Form 6-K
FORM 6-K
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Report of Foreign Private Issuer
Pursuant to Rule 13a-16 or 15d-16
of the Securities Exchange Act of 1934
For the Month of January 2010
Commission File Number 1-15182
DR. REDDYS LABORATORIES LIMITED
(Name of Registrant)
7-1-27, Ameerpet
Hyderabad, Andhra Pradesh 500 016, India
+91-40-23731946
(Address of Principal Executive Offices)
Indicate by check mark whether registrant files or will file annual reports under cover of Form
20-F or Form 40-F.
Form 20-F þ Form 40-F o
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by
Regulation S-T Rule 101(b)(1): o
Note: Regulation S-T Rule 101(b)(1) only permits the submission in paper of a Form 6-K if submitted
solely to provide an attached annual report to security holders.
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by
Regulation S-T Rule 101(b)(7): o
Note: Regulation S-T Rule 101(b)(7) only permits the submission in paper of a Form 6-K if submitted
to furnish a report or other document that the registrant foreign private issuer must furnish and
make public under the laws of the jurisdiction in which the registrant is incorporated, domiciled
or legally organized (the registrants home country), or under the rules of the home country
exchange on which the registrants securities are traded, as long as the report or other document
is not a press release, is not required to be and has not been distributed to the registrants
security holders, and, if discussing a material event, has already been the subject of a Form 6-K
submission or other Commission filing on EDGAR.
Indicate by check mark whether by furnishing the information contained in this Form, the registrant
is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the
Securities Exchange Act of 1934.
Yes o No þ
If Yes is marked, indicate below the file number assigned to registrant in connection with Rule
12g3-2(b):
Not applicable.
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Press Release
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Dr. Reddys Laboratories Ltd. |
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7-1-27 Ameerpet |
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Hyderabad 500 016 India |
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Tel: 91 40 373 1946 |
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Fax: 91 40 373 1955 |
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www.drreddys.com |
Dr. Reddys and Rheoscience announce headline results from First Phase III clinical trial of
Balaglitazone (DRF 2593)
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Significant reduction in HbA1c with Balaglitazone and improved safety profile |
January 04, 2010, Hyderabad: Dr. Reddys Laboratories Ltd. (NYSE: RDY) and Rheoscience, a
subsidiary of Nordic Bioscience A/S, today announced the headline results from the first phase III
study for their investigational agent, Balaglitazone. The study (Study 307) was a phase III,
randomized, double blind, parallel-group placebo- and active comparator-controlled clinical study
to determine the efficacy and safety of balaglitazone. The study showed that the trial met its
primary endpoint of reduction in HbA1c.
The study explored the impact of adding placebo, Balaglitazone 10mg, Balaglitazone 20mg or
Pioglitazone 45mg to a background treatment regimen of stable insulin therapy for a period of 26
weeks. The primary endpoint was HbA1c reduction, while several secondary endpoints including
fasting plasma glucose, oedema, weight gain, and body composition were considered.
In all, 409 patients were randomized in roughly equal proportions across the four arms of the
study. All three active arms (Balaglitazone 10mg, 20mg and Pioglitazone 45mg) showed similar levels
of efficacy with respect to both HbA1c and fasting plasma glucose.
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Balaglitazone 10mg |
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Balaglitazone 20mg |
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Pioglitazone 45mg |
HbA1c reduction against placebo
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0.99%
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1.11%
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1.22% |
FPG reduction against placebo
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1.42 mmol/L
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1.80 mmol/L
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1.35 mmol/L |
All three active arms showed good tolerability and adverse event profile, with Balaglitazone 10mg
demonstrating less water retention, less fat accumulation, lower weight/BMI gain and less bone loss
when compared to the Pioglitazone arm. Adverse events were numerically similar across the three
active arms, with adverse events of special interest (bone fracture, hematuria, heart failure,
cardiac ischemia, oedema, weight gain) being numerically under-represented in the Balaglitazone
10mg group compared to Pioglitazone 45mg.
These results offer the opportunity for a constructive series of dialogues with both potential
partners as well as regulatory agencies. We look forward to working with Rheoscience to define the
path forward for Balaglitazone, said GV Prasad, Vice Chairman & CEO, Dr. Reddys.
Commenting on these results, Dr. Claus Christiansen, Chairman- Nordic Bioscience said We are
encouraged by these results, which demonstrate the safety and efficacy of Balaglitazone, especially
of the 10mg dose in relation to Pioglitazone. We intend to further seek guidance from regulatory
agencies on additional studies needed to register Balaglitazone.
Data from the study will be submitted for presentation at upcoming international scientific
meetings and to peer-reviewed journals.
Notes to the Editor
About Balaglitazone
Balaglitazone is a novel partial agonist of PPAR-gamma, which elicits only 52% of the PPAR-gamma
activation observed with both pio- and rosiglitazone. Pre-clinical studies have indicated that
besides robust glucose lowering ability, balaglitazone results in lower body fluid accumulation,
lower fat accumulation, less heart enlargement and no reduction of bone formation, indicating that
Balaglitazone may be able to displace the balance between desired and side effects, and thus show a
better safety profile than full agonists of PPAR-gamma.
3
About the Balaglitazone programme
The Balaglitizone Phase III clinical trial programme is designed as multicenter, multi-country,
randomized, controlled (active or placebo), double-blind and open studies.
About Diabetes
Type 2 diabetes is a major cause of morbidity and mortality in the industrialized world, with
cardiovascular disease as the leading cause of death, accounting for almost 50% of all T2D deaths.
Furthermore, the number of T2D patients is increasing rapidly, and the number of patients is
expected to reach between 300 and 380 million by 2025, thereby placing an enormous economical
burden on global healthcare.
Disclaimer
This press release includes forward-looking statements, as defined in the U.S. Private Securities
Litigation Reform Act of 1995. We have based these forward-looking statements on our current
expectations and projections about future events. Such statements involve known and unknown risks,
uncertainties and other factors that may cause actual results to differ materially. Such factors
include, but are not limited to, changes in local and global economic conditions, our ability to
successfully implement our strategy, the market acceptance of and demand for our products, our
growth and expansion, technological change and our exposure to market risks. By their nature, these
expectations and projections are only estimates and could be materially different from actual
results in the future.
About Dr. Reddys
Established in 1984, Dr. Reddys Laboratories (NYSE: RDY) is an emerging global pharmaceutical
company. We fulfill our purpose of providing affordable and innovative medicines through three core
businesses: Pharmaceutical Services and Active Ingredients, Global Generics and Proprietary
Products. Our products are marketed globally, with a focus on India, US, UK, Germany and Russia.
www.drreddys.com
About Rheoscience
Rheoscience is a Danish biopharmaceutical company focused on the discovery and development of novel
pharmaceutical products for the treatment of metabolic diseases such as diabetes and obesity.
Rheoscience has unparalleled experience in developing drugs for metabolic disorders and draws on
this to advance its own pipeline of innovative compounds and to underpin its successful, profitable
contract research business.
For more information please contact:
Investors and Financial Analysts:
Kedar Upadhye at kedaru@drreddys.com / +91-40-66834297
Raghavender R at raghavenderr@drreddys.com / +91-40-66511529
Milan Kalawadia (USA) at mkalawadia@drreddys.com / +1 908-203-4931
Media:
M Mythili at mythilim@drreddys.com / +91-40-66511620
S Rajan at rajans@drreddys.com / +91-40- 66511725
4
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Press Release
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Dr. Reddys Laboratories Ltd. |
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7-1-27 Ameerpet |
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Hyderabad 500 016 India |
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Tel: 91 40 373 1946 |
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Fax: 91 40 373 1955 |
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www.drreddys.com |
Dr. Reddys Q3 FY10 Financial Results
Revenues at Rs. 17,296 million
EBITDA at Rs. 3,666 million
Profits after Tax adjusted for impairment at Rs. 2,307 million
Hyderabad, India, January 20, 2010: Dr. Reddys Laboratories Ltd. (NYSE: RDY) today announced its
unaudited financial results for the third quarter ended December 31, 2009 under International
Financial Reporting Standards (IFRS).
Key Highlights
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Consolidated revenues at Rs. 17.3 billion ($373 million) in Q3 FY10 as against Rs. 18.4
billion ($397 million) in Q3 FY09, representing a decline of 6%. Excluding revenues from
sumatriptan in the previous year, the 17% growth is largely driven by the key markets of
India and Russia in Global Generics and PSAI. |
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Consolidated revenues for nine months FY10 at Rs. 53.9 billion ($1.2 billion); YoY
growth of 9%. |
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EBITDA at Rs. 3.7 billion ($79 million) in Q3 FY10. EBITDA for nine months FY10 at Rs.
11.8 billion ($255 million) represents a YoY growth of 31%. Adjusted PBT for the quarter is
at Rs. 2.6 billion ($56 million). |
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During the quarter, many healthcare insurance providers in Germany announced their
final tender results indicating a higher pace of transition to the tender based model in
the German generics pharmaceutical market, with an associated significant deterioration in
prices from the previous years levels. As a result of this, the carrying value of
betapharms goodwill and intangibles were tested for impairment. A non-cash write-down of
intangible assets and beta brand amounting to Euro 48 million and a non-cash write-down
of goodwill amounting to Euro 76 million were recorded for the quarter. The overall net
impact on Income Statement was Euro 109 million after a reversal of deferred tax liability
relating to intangibles and beta brand. |
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Loss for the quarter is at Rs. 5.2 billion ($112 million) while Adjusted Profits after
tax (PAT) for the quarter is at Rs. 2.3 billion ($50 million). Adjusted PAT* for nine
months of this fiscal is at Rs. 7.3 billion ($158 million) as against adjusted PAT of Rs.
5.1 billion ($110 million) in the same period for previous year, representing a growth of
43%. |
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During the quarter, the company launched 27 new generic products, filed 16 new product
registrations and filed 11 DMFs globally. |
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Note: Adjusted PAT represents PAT adjusted for one-time impacts like impairment (Q3 FY10),
betapharm workforce restructure costs (Q1 FY10) and Atlanta facility closure costs (Q1 FY10) |
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All figures in millions, except EPS
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All dollar figures based on convenience translation rate of |
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1USD = Rs 46.40 |
Dr. Reddys Laboratories Limited and Subsidiaries
Unaudited Condensed Consolidated Income Statement
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Q3 FY10 |
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Q3 FY09 |
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Particulars |
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(Rs.) |
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% |
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($) |
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(Rs.) |
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% |
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Growth % |
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Revenue |
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373 |
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17,296 |
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100 |
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397 |
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18,401 |
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100 |
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(6 |
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Cost of revenues |
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183 |
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8,487 |
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49 |
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175 |
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8,129 |
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44 |
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4 |
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Gross profit |
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190 |
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8,809 |
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51 |
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221 |
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10,272 |
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56 |
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(14 |
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Operating Expenses |
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Selling, general & administrative
expenses(a) |
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117 |
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5,431 |
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31 |
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116 |
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5,382 |
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29 |
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1 |
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Research and development expenses, net |
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19 |
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892 |
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5 |
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22 |
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1,027 |
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6 |
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(13 |
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Write down of intangible assets |
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74 |
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3,456 |
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20 |
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Write down of goodwill |
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111 |
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5,147 |
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30 |
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Other (income)/expenses, net |
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(4 |
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(171 |
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(1 |
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2 |
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110 |
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1 |
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Total Operating Expenses |
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318 |
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14,755 |
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85 |
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140 |
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6,519 |
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35 |
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Results from operating activities |
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(128 |
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(5,946 |
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(34 |
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81 |
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3,753 |
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20 |
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Finance income (b) |
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(1 |
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(47 |
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(0 |
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(2 |
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(89 |
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(0 |
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Finance expenses (c) |
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2 |
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97 |
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1 |
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17 |
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788 |
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4 |
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Finance expenses, net |
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1 |
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50 |
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0 |
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15 |
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699 |
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4 |
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Share of profit/(loss) of equity
accounted investees |
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0 |
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2 |
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0 |
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0 |
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8 |
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0 |
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Profit before income tax |
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(129 |
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(5,994 |
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(35 |
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66 |
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3,062 |
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17 |
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Income tax expense |
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17 |
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777 |
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4 |
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(13 |
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(617 |
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(3 |
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Profit for the period |
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(112 |
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(5,217 |
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(30 |
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53 |
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2,445 |
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13 |
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Attributable to: |
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Equity holders of the company |
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(112 |
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(5,217 |
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(30 |
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53 |
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2,445 |
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13 |
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Minority interest |
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Profit for the period |
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(112 |
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(5,217 |
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(30 |
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53 |
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2,445 |
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13 |
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Diluted EPS |
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(0.7 |
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(30.9 |
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0.3 |
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14.5 |
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Notes: |
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Includes amortization charges of Rs. 374 million in Q3 FY10 and Rs. 340 million in Q3 FY09. |
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Includes forex loss of Rs. 44 million in Q3 FY10. |
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Includes forex loss of Rs. 493 million in Q3 FY09. |
6
Segmental Analysis
Global Generics
Revenues of Global Generics for the nine months at Rs. 37.4 billion ($807 million) represent a
growth of 7%.Revenues from Global Generics business at Rs. 11.7 billion ($253 million) in Q3 FY10
as against Rs. 13.7 billion ($295 million) in Q3 FY09. Excluding the revenues from sumatriptan the
growth is at 16% driven by the key markets of India and Russia.
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Revenues from North America at Rs. 3.0 billion ($64 million) in Q3 FY10 as against Rs.
6.7 billion ($143 million) in Q3 FY09. Excluding the revenues from sumatriptan the growth
is flat. |
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The total cumulative ANDA filings are 141. 62 ANDAs are pending approval at the USFDA
of which 35 are Para IVs and 13 are FTFs. |
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Revenues from Europe at Rs. 2.6 billion ($56 million) in Q3 FY10 as against Rs. 2.5
billion ($54 million) in Q3 FY09, representing a growth of 3%. |
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Revenues from Germany increase by 2% to Rs. 2.0 billion ($44 million) in Q3 FY10. |
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Revenues from Rest of Europe grew by 6% to Rs. 534 million ($12 million) in Q3 FY10. |
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Revenues from Russia & Other CIS markets at Rs. 2.8 billion ($60 million) in Q3 FY10 as
against Rs. 2.0 billion ($43 million) in Q3 FY09, representing a growth of 38%. |
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Revenues in Russia at Rs. 2.3 billion ($49 million) in Q3 FY10 as against Rs. 1.6
billion ($34 million) in Q3 FY09 representing a YoY growth of 45%. |
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The secondary prescription sales trend as per Pharmexpert for the eight months of
April to November compared to same period last year indicates a dollar growth of 13%
for Dr. Reddys as against the industrys growth of 2%. |
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Revenues in Other CIS markets increase by 13% to Rs. 488 million ($11 million) in Q3
FY10 as against Rs. 434 million ($9 million) in Q3 FY09. |
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Revenues in India at Rs. 2.6 billion ($57 million) in Q3 FY10 from Rs. 2.0 billion ($42
million), representing a growth of 34% led by key brands of Omez, Nise, Stamlo Beta,
Reditux & Stamlo. |
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The YoY growth of 34%, is largely driven by volume growth of 29% from existing
portfolio and 7% by new product launches. |
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The secondary sales trend as per ORG IMS for the eight months April to November 2009
indicates a growth of 20% for Dr. Reddys as against an industry growth of 16% and the
Top 10 Companies growth of 19%. |
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18 new products launched during the quarter. 56 new products launched in the nine
months FY10 contributed 4% to nine months sales. |
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Pharmaceutical Services and Active Ingredients (PSAI)
Revenues from Pharmaceutical Services & Active Ingredients for the nine months at Rs. 15.5 billion
($334 million) represent a growth of 11%. Revenues from (PSAI) at Rs. 5.2 billion ($113 million) in
Q3 FY10 as against Rs. 4.4 billion ($96 million) in Q3 FY09 ; YoY growth of 17% driven by the
regions of India and RoW.
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During the quarter, 11 DMFs were filed globally, with 3 in US and 8 in Europe. The
cumulative DMF filings as of Dec 09 are 388. |
Income Statement Highlights:
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Gross profit at Rs. 8.8 billion ($190 million) in Q3 FY10 represents a margin of 51% to
revenues as against 56% in Q3 FY09. This change in gross margins is on account of a
favorable mix of high margin revenues from sumatriptan in the previous year. |
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Selling, General & Administration (SG&A) expenses excluding amortization for the
quarter at Rs. 5.1 billion ($117 million), remained flat as compared to both previous year
and sequentially. |
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Amortization expenses for the quarter at Rs. 374 million ($8 million) showed a modest
growth from previous year of Rs. 340 million ($7 million). |
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Other operating income of Rs. 171 million in Q3 FY10 as against Other operating
expenses of Rs. 110 million in Q3 FY09. The movement is largely on account of the fact that
in Q3 FY09, a provision for damages payable of Rs. 224 million was recorded on account of
the German court upholding the validity of the olanzapine patent of the innovator in
Germany. |
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R&D expenses at Rs. 892 million in Q3 FY10 represent 5% of revenues. |
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Finance costs (net) are at Rs. 50 million in Q3 FY10 as against Rs. 699 million in Q3
FY09. The change is mainly on account of : |
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Net forex loss of Rs. 44 million in Q3 FY10 as against Rs. 493 million in Q3 FY09. |
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Net interest expense of Rs. 19 million in Q3 FY10 as against Rs. 215 million in Q3
FY09. |
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Loss for the quarter is at Rs. 5.2 billion ($112 million) and Adjusted PAT for the
quarter is at Rs. 2.3 billion ($50 million). Adjusted PAT for nine months FY10 is at Rs.
7.3 billion ($158 million) as against adjusted PAT of Rs. 5.1 billion ($110 million) in the
previous year, representing a growth of 43%. |
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The adjusted effective tax rate for the nine months is at 19%. |
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Adjusted diluted EPS is at Rs. 13.6 (29 cents) for the quarter and Rs. 43.3 (93 cents) for nine months FY10. |
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Capital expenditure for nine months FY10 is at Rs. 2.6 billion ($56 million). |
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About Dr. Reddys
Established in 1984, Dr. Reddys Laboratories (NYSE: RDY) is an emerging global pharmaceutical
company. We fulfill our purpose of providing affordable and innovative medicines through three
core businesses: Pharmaceutical Services and Active Ingredients, Global Generics and Proprietary
Products. Our products are marketed globally, with a focus on India, US, UK, Germany and Russia.
Disclaimer
This press release includes forward-looking statements, as defined in the U.S. Private Securities
Litigation Reform Act of 1995. We have based these forward-looking statements on our current
expectations and projections about future events. Such statements involve known and unknown
risks, uncertainties and other factors that may cause actual results to differ materially. Such
factors include, but are not limited to, changes in local and global economic conditions, our
ability to successfully implement our strategy, the market acceptance of and demand for our
products, our growth and expansion, technological change and our exposure to market risks. By
their nature, these expectations and projections are only estimates and could be materially
different from actual results in the future.
CONTACT INFORMATION
Investors and Financial Analysts:
Kedar Upadhye at kedaru@drreddys.com or on +91-40-66834297
Raghavender R at raghavenderr@drreddys.com or on +91-40-66511529
Milan Kalawadia (North America) at mkalawadia@drreddys.com or on +1-9082034931
Media:
M Mythili at mythilim@drreddys.com or on +91-40-66511620
Rajan S at rajans@drreddys.com or on +91-40- 66511725
Notes
1. |
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All the above analyses are based on consolidated IFRS financials. |
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2. |
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Detailed analysis of the financials is available on the Companys website at
www.drreddys.com. |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused
this report to be signed on its behalf by the undersigned, thereunto duly authorized.
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DR. REDDYS LABORATORIES LIMITED
(Registrant)
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By: |
/s/ V.S. Suresh
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Date: February 1, 2010 |
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Name: |
V.S. Suresh |
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Title: |
Company Secretary |
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