ORG-<br />
IMS]<br />
Ranked #2 in dermatology (after GSK), strong presence in over 10<br />
segments including female healthcare, paediatrics, respiratory, antiinfectives,<br />
cardiovascular, diabetology<br />
Increased focus on chronic lifestyle diseases<br />
Launched 45 new products and novel combinations including 15 first<br />
generics such as Strontium Ranelate, Diacerin, Eplerenone, Acitretin, S-<br />
ibuprofen<br />
Created 7 retail divisions, 1 institutional division for improved focus<br />
Grew field force (currently 1700 medical representatives) and increased<br />
focus on productivity improvements<br />
Driving supply chain cost down; new plant at Baddi for tax-efficiencies<br />
Commenced in-licensing and co-marketing tie-ups for novel products
India Formulations<br />
Segment Contribution to Revenue: Diversified across therapies<br />
Segment Contribution<br />
ORG MAT Mar 2005<br />
Alimentary T. &<br />
Metabolism<br />
Blood + B. Forming<br />
Organs<br />
Segment Contribution<br />
ORG MAT Mar 2006<br />
15% 3% 15%<br />
1%<br />
13% 5%<br />
12%<br />
4%<br />
32%<br />
Cardiovascular<br />
System<br />
Dermatologicals<br />
G. U. System & Sex<br />
Hormones<br />
Systemic Anti-<br />
Infectives<br />
7%<br />
14%<br />
17%<br />
4%<br />
3%<br />
16%<br />
32%<br />
1%<br />
Musculo-Skeletal<br />
System<br />
Respiratory<br />
System<br />
Sensory Organs<br />
6%
India Formulations<br />
Moving forward, the plan…<br />
Grow revenues by 10% p.a.<br />
Initiate presence in new segments: Oncology, Probiotics<br />
Strengthen presence in respiratory, pain management and metabolic<br />
diseases – in preparation for own NCE launches<br />
Grow mass-market division: Milieus through increased product launches,<br />
sales force hires and geographic expansion<br />
Increase in-licensing efforts for novel products to augment own pipeline<br />
Continue launching differentiated branded generics; focus on building<br />
power brands<br />
Improve cost-efficiencies and cash-cycle management
Less Regulated Markets<br />
Status in FY 2006<br />
Posted 25% growth in revenues<br />
Acquisition in South Africa – entry point<br />
to the largest African market; key<br />
requirement to expand presence in<br />
Africa<br />
Expansion to 7 other countries during<br />
the year<br />
Completed over 400 filings and received<br />
over 300 approvals for products across<br />
markets<br />
Consolidated position in existing<br />
markets: increased field force, launched<br />
many new products, reviewed portfolio<br />
to meet local requirements<br />
Plan going forward…<br />
Consolidate position in Russia<br />
Expand in South Africa – use the India<br />
advantage to file several products<br />
Focus on high potential country markets<br />
Diversify portfolio to include an oncology<br />
line – leverage the acquisition of<br />
Servycal in Argentina<br />
Continue registration of products across<br />
geographies<br />
Achieve over 40% growth in revenues<br />
over FY 2006<br />
Evaluate acquisition candidates in highpotential<br />
RoW markets
Latin America<br />
Status in FY 2006<br />
Acquired a company (Servycal) in Argentina: Provides opportunity to build an<br />
Oncology franchise across Latin America, going forward<br />
Expanded field force and also commenced commercial operations in several<br />
additional countries : Presence in 10 countries (including Brazil and Argentina) in<br />
Latin America<br />
Focused on specific therapeutic segments: Respiratory, Dermatology, Gynaecology.<br />
Grew by 197% over FY 2005 in Brazil<br />
Filed 19 dossiers in the key market of Brazil; obtained 11 product approvals and<br />
launched the products towards latter half of the year<br />
Completed the integration with India: ANVISA approval for Goa and Nasik plants,<br />
and 72-bed clinical trial unit for bio-equivalences
Latin America<br />
Going forward<br />
Expand presence in Oncology to other Latin American markets: use<br />
Argentina as the hub<br />
File over 50 dossiers in markets across Latin America with about 33 in<br />
Brazil. Launch 27 new products in Brazil.<br />
Margin expansion through increasing revenue for products filed from<br />
Indian parent<br />
Divisionalisation for greater focus – focus on high margin segments<br />
Achieve 100% growth in revenues over FY 2006
USA – Generic Formulations<br />
Progress till date<br />
Rapidly built up a generic sales front end in the USA with investments in distribution,<br />
finance systems and sales team<br />
Organic and inorganic build-up of portfolio<br />
• Filed 24 ANDAs with US FDA (including partner filings) till date<br />
• 10 Generics on market – own and partnered<br />
• Focus on niche segment of controlled substances and dermatology<br />
• 5 controlled substances licensed: 2 on market and 3 to be launched by<br />
November 2006<br />
• Paul Cap partnerships to finance product development in dermatology<br />
• Strategic co-development tie-ups concluded with Shasun and InvaGen: Together<br />
accounting for 20 additional filings to which <strong>Glenmark</strong> has marketing access<br />
• Excellent sales performance – locked in excess of 20-25% of the US market on most<br />
products within first year of launch<br />
• Achieved operating cash break-even in Q4, FY06 – within 3 years of set-up
USA – Generic Formulations<br />
Going forward: Multi-pronged build-out of Product Portfolio<br />
Oral solids: File 15-20 ANDAs in FY 07; Includes 3-5 XRs and healthy & exciting<br />
mix of P-II, P-III & at least 3 FTF/P-IV opportunities<br />
Niche topical generics: File 6 products in FY 07, working on 20+ steroidal, nonsteroidal<br />
and combination topicals. Tie-up with Paul Royalty Fund to finance<br />
derm product development<br />
Niche controlled substances: Launched 2 controlled substances out of five<br />
products licensed from two US based firms; remaining to be launched by<br />
November 2006. Segment offers lower competitive pressures. Further licensing<br />
efforts ongoing.<br />
Partnerships: Already announced partnerships will file over 8 generics with the<br />
USFDA in FY 2007<br />
Current status Target for FY 2007<br />
Marketed 10<br />
Marketed 18-22<br />
Under Approval 20<br />
Under approval 38-40<br />
Total Filings 30<br />
Total Filings 28-35<br />
Own filings 20<br />
Own filings 20-25
Europe / UK – Start-up phase<br />
Strategy & Progress<br />
Entry through a niche / branded strategy<br />
• Developing niche generic products, and partnering & creating alliances with<br />
European companies<br />
• Expanding Inorganically in select branded generics markets in the EU<br />
Establish front-end<br />
• EU headquarters, <strong>Glenmark</strong> Pharmaceuticals [UK] Ltd., set up in 2004<br />
• Team building in progress<br />
• Potential front-end acquisitions under review: Italy, Spain, CE and EE countries<br />
are the current focus
Active Pharmaceutical<br />
Ingredients
Active Pharmaceutical Ingredients<br />
Status in FY 2006<br />
Plan going forward…<br />
Revenue decline (12%) driven by:<br />
capacity diversion for captive APIs<br />
across US, India and LRM<br />
decline in prices in some key APIs<br />
Revenue growth in excess of 30%<br />
Complete capacity expansion in<br />
Ankleshwar, start construction in<br />
Aurangabad<br />
discontinuation of Valdecoxib<br />
File 12-14 DMFs per year<br />
Mix of revenues from segments:<br />
India and co-marketing – 48%<br />
Regulated APIs – 22%<br />
Commercial supplies to regulated<br />
markets to increase dramatically with<br />
several ANDA’s/Dossiers filed and<br />
pending from out 3rd party customers<br />
Rest of world – 30%<br />
Commenced commercial supplies of<br />
DMFs during year; several samples,<br />
validation, pivotal batches to global<br />
generic players for their ANDA/Dossier<br />
filings<br />
Develop several APIs annually to<br />
provide cost and timing advantage to<br />
complement our US and EU generic<br />
filings<br />
Continue to be a preferred 3rd party API<br />
supplier to the generic industry<br />
Filed 7 DMFs in the year<br />
Capacity de-bottlenecking initiated for<br />
Ankleshwar, commenced preconstruction<br />
work at new site<br />
Aurangabad
Financials and Projections
Financials and Projections<br />
Performance in FY 2006<br />
(In USD Million)<br />
FY 2006 FY 2005<br />
Audited<br />
Audited<br />
Operating income (A) 171.09<br />
139.87<br />
Expenditure (B) 140.11<br />
104.27<br />
EBITDA (Operations) (C =A-B) 30.98<br />
35.60<br />
EBT (Operations) (D) 22.41<br />
27.90<br />
Other Income (E) 2.90<br />
1.19<br />
PBT (F=D+E) 25.31<br />
29.09<br />
PAT (G) 19.87<br />
24.48<br />
Basic Earnings per share (in rupees) 7.28<br />
8.97<br />
Diluted Earnings per share (in<br />
rupees) 6.41<br />
8.16<br />
Note : 1. Average conversion rate for FY 2005-06 of Rs. 44.28 / USD 1.00<br />
2. Average conversion rate for FY 2004-05 of Rs. 44.94 / USD 1.00
Financials and Projections<br />
Revenues<br />
In USD Mn<br />
171<br />
Projections (in Mn USD)<br />
277 368 CAGR ~ 46.6%<br />
Business Mix<br />
22<br />
14<br />
7<br />
22<br />
89<br />
17<br />
34<br />
40<br />
98<br />
33<br />
37<br />
35<br />
35<br />
55<br />
108<br />
48<br />
47<br />
75<br />
NCE<br />
API<br />
India Formulation<br />
ROW<br />
Latam<br />
USA<br />
FY 2006 FY 2007 FY 2008<br />
Net Profits<br />
20.5 55-60<br />
70-75 CAGR ~ 84-91%<br />
* In USD Mn [Assumed exchange rate of ~44 INR/USD]
Summary
Summary-Key target milestones<br />
Research<br />
Conclude at least 2 licensing deals for NCEs<br />
Complete Phase II for GRC 8200 and GRC 3886; initiate Phase I trials on 3 NCE<br />
compounds<br />
Formulations<br />
Launch oncology and probiotic portfolios in India<br />
In-license novel products/co-marketing deals<br />
Roll out Oncology to LRM and Latin American markets<br />
Market 18-24 ANDAs in the US market<br />
File 15-20 solid dose ANDAs and another >6 topicals; include XRs and P-IV<br />
opportunities<br />
APIs<br />
File 12-14 DMFs<br />
Commence construction in Aurangabad, expand Ankhleshwar
Thank you