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     is a research-driven, global, fully integrated
pharmaceutical company. The Company is a leader in India in the discovery of new molecules [Both
NCES and Biologics] and is focused in the areas of inflammation [Asthma/COPD, etc] and metabolic
disorders [Diabetes, Obesity, etc]. The Company has branded generic formulation interests in over 95
countries across the world including India, Europe, Brazil, Rest of Latin America (excluding Argentina),
Russia/CIS, Africa and Asia. The formulations business spans several product segments such as
Dermatology, Internal Medicine, Respiratory, Diabetes, Pediatrics, Gynecology, ENT, and Oncology.

Glenmark Generics Limited (GGL) is a subsidiary of Glenmark Pharmaceuticals Limited (GPL) aims to be a
global integrated generic and API leader. GGL has an established presence in North America, EU and
Argentina and maintains marketing front-ends in these countries. GGL has a strong base in Formulations
development with teams operating out of laboratories in India and Latin America. The Company has a
state-of-the-art manufacturing plant at Goa, India that is approved by US FDA, TPD (Canada), MHRA, UK
and many other overseas regulatory authorities. GGL also markets over 45 Active pharmaceutical
ingredients (APIs) to more than 80 countries across the world and had over 30 USDMFs filed and/or
approved along with several DMFs in Canada.




Glenmark has built a visible and growing branded generic formulation presence across all its markets. A
number of its products have emerged as brand leaders in India and some of these markets. Glenmark
has made acquisitions in Brazil, South Africa and Czech Republic and is currently looking to acquire
companies in Europe.

 
 

Over the years, Glenmark has strengthened its integration across the pharmaceutical value chain
through operations across its various manufacturing plants:

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Nasik, India Solid orals, liquid orals, & external WHO-GMP, ANVISA, Ethiopia, Zimbabwe, Uganda,
creams, powders and capsules for Nigeria; Tanzania, Ghana, Sudan, R.D. Congo,
regulated markets MCC, South Africa, Oman, Ukraine, Colombia

Baddi, India Solid orals, semi-solid and liquid orals as US FDA, DDA Nepal, WHO-GMP; TPD Canada,
well as external preparations like lotions, ANVISA Brazil, MHRA UK, Ghana
creams, capsules, etc. for India and
semi-regulated markets
 Sao Paulo, Brazil Solid orals, semi-solid & liquid orals for ANVISA
Latin America

Vysoke Myto, Solid and SUKL, Czech Republic

Czech Republic semi-solid orals

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The company has a pipeline of 6 NCE and NBE molecules in clinical trials. In addition, the company has
two in-licensed molecules, Crofelemer and a novel monoclonal antibody, GBR 900

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cc: Drug maker Glenmark today said it along with its US-based partner has got the US health
regulator's nod to manufacture and market two oxycodone products, used for treating moderate to
severe pain, in the American market.

The company's US arm, Glenmark Generics Inc and Lehigh Valley Technologies (LVT) have received US
Food and Drug Administration nod for Oxycodone immediate release capsules, the company said in a
filing to the Bombay Stock Exchange.

The approval is for 5 mg capsule and 100 mg/5 ml oral solution, it said, adding, Glenmark Generics Inc
and LVT have also signed a new supply and marketing agreement.

Under the terms of agreement, LVT will be responsible for manufacturing of the Oxycodone product line
for Glenmark's exclusive marketing and distribution in the generic form, the company said. "LVT would
retain exclusive marketing rights to the branded version of the Oxycodone product line," it added.

Further, the US firm will also retain exclusive marketing rights to additional strengths of Oxycodone
product line in both generic and branded forms.

According to market research firm IMS health , Oxycodone Hydrochloride immediate release capsule
and liquid formulations had total market sales of USD 13 million for the 12 months ended September
2010.

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6 (
 cc: Glenmark Pharmaceuticals said it has received the US health regulator's approval to
market three generic products in the American market.

Glenmark Generics Inc, the US-based subsidiary of the company has received final approval from the US
Food and Drug Administration (USFDA) for two products, Indomethacin capsules in strengths of 25 mg
and 50 mg and Sulfamethoxazole and Trimethoprim tablets in double and single strengths, Glenmark
said in a statement.

͞These products are currently available and the company has commenced shipping from their New
Jersey facility,͟ the company said. According to IMS Health, total sales achieved for Indomethacin in the
US market for the 12 month period ending September 2010 were $20 million.

Sales of Sulfamethoxazole and Trimethoprim stood at $31 million for the same period in the US market.
While Indomethacin is used in treating arthritis, Sufamethoxazole and Trimethoprim tablets are
indicated for urinary tract infections.
Apart from two final approvals, the company received a tentative approval from USFDA for Eszopiclone,
the generic version of Sepracor's Lunesta, which according to IMS Health achieved annual sales of $760
million for the 12-month period ending September, 2010. Eszopiclone is used to treat insomnia

Earlier this year, Glenmark had entered into a settlement and licence agreement with Sepracor to
resolve a United States patent infringement suit related to its filing an abrreviatd new drug approval
(ANDA) for Eszopiclone with the USFDA. Under the terms of this agreement, Glenmark would be
permitted to launch its generic product after November 30, 2013, which is 2.5 months prior to the
expiry of Sepracor patent or May 30, 2014.

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c: Indian drug firm Glenmark has lost a patent case against US firm Abbott Laboratories
over hypertension drug Tarka, subsequently it will pay $16 million in damages to the US firm.

A federal jury in Newark, New Jersey, has rejected Glenmark's challenge to the validity of the patent
that expires in February 2015. Glenmark argued that the patent covered an invention that was
protected by an expired patent.

As per the latest order, Jurors awarded $15.2 million for lost profits and $8,03,514 for higher prices that
Abbott would have been able to charge had Glenmark not infringed the patent.

While Glenmark officials could not be reached for comments, sources said the company will appeal
against the verdict.

The Indian firm May last year got the US FDA's final approval to launch the generic version of the drug,
whose original patent was held by Sanofi Aventis but later sold to Abbott.

This was, however, challenged by Abbott which applied for preliminary injunction but the court had
overruled it. Subsequently, Glenmark launched the drug in June in the US market.

Abbott, which paid $290 million for an exclusive licence to Tarka, was seeking $25 million as
compensation for profit it lost because of Glenmark's sale of the generic drug. Paris-based Sanofi's
patent on Tarka was first approved by drug regulators in 1996.

Tarka is an anti-hypertension drug owned by Abbott and marketed by Sanofi Aventis with an annual sale
of $58 million.

Meanwhile, if the company, on a conservative basis, withholds the sale of the drug, its fourth quarter
revenues and earnings would be impacted accordingly. The damages, if awarded, would also reduce the
company's earnings for FY11.

However, these are likely to have negligible impact on the company's total performance. The revenue
loss stands at less than 4% of the company's annual revenues of 2,908 crore (on a trailing four quarter
basis).
 : 

For the third Quarter of FY͛2011, Glenmark͛s consolidated revenue was at Rs. 750.81 Cr as against Rs.
641.68 Cr, an increase of 17%. Revenue from the generics business was at Rs. 298.75 Cr, as against Rs.
280.44 Cr, a growth of 7%. The Specialty formulation business revenue was at Rs. 452.06 Cr as against
Rs. 361.24 Cr for the corresponding quarter of the previous year, registering a growth of 25%.

For the nine month ended Dec 31, 2010, Glenmark͛s consolidated revenue was at Rs. 2156.93 Cr as
against Rs. 1775.69 Cr, an increase of 21%. Revenue from the generics business was at Rs. 890.00 Cr, as
against Rs. 776.72 Cr, a growth of 15%. The Specialty formulation business revenue was at Rs. 1266.93
Cr as against Rs. 998.97 Cr for the corresponding nine months of the previous year, registering a growth
of 27%.


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US 204.08 188.64 8.18% 610.86 537.81 13.58%
Europe 15.4 6.62 132.63% 40.91 20.15 103.03%
Latin America 4.29 7.59 -43.48% 23.33 26.28 -11.23%
API 74.97 77.57 -3.35% 214.88 192.47 11.64%
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Latin America 52.82 28.03 88.44% 142.72 101.51 40.60%
ROW 115.42 90.57 27.44% 277.02 249.39 11.08%
Europe 44.76 35.12 27.45% 101.11 90.37 11.88%
India 239.03 184.27 29.72% 656.56 534.45 22.85%
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 Operating Profit Margin (%) 18.61%  20.87%  22.89%  20.35% 

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Net Profit Margin (%) 14.59% 14.66%  17.47% 12.86% 

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Sales for the formulation business in India increased to Rs. 239.03 Cr for the third Quarter of this
financial year as compared to Rs. 184.27 Cr in the previous corresponding quarter, recording a growth of
30%. According to the latest ORG-IMS data it was reported that the company registered value growth of
25.1% vis-à-vis that of the industry growth which was 15.8% [ORG: Apr ͛10 to Dec͛10] As per ORG-IMS
(MAT- Nov͛09 vs. MAT ʹ Nov͛10), Glenmark increased market share in various therapeutic categories viz.
Anti-infective from 1.14 % to 1.31 %; Cardiac from 1.85 % to 2.25%, Respiratory from 2.25 to 2.42 % ,
Pain from 0.92% to 0.99 %, Gynaecology 1.09 % to 1.23 % and dermatology from 7.86 % to 8.34 %.
During the quarter, the IF business introduced six new products. The main product launches were
Altacef-CV indicated for respiratory infections, Bon-K2 for osteoporosis and Candid soap for fungal
infections. Flublast, an anti-influenza medication launched in Aug͛10 performed very well during the
quarter.

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For the third quarter of the financial year, revenue from Africa, Asia and CIS region was Rs. 115.42 Cr as
against Rs. 90.57 Cr for the previous corresponding quarter, recording an increase of 27%. In the region,
Glenmark filed 30 product dossiers during the quarter and received 22 product approvals.

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The secondary sale for the Russian subsidiary has shown a good growth in the third quarter. According
to Pharmexpert data, on a MAT basis, the company is growing at a rate of 26% (market MAT December
2010 growth is at 7%) and has consistently improved rankings in the market to the current rank of 62 in
Dec 2010. In this quarter the company has launched Glencet, the first Generic for Levocetrizine in
Russia. The brand has received a positive response from doctors in the first month of the launch itself.
This launch will help Glenmark consolidate its position in both respiratory and dermatology segment,
the two key segments where the molecule is widely prescribed. With a growth rate of 54%
(Pharmexpert Dec 2010 data) we continue to be the fastest growing company in the dermatology
segment with healthy growth rates for all the Derma brands.

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The Africa Middle East has achieved a growth of 36% in quarter ended Dec͛10, aided by robust growth
from South Africa, Nigeria, Kenya, Sudan, Mauritius & Tanzania The quarter was also marked with
several first-to-market innovative products across therapeutic categories such as the introduction of
Glenmark into the lucrative Antiasthma segment in Kenya; the introduction of the high end cosmetic
range in the UAE; strengthening of the pain portfolio with the launch of Valus AP in Malawi.

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In Asia, the key markets of Malaysia, Vietnam and Myanmar recorded secondary sales growth of 40 %.
In Malaysia, new registrations for Montelukast, Adapalene MS and Demelan were obtained. These
registrations will help us make a strong entry in the hospital segment. Deriva MS and Klenzit MS were
launched in Malaysia, Vietnam, Philippines and Sri Lanka.

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Glenmark͛s revenue from its Latin American and Caribbean operations was at Rs. 52.82 Cr for the third
Quarter of 2010 ʹ 11 as against Rs. 28.03 Cr a growth of 88%. The growth is attributed to improvement
in the Brazilian business, contribution from newer markets like Venezuela, Peru, Ecuador as well as a low
base effect of the previous year. Going forward we expect strong sequential growth from the region. In
the region, Glenmark filed 10 product dossiers during the quarter and received 9 product approvals.

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Glenmark Europe͛s operations registered third quarter revenue of Rs. 44.76 Cr as compared to Rs. 35.12
Cr for the previous corresponding quarter, an increase of 27%. The region continues to explore new in-
licensing opportunities to grow the each of the businesses.


 :

For the third Quarter of FY͛2011, consolidated revenue from Generics business was at Rs. 298.75 Cr as
against Rs. 280.44 Cr, an increase of 7% in rupee terms over the corresponding quarter of the previous
year.

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Revenues for the third quarter of FY͛ 2011 were Rs. 204.08 Cr against revenue of Rs. 188.64 Cr in the
previous year, reflecting an increase of 8% in rupee terms over the corresponding quarter of the
previous year. During the third quarter, Glenmark was granted final approval by the United States Food
and Drug Administration (FDA) for five Abbreviated New Drug Applications (ANDA) and received
tentative approval on two. The Company launched a total of 6 products in the U.S. marketplace
comprised of a mix of immediate release tablets, extended release tablets, semi-solid and controlled
substance items. New products launched include Pramipexole Dihydrochloride Tablets, Mupirocin
Ointment, Felodipine ER Tablets, Indomethacin Capsules, SMX/TMP Tablets and Lithium Carbonate ER
Tablets 300mg.

The company is on course to file 13-15 ANDAs in FY͛11. In the final weeks of the quarter, Glenmark
launched Oxycodone capsules and oral solution in 5mg and 20mg/ml presentations, respectively. These
two items are approved New Drug Applications (NDA) and comprise Glenmark͛s primary portfolio of
pain management products. This niche market category maintains a high barrier to entry due to strict
DEA regulations thereby limiting the number of competitor companies and showcasing Glenmark as the
only generic company distributing these U.S FDA approved products. Oxycodone is manufactured for
Glenmark in the United States through a partnership and is distributed directly from its 75,000 square ft
warehouse located in Mahwah, New Jersey.

In November 2010, Glenmark Pharmaceuticals Limited and Glenmark Generics Inc., USA ( ͞Glenmark͟)
confirmed Triax Pharmaceuticals, LLC, Astellas Pharma Europe B.V. and Astellas Pharma International
B.V. ( ͞Astellas and Triax͟ ) filed a patent infringement suit on November 4, 2010 in the U.S. District
Court for the District of Delaware seeking to prevent Glenmark from commercializing its Abbreviated
New Drug Application (ANDA) for Hydrocortisone Butyrate cream 0.1%, their generic version of Locoid
Lipocream®, prior to expiration of the Orange Book patent. Based on information published by the U.S.
FDA, Glenmark believes it is the first applicant to file an ANDA with a paragraph IV certification for a
generic version of Locoid Lipocream®, and should its product be approved, Glenmark will be entitled to
180 days of generic market exclusivity.



%.'*!"#$
The European business continued to grow through a mix of product sales and licensing revenue. During
the quarter, GGBV, the Dutch entity, participated in different tenders in the Netherlands with leading
health insurance companies and won tenders for three more products with supplies commencing in
December͛10. The UK business also expanded its coverage of the market by adding several new
important accounts across the wholesaling and retail channels and also launched one more product in
UK in this quarter. The out licensing business successfully signed four more deals for licensing out and
supply of products in various EU markets and we also signed three deals for in-licensing products which
will be available for sales by the UK entity in the next year. In this quarter, Glenmark supported two new
product launches by third party customers in EU markets. During the quarter, Glenmark was granted
Five MAs for four products in different markets and we filed an MA Application for one product through
the DCP procedure. Overall, the business posted revenues of Rs. 15.40 Cr for the quarter, against
revenue of Rs. 6.62 Cr for the corresponding quarter of previous year showing a growth of 133% in
rupee terms.

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Glenmark͛s revenue from the Argentina operations were Rs. 4.29 Cr in the third quarter of 2010-11 as
against Rs. 7.59 Cr for the third quarter of the previous year, a decline of 44% in rupee terms. The
oncology business launched three new products in the quarter. The Argentina unit continues to support
Glenmark͛s oncology business worldwide and has facilitated the filing of 32 product dossiers across
subsidiaries

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Revenue from sale of API to regulated and Rest of the World (ROW) markets globally was Rs. 74.97 Cr
for Q3 FY11 against Rs. 77.57 Cr for Q3 of the previous year, recording a decline of 3% in rupee terms.
Prasugrel and Sitagliptin were launched in the ROW markets, combined with the award of Perindopril
annual tender in Malaysia.

The table below shows the summary of the consolidated financial results of Q1 FY͛ 09-10 and the
consolidated results for the 12 months ended March-09


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Face Value : Rs.1.00

Total Equity shares : 27.01Cr

Share Holding Pattern

Promoters : 52.41% FII : 27.94%

Residential Individuals : 12.26% Banks, FI͛s : 1.51%
MF͛s : 2.39% Private corp bodies : 1.97%
Govt./NRI/OCB/Others : 1.52%


 

Valuation based on standalone results

Adjusted Annualized EPS = Rs.8.60

Average P/E of Industry = 24.78
Average P/E Taken = 15
So the value of each share =
cc
Total Value of investments = Rs.992.91Cr
Total No of Shares = 27.01Cr
Value Per share =
 585
So the total value per share =
5787

Valuation based on consolidated results

Adjusted Annualized EPS = Rs.16.24

Average P/E of Industry = 24.78
Average P/E Taken = 15
So the value of each share =
6 5c

** For further details on Ratios and Comparison of Glenmark Pharma within its peers refer the
attachments at the end.

 

If we consider a 20 P/E multiple then the value becomes Rs.325 on consolidated basis. The stock is
trading at a significant discount to its other frontline peers. Given that the growth of the company's core
generics business remains promising, the current weakness in the stock offers a buying opportunity for
investors scouting the mid-cap space.

These pharma (basically generics based) companies should not be looked from only P/E point of view. If
one of the molecules hits the shelves the stock price may jump but from this point of view also the
prospects are looking grim in the near future because none of their molecules will be out before 2013.
Next quarter results might get impacted because of the lost patent case against US firm Abbott
Laboratories over hypertension drug Tarka, subsequently it will pay around Rs. 70 Cr in damages to the
US firm.

Even though the performance in First Nine months of FY͛2011 is good, but it has depleted after peaking
in the April to June quarter.