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 2011
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 announces the launch of Pantoprazole Sodium delayed-released tablets
Hyderabad, India, January 20, 2011 Dr. Reddys Laboratories (NYSE: RDY) today announced that it
has launched Pantoprazole Sodium Delayed-Released tablets (20mg and 40mg strengths), a
bioequivalent generic version of Protonix® Tablets in the US market. The Food & Drug
Administration (FDA) approved Dr. Reddys ANDA for Pantoprazole Sodium Delayed-Released tablets on
January 19, 2011.
Pantoprazole Sodium Delayed-Released tablets had total U.S. sales of approximately $1.8 billion for
the twelve months ending September 30, 2010 according to IMS Health. Both strengths of Dr. Reddys
Pantoprazole Sodium Delayed-Released tablets are available in 90 count bottles.
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
Dr. Reddys Laboratories Ltd. (NYSE: RDY) is an integrated global pharmaceutical company, committed
to providing affordable and innovative medicines for healthier lives. Through its three businesses
- Pharmaceutical Services and Active Ingredients, Global Generics and Proprietary Products Dr.
Reddys offers a portfolio of products and services including APIs, custom pharmaceutical services,
generics, biosimilars, differentiated formulations and NCEs. Therapeutic focus is on
gastro-intestinal, cardiovascular, diabetology, oncology, pain management, anti-infective and
pediatrics. Major markets include India, USA, Russia and CIS, Germany, UK, Venezuela, S. Africa,
Romania, and New Zealand. For more information, log on to: www.drreddys.com
Protonix®, is a registered Trademark of Nycomed GmbH
IMS National Sales Perspectives: Retail and Non-Retail MAT 09/2010
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 (USA) at mkalawadia@drreddys.com or on +1-908-203-4931
Media:
S Rajan at rajans@drreddys.com or on +91-40-66511725
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Press Release
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Dr. Reddys Laboratories Ltd.
7-1-27 Ameerpet
Hyderabad 500 016 India |
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Tel: 91 40 373 1946
Fax: 91 40 373 1955 |
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www.drreddys.com |
Dr. Reddys Q3 FY11 Financial Results
Revenues at Rs. 19.0 billion ($424 million), YoY growth of 10%
EBITDA at Rs. 4.0 billion ($90 million), YoY growth of 10%
Profit after Tax at Rs. 2.7 billion ($61 million), YoY adjusted growth of 19%*
Hyderabad, India, January 25th, 2011: Dr. Reddys Laboratories Ltd. (NYSE: RDY) today
announced its unaudited financial results for the quarter ended December 31st, 2010
under International Financial Reporting Standards (IFRS).
KEY HIGHLIGHTS
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Consolidated revenues are at Rs. 19.0 billion ($424 million) in Q3 FY11 versus Rs. 17.3 billion ($386 million) in Q3
FY10, year-on-year growth of 10%. |
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Revenues from Global Generics for Q3 FY11 are at Rs. 13.6 bn ($303 mn), year-on-year growth of 16%. |
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Revenues from PSAI are at Rs. 5.0 billion ($111 million) in Q3 FY11, year-on-year decline of 5%. |
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EBITDA of Rs. 4.0 billion ($90 million) in Q3 FY11, is at 21% of revenues with year-on-year growth of 10%. |
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Profit before Tax for Q3 FY11 is at Rs. 2.9 billion ($64 million), year-on-year adjusted growth of 11%*. |
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Profit after Tax for Q3 FY11 is at Rs. 2.7 billion ($61 million), is at 14% of revenues with year-on-year adjusted
growth of 19%. |
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During the quarter, the company launched 42 new generic products, filed 21 new product registrations and filed 9 DMFs
globally. |
Litigation settlements in US: Today the Company announces that it has entered into two settlement
agreements with AstraZeneca in US relating to the ANDA filed for the generic versions of
AstraZenecas Nexium® (esomeprazole) and Accolate® (zafirlukast). Under the terms of the
esomeprazole agreement, AstraZeneca has granted Dr. Reddys a license, subject to regulatory
approval, to launch a generic version of esomeprazole delayed-release capsules on May 27, 2014, or
earlier in certain circumstances. The terms of this agreement have not been disclosed. The
zafirlukast agreement ends all litigation related to the product and allows Dr. Reddys to continue
selling the product without risk. Dr. Reddys launched its zafirlukast product on November 18,
2010 following a favorable summary judgment decision.
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* |
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Note: Adjustment in the previous year represents one-time impairment charge of intangibles &
goodwill of Rs. 8,603 million and associated tax impact. |
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All figures in millions, except EPS
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All US $ figures based on a convenience translation rate of 1USD = Rs 44.80 |
Dr. Reddys Laboratories Limited and Subsidiaries
Unaudited Consolidated Income Statement
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Q3 FY11 |
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Q3 FY10 |
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Particulars |
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($) |
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(Rs.) |
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% |
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($) |
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(Rs.) |
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% |
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Growth % |
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Revenue |
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424 |
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18,985 |
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100 |
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386 |
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17,296 |
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100 |
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10 |
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Cost of revenues |
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191 |
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8,571 |
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45 |
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189 |
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8,487 |
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49 |
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1 |
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Gross profit |
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232 |
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10,414 |
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55 |
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197 |
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8,809 |
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51 |
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18 |
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Operating Expenses |
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Selling, general & administrative
expenses(a) |
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142 |
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6,374 |
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34 |
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121 |
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5,431 |
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31 |
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17 |
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Research and development expenses, net |
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29 |
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1,306 |
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7 |
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20 |
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892 |
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5 |
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46 |
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Write down of intangible assets |
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0 |
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0 |
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0 |
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77 |
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3,456 |
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20 |
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Write down of goodwill |
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0 |
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0 |
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0 |
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115 |
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5,147 |
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30 |
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Other operating expenses |
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(4 |
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(199 |
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(1 |
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(4 |
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(171 |
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(1 |
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17 |
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Total Operating Expenses |
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167 |
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7,480 |
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39 |
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329 |
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14,755 |
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85 |
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(49 |
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Results from operating activities |
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65 |
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2,934 |
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15 |
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(133 |
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(5,946 |
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(34 |
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Finance expenses, net (b) |
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1 |
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49 |
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0 |
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1 |
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50 |
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0 |
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(2 |
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Share of profit/(loss) of equity
accounted investees |
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(0 |
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(1 |
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(0 |
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0 |
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2 |
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0 |
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Profit before income tax |
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64 |
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2,884 |
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15 |
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(134 |
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(5,994 |
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(35 |
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Income tax expense |
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(3 |
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(152 |
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(1 |
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17 |
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777 |
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4 |
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Profit for the period |
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61 |
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2,732 |
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14 |
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(116 |
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(5,217 |
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(30 |
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Diluted EPS |
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0.4 |
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16.1 |
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(0.7 |
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(30.9 |
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Notes:
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(a) |
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Includes amortization charge of Rs. 307 million ($7 million) in Q3 FY11 and Rs. 374 million
($8 million) in Q3 FY10. |
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Includes forex gain of Rs. 45 million ($1 million) in Q3 FY11 and forex loss of Rs. 44
million ($1 million) in Q3 FY10. |
SEGMENTAL ANALYSIS
Global Generics
Revenues from Global Generics segment are at Rs. 13.6 billion ($303 million) in Q3 FY11,
year-on-year growth of 16% driven largely by our key market of North America.
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Revenues from North America at Rs. 4.8 billion ($106 million) in Q3 FY11 versus Rs. 3.0
billion ($66 million) in Q3 FY10, represents growth of 60% in rupee terms and 66% in dollar
terms. |
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Q3 FY11 is the fourth consecutive quarter demonstrating strong sequential growth in
the revenues. |
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Growth driven by new products launched in the last one year and market share
expansion in vertically integral products. |
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New launches during the quarter of Lansoprazole, Zafirlukast & Valacyclovir. |
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As of December 31, 2010, total cumulative ANDA filings are 165. Total ANDAs pending
approval at the USFDA are 74 of which 32 are Para IVs and 12 are FTFs. |
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Revenues from Europe at Rs. 2.1 billion ($47 million) in Q3 FY11 versus Rs. 2.6 billion
($58 million) in Q3 FY10, year-on-year decline of 18%. |
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Revenues from Germany at Rs. 1.4 billion ($31 million) in Q3 FY11. The decline of 33%
in rupee terms or 24% in Euro terms is largely due to price erosions caused by the
tenders. |
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Revenues from Rest of Europe grew by 39% to Rs. 744 million ($17 million) in Q3 FY11. |
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Revenues from Russia & Other CIS markets at Rs. 2.9 billion ($64 million) in Q3 FY11
versus Rs. 2.8 billion ($62 million) in Q3 FY10, growth of 4%. |
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Revenues in Russia at Rs. 2.4 billion ($55 million) in Q3 FY11 versus Rs. 2.3 billion
($51 million) in Q3 FY10, year-on-year growth of 7% in rupee terms and 11% in dollar
terms. |
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Growth on the high base of previous year is driven by volume increase across key
brands and new launches in the last twelve months. |
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Dr. Reddys secondary prescription sales growth stands at 21% (volume growth of
33%) versus industrys growth of 8% (volume growth of 12%). (Source: Pharmexpert
April-November 2010) |
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Revenues in Other CIS markets decreased by 11% to Rs. 434 million ($10 million) in Q3
FY11 versus Rs. 488 million ($11 million) in Q3 FY10. |
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Revenues in India at Rs. 3.0 billion ($67 million) in Q3 FY11 versus Rs. 2.6 billion
($59 million) in Q3 FY10, growth of 14%, consisting of volume growth of existing products
of approx 8% and new products contribution (last 12 month launches) of 6%. |
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16 new products launched during the quarter. |
Pharmaceutical Services and Active Ingredients (PSAI)
Revenues from PSAI are at Rs. 5.0 billion ($111 million) in Q3 FY11, year-on-year decline of 5% and
sequential growth of 8%.
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Growth in Active Ingredients business on the back of new launches and an improved order
books status was offset by the decline in the Pharmaceutical Services segment. |
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During the quarter 9 DMFs including 2 US DMFs were filed globally. The cumulative DMF
filings as of Dec 10 are 436 including 159 US DMFs. |
INCOME STATEMENT HIGHLIGHTS:
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Gross profit at Rs. 10.4 billion ($232 million) in Q3 FY11, gross margin of 55% to
revenues versus 51% in Q3 FY10. This improvement in gross margin is largely on account of
contribution in this quarter from new product launches in the US over the last one year. |
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Gross margins for Global Generics and Pharmaceutical Services and Active Ingredients
are at 65% and 28% versus 60% and 31% respectively, in the previous year. |
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Selling, General & Administration (SG&A) expenses including amortization for the
quarter, are at Rs. 6.4 billion ($142 million), increase of 17% over the previous year. |
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A part of the spend in this quarter is on account of one-time litigation costs in US
and higher selling and marketing costs linked to the seasonality in the branded markets
of India and OTC portfolio related spend in Russia. |
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R&D expenses at Rs. 1,306 million ($29 million) in Q3 FY11, increase of 46%. |
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Other Income of Rs. 199 million ($4 million) in Q3 FY11 versus Rs. 171 million ($4 million) in Q3 FY10. |
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Net Finance costs are at Rs. 49 million ($1 million) in Q3 FY11 versus Rs. 50 million ($1 million) in Q3 FY10. |
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Include net forex gain of Rs. 45 million ($1 million) in Q3 FY11 versus net forex
loss of Rs. 44 million ($1 million) in Q3 FY10. |
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EBITDA at Rs. 4.0 billion ($90 million) in Q3 FY11 is at 21% of sales with year-on-year
growth of 10%. |
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Net Profit after Tax for Q3 FY11 is at Rs. 2.7 billion ($61 million) is at 14% of sales
with year-on-year adjusted growth of 19%. |
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Diluted EPS is at Rs. 16.1 ($0.4) in Q3 FY11 versus adjusted Rs. 13.7 in Q3 FY10. |
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Capital expenditure for the quarter is at Rs. 2.3 billion ($52 million). |
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* |
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Note: Adjustment in the previous year represents one-time impairment charge of intangibles &
goodwill of Rs. 8,603 million and associated tax impact. |
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Appendix 1: Key Balance Sheet Items |
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(in millions) |
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As on 31th Dec 10 |
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As on 30th Sep 10 |
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Particulars |
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($) |
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(Rs.) |
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($) |
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(Rs.) |
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Cash and cash equivalents |
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92 |
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4,126 |
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138 |
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6,196 |
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Trade receivables |
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315 |
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14,093 |
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299 |
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13,376 |
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Inventories |
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340 |
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15,244 |
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329 |
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14,728 |
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Property, plant and equipment |
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605 |
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27,102 |
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567 |
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25,412 |
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Goodwill and Other Intangible assets |
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291 |
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13,017 |
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302 |
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13,511 |
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Loans and borrowings (current & non current) |
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308 |
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13,808 |
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324 |
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14,493 |
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Trade payables |
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165 |
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7,395 |
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221 |
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9,907 |
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Equity |
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1,075 |
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48,151 |
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1,010 |
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45,245 |
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Appendix 2: Q3 FY11 Revenue Mix by Segment |
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(in millions) |
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Q3 FY11 |
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Q3 FY10 |
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Particulars |
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($) |
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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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Global Generics |
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303 |
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13,589 |
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72 |
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262 |
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11,723 |
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68 |
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16 |
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North America |
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106 |
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4,765 |
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35 |
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66 |
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2,974 |
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25 |
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60 |
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Europe |
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47 |
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2,123 |
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16 |
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58 |
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2,579 |
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22 |
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(18 |
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India |
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67 |
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3,007 |
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22 |
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59 |
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2,627 |
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22 |
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14 |
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Russia & Other CIS |
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64 |
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2,875 |
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21 |
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62 |
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2,766 |
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24 |
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4 |
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RoW |
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18 |
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819 |
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6 |
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17 |
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778 |
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7 |
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5 |
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PSAI |
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111 |
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4,979 |
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26 |
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117 |
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5,237 |
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30 |
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(5 |
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North America |
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17 |
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770 |
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15 |
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16 |
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723 |
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14 |
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7 |
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Europe |
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41 |
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1,830 |
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37 |
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|
48 |
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2,161 |
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|
41 |
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(15 |
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India |
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|
14 |
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622 |
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|
12 |
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|
13 |
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|
602 |
|
|
|
12 |
|
|
|
3 |
|
RoW |
|
|
39 |
|
|
|
1,758 |
|
|
|
35 |
|
|
|
39 |
|
|
|
1,751 |
|
|
|
33 |
|
|
|
0 |
|
Proprietary Products |
|
|
9 |
|
|
|
417 |
|
|
|
2 |
|
|
|
7 |
|
|
|
336 |
|
|
|
2 |
|
|
|
24 |
|
Total |
|
|
424 |
|
|
|
18,985 |
|
|
|
100 |
|
|
|
386 |
|
|
|
17,296 |
|
|
|
100 |
|
|
|
10 |
|
7
|
|
|
Appendix 3: Q3 FY11 Revenue Mix by Geography |
|
(in millions) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Q3 FY11 |
|
|
Q3 FY10 |
|
|
|
|
Particulars |
|
($) |
|
|
(Rs.) |
|
|
% |
|
|
($) |
|
|
(Rs.) |
|
|
% |
|
|
Growth % |
|
North America |
|
|
130 |
|
|
|
5,823 |
|
|
|
31 |
|
|
|
88 |
|
|
|
3,933 |
|
|
|
23 |
|
|
|
48 |
|
Europe |
|
|
91 |
|
|
|
4,078 |
|
|
|
21 |
|
|
|
108 |
|
|
|
4,836 |
|
|
|
28 |
|
|
|
(16 |
) |
India |
|
|
81 |
|
|
|
3,632 |
|
|
|
19 |
|
|
|
72 |
|
|
|
3,232 |
|
|
|
19 |
|
|
|
12 |
|
Russia & Other CIS |
|
|
64 |
|
|
|
2,875 |
|
|
|
15 |
|
|
|
62 |
|
|
|
2,766 |
|
|
|
16 |
|
|
|
4 |
|
Others |
|
|
58 |
|
|
|
2,577 |
|
|
|
14 |
|
|
|
56 |
|
|
|
2,529 |
|
|
|
15 |
|
|
|
2 |
|
Total |
|
|
424 |
|
|
|
18,985 |
|
|
|
100 |
|
|
|
386 |
|
|
|
17,296 |
|
|
|
100 |
|
|
|
10 |
|
About Dr. Reddys
Established in 1984, Dr. Reddys Laboratories (NYSE: RDY) is a global pharmaceutical company. We
fulfill our purpose of providing affordable and innovative medicines through three core
businesses: Pharmaceutical Services & Active Ingredients, Global Generics and Proprietary
Products.
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:
Rajan S at rajans@drreddys.com or on +91-40- 66511725
8
|
|
|
Press Release
|
|
|
|
|
Dr. Reddys Laboratories Ltd.
|
|
|
7-1-27 Ameerpet
|
|
|
Hyderabad 500 016 India
|
|
|
Tel: 91 40 373 1946
|
|
|
Fax: 91 40 373 1955
|
|
|
www.drreddys.com |
Dr. Reddys provides update on the fexofenadine-pseudoephedrine 24 hour litigation
January 31, 2011, Hyderabad, India: Dr. Reddys Laboratories (NYSE: RDY) announced today that on
Friday, 28 January 2011, the U.S. District Court of New Jersey filed a Stipulation and Order
lifting an earlier motion for preliminary injunction and clearing the sale of Dr. Reddys generic
product version of Allegra® D24 (fexofenadine hydrochloride / pseudoephedrine hydrochloride 180mg /
240mg extended release tablet), which was approved by the FDA on March 16, 2010.
In addition, plaintiffs sanofi-aventis and Albany Molecular Research have been required to post a
security with the Court, an amount of USD 40 mn towards the possibility that the injunction had
been wrongfully granted. Having been excluded from launching the generic product since the June
2010 hearing, Dr. Reddys intends to pursue an award of this security.
®Allegra D24 is a registered trademark of sanofi-aventis.
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
Dr. Reddys Laboratories Ltd. (NYSE: RDY) is an integrated global pharmaceutical company, committed
to providing affordable and innovative medicines for healthier lives. Through its three businesses
- Pharmaceutical Services and Active Ingredients, Global Generics and Proprietary Products Dr.
Reddys offers a portfolio of products and services including APIs, custom pharmaceutical services,
generics, biosimilars, differentiated formulations and NCEs. Therapeutic focus is on
gastro-intestinal, cardiovascular, diabetology, oncology, pain management, anti-infective and
pediatrics. Major markets include India, USA, Russia and CIS, Germany, UK, Venezuela, S. Africa,
Romania, and New Zealand. For more information, log on to: www.drreddys.com
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 (USA) at mkalawadia@drreddys.com or on +1-908-203-4931
Media:
S Rajan at rajans@drreddys.com or on +91-40-66511725
9
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.
|
|
|
|
|
|
DR. REDDYS LABORATORIES LIMITED
(Registrant)
|
|
|
By: |
/s/ Sandeep Poddar
|
|
Date: February 1, 2011 |
|
Name: |
Sandeep Poddar |
|
|
|
Title: |
Company Secretary |
|
10